Aprotinin is a single-chain polypeptide derived from bovine tissues consisting of 58 aminoacid residues. It is an inhibitor of proteolytic enzymes including chymotrypsin, kallikrein, plasmin, and trypsin. It is used to reduce the risk for perioperative blood loss and the need for blood transfusion in high-risk patients during cardiopulmonary bypass for coronary artery bypass graft surgery. Aprotinin was marketed under the trade name Trasylol® as a solution for intravenous (IV) administration. However, the United States (US) Food and Drug Administration (FDA) formally withdrew approval in May of 2008 for aprotinin after studies confirmed that its use enhanced the risk of complications or death. In 2012, the European Medicines Agency (EMA) recommended aprotinin suspension in Europe as well. The substance is consequently made available only for very restricted research use. Aprotinin in combination with other drugs is still available for intraoperative administration as a topical sealant.
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 Aprotinin, 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.