البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
ALPRAZOLAM
JAMP PHARMA CORPORATION
N05BA12
ALPRAZOLAM
1MG
TABLET
ALPRAZOLAM 1MG
ORAL
100
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008003; AHFS:
CANCELLED POST MARKET
2020-04-01
Page 1 of 37 PRODUCT MONOGRAPH JAMP-ALPRAZOLAM 0.25 MG, 0.5 MG, 1 MG AND 2 MG ALPRAZOLAM TABLETS, USP ANXIOLYTIC – ANTIPANIC JAMP Pharma Corporation Date of Revision: July 24, 2018 1310 rue Nobel Boucherville, Québec J4B 5H3 CONTROL# 217423 Page 2 of 37 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 ....................................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................................... 22 PART II: SCIENTIFIC INFORMATION .......................................................................... 24 PHARMACEUTICAL INFORMATION ........................................................................................ 24 CLINICAL TRIALS .................................................... اقرأ الوثيقة كاملة