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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
520.100b - Amprolium drench.
(a) Chemical name. 1-(4-Amino-2-n-propyl - 5 - pyrimidinylmethyl) - 2 - picolinium chloride hydrochloride.
(b) Sponsor. See No. 050604 in 510.600(c) of this chapter.
(c) Related tolerances. See 556.50 of this chapter.
(d) Conditions of use. It is used for calves as follows: (1) Amount. 9.6 percent solution or 20 percent soluble powder.
(i) Indications for use. As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii.
(ii) Limitations. Add 3 fluid ounces of the 9.6 percent solution to 1 pint of water or 3 ounces of the 20 percent soluble powder to each quart of water and with a dose syringe administer 1 fluid ounce of this solution for each 100 pounds of body weight; this will provide a dose of approximately 10 milligrams per kilogram (2.2 pounds) of body weight; administer daily for 5 days; for a satisfactory diagnosis, a microscopic examination of the feces should be done by a veterinarian or diagnostic laboratory before treatment; when treating outbreaks, the drug should be administered promptly after diagnosis is determined; withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(2) Amount. 9.6 percent solution or 20 percent soluble powder.
(i) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii.
(ii) Limitations. Add 1 1/2 fluid ounces of the 9.6 percent solution to 1 pint of water or 1 1/2 ounces of the 20 percent soluble powder to each quart of water and with a dose syringe administer 1 fluid ounce of this solution for each 100 pounds of body weight; this will provide a dose of approximately 5 milligrams per kilogram (2.2 pounds) of body weight; administer daily for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard; withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63270, Nov. 28, 1997; 70 FR 16934, Apr. 4, 2005]
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