21 C.F.R. § 522.1850 Polysulfated glycosaminoglycan.
Title 21 - Food and Drugs
(a) Specifications. Each 1-milliliter ampule of sterile aqueous solution contains 250 milligrams of polysulfated glycosaminoglycan; each 5-milliliter ampule or vial contains 500 milligrams. (b) Sponsor. See No. 010797 in §510.600(c) of this chapter. (c) Conditions of use—horses. (1) Indications for use. Polysulfated glycosaminoglycan is for the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.– (2) Amount—(i) Intra-articular use (carpal): 250 milligrams once a week for 5 weeks. The joint area must be shaved, cleaned, and sterilized as in a surgical procedure prior to injection. If the joint reacts with excessive inflammation, after intra-articular treatment, cease therapy. (ii) Intramuscular use (carpal and hock): 500 milligrams every 4 days for 28 days. Injection site must be thoroughly cleansed prior to injection. (3) Limitations. Not for use in horses intended for food. Safe use in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—dogs—(1) Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints. (2) Dosage. 2 milligrams per pound of body weight by intramuscular injection. (3) Limitations. Administer intramuscularly twice weekly for up to 4 weeks (maximum of 8 injections). Do not exceed recommended dose or regimen. Do not mix with other drugs or solvents. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [54 FR 53053, Dec. 27, 1989, as amended at 61 FR 54333, Oct. 18, 1996; 62 FR 45158, Aug. 26, 1997]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1850 Polysulfated glycosaminoglycan.
