OEL Fastrac Catalog

Esafoxolaner (also known as (s)-afoxolaner) is a purified enantiomer of afoxolaner with insecticidal and acaricidal properties. The active substance esafoxolaner is an ectoparasiticide of the isoxazoline class. The active substance possesses one chiral center and is the enantiomeric pure S-form of the already authorized racemic afoxolaner. Esafoxolaner is indicated for veterinary use for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (fourth stage larval and adult Toxocara cati), hookworm (fourth stage larval and adult Ancylostoma tubaeforme and adult Ancylostoma braziliense), and tapeworm (Dipylidium caninum) infections. Esafoxolaner, combined with eprinomectin and praziquantel, kills adult fleas (Ctenocephalides felis). It is indicated for the treatment and prevention of flea infestations and the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations for one month in cats and kittens 8 weeks of age and older and weighing 1.8 pounds (lbs) or greater.

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 Esafoxolaner, just click the ADD TO CART button.

HBEL

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