Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
IRBESARTAN
AURO PHARMA INC
C09CA04
IRBESARTAN
150MG
TABLET
IRBESARTAN 150MG
ORAL
30/90/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131700002; AHFS:
APPROVED
2013-05-01
_AURO-IRBESARTAN PRODUCT MONOGRAPH _Page 1 of 34 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-IRBESARTAN Irbesartan tablets Tablets, 75 mg, 150 mg and 300 mg, Oral House Standard Angiotensin II AT 1 Receptor Blocker AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, ON, L4L 8K8, Canada Date of Initial Authorization: Apr 23, 2013 Date of Revision: June 15, 2023 Submission Control Number: 271691 _AURO-IRBESARTAN PRODUCT MONOGRAPH _Page 2 of 34 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 06/2023 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 .............................................................................................................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 Administ Կարդացեք ամբողջական փաստաթուղթը