BACLOFEN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BACLOFEN

Disponible desde:

APOTEX INC

Código ATC:

M03BX01

Designación común internacional (DCI):

BACLOFEN

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

BACLOFEN 20MG

Vía de administración:

ORAL

Unidades en paquete:

100/250/500/1000

tipo de receta:

Prescription

Área terapéutica:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Resumen del producto:

Active ingredient group (AIG) number: 0113246002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2014-08-23

Ficha técnica

Page 1 of 27
PRODUCT MONOGRAPH
BACLOFEN
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE August 18, 2014
TORONTO, ONTARIO
M9L 1T9
Control Number: 176430
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...............................................................................................
3
CLINICAL PHARMACOLOGY
......................................................................................................
3
INDICATIONS
..................................................................................................................................
5
CONTRAINDICATIONS
.................................................................................................................
5
WARNINGS
......................................................................................................................................
5
PRECAUTIONS
................................................................................................................................
7
ADVERSE REACTIONS
................................................................................................................
10
SYMPTOMS AND TREATMENT OF OVERDOSAGE
.............................................................. 13
DOSAGE AND ADMINISTRATION
............................................................................................
14
AVAILABILITY
.............................................................................................................................
15
CHEMISTRY AND PHARMACOLOGY
......................................................................................
17
TOXICOLOGY
...............................................................................................................................
18
TERATOLOGY AND REPRODUCTION STUDIES
....................................................................
20
SELECTED BIBLIOGRAPHY
...................................................................................................