CYESTRA-35 TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Sẵn có từ:

PALADIN LABS INC.

Mã ATC:

G03HB01

INN (Tên quốc tế):

CYPROTERONE AND ESTROGEN

Liều dùng:

2MG; 0.035MG

Dạng dược phẩm:

TABLET

Thành phần:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

21

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0232337001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2007-03-01

Đặc tính sản phẩm

______________________________________________________________________________________________
_
_CYESTRA-35 Product Monograph Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CYESTRA
®
-35
cyproterone acetate and ethinyl estradiol tablets
2 mg/0.035 mg
THERAPEUTIC CLASSIFICATION
Acne Therapy
Paladin Labs Inc.
Date of Preparation:
100 Alexis Nihon Blvd, Suite 600
January 17, 2019
St-Laurent, Quebec
Version: 6.0
H4M 2P2
Control # 223341
______________________________________________________________________________________________
_
_CYESTRA-35 Product Monograph Page 2 of 48 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................................3
SUMMARY PRODUCT INFORMATION
......................................................................................3
INDICATION AND CLINICAL USE
..............................................................................................3
CONTRAINDICATIONS
...............................................................................................................3
WARNINGS AND PRECAUTIONS
...............................................................................................4
ADVERSE
REACTIONS..............................................................................................................
13
DRUG INTERACTIONS
..............................................................................................................
16
DOSAGE AND
ADMINISTRATION
.........................................................................................
20
OVERDOSAGE
...........................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
22
STORAGE AND STABILITY
......................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
............................