البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
GLUCAGON AS HYDROCHLORIDE
NOVO NORDISK LTD., ISRAEL
H04AA01
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
GLUCAGON AS HYDROCHLORIDE 1 MG
S.C, I.M
Required
NOVO NORDISK A/S, DENMARK
GLUCAGON
GLUCAGON
Treatment of severe hypoglycaemia reactions which may occur in the management of insulin treated persons with diabetes.
2020-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only GLUCAGEN ® HYPOKIT ® 1 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ACTIVE INGREDIENT: glucagon 1 mg (as hydrochloride) INACTIVE INGREDIENTS AND ALLERGENS IN THIS MEDICINE: See section 6 ‘Additional information’. Also see section 2 under ‘Important information about some of this medicine’s ingredients’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? GlucaGen HypoKit is used for the treatment of severe hypoglycaemia reactions which may occur in patients with diabetes who are treated with insulin. GlucaGen HypoKit is intended for immediate, emergency use in children and adults with diabetes who use insulin. It is for use when these patients have passed out (become unconscious) because of very low blood sugar level. This effect is called “severe hypoglycaemia”. GlucaGen HypoKit is used when the patients are not able to take sugar by mouth. THERAPEUTIC GROUP: pancreatic hormones, glycogenolytic hormones. GlucaGen HypoKit contains the active ingredient “glucagon”. Glucagon is a natural hormone which has the opposite effect of insulin in the human body. It helps the liver to change something called “glycogen” into glucose (sugar). Glucose is then released into the blood stream – this makes the blood sugar level rise. FOR MEDICAL PROFESSIONALS: See section 7. 2. BEFORE USING THIS MEDICINE IMPORTANT INFORMATION • Make sure that your family members, people you work with or close friends know about GlucaGen HypoKit. Tell them that if you pass out (become unconscious) they should use GlucaGen اقرأ الوثيقة كاملة
_ _ 1. NAME OF THE MEDICINAL PRODUCT GlucaGen ® HypoKit 1 mg, powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Human glucagon produced in _Saccharomyces cerevisiae _ by recombinant DNA technology. One vial contains 1 mg glucagon as hydrochloride corresponding to 1 mg (1 IU) glucagon/ml after reconstitution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Before reconstitution the compacted powder should be white or nearly white. The solvent should be clear and colourless without particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated persons with diabetes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ _ 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. METHOD OF ADMINISTRATION Dissolve the compacted powder in the accompanying solvent, as described in section 6.6. _ _ 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. GlucaGen HypoKit IL SPC MAR 2023-Notification 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phaeocr اقرأ الوثيقة كاملة