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1 X 1 mg
Dosage for adult patients: Administer 1 mg by subcutaneous or intramuscular injection.
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.
Method of administration: Dissolve the compacted powder in the accompanying solvent, as described in the doctor leaflet.
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.
Treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated persons with diabetes mellitus.
Hypersensitivity to the active substance or to any of the excipients. Phaeocromocytoma.
Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution.
To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore the liver glycogen, when the patient has responded to the treatment.
Glucagon will not be effective in patients whose liver glycogen is depleted. For that reason, glucagon has little or no effect when the patient has been fasting for a prolonged period, or is suffering from adrenal insufficiency, chronic hypoglycaemia or alcohol induced hypoglycaemia.
Glucagon, unlike adrenaline, has no effect upon muscle phosphorylase and therefore cannot assist in the transference of carbohydrate from the much larger stores of glycogen that are present in the skeletal muscle.
The tip cap of the syringe included in the GlucaGen HypoKit contains natural rubber latex which may cause allergic reactions in latex sensitive individuals.
Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction. Glucagon is contraindicated in patients with phaeochromocytoma.
Severe adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, have been reported as ‘very rare’ (less than 1 case per 10,000 patients).
See prescribing information for full details.
Insulin: Reacts antagonistically towards glucagon.
Indomethacin: Glucagon may lose its ability to raise blood glucose or paradoxically may even produce hypoglycaemia.
Warfarin: Glucagon may increase the anticoagulant effect of warfarin.
Beta-blockers: Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of glucagon’s short half-life. The increase in blood pressure and pulse rate may require therapy in patients with coronary artery disease.
Interactions between GlucaGen and other drugs are not known when GlucaGen is used in the approved indications.
Pregnancy and Lactation
Pregnancy: Glucagon does not cross the human placenta barrier. The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy and the health of the unborn and the neonate. GlucaGen can be used during pregnancy.
Breast-feeding: Glucagon is cleared from the bloodstream very fast (mainly by the liver) (t1/2= 3–6 min.); thus the amount excreted in the milk of nursing mothers following treatment of severe hypoglycaemic reactions is expected to be extremely small. As glucagon is degraded in the digestive tract and cannot
be absorbed in its intact form, it will not exert any metabolic effect in the child. GlucaGen can be used during breast-feeding.
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.