PMS-IRBESARTAN-HCTZ TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Disponible des:

PHARMASCIENCE INC

Codi ATC:

C09DA04

Designació comuna internacional (DCI):

IRBESARTAN AND DIURETICS

Dosis:

150MG; 12.5MG

formulario farmacéutico:

TABLET

Composición:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

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: 0240086001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2011-03-21

Fitxa tècnica

_pms-IRBESARTAN-HCTZ (irbesartan and hydrochlorothiazide) _
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-IRBESARTAN-HCTZ
Irbesartan and Hydrochlorothiazide Tablets
Tablets, 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg, Oral
House Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
MAR 21, 2011
Date of Revision:
APR 12, 2023
Submission Control Number: 273098
_pms-IRBESARTAN-HCTZ (irbesartan and hydrochlorothiazide) _
_Page 2 of 54_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
06/2021
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
06/2021
7 Warnings and Precautions, Respiratory
04/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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