NAT-ALPRAZOLAM TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ALPRAZOLAM

Saatavilla:

NATCO PHARMA (CANADA) INC

ATC-koodi:

N05BA12

INN (Kansainvälinen yleisnimi):

ALPRAZOLAM

Annos:

0.25MG

Lääkemuoto:

TABLET

Koostumus:

ALPRAZOLAM 0.25MG

Antoreitti:

ORAL

Kpl paketissa:

100/500/1000

Prescription tyyppi:

Targeted (CDSA IV)

Terapeuttinen alue:

BENZODIAZEPINES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2018-06-30

Valmisteyhteenveto

_NAT-Alprazolam Product Monograph _
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_Page 1 of 36 _
PRODUCT MONOGRAPH
NAT-ALPRAZOLAM
alprazolam tablets USP
0.25 mg, 0.5 mg and 1 mg and 2 mg tablets
ANXIOLYTIC - ANTIPANIC
Natco Pharma (Canada) Inc.
2550 Argentia Road, Suite 116,
Mississauga, ON, L5N 5R1
Date of Revision: July 17, 2015
Submission Control No: 175395
_NAT-Alprazolam Product Monograph _
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_Page 2 of 36 _
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
....................................................................................................
11
DRUG INTERACTIONS
....................................................................................................
15
DOSAGE AND ADMINISTRATION
................................................................................
17
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 21
PART II: SCIENTIFIC INFORMATION
...................................................................................
23
PHARMACEUTICAL INFORMATION
............................................................................
23
CLINICAL TRIALS
.....................