Kraj: Indonezja
Język: indonezyjski
Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 4 BLISTER @ 7 TABLET PELEPASAN LAMBAT
2022-12-31
1 of 25 PROPOSED PACKAGING MATERIAL Code KOMBIGLYZE XR 5/1000 MG T-PI-01.04 Submission NDA Renewal Variation change detail no.: MU-30321-105619 (Pra-Reg), MU-30321- 107138 (Reg), MU-34237-59529 (Renal Impairment)_ _ Code of previous version KOMBIGLYZE XR 5/1000 MG T-PI-01.03 Changes Revision dosage form as per BPOM HAQ date 7 Dec 2022 Reference CDS version: 2017 CPIL version: SmPC country/version/date: GRL approval : 1 November 2022 Name & Date RM (7 December 2022) KOMBIGLYZE TM XR 5 MG/1000 MG _(saxagliptin/metformin HCl) _ _Extended-Release Tablet _ QUALITATIVE AND QUANTITATIVE COMPOSITION • KOMBIGLYZE XR is available for oral administration as extended release tablets containing: 5 mg saxagliptin and 1000 mg metformin hydrochloride (KOMBIGLYZE XR 5 mg/1000 mg). PHARMACEUTICAL FORM • KOMBIGLYZE XR 5 mg/1000 mg pink, biconvex, capsule shaped, extended release tablet, with 5/1000 printed on one side and 4223 printed on the other side, in blue ink. THERAPEUTIC INDICATION KOMBIGLYZE XR 5/1000 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone and/or those already being treated with the combination of saxagliptin and metformin as separate tablets. KOMBIGLYZE XR is not indicated for initial treatment of type 2 diabetes mellitus. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Recommended Dosage _ The dosage of antihyperglycemic therapy with KOMBIGLYZE XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended dose of saxagliptin and metformin extended release. KOMBIGLYZE XR should generally be administered once daily with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin, as appropriate. The following dosage forms are available: • KOMBIGLYZE XR (saxagliptin/metformin HCl) extended release tablets 5 mg/500 mg • KO Przeczytaj cały dokument