APO-CLOPIDOGREL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Beschikbaar vanaf:

APOTEX INC

ATC-code:

B01AC04

INN (Algemene Internationale Benaming):

CLOPIDOGREL

Dosering:

75MG

farmaceutische vorm:

TABLET

Samenstelling:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100/500

Prescription-type:

Prescription

Therapeutisch gebied:

PLATELET AGGREGATION INHIBITORS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-12-06

Productkenmerken

_APO-CLOPIDOGREL (clopidogrel tablets) Product Monograph _
_Page 1 of 65 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 mg and 300 mg Clopidogrel, as clopidogrel bisulfate, Oral
USP
Platelet Aggregation Inhibitor
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 04, 2013
Date of Revision:
JUN 19, 2023
Submission Control Number: 271440
_APO-CLOPIDOGREL (clopidogrel tablets) Product Monograph _
_Page 2 of 65 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
07/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
06/2023
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
.....................................................................................................5
4
DOSAGE AND ADMINISTRATION
.....................................................................................5
4.2
Recommended Dose and Dosage Adjustment
..............................................................5
4.4
Administration
............................................................................................................6
4.5
Missed
Dose...............................