Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
The solution shall be used only by, or under the direction of, a physician competent in CRRT treatments using haemofiltration, haemodiafiltration and haemodialysis.

Warnings:

Phoxilium should not be used in patients with hyperkalaemia (see section 4.3 Contraindications). 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, hyperphosphataemia may occur transiently after treatment is initiated. Decrease the infusion rate and confirm that the desired phosphate concentration is achieved. If hyperphosphataemia does not resolve, stop administration promptly (see section 4.3 Contraindications).

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. Blood glucose levels should be monitored regularly in diabetic patients (including careful consideration of patients receiving insulin or other glucose lowering medications), but also considered in non-diabetic patients, e.g. risk for silent hypoglycaemia 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.

The instructions for use (see section 6.6) 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.

Effects on Driving

4.7 Effects on ability to drive and use machines
Not relevant