21 CFR 522.1004 - Fomepizole.

§ 522.1004 Fomepizole.
(a) Specifications. Each vial contains 1.5 grams fomepizole (1.5 milliliter (mL) of 1.0 gram per mL solution).
(b) Sponsors. See Nos. 046129 and 063286 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—
(1) Amount. 20 milligrams per kilogram (mg/kg) of body weight intravenously initially, followed by 15 mg/kg at 12 and 24 hours, and 5 mg/kg at 36 hours.
(2) Indications for use. As an antidote for ethylene glycol (antifreeze) poisoning in dogs who have ingested or are suspected of having ingested ethylene glycol.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[61 FR 68147, Dec. 27, 1996, as amended at 71 FR 28266, May 16, 2006; 74 FR 26952, June 5, 2009; 74 FR 47725, Sept. 17, 2009; 77 FR 26697, May 7, 2012]
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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

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

  • 2015-06-16; vol. 80 # 115 - Tuesday, June 16, 2015
    1. 80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective June 16, 2015.
      21 CFR Parts 510, 520, 522, 526, and 528