European Union - English - EMA (European Medicines Agency)

prevtec microbia gmbh - live non-pathogenic escherichia coli o8:k87 - immunologicals for suidae, live bacterial vaccines, pig - pigs - for active immunisation of pigs against enterotoxigenic f4-positive escherichia coli in order to:reduce the incidence of moderate to severe post-weaning escherichia coli diarrhoea (pwd) in pigs;reduce the colonisation of the ileum and faecal shedding of enterotoxigenic f4-positive escherichia coli from infected pigs.

European Union - English - EMA (European Medicines Agency)

elanco gmbh - live non-pathogenic escherichia coli o141:k94 (f18ac) and o8:k87 (f4ac) - immunologicals for suidae, live bacterial vaccines - pigs - for active immunisation of pigs from 18 days of age against enterotoxigenic f4-positive and f18-positive escherichia coli in order to reduce the incidence of moderate to severe post-weaning e. coli diarrhoea (pwd) in infected pigs and to reduce the faecal shedding of enterotoxigenic f4-positive and f18-positive e. coli from infected pigs.

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

pfizer laboratories div pfizer inc - crisaborole (unii: q2r47hgr7p) (crisaborole - unii:q2r47hgr7p) - crisaborole 20 mg in 1 g - eucrisa is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. eucrisa is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. [see warnings and precautions (5.1)] risk summary available data from case reports with eucrisa use in pregnant women are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (mrhd) (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects in the u.s. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data rat and rabbit embryo-fetal development was assessed after oral administration of crisaborole. crisaborole did not cause adverse effects to the fetus at oral doses up to 300 mg/kg/day in pregnant rats during the period of organogenesis (3 times the mrhd on an area under the curve (auc) comparison basis). no crisaborole-related fetal malformations were noted after oral treatment with crisaborole in pregnant rats at doses up to 600 mg/kg/day (13 times the mrhd on an auc comparison basis) during the period of organogenesis. maternal toxicity was produced at this high dose of 600 mg/kg/day in pregnant rats and was associated with decreased fetal body weight and delayed skeletal ossification. crisaborole did not cause adverse effects to the fetus at oral doses up to the highest dose tested of 100 mg/kg/day in pregnant rabbits during the period of organogenesis (2 times the mrhd on an auc comparison basis). in a prenatal/postnatal development study, pregnant rats were treated with crisaborole at doses of 150, 300, or 600 mg/kg/day by oral gavage during gestation and lactation (from gestation day 7 through day 20 of lactation). crisaborole did not have any adverse effects on fetal development at doses up to 300 mg/kg/day (3 times the mrhd on an auc comparison basis). maternal toxicity was produced at the high dose of 600 mg/kg/day in pregnant rats and was associated with stillbirths, pup mortality, and reduced pup weights. risk summary there is no information available on the presence of eucrisa in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of eucrisa to women who are breastfeeding. eucrisa is systemically absorbed. the lack of clinical data during lactation precludes a clear determination of the risk of eucrisa to a breastfed infant. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eucrisa and any potential adverse effects on the breastfed infant from eucrisa or from the underlying maternal condition. the safety and effectiveness of eucrisa have been established in pediatric patients ages 3 months and older for topical treatment of mild to moderate atopic dermatitis. use of eucrisa administered twice daily in this age group is supported by data from two 28-day adequate, vehicle-controlled safety and efficacy trials (1,313 pediatric subjects ages 2 years to 17 years of whom 874 received eucrisa), a 28-day open-label, safety and pharmacokinetics (pk) trial (137 subjects ages 3 months to less than 2 years who received eucrisa), and another trial with an open-label period of up to 8 weeks (327 pediatric subjects ages 5 months to less than 18 years who received eucrisa) [see clinical pharmacology (12.3) and clinical studies (14)] . the safety and effectiveness of eucrisa in pediatric patients below the age of 3 months have not been established. clinical studies of eucrisa did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.

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

laboratory equipment pty ltd - 17157 - laboratory refrigerator - laboratory refrigerator is an ac-powered device intended for the storage of biological specimens, cultures and other laboratory preparations at temperatures between 2?c and 8?c. temperature is digitally controlled with high/low temperature memory and integrated alarm system.

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

encube ethicals private limited - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophyte. none. risk summary there are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth

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

alembic pharmaceuticals inc. - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes . none. risk summary there are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects in the u.s. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data oral administration: in an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 6 to 19) to pregnant female rats. in the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e., a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the mrhd based on auc comparisons]. no developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the mrhd based on auc comparisons). in an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 7 to 19) to pregnant female rabbits. in the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation loss was noted at 150 mg/kg/day tavaborole. no drug related malformations were noted in rabbits at 150 mg/kg/day tavaborole (155 times the mrhd based on auc comparisons). no embryofetal mortality was noted in rabbits at 50 mg/kg/day tavaborole (16 times the mrhd based on auc comparisons). in an oral prenatal and postnatal development study in rats, oral doses of 15, 60, and 100 mg/kg/day tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20). in the presence of minimal maternal toxicity, no embryofetal toxicity or effects on postnatal development were noted at 100 mg/kg/day (29 times the mrhd based on auc comparisons). topical administration: in a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole solution were administered during the period of organogenesis (gestational days 6 to 28) to pregnant female rabbits. a dose dependent increase in dermal irritation at the treatment site was noted at 5% and 10% tavaborole solution. a decrease in fetal bodyweight was noted at 10% tavaborole solution. no drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the mrhd based on auc comparisons). no embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times the mrhd based on auc comparisons). risk summary there is no information available on the presence of tavaborole topical solution in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of tavaborole topical solution to women who are breastfeeding. tavaborole topical solution is systemically absorbed. the lack of clinical data during lactation precludes a clear determination of the risk of tavaborole topical solution to a breastfed infant. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tavaborole topical solution and any potential adverse effects on the breastfed child from tavaborole topical solution or from the underlying maternal condition. the safety and efficacy of tavaborole topical solution were established in patients 6 years of age and older. use of tavaborole topical solution in these age groups is supported by evidence from adequate and well-controlled studies of tavaborole topical solution in adults with additional data from an open-label pharmacokinetics study of tavaborole in subjects 12 years to less than 17 years old [ see clinical pharmacology (12.3)]. in clinical trials of 791 subjects who were exposed to tavaborole topical solution, 19% were 65 years of age and over, while 4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

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

aleor dermaceuticals limited - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes . none. risk summary there are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, lo

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

amneal pharmaceuticals ny llc - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - tavaborole topical solution is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes . none. risk summary there are no available data on tavaborole use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, loss, or other adverse

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

padagis us llc - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes . none. risk summary there are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, lo

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

mayne pharma commercial llc - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes. none. risk summary there are no available data on tavaborole topical solution use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [ see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects in the u.s. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data oral administration: in an oral embryofetal development study in rats, oral doses of 30, 100, and 300 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 6-19) to pregnant female rats. in the presence of maternal toxicity, embryofetal toxicity (increased embryofetal resorption and/or deaths) and drug-related skeletal malformations and variations suggestive of delayed development (i.e., a delay in ossification) were noted in fetuses at 300 mg/kg/day tavaborole [570 times the mrhd based on auc comparisons]. no developmental toxicity was noted in rats at 100 mg/kg/day tavaborole (26 times the mrhd based on auc comparisons). in an oral embryofetal development study in rabbits, oral doses of 15, 50, and 150 mg/kg/day tavaborole were administered during the period of organogenesis (gestational days 7-19) to pregnant female rabbits. in the presence of maternal toxicity, excessive embryofetal mortality due to post-implantation loss was noted at 150 mg/kg/day tavaborole. no drug related malformations were noted in rabbits at 150 mg/kg/day tavaborole (155 times the mrhd based on auc comparisons). no embryofetal mortality was noted in rabbits at 50 mg/kg/day tavaborole (16 times the mrhd based on auc comparisons). in an oral pre-and post-natal development study in rats, oral doses of 15, 60, and 100 mg/kg/day tavaborole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20). in the presence of minimal maternal toxicity, no embryofetal toxicity or effects on postnatal development were noted at 100 mg/kg/day (29 times the mrhd based on auc comparisons). topical administration: in a dermal embryofetal development study in rabbits, topical doses of 1%, 5%, and 10% tavaborole solution were administered during the period of organogenesis (gestational days 6-28) to pregnant female rabbits. a dose dependent increase in dermal irritation at the treatment site was noted at 5% and 10% tavaborole solution. a decrease in fetal bodyweight was noted at 10% tavaborole solution. no drug related malformations were noted in rabbits at 10% tavaborole solution (36 times the mrhd based on auc comparisons). no embryofetal toxicity was noted in rabbits at 5% tavaborole solution (26 times the mrhd based on auc comparisons). risk summary there is no information available on the presence of tavaborole in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of tavaborole topical solution to women who are breastfeeding. tavaborole topical solution is systemically absorbed. the lack of clinical data during lactation precludes a clear determination of the risk of tavaborole topical solution to a breastfed infant. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tavaborole topical solution and any potential adverse effects on the breastfed child from tavaborole topical solution or from the underlying maternal condition. the safety and efficacy of tavaborole topical solution were established in patients 6 years of age and older. use of tavaborole topical solution in these age groups is supported by evidence from adequate and well-controlled studies of tavaborole topical solution in adults with additional data from an open-label pharmacokinetics study of tavaborole in subjects 12 years to less than 17 years old [ see clinical pharmacology (12.3) ]. in clinical trials of 791 subjects who were exposed to tavaborole topical solution, 19% were 65 years of age and over, while 4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. important information: tavaborole topical solution is for use on toenails only. do not use tavaborole topical solution in your mouth, eyes, or vagina. read the instructions for use that comes with tavaborole topical solution before you start using it. talk to your healthcare provider if you have any questions. how to apply tavaborole topical solution: your toenails should be clean and dry before you apply tavaborole topical solution. step 1 : before you apply tavaborole topical solution to your affected toenail for the first time, remove the cap from the tavaborole topical solution bottle. (see figure a ) throw away the cap. step 2 : remove the wrapping from the dropper that comes with tavaborole topical solution. insert the dropper into the tavaborole topical solution bottle. ( see figure b ) only apply tavaborole topical solution using the provided dropper. do not use the dropper for any other purpose. step 3: with the dropper inserted into the tavaborole topical solution, squeeze the bulb and then release the bulb to draw tavaborole topical solution into the dropper. step 4: remove the dropper from the bottle and hold the dropper tip over your affected toenail. step 5: slowly squeeze the bulb to apply tavaborole topical solution to your toenail. apply enough solution to completely cover your toenail. you may need to use more than one drop. ( see figure c ) figure c step 6: use the dropper tip to gently spread tavaborole topical solution to cover the entire toenail up to the edges of the toenail. ( see figure d ) figure d step 7: in addition to the top of the toenail, also apply tavaborole topical solution under the tip of the toenail. use the dropper tip to gently spread tavaborole topical solution under the entire tip of the toenail. (see figures eand f) step 8: repeat steps 3 to 7 to apply tavaborole topical solution to each affected toenail. let the tavaborole topical solution dry completely. this may take a couple of minutes. step 9: avoid getting tavaborole topical solution on skin that is not surrounding skin, use a tissue to wipe any excess solution from the surrounding skin. do not wipe tavaborole topical solution off of your toenails. step 10: after applying tavaborole topical solution to your toenails, insert the dropper back into the bottle and screw it on tightly. step 11: wash your hands with soap and water after applying tavaborole topical solution. this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: mayne pharma raleigh, nc 27609 revised: 10/2022