DIANE-35 TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Disponible desde:

BAYER INC

Código ATC:

G03HB01

Designación común internacional (DCI):

CYPROTERONE AND ESTROGEN

Dosis:

2MG; 35MCG

formulario farmacéutico:

TABLET

Composición:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 35MCG

Vía de administración:

ORAL

Unidades en paquete:

21

tipo de receta:

Prescription

Área terapéutica:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

1997-09-17

Ficha técnica

_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
.....