Complete Up To Date Information about Pulmotil 90 Type A Medicated Article.
NADA Number: 141-064 | |
| Proprietary Name |
Pulmotil® 90 Type A Medicated Article Pulmotil® 90 |
|---|---|
| Sponsor |
Elanco Animal Health, A Division of Eli Lilly & Co. |
| Sponsor Address |
Lilly Corporate Center Room 1-23, 12420 Parklawn Drive Indianapolis, IN 46285 USA |
| Ingredients |
Tilmicosin Phosphate |
| Species |
Swine, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Medicated feed |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
VFD |
| Patent Number |
4820695 |
| Exclusivity |
Granted for the control of swine respiratory disease associated with
Actinobacillus pleuropneumonia and Pasteurella multocida. Granted for the use tilmicosin phosphate in breeding females at all stages of reproduction, for the control of swine respiratory disease. |
| Withdrawal Time |
Swine: 7 days before slaughter |
|
Dosage Amount, Indications & Limitations |
558.618 Tilmicosin. Specifications: Type A medicated articles: 90.7 grams of tilmicosin (as tilmicosin phosphate) per pound (200 grams per kilogram). Conditions of use: Swine Amount: 181.8 grams to 363.6 grams tilmicosin per ton. Indications: For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida. Limitations: For use in swine feed only. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Do not allow horses or other equine access to feeds containing tilmicosin. Feed continuously as the sole ration for a 21-day period beginning approximately 7 days before an expected disease outbreak. Federal law restricts this drug to use under the professional supervision of a licensed veterinarian. Do not use in any feed containing bentonite. Any animal feed bearing or containing this drug shall be fed to animals only by or upon a lawful veterinary feed directive (VFD) issued by a licensed veterinarian in the course of the veterinarian's professional practice. VFD's for tilmicosin phosphate shall not be refilled. This drug and any article or feed manufactured from it shall bear the following cautionary statements: "Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice.'' A VFD shall contain the following information: The name, address, and phone number of the veterinarian and the client; identification of the animals to be treated, including, identification of the species, number of animals, and the location of the animals; date of treatment and, if different, date of prescribing the VFD drug; the condition or disease being diagnosed or treated; name of the animal drug; level of animal drug in feed and amount of feed; feeding instructions with withdrawal time; any special instructions and cautionary statements necessary for use of the drug in conformance with the approval; expiration date of VFD; number of refills, if permitted by approval; signature of the veterinarian; veterinarian's license number and name of the State issuing the license. |
| Tolerances |
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. |