OEL Fastrac Catalog

Sarolaner, also known as isooxazoline, is a member of the isoxazoline class of parasiticides. It is an antiparasitic agent. It is a veterinary drug and is not for use in humans (1, 3, 4). Sarolaner is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), for the treatment and control of tick infestations, for the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Sarolaner is also indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing the lxodes scapularis vector ticks (4, 5, 6). Sarolaner is indicated for the treatment of sarcoptic mange (Sarcoptes scabiei), ear mite (Otodectes cynotis) infestations, demodicosis (caused by Demodex canis), and for reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days after treatment. Sarolaner can be used as part of a treatment strategy for the control of flea allergy dermatitis in veterinary medicine (5). Sarolaner is used with selamectin as a topical solution for cats for treatment and prevention of flea infestations, treatment and control of tick infestations, and prevention of heartworm disease (7).

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 and the Permitted Daily Exposure (PDE) 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 Sarolaner, just click the ADD TO CART button.

HBEL

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