DIANE-35 TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

可用日期:

BAYER INC

ATC代码:

G03HB01

INN（国际名称）:

CYPROTERONE AND ESTROGEN

剂量:

2MG; 35MCG

药物剂型:

TABLET

组成:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 35MCG

给药途径:

ORAL

每包单位数:

21

处方类型:

Prescription

治疗领域:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

產品總結:

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

授权状态:

APPROVED

授权日期:

1997-09-17

产品特点

_DIANE-35 Product Monograph_
Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DIANE
®
-35
cyproterone acetate and ethinyl estradiol tablets
2 mg cyproterone acetate and 0.035 mg ethinyl estradiol tablets
Acne Therapy
Bayer Inc.
Date of Revision:
2920 Matheson Boulevard East
March 16, 2017
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Submission Control No.: 201157
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_DIANE-35 Product Monograph_
Page 2 of 44
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
16
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
22
STORAGE AND STABILITY
.................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART
II:
SCIENTIFIC
INFORMATION
.....