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21 C.F.R. § 522.2471   Tilmicosin.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.2471   Tilmicosin.

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

(b) Sponsor. See No. 000986 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 mg per kilogram (kg) body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pasteurella) haemolytica. For the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (P.) 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 28 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]

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