OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Prothionamide, just click the ADD TO CART button.

HBEL

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