FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them.
Danish: Virksomheden, der markedsfører Lutathera, skal iværksætte et program for information til patienterne for at sikre, at de forstår risikoen ved radioaktivitet og de forholdsregler, de skal tage for at begrænse udsættelsen af sig selv og af andre omkring dem.
English: Before starting treatment, the doctor will have checked that the patient's tumours have somatostatin receptors on their cell surfaces.
Danish: Før påbegyndelse af behandlingen har lægen kontrolleret, at patientens svulster har somatostatinreceptorer på celleoverfladen.
English: Lutathera is used is to treat GEP-NETs that cannot be removed by surgery, have spread to other parts of the body or are not responding to treatment.
Danish: Lutathera anvendes til behandling af svulster at typen GEP-NET, som ikke kan fjernes ved operation og har bredt sig til andre dele af kroppen, eller som ikke reagerer på behandlingen.
English: The full EPAR for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lutathera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Lutathera approved?
Danish: Hvorfor blev Lutathera godkendt?
English: For further information, including information on the precise method for giving the infusions, see the package leaflet.
Danish: Yderligere oplysninger, herunder den præcise metode til indgivelse af infusionerne, fremgår af indlægssedlen.
English: The European Medicines Agency considered that the benefits seen with Lutathera outweigh its risks and recommended it be approved in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde derfor, at fordelene ved Lutathera overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i EU.
English: What are the risks associated with Lutathera?
Danish: Hvilke risici er der forbundet med Lutathera?
English: Lutathera contains the active substance lutetium (177Lu) oxodotreotide.
Danish: Lutathera indeholder det aktive stof lutetium (177Lu) oxodotreotid.
English: Only a minority of patients with GEP-NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients.
Danish: Kun et mindretal af patienter med svulster af typen GEP-NET kan helbredes ved operation, og svulsterne vil hos de fleste patienter have bredt sig på diagnosetidspunktet.
English: Lutathera can help slow the worsening of the condition and its side effects are considered manageable.
Danish: Lutathera kan medvirke til at bremse forværringen af sygdommen, og dets bivirkninger anses for at kunne håndteres.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Lutathera 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 Lutathera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Lutathera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lutathera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Danish: Lutathera er et kræftlægemiddel til behandling af tarmsvulster af typen gastroenteropankreatiske neuroendokrine svulster (GEP-NET).
English: The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP-NETs.
Danish: Det aktive stof i Lutathera, lutetium (177Lu) oxodotreotid, virker ved at bindes til somatostatinreceptorer, som findes i stort antal i visse svulster af typen GEP-NET.
English: For practical information about using Lutathera, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lutathera, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The medicine is only for GEP-NETs that have receptors called somatostatin receptors on their cell surfaces.
Danish: Lægemidlet er kun til behandling af svulster af typen GEP-NET med somatostatin-receptorer på celleoverfladen.
English: Lutathera can help slow down the worsening of GEP-NETs.
Danish: Lutathera kan medvirke til at bremse forværringen af svulster af typen GEP-NET.
English: How is Lutathera used?
Danish: Hvordan anvendes Lutathera?
English: For the full list of all side effects reported with Lutathera, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Lutathera fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutathera 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 Lutathera.
English: What benefits of Lutathera have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lutathera?
English: How does Lutathera work?
Danish: Hvordan virker Lutathera?
English: They are taken once a day.
Danish: De tages én gang dagligt.
English: It is used to treat severe pain.
Danish: Det anvendes til behandling af stærke smerter.
English: The European Commission issued a decision on this opinion on 20 December 2010.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 20. december 2010.
English: This renewal was to be recognised in Germany, Ireland, Italy and the United Kingdom (the ‘concerned Member States').
Danish: Denne fornyelse skulle anerkendes i Tyskland, Irland, Italien og Det Forenede Kongerige ("de berørte medlemsstater").
English: What is Ethirfin?
Danish: Hvad er Ethirfin?
English: Ethirfin was authorised in the European Union (EU) under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 15 July 2005.
Danish: Ethirfin blev godkendt i EU efter en gensidig anerkendelsesprocedure på baggrund af den første markedsføringstilladelse, der blev udstedt af Danmark den 15. juli 2005.
English: Why was Ethirfin reviewed?
Danish: Hvorfor blev Ethirfin vurderet igen?
English: Because these Member States were not able to reach an agreement, the German and United Kingdom medicines regulatory agencies referred the matter to the CHMP for arbitration on 30 October 2009.
Danish: Da disse medlemsstater imidlertid ikke kunne nå til enighed, indbragte lægemiddelkontrolmyndighederne i Tyskland og Det Forenede Kongerige den 30. oktober 2009 sagen for CHMP med henblik på voldgift.
English: Ethirfin is a medicine that contains the active substance morphine sulphate.
Danish: Ethirfin er et lægemiddel, der indeholder det aktive stof morfinsulfat.
English: The company applied for the marketing authorisation to be renewed in Denmark (the ‘reference Member State').
Danish: Virksomheden ansøgte om fornyelse af markedsføringstilladelsen i Danmark ("referencemedlemsstaten").
English: Therefore the benefits of Ethirfin do not outweigh its risks, and the marketing authorisation for Ethirfin should not be renewed in all concerned Member States.
Danish: Fordelene ved Ethirfin opvejer derfor ikke risiciene, og markedsføringstilladelsen for Ethirfin bør ikke fornyes i alle de berørte medlemsstater.
English: The European Medicines Agency has completed an arbitration procedure for Ethirfin and associated names.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure for Ethirfin og relaterede navne.
English: The rapid release of the active substance is called ‘dose dumping' and could put patients at risk of exposure to large doses of morphine, leading to side effects such as respiratory depression (an inhibition of breathing).
Danish: Den hurtige frigivelse af det aktive stof kaldes "dosisdumping" og kan udsætte patienter for risiko for at blive eksponeret for store doser morfin, hvilket medfører bivirkninger såsom respirationsdepression (vejrtrækningsproblemer).
English: The Committee concluded that the marketing authorisation should not be renewed, as patients taking Ethirfin and alcohol are at risk of developing serious side effects.
Danish: Udvalget konkluderede, at markedsføringstilladelsen ikke bør fornyes, eftersom patienter, som tager Ethirfin og alkohol, har risiko for alvorlige bivirkninger.
English: The grounds for the referral were concerns that the active substance in the capsules could be released too quickly if the capsules are taken with alcohol, because they contain a ‘polymethacrylatetriethylcitrate' coating to control the release of morphine and this coating is soluble in alcohol.
Danish: Begrundelserne for indbringelsen var betænkeligheder med hensyn til, om det aktive stof i kapslerne kunne frigives for hurtigt, hvis kapslerne tages sammen med alkohol, fordi de indeholder et "polymethacrylat-triethylcitrat-"overtræk til regulering af frigivelsen af morfin, og dette overtræk er opløseligt i alkohol.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there is a significant interaction between Ethirfin and alcohol, and that patients taking Ethirfin and alcohol are at risk of developing serious side effects.
Danish: På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at der er en signifikant interaktion mellem Ethirfin og alkohol, og at patienter, der tager Ethirfin sammen med alkohol, har risiko for at udvikle alvorlige bivirkninger.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on the renewal of the marketing authorisation for Ethirfin.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) var blevet anmodet om at træffe afgørelse ved voldgift om en ændring i markedsføringstilladelsen for Ethirfin.
English: Ethirfin is available as ‘prolonged-release' capsules that release the active substance slowly.
Danish: Ethirfin fås som "depotkapsler", der frigiver det aktive stof langsomt.
English: Strength Pharmaceutical form
Danish: EU-nummer Særnavn Styrke Lægemiddel¬fo rm
English: Packaging Content
Danish: Pakningsstør relse
English: Annex IV Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations, as relevant
Danish: Bilag IV Videnskabelige konklusioner og begrundelse for opretholdelse af markedsføringstilladelserne eller ændring af betingelserne for markedsføringstilladelserne, som relevant
English: EPAR summary for the public
Danish: EPAR sammenfatning til offentligheden
English: More than half of these patients had taken HIV treatment in the past.
Danish: Over halvdelen af disse patienter havde tidligere fået hiv-behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Reyataz on 2 March 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Reyataz den 2. marts 2004.
English: This document is a summary of the European Public Assessment Report (EPAR) for Reyataz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Reyataz.
English: The full EPAR for Reyataz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Reyataz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In studies, side effects were similar in younger patients.
Danish: I undersøgelserne var bivirkningerne de samme hos de yngre patienter.
English: Other information about Reyataz:
Danish: Andre oplysninger om Reyataz:
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Danish: En lille dosis af et andet lægemiddel, ritonavir, gives normalt samtidig som en "booster".
English: What measures are being taken to ensure the safe and effective use of Reyataz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Reyataz?
English: It is available as capsules (100 mg, 150 mg, 200 mg and 300 mg) and oral powder (50 mg).
Danish: Det leveres som kapsler (100 mg, 150 mg, 200 mg og 300 mg) og som oralt pulver (50 mg/ml).
English: In patients who had been treated before, the results of the first study could not be interpreted, as a large number of patients left the study before its planned end.
Danish: Hos de tidligere behandlede patienter kunne der ikke udledes noget af resultaterne af den første undersøgelse, da en stor del af patienterne udtrådte af undersøgelsen inden dens planlagte afslutning.
English: The patients also had improvements in their immune systems.
Danish: Der sås også en forbedring af patienternes immunsystem.
English: Reyataz does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Reyataz kurerer ikke hiv-infektion eller aids, men det kan forsinke den beskadigelse af immunsystemet og den udvikling af infektioner og sygdomme, der er forbundet med aids.
English: Treatment with Reyataz should be started by a doctor who has experience in the treatment of HIV infection.
Danish: Behandlingen med Reyataz bør indledes af en læge med erfaring i behandling af hiv-infektion.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Reyataz.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Reyataz skal anvendes.
English: For more information about treatment with Reyataz, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Reyataz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For adults (aged 18 years or over), the recommended dose is 300 mg once a day.
Danish: Den anbefalede dosis til voksne (18 år og derover) er 300 mg én gang dagligt.
English: This finding was maintained after 96 weeks.
Danish: Disse resultater var stadig de samme efter 96 ugers behandling.
English: The main measure of effectiveness was the change in the levels of HIV in the patients' blood (viral load).
Danish: Det primære effektmål var ændringen af hiv-koncentrationen i patienternes blod (den virale belastning).
English: This allows a lower dose of atazanavir to be used for the same antiviral effect.
Danish: Dette gør det muligt at anvende en mindre dosis atazanavir, men alligevel at opnå den samme antivirale virkning.
English: In all of the studies, the patients also took two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Danish: I alle undersøgelserne fik patienterne også to nukleoside eller nukleotide reverse transkriptasehæmmere (NRTI'er, en type antivirale lægemidler).
English: Reyataz, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Reyataz tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Reyataz (protease inhibitors) do not work.
Danish: Lægemidlet forventes ikke at virke hos patienter, hos hvem flere af lægemidlerne fra samme klasse som Reyataz (proteasehæmmere) ikke har virket.
English: Reyataz is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Danish: Reyataz gives almindeligvis sammen med ritonavir for at få en bedre virkning, men læger kan overveje at ophøre med ritonavir hos voksne i særlige tilfælde.
English: Reyataz is an antiviral medicine that contains the active substance atazanavir.
Danish: Reyataz er et antiviralt lægemiddel, der indeholder det aktive stof atazanavir.
English: The study looked at the effect of the medicine on viral load and on the immune system, among other measures.
Danish: Undersøgelsen så nærmere på lægemidlets virkning på bl.a. den virale belastning og immunsystemet.
English: The active substance in Reyataz, atazanavir, is a protease inhibitor.
Danish: Det aktive stof i Reyataz, atazanavir, er en proteasehæmmer.
English: Ritonavir slows down the break-down of atazanavir, increasing the levels of atazanavir in the blood.
Danish: Ritonavir nedsætter den hastighed, hvormed atazanavir nedbrydes, og øger derved niveauet af atazanavir i blodet.
English: What is the risk associated with Reyataz?
Danish: Hvilken risiko er der forbundet med Reyataz?
English: In addition, Reyataz must not be given to patients taking rifampicin (used to treat tuberculosis), sildenafil (when this medicine is used to treat pulmonary arterial hypertension), St John's wort (a herbal medicine used to treat depression) or medicines that are broken down in the body in the same way as Reyataz and are harmful at high levels in the blood.
Danish: Ydermere må Reyataz ikke gives til patienter, som får rifampicin (til behandling af tuberkulose), sildenafil (når lægemidlet anvendes til behandling af pulmonal arteriel hypertension), perikum (et naturlægemiddel til behandling af depression) eller lægemidler, der i kroppen nedbrydes på samme måde som Reyataz, og som er skadelige, hvis deres koncentration i blodet bliver for høj.
English: For patients who have received HIV medicines before, doctors should prescribe Reyataz only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Reyataz.
Danish: Inden Reyataz ordineres til patienter, der tidligere har fået hiv-lægemidler, bør lægen først undersøge, hvilke lægemidler patienterne har fået, og have foretaget tests for at fastslå, at virusset sandsynligvis vil respondere på Reyataz.
English: Reyataz oral powder can be used for children aged at least 3 months and weighing at least 5 kg, and for patients who cannot swallow capsules.
Danish: Reyataz i oral pulverform kan anvendes til børn fra 3 måneders alderen, som vejer mindst 5 kg, samt til patienter, der ikke kan sluge kapsler.
English: It blocks an enzyme called protease, which is needed for the virus to multiply.
Danish: Det blokerer et enzym kaldet protease, der medvirker ved formeringen af virusset.
English: In younger patients, the dose of Reyataz depends on body weight.
Danish: Reyataz-dosen til yngre patienter afhænger af deres kropsvægt.
English: In patients who had not been treated before, ritonavir-boosted Reyataz capsules were as effective as ritonavir-boosted lopinavir.
Danish: Hos de ikke tidligere behandlede patienter var ritonavir-forstærket Reyataz i kapselform lige så effektivt som ritonavir-forstærket lopinavir.
English: Why has Reyataz been approved?
Danish: Hvorfor blev Reyataz godkendt?
English: In adults, the most common side effects with Reyataz (seen in between 1 and 10 patients in 100) are headache, ocular icterus (yellowing of the eyes), vomiting, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), rash, fatigue (tiredness) and jaundice (yellowing of the skin and eyes because of liver problems).
Danish: Hos voksne er de hyppigste bivirkninger ved Reyataz (set hos mellem 1 og 10 patienter ud af 100) hovedpine, okulær icterus (gulfarvning af øjnene), opkastning, diarré, mavesmerter, kvalme, dyspepsi (halsbrand), udslæt, lipodystrofisyndrom (ændringer i fordelingen af kropsfedtet), træthed og gulsot (gulfarvning af huden og øjnene forbundet med leverproblemer).
English: A further main study involved 172 patients who had achieved undetectable viral load (below 50 copies/ml) after treatment with Reyataz capsules and ritonavir.
Danish: En yderligere hovedundersøgelse omfattede 172 patienter, hos hvem der ikke kunne påvises viral belastning (under 50 kopier/ml) efter behandling med Reyataz i kapselform og ritonavir.
English: It compared continued treatment with either a higher dose of Reyataz without ritonavir or the boosted combination.
Danish: I den forbindelse blev fortsat behandling sammenlignet med enten Reyataz uden ritonavir eller den forstærkede kombination.
English: A measure of effectiveness was the viral load after treatment for 48 weeks.
Danish: Virkningen blev hovedsagelig målt på den virale belastning efter behandling i 48 uger.
English: Reyataz capsules boosted with ritonavir have also been studied in 41 patients aged between 6 and 18 years.
Danish: Reyataz i kapselform forstærket med ritonavir er også blevet undersøgt hos 41 patienter i alderen 6-18 år.
English: In the study in patients who already had undetectable viral loads with ritonavir-boosted Reyataz capsules, these were maintained in 68 of 87 patients (78%) who continued treatment with a higher dose of Reyataz without ritonavir, and in 64 of 85 (75%) who continued with the boosted combination.
Danish: I undersøgelsen af patienter, hos hvem der ikke kunne påvises viral belastning allerede efter behandling med ritonavir-forstærket Reyataz i kapselform, blev disse resultater fastholdt hos 68 ud af 87 patienter (78 %), der fortsatte behandlingen med en højere dosis Reyataz uden ritonavir, sammenlignet med 64 ud af 85 (75 %), der fortsatte med den forstærkede kombination.
English: Reyataz is used together with low-dose ritonavir and other antiviral medicines to treat adults and children aged 3 months and over and weighing at least 5 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Reyataz anvendes sammen med ritonavir i lave doser og andre antivirale lægemidler til behandling af voksne og børn fra 3 måneders alderen, som vejer mindst 5 kg, og som er smittet med humant immundefektvirus type 1 (hiv-1).
English: The other three studies involved a total of 743 patients who had taken treatment for HIV infection before: the first two compared Reyataz, taken with saquinavir (another antiviral medicine) but without ritonavir, with ritonavir-boosted saquinavir or ritonavir-boosted lopinavir.
Danish: De tre andre undersøgelser omfattede i alt 743 patienter, som tidligere var blevet behandlet for hiv-infektion: I de første to undersøgelser blev virkningen af Reyataz i kombination med saquinavir (et andet antiviralt lægemiddel), men uden ritonavir, sammenlignet med ritonavirforstærket saquinavir eller ritonavir-forstærket lopinavir.
English: Reyataz oral powder with ritonavir has been assessed in two main studies involving 155 children aged from 3 months up to 11 years.
Danish: Reyataz i oral pulverform i kombination med ritonavir er blevet undersøgt i to hovedundersøglser, der omfattede 155 børn i alderen 3 måneder til 11 år .
English: Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection.
Danish: Når enzymet blokeres, formerer virusset sig ikke normalt, så udbredelsen af infektionen bliver langsommere.