Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

botanicalab sdn bhd - vaccinium corymbosum -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mrz herbal healthy care - lycopersicon esculentum; punica granatum; daucus carota; citrus sinensis; malus domestica; vaccinium corymbosum -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

major interest sdn bhd - vaccinium macrocarpon; vaccinium corymbosum; lycium barbarum; daucus carota; tagetes erecta -

Združene države Amerike - angleščina - NLM (National Library of Medicine)

professional complementary health formulas - adrenalinum 6x argentum nitricum 6x arsenicum album 6x carbo vegetabilis 6x hydrangea arborescens 6x petroleum 6x acetaldehyde 12x coumarinum 12x gallicum acidum 12x histaminum hydrochloricum 12x indolum 12x mannan 12x rutin 12x aflatoxin 30x - for the temporary relief of gas, bloating, diarrhea, runny nose, sneezing, itching of the nose or throat, and itchy or watery eyes due to sensitivity to food allergens or autotoxins.* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

good manager holdings inc - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) -

Združene države Amerike - angleščina - NLM (National Library of Medicine)

shenzhen situya trading co., ltd. - camphor (synthetic) (unii: 5tjd82a1et) (camphor (synthetic) - unii:5tjd82a1et), silver cation (unii: 57n7b0k90a) (silver cation - unii:57n7b0k90a), echinacea angustifolia (unii: vb06av5us8) (echinacea angustifolia - unii:vb06av5us8), menthol (unii: l7t10eip3a) (menthol - unii:l7t10eip3a), fucus vesiculosus (unii: 535g2abx9m) (fucus vesiculosus - unii:535g2abx9m), thuja occidentalis bark (unii: 19rad88e6o) (thuja occidentalis bark - unii:19rad88e6o), melaleuca alternifolia (tea tree) leaf oil (unii: vi -

Združene države Amerike - angleščina - NLM (National Library of Medicine)

verrica pharmaceuticals inc. - cantharidin (unii: igl471wq8p) (cantharidin - unii:igl471wq8p) - ycanth is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. none risk summary there are no available data with use of ycanth in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies were not conducted with cantharidin. given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. 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. risk summary avoid application of ycanth topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. there are no data on the presence of cantharidin in either human or animal milk, or the effects on the breastfed infant or on milk production. breastfeeding is not expected to result in exposure of the child to the drug due to the low systemic absorption of ycanth following topical administration [see clinical pharmacology (12.3)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ycanth topical solution and any potential adverse effects on the breastfeeding child from ycanth topical solution or from the underlying maternal condition. risk summary the safety and effectiveness of ycanth for the treatment of molluscum contagiosum have been established in pediatric patients aged 2 years and older. the use of ycanth in pediatric patients is supported by results from adequate and well-controlled trials in patients 2 years of age and older; although the safety and efficacy of drug use for longer than 12 weeks has not been established [see clinical studies (14) ]. the safety and efficacy in pediatric patients below the age of 2 years have not been established. risk summary ycanth has not been studied in geriatric patients.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

bausch health us, llc - imiquimod (unii: p1qw714r7m) (imiquimod - unii:p1qw714r7m) - imiquimod 37.5 mg in 1 g - zyclara cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (ak) of the full face or balding scalp in immunocompetent adults. zyclara cream, 3.75% is indicated for the treatment of external genital and perianal warts (egw)/condyloma acuminata in patients 12 years or older. imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see use in specific populations (8.4)] . treatment with zyclara cream has not been studied for prevention or transmission of human papillomavirus (hpv). the safety and efficacy of zyclara cream have not been established in the treatment of: - urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease. - actinic keratosis when treated with more than one 2-cycle treatment course in the same area. - patients with xeroderma pigmentosum. - superficial basal cell carcinoma. - immunosuppressed patients. none. pregnancy category c: there are no adequate and well-controlled studies in pregnant women. zyclara cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the animal multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this section and in section 13.1. the animal multiples of human exposure were based on weekly dose comparisons for the carcinogenicity studies described in section 13.1. for the animal multiple of human exposure ratios presented in this section and section 13.1, the maximum recommended human dose (mrhd) was set at two packets (500 mg cream) per treatment of actinic keratosis with zyclara cream (imiquimod 3.75%, 18.75 mg imiquimod) for bsa comparison. the maximum human auc value obtained in the treatment of external genital and perianal warts was higher than that obtained in the treatment of actinic keratosis and was used in the calculation of animal multiples of mrhd that were based on auc comparison. systemic embryofetal development studies were conducted in rats and rabbits. oral doses of 1, 5, and 20 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6-15) to pregnant female rats. in the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (163x mrhd based on auc comparisons) included increased resorptions, decreased fetal body weights, delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues, and low-set ears. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 5 mg/kg/day (28x mrhd based on auc comparisons). intravenous doses of 0.5, 1, and 2 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (2.1x mrhd based on bsa comparisons), the highest dose evaluated in this study, or 1 mg/kg/day (115x mrhd based on auc comparisons). a combined fertility and peri- and postnatal development study was conducted in rats. oral doses of 1, 1.5, 3, and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation. no effects on growth, fertility, reproduction, or postnatal development were noted at doses up to 6 mg/kg/day (25x mrhd based on auc comparisons), the highest dose evaluated in this study. in the absence of maternal toxicity, bent limb bones were noted in the f1 fetuses at a dose of 6 mg/kg/day (25x mrhd based on auc comparisons). this fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. no treatment related effects on teratogenicity were noted at 3 mg/kg/day (12x mrhd based on auc comparisons). it is not known whether imiquimod is excreted in human milk following use of zyclara cream. because many drugs are excreted in human milk, caution should be exercised when zyclara cream is administered to nursing women. ak is a condition not generally seen within the pediatric population. the safety and effectiveness of zyclara cream for ak in patients less than 18 years of age have not been established. safety and effectiveness in patients with external genital/perianal warts below the age of 12 years have not been established. imiquimod 5% cream was evaluated in two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with molluscum contagiosum (mc) (470 exposed to imiquimod; median age 5 years, range 2-12 years). subjects applied imiquimod cream or vehicle 3 times weekly for up to 16 weeks. complete clearance (no mc lesions) was assessed at week 18. in study 1, the complete clearance rate was 24% (52/217) in the imiquimod cream group compared with 26% (28/106) in the vehicle group. in study 2, the clearance rates were 24% (60/253) in the imiquimod cream group compared with 28% (35/126) in the vehicle group. these studies failed to demonstrate efficacy. similar to the studies conducted in adults, the most frequently reported adverse reaction from two studies in children with molluscum contagiosum was application site reaction. adverse events which occurred more frequently in imiquimod-treated subjects compared with vehicle-treated subjects generally resembled those seen in studies in indications approved for adults and also included otitis media (5% imiquimod vs. 3% vehicle) and conjunctivitis (3% imiquimod vs. 2% vehicle). erythema was the most frequently reported local skin reaction. severe local skin reactions reported by imiquimod-treated subjects in the pediatric studies included erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion (2%) and weeping/exudate (2%). systemic absorption of imiquimod across the affected skin of 22 subjects aged 2 to 12 years with extensive mc involving at least 10% of the total body surface area was observed after single and multiple doses at a dosing frequency of three applications per week for 4 weeks. the investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subject’s weight. the overall median peak serum drug concentrations at the end of week 4 was between 0.26 and 1.06 ng/ml except in a 2-year-old female who was administered 2 packets of study drug per dose, had a c max of 9.66 ng/ml after multiple dosing. children aged 2-5 years received doses of 12.5 mg (one packet) or 25 mg (two packets) of imiquimod and had median multiple-dose peak serum drug levels of approximately 0.2 or 0.5 ng/ml, respectively. children aged 6-12 years received doses of 12.5 mg, 25 mg, or 37.5 mg (three packets) and had median multiple dose serum drug levels of approximately 0.1, 0.15, or 0.3 ng/ml, respectively. among the 20 subjects with evaluable laboratory assessments, the median wbc count decreased by 1.4*10 9 /l and the median absolute neutrophil count decreased by 1.42*10 9 /l. of the 320 subjects treated with zyclara cream in the ak clinical studies, 150 subjects (47%) were 65 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. clinical studies of zyclara cream for egw did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. of the 400 subjects treated with zyclara cream, 3.75% in the egw clinical studies, 5 subjects (1%) were 65 years or older.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

bryant ranch prepack - imiquimod (unii: p1qw714r7m) (imiquimod - unii:p1qw714r7m) - imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (ak) of the full face or balding scalp in immunocompetent adults. imiquimod cream, 3.75% is indicated for the treatment of external genital and perianal warts (egw)/condyloma acuminata in patients 12 years or older. imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see use in specific populations (8.4)] . treatment with imiquimod cream has not been studied for prevention or transmission of human papillomavirus (hpv). the safety and efficacy of imiquimod cream have not been established in the treatment of: none. pregnancy category c: there are no adequate and well-controlled studies in pregnant women. imiquimod cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the animal multiples of human exposure calculations were based on daily dose comparisons for the reproductive toxicology studies described in this section and in section 13.1. the animal multiples of human exposure were based on weekly dose comparisons for the carcinogenicity studies described in section 13.1. for the animal multiple of human exposure ratios presented in this section and section 13.1, the maximum recommended human dose (mrhd) was set at two packets (500 mg cream) per treatment of actinic keratosis with imiquimod cream (imiquimod 3.75%, 18.75 mg imiquimod) for bsa comparison. the maximum human auc value obtained in the treatment of external genital and perianal warts was higher than that obtained in the treatment of actinic keratosis and was used in the calculation of animal multiples of mrhd that were based on auc comparison. systemic embryofetal development studies were conducted in rats and rabbits. oral doses of 1, 5, and 20 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6-15) to pregnant female rats. in the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day (163x mrhd based on auc comparisons) included increased resorptions, decreased fetal body weights, delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses) demonstrated exencephaly, protruding tongues, and low-set ears. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 5 mg/kg/day (28x mrhd based on auc comparisons). intravenous doses of 0.5, 1, and 2 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (2.1x mrhd based on bsa comparisons), the highest dose evaluated in this study, or 1 mg/kg/day (115x mrhd based on auc comparisons). a combined fertility and peri- and postnatal development study was conducted in rats. oral doses of 1, 1.5, 3, and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating through the mating period and to female rats from 14 days prior to mating through parturition and lactation. no effects on growth, fertility, reproduction, or postnatal development were noted at doses up to 6 mg/kg/day (25x mrhd based on auc comparisons), the highest dose evaluated in this study. in the absence of maternal toxicity, bent limb bones were noted in the f1 fetuses at a dose of 6 mg/kg/day (25x mrhd based on auc comparisons). this fetal effect was also noted in the oral rat embryofetal development study conducted with imiquimod. no treatment related effects on teratogenicity were noted at 3 mg/kg/day (12x mrhd based on auc comparisons). it is not known whether imiquimod is excreted in human milk following use of imiquimod cream. because many drugs are excreted in human milk, caution should be exercised when imiquimod cream is administered to nursing women. ak is a condition not generally seen within the pediatric population. the safety and effectiveness of imiquimod cream for ak in patients less than 18 years of age have not been established. safety and effectiveness in patients with external genital/perianal warts below the age of 12 years have not been established. imiquimod 5% cream was evaluated in two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with molluscum contagiosum (mc) (470 exposed to imiquimod; median age 5 years, range 2-12 years). subjects applied imiquimod cream or vehicle 3 times weekly for up to 16 weeks. complete clearance (no mc lesions) was assessed at week 18. in study 1, the complete clearance rate was 24% (52/217) in the imiquimod cream group compared with 26% (28/106) in the vehicle group. in study 2, the clearance rates were 24% (60/253) in the imiquimod cream group compared with 28% (35/126) in the vehicle group. these studies failed to demonstrate efficacy. similar to the studies conducted in adults, the most frequently reported adverse reaction from two studies in children with molluscum contagiosum was application site reaction. adverse events which occurred more frequently in imiquimod-treated subjects compared with vehicle-treated subjects generally resembled those seen in studies in indications approved for adults and also included otitis media (5% imiquimod vs. 3% vehicle) and conjunctivitis (3% imiquimod vs. 2% vehicle). erythema was the most frequently reported local skin reaction. severe local skin reactions reported by imiquimod-treated subjects in the pediatric studies included erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion (2%) and weeping/exudate (2%). systemic absorption of imiquimod across the affected skin of 22 subjects aged 2 to 12 years with extensive mc involving at least 10% of the total body surface area was observed after single and multiple doses at a dosing frequency of three applications per week for 4 weeks. the investigator determined the dose applied, either 1, 2 or 3 packets per dose, based on the size of the treatment area and the subject’s weight. the overall median peak serum drug concentrations at the end of week 4 was between 0.26 and 1.06 ng/ml except in a 2-year-old female who was administered 2 packets of study drug per dose, had a cmax of 9.66 ng/ml after multiple dosing. children aged 2-5 years received doses of 12.5 mg (one packet) or 25 mg (two packets) of imiquimod and had median multiple-dose peak serum drug levels of approximately 0.2 or 0.5 ng/ml, respectively. children aged 6-12 years received doses of 12.5 mg, 25 mg, or 37.5 mg (three packets) and had median multiple dose serum drug levels of approximately 0.1, 0.15, or 0.3 ng/ml, respectively. among the 20 subjects with evaluable laboratory assessments, the median wbc count decreased by 1.4*109 /l and the median absolute neutrophil count decreased by 1.42*109 /l. of the 320 subjects treated with imiquimod cream in the ak clinical studies, 150 subjects (47%) were 65 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. clinical studies of imiquimod cream for egw did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. of the 400 subjects treated with imiquimod cream, 3.75% in the egw clinical studies, 5 subjects (1%) were 65 years or older.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

nature's innovation, inc. - thuja occidentalis leafy twig (unii: 1nt28v9397) (thuja occidentalis leafy twig - unii:1nt28v9397) - polypi and naevi symptom relief symptomatic treatment of molluscum contagiosum. molluscum contagiosum symptom relief. symptomatic homeopathic topical treatment of common molluscum contagiosum.