Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE
ASTRAZENECA INDONESIA - Indonesia
DAPAGLIFLOZIN PROPENADIOL; METFORMIN HYDROCHLORIDE
10/500 MG
TABLET SALUT SELAPUT
BOX, 4 BLISTERS @ 7 TABLET SALUT SELAPUT
ASTRAZENECA INDONESIA - Indonesia
2018-09-24
1 XIGDUO XR TM XR 10/500 MG; 10/1000 MG _(dapagliflozin/metformin HCl extended release) _ EXTENDED RELEASE FILM-COATED TABLET QUALITATIVE AND QUANTITATIVE COMPOSITION XIGDUO XR is available for oral administration as extended release film- coated tablets containing dapagliflozin and metformin hydrochloride as following quantitative composition: • XIGDUO XR 10/500 mg: Each film-coated tablet contains 10 mg dapagliflozin as dapagliflozin propanediol and 500 mg metformin HCl extended-release • XIGDUO XR 10/1000 mg: Each film-coated tablet contains 10 mg dapagliflozin as dapagliflozin propanediol and 1000 mg metformin HCl extended-release. PHARMACEUTICAL FORM XIGDUO XR is a combination of dapagliflozin and metformin HCl extended-release. XIGDUO XR tablets are available in the following dosage forms and strengths: • 10 mg/500 mg tablets are pink, biconvex, capsule shaped, film-coated tablets debossed with “1072” and “10/500” on one side and plain on the other side. • 10 mg/1000 mg tablets are yellow to dark yellow, biconvex, oval-shaped, and film- coated tablets with "1073" and "10/1000" debossed on one side and plain on the reverse side. THERAPEUTIC INDICATION XIGDUO XR (dapagliflozin and metformin HCl extended-release) is indicated as substitution therapy for treatment of type 2 diabetes mellitus in adjunct to diet and exercise to improve glycemic control in adults patients already controlled with dapagliflozin and metformin XR given concurrently at the same dose level (see section Clinical trials and Special warning and precautions for use for available data on combination therapy). For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections Special warnings and special precautions for use, Undesirable effects, and Pharmacodynamic properties. POSOLOGY AND METHOD OF ADMINISTRATION RECOMMENDED DOSING • Healthcare providers should individualize the starting dose of XIGDUO XR based on the patient’s curr Lue koko asiakirja