Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=se21.6.522_11145&rgn=div8
Timestamp: 2020-08-11 01:17:46
Document Index: 319486046

Matched Legal Cases: ['art 522', '§522', '§522', '§510', '§510', '§510', '§510', '§510', '§510']

Title 21 → Chapter I → Subchapter E → Part 522 → §522.1145
§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.
(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.
(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.
(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.
(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.
(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.
[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]