522.2424—Sodium thiamylal for injection.
(a) Specifications.
The drug is a sterile dry powder. It is reconstituted aseptically with sterile distilled water, water for injection, or sodium chloride injection, to a desired concentration of 0.5 to 4 percent sodium thiamylal.
(c) Conditions of use.
(1)
It is used as an ultra-short-acting anesthetic in dogs, cats, swine, horses, and cattle.
(2)
When diluted aseptically to the desired concentration and administered intravenously to effect, the average single dose is:
(i)
Dogs and cats: 8 milligrams per pound of body weight (when used with a preanesthetic, generally one-half the normal dose).
(iii)
Horses: Light anesthesia, 1 gram per 500 pounds to 1,100 pounds of body weight; deep anethesia, 1 gram per 300 pounds of body weight (40 milligrams per 12 pounds of body weight).
(iv)
Cattle: Short duration, 20 milligrams per 5 pounds of body weight; longer duration, 40 milligrams per 7 pounds of body weight.
(4)
NAS/NRC status: The conditions of use specified in this paragraph are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in § 514.111 of this chapter, but may require bioequivalency and safety information.