Sodium chloride

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SODIUM CHLORIDE (SODIUM CHLORIDE)

Composition:

Active substance: sodium chloride;

1 ml of solution contains 9 mg of sodium chloride;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear colorless liquid.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Electrolyte solutions. ATC code B05XA03.

Pharmacological properties.

Pharmacodynamics.

0.9% sodium chloride solution normalizes the water-electrolyte balance and eliminates fluid deficiency in the human body, which develops during dehydration or due to accumulation of extracellular fluid in large burn areas and trauma, as well as during abdominal surgeries and peritonitis. The drug improves tissue perfusion and enhances the effectiveness of blood transfusion measures in massive blood loss and severe forms of shock. It also exerts a detoxifying effect due to a transient increase in fluid volume, reduction of toxic substances concentration in the blood, and stimulation of diuresis.

Pharmacokinetics.

Rapidly eliminated from the vascular system. The drug remains in the vascular bed for a short period, after which it passes into the interstitial and intracellular compartments. After 1 hour, only about half of the administered solution remains in the blood vessels. Salts and fluid begin to be very rapidly excreted by the kidneys, increasing diuresis.

Clinical characteristics.

Indications.

For the preparation of medicinal solutions for topical and parenteral administration.

May be used locally for wound irrigation and irrigation of the nasal mucosa.

Contraindications.

Incompatibility between the active medicinal substance and the solvent.

Do not use for eye irrigation during ophthalmic surgeries.

Interaction with other medicinal products and other forms of interaction.

The product is compatible with most medicinal agents; therefore, it can be used for dissolving various medicinal products, except those incompatible with sodium chloride as a solvent.

Special precautions for use.

Before reconstituting the medicinal product, check whether sodium chloride solution can be used for dissolving this medicinal product.

Use during pregnancy or breastfeeding.

This medicinal product can be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Has no effect.

Method of administration and dosage.

Administer intravenously, intramuscularly, rectally, or subcutaneously (depending on the recommended route of administration).

For wound and mucous membrane irrigation, use sufficient amount of the solution.

Children.

The drug can be used in children.

Overdose.

Unlikely when used correctly.

Adverse reactions.

Not observed when the medicinal product is used correctly.

Reporting suspected adverse reactions

Reporting of adverse reactions following registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Incompatibilities. Determined by the medicinal product, which should be diluted with sodium chloride solution.

Packaging.

2 ml in a polyethylene ampoule. 10 ampoules per cardboard pack.

5 ml in a polyethylene ampoule. 10 or 50 ampoules per cardboard pack.

10 ml in a polyethylene ampoule. 10 ampoules per cardboard pack.

Prescription status. Prescription only.

Manufacturer. LLC "FARMASEL".

Manufacturer's name and address of the place of business.

3, Prorizna Street, village Kvitneve, Brovary District, Kyiv Oblast, 07408, Ukraine.