TARO-CYPROTERONE/ETHINYL ESTRADIOL TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
05-08-2020
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유효 성분:
CYPROTERONE ACETATE; ETHINYL ESTRADIOL
제공처:
SUN PHARMA CANADA INC
ATC 코드:
G03HB01
INN (International Name):
CYPROTERONE AND ESTROGEN
복용량:
2MG; 0.035MG
약제 형태:
TABLET
구성:
CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG
관리 경로:
ORAL
패키지 단위:
21+7
처방전 유형:
Prescription
치료 영역:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
제품 요약:
Active ingredient group (AIG) number: 0232337001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2020-08-05
제품 특성 요약
_Pr_
_TARO-CYPROTERONE/ETHINYL ESTRADIOL (CYPROTERONE ACETATE AND ETHINYL
ESTRADIOL TABLETS) PRODUCT MONOGRAPH _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-CYPROTERONE/ETHINYL ESTRADIOL
2 mg cyproterone acetate and 0.035 mg ethinyl estradiol tablets
Acne Therapy
Sun Pharma Canada Inc.
Date of Revision:
126 East Drive
August 5, 2020
Brampton, Ontario
L6T 1C1
Submission Control No.: 240914
_Pr_
_TARO-CYPROTERONE/ETHINYL ESTRADIOL (CYPROTERONE ACETATE AND ETHINYL
ESTRADIOL TABLETS) PRODUCT MONOGRAPH _
_Page 2 of 47 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................................
3
CONTRAINDICATIONS
..........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................................
19
OVERDOSAGE
.......................................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................................
21
STORAGE AND STABILITY
.................................................................................................................
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