Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 500 mg; alogliptin benzoate, Quantity: 17 mg (Equivalent: alogliptin, Qty 12.5 mg)
Takeda Pharmaceuticals Australia Pty Ltd
Alogliptin benzoate,Metformin hydrochloride
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; mannitol; titanium dioxide; magnesium stearate; iron oxide yellow; purified talc; crospovidone; povidone; hypromellose
Oral
14, 28, 112, 196, 20, 120, 180, 98, 10, 60, 56, 200
(S4) Prescription Only Medicine
NESINA MET is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,NESINA MET can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.
Visual Identification: Pale yellow, oblong, biconvex, film-coated tablet with 12.5/500 debossed on one side and 322M debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2013-10-22
NESINA MET ® _Alogliptin (as benzoate)/ Metformin hydrochloride_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nesina Met. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from https://takeda.com/en-au/what- we-do/our-products/. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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 NESINA MET IS USED FOR Nesina Met is used to lower blood sugar levels in adults with type 2 diabetes mellitus. Nesina Met is used when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin; metformin and insulin or metformin and medicines known as thiazolidinediones (e.g. pioglitazone). If you are already taking both alogliptin and metformin as separate tablets, Nesina Met can replace them in one tablet. Nesina Met is not for patients with type 1 diabetes mellitus or diabetic ketoacidosis (increased ketones in blood or urine). It is important that you continue to follow the advice on diet and exercise that your doctor or diabetes educator has given you. _TYPE 2 DIABETES MELLITUS_ Type 2 diabetes is also called non- insulin-dependent diabetes mellitus (NIDDM). Type 2 diabetes develops if the body does not make enough insulin, or if the insulin that yo Pročitajte cijeli dokument
_NESINA MET PI V6.0 (CCDS V4.0)_ _ _ _ _ _1 _ AUSTRALIAN PRODUCT INFORMATION NESINA MET ® 12.5 MG/500 MG, 12.5 MG/850 MG & 12.5 MG/1000 MG (ALOGLIPTIN / METFORMIN HYDROCHLORIDE) 1 NAME OF THE MEDICINE NESINA MET tablets contain 2 oral antihyperglycaemic drugs used in the management of type 2 diabetes: alogliptin (as benzoate), a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NESINA MET is available as film-coated tablets for oral administration containing alogliptin benzoate equivalent to 12.5 mg alogliptin free base and: • 500 mg metformin hydrochloride (12.5 mg/500 mg) or • 850 mg metformin hydrochloride (12.5 mg/850 mg) or • 1000 mg metformin hydrochloride (12.5 mg/1000 mg) Contains benzoates. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM NESINA MET is available in the following presentations: NESINA MET 12.5/500 film-coated tablets: Pale yellow, oblong, biconvex, film-coated tablet with “12.5/500” debossed on one side and “322M” debossed on the other side NESINA MET 12.5/850 film-coated tablets: Light yellow, oblong, biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side. NESINA MET 12.5/1000 film-coated tablets: Pale yellow, oblong, biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NESINA MET is indicated to improve glycaemic control in adult patients (≥ 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate, • when treatment with metformin alone does not provide adequate control; or • in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control. NESINA MET can also be used to replace separate tablets of aloglip Pročitajte cijeli dokument