FrancophonIA/ELRC3.0 huggingface dataset:
English: Median TTP values were 3.7 months (CI: 2.1-5.4 m) in the 24-h q3wk group and 2.3 months (CI: 2.0-3.5 m) in the 3-h qwk group (p=0.0302).
Danish: Middel-TTP-værdier var 3,7 måneder (CI: 2,1-5,4 m) i 24-h q3wk-gruppen og 2,3 måneder (CI: 2,0-3,5 m) i 3-h qwk-gruppen (p=0,0302).
English: If no infusion reaction is observed, subsequent PLD infusions may be administered over a 1-hour period (see also PLD Summary of Product Characteristics [SmPC] for specific administration advice).
Danish: Hvis der ikke observeres infusionsreaktioner, kan efterfølgende PLD-infusioner indgives i løbet af 1 time (se også produktresuméet for PLD for specifikke anvisninger vedrørende indgivelsen).
English: Since trabectedin is metabolised mainly by CYP3A4, the concentrations of trabectedin in plasma are likely to be increased in patients who are co-administered drugs that potently inhibit the activity of this isoenzyme.
Danish: Da trabectedin hovedsagelig metaboliseres ved CYP 3A4, vil plasmakoncentrationerne af trabectedin sandsynligvis blive forøget hos patienter, som samtidig får indgivet lægemidler, der kan hæmme aktiviteten af dette isoenzym.
English: All the previously described, could be a sign of damage to your muscles (rhabdomyolysis).
Danish: Alle de tidligere beskrevne symptomer kan være tegn på beskadigelse af Deres muskler (rabdomyolyse).
English: There is no specific antidote for extravasation of trabectedin.
Danish: Der findes ingen specifik antidot mod trabectedin-ekstravasation.
English: The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity.
Danish: De væsentligste forventede typer toksicitet er gastrointestinal toksicitet, knoglemarvssuppression og levertoksicitet.
English: Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent.
Danish: Yondelis må ikke indgives som en blanding med andre lægemidler i den samme infusion bortset fra fortyndingsmidlet.
English: If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted product 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 det ikke fortyndes og anvendes med det samme, er brugsfærdig opbevaringstid og forhold inden brugen af det rekonstituerede koncentrat brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 ºC - 8 ºC, medmindre det er blevet rekonstitueret under kontrollerede og godkendte aseptiske forhold.
English: Median OS (95% CI) (months)
Danish: Median OS (95 % CI) (måneder)
English: The inter-patient variability of the population estimate for plasma clearance of trabectedin was 49% and intra-patient variability was 28%.
Danish: I populationsestimeringen for trabectedins plasmaclearance var variabiliteten patienterne imellem 49 %, og variabiliteten hos den enkelte patient var 28 %.
English: Procedures for proper handling and disposal of cytotoxic medicinal products must be followed.
Danish: Procedurerne for korrekt håndtering og bortskaffelse af cytotoksiske lægemidler skal følges.
English: The study assessed the efficacy and safety of trabectedin vs. best supportive care (BSC) as second-line or later therapy for patients with advanced TRS unresponsive or intolerant to standard chemotherapy regimen.
Danish: Studiet vurderede effekten og sikkerheden af trabectedin sammenlignet med bedste understøttende behandling (BSC) som andenlinje- eller senere behandling for patienter med fremskreden TRS, der ikke responderede på eller ikke tolererede standard-kemoterapibehandling.
English: Thrombocytopenia:
Danish: Trombocytopeni:
English: If such combinations are needed, appropriate dose adjustments should be applied in the event of toxicities (see sections 4.2 and 4.4).
Danish: Dersom sådanne kombinationer er nødvendige, bør der foretages passende dosisjusteringer I tilfælde af toksicitetet (se pkt.
English: Yondelis is an anti-cancer medicine that works by preventing the tumour cells from multiplying.
Danish: Yondelis er et middel mod kræft, som virker ved at forhindre kræftcellerne i at formere sig.
English: Liver Function Test (LFT) abnormalities
Danish: Abnormiteter i leverfunktionstests (Liver Function Test - LFT)
English: • If you notice that Yondelis infusion leaks out of your vein while you are being given it.
Danish: • Hvis De bemærker, at Yondelis-infusionen siver ud af venen, mens De får det indgivet.
English: Yondelis in combination with pegylated liposomal doxorubicin (PLD: another anti-cancer medicine) is used for the treatment of patients with ovarian cancer that has come back after at least 1 previous therapy and are not resistant to anti-cancer medicines containing platinum compounds.
Danish: Yondelis i kombination med pegyleret liposomal doxorubicin (PLD: et andet lægemiddel mod kræft) anvendes til behandling af patienter med ovariekræft (kræft i æggestokkene), der er vendt tilbage efter mindst én tidligere behandling, og hvor patienterne ikke er resistente over for anticancerlægemidler, der indeholder platinkomponenter.
English: Most patients treated with Yondelis can be expected to have adverse reactions of any grade (91% in monotherapy and 99% in combination therapy) and less than one third serious adverse reactions of grade 3 or 4 severity (10% in monotherapy and 25% in combination therapy).
Danish: De fleste patienter, der behandles med Yondelis, kan forventes at få bivirkninger af en eller anden grad (91 % ved monoterapi og 99 % ved kombinationsterapi), og under en tredjedel kan forventes at få bivirkninger af sværhedsgrad 3 eller 4 (10 % ved monoterapi og 25 % ved kombinationsterapi).
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: It is also recommended to monitor LVEF at baseline and periodically during the treatment; particularly in patients at risk of cardiomyopathy from previous anthracycline exposure or in patients with symptoms of decreasing cardiac function.
Danish: Det anbefales også at kontrollere LVEF (Left Ventricular Ejection Fraction) ved baseline og regelmæssigt under behandlingen, specielt hos patienter med risiko for kardiomyopati pga. tidligere eksponering for anthracycliner og patienter med symptomer på nedsat hjertefunktion.
English: Overall Survival (Final analysis - n=522 events)
Danish: Samlet overlevelse (OS) (endelig analyse - n=522 hændelser)
English: During the treatment period, your doctor will carefully monitor you and decide the most appropriate dosage of
Danish: I hele behandlingsperioden vil lægen omhyggeligt kontrollere Dem og vælge den mest passende Yondelisdosis til Dem.
English: If you are given Yondelis or the combination Yondelis+PLD together with a medicine that might cause damage to the liver or to the muscles (rhabdomyolysis), you may need to be closely monitored,
Danish: Hvis De får Yondelis eller kombinationen Yondelis+PLD sammen med medicin, der kunne medføre skade på leveren eller musklerne (rabdomyolyse), kan det være nødvendigt at overvåge Dem nøje, da der kunne være øget risiko for beskadigelse.
English: Yondelis has been administered for 6 or more cycles in 29.5% and 52% of patients treated with the monotherapy and combination dose and schedule respectively.
Danish: Yondelis er blevet administreret i seks eller flere cyklusser hos 29,5 % og 52 % af de patienter, der blev behandlet med henholdsvis monoterapi- og kombinationsdosis.
English: Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove.
Danish: Trabectedin binder sig til deoxyribonucleinsyrens (DNA's) minor groove og bøjer derved helixen til DNA's major groove.
English: Results from an expanded access program for patients with STS (study ET743-SAR- 3002) show that among the 903 subjects assessed for OS, the median survival time was 11.9 months (95% CI: 11.2, 13.8).
Danish: Resultaterne af et “expanded access”-program for patienter med bløddelssarkom (STS) (studie ET743-SAR-3002) viser, at blandt de 903 patienter, der blev evalueret for samlet overlevelse (OS), var den gennemsnitlige overlevelsestid 11,9 måneder [95 % CI: 11,2-13,8].
English: Capillary Leak Syndrome (CLS)
Danish: Kapillærlækage-syndrom (CLS)
English: • You may experience difficulty in breathing, irregular heartbeat, decreased urine output, abrupt change in mental status, areas of mottled skin, extremely low blood pressure associated with abnormal laboratory test results (decrease in platelet count).
Danish: • De kan opleve åndedrætsbesvær, uregelmæssige hjerteslag, nedsat vandladning, pludselig ændring i sindstilstand, områder med skjoldet hud, ekstremt lavt blodtryk i forbindelse med unormale resultater af laboratorieprøver (nedsat trombocyttal).
English: Hyperbilirubinemia: Bilirubin peaks approximately a week after onset and resolves approximately two weeks after onset.
Danish: Hyperbilirubinæmi: Bilirubin når sit maksimum cirka en uge efter starten og normaliseres cirka to uger efter starten.
English: The protocol specified final time to progression (TTP) analysis showed a 26.6% reduction in the relative risk of progression for patients treated in the 24-h q3wk group [Hazard Ratio (HR)=0.734, Confidence Interval (CI): 0.554-0.974].
Danish: Den protokolspecificerede endelig tid til progressionsanalyse (time to progression - TTP) viste en 26,6 % reduktion i den relative risiko for progression for patienter, der blev behandlet i 24-h q3wk-gruppen [Hazard Ratio (HR)= 0,734; Konfidensinterval (CI): 0,554-0,974].
English: Yondelis with alcohol
Danish: Brug af Yondelis sammen med alkohol
English: Preparation for intravenous infusion
Danish: Klargøring til intravenøs infusion
English: In the Yondelis+PLD arm, non-white (mainly Asian) patients had a higher incidence than white patients in grade 3 or 4 adverse reactions (96% versus 87%), and serious adverse reactions (44% versus 23% all grades).
Danish: I armen Yondelis+PLD havde ikke-hvide (hovedsageligt asiatiske) patienter en hyppigere forekomst end hvide patienter af grad 3 eller 4 bivirkninger (96 % versus 87 %) og af alvorlige bivirkninger (44 % versus 23 % alle grader).
English: Appropriate procedures for proper handling and disposal of cytotoxic medicines must be followed.
Danish: De behørige procedurer for korrekt håndtering og destruktion af cytotoksiske lægemidler skal følges.
English: They were often the result of a combination of events including pancytopenia, febrile neutropenia, some of them with sepsis, hepatic involvement, renal or multiorgan failure and rhabdomyolysis.
Danish: De var ofte resultatet af en kombination af flere hændelser, herunder pancytopeni, febril neutropeni hvoraf nogle var med sepsis, leverlidelser, nyre- eller multiorgansvigt og rabdomyolyse.
English: • You may experience yellowing of your skin and eyeballs (jaundice), pain in the upper right area of your abdomen, nausea, vomiting, a general sense of not feeling well, difficulty in concentrating, disorientation or confusion, sleepiness.
Danish: • De kan opleve gulfarvning af huden og det hvide i øjnene (gulsot), smerter i øverste højre del af maven, kvalme, opkastning, en generel følelse af ubehag, koncentrationsbesvær, desorientering eller konfusion, søvnighed.
English: Yondelis or its combination with PLD must not be used if you have severe liver, kidney or cardiac damage.
Danish: Yondelis eller kombinationen Yondelis + PLD må ikke anvendes, hvis De har svær lever-, nyre- eller hjerteskade.
English: The use of central venous access is strongly recommended (see section 4.2).
Danish: Det anbefales på det kraftigste at anvende centralvenøs adgang (se pkt.
English: The table below displays the adverse reactions reported in patients with soft tissue sarcoma and ovarian cancer that were treated with Yondelis recommended regimen in each indication..
Danish: Tabellen nedenfor viser de bivirkninger, der blev indberettet hos patienter med bløddelssarkom og ovariecancer, der blev behandlet med det anbefalede regime for hver indikation.
English: Median OS with the 24-h q3wk regimen was 13.9 months (CI: 12.5-18.6) and 60.2% of patients were alive at 1 year (CI: 52.0-68.5%).
Danish: Middel-OS med 24-h q3wk-regimet var 13,9 måneder (CI: 12,5-18,6), og 60,2 % af patienterne var i live ved 1 år (CI: 52,0 %-68,5 %).
English: There is no relevant influence of renal function measured by creatinine clearance on trabectedin pharmacokinetics within the range of values (≥ 30.3 ml/min) present in the patients included in the clinical studies.
Danish: Nyrefunktionen, målt ved kreatininclearance, har ingen relevant indflydelse på trabectedins farmakokinetik inden for det område af værdier (≥ 30,3 ml/min), der er til stede hos patienter i de kliniske studier.
English: Talk to your doctor before using Yondelis
Danish: Kontakt lægen, før De bruger Yondelis.
English: Yondelis monotherapy and combination regimens must not be used in patients with creatinine clearance < 30 ml/min and < 60 ml/min respectively (see section 4.2).
Danish: Yondelis monoterapi- og kombinationsregimer må ikke anvendes til patienter med kreatininclearance henholdsvis < 30 ml/min og < 60 ml/min (se pkt.
English: Preclinical data indicate that trabectedin has limited effect on the cardiovascular, respiratory and central nervous system at exposures below the therapeutic clinical range, in terms of AUC.
Danish: Prækliniske data viser, at trabectedin har begrænset effekt på det kardiovaskulære og respiratoriske system og på centralnervesystemet ved eksponeringer under det terapeutiske, kliniske område (AUCareal under kurve).
English: Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4).
Danish: Alkoholindtagelse skal undgås under behandlingen med trabectedin på grund af lægemidlets levertoksicitet (se pkt.
English: • If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine despite being given anti-sickness medicines.
Danish: • Hvis De får kvalme, kaster op eller ikke er i stand til at drikke væske og derfor lader mindre vand, selv om De tager medicin mod kvalme.
English: Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide.
Danish: Indeholder også: saccharose, kaliumdihydrogenphosphat, phosphorsyre og kaliumhydroxid.
English: Similarly, the co-administration of trabectedin with potent inducers of CPY3A4 may increase the metabolic clearance of trabectedin.
Danish: På samme måde kan samtidig administration af trabectedin og potente inducere af CYP3A4 øge den metabolske clearance af trabectedin.
English: Yondelis must not be used in patients with elevated bilirubin.
Danish: Yondelis må ikke anvendes til patienter med forhøjet bilirubin.
English: Rhabdomyolysis and severe CPK elevations (> 5 x ULN)
Danish: Rabdomyolyse og alvorlige CPK-forhøjelser (> 5 x ULN)
English: The efficacy of Yondelis/PLD combination in relapsed ovarian cancer is based on ET743-OVA-301, a randomized phase 3 study of 672 patients who received either trabectedin (1.1 mg/m2) and PLD (30 mg/m2) every 3 weeks or PLD (50 mg/m2) every 4 weeks.
Danish: Vurdering af effekten af Yondelis/PLD-kombinationen til behandling af recidiverende ovariecancer er baseret på studie ET743-OVA-301, et randomiseret fase 3-studie med 672 patienter, der fik enten trabectedin (1,1 mg/m2) og PLD (30 mg/m2) hver tredje uge eller PLD (50 mg/m2) hver fjerde uge.
English: The effect of hepatic impairment on the pharmacokinetics of trabectedin was assessed in 15 cancer patients at doses ranging from 0.58 to 1.3 mg/m2 administered as 3-hour infusion.
Danish: Effekten af nedsat leverfunktion på trabectedins farmakokinetik er blevet vurderet hos 15 cancerpatienter ved doser i intervallet fra 0,58 til 1,3 mg/m2 administreret som 3-timers infusion.
English: If pregnancy occurs during treatment, the patient must be informed of the potential risk to the foetus (see section 5.3) and be monitored carefully.
Danish: Hvis graviditet indtræder under behandlingen, skal patienten informeres om de potentielle risici for fostret (se pkt.
English: Co-administration of Yondelis with potent inhibitors of the enzyme CYP3A4 should be avoided (see section 4.5).
Danish: Samtidig administration af Yondelis og potente hæmmere af enzym CYP 3A4 bør undgås (se pkt.
English: Volume (ml) = BSA (m2) x individual dose (mg/m2) 0.05 mg/ml
Danish: Volumen (ml) = BSA (m2) x individuel dosis (mg/m2) 0,05 mg/ml
English: In the multivariate analyses including PFI, treatment effect on overall survival was statistically significant favouring the Yondelis+PLD combination over PLD alone (all randomised: p=0.0285; platinum-sensitive population: p=0.0319).
Danish: I multivariat analyserne, der inkluderede PFI, var behandlingseffekten på samlet overlevelse statistisk signifikant til fordel for Yondelis+PLD-kombinationen versus PLD alene (alle randomiserede: p = 0,0285; platinsensitiv population: p = 0,0319).
English: Pulmonary embolism*
Danish: Lungeemboli*
English: Table 1 Dose modification table for Yondelis (as single agent for soft tissue sarcoma (STS) or in combination for ovarian cancer) and PLD
Danish: Tabel 1 Dosisjusteringsstabel for Yondelis (som enkelt lægemiddel mod bløddelssarkom (STS) eller i kombinationsbehandling mod ovariecancer) og PLD
English: • You may experience an abnormal build-up of fluid in the lungs, which leads to swelling (pulmonary oedema).
Danish: • De kan opleve en unormal ophobning af væske i lungerne, hvilket fører til hævelse (lungeødem).
English: Adverse reactions, included reversible elevation of liver enzymes and haematological events; in addition, fever, infection, dehydration and thrombosis/embolism were also reported.
Danish: Bivirkninger omfattede reversibelt forhøjede leverenzymer og hæmatologiske hændelser; der blev desuden rapporteret feber, infektion, dehydrering og trombose/emboli.
English: Patients with elevated serum bilirubin levels must not be treated with trabectedin (see section 4.2).
Danish: Patienter med forhøjede serumbilirubinniveauer må ikke behandles med trabectedin (se pkt.
English: You should have received training on the correct techniques to reconstitute and dilute Yondelis or its combination with PLD and you should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Danish: De skal have fået oplæring i de korrekte teknikker til at rekonstituere og fortynde Yondelis eller kombinationen Yondelis og PLD, og De skal bære beskyttelsestøj herunder maske, beskyttelsesbriller og handsker under rekonstitution og fortynding.
English: Potassium dihydrogen phosphate
Danish: Kaliumdihydrogenphosphat
English: Studies including patients with renal insufficiency (creatinine clearance < 30 ml/min for the monotherapy, and < 60 ml/min for the combination regimen) have not been conducted and therefore Yondelis must not be used in this patient population (see section 4.4).
Danish: Der er ikke foretaget undersøgelser, der inkluderede patienter med nyreinsufficiens (kreatininclearance < 30 ml/min i monoterapibehandlingen og < 60 ml/min i kombinationsbehandlingen), og Yondelis må derfor ikke anvendes hos denne patientpopulation (se pkt.
English: Hepatic failure: Rare cases of hepatic failure (including cases with fatal outcomes) have been reported in patients with serious underlying medical conditions treated with trabectedin, both in clinical trials and in post marketing setting.
Danish: Nedsat leverfunktion: Der er indberettet sjældne tilfælde af leverinsufficiens (herunder tilfælde med dødeligt udfald) hos patienter med svære underliggende sygdomme, som blev behandlet med trabectedin, både i kliniske studier og efter markedsføring.
English: Parenteral solutions should be inspected visually for particles prior to administration.
Danish: Den parenterale opløsning skal inspiceres visuelt for partikler inden indgift.
English: Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
Danish: Der er hos de fleste patienter indberettet reversible, akutte forhøjelser af aspartat-aminotransferase (ASAT) og alanin-aminotransferase (ALAT).
English: MARKETING AUTHORISATION NUMBER(S) Yondelis 0.25 mg
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) Yondelis 0,25 mg
English: • increased (examples are medicines containing ketoconazole or fluconazole (for fungal infections), ritonavir (for human immunodeficiency virus [HIV] infection), clarithromycin (for bacterial infections), aprepitant (to prevent nausea and vomiting), ciclosporin (inhibit the defensive system of the body) or verapamil (for high blood pressure and heart conditions)).
Danish: • øge virkningen af Yondelis, (eksempler er lægemidler, der indeholder ketoconazol eller fluconazol (mod svampeinfektioner), ritonavir (mod humant immundefektvirus- (HIV) infektion), clarithromycin (mod bakterieinfektioner), aprepitant (mod kvalme og opkastning), ciclosporin (hæmmer kroppens forsvarssystem) eller verapamil (mod højt blodtryk og hjertelidelser))
English: Findings observed included haematopoietic toxicity (severe leukopenia, anaemia, and lymphoid and bone marrow depletion) as well as increases in liver function tests, hepatocellular degeneration, intestinal epithelial necrosis, and severe local reactions at the injection site.
Danish: De observerede fund inkluderede hæmatopoietisk toksicitet (svær leukopeni og anæmi samt lymfoid depletion og depletion af knoglemarven) såvel som en forhøjelse i leverfunktionstests, hepatocellulær degeneration, intestinal epitelnekrose og svære lokale reaktioner ved injektionsstedet.
English: If you experience severe muscle pain or weakness, you should seek medical attention immediately.
Danish: Hvis De får svære muskelsmerter eller -svaghed, skal De omgående søge lægehjælp.
English: Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/or renal or multiorgan failure.
Danish: Der er i sjældne tilfælde blevet indberettet rabdomyolyse - sædvanligvis associeret med myelotoksicitet, alvorlige abnormiteter i leverfunktionstests og/eller nyre- eller multiorgansvigt.
English: The plasma trabectedin levels attained were 10.6 ± 5.4 (Cmax), higher than those reached in patients after infusion of 1,500 µg/m2 for 24 (Cmax of 1.8 ± 1.1 ng/ml) and similar to those reached after administration of the same dose by 3 hour infusion (Cmax of 10.8 ± 3.7 ng/ml).
Danish: De opnåede plasmakoncentrationer af trabectedin var 10,6 ± 5,4 (Cmax) højere end de koncentrationer, der blev nået hos patienter efter infusion af 1500 µg/m2 i 24 timer (Cmax på 1,8 ± 1,1 ng/ml), og tilsvarende de koncentrationer der blev nået efter administration af samme dosis ved en 3-timers infusion (Cmax på 10,8 ± 3,7 ng/ml).
English: It could be a sign of a condition (capillary leak syndrome) that can cause excessive accumulation of fluid in your tissues.
Danish: Dette kan være tegn på en tilstand kaldet kapillærlækagesyndrom, som kan forårsage en excessiv ophobning af væske i vævene.
English: Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy.
Danish: Yondelis skal administreres under supervision af en læge, der har erfaring i brugen af kemoterapi.
English: Combination of trabectedin with phenytoin or live attenuated vaccines is not recommended and with yellow fever vaccine is specifically contraindicated (see section 4.3).
Danish: En kombination af trabectedin og phenytoin eller levende, svækkede vacciner frarådes, og en kombination af trabectedin og vaccine mod gul feber er specifikt kontraindiceret (se pkt.
English: - If you get any side effects, talk to your doctor.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge.