(a)(1) Specifications. Each milliliter of solution contains 2 milligrams (mg) dexamethasone.
(1) Specifications. Each milliliter of solution contains 2 milligrams (mg) dexamethasone.
(2) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(i) Nos. 000061, 000859, and 061623 for use as in paragraph (a)(3) of this section.
(ii) Sponsors. See Nos. 054925 and 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section.
(3) Conditions of use--(i) Amount. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows:
(i) Amount. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows:
(A) Dogs. 0.25 to 1 mg.
(B) Cats. 0.125 to 0.5 mg.
(C) Horses. 2.5 to 5 mg.
(D) Cattle. 5 to 20 mg, depending on the severity of the condition.
(ii) Indications for use. The drug is indicated:
(A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses;
(B) As an anti-inflammatory agent in dogs and cats.
(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.
(b)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(2) Sponsor. See number in Sec. 510.600(c) of this chapter as follows:
(i) No. 061623 for use of 2.0 milligrams dexamethasone or 4.0 milligrams dexamethasone sodium phosphate injections.
(ii) No. 000402 for use of 2.0 milligrams dexamethasone or 4.0 milligrams dexamethasone sodium phosphate injections.
(3) Conditions of use--(i) Amount. Administer 0.25 to 1 mg by intravenous injection, repeated for 3 to 5 days or until a response is noted.
(i) Amount. Administer 0.25 to 1 mg by intravenous injection, repeated for 3 to 5 days or until a response is noted.
(ii) Indications for use. For use in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis, as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(2) Sponsor. See Nos. 000402 and 061623 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Administer 2.5 to 5.0 mg by intravenous injection.
(i) Amount. Administer 2.5 to 5.0 mg by intravenous injection.
(ii) Indications for use. For use in horses as a rapid adrenal glucocorticoid and/or anti-inflammatory agent.
(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.
(d)(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(2) Sponsors. See the following numbers in Sec. 510.600(c) of this chapter:
(i) Nos. 000859 and 054771 for intravenous or intramuscular use of 2.0 milligrams dexamethasone injection.
(ii) No. 054771 for intravenous use of 2.0 milligrams dexamethasone injection.
(3) Conditions of use--(i) Amount. Administer by intravenous or intramuscular injection as follows:
(i) Amount. Administer by intravenous or intramuscular injection as follows:
(A) Dogs: 0.25 to 1 mg.
(B) Cats: 0.125 to 0.5 mg.
(C) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs, cats, and horses as an anti-inflammatory agent.
(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.
(e)(1) Specifications. Each milliliter of solution contains 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(1) Specifications. Each milliliter of solution contains 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(2) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Administer by intravenous injection as follows:
(i) Amount. Administer by intravenous injection as follows:
(A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days.
(B) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs and horses for glucocorticoid and anti-inflammatory effect.
(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. [41 FR 28265, July 9, 1976]
Editorial Note: For Federal Register citations affecting Sec. 522.540, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.