AURO-IRBESARTAN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

IRBESARTAN

Disponibbli minn:

AURO PHARMA INC

Kodiċi ATC:

C09CA04

INN (Isem Internazzjonali):

IRBESARTAN

Dożaġġ:

300MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

IRBESARTAN 300MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/90/100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0131700003; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-05-01

Karatteristiċi tal-prodott

_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