21 C.F.R. § 522.2260 Sulfamethazine injectable solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous solution contains 250 milligrams of sulfamethazine sodium. (b) Sponsor. See No. 053501 in §510.600(c) of this chapter. (c) Related tolerances. See §556.670 of this chapter. (d) NAS/NRC status. The conditions of use 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. (e) Conditions of use—(1) Amount. 20 milliliters for each 50 pounds of body weight (100 milligrams per pound) initially, 20 milliliters per 100 pounds of body weight (50 milligrams per pound) daily thereafter for cattle. (2) Indications for use. For cattle for treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis and acute metritis (Streptococcus spp.) when caused by one or more pathogenic organisms sensitive to sulfamethazine. (3) Limitations. For intravenous use only. Not for use in lactating dairy animals. Withdraw medication from cattle 10 days prior to slaughter for food. If symptoms persist for 2 or 3 days, consult a veterinarian. Adequate water intake is important for animals treated with sulfonamides. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. [46 FR 62055, Dec. 22, 1981, as amended at 67 FR 78355, Dec. 24, 2002]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.2260 Sulfamethazine injectable solution.
