MULTIBIC

Continuous renal replacement therapy including the prescription of this medicinal product should be performed under the direction of a physician with experience in these treatments. Posology In acute kidney injury, a continuous treatment with a dose of 2000 ml/h multiBic 3mmol/l potassium is appropriate in adults with a body weight of 70 kg to remove metabolic waste products depending on the metabolic status of the patient.

The dose should be adapted to the body size of the patient. In patients with chronic kidney disease, unless clinically indicated otherwise, the dose of multiBic 3mmol/l potassium should be at least one third of the body weight per session with three sessions applied per week.

Increasing the volume applied per week or distributing this weekly volume to more than 3 treatments per week can be required. The dose and the duration of haemodialysis, haemofiltration or haemodiafiltration necessary in treatment of acute states of intoxication depends on the toxin and its concentration and the severity of clinical symptoms and has to be clinically decided on the individual patient’s condition.

A maximum dose of 75 litre per day is recommended. 1). Method of administration For intravenous use and haemodialysis. 6.

, hypokalaemia), hypophosphataemia, hyperglycaemia, and metabolic alkalosis. The exact frequency of such events is not known (cannot be estimated from the available data). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Use only after mixing of the two solutions. multiBic 3 mmol/l potassium should be warmed prior to use with appropriate equipment to approximately body temperature and must not be used under any circumstances below room temperature. The warming of the ready-to-use solution to approximately body temperature must be carefully controlled verifying that the ready-to-use solution is clear and without particles.

During application of the ready-to-use solution, white calcium carbonate precipitation has been observed in the tubing lines in rare cases, particularly close to the pump unit and the heating unit warming the ready-to-use solution.

Precipitations particularly can occur if the temperature of the ready-to-use solution at the inlet of the pump unit is already higher than 30°C. Therefore, the ready-to-use solution in the tubing lines must be closely visually inspected every 30 min during continuous renal replacement therapy in order to ensure, that the solution in the tubing system is clear and free from precipitate.

Precipitations may occur also with substantial delay after start of treatment. If precipitate is observed, the ready-to-use solution and the tubing lines used for continuous renal replacement therapy must be replaced immediately and the patient carefully monitored.

The serum potassium concentration must be checked regularly before and during continuous renal replacement therapy. The potassium status of the patient and its trend during the treatment must be considered: In case of hypokalaemia supplementation of potassium and / or changing to a solution for haemodialysis/haemofiltration with higher potassium concentration may be required.

In case of hyperkalaemia an increase in the applied dose and / or change to a solution for haemodialysis/haemofiltration with a lower potassium concentration may be indicated as well as usual measures of intensive care medicine. The serum sodium concentration must be checked regularly before and during use of this solution for haemodialysis/haemofiltration to control risks related to hypo/hypernatraemia.

1 - Hypokalaemia - Metabolic alkalosis Contraindications for use of the technical procedure itself: - Inadequate blood flow from vascular access - If there is a high risk of haemorrhage on account of systemic anticoagulation.