DIANE-35 TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Dostupné z:

BAYER INC

ATC kód:

G03HB01

INN (Medzinárodný Name):

CYPROTERONE AND ESTROGEN

Dávkovanie:

2MG; 35MCG

Forma lieku:

TABLET

Zloženie:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 35MCG

Spôsob podávania:

ORAL

Počet v balení:

21

Typ predpisu:

Prescription

Terapeutické oblasti:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

1997-09-17

Súhrn charakteristických

_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
.....