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(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.
(2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section.
(c) Conditions of use - (1) Horses - (i) Amount. (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours.
(B) 0.2 to 0.5 mg/lb body weight intravenously as required.
(ii) Indications for use. (A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus.
(B) For use as a tranquilizer and preanesthetic.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats - (i) Amount. 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours.
(ii) Indications for use. For use as a tranquilizer, preanesthetic, for minor operative procedures in conjunction with local anesthesia, as adjunctive therapy for tetanus, and as an antiemetic prior to worming; or to prevent motion sickness in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[46 FR 18962, Mar. 27, 1981, as amended at 68 FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974, Mar. 13, 2019]
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