| Printable Version |
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, dairy, excluding female breeding age animals) CATTLE (Cattle, beef) 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. |
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