Please note, this OEL/ADE monograph also applies to Prothionamide monohydrochloride (CAS RN 93778-13-3) and Prothionamide sulfoxide (CAS RN 62178-61-4). Prothionamide (also known as protionamide) is a thioamide derivative with antitubercular activity. Prothionamide is indicated for the treatment of all forms and stages of pulmonary and extrapulmonary tuberculosis as second-line drug in the case of proven multidrug resistance of the pathogens against first-line drugs. Prothionamide is also indicated for the treatment of diseases caused by so-called ubiquitous (atypical) mycobacteria, and the treatment of leprosy in the context of modified therapy regimens. Prothionamide is always used in combination with other antimycobacterial chemotherapeutics and only if susceptibility of the pathogen against prothionamide has been proven. Prothionamide has also been studied for the treatment of human immunodeficiency virus (HIV).
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Prothionamide, just click the ADD TO CART button.
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Affygility Solutions’ 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.