Hemosol Bo

Leaflet accompanying the packaging: information for the user

Hemosol B0 solution for hemodialysis/hemofiltration

Sodium chloride/calcium chloride dihydrate/magnesium chloride hexahydrate/lactic acid/sodium bicarbonate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further 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.

Table of contents of the leaflet

• 1. What is Hemosol B0 and what is it 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 disturbed chemical balance of the blood resulting from kidney failure. The treatment aims to remove accumulated metabolic products from the blood of patients whose kidneys do not function 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 one 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 it with your doctor, pharmacist, or nurse.

Hemosol B0 is a medicine that should be used in a hospital and can only be administered by professional healthcare workers. They will ensure the safe use of the medicine.

Before and during treatment, the patient's blood will be tested, e.g., acid-base balance and electrolyte levels in the blood, as well as all fluids administered (intravenous infusion) and excreted (urine excretion), even those not directly related to treatment.

Since Hemosol B0 does not contain potassium, particular attention should be paid to the potassium level in the patient's blood. If the patient has low potassium levels, supplementation may be necessary.

Children

There are no special warnings and precautions for the use of this medicine in children.

Hemosol B0 and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as medicines the patient plans to take, including those available without a prescription.

During treatment with Hemosol B0, the level of other medicines used at the same time may decrease. The attending doctor may recommend changing the medicines used so far.

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

• cardiac glycosides (used to treat certain heart diseases), as they increase the risk of irregular or arrhythmic heart rhythm (arrhythmia) if the potassium level in the blood is low (hypokalemia);
• vitamin D and calcium-containing medicines, as they may increase the risk of high calcium levels in the blood (hypercalcemia).

The addition of sodium bicarbonate (or another buffering substance) may increase the risk of metabolic alkalosis.

If citrate is used as an anticoagulant, it may decrease the calcium level in the serum.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult her doctor or pharmacist before using this medicine. No effect on fertility, pregnancy, or breastfeeding is expected. The attending doctor should consider the benefit-risk ratio before administering Hemosol B0 to a pregnant or breastfeeding patient.

Driving and using machines

Hemosol B0 has no effect on the ability to drive and use machines.

3. How to use Hemosol B0

Hemosol B0 is a medicine that should be used in a hospital and can only be administered by professional healthcare workers.

The volume of Hemosol B0, i.e., the applied dose, depends on the patient's clinical condition. The dose (volume) will be determined by the doctor responsible for the treatment.

Hemosol B0 can be administered directly into the bloodstream (intravenously) or through hemodialysis, during which the solution flows on one side of the dialysis membrane and blood on the other.

Using a higher dose of Hemosol B0 than recommended

Hemosol B0 is a medicine that should be used in a hospital and can only be administered by professional healthcare workers, and the balance of fluids, electrolytes, and acid-base balance will be closely monitored in the patient.

It is very unlikely that the patient will receive a higher dose of Hemosol B0 than recommended.

However, if an overdose occurs, the attending doctor will take the necessary measures and adjust the dose.

Overdose may lead to:

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

To learn about the instructions for using the medicine, see the section "Information intended for healthcare professionals only".

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

Frequency: unknown (frequency cannot be estimated from the available data)

• changes in mineral electrolyte levels in the blood (electrolyte imbalance, such as hypophosphatemia, hypokalemia);
• increased bicarbonate levels in the serum (metabolic alkalosis) or decreased bicarbonate levels in the serum (metabolic acidosis);
• abnormal water content in the body (overhydration or dehydration);
• nausea;
• vomiting;
• muscle cramps;
• low blood pressure (hypotension).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hemosol B0

Store the medicine in a place out of sight and reach of children.

Do not use this medicine after the expiry date stated on the back of the bag and the label on the carton after: Expiry date. The expiry date refers to the last day of the month stated.

Do not store below 4°C.

It has been shown that the ready-to-use solution maintains chemical and physical stability for 24 hours at 22°C. From a microbiological point of view, the ready-to-use solution should be used immediately. If it is not used immediately, the user is responsible for the storage time and conditions before use, and the storage time should not exceed 24 hours, including the treatment time.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 presented 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:

The 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 osmolality: 287 mOsm/l

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

What Hemosol B0 looks like and what the pack contains

Hemosol B0 is in a dual-chamber bag. The bag is placed in a transparent outer packaging.

To obtain the ready-to-use solution, the electrolyte solution (small chamber A) must be added to the buffering solution (large chamber B) after breaking the breakable seal immediately before use.

The ready-to-use solution is clear and colorless. Each bag (A+B) contains 5000 ml of solution for hemofiltration, hemodiafiltration, and/or hemodialysis.

Each carton contains two bags and one patient leaflet.

Marketing authorization 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 medicine is authorized for use 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.

Date of last revision of the leaflet: September 2024

Information intended for healthcare professionals only

Hemosol B0 solution for hemodialysis/hemofiltration

Precautions

Strictly follow the instructions for use/handling of the medicinal product Hemosol B0.

The solutions from both chambers mustbe mixed before use.

The use of a contaminated solution for hemofiltration may cause sepsis, shock, and death of the patient.

To increase patient comfort, Hemosol B0 can be warmed to a temperature of 37°C. Warming the solution before use should be done before reconstitution and only using a dry heat source. Solutions should not be warmed in a water bath or microwave oven. If the solution and packaging allow, before administration, the solution should be visually inspected for the presence of solid particles and color change. Do not administer if the solution is not clear or the seal is damaged.

Additional substitution of sodium bicarbonate may increase the risk of metabolic alkalosis.

Before starting treatment and during its duration, electrolyte balance and acid-base balance should be closely monitored. Since Hemosol B0 does not contain potassium, the potassium level in the serum must be monitored before and during hemofiltration and/or hemodialysis.

Supplementation of potassium may be necessary.

Phosphates can be added to the solution in a quantity of up to 1.2 mmol/l. In the case of 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 used depend on the electrolyte levels in the blood, acid-base balance, and the patient's overall clinical condition.

The method of administration (dose, infusion rate, and total volume) of the medicinal product Hemosol B0 should be determined by the doctor. Continuous hemofiltration removes excess fluid and electrolytes.

If fluid balance disorders occur, the patient's clinical condition should be closely monitored and fluid balance corrected if necessary.

If the patient has kidney failure, overdose may result in fluid overload and serious consequences, such as congestive heart failure, electrolyte or acid-base disorders.

Since the solution does not contain glucose, its administration may lead to hypoglycemia.

Blood glucose levels should be regularly monitored.

Hemosol B0 contains bicarbonate (bicarbonate) and lactate (a precursor to bicarbonate) that may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with the solution, it may be necessary to reduce the administration rate or discontinue the medicinal product.

Dosage

The commonly used flow rate of the substitution solution in hemofiltration and hemodiafiltration is:

Adults:

500-3000 ml/h.

The commonly used flow rate of the dialysate in continuous hemodialysis is:

Adults:

500-2500 ml/h.

In adults, the usual total flow rate is around 2000 to 2500 ml/h, which corresponds to a daily fluid volume of around 48 to 60 liters.

Children and adolescents

The range of flow rates of the substitution solution in hemofiltration and hemodiafiltration and the dialysate in continuous hemodialysis is:

Children (from newborns to adolescents up to 18 years): 1000-2000 ml/h/1.73 m2.

Required flow rates may be up to 4000 ml/h/1.73 m2, especially in younger children (≤10 kg). The absolute flow rate (in ml/h) in children and adolescents should not usually 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 buffering solution (large chamber B) after breaking the breakable seal immediately before use.

Use only with the appropriate equipment for extracorporeal renal replacement therapy.

During the procedure and administration of the medicinal product to the patient, aseptic technique should be used.

Use only when the outer protective packaging is undamaged, all seals are intact, the breakable seal is undamaged, and the solution is clear. Squeeze the bag firmly to check its integrity. If a leak is detected, the solution should be discarded immediately, as sterility cannot be guaranteed.

The large chamber B has a injection port that allows the addition of other necessary medicinal products after reconstitution. The doctor is responsible for assessing the compatibility of the additional medicinal product with Hemosol B0 by checking for color changes and/or precipitation, formation of insoluble complexes or crystals. Before adding the medicinal product, check if it is soluble and stable in water with a pH equal to the pH of Hemosol B0 (the pH of the ready-to-use solution is 7.0 to 8.5). Additional ingredients may not be compatible with the solution. Read the instructions for use of the added medicinal product.

Remove the fluid from the injection port, hold the bag upside down, administer the medicinal product to the injection port, and mix thoroughly. Start administering the solution immediately.

The introduction and mixing of additional ingredients must always be done before connecting the bag with the solution to the extracorporeal circuit.

I

Immediately before use, remove the outer packaging from the bag and discard all remaining packaging materials. Open the protective device by breaking the breakable seal located between the two chambers of the bag. The breakable seal will remain in the bag.

II

Make sure that all the fluid from the small chamber A has been transferred to the large chamber B.

III

Rinse the small chamber A twiceby expressing the mixed solution back into the small chamber A and then again into the large chamber B.

IV

If the small chamber A is empty: shake the large chamber B to mix its contents thoroughly. The solution is now ready for use, and the bag can be hung on a stand.

V

Each of the two access ports can be connected to a dialysis or exchange line.

V.a

If using a luer-type access, remove the cap and connect the male luer lock of the dialysis or exchange line to the female luer receptor on the bag; tighten. Hold the colored breakable seal with your thumb and fingers, and break it off at its base, moving it back and forth. Do not use tools. Check that the seal is completely separated and that the fluid flows freely. During treatment, the seal will remain in the luer port.

V.b

If using an injection port, first remove the cap by breaking it off. The injection port can be disinfected with disinfectants. Then, puncture the rubber septum with a needle. Check that the fluid flows freely.

The ready-to-use solution should be used immediately after removing the outer packaging.

If the ready-to-use solution is not used immediately, it should be used within 24 hours, including the treatment time, after adding the electrolyte solution to the buffering solution.

The ready-to-use solution is intended for single use only. Discard any unused solution immediately after use.

Any unused medicinal product or waste should be disposed of in accordance with local regulations.

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

Hemosol B0 is used in hospitals in intensive care units to correct disturbed chemical blood balance caused by kidney failure. The treatment aims to remove accumulated metabolic 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 one 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, the patient should discuss it with their doctor, pharmacist, or nurse.

Hemosol B0 is a medicine that should be used in a hospital and can only be administered by professional healthcare workers. They will ensure the safe use of the medicine.

Before and during treatment, the patient's blood will be tested, e.g., acid-base balance and electrolyte concentrations in the blood, as well as all administered (intravenous infusion) and removed (urine excretion) fluids, even those not directly related to the treatment.

Since Hemosol B0 does not contain potassium, particular attention should be paid to the patient's potassium levels. If low potassium levels are found in the patient, supplementation may be necessary.

Children

There are no special warnings and precautions for the use of this medicine in children.

Hemosol B0 and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

During treatment with Hemosol B0, the levels of other medicines used at the same time may decrease. The attending doctor may recommend changing the medicines used so far.

In particular, the doctor should be informed if the patient is taking any of the following medicines:

• cardiac glycosides (used to treat certain heart diseases), as they increase the risk of irregular or arrhythmic heart rhythm (arrhythmia) if potassium levels in the blood are low (hypokalemia);
• vitamin D and calcium-containing medicines, as they may increase the risk of high calcium levels in the blood (hypercalcemia).

Adding sodium bicarbonate (or another buffering substance) may increase the risk of metabolic alkalosis.

If citrate is used as an anticoagulant, it may lower calcium levels in the serum.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. No effects on fertility, pregnancy, or newborns/infants are expected. The attending doctor should consider the benefit-risk ratio before administering Hemosol B0 to a pregnant or breastfeeding patient.

Driving and using machines

Hemosol B0 has no influence on the ability to drive and use machines.

3. How to use Hemosol B0

Hemosol B0 is a medicine that should be used in a hospital and can only be administered by professional healthcare workers.

The volume of Hemosol B0, i.e., the dose used, depends on the patient's clinical condition. The dose (volume) will be determined by the doctor responsible for the treatment.

Hemosol B0 can be administered directly into the bloodstream (intravenously) or through hemodialysis, during which the solution flows on one side of the dialysis membrane and blood on the other.

Using a higher dose of Hemosol B0 than recommended

Hemosol B0 is a medicine that should be used in a hospital and can only be administered by professional healthcare workers, and fluid, electrolyte, and acid-base balance will be closely monitored in the patient.

It is very unlikely that the patient will receive a higher dose of Hemosol B0 than recommended.

However, if an overdose occurs, the attending doctor will take the necessary measures and adjust the dose.

Overdose may lead to:

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

To learn about the instructions for using the medicine, see the section "Information intended for healthcare professionals only".

In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Hemosol B0 can cause side effects, although not everybody gets them.

The following side effects have been reported:

Frequency: unknown (frequency cannot be estimated from the available data)

• changes in mineral electrolyte levels in the blood (electrolyte imbalance, such as hypophosphatemia, hypokalemia);
• increased bicarbonate levels in the serum (metabolic alkalosis) or decreased bicarbonate levels in the serum (metabolic acidosis);
• excessive or insufficient water content in the body (overhydration or dehydration);
• nausea;
• vomiting;
• muscle cramps;
• low blood pressure (hypotension).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Hemosol B0

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the back of the bag and the label on the carton after: Expiry date. The expiry date refers to the last day of the month stated.

Do not store below 4°C.

It has been demonstrated that the ready-to-use solution retains its chemical and physical stability 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 time and conditions before use, and the storage time should not exceed 24 hours, including the treatment time.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This 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 presented 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:

The 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 osmolality: 287 mOsm/l

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

What Hemosol B0 looks like and contents of the pack

Hemosol B0 is in a dual-chamber bag. The bag is placed in a transparent outer packaging.

To obtain the ready-to-use solution, the electrolyte solution (small chamber A) must be added to the buffering solution (large chamber B) after breaking the frangible stopper immediately before use.

The ready-to-use solution is clear and colorless. Each bag (A+B) contains 5000 ml of solution for hemofiltration, hemodiafiltration, and/or hemodialysis.

Each carton contains two bags and one patient leaflet.

Marketing Authorization 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 medicine is authorized 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.

Date of last revision of the leaflet: September 2024

Information intended for healthcare professionals only

Hemosol B0 Solution for Hemodialysis/Hemofiltration

Precautions

The instructions for use/handling of the medicinal product Hemosol B0 must be strictly followed.

The solutions from both chambers mustbe mixed before use.

Using a contaminated hemofiltration solution may cause sepsis, shock, and patient death.

To increase patient comfort, Hemosol B0 can be warmed to a temperature of 37°C. Warming the solution before use should be done before reconstitution and only using a dry heat source. The solutions should not be warmed in a water bath or microwave oven. Unless the solution and packaging allow, the solution should be visually inspected for particulate matter and color change before administration. Do not administer if the solution is not clear or the overwrap is damaged.

Additional bicarbonate substitution may increase the risk of metabolic alkalosis.

Before starting treatment and during its duration, electrolyte and acid-base balance should be closely monitored.

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 can 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 the medicinal product Hemosol B0 is used depend on the patient's blood electrolyte levels, acid-base balance, and overall clinical condition.

The method of administration (dose, infusion rate, and total volume) of the medicinal product Hemosol B0 should be determined by the doctor.

Continuous hemofiltration removes excess fluid and electrolytes.

If fluid balance disorders occur, the patient's clinical condition should be closely monitored and fluid balance corrected if necessary.

If the patient has kidney failure, overdose may lead to fluid overload and serious consequences, such as congestive heart failure, electrolyte or acid-base disturbances.

Since the solution does not contain glucose, its administration may lead to hypoglycemia.

Blood glucose levels should be regularly monitored.

Hemosol B0 contains bicarbonate (bicarbonate) and lactate (a precursor to bicarbonate) that may affect the patient's acid-base balance. If metabolic alkalosis occurs or worsens during treatment with the solution, it may be necessary to reduce the administration rate or discontinue the medicinal product.

Dosage

The commonly used flow rate of the substitution solution in hemofiltration and hemodiafiltration is:

Adults:

500-3000 ml/h.

The commonly used flow rate of the dialysis solution (dialysate) in continuous hemodialysis is:

Adults:

500-2500 ml/h.

In adults, the usual total flow rate is around 2000 to 2500 ml/h, which corresponds to a daily fluid volume of around 48 to 60 liters.

Children and adolescents

The range of flow rates of the substitution solution in hemofiltration and hemodiafiltration and the dialysis solution (dialysate) in continuous hemodialysis is:

Children (from newborns to adolescents up to 18 years): 1000-2000 ml/h/1.73 m2.

The required flow rates may be up to 4000 ml/h/1.73 m2, especially in younger children (≤10 kg). The absolute flow rate (in ml/h) in children and adolescents should not usually 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) should be added to the buffering solution (large chamber B) after breaking the frangible stopper immediately before use.

Use only with the appropriate equipment for extracorporeal renal replacement therapy.

During the procedure and administration of the medicinal product to the patient, aseptic technique should be used.

Use only if the outer protective packaging is undamaged, all seals are intact, the frangible stopper is undamaged, and the solution is clear. Firmly squeeze the bag to check its integrity. If a leak is detected, the solution should be discarded immediately, as sterility cannot be guaranteed.

The large chamber B has a injection port, which, after reconstitution of the solution, allows the addition of other necessary medicinal products. The doctor is responsible for assessing the compatibility of the additional medicinal product with Hemosol B0 by checking for color changes and/or precipitation, formation of insoluble complexes or crystals. Before adding the medicinal product, it should be checked if it is soluble and stable in water with a pH equal to the pH of Hemosol B0 (pH of the ready-to-use solution is 7.0 to 8.5). Additional ingredients may not be compatible with the solution. The instructions for use of the added medicinal product should be consulted.

Remove the fluid from the injection port, hold the bag upside down, administer the medicinal product to the injection port, and mix thoroughly. Administration of the solution should be started immediately.

Introduction and mixing of additional ingredients must always be performed before connecting the bag with the solution to the extracorporeal circuit.

I

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

II

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

III

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

IV

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

V

Either of the two access ports can be connected to a dialysis or exchange line.

V.a

If using a luer-type access, remove the cap by twisting and pulling, then connect the male luer lock of the dialysis or exchange line to the female luer receptor on the bag, pushing and twisting. Ensure the connection is fully seated and secure. The connection is now open. Check that the fluid flows freely. (See Figure V.a below).

When the dialysis or exchange lines are disconnected from the luer-type connection, the connection will be closed, and fluid flow will be stopped. The luer-type port is needle-free and can be disinfected with disinfectants.

V.b

If using an injection port, first remove the cap by breaking it off. The injection port can be disinfected with disinfectants. Then, puncture the rubber septum with a needle. Check that the 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 should be used within 24 hours, including the treatment time, after adding the electrolyte solution to the buffering solution.

The ready-to-use solution is for single use only. Any unused solution should be discarded immediately after use.

Any unused medicinal product or waste materials should be disposed of in accordance with local regulations.