	Printable Version

Proprietary Name	Tylan® Injection 200 mg Tylan® Injection 50 mg
NADA Number: 012-965
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	Tylosin
Species	Cattle, dairy, not lactating Cattle, beef Cat, no use class stated or implied Cattle, calves Dog, no use class stated or implied Swine, no use class stated or implied
Routes of Administration	Intramuscular
Dose Form	Liquid (solution)
Drug Form	Liquid (solution)
Dispensing Status	OTC
Patent Number
Withdrawal Time	Cattle: 21 days before slaughter. Swine: 14 days before slaughter.
Dosage Amount, Indications & Limitations	Specifications: Each milliliter of sterile solution of 50 percent propylene glycol with 4 percent benzyl alcohol contains 50 to 200 milligrams of tylosin activity (as tylosin base). Tylosin conforms to the appropriate antibiotic standard. Conditions of use: Cattle (beef and nonlactating dairy) Amount: 8 milligrams intramuscularly per pound of body weight once daily. Indications: Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes. Limitations: Administer for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear. Do not inject more than 10 milliliters per site. Do not use in lactating dairy cattle. Use a 50-milligram-per-milliliter solution for calves weighing less than 200 pounds. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Swine Amount: 4 milligrams intramuscularly per pound of body weight twice daily. Indications: Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella species; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed. Limitations: Administer for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. Do not inject more than 5 milliliters per site. If tylosin medicated drinking water is used as followup treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues. Dogs Amount: 3 to 5 milligrams intramuscularly per pound of body weight at 12- to 24-hour intervals. Indications: Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis laryngitis, tonsillitis, and pneumonia caused by Staphylococci species, hemolytic Streptococci species, and Pasteurella multocida. Limitations: If there is no response to therapy in 5 days, diagnosis and treatment should be reassessed. Use a 50-milligram-per-milliliter solution only. Dogs receiving a dose of less than 50 milligrams (1 milliliter) should be dosed with a tuberculin syringe. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cats Amount: 3 to 5 milligrams intramuscularly per pound of body weight at 12- to 24-hour intervals. Indications: Treatment of upper respiratory infections when caused by Staphylococci species and hemolytic Streptococci species and for feline pneumonitis when caused by tylosin susceptible organisms. Limitations: If there is no response to therapy in 5 days, diagnosis and treatment should be reassessed. Use a 50-milligram-per-milliliter solution only. Cats receiving a dose of less than 50 milligrams (1 milliliter) should be dosed with a tuberculin syringe. Federal law restricts this drug to use by or on the order of a licensed veterinarian. NAS/NRC status: These conditions of use are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by 514.111 of this chapter but may require bioequivalency and safety information.
Tolerances	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. b. Cattle: 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. d. Milk: 0.05 part per million (negligible residue). e. Eggs: 0.2 part per million (negligible residue).