Sodium chloride

INSTRUCTIONS for medical use of the medicinal product SODIUM CHLORIDE (Sodium chloride)

Composition:

Active substance: sodium chloride;

1 ml of solution contains sodium chloride 9 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Blood substitutes and perfusion solutions. Electrolyte solutions. ATC code B05X A03.

Pharmacological properties.

Pharmacodynamics.

Sodium chloride 9 mg/mL solution normalizes water-electrolyte balance and eliminates fluid deficiency in the human body that develops during dehydration or due to accumulation of extracellular fluid in large burn wounds and injuries, during abdominal surgeries, and in peritonitis.

Sodium chloride 9 mg/mL solution 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 leaves the vascular system. The medicinal product remains in the vascular compartment for a short period, after which it passes into the interstitial and intracellular compartments. After 1 hour, only approximately half of the administered solution remains in the blood vessels. Salts and fluid are very rapidly excreted by the kidneys, increasing diuresis.

Clinical characteristics.

Indications.

For replenishment of body fluid deficiency and as part of intensive care therapy; as a solvent for other compatible medicinal products. Can be used locally for wound irrigation, nasal mucosa, as well as for catheters and transfusion systems.

Contraindications.

Hyperhydration, hyperchloremia, hypernatremia, chloride acidosis, conditions associated with the risk of pulmonary edema development.

The medicinal product should not be used for eye irrigation during ophthalmological surgeries.

Interaction with other medicinal products and other types of interactions.

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

Special precautions.

During prolonged administration, especially in large volumes, it is necessary to monitor electrolyte levels in plasma and urine, as well as diuresis.

Use with caution in patients with impaired renal excretory function, decompensated heart defects, and ascites-edema syndrome in patients with liver cirrhosis.

Concomitant administration with corticosteroids or corticotropin requires constant monitoring of blood electrolyte levels.

In shock conditions and blood loss, transfusion of blood, plasma, and plasma substitutes can be performed simultaneously with the use of 9 mg/mL sodium chloride solution.

Use during pregnancy or breastfeeding.

The medicinal product may be used if indicated.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Administration and Dosage

Administer intravenously, rectally, and externally.

For intravenous infusion, administer up to 3 L or more of the solution per day at a rate of 4−10 mL/kg/hour, depending on the clinical condition and degree of fluid loss. May be used orally. Administer as enemas in doses of 75−100 mL. Use for wound and mucous membrane irrigation.

Children

In children with shock due to dehydration (without laboratory confirmation), administer 20−30 mL/kg. Subsequent dosage should be adjusted based on laboratory parameters. The total daily dose depends on the patient's water and electrolyte balance.

Overdose

May lead to chloride acidosis, increased renal potassium excretion, hyperhydration, and hypervolemia, which may result in cardiac failure. If symptoms of these conditions occur, administration of the drug should be discontinued, the patient's condition assessed, and appropriate supportive measures provided.

Side effects.

Not observed when the medicinal product is used correctly. With massive infusions, development of chloride acidosis is possible.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Freezing of the preparation is permitted during storage, provided the integrity of the bottle or bag is maintained.

Incompatibility.

Not established.

Packaging.

100 ml, 200 ml, 250 ml, 400 ml, or 500 ml in bottles; 250 ml, 500 ml, or 1000 ml in bags.

Prescription status. Prescription only.

Manufacturer. Limited liability company "Novofarm-Biosyntez".

Manufacturer's address and place of business.

38, Zhytomyrska Street, Zvyagel, Zvyagelskyi district, Zhytomyr region, 11700, Ukraine.