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 :

300MG

Legemiddelform:

TABLET

Sammensetning:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 300MG

Administreringsrute:

ORAL

Enheter i pakken:

4/30/100

Resept typen:

Prescription

Terapeutisk område:

PLATELET AGGREGATION INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0134440002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2020-12-10

Preparatomtale

_Product Monograph – PLAVIX_
_ _
_Page 1 of 60_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PLAVIX
®
Clopidogrel
Tablets, 75 and 300 mg Clopidogrel, as clopidogrel bisulfate
Manufacturer’s Standard
Platelet Aggregation Inhibitor
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval (Québec) H7V 0A3
Date of Revision:
October 13, 2020
Submission Control No: 239831
_ _
_Product Monograph – PLAVIX_
_ _
_Page 2 of 60_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Endocrine and Metabolism Oct. 2020
Warnings and Precautions, Hematologic Oct. 2020
Drug Interactions Oct. 2020
TABLE OF CONTENTS
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
.................................................................................................5
3
DOSAGE AND ADMINISTRATION
.............................................................................5
3.1
Recommended Dose and Dosage Adjustment
...........................................................5
3.2
Administration
...........................................................................................................6
3.3
Missed Dose
...............................................................................................................6
4
OVERDOSAGE
............................................................................