Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TICAGRELOR
ASTRAZENECA INDONESIA - Indonesia
TICAGRELOR
60 MG
TABLET SALUT SELAPUT
DUS, 4 BLISTER @ 14 TABLET SALUT SELAPUT
ASTRAZENECA Pharmaceuticals - Sweden
2018-01-23
1 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 ® 90 mg & 60 mg (TICAGRELOR) FILM-COATED TABLETS 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 : BRILINTA 90 mg co-administered with ASA 75-100 mg is indicated for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with acute coronary syndromes (ACS) [unstable angina, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)] including patients managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). BRILINTA 60 mg: BRILINTA 60 mg is indicated for the prevention of thrombotic events (cardiovascular death, myocar Baca dokumen lengkap