Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Empagliflozin 25mg; ;
Boehringer Ingelheim (NZ) Ltd
Empagliflozin 25 mg
25 mg
Film coated tablet
Active: Empagliflozin 25mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 02B38190
Prescription
Boehringer Ingelheim Bidachem SpA
Type 2 diabetes mellitus Glycaemic control: JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: Monotherapy - When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy - In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Further information in section 5.1).
Package - Contents - Shelf Life: Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
2014-06-27
JARDIANCE NZ CMI V06 1 JARDIANCE ® _FILM-COATED TABLETS _ _empagliflozin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Jardiance. 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 Jardiance against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medsafe.govt.nz/ Consumers/cmi/CMIForm.asp (New Zealand) and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT JARDIANCE IS USED FOR Jardiance is used to lower blood sugar levels in adults and children aged 10 years and older with type 2 diabetes mellitus. _TYPE 2 DIABETES MELLITUS _ It may be used when diet plus exercise do not provide adequate blood sugar level control either: • alone as a single medicine, or • in combination with certain other anti-diabetic medicines such as: • metformin, or • sulfonylurea medicines such as glimepiride and glibenclamide, or • pioglitazone, or • insulin, or • dipeptidyl peptidase-4 inhibitor medicines such as linagliptin. In adult patients with type 2 diabetes mellitus and cardiovascular disease, Jardiance can be used to reduce your risk of dying from your cardiovascular disease. Type 2 diabetes mellitus is also called non-insulin-dependent diabetes mellitus or NIDDM. Type 2 diabetes develops if the body does not make enough insulin, or if the insulin that your body makes does not work as well as it should. Insulin is a substance which helps to lower the level of sugar in your blood, especially after meals. Wh Preberite celoten dokument
JARDIANCE NZ DS v11 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME JARDIANCE 10 mg film coated tablets JARDIANCE 25 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION JARDIANCE 10 mg film coated tablets Each film coated tablet contains 10 mg empagliflozin. Excipient with known effect Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous. JARDIANCE 25 mg film coated tablets Each film coated tablet contains 25 mg empagliflozin. Excipient with known effect Each tablet contains lactose monohydrate equivalent to 107.4 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet (tablet). JARDIANCE 10 mg film-coated tablets Pale yellow, round, biconvex and bevel-edged tablets. One side is debossed with the code ‘S10’, the other side is debossed with the Boehringer Ingelheim company symbol. JARDIANCE 25 mg film-coated tablets Pale yellow, oval, biconvex tablets. One side is debossed with the code ‘S25’, the other side is debossed with the Boehringer Ingelheim company symbol. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS TYPE 2 DIABETES MELLITUS Glycaemic control: JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: _Monotherapy _ When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. _Add-on combination therapy _ In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Further Information section 5.1). JARDIANCE NZ DS v11 2 Prevention of cardiovascular events: JARDIANCE is indicated in adult patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1). To prevent cardiovascular deaths, JARDIANCE should be used in conjunction with Preberite celoten dokument