AG-DUTASTERIDE CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DUTASTERIDE

Disponible desde:

ANGITA PHARMA INC.

Código ATC:

G04CB02

Designación común internacional (DCI):

DUTASTERIDE

Dosis:

0.5MG

formulario farmacéutico:

CAPSULE

Composición:

DUTASTERIDE 0.5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

5 ALFA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0149361001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2019-02-12

Ficha técnica

PRODUCT MONOGRAPH
PR
AG-DUTASTERIDE
dutasteride capsules
Capsules, 0.5 mg
Professed Standard
Type I and II 5 Alpha-reductase Inhibitor
Angita Pharma Inc.
DATE OF REVISION:
1310 rue Nobel
February 11, 2019
Boucherville, Québec
J4B 5H3
SUBMISSION CONTROL NO.: 224154
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
12
DOSAGE AND ADMINISTRATION
..............................................................................
14
OVERDOSAGE
................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 15
STORAGE AND STABILITY
...........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
..........................................................................
19
CLINICAL TRIALS
..........................................................................................................
20
DETAILED PHARMACOLOGY
.........................................