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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 522 - Implantation or Injectable Dosage Form New Animal Drugs |
§ 522.2471 - Tilmicosin.
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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. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.735 of this chapter.
(e)(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.
femaleConditions 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. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Do not use in
this antibioticlactating dairy cattle 20 months of age or older. Use of
Do not slaughter within 42 days of last treatmenttilmicosin in this class of cattle may cause milk residues.
theFederal law restricts this drug to use by or on the order of a licensed veterinarian.
(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. Not for use in lactating ewes producing milk for human consumption. Animals intended for human consumption must not be slaughtered within 42 days of
Not for use in lactating ewes producing milk for human consumptionlast treatment.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[67 FR 72367, Dec. 5, 2002, as amended at 75 FR 9334, Mar. 2, 2010; 81 FR 48703, July 26, 2016; 87 FR 76421, Dec. 14, 2022; 88 FR 16548, Mar. 20, 2023]