21 C.F.R. § 558.600   Tiamulin.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds

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§ 558.600   Tiamulin.

(a) Specifications. Type A article containing 5, 10, or 113.4 grams of tiamulin (as tiamulin hydrogen fumarate) per pound.

(b) Approvals. See No. 058198 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.738 of this chapter.

(d) Special considerations—(1) Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

(2) Not for use in swine weighing over 250 pounds.

(3) Use as sole source of tiamulin.

(e) Conditions of use—(1) Swine. It is used as follows:

 ----------------------------------------------------------------------------------------------------------------                                   Combination in grams    Tiamulin in grams per ton             per ton          Indications for use        Limitations       Sponsor----------------------------------------------------------------------------------------------------------------(i) 10...........................  ....................  For increased rate of    Feed continuously       058198                                                          weight gain and          as the sole ration.                                                          improved feed                                                          efficiency.(ii) 35..........................  ....................  1. For control of swine  Feed continuously       058198                                                          dysentery associated     as sole ration on                                                          with Brachyspira         premises with a                                                          (formerly Serpulina or   history of swine                                                          Treponema)               dysentery but                                                          hyodysenteriae           where signs of                                                          susceptible to           disease have not                                                          tiamulin.                yet occurred or                                                                                   following approved                                                                                   treatment of                                                                                   disease. Withdraw                                                                                   2 days before                                                                                   slaughter.                                   ....................  2. For control of        Feed continuously       058198                                                          porcine proliferative    as the sole ration                                                          enteropathies            for not less than                                                          (ileitis) associated     10 days. Withdraw                                                          with Lawsonia            2 days before                                                          intracellularis.         slaughter.(iii) 35.........................  Chlortetracycline,    For treatment of swine   Feed continuously      048164,                                    approximately 400     bacterial enteritis      as sole ration for     058198                                    (varying with body    caused by Escherichia    14 days. Use as                                    weight and feed       coli and Salmonella      only source of                                    consumption to        choleraesuis and         chlortetracycline.                                    provide 10            bacterial pneumonia      Withdraw 2 days                                    milligrams of         caused by Pasteurella    before slaughter.                                    chlortetracycline     multocida susceptible   As                                    per pound of body     to chlortetracycline,    chlortetracycline                                    weight daily).        and control of swine     calcium complex,                                                          dysentery associated     Type A medicated                                                          with Brachyspira         articles                                                          (formerly Serpulina or   containing the                                                          Treponema)               equivalent of 50                                                          hyodysenteriae           to 100 grams per                                                          susceptible to           pound of                                                          tiamulin.                chlortetracycline                                                                                   hydrochloride                                                                                   provided by 046573                                                                                   and 048164 in                                                                                   § 510.600(c)                                                                                   of this chapter.(iv) 200.........................  ....................  For treatment of swine   Feed continuously       058198                                                          dysentery associated     as the sole feed                                                          with Brachyspira         for 14 consecutive                                                          (formerly Serpulina or   days. Withdraw                                                          Treponema)               feed 7 days before                                                          hyodysenteriae           slaughter.                                                          susceptible to                                                          tiamulin.----------------------------------------------------------------------------------------------------------------

(2) [Reserved]

[67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, 2005]

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