MINT-IRBESARTAN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

IRBESARTAN

Disponible desde:

MINT PHARMACEUTICALS INC

Código ATC:

C09CA04

Designación común internacional (DCI):

IRBESARTAN

Dosis:

150MG

formulario farmacéutico:

TABLET

Composición:

IRBESARTAN 150MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-12-09

Ficha técnica

_Product Monograph MINT-IRBESARTAN (Irbesartan) _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-IRBESARTAN
Irbesartan tablets
Tablets, 75, 150 and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
December 19, 2014
Date of Revision:
March 27, 2023
Submission Control Number: 271580
_Product Monograph MINT-IRBESARTAN (Irbesartan) _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
07/2021
TABLE OF CONTENTS
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
......................................................... 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Do