GLUCOSE-NOVOPHARM

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

Composition:

Active substance: glucose monohydrate;

1 ml of solution contains glucose monohydrate equivalent to 50 mg of anhydrous glucose;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physico-chemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions.

ATC code B05CX01.

Pharmacological properties.

Pharmacodynamics.

50 mg/ml glucose solution is isotonic with blood plasma and, when administered intravenously, replenishes the circulating blood volume, serves as a source of nutritive material in case of blood loss, and promotes elimination of toxins from the body. Glucose provides substrate-level replenishment of energy expenditure. Intravenous injections activate metabolic processes, improve hepatic antitoxic function, enhance myocardial contractile activity, dilate blood vessels, and increase diuresis.

Pharmacokinetics.

After administration, it rapidly distributes throughout the body tissues. It is excreted by the kidneys.

Clinical characteristics.

Indications.

• Hyper- and isotonic dehydration;
• in children, to prevent disturbances of water-electrolyte balance during surgical procedures;
• intoxication;
• hypoglycemia;
• as a solvent for other compatible medicinal solutions.

Contraindications.

Glucose solution is contraindicated in patients with:

• hyperglycemia;
• hypersensitivity to glucose.

Do not administer the medicinal product simultaneously with blood preparations.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with thiazide diuretics and furosemide, their ability to affect serum glucose levels should be taken into account. Insulin promotes glucose uptake 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 concurrently administered cardiac glycosides. Glucose is incompatible in solutions with aminophylline, barbiturates, hydrocortisone, kanamycin, soluble sulfonamides, and cyanocobalamin.

Special precautions for use.

The medicinal product should be administered with extreme caution to patients with intracranial and intraspinal hemorrhages.

When administering the medicinal product intravenously over a prolonged period, blood glucose levels must 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 administering large doses, subcutaneous insulin may be required at a dose of 1 IU per 4–5 g of glucose.

The contents of a single vial are intended for use in one patient only. After the vial seal is broken, any unused portion of the vial contents must be discarded.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate while driving or operating machinery.

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

Dosage and Administration.

The medicinal product should be administered intravenously by drip infusion. The dose for adults 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/hour).

Children.

The dose for children depends on age, body weight, clinical condition, and laboratory parameters.

Overdose.

Exaggeration of adverse reactions.

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

Adverse Reactions.

Electrolyte imbalance and general systemic reactions associated with massive infusions:

• Hypokalemia;
• Hypophosphatemia;
• Hypomagnesemia;
• Hyponatremia;
• Hypervolemia;
• Hyperglycemia;

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

Gastrointestinal disorders:

• Very rare – central nausea.

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

Shelf life. 3 years.

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

Incompatibility.

Glucose is incompatible in solutions with aminophylline, soluble barbiturates, erythromycin, hydrocortisone, warfarin, kanamycin, soluble sulfonamides, and cyanocobalamin.

Do not use in the same infusion system simultaneously or immediately before or after blood transfusion due to the risk of pseudoagglutination.

Packaging.

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

Prescription status. Prescription only.

Manufacturer. Limited liability company "Novopharm-Biosyntez".

Manufacturer's address and location of business activity.

38 Zhytomyrska Street, city of Zviahel, Zviahel district, Zhytomyr region, 11700, Ukraine.