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21 C.F.R. § 522.1193   Ivermectin and clorsulon injection.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.1193   Ivermectin and clorsulon injection.

(a) Specifications. Each milliliter of sterile aqueous solution contains 10 milligrams (1 percent) of ivermectin and 100 milligrams (10 percent) of clorsulon.

(b) Sponsor. See 050604 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.163 and 556.344 of this chapter.

(d) Conditions of use—(1) Amount. 1 milliliter (10 milligrams of ivermectin and 100 milligrams of clorsulon) per 50 kilograms (110 pounds).

(2) Indications for use. It is used in cattle for the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); liver flukes (adults only) (Fasciola hepatica); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). It is also used to control infections of D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; and H. placei and C. oncophora for 14 days after treatment.

(3) Limitations. For subcutaneous use only. Not for intravenous or intramuscular use. Do not treat cattle within 49 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[55 FR 38984, Sept. 24, 1990, as amended at 62 FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, June 7, 2004]

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