APO-ALPRAZ TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ALPRAZOLAM

Saadav alates:

APOTEX INC

ATC kood:

N05BA12

INN (Rahvusvaheline Nimetus):

ALPRAZOLAM

Annus:

0.25MG

Ravimvorm:

TABLET

Koostis:

ALPRAZOLAM 0.25MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/1000

Retsepti tüüp:

Targeted (CDSA IV)

Terapeutiline ala:

BENZODIAZEPINES

Toote kokkuvõte:

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

Volitamisolek:

MARKETED

Loa andmise kuupäev:

1990-12-31

Toote omadused

Page 1 of 41
PRODUCT MONOGRAPH
APO-ALPRAZ
ALPRAZOLAM TABLETS USP
0.25 MG, 0.5 MG AND 1.0 MG TABLETS
APO-ALPRAZ TS
ALPRAZOLAM TABLETS USP 2 MG TRISCORED TABLETS
ANXIOLYTIC-ANTIPANIC
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
November 3, 2021
TORONTO, ONTARIO
M9L 1T9
Submission Control No: 256073
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
..........................................................................................................................................
16
DOSAGE AND ADMINISTRATION
......................................................................................................................
20
OVERDOSAGE
........................................................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
....................................................................................................
22
STORAGE AND STABILITY
..................................................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................