United States - English - 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.

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

sahi cosmetics l.l.c. - octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51) -

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

actinomycin d -

Australia - English - 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.

New Zealand - English - 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

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

king bio inc. - official hpus: adrenalinum, anacardium orientale, blatta orientalis, formalinum, fumaria officinalis, glycerinum, graphites, magnesia muriatica, natrum pyruvicum, nitricum acidum, pituitarum posterium, phosphorus, phytolacca decandra, pulsatilla and sulphur., reference image cosmetic.jpg - uses for temporary relief of symptoms from cosmetics and household chemicals: - headaches - skin irritations - respiratory difficulties - body aches and pains - fatigue - difficulty sleeping - dizziness and nausea uses for temporary relief of symptoms from cosmetics and household chemicals: headaches, skin irritations, respiratory difficulties, body aches and pains, fatigue, difficulty sleeping, dizziness and nausea. reference image cosmetic.jpg

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

allergan, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - botox cosmetic (onabotulinumtoxina) is indicated in adult patients for the temporary improvement in the appearance of: - moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity - moderate to severe lateral canthal lines  associated with orbicularis oculi activity - moderate to severe forehead lines associated with frontalis muscle activity botox cosmetic is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see warnings and precautions ( 5.4 )] . botox cosmetic is contraindicated in the presence of infection at the proposed injection site(s). risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox cosmetic in pregnant women.   in animal studies, administrations of botox cosmetic during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated populations is unknown. data animal data when botox cosmetic (4, 8, or 16 units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. the no-effect dose for developmental toxicity in these studies (4 units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 units on a body weight basis (units/kg). when botox cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. these doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. the developmental no-effect doses in these studies of 1 unit/kg in rats is approximately equal the average high human dose of 64 units based on units/kg, and the developmental no-effect dose of 0.25 units/kg in rabbits is less than the average high human dose based on units/kg. when pregnant rats received single intramuscular injections (1, 4, or 16 units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. the developmental no-effect level for a single maternal dose in rats (16 units/kg) is approximately 16 times the average high human dose of 64 units based on units/kg. risk summary there are no data on the presence of botox cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for botox cosmetic and any potential adverse effects on the breastfed infant from botox cosmetic or from the underlying maternal conditions. safety and effectiveness in patients below the age of 18 years have not been established. glabellar lines in the two initial glabellar lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see clinical studies ( 14 )] . lateral canthal lines in the two lateral canthal lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. forehead lines in the two forehead lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.

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

garb2art cosmetics - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) -

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

efb australia pty ltd -

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

sprayd pty ltd - 47705 - cosmetic phototherapy system, professional - cosmetic phototherapy system, professional