Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
Metformin Hydrochloride; Vildagliptin
NOVARTIS (SINGAPORE) PTE LTD
A10BD08
1000.0 mg
TABLET, FILM COATED
Metformin Hydrochloride 1000.0 mg; Vildagliptin 50.0 mg
ORAL
Prescription Only
Novartis Pharma Produktions GmbH
ACTIVE
2009-08-11
GALVUS MET Drugs used in diabetes, combinations of oral blood glucose lowering drugs DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Three strengths are available. One tablet of Galvus Met contains: 50 mg vildagliptin and 500 mg metformin hydrochloride. Light yellow, ovaloid beveled edge, film-coated tablet imprinted with “NVR” on one side and “LLO” on the other side. 50 mg vildagliptin and 850 mg metformin hydrochloride. Yellow, ovaloid beveled edge, film-coated tablet imprinted with "NVR" on one side and "SEH" on the other side. 50 mg vildagliptin and 1,000 mg metformin hydrochloride. Dark yellow, ovaloid beveled edge, film-coated tablet imprinted with "NVR" on one side and "FLO" on the other side. ACTIVE SUBSTANCES Vildagliptin Metformin hydrochloride ACTIVE MOIETIES Vildagliptin and metformin Certain dosage strengths and dosage forms may not be available in all countries. EXCIPIENTS Ferric oxide red, ferric oxide yellow, hypromellose, hydroxypropylcellulose, magnesium stearate, polyethylene glycol, and talc. Pharmaceutical formulations may vary between countries. INDICATIONS For patients with Type 2 diabetes mellitus (T2DM): Galvus Met is indicated as an adjunct to diet and exercise to improve glycemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Galvus Met is indicated in combination with a sulfonylurea (SU) (i.e., triple combination therapy) as an Perskaitykite visą dokumentą
Galvus Met Aug 2023.SIN Page 1 of 28 GALVUS MET Drugs used in diabetes, combinations of oral blood glucose lowering drugs DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Three strengths are available. One tablet of Galvus Met contains: • 50 mg vildagliptin and 500 mg metformin hydrochloride. Light yellow, ovaloid beveled edge, film-coated tablet imprinted with “NVR” on one side and “LLO” on the other side. • 50 mg vildagliptin and 850 mg metformin hydrochloride. Yellow, ovaloid beveled edge, film-coated tablet imprinted with "NVR" on one side and "SEH" on the other side. • 50 mg vildagliptin and 1,000 mg metformin hydrochloride. Dark yellow, ovaloid beveled edge, film-coated tablet imprinted with "NVR" on one side and "FLO" on the other side. ACTIVE SUBSTANCES Vildagliptin Metformin hydrochloride ACTIVE MOIETIES Vildagliptin and metformin Certain dosage strengths and dosage forms ma y not be available in all countries. EXCIPIENTS Hydroxypropyl cellulose, hypromellose, iron oxide yellow, iron oxide red, macrogol, magnesium stearate, talc and titanium dioxide. Pharmaceutical formulations may vary between countries. INDIC ATIONS GalvusMet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control: • as initial therapy when diabetes is not adequately controlled by diet and exercise alone • as therapy in patients inadequately controlled with metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets • as combination therapy- in combination with other medicinal products, including insulin, when these do not provide adequate glycemic control (see section on Warnings and precautions, section on Interactions and section on Clinical Studies for available data on different combinations). Important limitations of Use Galvus Met Aug 2023.SIN Page 2 of 28 Galvus Met should not be used in patients with type 1 diabetes or for the treatment of diabeti Perskaitykite visą dokumentą