21 C.F.R. § 520.1242c   Levamisole hydrochloride and piperazine dihydrochloride.


Title 21 - Food and Drugs


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

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§ 520.1242c   Levamisole hydrochloride and piperazine dihydrochloride.

(a) Specifications. (1) The drug is an aqueous solution which contains in each fluid ounce 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.

(2) The drug is a soluble powder which when reconstituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use. It is used as a drench for horses as follows:

(1) Indications for use. An anthelmintic effective against infections of large strongyles (Strongylus vulgaris, S. edentatus), small strongyles (Cylicocercus spp., Cylicocylclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp. ), ascarids (Parascaris equorum), and pinworms (Oxyuris equii).

(2) Limitations. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals. Do not treat animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 32831, Aug. 5, 1975, as amended at 41 FR 48731, Nov. 5, 1976; 43 FR 11176 Mar. 17, 1978; 67 FR 63055, Oct. 10, 2002]

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