AURO-IRBESARTAN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

IRBESARTAN

Доступно од:

AURO PHARMA INC

АТЦ код:

C09CA04

INN (Међународно име):

IRBESARTAN

Дозирање:

150MG

Фармацеутски облик:

TABLET

Састав:

IRBESARTAN 150MG

Пут администрације:

ORAL

Јединице у пакету:

30/90/100/500

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0131700002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2013-05-01

Карактеристике производа

_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