GLUCAGEN HYPOKIT

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. 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. 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. 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. 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.

Summary of the safety profile 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).

When used in the diagnostic indication, hypoglycaemia/hypoglycaemic coma have been reported, especially in patients who have fasted. Cardiovascular adverse events, such as tachycardia and blood pressure changes have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.

Tabulated summary of adverse reactions Frequencies of undesirable effects considered related to treatment with GlucaGen during clinical trials and/or post-marketing surveillance are presented below. Undesirable effects which have not been observed in clinical trials, but have been reported spontaneously, are presented as ‘very rare’.

During marketed use reporting of adverse drug reactions is very rare (< 1/10,000). However, post-marketing experience is subject to under-reporting and this reporting rate should be interpreted in that light. Therapeutic indication System Organ Class Subject incidence Adverse drug reaction Immune system disorders Very rare < 1/10,000 Hypersensitivity reactions including anaphylactic reaction/shock Gastrointestinal disorders Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Nausea Vomiting Abdominal pain General disorders and administration site conditions Not known (cannot be estimated from the available data) Injection site reactions Paediatric population Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in children are expected to be the same as in adults.

Other special populations Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.

Traceability In order to improve the traceability of biological medicial products, the name and the batch number of the adminitered product should be clearly recorded. Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion.

Therapeutic indication 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.

Diagnostic indication Persons who have been given glucagon in connection with diagnostic procedures may experience discomfort, in particular if they have been fasting. Nausea, hypoglycaemia, and blood pressure changes have been reported in these situations.

After the end of a diagnostic procedure, oral carbohydrates should be given to patients who have been fasting, if this is compatible with the diagnostic procedure applied. If fasting is needed post-examination or in case of severe hypoglycaemia, glucose given intravenously may be required.

GlucaGen may increase myocardial oxygen demand, blood pressure, and pulse rate. Monitor patients with cardiac disease during use of GlucaGen as a diagnostic aid and treat if indicated. GlucaGen may cause short term hyperglycaemia in patients with diabetes mellitus when used as a diagnostic aid.

Monitor patients with diabetes for changes in blood glucose levels during use and treat if indicated. Caution should be observed in pateints with glucagonoma when usede a diagnotic aid. Therapeutic and diagnotic indications Glucagon reacts antagonistically towards insulin and caution should be observed if GlucaGen is used in patients with insulinoma.

1. Phaeocromocytoma.