JAMP-ALPRAZOLAM TABLET
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
24-07-2018
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
ALPRAZOLAM
Disponibbli minn:
JAMP PHARMA CORPORATION
Kodiċi ATC:
N05BA12
INN (Isem Internazzjonali):
ALPRAZOLAM
Dożaġġ:
0.25MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
ALPRAZOLAM 0.25MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
100/500
Tip ta 'preskrizzjoni:
Targeted (CDSA IV)
Żona terapewtika:
BENZODIAZEPINES
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0115008001; AHFS:
L-istatus ta 'awtorizzazzjoni:
CANCELLED POST MARKET
Data ta 'l-awtorizzazzjoni:
2020-04-01
Karatteristiċi tal-prodott
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
....................................................
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