BRILINTA

Země: Indonésie

Jazyk: indonéština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Jednotky v balení:

DUS, 4 BLISTER @ 14 TABLET SALUT SELAPUT

Datum autorizace:

2022-08-04

Charakteristika produktu

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