The Code of Federal Regulations of the United States of America

of body weight given three times per day. The drug should be given until all signs are alleviated. To reduce the possibility of a relapse, it is suggested that therapy be continued for a further period of a week to 10 days.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985]

§ 520.2320 Sulfanitran and aklomide in

combination.

(a) Chemical names. (1) Sulfanitran: Acetyl-(p-nitrophenyl)-sulfanilamide.

(2) Aklomide: 2-Chloro-4-nitrobenzamide.

(b) Specifications. (1) Sulfanitran conforms to the following specifications:

(i) Melting point range: 260° C. to 261° C.

(ii) Assay (by sodium nitrite titration): 97 to 100.5 percent.

(iii) Moisture (Method No. 6.123, "Toluene Distillation Method-Official Final Action" in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed., 1980, p. 83. Copies are available from the Association of Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, Washington, D.C. 20044, or available for inspection at the Office of the Federal Register, 1100 L St. NW., Washington, D.C. 20408): Not more than 2.0 percent. (iv) Molecular weight: 335.34. (v) Soluble in 0.1N sodium hydroxide, reprecipitating unchanged

acidification.

(2) Aklomide conforms to the following specifications:

(i) Minimum melting point: 170° C. (ii) Moisture content: Not to exceed 1.0 percent.

(iii) Purity: Not less than 98 percent on an anhydrous basis.

(d) Related tolerances. See §§ 556.30 and 556.680 of this chapter.

(e) Conditions of use. It is used in the drinking water of chickens as follows:

(1) Amount. 374-747 milligrams of sulfanitran with 477-954 milligrams of aklomide.

(2) Indications for use. As an aid in the treatment of coccidiosis caused by E. tenella, E. necatrix, and E. acervulina.

(3) Limitations. Administer for 2 days at 747 milligrams of sulfanitran per gallon and 954 milligrams of aklomide per gallon, followed by 5 days at 374 milligrams of sulfanitran per gallon and 477 milligrams of aklomide per gallon; do not treat birds over 6 weeks of age; do not administer within 5 days of slaughter; not for laying chickens.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 9396, Mar. 5, 1982]

(c) Sponsor. (1) Use of a 25-percent soluble powder and a 20-percent solution has been granted to No. 000006 in § 510.600(c) of this chapter for use as provided for in paragraph (e) of this section.

(2) Use of 3.44-percent and 12.85-percent solutions has been granted to No. 017800 in § 510.600(c) of this chapter for use as provided for in paragraphs (e) (1), (2), (3), (4)(i), and (4)(ii) of this section.

(d) NAS/NRC status. The conditions of use specified in this section have been reviewed by NAS/NRC and are found effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency information. Applications must be accompanied by a written commitment to undertake the human safety studies required by FDA.

(e) Conditions of use. It is used in drinking water as follows:

(1) Chickens. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti.

(ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for 2 more days. If bloody droppings

appear, repeat treatment at the 0.025 percent level for 2 more days. Do not change litter unless absolutely necessary. Do not give flushing mashes.

(2) Turkeys. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.

(ii) Administer at the 0.025 percent level for 2 days, skip 3 days, give for 2 days, skip 3 days and give for 2 more days. Repeat if necessary. Do not change litter unless absolutely necessary. Do not give flushing mashes.

(3) Chickens and turkeys. (i) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline.

(ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat treatment. If cholera has become established as the respiratory or chronic form, use feed medicated with sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not be kept for laying house replacements or breeders unless tests show they are not carriers.

(4) Cattle and calves. (i) For the control and treatment of outbreaks of coccidiosis caused by Eimeria bovis or E. zurnii.

(ii) Administer at the 0.015-percent level for 3 to 5 days in drinking water medicated with sulfaquinoxaline solution.

(iii) In lieu of treatment as provided in paragraph (e)(4)(ii) of this section, administer 1 teaspoon of 25-percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water.

(f) Limitations. Consult a veterinarian or poultry pathologist for diagnosis. May cause toxic reactions unless the drug is evenly mixed in water at dosages indicated and used according to directions. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Medicated chickens, turkeys, cattle, and calves must actually consume enough medicated water which provides a recommended dosage of ap

proximately 10 to 45 milligrams per pound per day in chickens, 3.5 to 55 milligrams per pound per day in turkeys, and approximately 6 milligrams per pound per day in cattle and calves depending on the age, class of animal, ambient temperature, and other factors. Not for use in lactating dairy cattle. Do not give to chickens, turkeys or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Make fresh drinking water daily.

[48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983]

§ 520.2325b Sulfaquinoxaline drench. (a) (b) [Reserved]

(e) Conditions of uses. As a 25-percent sulfaquinoxaline soluble powder.

(1) For the control and treatment of outbreaks of coccidiosis in cattle and calves caused by Eimeria bovis or E. zurnii.

(2) Give one teaspoon of 25 percent sulfaquinoxaline soluble powder for each 125 pounds of body weight for 3 to 5 days as a drench.

(f) Limitations. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined. Consult a veterinarian for diagnosis. Do not give to cattle within 10 days of slaughter for food. Not for use in lactating dairy cattle.

[48 FR 3964, Jan. 28, 1983]

(2) Indications for use. Use in dogs and cats as an aid in treatment of bacterial pneumonia and bacterial enteritis when caused by organisms sensitive to sulfisoxazole.1

(3) Limitations. Repeat dosage at 24-hour intervals until 2 to 3 days after disappearance of clinical symptoms. (Administration of one-half daily dosage at 12-hour intervals or one-third daily dosage at 8-hour intervals will provide a more constant blood level.) Provide adequate supply of drinking water. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian.1

[43 FR 60895, Dec. 29, 1978]

§ 520.2362 Thenium ciosylate tablets.

(a) Chemical name. (N,N-DimethylN-2-phenoxyethyl-N-2'-thenylammonium)-p-chlorobenzene-sulfonate.

(b) Specifications. Thenium closylate tablets contain thenium closylate equivalent to 500 milligrams thenium as base in each tablet.

(d) Conditions of use. (1) The tablets are administered orally to dogs as a single day treatment of canine ancylostomiasis by the removal from the intestines of the adult forms of the species Ancylostoma caninum and Uncinaria stenocephala (hookworms). Dogs weighing 10 pounds and over are administered 1 tablet as a single dose. Dogs weighing 5 to 10 pounds are administered one-half tablet twice during a single day. All dosages are given for 1 day only. The treatment should be repeated after 2 or 3 weeks.

(2) Suckling puppies or recently weaned puppies weighing less than 5 pounds should not be treated with the drug. Animals that are severely infected, exhibiting evidence of intestinal hemorrhage, debilitation, and anemia, should be given supportive treatment.

'These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981]

§ 520.2380 Thiabendazole forms.

§ 520.2380a

oral dosage

Thiabendazole top dressing and mineral protein feed block. (a) Chemical name. 2-(4-Thiazolyl)benzimidazole.

(b) Specifications. Conforms to N.F. XII.

(c) Sponsor. (1) See No. 017800 in § 510.600(c) of this chapter for the sponsor of the usage provided by paragraph (e)(1)(ii) of this section.

(2) See No. 000006 in § 510.600(c) of this chapter for the sponsor of the usages provided for by paragraph (e)(1)(ii) of this section.

(3) See No. 021930 in § 510.600(c) of this chapter for the sponsor of the usage provided for by paragraph (e)(2) of this section.

(d) Related tolerances. See § 556.730 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Horses-(i) Route of administration. In feed, as a top dressing.

(a) Amount. 2 grams per 100 pounds of body weight.

(b) Indications for use. For control of large strongyles, small strongyles, pinworms, and threadworms (including members of the genera Strongylus, Cyathostomum, Cylicobrachytus, and related genera, Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris,

mum, Oesophagodontus, Poteriostomum, Oxyuris, and Strongyloides.

(2) Limitations. Administer in a single dosage mixed with the normal grain ration given at one feeding. Warning: Not for use in horses intended for food.

(b) Amount. 4 grams per 100 pounds of body weight.

(1) Indications for use. For control of ascarids of the genus Parascaris.

(2) Limitations. Administer in a single dosage mixed with the normal grain ration given at one feeding. Warning: Not for use in horses intended for food.

(2) Cattle-(i) Route of administration. In feed block.

(ii) Amount. 3.3 percent block consumed at the recommended level of 0.11 pound per 100 pounds of body weight per day.

(iii) Indications for use. For control of infections of gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia and Cooperia). (iv) Limitations. Administer cattle on pasture or range accustomed to mineral protein block feeding for 3 days. Milk taken from animals during treatment and within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should formed by a veterinarian or diagnostic laboratory prior to worming. Animals maintained under conditions of constant worm exposure may require retreatment within 2 to 3 weeks. Animals that are severely parasitized, sick, or off feed should be isolated and a veterinarian consulted for advice concerning treatment.

be per

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976]

§ 520.2380b Thiabendazole drench or oral paste.

(a) Chemical name. 2-(4-Thiazolyl) benzimidazole.

(b) Specifications. Conforms to N.F. XII.

(c) Sponsor. See No. 000006 in § 510.600(c) of this chapter for the sponsor of the usages provided for by paragraph (e) of this section.

(d) Related tolerances. See § 556.730 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Horses. As a single liquid oral dose, administered as a drench or by stomach tube; or as an oral paste.

(i) Amount. 2 grams per 100 pounds of body weight.

(a) Indications for use. For the control of infections of large strongyles (Strongylus vulgaris, Strongylus endentatus), small strongyles (Cyathastomum, Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris), and threadworms (Strongyloides).

use

(a) Indications for use. For control of infections of ascardis (Parascaris). (b) Limitations. Not for horses to be slaughtered for food purposes. When administered by stomach tube, use only by or on the order of a licensed veterinarian. When for use as a liquid oral drench or an oral paste, consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(2) Pigs. As an oral paste.

(i) Amount. 200 milligrams for each 5 to 7 pounds of body weight per dose. (ii) Indications for use. For control of infections with Strongyloides ransomi. These infections are commonly found in Southeastern United States.

(iii) Limitations. Administer to baby pigs (1 to 8 weeks of age). Treatment may be repeated in 5 to 7 days if necessary. Before treatment, obtain an accurate diagnosis from a veterinarian or diagnostic laboratory. Do not treat within 30 days of slaughter.

(3) Cattle. Orally as a drench and in paste form using a dosing gun designed for the product.

(i) Amount. 3 grams per 100 pounds of body weight.

(a) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum).

(b) Limitations. For most effective results, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed prior to worming.

(ii) Amount. 5 grams per 100 pounds of body weight.

(a) Indications for use. Control of infections of Cooperia spp. or severe infections of other species in paragraph (e)(3)(i)(a) of this section.

(4) Sheep and goats. Orally, as a drench.

(i) Amount. 2 grams per 100 pounds of body weight.

(ii) Indications for use. Control of infections of gastrointestinal roundworms in sheep and goats. (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also active from 3 hours to 3 days following treatment against ova and larvae passed by sheep (good activity against Trichostrongylus colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against Haemonchus contortus and Oesophagostomum spp.).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from

Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Cha bertia spp., and Oesophagostomum spp.).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, 1976]

(a) Chemical name. 2-(4-Thiazolyl) benzimidazole.

(b) Specifications. Conforms to N.F. XII.

(d) Related tolerances. See § 556.730 of this chapter.

(e) Conditions of use. It is used as follows:

(1) Cattle. In a bolus.

(i) Amount. 3 grams per 100 pounds of body weight.

(a) Indications for use. Control of infections of gastrointestinal roundworms (general Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum).

(b) Limitations. As a single oral dose; may repeat once in 2 to 3 weeks; do not treat animals within 3 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.

(ii) Amount. 5 grams per 100 pounds of body weight.

(a) Indications for use. Control of severe infections of gastrointestinal

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