Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
exenatide, Quantity: 250 microgram/mL
AstraZeneca Pty Ltd
Exenatide
Injection, solution
Excipient Ingredients: sodium acetate; metacresol; glacial acetic acid; mannitol; water for injections
Subcutaneous
1 pre-filled pen (1.2 mL)
(S4) Prescription Only Medicine
Exenatide is indicated as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, or a combination of metformin and a basal insulin, but are not achieving adequate glycaemic control.
Visual Identification: Clear, colourless liquid.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2007-06-28
BYETTA ® _Exenatide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BYETTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. All medicines have risks and benefits. Your doctor has weighed the risks of you taking BYETTA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, CONSULT YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BYETTA IS USED FOR BYETTA is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus. It is used with metformin or a sulfonylurea. It may also be used with a combination of both metformin and a sulfonylurea. Your medicine can also be used in combination with a long acting insulin and metformin. Diabetes mellitus is a condition in which your pancreas does not produce enough insulin to control your blood sugar level. BYETTA helps your body to increase production of insulin when your blood sugar is high. BYETTA IS NOT A SUBSTITUTE FOR INSULIN IN PATIENTS WHO REQUIRE INSULIN TREATMENTS FOR THEIR DIABETES. This medicine has not been studied in children. This medicine is only available with a doctor's prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU USE BYETTA _WHEN YOU MUST NOT USE IT_ DO NOT USE BYETTA IF: • you have type 1 diabetes or diabetic ketoacidosis (often caused by very high blood glucose levels) • you are allergic to exenatide or meta-Cresol or any of the ingredients listed at the end of this leaflet • you have severe kidney problems or you are on dialysis DO NOT USE THE BYETTA PEN Lue koko asiakirja
BYETTA ® Product Information Doc ID-002465160 V8.0 1(25) AUSTRALIAN PRODUCT INFORMATION BYETTA ® (EXENATIDE) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Exenatide. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BYETTA 5 MICROGRAMS SOLUTION FOR INJECTION BYETTA 5 µg pre-filled pen contains 60 doses of sterile, preserved isotonic solution (approximately 1.2 mL). Each dose contains 5 µg exenatide in 20 microlitres (0.25 mg synthetic exenatide per mL). BYETTA 10 MICROGRAMS SOLUTION FOR INJECTION BYETTA 10 µg pre-filled pen contains 60 doses of sterile, preserved isotonic solution (approximately 2.4 mL). Each dose contains 10 µg exenatide in 40 microlitres (0.25 mg synthetic exenatide per mL). Each millilitre of BYETTA contains 250 µg of synthetic exenatide. For a full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Solution for injection. BYETTA is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exenatide is indicated as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, or a combination of metformin and a basal insulin, but are not achieving adequate glycaemic control. 4.2 DOSE AND METHOD OF ADMINISTRATION Exenatide therapy should be initiated at 5 μg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of BYETTA can then be increased to 10 μg BID to further improve glycaemic control. Doses higher than 10 µg BID are not recommended. Exenatide can be administered at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Exenatide should not be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose. BYETTA ® Product Information Doc ID-002465160 V8.0 2(25) Each dose of BYETTA should be administere Lue koko asiakirja