Држава: Малта
Језик: Енглески
Извор: Medicines Authority
GLUCAGON
NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark
H04AA01
GLUCAGON
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
GLUCAGON
POM
PANCREATIC HORMONES
Authorised
2005-10-12
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER GLUCAGEN HYPOKIT 1 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Glucagon READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS INJECTION BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, pharmacist or nurse. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What GlucaGen HypoKit is and what it is used for 2. What you need to know before you use GlucaGen HypoKit 3. How to use GlucaGen HypoKit 4. Possible side effects 5. How to store GlucaGen HypoKit 6. Contents of the pack and other information 7. Additional information for medical professionals 1. WHAT GLUCAGEN HYPOKIT IS AND WHAT IT IS USED FOR GlucaGen HypoKit contains the active substance “glucagon”. GlucaGen HypoKit is for immediate, emergency use for children and adults with diabetes who use insulin. It is used when they have passed out (become unconscious) because of very low blood sugar. This is called “severe hypoglycaemia”. GlucaGen HypoKit is used when they are not able to take sugar by mouth. 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. WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCAGEN HYPOKIT 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 HypoKit straight away. Page 2 of 6 • Show your family memb Прочитајте комплетан документ
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT GlucaGen 1 mg powder and solvent for solution for injection. 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 INDICATIONS Therapeutic indication GlucaGen is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated children and adults with diabetes mellitus. Diagnostic indication GlucaGen is indicated for motility inhibition in examinations of the gastrointestinal tract in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY • _Therapeutic indication (Severe hypoglycaemia) _ Dosage for adult patients: Administer 1 mg by subcutaneous or intramuscular injection. Page 2 of 9 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 t Прочитајте комплетан документ