Hemosol B0 solution for haemodialysis/haemofiltration

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium hydrogen carbonate; Sodium chloride; Sodium chloride ; Calcium chloride dihydrate ; Magnesium chloride hexahydrate; Sodium lactate ; Sodium hydrogen carbonate
Available from:
Baxter Holding B.V.
ATC code:
B05ZB
INN (International Name):
Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium hydrogen carbonate; Sodium chloride; Sodium chloride ; Calcium chloride dihydrate ; Magnesium chloride hexahydrate; Sodium lactate ; Sodium hydrogen carbonate
Pharmaceutical form:
Solution for haemodialysis/haemofiltration
Therapeutic area:
Hemofiltrates
Authorization status:
Not marketed
Authorization number:
PA2299/051/001
Authorization date:
1999-06-11

Read the complete document

Package Leaflet: Information for the user

Hemosol B0 solution for haemodialysis/haemofiltration

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

hydrogen carbonate.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2. What you need to know before you use 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 treatments to correct chemical imbalance of the

blood which is caused by kidney failure. The treatments are designed to remove accumulated waste

products from the blood when the kidneys are not functioning.

Hemosol

B0 is used in the following types of treatment in adult and children of all ages:

haemofiltration,

haemodiafiltration and

haemodialysis.

2.

What you need to know before you use Hemosol B0

Do not use Hemosol B0:

If you are allergic to one of the active substances or any of the other ingredients (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Hemosol B0.

Hemosol B0 is a product to be used in hospitals and administered by medical professionals only. They

will ensure a safe use of the medicine.

Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and

concentrations of salts in the blood (electrolytes) will be monitored, including all fluid you are given

(intravenous infusion) and that you produce (urine production), even those not directly related to the

therapy.

As Hemosol B0 is potassium-free, special attention will be given to the level of potassium in your

blood. Should you suffer from low potassium a potassium supplement might be necessary.

Children

There are no specific warnings and precautions when using this medicine for children.

Other medicines and Hemosol B0

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

This is because the concentration level in the blood of some of other medicines being taken may be

reduced during the treatment with Hemosol B0. Your doctor will decide if other medicines being taken

should be changed.

In particular tell your doctor if you are using either of the following:

Digitalis medicine (for treatment of certain heart conditions); as the risk of irregular or rapid

beating of the heart (cardiac arrhythmia) caused by digitalis is increased during a low

concentration of potassium in the blood (hypokalaemia).

Vitamin D and medicinal products containing calcium, as they can increase the risk of a high

concentration of calcium in the blood (hypercalcaemia).

Any addition of sodium bicarbonate (or other buffer source) may increase the risk of excess of

bicarbonate in your blood (

metabolic alkalosis

When citrate is used as an anticoagulant, it can reduce plasma calcium levels.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine. No effects on fertility or during

pregnancy or on the breast-fed newborn/infant are anticipated. Your doctor will decide if you should

be given Hemosol B0 if you are pregnant or breast-feeding.

Driving and using machines

Hemosol B0 will not have any effect on the ability to drive or use machines.

3.

How to use Hemosol B0

Hemosol B0 is a product to be used in hospitals and administered by medical professionals only.

The volume of Hemosol B0, and therefore the dose used, will depend on your condition. The dose

volume will be determined by the physician responsible for your treatment.

Hemosol B0 can be administered directly into the bloodstream (intravenously) or via haemodialysis,

where the solution flows on one side of a dialysis membrane while the blood flows on the other side.

If you use more Hemosol B0

than you should

Hemosol B0 is a product to be used in hospitals and administered by medical professionals only and

your fluid balance, electrolyte and acid-base balance will be carefully monitored.

Therefore, it is unlikely that you will use more Hemosol B0

than you should.

In the unlikely event that an overdose occurs, your doctor will take necessary corrective measures and

adjust your dose.

Overdose may result in:

fluid overload in your blood,

elevation of the bicarbonate blood level (metabolic alkalosis),

and/or reduction of levels of salts in the blood (hypophosphataemia, hypokalaemia).

For instructions for use, please see section “The following information is intended for healthcare

professionals only”.

If you have any further questions on the use of 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:

Not known: frequency cannot be estimated from the available data

Changes of levels of salts in the blood (electrolyte imbalances such as hypophosphataemia,

hypokalaemia)

Elevation of the plasma bicarbonate concentration (metabolic alkalosis) or reduction of the

plasma bicarbonate concentration (metabolic acidosis)

Abnormally high or low volume of water in the body (hyper or hypovolaemia)

Nausea

Vomiting

Muscle cramps

Low blood pressure (hypotension).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet.

You can also report side effects directly via:

Malta:

ADR Reporting Website:

www.medicinesauthority.gov.mt/adrportal

Republic of Ireland:

HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

United Kingdom:

Yellow Card Scheme

www.mhra.gov.uk/yellowcard

By reporting side effects you can help 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 which is stated on the back of the bag and the box label

after EXP. The expiry date refers to the last day of that month.

Do not store below 4°C.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours

at 22°C. From a microbiological point of view, the reconstituted solution should be used immediately.

If not used immediately in-use storage times and conditions prior to use are the responsibility of the

user and should not be longer than 24 hours including the duration of the treatment.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Hemosol B0 contains

The active substances before and after reconstitution are shown below.

Active substances before reconstitution:

1000 ml of solution

from the small compartment (A)

contains:

Calcium chloride, 2H

5.145 g

Magnesium chloride, 6 H

2.033 g

Lactic acid

5.4 g

1 000 ml of solution

from the large compartment (B)

contains:

Sodium hydrogen carbonate

3.09 g

Sodium chloride

6.45 g

Active substances after reconstitution:

The solutions in the compartments A (250 ml) and B (4750 ml) are mixed to give one reconstituted

solution (5000 ml) which composition is:

mmol/l

Calcium, Ca

1.75

Magnesium, Mg

Sodium, Na

Chloride, Cl

109.5

Lactate

Hydrogen carbonate, HCO

Theoretical Osmolarity: 287 mOsm/l

The other ingredients are:

carbon dioxide (E 290) and water for injections.

What Hemosol B0 looks like and contents of the pack

Hemosol B0 is presented in a two-compartment bag.

The bag is overwrapped with a transparent film.

The final reconstituted solution is obtained after breaking the frangible pin and mixing both solutions.

The reconstituted solution is clear and colourless. Each bag (A+B) contains 5000 ml solution for

haemofiltration, haemodiafiltration and/or haemodialysis.

Each box contains two bags and one package leaflet.

Marketing Authorisation Holder:

United Kingdom:

Baxter Healthcare Ltd,

Caxton Way,

Thetford, Norfolk,

IP24 3SE,

United Kingdom

Republic of Ireland and Malta:

Baxter Holding B.V.

Kobaltweg 49

3542 CE Utrecht

Netherlands

Manufacturer:

<Bieffe Medital S.p.A.,

Via Stelvio 94,

23035 Sondalo (SO),

Italy>

<Baxter Healthcare S.A.

Moneen Road,

Castlebar

County Mayo

F23 XR63

Ireland>

This medicinal product is authorised in the Member States of the EEA 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, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Hemosol B0.

Hungary: Hemosol káliummentes.

This leaflet was last revised in 12/2020

The following information is intended for healthcare professionals only

Hemosol B0 solution for haemodialysis/haemofiltration

Precautions

The instructions for use / handling for Hemosol B0 must be strictly followed.

The solutions in the two compartments

must

be mixed

before use

Use of a contaminated solution may cause sepsis, shock and fatal conditions.

Hemosol B0 may be warmed to 37°C to enhance patient comfort. Warming of the solution prior to use

should be done before reconstitution with dry heat only. Solutions should not be heated in water or in

a microwave oven. The solution should be inspected visually for particulate matter and discoloration

prior to administration, whenever solution and container permit. Do not administer unless the solution

is clear and the seal is intact.

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

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

As Hemosol B0 is potassium-free, the serum potassium concentration must be monitored before and

during haemofiltration and/or haemodialysis. Potassium supplement might be necessary.

Phosphate up to 1.2 mmol/L may be added to the solution. 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 used will depend on the blood concentration of

electrolytes, acid-base balance, and overall patient’s clinical condition. Administration (dose, infusion

rate and cumulative volume) of Hemosol B0 should be established by a physician. Continued

application of haemofiltration will remove excess fluid and electrolytes.

In case of fluid imbalance, the clinical situation must be carefully monitored and fluid balance should

be corrected as needed.

Overdose will result in fluid overload if the patient is suffering from renal failure, and it could lead to

severe consequences, such as congestive heart failure, electrolyte or acid-base disturbances.

Because the solution contains no glucose, administration may lead to hypoglycaemia. Blood glucose

levels should be monitored regularly.

Hemosol B0 contains hydrogen carbonate (bicarbonate), and lactate (a hydrogen carbonate precursor)

which can influence the patient’s acid-base balance. If metabolic alkalosis develops or worsens during

therapy with the solution, the administration rate may need to be decreased, or the administration

stopped.

Posology

Commonly used flow rates for the substitution solution in haemofiltration and haemodiafiltration are:

Adult

500-3000 mL/h

Commonly used flow rates for the dialysis solution (dialysate) in continuous haemodialysis are:

Adult

500-2500 mL/h

Commonly used flow rates in adults are approximately 2000 to 2500 ml/h which correspond to a daily

fluid volume of approximately 48 to 60 L.

Paediatric population

The range of flow rates for the substitution solution in haemofiltration and haemodiafiltration and for

the dialysis solution (dialysate) in continuous haemodialysis are:

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

Flow rates up to 4,000 mL/h/1.73 m

may be needed, especially in younger children (≤10 kg). The

absolute flow rate (in mL/h) in the paediatric population should generally not exceed the maximum

adult flow rate.

Instruction for use / handling

The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B)

after opening the frangible pin immediately before use to obtain the reconstituted solution.

Use only with appropriate extracorporeal renal replacement equipment.

Aseptic technique should be used throughout the handling and administration to the patient.

Use only if the overwrap is undamaged, all seals are intact, frangible pin is not broken and the solution

is clear. Press bag firmly to test for any leakage. If leakage is discovered, discard the solution

immediately since sterility can no longer be assured.

The large compartment B is fitted with an injection port for the possible addition of other necessary

drugs after reconstitution of the solution. It is the responsibility of the physician to judge the

compatibility of an additive medication with Hemosol B0 by checking for eventual colour change

and/or eventual precipitation, insoluble complexes or crystals. Before adding a medication, verify it is

soluble and stable in water within the pH limits of Hemosol B0 (pH limits of reconstituted solution is

7.0 to 8.5). Additives may be incompatible. The Instructions for Use of the medication to be added

must be consulted.

Remove any fluid from the injection port, hold the bag upside down, insert the drug through the

injection port and mix thoroughly. The solution must be administered immediately.

The introduction and mixing of additives must always be performed prior to connecting the solution

bag to the extracorporeal circuit.

I

Remove the over wrap from the bag immediately before use and discard any other packaging

materials. Open the seal by breaking the frangible pin between the two compartments of the bag.

The frangible pin will remain in the bag. (See figure I below)

II

Make sure all the fluid from the small compartment A is transferred into the large compartment

B. (See figure II below)

III

Rinse the small compartment A

twice

by pressing the mixed solution back into the small

compartment A and then back into the large compartment B. (See figure III below)

IV

When the small compartment A is empty: shake the large compartment B so that the contents

mix completely. The solution is now ready for use and the bag can be hung on the equipment.

(See figure IV below)

V

The dialysis or replacement line may be connected to either of the two access ports.

V.a

If the luer access is used, remove the cap with a twist and pull motion, and connect the male luer

lock on the dialysis or replacement line to the female luer receptor on the bag using a push and

twist motion. Ensure that the connection is fully seated and tighten. The connector is now open.

Verify that the fluid is flowing freely. (See figure V.a below)

When the dialysis or replacement line is disconnected from the luer connector, the connector

will close and the flow of the solution will stop. The luer port is a needle-less and swabbable

port.

V.b

If the injection port is used, first remove the snap-off cap. Then introduce the spike through the

rubber septum. Verify that the fluid is flowing freely. (See figure V.b below)

The solution should be used immediately after removal of the overwrap. If not used immediately, the

reconstituted solution should be used within 24 hours, including the duration of the treatment after

addition of the electrolyte solution to the buffer solution.

The reconstituted solution is for single use only. Discard any unused solution immediately after use.

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

requirements.

Package Leaflet: Information for the user

Hemosol B0 solution for haemodialysis/haemofiltration

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

hydrogen carbonate.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2. What you need to know before you use 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

2.

What Hemosol B0 is and what it is used for

Hemosol B0 is used in hospitals in intensive care treatments to correct chemical imbalance of the

blood which is caused by kidney failure. The treatments are designed to remove accumulated waste

products from the blood when the kidneys are not functioning.

Hemosol

B0 is used in the following types of treatment in adult and children of all ages:

haemofiltration,

haemodiafiltration and

haemodialysis.

3.

What you need to know before you use Hemosol B0

Do not use Hemosol B0:

If you are allergic to one of the active substances or any of the other ingredients (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Hemosol B0.

Hemosol B0 is a product to be used in hospitals and administered by medical professionals only. They

will ensure a safe use of the medicine.

Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and

concentrations of salts in the blood (electrolytes) will be monitored, including all fluid you are given

(intravenous infusion) and that you produce (urine production), even those not directly related to the

therapy.

As Hemosol B0 is potassium-free, special attention will be given to the level of potassium in your

blood. Should you suffer from low potassium a potassium supplement might be necessary.

Children

There are no specific warnings and precautions when using this medicine for children.

Other medicines and Hemosol B0

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

This is because the concentration level in the blood of some of other medicines being taken may be

reduced during the treatment with Hemosol B0. Your doctor will decide if other medicines being taken

should be changed.

In particular tell your doctor if you are using either of the following:

Digitalis medicine (for treatment of certain heart conditions); as the risk of irregular or rapid

beating of the heart (cardiac arrhythmia) caused by digitalis is increased during a low

concentration of potassium in the blood (hypokalaemia).

Vitamin D and medicinal products containing calcium, as they can increase the risk of a high

concentration of calcium in the blood (hypercalcaemia).

Any addition of sodium bicarbonate (or other buffer source) may increase the risk of excess of

bicarbonate in your blood (metabolic alkalosis).

When citrate is used as an anticoagulant, it can reduce plasma calcium levels.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine. No effects on fertility or during

pregnancy or on the breast-fed newborn/infant are anticipated. Your doctor will decide if you should

be given Hemosol B0 if you are pregnant or breast-feeding.

Driving and using machines

Hemosol B0 will not have any effect on the ability to drive or use machines.

3.

How to use Hemosol B0

Hemosol B0 is a product to be used in hospitals and administered by medical professionals only.

The volume of Hemosol B0, and therefore the dose used, will depend on your condition. The dose

volume will be determined by the physician responsible for your treatment.

Hemosol B0 can be administered directly into the bloodstream (intravenously) or via haemodialysis,

where the solution flows on one side of a dialysis membrane while the blood flows on the other side.

If you use more Hemosol B0

than you should

Hemosol B0 is a product to be used in hospitals and administered by medical professionals only and

your fluid balance, electrolyte and acid-base balance will be carefully monitored.

Therefore, it is unlikely that you will use more Hemosol B0

than you should.

In the unlikely event that an overdose occurs, your doctor will take necessary corrective measures and

adjust your dose.

Overdose may result in:

fluid overload in your blood,

elevation of the bicarbonate blood level (metabolic alkalosis),

and/or reduction of levels of salts in the blood (hypophosphataemia, hypokalaemia).

For instructions for use, please see section “The following information is intended for healthcare

professionals only”.

If you have any further questions on the use of 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.

Read the complete document

Health Products Regulatory Authority

11 December 2020

CRN009NJP

Page 1 of 7

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Hemosol B0 solution for haemodialysis/haemofiltration

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hemosol B0 consists of a two compartment PVC bag containing the electrolyte solution in the small compartment

(compartment A) and the buffer solution in the large compartment (compartment B).

BEFORE RECONSTITUTION

1 000 ml of electrolyte solution (small

compartment A) contains:

active substances:

Calcium chloride, 2H

Magnesium chloride, 6H

Lactic acid

5,145 g

2,033 g

5,4 g

1 000 ml of buffer solution (large

compartment B) contains:

active substances:

Sodium hydrogen carbonate

Sodium chloride

3,09 g

6,45 g

AFTER RECONSTITUTION

The small and the large compartments are mixed to give one reconstituted solution whose ionic composition is:

in mmol/l

in mEq/l

Calcium Ca

1,75

3,50

Magnesium Mg

Sodium Na

Chloride Cl

109,5

109,5

Lactate

Hydrogen carbonate HCO

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for haemodialysis/haemofiltration.

Clear and colourless reconstituted solution.

Theoretical Osmolarity: 287 mOsm/l

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

As substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous

haemodialysis for acute renal failure in adult and children of all ages.

Health Products Regulatory Authority

11 December 2020

CRN009NJP

Page 2 of 7

4.2 Posology and method of administration

Posology:

The rate at which Hemosol B0 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid

balance and overall clinical condition of the patient. The volume of replacement solution and/or dialysate to be administered

will also depend on the desired intensity (dose) of the treatment. The solution should be prescribed and administration (dose,

infusion rate, and cumulative volume) should be established only by a physician experienced in critical care medicine and CRRT

(Continuous Renal Replacement Therapy).

Commonly used flow rates for the substitution solution in haemofiltration and haemodiafiltration are:

Adult: 500 - 3000 mL/hour

Commonly used flow rates for the dialysis solution (dialysate) in continuous haemodialysis are:

Adult: 500 - 2500 mL/hour

Commonly used flow rates in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of

approximately 48 to 60 L.

Special population:

Elderly population

Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in

safety or effectiveness.

Paediatric population:

The range of flow rates for the substitution solution in haemofiltration and haemodiafiltration and for the dialysis solution

(dialysate) in continuous haemodialysis are:

Children (from neonates to adolescents to 18 years): 1000 to 2000 mL/h/1.73 m

Flow rates up to 4,000 mL/h/1.73 m

may be needed, especially in younger children (≤10 kg). The absolute flow rate (in mL/h)

in the paediatric population should generally not exceed the maximum adult flow rate.

Method of administration:

Intravenous use and for haemodialysis.

Hemosol B0, when used as a substitution solution is administered into the extracorporeal circuit before (pre-dilution) or after

the haemofilter or haemodiafilter (post-dilution).

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Warnings:

The substitution solution Hemosol B0 is potassium-free. The serum potassium concentration must be monitored before and

during hemofiltration and/or hemodialysis.

The electrolyte solution must be mixed with the buffer solution before use to obtain the final solution suitable for

haemofiltration/haemodiafiltration/continuous haemodialysis.

Use only with appropriate extracorporeal renal replacement equipment.

Health Products Regulatory Authority

11 December 2020

CRN009NJP

Page 3 of 7

Because the solution contains no glucose, administration may lead to hypoglycemia. Blood glucose levels should be monitored

regularly.

Hemosol B0 contains hydrogen carbonate (bicarbonate), and lactate (a hydrogen carbonate precursor) which can influence the

patient’s acid–base balance. If metabolic alkalosis develops or worsens during therapy with the solution, the administration rate

may need to be decreased, or the administration stopped.

The use of contaminated haemofiltration solution may cause sepsis, shock and fatal conditions.

Precautions for use:

Hemosol B0 may be warmed to 37 °C to enhance patient comfort. Warming of the solution prior to use should be done before

reconstitution with dry heat only. Solutions should not be heated in water or in a microwave oven. The solution should be

inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do

not administer unless the solution is clear and the seal is intact.

Before and during treatment, electrolyte and acid-base balance should be closely monitored throughout the procedure.

Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium

concentration should not exceed 4 mEq/L (4 mmol/L). Potassium supplement might be necessary.

The patient’s hemodynamic status and fluid balance should be monitored throughout the procedure and corrected as needed.

Paediatric population:

There are no specific warnings and precautions when using this medicine for children.

4.5 Interaction with other medicinal products and other forms of interactions

The blood concentration of filterable/dialysable drugs may be reduced during treatment. Corresponding corrective therapy

should be instituted if necessary to establish the desired blood concentrations for drugs removed during treatment.

Interactions with other medications due to electrolyte and/or acid-base imbalances can be avoided by correct dosage of the

solution for haemodialysis/haemofiltration and precise monitoring.

However, the following interactions are conceivable:

The risk of digitalis-induced cardiac arrhythmia is increased during hypokalaemia;

Vitamin D and vitamin D analogues, as well as medicinal products containing calcium (e.g. calcium chloride or calcium

gluconate used for maintenance of calcium homeostasis, in CRRT patients receiving citrate anticoagulation and calcium

carbonate as phosphate binder) can increase the risk of hypercalcaemia;

Additional sodium hydrogen carbonate (or other buffer source) contained in the CRRT fluids or in other fluids administered

during therapymay increase the risk of metabolic alkalosis;

When citrate is used as an anticoagulant, it contributes to the overall buffer load and can reduce plasma calcium levels.

4.6 Fertility, pregnancy and lactation

Pregnancy and breastfeeding

No effects during pregnancy or on the breast-fed newborn/infant are anticipated. There is no report on Hemosol B0 during

pregnancy or lactation but literature on renal replacement therapy during acute kidney injury does not suggest risks associated

with solutions. The prescriber should consider the benefit/risk relationship before administering Hemosol B0 to pregnant or

breast feeding women.

Fertility

There are no clinical data on fertility. However no effects on fertility are anticipated.

4.7 Effects on ability to drive and use machines

Not relevant.

Health Products Regulatory Authority

11 December 2020

CRN009NJP

Page 4 of 7

4.8 Undesirable effects

The following undesirable effects are reported from post-marketing experience. The table presented below is according to the

MedDRA system organ classification (SOC and Preferred Term Level).

Frequencies: Not known (cannot be estimated from the available data).

System Organ Class

Preferred Term

Frequency

Metabolism and nutrition disorders

Electrolyte imbalances, e.g.:hypophosphataemia, hypokalaemia

Not known

Acid-base balance disorders

Not known

Fluid imbalance

Not known

Vascular disorders

Hypotension

Not known

Gastrointestinal disorders

Nausea

Not known

Vomiting

Not known

Musculoskeletal and connective tissue disorders

Muscle spasms

Not known

Special attention must be taken for patients with hypokalaemia as this solution is potassium-free (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

4.9 Overdose

Overdose with Hemosol B0 substitution fluid should not occur if the procedure is carried out correctly and the fluid balance,

electrolyte and acid-base balance of the patient are carefully monitored.

However, overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acid-base disturbances.

If hypervolaemia or hypovolaemia occur, this should be corrected immediately.

If electrolyte imbalance and acid-base balance abnormalities (e.g., metabolic alkalosis, hypophosphataemia, hypokalaemia, etc.)

occur, stop administration promptly. There is no specific antidote for overdose. The risk can be minimized by close monitoring

and adequate supplementation during treatment (see section 4.4).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Hemofiltrates, ATC code: B05ZB.

Pharmacodynamic effects

Hemosol B0 is pharmacologically inactive. The sodium, calcium, magnesium and chloride ions are present at concentrations

similar to physiological levels in plasma.

Mechanism of action

The solution is used to replace water and electrolytes removed during haemofiltration or to serve as a suitable exchange

medium for use during haemodiafiltration or continuous haemodialysis.Hydrogen carbonate is used as an alkalising buffer.

5.2 Pharmacokinetic properties

Not relevant. The active ingredients are pharmacologically inactive and are present at concentrations similar to physiological

plasma levels.

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5.3 Preclinical safety data

Not relevant. The active ingredients are pharmacologically inactive and are present at concentrations similar to physiological

plasma levels.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

In the small compartment A: Water for injections

In the large compartment B: Water for injections, Carbon dioxide

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

It is the responsibility of the physician to judge the incompatibility of an additive medication with the Hemosol B0 solution by

checking for eventual colour change and/or eventual precipitation, insoluble complexes or crystals. The Instructions for Use of

the medication to be added must be consulted.

Before adding a drug, verify it is soluble and stable in water at the pH of Hemosol B0 (pH of reconstituted solution is 7.0 to 8.5).

The compatible medication must be added to the reconstituted solution and the solution must be administered immediately.

6.3 Shelf life

1 year as packaged for sale.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22° C. From a

microbiological point of view, once opened (i.e. connected to the line), and as hydrogen carbonate is present, the reconstituted

solution should be used immediately. Other in-use storage times and conditions prior to use are the responsibility of the user

and would not normally be longer than 24 hours, including the duration of the treatment.

6.4 Special precautions for storage

Do not store below +4°C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

The container made in Polyvinyl chloride (PVC) is a two-compartment bag. The 5000 ml bag is comprised of a small

compartment (250 ml) and a large compartment (4750 ml). The two compartments are separated by a frangible pin.

The large compartment B is fitted with an injection connector (or spike connector) made of polycarbonate (PC), which is closed

with a rubber disc covered by a cap as well as a luer connector (PC) with a frangible pin (PC) or a valve made of silicone rubber

for the connection of the bag with a suitable replacement solution line or dialysis line.

The bag is over wrapped with a transparent overwrap made of multilayer polymer film.

Each two-compartment bag contains 5000 ml.

Package size: 2 x 5000 ml in a box.

6.6 Special precautions for disposal and other handling

The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the

frangible pin immediately before use to obtain the reconstituted solution.

A patient information leaflet with detailed instruction for use is enclosed in the box.

Aseptic technique should be used throughout the handling and administration to the patient:

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Use only if the overwrap is not damaged, all seals are intact, frangible pin or peel seal is not broken, and the solution is clear.

Press bag firmly to test for any leakage. If leakage is discovered, discard the solution immediately since sterility can no longer

be assured.

The large compartment is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of

the solution.

Before adding a substance or medication, verify that it is soluble and stable in Hemosol B0, and that the pH range is

appropriate (pH of reconstituted solution is 7.0 to 8.5).

Additives may be incompatible. The instructions for use of the medication to be added and other relevant literature must be

consulted. After addition, if there is a colour change and/or the appearance of precipitates, insoluble complexes, or crystals, do

not use.

Mix the solution thoroughly when additives have been introduced. The introduction and mixing of additives must always be

performed prior to connecting the solution bag to the extracorporeal circuit.

If a frangible pin separates the two compartments of the bag and a frangible pin is located in the luer connector the following

instructions for use should be followed:

I Remove the over-wrap from the bag immediately before use and discard any other packaging materials.

Open the seal by breaking the frangible-pin between the two compartments of the bag. The frangible-pin will remain in the

bag.

II Make sure all the fluid from the small compartment A is transferred into the large compartment B.

III Rinse the small compartment A twice by pressing the mixed solution back into the small compartment and then back into

the large compartment B.

IV When the small compartment is empty: shake the large compartment B so that the contents mix completely.

The solution is now ready for use and the bag can be hung on the equipment.

V The dialysis or replacement line may be connected to either of the two access ports.

V.a If the luer connector is used, remove the cap and connect the male luer lock on the dialysis or replacement line to the

female luer receptor on the bag; tighten. Using thumb and fingers, break the coloured frangible pin at its base, and move it

back and forth. Do not use a tool. Verify that the pin is completely separated and that the fluid is flowing freely. The pin will

remain in the luer port during the treatment.

V.b If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that

the fluid is flowing freely.

If a frangible pin separates the two compartments of the bag and a valve is located in the luer connector, the following

instructions for use shall be followed:

I Remove the over wrap from the bag immediately before use and discard any other packaging materials. Open the seal by

breaking the frangible pin between the two compartments of the bag. The frangible pin will remain in the bag.

II Make sure all the fluid from the small compartment A is transferred into the large compartment B.

III Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back

into the large compartment B.

IV When the small compartment A is empty: shake the large compartment B so that the contents mix completely. The

solution is now ready for use and the bag can be hung on the equipment.

V The dialysis or replacement line may be connected to either of the two access ports.

Va If the luer access is used, remove the cap with a twist and pull motion, and connect the male luer lock on the dialysis or

replacement line to the female luer receptor on the bag using a push and twist motion. Ensure that the connection is fully

seated and tighten. The connector is now open. Verify that the fluid is flowing freely.

When the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of the

solution will stop. The luer port is a needle-less and swabbable port.

Vb If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that

the fluid is flowing freely.

The solution should be used immediately after removal of the over wrap. If not used immediately, the reconstituted solution

should be used within 24 hours, including the duration of the treatment, after addition of the electrolyte solution to the buffer

solution.

The reconstituted solution is for single use only. Do not use if container is damaged or if solution is not clear. Discard any

unused portion immediately after use.

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

7 MARKETING AUTHORISATION HOLDER

Health Products Regulatory Authority

11 December 2020

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Baxter Holding B.V.

Kobaltweg 49

3542CE Utrecht

Netherlands

8 MARKETING AUTHORISATION NUMBER

PA2299/051/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:11 June 1999

Date of last renewal: 15 October 2014

10 DATE OF REVISION OF THE TEXT

December 2020

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