FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Prevenar 13's benefits are greater than its risks and recommended that it be granted marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Prevenar 13 opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Prevenar 13.
English: Why has Prevenar 13 been approved?
Danish: Hvorfor blev Prevenar 13 godkendt?
English: For the full list of all side effects reported with Prevenar 13, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Prevenar 13 fremgår af indlægssedlen.
English: It is available as a suspension for injection that contains parts from 13 different types of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Danish: Det fås som en injektionsvæske, suspension, der indeholder dele af 13 forskellige typer af bakterien Streptococcus pneumoniae (S. pneumoniae).
English: Additional studies in children looked at the effects of giving booster vaccinations, switching from Prevenar to Prevenar 13 and using Prevenar 13 alongside other vaccines routinely given to children.
Danish: I yderligere undersøgelser af børn så man nærmere på virkningerne af at give boostervaccinationer, af at skifte fra Prevenar til Prevenar 13 og af at anvende Prevenar 13 sammen med andre vacciner, der rutinemæssigt gives til børn.
English: In adults and the elderly, the most common side effects (seen in more than 1 patient in 10) are decreased appetite, headaches, diarrhoea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue.
Danish: Hos voksne og ældre er de hyppigste bivirkninger (som optræder hos flere end 1 ud af 10 patienter) nedsat appetit, hovedpine, diarré, feber (forekommer kun som meget almindelig hos voksne i alderen 18 til 29 år), opkastning (forekommer kun som meget almindelig hos voksne i alderen 18 til 49 år), udslæt, reaktioner på injektionsstedet, begrænsning af armbevægelser, arthralgi og myalgi (led- og muskelsmerter), kulderystelser og træthed.
English: A third study, which involved 900 adults aged 18 to 49, compared the immune response to Prevenar 13 with the response in adults aged 60 to 64.
Danish: I en tredje undersøgelse, der omfattede 900 voksne i alderen 18 til 49 år, blev immunresponsen på Prevenar 13 sammenlignet med responsen hos voksne i alderen 60 til 64 år.
English: The most common side effects with Prevenar 13 (seen in more than 1 patient in 10) in children are decreased appetite, fever (only very common in children aged 6 weeks to 5 years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep.
Danish: De hyppigste bivirkninger ved Prevenar 13 (som optræder hos flere end 1 ud af 10 patienter) hos børn er nedsat appetit, feber (forekommer kun som meget almindelig hos børn i alderen seks uger til fem år), irritabilitet, reaktioner på injektionsstedet (rødme eller hård hud, hævelse, smerter eller ømhed), søvnighed og dårlig søvnkvalitet.
English: The first study involved 835 adults aged 50 to 64 years who had not previously been vaccinated against invasive disease caused by S. pneumoniae.
Danish: Den første undersøgelse omfattede 835 voksne i alderen 50 til 64 år, som ikke tidligere var blevet vaccineret mod invasiv sygdom forårsaget af S. pneumoniae.
English: All six of the additional polysaccharides in Prevenar 13 produced a response at least as good as the lowest response seen with Prevenar in the first main study.
Danish: Alle de seks øvrige polysaccharider i Prevenar 13 fremkaldte en respons, der var mindst lige så god som den laveste respons på Prevenar i den første hovedundersøgelse.
English: • children between 12 and 23 months of age should receive two doses with an interval of at least two months;
Danish: • Børn mellem 12 og 23 måneder bør have to doser med et interval på mindst to måneder.
English: The main measure of effectiveness was based on the number of subjects who developed a first episode of pneumonia caused by a type of S. pneumoniae covered by Prevenar 13.
Danish: Virkningen blev hovedsagelig bedømt på det antal personer, der fik en første episode med lungebetændelse forårsaget af en type S. pneumoniae, der er indeholdt i Prevenar 13.
English: The studies compared the immune response for Prevenar 13 with that for Prevenar against the seven polysaccharides that they share in common.
Danish: I undersøgelserne sammenlignedes immunresponsen for Prevenar 13 med Prevenar mod de syv polysaccharider, som de har til fælles.
English: The second study involved 938 adults aged 70 years or older who had already been vaccinated against invasive disease caused by S. pneumoniae at least five years earlier.
Danish: I den anden undersøgelse deltog 938 voksne i alderen 70 år og derover, som mindst fem år tidligere var blevet vaccineret mod invasiv sygdom forårsaget af S. pneumoniae.
English: In children under five years of age, Prevenar 13 produced a response that was at least as good as Prevenar for six of the seven S. pneumoniae polysaccharides they share in common in the first main study, and for five of the seven in the second.
Danish: Hos børn under fem år fremkaldte Prevenar 13 en respons, som var mindst lige så god som for Prevenar, for seks ud af de syv S. pneumoniae-polysaccharider, de har til fælles, i den første hovedundersøgelse og for fem ud af de syv i den anden undersøgelse.
English: The fourth study in adults over 65 years of age showed that Prevenar 13 reduced the incidence of pneumonia by almost half: 49 out of 42,240 (around 0.1%) subjects fell ill with pneumonia caused by
Danish: Den fjerde undersøgelse hos voksne over 65 år viste, at Prevenar 13 næsten halverede forekomsten af lungebetændelse: 49 ud af 42.240 (ca. 0,1 %) i vaccinegruppen fik lungebetændelse forårsaget af S. pneumoniae, sammenholdt med 90 ud af 42.256 (ca. 0,2%) i placebogruppen.
English: All six of the additional polysaccharides in Prevenar 13 produced a response that was similar to the response seen with Prevenar against the seven polysaccharides.
Danish: Alle de seks øvrige polysaccharider i Prevenar 13 fremkaldte en respons, der svarede til responsen på Prevenar mod de syv polysaccharider.
English: In children aged between five and 17 years old, Prevenar 13 produced a response that was at least as good as Prevenar for all seven S. pneumoniae polysaccharides they share in common.
Danish: Hos børn mellem fem og 17 år fremkaldte Prevenar 13 en respons, som var mindst lige så god som for Prevenar, for seks ud af de syv S. pneumoniae-polysaccharider, de har til fælles.
English: The immune response to the additional six polysaccharides in Prevenar 13 was compared with the lowest immune response to any of the polysaccharides in Prevenar.
Danish: Immunresponsen på de yderligere seks polysaccharider i Prevenar 13 blev sammenlignet med immunresponsen på den polysaccharid i Prevenar, som tegnede sig for den laveste immunrespons.
English: How has Prevenar 13 been studied?
Danish: Hvordan blev Prevenar 13 undersøgt?
English: A fourth study involved approximately 85,000 adults over 65 year of age who had not previously been vaccinated with the 23-valent polysaccharide vaccine, and compared Prevenar 13 with placebo (a dummy treatment).
Danish: En fjerde undersøgelse omfattede ca. 85.000 voksne over 65 år, der ikke havde tidligere var vaccineret med den 23-valente polysaccharidvaccine.
English: What benefit has Prevenar 13 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Prevenar 13?
English: How is Prevenar 13 used?
Danish: Hvordan anvendes Prevenar 13?
English: What is Prevenar 13?
Danish: Hvordan virker Prevenar 13?
English: What is Prevenar 13 used for?
Danish: Hvad anvendes Prevenar 13 til?
English: In adults aged 50 and older, in the first two main studies Prevenar 13 produced an immune response that was at least as good as the 23-valent polysaccharide vaccine for all 12 of the S. pneumoniae polysaccharides they share in common, and for several of these serotypes the immune response was better with Prevenar 13.
Danish: Hos voksne i alderen 50 år og derover var immunresponsen for Prevenar 13 i de første to hovedundersøgelser mindst lige så god som for 23-valent polysaccharidvaccinen for alle de 12
English: The full EPAR for Docetaxel Mylan 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 Mylan 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 Mylan on 31 January 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Docetaxel Mylan den 31 januar 2012.
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 Mylan.
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 Docetaxel Mylan.
English: It is available as a concentrate to make up into a solution for infusion (drip into a vein).
Danish: Det fås som et koncentrat til fremstilling af en opløsning til infusion (drop i en vene).
English: • head and neck cancer in patients whose cancer is advanced (has started to spread).
Danish: • kræft i hoved- og halsregionen hos patienter, hvis kræft er fremskreden (er begyndt at sprede sig).
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Docetaxel Mylan.
English: Docetaxel Mylan is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Danish: Docetaxel Mylan må kun bruges, når neutrofiltallet (koncentrationen af en form for hvide blodlegemer) er normalt (mindst 1 500 celler/mm3).
English: For more information about treatment with Docetaxel Mylan, 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 Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Mylan has been shown to be comparable to Taxotere.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Docetaxel Mylan er sammenligneligt med Taxotere.
English: Docetaxel Mylan is given as a one-hour infusion every three weeks.
Danish: Docetaxel Mylan gives hver tredje uge ved en infusion, der varer en time.
English: This means that Docetaxel Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Danish: Det betyder, at Docetaxel Mylan er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Taxotere.
English: Docetaxel Mylan can be used on its own after other treatments have failed.
Danish: Docetaxel Mylan kan bruges alene, når andre behandlinger ikke har haft effekt.
English: EPAR summary for the public docetaxel
Danish: EPAR sammendrag for offentligheden docetaxel
English: Docetaxel Mylan is used to treat the following types of cancer:
Danish: Docetaxel Mylan anvendes til behandling af følgende kræftformer:
English: No additional studies were needed as Docetaxel Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Danish: Der krævedes ingen supplerende undersøgelser, da Docetaxel Mylan er et generisk lægemiddel, der gives ved infusion og indeholder det samme aktive stof som referencelægemidlet Taxotere.
English: What are the benefits and risks of Docetaxel Mylan?
Danish: Hvilke fordele og risici er der forbundet med Docetaxel Mylan?
English: Other information about Docetaxel Mylan
Danish: Andre oplysninger om Docetaxel Mylan
English: Docetaxel Mylan is a ‘generic medicine'.
Danish: Docetaxel Mylan er et ‘generisk lægemiddel'.
English: Docetaxel Mylan should be used in wards specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Docetaxel Mylan bør kun anvendes på afdelinger, der er specialiseret i kemoterapi, under overvågning af en læge, der er specialiseret i brug af kemoterapi.
English: The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docetaxel Mylan, docetaxel, tilhører en gruppe lægemidler mod kræft, der kaldes taxaner.
English: The company also showed that the Docetaxel Mylan solution for infusion has comparable quality to that of Taxotere.
Danish: Virksomheden påviste også, at Docetaxel Mylan-opløsningen til infusion var af en kvalitet, som er sammenlignelig med kvaliteten af Taxotere.
English: Docetaxel Mylan is used with prednisone or prednisolone (anti-inflammatory medicines);
Danish: Docetaxel Mylan anvendes sammen med prednison eller prednisolon (antiinflammatoriske lægemidler),
English: Because Docetaxel Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Docetaxel Mylan er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Docetaxel Mylan is used with cisplatin and 5-fluorouracil.
Danish: Docetaxel Mylan anvendes sammen med cisplatin og 5-fluorouracil.
English: The company provided data from the published literature on docetaxel.
Danish: Virksomheden fremlagde data om docetaxel fra den offentliggjorte faglitteratur.
English: The Committee recommended that Docetaxel Mylan be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Docetaxel Mylan.
English: Docetaxel Mylan is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Danish: Docetaxel Mylan anvendes sammen med cisplatin og 5-fluorouracil (andre lægemidler mod kræft),
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Danish: Afhængigt af brystkræftens art og stadium kan det også anvendes sammen med andre midler mod kræft (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) til patienter, der endnu ikke har fået nogen behandling mod deres kræftsygdom, eller hos hvem andre behandlinger har været uden effekt.
English: Why has Docetaxel Mylan been approved?
Danish: Hvorfor blev Docetaxel Mylan godkendt?
English: How has Docetaxel Mylan been studied?
Danish: Hvordan blev Docetaxel Mylan undersøgt?
English: What is Docetaxel Mylan used for?
Danish: Hvad anvendes Docetaxel Mylan til?
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Mylan infusion.
Danish: Dagen før infusionen med Docetaxel Mylan gives patienten endvidere dexamethason (et antiinflammatorisk lægemiddel).
English: How is Docetaxel Mylan used?
Danish: Hvordan anvendes Docetaxel Mylan?
English: How does Docetaxel Mylan work?
Danish: Hvordan virker Docetaxel Mylan?
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform
English: It is used in adults and adolescents aged over 12 years and who weigh at least 35 kg.
Danish: Det anvendes til voksne og unge i alderen 12 år og derover, som vejer mindst 35 kg.
English: Other common side effects include diarrhoea and headache.
Danish: Andre almindelige bivirkninger omfatter diarré og hovedpine.
English: The full EPAR for Descovy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Descovy findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Descovy
Danish: Andre oplysninger om Descovy
English: This is a summary of the European public assessment report (EPAR) for Descovy.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Descovy.
English: A risk management plan has been developed to ensure that Descovy is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Descovy anvendes så sikkert som muligt.
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: By blocking reverse transcriptase, Descovy reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere reverse transcriptase mindsker Descovy hiv-mængden i blodet og holder den på et lavt niveau.
English: The company therefore presented data from the studies previously used to approve Genvoya, including 2 studies in 1,733 previously untreated adults, where around 90% of patients responded to treatment, and another study showing benefit was maintained when patients treated with other effective combinations were switched to Genvoya.
Danish: Derfor har virksomheden fremlagt data fra de studier, der dannede grundlag for godkendelsen af Genvoya, herunder 2 studier af 1 733 tidligere ubehandlede voksne, hvoraf ca. 90 % reagerede på behandlingen, samt et andet studie, der viste, at den gavnlige effekt blev opretholdt, når patienter i behandling med andre effektive kombinationer skiftede til Genvoya.
English: The company also provided data from supporting studies including studies looking at the way Descovy was absorbed in the body.
Danish: Virksomheden har også fremlagt data fra understøttende studier, hvor man bl.a. har undersøgt, hvordan Descovy absorberes i kroppen.
English: Why is Descovy approved?
Danish: Hvorfor blev Descovy godkendt?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Descovy's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Descovy opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Descovy?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Descovy?
English: They block the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Danish: De blokerer aktiviteten af reverse transcriptase, et enzym, som virusset producerer, så det kan formere sig i de celler, det har inficeret.
English: The most common side effect with Descovy (which may affect 1 in 10 people) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Descovy (som kan forekomme hos op til 1 ud af 10 personer) er kvalme.
English: What are the risks associated with Descovy?
Danish: Hvilke risici er der forbundet med Descovy?
English: Descovy can only be obtained with a prescription and treatment should be started by a doctor experienced in managing HIV infection.
Danish: Descovy udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hiv-infektioner.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Descovy, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Descovy, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Descovy is available as tablets, each containing 200 mg of emtricitabine and either 10 or 25 mg of tenofovir alafenamide.
Danish: Descovy fås som tabletter, der hver især indeholder 200 mg emtricitabin og enten 10 eller 25 mg tenofoviralafenamid.
English: What is Descovy and what is it used for?
Danish: Hvad er Descovy, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Descovy.
Danish: Det er ikke en praktisk vejledning i, hvordan Descovy bør anvendes.
English: The active substances in Descovy (emtricitabine and tenofovir alafenamide) are already approved to treat HIV infection together with two other active substances (elvitegravir and cobicistat) as part of the combination medicine Genvoya.
Danish: De aktive stoffer i Descovy (emtricitabin og tenofoviralafenamid) er allerede godkendt til behandling af hiv-infektion sammen med to andre aktive stoffer (elvitegravir og cobicistat) som komponenter i kombinationspræparatet Genvoya.
English: For the full list of all side effects and restrictions with Descovy, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Descovy fremgår af indlægssedlen.
English: For more information about treatment with Descovy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Descovy, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Descovy contains tenofovir alafenamide which is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.
Danish: Descovy indeholder tenofoviralafenamid, der er effektivt ved en lavere dosis end det almindeligt anerkendte lægemiddel tenofovirdisoproxil og giver mulighed for færre bivirkninger.
English: Descovy emtricitabine / tenofovir alafenamide
Danish: Descovy emtricitabin/tenofoviralafenamid
English: Descovy is an antiviral medicine used in combination with other medicines to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Descovy er et antiviralt lægemiddel, der anvendes sammen med andre lægemidler til behandling af personer smittet med hiv-1 (humant immundefektvirus type 1).
English: For practical information about using Descovy, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Descovy, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: These studies showed that Descovy produces comparable levels of emtricitabine and tenofovir alafenamide in the body to Genvoya.
Danish: Disse studier har vist, at Descovy giver de samme niveauer af emtricitabin og tenofoviralafenamid i kroppen som Genvoya.
English: Descovy contains the active substances emtricitabine and tenofovir alafenamide.
Danish: Descovy indeholder de aktive stoffer emtricitabin og tenofoviralafenamid.
English: What benefits of Descovy have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Descovy?
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Danish: Tenofovir og emtricitabin er beslægtede virusmidler af typen reverse transcriptasehæmmere.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR'en.