21 C.F.R. § 522.1484   Neomycin sulfate sterile 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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§ 522.1484   Neomycin sulfate sterile solution.

(a) Specifications. Each milliliter of sterile aqueous solution contains 50 milligrams of neomycin sulfate (equivalent to 35 milligrams of neomycin base).1

1 These claims are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 5 milligrams per pound of body weight daily divided into portions administered every 6 to 8 hours for 3 to 5 days.1

(2) Indications for use. Administer to dogs and cats for the treatment of acute and chronic bacterial infections due to organisms susceptible to neomycin.1

(3) Limitations. For intramuscular or intravenous use only. Neomycin is not for use parenterally in food-producing animals because of prolonged residues in edible tissues. Labeling shall bear an appropriate expiration date. For use by or on the order of a licensed veterinarian.1

[43 FR 48996, Oct. 20, 1978, as amended at 64 FR 403, Jan. 5, 1999]

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