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

• allergy to one of the active substances or any of the other ingredients (listed in section 6),
• a high concentration of potassium in your blood (hyperkalaemia),
• a high concentration of bicarbonate in the blood (metabolic alkalosis).

Presence of corn antigen in Prismasol cannot be excluded.

• Renal failure with pronounced hypercatabolism (abnormally increased catabolism), if the uraemic symptoms (symptoms caused by high concentration of urea in your blood) cannot be corrected with haemofiltration,
• Insufficient arterial pressure in the vascular access,
• Systemic anticoagulation (reduced clotting of your blood), if there is a high risk of haemorrhage (bleeding).

Talk to your doctor, pharmacist or nurse before using Prismasol.

The solution should be used only by, or under the direction of a doctor competent in renal failure treatments using haemofiltration, haemodiafiltration and continuous haemodialysis.

Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and concentrations of electrolytes (salts in the blood) 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.

Your blood glucose concentration should be closely monitored, especially if you are diabetic.

Tell your doctor or pharmacist if you are given, have recently been given or might be given any other medicines.

The blood concentration of some of your other medicines may be reduced during the treatment. Your doctor will decide if your medication 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 cardiac arrhythmia (irregular or rapid beating of the heart) caused by digitalis is increased during hypokalaemia (low concentration of potassium in your blood).
• Vitamin D and medicinal products containing calcium, as they can increase the risk of hypercalcaemia (a high concentration of calcium in your blood).
• Any addition of sodium hydrogen carbonate (or other buffer source) may increase the risk of metabolic alkalosis (excess of bicarbonate in your blood).
• When citrate is used as an anticoagulant (as a protective additive in dialysis equipment), 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. Your doctor will decide if you should be given Prismasol if you are pregnant or breast-feeding.

Prismasol is not known to affect the ability to drive or use machines.

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

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).

Overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acidbase disturbances.

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 are:

Before reconstitution:

1000 ml of electrolyte solution (from the small compartment (A)) contains

Calcium chloride dihydrate 5.145 g

Magnesium chloride hexahydrate 2.033 g

Glucose 22.000 g

(S)-Lactic acid 5.400 g

1000 ml of buffer solution (from the large compartment (B)) contains

Sodium chloride 6.450 g

Sodium hydrogen carbonate 3.090 g

Potassium chloride 0.314 g

After reconstitution:

The solutions in the compartments A (250 ml) and B (4750 ml) are mixed to give one reconstituted solution (5000 ml) of which the composition is:

Calcium (Ca2+) 1.75 mmol/l / 3.50 mEq/l

Magnesium (Mg2+) 0.50 mmol/l / 1.00 mEq/l

Sodium (Na+) 140.00 mmol/l / 140.00 mEq/l

Chloride (Cl-) 113.50 mmol/l / 113.50 mEq/l

Lactate 3.00 mmol/l / 3.00 mEq/l

Hydrogen carbonate (HCO3-) 32.00 mmol/l /32.00 mEq/l

Potassium (K+) 4.00 mmol/l / 4.00 mEq/l

Glucose 6.10 mmol/l

Theoretical Osmolarity: 301 mOsm/l

The other ingredients are: carbon dioxide (E 290), water for injections pH of the reconstituted solution: 7.0–8.5

Prismasol is presented in a twocompartment bag containing in the smaller compartment A, the electrolyte solution, and in the larger compartment B, the buffer solution. The final reconstituted solution is obtained after breaking the peel seal and mixing both solutions. The reconstituted solution is clear and slightly yellow. Each bag (A+B) contains 5000 ml solution for haemofiltration and haemodialysis. The bag is overwrapped with a transparent film.

Each box contains two bags and a 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungaria, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Prismasol 4.