OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to cefovecin sodium (CAS RN 141195-77-9). Cefovecin sodium is indicated in the United States for the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius and Streptococcus canis (Group G) and for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida. The European authorization lists additional indications, such as urinary tract infections (E. coli and proteus. spp) and beta-hemolytic Streptococci and P. multocida infections in dogs, as well as urinary tract infections (E.coli), and for Fusobacterium spp., Bacteroides spp. and Prevotella oralis infections in cats.

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 Cefovecin, just click the ADD TO CART button.

HBEL

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