21 C.F.R. § 522.1244 Levamisole phosphate injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous solution contains levamisole phosphate equivalent to 136.5 or 182 milligrams of levamisole hydrochloride (13.65 or 18.2 percent). (b) Sponsor. See Nos. 000061 and 057561 in §510.600 of this chapter for use of 13.65 percent injection, and see No. 053501 for use of 13.65 and 18.2 percent injection. (c) Conditions of use—(1) Amount. 2 milliliters per 100 pounds of body weight, subcutaneously in the neck. (2) Indications for use. (i) The 13.65 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus). (ii) The 18.2 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum) and lungworms (Dictyocaulus). (3) Limitations. Do not administer more than 10 milliliters per site. Cattle that are severely parasitized or maintained under conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after first treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Consult your veterinarian before using in severely debilitated animals or animals under severe stress. Do not administer to cattle within 7 days of slaughter. Do not administer to dairy animals of breeding age. [43 FR 20489, May 12, 1978, as amended at 43 FR 29289, July 7, 1978; 43 FR 60895, Dec. 29, 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR 63055, Oct. 10, 2002]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1244 Levamisole phosphate injection.
