Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Metformin hydrochloride 1000mg; ; Saxagliptin 2.5mg (as saxagliptin hydrochloride)
AstraZeneca Limited
Metformin hydrochloride 1000 mg
2.5mg/1000mg
Modified release tablet
Active: Metformin hydrochloride 1000mg Saxagliptin 2.5mg (as saxagliptin hydrochloride) Excipient: Carmellose sodium Hydrochloric acid Hypromellose Magnesium stearate Opacode blue S-1-10619 Opadry II yellow 85F92209 Opadry white 85F18422 Purified water
Prescription
Merck Sante SAS
Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.
Package - Contents - Shelf Life: Blister pack, Al/Al - 56 tablets - 36 months from date of manufacture stored at or below 30°C
2014-05-21
Kombiglyze ® XR Tablets CMI Copyright 1(7) 181119 KOMBIGLYZE _®_ XR_ _ SAXAGLIPTIN/METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLET CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KOMBIGLYZE XR. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking KOMBIGLYZE XR 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 KOMBIGLYZE XR IS USED FOR KOMBIGLYZE XR is used to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise. KOMBIGLYZE XR may also be used in combination with other medicines including insulin, a sulphonylurea (such as gliclazide) or a SGLT2 inhibitor (such as dapagliflozin) along with diet and exercise to treat type 2 diabetes. TYPE 2 DIABETES MELLITUS is a condition in which your body does not make enough insulin and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood and can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness and amputation . KOMBIGLYZE XR contains two active ingredients, saxagliptin and metformin hydrochloride (modified release). Saxagliptin is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase- 4 inhibitors), and metformin belongs to a class of medicines called biguanides. Saxagliptin and metformin work together to lower blood sugar levels in patients with type 2 diabetes mellitus. Your doctor may have prescribed this medicine for anoth Baca dokumen lengkapnya
1 K OMBIGLYZE XR Data Sheet 181119 Copyright NEW ZEALAND DATA SHEET 1. PRODUCT NAME KOMBIGLYZE ® XR 5 mg saxagliptin/500 mg metformin HCL extended-release tablets KOMBIGLYZE ® XR 5 mg saxagliptin/1000 mg metformin HCL extended-release tablets KOMBIGLYZE ® XR 2.5 mg saxagliptin/1000 mg metformin HCL extended-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION KOMBIGLYZE XR is available for oral administration as extended release tablets containing the following active ingredients: KOMBIGLYZE XR 5 mg/500 mg: 5 mg saxagliptin (as saxagliptin hydrochloride) and 500 mg metformin hydrochloride KOMBIGLYZE XR 5 mg/1000 mg: 5 mg saxagliptin (as saxagliptin hydrochloride) and 1000 mg metformin hydrochloride KOMBIGLYZE XR 2.5 mg/1000 mg: 2.5 mg saxagliptin (as saxagliptin hydrochloride) and 1000 mg metformin hydrochloride 3. PHARMACEUTICAL FORM Modified release tablets (referred to as extended release tablets). KOMBIGLYZE XR 5 mg/500 mg (saxagliptin/metformin HCl extended release) tablets are light brown to brown, biconvex, capsule shaped, film-coated tablets, with “5/500” printed on one side and “4221” printed on the other side, in blue ink. KOMBIGLYZE XR 5 mg/1000 mg (saxagliptin/metformin HCl extended-release) tablets are pink, biconvex, capsule shaped, film-coated tablets, with “5/1000” printed on one side and “4223” printed on the other side, in blue ink. KOMBIGLYZE XR 2.5 mg/1000 mg (saxagliptin/metformin HCl extended-release) tablets are pale yellow to light yellow, biconvex, capsule shaped, film-coated tablets, with “2.5/1000” printed on one side and “4222” printed on the other side, in blue ink. For a full list of excipients, see section 6.1. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. 2 K OMBIGLYZE XR Data Sheet 181119 Copyright 4.2 DOSE AND METHOD OF AD Baca dokumen lengkapnya