21 C.F.R. § 522.1870 Praziquantel injectable solution.
Title 21 - Food and Drugs
(a) Specification. Each milliliter contains 56.8 milligrams of praziquantel. (b) Sponsors. See 000859 and 059130 in §510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. For dogs 5 pounds and under, 0.3 milliliter (17.0 milligrams); for 6 to 10 pounds, 0.5 milliliter (28.4 milligrams); for 11 to 25 pounds, 1.0 milliliter (56.8 milligrams); if over 25 Pounds, 0.2 milliliter (11.4 milligrams) per 5 pounds body weight to a maximum of 3 milliliters (170.4 milligrams). (ii) Indications for use. For removal of canine cestodes Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and removal and control of canine cestode Echinococcus multilocularis. (iii) Limitations. For subcutaneous or intramuscular use; not intended for use in puppies less than 4 weeks of age; Federal law restricts the drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. For cats under 5 pounds, 0.2 milliliter (11.4 milligrams); 5 to 10 pounds, 0.4 milliliter (22.7 milligrams); 11 pounds and over, 0.6 milliliter (34.1 milligrams) maximum. (ii) Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis. (iii) Limitations. For subcutaneous or intramuscular injection only. Not intended for use in kittens less than 6 weeks of age. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [46 FR 10464, Feb. 3, 1981, as amended at 47 FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, 1993; 67 FR 79853, Dec. 31, 2002]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1870 Praziquantel injectable solution.
