Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10 mg; ; Metformin hydrochloride 500mg (with 0.5% Magnesium stearate);
AstraZeneca Limited
Dapagliflozin propanediol monohydrate 12.3 mg (equivalent to Dapagliflozin 10 mg)
10mg/500mg
Modified release tablet
Active: Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10 mg Metformin hydrochloride 500mg (with 0.5% Magnesium stearate) Excipient: Carmellose sodium Colloidal silicon dioxide Crospovidone Hypromellose Microcrystalline cellulose (PH302) Hypromellose (2910) Lactose Magnesium stearate Microcrystalline cellulose Opadry Pink 85F94333
Prescription
Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company
Glycaemic control XIGDUO XR is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). Prevention of hospitalisation for heart failure Dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 Pharmacodynamic properties – Clinical Efficacy and Safety). Prevention of new or worsening nephropathy Dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 Pharmacodynamic properties – Clinical Efficacy and Safety).
Package - Contents - Shelf Life: Blister pack, Al/Al - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C
2014-12-11
Xigduo XR Tablets Copyright 1(8) 180520 XIGDUO ® XR DAPAGLIFLOZIN/METFORMIN HYDROCHLORIDE MODIFIED RELEASE TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about XIGDUO XR. It does not contain all 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 XIGDUO 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 XIGDUO XR IS USED FOR XIGDUO XR is a prescription medicine used with diet, exercise and sometimes other medicines such as insulin , a sulphonylurea, or a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon like peptide 1 (GLP-1) receptor agonist such as exenatide, to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus. It can also help prevent hospitalisation for heart failure and kidney disease in patients with type 2 diabetes mellitus. TYPE 2 DIABETES MELLITUS Type 2 diabetes mellitus (also called non-insulin-dependent diabetes mellitus or NIDDM) is the condition of having high levels of blood sugar (hyperglycaemia). This is usually because your body does not make enough insulin and /or the insulin that your body produces does not work as well as it should. Left uncontrolled, the build-up of high levels of sugar in your blood can lead to serious medical problems. The main goal of treating type 2 diabetes mellitus is to control your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, which include kidney disease, blindness and amputation. XIGDUO XR contains two active ingredients, dapagliflozin and metformin hydrochloride. Dapagliflozin is a member of a class of medicines you take by mouth called SGLT-2 (Sodium Glucose Cotransporter-2) inhibitors and metformin belo Lestu allt skjalið
1 XIGDUO ® XR Data Sheet 070623 Copyright NEW ZEALAND DATA SHEET 1. PRODUCT NAME X IGDUO ® XR 5mg/1000mg, modified release tablet X IGDUO ® XR 10mg/500mg, modified release tablet X IGDUO ® XR 10mg/1000mg, modified release tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION X IGDUO XR 5 mg/1000 mg: Each film-coated tablet contains 5 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin HCl extended-release. X IGDUO XR 10 mg/500 mg: Each film-coated tablet contains 10 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin HCl extended-release. X IGDUO XR 10 mg/1000 mg: Each film-coated tablet contains 10 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin HCl extended-release. For the full list of excipients see section 6.1 - List of Excipients. 3. PHARMACEUTICAL FORM X IGDUO XR 5 mg/1000 mg tablets are pink to dark pink, biconvex, oval shaped, film-coated tablets debossed with “1071” and “5/1000” on one side and plain on the other side. X IGDUO XR 10 mg/500 mg tablets are pink, biconvex, capsule shaped, film-coated tablets debossed with “1072” and “10/500” on one side and plain on the other side. X IGDUO XR 10 mg/1000 mg tablets are yellow to dark yellow, biconvex, oval shaped, film-coated tablets debossed with “1073” and “10/1000” on one side and plain on the other side. DAPAGLIFLOZIN Dapagliflozin is described chemically as (1_S_)-1,5-anhydro-1-C-[4-chloro-3-[(4- ethoxyphenyl)methyl]phenyl]-D-glucitol, (_S_)-propylene glycol, monohydrate. The chemical structure of dapagliflozin propanediol monohydrate is: O HO H Cl O CH 3 OH HO HO H 3 C OH OH H . . H 2 O 2 XIGDUO ® XR Data Sheet 070623 Copyright METFORMIN HYDROCHLORIDE The chemical structure of metformin hydrochloride (_N,N_-dimethylimidodicarbonimidic diamide hydrochloride) is: 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GLYCAEMIC CONTROL X IGDUO XR is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with b Lestu allt skjalið