দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Glucagon hydrochloride 1mg (recombinant); ;
Novo Nordisk Pharmaceuticals Ltd
Glucagon hydrochloride 1 mg (recombinant)
1 mg
Solution for injection
Active: Glucagon hydrochloride 1mg (recombinant) Excipient: Lactose monohydrate Water for injection
Combination pack, powder+diluent in plastic box, 1 dose unit
Restricted
Restricted
Novo Nordisk A/S
Therapeutic Treatment of severe hypoglycaemic reactions, which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents. To prevent the occurrence of secondary hypoglycaemia, oral carbohydrate should be given to restore the hepatic glycogen when the patient has responded to the treatment. The mechanism and hence treatment of sulfonylurea-induced hypoglycaemia differs from that of severe insulin-induced hypoglycaemia in some important ways. Consciousness should preferably be restored by the administration of intravenous glucose. If glucagon is used due to the unavailability of intravenous glucose (e.g. before reaching a hospital) care should be taken to protect against secondary hypoglycaemia with constant monitoring of the patient's blood sugar level by medical personnel. Subsequent administration of intravenous glucose may be required.
Package - Contents - Shelf Life: Combination pack, powder+diluent in plastic box - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Syringe, Diluent - 1 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, - 1 mg - 36 months from date of manufacture stored at or below 25°C
1989-09-18
GlucaGen® HypoKit 1 GLUCAGEN® HYPOKIT CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING GLUCAGEN® HYPOKIT? GlucaGen® HypoKit contains the active ingredient glucagon hydrochloride. GlucaGen® HypoKit is used to treat severe hypoglycaemia (extremely low blood sugar levels, or a “hypo”) in people using insulin or taking tablets to control their diabetes, who have become unconscious. For more information, see Section 1. Why am I using GlucaGen® HypoKit? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GLUCAGEN® HYPOKIT? Do not use if you have ever had an allergic reaction to GlucaGen® HypoKit or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR FAST. For more information, see Section 2. What should I know before I use GlucaGen® HypoKit? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with GlucaGen® HypoKit and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE GLUCAGEN® HYPOKIT? The freeze-dried GlucaGen® powder should be dissolved in the water provided and then injected under the skin, into a muscle. More instructions can be found in Section 4. How do I use GlucaGen® HypoKit? and 8. Instructions for use in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GLUCAGEN® HYPOKIT? THINGS YOU SHOULD DO • Tell any doctor or pharmacist you visit that you keep a GlucaGen® HypoKit. • Check the expiry date printed on the pack. If your medicine has passed this date, do not use it. THINGS YOU SHOULD NOT DO • Use the medicine if: it does not look like a powder or powdery tablet before adding the water; the powder does not dissolve properly after adding the water; the solution looks like a gel. DRIVING OR USING MACHINES • If you are still experiencing the সম্পূর্ণ নথি পড়ুন
2 NEW ZEALAND DATASHEET 1 PRODUCT NAME GlucaGen ® HypoKit , powder and solvent for solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glucagon (rys) 1 mg/ml as hydrochloride, produced by genetic engineering from yeast (_Saccharomyces cerevisiae_). For full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM White crystalline powder (which may appear more like a powdery tablet upon settling) and clear colourless solvent for solution for injection. After reconstitution of glucagon with the solvent (Sterilised Water for Injections), each syringe contains glucagon 1 mg/ml. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications _Therapeutic _ Treatment of severe hypoglycaemic reactions, which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents. To prevent the occurrence of secondary hypoglycaemia, oral carbohydrate should be given to restore the hepatic glycogen when the patient has responded to the treatment. The mechanism and hence treatment of sulfonylurea-induced hypoglycaemia differs from that of severe insulin-induced hypoglycaemia in some important ways. Consciousness should preferably be restored by the administration of intravenous glucose. If glucagon is used due to the unavailability of intravenous glucose (e.g. before reaching a hospital) care should be taken to protect against secondary hypoglycaemia with constant monitoring of the patient’s blood sugar level by medical personnel. Subsequent administration of intravenous glucose may be required. _ _ _Diagnostic _ Motility inhibitor in examinations of the gastrointestinal tract in adults, e.g. double contrast radiography and endoscopy. 4.2 Dose and method of administration Before reconstitution the powder should be a white or nearly white powder (which may appear more like a powdery tablet upon settling). The solvent should be clear and colourless without particles. The freeze dried glucagon should be dissolved in the accompanying diluent. Inject the water for injections (1.1 mL) into the via সম্পূর্ণ নথি পড়ুন