21 C.F.R. § 520.48 Altrenogest solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest. (b) Sponsor. See No. 057926 in §510.600(c) of this chapter. (c) Tolerances. See §556.36 of this chapter. (d) Conditions of use—(1)Horses—(i)Amount. 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 consecutive days. (ii) Indications for use. For suppression of estrus in mares. (iii) Limitations. For oral use in horses only; avoid contact with the skin. Do not administer to horses intended for use as food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine—(i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top-dressing on a portion of each gilt's daily feed. (ii) Indications for use. For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. (iii) Limitations. Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment. [66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.48 Altrenogest solution.
