GLUCAGEN Powder and solvent for solution for injection Ref.[7838] Active ingredients: Glucagon

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 6–8 years) or 1 mg (children above 25 kg or older than 6–8 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.

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

In the case of overdose, the patient may experience nausea and vomiting. Due to the short half life of glucagon, these symptoms will be transient.

In case of dosages substantially above the approved range, the serum potassium may decrease and should be monitored and corrected, if needed.

GlucaGen 1 mg: Prior to reconstitution, the shelf life of the product is 36 months.

GlucaGen HypoKit 1 mg: Prior to reconstitution, the shelf life of the product is 36 months.

The reconstituted GlucaGen should be used immediately after preparation.

Do not freeze.

If, in rare cases, the reconstituted product shows any signs of fibril formation (viscous appearance) or insoluble matter, it should be discarded.

GlucaGen 1 mg: GlucaGen should be stored at a temperature of 2°C to 8°C (in a refrigerator). Store in the original package in order to protect from light.

GlucaGen HypoKit 1 mg: GlucaGen HypoKit should be stored at a temperature of 2-8°C (in a refrigerator). The user can store GlucaGen HypoKit at a temperature not exceeding 25°C for 18 months provided that the expiry date is not exceeded. Store in the original package in order to protect from light.

Container for GlucaGen:

Vial made of glass type I, Ph. Eur., closed with a bromobutyl stopper and covered with an aluminium cap.

Containers for solvent:

Vial made of glass type I, Ph. Eur., closed with a bromobutyl disc with teflon and covered with an aluminium cap

or

pre-filled syringe made of glass type I, Ph. Eur., with plunger (bromobutyl rubber) and needle.

The vials are provided with a tamperproof plastic cap which must be removed before use.

Not all presentations of GlucaGen may be marketed.

Reconstitution

GlucaGen 1 mg

Draw up the water for injections (1.1 ml) in a disposable syringe. Inject the water for injections into the vial containing the glucagon compacted powder.

Shake the vial gently until the glucagon is completely dissolved and the solution is clear. Withdraw the solution back into the syringe.

GlucaGen HypoKit 1 mg

Inject the water for injections (1.1 ml) into the vial containing the glucagon compacted powder. Shake the vial gently until the glucagon is completely dissolved and the solution is clear. Withdraw the solution back into the syringe.

Note that a syringe with a thinner needle and a finer graduation may be more suitable for use in diagnostic procedures.

The reconstituted solution appears clear and colourless and forms an injection of 1 mg (1 IU) per ml to be administered subcutaneously, intramuscularly or intravenously (injection).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.