344 Part 529—Certain Other Dos- Age Form New Animal

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§ 529.50 21 CFR Ch. I (4-1-96 Edition) (3) Limitations. Milk taken from ani- caused by susceptible organisms in- mals during treatment and for 36 hours cluding E. coli, Pseudomonas spp., and (three milkings) following the last Klebsiella ssp. treatment must not be used for food. (3) Limitations. For intrauterine infu- Treated animals must not be slaugh- sion in the horse only. Not for use in tered for food use for 28 days following horses intended for food. Federal law the last treatment. Cows with systemic restricts this drug to use by or on the clinical signs caused by mastitis should order of a licensed veterinarian. receive other appropriate therapy [48 FR 9640, Mar. 8, 1983, as amended at 53 FR under the direction of a licensed veteri- 27852, July 25, 1988] narian. Federal law restricts this drug to use by or on the order of a licensed § 529.360 Cephalothin discs. veterinarian. (a) Specifications. Cephalothin discs, [58 FR 58486, Nov. 2, 1993] comply with the requirements of § 460.1 of this chapter. PART 529ÐCERTAIN OTHER DOS- (b) Sponsor. See No. 000986 in AGE FORM NEW ANIMAL DRUGS § 510.600(c) of this chapter. (c) Conditions of use. (1) The discs are Sec. used for determining the in vitro sus- 529.50 Amikacin sulfate intrauterine solu- ceptibility of bacteria to cephaloridine tion. and cephalonium. 529.360 Cephalothin discs. (2) For veterinary laboratory diag- 529.365 Cephapirin sodium for nosis only. intramammary infusion. 529.400 Chlorhexidine tablets and suspen- § 529.365 Cephapirin sodium for sion. intramammary infusion. 529.810 Enflurane. 529.1003 Flurogestone acetate-impregnated (a) Specifications. Each 10-milliliter vaginal sponge. dose contains 200 milligrams of 529.1030 Formalin solution. cephapirin sodium activity in a peanut- 529.1044 Gentamicin sulfate in certain other oil gel. dosage forms. (b) Sponsor. See No. 000856 in 529.1044a Gentamicin sulfate intrauterine § 510.600(c) of this chapter. solution. (c) Related tolerances. See § 556.115 of 529.1044b Gentamicin sulfate solution. this chapter. 529.1115 Halothane. 529.1186 Isoflurane. (d) Conditions of use. (1) The drug is 529.1526 Nifurpirinol capsules. used for the treatment of lactating 529.2090 Salicylic acid. cows having bovine mastitis caused by 529.2464 Ticarcillin powder. susceptible strains of Streptococcus 529.2503 Tricaine methanesulfonate. agalactiae and Staphylococcus aureus. AUTHORITY: Sec. 512 of the Federal Food, (2) Administer one dose into each in- Drug, and Cosmetic Act (21 U.S.C. 360b). fected quarter immediately after the quarter has been completely milked SOURCE: 40 FR 13881, Mar. 27, 1975, unless otherwise noted. out. Do not milk out for 12 hours. Re- peat once only in 12 hours. If improve- § 529.50 Amikacin sulfate intrauterine ment is not noted within 48 hours after solution. treatment, consult your veterinarian. (a) Specifications. Each milliliter of (3) Milk that has been taken from sterile aqueous solution contains 250 animals during treatment and for 96 milligrams of amikacin (as the sul- hours (8 milkings) after the last treat- fate). ment must not be used for food. Treat- (b) Sponsor. See No. 000856 in ed animals must not be slaughtered for § 510.600(c) of this chapter. food until 4 days after the last treat- (c) Conditions of useÐ(1) Amount. Two ment. grams (8 milliliters) diluted with 200 [40 FR 57455, Dec. 10, 1975, as amended at 53 milliliters of sterile physiological sa- FR 27852, July 25, 1988] line per day for 3 consecutive days. (2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares when 344 VerDate 29<JUL>96 12:57 Aug 16, 1996 Jkt 167070 PO 00000 Frm 00340 Fmt 8010 Sfmt 8010 C:\CFR\21V6C1SE.TXT pfrm13 Food and Drug Administration, HHS § 529.1030 § 529.400 Chlorhexidine tablets and muscle relaxants with enflurane; not suspension. for use in horses intended for food; ob- (a) Specification. Each tablet and each serve all customary precautions for use 28-milliliter syringe of suspension con- of vascoconstrictor substances; Federal tain 1 gram of chlorhexidine law restricts this drug to use by or on dihydrochloride.1 the order of a licensed veterinarian. (b) Sponsor. See No. 000856 in [46 FR 18965, Mar. 27, 1981, as amended at 49 § 510.600(c) of this chapter. FR 13494, Apr. 5, 1984] (c) Conditions of useÐ(1) Amount. Place 1 or 2 tablets deep in each uter- § 529.1003 Flurogestone acetate-im- ine horn; or infuse a solution of 1 tab- pregnated vaginal sponge. let disolved in an appropriate amount (a) Specifications. Each vaginal sponge of clean boiled water; or infuse one sy- contains 20 milligrams of flurogestone ringe of suspension into the uterus.1 acetate. (2) Indications for use. For prevention (b) Sponsor. See No. 000014 in or treatment of metritis and vaginitis § 510.600(c) of this chapter. in cows and mares when caused by (c) Conditions of useÐ(1) Indications pathogens sensitive to chlorhexidine for use. For synchronizing estrus/ovula- dihydrochloride.1 tion in cycling adult ewes during their (3) Limitations. Prior to administra- normal breeding season. tion, remove any unattached placental (2) Limitations. Using applicator pro- membranes, any excess uterine fluid or vided, insert sponge into ewe's vagina debris, and carefully clean external 13 days before desired start of breeding. genitalia. Use a clean, sterile insemi- For intravaginal use in sheep only. Do nating pipette for administrating solu- not use in young ewes that have not tions and suspensions. Treatment may had lambs. Use plastic or rubber gloves 1 be repeated in 48 to 72 hours. when handling large numbers of [43 FR 10705, Feb. 23, 1979] sponges to minimize exposure to drug. Do not leave sponge in the vagina for § 529.810 Enflurane. more than 21 days. Ewes must not be (a) Specifications. The drug is a clear, slaughtered for food within 30 days of colorless, nonflammable, nonexplosive sponge removal. liquid. [49 FR 45420, Nov. 16, 1984] (b) Sponsor. See 010019 in § 510.600(c) of this chapter. § 529.1030 Formalin solution. (c) Conditions for useÐ(1) Amount. For induction of surgical anesthesia: 4 to 5 (a) Specifications. Formalin solution percent enflurane (with oxygen) for 10 is an aqueous solution containing ap- to 15 minutes. For maintenance of sur- proximately 37 percent by weight of gical anesthesia: 2.2 to 3.5 percent formaldehyde gas, U.S.P. enflurane (with oxygen). (b) Sponsor. Approval to firms identi- (2) Indications for use. For induction fied in § 510.600(c) of this chapter for use and maintenance of general anesthesia as indicated: in horses. (1) No. 050378 for use as in paragraph (3) Limitations. Administer by inhala- (c) of this section. tion; not for use in horses sensitive to (2) Nos. 049968 and 051212 for use as in halogenated anesthetics; increasing paragraphs (c)(1)(i), (c)(1)(ii), (c)(2)(i), depth of anesthesia may produce mus- (c)(2)(ii), and (c)(3) of this section. cle twitching, particularly about face, (c) Conditions of useÐ(1) Indications neck, and forelimb; not for use in preg- for use. The drug is added to the envi- nant mares, foals or weanlings; use less ronmental water as follows: than usual amounts of nondepolarizing (i) For control of the protozoa: Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis 1 These conditions are NAS/NRC reviewed spp., and Trichodina spp.; and the and deemed effective. Applications for these uses need not include effectiveness data as monogenetic trematodes: Cleidodiscus specified by § 514.111 of this chapter, but may spp., Gyrodactylus spp., and require bioequivalency and safety informa- Dactylogyrus spp. on salmon, trout, cat- tion. fish, largemouth bass, and bluegill. 345 VerDate 29<JUL>96 12:57 Aug 16, 1996 Jkt 167070 PO 00000 Frm 00341 Fmt 8010 Sfmt 8010 C:\CFR\21V6C1SE.TXT pfrm13 § 529.1044 21 CFR Ch. I (4-1-96 Edition) (ii) For control of fungi of the family heavy bloom of phytoplankton is Saprolegniaceae on salmon, trout, and present, or when the concentration of esocid eggs. dissolved oxygen is less than 5 milli- (iii) For control of external proto- grams per liter. zoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp. on penaeid [51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, shrimp. 1994] (2) Amount. The drug concentrations required are as follows: § 529.1044 Gentamicin sulfate in cer- (i) For control of external parasites tain other dosage forms. on fish: § 529.1044a Gentamicin sulfate intra- Concentration of formalin uterine solution. (microliters per liter) (a) Specifications. Each milliliter of Fish Tanks and Earthen raceways (for ponds (in- the drug contains 50 or 100 milligrams up to 1 hour) definitely) of gentamicin (as the sulfate) in sterile Salmon and trout: aqueous solution. Above 50 ° F ................. Up to 170 ........ 15±25 (b) Sponsor. See Nos. 000061, 000856, Below 50 ° F ................. Up to 250 ........ 15±25 054273, 057561, and 058711 in § 510.600(c) of Catfish, largemouth Up to 250 ........ 1 15±25 bass, and bluegill. this chapter. (c) Conditions of use. (1) The drug is 1 Use the lower concentrations when pond is heavily loaded with fish or phytoplankton. indicated for use for control of bac- terial infections of the uterus in horses (ii) For control of fungi of the (metritis) and as an aid in improving Saprolegniaceae on salmon, trout, and conception in mares with uterine infec- esocid eggs: Apply in constant flow tions caused by bacteria sensitive to water supply of incubating facilities gentamicin. for 15 minutes. Concentration of for- (2) It is administered at a dosage malin used is 1,000 to 2,000 microliters level of 2 to 2.5 grams per day for 3 to per liter.
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  • Central and Peripheral Neurotoxic Effects of Ivermectin in Rats

    Central and Peripheral Neurotoxic Effects of Ivermectin in Rats

    FULL PAPER Toxicology Central and Peripheral Neurotoxic Effects of Ivermectin in Rats Saša M TRAILOVIĆ1) and Jelena Trailović NEDELJKOVIĆ2) 1)Faculty of Veterinary Medicine, Department of Pharmacology and Toxicology, University of Belgrade, Bulevar oslobodjenja 18, Belgrade 11000 and 2)Faculty of Veterinary Medicine, Department of Nutrition, University of Belgrade, Bulevar oslobodjenja 18, Belgrade 11000, Serbia (Received 27 September 2010/Accepted 6 December 2010/Published online in J-STAGE 20 December 2010) ABSTRACT. Ivermectin is considered a very safe drug; however, there are reports of toxic effects in particularly sensitive populations or due to accidental overdose. The aim of this study was (1) to further characterize the central and peripheral toxic effects of ivermectin in animals and (2) to determine possible therapeutic strategies for use in cases of ivermectin poisoning. We tested the effects of exper- imental doses of ivermectin previously reported to cause various intensities of CNS depression. However, in our study, ivermectin at 2.5, 5.0 and 7.5 mg/kg i.v. did not produce visible CNS depression in rats and 10 mg/kg resulted in sleepiness and staggering 10 to 40 min after application, while a dose of 15 mg/kg caused CNS depression very similar to general anesthesia. Ivermectin dose-dependently potentiates thiopentone-induced sleeping time in rats. Flumazenil (0.2 mg/kg), the benzodiazepine antagonist, did not affect the action of thiopentone; however, it significantly reduced sleeping time in rats treated with a combination of ivermectin (10 mg/kg) and thiopen- tone (25 mg/kg; from 189.86 45.28 min to 83.13 32.22 min; mean SD).