21 C.F.R. § 522.2121   Spectinomycin sulfate solution.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.2121   Spectinomycin sulfate solution.

(a) Specifications. Each milliliter of sterile aqueous solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams of spectinomycin.

(b) Sponsor. See 000009 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.600 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Dose. 10 to 15 milligrams per kilogram of body weight, at 24-hour intervals for 3 to 5 consecutive days.

(ii) Indications for use. For the treatment of bovine respiratory disease (pneumonia) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus.

(iii) Limitations. For subcutaneous injection in the neck. Do not inject more than 50 milliliters at each site. Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[63 FR 24107, May 1, 1998]

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