Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Gambro Lundia AB, Magistratsvägen 16, 226 43 Lund, Sweden
Pharmacotherapeutic group: Haemofiltrates
ATC code: B05ZB
The constituents of Biphozyl are naturally and physiologically occurring electrolytes. Sodium, potassium, magnesium, chloride and phosphate ions are present at concentrations similar to physiological levels in plasma. The concentrations of these electrolytes are the same whether the solution is used as a replacement or as a dialysate.
Sodium and potassium concentrations in the replacement solutions are kept within the normal range of serum concentration. Chloride concentration in the formulation depends on the relative amount of the other electrolytes. Hydrogen carbonate, the physiological buffer of the body, is used as an alkalizing buffer.
From a pharmacodynamic point of view, this drug product after reconstitution is pharmacologically inactive. The drug substances are normal constituents of the physiological plasma and their concentrations in the solutions are only aimed to restore or normalize the plasma acid-base and electrolyte balance. Toxic effects due the use of Biphozyl are not expected at therapeutic dose.
Sodium, potassium, magnesium, chloride and phosphate ions are present at concentrations similar to physiological levels in plasma. Absorption and distribution of the constituents of Biphozyl is determined by the patient’s clinical condition, metabolic status, and residual renal function. All the ingredients are present at physiological concentrations. Additional pharmacokinetics studies are therefore not considered relevant or applicable in this scenario.
The drug substances included are physiological components in human plasma. According to the available information and the clinical experience with these substances used in chronic treatment of renal failure or in intensive care units, no toxic effects are expected at therapeutic dose.
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