国家: 加拿大
语言: 英文
来源: Health Canada
IRBESARTAN
APOTEX INC
C09CA04
IRBESARTAN
300MG
TABLET
IRBESARTAN 300MG
ORAL
100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131700003; AHFS:
APPROVED
2012-05-25
_Product Monograph Master Template _ _APO-IRBESARTAN _ Page 1 of 35 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-IRBESARTAN Irbesartan tablets Tablets, 75 mg, 150 mg and 300 mg, Oral USP Angiotensin II AT 1 Receptor Blocker APOTEX INC. 150 SIGNET DRIVE TORONTO, ONTARIO M9L 1T9 Date of Initial Authorization: May 24, 2012 Date of Revision: August 12, 2021 Submission Control Number: 251515 _Product Monograph Master Template _ _APO-IRBESARTAN _ Page 2 of 35 RECENT MAJOR LABEL CHANGES 7. WARNINGS AND PRECAUTIONS 08/2021 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 ................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 4 4 DOSAGE AND ADMINISTRATION ..................................................................................... 5 4.1 Dosing Considerations ................................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment Essential Hypertension ................................ 5 4.4 Administration ........................................................................................................... 6 4.5 Missed Dose ........ 阅读完整的文件