Maa: Kanada
Kieli: englanti
Lähde: Health Canada
CLOPIDOGREL (CLOPIDOGREL BISULFATE)
TEVA CANADA LIMITED
B01AC04
CLOPIDOGREL
75MG
TABLET
CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG
ORAL
30/100/500
Prescription
PLATELET AGGREGATION INHIBITORS
Active ingredient group (AIG) number: 0134440001; AHFS:
APPROVED
2011-12-14
TEVA-CLOPIDOGREL (Clopidogrel Tablets) _ _ Page 1 of 68 _ _ 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) _ _ 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 Lue koko asiakirja