AURO-SILODOSIN CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

SILODOSIN

Saatavilla:

AURO PHARMA INC

ATC-koodi:

G04CA04

INN (Kansainvälinen yleisnimi):

SILODOSIN

Annos:

4MG

Lääkemuoto:

CAPSULE

Koostumus:

SILODOSIN 4MG

Antoreitti:

ORAL

Kpl paketissa:

30/90/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Selective Alfa-1-Adrenergic Blocking Agents

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0152869001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-06-15

Valmisteyhteenveto

Page 1 of 32
PRODUCT MONOGRAPH
PR AURO-SILODOSIN
Silodosin Capsules
4 mg and 8 mg
Selective antagonist for ALPHA
1A
Adrenoreceptor subtype in the prostate and bladder
Date of Preparation:
July 5, 2018
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Submission
Control No.:
204041
Page 2 of 32
TABLE OF CONTENTS
PART I:
HEALTH PROFESSIONAL INFORMATION
................................................... 3
SUMMARY OF PRODUCT INFORMATION
.............................................................. 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
.............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE
REACTIONS..............................................................................................
5
DRUG INTERACTIONS
..............................................................................................
8
DOSAGE AND ADMINISTRATION
.........................................................................
10
OVERDOSAGE
.........................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 11
STORAGE AND STABILITY
....................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
................................................................... 15
DOSAGE FORMS, COMPOSITION AND
PACKAGING........................................... 15
PART II: SCIENTIFIC INFORMATION
..........................................................................
16
PHARMACEUTICAL INFORMATION
.....................................................................
16
CLINICAL TRIALS
...................................................................................................
17
DETAILE