Solution for hemofiltration Hbiofluids

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 1.75 mmol/l, Potassium 2 mmol/l, Bicarbonate 36 mmol/l
Bag 500 + 5000 ml
A.I.C. 031533096
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-electrolyte balance
(electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed
through purification (dialyzable substances).

2. What you should know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please consult your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered exclusively by healthcare professionals.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal hemorrhage
• Bleeding of a blood vessel within the skull (Intracranial hemorrhage)
• Organ injuries outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) blood sodium concentration
• Low (Hypokalemia) and high (Hyperkalemia) blood potassium concentration
• High blood calcium concentration (Hypercalcemia)
• High blood magnesium concentration (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Blood clot formation within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
The bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 294 mOsm/l

• Other components: water for injections and acetic acid 80%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this leaflet refers.
Description of Soluzione per Emofiltrazione HBiofluids and contents of the pack
Soluzione per Emofiltrazione HBiofluids is supplied in a two-compartment bag. The smaller
compartment (500 ml) contains the acidic solution, while the larger compartment contains the
basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of any losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution should be exercised when using this solution in conditions associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by appropriate pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C prior to use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless, or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single, uninterrupted use and any residual solution must not be reused.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with Soluzione per Emofiltrazione HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
The addition of medications to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PATIENT LEAFLET: INFORMATION FOR THE PATIENT

Solution for Hemofiltration HBiofluids

Glucose 1 g/l, Calcium 1.75 mmol/l, Potassium 2 mmol/l, Bicarbonate 32 mmol/l
Bag 500 + 5000 ml
A.I.C. 031533108
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used in the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you should know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before you are administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered to you exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, method of administration, and technique used will be determined by the physician on a case-by-case basis according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) sodium levels in blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium levels in blood
• High calcium levels in blood (Hypercalcaemia)
• High magnesium levels in blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at website www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be kept protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the package and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances per 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 294 mOsm/l

• Other components: water for injections and acetic acid 80%. For the qualitative and quantitative composition in grams per litre of the specific formulation, refer to the label of the bag to which this package leaflet refers.

Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a two-compartment bag. The smaller compartment (500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution should be exercised when using this solution in conditions associated with a high risk of bleeding (e.g., head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from traction, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Heating should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate container or compartment and mixed with the electrolyte solution at the time of use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, warm and thoroughly mix the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single and uninterrupted use only, and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or slightly straw-yellow, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution at the time of use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container. The solution must be clear, colourless or slightly straw-yellow, and free from visible particles. It is intended for single and uninterrupted use only, and any residual solution must not be reused.

After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 1.5 mmol/l, Potassium 2 mmol/l, Lactate 32 mmol/l
2000 ml bag
A.I.C. 031533110
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used in the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you should know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered to you exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you may receive Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician on a case-by-case basis according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you are given more HBiofluids Hemofiltration Solution than you should receive
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal hemorrhage
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Organ injuries outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium levels in blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium levels in blood
• High calcium levels in blood (Hypercalcemia)
• High magnesium levels in blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Blood clot formation within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date applies to the product stored in its original, undamaged packaging and kept under the recommended storage conditions.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 4.5-6.5
Theoretical osmolarity: 296 mOsm/l

• The other component is water for injections.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is presented as a solution contained in a plastic bag.
The bag contains 2000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids,
congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be required.
Caution must be exercised when using the solution in circumstances associated with a high risk of bleeding (e.g.
head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit in pre- or post-dilution mode, using lines controlled by
appropriate pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to traction, the solution may be warmed to 37°C prior to use, inside the sealed protective bag.
Heating should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
Check the correct dilution before use. Measure accurately the volume to be withdrawn.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution must be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or slightly yellowish, or if it contains particles.
All standard precautions should be followed to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to prevent the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Glucose 1 g/l, Calcium 1.75 mmol/l, Potassium 2 mmol/l, Bicarbonate 32 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533134
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water and electrolyte balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you need to know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory insufficiency),
• if you have abnormal levels of cholesterol and triglycerides in the blood (lipid metabolism disorders),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before you are administered HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare personnel.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions on use, see the section “The following information is intended exclusively for physicians or healthcare professionals.”

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Low blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) sodium concentration in blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcaemia)
• High magnesium concentration in blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Blood clot formation within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the package and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 294 mOsm/l

• Other components: water for injections and 80% acetic acid.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a two-compartment bag. The smaller compartment (500 ml)
contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution should be exercised when using this solution in conditions associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre- or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from cold temperature, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must be performed immediately before use.
Ensure correct dilution before administration. Measure the volume to be withdrawn accurately.
Method and time of administration
Dosage
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to avoid microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, warm and thoroughly mix the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single and uninterrupted use only, and any remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution at the time of use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments are mixed;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single and uninterrupted use only, and any remaining solution must not be reused.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to prevent the risk of cardiac arrest.
Addition of medicinal products to the solution may be performed only upon medical prescription and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Glucose 1 g/l, Calcium 1.5 mmol/l, Potassium 2.5 mmol/l, Bicarbonate 32 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533146
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered exclusively by healthcare professionals.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you may use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on an assessment of the risk/benefit ratio according to your condition.

Driving and using machines
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician on a case-by-case basis according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal haemorrhage
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Fluid and electrolyte disorders

• Low (Hyponatraemia) and high (Hypernatraemia) blood sodium concentrations
• Low (Hypokalaemia) and high (Hyperkalaemia) blood potassium concentrations
• High blood calcium concentration (Hypercalcaemia)
• High blood magnesium concentration (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Blood clot formation within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor.
You may also report side effects directly through the national reporting system at the website: www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be kept protected from direct light, in a dry and clean place.
Once the container has been opened, the medicine must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in its original, undamaged packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 297 mOsm/l

• Other components: water for injections and hydrochloric acid 37%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, please refer to
the label of the bag to which this package leaflet refers.
Description of Soluzione per Emofiltrazione HBiofluids and contents of the pack
Soluzione per Emofiltrazione HBiofluids is supplied in a two-compartment bag. The smaller compartment
(500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two
solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be closely monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive
heart failure, or shock.
Replacement of any losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using this solution in conditions associated with a high risk of bleeding (e.g.
head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines
controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from traction, the solution may be warmed to 37°C before use, while still in its sealed
protective bag. Heating should be performed using dry heat; ideally, a specifically designed heating plate
should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution
containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined by the physician according to individual
patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium
and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate
container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires a connecting set between the bag and the patient's catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for
use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any
remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or
slightly yellowish, or if it contains particles.
All standard precautions to maintain sterility before and during use must be observed.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with
the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for
single, uninterrupted use, and any remaining solution must not be reused.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with Soluzione per Emofiltrazione HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the
risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon medical instruction and must be carefully
evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or
(in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Glucose 1 g/l, Calcium 1.5 mmol/l, Potassium 3.5 mmol/l, Bicarbonate 34 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533159
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be purified (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory insufficiency),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please speak with your doctor or nurse before you are administered Hemofiltration Solution HBiofluids. Hemofiltration Solution HBiofluids will be administered exclusively by healthcare professionals.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician on a case-by-case basis according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you are given more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) increased blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Bleeding from a blood vessel within the brain (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) blood sodium levels
• Low (Hypokalaemia) and high (Hyperkalaemia) blood potassium levels
• High blood calcium levels (Hypercalcaemia)
• High blood magnesium levels (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Blood clot formation within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be kept protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the package and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances per 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 295 mOsm/l

• Other components are water for injections and hydrochloric acid 37%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a dual-compartment bag. The smaller compartment (500 ml)
contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration can lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution should be exercised when using the solution in situations associated with a high risk of bleeding (e.g. cranial trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C prior to use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the one containing the other components (acidic solution). Mixing must occur immediately before use.
Check correct dilution before use. Measure accurately the volume to be withdrawn.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate container or compartment and mixed with the electrolyte solution immediately before use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or slightly yellowish, or if it contains particles.
Take all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of your hand so that the membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container. The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single, uninterrupted use and any residual solution must not be reused.

After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon medical instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 1.5 mmol/l, Potassium 4 mmol/l, Bicarbonate 36 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533161
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-electrolyte balance
(electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you should know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered to you exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and operating machinery
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions on use, see the section "The following information is intended exclusively for physicians or healthcare professionals".
If you are given more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding (Gastrointestinal haemorrhage)
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) sodium concentration in blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcaemia)
• High magnesium concentration in blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Blood clot formation within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor.
You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste. Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in its original, undamaged packaging, stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 301 mOsm/l

• Other components: water for injections and hydrochloric acid 37%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a two-compartment bag. The smaller compartment (500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure or shock.
Replacement of potential losses of proteins, amino acids and water-soluble vitamins may be necessary.
Caution should be exercised when using this solution in conditions associated with a high risk of bleeding (e.g. head trauma, recent surgical procedures, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to traction, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid connector contamination, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure accurately the volume to be withdrawn.
Method and timing of administration
Dosing
Dosage, route of administration and technique are determined by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate container or compartment and mixed with the electrolyte solution immediately before use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires a connection set between the bag and the patient's catheter.
Before use, warm and thoroughly mix the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any unused portion must not be retained.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or slightly yellowish, or if it contains particles.
Take all usual precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overbag and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish and free from visible particles. It is intended for single, uninterrupted use and any unused portion must not be retained.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Calcium 2 mmol/l, Potassium 1.5 mmol/l, Bicarbonate 30 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533173
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered to you exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you are given more HBiofluids Hemofiltration Solution than you should receive
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), alterations in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The possible adverse reactions are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal hemorrhage
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in the blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in the blood
• High calcium concentration in the blood (Hypercalcemia)
• High magnesium concentration in the blood (Hypermagnesemia)

Systemic disorders and conditions related to the administration site

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor. You may also report adverse reactions directly via the national reporting system at website www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicine must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 291 mOsm/l

• Other components: water for injections and acetic acid 80%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a two-compartment bag. The smaller compartment (500 ml)
contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using this solution in situations associated with a high risk of bleeding (e.g., cranial trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre- or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold temperature, the solution may be warmed to 37°C prior to use, while still in its sealed protective bag. Heating should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the one containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium concentration in the solution depends on the patient's serum potassium levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any unused portion must not be retained.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless, or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overbag and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single, uninterrupted use, and any unused portion must not be retained.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 2 mmol/l, Bicarbonate 30 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533185
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be purified (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before you are administered HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare personnel.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician on a case-by-case basis according to individual needs.
For instructions for use, see the section “The following information is intended exclusively for physicians or healthcare professionals”.

If you are given more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Fluid and electrolyte disorders

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in the blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in the blood
• High calcium concentration in the blood (Hypercalcemia)
• High magnesium concentration in the blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at the website: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be kept protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 294 mOsm/l

• Other components are: water for injections and 80% acetic acid.

For the qualitative and quantitative composition of the specific formulation in grams/litre, please refer to
the label of the bag to which this package leaflet refers.
Description of Soluzione per Emofiltrazione HBiofluids and contents of the pack
Soluzione per Emofiltrazione HBiofluids is supplied in a two-compartment bag. The smaller compartment
(500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after rupture of the internal membrane and mixing the two
solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorisation Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids,
congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution should be exercised when using this solution in circumstances associated with a high risk of
bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines
controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C before use, while still in its sealed
protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate
should be used.
To avoid contamination of the connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution
containing the other components (acidic solution). Mixing must occur immediately before use.
Check correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined by the physician according to individual
patient needs.
The choice of glucose concentration in the solution depends on the patient's blood glucose level.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a
separate container or compartment and mixed with the electrolyte solution at the time of use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's
catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for
use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any
remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or
slightly yellowish, or if it contains particles.
Take all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with
the electrolyte solution at the time of use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for
single, uninterrupted use and any remaining solution must not be reused.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with Soluzione per Emofiltrazione HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the
risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully
evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in
diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 2 mmol/l, Potassium 4 mmol/l, Bicarbonate 35 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533197
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-electrolyte balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before Hemofiltration Solution HBiofluids is administered to you.
Hemofiltration Solution HBiofluids will be administered exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on an assessment of the risk-benefit ratio according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions on use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below by the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decrease in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) sodium concentration in blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcaemia)
• High magnesium concentration in blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicine must be used immediately. Unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 302 mOsm/L

• Other components: water for injections and 80% acetic acid.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a two-compartment bag. The smaller compartment (500 mL)
contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution should be exercised when using the solution in conditions associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from cold, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Check proper dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
The dosage, route of administration, and technique used are determined by the physician on a case-by-case basis according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, warm and thoroughly mix the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use only, and any unused portion must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless, or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overbag and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to ensure homogeneous mixing of the solution;
4. Use immediately after opening the container. The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single, uninterrupted use only, and any unused portion must not be reused.

After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Serum potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of medications to the solution may be performed only upon medical instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 2 mmol/l, Potassium 1.5 mmol/l, Bicarbonate 30 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533209
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• if you have severe breathing difficulties (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please consult your doctor or nurse before receiving HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare professionals.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy or breastfeeding, after evaluating the risk/benefit ratio based on your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician,
according to individual needs.
For instructions on use, see the section “The following information is intended exclusively for physicians
or healthcare professionals.”

If you are given more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be administered more infusion solution than required, as your doctor
or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced
blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic
patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal hemorrhage
• Bleeding within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcemia)
• High magnesium concentration in blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date applies to the product kept unopened and stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 297 mOsm/l

• Other components: water for injections and 80% acetic acid.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of Soluzione per Emofiltrazione HBiofluids and contents of the pack
Soluzione per Emofiltrazione HBiofluids is supplied in a two-compartment bag. The smaller compartment (500 ml)
contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorisation Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using this solution in circumstances associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold temperature, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid connector contamination, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the one containing the other components (acidic solution). Mixing must be performed immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
The dosage, route of administration, and technique used are determined by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution at the time of use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Soluzioni per Emofiltrazione requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution must be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single and uninterrupted use, and any unused portion must not be retained.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless, or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution at the time of use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the membrane opens and the contents of both compartments are mixed;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless, or slightly yellowish, and free from visible particles. It is intended for single and uninterrupted use, and any unused portion must not be retained.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with Soluzione per Emofiltrazione HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to prevent the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Glucose 1 g/l, Calcium 2 mmol/l, Potassium 1.5 mmol/l, Bicarbonate 35 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533211
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-electrolyte balance
(electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed
through purification (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please consult your doctor or nurse before receiving HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, please seek advice from your doctor or nurse before using this medicine. There are no clinical data available on the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and operating machinery
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined on a case-by-case basis by the physician according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals".
If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergies (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal haemorrhage
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in the blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in the blood
• High calcium concentration in the blood (Hypercalcemia)
• High magnesium concentration in the blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at website: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be kept protected from direct light, in a dry and clean place.
Once the container has been opened, the medicine must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in its original, undamaged packaging, stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 297 mOsm/l

• Other components: water for injections and acetic acid 80%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is supplied in a dual-compartment bag. The smaller compartment (500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using the solution in circumstances associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by appropriate pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from cold temperature, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosage
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or slightly straw-yellow, or if it contains particles.
All standard precautions should be taken to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overbag and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments mix;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly straw-yellow, and free from visible particles. It is intended for single, uninterrupted use, and any remaining solution must not be reused.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may only be performed upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Calcium 1.75 mmol/l, Bicarbonate 32 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533223
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What HBiofluids Hemofiltration Solution is and what it is used for
2. What you need to know before using HBiofluids Hemofiltration Solution
3. How to use HBiofluids Hemofiltration Solution
4. Possible side effects
5. How to store HBiofluids Hemofiltration Solution
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Consult your doctor or nurse before being administered HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare personnel.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can receive HBiofluids Hemofiltration Solution during pregnancy or breastfeeding, after evaluating the risk/benefit ratio based on your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Bleeding from a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) concentration of sodium in the blood
• Low (Hypokalaemia) and high (Hyperkalaemia) concentration of potassium in the blood
• High concentration of calcium in the blood (Hypercalcaemia)
• High concentration of magnesium in the blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 287 mOsm/l

• Other components: water for injections and lactic acid 90%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this package leaflet refers.
Description of the appearance of Hemofiltration Solution HBiofluids and contents of the pack
Hemofiltration Solution HBiofluids is supplied in a two-compartment bag. The smaller compartment (500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure or shock.
Replacement of potential losses of proteins, amino acids and water-soluble vitamins may be necessary.
Caution is required when using the solution in conditions associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre- or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C before use, inside the sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
The dosage, route of administration and technique used are determined by the physician according to individual patient needs.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution must be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or slightly yellowish, or if it contains particles.
Take all usual precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overwrap and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments are mixed;
3. With both hands, alternately press the two compartments to homogenize the solution;
4. Use immediately after opening the container. The solution must be clear, colourless or slightly yellowish and free from visible particles. It is intended for single, uninterrupted use and any remaining solution must not be reused.

After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with Hemofiltration Solution HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon medical instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Glucose 1 g/l, Calcium 1.75 mmol/l, Bicarbonate 32 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533235
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalances), and in the treatment of poisonings caused by substances that can be removed by purification (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing difficulty (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please speak with your doctor or nurse before being administered HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare professionals.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, please consult your doctor or nurse before using this medicine. Clinical data regarding the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding are not available, nor are animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you are given more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding (Gastrointestinal haemorrhage)
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) sodium levels in the blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium levels in the blood
• High calcium levels in the blood (Hypercalcaemia)
• High magnesium levels in the blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 290 mOsm/l

• Other components: water for injections and acetic acid 80%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this patient information leaflet refers.

Description of the appearance of Hemofiltration Solution HBiofluids and contents of the pack
Hemofiltration Solution HBiofluids is supplied in a two-compartment bag. The smaller compartment (500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.

Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:

Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using this solution in circumstances associated with a high risk of bleeding (e.g. head trauma, recent surgical procedures, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from cold temperature, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Verify correct dilution before use. Measure accurately the volume to be withdrawn.

Method and time of administration
Dosage
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
The choice of glucose concentration in the solution depends on the patient's blood glucose level.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution at the time of use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.

Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution must be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or slightly yellowish, or if it contains particles.
All standard precautions should be followed to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution at the time of use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overbag and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments are mixed;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container. The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single, uninterrupted use, and any remaining solution must not be reused.

After mixing, check that the solution is clear and free from precipitates.

Interactions
No interaction studies have been conducted with Hemofiltration Solution HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon medical instruction and must be carefully evaluated.

Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 1.75 mmol/l, Potassium 4 mmol/l, Bicarbonate 32 mmol/l
Bag 500 + 4500 ml
A.I.C. 031533247
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-electrolyte balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare personnel.
Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
Clinical data on the use of HBiofluids Hemofiltration Solution during pregnancy and breastfeeding are not available, nor are animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy or breastfeeding, after evaluating the risk/benefit ratio based on your condition.
Driving and using machines
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Low blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) blood sodium concentration
• Low (Hypokalaemia) and high (Hyperkalaemia) blood potassium concentration
• High blood calcium concentration (Hypercalcaemia)
• High blood magnesium concentration (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly through the national reporting system at website www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
The bags must be kept protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Do not use this medicinal product after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the product kept in its original, undamaged packaging and properly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0-8.5
Theoretical osmolarity: 298 mOsm/l

• Other components: water for injections and acetic acid 80%.

For the qualitative and quantitative composition of the specific formulation in grams/litre, please refer to the label of the bag to which this package leaflet refers.
Description of the appearance of Hemofiltration Solution HBiofluids and contents of the pack
Hemofiltration Solution HBiofluids is supplied in a two-compartment bag. The smaller compartment (500 ml) contains the acidic solution, while the larger compartment contains the basic solution.
The final reconstituted solution is obtained after breaking the internal membrane and mixing the two solutions.
The bag is enclosed in a protective overwrap.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using this solution in circumstances associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold temperature, the solution may be warmed to 37°C prior to use, while still inside the sealed protective bag. Heating should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
The final solution must be prepared by mixing the solution containing sodium bicarbonate with the solution containing the other components (acidic solution). Mixing must occur immediately before use.
Ensure correct dilution before use. Measure the volume to be withdrawn accurately.
Method and time of administration
Dosing
Dosage, route of administration, and technique are determined by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be kept in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of Hemofiltration Solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, warm and thoroughly mix the solution to body temperature (see Instructions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any unused portion must not be retained.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
The sodium bicarbonate solution contained in the larger compartment of the same bag must be mixed with the electrolyte solution immediately before use.
Before use, the two compartments must be connected to allow mixing of the two solutions, as follows:

1. Remove the overbag and check for leaks;
2. Place the bag on a flat surface and press the larger compartment with the palm of the hand so that the internal membrane opens and the contents of both compartments are mixed;
3. Alternately press both compartments with both hands to homogenize the solution;
4. Use immediately after opening the container.

The solution must be clear, colourless or slightly yellowish, and free from visible particles. It is intended for single, uninterrupted use, and any unused portion must not be retained.
After mixing, check that the solution is clear and free from precipitates.
Interactions
No interaction studies have been conducted with Hemofiltration Solution HBiofluids.
Serum potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of medications to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Bicarbonate 145 mmol/l
Bag 5000 ml
A.I.C. 031533250
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances of water-electrolyte balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please speak to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, please consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a benefit-risk assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, side effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions for use, see the section “The following information is intended exclusively for physicians or healthcare professionals.”

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), changes in blood electrolyte levels (electrolyte disturbances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergies (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decrease in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal hemorrhage
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in the blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in the blood
• High calcium concentration in the blood (Hypercalcemia)
• High magnesium concentration in the blood (Hypermagnesemia)

General disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store HBiofluids Hemofiltration Solution

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
The bags must be stored protected from direct light, in a dry and clean place.
Once removed from the outer packaging, the medicine must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 7.0 – 8.5
Theoretical osmolarity: 290 mOsm/l

• The other component is water for injections. For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this package leaflet refers.

Description of the appearance of Hemofiltration Solution HBiofluids and contents of the pack
Hemofiltration Solution HBiofluids is a solution contained in a plastic bag.
The bag contains 5000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using the solution in circumstances associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre- or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from traction, the solution may be warmed to 37°C before use, while still in its sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid connector contamination, the bag must not be warmed by immersion in water.
Verify the correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration, and technique are determined case by case by the physician according to individual patient needs.
When the final formulation includes bicarbonate, sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution at the time of use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, warm and thoroughly shake the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colorless or slightly yellowish, or if it contains particles.
All standard precautions should be followed to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with Hemofiltration Solution HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
The addition of medications to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 1 mmol/l, Potassium 1 mmol/l, Lactate 45 mmol/l
5000 ml bag
A.I.C. 031533262
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water and electrolyte balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory insufficiency),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician on a case-by-case basis according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals."

If you are given more HBiofluids Hemofiltration Solution than you should receive
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) elevated blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects listed below are categorized according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decrease in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in the blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in the blood
• High calcium concentration in the blood (Hypercalcemia)
• High magnesium concentration in the blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
The bags must be stored protected from direct light, in a dry and clean place.
Once the container is opened, the medicine must be used immediately. Unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the product in its original, undamaged packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 4.5 – 6.5
Theoretical osmolarity: 293 mOsm/l

• The other component is water for injections.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of Hemofiltration Solution HBiofluids and contents of the pack
Hemofiltration Solution HBiofluids is a solution presented in a plastic bag.
The bag contains 5000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids,
congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be required.
Caution must be exercised when using the solution in circumstances associated with a high risk of bleeding (e.g.
head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by
appropriate pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C prior to use, while still in its sealed protective bag.
Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be warmed by immersion in water.
Verify the correct dilution before use. Measure the volume to be withdrawn accurately.
Method and time of administration
Dosing
The dosage, route of administration, and technique used are determined on a case-by-case basis by the
physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and glucose levels.
When the final formulation includes bicarbonate, the sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution must be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use only, and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear and colourless or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with Hemofiltration Solution HBiofluids.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to prevent the risk of cardiac arrest.
The addition of medications to the solution may be performed only upon medical indication and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PATIENT LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Calcium 1 mmol/l, Potassium 1 mmol/l, Lactate 45 mmol/l
5000 ml bag
A.I.C. 031533274
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
  Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water-salt balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory insufficiency),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered to you exclusively by healthcare professionals.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine. There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined by the physician on a case-by-case basis, according to individual needs.
For instructions for use, see the section "The following information is intended exclusively for physicians or healthcare professionals".

If you are given more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decrease in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal bleeding
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Fluid and electrolyte imbalance disorders

• Low (Hyponatremia) and high (Hypernatremia) concentration of sodium in the blood
• Low (Hypokalemia) and high (Hyperkalemia) concentration of potassium in the blood
• High concentration of calcium in the blood (Hypercalcemia)
• High concentration of magnesium in the blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the product kept in intact packaging and stored correctly.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 5.0 – 7.5
Theoretical osmolarity: 287 mOsm/l

• The other component is water for injections.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is a solution contained in a plastic bag.
The bag contains 5000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using this solution in circumstances associated with a high risk of bleeding (e.g., head trauma, recent surgery, etc.).
The solution must be infused into the extracorporeal circuit either pre-dilution or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C prior to use, while still in its sealed protective bag.
Heating must be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
Verify the correct dilution before use. Measure accurately the volume to be withdrawn.
Method and timing of administration
Dosing
The dosage, route of administration, and technique used are determined by the physician according to individual patient needs.
The choice of potassium concentration in the solution depends on the patient's serum potassium levels.
When the final formulation includes bicarbonate, sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution at the time of use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connection set between the bag and the patient's catheter.
Before use, warm and thoroughly shake the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any residual solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colorless, or slightly straw-yellow, or if it contains particles.
All standard precautions must be followed to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
The addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.

PATIENT INFORMATION LEAFLET

Hemofiltration Solution HBiofluids

Glucose 1 g/l, Calcium 1.5 mmol/l, Potassium 2 mmol/l, Lactate 42 mmol/l
Bag 5000 ml
A.I.C. 031533286
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water-electrolyte balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory insufficiency),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before being administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy or breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare professionals.
The dose, route of administration, and technique used will be determined by the physician according to individual needs.
For instructions on use, see the section “The following information is intended exclusively for physicians or healthcare professionals.”

If you are given more HBiofluids Hemofiltration Solution than you should receive
It is highly unlikely that you will be administered more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), decreased blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) high blood glucose levels (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, classified according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Reduction in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal hemorrhage
• Rupture of a blood vessel within the skull (Intracranial hemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal hemorrhage)
• Bleeding inside the eye (Intraocular hemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatremia) and high (Hypernatremia) sodium concentration in blood
• Low (Hypokalemia) and high (Hyperkalemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcemia)
• High magnesium concentration in blood (Hypermagnesemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date applies to the product when unopened and properly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 4.5 – 6.5
Theoretical osmolarity: 296 mOsm/l

• The other component is water for injections.

For the qualitative and quantitative composition of the specific formulation in grams/litre, please refer to
the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is a solution contained in a plastic bag.
The bag contains 5000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids,
congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be necessary.
Caution must be exercised when using the solution in circumstances associated with a high risk of bleeding (e.g.
head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit in pre- or post-dilution mode, using lines controlled by
dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from traction, the solution may be warmed to 37°C before use, while still in the sealed protective bag.
Heating should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
Verify the correct dilution before use. Measure the volume to be withdrawn accurately.
Method and duration of administration
Dosing
Dosage, administration method, and technique are determined by the physician on a case-by-case basis according to individual needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and glucose levels.
When the final formulation includes bicarbonate, sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution must be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use, and any remaining residue must not be used.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless, or slightly yellowish, or if it contains particles.
All standard precautions must be followed to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
The addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Hemofiltration Solution HBiofluids

Calcium 1.5 mmol/l, Potassium 1.5 mmol/l, Lactate 40 mmol/l
5000 ml bag
A.I.C. 031533298
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Package contents and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems
(acute renal failure), excessive fluid retention (fluid overload), disturbances in water and electrolyte balance (electrolyte imbalance), and in the treatment of intoxications caused by substances that can be removed through purification (dialyzable substances).

2. What you need to know before using Hemofiltration Solution HBiofluids

Do not use Hemofiltration Solution HBiofluids

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Talk to your doctor or nurse before you are administered Hemofiltration Solution HBiofluids.
Hemofiltration Solution HBiofluids will be administered to you exclusively by healthcare personnel.

Other medicines and Hemofiltration Solution HBiofluids
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
There are no clinical data available on the use of Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, nor are there animal studies available. Your doctor will decide whether you can use Hemofiltration Solution HBiofluids during pregnancy and breastfeeding, based on a risk/benefit assessment according to your individual condition.

Driving and using machines
If you are undergoing hemofiltration therapy, adverse effects may occur that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, route of administration, and technique used will be determined each time by the physician according to individual needs.
For instructions on use, see the section "The following information is intended exclusively for physicians or healthcare professionals".

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) increased blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching (Pruritus)

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decrease in blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal haemorrhage
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heartbeat (Arrhythmias)

Disorders of fluid and electrolyte balance

• Low (Hyponatraemia) and high (Hypernatraemia) sodium concentration in blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcaemia)
• High magnesium concentration in blood (Hypermagnesaemia)

Systemic disorders and conditions related to the administration site

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Any unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 5.0 – 7.5
Theoretical osmolarity: 290 mOsm/l

• The other component is water for injections. For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this package leaflet refers.

Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is a solution contained in a plastic bag.
The bag contains 5000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
This solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure or shock.
Replacement of any losses of proteins, amino acids and water-soluble vitamins may be required.
Caution must be exercised when using the solution in circumstances associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit either pre- or post-dilution, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort due to cold, the solution may be warmed to 37°C prior to use, while still in its sealed protective bag. Heating should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid contamination of connectors, the bag must not be heated by immersion in water.
Verify correct dilution before use. Measure the volume to be withdrawn accurately.
Method and timing of administration
Dosing
Dosage, route of administration and technique are determined by the physician on a case-by-case basis according to individual patient needs.
The choice of potassium concentration in the solution depends on the patient's serum potassium levels.
When the final formulation includes bicarbonate, sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution immediately before use.
All necessary precautions must be taken during these procedures to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, the solution should be warmed and thoroughly mixed to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or slightly straw-yellow, or if it contains particles.
Take all usual precautions to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of medicinal products to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances or (in diabetic patients) hyperglycemia.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

HBiofluids Hemofiltration Solution

Glucose 1 g/l, Calcium 1.5 mmol/l, Potassium 2 mmol/l, Lactate 32 mmol/l
5000 ml bag
A.I.C. 031533300
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for
2. What you need to know before using Soluzione per Emofiltrazione HBiofluids
3. How to use Soluzione per Emofiltrazione HBiofluids
4. Possible side effects
5. How to store Soluzione per Emofiltrazione HBiofluids
6. Contents of the pack and other information

1. What Soluzione per Emofiltrazione HBiofluids is and what it is used for

Soluzione per Emofiltrazione HBiofluids is used for the treatment of patients with severe kidney problems (acute renal failure), excessive fluid retention (fluid overload), disturbances in water and electrolyte balance (electrolyte imbalances), and in the treatment of intoxications caused by substances that can be removed by purification (dialyzable substances).

2. What you should know before using HBiofluids Hemofiltration Solution

Do not use HBiofluids Hemofiltration Solution

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing fatigue (severe respiratory failure),
• if you have abnormal levels of cholesterol and triglycerides in the blood (disorders of lipid metabolism),
• if you are malnourished.

Warnings and precautions
Please speak with your doctor or nurse before receiving HBiofluids Hemofiltration Solution.
HBiofluids Hemofiltration Solution will be administered exclusively by healthcare personnel.

Other medicines and HBiofluids Hemofiltration Solution
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.
Clinical data on treatment with HBiofluids Hemofiltration Solution during pregnancy and breastfeeding are not available, nor are animal studies available. Your doctor will decide whether you can use HBiofluids Hemofiltration Solution during pregnancy or breastfeeding, based on a risk/benefit assessment according to your condition.

Driving and operating machinery
If you are undergoing hemofiltration therapy, you may experience adverse effects that could impair your ability to drive or operate machinery.

3. How to use HBiofluids Hemofiltration Solution

HBiofluids Hemofiltration Solution will be administered to you exclusively by healthcare personnel.
The dose, method of administration, and technique used will be determined by the physician according to individual needs.
For instructions for use, see the section “The following information is intended exclusively for physicians or healthcare professionals”.

If you receive more HBiofluids Hemofiltration Solution than you should
It is highly unlikely that you will be given more infusion solution than required, as your doctor or nurse will monitor you during treatment.
In case of overdose, you may experience, among other effects, increased blood volume (hypervolemia), reduced blood volume (hypovolemia), disturbances in blood electrolyte levels (electrolyte imbalances), or (in diabetic patients) increased blood glucose concentration (hyperglycemia).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below according to the following frequency:
Not known (frequency cannot be estimated from the available data):
Immune system disorders

• Allergic reactions (Hypersensitivity reactions)
• Itching

Gastrointestinal disorders

• Nausea
• Vomiting
• Abdominal cramps

Vascular disorders

• Decreased blood pressure (Hypotension)
• Blockage of veins and/or arteries due to air bubbles (Gas embolism)
• Gastrointestinal haemorrhage
• Rupture of a blood vessel within the skull (Intracranial haemorrhage)
• Bleeding in organs outside the peritoneum (Retroperitoneal haemorrhage)
• Bleeding inside the eye (Intraocular haemorrhage)

Nervous system disorders

• Muscle cramps
• Seizures

Psychiatric disorders

• Insomnia
• Dementia

Cardiac disorders

• Changes in heart rhythm (Arrhythmias)

Fluid and electrolyte balance disorders

• Low (Hyponatraemia) and high (Hypernatraemia) sodium concentration in blood
• Low (Hypokalaemia) and high (Hyperkalaemia) potassium concentration in blood
• High calcium concentration in blood (Hypercalcaemia)
• High magnesium concentration in blood (Hypermagnesaemia)

Systemic disorders and administration site conditions

• Fever (Febrile reactions)
• Narrowing of blood vessels (Stenosis)
• Formation of blood clots within blood vessels (Thrombosis)
• Infection at the infusion site
• Subcutaneous swelling due to fluid accumulation (Abscess formation)

Following the instructions provided in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hemofiltration Solution HBiofluids

Keep this medicinal product out of the sight and reach of children.
Do not freeze.
Do not store below +4°C.
Store in the original packaging and in a tightly closed container.
Bags must be stored protected from direct light, in a dry and clean place.
Once the container has been opened, the medicinal product must be used immediately. Unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Do not use this medicinal product after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the product in intact packaging, correctly stored.

6. Contents of the pack and other information

What Soluzione per Emofiltrazione HBiofluids contains

• The active substances in 1000 ml of solution are:

pH 4.5 – 6.5
Theoretical osmolarity: 296 mOsm/L

• The other component is water for injections.

For the qualitative and quantitative composition of the specific formulation in grams/litre, refer to the label of the bag to which this package leaflet refers.
Description of the appearance of HBiofluids Hemofiltration Solution and contents of the pack
HBiofluids Hemofiltration Solution is a solution presented in a plastic bag.
The bag contains 5000 ml of solution.
The bag is wrapped in a protective film.
Marketing Authorization Holder and Manufacturer
Haemopharm Biofluids S.r.l.
Via dell’Industria, 6
23030 – Tovo di Sant’Agata (SO)
Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
The solution must not be used for intravenous infusion.
The patient's fluid and electrolyte balance must be carefully monitored.
Overhydration and dehydration may lead to serious consequences such as depletion of body fluids, congestive heart failure, or shock.
Replacement of potential losses of proteins, amino acids, and water-soluble vitamins may be required.
Caution must be exercised when using the solution in conditions associated with a high risk of bleeding (e.g. head trauma, recent surgery, etc.).
The solution should be infused into the extracorporeal circuit in pre- or post-dilution mode, using lines controlled by dedicated pumps.
Connection and disconnection procedures of the bag must be performed under aseptic conditions.
To reduce discomfort from traction, the solution may be warmed to 37°C prior to use, inside the sealed protective bag. Warming should be performed using dry heat; ideally, a specifically designed heating plate should be used.
To avoid connector contamination, the bag must not be warmed by immersion in water.
Verify correct dilution before use. Measure accurately the volume to be withdrawn.
Method and timing of administration
Dosing
The dosage, route of administration, and technique used are determined on a case-by-case basis by the physician according to individual patient needs.
The choice of potassium and glucose concentration in the solution depends on the patient's serum potassium and blood glucose levels.
When the final formulation includes bicarbonate, sodium bicarbonate solution must be contained in a separate container or compartment and mixed with the electrolyte solution at the time of use.
During these procedures, all necessary precautions must be taken to prevent microbial contamination.
Administration
The use of hemofiltration solutions requires the use of a connecting set between the bag and the patient's catheter.
Before use, warm and thoroughly mix the solution to body temperature (see Precautions for use).
Shake the medicinal product well before use.
Use the solution immediately after opening the container; it is intended for single, uninterrupted use and any remaining solution must not be reused.
Do not use the medicinal product if the packaging is damaged or if the solution is not clear, colourless or slightly straw-yellow, or if it contains particles.
All standard precautions must be followed to maintain sterility before and during use.
Interactions
No interaction studies have been conducted with HBiofluids Hemofiltration Solution.
Plasma potassium levels in patients receiving digitalis therapy should be frequently monitored to avoid the risk of cardiac arrest.
Addition of drugs to the solution may be performed only upon physician's instruction and must be carefully evaluated.
Overdose
Potential consequences of overdose include hypervolemia, hypovolemia, electrolyte disturbances, or (in diabetic patients) hyperglycemia.