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

merck sharp & dohme llc - 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 reside in subcutaneous nodules which are infrequently palpable. surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites. stromectol is contraindicated in patients who are hypersensitive to any component of this product.

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

galderma laboratories, l.p. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 10 mg in 1 g - soolantra cream is indicated for the treatment of inflammatory lesions of rosacea. none. risk summary the available data on the use of ivermectin, including soolantra 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 ha

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.

New Zealand - English - Ministry for Primary Industries

elanco australasia pty ltd - albendazole; cobalt edta; sodium selenate; ivermectin; levamisole hydrochloride - albendazole 20 g/litre; cobalt edta 12.6 g/litre; sodium selenate 0.95 g/litre; ivermectin 0.88 g/litre; levamisole hydrochloride 30 g/litre - endoparasiticide

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

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

elanco australasia pty ltd - ivermectin; levamisole as levamisole hydrochloride; albendazole; cobalt as cobalt edta; selenium as sodium selenate - oral solution/suspension - ivermectin anthelmintic active 0.8 g/l; levamisole as levamisole hydrochloride anthelmintic active 25.5 g/l; albendazole carbamate-benzimidazole active 20.0 g/l; cobalt as cobalt edta mineral-cobalt active 1.76 g/l; selenium as sodium selenate mineral-selenium active 0.4 g/l - parasiticides - sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - barber's pole worm-haemonchus contortus | black scour worm - trichostrongylus spp. | cooperia curticei | cooperia oncophora | intestinal threadworm - s. papillosus | large lungworm - dictyocaulus filaria | large mouthed bowel worm | nasal bot - parasitic larval stage | nematodirus filicollis | nodule worm - o. columbianum | sheep itch mite | small brown stomach worm-ostertagia spp. | stomach hair worm | thin necked intestinal worm-n. spathiger | whipworm - trichuris ovis | psorobia ovis | sheep nasal bot fly | small intestinal worm | teladorsagia | thin necked intestinal worm | thin necked intestinal worm-ad | trichostrongylus colubriformis | trichostrongylus vitrinus

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

boehringer ingelheim animal health australia pty. ltd. - ivermectin; albendazole - misc. intra ruminal device - ivermectin anthelmintic active 40.6 mg; albendazole carbamate-benzimidazole active 1.38 g - parasiticides - sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - barber's pole worm-haemonchus contortus | cooperia curticei | intestinal hair worm - t. colubriformis | intestinal threadworm - s. papillosus | large bowel worm - oesophagostomum spp. | large lungworm - dictyocaulus filaria | large mouthed bowel worm | nematodirus filicollis | nodule worm - oesophagostomum spp. | protostrongylus rufescens | small brown stomach worm-ostertagia spp. | stomach hair worm | whipworm - trichuris ovis | black scour worm | small intestinal worm | teladorsagia | thin necked intestinal worm

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

sanofi pasteur, inc - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 0.585 g in 117 g