ALPRAZOLAM TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ALPRAZOLAM

Dostupno od:

SANIS HEALTH INC

ATC koda:

N05BA12

INN (International ime):

ALPRAZOLAM

Doziranje:

0.25MG

Farmaceutski oblik:

TABLET

Sastav:

ALPRAZOLAM 0.25MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Targeted (CDSA IV)

Područje terapije:

BENZODIAZEPINES

Proizvod sažetak:

Active ingredient group (AIG) number: 0115008001; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2021-12-01

Svojstava lijeka

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
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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
...............................................................................