Hemosol B0 solution for haemodialysis/haemofiltration

• 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.

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

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

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.

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

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.

If you are pregnant or breastfeeding, 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.

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

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 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:

By reporting side effects you can help provide more information on the safety of this medicine.

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, 2H₂O 5.145 g

Magnesium chloride, 6 H₂O 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, Ca²⁺ 1.75

Magnesium, Mg²⁺ 0.5

Sodium, Na⁺ 140

Chloride, Cl⁻ 109.5

Lactate 3

Hydrogen carbonate, HCO₃⁻ 32

Theoretical Osmolarity: 287 mOsm/l

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

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 peel seal 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.

This medicine 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.