Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
CYPROTERONE ACETATE
GENERIC MEDICAL PARTNERS INC
G03HA01
CYPROTERONE
50MG
TABLET
CYPROTERONE ACETATE 50MG
ORAL
60/100
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0116806001; AHFS:
APPROVED
2012-08-08
_ _ _Pr_ _MED-CYPROTERONE Product Monograph _ _Page 1 of 34 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MED-CYPROTERONE cyproterone acetate tablets Tablets, 50 m g, Oral Antiandrog en Generic Medical Partners Inc.: Date of Initial Authorization: 1500 Don Mills Road, Suite 711 Aug 8, 2012 Toronto, Ontario M3B 3K4 Date of Revision: Canada Dec 2, 2021 Submission Control No.: 255102 _ _ _Pr_ _MED-CYPROTERONE Product Monograph _ _Page 2 of 34 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 12/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 12/2021 7 WARNINGS AND PRECAUTIONS - Carcinogenesis and Mutagenesis 12/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................................ 4 1. INDICATIONS ................................................................................................................. 4 2. CONTRAINDICATIONS ..................................................................................................... 4 3. SERIOUS WARNINGS AND PRECAUTIONS .......................................................................... 4 4. DOSAGE AND ADMINISTRATION ...................................................................................... 4 4.1 Dosing Considerations ................................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment ................................................................ 5 5. OVERDOSAGE ................................................................................................................ 5 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................... 5 7. WARNINGS AND PRECAUTIONS ....................................... Soma hati kamili