Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
EXENATIDE
ASTRAZENECA (ISRAEL) LTD
A10BX04
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
EXENATIDE 2 MG
S.C
Required
ASTRA ZENECA AB., SWEDEN
EXENATIDE
EXENATIDE
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 including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control
2018-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only Name of the preparation: BYDUREON ® 2 mg Once a week injection pen Powder and solvent for suspension for injection in pre-filled pen Composition: Each pen contains: Exenatide 2 mg Inactive ingredients and allergens: see Section 6 “Further Information”. Read this leaflet carefully in its entirety before using this medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. This medicine is not intended for children below 18 years of age. Essential information about Bydureon: • Bydureon used in combination with a sulphonylurea may cause a decrease in blood sugar levels (hypoglycemia). Be sure to check your blood sugar level regularly during the course of treatment with the medicine (see below sections 2 “Before using the medicine” and 4 “Side effects”). • Bydureon is not intended for treatment of type 1 diabetes (insulin dependent diabetes) and diabetic ketoacidosis. • Bydureon is intended for injection under the skin, once a week, at any hour of the day, and with no relation to meals. • Treatment with the medicine is not recommended for patients with kidney problems, patients on dialysis, women who are pregnant or breastfeeding (see section 2 below “Before using the medicine”). 1. WHAT IS THE MEDICINE INTENDED FOR? Bydureon is an injectable medicine used to improve control of blood sugar levels in adult patients with type 2 diabetes (diabetes mellitus). Bydureon is given in combination with additional anti-diabetes medicines: metformin, sulphonylurea, thiazolidinediones, SGLT2 inhibitors and/or a long-acting insulin. Your doctor prescribed treatment with Bydureon for you as an additional medicin Baca dokumen lengkapnya
BYDUREON 2MG 1. NAME OF THE MEDICINAL PRODUCT BYDUREON 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 2 mg of exenatide. After reconstitution suspension, each pen delivers a dose of 2 mg in 0.65 ml. For a 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 18 years and older 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 (see section 4.4, 4.5 and 5.1 for available data on different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2 mg exenatide once weekly. Patients switching from exenatide twice daily (BYETTA) to BYDUREON may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy. When BYDUREON is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued. When BYDUREON is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4). BYDUREON should be administered once a week on the same day each week. The day of weekly administration can be changed if necessary, as long as the next dose is administered at least one day (24 hours) later. BYDUREON can be administered at any time of day, with or without meals. If a dose is missed, it should be administered as soon as practical. For the next injection patients can return to their chosen injection day. Howeve Baca dokumen lengkapnya