MYLAN-ALPRAZOLAM TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ALPRAZOLAM

Disponibbli minn:

MYLAN PHARMACEUTICALS ULC

Kodiċi ATC:

N05BA12

INN (Isem Internazzjonali):

ALPRAZOLAM

Dożaġġ:

0.25MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ALPRAZOLAM 0.25MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/1000

Tip ta 'preskrizzjoni:

Targeted (CDSA IV)

Żona terapewtika:

BENZODIAZEPINES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2017-12-12

Karatteristiċi tal-prodott

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