Glucose solution 5 % for infusion

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glucose 5% Infusion Solution (Glucosi solutio 5% PRO INFUSIONIBUS)

Composition:

Active substance: glucose;

100 ml of solution contain glucose (calculated as anhydrous glucose) 5 g;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless or slightly yellowish liquid, theoretical osmolarity – 278 mosmol/L, pH 3.5–6.5.

Pharmacotherapeutic group. Blood substitutes and perfusion solutions.

ATC code B05CX01.

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 nutrient material in case of blood loss, and also promotes elimination of toxins from the body. Glucose provides substrate replenishment of energy expenditure. With intravenous injections, it activates metabolic processes, improves hepatic antitoxic function, enhances myocardial contractile activity, dilates blood vessels, and increases diuresis.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

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

Contraindications.

5% glucose solution is contraindicated in patients with:

• hyperglycemia;
• hypersensitivity to glucose.

The drug must not be administered simultaneously with blood products.

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 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, soluble barbiturates, hydrocortisone, kanamycin, soluble sulfonamides, and cyanocobalamin.

Special precautions.

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

When administering the drug intravenously over a prolonged period, blood glucose levels should be monitored.

To prevent the development of plasma hypoosmolality, 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 vial may be used for a single patient only. After the container or polyethylene vial has been opened, any unused portion of the solution must be discarded.

Use during pregnancy or breastfeeding.

The drug may be administered when indicated.

Ability to affect reaction rate while driving or operating machinery.

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

Method of Administration and Dosage.

The drug is 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.

Dosage 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.

General systemic reactions, electrolyte imbalances:

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

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

Gastrointestinal disorders:

• very rare – central nausea.

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

Shelf life. 3 years.

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

Freezing of the preparation does not constitute a contraindication for use, provided the bottle remains hermetically sealed. Non-wettability of the inner surface of the bottle is not a contraindication for the use of the preparation.

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 with, before, or after blood transfusion due to the risk of pseudoagglutination.

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

Prescription status. Prescription only.

Manufacturer. Private Joint-Stock Company "Infuziya".

Manufacturer's address and place of business.

Ukraine, 21034, Vinnytsia, Voloshkova St., b. 55
or
Ukraine, 23219, Vinnytsia region, Vinnytsia district, village Vinnytski Khutory, Nemirivske Highway, b. 84A.

Marketing Authorization Holder. Private Joint-Stock Company "Infuziya".

Address of the Marketing Authorization Holder.

Ukraine, 04073, Kyiv, Moskovske Avenue, b. 21-A.