FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Yondelis.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Yondelis.
English: This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer.
Danish: Derved kan det forhindre cellerne i at dele sig for hurtigt og bremse væksten af forskellige kræfttyper.
English: In both studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.
Danish: Det primære effektmål var, hvor lang tid patienterne levede uden at sygdommen forværredes.
English: ‘Advanced' means that the cancer has started to spread.
Danish: At kræften er fremskreden, vil sige, at den er begyndt at brede sig.
English: A risk management plan has been developed to ensure that Yondelis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Yondelis anvendes så sikkert som muligt.
English: Around two-thirds of the patients had cancer that was sensitive to platinum-containing medicines.
Danish: Omkring to tredjedele af patienterne havde kræft, som var sensitiv over for platinholdige lægemidler.
English: Cancer is a disease where cells divide too quickly, usually because the way their genes work is faulty.
Danish: Kræft er en sygdom, hvor cellerne deler sig for hurtigt, fordi deres gener fungerer forkert.
English: The study compared two different dosing schedules of Yondelis: three times per month, or once every three weeks.
Danish: I undersøgelsen sammenlignedes to forskellige doseringsplaner for Yondelis: tre gange månedligt og én gang hver tredje uge.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Yondelis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Yondelis.
English: Yondelis must not be used in patients who have any serious or uncontrolled infection, in combination with the vaccine for yellow fever, or in breast-feeding women.
Danish: Yondelis må ikke anvendes hos patienter med alvorlige eller ukontrollerede infektioner, i kombination med vaccine mod gul feber eller hos ammende kvinder.
English: Other information about Yondelis
Danish: Andre oplysninger om Yondelis
English: Yondelis is used to treat adults with two types of cancer:
Danish: Yondelis anvendes til behandling af voksne med to kræfttyper:
English: The full EPAR for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Yondelis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working.
Danish: Alle patienterne havde tidligere fået antracykliner og ifosfamid, men disse lægemidler virkede ikke længere.
English: • soft-tissue sarcoma.
Danish: • bløddelssarkom (soft-tissue sarcoma).
English: To prevent vomiting and to protect the liver, patients must receive an infusion of corticosteroids such as dexamethasone before treatment.
Danish: For at undgå opkastning og for at beskytte leveren skal patienten inden behandlingen have en infusion med et kortikosteroid, f.eks. dexamethason.
English: If the patient's blood counts are abnormal, infusion with Yondelis should be delayed, the dose of Yondelis should be reduced or other medicines can be used to treat the blood problems.
Danish: Hvis patientens blodcelletal er unormalt, bør infusionen af Yondelis udsættes eller dosis mindskes, eller der kan anvendes andre lægemidler til at behandle blodproblemerne.
English: • ovarian cancer (cancer of the ovaries) that has relapsed (come back after previous treatment) and is sensitive to medicines containing platinum.
Danish: • ovariecancer (kræft i æggestokkene), som er vendt tilbage efter tidligere behandling, og som er sensitiv over for platinholdige lægemidler.
English: It should only be used by qualified oncologists (cancer specialists) or other health professionals who are specialised in giving cytotoxic (cell-killing) medicines.
Danish: Det bør kun anvendes af uddannede onkologer (kræftspecialister) eller andre sundhedsmedarbejdere, der er specialiserede i anvendelse af cytotoksisk (cellevæksthæmmende) medicin.
English: The active substance in Yondelis, trabectedin, is a synthetic version of a substance that was originally extracted from a species of tunicate or ‘sea squirt' (a marine animal).
Danish: Det aktive stof i Yondelis, trabectedin, er en syntetisk version af et stof, der oprindeligt blev udvundet af en art sækdyr eller ”søpung” (et havdyr).
English: For more information about treatment with Yondelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Yondelis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Yondelis is a cancer medicine that contains the active substance trabectedin.
Danish: Yondelis er et kræftlægemiddel, som indeholder det aktive stof trabectedin.
English: The effect of Yondelis was more pronounced in the women whose cancer was sensitive to platinum-containing medicines.
Danish: Virkningen af Yondelis var mere udtalt hos kvinder, hvis kræft var sensitiv over for platinholdige lægemidler.
English: Most patients treated with Yondelis can be expected to have side effects.
Danish: De fleste patienter, der behandles med Yondelis, må forventes at få bivirkninger.
English: For ovarian cancer, Yondelis in combination with PLD was compared with PLD alone in one main study involving 672 women whose disease had come back or got worse after previous treatment.
Danish: For ovariecancer blev kombinationen Yondelis og PLD sammenlignet med PLD alene i en hovedundersøgelse med 672 kvinder, hvis sygdom var vendt tilbage eller var forværret efter tidligere behandling.
English: It is recommended that Yondelis be given through a central venous line (a thin tube leading from the skin into the large veins just above the heart).
Danish: Det anbefales at give Yondelis gennem et centralt venekateter (et tyndt rør, der fra huden fører ind i en af de store vener lige over hjertet).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Yondelis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Yondelis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The most common side effects of any severity were neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), vomiting, increase in liver enzymes, anaemia (low red blood cell counts), tiredness, thrombocytopenia (low blood platelet counts), loss of appetite and diarrhoea.
Danish: De almindeligste bivirkninger af mere alvorlig art er neutropeni (for lavt antal neutrofile, en type hvide blodlegemer), kvalme, opkastning, forhøjede leverenzymer, anæmi (for lavt antal røde blodlegemer) træthed, trombocytopeni (for lavt antal blodplader), appetitløshed og diarré.
English: Because the numbers of patients with soft-tissue sarcoma and ovarian cancer are low, the diseases are considered ‘rare', and Yondelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 May 2001 (for soft-tissue sarcoma) and on 17 October 2003 (for ovarian cancer).
Danish: Da antallet af patienter med bløddelssarkom og ovariecancer er lavt, betragtes sygdommene som ”sjældne”, og Yondelis blev udpeget som "lægemiddel til sjældne sygdomme" den 30. maj 2001 (for bløddelssarkom) og den 17. oktober 2003 (for ovariecancer).
English: For ovarian cancer, it is given at a dose of 1.1 mg/m2 every three weeks as an infusion lasting three hours, immediately after the PLD infusion.
Danish: Til ovariecancer er dosis 1,1 mg/m2 hver tredje uge, der gives som en infusion over tre timer umiddelbart efter PLD-infusionen.
English: It is available as a powder that is made up into a solution for infusion (drip into a vein).
Danish: Det leveres som et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: Yondelis was originally authorised under ‘exceptional circumstances', because, limited information was available at the time of approval on soft-tissue sarcoma.
Danish: Yondelis blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet kun forelå sparsomme oplysninger bløddelssarkom.
English: The CHMP concluded that Yondelis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP afgjorde, at fordelene ved Yondelis opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Yondelis.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Yondelis findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: Yondelis is used in combination with pegylated liposomal doxorubicin (PLD, another cancer medicine).
Danish: Yondelis anvendes i kombination med pegyleret liposomalt doxorubicin (PLD, et andet kræftmiddel).
English: Yondelis must be given under the supervision of a doctor who is experienced in the use of chemotherapy (medicines to treat cancer).
Danish: Yondelis skal gives under opsyn af en læge med erfaring i brug af kemoterapi (lægemidler til behandling af kræft).
English: Around 10% of those patients treated with Yondelis as a single agent and 25% treated with Yondelis in combination therapy can be expected to have serious side effects.
Danish: Ca. 10 % af de patienter, der behandles med Yondelis som eneste behandling, og 25 % af dem, der behandles med Yondelis i kombinationsbehandling, må forventes at få alvorlige bivirkninger.
English: For soft-tissue sarcoma, Yondelis was more effective when it was given once every three weeks than when it was given with the alternative dosing schedule.
Danish: Til bløddelssarkom var Yondelis mere effektivt, når det blev givet én gang hver tredje uge, end når det blev givet efter den anden doseringsplan.
English: What measures are being taken to ensure the safe and effective use of Yondelis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Yondelis
English: Patients receiving it once every three weeks lived for an average of 3.8 months without their disease getting worse, compared with 2.1 months in those receiving Yondelis three times per month.
Danish: Patienter, der fik Yondelis én gang hver tredje uge, levede i gennemsnit 3,8 måneder, uden at sygdommen blev værre, sammenholdt med 2,1 måneder for dem, der fik lægemidlet tre gange om måneden.
English: • advanced soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.
Danish: • fremskredent bløddelssarkom, som er en kræfttype, der udgår fra kroppens bløde støttevæv.
English: Fatal side effects have occurred in 1.9% and 0.9% of patients treated with Yondelis as a single agent and combination therapy, respectively.
Danish: Dødelige bivirkninger er forekommet hos 1,9 % af de patienter, der er behandlet med Yondelis som eneste behandling, og 0,9 % af dem, der har fået kombinationsbehandling.
English: What is the risk associated with Yondelis?
Danish: Hvilken risiko er der forbundet med Yondelis?
English: For soft-tissue sarcoma, Yondelis has been studied in one main study involving 266 patients with liposarcoma (a sarcoma originating in fat cells) or leiomyosarcoma (a sarcoma originating in ‘smooth' or involuntary muscle cells) that was advanced or metastatic (had spread to other parts of the body).
Danish: For bløddelssarkom blev Yondelis undersøgt i en hovedundersøgelse med 266 patienter med liposarkom (et sarkom, der udgår fra fedtceller) eller leiomyosarkom (et sarkom, der udgår fra glatmuskulatur).
English: Yondelis is used when treatment with anthracyclines and ifosfamide (other cancer medicines) have stopped working, or in patients who cannot be given these medicines;
Danish: Yondelis anvendes, når antracykliner og ifosfamid (andre kræftmidler) ikke længere virker eller ikke kan anvendes til patienten
English: Why has Yondelis been approved?
Danish: Hvorfor blev Yondelis godkendt?
English: For the full list of all side effects reported with Yondelis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Yondelis fremgår af indlægssedlen.
English: Trabectedin works by attaching to the DNA, the chemical molecule that makes up genes, and preventing some genes in human cells from increasing their activity.
Danish: Trabectedin virker ved at bindes til dna, det kemiske molekyle, generne består af.
English: For soft-tissue sarcoma, the recommended dose of Yondelis is 1.5 mg per square metre of body surface area (calculated using the patient's height and weight), given as a single infusion lasting 24 hours every three weeks.
Danish: Til bløddelssarkom er den anbefalede dosis Yondelis 1,5 mg dagligt pr. kvadratmeter legemsoverflade, beregnet efter patientens højde og vægt.
English: EPAR summary for the public trabectedin
Danish: EPAR - sammendrag for offentligheden
English: What is Yondelis?
Danish: Hvad er Yondelis?
English: What benefit has Yondelis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Yondelis?
English: For ovarian cancer, the combination of Yondelis and PLD was more effective than PLD alone: patients receiving the combination treatment lived for an average of 7.3 months without their disease getting worse, compared with 5.8 months in those receiving PLD alone.
Danish: De patienter, som fik kombinationsbehandlingen, levede gennemsnitligt 7,3 måneder, uden at sygdommen blev værre, sammenlignet med 5,8 måneder for dem, der kun fik PLD.
English: How has Yondelis been studied?
Danish: Hvordan blev Yondelis undersøgt?
English: What is Yondelis used for?
Danish: Hvad anvendes Yondelis til?
English: How is Yondelis used?
Danish: Hvordan anvendes Yondelis?
English: How does Yondelis work?
Danish: Hvordan virker Yondelis?
English: The recommended starting dose is 1 capsule a day.
Danish: Den anbefalede startdosis er én kapsel dagligt.
English: Patients should have tests to check how well their heart is working before beginning treatment and regularly during treatment.
Danish: Patienterne bør få foretaget undersøgelser for at kontrollere, hvor godt deres hjerte virker, inden behandlingen påbegyndes og regelmæssigt under behandlingen.
English: The dose can be increased up to 3 capsules a day, depending on the intensity of the symptoms and how the patient responds to treatment.
Danish: Dosis kan øges til op til tre kapsler dagligt afhængig af symptomernes intensitet, og hvordan patienten reagerer på behandlingen.
English: After 18 days of treatment, the average score for patients treated with Namuscla decreased from 66 to 24, while the score for patients given placebo went from 75 to 66.
Danish: Efter 18 dages behandling faldt den gennemsnitlige score hos de patienter, som blev behandlet med Namuscla, fra 66 til 24, mens scoren hos de patienter, der fik placebo, gik fra 75 til 66.
English: Namuscla (mexiletine)
Danish: Namuscla (mexiletin)
English: By blocking them, the medicine helps to reduce the stiffness that occurs when the contractions are prolonged.
Danish: Ved at blokere dem hjælper lægemidlet med at mindske den stivhed, der opstår, når sammentrækningerne forlænges.
English: The company also provided supportive data on the effectiveness of Namuscla from the literature.
Danish: Virksomheden forelagde også understøttende data om effektiviteten af Namuscla fra litteraturen.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU3141353.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/EU3141353.
English: As for all medicines, data on the use of Namuscla are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Namuscla løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Namuscla?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Namuscla?
English: Further information on Namuscla can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Namuscla.
Danish: Yderligere information om Namuscla findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Namuscla.
English: Namuscla must also not be used in patients with various heart problems, or together with certain medicines.
Danish: Namuscla må heller ikke anvendes hos patienter med forskellige hjerteproblemer eller sammen med visse lægemidler.
English: For more information about using Namuscla, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Namuscla, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The safety profile of Namuscla is well known and its side effects affecting the heart are considered to be manageable with restrictions in use and monitoring during treatment.
Danish: Sikkerhedsprofilen for Namuscla er velkendt, og de bivirkninger ved lægemidler, som berører hjertet, anses for at kunne håndteres med begrænsninger af anvendelsen og overvågning under behandlingen.
English: Because it has a similar effect on the heart muscle, mexiletine has also been used for many years in patients with abnormal heart rhythm.
Danish: Fordi mexiletin har en tilsvarende virkning på hjertemusklen, er det i mange år også blevet anvendt til patienter med unormal hjerterytme.
English: The European Medicines Agency therefore decided that Namuscla's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Namuscla opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Namuscla and what is it used for?
Danish: Hvad er Namuscla, og hvad anvendes det til?
English: Other information about Namuscla
Danish: Andre oplysninger om Namuscla
English: An overview of Namuscla and why it is authorised in the EU
Danish: En oversigt over Namuscla, og hvorfor det er godkendt i EU
English: Side effects reported with Namuscla are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Namuscla vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Why is Namuscla authorised in the EU?
Danish: Hvorfor blev Namuscla godkendt i EU?
English: Myotonic disorders are rare, and Namuscla was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 November 2014.
Danish: Myotone sygdomme er sjældne, og Namuscla blev udpeget som "lægemiddel til sjældne sygdomme" den 19. november 2014.
English: Namuscla can only be obtained with a prescription.
Danish: Namuscla udleveres kun efter recept.
English: The most serious side effects reported (which may affect up to 1 in 10,000 people) are arrhythmias (disturbances of heart rhythm) and a severe reaction affecting skin, blood and internal organs, known as drug reaction with eosinophilia and systemic symptoms (DRESS).
Danish: De mest alvorlige indberettede bivirkninger (som kan forekomme hos op til 1 ud af 10.000 patienter) er hjerterytmeforstyrrelser (arytmi) og en alvorlig reaktion, der berører huden, blodet og de indre organer, kaldet lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS).
English: In one study involving 25 patients with non-dystrophic myotonia, Namuscla was shown to be more effective than placebo (a dummy treatment) at reducing muscle stiffness.
Danish: I et studie, der omfattede 25 patienter med ikke-dystrofisk myotoni, blev Namuscla påvist at være mere effektivt end placebo (en virkningsløs behandling) til at mindske muskelstivhed.
English: The active substance in Namuscla, mexiletine, works by blocking channels in muscle cells that allow sodium ions (electrically charged particles) to pass in and out.
Danish: Det aktive stof i Namuscla, mexiletin, virker ved at blokere de kanaler i muskelcellerne, hvor natriumioner (elektrisk ladede partikler) passerer ind og ud.
English: Namuscla must not be used in patients who are hypersensitive (allergic) to the active substance, mexiletine, to any other ingredients of the medicine, or to local anaesthetics (medicines that block out sensation used to prevent pain in a part of the body).
Danish: Namuscla må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for det aktive stof, mexiletin, eller andre af indholdsstofferne i lægemidlet eller over for lokalbedøvelsesmidler (lægemidler, som blokerer følelsen og anvendes til at forhindre smerte i en del af kroppen).
English: Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles are slow to relax after contraction.
Danish: Patienter med ikke-dystrofiske myotone sygdomme oplever muskelstivhed og smerter, fordi deres muskler er lang tid om at slappe af efter sammentrækning.
English: What are the risks associated with Namuscla?
Danish: Hvilke risici er der forbundet med Namuscla?
English: The most common side effects with Namuscla (which may affect more than 1 in 10 people) are abdominal (belly) pain and insomnia (difficulty sleeping).
Danish: De hyppigste bivirkninger ved Namuscla (som optræder hos mere end 1 ud af 10 patienter) er mavesmerter og søvnløshed (søvnbesvær).
English: The company that markets Namuscla will provide educational material for doctors and a ‘patient alert card' with important information about the risks associated with the medicine, in particular the risk of arrhythmias.
Danish: Virksomheden, der markedsfører Namuscla, sørger for udlevering af vejledningsmateriale til læger og patientkort med vigtig information om risiciene ved lægemidlet, navnlig risikoen for hjerterytmeforstyrrelser (arytmi).
English: Namuscla was shown to be effective at easing the symptoms of myotonia in patients with nondystrophic myotonic disorders, thus improving their quality of life.
Danish: Namuscla blev påvist at være effektivt til at lindre symptomerne på myotoni hos patienter med ikkedystrofiske myotone sygdomme, hvorved deres livskvalitet forbedres.
English: These sodium channels play a role in the contraction and relaxation of muscles and are hyperactive in patients with myotonic disorders, causing excessive contractions and stiffness.
Danish: Disse natriumkanaler medvirker ved muskelsammentrækning og -afslapning og er hyperaktive hos patienter med myotone sygdomme, hvilket medfører overdreven sammentrækning og stivhed.
English: Non-dystrophic means no muscle wasting occurs in patients affected by the condition.
Danish: Ikke-dystrofisk betyder, at der ikke forekommer muskelsvind hos patienter med denne tilstand.
English: Namuscla is available as capsules to be taken by mouth.
Danish: Namuscla fås som kapsler, der tages gennem munden.
English: Namuscla is a medicine used to treat symptoms of myotonia (muscle stiffness) in patients with nondystrophic myotonic disorders, a group of inherited muscle disorders.
Danish: Namuscla er et lægemiddel, som bruges til at behandle symptomer på myotoni (muskelstivhed) hos patienter med ikke-dystrofiske myotone sygdomme, som er en gruppe arvelige muskelsygdomme.