Please note, this OEL/ADE monograph also applies to cefazolin sodium (CAS RN 27164-46-1). Cefazolin is indicated for the treatment of susceptible bacterial infections including genital infection, bone and joint infections, skin and skin layer infections, pneumonia, respiratory tract infection, sepsis and urinary tract infections. Cefazolin sodium is a semi-synthetic cephalosporin that specifically targets bacterial cell wall synthesis and demonstrates bactericidal activity against most strains of gram-positive aerobes including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes, as well as gram-negative aerobes such as Escherichia coli and Proteus mirabilis. Resistance to cefazolin has been demonstrated in methicillin-resistant staphylococci, many strains of enterococci, and most strains of indole positive Proteus (Proteus vulgaris), Morganella morganii, and species of Enterobacter, Serratia, and Pseudomonas.
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:
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