ACCEL-CLOPIDOGREL TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Dostupné s:

ACCEL PHARMA INC

ATC kód:

B01AC04

INN (Mezinárodní Name):

CLOPIDOGREL

Dávkování:

75MG

Léková forma:

TABLET

Složení:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Podání:

ORAL

Jednotky v balení:

30/100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

PLATELET AGGREGATION INHIBITORS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2015-11-09

Charakteristika produktu

_Page 1 of 54_
PRODUCT MONOGRAPH
Pr
ACCEL-CLOPIDOGREL
Clopidogrel Tablets, USP
75 and 300 mg Clopidogrel, as clopidogrel bisulfate
Platelet Aggregation Inhibitor
Accel Pharma Inc.
Date of Revision:
99 Place Frontenac
November 6, 2014
Pointe-Claire, Quebec
H9R 4Z7
Submission Control No.: 178829
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_Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT
INFORMATION...............................................................................3
INDICATIONS AND CLINICAL
USE.....................................................................................3
CONTRAINDICATIONS...........................................................................................................4
WARNINGS AND
PRECAUTIONS.........................................................................................4
ADVERSE REACTIONS
..........................................................................................................7
DRUG
INTERACTIONS.........................................................................................................15
DOSAGE AND
ADMINISTRATION.....................................................................................19
OVERDOSAGE........................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
...................................................................21
STORAGE AND
STABILITY.................................................................................................24
SPECIAL HANDLING INSTRUCTIONS
..............................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................25
PART II: SCIENTIFIC
INFORMATION................................................................................26
PHARMACEUTICAL INFORMATION
..................................................................