Part 522—implantation or Injectable Dosage Form New Animal Drugs

§ 522.313a Ceftiofur crystalline free acid. * * * * * (e) * * * (2) * * * (i) Amount. For subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle. For SC injection in the middle third of the posterior aspect of the ear or in the base of the ear in beef and non-lactating dairy cattle. (A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight as a single injection. (B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight given as two injections in the base of the ear approximately 72 hours apart. (ii) Indications for use—(A) Singledose regimen: For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle. For the control of respiratory disease in beef and nonlactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle. (B) Two-dose regimen: For the treatment of acute metritis (0-to 10-days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle. (iii) Limitations. Following label use as either a single-dose or 2-dose regimen, a 13-day pre-slaughter withdrawal period is required after the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. * * * * *