MED-CYPROTERONE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CYPROTERONE ACETATE

Sẵn có từ:

GENERIC MEDICAL PARTNERS INC

Mã ATC:

G03HA01

INN (Tên quốc tế):

CYPROTERONE

Liều dùng:

50MG

Dạng dược phẩm:

TABLET

Thành phần:

CYPROTERONE ACETATE 50MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

60/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0116806001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2012-08-08

Đặc tính sản phẩm

_ _
_Pr_
_MED-CYPROTERONE Product Monograph _
_Page 1 of 34 _
PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MED-CYPROTERONE
cyproterone acetate
tablets
Tablets, 50
m
g, Oral
Antiandrog en
Generic Medical Partners Inc.:
Date of Initial Authorization:
1500 Don Mills Road, Suite 711
Aug 8, 2012
Toronto, Ontario
M3B 3K4
Date of Revision:
Canada
Dec 2, 2021
Submission Control No.: 255102
_ _
_Pr_
_MED-CYPROTERONE Product Monograph _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
12/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
12/2021
7 WARNINGS AND PRECAUTIONS - Carcinogenesis and Mutagenesis
12/2021
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1.
INDICATIONS
.................................................................................................................
4
2.
CONTRAINDICATIONS
.....................................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS
..........................................................................
4
4.
DOSAGE AND ADMINISTRATION
......................................................................................
4
4.1 Dosing Considerations
................................................................................................
4
4.2 Recommended Dose and Dosage
Adjustment
................................................................ 5
5.
OVERDOSAGE
................................................................................................................
5
6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.......................................... 5
7.
WARNINGS AND PRECAUTIONS
.......................................