§ 522.1145 Hyaluronate. ( a ) ( 1 ) *Specifications.* Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
( 2 ) *Sponsor.* See 054771 in § 510.600(c).
( 3 ) *Conditions of use* — ( i ) *Amount.* Small and medium-size joints (carpal, fetlock): 20 mg; larger joint (hock): 40 mg. Treatment may be repeated at weekly intervals for a total of three treatments.
( ii ) *Indications for use.* Treatment of joint dysfunction in horses 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.
( b ) ( 1 ) *Specifications.* Each milliliter of sterile aqueous solution contains 5 milligrams of hyaluronate sodium.
( 2 ) *Sponsor.* See 054771 in § 510.600(c) of this chapter.
( 3 ) *Conditions of use* — ( i ) *Amount.* Small and medium-size joints (carpal, fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be repeated at weekly intervals for a total of four treatments.
( ii ) *Indications for use.* Treatment of joint dysfunction in horses 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.
( c ) ( 1 ) *Specifications.* Each milliliter of sterile aqueous solution contains 10 milligrams of hyaluronate sodium.
( 2 ) *Sponsor.* See No. 000010 in § 510.600(c) of this chapter.
( 3 ) *Conditions of use* — ( i ) *Amount.* Small and medium-size joints (carpal, fetlock): 20 mg. Treatment may be repeated after 1 or more weeks but not to exceed 2 injections per week for a total of 4 weeks.
( ii ) *Indications for use.* For the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious 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.
( 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.* 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.
( 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 ) *Sponsors.* See sponsors in § 510.600(c) of this chapter: ( i ) No. 000010 for use of products described in paragraph (e)(1) as in paragraph (e)(3) of this section.
( ii ) No. 017030 for use of product described in paragraph (e)(1)(i) as in paragraph (e)(3) of this section.
( 3 ) *Conditions of use* — ( 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 mg; larger joint (hock): 44 mg. Treatment may be repeated at weekly intervals for a total of three treatments.
( ii ) *Indications for use.* Treatment of joint dysfunction in horses 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.
[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; 75 FR 1274, Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 34279, June 16, 2015; 84 FR 39184, Aug. 9, 2019]