JAMP ALPRAZOLAM TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ALPRAZOLAM

Pieejams no:

JAMP PHARMA CORPORATION

ATĶ kods:

N05BA12

SNN (starptautisko nepatentēto nosaukumu):

ALPRAZOLAM

Deva:

2MG

Zāļu forma:

TABLET

Kompozīcija:

ALPRAZOLAM 2MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500/1000

Receptes veids:

Targeted (CDSA IV)

Ārstniecības joma:

BENZODIAZEPINES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-09-15

Produkta apraksts

JAMP-Alprazolam (alprazolam)-Product Monograph Page 1 of 43
PRODUCT MONOGRAPH JAMP ALPRAZOLAM
Alprazolam Tablets, USP
0.25 mg, 0.5 mg, 1 mg and 2 mg
ANXIOLYTIC
– ANTIPANIC
JAMP Pharma Corporation Date of Revision:
1310 rue Nobel August 12, 2021
Boucherville,
Quebec
J4B 5H3
Submission
Control No.: 253380
JAMP-Alprazolam (alprazolam)-Product Monograph Page 2 of 43
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
............................................................. 23
STORAGE AND STABILITY
......................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
................................................................. 26
PHARMACEUTICAL INFORMATION
........................................................................
26
CLINICAL TRIALS
....................................................................................................
26
DETAILED PHARMACOLOGY
........................................