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

cipla usa 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 6-19) 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 to women who are breastfeeding. tavaborole 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)

taro pharmaceuticals u.s.a., 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, lo

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

lupin 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 defec

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

bryant ranch prepack - 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 Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). fungal infections of the skin and nails caused by trichophyton (e.g. t. rubrum, t.mentagrophytes, t. verrucosum,t. violaceum), microsporum canis and epidermophyton floccosum. oral terbinafine hydrochloride tablets are indicated in the treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) where oral therapy is considered appropriate due to the s -

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

cosette pharmaceuticals, inc. - griseofulvin (unii: 32hrv3e3d5) (griseofulvin - unii:32hrv3e3d5) - griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:     tinea corporis     tinea pedis     tinea cruris     tinea barbae     tinea capitis tinea unguium when caused by one or more of the following species of fungi:  epidermophyton floccosum  microsporum audouinii  microsporum canis  microsporum gypseum  trichophyton crateriform  trichophyton gallinae  trichophyton interdigitalis  trichophyton megnini  trichophyton mentagrophytes  trichophyton rubrum  trichophyton schoenleini  trichophyton sulphureum  trichophyton tonsurans  trichophyton verrucosum note: prior to therapy, a dermatophyte should be identified as responsible for the infection. prior to initiating treatment, appropriate specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. griseofulvin is not effective in the following: bacterial infections coccidioidomycosis candidiasis (moniliasis) north american blastomycosis histoplasmosis cryptococcosis (torulosis) actinomycosis tinea versicolor sporotrichosis nocardiosis chromoblastomycosis the use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone. griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. griseofulvin may cause fetal harm when administered to a pregnant woman. two published cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy, therefore, griseofulvin is contraindicated in women who are or may become pregnant during treatment. women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on griseofulvin (see also precautions, drug interactions ). if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. although no direct causal relationship has been established, spontaneous abortion has been reported rarely coincident with the use of griseofulvin. note: the maximum recommended human dose (mrhd) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. if higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. for example, if a 1000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2. griseofulvin has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4x the maximum recommended human dose (mrhd) based on body surface area (bsa)]. griseofulvin also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with griseofulvin at doses of 500 to 1000 mg/week. there are reports of teratogenicity in a golden retriever when doses of 750 mg/day [1.2x the mrhd based on bsa] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9x the mrhd based on bsa] for intervals from one week up to the entire gestation period. teratogenicity was also seen in mice when griseofulvin was administered in doses equivalent to 5g/kg/day [40x the mrhd based on bsa] for 2 consecutive days at various stages of the pregnancy.

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

viona 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, los

France - English - HMA (Heads of Medicines Agencies)

intervet deutschland gmbh - trichophyton verrucosum 7000000 iu/ml - powder and solvent for suspension for injection - cattle food - trichophyton vaccine

Slovenia - English - HMA (Heads of Medicines Agencies)

intervet deutschland gmbh - trichophyton verrucosum 7000000 iu/ml - powder and solvent for suspension for injection - cattle food - trichophyton vaccine

Germany - English - HMA (Heads of Medicines Agencies)

intervet deutschland gmbh - trichophyton verrucosum 7000000 iu/ml - powder and solvent for suspension for injection - cattle food - trichophyton vaccine