SODIUM CHLORIDE-DARNITSA

INSTRUCTIONS for medical use of the medicinal product SODIUM CHLORIDE-DARNITSA (SODIUM CHLORIDE-DARNITSA)

Composition:

Active ingredient: sodium chloride;

1 ml of solution contains sodium chloride 9.0 mg;

Ion composition per 1 l of medicinal product: Na⁺ – 154 mmol, Cl^¯ – 154 mmol;

Excipient: water for injections.

Medicinal form. Infusion solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group.

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

Pharmacological Properties

Pharmacodynamics

0.9% sodium chloride solution normalizes water-electrolyte balance and corrects fluid deficiency in the human body, which develops in dehydration or due to accumulation of extracellular fluid in large burn areas and traumatic injuries, during abdominal surgeries, and in peritonitis.

0.9% sodium chloride 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

The solution is rapidly eliminated from the vascular system. The medicinal product 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 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, hyperchloremic acidosis, conditions associated with the risk of developing pulmonary edema.

The medicinal product should not be used for eye irrigation during ophthalmic surgery.

Interaction with other medicinal products and other types of interactions.

0.9% sodium chloride solution is compatible with most medicinal products, therefore it is commonly used as a solvent for various drugs, except for those medicinal products which are incompatible with sodium chloride as a solvent.

Administration of 0.9% sodium chloride may result in decreased lithium levels.

Special precautions for use.

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

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.

Patients receiving lithium preparations should avoid very high or very low sodium intake. Monitoring of blood lithium levels is recommended.

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

Use during pregnancy or breastfeeding.
The medicinal product may be used if clinically indicated.

Ability to influence reaction rate while driving or operating machinery. Does not affect.

Administration and Dosage

Administered intravenously, rectally, and externally.

Dosage

Administer intravenously by drip infusion at a rate of 4–10 mL/kg/hour, up to 3 L or more of solution per day, depending on the clinical condition and degree of fluid loss; may be administered orally; administered in enemas at doses of 75–100 mL; used for wound and mucous membrane irrigation.

Administration Method

Do not insert the needle(s) into areas of the polymer bottle not intended for this purpose—use only sterile ports!

For infusion therapy, follow this procedure:

1. Remove the protective plastic cap with the first-opening indicator (if present);
2. Remove protective valve(s) No. 1 as shown in Figures 1 and 2 (the manufacturer may use different types and materials for protective valves);
3. Remove the needle cap and insert the needle into any of the special ports No. 2 of the infusion bottle (see Figures 1 and 2);
4. The other sterile port may be used either for introducing other medicinal products into the infusion bottle (No. 4, see Figure 3), or, if the flow rate is insufficient, for a venting needle (No. 4, see Figure 3);
5. Hang the solution bottle using the special ring No. 3 located at the bottom of the bottle (see Figure 3).

Children.

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

Overdose.

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

Side effects.

Not observed when the medicinal product is used correctly.

Hyperchloremic acidosis may develop during massive infusions.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

100 ml, or 200 ml, or 250 ml, or 400 ml, or 500 ml in vials.

100 ml in vials, 40 vials in cartons.

200 ml, or 250 ml, or 400 ml, or 500 ml in vials, 20 vials in cartons.

Prescription status.

Prescription only.

Manufacturer.

JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.