国: インドネシア
言語: インドネシア語
ソース: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
ASTRAZENECA INDONESIA - Indonesia
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
500 MG/5 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT
ASTRAZENECA UK LIMITED
2018-01-24
1 of 23 Proposed packaging material Code Kombiglyze XR 5/500 (28s) FCT-PI-01.01 Submission NDA Renewal Variation change detail no.: MU-34237-59529_ _ Code of previous version N/A Changes CDS Update 2017 - Renal Impairment BPOM Letter Date 8 Feb 2022 on Pharmacokinetic properties – special population Reference CDS version: 2017 CPIL version: SmPC country/version/date: GRL approval: 28 April 2022 Name & Date SRF (02 June 2022) KOMBIGLYZE TM XR 5 MG/500 MG _(saxagliptin/metformin HCl extended release) _ FILM-COATED TABLET QUALITATIVE AND QUANTITATIVE COMPOSITION KOMBIGLYZE XR is available for oral administration as tablets containing either 5.58 mg saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin and 500 mg metformin hydrochloride (KOMBIGLYZE XR 5 mg/500 mg). PHARMACEUTICAL FORM KOMBIGLYZE XR 5 mg/500 mg are light brown to brown, biconvex, capsule shaped, film- coated tablet, with 5/500 printed on one side and 4221 printed on the other side, in blue ink. THERAPEUTIC INDICATION KOMBIGLYZE XR 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 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/50 完全なドキュメントを読む