21 C.F.R. § 520.903d Febantel-praziquantel paste.
Title 21 - Food and Drugs
(a) Specifications. Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel. (b) Sponsor. See No. 000859 in §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. (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). (ii) Cats and kittens: For removal of hookworms (Ancylostoma tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum and Taenia taeniaeformis). (3) Limitations. Do not use in pregnant animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (4) Special considerations. Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction. [50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.903d Febantel-praziquantel paste.
