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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER E: ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 520: ORAL DOSAGE FORM NEW ANIMAL DRUGS
520.2611 - Trimethoprim and sulfadiazine paste.
(a) Specifications. Each gram (g) of paste contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine.
(b) Sponsors. See sponsors in ? 510.600(c) of this chapter:
(1) No. 000856 for product administered as in paragraph (c)(1)(i) of this section.
(2) No. 000061 for product administered as in paragraph (c)(1)(ii) of this section.
(c) Conditions of use in horses?(1) Amount. Administer orally as a single daily dose for 5 to 7 days:
(i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day.
(ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) per 110 pounds (50 kilograms) of body weight per day.
(2) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory infections, acute urogenital infections, and wound infections and abscesses.
(3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[71 FR 30802, May 31, 2006]
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