Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Glucagon
Tetris Pharma B.V
H04AA01
glucagon
Pancreatic hormones, Glycogenolytic hormones
Diabetes Mellitus
Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.
Revision: 5
Authorised
2021-02-11
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER OGLUO 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN OGLUO 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN glucagon READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE 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 Ogluo is and what it is used for 2. What you need to know before you use Ogluo 3. How to use Ogluo 4. Possible side effects 5. How to store Ogluo 6. Contents of the pack and other information 1. WHAT OGLUO IS AND WHAT IT IS USED FOR Ogluo contains the active substance glucagon, which belongs to a group of medicines called glycogenolytic hormones. It is used to treat severe hypoglycaemia (very low blood sugar) in people with diabetes. It is for use in adults, adolescents, and children aged 2 years or older. Ogluo is a ready-to-use, pre-filled pen that contains a single dose of the active substance, glucagon. It is a subcutaneous injection, meaning that the medicine is administered under the skin using a needle. Glucagon is a natural hormone produced by the pancreas, which has the opposite effect of insulin in the human body. It helps the liver to convert stored sugar in the liver called ‘glycogen’ into glucose (sugar). Glucose is then released into the blood stream, which makes the blood sugar level rise, reducing the effects of hypoglycaemia. INFORMATION ON HYPOGLYCAEMIA Early symptoms of hypoglycaemia (low blood sugar) include: • sweating • drowsiness • dizziness • sleep disturbances • palpitation • anxiety • tremor • blurred vision • hunger • Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ogluo 0.5 mg solution for injection in pre-filled pen. Ogluo 1 mg solution for injection in pre-filled pen. Ogluo 0.5 mg solution for injection in pre-filled syringe. Ogluo 1 mg solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ogluo 0.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 0.5 mg glucagon in 0.1 mL. Ogluo 1 mg solution for injection in pre-filled pen Each pre-filled pen contains 1 mg glucagon in 0.2 mL. Ogluo 0.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 0.5 mg glucagon in 0.1 mL. Ogluo 1 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 1 mg glucagon in 0.2 mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) A clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents (≥6_ _years)_ The recommended dose is 1 mg, administrated by subcutaneous injection. _Paediatric population (≥2 to <6_ _years) _ 3 • The recommended dose for paediatric patients who weigh less than 25 kg is 0.5 mg administered by subcutaneous injection. • The recommended dose for paediatric patients who weigh 25 kg or greater is 1 mg administered by subcutaneous injection. _ _ _Time to respond and additional doses _ The patient will normally respond within 15 minutes. When the patient has responded to the treatment, give an oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia. If the patient does not respond within 15 minutes, an additional dose of Ogluo from a new device may be administered while waiting for emergency assistance. It is recommended that patients are prescribed Przeczytaj cały dokument