PRO-ALPRAZOLAM TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Osta se nyt

Lataa Valmisteyhteenveto (SPC)
21-03-2022

Aktiivinen ainesosa:

ALPRAZOLAM

Saatavilla:

PRO DOC LIMITEE

ATC-koodi:

N05BA12

INN (Kansainvälinen yleisnimi):

ALPRAZOLAM

Annos:

0.5MG

Lääkemuoto:

TABLET

Koostumus:

ALPRAZOLAM 0.5MG

Antoreitti:

ORAL

Kpl paketissa:

100/1000

Prescription tyyppi:

Targeted (CDSA IV)

Terapeuttinen alue:

BENZODIAZEPINES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0115008002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2022-03-22

Valmisteyhteenveto

                                Page 1 of 41
PRODUCT MONOGRAPH
PRO-ALPRAZOLAM
ALPRAZOLAM TABLETS USP
0.25 MG, 0.5 MG AND 1.0 MG TABLETS
PRO-ALPRAZOLAM TS
ALPRAZOLAM TABLETS USP 2 MG TRISCORED TABLETS
ANXIOLYTIC-ANTIPANIC
DATE OF REVISION:
March
21, 2022
PRO DOC LTÉE
2925, BOUL.
INDUSTRIEL
LAVAL, QUÉBEC
H7L 3W9
Submission
Control
No.:
261753
Page 2 of 41
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
.........................................................................................................................................
13
DRUG INTERACTIONS
..........................................................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................................................
20
OVERDOSAGE
........................................................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
....................................................................................................
22
STORAGE AND STABILITY
..................................................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................
                                
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