Pays: Canada
Langue: anglais
Source: Health Canada
CYPROTERONE ACETATE; ETHINYL ESTRADIOL
TEVA CANADA LIMITED
G03HB01
CYPROTERONE AND ESTROGEN
2MG; 0.035MG
TABLET
CYPROTERONE ACETATE 2MG; ETHINYL ESTRADIOL 0.035MG
ORAL
21
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0232337001; AHFS:
APPROVED
2018-03-08
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 _Page _ _2 _ 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 ............................................ Lire le document complet