Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Glucagon hydr0chloride
PCO Manufacturing Ltd.
H04AA01
Glucagon hydr0chloride
1 milligram(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
glucagon
Authorised
2014-10-10
_ _ 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 onto 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. • Show your family members and others where you keep Đọc toàn bộ tài liệu
Health Products Regulatory Authority 01 December 2019 CRN0099FT Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 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. _Product imported fromtheCzech Republic, Poland and the United Kingdom: _Before reconstitution the powder should be white or nearly white powder. The solvent should be clear and colourless without particles. 4 CLINICAL PARTICULARS As per PA0218/031/002. 5 PHARMACOLOGICAL PROPERTIES As per PA0218/031/002. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Hydrochloric acid for pH adjustment Sodium hydroxide for pH adjustment Water for injections The reconstituted solution contains glucagon 1 mg/ml and lactose monohydrate 107 mg/ml. 6.2 INCOMPATIBILITIES There are no known incompatibilities with GlucaGen. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. The reconstituted GlucaGen should be used immediately after preparation. 6.4 SPECIAL PRECAUTIONS FOR STORAGE GlucaGen HypoKit should be stored at a temperature of 2-8°C (in a refrigerator). The user can store GlucaGen HypoKit at a temperature not exceeding 25ºC for 18 months provided that the expiry date is not exceeded. Store in the original package in order to protect from light. Do not freeze. Health Products Regulatory Authority 01 December 2019 CRN0099FT Page 2 of 2 If in rare cases, the reconstituted product shows any signs of fibril formation (viscous appearance) or insoluble matter it should be discarded. 6.5 NATURE AND CONTENTS OF CONTAINE Đọc toàn bộ tài liệu