PRO-ALPRAZOLAM TS TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
21-03-2022
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Aktiv ingrediens:
ALPRAZOLAM
Tilgjengelig fra:
PRO DOC LIMITEE
ATC-kode:
N05BA12
INN (International Name):
ALPRAZOLAM
Dosering :
2MG
Legemiddelform:
TABLET
Sammensetning:
ALPRAZOLAM 2MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Targeted (CDSA IV)
Terapeutisk område:
BENZODIAZEPINES
Produkt oppsummering:
Active ingredient group (AIG) number: 0115008004; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2022-03-22
Preparatomtale
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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