21 CFR 522.1077 - Gonadorelin hydrochloride.

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§ 522.1077 Gonadorelin.

(a) Specifications. Each milliliter (mL) of solution contains:

(1) 43 micrograms (µg) of gonadorelin as gonadorelin acetate;

(2) 100 µg of gonadorelin as gonadorelin acetate;

(3) 50 µg of gonadorelin as gonadorelin diacetate tetrahydrate; or

(4) 50 µg of gonadorelin as gonadorelin hydrochloride.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) No. 000061 for use of the 43-µg/mL product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of this section.

(2) No. 068504 for use of the 100-µg/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of this section.

(3) Nos. 050604 for use of the 50-µg/mL product described in paragraph (a)(3) as in paragraphs (d)(1)(ii) and (d)(2) of this section.

(4) No. 054771 for use of the 50-µg/mL product described in paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vi), and (d)(2) of this section.

(c) Special considerations. Concurrent luteolytic drug use is approved as follows:

(1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of this section as provided by No. 000061 in § 510.600(c) of this chapter.

(2) Cloprostenol injection for use as in paragraph (d)(1)(v) of this section as provided by No. 000061 or No. 068504 in § 510.600(c) of this chapter.

(3) Dinoprost injection for use as in paragraph (d)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter.

(d) Conditions of use in cattle -

(1) Indications for use and amounts - (i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 µg gonadorelin by intramuscular or intravenous injection.

(ii) For the treatment of ovarian follicular cysts in dairy cattle: Administer 100 µg gonadorelin by intramuscular or intravenous injection.

(iii) For the treatment of ovarian follicular cysts in cattle: Administer 100 µg gonadorelin by intramuscular injection.

(iv) For use with cloprostenol injection to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection.

(v) For use with cloprostenol injection to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin by intramuscular injection.

(vi) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 µg gonadorelin by intramuscular injection.

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

[80 FR 34279, June 16, 2015, as amended at 81 FR 36789, June 8, 2016]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558
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