FrancophonIA/ELRC3.0 huggingface dataset:
English: Systemic exposure after intravenous administration as a constant rate infusion is dose proportional at doses up to and including 1.8 mg/m2.
Danish: Systemisk eksponering efter intravenøs administration som en infusion med konstant hastighed er dosisproportional ved doser op til og med 1,8 mg/m2.
English: There is no specific antidote for trabectedin currently available.
Danish: Der er på nuværende tidspunkt ingen tilgængelig specifik antidot til trabectedin.
English: • If you develop a fever as Yondelis may cause side-effects affecting your blood and liver.
Danish: • Hvis De får feber, da Yondelis kan give bivirkninger, der påvirker blodet og leveren.
English: Fertility studies with trabectedin were not performed but limited histopathological changes were observed in the gonads in the repeat dose toxicity studies.
Danish: Der er ikke udført fertilitetsstudier med trabectedin, men der blev observeret begrænsede histopatologiske ændringer i gonaderne i de toksicitetsstudier, hvor der blev givet gentagne doser.
English: If trabectedin is used at the end of pregnancy, potential adverse reactions should be monitored carefully in the newborns.
Danish: Hvis trabectedin anvendes i graviditetens sidste fase, bør potentielle bivirkninger monitoreres omhyggeligt hos de nyfødte.
English: Overall survival, n (%) Secondary endpoints n=345
Danish: Samlet overlevelse, n (%) Sekundære endepunkter n=345
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and further dilution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter rekonstitution og yderligere fortynding.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Their finding of possible or probable trabectedin causality in 5 of 6 fatal cases among 14 probable CLS cases warrants an update of the SmPC within this procedure to reflect there are cases with a fatal outcome.
Danish: Deres fund af mulig eller sandsynlig trabectedinkausalitet i 5 ud af 6 tilfælde med dødelig udgang blandt 14 sandsynlige CLS-tilfælde gør det relevant at opdatere produktresuméet som et led i denne procedure for at afspejle, at der er tilfælde med dødelig udgang.
English: Instructions for use - preparation, handling and disposal
Danish: Brugsanvisning - klargøring, håndtering og bortskaffelse
English: Patients with increases in AST, ALT and alkaline phosphatase between cycles may necessitate dose adjustments (see section 4.2).
Danish: Patienter med forhøjelser af ASAT, ALAT og alkalisk fosfatase mellem cyklusserne kan have behov for dosisjusteringer (se pkt.
English: Trabectedin does not induce or inhibit major cytochrome P450 enzymes.
Danish: Trabectedin hverken inducerer eller hæmmer væsentlige cytokrom P450-enzymer.
English: When ketoconazole was co-administered with trabectedin, the plasma exposure of trabectedin was increased by approximately 21% for Cmax and 66% for AUC, but no new safety concerns were identified.
Danish: Når ketoconazol blev administreret sammen med trabectedin, blev plasmaeksponeringen for trabectedin øget med cirka 21 % for Cmax og 66 % for AUC, men der blev ikke identificeret nogen nye sikkerhedsproblemer.
English: Following intravenous administration, trabectedin demonstrates a high apparent volume of distribution, consistent with extensive tissue and plasma protein binding (94 to 98% of trabectedin in plasma is protein bound).
Danish: Efter intravenøs administration viser trabectedin et højt tilsyneladende fordelingsvolumen i overensstemmelse med ekstensiv vævs- og plasmaproteinbinding (94 % til 98 % af trabectedin i plasma er proteinbundet).
English: If severe neutropenia (ANC < 500 cells/mm3) lasting more than 5 days or associated with fever or infection occurs, dose reduction is recommended (see section 4.2).
Danish: Hvis svær neutropeni (ANC < 500 celler/mm3) varer længere end fem dage eller er forbundet med feber, eller hvis der optræder infektion, anbefales dosisreduktion (se pkt.
English: The effect of medicines containing phenytoin (for epilepsy) may be decreased if given together with Yondelis and this is therefore not recommended.
Danish: Virkningen af lægemidler, der indeholder phenytoin (til behandling af epilepsi) kan blive nedsat, hvis de gives sammen med Yondelis, og dette frarådes derfor.
English: However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy.
Danish: Baseret på trabectedins virkningsmekanisme kan trabectedin dog forårsage alvorlige medfødte misdannelser, hvis det indgives under graviditet.
English: The effects of trabectedin on cardiovascular and respiratory function have been investigated in vivo (anesthetised Cynomolgus monkeys).
Danish: Virkningen af trabectedin på den kardiovaskulære og respiratoriske funktion er blevet undersøgt in vivo (bedøvede Cynomolgus-aber).
English: The median patient age was 56 years (range 17 to 81), 30% were male, 77% Caucasian, 12% African American and 4% Asian.
Danish: Patienternes medianalder var 56 år (interval 17 til 81), 30 % var mænd, 77 % kaukasiere, 12 % afroamerikanere og 4 % asiater.
English: The distribution volume at steady state of trabectedin in human subjects exceeds 5,000 l.
Danish: Trabectedins fordelingsvolumen ved steady-state hos forsøgspersoner overskrider 5.000 l.
English: Septic shock
Danish: Septisk chok
English: All patients must receive corticosteroids e.g. 20 mg of dexamethasone intravenously 30 minutes prior to PLD (in combination therapy) or Yondelis (in monotherapy); not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects.
Danish: Alle patienter skal have indgivet kortikosteroider f.eks. 20 mg dexamethason intravenøst 30 minutter inden indgivelse af PLD (ved kombinationsbehandling) eller Yondelis (ved monoterapi); ikke blot som antiemetisk profylakse, men også fordi det tilsyneladende har leverbeskyttende virkning.
English: Withdraw the appropriate amount of reconstituted solution from the vial.
Danish: Den passende mængde rekonstitueret opløsning skal trækkes op fra hætteglasset.
English: Some potential risk factors that may have contributed to increased trabectedin toxicity observed in these cases were dose management inconsistent with recommended guidelines, potential CYP3A4 interaction due to multiple competing CYP3A4 substrates or CYP3A4 inhibitors, or lack of dexamethasone prophylaxis.
Danish: Visse potentielle risikofaktorer, der kan have bidraget til øget trabectedin-toksicitet observeret i disse tilfælde, var dosering, som ikke stemte overens med de anbefalede retningslinjer, potentiel CYP3A4-interaktion som følge af flere konkurrerende CYP3A4-substrater eller CYP3A4-hæmmere eller undladelse af dexamethasonprofylakse.
English: You will be given a medicine before and as needed during the treatment with Yondelis in order to protect your liver and to reduce the risk of side effects such as feeling sick (nausea) and vomiting.
Danish: De vil få medicin før og om nødvendigt under behandlingen med Yondelis for at beskytte Deres lever og for at reducere risikoen for bivirkninger såsom kvalme og opkastning.
English: Liver function tests should be monitored during treatment with Yondelis as dose adjustments may be indicated (see Table 1 and section 4.4).
Danish: Leverfunktionstest bør monitoreres under behandling med Yondelis, da dosisjusteringer kan være indikeret (se tabel 1 og pkt.
English: Independent radiology review, all randomised n=337
Danish: Uafhængig radiologisk evaluering, alle randomiserede n=337
English: • When Yondelis is used in combination with PLD, you may have syncope also called fainting.
Danish: • Når Yondelis anvendes i kombination med PLD kan De opleve synkope, også kaldet besvimelse.
English: No data are available in patients with a creatinine clearance of less than 30.3 ml/min.
Danish: Der er ingen tilgængelige data fra patienter, der viser en kreatininclearance på mindre end 30,3 ml/min.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk: Skal håndteres med forsigtighed.
English: You must not use Yondelis if you will receive yellow fever vaccine and it is not recommended that you use Yondelis if you will receive a vaccine containing live virus particles.
Danish: De må ikke få Yondelis, hvis De skal vaccineres mod gul feber, og De bør ikke få Yondelis, hvis De skal vaccineres med en vaccine, der indeholder levende viruspartikler.
English: Trabectedin extravasation may cause tissue necrosis requiring debridement.
Danish: Trabectedin-ekstravasation kan forårsage vævsnekrose, der kræver debridement.
English: See the PLD SmPC for more detailed information on PLD dose adjustments.
Danish: Se produktresuméet for PLD for yderligere oplysninger vedrørende dosisjusteringer af PLD.
English: Additional monitoring of haematological parameters bilirubin, alkaline phosphatase, aminotransferases and CPK should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles.
Danish: Der bør foretages yderligere monitorering af hæmatologiske parametre - bilirubin, alkalisk fosfatase, aminotransferaser og CPK - ugentlig i behandlingens to første cyklusser og mindst én gang mellem behandlingerne i efterfølgende cyklusser.
English: Furthermore, you could feel like your heart is beating too hard or too fast in your chest (palpitations), have a weakness in the ventricles, the heart's major pumping chambers (left ventricular dysfunction), or a sudden blockage in a lung artery (pulmonary embolism).
Danish: Derudover kan De føle, at Deres hjerte slår for hårdt eller for hurtigt i brystet (hjertebanken), få en svaghed i ventriklerne, hjertets vigtigeste pumpekamre (venstre ventrikeldysfunktion) eller en pludselig blokering i en lungearterie (lungeemboli).
English: Do not use Yondelis:
Danish: Brug ikke Yondelis:
English: Overall Response Rate (ORR)
Danish: Samlet responsrate (ORR)
English: It may present as red skin of the palms, fingers, and soles of the feet that later may become swollen and violaceous.
Danish: Det kan vise sig som rød hud i håndfladerne og på fingrene og fodsålerne, som senere kan hæve og blive blåviolette.
English: However, the incidences of clinical complications related to haematological toxicity such as severe infections or bleeding, or those leading to death or treatment termination, were similar in both subpopulations.
Danish: Hyppigheden af kliniske komplikationer relateret til hæmatologisk toksicitet såsom svære infektioner eller blødning, eller komplikationer, der førte til død eller afbrydelse af behandlingen, var dog sammenlignelig hos de 2 subpopulationer.
English: Dehydration Hypokalaemia
Danish: Dehydrering Hypokaliæmi
English: After a dose of radiolabelled trabectedin administered to cancer patients, faecal mean (SD) recovery of total radioactivity is 58% (17%), and urinary mean (SD) recovery is 5.8% (1.73%).
Danish: Efter at en dosis radiomærket trabectedin er indgivet til kræftpatienter, er den fækale middelgenindvinding (SD) af den totale radioaktivitet 58 % (17 %), og middelgenindvinding fra urinen (SD) er 5,8 % (1,73 %).
English: Capillary leak syndrome (CLS) is usually characterized by peripheral oedema, hypotension which is relatively well tolerated, oliguria with acute pre-renal failure.
Danish: Kapillærlækage-syndrom (CLS) er normalt kendetegnet ved perifert ødem, hypotension, som er relativt veltolereret, oliguri med akut prærenalt svigt.
English: Overall survival in platinum-sensitive population (Final analysis n=316 events) n=218
Danish: Samlet overlevelse hos platinsensitiv population (endelig analyse - n= 316 hændelser) n=218
English: Yondelis should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3.
Danish: Yondelis bør ikke indgives til patienter med baseline-neutrofiltal på under 1.500 celler/mm3 og blodpladetal på under 100.000 celler/mm3.
English: A full blood cell count including differential and platelet count must be performed at baseline, weekly for the first two cycles and then once between cycles (see section 4.2).
Danish: Der skal udføres en komplet blodcelletælling, herunder differential- og blodpladetælling ved baseline, ugentlig i de første to cyklusser og derefter én gang mellem cyklusserne (se pkt.
English: To minimize the risk of PLD infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute.
Danish: Med henblik på at minimere risikoen for reaktioner over for PLD-infusionen indgives den første dosis med en hastighed på højst 1 mg/minut.
English: Chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Danish: Der er påvist kemisk og fysisk stabilitet i 30 timer op til 25 ºC.
English: Patients with elevated serum bilirubin levels at baseline must not be treated with Yondelis.
Danish: Patienter med forhøjede serumbilirubinniveauer ved baseline må ikke behandles med Yondelis.
English: • Your doctor may require blood tests in certain situations in order to avoid that you develop muscle damage (rhabdomyolysis).
Danish: • Deres læge kan i visse situationer rekvirere blodprøver med henblik på at undgå, at De udvikler muskelskade (rabdomyolyse).
English: Instructions for handling and disposal
Danish: Anvisninger for håndtering og bortskaffelse
English: Based on the population estimate for plasma clearance of trabectedin (30.9 l/h) and blood/plasma ratio (0.89), the clearance of trabectedin in whole blood is approximately 35 l/h.
Danish: Baseret på populationsestimeringen for trabectedins plasmaclearance (30,9 l/t) og blod/plasmaforhold (0,89) er trabectedins clearance i fuldblod cirka 35 l/t.
English: Three patients achieved stable disease (one with rhabdomyosarcoma after 15 cycles, one with spindle cell sarcoma after 2 cycles, and one with Ewing sarcoma after 4 cycles.
Danish: Tre patienter opnåede stabil sygdom (én med rabdomyosarkom efter 15 cyklusser, én med tencellesarkom efter 2 cyklusser og én med Ewings sarkom efter 4 cyklusser).
English: No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Danish: Der er ikke blevet observeret uforligeligheder mellem Yondelis og type I glasflasker, polyvinylklorid (PVC) og polyethylen (PE) poser og slanger, polyisopren-reservoirer og implanterbare veneportsystemer af titanium.
English: Concomitant administration of inhibitors of P-gp, e.g. cyclosporine and verapamil, may alter trabectedin distribution and/or elimination.
Danish: Samtidig administration af hæmmere af P-gp, f.eks. ciclosporin og verapamil, kan ændre trabectedins distribution og/eller elimination.
English: Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
Danish: Utilsigtet kontakt med hud, øjne eller slimhinder skal behandles omgående med rigelige mængder vand.
English: One partial response (PR) centrally confirmed was observed: overall RR: 2.5% CI95% (0.1%-13.2%).
Danish: En centralt bekræftet partiel respons blev observeret: samlet RR: 2,5 % (95 % CI: 0,1 %-13,2 %).
English: Secondary CLSs are mostly due to malignant hematological diseases, viral infections, and treatments such as chemotherapies and therapeutic growth factors.
Danish: Sekundære CLS'er skyldes som oftest maligne hæmatologiske sygdomme, virusinfektioner og behandlinger som f.eks. kemoterapier og terapeutiske vækstfaktorer.
English: • feel an excess of fluid in the body (oedema)
Danish: • få overskydende væske i kroppen (ødem)
English: • be more prone to infections.
Danish: • lettere få infektioner.
English: - if you are allergic to trabectedin or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for trabectedin eller et af de øvrige indholdsstoffer i Yondelis (angivet i punkt 6).
English: Patients in the trabectedin arm were required to receive dexamethasone 20 mg intravenous injection prior to each trabectedin infusion.
Danish: Patienterne i trabectedin-gruppen skulle modtage intravenøse injektioner af 20 mg dexamethason inden hver infusion af trabectedin.
English: • have nose bleeds
Danish: • få næseblod
English: A population pharmacokinetic analysis showed that plasma trabectedin concentrations observed in the Japanese population at dose level 1.2 mg/m2 were equivalent to those obtained in the non-Japanese western population at 1.5 mg/m².
Danish: En farmakokinetisk populationsanalyse viste, at plasmakoncentrationerne af trabectidin, der blev iagttaget hos den japanske population ved et dosisniveau på 1,2 mg/m2, svarede til de koncentrationer, der blev opnået hos den ikke-japanske, vestlige population ved 1,5 mg/m2.
English: Skin hyperpigmentation*
Danish: Hyperpigmenteret hud*
English: It requires further dilution and is for single-use only.
Danish: Opløsningen skal fortyndes yderligere og er kun til engangsbrug.
English: A population pharmacokinetic analysis indicated that the plasma clearance of trabectedin is not influenced by age (range 19-83 years), gender, total body weight (range: 36 to 148 kg) or body surface area (range: 0.9 to 2.8 m2).
Danish: En farmakokinetisk analyse af populationen viste, at trabectedins plasmaclearance hverken påvirkes af alder (i området 19-83 år), køn, total legemsvægt (interval: 36 til 148 kg) eller legemsoverflade (interval: 0,9 til 2,8 m2).
English: There may be blistering, peeling and darkening of the skin over the site.
Danish: Der kan forekomme blærer, afskalning eller mørkfarvning af huden over stedet.
English: • Higher skin pigmentation could occur in patients receiving Yondelis with PLD for ovarian cancer.
Danish: • En stærkere pigmentering af huden kan forekomme hos patienter der får Yondelis med PLD for ovariecancer.
English: AST/ALT increases:
Danish: ASAT/ALAT-forhøjelser:
English: Blood bilirubin increased
Danish: Forhøjet Blodbilirubin
English: When rifampicin was co-administered with trabectedin, it resulted in reduced plasma exposure of trabectedin by approximately 22% for Cmax and 31% for AUC.
Danish: Når rifampicin blev administreret sammen med trabectedin, medførte det reduceret plasmaeksponering for trabectedin med cirka 22 % for Cmax og 31 % for AUC.
English: Anti-emetic prophylaxis with corticosteroids such as dexamethasone must be administered to all patients (see section 4.2).
Danish: Der skal administreres antiemetisk profylakse med kortikosteroider såsom dexamethason til alle patienter (se pkt.
English: All randomised n=337
Danish: Alle randomiserede n=337
English: No cumulative toxicities have been observed in patients treated with multiple cycles.
Danish: Der er ikke observeret kumulativ toksicitet hos patienter, der gennemgik flere behandlingscyklusser.
English: * Adverse drug reaction only for Ovarian cancer
Danish: * Bivirkning kun for ovariecancer
English: See also PLD Summary of Product Characteristics for more detailed information on warnings and precautions.
Danish: Se også produktresuméet for PLD for yderligere oplysninger vedrørende advarsler og forsigtighedsregler.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Yondelis 0.25 mg
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Yondelis 0,25 mg
English: Trabectedin must not be used in patients with CPK > 2.5 x ULN (see section 4.2).
Danish: Trabectedin må ikke anvendes til patienter med CPK > 2,5 x ULN (se pkt.
English: Yondelis should not be used in children below 18 years of age with paediatric sarcomas.
Danish: Yondelis bør ikke anvendes til børn under 18 år med pædiatriske sarkomer.
English: Median PFS (95% CI) (months)
Danish: Median PFS (95 % CI) (måneder)
English: If a diagnosis of CLS is confirmed after exclusion of other causes, the treating physician should discontinue trabectedin and initiate CLS treatment according to institutional guidelines (see sections 4.2 and 4.8).
Danish: Hvis diagnosen CLS bekræftes efter udelukkelse af andre forklaringer, bør den behandlende læge seponere trabectedin og påbegynde behandling for CLS ifølge de lokale retningslinjer (se pkt.
English: Liver function tests predicting severe toxicity (meeting Hy´s law) and clinical manifestations of severe hepatic injury were uncommon with a lower than 1% incidence of individual signs and symptoms including jaundice, hepatomegaly or liver pain.
Danish: Leverfunktionstests, der forudså svær toksicitet (opfyldte Hys lov) og kliniske tilfælde af svær leverskade var ualmindelige med mindre end 1 % forekomst af individuelle tegn og symptomer herunder gulsot, hepatomegali eller leversmerte.
English: Concomitant use of trabectedin with phenytoin may reduce phenytoin absorption leading to an exacerbation of convulsions.
Danish: Samtidig brug af trabectedin og phenytoin kan reducere phenytoins absorption, hvilket kan medføre forværring af kramper.
English: Trabectedin has been shown to exert antiproliferative in vitro and in vivo activity against a range of human tumour cell lines and experimental tumours, including malignancies such as sarcoma, breast, non-small cell lung, ovarian and melanoma.
Danish: Trabectedin har vist sig at udvise antiproliferativ in vitro og in vivo-aktivitet imod en række humane tumorcellelinier og eksperimentelle tumorer, herunder maligniteter såsom sarkomer, brystkræft, ikkesmåcellet lungekræft, æggestokskræft og melanom.
English: If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted solution are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke fortyndes og anvendes med det samme, er brugsfærdig opbevaringstid og forhold før brugen af den rekonstituerede opløsning brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2ºC - 8ºC, medmindre det er blevet rekonstitueret under kontrollerede og godkendte aseptiske forhold.
English: If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine, despite being given anti-sickness medicine, you should immediately seek medical help.
Danish: Hvis De får kvalme, kaster op eller ikke er i stand til at drikke væske og derfor urinerer mindre, selv om De får medicin mod kvalme, skal De omgående søge lægehjælp.
English: Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Danish: Data vedrørende effekt er hovedsagelig baseret på patienter med liposarkom og leiomyosarkom.
English: Patients must meet specific criteria on hepatic function parameters to start treatment with Yondelis.
Danish: Patienterne skal opfylde specifikke kriterier vedrørende leverfunktionsparametre for at kunne starte behandling med Yondelis.
English: Volume (ml) = BSA (m2) x individual dose (mg/m2)
Danish: Volumen (ml) = BSA (m2) x individuel dosis (mg/m2)
English: • Patients receiving Yondelis plus PLD for ovarian cancer may also have the hand and foot syndrome.
Danish: • Patienter, der får Yondelis plus PLD for ovariecancer kan også få hånd- og fod-syndrom.
English: Personnel should be trained in the correct techniques to reconstitute and dilute the medicinal product and should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Danish: Personalet skal uddannes i de korrekte teknikker til rekonstitution og fortynding af lægemidlet, og de skal bære beskyttelsestøj herunder maske, beskyttelsesbriller og handsker under rekonstitutions- og fortyndingsprocessen.
English: Grade 4 elevations of AST and ALT occurred in 1% and 2% of cycles respectively.
Danish: Grad 4-forhøjelser af ASAT og ALAT forekom i henholdsvis 1 % og 2 % af cyklusserne.
English: In SAR-2005 phase I-II study, a total of 50 paediatric patients with rhabdomyosarcoma, Ewing sarcoma or non rhabdomyosarcoma soft tissue sarcoma were enrolled.
Danish: I fase I-II-studiet SAR-2005 deltog i alt 50 pædiatriske patienter med rabdomyosarkom, Ewings sarkom eller non-rabdomyosarkom-bløddelssarkom (NRSTS).