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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.1453

§ 520.1453. Moxidectin and praziquantel gel.

259 words·~1 min read·/us/cfr/t21/s§ 520.1453·

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(a)Specifications. Each milliliter of gel contains 20 milligrams
(mg)(2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Special considerations. See § 500.25 of this chapter.
(d)Conditions of use in horses and ponies—(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight.
(2)Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): (Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus, and C. radiatus; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses strongyle egg production for 84 days.
(3)Limitations. Do not use in horses intended for human consumption. [68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014]
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§ 520.1453
Moxidectin and praziquantel gel.
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