BRILINTA

Nazione: Indonesia

Lingua: indonesiano

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

Commercializzato da:

ASTRAZENECA INDONESIA - Indonesia -

Dosaggio:

90 MG

Forma farmaceutica:

ORODISPERSIBLE TABLET

Composizione:

TICAGRELOR

Confezione:

DUS, 7 BLISTER @ 8 TABLET ORODISPERSIBLE

Classe:

Obat

Prodotto da:

ASTRAZENECA AB - Sweden

Stato dell'autorizzazione:

Berlakus/d 31-03-2028

Data dell'autorizzazione:

2023-03-31

Scheda tecnica

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 -