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NADA Number: 012-965

Proprietary Name Tylan® Injection 200 mg
Tylan® Injection 50 mg
Sponsor Elanco Animal Health, A Division of Eli Lilly & Co.
Sponsor Address Lilly Corporate Center

Indianapolis, IN    46285
USA
Ingredients Tylosin
Species (Class) CATS (DOMESTIC) (Cat, no use class stated or implied)
CATTLE (Cattle, beef)
CATTLE (Cattle, calves)
CATTLE (Cattle, dairy, not lactating)
DOGS (Dog, no use class stated or implied)
SWINE (Swine, no use class stated or implied)
Routes of Administration Intramuscular
Dosage Form LIQUID (SOLUTION)
Dispensing Status OTC
Patent Number (Expiration Date) (No Expiration Date)
Withdrawal Time A withdrawal period has not been established for this product in pre-ruminating calves. Discontinue use in cattle 21 days before slaughter.

Discontinue use in swine 14 days before slaughter.

 


Specifications

Contains 50 to 200 milligrams of tylosin activity (as tylosin base).


Dosage Amount,
Indications
& Limitations

Cattle (beef and nonlactating dairy)
     
Dosage: 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. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Use a 50-milligram-per-milliliter solution for calves weighing less than 200 pounds. Do not use in calves to be processed for veal.

Swine

Dosage: 4 milligrams 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 follow-up 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

Dosage: 3 to 5 mg 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: 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

Dosage: 3 to 5 mg 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: 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.

 

 

 

 

 

 

 

 

 

Tolerances

Tylosin: 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).