MINT-CLOPIDOGREL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Disponible des:

MINT PHARMACEUTICALS 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:

30/500

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:

2022-03-24

Fitxa tècnica

_MINT-CLOPIDOGREL (Clopidogrel Tablets) _
_Page 1 of 59 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 and 300 mg Clopidogrel, as clopidogrel bisulfate, Oral
House Standard
Platelet Aggregation Inhibitor
Date of Initial
Authorization:
JUL 12,
2013
Date of Revision:
APR 13,
2023
Mint
Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, ON, L5T 2M3
Canada
Submission
Control
No.:
273299
_MINT-CLOPIDOGREL (Clopidogrel Tablets) _
_Page 2 of 59 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic 04/2023
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
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4
1.2 Geriatrics
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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
..............................