PHOXILIUM

Posology:

The volume and rate at which Phoxilium 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 Phoxilium should only be established by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy). The dose volume is therefore at the discretion and prescription of the responsible physician.

The range of flow rates for the replacement solution in haemofiltration and haemodiafiltration are: Adult: 500 - 3000 ml/hour The range of flow rates for the dialysate in continuous haemodialysis and continuous haemodiafiltration are: Adult: 500 - 2500 ml/hour 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.

Method of administration:

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

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Undesirable effects can result from the solution used or the treatment. Bicarbonate-buffered haemofiltration and haemodialysis solutions are generally well tolerated. The following undesirable effects have been reported from post-marketing experience.

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, metabolic alkalosis not known Vascular disorder Hypotension* not known Nausea* not knownGastrointes tinal disorder 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.

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The solution shall 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 Phoxilium 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 Phoxilium is used as a dialysate, administration of a potassium-free dialysate may be necessary to increase the rate of potassium removal. Because Phoxilium 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 Contraindication). Electrolyte and blood acid/base parameters should be monitored regularly in patients treated with Phoxilium. Phoxilium contains hydrogen phosphate, a weak acid that can influence the patient’s acid/base balance.

If metabolic acidosis develops or worsens during therapy with Phoxilium, the infusion rate may need to be decreased or its administration stopped. Because Phoxilium 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 Do not administer the solution unless it is clear. Aseptic technique must be used during connection / disconnection of the line sets to the Phoxilium container. Use only with an appropriate extracorporal renal replacement equipment.

Special precautions for use:

Phoxilium 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. Phoxilium 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 shall be closely monitored throughout the procedure including all fluid inputs and outputs, even those not directly related to CRRT.

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.

1. Solution dependent contraindications • Hyperkalaemia • Metabolic alkalosis • Hyperphosphataemia Haemofiltration/- dialysis dependent contraindications • Renal failure with pronounced hypercatabolism, if the uraemic symptoms cannot be corrected with haemofiltration or haemodiafiltration, • Insufficient arterial pressure in the vascular access, • Systemic anticoagulation if there is a high risk of haemorrhage.