(b)Specifications. Flumethasone suspension is sterile and each milliliter of the drug contains: 2 milligrams of flumethasone, 20 milligrams of propylene glycol, 9 milligrams of benzyl alcohol (as preservative), 8 milligrams of sodium chloride, 0.02 milligram of polysorbate-80, 0.1 milligram of citric acid, and water for injection q.s.
(c)Sponsor. See No. 000856 in § 510.600(c) of this chapter.
(d)Conditions of use.
(1) It is recommended in the various disease states involving synovial structures (joints) of horses where excessive synovial fluid of inflammatory origin is present and where permanent structural changes do not exist. Such conditions include arthritis, carpitis, and osselets.
(2) The drug is administered intraarticularly at a dosage level of 6 to 10 milligrams per injection. The dosage level is dependent upon the size of the involved synovial structure and the degree of severity of the condition under treatment. The dosage is limited to a single injection per week in any one synovial structure.
(3) Clinical and experimental data have demonstrated that corticosteroids administered orally and parenterally to animals during the last trimester of pregnancy may induce the first stage of parturition and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. The drug is not to be used in horses intended for slaughter for food purposes.
(4) For use only by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979, as amended at 61 FR 5506, Feb. 13, 1996]
Title 21 published on 2014-04-01
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