[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.650]

[Page 231]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.650  Dihydrostreptomycin sulfate injection.

    (a) Specifications. Each milliliter contains dihydrostreptomycin 
sulfate equivalent to 500 milligrams of dihydrostreptomycin.
    (b) Sponsor. See Nos. 000069 and 055529 in Sec. 510.600(c) of this 
chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions of use were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter but may require bioequivalency 
and safety information.
    (d) Conditions of use--(1) Amount. 5 milligrams per pound of body 
weight every 12 hours.
    (2) Indications for use. Treatment of leptospirosis in dogs and 
horses due to Leptospira canicola, L. icterohemorrhagiae, and L. pomona; 
in cattle due to L. pomona; and in swine due to L. pomona; and L. 
grippotyphosa.
    (3) Limitations. Administer by deep intramuscular injection only. 
Treatment should be continued for 3 to 5 days or until the urine is free 
of leptospira for at least 72 hours as measured by darkfield microscopic 
examination. Treatment with subtherapeutic dosages, excessive duration 
of therapy, or inappropriate use of this antibiotic may lead to the 
emergence of streptomycin or dihydrostreptomycin resistant organisms. 
Discontinue use 30 days before slaughter for food. Not for use in 
animals producing milk because use of the drug will contaminate the 
milk. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]