APO-IRBESARTAN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

IRBESARTAN

Disponible des:

APOTEX INC

Codi ATC:

C09CA04

Designació comuna internacional (DCI):

IRBESARTAN

Dosis:

300MG

formulario farmacéutico:

TABLET

Composición:

IRBESARTAN 300MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-05-25

Fitxa tècnica

_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 1 of 35
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-IRBESARTAN
Irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
Date of Initial Authorization:
May 24, 2012
Date of Revision:
August 12, 2021
Submission Control Number: 251515
_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 2 of 35
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
08/2021
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 Essential Hypertension
................................ 5
4.4 Administration
...........................................................................................................
6
4.5 Missed Dose
........