FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Insulin Human Winthrop?
Danish: Hvilken risiko er der forbundet med Insulin Human Winthrop?
English: What is Insulin Human Winthrop?
Danish: Hvad er Insulin Human Winthrop?
English: How has Insulin Human Winthrop been studied?
Danish: Hvordan blev Insulin Human Winthrop undersøgt?
English: Insulin Human Winthrop should be given before meals.
Danish: Insulin Human Winthrop skal indgives før et måltid (nøjagtige tidsangivelser findes i indlægssedlen).
English: What is Insulin Human Winthrop used for?
Danish: Hvad anvendes Insulin Human Winthrop til?
English: How is Insulin Human Winthrop used?
Danish: Hvordan anvendes Insulin Human Winthrop?
English: How does Insulin Human Winthrop work?
Danish: Hvordan virker Insulin Human Winthrop?
English: What benefit has Insulin Human Winthrop shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Insulin Human Winthrop?
English: The safety profile of the medicine is considered acceptable.
Danish: Lægemidlets sikkerhedsprofil anses for at være acceptabel.
English: Xeloda received a marketing authorisation valid throughout the EU on 2 February 2001.
Danish: Xeloda fik en markedsføringstilladelse med gyldighed i hele EU den 2. februar 2001.
English: Xeloda must also not be used in the following groups:
Danish: Xeloda må desuden ikke anvendes til følgende grupper:
English: The tablets are given twice daily for 14 days followed by a 7-day gap before the next course.
Danish: Tabletterne gives to gange dagligt i 14 dage, efterfulgt af en 7-dages pause inden næste behandlingsserie.
English: Further information on Xeloda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xeloda.
Danish: Yderligere information om Xeloda findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Xeloda.
English: Xeloda (capecitabine)
Danish: Xeloda (capecitabin)
English: Xeloda is available as tablets (150 and 500 mg).
Danish: Det leveres som tabletter (150 og 500 mg).
English: The dose depends on the patient's height and weight and the type of cancer being treated.
Danish: Dosis afhænger af patientens højde og vægt og den behandlede kræfttype.
English: Treatment is continued for 6 months after colon surgery.
Danish: Behandlingen fortsættes i seks måneder efter tyktarmsoperationen.
English: Other information about Xeloda
Danish: Andre oplysninger om Xeloda
English: As for all medicines, data on the use of Xeloda are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Xeloda løbende overvåget.
English: Xeloda tablets should be taken within 30 minutes after a meal.
Danish: Xeloda-tabletter tages med vand inden for 30 minutter efter et måltid.
English: What measures are being taken to ensure the safe and effective use of Xeloda?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xeloda?
English: • pregnant or breastfeeding women;
Danish: • gravide eller ammende kvinder
English: For more information about using Xeloda, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Xeloda, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Xeloda'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 Xeloda opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Xeloda are diarrhoea, nausea (feeling sick), vomiting, abdominal (belly) pain, stomatitis (sores in the mouth), palmar-plantar erythrodysaesthesia (hand-foot syndrome, a skin reaction with rash and pain on the hands and feet), tiredness, weakness, loss of appetite, problems due to formation of blood clots in the blood vessels, heart problems and kidney problems in patients who already have reduced kidney function.
Danish: De hyppigste bivirkninger ved Xeloda er diarré, kvalme, opkastning, mavesmerter, stomatitis (sår i munden), palmar-plantar erythrodysæstesi (hånd-fodsyndrom, hudreaktion med udslæt og smerte på hænder og fødder), træthed, svaghed, appetitløshed, problemer som følge af dannelse af blodpropper i blodkarrene, hjerteproblemer og nyreproblemer hos patienter, der allerede har nedsat nyrefunktion.
English: Xeloda contains the active substance capecitabine.
Danish: Xeloda indeholder det aktive stof capecitabin.
English: As a result, it prevents the growth of tumour cells and eventually kills them.
Danish: Derved hæmmes væksten af kræftcellerne, der til sidst dør.
English: Side effects reported with Xeloda are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Xeloda vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Fluorouracil is very similar to pyrimidine.
Danish: Fluorouracil ligner i høj grad pyrimidin.
English: The disease responded in 19 to 25% of patients treated with Xeloda, compared with 12 to 15% with the comparator combination.
Danish: Sygdommen udviste respons på behandlingen hos 19 til 25 % af de patienter, der blev behandlet med Xeloda, sammenlignet med 12 til 15 % hos dem, der fik sammenligningskombinationen.
English: For other types of cancer, treatment is stopped if the disease gets worse or the side effects are unacceptable.
Danish: For de andre kræftformers vedkommende afbrydes behandlingen, hvis sygdommen forværres, eller bivirkningerne ikke kan tolereres.
English: Xeloda should only be prescribed by a doctor who is experienced in the use of cancer medicines.
Danish: Xeloda bør kun ordineres af en læge med erfaring i brug af kræftlægemidler.
English: Xeloda is taken as tablets, while fluorouracil normally needs to be injected.
Danish: Xeloda tages som tabletter, mens fluorouracil sædvanligvis må gives ved indsprøjtning.
English: • patients taking brivudine (an antiviral medicine for treating shingles or chickenpox) or who have taken it in the last 4 weeks.
Danish: • patienter, der tager brivudin (et antiviralt lægemiddel til behandling af helvedesild eller skoldkopper), eller som har taget det inden for de sidste 4 uger.
English: An overview of Xeloda and why it is authorised in the EU
Danish: En oversigt over Xeloda, og hvorfor det er godkendt i EU
English: About two-thirds of the patients taking Xeloda or the combination remained disease-free throughout the 3.8 years of the study.
Danish: Ca. to tredjedele af de patienter, der fik Xeloda eller kombinationen, var fortsat sygdomsfri i de 3,8 år, som studiet varede.
English: What is Xeloda and what is it used for?
Danish: Hvad er Xeloda, og hvad anvendes det til?
English: • patients who have had severe and unexpected reactions to fluoropyrimidine therapy;
Danish: • patienter, som har haft svære, uventede reaktioner mod behandling med fluoropyrimidin
English: • patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
Danish: • patienter med svær leukopeni, neutropeni eller trombocytopeni (for lavt antal hvide blodlegemer eller blodplader i blodet)
English: Why is Xeloda authorised in the EU?
Danish: Hvorfor blev Xeloda godkendt i EU?
English: In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Danish: I kroppen indtager fluorouracil pyrimidinets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelse af ny dna.
English: Capecitabine is a ‘prodrug' that is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Danish: Capecitabin er et "prodrug" (et forstadium), der i kroppen omdannes til fluoruracil, men omdannelsen sker i højere grad i svulstcellerne end i normalt væv.
English: Patients taking Xeloda with docetaxel had a longer time before the disease got worse compared with patients taking docetaxel on its own (186 days compared with 128 days).
Danish: Hos patienter, der fik Xeloda med docetaxel, varede det længere tid, inden sygdommen blev forværret sammenlignet med patienter, der fik docetaxel, anvendt alene, (186 dage i forhold til 128 dage).
English: What are the risks associated with Xeloda?
Danish: Hvilke risici er der forbundet med Xeloda?
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Danish: • metastatisk kolorektal cancer (kræft i tyktarmen, der har bredt sig til andre dele af kroppen).
English: Two smaller studies (238 patients) showed that Xeloda was effective after treatment with taxanes and anthracyclines did not work.
Danish: To mindre studier (238 patienter) viste, at Xeloda var effektivt efter behandling med taxaner, og at antracycliner ikke virkede.
English: Xeloda is used on its own or with other cancer medicines;
Danish: Xeloda anvendes alene eller sammen med andre kræftlægemidler
English: Results showed that when either Xeloda or fluorouracil and folinic acid were used with oxaliplatin, it took an average of 8 months for the disease to get worse in patients who had not been treated before, and 5 months in patients whose previous treatment had not worked.
Danish: Resultaterne viste, at når enten Xeloda eller fluorouracil og folinsyre blev givet sammen med oxaliplatin, varede det gennemsnitligt otte måneder, før sygdommen forværredes hos ikke tidligere behandlede patienter, og fem måneder hos patienter, hvis tidligere behandling ikke var lykkedes.
English: Xeloda must not be used in people who may be hypersensitive (allergic) to capecitabine, to any of the other ingredients, or to fluorouracil.
Danish: Xeloda må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for capecitabin, andre af indholdsstofferne eller over for fluoruracil.
English: The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Danish: Det aktive stof i Xeloda, capecitabin, er et cytotoksisk lægemiddel (dvs. det dræber celler, der deler sig, f.eks. kræftceller) og tilhører gruppen af antimetabolitter (stofskiftehæmmere).
English: Xeloda is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes' stage C colon cancer;
Danish: Xeloda anvendes alene eller sammen med andre kræftlægemidler til patienter, der er opereret for tyktarmskræft i stadium III eller Dukes' stadium C
English: Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
Danish: Xeloda anvendes sammen med andre kræftlægemidler, herunder et platinholdigt kræftlægemiddel såsom cisplatin
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of cancer medicine) has failed or when further treatment with anthracyclines is not suitable for the patient.
Danish: Det kan desuden bruges alene, når antracycliner og taxaner (en anden type kræftlægemidler) ikke virker, eller når yderligere behandling med antracycliner ikke er hensigtsmæssigt.
English: Also, the results of a published study involving 1,002 patients showed that patients taking combinations of medicines that included Xeloda survived for a similar period as those taking combinations that included fluorouracil.
Danish: Desuden viste resultaterne fra et offentliggjort studie, der omfattede 1.002 patienter, at patienter, der fik kombinationsbehandling med Xeloda, overlevede i en lige så lang periode som dem, der fik kombinationsbehandling med fluorouracil.
English: Xeloda is a cancer medicine that is used to treat:
Danish: Xeloda er et lægemiddel, der anvendes til behandling af:
English: • patients with severe liver or kidney disease;
Danish: • patienter med svær lever- eller nyresygdom
English: In locally advanced or metastatic breast cancer, Xeloda with docetaxel was more effective than docetaxel on its own in a study involving 511 women.
Danish: Med hensyn til lokalt fremskreden eller metastatisk brystkræft var Xeloda, anvendt med docetaxel, mere effektivt end docetaxel, anvendt alene, i et studie, der omfattede 511 kvinder.
English: Xeloda has been shown to be effective in treating colon, colorectal, gastric and breast cancer.
Danish: Xeloda har vist sig effektivt til at behandle patienter med tyktarmskræft, enedetarmskræft, mavekræft og brystkræft.
English: • patients with complete absence of activity of the dihydropyrimidine dehydrogenase enzyme;
Danish: • patienter med for lavt indhold i blodet af enzymet dihydropyrimidin dehydrogenase
English: Xeloda is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed.
Danish: Xeloda anvendes sammen med docetaxel (et andet kræftlægemiddel), hvis behandling med antracykliner (en anden type kræftlægemidler) ikke har virket.
English: For the full list of side effects reported with Xeloda, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Xeloda fremgår af indlægssedlen.
English: How is Xeloda used?
Danish: Hvordan anvendes Xeloda?
English: In advanced gastric cancer, Xeloda with cisplatin was as effective as a combination of fluorouracil and cisplatin in slowing down the disease in a study involving 316 patients.
Danish: Ved fremskreden mavekræft var Xeloda med cisplatin lige så effektivt som en kombination af fluoruracil og cisplatin til at forhale sygdommen i et studie, hvori der indgik 316 patienter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeloda 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 Xeloda.
English: What benefits of Xeloda have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xeloda?
English: In metastatic colorectal cancer, Xeloda taken on its own was as effective as the combination of fluorouracil and folinic acid in 2 studies involving 1,207 patients.
Danish: Til behandling af metastatisk tyktarmskræft var Xeloda, anvendt alene, lige så effektivt som kombinationen af fluorouracil og folinsyre i to studier, der omfattede 1.207 patienter.
English: How does Xeloda work?
Danish: Hvordan virker Xeloda?
English: It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving fluorouracil and cisplatin.
Danish: Hos de patienter, der fik Xeloda og cisplatin, gik der 5,6 måneder, uden at sygdommen skred frem, mens der gik 5,0 måneder hos dem, der fik fluorouracil og cisplatin.
English: Xeloda has also been compared with the combination of fluorouracil and folinic acid, both used in combination with oxaliplatin, in 2 studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients in whom previous treatment with irinotecan and a fluoropyrimidine (a group of cancer medicines that includes fluorouracil) had not worked.
Danish: Det første omfattede 2.035 patienter, der ikke tidligere havde været behandlet, og det andet omfattede 627 patienter, hos hvem tidligere behandling med irinotecan og et fluoropyrimidin (en gruppe kræftlægemidler, der omfatter fluorouracil)ikke havde virket.
English: In colon cancer, Xeloda on its own has been shown to be as effective as the combination of fluorouracil and folinic acid (a medicine that enhances the effects of fluorouracil) in a main study involving 1,987 patients who had had surgery for their cancer.
Danish: Med hensyn til tyktarmskræft har Xeloda, anvendt alene, vist sig at være lige så effektivt som en kombination af fluorouracil og folinsyre (et lægemiddel, der øger virkningen af fluorouracil) i et hovedstudie, der omfattede 1.987 kræftopererede patienter.
English: Another study involving 1,886 patients who had had surgery showed that Xeloda together with oxaliplatin (another cancer medicine) was more effective than the combination of fluorouracil and folinic acid: patients taking Xeloda and oxaliplatin had 20% lower risk of getting cancer again or death compared with patients taking fluorouracil and folinic acid.
Danish: I et andet studie, der omfattede 1.886 opererede patienter, var Xeloda sammen med oxaliplatin (et andet kræftlægemiddel) mere effektivt end kombinationen af fluoruracil og folinsyre.
English: Gastric cancer
Danish: Mavekræft
English: Ref. EMEA/551181/2008
Danish: EMEA/599/113/2008
English: London, 23 October 2008 Doc.
Danish: London, den 23. oktober 2008 Ref. dok.
English: What documentation was presented to support this application?
Danish: Hvilken dokumentation blev der fremlagt for at underbygge denne ansøgning?
English: • episodes of major depression;
Danish: • tilfælde af alvorlig depression
English: They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Danish: De kan anmode om en revurdering af udtalelsen senest 15 dage efter modtagelse af meddelelsen om denne negative udtalelse.
English: These were measured using standard scales and questionnaires.
Danish: Det blev målt ved hjælp af standardskalaer og spørgeskemaer.
English: The cause of fibromyalgia is not known.
Danish: Årsagen til fibromyalgi kendes ikke.
English: It is used for the treatment of adults with the following diseases:
Danish: Det anvendes til behandling af voksne med:
English: In all of the studies, the main measures of effectiveness were based on changes in the patients' symptoms, particularly pain levels, and their overall state of health.
Danish: I alle undersøgelserne var de primære effektmål baseret på ændringer i patienternes symptomer, særlig smerteniveauet, og deres generelle helbredstilstand.
English: International non-proprietary name (INN): duloxetine
Danish: Internationalt fællesnavn (INN): duloxetin
English: What is happening for duloxetine used for the treatment of other diseases?
Danish: Hvad sker der med duloxetin til behandling af andre sygdomme?
English: The results of five studies involving a total of 1,718 adults with fibromyalgia were presented to the CHMP to support the application.
Danish: Resultatet af fem undersøgelser af i alt 1 718 voksne med fibromyalgi blev forelagt CHMP for at underbygge ansøgningen.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: • generaliseret angst (vedvarende angst eller nervøsitet over dagligdags ting).
English: It is available as gastroresistant capsules.
Danish: Det leveres som gastroresistente kapsler.
English: The change concerned an extension of indication to add the treatment of fibromyalgia.
Danish: Ansøgningen om ændring vedrørte en udvidelse af indikationen til også at omfatte behandling af fibromyalgi.
English: Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Danish: Fibromyalgi kan også give andre symptomer som ømhed, stivhed, træthed, angst og ændringer i patientens søvn, følelser og tanker.
English: Cymbalta/Xeristar has been authorised since December 2004.
Danish: Cymbalta/Xeristar har været godkendt siden december 2004.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Danish: "Gastroresistent" betyder, at kapslernes indhold passerer gennem maven og først bliver nedbrudt, når det når ned i tarmene.
English: On 23 October 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules.
Danish: Den 23. oktober 2008 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori udvalget anbefaler afslag på ansøgning om ændring af markedsføringstilladelsen for lægemidlet Cymbalta/Xeristar 30 mg og 60 mg gastroresistente kapsler.
English: Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta/Xeristar
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om ændring af markedsføringstilladelsen for Cymbalta/Xeristar
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre neurotransmitterne 5-hydroxytrypamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nerveceller i hjernen og rygmarven.
English: Since these neurotransmitters are thought to be involved in fibromyalgia, blocking their re-uptake into nerve cells is expected to improve the symptoms of the disease.
Danish: Da disse neurotransmittere også menes at være en medvirkende faktor ved fibromyalgi, forventes blokering af genoptagelsen af disse i nervecellerne at forbedre symptomerne på sygdommen.
English: The fifth, a long-term study, compared the effects of two doses of Cymbalta/Xeristar over a year in 307 patients.
Danish: Den femte undersøgelse var langvarig, og heri sammenlignedes virkningen af to doser Cymbalta/Xeristar i løbet af et år hos 307 patienter.
English: There are no consequences on the use of Cymbalta/Xeristar, Ariclaim or Yentreve in their authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Der er ingen konsekvenser for anvendelsen af Cymbalta/Xeristar, Ariclaim eller Yentreve til de for disse lægemidler allerede godkendte indikationer, hvor benefit/risk-forholdet forbliver uændret.
English: Cymbalta/Xeristar is a medicine containing the active substance duloxetine.
Danish: Cymbalta/Xeristar er et lægemiddel, som indeholder det aktive stof duloxetin.
English: Duloxetine, under the names Ariclaim and Yentreve, is also authorised for use in stress urinary incontinence.
Danish: Duloxetin er under navnene Ariclaim og Yentreve også godkendt til anvendelse ved stressinkontinens.
English: Cymbalta/Xeristar was also expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Danish: Man havde forventet, at Cymbalta/Xeristar også skulle anvendes til behandling af voksne med fibromyalgi, en sygdom, som giver vedvarende, udbredte smerter og smertereaktioner ved berøring.
English: What are the consequences of the refusal for patients in clinical trials with Cymbalta/Xeristar?
Danish: Hvilke konsekvenser har afslaget for patienter, som deltager i kliniske undersøgelser med Cymbalta/Xeristar?
English: The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.
Danish: CHMP konkluderede også, at den langvarige undersøgelse var utilstrækkelig til at påvise effekten af lægemidlet, og at der var behov for en langvarig undersøgelse, som sammenlignede Cymbalta/Xeristar med placebo.
English: Cymbalta/Xeristar was expected to be used in fibromyalgia patients with or without depression.
Danish: Det var forventet, at Cymbalta/Xeristar skulle anvendes til patienter med fibromyalgi med eller uden depression.
English: The companies informed the CHMP that there are currently no ongoing clinical trials with Cymbalta/Xeristar in fibromyalgia patients in Europe.
Danish: Virksomhederne informerede CHMP om, at der i øjeblikket ikke foregår kliniske undersøgelser med Cymbalta/Xeristar hos fibromyalgipatienter i Europa.