Страна: Канада
Язык: английский
Источник: Health Canada
ALPRAZOLAM
APOTEX INC
N05BA12
ALPRAZOLAM
2MG
TABLET
ALPRAZOLAM 2MG
ORAL
100
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008004; AHFS:
APPROVED
2001-03-29
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 ............................................ Прочитать полный документ