Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ASTRAZENECA INDONESIA - Indonesia -
90 MG
ORODISPERSIBLE TABLET
TICAGRELOR
DUS, 7 BLISTER @ 8 TABLET ORODISPERSIBLE
Obat
ASTRAZENECA AB - Sweden
Berlakus/d 31-03-2028
2023-03-31
Proposed packaging material Code Brilinta 90, 60 mg (56s) FCT, ODT-PI-01.01 Submission NDA Renewal Variation change detail no.: MU-20326-117611, MU- 20326-122045, MU-86997-136308 Code of previous version N/A Changes New Product Information Creation for Brilinta ODT New Dosage Form Reference CDS version: 2017 CPIL version: SmPC country/version/date: EU SmPC/2019 GRL approval: Name & Date ASR (29 November 2022) BRILINTA ® 90 mg & 60 mg (TICAGRELOR) FILM-COATED TABLETS 90 mg (TICAGRELOR)_ ORODISPERSIBLE_ TABLET QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 90 mg of ticagrelor _Each tablet contains 60 mg of ticagrelor_ Each orodispersable tablet contains 90 mg of ticagrelor PHARMACEUTICAL FORM 90 mg - Round, biconvex, yellow, film-coated tablets. The tablets are marked with “90” above “T” on one side and plain on the other. WARNING: BLEEDING RISK BRILINTA, LIKE OTHER ANTIPLATELET AGENTS, CAN CAUSE SIGNIFICANT, SOMETIMES FATAL, BLEEDING. DO NOT USE BRILINTA IN PATIENTS WITH ACTIVE PATHOLOGICAL BLEEDING OR A HISTORY OF INTRACRANIAL HEMORRHAGE. DO NOT START BRILINTA IN PATIENTS PLANNED TO UNDERGO URGENT CORONARY ARTERY BYPASS GRAFT SURGERY (CABG). WHEN POSSIBLE, DISCONTINUE BRILINTA AT LEAST 5 DAYS PRIOR TO ANY SURGERY. SUSPECT BLEEDING IN ANY PATIENT WHO IS HYPOTENSIVE AND HAS RECENTLY UNDERGONE CORONARY ANGIOGRAPHY, PERCUTANEOUS CORONARY INTERVENTION (PCI), CABG, OR OTHER SURGICAL PROCEDURES IN THE SETTING OF BRILINTA. IF POSSIBLE, MANAGE BLEEDING WITHOUT DISCONTINUING BRILINTA. STOPPING BRILINTA INCREASES THE RISK OF SUBSEQUENT CARDIOVASCULAR EVENTS. WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS MAINTENANCE DOSES OF ASPIRIN ABOVE 100 MG REDUCE THE EFFECTIVENESS OF BRILINTA AND SHOULD BE AVOIDED. AFTER ANY INITIAL DOSE, USE WITH ASPIRIN 75-100 MG PER DAY. DISETUJUI OLEH BPOM : 28/02/2023 EREG10042212100136 60 mg - Round, biconvex, pink, film-coated tablets. The tablets are marked with “60” above “T” on one side and plain on the other. Orodispersible tablet - Lesen Sie das vollständige Dokument