BIPHOZYL

Posology The volume and rate at which Biphozyl is administered depends on the blood concentration of phosphate and other 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.

Administration (dose, infusion rate and cumulative volume) of Biphozyl should only be established by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy). The range of flow rates when used as replacement solution in haemofiltration and haemodiafiltration are: Adult: 500 - 3000 ml/h The range of flow rates when used as dialysate in continuous haemodialysis and continuous haemodiafiltration are: Adult: 500 - 2500 ml/h Commonly used combined total flow rates for CRRT (dialysate and replacement solutions) in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of approximately 48 to 60 l .

73 m2. For adolescents (12-18 years), the adult dose recommendation should be used when the paediatric dose is calculated to exceed the maximum adult dose Elderly patients Adults > 65 years of age: Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness.

Method of administration Intravenous use and use in haemodialysis. Biphozyl, when used as a replacement solution, is administered into the extracorporeal circuit before (pre-dilution) or after (post-dilution) the haemofilter or haemodiafilter.

Biphozyl, when used as a dialysate, it is administered in the dialysate compartment of the extracorporeal filter separated from the blood flow by a semipermeable membrane. 6 (Special precautions for disposal and other handling).

Undesirable effects can result from the Biphozyl solution used or the dialysis treatment. 4. The following undesirable effects are reported from post-marketing experience. Hydrogen carbonate-buffered haemofiltration and haemodialysis solutions are generally well tolerated.

The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies cannot be estimated from the available data. g. metabolic acidosis not known Vascular disorder Hypotension* not known Gastrointe stinal disorder Nausea* not known Vomiting* not known Muscoskel etal and connective tissue disorders Muscle cramps* not known * undesirable effects related generally to dialysis treatments 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 the Yellow Card Scheme. uk/yellowcard.

The solution should be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis. 3). The serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis.

Because Biphozyl is a potassium-containing solution, hyperkalaemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired potassium concentration is achieved. If hyperkalaemia does not resolve, stop administration promptly.

If hyperkalaemia develops when Biphozyl is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal. Because Biphozyl is a phosphate-containing solution, hyperphosphatemia may occur transiently after treatment is initiated.

Decrease the infusion rate and confirm that the desired phosphate concentration is achieved. 3). Electrolyte and blood acid–base parameters should be monitored regularly in patients treated with Biphozyl. Biphozyl contains hydrogen phosphate, a weak acid that can influence the patient’s acid–base balance.

If metabolic acidosis develops or worsens during therapy with Biphozyl, the infusion rate may need to be decreased or its administration stopped. Because Biphozyl contains no glucose, administration may lead to hypoglycaemia. g. risk for silent hypoglycemia during the procedure.

If hypoglycaemia develops, use of a glucose- containing solution should be considered. Other corrective measures may be necessary to maintain desired glycaemic control. 6) must be strictly followed. The solutions in the two compartments must be mixed before use.

Use of a contaminated solution may cause sepsis and shock. Use only with an appropriate extracorporal renal replacement equipment. 8). Infusion of calcium might be necessary. Biphozyl 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. Biphozyl 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.

Haemodynamic status, fluid balance, electrolyte and acid-base balance should be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT. The content of hydrogen carbonate in Biphozyl is at the lower end of the normal range for blood concentration.

Biphozyl is appropriate when using citrate anticoagulation, as citrate is metabolized to hydrogen carbonate, or when CRRT has been able to restore normal pH values. Assessment of buffer needs through measurement of repeated blood acid/base parameters and review of the overall therapy is mandatory.

A solution with higher hydrogen carbonate content may be required. In case of hypervolaemia, the net ultrafiltration rate prescribed for the CRRT device can be increased and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be reduced.

In case of hypovolaemia, the net ultrafiltration rate prescribed for the CRRT device can be reduced and/or the rate of administration of solutions other than replacement fluid and/or dialysate can be increased. 3.

1. Hypocalcaemia unless calcium is provided to the patient by other sources. Hyperkalaemia. Hyperphosphatemia.