FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Lysodren (seen in more than 1 patient in 10) are increased blood levels of liver enzymes, cholesterol and triglycerides (a type of fat), leucopenia (low white blood cell counts), prolonged bleeding time, ataxia (difficulty co-ordinating movements), paraesthesia (abnormal sensations like pins and needles), vertigo (a spinning sensation), sleepiness, mucositis (inflammation of the mucous membranes, such as the lining of the mouth), vomiting, diarrhoea, nausea (feeling sick), epigastric discomfort (discomfort around the stomach), skin rash, myasthenia (muscle weakness), adrenal insufficiency (reduced adrenal gland activity), loss of appetite, asthenia (weakness), gynaecomastia (breast enlargement) and confusion.
Danish: De almindeligste bivirkninger ved Lysodren (der optræder hos flere end 1 ud af 10 patienter) er forhøjet antal leverenzymer, forhøjet indhold af kolesterol og triglycerider (en bestemt type fedtstoffer) i blodet, for lavt indhold af hvide blodlegemer, forlænget blødningstid, forstyrrelse i samordningen af bevægelser, føleforstyrrelser som prikken og stikken, svimmelhed, søvnighed, slimhindebetændelse f.eks. i munden, opkastning, diarré, kvalme, ubehagsfølelse i maven, udslæt, muskelsvaghed, nedsat binyrefunktion, anoreksi, slaphed, gynækomasti (brystforstørrelse) og forvirring.
English: The studies included over 500 adults and children, who were treated for various lengths of time with mitotane, either alone or in combination with other anticancer medicines.
Danish: Undersøgelserne omfattede over 500 voksne og børn, der blev behandlet i forskellige tidsrum med mitotan, anvendt enten alene eller i kombination med andre kræftmidler.
English: The recommended starting dose in adults is 2 to 3 g per day, divided into two or three doses, taken with meals containing fatty food.
Danish: Den anbefalede startdosis til voksne er 2-3 g dagligt, fordelt på to eller tre doser, der tages sammen med fedtholdige måltider.
English: For more information about treatment with Lysodren, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lysodren, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The dose is increased in a stepwise manner until it reaches an ‘optimal' dose that gives the best results without causing unacceptable side effects.
Danish: Dosis øges trinvis til en ”optimal” dosis, hvor virkningen er bedst uden uacceptable bivirkninger.
English: Lysodren is a medicine that contains the active substance mitotane.
Danish: Lysodren er et lægemiddel, der indeholder det aktive stof mitotan.
English: The full EPAR for Lysodren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lysodren findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It should also be used with caution in elderly patients, with frequent monitoring of blood levels.
Danish: Hos ældre patienter bør det også anvendes med forsigtighed, og koncentrationen i blodet bør kontrolleres ofte.
English: Patients who take Lysodren should receive the ‘Lysodren patient card' that they should carry with them in case of emergency, to inform healthcare professionals (such as doctors and nurses) that they are taking the medicine.
Danish: Patienter, der får Lysodren, skal have udleveret et patientkort, som de skal have på sig, for at sundhedspersonalet (f.eks. læger og sygeplejersker) i en nødsituation kan se, at de får medicinen.
English: Overall, the studies suggested that Lysodren could provide a benefit in patients with advanced adrenal cortical carcinoma, by increasing survival times (by over five years in a few cases) and causing shrinkage or stabilisation of tumour size in 20 to 30% of patients.
Danish: Tilsammen viste undersøgelserne, at Lysodren kan være til gavn hos patienter med fremskreden binyrebarkkræft dels ved at overlevelsestiden forlænges (i enkelte tilfælde med over fem år), dels ved at svulsten svinder eller stabiliseres hos 20 til 30 % af patienterne.
English: The Committee recommended that Lysodren be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Lysodren.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Lysodren 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 Lysodren findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Lysodren must not be used in people who are hypersensitive (allergic) to mitotane or any of the other ingredients.
Danish: Lysodren må ikke anvendes til personer, som er overfølsomme (allergiske) over for mitotan eller nogen af indholdsstofferne.
English: It must not be used in patients who are breast-feeding or who are taking spironolactone (a diuretic).
Danish: Det må ikke anvendes hos patienter, der ammer eller får spironolacton (et vanddrivende middel).
English: What is the risk associated with Lysodren?
Danish: Hvilken risiko er der forbundet med Lysodren?
English: It also reduced the symptoms of the disease, particularly in patients whose cancer was producing high hormone levels.
Danish: Det mindskede desuden sygdomssymptomerne, navnlig hos patienter, hos hvem sygdommen medfører forhøjet hormonindhold.
English: Because the number of patients with adrenal cortical carcinoma is low, the disease is considered ‘rare', and Lysodren was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 June
Danish: Da der kun findes få patienter med binyrekræft, blev, blev Lysodren udpeget som "lægemiddel til sjældne sygdomme" den 12. juni 2002
English: It presented the results of 220 studies published since 1990 on the use of the medicine in unresectable, metastatic adrenal cortical carcinoma.
Danish: Firmaet fremlagde resultaterne af 220 undersøgelser, der er offentliggjort siden 1990 og vedrører anvendelsen af dette lægemiddel ved ikke opererbar metastatisk binyrebarkkræft.
English: Together, these effects reduce the levels of the hormones in the body, improving the symptoms of the disease.
Danish: Tilsammen mindsker disse virkninger indholdet af hormoner i kroppen og dermed sygdomssymptomerne.
English: The main measures of effectiveness in the studies included survival time, the reduction in tumour size and the time spent free of the symptoms of the disease.
Danish: I undersøgelserne blev virkningen hovedsagelig bedømt på overlevelsestiden, mindskelsen i svulstens størrelse og det tidsrum, patienterne var symptomfri.
English: The CHMP decided that Lysodren's benefits are greater than its risks for the treatment of advanced adrenal cortical carcinoma, but noted that the effect of Lysodren has not been established in adrenal cortical carcinoma that is not producing high levels of steroid hormones.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Lysodren opvejer risiciene til behandling af fremskreden binyrebarkkræft, men at det ikke var bevist, at Lysodren virker ved binyrebarkkræft, der ikke forårsager store mængder steroidhormoner.
English: The active substance in Lysodren, mitotane, is thought to work by preventing cells in the adrenal gland from working properly, by damaging their mitochondria (the energy-producing components), reducing the production of some steroid hormones.
Danish: Det aktive stof i Lysodren, mitotan, menes at virke ved at forhindre cellerne i binyrerne i at fungere korrekt, fordi det beskadiger mitokondrierne (de energiproducerende cellebestanddele).
English: Why has Lysodren been approved?
Danish: Hvorfor blev Lysodren godkendt?
English: The levels of the active substance in the blood should be monitored frequently, with the final target dose aiming to reach blood levels between 14 and 20 mg per litre.
Danish: Den endelige dosis bør resultere i en koncentration i blodet på mellem 14 og 20 mg pr. liter.
English: For the full list of all side effects reported with Lysodren, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Lysodren fremgår af indlægssedlen.
English: It is used when the cancer is unresectable (cannot be removed by surgery), is metastatic (has spread to other parts of the body), or has relapsed (returned after treatment).
Danish: Det anvendes, hvis kræften ikke kan fjernes ved operation, hvis den har bredt sig fra det oprindelige sygdomssted til andre dele af kroppen, eller hvis der er kommet tilbagefald af sygdommen efter behandling.
English: When this area develops cancer, levels of these hormones can increase, causing the symptoms of the disease.
Danish: Hvis der udvikles kræft i dette område, kan indholdet af disse hormoner stige.
English: There is limited information on the use of Lysodren in children, but a daily starting dose of 1.5 to 3.5 g per square metre body surface area (calculated using the child's height and weight) is recommended.
Danish: Der anbefales imidlertid en startdosis på 1,5 til 3,5 g dagligt pr. kvadratmeter legemsoverflade, beregnet efter barnets højde og vægt.
English: Limited information was available on the use of mitotane in children, but overall, the children remained disease free for an average of seven months when taking the medicine.
Danish: Alt i alt blev børnene dog sygdomsfri i gennemsnitligt syv måneder, når de fik medicinen.
English: What is Lysodren?
Danish: Hvad er Lysodren?
English: The cortex of the adrenal gland produces steroid hormones.
Danish: Binyrebarken producerer hormoner, der kaldes steroider.
English: A starting dose of 4 to 6 g per day can be used in patients who need urgent control of Cushing's syndrome (a set of symptoms of adrenal gland cancer caused by high hormone levels).
Danish: Til patienter med tvingende behov for behandling af Cushings syndrom (et symptomkompleks, der optræder ved binyrekræft og skyldes højt hormonindhold) kan anvendes en startdosis på 4 til 6 g dagligt.
English: Since the active substance in Lysodren, mitotane, is a well-established medicine that has been used in the treatment of adrenal cortical carcinoma in Europe since 1959, the company presented information from the published literature to support its application for Lysodren.
Danish: Det aktive stof i Lysodren, mitotan, er et gennemprøvet lægemiddel, der har været anvendt til behandling af binyrebarkkræft i Europa siden 1959.
English: The dose may be reduced or treatment interrupted if the patient experiences side effects.
Danish: Hvis patienter får bivirkninger, kan dosis nedsættes eller behandlingen ophøre.
English: How has Lysodren been studied?
Danish: Hvordan blev Lysodren undersøgt?
English: Lysodren is used to treat the symptoms of advanced adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland).
Danish: Lysodren anvendes til behandling af symptomerne på fremskreden binyrebarkkræft.
English: What benefit has Lysodren shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Lysodren?
English: What is Lysodren used for?
Danish: Hvad anvendes Lysodren til?
English: How is Lysodren used?
Danish: Hvordan anvendes Lysodren?
English: Lysodren is not recommended for use in patients with severe liver or kidney problems, and it should be used with caution in those with mild or moderate liver or kidney problems.
Danish: Ved lette til moderate lever- eller nyreproblemer bør det anvendes med forsigtighed.
English: How does Lysodren work?
Danish: Hvordan virker Lysodren?
English: This overview was last updated in 11-2018.
Danish: Denne oversigt blev sidst ajourført i 11-2018.
English: Afinitor received a marketing authorisation valid throughout the EU on 03 August 2009.
Danish: Afinitor fik en markedsføringstilladelse med gyldighed i hele EU den 3. august 2009.
English: This complex then blocks mTOR.
Danish: Dette kompleks hæmmer derefter mTOR.
English: Other information about Afinitor
Danish: Andre oplysninger om Afinitor
English: Further information on Afinitor can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Afinitor.
Danish: Yderligere information om Afinitor findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Afinitor.
English: Afinitor is available as tablets (2.5, 5 and 10 mg) and the recommended dose is 10 mg once a day.
Danish: Lægemidlet fås som tabletter (2,5, 5 og 10 mg), og den anbefalede startdosis er 10 mg en gang dagligt.
English: Doses need to be reduced for patients with liver problems.
Danish: Dosis skal reduceres hos patienter med leverproblemer.
English: As for all medicines, data on the use of Afinitor are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Afinitor løbende overvåget.
English: Treatment should continue for as long as it works or until side effects become unacceptable.
Danish: Behandlingen bør fortsættes, så længe den virker, eller indtil patientens bivirkninger bliver uacceptable.
English: What is Afinitor and what is it used for?
Danish: Hvad er Afinitor, og hvad anvendes det til?
English: The doctor may reduce the dose or stop treatment for a short period if the patient has severe or intolerable side effects.
Danish: Lægen kan reducere dosen eller afbryde behandlingen i en kort periode, hvis patienten får alvorlige eller utålelige bivirkninger.
English: What measures are being taken to ensure the safe and effective use of Afinitor?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Afinitor?
English: Afinitor is a cancer medicine used to treat the following cancers:
Danish: Afinitor er et kræftlægemiddel, der anvendes til behandling af følgende kræfttyper:
English: The European Medicines Agency decided that Afinitor's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Afinitor opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: This slows down the growth and spread of the cancer.
Danish: Dette forsinker kræftens vækst og spredning.
English: For more information about using Afinitor, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Afinitor, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Why is Afinitor authorised in the EU?
Danish: Hvorfor blev Afinitor godkendt i EU?
English: Afinitor contains the active substance everolimus.
Danish: Afinitor indeholder det aktive stof everolimus.
English: An overview of Afinitor and why it is authorised in the EU
Danish: En oversigt over Afinitor, og hvorfor det er godkendt i EU
English: Side effects reported with Afinitor are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Afinitor vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What are the risks associated with Afinitor?
Danish: Hvilke risici er der forbundet med Afinitor?
English: In the body, everolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Danish: I kroppen binder everolimus sig først til et protein kaldet FKBP-12, der findes i cellerne, hvorved det danner et "kompleks".
English: Afinitor can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer treatments.
Danish: Afinitor udleveres kun efter recept, og behandlingen bør iværksættes og følges af en læge med erfaring i brug af kræftlægemidler.
English: It is used when the cancer is metastatic (has spread to other parts of the body) or when it cannot be surgically removed;
Danish: Det anvendes, hvis kræften er metastatisk (dvs. har bredt sig til andre dele af kroppen) eller ikke kan fjernes ved operation
English: The most common side effects with Afinitor (which may affect more than 1 in 10 people) are rash, itching, nausea, decreased appetite, dysgeusia (taste disturbances), headache, weight loss, peripheral oedema (swelling, especially of the ankles and feet), cough, anaemia (low red blood cell counts), tiredness, diarrhoea, weakness, infections, stomatitis (inflammation of the lining of the mouth), hyperglycaemia (high blood glucose levels), hypercholesterolaemia (high blood cholesterol levels), pneumonitis (inflammation of the lungs) and nosebleeds.
Danish: De hyppigste bivirkninger ved Afinitor (som kan forekomme hos op til 1 ud af 10 personer) er udslæt, kløe, kvalme, nedsat appetit, smagsforstyrrelser, hovedpine, vægttab, perifert ødem (hævelse, især på ankler og fødder), hoste, anæmi (lavt antal røde blodlegemer), træthed, diarré, kraftesløshed, infektioner, inflammation af mundslimhinden (stomatitis), højt blodsukkerniveau (hyperglykæmi),
English: Pancreatic neuroendocrine tumours
Danish: Pancreatiske neuroendokrine tumorer
English: The active substance in Afinitor, everolimus, blocks an enzyme called ‘mammalian target of rapamycin' (mTOR).
Danish: Det aktive stof i Afinitor, everolimus, blokerer et enzym, der kaldes det "mammale mål for rapamycin" ("mammalian target of rapamycin", mTOR).
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply.
Danish: Da mTOR medvirker til at kontrollere cellernes deling og blodkarrenes vækst, forhindrer Afinitor tumorcellerne i at dele sig og reducerer blodforsyningen til dem.
English: Afinitor must not be used in people who are hypersensitive (allergic) to other rapamycin derivatives (substances with a similar structure to everolimus) or to any of the other ingredients.
Danish: Afinitor må ikke anvendes til personer, der er overfølsomme (allergiske) over for andre rapamycinderivater (stoffer med en struktur, der ligner everolimus') eller andre af indholdsstofferne.
English: The tablets should be taken at the same time every day and consistently with or without food.
Danish: Tabletterne bør tages på samme tid hver dag.
English: • breast cancer that is advanced (has started to spread) in women who have been through their menopause.
Danish: • brystkræft, der er fremskreden (er begyndt at brede sig) hos kvinder efter overgangsalderen.
English: The Agency also concluded that the 7-month delay in disease progression for patients with neuroendocrine tumours originating in the lungs or gut was valuable, despite the known side effects of Afinitor.
Danish: Agenturet konkluderede endvidere, at den 7-måneders forsinkelse af sygdommens fremadskriden hos patienter med neuroendokrine tumorer med oprindelse i lungerne eller tarmen var værdifuld trods de kendte bivirkninger ved Afinitor.
English: Afinitor is used in breast cancer that is ‘hormone receptor-positive' (when the cancer cells have oestrogen receptors on their surface) and ‘HER2/neu negative' (when the cancer cells do not contain high levels of the HER2/neu [human epidermal growth factor receptor-2] protein).
Danish: Afinitor anvendes til behandling af brystkræft, der er "hormonreceptor-positiv" (hvor kræftcellerne har østrogenreceptorer på overfladen) og "HER2/neu-negativ" (hvor kræftcellerne ikke har et højt indhold af proteinet HER2/neu [human epidermal vækstfaktorreceptor-2]).
English: • advanced renal cell carcinoma (a kidney cancer), when the cancer has worsened despite treatment with a ‘VEGF-targeted' medicine (a type of medicine that blocks the effects of vascular endothelial growth factor proteins).
Danish: • fremskredent renalcellekarcinom (nyrekræft), når kræften er forværret på trods af behandling med en type lægemidler kaldet VEGF-hæmmere (der blokerer virkningerne af vaskulære endoteliale vækstfaktorproteiner).
English: • neuroendocrine tumours originating in the lungs or gut, when the cancer cells are welldifferentiated and the cancer is metastatic or cannot be removed by surgery.
Danish: • neuroendokrine tumorer med oprindelse i lungerne eller tarmen, når kræftcellerne er veldifferentierede, og kræften er metastatisk eller ikke kan fjernes ved operation
English: Afinitor is used together with a medicine called exemestane after other treatments called ‘nonsteroidal aromatase inhibitors' have not worked;
Danish: Afinitor anvendes sammen med lægemidlet exemestan, når behandling med en anden type lægemidler kaldet nonsteroide aromatasehæmmere ikke har virket
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) when the cancer cells are well- or moderately differentiated (which means that they can be distinguished from normal pancreas cells).
Danish: • pancreatiske neuroendokrine tumorer (tumorer i de hormonproducerende celler i bugspytkirtlen), hvor kræftcellerne er veldifferentierede eller moderat differentierede (hvilket betyder, at det er muligt at skelne dem fra normale celler i bugspytkirtlen).
English: Afinitor slowed down disease progression in patients with advanced neuroendocrine tumours of pancreatic origin, advanced renal cell carcinoma and hormone-receptorpositive advanced breast cancer.
Danish: Afinitor hæmmede sygdommens fremadskriden hos patienter med fremskredne neuroendokrine tumorer med oprindelse i bugspytkirtlen, fremskredent renalcellekarcinom og hormonreceptorpositiv fremskreden brystkræft.
English: Afinitor was studied in 416 patients with advanced renal cell carcinoma that had got worse despite treatment with VEGF-targeted medicines (sunitinib, sorafenib or both).
Danish: Afinitor blev undersøgt i et studie med 416 patienter med fremskredent renalcellekarcinom, som var blevet værre trods behandling med VEGF-hæmmende lægemidler (sunitinib, sorafenib eller begge).
English: Afinitor in combination with exemestane has been studied in 724 patients with hormone receptorpositive and HER2/neu-negative advanced breast cancer which had got worse after treatment with letrozole and anastrazole (non-steroidal aromatase inhibitors).
Danish: Afinitor i kombination med exemestan blev undersøgt i et studie med 724 patienter med hormonreceptorpositiv og HER2/neu-negativ fremskreden brystkræft, der var blevet værre efter behandling med letrozol og anastrazol ("non-steroide aromatasehæmmere").
English: For the full list of side effects of Afinitor, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Afinitor fremgår af indlægssedlen.
English: How is Afinitor used?
Danish: Hvordan anvendes Afinitor?
English: What benefits of Afinitor have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Afinitor?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Afinitor have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Afinitor.
English: Neuroendocrine tumours originating in the lung or gut
Danish: Neuroendokrine tumorer med oprindelse i lungerne eller tarmen
English: Afinitor was studied in 302 patients with advanced neuroendocrine tumours of lung or gut origin.
Danish: Afinitor blev undersøgt i et studie med 302 patienter med fremskredne neuroendokrine tumorer med oprindelse i lungerne eller tarmen.
English: Patients who received Afinitor and best supportive treatments lived for an average of 11 months without the disease getting worse compared with around 4 months for patients who received placebo and best supportive treatments to relieve disease symptoms.
Danish: De patienter, som fik Afinitor og den bedste understøttende behandling, levede i gennemsnit 11 måneder, uden at sygdommen blev værre, sammenlignet med ca. 4 måneder for de patienter, der fik placebo og den bedste understøttende behandling for at lindre symptomerne på sygdommen.