BIPHOZYL Solution for haemodialysis/haemofiltration

The solution must only be used by, or under the supervision of, a physician competent in CRRT treatment using haemofiltration, haemodiafiltration, and haemodialysis. Warnings Biphozyl must not be used in patients with hyperkalaemia (see section 4.3).‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Serum potassium concentration must be monitored before and during haemofiltration and/or haemodialysis. Since the 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, discontinue administration immediately. 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. Since the 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, discontinue administration immediately (see section 4.3). In patients treated with Biphozyl, blood electrolyte levels and acid-base balance parameters must be monitored regularly. 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 entirely. Since 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 considered 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 result in 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 required. For improved patient comfort, Biphozyl may be warmed to 37 °C. Warming of the solution before use should only be carried out 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 closely monitored, including all fluids administered and removed, including those not directly related to CRRT. The bicarbonate content in 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 by reviewing the overall treatment. A solution with a higher bicarbonate content may be required. In case of hypervolaemia, the net ultrafiltration rate prescribed for the CRRT device may be increased and/or the administration rate of solutions other than replacement solutions and/or dialysate may be reduced. In case of hypovolaemia, the net ultrafiltration rate prescribed for the CRRT device may be reduced and/or the administration rate of solutions other than replacement solutions and/or dialysate may be increased (see section 4.9). For general warnings/contraindications related to treatment, see section 4.3.