The Code of Federal Regulations of the United States of America

(3) Conditions of use. It is used in puppies and dogs as follows:

(i) Amount. Equivalent of 2.27 milligrams of pyrantel base per pound of body weight.

(ii) Indications for use. For the removal of large roundworms (Toxocara canis and Toxascarias leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala).

(iii) Limitations. Administer in the animal's feed bowl as a single dose by itself or mixed in a small quantity of food. Additional treatment may be required and should be confirmed by fecal examination within 2 to 4 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(4) Conditions of use. It is used in puppies and adult dogs and in lactating bitches after whelping as follows:

(i) Amount. Equivalent to 2.27 milligrams of pyrantel base per pound of body weight.

(ii) Indications for use. To prevent reinfections of Toxocara canis.

(iii) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

[42 FR 28534, June 3, 1977, as amended at 44 FR 36381, June 22 1979; 45 FR 10760, Feb. 19, 1980; 47 FR 16776, Apr. 20, 1982; 51 FR 11440, Apr. 3, 1986]

§ 520.2044 Pyrantel pamoate paste.

(a) Specifications. Each milliliter of paste contains 180 milligrams of pyrantel base (as pyrantel pamoate).

(b) Sponsor. See 000069 in § 510.600(c) of this chapter.

(1) Amount. Equivalent of 3 milligrams pyrantel base per pound of body weight.

(2) Indications for use. For removal and control of infections from the following mature parasites: large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum).

(3) Limitations. Administer as single dose by depositing paste on dorsum of the tongue using the dose syringe. Not for use in horses intended for food. It is recommended that severely debilitated animals not be treated with this preparation. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[47 FR 47377, Oct. 26, 1982; 48 FR 3367, Jan. 25, 1983]

§ 520.2045 Pyrantel tartrate powder; pyrantel tartrate pellets.

(a) Specifications. (1) Pyrantel tartrate powder horse wormer contains 11.3 percent and swine wormer 10.6 percent pyrantel tartrate.

(2) Pyrantel tartrate pellets colt and horse wormer contains 1.25 percent pyrantel tartrate.

(b) Sponsor. (1) See No. 000069 in § 510.600(c) of this chapter for conditions of use provided for in paragraphs (d) (1) and (2) of this section.

(2) See No. 017800 in § 510.600(c) of this chapter, for conditions of use provided for in paragraph (d)(3) of this section.

(d) Conditions of use. It is used in: (1) Horses and ponies:

(i) For the removal and control of infections from the following mature parasites: Large strongyles (Strongylus vulgaris, Strongylus edentatus, Strongylus equinus), small strongyles (Trichonema spp., Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).

(ii) It is administered as a single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body weight mixed with the usual grain ration.

(iii) It is recommended that severely debilitated animals not be treated with this drug. Do not administer by stomach tube or dose syringe. The drug should be used immediately after the package is opened.

(iv) Warning: Not for use in horses and ponies to be slaughtered for food purposes.

(2) Swine:

(i) For the removal and control of large roundworms (Ascaris suum) and nodular worm (Oesophagostomum) infections.

(ii) It is added to feed at 0.4 gram pyrantel tartrate per pound of nonpelleted ration. The ration is administered as a single treatment as the sole ration at the rate of 1 pound per 40 pounds of animal weight for animals up to 200 pounds. Animals 200 pounds and over are administered 5 pounds of ration per animal.

(iii) Fast pigs over night for optimum results. Water should be made available to animals during fasting and treatment periods. Consult veterinarian before using in severely debilitated animals. The drug should be used immediately after the package is opened. (iv) Warning: Do not treat within 24 hours of slaughter.

(3) Horses and colts:

(ii) It is administered as a single dose at 12.5 milligrams of pyrantel tartrate per 2.2 pounds of body weight mixed with the usual grain ration.

(iii) It is recommended that severely debilitated animals not be treated with this drug.

(iv) Warning: Do not use in horses or colts intended for food.

§ 520.2080 Ronnel oral dosage forms.

[48 FR 15243, Apr. 8, 1983]

§ 520.2080a Ronnel blocks.

(a) Specifications. Each pound of block contains 25 grams of ronnel (5.5 percent).

(b) Sponsor. See 021930 in § 510.600(c) of this chapter.

(d) Conditions of use-(1) Amount. 0.25 pound of block (6.24 grams of ronnel) per 100 pounds of body weight

per head per month for not less than 75 days.

(2) Indications for use. Control of grubs and hornflies.

(3) Limitations. Administer free choice to beef cattle and nonlactating dairy animals. Provide 1 block per 15 head of cattle. Use as sole source of ronnel. Do not allow cattle access to salt or other mineral while being fed this product. Withdraw from dairy animals 10 days before calving. If animals freshen during medication, or if medication has not been withdrawn 10 days before freshening, milk must not be used for food for 10 days after the last treatment. Withdraw 10 days before slaughter. Labeling shall also include a warning that ronnel is a cholinesterase inhibitor. Do not use this product simultaneously or within a few days before or after exposure to cholinesterase inhibiting drugs, pesticides, or chemicals.

[48 FR 15243, Apr. 8, 1983]

§ 520.2080b Ronnel tablets.

(a) Specifications. Each tablet contains 250 milligrams, 500 milligrams, or 1 gram of ronnel.

(b) Sponsor. See No. 011716 in § 510.600(c) of this chapter.

(c) Generic status. These conditions of use were reviewed and found effective by FDA before October 10, 1962. New animal drug applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(d) Conditions of use-(1) Indications for use. Dogs: Treatment of demodectic mange, tick, flea, and lice infections. Cats: Treatment of flea infestations.

(2) Dosage. (i) Demodectic mange in dogs: 25 milligrams per pound of body weight daily, preferably in divided doses; in very severe infections, 35 milligrams per pound of body weight daily; continue treatment 3 weeks after all mites in skin scrapings are dead.

(ii) Ticks in dogs: 50 milligrams per pound of body weight daily in single or divided doses; when improvement noted, reduce to maintenance level of

12.5 milligrams per pound of body weight daily.

(iii) Fleas and lice in dogs, or fleas in cats: 25 milligrams per pound of body weight every other day in single or divided doses; with continued control, decrease to 12.5 milligrams per pound of body weight every other day.

(3) Limitations. Oral treatment of demodectic mange or ticks in dogs may be combined with application of topical ronnel solutions. Ronnel is a cholinesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treatment with or exposure to cholineserase inhibiting drugs, pesticides, or chemicals. Atropine is an antidote. Treat symptomatically. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 15244, Apr. 8, 1983]

§ 520.2087 Roxarsone soluble powder.

(a) Specifications. Each ounce (avoirdupois) of soluble powder contains 21.7 grams of roxarsone (monosodium 3-nitro-4-hydroxyphenylarsonate).

(b) Sponsor. See No. 017210 in § 510.600(c) of this chapter.

(d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(e) Conditions of use-(1) Growing chickens and growing turkeys-(i) Amount. 0.002 percent roxarsone in drinking water (one packet per each 250 gallons of drinking water).

(ii) Indications for use. For increased rate of weight gain, improved feed efficiency, and improved pigmentation.

(ii) Indications for use. As an aid in the treatment of swine dysentery (hemorrhagic enteritis or bloody scours).

(iii) Limitations. Administer drinking water continuously for not more than 6 days. Administer drench once daily for 1 or 2 days. If no improvement is observed, consult a veterinarian. Treatment may be repeated after 5 days. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.

[46 FR 41039, Aug. 14, 1981]

§ 520.2088 Roxarsone tablets.

(a)(1) Specifications. Each tablet contains 36 milligrams of roxarsone (3nitro-4-hydroxyphenylarsonic acid).

(2) Sponsor. See No. 017210 in § 510.600(c) of this chapter.

(3) Related tolerances. See § 556.60 of this chapter.

(4) NAS/NRC status. The weight gain, feed efficiency, and pigmentation claims are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(5) Conditions of use-(i) Growing chickens and growing turkeys-(a) Amount. Dissolve 2 tablets in each gallon of drinking water (0.002 percent roxarsone).

(b) Indications for use. For increased rate of weight gain, improved feed efficiency, and improved pigmentation. (c) Limitations. Administer continuously throughout growing period. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.

(ii) Growing chickens-(a) Amount. Dissolve 8 tablets in each gallon of drinking water (0.008 percent roxarsone).

(b) Indications for use. As an aid in the prevention of coccidiosis due to Eimeria tenella.

(c) Limitations. Administer for not more than 10 consecutive days. Treatment may be repeated after 5 days off medication. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.

(b)(1) Specifications. Each tablet contains 400 milligrams of roxarsone (3-nitro-4-hydroxyphenylarsonic acid). (2) Sponsor. See No. 017210 in § 510.600(c) of this chapter.

(3) Related tolerances. See § 556.60 of this chapter.

(4) NAS/NRC status. These conditions are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(5) Conditions of use—(i) Swine—(a) Amount. 1 tablet (400 milligrams) per gallon of drinking water for no more than 6 days, or 1 tablet (400 milligrams) per 2 fluid ounces of warm water per 50 pounds of body weight as a drench once daily for 1 to 2 days.

(b) Indications for use. As an aid in the treatment of swine dysentery (hemorrhagic enteritis or bloody scours).

(c) Limitations. Treatment may be repeated after 5 days off medication. If no improvement is observed, consult a veterinarian. Treated animals must consume enough medicated water to provide a therapeutic dose. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.

(ii) [Reserved]

[46 FR 41040, Aug. 14, 1981, as amended at 46 FR 42448, Aug. 21, 1981; 47 FR 15238, Apr. 9, 1982]

§ 520.2100 Selenium, vitamin E capsules.

(a) Specifications. The capsules contain 2.19 milligrams of sodium selenite (equivalent to 1 milligram of selenium) and 56.2 milligrams of vitamin E (68 I.U.) (as d-alpha tocopheryl acid succinate) or 0.548 milligram of sodium selenite (equivalent to .25 milligram of selenium and 14 milligrams of vitamin E (17 I.U.) (as d-alpha tocopheryl acid succinate.)

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is intended for use as an aid in alleviating and controlling inflammation, pain, and lameness associated with certain arthropathies in dogs.

(2) The capsules are administered orally with the larger capsules administered at a dosage level of 1 capsule

per 20 pounds of body weight to a maximum of 5 capsules with the dosage repeated at 3 day intervals until a satisfactory therapeutic response is observed. A maintenance dosage is then administered consisting of 1 capsule per 40 pounds of body weight, with a minimum of 1 capsule per 40 pounds of body weight, with a minimum of 1 capsule, given every 3 days, or 7 days, or longer, as required to maintain improvement or an asymptomatic condition. For dogs

under 20 pounds of body weight, the small capsules are administered orally at a dosage level of 1 per 5 pounds of body weight with a minimum of 1 capsule which dosage is repeated at 3 day intervals until a satisfactory response is observed then a maintenance regimen is initiated with 1 capsule per 10 pounds of body weight, minimum of 1 capsule, every 3 days, or 7 days, or longer as required to maintain continued improvement or an asymptomatic condition.

(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 52 FR 7832, Mar. 13, 1987; 52 FR 9756, Mar. 26, 1987]

§ 520.2122 Spectinomycin dihydrochloride oral solution.

(a) Specifications. The spectinomycin dihydrochloride pentahydrate used in manufacturing the drug is the antibiotic substance produced by growth of Streptomyces flavopersicus (var. Abbott) or the same antibiotic substance produced by any other means. The drug is packaged as an aqueous solution containing 50 milligrams of spectinomycin activity per milliliter.

(b) Sponsors. (1) See No. 050604 in § 510.600(c) of this chapter.

(2) See No. 000033 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) It is used for the treatment and control of infectious bacterial enteritis (white scours) associated with E. coli in pigs under 4 weeks of age.

(2) It is administered orally at the rate of 50 milligrams per 10 pounds body weight twice daily for 3 to 5 days.

(3) Do not administer to pigs over 15 pounds body weight or over 4 weeks of age. Do not administer within 21 days of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 46 FR 60570, Dec. 11, 1981]

§ 520.2123 Spectinomycin dihydrochloride pentahydrate oral dosage forms.

§ 520.2123a Spectinomycin dihydrochloride pentahydrate tablets.

(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.

(c) Special considerations. The quantities of spectinomycin cited in this section refer to the equivalent weight of base activity for the drug.

(d) Conditions of use. (1) The tablets are administered orally to dogs in the treatment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin.

(2) The drug is administered orally to provide 10 milligrams per pound of body weight twice daily. The tablets may be placed in the animal's mouth or crushed and administered in milk or in the feed. Dosage may be continued for 4 consecutive days. Should no improvement be observed, discontinue drug and redetermine diagnosis.

(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 47 FR 14149, Apr. 2, 1982]

§ 520.2123b Spectinomycin dihydrochloride pentahydrate soluble powder. (a) Specifications. The spectinomycin dihydrochloride pentahydrate used in manufacturing the drug is the antibiotic substance produced by growth of Streptomyces flavopersicus (var. Abbott) or the same antibiotic substance produced by any other means. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.

this section refer to the equivalent weight of base activity for the drug. (d) Related tolerances. See § 556.600 of this chapter.

(e) Conditions of use. (1) It is administered in the drinking water of growing chickens at 2 grams of spectinomycin per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination It is administered as an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO). Do not administer to laying chickens. Do not administer within 5 days of slaughter.

(2) It is administered in the drinking water of floor-raised broiler chickens at 0.5 gram of spectinomycin per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination. It is administered for increased rate of weight gain and improved feed efficiency. Do not administer to laying chickens. Do not administer within 5 days of slaughter.

(3) It is administered in drinking water of broiler chickens at 1 gram of spectinomycin per gallon of water as the only source of drinking water for the first 3 to 5 days of life as an aid in controlling infectious synovitis due to Mycoplasma synoviae. Do not administer to laying chickens. Do not administer within 5 days of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980]

(a) Specifications. Each tablet contains 2 milligrams of stanozolol.

(b) Sponsor. No. 000934 in § 510.600(c) of this chapter.

(2) Administered orally to cats and small breeds of dogs, 2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. The tablets may be crushed and administered in feed.

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