PRISMASOL

Posology:

The rate at which Prismasol 4 mmol/l Potassium 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). Flow rates for the substitution solution in haemofiltration and haemodiafiltration are: Adult: 500 - 3000 mL/hour Flow rates for the dialysis solution (dialysate) in continuous haemodialysis and continuous haemodiafiltration 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. Prismasol 4 mmol/l Potassium, when used as a substitution solution is administered into the extracorporeal circuit before (pre-dilution) or after the haemofilter or haemodiafilter (post-dilution).

6 Special precautions for disposal and other handling.

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). g. : fluid retention, dehydration Not known Metabolism and nutrition disorders Hyperglycaemia Not known Vascular disorders Hypotension Not known Nausea Not knownGastrointestinal disorders Vomiting Not known Musculoskeletal and connective tissue disorders Muscle spasms Not known Investigations Calcium ionized increased Not known 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. uk/yellowcard

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

Warnings:

The electrolyte solution must be mixed with the buffer solution before use to obtain the reconstituted solution suitable for haemofiltration / haemodiafiltration / continuous haemodialysis. Use only with appropriate extracorporeal renal replacement equipment.

The solution is a potassium-containing solution. The solution should not be used in patients with hyperkalaemia. The serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis. If hyperkalaemia occurs after treatment is initiated, additional sources of potassium influencing blood concentrations should be assessed.

When the solution is used as a replacement solution, decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalaemia does not resolve, stop the infusion promptly. If hyperkalaemia develops when the solution is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal.

Despite no cases of severe corn hypersensitivity reactions being reported with Prismasol, solutions containing glucose derived from hydrolysed maize starch should not be used in patients with a known allergy to maize or maize products.

The administration must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Because the solution contains glucose and lactate hyperglycaemia may develop, especially in diabetic patients.

Blood glucose levels should be monitored regularly. If hyperglycaemia develops, administration of glucose-free replacement solution/dialysate may be necessary. Other corrective measures may be needed to maintain desired glycaemic control.

Prismasol 4 mmol/l Potassium 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 and haemodialysis solution may cause sepsis, shock and death.

Special precautions for use:

Prismasol 4 mmol/l Potassium 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. Use sodium phosphate if adding phosphate to the bag. Inorganic phosphate must be substituted in cases of hypophosphataemia. The patient’s haemodynamic 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.

* Solution dependent contraindications • Hyperkalaemia • Metabolic alkalosis. * Please pay attention that glucose contained in Prismasol may be produced from hydrolysed corn starch and therefore the presence of corn antigen in the finished product, as hypersensitivity reactions, cannot be excluded.

Haemofiltration/- dialysis dependent contraindications • Renal failure with pronounced hypercatabolism, if the uraemic symptoms cannot be corrected with haemofiltration, • Insufficient arterial pressure in the vascular access, • Systemic anticoagulation (high risk of haemorrhage).