Land: Kanada
Sprache: Englisch
Quelle: Health Canada
ALPRAZOLAM
PRO DOC LIMITEE
N05BA12
ALPRAZOLAM
0.5MG
TABLET
ALPRAZOLAM 0.5MG
ORAL
100/1000
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008002; AHFS:
APPROVED
2022-03-22
Page 1 of 41 PRODUCT MONOGRAPH PRO-ALPRAZOLAM ALPRAZOLAM TABLETS USP 0.25 MG, 0.5 MG AND 1.0 MG TABLETS PRO-ALPRAZOLAM TS ALPRAZOLAM TABLETS USP 2 MG TRISCORED TABLETS ANXIOLYTIC-ANTIPANIC DATE OF REVISION: March 21, 2022 PRO DOC LTÉE 2925, BOUL. INDUSTRIEL LAVAL, QUÉBEC H7L 3W9 Submission Control No.: 261753 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 .......................................................................................................................................... 17 DOSAGE AND ADMINISTRATION ...................................................................................................................... 20 OVERDOSAGE ........................................................................................................................................................ 22 ACTION AND CLINICAL PHARMACOLOGY .................................................................................................... 22 STORAGE AND STABILITY .................................................................................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................... Lesen Sie das vollständige Dokument