CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL

Disponible desde:

ALEMBIC PHARMACEUTICALS LIMITED

Código ATC:

C09DA06

Designación común internacional (DCI):

CANDERSARTAN AND DIURETICS

Dosis:

12.5MG; 32MG

formulario farmacéutico:

TABLET

Composición:

HYDROCHLOROTHIAZIDE 12.5MG; CANDESARTAN CILEXETIL 32MG

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: 0244181002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-06-11

Ficha técnica

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_Candesartan Cilexetil and Hydrochlorothiazide Tablets Product
Monograph Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS
candesartan cilexetil and hydrochlorothiazide
tablets
Tablets, 16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg, Oral use
House Standard
Angiotensin II AT
1
Receptor Blocker + Diuretic
CANADIAN IMPORTER AND DISTRIBUTOR:
Alembic Pharmaceuticals Canada Ltd.
225 Gibraltar Road, Unit 5
Vaughan, Ontario
L4H 4P9, Canada
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
Alembic Road, Vadodara 390003,
Gujarat, India. Date of Initial Authorization:
June 11, 2014
Submission
Control Number: 259876 Date of Revision: July 22, 2022
______________________________________________________________________________
_Candesartan Cilexetil and Hydrochlorothiazide Tablets Product
Monograph Page 2 of 50_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions – Ophthalmologic
07/2022
7 Warnings and Precautions – Carcinogenesis and Mutagenesis
07/2022
7 Warnings and Precautions – Skin
07/2022
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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TABLE OF
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PART I: HEALTH PROFESSIONAL INFORMATION
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INDICATIONS…………………………………
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1.1
Pediatrics….…………………………………..….………………………………..4
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Geriatrics….……………………………………...………………………………..4
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CONTRAINDICATIONS
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SERIOUS WARNINGS AND PRECAUTIONS BOX
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