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(a) Specifications. Each milliliter (mL) of solution contains:
(1) 43 micrograms ([micro]g) of gonadorelin as gonadorelin acetate;
(2) 100 [micro]g of gonadorelin as gonadorelin acetate;
(3) 50 [micro]g of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 [micro]g gonadorelin); or
(4) 50 [micro]g 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-[micro]g/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
(2) No. 068504 for use of the 100-[micro]g/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.
(3) Nos. 000010 and 061133 for use of the 50-[micro]g/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section.
(4) No. 054771 for use of the 50-[micro]g/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
(c) Related tolerances. See § 556.304 of this chapter.
(d) Special considerations. (1) Concurrent luteolytic drug use is approved as follows:
(i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No. 000061 in § 510.600(c) of this chapter.
(ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of this section as provided by No. 068504 in § 510.600(c) of this chapter.
(iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of this section as provided by Nos. 000010 in § 510.600(c) of this chapter.
(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter.
(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use in cattle - (1) Indications for use and amounts. (i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 [micro]g gonadorelin (No. 000061), or 100 [micro]g gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 [micro]g gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection.
(ii) For the treatment of ovarian follicular cysts in cattle: Administer 100 [micro]g gonadorelin hydrochloride by intramuscular injection.
(iii) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in beef cows and lactating dairy cows: Administer to each cow 86 [micro]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 [micro]g gonadorelin by intramuscular injection.
(iv) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 [micro]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [micro]g gonadorelin by intramuscular injection.
(v) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 [micro]g gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [micro]g gonadorelin diacetate tetrahydrate 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 [micro]g 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 [micro]g gonadorelin by intramuscular injection.
(2) [Reserved]
[83 FR 64740, Dec. 18, 2018, as amended at 84 FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 84 FR 32992, July 11, 2019; 86 FR 13184, Mar. 8, 2021; 86 FR 14820, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 88 FR 27699, May 3, 2023]
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