Source: Heads of Medicines Agencies (EU) Revision Year: 2018 Publisher: B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany, Phone: +49 5661 71 0, Fax: +49 5661 71 4567
Pharmacotherapeutic group: Solutions affecting the electrolyte balance, electrolytes
ATC code: B05BB01
This medicinal product is an isotonic electrolyte solution with electrolyte concentrations adapted to plasma electrolyte concentrations. It is used to correct extracellular fluid losses (i.e. losses of water and electrolytes in proportional amounts). The supply of the solution is aimed to restore as well as maintain normal osmotic conditions in the extracellular and intracellular space.
The anion pattern represents a balanced combination of chloride, acetate, and malate which counteracts metabolic acidosis.
Since the ingredients of Sterofundin ISO are infused intravenously their bioavailability is 100%.
Sodium and chloride mainly distribute in the extracellular space, whereas the preferential distribution of potassium, magnesium and calcium is intracellular. The kidneys are the main route of excretion for sodium, potassium, magnesium, and chloride but small amounts are lost via the skin and intestinal tract. Calcium is excreted in approximately equal amounts in urine and endogenous intestinal secretion.
During the infusion of acetate and malate, their plasma levels rise and appear to reach a steady state. Following termination of the infusion, the acetate and malate concentrations rapidly diminish. Acetate and malate excretion in urine rises during the infusion. However, their metabolism by body tissues is so rapid that only a small fraction appears in urine.
No preclinical studies have been conducted with Sterofundin ISO. There are no data of relevance to the prescriber additional to those already included elsewhere in the SPC.
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