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NADA Number: 013-076

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

Indianapolis, IN    46285
USA
Ingredients Tylosin Tartrate
Species (Class) BEES (Honey bees)
CHICKENS (Chicken, broilers)
CHICKENS (Chicken, not laying eggs for human consumption)
CHICKENS (Chicken, replacements)
SWINE (Swine, no use class stated or implied)
TURKEYS (Turkey, not laying eggs for human consumption)
Routes of Administration Per Os
Dosage Form Liquid (solution)
Dispensing Status OTC
Patent Number (Expiration Date) 4048268 (No Expiration Date)
4283388 (No Expiration Date)
Exclusivity

For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with TYLAN® Soluble (tylosin) in drinking water.

Expiration Date: November 13, 2011

Withdrawal Time Chicken: 1 day before slaughter. Turkey: 5 days before slaughter. Swine: 2 days before slaughter. Honey bees: at least 4 weeks prior to main honey flow
Dosage Amount,
Indications
& Limitations

520.2640 Tylosin.

Specifications: Tylosin is the antibiotic substance produced by growth of Streptomyces fradiae or the same antibiotic substance produced by any other means.

Conditions of use:

Chickens

Amount: 2 grams per gallon of drinking water.

Indications: Aid in the treatment of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum sensitive to tylosin at time of vaccination or other stress in chickens. For the control of chronic respiratory disease (CRD) caused by Mycoplasma synoviae sensitive to tylosin in broiler chickens.

Limitations: Do not use in layers producing eggs for human consumption. Administer from 1 to 5 days as sole source of drinking water. Treated chickens should consume enough medicated drinking water to provide 50 milligrams of tylosin per pound of body weight per day. Prepare a fresh solution every 3 days.

Turkeys

Amount: 2 grams per gallon of drinking water.

Indications: Maintaining weight gains and feed efficiency in the presence of infectious sinusitis caused by Mycoplasma gallisepticum sensitive to tylosin.

Limitations: Do not use in layers producing eggs for human consumption. Administer from 2 to 5 days as sole source of drinking water. Treated turkeys should consume enough medicated drinking water to provide 60 milligrams of tylosin per pound of body weight per day. Prepare a fresh solution every 3 days. When sinus swelling is present, inject the sinus with tylosin injectable simultaneously with the drinking water treatment. Swine

Amount: 0.50 grams per 200 gallons of drinking water.

Indications: For the control and treatment of swine dysentery (bloody scours) caused by pathogens sensitive to tylosin.

Limitations: As only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated. Mix fresh solution daily. Medication must be withheld from animals 48 hours prior to slaughter.

Honey bees

Amount: Mix 200 milligrams tylosin in 20 grams confectioners'/powdered sugar. Use immediately. Apply (dust) this mixture over the top bars of the brood chamber once weekly for 3 weeks.

Indications: For the control of American foulbrood (Paenibacillus larvae).

Limitations: The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow.

Tolerances

Tylosin Tartrate: Tolerances are established for residues of tylosin in edible products of animals as follows: a. Chickens and turkeys: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney. c. Swine: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney. e. Eggs: 0.2 part per million (negligible residue).