GLUCOSE-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLUCOSE-DARNITSA (GLUCOSE-DARNITSA)

Composition:

Active substance: glucose monohydrate;

1 ml of solution contains glucose monohydrate 50 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions.

ATC code B05C X01.

Pharmacological Properties.

Pharmacodynamics.

5 % glucose solution is isotonic with respect to blood plasma and, when administered intravenously, replenishes the circulating blood volume, serves as a source of nutritive material in case of blood loss, and also promotes elimination of toxins from the body. Glucose provides substrate-based replenishment of energy expenditure. During intravenous infusions, it activates metabolic processes, improves hepatic antitoxic function, enhances myocardial contractile activity, dilates blood vessels, and increases diuresis.

Pharmacokinetics.

After administration, it is rapidly distributed in body tissues. It is excreted by the kidneys.

Clinical characteristics.

Indications.

• Hyper- and isotonic dehydration;
• prevention of water-electrolyte imbalance in children during surgical procedures;
• intoxication;
• hypoglycemia;
• used as a solvent for other compatible medicinal solutions.

Contraindications.

• Hyperglycemia.
• Hypersensitivity to dextrose.

The medicinal product must not be administered simultaneously with blood preparations.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with thiazide diuretics and furosemide, their ability to affect serum glucose levels should be taken into account.

Insulin promotes the uptake of glucose into peripheral tissues.

Glucose solution reduces the hepatotoxic effect of pyrazinamide.

Administration of a large volume of glucose solution may lead to the development of hypokalemia, which increases the toxicity of cardiac glycosides.

The medicinal product Glucose-Darnytsia is incompatible in solutions with aminophylline, barbiturates, hydrocortisone, kanamycin, soluble sulfonamides, cyanocobalamin.

Special precautions.

The medicinal product should be used with extreme caution in patients with intracranial and intraspinal hemorrhages.

When the medicinal product is administered intravenously for prolonged periods, blood glucose levels should be monitored.

To prevent the development of hypoosmolarity of plasma, a 5% glucose solution may be combined with the administration of isotonic sodium chloride solution.

When large doses are administered, subcutaneous insulin may be prescribed as needed at a dose of 1 IU per 4–5 g of glucose.

The contents of a vial should be used for one patient only. After the container's seal is broken, any unused portion of the solution in the bottle or vial must be discarded.

Use during pregnancy or breastfeeding.

The medicinal product may be used if clinically indicated.

Ability to affect reaction rate when driving or operating machinery.

Data are lacking due to the exclusive use of the medicinal product under hospital conditions.

Method of Administration and Dosage.

Dosage

The adult dose is up to 1500 mL per day. The maximum daily dose for adults is 2000 mL. If necessary, the maximum infusion rate for adults is 150 drops per minute (500 mL/h).

Method of Administration

Do not insert the needle(s) into areas of the plastic bottle not intended for this purpose!

To perform infusion therapy, follow this procedure:

1. Remove the protective plastic cap with tamper-evident seal (if used);
2. Remove protective closure(s) № 1 as shown in Fig. 1 (the manufacturer may use different types and materials for protective closures).
3. Remove the cap from the air vent needle and insert it into sterile membrane № 2 (see Fig. 2) or into one of the special openings № 3 (see Fig. 2).
4. Remove the cap from the needle and insert it into the special opening № 3 of the infusion bottle (see Fig. 2).
5. Hang the solution bottle using the special ring № 4 located at the bottom of the bottle (see Fig. 3).

Children.

For children, the dose depends on age, body weight, condition, and laboratory parameters.

Overdose.

Excessive manifestations of adverse reactions may occur.

Hyperglycemia and hypotonic hyperhydration may develop. In case of overdose, symptomatic treatment and administration of regular insulin preparations should be prescribed.

Adverse reactions.

Gastrointestinal disorders: very rare – central nausea.

Metabolism and nutrition disorders: electrolyte imbalance and general body reactions associated with massive infusions:

• hypokalemia;
• hypophosphatemia;
• hypomagnesemia;
• hyponatremia;
• hypervolemia;
• hyperglycemia.

Immune system disorders: allergic reactions (hyperthermia, skin rashes, angioneurotic edema, shock).

If adverse reactions occur, infusion should be discontinued, the patient's condition assessed, and appropriate medical assistance provided.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Incompatibility.

The medicinal product Glucose-Darnytsia is incompatible in solutions with aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, and cyanocobalamin. Do not use in the same system during, before, or after blood transfusion due to the risk of pseudoagglutination.

Packaging.

200 ml, 250 ml, 400 ml, or 500 ml in bottles.

200 ml, 250 ml, 400 ml, or 500 ml in bottles, 20 bottles per carton.

Prescription status. Prescription only.

Manufacturer. JSC "Pharmaceutical Company "Darnitsya".

Manufacturer's address and place of business.

13, Boryspilska Street, Kyiv, 02093, Ukraine.