SODIUM CHLORIDE - DARNITSA

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SODIUM CHLORIDE-DARNITSA

Composition:

Active substance: sodium chloride;

1 ml of solution contains sodium chloride 9 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear colorless liquid, salty to taste.

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

Pharmacological properties.

Pharmacodynamics.

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

Rapidly leaves 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, approximately half of the infused solution remains in the blood vessels. Salts and fluid begin to be very rapidly excreted by the kidneys, increasing diuresis.

Clinical characteristics.

Indications.

Preparation of solutions of medicinal products for topical and parenteral administration; local use for irrigation of wounds, nasal mucosa, as well as catheters and transfusion systems.

Contraindications.

Incompatibility of the main medicinal product with the solvent. The medicinal product must not be used for eye irrigation during ophthalmic surgery.

Interaction with other medicinal products and other types of interactions.

Sodium chloride-Darnytsia is compatible with most medicinal products, therefore it can be used to dissolve various medicinal products—except those medicinal products which are incompatible with sodium chloride as a solvent.

Special precautions for use.

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

Use during pregnancy or breastfeeding.

The medicinal product can be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage.

The medicinal product should be used as a solvent for parenteral administration of the main medicinal agent.

For wound and mucous membrane irrigation, apply the solution in sufficient quantity.

Children.

The medicinal product can be used in children.

Overdose.

Unlikely when used correctly.

Side effects.

Not observed when the medicinal product is used correctly.

Shelf life. 5 years.

Storage conditions.

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

Keep out of reach of children.

Incompatibility.

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

Packaging.

5 ml in a vial; 5 vials in a blister pack; 2 blister packs in a carton;

10 ml in a vial; 5 vials in a blister pack; 2 blister packs in a carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Pharmaceutical company "Darnitsa".

Manufacturer's address.

13, Borispilska Street, Kyiv, 02093, Ukraine.