natgillin/translations-raw huggingface dataset:
Ydermere skal virksomheden foretage analyser for at finde ud af, hvilke patienter der kan forventes at have størst fordel af behandling med Keytruda.
Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.
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.
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.
Før behandlingen indledes, bør patienter med NSCLC, tidligere ubehandlet urotelial kræft eller HNSCC have tjekket deres niveau af PD-L1.
Before starting treatment, patients with NSCLC, previously untreated urothelial cancer or HNSCC should have tests to check their levels of PD-L1.
Hvis du ønsker mere information om anvendelsen af Keytruda, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Keytruda, see the package leaflet or contact your doctor or pharmacist.
Keytruda indeholder det aktive stof pembrolizumab.
Keytruda contains the active substance pembrolizumab.
Keytruda gives som infusionsvæske (drop) i en vene.
Keytruda is given as an infusion (drip) into a vein.
De hyppigste bivirkninger ved Keytruda (som optræder hos mere end 1 ud af 5 patienter) er træthed, kvalme og diarré.
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.
Ved at blokere PD-1 forhindrer pembrolizumab kræften i at afbryde disse immuncellers aktivitet, og derved øges immunsystemets evne til at dræbe kræftcellerne.
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.
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.
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.
• klassisk Hodgkins lymfom, en form for kræft i de hvide blodlegemer
• classical Hodgkin lymphoma, a cancer of the white blood cells,
Ikkesmåcellet lungekræft (NSCLC)
Non-small cell lung cancer (NSCLC)
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.
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.
Keytruda er også effektivt som kombinationsbehandling for en type NSCLC kaldet ikkeplanocellulær kræft, baseret på den pågældende type cancercelle.
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.
Hvilke risici er der forbundet med Keytruda?
What are the risks associated with Keytruda?
Keytruda forsinkede ikke forværring af sygdommen sammenlignet med de andre kræftlægemidler (der gik henholdsvis to og tre måneder, inden sygdommen forværredes).
Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).
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).
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).
Til de øvrige kræftformer anvendes Keytruda alene.
For the other cancers, Keytruda is only used on its own.
Hudkræft
Skin cancer
• melanomer, en form for hudkræft
• melanoma, a skin cancer,
Ved nogle kræftformer gives det kun til patienter, hvis tumorer danner store mængder af et bestemt protein (PD-L1).
In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.
Efter 18 måneder var 81% af de patienter, der fik kombinationsbehandlingen, stadig i live, sammenlignet med 71% af dem, der fik sunitinib.
At 18 months, 81% of the patients given the combination were alive, compared with 71% in the sunitinib group.
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).
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).
Til nyrecellekarcinom anvendes Keytruda i kombination med andre kræftlægemidler.
For renal cell carcinoma, Keytruda is used in combination with other cancer medicines.
Efter halvandet års behandling var 72 % af de patienter, der fik Keytruda, stadig sygdomsfrie sammenlignet med 54 % af de patienter, der fik placebo.
After one and a half years of treatment, 72% of patients on Keytruda were still disease-free compared with 54% of patients on placebo.
Et andet studie omfattede 834 patienter med melanomer, som fik enten Keytruda eller et andet lægemiddel (ipilimumab).
A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab.
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.
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.
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.
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.
De patienter, der blev behandlet med Keytruda, levede i gennemsnit ca. 10 måneder sammenlignet med ca. 7 måneder for de andre kræftlægemidler.
Patients treated with Keytruda lived on average around 10 months compared with around 7 months with the other cancer medicines.
Keytruda er også effektivt til at forhindre melanomer i at vende tilbage hos patienter, der er blevet opereret.
Keytruda is also effective in preventing melanoma from coming back in patients who have had surgery.
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.
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.
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.
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.
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.
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.
Den fuldstændige liste over bivirkninger og begrænsninger ved Keytruda fremgår af indlægssedlen.
For the full list of side effects and restrictions with Keytruda, see the package leaflet.
Hvordan anvendes Keytruda?
How is Keytruda used?
• 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.
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.
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.
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.
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.
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.
Keytruda anvendes også til at forhindre kræft i at vende tilbage, efter at patienterne har fået fjernet melanomer ved operation (tillægsbehandling).
Keytruda is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma (adjuvant therapy).
• kræft i hovedet og halsen kaldet planocellulært karcinom i hoved- og halsregionen (HNSCC)
• a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC),
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.
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.
Patienterne i Keytruda-gruppen levede i gennemsnitligt ca. 6 måneder uden forværring af sygdommen sammenholdt med 4,8 måned for patienterne i placebogruppen.
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.
De patienter, der fik Keytruda, levede i op til 5,6 måneder uden at sygdommen blev værre, sammenholdt med 2,8 måneder for ipilimumab.
Patients treated with Keytruda lived for up to 5.6 months without their disease getting worse compared with 2.8 months with ipilimumab.
Keytruda forbedrer overlevelsen hos patienter med urotelial kræft.
Keytruda improves survival of patients with urothelial cancer.
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.
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.
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.
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.
Hvordan virker Keytruda?
How does Keytruda work?
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.
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.
Desuden levede de patienter, der fik Keytruda alene, i gennemsnit 12,3 måneder sammenlignet med 10,3 måneder for patienter, der fik andre standardbehandlinger.
In addition, patients taking Keytruda alone lived on average 12.3 months compared with 10.3 months for patients taking other standard treatments.
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.
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.
I et hovedstudie med 210 patienter medførte Keytruda fuld eller delvis remission (bedring) af kræften hos 145 patienter (69 %).
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.
Hvilke fordele viser studierne, at der er ved Keytruda?
What benefits of Keytruda have been shown in studies?
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.
Keytruda is also effective in improving survival of patients with head and neck squamous cell carcinoma (HNSCC) that had spread or come back.
Keytruda er også effektivt til at forbedre overlevelsen af patienter med nyrecellekræft.
Keytruda is also effective in improving survival of patients with renal cell cancer.
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.
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.
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 %).
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.
Patienterne levede i gennemsnit ca. 11 måneder uden sygdomsforværring.
The average time that patients lived without their disease getting worse again was around 11 months.
• urotelial kræft, en form for kræft i blæren og urinvejene
• urothelial cancer, a cancer of the bladder and urinary tract,
Hoved- og halskræft
Head and neck cancer
• ikkesmåcellet lungekræft (NSCLC)
• non-small cell lung cancer (NSCLC), a type of lung cancer,
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.
Patients taking the Keytruda combination lived on average for 13.6 months compared with 10.4 months for patients taking other standard treatments.
Keytruda var mere effektivt hos patienter, der testede stærkt positive for PD-L1.
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.
Nyrekræft
Kidney cancer
--1 En dosis (0,5 ml) indeholder::
--1 1 dose (0.5 ml) contains:
Rekombinant lipideret fHbp (faktor H bindingsprotein) Produceret i Escherichia coli-celler vha. rekombinant DNA-teknologi Adsorberet på aluminiumphosphat (0,25 milligram aluminium pr. dosis)
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)
Neisseria meningitidis serogruppe B fHbp underfamilie A
Neisseria meningitidis serogroup B fHbp subfamily A
Neisseria meningitidis serogruppe B fHbp underfamilie B
Neisseria meningitidis serogroup B fHbp subfamily B
1 fyldt injektionssprøjte med kanyle
1 pre-filled syringe with needle
Den anbefalede dosis er 0,14 mg pr. kg legemsvægt én gang dagligt i fem dage i træk.
The recommended dose is 0.14 mg per kilogram body weight, once a day for five days.
Andre oplysninger om Litak:
Other information about Litak:
Markedsføringstilladelsen blev fornyet den 14. april 2009.
The marketing authorisation was renewed on 14 April 2009.
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).
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).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Litak til Lipomed GmbH den 14. april 2004.
The European Commission granted a marketing authorisation valid throughout the EU for Litak to Lipomed GmbH on 14 April 2004.
Da cladribin har været anvendt i en række år, fremlagde virksomheden data fra den offentliggjorte litteratur.
Because cladribine has been used for a number of years, the company presented data from the published literature.
Litak blev ikke sammenlignet med andre behandlinger i den undersøgelse.
Litak was not compared with any other treatments in this study.
Litak gives som en injektion under huden.
Litak is given as an injection under the skin.
Behandling med Litak skal startes af en læge med erfaring i kræftbehandling.
Litak treatment should be started by a doctor who has experience in the use of cancer treatments.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Litak.
The Committee recommended that Litak be given marketing authorisation.
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.
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).
De primære mål for virkning var antallet af patienter, der opnåede fuldstændig og delvis bedring af deres tilstand efter behandlingen.
The main measures of effectiveness were the numbers of patients who had complete and partial remission following treatment.
CdATP kan også påvirke andre celler, især andre typer blodceller, og dét kan fremkalde bivirkninger.
CdATP can also affect other cells, particularly other types of blood cell, which can cause side effects.
Hvilken risiko er der forbundet med Litak?
What is the risk associated with Litak?
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) LITAK EPAR - sammendrag for offentligheden
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LITAK EPAR summary for the public
Det hører til den gruppe af lægemidler mod kræft, der hedder antimetabolitter.
It belongs to the group of anticancer medicines called ‘antimetabolites'.
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.
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.
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.
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.
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.
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.
Den fuldstændige EPAR for Litak findes her.
The full EPAR for Litak can be found here.
Det bør anvendes med forsigtighed hos patienter over 65 år, med hyppig overvågning af blodtal og lever- og nyrefunktion.
It should be used with caution in patients over 65 years of age, with frequent monitoring of blood counts, the liver and the kidneys.
Hvorfor blev Litak godkendt?
Why has Litak been approved?
Litak er blevet undersøgt i én hovedundersøgelse, hvor i alt 63 voksne med hårcelleleukæmi deltog.
Litak has been examined in one main study involving 63 adults with hairy cell leukaemia.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme vedrørende Litak findes her.
The summary of opinion of the Committee for Orphan Medicinal Products for Litak is available here.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Litak opvejer risiciene til behandling af hårcelleleukæmi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Litak's benefits are greater than its risks for the treatment of hairy cell leukaemia.
Purin er et af de grundlæggende kemiske stoffer, som dna består af.
Purine is one of the fundamental chemicals that make up DNA.