BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION [SIN15514P]

Product Info

BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION

[SIN15514P]

4.1 THERAPEUTIC INDICATIONS
Biphozyl solution is used as replacement solution and as dialysate for treatment of acute kidney injury during continuous renal replacement therapy (CRRT). Biphozyl solution is used in a post-acute phase after initiation of renal replacement therapy when pH, potassium and phosphate concentration have returned to normal. Biphozyl solution is also used when other buffer sources are available as well as during regional citrate anticoagulation. Moreover, Biphozyl solution is used in patients with hypercalcaemia.

Biphozyl solution may also be used in cases of drug poisoning or intoxications when the substances are dialysable or filterable.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION

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:

The range of flow rates when used as dialysate in continuous haemodialysis and continuous haemodiafiltration are:

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.

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

Biphozyl 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 (Special precautions for disposal and other handling) – 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.

• Hypocalcaemia unless calcium is provided to the patient by other sources.

• Hyperkalaemia.

• Hyperphosphatemia.