País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Exenatide 250 µg/mL;
AstraZeneca Limited
Exenatide 250 µg/mL
5µg/20µL
Solution for injection
Active: Exenatide 250 µg/mL Excipient: Glacial acetic acid Mannitol Metacresol Sodium acetate trihydrate Water for injection
Cartridge, glass, 1.2 mL (1.4 mL cartridge), 60 dose units
Prescription
Prescription
Bachem Americas Inc
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 but are not achieving adequate glycaemic control. To improve glycaemic control in patients with type 2 diabetes mellitus in combination with a basal insulin with or without metformin and/or a thiozolidinedione.
Package - Contents - Shelf Life: Cartridge, glass, 1.2 mL (1.4 mL cartridge) - 60 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days opened stored at or below 25°C protect from light
2005-11-28
Byetta® CMI 270520 Copyright 1(7) BYETTA ® EXENATIDE 5 ΜG/20 ΜL OR 10 ΜG/40 ΜL SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about BYETTA. It does not contain all the information that is known about BYETTA. 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 will have 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, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS BYETTA IS USED FOR BYETTA is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus. BYETTA is used with other diabetic medicines such as 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. 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-Cr Leer el documento completo
B YETTA Data Sheet 160822 Copyright NEW ZEALAND DATA SHEET 1. PRODUCT NAME B YETTA ® 5 micrograms; Solution for Injection. B YETTA ® 10 micrograms; Solution for Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION B YETTA 5: Each dose contains 5 micrograms (µg) of exenatide in 20 microlitres (µL), (250 µg exenatide per mL. B YETTA 10: Each dose contains 10 micrograms (µg) of exenatide in 40 microlitres (µL), (250 µg exenatide per mL). Excipient with known effect: B YETTA 5: Each dose contains 44 µg metacresol. B YETTA 10: Each dose contains 88 µg metacresol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection B YETTA is a clear colourless solution. B YETTA is supplied as a sterile, preserved solution for subcutaneous injection in a glass cartridge that has been assembled in an injector pen. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS B YETTA is indicated as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulphonylurea, or a combination of metformin and a sulphonylurea but are not achieving adequate glycaemic control. Exenatide is indicated to improve glycaemic control in patients with type 2 diabetes mellitus in combination with a basal insulin, with or without metformin and/or a thiazolidinedione. 4.2 DOSE AND METHOD OF ADMINISTRATION B YETTA 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 B YETTA can then be increased to 10 μg BID to further improve glycaemic control. Doses higher than 10 µg BID are not recommended. B YETTA Data Sheet 160822 Copyright 2 B YETTA 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). B YETTA SHOULD NOT be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose. Leer el documento completo