PMS-SILODOSIN CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

SILODOSIN

Saatavilla:

PHARMASCIENCE INC

ATC-koodi:

G04CA04

INN (Kansainvälinen yleisnimi):

SILODOSIN

Annos:

4MG

Lääkemuoto:

CAPSULE

Koostumus:

SILODOSIN 4MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Selective Alfa-1-Adrenergic Blocking Agents

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-07-06

Valmisteyhteenveto

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
...............................................................