ALPRAZOLAM TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
06-06-2019

Aktiv bestanddel:

ALPRAZOLAM

Tilgængelig fra:

SANIS HEALTH INC

ATC-kode:

N05BA12

INN (International Name):

ALPRAZOLAM

Dosering:

0.25MG

Lægemiddelform:

TABLET

Sammensætning:

ALPRAZOLAM 0.25MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Targeted (CDSA IV)

Terapeutisk område:

BENZODIAZEPINES

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2021-12-01

Produktets egenskaber

                                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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