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TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS
520.1044c - Gentamicin sulfate soluble powder.
(a) Specifications. Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 16.7, 66.7, or 333.3 milligrams of gentamicin.
(b) Sponsor. See Nos. 000061 and 057561 in 510.600(c) of this chapter.
(c) Related tolerances. See 556.300 of this chapter.
(d) Conditions of use(1) Amount. Colibacillosis: gentamicin sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking water for 3 consecutive days, to provide 0.5 milligram per pound of body weight per day; swine dysentery: gentamicin sulfate equivalent to 50 milligrams of gentamicin per gallon of drinking water for 3 consecutive days, to provide 1 milligram per pound of body weight per day.
(2) Indications for use. In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with Treponema hyodysenteriae.
(3) Limitations. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Treatment may be repeated if dysentery recurs. Do not slaughter treated swine for food for at least 10 days following treatment.
[49 FR 29778, July 24, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 52 FR 48675, Dec. 24, 1987; 62 FR 29013, May 29, 1997]
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