ANDROCUR TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CYPROTERONE ACETATE

Saatavilla:

BAYER INC

ATC-koodi:

G03HA01

INN (Kansainvälinen yleisnimi):

CYPROTERONE

Annos:

50MG

Lääkemuoto:

TABLET

Koostumus:

CYPROTERONE ACETATE 50MG

Antoreitti:

ORAL

Kpl paketissa:

60

Prescription tyyppi:

Prescription

Terapeuttinen alue:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0116806001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2007-03-21

Valmisteyhteenveto

_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
.........