FrancophonIA/ELRC3.0 huggingface dataset:
English: • Relevant safety and efficacy data in patients with age-related hypogonadism and established physiological reference values in older patients are lacking, and further studies are needed.
Danish: • Der savnes dels relevante data om sikkerhed og virkning hos patienter med aldersrelateret hypogonadisme, dels fastlæggelse af fysiologiske referenceværdier hos ældre patienter.
English: As the CMDh position was adopted by consensus, it will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Danish: Da CMDh's standpunkt blev vedtaget enstemmigt, skal det nu i henhold til en vedtagen tidsplan gennemføres direkte i de medlemsstater, hvor disse lægemidler er godkendt.
English: The PRAC recommended updating the product information in line with the latest evidence and to provide warnings about those who might be at increased risk of heart problems.
Danish: PRAC anbefalede, produktoplysningerne ajourføres svarende til de nyeste undersøgelsesresultater, og at der gives advarsler vedrørende patienter med mulig forhøjet risiko for hjerteproblemer.
English: The use of testosterone in healthy older men is not an authorised use in the EU.
Danish: Anvendelse af testosteron hos raske ældre mænd er ikke en godkendt anvendelse i EU.
English: • The product information will also be amended to make it clear that these medicines should only be given to men in whom both signs and symptoms and laboratory tests confirm abnormally low levels of testosterone.
Danish: • Produktoplysningerne er desuden blevet ændret, så det fremgår, at disse lægemidler kun bør gives til mænd, hos hvem tegn, symptomer og laboratorieprøver bekræfter et abnormt lavt niveau af testosteron.
English: The CMDh has endorsed the PRAC recommendations by consensus and they will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Danish: CMDh har vedtaget PRAC's anbefalinger enstemmigt og de skal nu i henhold til en vedtagen tidsplan gennemføres direkte af de medlemsstater, hvor lægemidlerne er godkendt.
English: The CMDh1, a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism).
Danish: CMDhfn, der repræsenterer EU's medlemsstater, har enstemmigt fastslået, at der ikke er entydigt bevis for øget risiko for hjerteproblemer med lægemidler indeholdende testosteron hos mænd med mangel på hormonet (hypogonadisme).
English: • Patients who are prescribed testosterone should remind their doctors if they are being treated for high blood pressure, as testosterone can also increase blood pressure.
Danish: • Patienter, som får ordineret testosteron og er i behandling for højt blodtryk, bør minde lægen om, at testosteron også kan øge blodtrykket.
English: • Some recent studies have shown an increased risk of cardiovascular events in men treated with testosterone.
Danish: • Visse nyere undersøgelser viser øget risiko for kardiovaskulære hændelser hos mænd ved behandling med testosteron.
English: Corona G, Maseroli E, Rastrelli G, et al. Cardiovascular risk associated with testosterone boosting medications: a systematic review and metaanalysis.
Danish: Corona G, Maseroli E, Rastrelli G, et al. Cardiovascular risk associated with testosteron boosting medications: a systematic review and metaanalysis.
English: Xu L, Freeman G, Cowling BJ, et al. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
Danish: Xu L, Freeman G, Cowling BJ, et al. testosteron therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
English: Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development and function in men.
Danish: Lægemidler indeholdende testosteron virker ved at erstatte det manglende testosteron, så det normale indhold af testosteron genetableres for at sikre normal seksuel udvikling og funktion hos mænd.
English: Vigen R, O'Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.
Danish: Vigen R, O'Donnell CI, Barón AE, et al. Association of testosteron therapy with mortality, myocardial infarction, and stroke in men with low testosteron levels.
English: Medicines containing testosterone are licensed in the EU to treat men with abnormally low levels of the hormone (hypogonadism).
Danish: Lægemidler indeholdende testosteron er godkendt i EU til behandling af mænd med abnormt lavt indhold af hormonet (hypogonadisme).
English: • Although some studies show an increased risk of cardiovascular events in men treated with testosterone, findings in the literature do not show this consistently.
Danish: • Skønt disse undersøgelser viser øget risiko for kardiovaskulære hændelser hos mænd i behandling med testosteron, er resultaterne i litteraturen ikke samstemmende hvad dette angår.
English: Testosterone-containing medicines are used to replace testosterone in men with hypogonadism.
Danish: Lægemidler indeholdende testosteron anvendes til at erstatte testosteron hos mænd med hypogonadisme.
English: In particular, concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease.1-3
Danish: Navnlig er der rejst betænkelighed ved den potentielle øgede risiko for kardiovaskulære hændelser, især myokardieinfarkt, ved behandling med testosteron af mænd med præeksisterende hjertesygdom1-3.
English: Baillargeon J, Urban RJ, Kuo Y-F, et al. Risk of myocardial infarction in older men receiving testosterone therapy.
Danish: Baillargeon J, Urban RJ, Kuo Y-F, et al. Risk of myocardial infarction in older men receiving testosteron therapy.
English: The benefit-risk balance of these medicines has been reviewed following recent published evidence pointing to an increased risk of cardiovascular events, particularly myocardial infarction, in men treated with testosterone.
Danish: Gennemgangen af benefit/risk-forholdet for sådanne lægemidler har fundet sted, efter at nylig offentliggjort evidens peger på øget risiko for kardiovaskulære hændelser, navnlig myokardieinfarkt, hos mænd ved behandling med testosteron.
English: The level of testosterone falls naturally with age and testosterone-containing medicines are not approved in the EU for use to boost testosterone levels in healthy older men.
Danish: Indholdet af testosteron aftager naturligt med alderen, og lægemidler indeholdende testosteron er ikke godkendt i EU til at øge indholdet af testosteron hos raske ældre mænd.
English: It should be borne in mind that physiological testosterone levels decrease somewhat with age, though there is no current consensus on appropriate age-specific testosterone reference values, and use to boost these levels in healthy older men is not an authorised use in the EU.
Danish: Det må haves for øje, at de fysiologiske koncentrationer af testosteron aftager med alderen, skønt der på nuværende tidspunkt ikke er konsensus om aldersspecifikke referenceværdier for testosteron, og anvendelse til at forhøje koncentrationerne hos raske ældre mænd er ikke godkendt i EU.
English: • There is not much information on the use of testosterone medicines in men over 65 years of age.
Danish: • Hos mænd over 65 år er der ikke megen information om anvendelse af lægemidler indeholdende testosteron.
English: Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorised use of the medicine in the EU.
Danish: Indholdet af testosteron aftager i et vist omfang med alderen, men genoprettelse heraf hos sunde ældre mænd er ikke en godkendt anvendelse af lægemidlet i EU.
English: Information to healthcare professionals Testosterone-containing medicines are licensed in the EU for the treatment of male hypogonadism.
Danish: Information til sundhedspersoner Lægemidler indeholdende testosteron er i EU godkendt til behandling af hypogonadisme hos mænd.
English: The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests.
Danish: Det skal klart fremgå af produktoplysningerne, at testosteron kun bør anvendes, når det ved tegn og symptomer og passende laboratorieprøver er bekræftet, at indholdet af hormonet er abnormt lavt.
English: The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems.
Danish: Ikke entydigt bevis for, at lægemidler med testosteron øger risikoen for hjerteproblemer
English: In men with hypogonadism, testosterone levels are abnormally low, affecting normal sexual development and function.
Danish: Hos mænd med hypogonadisme er niveauet af testosteron abnormt lavt.
English: The PRAC considered these studies along with available data from other studies and analyses, and information on safety collected since marketing, and found that the evidence regarding the risk of heart problems was inconsistent: some studies suggested increased risk, while others did not, and some of the studies had problems with the design that limited the conclusions that could be drawn from them.
Danish: Udvalget fandt, at beviserne på risikoen for hjerteproblemer ikke var entydige: Mens nogle undersøgelser tydede på øget risiko, gjorde andre det ikke, og nogle af undersøgelserne havde mangler i deres tilrettelæggelse, der begrænsede de konklusioner, der kunne drages af dem. PRAC hæftede sig også ved, at mangel på testosteron i sig selv kan øge risikoen for hjerteproblemer.
English: Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels.
Danish: Hildreth KL, Barry DW, Moreau KL, et al. Effects of testosteron and progressive resistance exercise in healthy, highly functioning older men with low-normal testosteron levels.
English: Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.
Danish: Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosteron therapy prescription in men.
English: The review was started because of some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it.
Danish: Gennemgangen blev foretaget, fordi visse nyere undersøgelser viser højere forekomst af hjerteproblemer hos mænd, som får testosteron, end hos mænd, som ikke får det. PRAC gennemgik disse undersøgelser sammen med foreliggende data fra andre undersøgelser og analyser og sikkerhedsoplysninger indsamlet siden markedsføringen.
English: The name of the medicine was changed to Ecansya on 16 November 2012.
Danish: Lægemidlets navn blev ændret til Ecansya den 16. november 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Krka on 20 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Capecitabine Krka den 20. april 2012.
English: The full EPAR for Ecansya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ecansya findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ecansya tablets should be swallowed with water within the 30 minutes after a meal.
Danish: Ecansya-tabletterne sluges hele med vand inden for 30 minutter efter et måltid.
English: This is a summary of the European public assessment report (EPAR) for Ecansya.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ecansya.
English: Ecansya is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Ecansya tages to gange dagligt i doser mellem 625 og 1 250 mg pr. kvadratmeter legemsoverflade (beregnet ved anvendelse af patientens højde og vægt).
English: Ecansya capecitabine
Danish: Ecansya capecitabin
English: Previously known as Capecitabine Krka.
Danish: Tidligere kendt som Capecitabine Krka.
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 Ecansya.
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 anvendelsesbetingelserne for Ecansya.
English: What are the benefits and risks of Ecansya?
Danish: Hvilke fordele og risici er der forbundet med Ecansya?
English: For more information about treatment with Ecansya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ecansya, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Committee recommended that Ecansya be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Ecansya.
English: Other information about Ecansya
Danish: Andre oplysninger om Ecansya:
English: Because Ecansya is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ecansya er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: The CHMP concluded that, in accordance with EU requirements, Ecansya has been shown to have comparable quality and to be bioequivalent to Xeloda.
Danish: CHMP konkluderede, at Ecansya i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Xeloda.
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) 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 5-fluoruracil (5-FU), men omdannelsen sker i højere grad i svulstcellerne end i normalt væv.
English: Ecansya is a ‘generic' and a ‘hybrid' medicine.
Danish: Ecansya er et ”generisk lægemiddel” og et ”hybridt lægemiddel”.
English: Ecansya should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Danish: Ecansya bør kun ordineres af en læge, som er specialiseret i brug af lægemidler mod kræft.
English: The company provided data from the published literature on capecitabine.
Danish: Virksomheden fremlagde data fra faglitteraturen om capecitabin.
English: The company carried out a ‘bioequivalence' study to show that 500 mg Ecansya produces the same levels of capecitabine in the blood as 500 mg of the reference medicine.
Danish: Virksomheden gennemførte en bioækvivalensundersøgelse for at påvise, at Ecansya danner den samme mængde capecitabin i blodet som 500 mg af referencelægemidlet.
English: Ecansya is used with or without other anticancer medicines;
Danish: Ecansya anvendes med eller uden andre lægemidler mod kræft,
English: Ecansya is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Danish: Ecansya kan anvendes med eller uden andre midler mod kræft til patienter, der er opereret for tyktarmskræft i ‘stadium III' eller ‘Dukes' stadium C',
English: For more information on generic and hybrid medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar her.
English: The active substance in Ecansya, 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 Ecansya, capecitabin, er et cytotoksisk lægemiddel (et lægemiddel, som dræber celler, der deler sig såsom kræftceller) og tilhører gruppen af 'antimetabolitter' (stofskiftehæmmere).
English: Ecansya is an anticancer medicine.
Danish: Ecansya er et lægemiddel mod kræft.
English: Ecansya is a medicine that contains the active substance capecitabine.
Danish: Ecansya er et lægemiddel, der indeholder det aktive stof capecitabin.
English: Why has Ecansya been approved?
Danish: Hvorfor blev Ecansya godkendt?
English: Ecansya is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Danish: Ecansya anvendes sammen med andre lægemidler mod kræft, herunder et platinholdigt kræftmiddel såsom cisplatin,
English: Ecansya is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Danish: Ecansya anvendes her sammen med docetaxel (et andet lægemiddel mod kræft) efter svigt af antracykliner (en anden form for lægemiddel mod kræft).
English: What is Ecansya?
Danish: Hvad er Ecansya?
English: Pyrimidine is part of the genetic material of cells (DNA and RNA).
Danish: 5-FU er en pyrimidinanalog Pyrimidiner er en del af cellernes genetiske materiale (dna og rna).
English: What is Ecansya used for?
Danish: Hvad anvendes Ecansya til?
English: How has Ecansya been studied?
Danish: Hvordan blev Ecansya undersøgt?
English: This means that it is similar to a ‘reference medicine', but it contains capecitabine at a new strength in addition to existing strengths: while the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Ecansya is also available as 300 mg tablets.
Danish: Mens referencelægemidlet Xeloda fås som 150 og 500 mg tabletter, fås Ecansya også som 300 mg tabletter.
English: How is Ecansya used?
Danish: Hvordan anvendes Ecansya?
English: How does Ecansya work?
Danish: Hvordan virker Ecansya?
English: It is used in the following types of cancer:
Danish: Det anvendes til behandling af følgende kræftformer:
English: The full EPAR for Docetaxel Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Docetaxel Teva 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 Docetaxel Teva on 26 January 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Docetaxel Teva den 26. januar 2010.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Teva.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Docetaxel Teva.
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Danish: Når celleskelettet holdes intakt, kan cellerne ikke dele sig, og de vil til sidst dø.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Danish: • kræft i hoved- og halsregionen hos patienter, hvis kræft er lokalt fremskreden (som er vokset, men ikke har spredt sig).
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 Docetaxel Teva.
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 Docetaxel Teva skal anvendes.
English: For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Docetaxel Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Docetaxel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Danish: Det betyder, at Docetaxel Teva er identisk med et ”eferencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Taxotere.
English: Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm3.)
Danish: Docetaxel Teva må kun bruges, når neutrofiltallet (koncentrationen af en form for hvide blodlegemer) er mindst 1 500 celler/mm3.
English: Docetaxel Teva is given as a one-hour infusion every three weeks.
Danish: Docetaxel Teva gives hver tredje uge ved en infusion, der varer en time.
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Danish: Docetaxel blokerer den fase af celledelingen, hvor cellernes indre skelet nedbrydes, så cellerne kan dele sig.
English: In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.
Danish: Derudover fremlagde virksomheden undersøgelsesresultater til påvisning af, at kvaliteten af Docetaxel Teva infusionsopløsning svarer til kvaliteten af Taxotere.
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil.
Danish: Docetaxel Teva anvendes sammen med cisplatin og 5-fluorouracil.
English: No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Docetaxel Teva er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Taxotere.
English: Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel.
Danish: Da Docetaxel Teva er et generisk lægemiddel, fremlagde virksomheden data fra den offentliggjorte faglitteratur om docetaxel.
English: Other information about Docetaxel Teva
Danish: Andre oplysninger om Docetaxel Teva
English: The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docetaxel Teva, docetaxel, tilhører en gruppe kræftlægemidler, der kaldes taxaner.
English: Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Docetaxel Teva er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Docetaxel Teva is a ‘generic medicine'.
Danish: Docetaxel Teva er et ‘generisk lægemiddel'.
English: Docetaxel Teva can be used on its own after other treatments have failed.
Danish: Docetaxel Teva kan bruges som eneste behandling, når andre lægemidler har været uden virkning.
English: Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);
Danish: Docetaxel Teva anvendes sammen med prednison eller prednisolon (antiinflammatoriske lægemidler).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Docetaxel Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Taxotere.
English: What benefit and risk of Docetaxel Teva?
Danish: Hvilken fordel og risiko er der forbundet med Docetaxel Teva?