21 C.F.R. § 522.1004 Fomepizole.
Title 21 - Food and Drugs
(a) Specifications. Each vial contains 1.5 grams fomepizole (1.5 milliliter (mL) of 1.0 gram per mL solution). (b) Sponsor. See No. 068727 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]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1004 Fomepizole.
