Glucagen 1 mg hypokit lyophilized powder for solution for injection 1 IU vial with solvent in a 1 ml syringe No. 1

Lyophilisate and solvent for injection solution "GlucaGen ® 1 mg HypoKit" is used for the following indications:

Composition

The active substance is glucagon (human glucagon produced by recombinant DNA technology in Saccharomyces cerevisiae). One vial contains 1 mg of biosynthetic glucagon hydrochloride, which is equivalent to 1 mg (1 IU) glucagon / ml after reconstitution of the drug).

Excipients: lactose monohydrate; concentrated hydrochloric acid; sodium hydroxide; solvent: water for injections.

The reconstituted solution contains 107 mg/ml lactose monohydrate.

Contraindication

Method of application

Therapeutic indication (severe hypoglycemia)

Adult dosage: Administer 1 mg by subcutaneous or intramuscular injection.

Children (<18 years): GlucaGen® 1 mg HypoKit can be used to treat severe hypoglycemia in children and adolescents. Use in children depends on the age and/or body weight of the child:

Diagnostic indication (inhibition of gastrointestinal peristalsis)

Dosage for adult patients: The diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small intestine is 0.2-0.5 mg as an intravenous injection or 1 mg intramuscularly; the dose for relaxation of the colon is 0.5-0.7 mg or 1-2 mg intramuscularly.

Children (<18 years): The safety and efficacy of GlucaGen® 1 mg HypoKit for inhibition of gastrointestinal motility in children and adolescents have not been studied. Data are not available.

An introductory part of the instructions is provided, read the full instructions inside the package.

Application features

Pregnant women

GlucaGen® 1 mg HypoKit can be used to treat severe hypoglycemia during pregnancy.

GlucaGen® 1 mg HypoKit can be used during breastfeeding.

Drivers

After an episode of severe hypoglycemia, the patient's concentration and ability to react may be impaired. Therefore, after an episode of hypoglycemia, the patient should not drive or operate machinery until the patient's health condition has fully stabilized.

In some cases, hypoglycemia has been reported after diagnostic procedures. Therefore, driving or operating machinery should only be done after a meal rich in carbohydrates.

Overdose

Administration of an excessive dose of GlucaGen® 1 mg HypoKit may cause nausea and vomiting. Due to the short half-life of glucagon, these symptoms resolve quickly. Specific treatment is usually not required in these cases. In the event of a very significant overdose, a decrease in serum potassium concentration is possible, which requires monitoring and, if necessary, correction.

Side effects

The most common side effects after the administration of GlucaGen® 1 mg HypoKit are nausea and vomiting, especially when a dose of more than 1 mg is administered rapidly (less than one minute). Sometimes nausea and vomiting can occur 2-3 hours after the injection.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Store in a place protected from light and out of the reach of children.

The solution should be administered immediately after preparation. Do not save the solution for later use.

Never use after the expiration date indicated on the package.

In rare cases, when fibrils or insoluble particles are detected in the solution after reconstitution, the drug should be destroyed.

Shelf life - 2 years.