OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Aprotinin, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.