MULTIBIC

What it is multiBic is a solution for haemofiltration comprised of electrolytes needed for continuous renal replacement therapies. It is used as a substitution solution in haemofiltration therapy. multiBic is provided in a two-compartment bag with 4.75 L of an alkaline bicarbonate solution in one compartment and 0.25 L of an acidic electrolyte glucose solution in the other compartment to give a total volume of 5 L after mixing.

Approved indications

— Replacement fluid administered intravenously in patients with acute renal failure in intensive care units.

Dosing overview

The ready-to-use multiBic solution is infused into the extracorporeal circulation by means of a metering pump. The filtration rate is prescribed by the attending physician depending on the clinical status and body weight of the patient, with a total filtration rate of 20–25 mL/kg/h appropriate in adults to remove metabolic waste products depending on the metabolic status of the patient. A maximum filtration rate of 75 L per day is recommended. The ready-to-use solution must be used immediately, but within a maximum of 48 hours after mixing.

Key safety warnings

The haemofiltration solution should be warmed prior to infusion with appropriate equipment to approximately body temperature and must not be infused under any circumstances below room temperature. The warming must be carefully controlled verifying that the solution is clear and without particles. White calcium carbonate precipitation has been observed in the tubing lines in rare cases, particularly close to the pump unit and the heating unit, particularly if the temperature of the ready-to-use solution at the inlet of the pump unit is already higher than 30°C. The multiBic solution in the tubing lines should be closely visually inspected every 30 minutes during continuous renal replacement therapy to ensure the solution in the tubing system is clear and free from precipitate. If precipitate is observed, the ready-to-use solution and continuous renal replacement therapy tubing lines must be replaced immediately and the patient carefully monitored. The serum sodium and potassium concentrations must be checked regularly before and during use of this solution. The potassium status of the patient and its trend during haemofiltration must be considered. The following parameters should be monitored before and during haemofiltration: serum sodium, serum calcium, serum magnesium, serum phosphate, serum glucose, acid-base status, levels of urea and creatinine, body weight and fluid balance.

Contraindications multiBic potassium-free solution should not be used in patients suffering from hypokalaemia, metabolic alkalosis, or hypersensitivity to the active substances or any of the excipients. multiBic solution containing 4 mmol/L potassium should not be used in patients suffering from hyperkalaemia, metabolic alkalosis, or hypersensitivity to the active substances or any of the excipients. Haemofiltration-dependent contraindications due to the technical procedure itself include renal failure with increased hypercatabolism in cases where uraemic symptoms can no longer be relieved by haemofiltration, inadequate blood flow from vascular access, and high risk of haemorrhage on account of systemic anticoagulation.

Regulatory history multiBic potassium-free (ARTG

357591) and multiBic 4 mmol/L potassium (ARTG 357590) were both first listed on the ARTG on 2 August 2021. The product was first approved on 4 March 2014.