Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
exenatide
AstraZeneca AB
A10BJ01
exenatide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations).Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with:MetforminSulphonylureaThiazolidinedioneMetformin and sulphonylureaMetformin and thiazolidinedionein adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Revision: 25
Authorised
2011-06-17
104 B. PACKAGE LEAFLET 105 PACKAGE LEAFLET: INFORMATION FOR THE USER BYDUREON 2 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION exenatide 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 diabetes 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, pharmacist, or diabetes nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bydureon is and what it is used for 2. What you need to know before you use Bydureon 3. How to use Bydureon 4. Possible side effects 5. How to store Bydureon 6. Contents of the pack and other information 1. WHAT BYDUREON IS AND WHAT IT IS USED FOR Bydureon contains the active substance exenatide. It is an injectable medicine used to improve blood sugar control in adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus. This medicine is used in combination with the following diabetes medicines: metformin, sulphonylureas, thiazolidinediones (combination therapy with thiazolidinedione was only studied in adult patients), SGLT2 inhibitors and/or a long-acting insulin. Your doctor is now prescribing this medicine as an additional medicine to help control your blood sugar. Continue to follow your food and exercise plan. You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or your body is not able to use the insulin properly. This medicine helps your body to increase the production of insulin when your blood sugar is high. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BYDUREON DO NOT USE BYDUREON: - If you are allergic to exenatide or any of the other ingredients of this medicine (listed Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Bydureon 2 mg powder and solvent for prolonged-release suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2 mg of exenatide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection. Powder: white to off-white powder. Solvent: clear, colourless to pale yellow to pale brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bydureon is indicated in adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2 mg exenatide once weekly. Patients switching from immediate-release (Byetta) to prolonged-release (Bydureon or Bydureon BCise) exenatide, may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy. Patients switching between the prolonged-release exenatide products (Bydureon or Bydureon BCise) may do so, with no expected relevant effect on blood glucose concentrations. When prolonged-release exenatide is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued. When added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4). Combination therapy with thiazolidinedione was only studied in adult patients. Prolonged-release exenatide should be administered once a week on the same Läs hela dokumentet