Spojené státy - angličtina - NLM (National Library of Medicine)

recordati rare diseases, inc. - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin 0.5 mg in 1 ml - cosmegen is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. cosmegen 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. cosmegen 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, cosmegen 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 cosmegen, advise women not to breastfeed during treatment with cosmegen 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 cosmegen [see use in specific population ( 8.1)]. contraception cosmegen 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 cosmegen 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 cosmegen 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 cosmegen have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. clinical studies of cosmegen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Spojené státy - angličtina - NLM (National Library of Medicine)

ax pharmaceutical corp - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) -

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

recordati rare diseases australia pty ltd - dactinomycin, quantity: 500 microgram - injection, powder for - excipient ingredients: mannitol - wilm's tumour; rhabdomyosarcoma; carcinoma of the testes and uterus. other neoplasms: actinomycin d given iv or by regional perfusion, either alone or with other antineoplastic compounds or with x-ray therapy in the palliative treatment of ewing's sarcoma and sarcoma botryoides; non-metastatic ewing's carcinoma. actinomyin d and radiation therapy; actinomycin d in various types of sarcoma, carcinoma and adenocarcinoma using isolation-perfusion technique. for full list of indications refer to approved pi document.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - dactinomycin 0.5mg;   - powder for injection - 0.5 mg - active: dactinomycin 0.5mg   excipient: mannitol

Singapur - angličtina - HSA (Health Sciences Authority)

shoei universal corporation pte ltd - dactinomycin - injection, powder, for solution - 0.5 mg/vial - dactinomycin 0.5 mg/vial

Kanada - angličtina - Health Canada

recordati rare diseases canada inc - dactinomycin - powder for solution - 0.5mg - dactinomycin 0.5mg - antineoplastic agents

Malta - angličtina - Medicines Authority

cherubino limited delf building, sliema road, gzira, gzr 1637, malta - dactinomycin - powder for solution for injection - dactinomycin 500 µg - antineoplastic agents

Malta - angličtina - Medicines Authority

recordati rare disease immeuble “le wilson”, 70, avenue du général de gaulle, f-92800 puteaux, france - dactinomycin - powder for solution for injection - dactinomycin 500 µg - antineoplastic agents

Keňa - angličtina - Pharmacy and Poisons Board

dactinomycin - injection - 500mcg - dactinomycin

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

lundbeck pharmaceuticals ireland - dactinomycin - pdr for soln for injection - 0.5 milligram