ACH-FINASTERIDE TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

FINASTERIDE

มีจำหน่ายจาก:

ACCORD HEALTHCARE INC

รหัส ATC:

G04CB01

INN (ชื่อสากล):

FINASTERIDE

ปริมาณ:

5MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

FINASTERIDE 5MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30/100/500

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

5 ALFA REDUCTASE INHIBITORS

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2010-08-03

สรุปลักษณะสินค้า

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