ACH-FINASTERIDE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FINASTERIDE

Boleh didapati daripada:

ACCORD HEALTHCARE INC

Kod ATC:

G04CB01

INN (Nama Antarabangsa):

FINASTERIDE

Dos:

5MG

Borang farmaseutikal:

TABLET

Komposisi:

FINASTERIDE 5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

5 ALFA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0124110001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2010-08-03

Ciri produk

PRODUCT MONOGRAPH
PR
ACH-FINASTERIDE
Finasteride
Film-coated Tablets 5 mg
Type II 5α-reductase inhibitor
Accord Healthcare Inc.
Date of revision:
3535 boul. St-Charles, Suite 704
December 10, 2019
Kirkland, QC, H9H 5B9
Canada
SUBMISSION CONTROL NO: 234075
_ ACH-FINASTERIDE (finasteride)_
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................................
3
INDICATIONS AND CLINICAL USE
.......................................................................................
3
CONTRAINDICATIONS............................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
5
DRUG INTERACTIONS
............................................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................................
9
OVERDOSAGE
........................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
10
STORAGE AND STABILITY
..................................................................................................
11
SPECIAL HANDLING
INSTRUCTIONS.................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 11
PART II: SCIENTIFIC INFORMATION
.................................................................................
12
PHARMACEUTICAL INFORMATION
.............................................