Cyproterone acetate is indicated for the management of patients with prostatic cancer 1) to suppress "flare" with initial lutenizing hormone releasing hormone (LHRH) analogue therapy, 2) in long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred, and 3) in the treatment of hot flushes in patients under treatment with LHRH analogues or who have been castrated. It is marketed under the trade name Cyprostat® 2), and is not approved in the United States. In addition, cyproterone acetate is used in combination with estradiol as an oral contraceptive and for the treatment for severe acne in women with symptoms of androgenization.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.