Evropska unija - latvijščina - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuksimabs, bēta - neiroblastoma - antineoplastiski līdzekļi - qarziba ir indicēts, lai ārstētu augsta riska neiroblastoma pacientiem vecumā no 12 mēnešiem un vairāk, kuri ir saņēmuši indukcijas ķīmijterapija un panākt vismaz daļēju atbildi, seko myeloablative terapijas un cilmes šūnu transplantāciju, kā arī pacientiem ar vēsturi relapsed vai ugunsizturīgs neiroblastoma, ar vai bez atlikuma slimības. pirms recidivējošas neiroblastomas ārstēšanas jebkuras aktīvi progresējošas slimības stabilizē ar citiem piemērotiem pasākumiem. pacientiem, kam anamnēzē ir relapsed/ugunsizturīgi slimību un pacientiem, kas nav sasniegušas pilnīgu atbildi pēc pirmās līnijas terapija, qarziba būtu jāapvieno ar interleikīna 2 (il 2).

Evropska unija - latvijščina - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuksimabs - neiroblastoma - antineoplastiski līdzekļi - unituxin ir indicēts augsta riska neiroblastomu pacientiem, kuru vecums nepārsniedz divpadsmit mēnešus, lai 17years, kas agrāk saņēmis indukcijas ķīmijterapiju un sasniegt vismaz daļēju atbildi, seko myeloablative terapiju un ņemtu autologo cilmes šūnu apstrādes transplantācijas (asct). to ievada kombinācijā ar granulocītu-makrofāgu koloniju stimulējošo faktoru (gm-csf), interleukīnu-2 (il-2) un izotretinoīnu.

Evropska unija - norveščina - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastom - antineoplastiske midler - unituxin er indisert for behandling av høy risiko neuroblastom hos pasienter i alderen 12 måneder til 17years, som tidligere har mottatt induksjon kjemoterapi og oppnås minst delvis svar, etterfulgt av myeloablative terapi og autologous stilk cellen transplantasjon (asct). det administreres i kombinasjon med granulocyt-makrofag kolonistimulerende faktor (gm-csf), interleukin-2 (il-2) og isotretinoin.

Grčija - grščina - Εθνικός Οργανισμός Φαρμάκων

ΙΦΕΤ ΑΕ 18ο χλμ. Λεωφ. Μαραθώνος,, 153 51 153 51, Παλλήνη Αττικής 210.6603400-6603522 - dinutuximab beta - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 4,5mg/ml - dinutuximab beta 20mg - dinutuximab

Evropska unija - portugalščina - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - neuroblastoma - agentes antineoplásicos - qarziba é indicado para o tratamento de alto risco, neuroblastoma, em pacientes com idade entre 12 meses e acima, que já tenham recebido quimioterapia de indução e alcançado pelo menos uma resposta parcial, seguido por terapia mieloablativa e transplante de células-tronco, assim como os pacientes com história de recidivado ou refratário neuroblastoma, com ou sem doença residual. antes do tratamento do neuroblastoma recidivante, qualquer doença progredindo ativamente deve ser estabilizada por outras medidas adequadas. em pacientes com uma história de recaída/doença refratária e em pacientes que não tenham conseguido uma resposta completa após a terapia de primeira linha, qarziba deve ser combinado com a interleucina 2 (il 2).

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

united therapeutics corporation - dinutuximab (unii: 7sqy4zud30) (dinutuximab - unii:7sqy4zud30) - dinutuximab 3.5 mg in 1 ml - unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and 13-cis-retinoic acid (ra), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see clinical studies (14)]. unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. risk summary based on its mechanism of action, unituxin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. risk summary there is no information available on the presence of dinutuximab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, human igg is present in human milk. because of the potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during treatment with unituxin. contraception females unituxin may cause fetal harm [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of unituxin. the safety and effectiveness of unituxin as part of multi-agent, multimodality therapy have been established in pediatric patients with high-risk neuroblastoma based on results of an open-label, randomized (1:1) trial conducted in 226 patients aged 11 months to 15 years (median age 3.8 years) (study 1). prior to enrollment, patients achieved at least a partial response to prior first-line therapy for high-risk neuroblastoma consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and received radiation therapy to residual soft tissue disease. patients randomized to the unituxin/13-cis-retinoic acid (ra) arm (unituxin/ra) received up to 5 cycles of unituxin in combination with alternating cycles of granulocyte-macrophage colony-stimulating factor (gm-csf) and interleukin-2 (il-2) plus ra, followed by 1 cycle of ra alone. patients randomized to the ra arm received up to 6 cycles of ra monotherapy. study 1 demonstrated an improvement in event-free survival (efs) and overall survival (os) in patients in the unituxin/ra arm compared to those in the ra arm [see adverse reactions (6), clinical pharmacology (12), and clinical studies (14)] . juvenile animal toxicity data juvenile monkeys (13 to 18 months of age at study start) received dinutuximab daily via intravenous infusion for 4 consecutive days over five 28-day cycles at doses of 1, 3, or 10 mg/kg. monkeys also received morphine during infusion for pain management. at the high dose of 10 mg/kg (approximately equal to the 17.5 mg/m2 clinical dose), mild degeneration of nerve fibers in the brain (medulla oblongata) and moderate degeneration of nerve fibers in the spinal cord (cervical, thoracic, and lumbar) were present. mild neuronal and nerve fiber degeneration were also present in the dorsal root ganglia (cervical, thoracic, and lumbar). nerve fiber degeneration in the spinal cord and neuronal degeneration in dorsal root ganglia persisted 6 months after the end of dosing, though at lower severity. at the 10 mg/kg dose level, nerve conduction velocity (ncv) analysis showed motor and sensory ncv decreases of less than 10% compared to vehicle controls, starting on day 27 and continuing to day 83. sensory ncv decreases were still present at the end of the dosing period but were on a trend towards recovery 6 months after the end of dosing. the safety and effectiveness of unituxin in geriatric patients have not been established. unituxin has not been studied in patients with renal impairment. unituxin has not been studied in patients with hepatic impairment.

Evropska unija - bolgarščina - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - невробластом - Антинеопластични средства - qarziba е показан за лечение на нейробластомы висок риск при пациенти на възраст от 12 месеца и по-горе, които преди това са получавали индукционную химиотерапия и постигнат поне частичен отговор, след миелоаблативной терапия и трансплантация на стволови клетки, както и пациенти с анамнеза за рецидивиращи или продължителна нейробластомой, с или без остатъчна болест. Преди лечението на рецидивирания невробластом, всяко активно прогресиращо заболяване трябва да се стабилизира чрез други подходящи мерки. При пациенти с пристъпно/продължителна форма на заболяване и при пациенти, които не са постигнали пълен отговор след първа линия терапия, qarziba трябва да бъде съчетана с интерлейкином 2 (il 2).

Evropska unija - malteščina - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - neuroblastoma - aġenti antineoplastiċi - qarziba huwa indikat għall-kura ta 'riskju għoli newroblastoma f'pazjenti ta'età ta'12-il xahar'il fuq, li qabel kienu ħadu l-kimoterapija ta' induzzjoni u kiseb għall-inqas rispons parzjali, segwita minn terapija mijeloablattiva u trapjant b ' ċelluli staminali, kif ukoll il-pazjenti bi storja ta all rikadut jew refrattarju newroblastoma, bi jew mingħajr residwu-marda. qabel it-trattament tan-newblastoma li reġa 'rkadew, kwalunkwe marda li timxi attivament għandha tkun stabbilizzata b'miżuri oħra xierqa. f'pazjenti bi storja ta reġgħet tfaċċat/refrattarja-marda u fil-pazjenti li ma kinux laħqu rispons komplet wara l-ewwel linja ta 'terapija, qarziba għandu jkun ikkombinat ma' interleukin-2 (il-2).

Evropska unija - slovaščina - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - neuroblastómu - antineoplastické činidlá - qarziba je indikovaný na liečbu vysokého rizika neuroblastoma u pacientov vo veku 12 mesiacov a viac, ktorí v minulosti dostali indukčnú chemoterapiu a dosiahnuť aspoň čiastočnú odpoveď, nasleduje myeloablative terapie a transplantáciu kmeňových buniek, ako aj u pacientov s anamnézou relapsed alebo žiaruvzdorné neuroblastoma, s alebo bez reziduálneho ochorenia. pred liečbou recidivujúceho neuroblastómu by sa akékoľvek aktívne progresívne ochorenie malo stabilizovať inými vhodnými opatreniami. u pacientov s anamnézou relapsed/žiaruvzdorné ochorenia a u pacientov, ktorí nedosiahli úplnú odpoveď po liečbu prvej línie, qarziba by mali byť kombinované s interleukín 2 (il 2).

Evropska unija - litovščina - EMA (European Medicines Agency)

recordati netherlands b.v. - dinutuximab beta - neuroblastoma - antinavikiniai vaistai - qarziba fluorouracilu ir folino didelės rizikos neuroblastoma pacientų amžius 12 mėnesių ir daugiau, kurie anksčiau gavo indukcinės chemoterapijos ir pasiekti bent dalinį atsakymą, po myeloablative terapijos ir kamieninių ląstelių transplantacijos, taip pat pacientams su istorija atsinaujino arba ugniai atsparios neuroblastoma, su arba be liekamųjų ligos. prieš gydant recidyvuojančią neuroblastomą, bet kokia aktyviai progresuojanti liga turi būti stabilizuota kitomis tinkamomis priemonėmis. pacientams, kurių istorija atsinaujino/ugniai atsparios ligos ir pacientams, kurie nepasiekė išsamų atsakymą po pirmos linijos terapija, qarziba turėtų būti derinamas su interleukinas 2 (il 2).