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NADA Number: 140-929

Proprietary Name Micotil® 300
Sponsor Elanco Animal Health, A Division of Eli Lilly & Co.
Sponsor Address Lilly Corporate Center

Indianapolis, IN    46285
USA
Ingredients Tilmicosin Phosphate
Species (Class) CATTLE (Cattle, beef)
CATTLE (Cattle, dairy, excluding female breeding age animals)
SHEEP (DOMESTIC) (Sheep, no use class stated or implied)
Routes of Administration Subcutaneous
Dosage Form Liquid
Dispensing Status RX
Patent Number (Expiration Date) 4820695 (No Expiration Date)
5574020 (No Expiration Date)
Exclusivity Granted for the subcutaneous use of the liquid product for the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica. The drug is limited to use by or on the order of an licensed veterinarian. It is not for use in female dairy cattle 20 months of age or older, veal calves, calves under one month of age, or calves being fed an all milk diet.
Granted for the use of tilmicosin in cattle with a new therapeutic claim.
Withdrawal Time Cattle and pre-ruminating calves: 28 days before slaughter. A withdrawal time for pre-ruminating veal calves has not been established. Sheep: 28 days before slaughter.
Dosage Amount,
Indications
& Limitations

522.2471 Tilmicosin

Specifications: Each milliliter contains 300 milligrams of tilmicosin base as tilmicosin phosphate.

Special considerations: Not for human use. Use of this antibiotic in humans may prove fatal. Do not use in automatically powered syringes.

Conditions of use:

Cattle

Amount: 10 milligrams per kilogram body weight.

Indications: For the treatment of bovine respiratory disease associated with Pasteurella haemolytica. For the control of respiratory disease in cattle at high risk of developing BRD associated with P. haemolytica.

Limitations: Use as a single subcutaneous injection. 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.

Sheep

Amount: 10 milligrams per kilogram body weight.

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

Limitations: Use as a single subcutaneous injection. Do not slaughter within 28 days of last treatment.

Tolerances

Tilmicosin Phosphate: Cattle a. Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 1.2 parts per million (ppm). b. Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm.

Swine a. Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 7.5 ppm. b. Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm.

Sheep a. Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 1.2 ppm.

b. Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm.