TYLAN® 50 Elanco tylosin Injection For Use in Swine, Beef Cattle and Non-lactating Dairy Cattle Only NADA 12-965 Approved by FDA DESCRIPTION: Tylan 50 Injection is a sterile solution of tylosin base in 50% propylene glycol with 4% benzyl alcohol and water for injection. Each mL contains 50 mg of tylosin activity (as tylosin base). ACTIONS: Tylan has an antibacterial spectrum that is essentially gram-positive, but it is also active against certain spirochetes, large viruses, and certain gram-negative organisms (not including coliforms). It has also been found to be active against certain Mycoplasma species. INDICATIONS: In beef cattle and non-lactating dairy cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Actinomyces pyogenes; foot rot (necrotic pododermatitis) and diphtheria caused by Fusobacterium necorphorum and metritis caused by Actinomyces pyogenes. In swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; acute swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed. ADMINISTRATION AND DOSAGE: Tylan 50 Injection is administered intramuscularly. BEEF CATTLE AND NON-LACTATING DAIRY CATTLE-Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 6.25 pounds). Treatment should be continued for 24 hours following remission of disease signs, not to exceed 5 days. Do not inject more than 10 mL per site. This formulation is recommended for use in calves weighing less than 200 pounds. SWINE-Inject intramuscularly 4 mg per pound of body weight (1 mL per 12.5 pounds) twice daily. Treatment should be continued for 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site. SIDE EFFECTS: Side effects consisting of an edema of the rectal mucosa, anal protrusion, diarrhea, erythema, and pruritus have been observed in some hogs following the use of tylosin. Discontinuation of treatment effected an uneventful recovery from the reaction. CAUTION: Do not mix Tylan 50 Injection with other injectable solutions as this may cause a precipitation of the active ingredients. Do not administer to horses or other equines. Injection of tylosin in equines has been fatal. PRECAUTION: Adverse reactions, including shock and death may result from overdosage in baby pigs. Do not attempt injection into pigs weighing less than 6.25 pounds (0.5 mL), unless the syringe is capable of accurately delivering 0.1 mL. If tylosin medicated drinking water is used as a followup treatment for swine dysentery the animal should thereafter receive feed containing 40 to 100 g of tylosin per ton for 2 weeks to assure depletion of tissue residues. WARNING: Discontinue use in cattle 21 days before slaughter. Discontinue use in swine 14 days before slaughter. Do not use in lactating dairy cattle. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. HOW SUPPLIED: Tylan 50 Injection is supplied in 100 mL vials with aluminum sealed rubber stoppers.