PHOXILIUM 1.2 MMOL/L PHOSPHATE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION [SIN15730P]

Product Info

PHOXILIUM 1.2 MMOL/L PHOSPHATE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION

[SIN15730P]

4.1 Therapeutic indications
PHOXILIUM solution is used for CRRT (Continuous Renal Replacement Therapy) in critically ill patients with ARF (Acute Renal Failure) when pH and kalaemia have been restored to normal and when the patients need phosphate supplementation for loss of phosphate in the ultrafiltrate or to the dialysate during CRRT.

PHOXILIUM solution may also be used in cases of drug poisoning or intoxications when the poisons are dialyzable or pass through the membrane.

PHOXILIUM solution is indicated for use in patients with normal kalaemia and normal or hypophosphataemia.

4.2 Posology and method of administration

Posology:
The volume and rate at which PHOXILIUM solution 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 solution 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.

Paediatric population:
In children from neonates to adolescents to 18 years, the range of flow rates used as substitution solution in haemofiltration and haemodiafiltration and as dialysis solution (dialysate) in continuous haemodialysis and continuous haemodiafiltration are 1000 to 4000 ml/h/1.73 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 solution, when used as a replacement solution is administered into the extracorporeal circuit before (pre-dilution) or after the haemofilter or haemodiafilter (post-dilution).

PHOXILIUM solution, 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.

For instructions on reconstitution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.