subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.1620"
section_subject: "Orgotein for injection."
cfr_reference: "21 CFR 522.1620"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.