DOM-CANDESARTAN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CANDESARTAN CILEXETIL

Disponible desde:

DOMINION PHARMACAL

Código ATC:

C09CA06

Designación común internacional (DCI):

CANDESARTAN

Dosis:

8MG

formulario farmacéutico:

TABLET

Composición:

CANDESARTAN CILEXETIL 8MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0135220002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2019-02-07

Ficha técnica

_Dom-CANDESARTAN Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
DOM-CANDESARTAN
Candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
DOMINION PHARMACAL
6111 Av. Royalmount, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION
:
October 19, 2016
Submission Control No: 198053
_Dom-CANDESARTAN Product Monograph_
_Page 2 of 38_
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
...................................................................................................
8
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................