PLAVIX TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Commercializzato da:

SANOFI-AVENTIS CANADA INC

Codice ATC:

B01AC04

INN (Nome Internazionale):

CLOPIDOGREL

Dosaggio:

300MG

Forma farmaceutica:

TABLET

Composizione:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 300MG

Via di somministrazione:

ORAL

Confezione:

4/30/100

Tipo di ricetta:

Prescription

Area terapeutica:

PLATELET AGGREGATION INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2020-12-10

Scheda tecnica

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