Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
exenatide
AstraZeneca AB
A10BJ01
exenatide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Byetta is indicated for treatment of type-2 diabetes mellitus in combination with:metformin;sulphonylureas;thiazolidinediones;metformin and a sulphonylurea;metformin and a thiazolidinedione;in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.
Revision: 29
Authorised
2006-11-20
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BYETTA 5 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN BYETTA 10 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN 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 Byetta is and what it is used for 2. What you need to know before you use Byetta 3. How to use Byetta 4. Possible side effects 5. How to store Byetta 6. Contents of the pack and other information 1. WHAT BYETTA IS AND WHAT IT IS USED FOR Byetta contains the active substance exenatide. It is an injectable medicine used to improve blood sugar control in adults with type 2 (non-insulin dependent) diabetes mellitus. Byetta is used with other diabetic medicines called metformin, sulphonylureas, thiazolidinediones and basal or long acting insulins. Your doctor is now prescribing Byetta 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 if your body is not able to use the insulin properly. The medicine in Byetta helps your body to increase the production of insulin when your blood sugar is high. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BYETTA DO NOT USE BYETTA: - If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist, or diabetes nurse before using Byetta Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Byetta 5 micrograms solution for injection in pre-filled pen Byetta 10 micrograms solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres (mcl), (0.25 mg exenatide per mL). Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres (mcl), (0.25 mg exenatide per mL). Excipient with known effect: Byetta 5 mcg: Each dose contains 44 mcg metacresol. Byetta 10 mcg: Each dose contains 88 mcg metacresol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Byetta is indicated for treatment of type 2 diabetes mellitus in combination with: - metformin - sulphonylureas - thiazolidinediones - metformin and a sulphonylurea - metformin and a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Immediate-release exenatide (Byetta) therapy should be initiated at 5 mcg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of exenatide can then be increased to 10 mcg BID to further improve glycaemic control. Doses higher than 10 mcg BID are not recommended. Immediate-release exenatide is available as either a 5 mcg or a 10 mcg exenatide per dose pre-filled pen. 3 Immediate-release exenatide can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart). Immediate-release exenatide should not be administered after a meal. If an i Soma hati kamili