APO-CLOPIDOGREL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Disponible des:

APOTEX INC

Codi ATC:

B01AC04

Designació comuna internacional (DCI):

CLOPIDOGREL

Dosis:

300MG

formulario farmacéutico:

TABLET

Composición:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 300MG

Vía de administración:

ORAL

Unidades en paquete:

30/100/500

tipo de receta:

Prescription

Área terapéutica:

PLATELET AGGREGATION INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-01-04

Fitxa tècnica

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