Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة الأردنية لإنتاج الأدوية - jordan pharmaceutical manufacturer (jpm) - mebendazole 100 mg - 100 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة الأردنية لإنتاج الأدوية - jordan pharmaceutical manufacturer (jpm) - mebendazole 100 mg - 100 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة الأردنية لإنتاج الأدوية - jordan pharmaceutical manufacturer (jpm) - mebendazole 100 mg - 100 mg

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

amneal pharmaceuticals llc - mebendazole (unii: 81g6i5v05i) (mebendazole - unii:81g6i5v05i) - mebendazole 100 mg - emverm® is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by ancylostoma duodenale (hookworm), ascaris lumbricoides (roundworm), enterobius vermicularis (pinworm), necator americanus (hookworm), and trichuris trichiura (whipworm). emverm® is contraindicated in persons with a known hypersensitivity to the drug or its excipients. risk summary the available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see data]. there are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see clinical considerations] . in animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral doses as low as 10 mg/kg (approximately 0.5-fold the total daily maximum recommended human dose [mrhd]). maternal toxicity was present at the highest of these doses [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risks untreated soil transmitted helminth infections in pregnancy are associated with adverse outcomes including maternal iron deficiency anemia, low birth weight, neonatal and maternal death. data human data several published studies, including prospective pregnancy registries, case-control, retrospective cohort, and randomized controlled studies, have reported no association between mebendazole use and a potential risk of major birth defects or miscarriage. overall, these studies did not identify a specific pattern or frequency of major birth defects with mebendazole use. however, these studies cannot definitely establish the absence of any mebendazole-associated risk because of methodological limitations, including recall bias, confounding factors and, in some cases, small sample size or exclusion of first trimester mebendazole exposures. animal data embryo-fetal developmental toxicity studies in rats revealed no adverse effects on dams or their progeny at doses up to 2.5 mg/kg/day on gestation days 6–15 (the period of organogenesis). dosing at ≥10 mg/kg/day resulted in a lowered body weight gain and a decreased pregnancy rate. maternal toxicity, including body weight loss in one animal and maternal death in 11 of 20 animals, was seen at 40 mg/kg/day. at 10 mg/kg/day, increased embryo-fetal resorption (100% were resorbed at 40 mg/kg/day), decreased pup weight and increased incidence of malformations (primarily skeletal) were observed. mebendazole was also embryotoxic and teratogenic in pregnant rats at single oral doses during organogenesis as low as 10 mg/kg (approximately 0.5-fold the total daily mrhd, based on mg/m2 ). in embryo-fetal developmental toxicity studies in mice dosed on gestation days 6–15, doses of 10 mg/kg/day and higher resulted in decreased body weight gain at 10 and 40 mg/kg/day and a higher mortality rate at 40 mg/kg/day. at doses of 10 mg/kg/day (approximately 0.2-fold the total daily mrhd, based on mg/m2 ) and higher, embryo-fetal resorption increased (100% at 40 mg/kg) and fetal malformations, including skeletal, cranial, and soft tissue anomalies, were present. dosing of hamsters and rabbits did not result in embryotoxicity or teratogenicity at doses up to 40 mg/kg/day (1.6 to 3.9-fold the total daily mrhd, based on mg/m2 ). in a peri- and post-natal toxicity study in rats, mebendazole did not adversely affect dams or their progeny at 20 mg/kg/day. at 40 mg/kg (1.9-fold the total daily mrhd, based on mg/m2 ), a reduction of the number of live pups was observed and there was no survival at weaning. no abnormalities were found on gross and radiographic examination of pups at birth. risk summary limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. there are no reports of effects on the breastfed infant, and the limited reports on the effects on milk production are inconsistent. the limited clinical data during lactation precludes a clear determination of the risk of emverm® to a breastfed infant; therefore, developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for emverm® and any potential adverse effects on the breastfed infant from emverm® or from the underlying maternal condition. the safety and effectiveness of emverm® 100 mg chewable tablets has not been established in pediatric patients less than two years of age. convulsions have been reported with mebendazole use in children less than one year of age [see warnings and precautions (5.1) and adverse reactions (6.2)]. clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Israel - English - Ministry of Health

j-c health care ltd - mebendazole - tablets - mebendazole 100 mg - mebendazole - mebendazole - treatment of trichuris trichiura (whipworm). ascaris lumbricoides (roundworm). ancylostoma duodenale (common hookworm). necator americanus (american hookworm), strongyloidiasis, enterobius vermicularis (pinworm) and teniasis in single or mixed infections.

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

arrotex pharmaceuticals pty ltd - mebendazole, quantity: 100 mg - tablet, chewable - excipient ingredients: magnesium stearate; sunset yellow fcf; colloidal anhydrous silica; polysorbate 80; purified talc; microcrystalline cellulose; saccharin sodium; sodium starch glycollate; maize starch; flavour - for the treatment of threadworm, roundworm, whipworm, hookworm, pinworm, tapeworm, and mixed helminthic infestations.

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

cipla australia pty ltd - mebendazole, quantity: 100 mg - tablet, chewable - excipient ingredients: colloidal anhydrous silica; polysorbate 80; sodium starch glycollate; sunset yellow fcf; microcrystalline cellulose; purified talc; maize starch; magnesium stearate; saccharin sodium; flavour - for the treatment of threadworm, roundworm, whipworm, hookworm, pinworm, tapeworm, and mixed helminthic infestations.

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

cipla australia pty ltd - mebendazole -

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

generic health pty ltd - mebendazole, quantity: 100 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; sodium lauryl sulfate; microcrystalline cellulose; colloidal anhydrous silica; hydrogenated cottonseed oil; saccharin sodium; sunset yellow fcf; purified talc; sodium starch glycollate; flavour - for treatment of single or mixed helminthic infestations of enterobius vermicularis (threadworm), ascaris lumbricoides (roundworm), trichuris trichura (whipworm) and of ancylostoma duodenale and necator americanus (hookworm).

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

noumed pharmaceuticals pty ltd - mebendazole, quantity: 100 mg - tablet, chewable - excipient ingredients: maize starch; purified talc; polysorbate 80; magnesium stearate; microcrystalline cellulose; saccharin sodium; sodium starch glycollate; sunset yellow fcf; colloidal anhydrous silica; flavour - for the treatment of threadworm, roundworm, whipworm, hookworm, pinworm, tapeworm, and mixed helminthic infestations.