21 CFR 522.2640 - Tylosin.

§ 522.2640 Tylosin.

(a)Specifications. Each milliliter (mL) of solution contains 50 or 200 milligrams (mg) of tylosin activity (as tylosin base).

(b)Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 000986 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section.

(2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section.

(c)Related tolerances. See § 556.740 of this chapter.

(d)Special considerations. Labeling must bear the warning statements: “Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.”

(e)Conditions of use -

(1)Beef cattle and nonlactating dairy cattle -

(i)Amount. Administer 8 mg per pound (mg/lb) of body weight by intramuscular injection once daily for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear.

(ii)Indications for use. 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 A. pyogenes.

(iii)Limitations. Do not inject more than 10 mL per site. Use a 50-mg/mL solution for calves weighing less than 200 pounds. Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. 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. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves.

(2)Swine -

(i)Amount. Administer 4 mg/lb of body weight by intramuscular injection twice daily for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. If tylosin medicated drinking water is used as a 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.

(ii)Indications for use. Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

(iii)Limitations. Do not inject more than 5 mL per site. Adverse reactions, including shock and death may result from overdosage in baby pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs weighing less than 25 lbs. Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product.

(3)Dogs and cats -

(i)Amount. Administer 3 to 5 mg/lb of body weight by intramuscular injection at 12- to 24-hour intervals.

(ii)Indications for use -

(A)Dogs. Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., hemolytic Streptococci spp., and Pasteurella multocida.

(B)Cats. Treatment of upper respiratory infections when caused by Staphylococci spp. and hemolytic Streptococci spp. and for feline pneumonitis when caused by tylosin-susceptible organisms.

(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 81 FR 67151, Sept. 30, 2016]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS