Country: Canada
Language: English
Source: Health Canada
BROMAZEPAM
PRO DOC LIMITEE
N05BA08
BROMAZEPAM
3MG
TABLET
BROMAZEPAM 3MG
ORAL
100/500
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0114488003; AHFS:
CANCELLED POST MARKET
2019-04-10
1 PRODUCT MONOGRAPH BROMAZEPAM – 3 BROMAZEPAM – 6 BROMAZEPAM 3 MG AND 6 MG TABLETS ANXIOLYTIC - SEDATIVE PRO DOC LTÉE DATE OF REVISION: 2925, boul. Industriel November 7, 2014 Laval, Quebec H7L 3W9 _Control No.: 179224_ 2 TABLE OF CONTENTS PART I: HEALTH PROFFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS ....................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 9 DRUG INTERACTIONS ....................................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................................... 12 OVERDOSAGE ...................................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY.................................................................. 15 STORAGE AND STABILITY ............................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 16 PART II: SCIENTIFIC INFORMATION ............................................................................. 17 PHARMACEUTICAL INFORMATION ............................................................................... 17 CLINICAL TRIALS ............................................................................................................... 18 DETAILED PHARMACOLOGY .................................................... Read the complete document