PLAVIX

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

CLOPIDOGREL HYDROGEN SULFATE

제공처:

AVENTIS PHARMA - Indonesia

INN (International Name):

CLOPIDOGREL HYDROGEN SULFATE

복용량:

75 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Manufactured by:

AVENTIS PHARMA - Indonesia

승인 날짜:

2018-08-14

제품 특성 요약

ID REG: EREG10002212200251, 253
DISETUJUI OLEH BPOM 13 JANUARI 2023
Plavix CCDS Update V30
1 of 22
PLAVIX

CLOPIDOGREL
COMPOSITION
PLAVIX 75 MG FILM-COATED TABLET
Each film-coated tablet contains 97.875 mg of Clopidogrel hydrogen
sulphate form II (molar
equivalent of 75 mg of Clopidogrel base).
PLAVIX 300 MG FILM-COATED TABLET
Each film-coated tablet contains 391.5 mg of Clopidogrel
hydrogen sulphate form II
(molar
equivalent of 300 mg of Clopidogrel base).
PHARMACEUTICAL FORM
PLAVIX 75 MG FILM-COATED TABLET
Film-coated tablet: pink, round, biconvex, engraved with <<75>> on one
side and <<1171>>
on the other side.
PLAVIX 300 MG FILM-COATED TABLET
Film-coated tablet: pink, oblong, engraved with <<300>> on one side
and <<1332>> on the
other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Clopidogrel is indicated for the secondary prevention of
atherothrombotic events in:
•
Patients suffering from myocardial
infarction (from a few days until
less than 35 days),
ischemic stroke (from 7 days until
less than 6 months) or established peripheral
arterial
disease.
•
Patients suffering from acute coronary syndrome:
•
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
myocardial
infarction),
including patients undergoing a STENT placement
following
percutaneous coronary intervention, in combination with
acetylsalicylic acid (ASA).
•
ST segment elevation acute myocardial infarction, in combination with
ASA in medically
treated patients eligible for thrombolytic therapy.
In patients with moderate to high-risk Transient Ischemic Attack (TIA)
or minor Ischemic Stroke
(IS)
Clopidogrel in combination with ASA is indicated in:
•
Adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or
minor IS (NIHSS ≤3)
within 24 hours of either the TIA or IS event.
For further information please refer to “_Pharmacodynamic
properties_”.
POSOLOGY AND METHOD OF ADMINISTRATION
•
Adults and elderly
This 300 mg tablet of clopidogrel is intended for use as a loading
dose in patients suffer