Ceftiofur

Please note, this OEL/ADE monograph also applies to ceftiofur hydrochloride (CAS RN 103980-44-5) and ceftiofur sodium (CAS RN 104010-37-9). In swine, ceftiofur hydrochloride or sodium as an intramuscular (IM) injection is indicated for treatment and control of bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis and Streptococcus suis. In cattle, ceftiofur hydrochloride or sodium as a subcutaneous (SC) or IM injection, is indicated for treatment of Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus and acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur. In sheep and goat, ceftiofur sodium as an IM only injection, is indicated for treatment of sheep respiratory disease (sheep pneumonia) and caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. In horses, as an IM only injection, ceftiofur sodium is indicated for treatment of respiratory infections associated with Streptococcus zooepidemicus. In dogs, ceftiofur sodium as an SC only injection, is indicated for the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis. In day-old chicks and day-old turkey poults, ceftiofur sodium as an SC only injection, is indicated for the control of early mortality, associated with E. coli organisms susceptible to ceftiofur.

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.

Ceftiofur

CAS Registry Number:
80370-57-6
Trade names:
Excenel®, Ceftiflex® and Naxcel®
Cost:
$639 USD

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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), 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

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories