Страна: Канада
Язык: английский
Источник: Health Canada
CLOPIDOGREL (CLOPIDOGREL BISULFATE)
SANOFI-AVENTIS CANADA INC
B01AC04
CLOPIDOGREL
75MG
TABLET
CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG
ORAL
28/500
Prescription
PLATELET AGGREGATION INHIBITORS
Active ingredient group (AIG) number: 0134440001; AHFS:
APPROVED
1998-10-07
_ _ _PLAVIX (clopidogrel bisulfate) _ _Page 1 of 57 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PLAVIX® Clopidogrel Tablets, 75 mg Clopidogrel, as clopidogrel bisulfate, Oral Manufacturer’s Standard Platelet Aggregation Inhibitor sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval (Québec) H7V 0A3 Date of Initial Authorization: OCT 07, 1998 Date of Revision: October 20, 2022 Submission Control Number: 264401 _ _ _PLAVIX (clopidogrel bisulfate) _ _Page 2 of 57 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 10/2020 7 WARNINGS AND PRECAUTIONS, Hematologic 10/2022 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 ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.4 Administration................................................................................................... 5 4.5 Missed Dose ................................................................................................... Прочитать полный документ