(a) Specifications. Each single-dose, 10-milliliter syringe contains:

(1) 125 milligrams (mg) ceftiofur equivalents as the hydrochloride salt; or

(2) 500 mg ceftiofur equivalents as the hydrochloride salt.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.113 of this chapter.

(d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows—(1) Amount. Infuse the contents of one syringe (125 mg ceftiofur equivalents) into each affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.

(2) Indications for use. For the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli; and the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and S. dysgalactiae.

(3) Limitations. Milk taken from cows during treatment (a maximum of 8 daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to 8 consecutive days, a 2-day preslaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Special considerations. Federal law prohibits extralabel use of this drug in lactating dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.

(e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows—(1) Amount. Infuse the contents of one syringe (500 mg ceftiofur equivalents) into each affected quarter at the time of dry off.

(2) Indications for use. For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.

(3) Limitations. Milk taken from cows completing a 30-day dry-off period may be used for food with no milk discard due to ceftiofur residues. Following intramammary infusion, a 16-day preslaughter withdrawal period is required for treated cows. No preslaughter withdrawal period is required for neonatal calves from treated cows regardless of colostrum consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Special considerations. Federal law prohibits extralabel use of this drug in dry dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food-producing species/production classes.