Please note, this OEL/ADE monograph also applies to netilmicin (CAS RN 56391-56-1). Netilmicin is an aminoglycoside antibiotic indicated for the treatment of bacteremia, septicemia, respiratory tract infections, biliary tract infections, urinary tract infections, bone and joint infections, meningitis, ventriculitis, skin and soft-tissue infection, burns, wounds, and peri-operative infections caused by susceptible strains. Netilmicin sulfate is the sulfate salt form of netilmicin, a semisynthetic, water soluble aminoglycoside antibiotic. Its antibacterial activity is broad against aerobic gram-negative bacilli. It is not metabolized by most of the aminoglycoside-inactivating enzymes, and it therefore may be active against certain bacteria that are resistant to gentamicin. Netilmicin is derived from sisomicin, a naturally occurring aminoglycoside antibiotic produced by the fermentation of Micromonospora inyoensis. Netilmicin irreversibly binds to the 16S rRNA and S12 protein of the bacterial 30S ribosomal subunit. As a result, this agent interferes with the assembly of initiation complex between mRNA and the bacterial ribosome, thereby inhibiting the initiation of protein synthesis. In addition, netilmicin induces misreading of the mRNA template and causes a translational frameshift, thereby resulting in premature termination. This ultimately leads to bacterial cell death.
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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