Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TICAGRELOR
ASTRAZENECA INDONESIA - Indonesia
TICAGRELOR
90 Mg
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 14 TABLET SALUT SELAPUT
ASTRAZENECA PHARMACEUTICAL COMPANY LTD. - China
2021-03-23
PROPOSED PACKAGING MATERIAL Code Brilinta 90 60 (56s & 14s) FCT-PI-01.043 Submission NDA Renewal Variation change detail no.: MU-70180-113758 (90 Pra- Reg THALES), MU-70180-123012 (90 Reg THALES), MU-86997-136308- 852368 (60 Sleep Apnea), MU-86997-136308-852369 (90 Sleep Apnea) Code of previous version Brilinta 90 60 (56s & 14s) FCT-PI-01.03 Changes Alignment with BPOM HAQ on 22 November 2022 Reference CDS version: 9.0 and 10.0 CPIL version: SmPC country/version/date: USPI (2020) GRL approval: 20 December 2022 Name & Date FR (4 January 2023) 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. BRILINTA ® TICAGRELOR Film-coated tablets 90 mg & 60 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 90 mg of ticagrelor Each tablet contains 60 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. 60 mg - Round, biconvex, pink, film-coated tablets. The tablets are marked with “60” above “T” on one side and plain on the other. INDICATIONS BRILINTA 90 MG: DISETUJUI OLEH B Lue koko asiakirja