Maa: Kanada
Kieli: englanti
Lähde: Health Canada
SILODOSIN
PHARMASCIENCE INC
G04CA04
SILODOSIN
8MG
CAPSULE
SILODOSIN 8MG
ORAL
15G/50G
Prescription
Selective Alfa-1-Adrenergic Blocking Agents
Active ingredient group (AIG) number: 0152869002; AHFS:
APPROVED
2021-07-06
PRODUCT MONOGRAPH PR PMS-SILODOSIN Silodosin Capsules 4 mg and 8 mg Selective antagonist for ALPHA 1A Adrenoreceptor subtype in the prostate and bladder ATC code: G04C A04 PHARMASCIENCE INC. Date of Preparation: 6111 Royalmount Ave., Suite 100 July 2, 2021 Montréal, Québec H4P 2T4 www.pharmascience.com Submission Control No.: 233693 _pms-SILODOSIN _ _–_ _ Product Monograph page 2 of 38 _ Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ............................................................3 SUMMARY PRODUCT INFORMATION..........................................................................3 INDICATIONS AND CLINICAL USE ...............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS...................................................................................4 ADVERSE REACTIONS ...................................................................................................6 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ............................................................................... 12 OVERDOSAGE ............................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 13 STORAGE AND STABILITY .......................................................................................... 18 SPECIAL HANDLING INSTRUCTIONS......................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 19 PART II: SCIENTIFIC INFORMATION................................................................................ 20 PHARMACEUTICAL INFORMATION ............................................................... Lue koko asiakirja