PRO-ALPRAZOLAM TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
21-03-2022
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Aktiva substanser:
ALPRAZOLAM
Tillgänglig från:
PRO DOC LIMITEE
ATC-kod:
N05BA12
INN (International namn):
ALPRAZOLAM
Dos:
1MG
Läkemedelsform:
TABLET
Sammansättning:
ALPRAZOLAM 1MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Targeted (CDSA IV)
Terapiområde:
BENZODIAZEPINES
Produktsammanfattning:
Active ingredient group (AIG) number: 0115008003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2003-12-17
Produktens egenskaper
Page 1 of 41
PRODUCT MONOGRAPH
PRO-ALPRAZOLAM
ALPRAZOLAM TABLETS USP
0.25 MG, 0.5 MG AND 1.0 MG TABLETS
PRO-ALPRAZOLAM TS
ALPRAZOLAM TABLETS USP 2 MG TRISCORED TABLETS
ANXIOLYTIC-ANTIPANIC
DATE OF REVISION:
March
21, 2022
PRO DOC LTÉE
2925, BOUL.
INDUSTRIEL
LAVAL, QUÉBEC
H7L 3W9
Submission
Control
No.:
261753
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................................
3
CONTRAINDICATIONS
...........................................................................................................................................
5
WARNINGS AND PRECAUTIONS
..........................................................................................................................
5
ADVERSE REACTIONS
.........................................................................................................................................
13
DRUG INTERACTIONS
..........................................................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................................................
20
OVERDOSAGE
........................................................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
....................................................................................................
22
STORAGE AND STABILITY
..................................................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................
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