Please note, this OEL/ADE monograph also applies to Bromfenac (CAS RN 91714-94-2). Bromfenac is indicated for the treatment of postoperative inflammation and eye pain following cataract surgery. Bromfenac, a nonsteroidal anti-inflammatory drug (NSAID), blocks prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2, thereby reducing inflammation. Prostaglandins have been shown in animal models to be mediators of certain kinds of intraocular inflammation, and have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, increased white blood cells, and increased intraocular pressure. Bromfenac has been shown to have potent anti-inflammatory, pain-relieving, and fever-reducing properties.
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 Bromfenac Sodium, just click the ADD TO CART button.
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Affygility Solutions’s 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.