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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.445c—Chlortetracycline tablets and boluses.

CFR

520.445c—Chlortetracycline tablets and boluses.

(a) Specifications. Each tablet/bolus contains 25, 250, or 500 milligrams of chlortetracycline hydrochloride.
(b) Sponsors. See No. 000010 in § 510.600(c) of this chapter for the 250-milligram chlortetracycline hydrochloride bolus; see No. 053501 for the 25-milligram tablet and the 500 milligram bolus.
(c) Related tolerances. See § 556.150 of this chapter.
(d) National Academy of Sciences/National Research Council NAS/NRC) status. The conditions of use specified in this section were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in § 514.111 of this chapter but may require bioequivalency and safety information.
(e) Conditions of use. Calves —(1) Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days.
(i) Indications for use. Treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Klesbsiella spp., and Hemophilus spp.
(ii) Limitations. Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.
(2) Amount. One 25 milligram tablet for each 5 pounds of body weight every 12 hours daily for 3 to 5 days.
(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.
(ii) Limitations. Administer tablet directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; when feeding milk or milk replacer, administration 1 hour before or 2 hours after feeding; do not administer within 24 hours of slaughter.
(3) Amount. One 500 milligram bolus per 100 pounds of body weight twice a day for 3 to 5 days.
(i) Indications for use. Treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.
(ii) Limitations. Administer directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.

Code of Federal Regulations

[57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]
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