FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets).
Danish: De mest almindelige alvorlige bivirkninger (der kan forekomme hos mere end 1 ud af 50 patienter) omfatter diarré, kvalme og opkastning, lavt antal hvide blodlegemer (neutropeni) og feber, blodforgiftning (sepsis) og lungebetændelse, chok, dehydrering, nyresvigt og lavt antal blodplader (trombocytopeni).
English: Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine.
Danish: Onivyde er blevet vurderet i et hovedstudie, der omfattede 417 patienter med metastatisk adenokarcinom i bugspytkirtlen, hvor kræftsygdommen var blevet værre på trods af behandling med et kræftlægemiddel, der indeholdt gemcitabin.
English: Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Onivyde fås som et koncentrat, der fortyndes til en opløsning, som gives som infusion (drop) i en vene.
English: For the full list of side effects of Onivyde, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Onivyde fremgår af indlægssedlen.
English: How does Onivyde work?
Danish: Hvordan virker Onivyde?
English: Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas.
Danish: Onivyde er et lægemiddel til behandling af en type kræft i pankreas (bugspytkirtlen), som kaldes metastatisk adenokarcinom i pankreas (bugspytkirtelkræft).
English: How is Onivyde used?
Danish: Hvordan anvendes Onivyde?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onivyde have 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 Onivyde.
English: What benefits of Onivyde have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Onivyde?
English: The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.
Danish: De patienter, der fik de tre lægemidler i kombination, levede i ca. 6,1 måneder, mens de patienter, der fik 5-fluorouracil plus leucovorin, levede i 4,2 måneder, og de patienter, der fik Onivyde alene, levede i 4,9 måneder.
English: The Agency considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.
Danish: Agenturet har vurderet, at den øgede levetid ved brug af Onivyde i kombination med 5-fluorouracil og leucovorin er værdifuld hos tidligere behandlede patienter med metastatisk adenokarcinom i bugspytkirtlen, som kun har begrænsede behandlingsmuligheder.
English: The full EPAR for Imatinib Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Imatinib Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Accord on 1 July 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Imatinib Accord den 1. juli 2013.
English: Imatinib Accord is available as tablets (100 and 400 mg).
Danish: Imatinib Accord leveres som tabletter (100 og 400 mg).
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Danish: Det anvendes også til voksne og børn i den "kroniske fase" af sygdommen, hvis den ikke reagerer på interferon alfa (et andet lægemiddel mod kræft), og i de mere fremskredne faser af sygdommen ("accelereret fase" og "blastkrise")
English: These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Danish: Disse enzymer findes i visse receptorer på kræftcellernes overflade, herunder de receptorer, der medvirker til at stimulere cellerne til at dele sig ukontrolleret.
English: This is a summary of the European public assessment report (EPAR) for Imatinib Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imatinib Accord.
English: As for every medicine, the company provided studies on the quality of Imatinib Accord.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Imatinib Accord.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Accord.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Glivec, og det er ikke nødvendigt at gentage disse med Imatinib Accord.
English: The Agency recommended that Imatinib Accord be approved for use in the EU.
Danish: Agenturet anbefalede, at Imatinib Accord godkendes til anvendelse i EU.
English: Imatinib Accord is a cancer medicine used to treat the following diseases:
Danish: Imatinib Accord er et lægemiddel mod kræft, som anvendes til at behandle følgende sygdomme:
English: The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Imatinib Accord er af sammenlignelig kvalitet og er bioækvivalent med Glivec.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine, Glivec.
Danish: Virksomheden gennemførte også undersøgelser, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet, Glivec.
English: Imatinib Accord is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Danish: Imatinib Accord anvendes, når patienten er "Philadelphiakromosompositiv" (Ph+).
English: Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Imatinib Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Danish: Det anvendes desuden alene hos voksne til behandling af Ph+ ALL ved tilbagefald af sygdommen efter forudgående behandling eller når sygdommen ikke reagerer på andre lægemidler
English: This means that Imatinib Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Danish: Det betyder, at Imatinib Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Glivec.
English: Imatinib Accord is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Danish: Imatinib Accord gives gennem munden sammen med et måltid og et stort glas vand for at mindske risikoen for irritation af mave-tarmkanalen.
English: Imatinib Accord is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Danish: Imatinib Accord anvendes til behandling af voksne med DFSP, der ikke kan fjernes ved operation, og til voksne, som er uegnede til operation, når der er tilbagefald af kræften efter behandling, eller når den har bredt sig til andre dele af kroppen.
English: What measures are being taken to ensure the safe and effective use of Imatinib Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imatinib Accord?
English: For more information about treatment with Imatinib Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Imatinib Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Imatinib Accord
Danish: Andre oplysninger om Imatinib Accord
English: By blocking these receptors, Imatinib Accord helps to control cell division.
Danish: Ved at blokere disse receptorer er Imatinib Accord med til at begrænse celledelingen.
English: Imatinib Accord contains the active substance imatinib.
Danish: Imatinib Accord indeholder det aktive stof imatinib.
English: Therefore, the Agency's view was that, as for Glivec, the benefit outweighs the identified risk.
Danish: Agenturet fandt derfor, at fordelene er større end risiciene, ligesom for Glivec.
English: Imatinib Accord is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Danish: Imatinib Accord anvendes i kombination med andre kræftlægemidler til voksne og børn, som for nylig har fået diagnosticeret Ph+ ALL.
English: The active substance in Imatinib Accord, imatinib, is a protein-tyrosine kinase inhibitor.
Danish: Det aktive indholdsstof i Imatinib Accord, imatinib, er en protein-tyrosinkinasehæmmer.
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Danish: • myelodysplastiske eller myeloproliferative sygdomme (MD/MPD), som er en gruppe af sygdomme, hvor kroppen producerer et stort antal unormale blodlegemer.
English: What is Imatinib Accord and what is it used for?
Danish: Hvad er Imatinib Accord, og hvad anvendes det til?
English: What are the benefits and risks of Imatinib Accord?
Danish: Hvilken fordel og risiko er der forbundet med Imatinib Accord?
English: Imatinib Accord is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Danish: Imatinib Accord anvendes til behandling af voksne med HES eller CEL, hos hvem der forekommer en særlig-omarrangering af de to gener FIP1L1 og PDGFRα
English: It is not intended to provide practical advice on how to use Imatinib Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Imatinib Accord bør anvendes.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Danish: • dermatofibrosarcoma protuberans (DFSP), en form for kræft (sarkom), hvor cellerne i vævet under huden begynder at dele sig ukontrolleret.
English: Imatinib Accord is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for bone marrow transplantation.
Danish: Imatinib Accord anvendes til voksne og børn, som for nylig har fået diagnosticeret Ph+ CML og ikke er egnede til en knoglemarvstransplantation.
English: For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Imatinib Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Imatinib Accord is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Danish: Imatinib Accord anvendes til behandling af voksne med MD/MPD, hos hvem genet for blodpladederiveret vækstfaktorreceptor (PDGFR) har omarrangeret sig
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Danish: • fremskredent hypereosinofilt syndrom (HES) eller kronisk eosinofil leukæmi (CEL), som er sygdomme, hvor eosinofiler (en anden form for hvide blodlegemer) begynder at vokse ukontrolleret.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Accord have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Imatinib Accord.
English: Why is Imatinib Accord approved?
Danish: Hvorfor blev Imatinib Accord godkendt?
English: • chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Danish: • kronisk myeloid leukæmi (CML), en form for kræft, som angriber de hvide blodlegemer, hvori der er granulocytter (en form for hvide blodlegemer), som begynder at vokse ukontrolleret.
English: How has Imatinib Accord been studied?
Danish: Hvordan blev Imatinib Accord undersøgt?
English: How is Imatinib Accord used?
Danish: Hvordan anvendes Imatinib Accord?
English: How does Imatinib Accord work?
Danish: Hvordan virker Imatinib Accord?
English: In such a case, treatment must be stopped immediately.
Danish: I sådanne tilfælde skal behandlingen straks ophøre.
English: However, an in-depth review did not find any conclusive evidence that this was the case.
Danish: En tilbundsgående gennemgang gav imidlertid ikke afgørende bevis for, at dette var tilfældet.
English: The review of testosterone was initiated on 27 March 2014 at the request of Estonia, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af testosteron blev indledt den 27. marts 2014 på anmodning af Estland i medfør af artikel 31 i direktiv 2001/83/EF.
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Danish: PRAC's anbefaling blev overgivet til CMDh, som vedtog et endeligt standpunkt.
English: Testosterone levels should then be monitored regularly during treatment.
Danish: Indholdet af testosteron bør derefter overvåges regelmæssigt under behandlingen.
English: Available at: https://www.aace.com/files/late-breaking-abstracts2014.pdf
Danish: Available at: https://www.aace.com/files/late-breakingabstracts-2014.pdf 7.
English: Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly.
Danish: Hæmoglobin, hæmatokrit, leverfunktion og lipidprofil i blodet bør ligeledes overvåges regelmæssigt.
English: They are available as various formulations such as oral capsules, implants to be injected under the skin and as patches, gels or solutions to be applied to the skin.
Danish: De fås i forskellige formuleringer såsom orale kapsler, implantater til injektion under huden, og depotplastre, geler eller opløsninger til påføring på huden.
English: • Patients who have any concerns about their treatment should discuss them with their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål til deres behandling, skal tale med lægen eller apotekspersonalet derom.
English: It follows concerns over reports about side effects of these medicines on the heart.
Danish: Den fulgte efter betænkelighed ved indberetninger om bivirkninger på hjertet af sådanne lægemidler.
English: • There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age.
Danish: • Der er kun begrænsede erfaringer om sikkerheden og virkningen af disse lægemidler hos patienter over 65 år.
English: A review of these data was first conducted by the PRAC, the EMA's Committee responsible for the evaluation of safety issues for human medicines.
Danish: Disse oplysninger blev først gennemgået PRAC, som er EMA's udvalg med ansvar for vurdering af sikkerhedsmæssige spørgsmål i forbindelse med lægemidler til mennesker.
English: Testosterone-containing medicines have been authorised in all EU Member States via national procedures under various trade names.
Danish: Lægemidler indeholdende testosteron er godkendt i alle EU's medlemsstater via nationale procedurer under forskellige handelsnavne.
English: Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: the low T experience.
Danish: testosteron therapy is not associated with higher risk of myocardial infarction or stroke: the low T experience.
English: Possible signs and symptoms include incomplete sexual development, decreased sexual function, infertility, fatigue, depressed mood, mild anaemia, reduced muscle bulk and strength and increased body fat.
Danish: Mulige symptomer er ufuldstændig seksuel udvikling, nedsat seksuel funktion, ufrugtbarhed, træthed, depression, let anæmi, nedsat muskelvolumen og -styrke og øget kropsfedt.
English: Taking all the data into account, the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive.
Danish: Når samtlige data tages i betragtning, er signalet om øget kardiovaskulær risiko ved anvendelse af testosteron fortsat svagt og inkonklusivt.
English: • As a precaution, the product information for these medicines will be updated with the latest information on the risks together with some additional warnings for safe use, and the safety of the medicines will continue to be closely monitored.
Danish: • Som en sikkerhedsforanstaltning vil produktoplysningerne for disse lægemidler blive ajourført med den nyeste viden om risiciene sammen med ekstra advarsler om sikker brug, og lægemidlernes sikkerhed vil fortsat blive overvåget tæt.
English: • The cardiovascular safety of testosterone medicines will continue to be monitored and the findings of ongoing studies will be reflected in the next regular benefit-risk assessments when available.
Danish: • Den kardiovaskulære sikkerhed af lægemidler indeholdende testosteron vil fortsat blive overvåget, og resultaterne af igangværende undersøgelser vil afspejle sig i de næste planmæssige benefit/risk-vurderinger, når de foreligger.
English: The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review (to which these medicines, like all medicines in the EU, are subject).
Danish: PRAC fandt endvidere, at risiciene for virkninger på hjertet og kredsløbet og eventuelle mekanismer bag sådanne virkninger fortsat bør overvåges, og at oplysninger fra igangværende undersøgelser bør indgå i den næste planmæssige sikkerhedsgennemgang (som finder sted for disse lægemidler ligesom for alle andre lægemidler i EU).
English: • Some recent studies have suggested that using testosterone may increase a man's risk of heart attacks or other serious effects on the heart and circulation.
Danish: • Visse nyere undersøgelser har tydet på, at brug af testosteron kan øge mænds risiko for hjerteanfald eller andre alvorlige virkninger på hjerte og kredsløb.
English: • In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Danish: • Hos patienter med svær hjerte-, lever- eller nyreinsufficiens eller iskæmisk hjertesygdom kan testosteron medføre svære komplikationer kendetegnet af ødem med eller uden kongestiv hjerteinsufficiens.
English: • Caution is also advised in patients with pre-existing hypertension, since testosterone may cause an increase in blood pressure.
Danish: • Forsigtighed tilrådes ligeledes hos patienter med præeksisterende hypertension, da testosteron kan medføre, blodtryksstigning.
English: The changes to the product information for testosterone medicines are based on a PRAC review of data available from clinical trials, observational studies, meta-analyses, post-marketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Danish: Ændringerne i produktoplysningerne for lægemidler indeholdende testosteron er baseret på PRAC's gennemgang af foreliggende data fra kliniske undersøgelser, observationsundersøgelser, metaanalyser, data efter markedsføring og yderligere publicerede data om de kardiovaskulære risici ved behandling med testosteron.
English: • However, other findings4-7 do not provide evidence of an association between testosterone and cardiovascular events, and data from a multinational observational registry study (RHYME) looking at prostate health outcomes in men treated with testosterone for over 2 years also indicate cardiovascular events within the anticipated range.
Danish: • Andre resultater4-7 giver imidlertid ikke evidens for en sammenhæng mellem testosteron og kardiovaskulære hændelser, og data fra en multinational observationsundersøgelse med registrering (RHYME) vedrørende prostatarelaterede udfald hos mænd behandlet med testosteron i over to år viser ligeledes, at de kardiovaskulære hændelser er inden for det forventede område.
English: • Testosterone replacement therapy should only be given when deficiency of the hormone has been confirmed by clinical features and biochemical tests.
Danish: • Substitutionsbehandling med testosteron bør kun anvendes, når mangel på hormonet er bekræftet ved kliniske symptomer og biokemiske prøver.
English: However, the product information is to be updated in line with the most current available evidence on safety, and with warnings that the lack of testosterone should be confirmed by signs and symptoms and laboratory tests before treating men with these medicines.
Danish: Produktoplysningerne skal dog ajourføres med den nyeste foreliggende viden om sikkerheden og med advarsler om, at mangel på testosteron skal være bekræftet af tegn og symptomer og ved laboratorieprøver, før mænd sættes i behandling med de pågældende lægemidler.
English: Testosterone is a hormone, known as an androgen, responsible for the development and maintenance of reproductive function and sexual characteristics in men.
Danish: Testosteron er et hormon, der kaldes et androgen og er ansvarligt for udvikling og vedligeholdelse af forplantningsfunktion og kønskarakteristika hos mænd.
English: • Testosterone is a hormone responsible for normal sexual development and function in men.
Danish: • Testosteron er et hormon, der er ansvarligt for mænds normale seksuelle udvikling og funktion.
English: The CMDh position follows a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked at the risk of serious problems affecting the heart and circulation, particularly heart attacks, in men treated with these medicines.
Danish: CMDh's udtalelse følger efter en gennemgang foretaget EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC), som gennemgik risikoen for alvorlige hjerte- og kredsløbsproblemer, navnlig hjerteanfald, hos mænd i behandling med sådanne lægemidler.