Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 520  /  Sec. 520.903 Febantel oral dosage forms. Sec. 520.903a Febantel paste.

(a) Specifications. Each gram of paste contains 455 milligrams (45.5 percent) febantel.

(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in horses--(1) Amount. Administer paste orally at 6 milligrams per kilogram (2.73 milligrams per pound) of body weight on the base of the tongue or well mixed into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.

(1) Amount. Administer paste orally at 6 milligrams per kilogram (2.73 milligrams per pound) of body weight on the base of the tongue or well mixed into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.

(2) Indications for use. For removal of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum--sexually mature and immature); pinworms (Oxyuris equi--adult and 4th stage larva); and various small strongyles in horses, foals, and ponies.

(3) Limitations. Do not use in horses intended for human consumption. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [79 FR 28821, May 20, 2014] Sec. 520.903b Febantel suspension.

(a) Specifications. Each ounce of suspension contains 2.75 grams (9.3 percent ounce) febantel.

(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in horses--(1) Amount. 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight). Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.

(1) Amount. 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight). Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.

(2) Indications for use. For removal of ascarids (Parascaris equorum--adult and sexually immature), pinworms (Oxyuris equi--adult and 4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus, S. equinus), and various small strongyles in horses, breeding stallions and mares, pregnant mares, foals, and ponies.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Special considerations. Febantel suspension may be used in combination with trichlorfon oral liquid in accordance with the provisions of Sec. 520.2520c, this section, and the following conditions:

(1) Combine 1 part febantel suspension with 5 parts trichlorfon liquid.

(2) Allow animal to consume a portion of daily grain ration; administer mixture by stomach tube at rate of 18 milliliters per 100 pounds of body weight. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR 28821, May 20, 2014] Sec. 520.903c [Reserved] Sec. 520.903d Febantel and praziquantel paste.

(a) Specifications. Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel.

(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.

(c) Conditions of use--(1) Amount--(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.

(1) Amount--(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.

(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.

(ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days.

(2) Indications for use. (i) Dogs and puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms (Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina), and tapeworms (Dipylidium caninum and Taenia pisiformis).

(i) Dogs and puppies: For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms (Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina), and tapeworms (Dipylidium caninum and Taenia pisiformis).

(ii) Cats and kittens: For removal of hookworms (Ancylostoma tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum and Taenia taeniaeformis).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; 79 FR 28821, May 20, 2014] Sec. 520.903e Febantel tablets.

(a) Specifications. Each scored tablet contains 27.2 milligrams of febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams of febantel for use in dogs, puppies, and cats.

(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.

(c) Conditions of use--(1) Amount--(i) Dogs and cats. Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(1) Amount--(i) Dogs and cats. Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(i) Dogs and cats. Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(ii) Puppies and kittens fewer than 6 months of age. Fifteen milligrams per kilogram body weight. Administer once daily for 3 consecutive days.

(2) Indications for use. (i) For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), ascarids (Toxocara canis and Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and puppies.

(i) For removal of hookworms (Ancylostoma caninum and Uncinaria stenocephala), ascarids (Toxocara canis and Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and puppies.

(ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids (Toxocara cati) in cats and kittens.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [56 FR 50655, Oct. 8, 1991, as amended at 79 FR 28821, May 20, 2014]