MYLAN-TELMISARTAN HCTZ TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C09DA07

Designación común internacional (DCI):

TELMISARTAN AND DIURETICS

Dosis:

80MG; 12.5MG

formulario farmacéutico:

TABLET

Composición:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Vía de administración:

ORAL

Unidades en paquete:

28/100/500

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0244783001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2017-05-08

Ficha técnica

1
_ _
PRODUCT MONOGRAPH
PR
MYLAN-TELMISARTAN HCTZ
Telmisartan/Hydrochlorothiazide Tablets
80/12.5 mg and 80/25 mg
Angiotensin II AT
1
Receptor Blocker/Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 162850
Date of Revision: July 17, 2013
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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
27
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 35
PART II: SCIENTIFIC INFORMATION
.........................................................................
36
PHARMACEUTICAL INFORMATION
.................................................................................
36
CLINICAL TRIALS
.............................................................................................................