FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of the main efficacy analyses are summarised in the table below:
Danish: Resultaterne af de vigtigste effektanalyser er opsummeret i tabellen nedenfor:
English: • You may have a reaction at the site of injection.
Danish: • De kan få en reaktion ved injektionsstedet.
English: Other P450 enzymes may contribute to metabolism.
Danish: Andre P450-enzymer kan medvirke til metaboliseringen.
English: Patients who experience any of these adverse reactions during therapy must not drive or operate machines.
Danish: Patienter, der oplever nogen af disse bivirkninger under behandlingen, må ikke føre motorkøretøj eller betjene maskiner.
English: Maximum fetal tissue radioactivity concentration was similar to that in maternal plasma or blood.
Danish: Den maksimale radioaktive koncentration i vævet hos fostrene var den samme som i moderens plasma eller blod.
English: • Your doctor will order regular blood tests to detect any abnormalities in the blood.
Danish: • Deres læge vil ordinere regelmæssige blodprøver med henblik på at opdage eventuelle afvigelser i blodet.
English: Tell your doctor if you know or suspect that you have any liver, kidney or cardiac problems before starting the treatment with Yondelis.
Danish: Fortæl det til lægen, hvis De ved eller har mistanke om, at De har et lever-, nyre- eller hjerteproblem, inden De begynder behandling med Yondelis.
English: Adverse reactions are listed by System Organ Class and frequency.
Danish: Bivirkninger er anført efter systemorganklasse og hyppighed.
English: Overall 20% of the 1,164 patients in the integrated safety analysis of monotherapy clinical trials were over 65 years.
Danish: Alt i alt var 20 % af de 1.164 patienter i den integrerede sikkerhedsanalyse i de kliniske studier med monoterapi over 65 år.
English: If pregnancy occurs during treatment the possibility of genetic counselling should be considered.
Danish: Hvis der forekommer graviditet under behandlingen, skal muligheden for genetisk rådgivning undersøges.
English: Trabectedin pharmacokinetic profile is consistent with a multiple-compartment disposition model.
Danish: Trabectedins farmakokinetiske profil er overensstemmende med en ”multiple-compartment” dispositionsmodel.
English: However, fatigue and/or asthenia have been reported in patients receiving trabectedin.
Danish: Imidlertid er der indberettet træthed og/eller asteni hos patienter, der fik trabectedin.
English: Treatment with Yondelis should be discontinued until the patient fully recovers.
Danish: Behandlingen med Yondelis bør afbrydes, indtil patienten er kommet sig fuldstændigt.
English: A rapid decline in serum albumin level may be indicative of CLS.
Danish: Et hurtigt fald i serumalbuminniveauet kan være tegn på CLS.
English: Do not use this medicine if you notice visible particles after the reconstitution or dilution of the medicine.
Danish: Brug ikke lægemidlet, hvis De kan se synlige partikler efter rekonstitution eller fortynding af lægemidlet.
English: Efficacy analyses from ET743-OVA-301 Yondelis+PLD
Danish: Effektanalyser fra studie ET743-OVA-301 Yondelis+PLD
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis De er gravid, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De får dette lægemiddel.
English: Medicines containing statins (for lowering cholesterol levels and preventing cardiovascular disease) is an example of medicines that may cause muscle damage.
Danish: Medicin, der indeholder statiner (til sænkning af kolesterolniveauer samt til forebyggelse af hjerte-kar-sygdomme), er et eksempel på medicin, der kunne forårsage muskelbeskadigelse.
English: From a microbiological point of view, the reconstituted solution should be diluted and used immediately.
Danish: Fra et mikrobiologisk synspunkt bør den rekonstituerede opløsning fortyndes og anvendes med det samme.
English: It is recommended to monitor patients for clinical cardiac signs or symptoms.
Danish: Det anbefales at overvåge patienterne for kliniske tegn eller symptomer på hjerteinsufficiens.
English: The infusion is given to you every 3 weeks, although occasionally your doctor may recommend dose delays to ensure that you receive the most appropriate dose of Yondelis.
Danish: De vil få en infusion hver tredje uge, men af og til vil Deres læge muligvis anbefale, at infusionen udskydes for at sikre, at De får den mest egnede dosis Yondelis.
English: Second reduction
Danish: Anden reduktion
English: An infection could also give you a raised temperature
Danish: En infektion kan også give Dem temperaturforhøjelse (feber).
English: Electrocardiogram (ECG) investigations
Danish: Elektrokardiogram- (ekg-)undersøgelser
English: Trabectedin can have genotoxic effects.
Danish: Trabectedin kan have genotoksiske virkninger.
English: If you are not sure what the side effects below are, you should ask your doctor to explain them to you in more detail.
Danish: Hvis De er usikker på nedenstående bivirkninger, skal De bede lægen om at forklare dem mere detaljeret.
English: Dizziness Dysgeusia Peripheral sensory neuropathy Syncope*
Danish: Svimmelhed Dysgeusi Perifer sensorisk neuropati Synkope*
English: What Yondelis contains:
Danish: Yondelis indeholder:
English: Gamma-glutamyltransferase increased
Danish: Gamma glutamyltransferase forhøjet
English: If symptoms of possible CLS develop, such as unexplained oedema with or without hypotension, the treating physician should reassess serum albumin level.
Danish: Hvis der opstår mulige symptomer på CLS, såsom uforklarligt ødem med eller uden hypotension, bør den behandlende læge genvurdere serumalbuminniveauet.
English: First reduction
Danish: Første reduktion
English: There is limited data on the effects of trabectedin overdose.
Danish: Der findes kun begrænsede data vedrørende virkningerne af overdosering med trabectedin.
English: A 1 hour infusion schedule was selected to attain maximum plasma levels (Cmax values) in the range of those observed in the clinic.
Danish: Der blev valgt en 1-times infusionsplan til at opnå maksimale plasmakoncentrationerer (Cmax værdier) inden for de områder, der blev observeret på hospitalet/klinikken.
English: If this is not possible, close monitoring of toxicities are required and dose reductions of trabectedin should be considered.
Danish: Hvis dette ikke er muligt, kræves der nøje monitorering af toksicitet, og det bør overvejes at nedsætte trabectedin-dosis.
English: Mortality in the presence of hepatic injury occurred in less than 1% of patients in both regimens.
Danish: Mortalitet, hvor der blev konstateret beskadigelse af leveren, forekom hos færre end 1 % af patienterne i begge regimer.
English: Once the infusion is prepared, it should be administered immediately.
Danish: Når først infusionen er klargjort, bør den indgives med det samme.
English: Dose adjustments during treatment
Danish: Dosisjusteringer under behandlingen
English: The low recovery (< 9% in all studied patients) of total radioactivity in the urine after a single dose of 14C-labelled trabectedin indicates that renal impairment has little influence on the elimination of trabectedin or its metabolites.
Danish: Den lave genindvinding (< 9 % hos alle undersøgte patienter) af total radioaktivitet i urinen efter en enkelt dosis 14C-mærket trabectedin viser, at nedsat nyrefunktion kun har ringe indflydelse på eliminationen af trabectedin eller på dets metabolitter.
English: The percentages of patients anaemic at baseline were 46% and 35% respectively.
Danish: Procentdelene af patienter, der var anæmiske ved baseline, var henholdsvis 46 % og 35 %.
English: In the event that further dose reductions are necessary, treatment discontinuation should be considered.
Danish: I tilfælde hvor yderligere dosisreduktioner er nødvendige, skal det overvejes at afbryde behandlingen.
English: It is not known whether trabectedin is excreted in human milk.
Danish: Det er ukendt, om trabectedin udskilles i human mælk.
English: The monotherapy and combination regimens have been used for up to 38 and 21 cycles respectively.
Danish: Monoterapi- og kombinationsregimerne er blevet anvendt i op til henholdsvis 38 og 21 cyklusser.
English: The median time to reach the peak values was 5 days for both AST and ALT.
Danish: Middeltid til at nå peak-værdier var 5 dage for både ASAT og ALAT.
English: If any of the following events occur at any time between cycles, the dose must be reduced one level, according to table 1 below, for subsequent cycles:
Danish: Hvis en eller flere af de nedenstående hændelser optræder på et hvilket som helst tidspunkt mellem cyklusserne, skal dosis reduceres ét trin ifølge tabel 1 nedenfor i de efterfølgende cyklusser:
English: Trabectedin was administered as a 24-hour intravenous infusion every 21 days.
Danish: Trabectedin blev indgivet som en 24-timers intravenøs infusion hver 21. dag.
English: Most of the values had decreased to grade 1 or resolved by day 14-15 (see section 4.4).
Danish: De fleste af værdierne var faldet til grad 1 eller normaliseret ved dag 14-15 (se pkt.
English: Like all medicines, this medicine or its combination with PLD can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: PLD Hazard/Odds ratio p-value Progression Free Survival
Danish: PLD Hazard/odds ratio p-værdi Progressionsfri overlevelse (PFS)
English: - if you will receive yellow fever vaccine.
Danish: - hvis De skal vaccineres mod gul feber.
English: If a pregnancy should occur you must tell your doctor immediately and genetic counselling is recommended since Yondelis can cause genetic damage.
Danish: Hvis De skulle blive gravid, skal De omgående fortælle det til lægen, og det anbefales at få genetisk rådgivning, da Yondelis kan medføre genetiske skader.
English: Neutropenia is the most common haematological toxicity.
Danish: Neutropeni er den mest almindelige hæmatologiske toksicitet.
English: (See also PLD Summary of Product Characteristics for specific handling instructions).
Danish: (Se også produktresuméet for PLD for specifikke anvisninger vedrørende håndteringen.)
English: If this occurs, active supportive therapy should be started immediately.
Danish: Hvis dette sker, bør der omgående iværksættes støttende behandling.
English: Of the 333 patients with ovarian cancer who received trabectedin in combination with PLD, 24% were 65 years of age or older and 6% were over 75 years.
Danish: Af de 333 patienter med ovariecancer, der fik trabectedin i kombination med PLD, var 24 % 65 år eller ældre, og 6 % var over 75 år.
English: This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle.
Danish: Denne binding til DNA udløser en kaskade af hændelser, der påvirker flere transskriptionsfaktorer, DNA-bindende proteiner og DNA-reparationsmekanismer, hvilket resulterer i forstyrrelse af cellecyklussen.
English: Yondelis contains the active substance trabectedin.
Danish: Yondelis indeholder det aktive indholdsstof trabectedin.
English: In clinical trials, there were no pre-defined limits to the number of cycles administered.
Danish: I kliniske studier var der ingen prædefinerede grænser for antallet af behandlingscyklusser.
English: Thus the trabectedin extraction ratio can be considered moderate.
Danish: Trabectedins ekstraktionsforhold kan derfor betragtes som moderat.
English: Eight patients were treated with a dose of 1.3 mg/m2 and 42 with 1.5 mg/m2.
Danish: Otte patienter blev behandlet med en dosis på 1,3 mg/m2 og 42 med 1,5 mg/m2.
English: The following safety profile of Yondelis is based on adverse reactions reported in clinical trials, postauthorisation safety studies and spontaneous reporting.
Danish: Den følgende sikkerhedsprofil for Yondelis er baseret på bivirkninger indberettet i kliniske studier, i sikkerhedsstudier, foretaget efter godkendelse, og fra spontane bivirkningsindberetninger.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trabectedin, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for trabectedin er CHMP nået frem til følgende videnskabelige konklusioner:
English: - Absolute neutrophil count (ANC) ≥ 1,500/mm3
Danish: - Absolut neutrofiltal (ANC) ≥ 1.500/mm3.
English: In the event of an overdose, patients should be closely monitored and symptomatic supportive care measures instituted as required.
Danish: I tilfælde af en overdosering bør patienten monitoreres nøje, og der bør iværksættes symptomatisk støttende behandling efter behov.
English: Patients in the trabectedin and dacarbazine arms received a median of 4 and 2 cycles respectively.
Danish: Patienterne i trabectedin- og dacarbazin-grupperne modtog en median på henholdsvis 4 og 2 cyklusser.
English: Therefore, CPK should be closely monitored whenever a patient may be experiencing any of these toxicities or muscle weakness or muscle pain.
Danish: CPK bør derfor monitoreres nøje, hvis der er mistanke om, at en patient lider af en af disse typer toksicitet eller oplever muskelsvaghed eller muskelsmerte.
English: Log rank test b Fisher's test
Danish: * Primær effektanalyse a Log rank test b Fishers test
English: Hypersensitivity
Danish: Hypersensibilitet
English: Neutrophil nadirs occurred at a median of 15 days and recovered within a week.
Danish: Det neutrofile nadir optrådte med en median på 15 dage og normaliseredes inden for en uge.
English: If you use any of the following medicines during your treatment with Yondelis, you need to be closely monitored as the effects of Yondelis are:
Danish: Hvis De bruger nogle af følgende lægemidler under Deres behandling med Yondelis, er det nødvendigt at overvåge Dem nøje, da virkningerne af Yondelis er:
English: Patients who develop fever should promptly seek medical attention.
Danish: Patienter, der udvikler feber, bør omgående søge lægehjælp.
English: Tel: +34 91 846 60 00
Danish: Tlf.: +34 91 846 60 00
English: If rhabdomyolysis occurs, supportive measures such as parenteral hydration, urine alkalinisation and dialysis should be promptly established, as indicated.
Danish: Hvis der forekommer rabdomyolyse, skal der omgående iværksættes støttende foranstaltninger såsom parenteral hydrering, alkalinisering af urinen og dialyse, som indiceret.
English: Based on an ad-hoc review of CLS cases performed by an External Independent Adjudication Committee (IAC), it was determined possible or probable trabectedin causality in 5 out of 6 fatal cases among 14 probable CLS cases.
Danish: Baseret på en ad-hoc-gennemgang af CLS-tilfælde udført af en ekstern uafhængig bedømmelsekomité (IAC - Independent Adjudication Committee) blev det bedømt, at trabectedinkausalitet var mulig eller sandsynlig i 5 ud af 6 tilfælde med dødelig udgang blandt 14 sandsynlige CLS-tilfælde.
English: Serious side effects caused by the treatment with Yondelis:
Danish: Alvorlige bivirkninger forårsaget af behandlingen med Yondelis:
English: In this population febrile neutropenia occurred in 2% of patients and in < 1% of cycles.
Danish: Hos denne population optrådte febril neutropeni hos 2 % af patienterne og i < 1 % af cyklusserne.
English: Two in vivo drug-drug interaction phase 1 studies have confirmed trends toward increased and decreased trabectedin exposures when administered with ketoconazole and rifampicin, respectively.
Danish: To in vivo fase 1-lægemiddelinteraktionsstudier har bekræftet trends i retning af øgede og sænkede trabectedin-eksponeringer ved administration sammen med henholdsvis ketoconazol og rifampicin.
English: Most transaminase elevations improved to grade 1 or to pre-retreatment levels within 15 days, and less than 2% of cycles had recovering times longer than 25 days.
Danish: De fleste transaminaseforhøjelser blev inden for 15 dage forbedret til grad 1 eller til de niveauer, der blev målt inden behandlingen, og i mindre end 2 % af cyklusserne gik der mere end 25 dage, inden værdierne blev normaliseret.
English: If any of these toxicities reappear in subsequent cycles in a patient exhibiting clinical benefit, the dose may be further reduced (see below).
Danish: Hvis en af disse typer toksicitet optræder igen i efterfølgende cyklusser hos en patient, der udviser klinisk gavn af behandlingen, skal dosis reduceres yderligere (se nedenfor).
English: In order to avoid irritation at the site of injection it is recommended that Yondelis is given to you through a central venous line.
Danish: For at undgå irritation på injektionsstedet anbefales det, at Yondelis indgives til Dem gennem et centralt venekateter.
English: Trabectedin should not be used during pregnancy.
Danish: Trabectedin bør ikke anvendes under graviditet.
English: These trials evaluated a total of 100 patients with lipo- and leiomyosarcoma and 83 patients with other types of sarcoma.
Danish: Disse studier evaluerede i alt 100 patienter med lipo- og leiomyosarkom og 83 patienter med andre typer sarkom.
English: Uncommon Rare
Danish: Almindelig Ikke almindelig Sjælden
English: Both adverse reactions and laboratory values have been used to provide frequencies.
Danish: Der er både anvendt bivirkninger og laboratorieværdier til at udregne hyppighederne.
English: Alcohol consumption must be avoided during treatment with Yondelis as this may harm the liver.
Danish: Alkoholindtagelse bør undgås under behandling med Yondelis, da dette kan skade leveren.
English: Colony stimulating factors can be administered for haematologic toxicity according to local standard practice.
Danish: Kolonistimulerende faktorer kan administreres i forbindelse med hæmatologisk toksicitet ifølge lokal standardpraksis.
English: Appropriate aseptic techniques must be used to prepare the infusion solution (see Instructions for reconstitution and for dilution).
Danish: Der skal anvendes passende aseptisk teknik til tilberedning af infusionsvæsken (se Vejledning i rekonstitution og fortynding).
English: Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Danish: Myelosuppression og levertoksicitet blev identificeret som den primære toksicitet i forbindelse med trabectedin.
English: On the basis of the scientific conclusions for trabectedin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing trabectedin is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for trabectedin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder trabectedin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: There could also be damage to your nerves which may result in muscle pain, weakness and numbness.
Danish: Der kan også være skade på Deres nerver, hvilket kan resultere i muskelsmerter, svaghed og følelsesløshed.
English: The reconstituted solution results in a clear, colourless or slightly yellowish solution, essentially free of visible particles.
Danish: Den rekonstituerede opløsning er en klar, farveløs eller let gullig opløsning, i alt væsentligt fri for synlige partikler.
English: Marketing Authorisation Holder and Manufacturer:
Danish: Indehaver af markedsføringstilladelsen og fremstiller:
English: In a placebo-controlled QT/QTc study, trabectedin did not prolong the QTc interval in patients with advanced solid malignancies.
Danish: I et placebokontrolleret QT/QTc-studie forlængede trabectedin ikke QTc-intervallet hos patienter med fremskreden solid malignitet.
English: Thus the use of any of these medicines together with Yondelis should be avoided, if possible.
Danish: Derfor bør anvendelse af disse lægemidler sammen med Yondelis så vidt muligt undgås.
English: Considering the nature of the compound (cytotoxic and mutagenic), it is likely to affect the reproductive capacity.
Danish: Stoffets art taget i betragtning (cytotoksisk og mutagent) er det sandsynligt, at stoffet vil påvirke forplantningsevnen.
English: It followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Danish: Neutropeni fulgte et forudsigeligt mønster med hurtig start og reversibilitet og associeredes sjældent med feber eller infektion.
English: Every time you are given Yondelis for the treatment of soft tissue sarcoma, it will take about 24 hours for all of the solution to enter your blood.
Danish: Hver gang De får Yondelis til behandling af bløddelssarkom, vil det tage ca. 24 timer at få al opløsningen ind i blodet.
English: Once a dose has been reduced because of toxicity, dose escalation in the subsequent cycles is not recommended.
Danish: Hvis en dosis er blevet reduceret på grund af toksicitet, frarådes det at foretage dosisoptrapning i de efterfølgende cyklusser.
English: Do not drive or use any tools or machines if you are experiencing any of these side effects.
Danish: De må ikke føre motorkøretøj, og De må ikke betjene værktøj eller maskiner, hvis De får nogle af disse bivirkninger.
English: No data are available comparing Yondelis+PLD to a platinum-based regimen in platinum-sensitive patients.
Danish: Der foreligger ingen data, der sammenligner Yondelis+PLD med et platinbaseret regime hos platinfølsomme patienter.
English: Patients may develop a potentially severe injection site reaction when trabectedin is administered through a peripheral venous line.
Danish: Patienterne kan udvikle en potentielt alvorlig reaktion ved injektionsstedet, hvis trabectedin indgives gennem et perifert venekateter.
English: The following criteria are required to allow treatment with Yondelis:
Danish: Følgende kriterier skal være opfyldt for at tillade behandling med Yondelis:
English: Yondelis should not be used during pregnancy.
Danish: Yondelis bør ikke anvendes under graviditet.
English: The differences were mainly observed in relation with neutropenia (93% versus 66%), anaemia (37% versus 14%) and thrombocytopenia (41% versus 19%).
Danish: Forskellene blev hovedsageligt observeret i forbindelse med neutropeni (93 % versus 66 %), anæmi (37 % versus 14 %) og trombocytopeni (41 % versus 19 %).
English: Grades 3 or 4 neutropenia and thrombocytopenia associated with Yondelis therapy have been very commonly reported.
Danish: Grad 3- eller 4-neutropeni og trombocytopeni associeret med Yondelis-behandling er indberettet meget hyppigt.
English: Neutropenia:
Danish: Neutropeni:
English: Secondary analyses of PFS and response rate also favoured the combination arm.
Danish: Sekundære analyser af PFS og responsrate faldt ud til fordel for kombinationsbehandlingen.
English: Preclinical data have demonstrated that trabectedin is a substrate to P-gp.
Danish: Prækliniske data har påvist, at trabectedin er et P-gp-substrat.
English: Date of latest renewal: 03 August 2012
Danish: Dato for første markedsføringstilladelse: 17. september 2007 Dato for seneste fornyelse: 3. august 2012
English: PFS (months; 95% CI) ORR, n (%); Odds ratio (95% CI) DOR (months; 95% CI) CBR, n (%); Odds ratio (95% CI)
Danish: PFS (måneder; 95 % CI) ORR, n (%); Odds ratio (95 % CI) DOR (måneder; 95 % CI) CBR, n (%); Odds ratio (95 % CI)
English: Cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for the oxidative metabolism of trabectedin at clinically relevant concentrations.
Danish: Cytokrom P450 3A4 er det vigtigste cytokrom P450-isozym, der er ansvarlig for trabectedins oxidative metabolisme ved klinisk relevante koncentrationer.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis De tager anden medicin eller har gjort det for nylig.
English: Yondelis is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised during handling.
Danish: Yondelis er et cytotoksisk anticancerlægemiddel, og som med andre potentielt toksiske stoffer skal der udvises forsigtighed under håndteringen.