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Progesterone and Estradiol Benzoate. (Iii) Limitations

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Progesterone and Estradiol Benzoate. (Iii) Limitations Food and Drug Administration, HHS § 522.1940 0.28 milligrams of isopropamide) in (ii) Indications for use. For increased buffered aqueous solution. rate of weight gain. (b) Sponsor. See No. 000069 in (iii) Limitations. For use in suckling § 510.600(c) of this chapter. beef calves (at least 45 days of age) up (c) Conditions of use. (1) The drug is to 400 pounds (lb) of body weight. For used in dogs and cats in which gastro- subcutaneous ear implantation, one intestinal disturbances are associated dose per animal. Do not use in bull with emotional stress. calves intended for reproduction. Safe- (2) Dosage is administered by sub- ty and effectiveness have not been es- cutaneous injection twice daily as fol- tablished in veal calves. A withdrawal lows: period has not been established for this product in preruminating calves. Do Dosage in Weight of animal in pounds Milliliters not use in calves to be processed for veal. Up to 4 ................................................................. 0.25 (2) Steers—(i) Amount—(A) 200 mg pro- 5 to 14 ................................................................. 0.5–1 15 to 30 ............................................................... 2–3 gesterone and 20 mg estradiol benzoate 30 to 45 ............................................................... 3–4 (one implant consisting of 8 pellets, 45 to 60 ............................................................... 4–5 each pellet containing 25 mg progester- Over 60 ................................................................ 6 one and 2.5 mg estradiol benzoate) per implant dose. Following the last injection, admin- (B) 200 mg progesterone and 20 mg es- ister prochlorperazine and tradiol benzoate (one implant con- isopropamide sustained release cap- sisting of 9 pellets, each of 8 pellets sules as indicated. containing 25 mg progesterone and 2.5 (3) For use only by or on the order of mg estradiol benzoate, and 1 pellet con- a licensed veterinarian. taining 29 mg tylosin tartrate) per im- [40 FR 13858, Mar. 27, 1975, as amended at 56 plant dose. FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, (ii) Indications for use. For increased 1995] rate of weight gain and improved feed efficiency. § 522.1940 Progesterone and estradiol benzoate. (iii) Limitations. For animals weigh- ing 400 lb or more; for subcutaneous ear (a) Sponsors. See sponsors in implantation, one dose per animal. § 510.600(c) of this chapter for use as in Safety and effectiveness have not been paragraph (c) of this section: established in veal calves. A with- (1) No. 000856 for use as in paragraphs drawal period has not been established (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), for this product in preruminating (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and calves. Do not use in calves to be proc- (c)(3) of this section. essed for veal. (2) No. 000986 for use as in paragraphs (3) Steers fed in confinement for slaugh- (c)(1) and (c)(2) of this section. ter—(i) Amount. Reimplant 200 mg pro- (b) Related tolerances. See §§ 556.240 gesterone and 20 mg estradiol benzoate and 556.540 of this chapter. on approximately day 70 following an (c) Conditions of use in cattle. It is initial implant of 100 mg progesterone used for implantation as follows: and 10 mg estradiol benzoate or 200 mg (1) Suckling beef calves—(i) Amount— progesterone and 20 mg estradiol ben- (A) 100 milligrams (mg) progesterone zoate. and 10 mg estradiol benzoate (one im- plant consisting of 4 pellets, each pel- (ii) Indications for use. For additional let containing 25 mg progesterone and improvement in rate of weight gain. 2.5 mg estradiol benzoate) per implant (iii) Limitations. For subcutaneous ear dose. implantation. Safety and effectiveness (B) 100 mg progesterone and 10 mg es- have not been established in veal tradiol benzoate (one implant con- calves. A withdrawal period has not sisting of 5 pellets, each of 4 pellets been established for this product in containing 25 mg progesterone and 2.5 preruminating calves. Do not use in mg estradiol benzoate, and 1 pellet con- calves to be processed for veal. taining 29 mg tylosin tartrate) per im- [69 FR 70055, Dec. 2, 2004, as amended at 77 plant dose. FR 31723, May 30, 2012] 307 VerDate Mar<15>2010 18:11 May 03, 2013 Jkt 229073 PO 00000 Frm 00317 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150.
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