APO-ALPRAZ TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
03-11-2021
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
ALPRAZOLAM
Beschikbaar vanaf:
APOTEX INC
ATC-code:
N05BA12
INN (Algemene Internationale Benaming):
ALPRAZOLAM
Dosering:
0.25MG
farmaceutische vorm:
TABLET
Samenstelling:
ALPRAZOLAM 0.25MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/1000
Prescription-type:
Targeted (CDSA IV)
Therapeutisch gebied:
BENZODIAZEPINES
Product samenvatting:
Active ingredient group (AIG) number: 0115008001; AHFS:
Autorisatie-status:
MARKETED
Autorisatie datum:
1990-12-31
Productkenmerken
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
............................................
Lees het volledige document
