21 C.F.R. § 522.1145 Hyaluronate sodium.
Title 21 - Food and Drugs
(a)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. (2) Sponsor. See 000009 in §510.600(c). (3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock)—20 milligrams; larger joint (hock)—40 milligrams. (ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. (iii) Limitations. For intra-articular injection in horses only. Treatment may be repeated at weekly intervals for a total of three treatments. 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. (b)(1) Specifications. Each milliliter of sterile aqueous solution contains 5 milligrams of hyaluronate sodium. (2) Sponsor. See 053501 in §510.600(c) of this chapter. (3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock)—10 milligrams; larger joint (hock)—20 milligrams. (ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. (iii) Limitations. For intraarticular injection in horses only. Treatment may be repeated at weekly intervals for a total of four treatments. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (c)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. (2) Sponsor. See 000856 in §510.600(c) of this chapter. (3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock)—20 milligrams. (ii) Indications for use. Treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic noninfectious synovitis associated with equine osteoarthritis. (iii) Limitations. For intraarticular injection in horses only. Treatment may be repeated after 1 or more weeks but not to exceed 2 injections per week for a total of 4 weeks. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d)(1) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium. (2) Sponsor. See 000061 in §510.600(c) of this chapter. (3) Conditions of use—(i) Amount. 50 milligrams in carpal and fetlock joints. (ii) Indications for use. For treatment of equine carpal and fetlock joint dysfunction caused by traumatic and/or degenerative joint disease of mild to moderate severity. (iii) Limitations. For intraarticular injection in horses only. Not for use in horses intended for food. Not intended for use in breeding animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e)(1) Specifications. Each milliliter of solution contains: (i) 10 milligrams (mg) hyaluronate sodium; or (ii) 10 mg hyaluronate sodium with benzyl alcohol as a preservative. (2) Sponsor. See No. 000859 in §510.600(c) of this chapter. (3) Conditions of use in horses—(i) Amount. 20 mg of the product described in paragraph (e)(1)(i) of this section by intra-articular injection into the carpus or fetlock; or 40 mg of the product described in paragraph (e)(1)(i) or (e)(1)(ii) of this section by slow intravenous injection into the jugular vein. Treatment may be repeated at weekly intervals for a total of three treatments. (ii) Indications for use. For treatment of carpal or fetlock joint dysfunction due to noninfectious synovitis associated with equine osteoarthritis. (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. (f)(1) Specifications. Each milliliter of sterile aqueous solution contains 11 milligrams of hyaluronate sodium. (2) Sponsor. See 060865 in §510.600(c). (3) Conditions of use—(i) Amount. Small and medium-size joints (carpal, fetlock)—22 milligrams; larger joint (hock)—44 milligrams. (ii) Indications for use. Treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. (iii) Limitations. For intra-articular injection in horses only. Treatment may be repeated at weekly intervals for a total of three treatments. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, July 12, 2006]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1145 Hyaluronate sodium.
