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

mylan institutional llc - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

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

prasco laboratories - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin 0.5 mg in 1 ml - dactinomycin is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. none. risk summary based on findings from animal studies and its mechanism of action, dactinomycin can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . in animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose ( see data ). advise pregnant women of the potential risk to a fetus [see use in special populations ( 8.3)] . 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. data animal data dactinomycin was teratogenic in animals. administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1250 mcg/m 2 . risk summary there are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants from dactinomycin, advise women not to breastfeed during treatment with dactinomycin and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating dactinomycin [see use in specific population ( 8.1)]. contraception dactinomycin can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)]. females advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for at least 6 months after the final dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after the final dose [see nonclinical toxicology ( 13.1)]. the safety and effectiveness of dactinomycin have been established in pediatric patients with wilms tumor, rhabdomyosarcoma, ewing sarcoma, and metastatic nonseminomatous testicular cancer. the safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. the safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

mylan institutional llc - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin 0.5 mg in 1 ml - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

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

xgen pharmaceuticals djb, inc. - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

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

eugia us llc - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. none. risk summary based on findings from animal studies and its mechanism of action dactinomycin can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . in animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose (see data) . advise pregnant women of the potential risk to a fetus [see use in special populations (8.3) ]. 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. data animal data dactinomycin was teratogenic in animals. administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1,250 mcg/m2 . risk summary there are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants from dactinomycin, advise women not to breastfeed during treatment with dactinomycin for injection and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating dactinomycin [see use in specific population (8.1)]. contraception dactinomycin can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. females advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for at least 6 months after the final dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after the final dose [ see nonclinical toxicology (13.1) ]. the safety and effectiveness of dactinomycin have been established in pediatric patients with wilms tumor, rhabdomyosarcoma, ewing sarcoma, and metastatic nonseminomatous testicular cancer. the safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. the safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

hisun pharmaceuticals usa, inc. - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

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

meitheal pharmaceuticals inc. - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

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

auromedics pharma llc - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional s

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

suzhou qianyuan biotechnology co., ltd. - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) -

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

bluebay shandong co.,ltd - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) -