Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
vildagliptin, Quantity: 50 mg; metformin hydrochloride, Quantity: 1000 mg
Novartis Pharmaceuticals Australia Pty Ltd
Metformin hydrochloride,Vildagliptin
Tablet, film coated
Excipient Ingredients: iron oxide yellow; titanium dioxide; hypromellose; macrogol 4000; hyprolose; purified talc; magnesium stearate
Oral
120, 360, 60, 10, 180, 30
(S4) Prescription Only Medicine
For patients with Type 2 diabetes mellitus (T2DM):,GALVUMET is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Treatment should not be initiated with this fixed-dose combination.,GALVUMET is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.,GALVUMET is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Visual Identification: Dark yellow, ovaloid bevelled edge, film coated tablet debossed with "NVR" on one side and "FLO" on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-12-13
GALVUMET ® _Vildagliptin/Metformin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Galvumet. 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 THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. 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 provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GALVUMET IS USED FOR Galvumet is used to treat type 2 diabetes mellitus in people who are already taking vildagliptin and metformin tablets separately, or whose diabetes cannot be controlled by metformin alone. Galvumet is also used with a sulfonylurea by patients whose blood sugar levels are not adequately controlled when taking only metformin and a sulfonylurea. Galvumet is also added to insulin in patients when a stable dose of insulin and metformin do not provide adequate blood sugar control. It is prescribed by your doctor together with diet and exercise. Galvumet contains two ingredients: vildagliptin, which belongs to a class of medicines called 'islet enhancers', and metformin, which belongs to the 'biguanide' class. Type 2 diabetes mellitus used to be known as 'non-insulin-dependent diabetes mellitus (NIDDM)' or 'maturity onset diabetes'. Type 2 diabetes develops if the body does not produce enough insulin, or where the insulin that your body makes does not work as well Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION – GALVUMET ® (VILDAGLIPTIN/METFORMIN HYDROCHLORIDE) FILM-COATED TABLET 1 NAME OF THE MEDICINE vildagliptin/metformin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GALVUMET film coated tablets are available in 3 strengths: • GALVUMET 50/500: 50 mg vildagliptin and 500 mg metformin hydrochloride • GALVUMET 50/850: 50 mg vildagliptin and 850 mg metformin hydrochloride • GALVUMET 50/1000: 50 mg vildagliptin and 1,000 mg metformin hydrochloride For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM GALVUMET 50/500: light yellow, ovaloid bevelled edge, film-coated tablet imprinted with "NVR" on one side and "LLO" on the other side. GALVUMET 50/850: yellow, ovaloid bevelled edge, film-coated tablet imprinted with "NVR" on one side and "SEH" on the other side. GALVUMET 50/1000: dark yellow, ovaloid bevelled edge, film-coated tablet imprinted with "NVR" on one side and "FLO" on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For patients with Type 2 diabetes mellitus (T2DM): GALVUMET is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Treatment should not be initiated with this fixed-dose combination. GALVUMET is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea. GALVUMET is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. 2 4.2 D OSE AND METHOD OF ADMINISTRATION LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. THE MAIN RISK FACTOR IS RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD AGE Przeczytaj cały dokument