(a) Specifications. Each milliliter of solution contains 300 milligrams (mg) tilmicosin base as tilmicosin phosphate.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.735 of this chapter.

(d) Special considerations.

(1) Not for human use. Use of this antibiotic in humans may prove fatal. Do not use in automatically powered syringes.

(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Conditions of use—(1) Cattle—(i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica.

(iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Use of this antibiotic in this class of cattle may cause milk residues. Do not slaughter within 42 days of last treatment.

(2) Sheep—(i) Amount. 10 mg/kg body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of ovine respiratory disease (ORD) associated with Mannheimia (P.) haemolytica.

(iii) Limitations. Do not slaughter within 28 days of last treatment.

[67 FR 72367, Dec. 5, 2002, as amended at 75 FR 9334, Mar. 2, 2010; 81 FR 48703, July 26, 2016]