MYLAN-ALPRAZOLAM TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ALPRAZOLAM

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

N05BA12

Designación común internacional (DCI):

ALPRAZOLAM

Dosis:

0.25MG

formulario farmacéutico:

TABLET

Composición:

ALPRAZOLAM 0.25MG

Vía de administración:

ORAL

Unidades en paquete:

100/1000

tipo de receta:

Targeted (CDSA IV)

Área terapéutica:

BENZODIAZEPINES

Resumen del producto:

Active ingredient group (AIG) number: 0115008001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2017-12-12

Ficha técnica

PRODUCT MONOGRAPH
MYLAN-ALPRAZOLAM
ALPRAZOLAM TABLETS, USP 0.25 MG, 0.5 MG, 1 MG, AND 2 MG
ANXIOLYTIC - ANTIPANIC
Mylan Pharmaceuticals ULC
Date of Revision: June 6, 2019
85 Advance Road,
Etobicoke, Ontario
M8Z 2S6
Control No.: 228228
IMPORTANT
: PLEASE READ
2
PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................................
3
SUMMARY
PRODUCT
INFORMATION
............................................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
..................................................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.....................................................................................................................................
6
ADVERSE
REACTIONS
.....................................................................................................................................................
13
DRUG
INTERACTIONS
.....................................................................................................................................................
17
DOSAGE
AND
ADMINISTRATION
..................................................................................................................................
20
OVERDOSAGE
...................................................................................................................................................................
21
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................................................................
22
STABILITY
AND
STORAGE
RECOMMENDATIONS
....................................................................................................
23
DOSAGE
FORMS,
COMPOSITION
AN