HEMOSOL B0

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. 73 m2 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). 6.

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). 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 Yellow Card Scheme. uk/yellowcard

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. 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.

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