Hemosol bo

Package leaflet: Information for the user

Hemosol B0 solution for haemodialysis/haemofiltration
Sodium chloride/calcium chloride dihydrate/magnesium chloride hexahydrate/lactic acid/sodium
hydrogencarbonate
Please read all of this leaflet carefully before this medicine is used, because it contains
important information for the patient.

• Keep this leaflet, as it may need to be read again.
• If there are any uncertainties, consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Hemosol B0 is and what it is used for
2. Important information before using Hemosol B0
3. How to use Hemosol B0
4. Possible side effects
5. How to store Hemosol B0
6. Contents of the pack and other information

1. What Hemosol B0 is and what it is used for

Hemosol B0 is used in hospitals in intensive care units to correct chemical imbalances in the blood caused by kidney failure. The treatment aims to remove accumulated metabolic waste products from the blood in people whose kidneys are not functioning properly.
Hemosol B0 is used in adults and children of all ages in the following types of treatment:

• haemofiltration,
• haemodiafiltration, and
• haemodialysis.

2. Important information before using Hemosol B0

When not to use Hemosol B0:
If the patient is allergic to any of the active substances or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Hemosol B0, discuss this with your doctor, pharmacist, or
nurse.
Hemosol B0 is a medicine intended for hospital use and must be administered only by
healthcare professionals. They will ensure the safe use of the medicine.
Before and during treatment, the patient's blood will be monitored, for example, acid-base balance and blood electrolyte (salt) levels will be checked, as well as all fluids administered (intravenous infusions) and fluids removed (urine output), even those not directly related to the treatment.

Because Hemosol B0 does not contain potassium, special attention must be paid to the patient's blood potassium levels. If low potassium levels (hypokalaemia) are detected, potassium supplementation may be necessary.

Children
There are no specific warnings or precautions regarding the use of this medicine in children.

Hemosol B0 and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

During treatment with Hemosol B0, blood levels of other concurrently administered medicines may decrease. The treating physician may need to adjust the dosage of these medicines.

In particular, inform the doctor if the patient is taking any of the following medicines:

• Cardiac glycosides (used in the treatment of certain heart conditions), as they increase the risk of irregular or episodic heart rhythm (arrhythmias) when blood potassium levels are low (hypokalaemia);
• Vitamin D and calcium-containing medicines, as they may increase the risk of high blood calcium levels (hypercalcaemia).

The addition of sodium bicarbonate (or other buffering substances) may increase the risk of excess bicarbonate in the blood (metabolic alkalosis).
If citrate is used as an anticoagulant, it may reduce serum calcium levels.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The medicine is not expected to affect fertility, pregnancy, or newborns/breastfed children. The treating physician should weigh the benefits against the risks before administering Hemosol B0 to a pregnant or breastfeeding patient.

Driving and operating machinery
Hemosol B0 has no influence on the ability to drive or operate machinery.

3. How to use Hemosol B0

Hemosol B0 is a medicine that must be used in a hospital setting and may be administered only by
healthcare professionals.
The volume of Hemosol B0, i.e. the dose administered, depends on the patient's clinical condition. The
dose (volume) will be determined by the physician responsible for treatment.
Hemosol B0 may be administered directly into the bloodstream (intravenously) or via hemodialysis,
during which the solution passes on one side of the dialysis membrane and blood on the other.

Use of a higher than recommended dose of Hemosol B0
Hemosol B0 is a medicine that must be used in a hospital setting and may be administered only by
healthcare professionals, and the patient's fluid and electrolyte balance as well as acid-base balance
will be closely monitored.
Therefore, it is very unlikely that a patient would receive a higher dose of Hemosol B0 than recommended.
However, in the event of an overdose, the treating physician will take necessary corrective measures and adjust the dose accordingly.
An overdose may lead to:

• excessive fluid volume in the blood,
• increased bicarbonate concentration in the blood (metabolic alkalosis),
• and (or) decreased salt levels in the blood (hypophosphatemia, hypokalemia).

For instructions on how to use the medicine, see section "Information intended exclusively for medical professionals".
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions have been reported:
Frequency: not known (frequency cannot be estimated from available data)

• changes in blood mineral salt concentrations (electrolyte imbalance, such as hypophosphatemia, hypokalemia);
• increased bicarbonate concentration in plasma (metabolic alkalosis) or decreased bicarbonate concentration in plasma (metabolic acidosis);
• abnormally high or low body water content (overhydration or dehydration);
• nausea;
• vomiting;
• muscle cramps;
• low blood pressure (hypotension).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Hemosol B0

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the back of the bag and on the box label under: Expiry date. The expiry date refers to the last day of the stated month.
Do not store below 4°C.
Chemical and physical stability of the ready-to-use solution has been demonstrated for 24 hours at 22°C. From a microbiological point of view, the ready-to-use solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to use, which should not exceed 24 hours, including the duration of administration.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Hemosol B0 contains
The active substances before and after mixing are listed below.
Active substances before mixing:
1000 ml of solution in the small chamber (A) contains:
Calcium chloride, 2H₂O 5.145 g
Magnesium chloride, 6H₂O 2.033 g
Lactic acid 5.4 g
1000 ml of solution in the large chamber (B) contains:
Sodium hydrogen carbonate 3.09 g
Sodium chloride 6.45 g

Active substances after mixing:
Composition of the solution (5000 ml) obtained after mixing the contents of chamber A (250 ml) and chamber B (4750 ml) is as follows:
mmol/l
Calcium, Ca 1.75
Magnesium, Mg 0.5
Sodium, Na 140
Chloride, Cl 109.5
Lactate 3
Bicarbonate, HCO₃ 32
Theoretical osmolarity: 287 mOsm/l

Other ingredients: carbon dioxide (E 290) and water for injections.

What Hemosol B0 looks like and contents of the pack
Hemosol B0 is supplied in a dual-chamber bag. The bag is placed in a transparent outer packaging.
To obtain the ready-to-use solution, the breakable seal must be opened and both solutions mixed.
The ready-to-use solution is clear and colourless. Each bag (A+B) contains 5000 ml of solution for haemofiltration, haemodiafiltration and/or haemodialysis.
Each carton contains two bags and one patient leaflet.

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

Manufacturer
Bieffe Medital S.p.A.,
Via Stelvio 94,
23035 Sondalo (SO),
Italy
or
Vantive Manufacturing Limited,
Moneen Road,
Castlebar,
County Mayo
F23 XR63
Ireland

This medicinal product is authorised in the European Economic Area and in Great Britain (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Hemosol B0.

---

Information intended exclusively for healthcare professionals

Hemosol B0 solution for hemodialysis/hemofiltration
Precautions
Strict adherence to the instructions for use/handling of the medicinal product Hemosol B0 is required.
Solutions from both chambers must be mixed before use.
Administration of a contaminated solution for hemofiltration may lead to sepsis, shock, and patient death.
To increase patient comfort, Hemosol B0 may be warmed to 37°C. Warming of the solution before use should be performed prior to reconstitution and only using a dry heat source. Do not warm solutions in a water bath or microwave oven. If the solution and packaging permit, visually inspect the solution before administration to detect the presence of particulate matter or discoloration. Do not administer if the solution is not clear or if the seal is damaged.
Additional substitution of sodium bicarbonate may increase the risk of metabolic alkalosis.
Electrolyte balance and acid-base balance must be closely monitored before and during treatment. Since Hemosol B0 does not contain potassium, serum potassium levels must be monitored before and during hemofiltration and/or hemodialysis. Potassium supplementation may be necessary.
Phosphates may be added to the solution up to 1.2 mmol/l. When adding potassium phosphate, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).
The volume and rate at which the medicinal product Hemosol B0 is administered depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The method of administration (dose, infusion rate, and total volume) of Hemosol B0 should be determined by a physician. Continuous hemofiltration removes excess fluid and electrolytes.
If fluid balance disturbances occur, the patient's clinical status must be closely monitored and fluid balance corrected as needed.
In patients with renal failure, overdose may result in fluid overload and serious consequences such as congestive heart failure, electrolyte imbalances, or acid-base disturbances.
Since the solution does not contain glucose, its administration may lead to hypoglycemia. Blood glucose levels should be monitored regularly.
Hemosol B0 contains bicarbonate and lactate (a bicarbonate precursor), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with this solution, it may be necessary to reduce the infusion rate or discontinue administration of the medicinal product.

Dosage
The commonly used flow rate of substitution solution in hemofiltration and hemodiafiltration is:
Adults: 500–3000 ml/hour.
The commonly used flow rate of dialysis solution (dialysate) in continuous hemodialysis is:
Adults: 500–2500 ml/hour.
In adults, the total flow rate usually applied ranges from approximately 2000 to 2500 ml/hour, corresponding to a daily fluid volume between approximately 48 and 60 liters.

Children and adolescents
The range of substitution solution flow rates in hemofiltration and hemodiafiltration, and dialysis solution (dialysate) flow rates in continuous hemodialysis is:
Children (from newborns up to adolescents aged 18 years): 1000–2000 ml/hour/1.73 m².
Required flow rates may reach up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). The absolute flow rate (in ml/hour) in children and adolescents should generally not exceed the maximum flow rate used in adults.

Instructions for use/handling
To obtain a ready-to-use solution, the electrolyte solution (small chamber A) must be added to the buffer solution (large chamber B) by breaking the frangible seal immediately before use.
Use only with appropriate extracorporeal renal replacement therapy equipment.
Aseptic technique must be used during handling and administration of the medicinal product to the patient.
Use only if the outer protective packaging is intact, all seals are undamaged, the frangible seal is intact, and the solution is clear. Squeeze the bag firmly to check for leaks. If leakage is observed, discard the solution immediately, as sterility cannot be guaranteed.
The large chamber B is equipped with an injection port, which allows the addition of other necessary medicinal products after reconstitution. The physician is responsible for assessing compatibility of the additional medicinal product with Hemosol B0 by checking for color change and/or precipitation, formation of insoluble complexes, or crystals. Before adding a medicinal product, verify that it is soluble and stable in water at the pH of Hemosol B0 (the pH of the ready-to-use solution is 7.0 to 8.5). Additional components may be incompatible with the solution. Refer to the instructions for use of the added medicinal product.
Remove fluid from the injection port, hold the bag upside down, add the medicinal product to the injection port, and mix thoroughly. Begin administration of the solution immediately.
Introduction and mixing of additional components must always be performed before connecting the solution bag to the extracorporeal circuit.

I Immediately before use, remove the outer packaging from the bag and discard all other packaging materials. Open the closure by grasping the small chamber with both hands and pressing until an opening forms in the frangible seal separating the two chambers. (See Figure I below).
II Press the large chamber with both hands until the frangible seal between the two chambers is completely opened. (See Figure II below).
III Ensure thorough mixing by gently agitating the bag. The solution is now ready for use and the bag may be hung on an IV pole. (See Figure III below).
IV A dialysis or exchange line can be connected to each of the two access ports.
IV.a If using a luer-type access, remove the cap by twisting and pulling, then connect the male luer-lock end of the dialysis or exchange line to the female luer receptor on the bag by pushing and twisting. Ensure the connection is fully seated and secure. The connection is now open. Check that fluid flows freely. (See Figure IV.a below).
When dialysis or exchange lines are disconnected from the luer connector, the connection will close and fluid flow will stop. The luer port is needle-free and can be disinfected with antiseptic agents.
IV.b If using the injection port, first remove the cap by breaking it off. The injection port can be disinfected with antiseptic agents. Then puncture the rubber septum with a spike. Check that fluid flows freely. (See Figure IV.b below).

The ready-to-use solution should be used immediately after removal of the outer packaging. If the ready-to-use solution is not used immediately, it should be used within 24 hours, including treatment time, after adding the electrolyte solution to the buffer solution. The ready-to-use solution is intended for single use only. Any unused solution must be discarded immediately after use.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Package leaflet: information for the user

Hemosol B0 solution for hemodialysis/hemofiltration
Sodium chloride/calcium chloride dihydrate/magnesium chloride hexahydrate/lactic acid/sodium bicarbonate
Please read all of this leaflet carefully before using this medicine because it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Hemosol B0 is and what it is used for
2. Important information before using Hemosol B0
3. How to use Hemosol B0
4. Possible side effects
5. How to store Hemosol B0
6. Contents of the pack and other information

1. What is Hemosol B0 and what is it used for

Hemosol B0 is used in hospitals in intensive care units to correct disturbed blood chemical balance resulting from kidney failure. The treatment aims to remove accumulated metabolic waste products from the blood in patients whose kidneys are not functioning properly.
Hemosol B0 is used in adults and children of all ages in the following types of treatment:

• hemofiltration,
• hemodiafiltration, and
• hemodialysis.

2. Important information before using Hemosol B0

When not to use Hemosol B0:
If the patient is allergic to any of the active substances or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Hemosol B0, discuss this with the doctor, pharmacist, or
nurse.
Hemosol B0 is a medicine intended for hospital use and must be administered only by
healthcare professionals. They will ensure the safe use of the medicine.
Before and during treatment, the patient's blood will be monitored, for example, acid-base balance and blood electrolyte (salt) levels will be checked, as well as all fluids administered (intravenous infusions) and removed (urine output), even those not directly related to the treatment.
Because Hemosol B0 does not contain potassium, special attention must be paid to the patient's blood potassium levels. If low blood potassium (hypokalaemia) is detected, potassium supplementation may be necessary.

Children
There are no specific warnings or precautions regarding the use of this medicine in children.

Hemosol B0 and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
During treatment with Hemosol B0, blood levels of other concurrently administered medicines may decrease. The treating physician may need to adjust the dosage of currently used medicines.
In particular, inform the doctor if the patient is taking any of the following medicines:

• Cardiac glycosides (used in the treatment of certain heart diseases), as they increase the risk of irregular or paroxysmal heart rhythm (arrhythmias) if blood potassium levels are low (hypokalaemia);
• Vitamin D and calcium-containing medicines, as they may increase the risk of high blood calcium levels (hypercalcaemia).

The addition of sodium bicarbonate (or another buffering substance) may increase the risk of excess bicarbonate in the blood (metabolic alkalosis).
If citrate is used as an anticoagulant, it may reduce serum calcium levels.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The medicine is not expected to affect fertility, pregnancy, or newborns/breastfed children. The treating physician should weigh the benefits against the risks before administering Hemosol B0 to a pregnant or breastfeeding patient.

Driving and operating machinery
Hemosol B0 has no effect on the ability to drive or operate machinery.

3. How to use Hemosol B0

Hemosol B0 is a medicine that must be used in a hospital setting and may be administered only by
healthcare professionals.
The volume of Hemosol B0, i.e. the dose administered, depends on the patient's clinical condition. The
dose (volume) will be determined by the physician responsible for treatment.
Hemosol B0 may be given directly into the bloodstream (intravenously) or via haemodialysis, during
which the solution passes on one side of the dialysis membrane and blood on the other.

Use of a higher than recommended dose of Hemosol B0
Hemosol B0 is a medicine that must be used in a hospital setting and may be administered only by
healthcare professionals, and fluid balance, electrolyte balance, and acid-base balance will be carefully
monitored in the patient.
Therefore, it is very unlikely that a patient will receive a higher dose of Hemosol B0 than recommended.
However, if overdose occurs, the treating physician will take necessary corrective measures and adjust the dose.
Overdose may lead to:

• excessive fluid in the blood,
• increased bicarbonate concentration in the blood (metabolic alkalosis),
• and (or) decreased blood salt levels (hypophosphatemia, hypokalemia).

For instructions on how to use the medicine, see section “Information intended exclusively for medical personnel”.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported:
Frequency: not known (frequency cannot be estimated from the available data)

• changes in blood mineral concentrations (electrolyte imbalance, such as hypophosphatemia, hypokalemia);
• increased bicarbonate concentration in plasma (metabolic alkalosis) or decreased bicarbonate concentration in plasma (metabolic acidosis);
• abnormally high or low body water content (overhydration or dehydration);
• nausea;
• vomiting;
• muscle cramps;
• low blood pressure (hypotension).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hemosol B0

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the back of the bag and the carton label under: Expiry date. The expiry date refers to the last day of the stated month.
Do not store below 4°C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 22°C for the ready-to-use solution. From a microbiological point of view, the ready-to-use solution should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to use, which should not exceed 24 hours, including the duration of treatment.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Hemosol B0 contains
The active substances before and after mixing are listed below.
Active substances before mixing:
1000 ml of solution in the small chamber (A) contains:
Calcium chloride, 2H₂O 5.145 g
Magnesium chloride, 6H₂O 2.033 g
Lactic acid 5.4 g
1000 ml of solution in the large chamber (B) contains:
Sodium bicarbonate 3.09 g
Sodium chloride 6.45 g

Active substances after mixing:
Composition of the solution (5000 ml) obtained after mixing the contents of chamber A (250 ml) and chamber B (4750 ml) is as follows:
mmol/l
Calcium, Ca 1.75
Magnesium, Mg 0.5
Sodium, Na 140
Chloride, Cl 109.5
Lactate 3
Bicarbonate, HCO₃ 32
Theoretical osmolarity: 287 mOsm/l

Other ingredients: carbon dioxide (E 290) and water for injections.

What Hemosol B0 looks like and contents of the pack
Hemosol B0 is supplied in a dual-chamber bag. The bag is enclosed in a transparent outer packaging.
To obtain the ready-to-use solution, break the breakable seal and mix both solutions.
The ready-to-use solution is clear and colourless. Each bag (A+B) contains 5000 ml of solution for haemofiltration, haemodiafiltration and/or haemodialysis.
Each carton contains two bags and one patient leaflet.

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

Manufacturer
Bieffe Medital S.p.A.,
Via Stelvio 94,
23035 Sondalo (SO),
Italy
or
Vantive Manufacturing Limited,
Moneen Road,
Castlebar,
County Mayo
F23 XR63
Ireland

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Hemosol B0.

---

Information intended exclusively for healthcare professionals

Hemosol B0 solution for hemodialysis/hemofiltration
Precautions
Strict adherence to the instructions for use/handling of the medicinal product Hemosol B0 is required.
Solutions from both chambers must be mixed before use.
Administration of a contaminated solution for hemofiltration may lead to sepsis, shock, and patient death.
To increase patient comfort, Hemosol B0 may be warmed to 37°C. Warming of the solution before use should be performed prior to reconstitution and exclusively using a dry heat source. Solutions must not be warmed in a water bath or microwave oven. If the solution and packaging permit, the solution should be visually inspected before administration to detect the presence of particulate matter or discoloration. Do not administer if the solution is not clear or if the seal is damaged.
Additional substitution of sodium bicarbonate may increase the risk of metabolic alkalosis.
Electrolyte balance and acid-base balance must be closely monitored before and during treatment. Since Hemosol B0 does not contain potassium, serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis. Potassium supplementation may be necessary.
Phosphates may be added to the solution up to a concentration of 1.2 mmol/l. When potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).
The volume and rate at which the medicinal product Hemosol B0 is administered depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The method of administration (dose, infusion rate, and total volume) of Hemosol B0 should be determined by a physician. Continuous hemofiltration removes excess fluid and electrolytes.
If a fluid balance disorder occurs, the patient's clinical status must be closely monitored and fluid balance corrected as needed.
In patients with renal failure, overdose may lead to fluid overload and serious consequences such as congestive heart failure, electrolyte disturbances, or acid-base imbalances.
Since the solution does not contain glucose, its administration may lead to hypoglycemia. Blood glucose concentration should be monitored regularly.
Hemosol B0 contains bicarbonate and lactate (a bicarbonate precursor), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with this solution, it may be necessary to reduce the infusion rate or discontinue administration of the medicinal product.

Dosage
The commonly used flow rate of substitution solution in hemofiltration and hemodiafiltration is:
Adults: 500–3000 ml/hour.
The commonly used flow rate of dialysis solution (dialysate) in continuous hemodialysis is:
Adults: 500–2500 ml/hour.
In adults, the total flow rate usually applied ranges from approximately 2000 to 2500 ml/hour, corresponding to a daily fluid volume between approximately 48 and 60 liters.

Children and adolescents
The range of flow rates for substitution solution in hemofiltration and hemodiafiltration and dialysis solution (dialysate) in continuous hemodialysis is:
Children (from newborns to adolescents up to 18 years): 1000–2000 ml/hour/1.73 m².
Required flow rates may reach up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). The absolute flow rate (in ml/hour) in children and adolescents should generally not exceed the maximum flow rate used in adults.

Instructions for use/handling
To obtain a ready-to-use solution, the electrolyte solution (small chamber A) must be added to the buffer solution (large chamber B) by breaking the frangible seal immediately before use.
Use only with appropriate equipment for extracorporeal renal replacement therapy.
Aseptic technique must be used during handling and administration of the medicinal product to the patient.
Use only if the outer protective packaging is intact, all seals are undamaged, the frangible seal is intact, and the solution is clear. Squeeze the bag firmly to check for leaks. If leakage is observed, the solution must be discarded immediately, as sterility cannot be guaranteed.
The large chamber B is equipped with an injection port, which allows the addition of other necessary medicinal products after reconstitution. The physician is responsible for assessing compatibility of the additional medicinal product with Hemosol B0 by checking for color change and/or precipitation, formation of insoluble complexes or crystals. Before adding a medicinal product, verify that it is soluble and stable in water at a pH equal to that of Hemosol B0 (the pH of the ready-to-use solution is 7.0 to 8.5). Additional components may be incompatible with the solution. Refer to the instructions for use of the added medicinal product.
Remove fluid from the injection port, hold the bag upside down, add the medicinal product to the injection port, and mix thoroughly. Begin administration of the solution immediately.
Introduction and mixing of additional components must always be performed before connecting the solution bag to the extracorporeal circuit.

I Immediately before use, remove the outer packaging from the bag and discard all remaining packaging materials. Open the seal by breaking the frangible seal located between the two chambers of the bag. The frangible seal remains in the bag. (See Figure I below).

II Ensure that all fluid from small chamber A has been transferred into large chamber B. (See Figure II below).

III Rinse small chamber A twice by squeezing the mixed solution back into small chamber A and then again into large chamber B. (See Figure III below).

IV If small chamber A is empty: shake large chamber B to ensure complete mixing of its contents. The solution is now ready for use and the bag may be hung on an IV stand. (See Figure IV below).

V A dialysis or replacement line can be connected to each of the two access ports.

V.a If using a luer-type access, remove the cap and connect the male luer-lock end of the dialysis or replacement line to the female luer receptor on the bag; tighten securely. Using thumb and fingers, snap the colored frangible seal at its base and move it back and forth. Do not use tools. Check that the seal is completely separated and that fluid flows freely. The seal remains in the luer port during treatment. (See Figure V.a below).

V.b If using the injection port, first remove the cap by snapping it off. The injection port may be disinfected with antiseptic agents. Then puncture the rubber septum with a spike. Check that fluid flows freely. (See Figure V.b below).

The ready-to-use solution should be used immediately after removal of the outer packaging.
If the ready-to-use solution is not used immediately, it must be used within 24 hours, including treatment time, after adding the electrolyte solution to the buffer solution.
The ready-to-use solution is intended for single use only. Unused solution must be discarded immediately after use.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Package leaflet: information for the user

Hemosol B0 solution for hemodialysis/hemofiltration
Sodium chloride/calcium chloride dihydrate/magnesium chloride hexahydrate/lactic acid/sodium bicarbonate
Please read this leaflet carefully before using this medicine because it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Hemosol B0 is and what it is used for
2. Important information before using Hemosol B0
3. How to use Hemosol B0
4. Possible side effects
5. How to store Hemosol B0
6. Contents of the packaging and other information

1. What is Hemosol B0 and what is it used for

Hemosol B0 is used in hospitals in intensive care units to correct imbalanced blood chemistry caused by kidney failure. The treatment aims to remove accumulated metabolic waste products from the blood in patients whose kidneys are not functioning properly.
Hemosol B0 is used in adults and children of all ages in the following types of treatment:

• hemofiltration,
• hemodiafiltration, and
• hemodialysis.

2. Important information before using Hemosol B0

When not to use Hemosol B0:
If the patient is allergic to any of the active substances or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Hemosol B0, discuss this with the doctor, pharmacist, or
nurse.

Hemosol B0 is a medicine intended for hospital use and must be administered only by
healthcare professionals. They will ensure the safe use of the medicine.

Before and during treatment, the patient's blood will be monitored, for example, acid-base balance and blood electrolyte (salt) levels will be checked, as well as all fluids administered (intravenous infusions) and removed (urine output), even those not directly related to the treatment.

Since Hemosol B0 does not contain potassium, special attention must be paid to the patient's blood potassium levels. If low potassium levels (hypokalaemia) are detected, potassium supplementation may be necessary.

Children
There are no specific warnings or precautions regarding the use of this medicine in children.

Hemosol B0 and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

During treatment with Hemosol B0, blood levels of other concomitantly administered medicines may decrease. The treating physician may need to adjust or change the patient's current medication regimen.

In particular, inform the doctor if the patient is taking any of the following medicines:

• cardiac glycosides (used in the treatment of certain heart conditions), as they increase the risk of irregular or paroxysmal heart rhythm (arrhythmias) when blood potassium levels are low (hypokalaemia);
• vitamin D and calcium-containing medicines, as they may increase the risk of high blood calcium levels (hypercalcaemia).

The addition of sodium bicarbonate (or another buffering substance) may increase the risk of elevated blood bicarbonate levels (metabolic alkalosis).
If citrate is used as an anticoagulant, it may reduce serum calcium levels.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. No effects of the medicine on fertility, pregnancy, or newborns/breastfed children are anticipated. The treating physician should evaluate the benefit-risk ratio before administering Hemosol B0 to a pregnant or breastfeeding patient.

Driving and operating machinery
Hemosol B0 has no influence on the ability to drive or operate machinery.

3. How to use Hemosol B0

Hemosol B0 is a medicine that must be used in a hospital and can only be administered by
healthcare professionals.
The volume of Hemosol B0, i.e. the dose administered, depends on the patient's clinical condition. The
dose (volume) will be determined by the physician responsible for treatment.
Hemosol B0 may be given directly into the bloodstream (intravenously) or via hemodialysis, during
which the solution passes on one side of the dialysis membrane and blood on the other.

Use of a higher than recommended dose of Hemosol B0
Hemosol B0 is a medicine that must be used in a hospital and can only be administered by
healthcare professionals, and the patient's fluid and electrolyte balance as well as acid-base balance
will be closely monitored.
Therefore, it is very unlikely that a patient would receive a higher dose of Hemosol B0 than
recommended.
However, if an overdose occurs, the treating physician will take necessary corrective measures and
adjust the dose accordingly.
Overdose may lead to:

• excessive fluid volume in the blood,
• increased bicarbonate concentration in the blood (metabolic alkalosis),
• and (or) decreased salt concentration in the blood (hypophosphatemia, hypokalemia).

For instructions on how to use the medicine, see section "Information intended exclusively for
medical professionals".
If you have any further questions concerning the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions have been reported:
Frequency: not known (frequency cannot be estimated from the available data)

• changes in blood mineral salt concentrations (electrolyte imbalance, such as hypophosphatemia, hypokalemia);
• increased bicarbonate concentration in plasma (metabolic alkalosis) or decreased bicarbonate concentration in plasma (metabolic acidosis);
• abnormally high or low body water content (overhydration or dehydration);
• nausea;
• vomiting;
• muscle cramps;
• low blood pressure (hypotension).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Hemosol B0

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the back of the bag and the carton label under: Expiry date. The expiry date refers to the last day of the stated month.
Do not store at temperatures below 4°C.
Chemical and physical stability of the ready-to-use solution has been demonstrated for 24 hours at 22°C. From a microbiological point of view, the ready-to-use solution should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and the storage time should not exceed 24 hours, including the treatment time.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Hemosol B0 contains
The active substances before and after mixing are listed below.
Active substances before mixing:
1000 ml of solution contained in the small chamber (A) contains:
Calcium chloride, 2H₂O 5.145 g
Magnesium chloride, 6H₂O 2.033 g
Lactic acid 5.4 g
1000 ml of solution contained in the large chamber (B) contains:
Sodium bicarbonate 3.09 g
Sodium chloride 6.45 g
Active substances after mixing:
Composition of the solution (5000 ml) obtained after mixing the contents of chamber A (250 ml) and chamber B (4750 ml) is as follows:
mmol/l
Calcium, Ca 1.75
Magnesium, Mg 0.5
Sodium, Na 140
Chloride, Cl 109.5
Lactate 3
Bicarbonate, HCO₃ 32
Theoretical osmolarity: 287 mOsm/l
Other ingredients: carbon dioxide (E 290) and water for injections.
What Hemosol B0 looks like and contents of the pack
Hemosol B0 is supplied in a dual-chamber bag. The bag is enclosed in a transparent outer packaging.
To obtain the ready-to-use solution, the breakable seal must be broken and both solutions mixed.
The ready-to-use solution is clear and colourless. Each bag (A+B) contains 5000 ml of solution for haemofiltration, haemodiafiltration and/or haemodialysis.
Each carton contains two bags and one patient leaflet.
Marketing Authorisation Holder
Vantive Belgium SRL
Boulevard d’Angleterre 2
1420 Braine-l’Alleud
Belgium
Manufacturer
Bieffe Medital S.p.A.,
Via Stelvio 94,
23035 Sondalo (SO),
Italy
or
Vantive Manufacturing Limited,
Moneen Road,
Castlebar,
County Mayo
F23 XR63
Ireland
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Hemosol B0.

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Information intended exclusively for medical professionals

Hemosol B0 solution for hemodialysis/hemofiltration
Precautions
Strictly follow the instructions for use/handling of the medicinal product Hemosol B0.
Solutions from both chambers must be mixed before use.
Administration of a contaminated solution for hemofiltration may lead to sepsis, shock, and patient death.
To increase patient comfort, Hemosol B0 may be warmed to 37°C. Warming the solution before use must be performed prior to reconstitution and only using a dry heat source. Do not warm solutions in a water bath or microwave oven. If the solution and container permit, visually inspect the solution before administration for presence of particulate matter or discoloration. Do not administer if the solution is not clear or if the seal is damaged.
Additional substitution of sodium bicarbonate may increase the risk of metabolic alkalosis.
Electrolyte balance and acid-base balance must be closely monitored before and during treatment. Since Hemosol B0 does not contain potassium, serum potassium levels must be monitored before and during hemofiltration and/or hemodialysis. Potassium supplementation may be necessary.
Phosphates may be added to the solution up to 1.2 mmol/l. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/l (4 mmol/l).
The volume and rate at which Hemosol B0 is administered depend on blood electrolyte concentrations, acid-base balance, and the patient's overall clinical condition. The method of administration (dose, infusion rate, and total volume) of Hemosol B0 must be determined by a physician. Continuous hemofiltration removes excess fluid and electrolytes.
If fluid imbalance occurs, the patient's clinical status must be closely monitored and fluid balance corrected as needed.
In patients with renal failure, overdose may result in fluid overload and serious consequences such as congestive heart failure, electrolyte disturbances, or acid-base imbalances.
Since the solution does not contain glucose, its administration may lead to hypoglycemia. Blood glucose levels should be monitored regularly.
Hemosol B0 contains bicarbonate and lactate (a bicarbonate precursor), which may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with this solution, it may be necessary to reduce or interrupt the administration rate of the medicinal product.

Dosage
Commonly used flow rates of substitution solution in hemofiltration and hemodiafiltration are:
Adults: 500–3000 ml/hour.
Commonly used flow rates of dialysis solution (dialysate) in continuous hemodialysis are:
Adults: 500–2500 ml/hour.
In adults, the total flow rate is typically between approximately 2000 and 2500 ml/hour, corresponding to a daily fluid volume ranging from about 48 to 60 liters.

Children and adolescents
Flow rate range for substitution solution in hemofiltration and hemodiafiltration and dialysis solution (dialysate) in continuous hemodialysis:
Children (from newborns up to adolescents aged 18 years): 1000–2000 ml/hour/1.73 m².
Required flow rates may reach up to 4000 ml/hour/1.73 m², especially in younger children (≤10 kg). Absolute flow rate (in ml/hour) in children and adolescents generally should not exceed the maximum flow rate used in adults.

Instructions for use/handling
To obtain the ready-to-use solution, the electrolyte solution (small chamber A) must be added to the buffer solution (large chamber B) by breaking the frangible seal immediately before use.
Use only with appropriate equipment for extracorporeal renal replacement therapy.
Aseptic technique must be used during handling and administration of the medicinal product to the patient.
Use only if the outer protective packaging is intact, all seals are undamaged, the frangible seal is unbroken, and the solution is clear. Squeeze the bag firmly to check for leakage. If leakage is observed, discard the solution immediately, as sterility cannot be guaranteed.
The large chamber B is equipped with an injection port, which allows addition of other necessary medicinal products after reconstitution. The physician is responsible for assessing compatibility of the additional medicinal product with Hemosol B0 by checking for absence of color change and/or precipitation, formation of insoluble complexes or crystals. Before adding a medicinal product, verify that it is soluble and stable in water at a pH equal to that of Hemosol B0 (pH of the ready-to-use solution is 7.0 to 8.5). Additional components may be incompatible with the solution. Refer to the instructions for use of the added medicinal product.
Remove fluid from the injection port, hold the bag upside down, add the medicinal product into the injection port, and mix thoroughly. Begin administration of the solution immediately.
Introduction and mixing of additional components must always be performed before connecting the solution bag to the extracorporeal circuit.

I Immediately before use, remove the outer packaging from the bag and discard all other packaging materials. Open the seal by breaking the frangible seal located between the two chambers of the bag. The frangible seal remains inside the bag. (See Figure I below).

II Ensure that all fluid from small chamber A has been transferred into large chamber B. (See Figure II below).

III Rinse small chamber A twice by squeezing the mixed solution back into small chamber A and then again into large chamber B. (See Figure III below).

IV When small chamber A is empty: shake large chamber B to ensure complete mixing of its contents. The solution is now ready for use and the bag may be hung on an IV pole. (See Figure IV below).

V Dialysis or replacement lines can be connected to each of the two access ports.

V.a If using a luer-type access, remove the cap by twisting and pulling, then connect the male luer-lock end of the dialysis or replacement line to the female luer-receptor on the bag, pushing and twisting to secure. Ensure the connection is fully seated and secure. The connection is now open. Check that fluid flows freely. (See Figure V.a below).
When dialysis or replacement lines are disconnected from the luer connector, the connection will close automatically and fluid flow will stop. The luer port is needle-free and can be wiped with disinfectants.

V.b If using the injection port, first remove the cap by breaking it off. The injection port can be wiped with disinfectants. Then puncture the rubber septum with a spike. Check that fluid flows freely. (See Figure V.b below).

The ready-to-use solution should be used immediately after removal of the outer packaging.
If the ready-to-use solution is not used immediately, it must be used within 24 hours, including treatment time, after adding the electrolyte solution to the buffer solution.
The ready-to-use solution is for single use only. Any unused solution must be discarded immediately after use.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.