PRO-ALPRAZOLAM TS TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
21-03-2022
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ALPRAZOLAM
Fáanlegur frá:
PRO DOC LIMITEE
ATC númer:
N05BA12
INN (Alþjóðlegt nafn):
ALPRAZOLAM
Skammtar:
2MG
Lyfjaform:
TABLET
Samsetning:
ALPRAZOLAM 2MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Targeted (CDSA IV)
Lækningarsvæði:
BENZODIAZEPINES
Vörulýsing:
Active ingredient group (AIG) number: 0115008004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2022-03-22
Vara einkenni
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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