OEL Fastrac Catalog

Ponazuril is indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona. Ponazuril is a triazine-based drug that acts to inhibit enzyme systems in protozoa and/or decreasing pyrimidine synthesis. It is specific for apicomplexan organisms because the action attacks the apicoplast organelle in protozoa. This action produces a specific effect as an antiprotozoal agent without affecting other organisms. Because ponazuril is a weak acid with high lipid solubility, it is able to cross the intact blood-brain barrier and enter the cerebrospinal fluid (CSF), most likely by passive diffusion.

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 Ponazuril, just click the ADD TO CART button.

HBEL

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