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NADA Number: 045-863

Proprietary Name Palosein
Sponsor OXIS International, Inc.
Sponsor Address 6040 N. Cutter Circle, Suite 317
Portland, OR    97217-3935
USA
Ingredients Orgotein
Species (Class) DOGS (Dog, no use class stated or implied)
EQUIDS (Horse, not for meat production)
Routes of Administration Intramuscular
Subcutaneous
Dosage Form Liquid (solution)
Dispensing Status RX
Patent Number (Expiration Date) 3637640 (No Expiration Date)
3637641 (No Expiration Date)
3758682 (No Expiration Date)
3773928 (No Expiration Date)
3773929 (No Expiration Date)
Dosage Amount,
Indications
& Limitations

522.1620 Orgotein for injection.

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

Conditions of use:

Horses

Amount: It is administered by deep intramuscular injection at a dosage level of 5 milligrams 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.

Indications: It is used in the treatment of soft tissue inflammation associated with the musculoskeletal system.

Limitations: Not for use in horses intended for food.

Dogs

Amount: It is administered by subcutaneous injection at a dosage level of 5 milligrams every day for 6 days, and thereafter, every other day for 8 days. In less severe conditions shorter courses of therapy may be indicated.

Indications; 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.

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