FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefit has Twinrix Paediatric shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Twinrix Pædiatrisk?
English: How is Twinrix Paediatric used?
Danish: Hvordan anvendes Twinrix Pædiatrisk?
English: How does Twinrix Paediatric work?
Danish: Hvordan virker Twinrix Pædiatrisk?
English: Ocaliva received a marketing authorisation valid throughout the EU on 12 December 2016.
Danish: Ocaliva fik en markedsføringstilladelse med gyldighed i hele EU den 12. december 2016.
English: Ocaliva has been given ‘conditional authorisation'.
Danish: Ocaliva har fået en "betinget godkendelse".
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt denne oversigt.
English: Other information about Ocaliva
Danish: Andre oplysninger om Ocaliva
English: This may lead to scarring and liver failure, and may increase the risk of liver cancer.
Danish: Dette kan føre til ardannelse og leversvigt, og kan øge risikoen for leverkræft.
English: What measures are being taken to ensure the safe and effective use of Ocaliva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ocaliva?
English: The recommended starting dose is 5 mg once a day or 5 mg once a week, depending on the patient's degree of liver impairment (which should be determined before starting treatment with Ocaliva).
Danish: Den anbefalede startdosis er 5 mg én gang dagligt eller 5 mg én gang om ugen, afhængigt af hvor nedsat patientens leverfunktion er (hvilket skal bestemmes inden behandlingen med Ocaliva påbegyndes).
English: Ocaliva is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Danish: Ocaliva fås som tabletter (5 og 10 mg) og udleveres kun efter recept.
English: Itching is also the most common side effect that can lead to discontinuation of treatment.
Danish: Kløe er desuden den hyppigste bivirkning, der kan medføre, at behandlingen må stoppes.
English: As for all medicines, data on the use of Ocaliva is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Ocaliva løbende overvåget.
English: Further information on Ocaliva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere oplysninger om Ocaliva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Ocaliva authorised in the EU?
Danish: Hvorfor blev Ocaliva godkendt i EU?
English: The European Medicines Agency therefore decided that Ocaliva's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Ocaliva opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The safety profile of the medicine was considered to be favourable, with side effects that were tolerable and manageable with supportive treatment (e.g. for itching) and dose adjustments.
Danish: Sikkerhedsprofilen af lægemidlet blev anset for at være gunstig, idet bivirkningerne var tålelige og kunne håndteres med støttende behandling (f.eks. mod kløe) og dosisjustering.
English: An overview of Ocaliva and why it is authorised in the EU
Danish: Oversigt over Ocaliva, og hvorfor det er godkendt i EU
English: What is Ocaliva and what is it used for?
Danish: Hvad er Ocaliva, og hvad anvendes det til?
English: Ocaliva contains the active substance obeticholic acid.
Danish: Ocaliva indeholder det aktive stof obeticholsyre.
English: Since Ocaliva has been granted a conditional authorisation, the company that markets Ocaliva will provide additional data from two studies to confirm the effectiveness and safety of the medicine.
Danish: Da Ocaliva har fået en betinget godkendelse, skal virksomheden, der markedsfører Ocaliva, fremlægge yderligere data fra to undersøgelser med henblik på yderligere bekræftelse af virkningen af og sikkerheden ved lægemidlet.
English: Side effects reported with Ocaliva are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ocaliva vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Ocaliva (obeticholic acid)
Danish: Ocaliva (obeticholsyre)
English: Patients with primary biliary cholangitis have limited treatment options.
Danish: Hos patienter med primær biliær kolangitis er behandlingsmulighederne begrænsede.
English: For more information about using Ocaliva, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Ocaliva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: After a few months, if Ocaliva is well tolerated the dose can be increased.
Danish: Når der er gået nogle få måneder, og Ocaliva tåles godt, kan dosis forhøjes.
English: However, the clinical benefits of Ocaliva need to be demonstrated in further studies.
Danish: De kliniske fordele ved Ocaliva skal dog påvises i yderligere undersøgelser.
English: Primary biliary cholangitis is rare, and Ocaliva was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 July 2010.
Danish: Primær biliær kolangitis er en sjælden sygdom, og Ocaliva blev udpeget som "lægemiddel til sjældne sygdomme" den 27. juli 2010.
English: The first study is designed to demonstrate the clinical benefit of Ocaliva, while the second study will investigate the benefits of Ocaliva in patients with moderate to severe liver disease.
Danish: Den første undersøgelse er udformet med henblik på at påvise den kliniske fordel ved Ocaliva, mens den anden skal undersøge fordelene ved Ocaliva hos patienter med moderat til svær leversygdom.
English: Ocaliva was compared with placebo (a dummy treatment) in a main study involving 217 adults with primary biliary cholangitis who either had been taking UDCA for at least 1 year, or who could not take UDCA.
Danish: Ocaliva blev sammenlignet med placebo (en virkningsløs behandling) i en hovedundersøgelse med 217 voksne med primær biliær kolangitis, som enten havde fået UDCA i mindst ét år eller ikke kunne anvende UDCA.
English: The measure of effectiveness was based on the number of patients whose blood levels of the substances bilirubin and ALP (markers of liver damage) decreased by at least 15% (for ALP) and below a certain value considered normal (for bilirubin) after 1 year of treatment.
Danish: Virkningen blev målt på det antal patienter, hvis indhold i blodet af stofferne bilirubin og ALP (markører for leverskade) efter et års behandling var faldet med mindst 15 % (for ALP) henholdsvis var under en bestemt værdi, der anses for normal (for bilirubin).
English: Ocaliva must not be used in patients whose bile ducts are completely blocked.
Danish: Ocaliva må ikke anvendes hos patienter, hvor galdegangene er fuldstændig blokeret.
English: Reductions in bilirubin and ALP were to an extent which is indicative of an improvement in the condition of the liver.
Danish: Bilirubin og ALP blev reduceret i et omfang, der viser bedring i leverens tilstand.
English: It is used together with another medicine, ursodeoxycholic acid (UDCA), in patients who do not respond sufficiently to UDCA alone, and on its own in patients who cannot take UDCA.
Danish: Det anvendes sammen med et andet lægemiddel, ursodeoxycholsyre (UDCA), hos patienter, hvor UDCA alene ikke virker tilstrækkeligt.
English: The most common side effects with Ocaliva are itching (which may affect more than 6 in 10 people) and tiredness (which may affect more than 2 in 10 people).
Danish: De hyppigste bivirkninger ved Ocaliva er kløe (som optræder hos mere end 6 ud af 10 patienter) og træthed (som optræder hos mere end 2 ud af 10 patienter).
English: Ocaliva has been shown to reduce the blood levels of bilirubin and ALP in patients with primary biliary cholangitis, including those who could not be treated with UDCA.
Danish: Det er påvist, at Ocaliva nedsætter blodets indhold af bilirubin og ALP hos patienter med primær biliær kolangitis, herunder dem, der ikke kunne behandles med UDCA.
English: The active substance in Ocaliva, obeticholic acid, is a modified form of a bile acid (the main components of bile).
Danish: Det aktive stof i Ocaliva, obeticholsyre, er en modificeret form af en galdesyre (som udgør hovedparten af galden).
English: What are the risks associated with Ocaliva?
Danish: Hvilke risici er der forbundet med Ocaliva?
English: Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis.
Danish: Ocaliva anvendes til behandling af voksne med en leversygdom, der kaldes primær biliær kolangitis.
English: In the majority of cases seen, itching occurred within the first month of treatment and tended to resolve over time while continuing treatment.
Danish: I de fleste tilfælde optrådte kløe inden for den første måneds behandling.
English: Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the small bile ducts in the liver.
Danish: Primær biliær kolangitis er en autoimmun sygdom, hvor de små galdegange i leveren gradvis ødelægges.
English: The study showed that Ocaliva was more effective than placebo at reducing the blood levels of bilirubin and ALP: levels decreased by the required amount in 47% (34 out of 73) of patients treated with Ocaliva 10 mg and in 46% (32 out of 70) of patients treated with increasing doses of Ocaliva (from 5 mg up to 10 mg), compared with 10% (7 out of 73) of patients on placebo.
Danish: Niveauerne faldt i det nødvendige omfang hos 47 % (34 ud af 73) af de patienter, der fik 10 mg Ocaliva, og hos 46 % (32 ud af 70) af dem, der fik en stigende dosis af Ocaliva (fra 5 mg op til 10 mg).
English: How is Ocaliva used?
Danish: Hvordan anvendes Ocaliva?
English: As a result of the damage to the ducts, bile builds up in the liver causing damage to the liver tissue.
Danish: Som følge af skaden på gangene ophobes der galde i leveren, hvilket medfører skade på levervævet.
English: By attaching to these receptors, Ocaliva reduces the production of bile in the liver, preventing it from building up and damaging the liver tissue.
Danish: Ved at bindes til disse receptorer nedsætter Ocaliva galdedannelsen i leveren, så det undgås, at galden ophobes og skader levervævet.
English: What information is still awaited for Ocaliva?
Danish: Hvilke oplysninger afventes der stadig for Ocaliva?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ocaliva have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ocaliva.
English: These ducts transport fluid called bile from the liver to the intestines, where it is used to help digest fats.
Danish: Disse gange fører galde fra leveren til tarmene, hvor den medvirker til fordøjelsen af fedtstoffer.
English: Doses can be reduced or treatment may need to be stopped in patients who experience intolerable itching (a possible side effect with Ocaliva).
Danish: Hvis patienten får utålelig kløe (en mulig bivirkning ved Ocaliva), kan dosis sættes ned, eller det kan være nødvendigt at stoppe behandlingen.
English: For the list of all side effects with Ocaliva, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ocaliva fremgår af indlægssedlen.
English: What benefits of Ocaliva have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ocaliva?
English: How does Ocaliva work?
Danish: Hvordan virker Ocaliva?
English: It works mainly by attaching to receptors in the liver and gut (farnesoid X receptors) which control the production of bile.
Danish: (farnesoid X-receptorer), der kontrollerer dannelsen af galde.
English: It is used for:
Danish: Det anvendes til:
English: Tarceva is taken at least one hour before or two hours after food.
Danish: Tarceva tages mindst én time før eller to timer efter et måltid.
English: Tarceva received a marketing authorisation valid throughout the EU on 19 September 2005.
Danish: Tarceva fik markedsføringstilladelse med gyldighed i hele EU den 19. september 2005.
English: Other information about Tarceva
Danish: Andre oplysninger om Tarceva
English: Further information on Tarceva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Tarceva.
Danish: Yderligere information om Tarceva findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Tarceva.
English: The medicine is available as tablets (25, 100 and 150 mg).
Danish: Lægemidlet fås som tabletter (25, 100 og 150 mg).
English: Pancreatic cancer
Danish: Kræft i bugspytkirtlen
English: As for all medicines, data on the use of Tarceva are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Tarceva løbende overvåget.
English: The medicine contains the active substance erlotinib.
Danish: Lægemidlet indeholder det aktive stof erlotinib.
English: What is Tarceva and what is it used for?
Danish: Hvad er Tarceva, og hvad anvendes det til?
English: An overview of Tarceva and why it is authorised in the EU
Danish: En oversigt over Tarceva, og hvorfor det er godkendt i EU
English: Patients taking Tarceva should stop smoking, as smoking can decrease the amount of the medicine in the blood.
Danish: Patienter, som behandles med Tarceva, bør holde op med at ryge, da rygning kan sænke indholdet af lægemidlet i blodet.
English: What measures are being taken to ensure the safe and effective use of Tarceva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tarceva?
English: For more information about using Tarceva, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tarceva, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The active substance in Tarceva, erlotinib, belongs to the group ‘EGFR inhibitors'.
Danish: Det aktive stof i Tarceva, erlotinib, tilhører gruppen "EGFR-hæmmere".
English: Tarceva can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Danish: Tarceva udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i brug af kræftlægemidler.
English: The European Medicines Agency therefore decided that Tarceva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Tarceva opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Tarceva.
English: Stable means that the cancer has neither improved nor worsened with chemotherapy (medicines to treat cancer);
Danish: "Stabil" betyder, at kræften hverken er forbedret eller forværret med kemoterapi (lægemidler til behandling af kræft)
English: Why is Tarceva authorised in the EU?
Danish: Hvorfor blev Tarceva godkendt i EU?
English: Side effects reported with Tarceva are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Tarceva vurderes omhyggeligt, og der træffes de nødvendige forholdsregler til at beskytte patienterne.
English: What are the risks associated with Tarceva?
Danish: Hvilke risici er der forbundet med Tarceva?
English: For pancreatic cancer, it is 100 mg daily.
Danish: Ved kræft i bugspytkirtlen er den 100 mg dagligt.
English: As a result of this block, the tumour cells can no longer receive the messages needed for growing and for spreading (metastasis).
Danish: Denne blokering gør, at kræftcellerne ikke længere kan modtage de signaler, der får dem til at vokse og brede sig (metastase).
English: As a result, Tarceva helps to stop the cancer from growing and spreading through the body.
Danish: Tarceva er derfor med til at hindre, at kræften vokser og breder sig i kroppen.
English: • previously untreated patients whose cancer cells have certain changes (‘activating mutations') in the gene for a protein called epidermal growth factor receptor (EGFR);
Danish: • tidligere ubehandlede patienter, hvis kræftceller viser tegn på ændringer ("aktiverende mutationer") i genet for et protein kaldet epidermal vækstfaktorreceptor (EGFR)
English: The study compared how long patients survived when Tarceva was used early in the study with how long they survived when Tarceva was used later in the study.
Danish: Studiet rummede en sammenligning af, hvor længe patienterne overlevede, når Tarceva blev brugt tidligt i studiet, med hvor længe de overlevede, hvis Tarceva blev brugt senere i studiet.
English: The study found no advantage to early use of the medicine, as patients treated with Tarceva early in the study did not live longer than those treated with Tarceva later in the study (after the disease had progressed).
Danish: Studiet påviste ingen fordel ved tidlig brug af lægemidlet, idet patienter behandlet tidligt med Tarceva ikke levede længere end dem, der blev behandlet med Tarceva senere i studiet (efter sygdomsforværring).
English: As Tarceva seems more effective in patients with pancreatic cancer who develop a rash, treatment should be re-assessed after 4 to 8 weeks if no rash has developed.
Danish: Da Tarceva synes at være mere effektivt hos patienter med kræft i bugspytkirtlen, som har fået udslæt, bør behandlingen tages op til fornyet vurdering efter 4 til 8 uger,
English: Tarceva is also used in patients with metastatic pancreatic cancer, in combination with gemcitabine (another cancer medicine).
Danish: Tarceva anvendes desuden til patienter med metastatisk kræft i bugspytkirtlen i kombination med gemcitabin (et andet kræftlægemiddel).
English: How is Tarceva used?
Danish: Hvordan anvendes Tarceva?
English: However, there was no advantage for patients whose cancer had not spread beyond the pancreas.
Danish: Der kunne dog ikke konstateres nogen fordel for patienter, hvis kræft i bugspytkirtlen ikke havde bredt sig til andre organer.
English: Tarceva can prolong the time the patients live without their disease getting worse and prolong life in some patients.
Danish: Tarceva kan forlænge den tid, som patienterne lever uden forværring af deres sygdom, og forlænge nogle patienters levetid.
English: For the full list of side effects and restrictions with Tarceva, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Tarceva fremgår af indlægssedlen.
English: Tarceva is a cancer medicine used in non-small-cell lung cancer (NSCLC) that is advanced (the cancer has started to spread) or metastatic (it has already spread to other parts of the body).
Danish: Tarceva er et kræftlægemiddel, der anvendes til behandling af ikkesmåcellet lungekræft, som er "fremskreden" (kræften er begyndt at brede sig) eller "metastatisk" (den har allerede bredt sig til andre dele af kroppen).
English: Among the patients who took Tarceva, the average survival was 8.6 months in those whose tumours were ‘EGFR IHC-positive' (had EGFRs on the cell surface), and 5.0 months in those whose tumours were EGFR IHC-negative.
Danish: Blandt de patienter, som tog Tarceva, var den gennemsnitlige overlevelsestid 8,6 måneder for dem, hvis tumorer var "EGFR IHC-positive" (dvs. havde EGFR'er på cellernes overflade), og 5,0 måneder for dem, hvis tumorer var "EGFR IHC-negative".
English: If needed (for example because of side effects), the dose may be reduced in 50-mg steps.
Danish: Dosis kan om nødvendigt nedsættes med 50 mg ad gangen (f.eks. på grund af bivirkninger).
English: Tarceva in combination with gemcitabine was studied in 569 patients with pancreatic cancer that was advanced, unresectable (that cannot be removed by surgery) or metastatic.
Danish: Tarceva i kombination med gemcitabin blev undersøgt hos 569 patienter, som havde kræft i bugspytkirtlen, der var fremskreden, inoperabel (som ikke kan fjernes ved et kirurgisk indgreb) eller metastatisk.
English: The greatest benefit was in a subgroup of 49 patients with EGFR activating mutations: those taking Tarceva (22 patients) lived for an average of 44.6 weeks without their disease getting worse, compared with 13 weeks for those taking placebo (27 patients).
Danish: Den største gavnlige virkning sås i en undergruppe med 49 patienter med EGFR-aktiverende mutationer: De, som tog Tarceva (22 patienter), levede gennemsnitligt i 44,6 uger uden sygdomsforværring sammenholdt med 13 uger hos dem, der tog placebo (27 patienter).
English: • The fourth study compared Tarceva with placebo in 731 patients in whom at least one previous chemotherapy treatment had not worked.
Danish: • I det fjerde studie blev Tarceva sammenlignet med placebo hos 731 patienter, for hvem mindst én tidligere kemoterapibehandling ikke havde virket.
English: In NSCLC, Tarceva has been mainly studied in four studies.
Danish: Hvad angår ikkesmåcellet lungekræft, blev Tarceva hovedsageligt undersøgt i fire studier:
English: • patients with EGFR activating mutations whose disease is stable after initial chemotherapy.
Danish: • patienter med EGFR-aktiverende mutationer, hvis sygdom er stabil efter indledende kemoterapi.
English: In the study of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects were tiredness (affecting 73% of patients), rash (69%) and diarrhoea (48%).
Danish: I studiet af Tarceva anvendt i kombination med gemcitabin mod kræft i bugspytkirtlen var de hyppigste bivirkninger træthed (set hos 73 % af patienterne), udslæt (69 %) og diarré (48 %).
English: What benefits of Tarceva have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Tarceva?
English: Erlotinib blocks EGFRs, which can be found on some tumour cells.
Danish: Erlotinib blokerer EGFR'er, der kan optræde på overfladen af visse kræftceller.
English: Overall, Tarceva marginally increased how long patients lived without their disease getting worse and how long they survived.
Danish: Samlet set medførte Tarceva en marginal forøgelse af den tid, patienterne levede uden sygdomsforværring, og af overlevelsestiden.
English: For NSCLC, the usual dose is 150 mg daily.
Danish: Ved ikkesmåcellet lungekræft er den sædvanlige dosis 150 mg dagligt.
English: Patients with NSCLC should be tested for EGFR activating mutation before starting Tarceva, unless previous chemotherapy has not worked and other treatments are not suitable.
Danish: Patienter med ikkesmåcellet lungekræft bør testes for EGFR-aktiverende mutationer, inden behandling med Tarceva påbegyndes, medmindre tidligere kemoterapi ikke har virket, og andre behandlinger ikke er egnede.
English: Patients taking Tarceva survived for an average of 6.7 months, compared with 4.7 months for the patients taking placebo.
Danish: Patienter, der tog Tarceva, overlevede i gennemsnit 6,7 måneder sammenholdt med 4,7 måneder for dem, der tog placebo.
English: In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (affecting 75% of patients), diarrhoea (54%), loss of appetite and tiredness (52% each).
Danish: I studierne var de hyppigste bivirkninger ved Tarceva anvendt som monoterapi (alene) til lungekræft udslæt (set hos 75 % af patienterne), diarré (54 %), appetitløshed og træthed (52 % for begge).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tarceva have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tarceva.
English: The side effects reported with Tarceva are considered manageable.
Danish: De indberettede bivirkninger ved dette lægemiddel vurderes at være håndterbare.