DISOL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DISOLUM (DISOLUM)

Composition:

Active substances: sodium acetate trihydrate, sodium chloride;

100 ml of solution contain: sodium acetate trihydrate – 200 mg, sodium chloride – 600 mg;

Ionic composition per 1000 ml of the product: Na+ – 117 mmol, Cl¯ – 103 mmol, acetate – 15 mmol;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity – 235 mOsmol/l; pH 6.5–7.5.

Pharmacotherapeutic group. Solutions used for correction of electrolyte balance disorders. Electrolytes.

ATC code B05B B01.

Pharmacological properties.

Pharmacodynamics.

Restores circulating blood volume. Reduces hyperkalemia and its consequences in the treatment of fluid and electrolyte imbalances, improves capillary circulation and kidney function. Exhibits detoxifying effect due to a transient increase in fluid volume, reduction of toxic substances concentration in blood, and stimulation of diuresis.

Pharmacokinetics.

The drug remains in the vascular system for a short period, rapidly transfers into the interstitial space and is metabolized in the liver. It is excreted by the kidneys, enhancing diuresis.

Clinical characteristics.

Indications.

Correction of hyperkalemia and its consequences in dehydration and body intoxications occurring in various infectious diseases (acute dysentery, food toxicoinfection, El-Tor cholera).

Contraindications.

Hypersensitivity to the components of the drug. Risk of developing cerebral and pulmonary edema, hyperhydration.

Interaction with other medicinal products and other types of interactions.

Not established.

Special precautions for use.

Before administration, warm the solution to +36–38 °C. Administer with caution to patients with impaired renal excretory function, decompensated heart defects, and edema-ascites syndrome in patients with liver cirrhosis.

Use during pregnancy or breastfeeding.

There is no experience with the use of the drug during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Data regarding the effect of the drug on reaction rate while driving or operating machinery are lacking, as the drug should be administered exclusively under hospital conditions.

Method of Administration and Dosage.

Administer intravenously by drip infusion. Before use, warm the solution to +36–38 °C. The total volume of administered solution should correspond to the volume of fluid lost.

Assess the balance of fluid intake and fluid loss every 6 hours! After correction of hyperkalemia, continue fluid and electrolyte therapy with trisol or acesol solutions.

Children.

There are no data regarding restrictions on the use of the drug in children. Dosage regimen should be adjusted according to laboratory parameters. The total daily dose depends on the water-electrolyte balance and laboratory findings.

Overdose.

Hypokalemia, hypernatremia. Due to hyperhydration and hypervolemia, cardiac failure may develop.

Adverse reactions.

Hypersensitivity reactions are possible in case of individual intolerance to any component of the drug.

Shelf life. 5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Freezing of the drug does not contraindicate its use, provided the bottle remains sealed. Non-wetting of the inner surface of the bottle is not a contraindication for the use of the drug.

Incompatibility. There are no data on incompatibility of Disol with other medicinal products.

Packaging. 400 ml in bottles.

Prescription status. Prescription only.

Manufacturer. Private joint-stock company "Infuziya".

Manufacturer's address and location of business operations.

Ukraine, 21034, Vinnytsia, Voloshkova St., b. 55
or Ukraine, 23219, Vinnytsia Oblast, Vinnytsia Raion, village Vinnytski Khutory, Nemirivske Shose St., b. 84A.

Marketing Authorization Holder. Private joint-stock company "Infuziya".

Address of the Marketing Authorization Holder and/or its representative.

Ukraine, 04073, Kyiv, Moskovskyi Prospekt, b. 21-A.