Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ALPRAZOLAM
BGP PHARMA ULC
N05BA12
ALPRAZOLAM
0.5MG
TABLET
ALPRAZOLAM 0.5MG
ORAL
15G/50G
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0115008002; AHFS:
APPROVED
2020-05-01
PRODUCT MONOGRAPH XANAX ® alprazolam tablets USP 0.25 mg, 0.5 mg and 1 mg tablets XANAX TS ® alprazolam tablets USP 2 mg triscored tablets ANXIOLYTIC - ANTIPANIC BGP Pharma ULC 85 Advance Road Etobicoke, Ontario Canada, M8Z 2S6 Submission Control No: 273630 ® UPJOHN US 2 LLC BGP Pharma ULC, a Viatris company, Licensee © BGP Pharma ULC, 2023 Date of Preparation: APR 20, 2023 _ _ _XANAX and XANAX TS (alprazolam) _ _–_ _ Product Monograph _ _Page 2 of 41_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................4 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................14 DRUG INTERACTIONS ..................................................................................................18 DOSAGE AND ADMINISTRATION ..............................................................................21 OVERDOSAGE ................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ............................................................24 STORAGE AND STABILITY ..........................................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ...............................................................................27 PHARMACEUTICAL INFORMATION ..........................................................................27 CLINICAL TRIALS ......................... Soma hati kamili