SODIUM CHLORIDE 0.45% Solution for Infusion Ref.[8050] Active ingredients: Sodium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Pharmacodynamic properties

Pharmacotherapeutic group: "Electrolyte solutions"
ATC code: B05XA03

Sodium Chloride 0.45% Solution for Infusion is a hypotonic solution, with an approximate osmolarity of 154 mOsm/l.

The pharmacodynamic properties of the solution are those of the sodium and chloride ions in maintaining the fluid and electrolyte balance. Ions, such as sodium, circulate through the cell membrane, using various mechanisms of transport, among which is the sodium pump (Na-K-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, and also in renal function.

Chloride is mainly an extracellular anion. Intracellular chloride is in high concentration in red blood cells and gastric mucosa. Reabsorption of chloride follows reabsorption of sodium.

When medication is added to Sodium Chloride 0.45% Solution for Infusion, the overall pharmacodynamics of the solution will depend on the nature of the medicinal product used.

Pharmacokinetic properties

Sodium and Chloride are mainly distributed in blood and extracellular compartiments (Na+: 142 mmol/l – Cl-: 103 mmol/l).

Sodium is predominantly excreted by the kidney with a renal reabsorption.

Small amounts of sodium are lost in the faeces and sweat at the skin level.

When medication is added to Sodium Chloride 0.45% Solution for Infusion, the overall pharmacokinetics of the solution will depend on the nature of the medicinal product used.

Preclinical safety data

Preclinical safety data of this solution for infusion in animals are not relevant since its constituents are physiological components of animal and human plasma.

Toxic effects are not to be expected under the condition of clinical application.

The safety of potential additives should be considered separately.

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