Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; VILDAGLIPTIN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
METFORMIN HYDROCHLORIDE; VILDAGLIPTIN
60tablet Tablets; 30tablet Tablets
NOVARTIS PHARMA PRODUKTIONS GMBH
GALVUS ® MET Vidagliptin and Metformin fixed combination (50mg/500mg, 50mg/850mg, 50mg/1000mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. WHAT GALVUS MET IS USED FOR 2. HOW GALVUS MET WORKS 3. BEFORE YOU USE GALVUS MET 4. HOW TO USE GALVUS MET 5. WHILE YOU ARE USING GALVUS MET 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF GALVUS MET 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT GALVUS MET IS USED FOR Galvus Met is available as tablets. Each Galvus Met tablet contains two active substances: vildagliptin and metformin hydrochloride. Both substances belong to a group of medicines called “oral antidiabetics”. Three dosage strengths are available (vildagliptin/metformin hydrochloride) 50 mg/500 mg, 50 mg/850 mg and 50 mg/1,000 mg. Galvus Met is a medicine used to treat type 2 diabetes. It helps to control the level of sugar in the blood. It is prescribed as an adjunct to diet and exercise to improve control over body sugar levels - as a first diabetes treatment in patients whose diabetes is not adequately controlled by diet and exercise alone; - in patients who have already received treatment with vildagliptin and metformin hydrochloride together as separate tablets; - or whose diabetes is not adequately controlled with metformin hydrochloride or vildagliptin alone, in combination with other medicinal products from the treatment of diabetes, including insulin when these do not provide adequate glycemic control. HOW GALVUS MET WORKS Galvus Met works by making the pancreas produce more insulin and less glucagon (effect of vildagliptin) and also by helping the body to make better use of the insulin it produces (effect of metformin hydrochloride). Galvus Met helps to control the blood sugar level. It is important that you continue to follow the diet and/or exercise recommended to you while you are on treatment with Galvus Met. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU US Izlasiet visu dokumentu
Novartis Page 2 Malaysia Package Insert 13-Jul-2020 Galvus Met 1. NAME OF THE MEDICINAL PRODUCT Galvus Met 50 mg/500 mg film-coated tablets Galvus Met 50 mg/850 mg film-coated tablets Galvus Met 50 mg/1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Galvus Met 50 mg/500 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 500 mg of metformin hydrochloride (corresponding to 390 mg of metformin). Galvus Met 50 mg/850 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin). Galvus Met 50 mg/1000 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Galvus Met 50 mg/500 mg film-coated tablets Light yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “LLO” on the other side. Galvus Met 50 mg/850 mg film-coated tablets Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side. Galvus Met 50 mg/1000 mg film-coated tablets Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side. Novartis Page 3 Malaysia Package Insert 13-Jul-2020 Galvus Met 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galvus Met is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: - as initial therapy when diabetes is not adequately controlled by diet and exercise alone - in patients who are inadequately controlled with metformin hydrochloride alone - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, inclu Izlasiet visu dokumentu