MYLAN-ALPRAZOLAM TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
06-06-2019
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Aktiva substanser:
ALPRAZOLAM
Tillgänglig från:
MYLAN PHARMACEUTICALS ULC
ATC-kod:
N05BA12
INN (International namn):
ALPRAZOLAM
Dos:
1MG
Läkemedelsform:
TABLET
Sammansättning:
ALPRAZOLAM 1MG
Administreringssätt:
ORAL
Enheter i paketet:
100/1000
Receptbelagda typ:
Targeted (CDSA IV)
Terapiområde:
BENZODIAZEPINES
Produktsammanfattning:
Active ingredient group (AIG) number: 0115008003; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2017-09-22
Produktens egenskaper
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
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