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

substipharm - ivermectin 3 mg - tablet - 3 mg - ivermectin 3 mg - ivermectin

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

intervet australia pty limited - ivermectin - topical solution/suspension - ivermectin anthelmintic active 5.0 g/l - 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 - t. colubriformis | intestinal threadworm - s. papillosus | large bowel worm - o. venulosum | longnosed cattle louse | 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 | thin necked intestinal worm | tubercle-bearing louse | whipworm (adult) - trichuris spp. | black scour worm | cattlebiting louse | damalinia bovis (old name) | including inhibited stages | large lungworm | little blue sucking louse | long-nosed 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)

sparhawk laboratories, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 10 mg in 1 ml - cattle :  ivermectin 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 inhibitedo. 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 iscabies: psoroptes ovis     (syn.p. communis var.bovis ) sarcoptes scabiei var. bovis ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection withdictyocaulus 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 :  ivermectin injection is indicated for the effective treatment and control of the follwoing harmful species of gastrointestinal roundworms, lungworms, lice and mange mites in swine: gastrointestinal roundworms large roundworm,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 (somtic larvae) sows must be treated at least seven days before farrowing to prevent infection in piglets. lungworm: metastrongylus spp . (adults) lice: haematopinus suis mange mites: sarcoptes scabiei  var. suis

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

durvet - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 0.8 mg in 1 ml - for the treatment and control of worms and bots of sheep - 20- 100 lb doses (240 ml) - 83- 100 lb doses (960 ml) see booklet for additional information. restricted drug (california) - use only as directed for animal use only • keep out of reach of children approved by fda under anada # 200-327 manufactured for: durvet, inc. blue springs, mo u.s.a. www.durvet.com ivermectin sheep drench provides treatment and control of adult and fourth-stage larvae of the following parasites: gastrointestinal roundworms – haemonchus contortus , ostertagia circumcincta , trichostrongylus axei , t. colubriformis , cooperia curticei , nematodirus spathiger , n. battus , and oesophagostomum columbianum ; lungworms – dictyocaulus filaria ; and all the larval stages of nasal bot – oestrus ovis . it also provides treatment and control of adult forms only of the following gastrointestinal roundworms – haemonchus placei , cooperia oncophora , strongyloides papillosus , oesophagostomum venulosum , trichuris ovis , and chabertia ovina

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

med-pharmex, inc - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin 1.87 g in 100 g - indications : consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. ivermectin paste provides effective treatment and 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 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 larvae; pinworms (adults and fourth-stage larvae) – ox

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

actavis pharma, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin cream, 1% 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

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

durvet, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d), clorsulon (unii: eg1zdo6lrd) (clorsulon - unii:eg1zdo6lrd) - indications ivermectin plus is indicated for the effective treatment and control of the following parasites 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 bunostomum phlebotomum nematodirus helvetianus  (adults only) n. spathiger  (adults only) oesophagostomum radiatum lungworms  (adults and fourth-stage larvae): dictyocaulus viviparus liver flukes: fasciola hepatica  (adults only) cattle grubs  (parasitic stages): hypoderma bovis h. lineatum sucking lice: linognathus vituli haematopinus eurysternus solenopotes capillatus mange mites  (cattle scab*): psoroptes ovis  (syn. p. communis  var. bovis) sarcoptes scabiei  var. bovis persistent activity ivermectin and clorsulon injection has been proved to effectively control infections and to protect cattle from reinfection with dictyocaulus viviparu

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

viona pharmaceuticals inc - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. none. there are no adequate and well-controlled studies in pregnant women. ivermectin cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. note: the animal multiples of human exposure calculations were based on auc comparisons. the maximum topical human dose (mthd) of ivermectin cream is 1 g applied once daily. 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 rabbi

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.