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)

taro pharmaceuticals u.s.a., inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older. ivermectin 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 ivermectin 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

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

nucare pharmaceuticals,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 palp

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

padagis us llc - 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 lvermectin 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 lvermectin 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)

bryant ranch prepack - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. none. pregnancy category c. 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. systemic embryofetal development studies were conducted in rats and rabbits. oral doses of 1.5 mg/kg/day, 4 mg/kg/day, and 12 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 6 to 17) to pregnant female rats. maternal death occurred at 12 mg/kg/day (1909x mthd). cleft palate occurred in the fetuses from the 12 mg/kg/day (1909x mthd) group. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 4 mg/kg/day (708x mthd). oral doses of 0.5 mg/kg/day, 1.5 mg/kg/day, 2.5

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

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

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

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

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - ivermectin, quantity: 3 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; butylated hydroxyanisole; citric acid - stromectol (ivermectin) is indicated for the treatment of: a) onchocerciasis and intestinal strongyloidiasis (anguillulosis). b) crusted scabies in conjunction with topical therapy c) human sarcoptic scabies when prior topical treatment has failed or is contraindicated. treatment is only justified when the diagnosis of scabies has been established clinically and /or by parasitological examination. without formal diagnosis, treatment is not justified in case of pruritus alone.?

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

durvet, inc. - ivermectin (unii: 8883yp2r6d) (ivermectin - unii:8883yp2r6d) - 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 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): dictyocauius 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 ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with dictyocaulus viviparus and oesophagostomum radiat