DUTASTERIDE CAPSULES

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DUTASTERIDE

Mevcut itibaren:

STRIDES PHARMA CANADA INC

ATC kodu:

G04CB02

INN (International Adı):

DUTASTERIDE

Doz:

0.5MG

Farmasötik formu:

CAPSULE

Kompozisyon:

DUTASTERIDE 0.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

5 ALFA REDUCTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0149361001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-06-03

Ürün özellikleri

Dutasteride Capsules – Product Monograph
Page 1 of 50
PRODUCT MONOGRAPH
PR
DUTASTERIDE CAPSULES
DUTASTERIDE CAPSULES
0.5 MG
TYPE I AND II 5 ALPHA-REDUCTASE INHIBITOR DATE OF PREPARATION:
May 31, 2019
STRIDES PHARMA CANADA INC.
2401 BRISTOL CIRCLE, UNIT 206
OAKVILLE, ONTARIO
L6H 5S9
SUBMISSION CONTROL NO.: 227708
Dutasteride Capsules – Product Monograph
Page 2 of 50
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
...................................................................................................
8
DRUG
INTERACTIONS
.................................................................................................
13
DOSAGE
AND
ADMINISTRATION
..............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................ 17
STORAGE
AND
STABILITY
.........................................................................................
19
SPECIAL
HANDLING
INSTRUCTIONS
.......................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION
.........................................................................
21
CLINICAL
TRIALS
..