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Title 21: Food and Drugs

« Home / Title 21 - Food and Drugs--Volume 6 / 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 / § 520.1198 Ivermectin and praziquantel paste.

§ 520.1198 Ivermectin and praziquantel paste.

(a) Specifications. Each milligram (mg) of paste contains:

(1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel.

(2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel.

(3) 0.0187 mg (1.87 percent) ivermectin and 0.2338 mg (23.38 percent) praziquantel.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. -

(1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section.

(2) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section.

(3) No. 000010 for use of products described in paragraph (a)(3) of this section as in paragraphs (d)(1)(iii), (d)(2)(iii) and (d)(3) of this section.

(d) Conditions of use in horses - (1) Amount - (i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight.

(ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight.

(iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel (1.14 mg/lb).

(2) Indications for use - (i) For treatment and control of the following parasites: Tapeworms - Anoplocephala perfoliata; Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles - fourth-stage larvae; Pinworms (adults and fourth-stage larvae) - Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of Onchocerca sp.

(ii) For treatment and control of the following parasites: Tapeworms - Anoplocephala perfoliata; Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Cyathostomum spp.; Cylicocyclus spp.; Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles - fourth-stage larvae; Pinworms (adults and fourth-stage larvae) - Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp.; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(iii) For treatment and control of the following parasites in horses over 5 months of age: Tapeworms - Anoplocephala perfoliata; Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles - fourth-stage larvae; Pinworms (adults and fourth-stage larvae) - Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of Onchocerca sp.

(3) Limitations. For oral use only. Do not use in horses intended for human consumption.

[68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014; 84 FR 39183, Aug. 9, 2019]