PMS-IRBESARTAN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

IRBESARTAN

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

C09CA04

INN (International Nazwa):

IRBESARTAN

Dawkowanie:

75MG

Forma farmaceutyczna:

TABLET

Skład:

IRBESARTAN 75MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131700001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2011-03-21

Charakterystyka produktu

_pms-IRBESARTAN (irbesartan) _
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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) _
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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
.......................................