Please note, this OEL/ADE monograph also applies to Avibactam sodium (CAS RN 1192491-61- 4) XXXX (CAS RN XXX). Avibactam is a non-β-lactam β-lactamase inhibitor that is available in combination with ceftazidime. This combination (ceftazidime-avibactam) in combination with metronidazole is indicated for the treatment of complicated intra-abdominal infections (cIAIs) caused by susceptible microorganisms that include Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older. Ceftazidime combined with avibactam is also indicated for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis caused by susceptible microorganisms which include Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Proteus species, and Pseudomonas aeruginosa in patients 18 years or older.
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 Avibactam, 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.