SODIUM CHLORIDE

INSTRUCTION for medical use of the medicinal product Sodium Chloride (SODIUM CHLORIDE)

Composition:

Active substance: sodium chloride;

1 ml of solution contains sodium chloride 9.0 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid, theoretical osmolarity 308 mOsmol/L. Ionic composition per 1 L of the product: Na⁺ – 154 mmol, Cl^¯ – 154 mmol.

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

Pharmacological properties.

Pharmacodynamics.

0.9% sodium chloride solution normalizes 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 wounds and trauma, during abdominal surgeries, and peritonitis.

0.9% sodium chloride solution improves tissue perfusion and enhances the effectiveness of blood transfusion procedures 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.

The solution rapidly leaves 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 approximately half of the administered solution remains within blood vessels. Salts and fluids are very rapidly excreted by the kidneys, increasing diuresis.

Clinical characteristics.

Indications.

For replenishing fluid deficiency in the body and as part of intensive care measures; 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 developing pulmonary edema.

The preparation must not be used for eye irrigation during ophthalmic surgery.

Interaction with other medicinal products and other types of interactions.

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

Special precautions for use.

During prolonged administration, especially in large volumes, plasma and urine electrolyte levels as well as diuresis should be monitored.

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

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

In shock states and blood loss, transfusion of blood, plasma, and plasma substitutes may be performed simultaneously with the administration of 0.9% sodium chloride solution.

Use during pregnancy or breastfeeding.

The drug may be used if clinically indicated.

Ability to affect driving or operating machinery.

Does not affect.

Administration and Dosage

Administer intravenously, rectally, and externally.

For intravenous infusion, 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 administered orally; administer as enemas in doses of 75–100 mL; use for wound and mucous membrane irrigation.

Children. In children with shock dehydration (without laboratory assessment), administer 20–30 mL/kg body weight. Subsequently, the dosing regimen should be adjusted based on laboratory parameters. The total daily dose depends on the water-electrolyte balance.

Overdose.

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

Side effects.

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

Shelf life. 2 years.

Storage conditions. Store in a place inaccessible to children, at a temperature not exceeding 25 °C. Store in the original packaging.

Incompatibility. Not established.

Packaging.

100 ml, 200 ml, or 400 ml in glass bottles;

1000 ml or 3000 ml in polymer containers (in the form of a bag);

100 ml, 200 ml, 250 ml, 400 ml, or 500 ml in polymer containers (in the form of a bottle).

Prescription status. Prescription only.

Manufacturer. Yuria-Pharm LLC.

Manufacturer's address and place of business.

108, Kozbirska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.