TEVA-IRBESARTAN/HCTZ TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

C09DA04

Designación común internacional (DCI):

IRBESARTAN AND DIURETICS

Dosis:

300MG; 25MG

formulario farmacéutico:

TABLET

Composición:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

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: 0240086003; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-04-10

Ficha técnica

PRODUCT MONOGRAPH
PR
TEVA-IRBESARTAN/HCTZ
(irbesartan/hydrochlorothiazide)
tablets 150/12.5 mg, 300/12.5 mg and 300/25 mg
Teva Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 190673
Date of Revision:
January 18, 2016
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
9
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLINICAL TRIALS
.................................................................................................................
28
DETAILED PHARMACOLOGY
..............................................................