21 C.F.R. § 522.2630 Tulathromycin.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) tulathromycin. (b) Sponsor. See No. 000069 in §510.600(c) of this chapter. (c) Related tolerances. See §556.745 of this chapter. (d) Conditions of use—(1) Beef and nonlactating dairy cattle—(i) Amount. 2.5 mg per kilogram (/kg) body weight as a single subcutaneous injection in the neck. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (Haemophilus somnus); for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine—(i) Amount. 2.5 mg/kg body weight as a single intramuscular injection in the neck. (ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobaccillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis. (iii) Limitations. Swine intended for human consumption must not be slaughtered within 5 days from the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [70 FR 39918, July 12, 2005]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.2630 Tulathromycin.
