ALPRAZOLAM TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
06-06-2019
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Aktivna sestavina:
ALPRAZOLAM
Dostopno od:
SANIS HEALTH INC
Koda artikla:
N05BA12
INN (mednarodno ime):
ALPRAZOLAM
Odmerek:
0.25MG
Farmacevtska oblika:
TABLET
Sestava:
ALPRAZOLAM 0.25MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Targeted (CDSA IV)
Terapevtsko območje:
BENZODIAZEPINES
Povzetek izdelek:
Active ingredient group (AIG) number: 0115008001; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2021-12-01
Lastnosti izdelka
PRODUCT MONOGRAPH
ALPRAZOLAM
(Alprazolam)
0.25 mg and 0.5 mg Tablets
USP
ANXIOLYTIC - ANTIPANIC
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle,
June 6, 2019
Brampton, Ontario
L6Y 5S5
www.sanis.com
Control No.: 228154
2
_ _
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
..............................................................................................................
12
DRUG INTERACTIONS
..............................................................................................................
16
DOSAGE AND ADMINISTRATION
..........................................................................................
19
OVERDOSAGE
.............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
21
STORAGE AND STABILITY
......................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 23
PART II: SCIENTIFIC INFORMATION
...................................................................................
24
PHARMACEUTICAL
INFORMATION......................................................................................
24
CLINICAL TRIALS
...............................................................................
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