PMS-IRBESARTAN TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IRBESARTAN

Tillgänglig från:

PHARMASCIENCE INC

ATC-kod:

C09CA04

INN (International namn):

IRBESARTAN

Dos:

150MG

Läkemedelsform:

TABLET

Sammansättning:

IRBESARTAN 150MG

Administreringssätt:

ORAL

Enheter i paketet:

100/500

Receptbelagda typ:

Prescription

Terapiområde:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2011-03-21

Produktens egenskaper

_pms-IRBESARTAN (irbesartan) _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-IRBESARTAN
Irbesartan Tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite # 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 271234
Date of Initial Authorization:
March 21, 2011
Date of Revision:
March 2, 2023
_pms-IRBESARTAN (irbesartan) _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
7
WARNINGS AND PRECAUTIONS
06/2021
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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................ 5
4.4
Administration
.......................................