Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
linagliptin, Quantity: 2.5 mg; metformin hydrochloride, Quantity: 500 mg
Boehringer Ingelheim Pty Ltd
Linagliptin,Metformin hydrochloride
Tablet, film coated
Excipient Ingredients: hypromellose; iron oxide yellow; propylene glycol; copovidone; colloidal anhydrous silica; arginine; maize starch; purified talc; magnesium stearate; titanium dioxide
Oral
120, 30, 14, 10, 84, 56, 28, 100, 98, 90, 60
(S4) Prescription Only Medicine
TRAJENTAMET is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin.,TRAJENTAMET is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea.,TRAJENTAMET is indicated in combination with an SGLT2 inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an SGLT2 inhibitor.,TRAJENTAMET is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.
Visual Identification: 2.5 mg/500 mg: Light yellow, oval, biconvex film coated tablets, one side debossed with the company symbol and the other side debossed with D2/500; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-05-21
TRAJENTAMET ® _TABLETS_ _linagliptin / metformin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Trajentamet. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Trajentamet 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.medicines.org.au 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 TRAJENTAMET IS USED FOR Trajentamet is used to lower blood sugar levels in patients with 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: • sulfonylurea medicines such as glimepiride and glibenclamide, or • insulin, or • sodium-glucose transporter 2 inhibitor medicines such as empagliflozin. Type 2 diabetes mellitus is also called non-insulin-dependent diabetes mellitus or NIDDM. Type 2 diabetes mellitus 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. When the level of sugar builds up in your blood, this can cause damage to the body's cells and lead to serious problems with your heart, brain, eyes, circulation, nerves or kidneys. _HOW TRAJENTAMET WORKS_ Trajentamet contains two different active substances, linagliptin a Baca dokumen lengkap
TRAJENTAMET PI0140-15 Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION – TRAJENTAMET (LINAGLIPTIN/METFORMIN HYDROCHLORIDE) FILM-COATED TABLET 1 NAME OF THE MEDICINE linagliptin and metformin hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TRAJENTAMET contains two oral antihyperglycaemic drugs used in the management of type 2 diabetes mellitus (T2DM): linagliptin (a dipeptidyl peptidase-4 (DPP-4) inhibitor) and metformin hydrochloride. TRAJENTAMET are film-coated tablets for oral administration: • TRAJENTAMET 2.5 mg/500 mg contains 2.5 mg linagliptin and 500 mg metformin hydrochloride • TRAJENTAMET 2.5 mg/850 mg contains 2.5 mg linagliptin and 850 mg metformin hydrochloride • TRAJENTAMET 2.5 mg/1000 mg contains 2.5 mg linagliptin and 1000 mg metformin hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TRAJENTAMET is available in three strengths: TRAJENTAMET 2.5 mg/500 mg - oval, biconvex, light yellow, one side debossed with the Boehringer Ingelheim company symbol, the other side debossed with ‘D2/500’. TRAJENTAMET 2.5 mg/850 mg - oval, biconvex, light orange, one side debossed with the Boehringer Ingelheim company symbol, the other side debossed with ‘D2/850’. TRAJENTAMET 2.5 mg/1000 mg - oval, biconvex, light pink, one side debossed with the Boehringer Ingelheim company symbol, the other side debossed with ‘D2/1000’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRAJENTAMET is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin. TRAJENTAMET is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a su Baca dokumen lengkap