Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 520  /  Sec. 520.1450 Morantel tartrate oral dosage forms. Sec. 520.1450a Morantel tartrate bolus.

(a) Specifications. Each bolus contains 2.2 grams morantel tartrate equivalent to 1.3 grams of morantel base.

(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

(c) Related tolerances. See Sec. 556.425 of this chapter.

(d) Conditions of use--(1) Amount. One bolus per 500 pounds of body weight (4.4 milligrams per pound of body weight) as a single oral dose. Boluses may be divided in half for more accurate dosing as follows: up to 325 pounds, \1/2\ bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 1\1/2\ boluses; and 901 to 1,200 pounds, 2 boluses.

(1) Amount. One bolus per 500 pounds of body weight (4.4 milligrams per pound of body weight) as a single oral dose. Boluses may be divided in half for more accurate dosing as follows: up to 325 pounds, \1/2\ bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 1\1/2\ boluses; and 901 to 1,200 pounds, 2 boluses.

(2) Indications for use. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum).

(3) Limitations. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. Do not treat within 14 days of slaughter. [46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, and amended at 51 FR 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] Sec. 520.1450b Morantel tartrate cartridge.

(a) Specifications. The drug product consists of a stainless-steel cylinder having both ends closed with polyethylene diffusing discs and containing a morantel tartrate paste. The paste contains 22.7 grams of morantel tartrate equivalent to 13.5 grams of morantel base.

(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

(c) Related tolerances. See Sec. 556.425 of this chapter.

(d) Conditions of use--(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.

(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.

(2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.

(3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 106 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. [49 FR 47831, Dec. 7, 1984, as amended at 51 FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, 1986; 78 FR 28825, May 20, 2014] Sec. 520.1450c Morantel tartrate sustained-release trilaminate cylinder/sheet.

(a) Specifications. The drug product consists of a trilaminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base.

(b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.

(c) Related tolerances. See Sec. 556.425 of this chapter.

(d) Conditions of use--(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.

(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.

(2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.

(3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014]