GLUCAGEN FOR INJECTION 1 mg/ml

4.1 Indications

Therapeutic indication

GlucaGen® is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated children and adults with diabetes mellitus.

Diagnostic indication

GlucaGen® is indicated for motility inhibition in examinations of the gastrointestinal tract in adults.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Pheochromocytoma.

4.2 Posology and method of administration

Posology

• Therapeutic indication (Severe hypoglycaemia)

Dosage for adult patients: Administer 1 mg by subcutaneous or intramuscular injection.

Special populations

Paediatric population (< 18 years old): GlucaGen® can be used for the treatment of severe hypoglycaemia in children and adolescents.

Dosage for paediatric patients: Administer 0.5 mg (children below 25 kg or younger than 8 years) or 1 mg (children above 25 kg or older than 8 years).

Elderly (≥ 65 years old): GlucaGen® can be used in elderly patients.

Renal and hepatic impairment: GlucaGen® can be used in patients with renal and hepatic impairment.

• Diagnostic indication (Inhibition of gastrointestinal motility)

Dosage for adult patients: The diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2–0.5 mg given as intravenous injection or 1 mg given intramuscularly; the dose to relax the colon is 0.5–0.75 mg intravenously or 1–2 mg intramuscularly.

Special populations

Paediatric population (< 18 years old): The safety and efficacy of GlucaGen® for inhibition of gastrointestinal motility in children and adolescents have not been established. No data are available.

Elderly (≥ 65 years old): GlucaGen® can be used in elderly patients.

Renal and hepatic impairment: GlucaGen® can be used in patients with renal and hepatic impairment.

Method of administration

Dissolve the compacted powder in the accompanying solvent, as described in section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Therapeutic indication (Severe hypoglycaemia):

Administer by subcutaneous or intramuscular injection. The patient will normally respond within 10 minutes. When the patient has responded to the treatment, give oral carbohydrates to restore the liver glycogen and prevent relapse of hypoglycaemia. If the patient does not respond within 10 minutes, intravenous glucose should be given.

Diagnostic indication (Inhibition of gastrointestinal motility):

GlucaGen® must be administered by medical personnel. Onset of action after an intravenous injection of 0.2–0.5 mg occurs within one minute and the duration of effect is between 5 and 20 minutes. The onset of action after an intramuscular injection of 1–2 mg occurs after 5–15 minutes and lasts approximately 10–40 minutes.

After the end of the diagnostic procedure, oral carbohydrates should be given, if this is compatible with the diagnostic procedure applied.