APO-ALPRAZ TABLET
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
03-11-2021
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:
APOTEX INC
Kodiċi ATC:
N05BA12
INN (Isem Internazzjonali):
ALPRAZOLAM
Dożaġġ:
0.5MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
ALPRAZOLAM 0.5MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
100/500/1000
Tip ta 'preskrizzjoni:
Targeted (CDSA IV)
Żona terapewtika:
BENZODIAZEPINES
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0115008002; AHFS:
L-istatus ta 'awtorizzazzjoni:
MARKETED
Data ta 'l-awtorizzazzjoni:
1990-12-31
Karatteristiċi tal-prodott
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
............................................
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