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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2014]
[CITE: 21CFR522.1620]



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

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1620 Orgotein for injection.

(a) Specifications. Orgotein for injection is packaged in a vial containing 5 milligrams of orgotein and 10 milligrams of sucrose as lyophilized sterile nonpyrogenic powder with directions for dissolving the contents of the vial in 2 milliliters of diluent which is sodium chloride injection, U.S.P.

(b) Sponsor. See No. 024991 in 510.600(c) of this chapter.

(c) Conditions of use --(1) Horses --(i) Amount. Administer by deep intramuscular injection at a dosage level of 5 milligrams (mg) every other day for 2 weeks and twice weekly for 2 to 3 more weeks. Severe cases, both acute and chronic, may benefit more from daily therapy initially. Dosage may be continued beyond 5 weeks if satisfactory improvement has not been achieved.

(ii) Indications for use. It is used in the treatment of soft tissue inflammation associated with the musculoskeletal system.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs --(i) Amount. Administer by subcutaneous injection 5 mg daily for 6 days, and thereafter, every other day for 8 days. In less severe conditions, shorter courses of therapy may be indicated.

(ii) Indications for use. It is used for the relief of inflammation associated with ankylosing spondylitis, spondylosis, and disc disease. When severe nerve damage is present, response will occur much more slowly, if at all.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 32583, Aug. 4, 1976; 79 FR 16192, Mar. 25, 2014]

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