البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
vildagliptin, Quantity: 50 mg
Novartis Pharmaceuticals Australia Pty Ltd
Vildagliptin
Tablet, uncoated
Excipient Ingredients: sodium starch glycollate; magnesium stearate; lactose; microcrystalline cellulose
Oral
60 tablets, 112 tablets, 14 tablets
(S4) Prescription Only Medicine
Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes: - As monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. - In dual combination with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. - In triple combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. - In combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control.
Visual Identification: White to light yellowish, round, flat faced, bevelled edge tablet. One side debossed with 'NVR' and the other side with 'FB'.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2010-03-02
GALVUS ® _vildagliptin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Galvus. 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 GALVUS IS USED FOR Galvus is used to lower blood sugar levels in patients with type 2 diabetes mellitus either alone (if you are unable to take metformin) or in combination with certain other medicines (metformin, or a sulfonylurea medicine, or pioglitazone, or metformin and a sulfonylurea, or insulin injections), when diet plus exercise plus the single or dual medicines do not provide adequate blood sugar level control. _TYPE 2 DIABETES MELLITUS_ 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 as it should. It can also develop if the body produces too much glucagon. Insulin is a substance which helps to lower the level of sugar in your blood, especially after meals. Glucagon is another substance which triggers the production of sugar by the liver, causing the blood sugar to rise. The pancreas makes both of these substances. Galvus is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl pe اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION – GALVUS ® (VILDAGLIPTIN) TABLETS 1 NAME OF THE MEDICINE The active ingredient of GALVUS is vildagliptin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vildagliptin is a white to slightly yellowish or slightly greyish crystalline powder with a melting point/range of approximately 150°C. It is freely soluble in water. Each GALVUS tablet contains 50 mg vildagliptin, lactose anhydrous, magnesium stearate, cellulose – microcrystalline and sodium starch glycollate. Excipients with known effect: lactose 3 PHARMACEUTICAL FORM GALVUS (vildagliptin) is available as a 50 mg tablet. 50 mg: white to light yellowish, round flat-faced with bevelled edges, unscored tablet. One side is debossed with "NVR" and the other side with "FB". 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes: • As monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. • In dual combination with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. • In triple combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. • In combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control. 4.2 D OSE AND METHOD OF ADMINISTRATION The management of antidiabetic therapy should be individualised. Doses greater than 100 mg are not recommended. Vildagliptin can be administered orally with or without a meal. The 50 mg dose should be administered once daily in the morning. The 100 mg daily dose should be administered as two divided doses of 50 mg taken in the morning and evening. 2 If a dose of Galvus is اقرأ الوثيقة كاملة