TEVA-CYPROTERONE / ETHINYL ESTRADIOL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Achète-le

Ingrédients actifs:

CYPROTERONE ACETATE; ETHINYL ESTRADIOL

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

G03HB01

DCI (Dénomination commune internationale):

CYPROTERONE AND ESTROGEN

Dosage:

2MG; 0.035MG

forme pharmaceutique:

TABLET

Composition:

CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG

Mode d'administration:

ORAL

Unités en paquet:

21

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-03-08

Résumé des caractéristiques du produit

                                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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