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 physico-chemical properties: clear, colorless liquid.

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

Pharmacological Properties

Pharmacodynamics

Sodium chloride 0.9% 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 and trauma areas, as well as during abdominal surgeries and peritonitis.

Sodium chloride 0.9% solution improves tissue perfusion and enhances the effectiveness of blood transfusion measures in massive blood loss and severe forms of shock.

It also exhibits a detoxifying effect due to a transient increase in fluid volume, reduction in the concentration of toxic substances in the blood, and stimulation of diuresis.

Pharmacokinetics

The solution is rapidly eliminated from the vascular system. The preparation 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 within 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 therapy 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 ophthalmological surgeries.

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 drugs—except for those products which are incompatible with sodium chloride as a solvent.

Special precautions.

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

Exercise caution when administering to patients with impaired renal excretory function, decompensated heart defects, or edema-ascites syndrome in patients with liver cirrhosis.

Concomitant use with corticosteroids or corticotropin requires continuous monitoring of blood electrolyte levels.

In shock states and blood loss, transfusion of blood, plasma, or plasma substitutes can be performed simultaneously with the use of 0.9% Sodium Chloride solution.

Use during pregnancy or breastfeeding.

The drug may be used if indicated.

Ability to affect the speed of reactions when driving or operating machinery. Does not affect.

Method of Administration and Dosage

Administer intravenously, rectally, and externally.

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

Children

In children with shock-related dehydration (without defined laboratory parameters), administer 20–30 mL/kg. Subsequent dosing should be adjusted based on laboratory parameters. The total daily dose depends on fluid and electrolyte balance, among other factors.

Overdose

May lead to hyperchloremic 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.

Adverse reactions.

Not observed when the medicinal product is used correctly. Chloride acidosis may develop with massive infusions.

Shelf life. 5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility.

Not established.

Packaging. 100 ml, 200 ml or 400 ml in glass bottles.

Prescription status. Prescription only.

Manufacturer. JSC "Galichpharm".

Manufacturer's address and place of business.

6/8 Opryshkovska Street, Lviv, Ukraine, 79024.

Marketing Authorization Holder. JSC "Galichpharm", Ukraine.

Address of the Marketing Authorization Holder.

6/8 Opryshkovska Street, Lviv, Ukraine, 79024.