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

bimeda, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 200 ug - consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. equell (ivermectin) paste provides effective control of the following parasites in horses: large strongyles (adults)   strongylus vulgaris (also early forms in blood vessels)   s. edentatus (also tissue stages)   s. equinus   triodontophorus spp. including t. brevicauda, t. serratus   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, c. pateratum   cylicocyclus spp. including c. insigne, c. leptostomum, c. nassatus, c. brevicapsulatus   cylicostephanus spp. including c. calicatus, c. goldi, c. longibursatus, c. minutus   cylicodontophorus spp.   petrovinema poculatum small strongyles (fourth-stage larvae) pinworms (adults and fourth-stage larvae)   oxyuris equi ascarids (adults and th

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

boehringer ingelheim animal health australia pty. ltd. - ivermectin - oral tablet - ivermectin anthelmintic active 272.0 ug/tb - parasiticides - dog | bitch | castrate | puppy - heartworm

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

boehringer ingelheim animal health belgium sa-nv - ivermectin 18,7 mg/g - oral paste - 18,7 mg/g - ivermectin 18.7 mg/g - ivermectin - horse

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

chemo centroamericana s.a. - ivermectina - ivermectina....6.00 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

calox de costa rica, s.a. - ivermectina - ivermectina....6.000 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

megalabs argentina s.a.u. - ivermectina - ivermectina....6,00 mg

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

virbac - ivermectin(10mg/ml) - oral solution/suspension - anthelmintic - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - ascarid - parasacris equorium | bots - gasterophilus spp. | cutaneous onchocerciasis | habronema spp. | intestinal threadworm - s. westeri | large mouth stomach worm | large strongyles - strongylus edentatus | large strongyles - strongylus equinus | large strongyles - strongylus vulgaris | large strongyles - triodontophorus spp. | lungworm - dictyocaulus arnfieldi | neck threadworm | pinworm - oxyuris equi | small strongyles - cyathostomum spp. | small strongyles - cylicocyclus spp. | small strongyles - cylicodontophorus spp | small strongyles - cylicostephanus spp. | small strongyles - gyalocephalus spp. | stomach hair worm | summer sores | bloodworm | bot fly | bot fly - oral and gastric sta | cutaneous larvae | cutaneous onchocerciasis | gasterophilus haemorrhoidalis | gasterophilus inermis | gasterophilus intestinalis | gasterophilus nasalis | gasterophilus pecorum | red worm | stomach bot | summer sores

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

bimeda (australia) pty. limited - clorsulon; ivermectin - parenteral liquid/solution/suspension - clorsulon ungrouped active 100.0 mg/ml; ivermectin anthelmintic active 10.0 mg/ml - parasiticides

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.