BRILINTA

Nchi: Indonesia

Lugha: Kiindonesia

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

Viambatanisho vya kazi:

TICAGRELOR

Inapatikana kutoka:

ASTRAZENECA INDONESIA - Indonesia

INN (Jina la Kimataifa):

TICAGRELOR

Kipimo:

90 MG

Dawa fomu:

TABLET SALUT SELAPUT

Vitengo katika mfuko:

DUS, 4 BLISTER @ 14 TABLET SALUT SELAPUT

Viwandani na:

ASTRAZENECA PHARMACEUTICAL COMPANY LTD. - China

Idhini ya tarehe:

2021-02-17

Tabia za bidhaa

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