Hospasol

PACKAGE LEAFLET: INFORMATION FOR THE USER

HOSPASOL

145 mmol/l Infusion Solution
Sodium bicarbonate
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, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Hospasol 145 mmol/l is and what it is used for
2. What you need to know before using Hospasol 145 mmol/l
3. How to use Hospasol 145 mmol/l
4. Possible side effects
5. How to store Hospasol 145 mmol/l
6. Contents of the pack and other information

1. WHAT HOSPASOL 145 mmol/l IS AND WHAT IT IS USED FOR

Hospasol 145 mmol/l is used in hospitals or specialized centers for dialysis treatment to correct chemical imbalances in the blood caused by renal failure.
It replaces the bicarbonate (hydrogen carbonate) lost from the body during:
❖ Acetate-Free Biofiltration (AFB) or
❖ Continuous Veno-Venous Hemofiltration without Acetate (AFCVVH).
It also helps restore bicarbonate levels in the body, which become depleted when kidney function is impaired (renal failure).

2. WHAT YOU SHOULD KNOW BEFORE USING HOSPASOL 145 mmol/l

Do not use Hospasol 145 mmol/l

• during dialysis techniques where buffer supplementation is already being used.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Hospasol 145 mmol/l. It is important to monitor electrolyte concentrations in the blood and the body's acid-base balance. Blood composition will therefore be checked at regular intervals.
Particular attention must be paid to:
• blood pH levels. If pH is high (alkalosis), do not use Hospasol 145 mmol/l.
• sodium levels in the blood in case of cardiac disorders and/or renal failure. An overdose of sodium may cause fluid retention in the body (hypervolemia), particularly in the lungs (pulmonary edema).
• blood vessels, as inflammation associated with thrombosis (thrombophlebitis) may occur if the product is administered into a smaller (peripheral) vein.
• blood levels of proteins, amino acids, and water-soluble vitamins, as significant losses of these substances may occur during dialysis.

Other medicines and Hospasol 145 mmol/l
Inform your doctor, pharmacist, or nurse if you are currently taking, have recently taken, or might take any other medicines. The blood concentration of some of these medicines may decrease during treatment with Hospasol 145 mmol/l. Your doctor will decide whether any of these medicines need to be replaced.

Pregnancy, breastfeeding, and fertility
There are no adequate data regarding the use of Hospasol 145 mmol/l during pregnancy or breastfeeding. Your doctor must decide whether to administer Hospasol 145 mmol/l if you are pregnant or breastfeeding.

Driving and using machines
Hospasol 145 mmol/l does not affect the ability to drive vehicles or operate machinery.

3. HOW TO USE HOSPASOL 145 mmol/l

Hospasol 145 mmol/l is a product intended for use in hospitals or specialized centers using dialysis machines.
It must be administered only by healthcare professionals.
The volume of Hospasol 145 mmol/l, and therefore the dose, will depend on your clinical condition. The dose volume will be determined by the physician in charge of your treatment.
Do not use Hospasol 145 mmol/l if the solution is cloudy or if the outer packaging is damaged. All seals must be intact.
If you use more Hospasol 145 mmol/l than you should
Overdose may lead to abnormally low levels of potassium (hypokalemia) and/or glucose (hypoglycemia) in the blood. In case of overdose, administration of Hospasol 145 mmol/l must be immediately stopped and dialysis should be continued with frequent blood gas and electrolyte monitoring.
The physician will take all necessary corrective measures and adjust the dose accordingly.
If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some adverse reactions possibly caused by the haemodialysis procedure may occur, such as:

• malaise (nausea)
• disturbances (vomiting)
• muscle cramps
• high blood pressure (hypertension)
• chills
• fever

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE HOSPASOL 145 mmol/l

Keep this medicine out of the sight and reach of children.
Do not use Hospasol 145 mmol/l after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Do not store at temperatures below 4°C.
Hospasol 145 mmol/l may be disposed of in wastewater without harming the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Hospasol 145 mmol/l contains
The active substance is:
1000 ml of solution contains:
Sodium bicarbonate 12.18 g
Equivalent to
Sodium, Na 145 mmol/l (145 mEq/l)
Bicarbonate, HCO(_3^-) 145 mmol/l (145 mEq/l)
Theoretical osmolarity: 290 mOsm/l
The excipients are:

• carbon dioxide (for pH adjustment)
• water for injections.

Description of the appearance of Hospasol 145 mmol/l and pack contents
Hospasol 145 mmol/l is available in a single-compartment bag. The solution is clear and colourless.
Each bag contains 3000 ml or 5000 ml of infusion solution. The bag is enclosed in a transparent film.
Each carton contains three 3000 ml bags or two 5000 ml bags and a package leaflet.

Marketing Authorization Holder
Vantive Belgium SRL
Boulevard d’Angleterre 2
1420 Braine-l’Alleud
Belgium

Manufacturer responsible for batch release
Bieffe Medital S.p.A. Sondalo Plant, Via Stelvio 94, 23035 Sondalo (SO), Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
HOSPASOL 145 mmol/l infusion solution
The use of a buffer-free dialysate (containing neither acetate nor bicarbonate) is essential. A dialysate with an appropriate composition for Acetate-Free Biofiltration must be selected.
The use of a buffer-free replacement fluid (containing neither acetate nor bicarbonate) is essential. A replacement fluid with an appropriate composition for Acetate-Free Continuous Veno-Venous Haemofiltration must be selected.
Hospasol 145 mmol/l must be administered alone, without other medicinal products, especially solutions containing calcium or magnesium, as they may cause precipitation of calcium carbonate or magnesium carbonate.
Hospasol 145 mmol/l is infused into the venous return line or into the extracorporeal circuit either before (pre-dilution) or after (post-dilution) the haemofilter.
The responsible physician must determine the volume, flow rate, and duration of dialysis.
Typical flow rates used in Acetate-Free Biofiltration are:
Adults, adolescents and elderly: 2000 to 2500 ml/hour
Children: 40 to 60 ml/kg/hour
Typical flow rates used in Acetate-Free Continuous Veno-Venous Haemofiltration are:
Adults, adolescents and elderly: 100 to 600 ml/hour
Children: 2 to 12 ml/kg/hour

INSTRUCTIONS FOR USE AND HANDLING
Hospasol 145 mmol/l is intended for exclusive use in dialysis machines specifically designed for Acetate-Free Biofiltration (a special haemodialysis technique) or Acetate-Free Continuous Veno-Venous Haemofiltration.
Consult the dialysis equipment user instructions before starting treatment with Hospasol 145 mmol/l.
Do not remove the product from its secondary packaging until ready for use.
Hospasol 145 mmol/l should only be used if the solution is clear, particle-free, and all seals are intact.
Maintain aseptic techniques throughout administration to the patient.
Before connection and after removal of the bag connector cap (safelink), disinfectant must be applied inside the safelink.
Before disconnection, it is recommended to disinfect the external surfaces of the line connector and the safelink.
The solution is for single use only. After use, any unused solution must be immediately discarded.
From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

PACKAGE LEAFLET: INFORMATION FOR THE USER

HOSPASOL®
145 mmol/l Infusion Solution
Sodium bicarbonate
Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Hospasol 145 mmol/l is and what it is used for
2. Before you use Hospasol 145 mmol/l
3. How to use Hospasol 145 mmol/l
4. Possible side effects
5. How to store Hospasol 145 mmol/l
6. Further information

1. WHAT HOSPASOL 145 MMOL/L IS AND WHAT IT IS USED FOR

Hospasol 145 mmol/l is used in hospitals or specialized centers for dialysis treatment to correct chemical imbalances in the blood caused by renal failure.
It replaces bicarbonate (hydrogen carbonate) lost by the body during:

• Acetate-Free Biofiltration (AFB), or
• Acetate-Free Continuous Veno-Venous Hemofiltration (AFCVVH).

It also helps restore bicarbonate levels in the body, which become depleted when kidney function is impaired (renal failure).

2. BEFORE USING HOSPASOL 145 MMOL/L Do not use Hospasol 145 mmol/l

• during dialysis procedures where buffer supplementation is already being used.

Exercise particular caution with Hospasol 145 mmol/l
It is important to monitor blood electrolyte levels and the body's acid-base balance. Blood composition will therefore be checked at regular intervals.
Particular attention must be paid to:

• blood pH levels. If pH is high (alkalosis), do not use Hospasol 145 mmol/l.
• blood sodium levels in case of heart disorders and/or renal failure. Excessive sodium administration may cause fluid retention in the body (hypervolemia), particularly in the lungs (pulmonary edema).
• blood vessels, as inflammation associated with thrombosis (thrombophlebitis) may occur if the product is administered into a smaller (peripheral) vein.
• blood levels of proteins, amino acids, and water-soluble vitamins, as significant losses of these substances may occur during dialysis.

Use of Hospasol 145 mmol/l with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. The blood concentration of some of these medicines may decrease during treatment with Hospasol 145 mmol/l. Your doctor will decide whether any of these medicines need to be replaced.

Pregnancy and breastfeeding
There are no adequate data regarding the use of Hospasol 145 mmol/l during pregnancy or breastfeeding. Your doctor must decide whether to administer Hospasol 145 mmol/l if you are pregnant or breastfeeding.

3. HOW TO USE HOSPASOL 145 MMOL/L

Hospasol 145 mmol/l is a product intended for use in hospitals or specialized centers with the aid of dialysis machines. It must be administered only by healthcare professionals.
The volume of Hospasol 145 mmol/l, and therefore the dose, will depend on your clinical condition. The dose volume will be determined by the physician in charge of the treatment.
Do not use Hospasol 145 mmol/l if the solution is cloudy or if the outer packaging is damaged. All seals must be intact.
If you use more Hospasol 145 mmol/l than you should
Overdose may lead to abnormally low blood levels of potassium (hypokalemia) and/or glucose (hypoglycemia). In case of overdose, administration of Hospasol 145 mmol/l must be immediately discontinued and dialysis should continue with frequent blood gas monitoring.
The physician will take all necessary corrective measures and adjust the dose accordingly.
If you have any doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Hospasol 145 mmol/l may cause adverse reactions, although not everybody experiences them.
Some adverse reactions may occur that are possibly related to the haemodialysis procedure itself, such as:

• malaise (nausea) or disturbances (vomiting) or muscle cramps
• high blood pressure (hypertension)
• chills
• fever

If any of these adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE HOSPASOL 145 MMOL/L

Keep out of the reach and sight of children.
Do not use Hospasol 145 mmol/l after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Do not store at temperatures below 4°C.
Hospasol 145 mmol/l may be disposed of in wastewater without harming the environment.

6. OTHER INFORMATION What Hospasol 145 mmol/l Contains

The active substance is:
1000 ml of solution contains: Sodium bicarbonate 12.18 g
Equivalent to:
Sodium, Na+ 145 mmol/l (145 mEq/l)
Bicarbonate, HCO3- 145 mmol/l (145 mEq/l)
Theoretical osmolarity: 290 mOsm/l

The excipients are:
• carbon dioxide (for pH adjustment)
• water for injections.

Description of the appearance of Hospasol 145 mmol/l and pack contents
Hospasol 145 mmol/l is available in a single-compartment bag. The solution is clear and colourless. Each bag contains 3000 ml or 5000 ml of infusion solution. The bag is enclosed in a transparent overwrap.
Each carton contains three 3000 ml bags or two 5000 ml bags and a package leaflet.

Marketing Authorization Holder
Vantive Belgium SRL
Boulevard d’Angleterre 2
1420 Braine-l’Alleud
Belgium

Responsible manufacturer for batch release
Bieffe Medital S.p.A., Via Stelvio 94, 23035 Sondalo (SO), Italy

This package leaflet was last approved on

---

The following information is intended exclusively for physicians or healthcare professionals:
HOSPASOL® 145 mmol/l infusion solution

The use of a dialysate without buffer (not containing acetate or bicarbonate) is essential. A dialysate with an appropriate composition for acetate-free biofiltration must be selected.

The use of a replacement fluid without buffer (not containing acetate or bicarbonate) is essential. A replacement fluid with an appropriate composition for continuous veno-venous hemofiltration without acetate must be selected.

Hospasol 145 mmol/l must be administered alone, without other medicinal products, especially solutions containing calcium or magnesium, as they may cause precipitation of calcium carbonate or magnesium carbonate.

Hospasol 145 mmol/l is infused into the venous return line or into the extracorporeal circuit either before (pre-dilution) or after (post-dilution) the hemofilter.

The responsible physician must determine the volume, flow rate, and duration of dialysis.

Flow rates commonly used in acetate-free biofiltration are:
Adults, adolescents, and elderly: 2000 to 2500 ml/hour
Children: 40 to 60 ml/kg/hour

Flow rates commonly used in continuous veno-venous hemofiltration without acetate are:
Adults, adolescents, and elderly: 100 to 600 ml/hour
Children: 2 to 12 ml/kg/hour

INSTRUCTIONS FOR USE AND HANDLING

Hospasol 145 mmol/l is intended for exclusive use in dialysis machines specifically designed for acetate-free biofiltration (a special hemodialysis technique) or continuous veno-venous hemofiltration without acetate.

Consult the dialysis equipment user instructions before starting treatment with Hospasol 145 mmol/l.

Do not remove the product from its secondary packaging until ready for use.

Hospasol 145 mmol/l should only be used if the solution is clear, particle-free, and all seals are intact.

Maintain aseptic techniques throughout administration to the patient.

Before connection and after removing the cap from the bag connector (safelink), disinfectant must be applied inside the safelink.

Before disconnection, it is recommended to disinfect the external surfaces of the tubing connector and the safelink.

The solution is for single use only. Any unused solution remaining after use must be immediately discarded.

From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.

PATIENT LEAFLET: INFORMATION FOR THE USER

HOSPASOL

167 mmol/l Solution for infusion
Sodium bicarbonate
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, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Contents of this leaflet:
  1. What Hospasol 167 mmol/l is and what it is used for
  2. What you need to know before using Hospasol 167 mmol/l
  3. How to use Hospasol 167 mmol/l
  4. Possible side effects
  5. How to store Hospasol 167 mmol/l
  6. Contents of the pack and other information

2. WHAT HOSPASOL 167 mmol/l IS AND WHAT IT IS USED FOR

Hospasol 167 mmol/l is used in hospitals or specialized hemodialysis treatment centers to correct the chemical imbalance in the blood caused by renal failure.
It replaces bicarbonate (hydrogen carbonate) lost by the body during:
❖ Acetate-Free Biofiltration (AFB) or
❖ Acetate-Free Continuous Veno-Venous Hemofiltration (AFCVVH).
It also helps restore bicarbonate levels in the body, which become depleted when kidney function is impaired (renal failure).

4. WHAT YOU NEED TO KNOW BEFORE USING HOSPASOL 167 mmol/l

Do not use Hospasol 167 mmol/l

• during dialysis techniques where buffer supplementation is already being used.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Hospasol 167 mmol/l. It is important to monitor blood electrolyte concentrations and the body's acid-base balance. Blood composition will therefore be checked at regular intervals.
Particular attention must be paid to:
• blood pH levels. If pH is high (alkalosis), do not use Hospasol 167 mmol/l.
• blood sodium levels in case of cardiac disorders and/or renal failure. Excessive sodium administration may cause fluid retention in the body (hypervolemia), particularly in the lungs (pulmonary edema).
• blood vessels, as inflammation associated with blood clots (thrombophlebitis) may occur if the product is administered into a smaller (peripheral) vein.
• blood levels of proteins, amino acids, and water-soluble vitamins, as significant losses of these substances may occur during dialysis.

Other medicines and Hospasol 167 mmol/l
Inform your doctor, pharmacist, or nurse if you are currently taking, have recently taken, or might take any other medicines. The blood concentration of some of these medicines may decrease during treatment with Hospasol 167 mmol/l. Your doctor will decide whether any of these medicines need to be replaced.

Pregnancy, breastfeeding, and fertility
There are no adequate data on the use of Hospasol 167 mmol/l during pregnancy or breastfeeding. Your doctor must decide whether to administer Hospasol 167 mmol/l during pregnancy or while breastfeeding.

Driving and using machines
Hospasol 167 mmol/l has no effect on the ability to drive vehicles or operate machinery.

5. HOW TO USE HOSPASOL 167 mmol/l

Hospasol 167 mmol/l is a product intended for use in hospitals or specialized centers with the aid of dialysis machines. It must be administered only by healthcare professionals.
The volume of Hospasol 167 mmol/l, and therefore the dose, will depend on your clinical condition. The dose volume will be determined by the physician in charge of the treatment.
Do not use Hospasol 167 mmol/l if the solution is cloudy or if the outer packaging is damaged. All seals must be intact.
If you use more Hospasol 167 mmol/l than you should
Overdose may lead to abnormally low blood levels of potassium (hypokalemia) and/or glucose (hypoglycemia). In case of overdose, administration of Hospasol 167 mmol/l must be immediately stopped and dialysis should be performed with frequent blood gas monitoring.
The physician will take all necessary corrective measures and adjust the dose accordingly.
If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may occur that are possibly related to the haemodialysis procedure, such as:

• malaise (nausea)
• gastrointestinal disturbances (vomiting)
• muscle cramps
• high blood pressure (hypertension)
• chills
• fever

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report adverse reactions directly via
undesirable effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE HOSPASOL 167 mmol/l

Keep this medicine out of the sight and reach of children.
Do not use Hospasol 167 mmol/l after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Do not store at temperatures below 4°C.
Hospasol 167 mmol/l may be disposed of via wastewater without harming the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Hospasol 167 mmol/l contains
The active substance is:
1000 ml of solution contain:
Sodium bicarbonate 14 g
Equivalent to
Sodium, Na 167 mmol/l (167 mEq/l)
Bicarbonate, HCO₃ 167 mmol/l (167 mEq/l)
Theoretical osmolarity: 334 mOsm/l

The excipients are:

• carbon dioxide (for pH adjustment)
• water for injections.

Description of the appearance of Hospasol 167 mmol/l and pack contents
Hospasol 167 mmol/l is available in a single-compartment bag. The solution is clear and colourless.
Each bag contains 3000 ml or 5000 ml of infusion solution. The bag is enclosed in a transparent film.
Each carton contains three 3000 ml bags or two 5000 ml bags and a package leaflet.

Marketing Authorisation Holder
Vantive Belgium SRL
Boulevard d’Angleterre 2
1420 Braine-l’Alleud
Belgium

Responsible manufacturer for batch release
Bieffe Medital S.p.A. Sondalo facility, Via Stelvio 94, 23035 Sondalo (SO), Italy

---

The following information is intended exclusively for physicians or healthcare professionals:
HOSPASOL 167 mmol/l infusion solution
The use of a buffer-free dialysate (containing neither acetate nor bicarbonate) is essential. A dialysate with an appropriate composition for Acetate-Free Biofiltration must be selected.
The use of a buffer-free replacement fluid (containing neither acetate nor bicarbonate) is essential. A replacement fluid with an appropriate composition for Acetate-Free Continuous Veno-Venous Hemofiltration must be selected.
Hospasol 167 mmol/l must be administered alone, without other medicinal products, especially solutions containing calcium or magnesium, as they may cause precipitation of calcium or magnesium carbonate.
Hospasol 167 mmol/l is infused into the venous return line or into the extracorporeal circuit either before (pre-dilution) or after (post-dilution) the hemofilter.
The responsible physician must determine the volume, flow rate, and duration of dialysis.
Commonly used flow rates in Acetate-Free Biofiltration are:
Adults, adolescents and elderly: 1500 to 2000 ml/hour
Children: 30 to 40 ml/kg/hour

Commonly used flow rates in Acetate-Free Continuous Veno-Venous Hemofiltration are:
Adults, adolescents and elderly: 85 to 530 ml/hour
Children: 1.70 to 10.5 ml/kg/hour

INSTRUCTIONS FOR USE AND HANDLING
Hospasol 167 mmol/l is intended for exclusive use in dialysis machines specifically designed for Acetate-Free Biofiltration (a special hemodialysis technique) or Acetate-Free Continuous Veno-Venous Hemofiltration.
Consult the instructions for use of the dialysis equipment before starting treatment with Hospasol 167 mmol/l.
Do not remove the product from its secondary packaging until ready for use.
Hospasol 167 mmol/l should only be used if the solution is clear, particle-free, and all seals are intact.
Maintain aseptic techniques throughout administration to the patient.
Before connection, and after removing the cap from the bag connector (safelink), disinfectant must be applied to the inside of the safelink.
Before disconnection, it is recommended to disinfect the external surfaces of the line connector and safelink.
The solution is for single use only. After use, any unused solution must be immediately discarded.
From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

PACKAGE LEAFLET: INFORMATION FOR THE USER
HOSPASOL®
167 mmol/l Infusion Solution
Sodium Bicarbonate

Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:
7. What Hospasol 167 mmol/l is and what it is used for
8. Before using Hospasol 167 mmol/l
9. How to use Hospasol 167 mmol/l
10. Possible side effects
11. How to store Hospasol 167 mmol/l
12. Further information

7. WHAT HOSPASOL 167 MMOL/L IS AND WHAT IT IS USED FOR

Hospasol 167 mmol/l is used in hospitals or specialized dialysis treatment centers to correct the chemical imbalance in the blood caused by renal failure.
It replaces bicarbonate (hydrogen carbonate) lost from the body during:

• Acetate-Free Biofiltration (AFB) or Acetate-Free Continuous Veno-Venous Haemofiltration (AFCVVH). It also helps restore bicarbonate levels in the body, which become depleted when kidney function is impaired (renal failure).

8. BEFORE USING HOSPASOL 167 MMOL/L Do not use Hospasol 167 mmol/l

• during dialysis techniques where buffer supplementation is already being used.

Exercise particular caution with Hospasol 167 mmol/l
It is important to monitor blood salt concentrations (electrolytes) and the body's acid-base balance.
Blood composition will therefore be checked at regular intervals.
Particular attention must be paid to:

• the pH value in the blood. If pH is high (alkalosis), do not use Hospasol 167 mmol/l.
• sodium levels in the blood in case of heart disorders and/or renal failure. Excess sodium may cause fluid retention in the body (hypervolemia), particularly in the lungs (pulmonary edema).
• blood vessels, because inflammation associated with blood clots (thrombophlebitis) may occur if the product is administered into a smaller (peripheral) vein.
• blood levels of proteins, amino acids, and water-soluble vitamins, since significant losses of these substances may occur during dialysis.

Use of Hospasol 167 mmol/l with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. Indeed, the blood concentration of some of these medicines may decrease during treatment with Hospasol 167 mmol/l. Your doctor will decide whether any of these medicines need to be replaced.

Pregnancy and breastfeeding
There are no adequate data regarding the use of Hospasol 167 mmol/l during pregnancy or breastfeeding. Your doctor must decide whether to administer Hospasol 167 mmol/l if you are pregnant or breastfeeding.

9. HOW TO USE HOSPASOL 167 MMOL/L

Hospasol 167 mmol/l is a product intended for use in hospitals or specialized centers with the aid of dialysis machines. It must be administered only by healthcare professionals.
The volume of Hospasol 167 mmol/l, and therefore the dose, will depend on your clinical condition. The dose volume will be determined by the physician in charge of treatment.
Do not use Hospasol 167 mmol/l if the solution is cloudy or if the outer packaging is damaged. All seals must be intact.
If you use more Hospasol 167 mmol/l than you should
Overdose may lead to abnormally low blood levels of potassium (hypokalemia) and/or glucose (hypoglycemia). In case of overdose, administration of Hospasol 167 mmol/l must be immediately stopped and dialysis should be performed with frequent blood gas monitoring.
The physician will take all necessary corrective measures and adjust the dose accordingly.
If you have any doubts about how to use the product, consult your doctor or pharmacist.

10. POSSIBLE ADVERSE REACTIONS

Like all medicines, Hospasol 167 mmol/l may cause adverse reactions, although not everyone will experience them.
Some adverse reactions possibly caused by the haemodialysis process may occur, such as:
o malaise (nausea) or gastrointestinal disturbances (vomiting) or muscle cramps
o high blood pressure (hypertension)
o chills
o fever

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

11. HOW TO STORE HOSPASOL 167 MMOL/L

Keep out of the reach and sight of children.
Do not use Hospasol 167 mmol/L after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Do not store at temperatures below 4°C.
Hospasol 167 mmol/L may be disposed of via wastewater without harming the environment.

12. OTHER INFORMATION What Hospasol 167 mmol/l contains

The active substance is:
1000 ml of solution contains: Sodium bicarbonate 14 g
Equivalent to:
Sodium, Na+ 167 mmol/l (167 mEq/l)
Bicarbonate, HCO3- 167 mmol/l (167 mEq/l)
Theoretical osmolarity: 334 mOsm/l

The excipients are:

• carbon dioxide (for pH adjustment)
• water for injections.

Description of the appearance of Hospasol 167 mmol/l and pack contents
Hospasol 167 mmol/l is available in a single-compartment bag. The solution is clear and colourless. Each bag contains 3000 ml or 5000 ml of infusion solution. The bag is wrapped in a transparent film.
Each carton contains either three 3000 ml bags or two 5000 ml bags and a package leaflet.

Marketing Authorization Holder
Vantive Belgium SRL
Boulevard d’Angleterre 2
1420 Braine-l’Alleud
Belgium

Responsible manufacturer for batch release
Bieffe Medital S.p.A., Via Stelvio 94, 23035 Sondalo (SO), Italy

This package leaflet was last approved on

---

The following information is intended for healthcare professionals only:
HOSPASOL® 167 mmol/l infusion solution
The use of a buffer-free dialysate (not containing acetate or bicarbonate) is essential. A dialysate with an appropriate composition for acetate-free haemodiafiltration must be selected.
The use of a buffer-free replacement fluid (not containing acetate or bicarbonate) is essential. A replacement fluid with an appropriate composition for continuous veno-venous haemofiltration without acetate must be selected.
Hospasol 167 mmol/l must be administered alone, without other medicinal products, especially solutions containing calcium or magnesium, as they may cause precipitation of calcium or magnesium carbonate.
Hospasol 167 mmol/l is infused into the venous return line or into the extracorporeal circuit either before (pre-dilution) or after (post-dilution) the haemofilter.
The responsible physician must determine the volume, flow rate, and duration of dialysis.
Commonly used flow rates in acetate-free haemodiafiltration are:
Adults, adolescents and elderly: 1500 to 2000 ml/hour
Children: 30 to 40 ml/kg/hour

Commonly used flow rates in continuous veno-venous haemofiltration without acetate are:
Adults, adolescents and elderly: 85 to 530 ml/hour
Children: 1.70 to 10.5 ml/kg/hour

INSTRUCTIONS FOR USE AND HANDLING
Hospasol 167 mmol/l is designed for exclusive use in dialysis machines specifically designed for acetate-free haemodiafiltration (a special haemodialysis technique) or continuous veno-venous haemofiltration without acetate.
Consult the dialysis equipment’s instructions for use before starting treatment with Hospasol 167 mmol/l.
Do not remove the product from its secondary packaging until ready for use.
Hospasol 167 mmol/l should only be used if the solution is clear, free from particles, and all seals are intact.
Maintain aseptic techniques throughout administration to the patient.
Before connection, and after removing the cap from the bag connector (safelink), disinfectant must be applied inside the safelink.
Before disconnection, it is recommended to disinfect the external surfaces of the line connector and the safelink.
The solution is for single use only. Any unused solution remaining after use must be immediately discarded.
From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.