Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
CYPROTERONE ACETATE
BAYER INC
G03HA01
CYPROTERONE
50MG
TABLET
CYPROTERONE ACETATE 50MG
ORAL
60
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0116806001; AHFS:
APPROVED
2007-03-21
_ANDROCUR Product Monograph_ Page 1 of 32 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ANDROCUR ® cyproterone acetate tablets 50 mg PR ANDROCUR ® DEPOT Cyproterone acetate injection 100 mg/mL Antiandrogen Bayer Inc. 2920 Matheson Blvd East, Mississauga, Ontario L4W 5R6 www.bayer.ca Date of Initial Approval: April 26, 1985 Date of Revision: May 13, 2021 Submission Control No: 245903 © 2021, Bayer Inc. ® TM see www.bayer.ca/tm-mc. _ANDROCUR Product Monograph_ Page 2 of 32 Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ...................................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................................................................... 3 1. INDICATIONS ................................................................................................................................................................ 3 2. CONTRAINDICATIONS ................................................................................................................................................. 3 3. SERIOUS WARNINGS AND PRECAUTIONS ................................................................................................................. 3 4. DOSAGE AND ADMINISTRATION................................................................................................................................ 3 4.1 Dosing Considerations .......................................................................................................................................... 3 4.2 Recommended Dose and Dosage Adjustment.................................................................................................... 3 4.3 Reconstitution ....................................................................................................................................................... 4 4.4 Administration ......... Izlasiet visu dokumentu