Please note, this OEL/ADE monograph also applies to sulfadimethoxine sodium (CAS RN 1037-50-9). Sulfadimethoxine is a sulfonamide antibacterial used to treat many infections, including the treatment of respiratory, urinary tract, enteric, and soft tissue infections. It is most frequently used in veterinary medicine, although it is approved in some countries for use in humans. Sulfadimethoxine is approved in Russia for use in humans, including children, and is available as an over-the-counter medication indicated for infectious and inflammatory diseases caused by microorganisms sensitive to sulfadimethoxine, including tonsillitis, sinusitis, otitis media, bronchitis, dysentery, inflammatory diseases of the biliary and urinary tract, erysipelas, wound infections, and trachoma, In United States, Canada, Europe and Australia, sulfadimethoxine is only approved in a veterinary medicinal product.
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 Sulfadimethoxine, just click the ADD TO CART button.
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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.