United States - English - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. none. risk summary the available data on the use of ivermectin, including ivermectin cream, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (mrhd), respectively. these orally administered doses were maternally toxic to pregnant rats and rabbits. in a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data no adequate and well-controlled trials of ivermectin cream have been conducted in pregnant women. retrospective observational studies evaluated pregnancy outcomes in over 700 women in various stages of pregnancy who received oral ivermectin for the treatment of soil-transmitted helminths in rural africa. in an additional, randomized open-label trial, 397 pregnant women in their second trimester received a single dose of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths. when compared with a pregnant, untreated population, no differences in pregnancy outcomes were observed between the treated and untreated populations. these studies cannot definitively establish or exclude any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester. animal data systemic embryofetal development studies were conducted in rats and rabbits. oral doses of 1.5, 4, and 12 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rats. maternal death occurred at 12 mg/kg/day [1909 times the mrhd based on area under the curve (auc) comparison]. cleft palate occurred in the fetuses from the 12 mg/kg/day (1909 times the mrhd based on auc comparison) group. no treatment related embryofetal toxicity or malformations were noted at 4 mg/kg/day (708 times the mrhd based on auc comparison). oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rabbits. maternal death occurred at doses ≥ 2.5 mg/kg/day (72 times the mrhd based on auc comparison). carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354 times the mrhd based on auc comparison) group. fetal weight decrease was noted at 3.5 mg/kg/day (146 times the mrhd based on auc comparison). no treatment related embryofetal toxicity or malformations were noted at 2.5 mg/kg/day (72 times the mrhd based on auc comparison). a pre- and postnatal development study was conducted in rats. oral doses of 1, 2 and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6-20 and lactation days 2-20. neonatal death occurred at doses ≥ 2 mg/kg/day. behavior development of newborn rats was adversely affected at all doses. risk summary the presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated. there are no data available regarding the effects of ivermectin on milk production. published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. however, there is insufficient information from this report to determine the effects of ivermectin on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ivermectin cream and any potential adverse effects on the breastfed infant from ivermectin cream or from the underlying maternal conditions. safety and effectiveness of ivermectin cream in pediatric patients have not been established. of the 1371 subjects in the two pivotal clinical studies of ivermectin cream, 170 (12.4%) were 65 and over, while 37 (2.7%) were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. ivermectin (eye-ver-mek-tin) cream, 1% important: ivermectin cream is for use on the skin only (topical use). do not use ivermectin cream in your mouth, eyes, or vagina. read and follow the steps below so that you use ivermectin cream correctly. how should i store ivermectin cream? keep ivermectin cream and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by padagis® yeruham, israel www.padagis.com rev 10-22 3y100 rc ph3

United States - English - NLM (National Library of Medicine)

mayne pharma inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. none. risk summary the available data on the use of ivermectin, including ivermectin cream, in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (mrhd), respectively. these orally administered doses were maternally toxic to pregnant rats and rabbits. in a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data no adequate and well-controlled trials of ivermectin cream have been conducted in pregnant women. retrospective observational studies evaluated pregnancy outcomes in over 700 women in various stages of pregnancy who received oral ivermectin for the treatment of soil-transmitted helminths in rural africa. in an additional, randomized open-label trial, 397 pregnant women in their second trimester received a single dose of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths. when compared with a pregnant, untreated population, no differences in pregnancy outcomes were observed between the treated and untreated populations. these studies cannot definitively establish or exclude any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester. animal data systemic embryofetal development studies were conducted in rats and rabbits. oral doses of 1.5, 4, and 12mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rats. maternal death occurred at 12 mg/kg/day [1909 times the mrhd based on area under the curve (auc) comparison]. cleft palate occurred in the fetuses from the 12 mg/kg/day (1909 times the mrhd based on auc comparison) group. no treatment related embryofetal toxicity or malformations were noted at 4 mg/kg/day (708 times the mrhd based on auc comparison). oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rabbits. maternal death occurred at doses ≥ 2.5 mg/kg/day (72 times the mrhd based on auc comparison). carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354 times the mrhd based on auc comparison) group. fetal weight decrease was noted at 3.5 mg/kg/day (146 times the mrhd based on auc comparison). no treatment related embryofetal toxicity or malformations were noted at 2.5 mg/kg/day (72 times the mrhd based on auc comparison). a pre- and postnatal development study was conducted in rats. oral doses of 1, 2 and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6-20 and lactation days 2-20. neonatal death occurred at doses ≥ 2 mg/kg/day. behavior development of newborn rats was adversely affected at all doses. risk summary the presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated. there are no data available regarding the effects of ivermectin on milk production. published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. however, there is insufficient information from this report to determine the effects of ivermectin on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ivermectin cream and any potential adverse effects on the breastfed infant from ivermectin cream or from the underlying maternal conditions. safety and effectiveness of ivermectin cream in pediatric patients have not been established. of the 1371 subjects in the two pivotal clinical studies of ivermectin cream, 170 (12.4%) were 65 and over, while 37 (2.7%) were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

United States - English - NLM (National Library of Medicine)

asclemed usa, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin is indicated for the treatment of the following infections: ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite strongyloides stercoralis . this indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin (see clinical pharmacology, clinical studies ). ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite onchocerca volvulus . this indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of west africa. the comparative studies used diethylcarbamazine citrate (dec-c). note: ivermectin has no activity against adult onchocerca volvulus parasites. the adult parasites reside in subcutaneous nodules which are infrequently palpable. surgical excision of these nodules (no

United States - English - NLM (National Library of Medicine)

merial, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d), praziquantel (unii: 6490c9u457) (praziquantel - unii:6490c9u457) - ivermectin 15.5 mg in 1 g - indications: consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. zimecterin® gold (ivermectin/praziquantel) paste provides effective treatment and control of the following parasites in horses. tapeworms – anoplocephala perfoliata , large strongyles (adults) – strongylus vulgaris (also early forms in blood vessels), s. edentatus (also tissue stages), s. equinus , triodontophorus spp. including t. brevicauda and t. serratus and craterostomum acuticaudatum ; small strongyles (adults, including those resistant to some benzimidazole class compounds) – coronocyclus spp. including c. coronatus, c. labiatus and c. labratus, cyathostomum spp. including c. catinatum and c. pateratum , cylicocyclus spp. including c. insigne , c. leptostomum , c. nassatus , and c. brevicapsulatus , cylicodontophorus spp., cylicostephanus spp., including c. calicatus , c. goldi, c. longibursatus and c. minutus , and petrovinema poculatum ; small strongyles – fourth-stage larv

United States - English - NLM (National Library of Medicine)

bimeda, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d), praziquantel (unii: 6490c9u457) (praziquantel - unii:6490c9u457) - ivermectin 200 ug - consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. equimax (ivermectin/praziquantel) oral paste is indicated for the treatment and control of the following parasites: tapeworms anoplocephala perfoliata large strongyles (adults) strongylus vulgaris (also early forms in blood vessels) s. edentatus (also tissue stages) s. equinus triodontophorus spp. small strongyles (adults, including those resistant to some benzimidazole class compounds) cyathostomum spp. cylicocyclus spp. cylicostephanus spp. cylicodontophorus spp. small strongyles (fourth-stage larvae) pinworms (adults and fourth-stage larvae) oxyuris equi ascarids (adults and third- and fourth-stage larvae) parascaris equorum hairworms (adults) trichostrongylus axei large-mouth stomach worms (adults) habronema muscae bots (oral and gastric stages) gasterophilus spp. lungworms (adults and fourth-stage larvae) dictyocaulus arnfieldi

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

the hunter river company pty limited - ivermectin - topical solution/suspension - ivermectin anthelmintic active 5.0 mg/ml - parasiticides - cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | steer - barber's pole worm - haemonchus placei | buffalo fly | cattle biting louse | cattle tick - see label resistant strain | chorioptic mange mite | cooperia oncophora | cooperia punctata | eyeworm - thelazia spp. | intestinal hair worm | intestinal threadworm - s. papillosus | large bowel worm - o. venulosum | lungworm - dictyocaulus viviparus | mange mite - s. scabiei var. bovis | nodule worm - oesophagostomum radiatum | shortnosed cattle louse | small brown stomach worm - o. ostertagi | small intestinal worm - cooperia spp. | stomach hair worm | sucking lice - linognathus vituli | thin necked intestinal worm | tubercle-bearing louse | whipworm (adult) - trichuris spp. | cattlebiting louse | damalinia bovis (old name) | including inhibited stages | large lungworm | little blue sucking louse | short nosed sucking louse | small intestinal worm | ticks amidine resistant strain | ticks organophosphorus resista | ticks synthetic pyrethroid res

United States - English - NLM (National Library of Medicine)

vedco, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 10 mg in 1 ml - promectin (ivermectin) injection has been proved to effectively control infections and to protect cattle from reinfection with dictyocaulus viviparus and oesophagostomum radiatum for 28 days after treatment; ostertagia ostertagi, trichostrongylus axei and cooperia punctata for 21 days after treatment; haemonchus placei and cooperia oncophora for 14 days after treatment. swine :  promectin (ivermectin) injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice and mange mites in swine:

United States - English - NLM (National Library of Medicine)

bimeda, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 10 mg in 1 ml - bimectin® (ivermectin) injection for cattle and swine 1% sterile solution a parasiticide for the treatment and control of internal and external parasites of cattle and swine. consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. introduction bimectin (ivermectin) is an injectable parasiticide for cattle and swine. one low-volume dose effectively treats and controls the following internal and external parasites that may impair the health of cattle and swine: gastrointestinal roundworms (including inhibited ostertagia ostertagi in cattle), lungworms, grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms, lungworms, lice, and mange mites of swine. product description ivermectin is derived from the avermectins, a family of potent, broadspectrum antiparasitic agents isolated from fermentation of streptomyces avermitilis . bimectin injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. bimectin injection is formulated to deliver the recommended dose level of 200 mcg ivermectin/kilogram of body weight in cattle when given subcutaneously at the rate of 1 ml/110lb (50kg). in swine, bimectin injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 ml per 75lb (33kg). mode of action ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. this leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (gaba). the margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier. indications cattle: bimectin injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle: gastrointestinal roundworms (adults and fourth-stage larvae): ostertagia ostertagi (including inhibited o. ostertagi), o. lyrata, haemonchus placei, trichostrongylus axei, t. colubriformis, cooperia oncophora, c. punctata, c. pectinata, oesophagostomum radiatum, bunostomum phlebotomum, nematodirus helvetianus (adults only), n. spathiger (adults only) lungworms (adults and fourth-stage larvae): dictyocaulus viviparus cattle grubs (parasitic stages): hypoderma bovis, h. lineatum sucking lice: linognathus vituli, haematopinus eurysternus, solenopotes capillatus mites (scabies): psoroptes ovis (syn. p. communis var. bovis ), sarcoptes scabiei var. bovis persistent activity ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with dictyocaulus viviparus and oesophagostomum radiatum for 28 days after treatment; ostertagia ostertagi, trichostrongylus axei and cooperia punctat a for 21 days after treatment; haemonchus placei and cooperia oncophora for 14 days after treatment. swine: bimectin injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine gastrointestinal roundworms : large roundworms, ascaris suum (adults and fourth-stage larvae), red stomach worm, hyostrongylus rubidus (adults and fourth-stage larvae), nodular worm, oesophagostomum spp. (adults and fourth-stage larvae), threadworm, strongyloides ransomi (adults) somatic roundworm larvae: threadworm, strongyloides ransomi (somatic larvae) sows must be treated at least seven days before farrowing to prevent infection in piglets. lungworms : metastrongylus spp. (adults) lice: haematopinus suis mange mites: sarcoptes scabiei var. suis dosage: cattle: bimectin injection should be given only by subcutaneous injection under the loose skin in front of or behind the shoulder at the recommended dose level of 200 mcg of ivermectin per kilogram of body weight. each ml of bimectin contains 10 mg of ivermectin, sufficient to treat 110 lb (50 kg) of body weight (maximum 10 ml per injection site). swine: bimectin injection should be given only by subcutaneous injection in the neck of swine at the recommended dose level of 300 mcg of ivermectin per kilogram (2.2 lb) of body weight. each ml of bimectin contains 10 mg of ivermectin, sufficient to treat 75 lb of body weight.  breeding animals (sows,gilts, and boars)  do not underdose. ensure each animal receives a complete dose based on a current body weight. underdosing may result in ineffective treatment, and encourage the development of parasite resistance. administration cattle: bimectin injection is to be given subcutaneously only, to reduce risk of potentially fatal clostridial infection of the injection site. animals should be appropriately restrained to achieve the proper route of administration. use of a 16-gauge, 1/2 to 3/4" needle is suggested. inject under the loose skin in front of or behind the shoulder (see illustration). when using the 50 ml, 250 ml, 500 ml or 1000 ml package size, use only automatic syringe equipment. use sterile equipment and sanitize the injection site by applying a suitable disinfectant. clean, properly disinfected needles should be used to reduce the potential for injection site infections. no special handling or protective clothing is necessary. swine: bimectin (ivermectin) injection is to be given subcutaneously in the neck. animals should be appropriately restrained to achieve the proper route of administration. use of a 16- or 18- gauge needle is suggested for sows and boars, while an 18- or 20- gauge needle may be appropriate for young animals. inject under the skin, immediately behind the ear (see illustration). when using the 50 ml, 250 ml, 500 ml or 1000 ml package size, use only automatic syringe equipment. as with any injection, sterile equipment should be used. the injection site should be cleaned and disinfected with alcohol before injection. the rubber stopper should also be disinfected with alcohol to prevent contamination of the contents. mild and transient pain reactions may be seen in some swine following subcutaneous administration. recommended treatment program swine: at the time of initiating any parasite control program, it is important to treat all breeding animals in the herd. after the initial treatment, use bimectin (ivermectin) injection regularly as follows: breeding animals sows: treat prior to farrowing, preferably 7-14 days before, to minimize infection of piglets. gilts:   treat 7-14 days prior to breeding.             treat 7-14 days prior to farrowing. boars: frequency and need for treatments are dependent upon exposure. treat at least two times a year. feeder pigs (weaners/growers/finishers) all weaner/feeder pigs should be treated before placement in clean quarters. pigs exposed to contaminated soil or pasture may need retreatment if reinfection occurs. note: (1) bimectin injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. however, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week after treatment. sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs. (2) louse eggs are unaffected by bimectin injection and may require up to three weeks to hatch. louse infestations developing from hatching eggs may require retreatment. (3) consult a veterinarian for aid in the diagnosis and control of internal and external parasites of swine. special minor use reindeer: for the treatment and control of warbles (oedemagena tarandi ) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. follow use directions for cattle as described under administration. american bison: for the treatment and control of grubs (hypoderma bovis ) in american bison, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. follow use directions for cattle as described under administration. residue warning: do not treat reindeer or american bison within 8 weeks (56 days) for slaughter. warning not for use in humans. keep this and all drugs out of the reach of children. the safety data sheet (sds) contains more detailed occupational safety information. to report suspected adverse drug events, for technical assistance, or to obtain a copy of the sds, contact bimeda, inc. at 1-888-524-6332. for additional information about adverse drug experience reporting for animal drugs, contact fda at 1-888-fda-vets or www.fda.gov/reportanimalae. residue warning: do not treat cattle within 35 days of slaughter. because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. a withdrawal period has not been established for this product in pre-ruminating calves. do not use in calves to be processed for veal. do not treat swine within 18 days of slaughter. precautions transitory discomfort has been observed in some cattle following subcutaneous administration. a low incidence of soft tissue swelling at the injection site has been observed. these reactions have disappeared without treatment. for cattle, divide doses greater than 10 ml between two injection sites to reduce occasional discomfort or site reaction. use sterile equipment and sanitize the injection site by applying a suitable disinfectant. clean, properly disinfected needles should be used to reduce the potential for injection site infections. observe cattle for injection site reactions. reactions may be due to clostridial infection and should be aggressively treated with appropriate antibiotics. if injection site infections are suspected, consult your veterinarian. this product is not for intravenous or intramuscular use. protect product from light. bimectin injection for cattle and swine has been developed specifically for use in cattle, swine, reindeer, and american bison only . this product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result. restricted drug (california) - use only as directed. when to treat cattle with grubs bimectin effectively controls all stages of cattle grubs. however, proper timing of treatment is important. for most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. destruction of hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. killing hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause salivation and bloat; killing h. bovis when it is in the vertebral canal may cause staggering or paralysis. these reactions are not specific to treatment with bimectin, but can occur with any successful treatment of grubs. cattle should be treated either before or after these stages of grub development. consult your veterinarian concerning the proper time for treatment. cattle treated with bimectin after the end of the heel fly season may be retreated with bimectin during the winter for internal parasites, mange mites, or sucking lice without danger of grub-related reactions. a planned parasite control program is recommended. other warnings: parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). a decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. your parasite management plan should be adjusted accordingly based on regular monitoring. environmental safety studies indicate that when ivermectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. free ivermectin may adversely affect fish and certain aquatic organisms on which they feed. do not permit water runoff from feedlots or production sites to enter lakes, streams or ponds. do not contaminate water by direct application or by the improper disposal of drug containers. dispose of containers in an approved landfill or by incineration. as with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. the magnitude and duration of such effects are species and life-cycle specific. when used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects. how supplied: bimectin injection for cattle and swine is available in four ready-to-use sizes: the 50 ml plastic bottle suitable for use with automatic syringe equipment. each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle or 100 head of 38 lb (17.3 kg) swine. the 250 ml plastic bottle suitable for use with automatic syringe equipment. each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle or 500 head of 38 lb (17.3 kg) swine. the 500 ml plastic bottle suitable for use with automatic syringe equipment. each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine. the 1000 ml plastic bottle suitable for use with automatic syringe equipment. each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle or 2000 head of 38 lb (17.3 kg) swine. storage: store at 20°c to 25°c (68°f to 77°f). protect from light. approved by fda under anada # 200-447 bimectin® is a registered trademark of bimeda, inc. manufactured for: bimeda, inc. le sueur, mn 56058 www.bimeda.com

United States - English - NLM (National Library of Medicine)

arbor pharmaceuticals - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 5 mg in 1 g - sklice® lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. sklice lotion should be used in the context of an overall lice management program: - wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels. - wash personal care items such as combs, brushes and hair clips in hot water. - a fine-tooth comb or special nit comb may be used to remove dead lice and nits. none. risk summary there are no studies with the use of sklice lotion in pregnant women. epidemiologic studies with the use of oral ivermectin during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester (see data) . however, systemic exposure from topical use of ivermectin is much lower than that from oral use [see clinical pharmacology (12.3)]. in animal reproduct

United States - English - NLM (National Library of Medicine)

department of state health services, pharmacy branch - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 3 mg - stromectol is indicated for the treatment of the following infections: strongyloidiasis of the intestinal tract . stromectol is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite strongyloides stercoralis . this indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (see clinical pharmacology, clinical studies.) onchocerciasis . stromectol is indicated for the treatment of onchocerciasis due to the nematode parasite onchocerca volvulus . this indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of west africa. the comparative studies used diethylcarbamazine citrate (dec-c). note: stromectol has no activity against adult onchocerca volvulus parasites. the adult parasites resid