Special Warning : אזהרת שימוש

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.

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.

Effects on Driving

4.7 Effects on ability to drive and use machines
Not relevant