Država: Kanada
Jezik: angleščina
Source: Health Canada
ALPRAZOLAM
NATCO PHARMA (CANADA) INC
N05BA12
ALPRAZOLAM
1MG
TABLET
ALPRAZOLAM 1MG
ORAL
100/500/1000
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008003; AHFS:
CANCELLED POST MARKET
2018-06-30
_NAT-Alprazolam Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 36 _ PRODUCT MONOGRAPH NAT-ALPRAZOLAM alprazolam tablets USP 0.25 mg, 0.5 mg and 1 mg and 2 mg tablets ANXIOLYTIC - ANTIPANIC Natco Pharma (Canada) Inc. 2550 Argentia Road, Suite 116, Mississauga, ON, L5N 5R1 Date of Revision: July 17, 2015 Submission Control No: 175395 _NAT-Alprazolam Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 36 _ 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 .................................................................................................... 11 DRUG INTERACTIONS .................................................................................................... 15 DOSAGE AND ADMINISTRATION ................................................................................ 17 OVERDOSAGE ................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 20 STORAGE AND STABILITY ............................................................................................ 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 21 PART II: SCIENTIFIC INFORMATION ................................................................................... 23 PHARMACEUTICAL INFORMATION ............................................................................ 23 CLINICAL TRIALS ..................... Preberite celoten dokument