BIPHOZYL Solution for haemodialysis/haemofiltration

The solution must only be used by or under the supervision of a physician competent in the treatment with CRRT using haemofiltration, haemodiafiltration and haemodialysis. Warnings Biphozyl should not be used in patients with hyperkalaemia (see section 4.3). Serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis. As Biphozyl solution contains potassium, transient hyperkalaemia may occur after initiation of treatment. Reduce the infusion rate and verify that the desired potassium concentration is achieved. If hyperkalaemia does not resolve, immediately discontinue administration of the product. If hyperkalaemia develops when Biphozyl is used as a dialysate, it may be necessary to increase the rate of potassium removal by administering a potassium-free dialysate. As Biphozyl solution contains phosphate, transient hyperphosphataemia may occur after initiation of treatment. Reduce the infusion rate and verify that the desired phosphate concentration is achieved. If hyperphosphataemia does not resolve, immediately discontinue administration of the product (see section 4.3). Electrolyte levels and acid-base balance parameters in the blood must be monitored regularly in patients treated with Biphozyl. Biphozyl contains hydrogen phosphate, which is a weak acid that may affect the patient's acid-base balance. If metabolic acidosis develops or worsens during treatment with Biphozyl, it may be necessary to reduce the infusion rate or discontinue administration of the product entirely. As Biphozyl does not contain glucose, its administration may lead to hypoglycaemia. Blood glucose levels must be monitored regularly in diabetic patients (including careful assessment of patients receiving insulin or other glucose-lowering agents) and should also be taken into consideration in non-diabetic patients, e.g. those at risk of asymptomatic hypoglycaemia during the procedure. If hypoglycaemia develops, the use of a glucose-containing solution should be considered. Additional corrective measures may be necessary to maintain the desired glycaemic control. The instructions for use must be strictly followed (see section 6.6). The solutions in both compartments must be mixed before use. Use of a contaminated solution may lead to sepsis and shock. Use only with an appropriate extracorporeal device intended for renal replacement therapy. Special precautions for use Biphozyl does not contain calcium and may cause hypocalcaemia (see section 4.8). Calcium infusion may be necessary. For improved patient comfort, Biphozyl may be warmed to 37 °C. Warming of the solution before use should only be performed using dry heat prior to reconstitution. Solutions must not be heated in water or in a microwave oven. Biphozyl should be visually inspected for particulate matter and discolouration prior to administration whenever the solution and container permit. The solution should only be administered if it is clear and the seal is intact. During the procedure, the patient's haemodynamic status, fluid balance, electrolyte levels and acid-base balance must be carefully monitored, including all fluids administered and removed, even those not directly related to CRRT. The bicarbonate content of Biphozyl is at the lower end of the normal blood concentration range. Biphozyl is suitable for use with citrate anticoagulation (as citrate is metabolised to bicarbonate) or when normal pH has been restored by CRRT. The need for buffers must be assessed by repeated measurements of acid-base balance parameters in the blood and review of the overall treatment. A solution with a higher bicarbonate content may be required. In the event of hypervolaemia, the net ultrafiltration rate prescribed for the CRRT device may be increased and/or the rate of administration of solutions other than replacement solutions and/or dialysis solution may be decreased. In the event of hypovolaemia, the net ultrafiltration rate prescribed for the CRRT device may be decreased and/or the rate of administration of solutions other than replacement solutions and/or dialysis solution may be increased (see section 4.9). For general warnings/contraindications related to the treatment, see section 4.3.