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21 C.F.R. § 520.1498   Nitazoxanide paste.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.1498   Nitazoxanide paste.

(a) Specifications. Each milligram (mg) of paste contains 0.32 mg nitazoxanide.

(b) Sponsor. See No. 065274 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. On days 1 through 5, administer 11.36 mg per pound (/lb) body weight; on days 6 through 28, administer 22.72 mg/lb body weight.

(2) Indications for use—For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

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

[69 FR 500, Jan. 6, 2004]

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