Страна: Канада
Език: английски
Източник: Health Canada
ALPRAZOLAM
SANIS HEALTH INC
N05BA12
ALPRAZOLAM
0.50MG
TABLET
ALPRAZOLAM 0.50MG
ORAL
100
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008002; AHFS:
CANCELLED POST MARKET
2021-12-01
PRODUCT MONOGRAPH ALPRAZOLAM (Alprazolam) 0.25 mg and 0.5 mg Tablets USP ANXIOLYTIC - ANTIPANIC Sanis Health Inc. Date of Revision: 1 President’s Choice Circle, June 6, 2019 Brampton, Ontario L6Y 5S5 www.sanis.com Control No.: 228154 2 _ _ 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 ...................................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 23 PART II: SCIENTIFIC INFORMATION ................................................................................... 24 PHARMACEUTICAL INFORMATION...................................................................................... 24 CLINICAL TRIALS ............................................................................... Прочетете целия документ