PLAVIX TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Tilgjengelig fra:

SANOFI-AVENTIS CANADA INC

ATC-kode:

B01AC04

INN (International Name):

CLOPIDOGREL

Dosering :

75MG

Legemiddelform:

TABLET

Sammensetning:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Administreringsrute:

ORAL

Enheter i pakken:

28/500

Resept typen:

Prescription

Terapeutisk område:

PLATELET AGGREGATION INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

1998-10-07

Preparatomtale

_ _
_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
...................................................................................................