522.1720—Phenylbutazone injection.
(a) Specifications.
The drug contains 100 or 200 milligrams of phenylbutazone in each milliliter of sterile aqueous solution.
(b) Sponsors.
(1)
Approval for use of the 200 milligrams per milliliter drug in dogs and horses: See sponsor Nos. 000061, 000856, 059130, and 061623 in § 510.600(c) of this chapter.
(2)
Approval for use of the 200 milligrams per milliliter drug for use in horses: See sponsor Nos. 000010 and 058005 in § 510.600(c) of this chapter.
(3)
Approval for use of the 100 milligrams per milliliter drug in dogs and horses: See sponsor No. 000856 in § 510.600(c) of this chapter.
(c) Conditions of use for dogs.
(1)
It is used for the relief of inflammatory conditions associated with the musculoskeletal system.
(2)
It is administered intravenously at a dosage level of 10 milligrams per pound of body weight daily in 3 divided doses, not to exceed 800 milligrams daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.
(d) Conditions of use for horses.
(1)
It is used for the relief of inflammatory conditions associated with the musculoskeletal system.
(2)
It is administered intravenously at a dosage level of 1 to 2 grams per 1,000 pounds of body weight daily in 3 divided doses, not to exceed 4 grams daily. Limit intravenous administration to not more than 5 successive days.