PLAVIX TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

B01AC04

INN (Nama Internasional):

CLOPIDOGREL

Dosis:

75MG

Bentuk farmasi:

TABLET

Komposisi:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Rute administrasi :

ORAL

Unit dalam paket:

28/500

Jenis Resep:

Prescription

Area terapi:

PLATELET AGGREGATION INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0134440001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1998-10-07

Karakteristik produk

_ _
_PLAVIX (clopidogrel bisulfate) _
_Page 1 of 57 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PLAVIX®
Clopidogrel
Tablets, 75 mg Clopidogrel, as clopidogrel bisulfate, Oral
Manufacturer’s Standard
Platelet Aggregation Inhibitor
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval (Québec) H7V 0A3
Date of Initial Authorization:
OCT 07, 1998
Date of Revision:
October 20, 2022
Submission Control Number: 264401
_ _
_PLAVIX (clopidogrel bisulfate) _
_Page 2 of 57 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
10/2020
7 WARNINGS AND PRECAUTIONS, Hematologic
10/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.4
Administration...................................................................................................
5
4.5
Missed Dose
...................................................................................................