TARO-CYPROTERONE/ETHINYL ESTRADIOL TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Dostupno od:

SUN PHARMA CANADA INC

ATC koda:

G03HB01

INN (International ime):

CYPROTERONE AND ESTROGEN

Doziranje:

2MG; 0.035MG

Farmaceutski oblik:

TABLET

Sastav:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG

Administracija rute:

ORAL

Jedinice u paketu:

21+7

Tip recepta:

Prescription

Područje terapije:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2020-08-05

Svojstava lijeka

_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
.................................................................................................................