FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.
Danish: Ydermere skal virksomheden foretage analyser for at finde ud af, hvilke patienter der kan forventes at have størst fordel af behandling med Keytruda.
English: Keytruda partially or completely clears cancer cells in classical Hodgkin lymphoma that has not improved or had returned after treatment with brentuximab vedotin, with or without an autologous stem cell transplantation.
Danish: Keytruda fjerner helt eller delvist kræftcellerne ved klassisk Hodgkins lymfom, som ikke er forbedret, eller som var vendt tilbage efter behandling med brentuximab vedotin, med eller uden autolog stamcelletransplantation.
English: Before starting treatment, patients with NSCLC, previously untreated urothelial cancer or HNSCC should have tests to check their levels of PD-L1.
Danish: Før behandlingen indledes, bør patienter med NSCLC, tidligere ubehandlet urotelial kræft eller HNSCC have tjekket deres niveau af PD-L1.
English: For more information about using Keytruda, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Keytruda, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Keytruda contains the active substance pembrolizumab.
Danish: Keytruda indeholder det aktive stof pembrolizumab.
English: Keytruda is given as an infusion (drip) into a vein.
Danish: Keytruda gives som infusionsvæske (drop) i en vene.
English: The most common side effects of Keytruda given alone (which may affect more than 1 in 5 people) are tiredness, nausea (feeling sick) and diarrhoea.
Danish: De hyppigste bivirkninger ved Keytruda (som optræder hos mere end 1 ud af 5 patienter) er træthed, kvalme og diarré.
English: By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the immune system's ability to kill the cancer cells.
Danish: Ved at blokere PD-1 forhindrer pembrolizumab kræften i at afbryde disse immuncellers aktivitet, og derved øges immunsystemets evne til at dræbe kræftcellerne.
English: Some cancers can make a protein (PD-L1) that combines with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Danish: Nogle kræftformer kan danne et protein (PD-L1), der i kombination med PD-1 indvirker på visse celler i immunsystemet (kroppens naturlige forsvar) ved at afbryde deres aktivitet og forhindre dem i angribe kræften.
English: • classical Hodgkin lymphoma, a cancer of the white blood cells,
Danish: • klassisk Hodgkins lymfom, en form for kræft i de hvide blodlegemer
English: Non-small cell lung cancer (NSCLC)
Danish: Ikkesmåcellet lungekræft (NSCLC)
English: Another study in 882 patients with HNSCC showed that Keytruda alone or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy is effective at prolonging patients' lives when HNSCC tests positive for a certain level of PD-L1.
Danish: Et andet studie hos 882 patienter med HNSCC viste, at Keytruda alene eller i kombination med platinog 5-fluorouracilbaseret (5-FU) kemoterapi er effektivt til at forlænge patienternes liv, når HNSCC testes positiv for et vist niveau af PD-L1.
English: Keytruda is also effective in combination treatment of a type of NSCLC known as ‘non-squamous' cancer, based on the type of cancer cells involved.
Danish: Keytruda er også effektivt som kombinationsbehandling for en type NSCLC kaldet ikkeplanocellulær kræft, baseret på den pågældende type cancercelle.
English: What are the risks associated with Keytruda?
Danish: Hvilke risici er der forbundet med Keytruda?
English: Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).
Danish: Keytruda forsinkede ikke forværring af sygdommen sammenlignet med de andre kræftlægemidler (der gik henholdsvis to og tre måneder, inden sygdommen forværredes).
English: A third study in 1,019 patients who had had surgery and who were at high risk for their cancer coming back compared Keytruda to placebo (a dummy treatment).
Danish: I et tredje studie med 1.019 patienter, der var blevet opereret og havde stor risiko for, at kræften vendte tilbage, blev Keytruda sammenlignet med placebo (en uvirksom behandling).
English: For the other cancers, Keytruda is only used on its own.
Danish: Til de øvrige kræftformer anvendes Keytruda alene.
English: Skin cancer
Danish: Hudkræft
English: • melanoma, a skin cancer,
Danish: • melanomer, en form for hudkræft
English: In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.
Danish: Ved nogle kræftformer gives det kun til patienter, hvis tumorer danner store mængder af et bestemt protein (PD-L1).
English: At 18 months, 81% of the patients given the combination were alive, compared with 71% in the sunitinib group.
Danish: Efter 18 måneder var 81% af de patienter, der fik kombinationsbehandlingen, stadig i live, sammenlignet med 71% af dem, der fik sunitinib.
English: A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine).
Danish: Et studie omfattede 542 patienter, der tidligere var blevet behandlet med platinbaserede lægemidler, og som fik enten Keytruda eller et andet kræftlægemiddel valgt af lægen (paclitaxel, docetaxel eller vinflunin).
English: For renal cell carcinoma, Keytruda is used in combination with other cancer medicines.
Danish: Til nyrecellekarcinom anvendes Keytruda i kombination med andre kræftlægemidler.
English: After one and a half years of treatment, 72% of patients on Keytruda were still disease-free compared with 54% of patients on placebo.
Danish: Efter halvandet års behandling var 72 % af de patienter, der fik Keytruda, stadig sygdomsfrie sammenlignet med 54 % af de patienter, der fik placebo.
English: A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab.
Danish: Et andet studie omfattede 834 patienter med melanomer, som fik enten Keytruda eller et andet lægemiddel (ipilimumab).
English: Also, up to 74% of patients treated with Keytruda lived for at least 12 months after the start of their treatment compared with 59% of patients on ipilimumab.
Danish: Endvidere levede op til 74 % af de patienter, der blev behandlet med Keytruda, i mindst 12 måneder efter påbegyndelsen af deres behandling, sammenholdt med 59 % af dem, der fik ipilimumab.
English: In a further study of 559 patients with ‘squamous' NSCLC that had spread, patients given Keytruda with carboplatin and paclitaxel or nab-paclitaxel lived on average for 15.9 months compared with 11.3 months for patients given placebo with carboplatin and paclitaxel or nab-paclitaxel.
Danish: I et yderligere studie, der omfattede 559 patienter med planocellulært NSCLC, som havde spredt sig, levede de patienter, der fik Keytruda sammen med carboplatin og paclitaxel eller nab-paclitaxel, i gennemsnit 15,9 måneder sammenlignet med 11,3 måneder for de patienter, der fik placebo sammen med carboplatin og paclitaxel eller nab-paclitaxel.
English: Patients treated with Keytruda lived on average around 10 months compared with around 7 months with the other cancer medicines.
Danish: De patienter, der blev behandlet med Keytruda, levede i gennemsnit ca. 10 måneder sammenlignet med ca. 7 måneder for de andre kræftlægemidler.
English: Keytruda is also effective in preventing melanoma from coming back in patients who have had surgery.
Danish: Keytruda er også effektivt til at forhindre melanomer i at vende tilbage hos patienter, der er blevet opereret.
English: Results from a study of 540 previously treated patients with melanoma showed that 2 years after start of treatment, the disease had not worsened in 16% of patients treated with Keytruda compared with less than 1% of patients treated with chemotherapy.
Danish: Resultater fra et studie med 540 tidligere behandlede patienter med melanomer viste, at sygdommen 2 år efter påbegyndelse af behandlingen ikke var forværret hos 16 % af de patienter, der blev behandlet med Keytruda, sammenholdt med under 1 % af dem, der blev behandlet med kemoterapi.
English: In a study of 495 patients, patients treated with Keytruda who had high levels of PD-L1 lived on average for 11.6 months while those taking standard cancer treatments lived for 6.6 months.
Danish: I et studie med 495 patienter levede de patienter, der fik Keytruda, og som havde høje niveauer af PD-L1, i gennemsnit 11,6 måneder, mens dem, der fik standardkræftbehandlinger, levede i 6,6 måneder.
English: Keytruda is effective at improving survival or delaying the worsening of disease in patients with advanced cancers or cancers that have spread or come back.
Danish: Keytruda er effektivt til at forbedre overlevelsen eller sinke forværring af sygdommen hos patienter med fremskreden kræft eller kræft, som har spredt sig eller er vendt tilbage.
English: For the full list of side effects and restrictions with Keytruda, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Keytruda fremgår af indlægssedlen.
English: How is Keytruda used?
Danish: Hvordan anvendes Keytruda?
English: Keytruda is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments.
Danish: • nyrecellekarcinom (en form for kræft i nyrerne) Keytruda anvendes primært mod kræft, der er fremskreden, eller som har spredt sig til andre dele af kroppen (metastatisk), eller som ikke reagerer på andre behandlinger.
English: In this study, disease did not get worse for 5.1 months on average in patients taking Keytruda combination, 3.2 months in patients taking Keytruda alone and 5.0 months in patients taking other standard treatments.
Danish: I dette studie blev sygdommen ikke forværret i 5,1 måneder i gennemsnit hos de patienter, der fik Keytruda-kombinationen, 3,2 måneder hos patienter, der fik Keytruda alene, og 5,0 måneder hos patienter, der fik andre standardbehandlinger.
English: In a study looking at around 1,000 previously treated patients, patients lived longer with Keytruda given alone (around 11 months) than with another cancer medicine called docetaxel (around 8 months) and the period during which the disease did not get worse was around 4 months with both treatments.
Danish: I et studie med ca. 1.000 tidligere behandlede patienter levede patienterne længere ved behandling med Keytruda alene (ca. 11 måneder) end ved behandling med et andet kræftlægemiddel kaldet docetaxel (ca. 8 måneder), og den periode, hvor sygdommen ikke forværredes, var ca. 4 måneder for begge behandlinger.
English: Keytruda is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma (adjuvant therapy).
Danish: Keytruda anvendes også til at forhindre kræft i at vende tilbage, efter at patienterne har fået fjernet melanomer ved operation (tillægsbehandling).
English: • a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC),
Danish: • kræft i hovedet og halsen kaldet planocellulært karcinom i hoved- og halsregionen (HNSCC)
English: In a study of 616 patients with non-squamous NSCLC that had spread, 69% of patients taking Keytruda with pemetrexed and platinum chemotherapy were alive at 11 months, compared with less than half of patients who had only pemetrexed and platinum chemotherapy.
Danish: I et studie med 616 patienter med ikkeplanocellulært NSCLC, der havde spredt sig, var 69 % af de patienter, der fik Keytruda sammen med pemetrexed og platinbaseret kemoterapi, i live efter 11 måneder sammenholdt med mindre end halvdelen af de patienter, som kun fik pemetrexed og platinbaseret kemoterapi.
English: Patients in the Keytruda group lived on average for around 6 months without their disease getting worse compared with 4.8 months for patients in the placebo group.
Danish: Patienterne i Keytruda-gruppen levede i gennemsnitligt ca. 6 måneder uden forværring af sygdommen sammenholdt med 4,8 måned for patienterne i placebogruppen.
English: Patients treated with Keytruda lived for up to 5.6 months without their disease getting worse compared with 2.8 months with ipilimumab.
Danish: De patienter, der fik Keytruda, levede i op til 5,6 måneder uden at sygdommen blev værre, sammenholdt med 2,8 måneder for ipilimumab.
English: Keytruda improves survival of patients with urothelial cancer.
Danish: Keytruda forbedrer overlevelsen hos patienter med urotelial kræft.
English: Keytruda is also effective in delaying worsening of the disease and improving survival in patients with NSCLC that tested positive for the PD-L1 protein.
Danish: Keytruda er også effektivt til at sinke forværringen af sygdommen og forbedre overlevelsen hos patienter med ikke-småcellet lungekræft, der er testet positiv for PD-L1-proteinet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Keytruda have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Keytruda.
English: How does Keytruda work?
Danish: Hvordan virker Keytruda?
English: In a study of 861 patients with renal cell carcinoma, patients given Keytruda in combination with an already authorised medicine for renal cell carcinoma, axitinib, lived for around 15 months without their disease getting worse, compared with 11 months for patients who received treatment with another renal cell carcinoma medicine, sunitinib, which was used as a control treatment.
Danish: I et studie hos 861 patienter med nyrecellekarcinom levede de patienter, der fik Keytruda kombineret med et lægemiddel, der allerede er godkendt til behandling af nyrecellekarcinom, i 15 måneder, uden at sygdommen forværredes, sammenlignet med 11 måneder for patienter, der fik behandling med et andet lægemiddel mod nyrecellekarcinom, sunitinib, der blev anvendt som kontrolbehandling.
English: In addition, patients taking Keytruda alone lived on average 12.3 months compared with 10.3 months for patients taking other standard treatments.
Danish: Desuden levede de patienter, der fik Keytruda alene, i gennemsnit 12,3 måneder sammenlignet med 10,3 måneder for patienter, der fik andre standardbehandlinger.
English: In addition, patients who had Keytruda treatment lived on average for 8.8 months without the disease getting worse compared with 4.9 months for patients who were not given Keytruda.
Danish: De patienter, der blev behandlet med Keytruda, overlevede desuden i gennemsnit 8,8 måneder uden sygdomsforværring sammenholdt med 4,9 måneder for de patienter, der ikke fik Keytruda.
English: In a main study of 210 patients, Keytruda produced a complete or partial remission (clearing) of the cancer in 145 patients (69%); a complete remission occurred in 47 (22%) of them, meaning they no longer had any signs of cancer.
Danish: I et hovedstudie med 210 patienter medførte Keytruda fuld eller delvis remission (bedring) af kræften hos 145 patienter (69 %).
English: What benefits of Keytruda have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Keytruda?
English: Keytruda is also effective in improving survival of patients with head and neck squamous cell carcinoma (HNSCC) that had spread or come back.
Danish: Keytruda er også effektivt til forbedring af overlevelsen hos patienter med planocellulært karcinom i hoved- og halsregionen (SCCHN), der har spredt sig eller er vendt tilbage.
English: Keytruda is also effective in improving survival of patients with renal cell cancer.
Danish: Keytruda er også effektivt til at forbedre overlevelsen af patienter med nyrecellekræft.
English: In a second lung cancer study of 305 patients whose tumours tested strongly for PD-L1 who had not been treated before, patients on Keytruda lived for around 10 months without their disease getting worse compared with 6 months in patients receiving platinum-based chemotherapy.
Danish: Et andet lungekræftstudie med 305 patienter, der ikke tidligere var blevet behandlet, og hvis tumorer testede stærkt positive for PD-L1, viste, at de patienter, som fik Keytruda, levede i ca. 10 måneder, uden at deres sygdom forværredes, sammenholdt med 6 måneder for patienter, som fik platinbaseret kemoterapi.
English: In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 30 (8%) of them, meaning they no longer had any signs of cancer.
Danish: I et andet hovedstudie med 370 patienter, som ikke kunne behandles med cisplatinholdige lægemidler, medførte Keytruda fuld eller delvis remission (bedring) af kræften hos 108 patienter (29 %).
English: The average time that patients lived without their disease getting worse again was around 11 months.
Danish: Patienterne levede i gennemsnit ca. 11 måneder uden sygdomsforværring.
English: • urothelial cancer, a cancer of the bladder and urinary tract,
Danish: • urotelial kræft, en form for kræft i blæren og urinvejene
English: Head and neck cancer
Danish: Hoved- og halskræft
English: • non-small cell lung cancer (NSCLC), a type of lung cancer,
Danish: • ikkesmåcellet lungekræft (NSCLC)
English: Patients taking the Keytruda combination lived on average for 13.6 months compared with 10.4 months for patients taking other standard treatments.
Danish: De patienter, der fik Keytruda, levede i gennemsnit i 13,6 måneder sammenlignet med 12,3 måneder for de patienter, der fik Keytruda alene, og 10,4 måneder for de patienter, der fik andre standardbehandlinger.
English: Keytruda was more effective in patients who tested strongly for PD-L1, with these patients living for 15 months on average, 5 months of which without their disease worsening.
Danish: Keytruda var mere effektivt hos patienter, der testede stærkt positive for PD-L1.
English: Kidney cancer
Danish: Nyrekræft
English: --1 1 dose (0.5 ml) contains:
Danish: --1 En dosis (0,5 ml) indeholder::
English: Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
Danish: Rekombinant lipideret fHbp (faktor H bindingsprotein) Produceret i Escherichia coli-celler vha. rekombinant DNA-teknologi Adsorberet på aluminiumphosphat (0,25 milligram aluminium pr. dosis)
English: Neisseria meningitidis serogroup B fHbp subfamily A
Danish: Neisseria meningitidis serogruppe B fHbp underfamilie A
English: Neisseria meningitidis serogroup B fHbp subfamily B
Danish: Neisseria meningitidis serogruppe B fHbp underfamilie B
English: 1 pre-filled syringe with needle
Danish: 1 fyldt injektionssprøjte med kanyle
English: The recommended dose is 0.14 mg per kilogram body weight, once a day for five days.
Danish: Den anbefalede dosis er 0,14 mg pr. kg legemsvægt én gang dagligt i fem dage i træk.
English: Other information about Litak:
Danish: Andre oplysninger om Litak:
English: The marketing authorisation was renewed on 14 April 2009.
Danish: Markedsføringstilladelsen blev fornyet den 14. april 2009.
English: In the main study, 97% of the patients had either complete or partial remission (60 out of 62), and 76% had complete remission (47 out of 62).
Danish: I hovedundersøgelsen oplevede 97 % af patienterne enten en fuldstændig eller delvis bedring (60 ud af 62), og 76 % oplevede fuldstændig bedring (47 ud af 62).
English: The European Commission granted a marketing authorisation valid throughout the EU for Litak to Lipomed GmbH on 14 April 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Litak til Lipomed GmbH den 14. april 2004.
English: Because cladribine has been used for a number of years, the company presented data from the published literature.
Danish: Da cladribin har været anvendt i en række år, fremlagde virksomheden data fra den offentliggjorte litteratur.
English: Litak was not compared with any other treatments in this study.
Danish: Litak blev ikke sammenlignet med andre behandlinger i den undersøgelse.
English: Litak is given as an injection under the skin.
Danish: Litak gives som en injektion under huden.
English: Litak treatment should be started by a doctor who has experience in the use of cancer treatments.
Danish: Behandling med Litak skal startes af en læge med erfaring i kræftbehandling.
English: The Committee recommended that Litak be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Litak.
English: The most common side effects with Litak (seen in more than 1 patient in 10) are infections, pancytopenia or myelosuppression (low blood cell counts), purpura (bruising), immunosuppression (a weakened immune system), decreased appetite, headache, dizziness, abnormal breath and chest sounds, cough, nausea (feeling sick), vomiting, constipation, diarrhoea, rash, localised exanthema (skin eruptions), diaphoresis (excessive sweating), injection site reactions (pain and inflammation at the site of injection), fever, fatigue (tiredness), chills and asthenia (weakness).
Danish: De almindeligste bivirkninger ved Litak (om optræder hos flere end 1 ud af 10 patienter) er infektioner, for lavt antal blodlegemer, blå mærker, svækket immunsystem, nedsat appetit, hovedpine, svimmelhed, unormale lyde ved vejrtrækning og fra brystet, hoste, kvalme, opkast, forstoppelse, diarré, udslæt, lokaliseret exanthem (hududslæt), overdreven sveden, smerter og betændelse på injektionsstedet, feber, træthed, kulderystelser og svaghed.
English: The main measures of effectiveness were the numbers of patients who had complete and partial remission following treatment.
Danish: De primære mål for virkning var antallet af patienter, der opnåede fuldstændig og delvis bedring af deres tilstand efter behandlingen.
English: CdATP can also affect other cells, particularly other types of blood cell, which can cause side effects.
Danish: CdATP kan også påvirke andre celler, især andre typer blodceller, og dét kan fremkalde bivirkninger.
English: What is the risk associated with Litak?
Danish: Hvilken risiko er der forbundet med Litak?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LITAK EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) LITAK EPAR - sammendrag for offentligheden
English: It belongs to the group of anticancer medicines called ‘antimetabolites'.
Danish: Det hører til den gruppe af lægemidler mod kræft, der hedder antimetabolitter.
English: Complete remission is the disappearance of all evidence of disease, whereas partial remission is improved blood counts and the reduction in the number of cancerous cells.
Danish: Fuldstændig bedring er defineret som forsvinden af alle tegn på sygdommen, mens delvis bedring er defineret som forbedrede blodtal og reduktion af antallet af kræftceller.
English: Cladribine has been in use in anticancer medicines since the 1980s and it has been available as an intravenous infusion (drip into a vein) in some European Union (EU) Member States since 1993.
Danish: Cladribin har været anvendt som lægemiddel mod kræft siden 1980'erne, og det har været på markedet som intravenøs infusion (drop i en blodåre) i nogle af EU's medlemsstater siden 1993.
English: These results were similar to those seen in other published studies using intravenous cladribine and were better than results seen with alternative treatments such as interferon alfa and pentostatin.
Danish: Disse resultater svarede til resultaterne fra andre offentliggjorte undersøgelser, hvor den intravenøse anvendelse af cladribin er undersøgt, og var bedre end resultaterne af behandling med alternative lægemidler såsom interferon-alfa og pentostatin.
English: The full EPAR for Litak can be found here.
Danish: Den fuldstændige EPAR for Litak findes her.