21 CFR 522.2063 - Pyrilamine maleate injection.

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§ 522.2063 Pyrilamine maleate injection.
(a) Specifications. The drug is a sterile aqueous solution with each milliliter containing 20 milligrams of pyrilamine maleate.
(b) Sponsors. See No. 000061 in § 510.600(c) of this chapter for uses in paragraph (c)(2)(i) of this section; see No. 061623 in § 510.600(c) of this chapter for uses in paragraph (c)(2)(ii) of this section.
(c) Conditions of use.
(1) It is intended for treating horses in conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease.1

Footnote(s):
1 These conditions are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(2)
(i) It is administered intramuscularly, subcutaneously, or intravenously. Local injection at the site of insect bites may be indicated in severe cases. Intravenous injections must be given slowly to avoid symptoms of overdosage. Dosage may be repeated every 6 to 12 hours whenever necessary. Horses, 40 to 60 milligrams per 100 pounds body weight; foals, 20 milligrams per 100 pounds body weight.1
(ii) It is administered intravenously. Intravenous injections must be given slowly to avoid symptoms of overdosage. Dosage may be repeated every 6 to 12 hours if necessary. Horses, 40 to 60 milligrams per 100 pounds body weight; foals, 20 milligrams per 100 pounds body weight.1
(3) Do not use in horses intended for food purposes.1
(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1
[40 FR 13858, Mar. 27, 1975; 41 FR 9150, Mar. 3, 1976, as amended at 42 FR 13549, Mar. 11, 1977; 42 FR 61256, Dec. 2, 1977; 51 FR 41477, Nov. 17, 1986; 52 FR 7832, Mar. 13, 1987; 54 FR 1164, Jan. 12, 1989; 68 FR 59881, Oct. 20, 2003]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558