TEVA-CYPROTERONE / ETHINYL ESTRADIOL TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
16-07-2018
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ingredients actius:
CYPROTERONE ACETATE; ETHINYL ESTRADIOL
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
G03HB01
Designació comuna internacional (DCI):
CYPROTERONE AND ESTROGEN
Dosis:
2MG; 0.035MG
formulario farmacéutico:
TABLET
Composición:
CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG
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:
2018-03-08
Fitxa tècnica
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CYPROTERONE / ETHINYL ESTRADIOL
cyproterone acetate and ethinyl estradiol tablets
2 mg/ 0.035 mg
THERAPEUTIC CLASSIFICATION
Acne Therapy
Teva Canada Limited
Date of Revision: July 16, 2018
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control # 215473
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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
...................................................................................
24
PHARMACEUTICAL INFORMATION
............................................
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