TEVA-CLOPIDOGREL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

B01AC04

INN（国際名）:

CLOPIDOGREL

投薬量:

75MG

医薬品形態:

TABLET

構図:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

投与経路:

ORAL

パッケージ内のユニット:

30/100/500

処方タイプ:

Prescription

治療領域:

PLATELET AGGREGATION INHIBITORS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2011-12-14

製品の特徴

TEVA-CLOPIDOGREL (Clopidogrel Tablets)
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Page 1 of 68
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 mg and 300 mg clopidogrel (as clopidogrel bisulfate), Oral
Teva Standard
Platelet Aggregation Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 267470
Date of Initial Authorization:
December 14, 2011
Date of Revision:
January 12, 2023
TEVA-CLOPIDOGREL (Clopidogrel Tablets)
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Page 2 of 68
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
03/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
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
Adm