Food and Drug Administration, HHS § 522.1242

§ 522.1222 Ketamine. § 522.1225 Ketoprofen. (a) Specifications. Each milliliter con- (a) Specifications. Each milliliter of tains ketamine hydrochloride equiva- solution contains 100 milligrams (mg) lent to 100 milligrams (mg) ketamine of ketoprofen. base activity. (b) Sponsor. See No. 054771 in (b) Sponsors. See Nos. 000859, 026637, § 510.600(c) of this chapter. 054628, 054771, 059399, and 063286 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter. Amount. Administer by intravenous in- jection 1.0 mg per pound of body weight (c) Special considerations. Federal law once daily for up to 5 days. restricts this drug to use by or on the (2) Indications for use. For alleviation order of a licensed veterinarian. of inflammation and pain associated (d) Conditions of use—(1) Cats—(i) with musculoskeletal disorders in Amount. 5 to 15 mg/pound body weight horses. intramuscularly, depending on the ef- (3) Limitations. Do not use in horses fect desired. intended for human consumption. Fed- (ii) Indications for use. For restraint eral law restricts this drug to use by or or as the sole anesthetic agent in diag- on the order of a licensed veterinarian. nostic or minor, brief surgical proce- [79 FR 16191, Mar. 25, 2014] dures that do not require skeletal mus- cle relaxation. § 522.1242 Levamisole. (2) Subhuman primates—(i) Amount. 3 (a) Specifications. Each milliliter of to 15 mg/kilogram body weight solution contains levamisole phosphate intramuscularly, depending upon the equivalent to 136.5 or 182 milligrams of species, general condition, and age of levamisole hydrochloride (13.65 or 18.2 the subject. percent). (ii) Indications for use. For restraint. (b) Sponsor. See Nos. 000061 and 057561 [67 FR 17283, Apr. 10, 2002, as amended at 73 in § 510.600 of this chapter for use of FR 8192, Feb. 13, 2008. Redesignated at 79 FR 13.65 percent injection, and see No. 16191, Mar. 25, 2014, as amended at 80 FR 054771 for use of 13.65 and 18.2 percent 13229, Mar. 13, 2015] injection. (c) Conditions of use—(1) Amount. 2 § 522.1223 Ketamine, promazine, and milliliters per 100 pounds of body aminopentamide. weight, subcutaneously in the neck. (a) Specifications. Each milliliter of (2) Indications for use. (i) The 13.65 percent injection is used as an anthel- solution contains ketamine hydro- mintic in cattle for treatment of the chloride equivalent to 100 milligrams following parasites: stomach worms (mg) ketamine base activity, 7.5 (mg) (Haemonchus, Trichostrongylus, of promazine hydrochloride, and 0.0625 Ostertagia), intestinal worms mg of aminopentamide hydrogen sul- (Trichostrongylus, Cooperia, fate. Nematodirus, Bunostomum, (b) Sponsor. See No. 054771 in Oesophagostomum, Chabertia), and § 510.600(c) of this chapter. lungworms (Dictyocaulus). (c) Conditions of use in cats—(1) (ii) The 18.2 percent injection is used Amount. Administer by intramuscular as an anthelmintic in cattle for treat- injection 15 to 20 mg ketamine base per ment of the following parasites: stom- pound of body weight, depending on the ach worms (Haemonchus, effect desired. Trichostrongylus, Ostertagia), intestinal (2) Indications for use. It is used in worms (Trichostrongylus, Cooperia, cats as the sole anesthetic agent for Nematodirus, Bunostomum, ovariohysterectomy and general sur- Oesophagostomum) and lungworms gery. (Dictyocaulus). (3) Limitations. Federal law restricts (3) Limitations. Do not administer this drug to use by or on the order of a more than 10 milliliters per site. Cattle that are severely parasitized or main- licensed veterinarian. tained under conditions of constant [79 FR 16191, Mar. 25, 2014] helminth exposure may require re-

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