natgillin/translations-raw huggingface dataset:
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.
Da der kun findes et lille antal patienter med hårcelleleukæmi, anses sygdommen for at være sjælden, og Litak blev udpeget som lægemiddel til sjældne sygdomme den 18. september 2001. 
Because the number of patients with hairy cell leukaemia is low, the disease is considered ‘rare', and Litak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 September 2001.
Litak må heller ikke anvendes til behandling af gravide eller ammende kvinder, patienter under 18 år, patienter med moderat til svær lever- eller nyresygdom eller i en kombination med andre lægemidler, der nedsætter produktionen af blodlegemer. 
Litak must not be used during pregnancy or breast-feeding, in patients less than 18 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.
Begrebet 'hårcelle' anvendes, fordi der ses nogle hårlignende pigge på overfladen af lymfocytterne, når de betragtes med mikroskop. 
The term ‘hairy cell' refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.
Hvad er Litak? 
What is Litak?
Det aktive stof i Litak, cladribin, er en cellegift, dvs. et lægemiddel, der dræber celler, der deler sig, f.eks. kræftcellerne. 
The active substance in Litak, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Dermed forhindres cellerne i at dele sig, og leukæmien udvikler sig som følge deraf langsommere. 
This prevents the cells from dividing, slowing down the progression of leukaemia.
I kroppen omdannes Cladribin i lymfocytterne til et kemisk stof kaldet CdATP, der forstyrrer produktionen af ny dna. 
In the body, cladribine is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA.
Patienterne kan efter grundig oplæring selv foretage injektionen. 
Patients can inject themselves once they have been trained appropriately.
Litak må ikke gives til patienter med moderat til svær lever- eller nyresygdom. 
Litak must not be given to patients with moderate to severe liver or kidney disease.
Cladribin er en purinanalog (et stof, der har en kemisk struktur svarende til purin). 
Cladribine is an ‘analogue' of purine (a substance that has a similar chemical structure to purine).
Litak er en opløsning til injektion, der indeholder det aktive stof cladribin. 
Litak is a solution for injection that contains the active substance cladribine.
Hvilken fordel viser undersøgelserne, at der er ved Litak? 
What benefit has Litak shown during the studies?
Hvad anvendes Litak til? 
What is Litak used for?
Den fuldstændige liste over de indberettede bivirkninger ved Litak fremgår af indlægssedlen. 
For the full list of all side effects reported with Litak, see the Package Leaflet.
Hvordan blev Litak undersøgt? 
How has Litak been studied?
Hvordan anvendes Litak? 
How is Litak used?
Det er en form for kræft i blodet, hvor der produceres for mange af den type hvide blodlegemer, der hedder B-lymfocytter. 
Litak is used to treat adults with hairy cell leukaemia, a cancer of blood in which too many B-lymphocytes (a type of white blood cell) are produced.
Patienter, der kan være overfølsomme (allergiske) over for cladribin eller andre af indholdsstofferne, bør ikke anvende Litak. 
Litak should not be used in people who may be hypersensitive (allergic) to cladribine or any of the other ingredients.
Hvordan virker Litak? 
How does Litak work?
Hvad angår kvalitetsaspekter: 
With respect to quality aspects,
Proceduren blev indledt den 29. marts 2007. 
The procedure started on 29 March 2007.
Indehaveren af markedsføringstilladelsen fremlagde supplerende oplysninger den 16. oktober 2007. 
The Marketing Authorisation Holder provided supplementary information on 16 October 2007.
London, den 23. juli 2008 Ref. dok. 
London, 23 July 2008 Doc.
Europa-Kommissionen vedtog en afgørelse den 23. juli 2008. 
A Decision was issued by the European Commission on 23 July 2008.
Voksne og børn over 12 år 
Adults and children above 12 years
Bipolar sygdom 
Bipolar disorder
Lægemiddelstoffet og lægemidlet er udførligt beskrevet, og der er fremlagt generelt tilfredsstillende dokumentation. 
The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
Børn fra 2 til 12 år 
Children 2 to 12 years
EMEA/476652/2008 
Ref. EMEA/CHMP/212114/2008
Lamictal og tilknyttede navne, leveret som tabletter på 25 mg, 50 mg, 100 mg og 200 mg og dispergible tabletter/tyggetabletter på 2 mg, 5 mg, 25 mg, 50 mg, 100 mg og 200 mg, er et antiepileptikum, der anvendes til behandling af epilepsi og bipolar sygdom. 
Lamictal and associated names, 25 mg, 50 mg, 100 mg, 200 mg tablet and 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, dispersible / chewable tablet, is an antiepileptic drug, used for the treatment of epilepsy and Bipolar Disorder.
De hjælpestoffer, der er anvendt i formuleringen af lægemidlet, og fremstillingsprocesserne er standard for de foreslåede lægemiddelformer. 
The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
Resultaterne viser, at lægemiddelstoffet og lægemidlet kan reproduceres. 
The results indicate that the drug substance and drug product can be reproducibly manufactured.
Voksne over 18 år 
Adults 18 years and above
Lamictal er indiceret til forebyggelse af humørsvingninger hos patienter med bipolar sygdom, fortrinsvis forebyggelse af depressive episoder. 
Lamictal is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes.
Begrundelsen for indbringelsen var, at der er forskelle mellem medlemsstaternes produktresuméer, herunder kvalitetsaspekter, for Lamictal og tilknyttede navne, som er godkendt i EU-medlemsstaterne, hvad angår indikationerne: 
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Lamictal and associated names approved across EU Member States, with respect to the indication,
Den 1. marts 2007 indbragte GlaxoSmithKline Research & Development Limited en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF med senere ændringer for at harmonisere produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, der er godkendt i medlemsstaterne, for lægemidlet Lamictal og tilknyttede navne. 
On 1 March 2007, GlaxoSmithKline Research & Development Limited presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Lamictal and associated names.
På mødet den 21.-24. april 2008 fandt Udvalget for Humanmedicinske lægemidler i lyset af alle de foreliggende data og faglige drøftelser i udvalget, at forslaget om harmonisering af produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, var acceptabelt, og at ændringerne burde foretages. 
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Efter opnåelse af kontrol over de epileptiske anfald ved hjælp af tillægsbehandlingen kan behandling med ledsagende antiepileptiske lægemidler ophøre, og patienterne kan fortsætte med Lamictal som monoterapi. 
After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on Lamictal monotherapy.
Udvalget for Humanmedicinske Lægemidler afgav den 24. april 2008 en positiv udtalelse, hvori udvalget henstillede til harmonisering af produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, for Lamictal og tilknyttede navne. 
The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Lamictal and associated names.
Lamictal er indiceret til anvendelse som tillægsbehandling eller monoterapi ved behandling af epilepsi med partielle og/eller generaliserede anfald, herunder tonisk-kloniske kramper og anfald forbundet med Lennox-Gastaut syndrom. 
Lamictal is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
De faglige konklusioner fremgår af bilag II, og bilag III indeholder ændringerne til produktresumé, etikettering og indlægsseddel. 
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Lamictal er indiceret til anvendelse som tillægsbehandling ved behandling af epilepsi med partielle og generaliserede anfald, herunder tonisk-kloniske kramper og anfald forbundet med Lennox-Gastaut syndrom. 
Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.