DIANE-35 TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
23-03-2017
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ingredients actius:
CYPROTERONE ACETATE; ETHINYL ESTRADIOL
Disponible des:
BAYER INC
Codi ATC:
G03HB01
Designació comuna 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:
Estat d'Autorització:
APPROVED
Data d'autorització:
1997-09-17
Fitxa tècnica
_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
.....
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