XANAX TS TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ALPRAZOLAM

Verfügbar ab:

BGP PHARMA ULC

ATC-Code:

N05BA12

INN (Internationale Bezeichnung):

ALPRAZOLAM

Dosierung:

2MG

Darreichungsform:

TABLET

Zusammensetzung:

ALPRAZOLAM 2MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Targeted (CDSA IV)

Therapiebereich:

BENZODIAZEPINES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0115008004; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2020-05-01

Fachinformation

PRODUCT MONOGRAPH
XANAX
®
alprazolam tablets USP
0.25 mg, 0.5 mg and 1 mg tablets
XANAX TS
®
alprazolam tablets USP
2 mg triscored tablets
ANXIOLYTIC - ANTIPANIC
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
Canada, M8Z 2S6
Submission Control No: 273630
®
UPJOHN US 2 LLC
BGP Pharma ULC, a Viatris company, Licensee
©
BGP Pharma ULC, 2023
Date
of
Preparation:
APR
20, 2023
_ _
_XANAX and XANAX TS (alprazolam) _
_–_
_ Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
.........................