JAMP-ALPRAZOLAM TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ALPRAZOLAM

Boleh didapati daripada:

JAMP PHARMA CORPORATION

Kod ATC:

N05BA12

INN (Nama Antarabangsa):

ALPRAZOLAM

Dos:

0.25MG

Borang farmaseutikal:

TABLET

Komposisi:

ALPRAZOLAM 0.25MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Targeted (CDSA IV)

Kawasan terapeutik:

BENZODIAZEPINES

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2020-04-01

Ciri produk

Page 1 of 37
PRODUCT MONOGRAPH
JAMP-ALPRAZOLAM
0.25 MG, 0.5 MG, 1 MG AND 2 MG
ALPRAZOLAM TABLETS, USP
ANXIOLYTIC – ANTIPANIC
JAMP Pharma Corporation
Date of Revision: July 24, 2018
1310 rue Nobel
Boucherville, Québec
J4B 5H3
CONTROL# 217423
Page 2 of 37
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
.......................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 22
PART II: SCIENTIFIC INFORMATION
..........................................................................
24
PHARMACEUTICAL INFORMATION
........................................................................................
24
CLINICAL TRIALS
....................................................