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Solution for Haemodialysis/ Haemofiltration
2 X 5000 ml
The volume of the drug used will depend on the clinical condition of the patient and the targeted fluid balance. 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 and adolescents: 500 – 3000 ml/hour.
Children: 15 – 35 ml/kg/hour. The range of flow rates for the dialysis solution (dialysate) in continuous haemodialysis and continuous haemodiafiltration are:
Adult and adolescents: 500 – 2500 ml/hour.
Children: 15 – 30 ml/kg/hour. Commonly used flow rates in adults are approximately 2000 ml/h which correspond to a daily replacement fluid volume of approximately 48 l.
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).
This formulation 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. May also be used in cases of drug poisoning or intoxications when the poisons are dialysable or pass through the membrane. Patients with normal kalaemia and normal or hypophosphataemia.
Hypersensitivity to the active substance (s) or to any of the excipients.
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 aemodiafiltration, Insufficient arterial pressure in the vascular access, Systemic anticoagulation if there is a high risk of haemorrhage. The solution shall be used only by, or under the direction of, a physician competent in renal failure treatments using haemofiltration and continuous haemodialysis. Check to make sure that the solutions are clear and that all seals are intact before mixing. Carefully follow the Solution A must be mixed with solution B before use to obtain the reconstituted solution suitable for haemofiltration and continuous haemodialysis.
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 extra-renal replacement equipment. The heating of this solution to body temperature (37°C) must be carefully controlled. It should also be visually verified that the solution is clear and without particles prior to administration. If not, discard and do not use the solution. Haemodynamic status, fluid balance, electrolyte and acid-base balance shall be closely monitored throughout the procedure.In case of fluid imbalance (i.e. cardiac failure, head trauma, etc), the clinical condition of the patient must be carefully monitored with restoration of normal fluid balance. The use of contaminated haemofiltration and haemodialysis solution may cause sepsis and shock.
Vomiting, muscle cramps and hypotension.
See prescribing information for full details.
The blood concentration of filterable/dialysable drugs may be reduced during treatment due to their removal by the haemodialyser, haemofilter or haemodiafilter. Corresponding corrective therapy should be instituted if necessary to establish the correct doses for drugs removed during the procedures. Interactions with other medications can be avoided by correct dosage of the solution for haemofiltration and haemodialysis. The following are several examples of potential drug interactions with this drug: Vitamin D and medicinal products containing calcium (e.g. calcium carbonate as phosphate binder), can increase the risk of hypercalcaemia, Additional sodium bicarbonate administered in the substitution fluid may increase the risk of metabolic alkalosis.
Pregnancy and Lactation
This drug can be used during pregnancy and breast-feeding.
Overdose with this drug should not occur if the procedure is carried out correctly and the fluid balance, electrolyte and acid-base balance of the patient are carefully monitored by trained medical personnel. However, overdose resulting in fluid overload can occur in patients with acute or chronic renal failure. Continuation of treatment with haemofiltration or haemodiafiltration can be used to increase the volume of fluid removal by means of ultrafiltration, to restore normal fluid and thus correct the overdose. Thus in cases of overhydration, the ultrafiltration rate of the haemofilter or haemodiafilter must be increased and the rate of administration of the replacement solution for haemofiltration or haemodiafiltration be reduced. In cases of severe dehydration during haemofiltration or haemodiafiltration it is necessary to decrease ultrafiltration and to increase the administration of replacement solution in order to restore normal fluid balance. Phoxilium overdose can lead to severe clinical condition, such as congestive heart failure, electrolyte or acid-base disturbances.
Storage: Store between +4°C – +30ºC. Do not refrigerate or freeze.