FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients treated with Xultophy in these studies achieved control of their blood glucose (HbA1c below 7.0%) and many achieved HbA1c below 6.5%.
Danish: Størstedelen af de patienter, der blev behandlet med Xultophy i disse undersøgelser, opnåede kontrol af blodsukkeret (et HbA1c på under 7,0 %), og mange nåede et HbA1c på under 6,5 %.
English: Patients can inject themselves with Xultophy if they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne med Xultophy, hvis de er behørigt instrueret heri.
English: What is Xultophy and what is it used for?
Danish: Hvad er Xultophy, og hvad anvendes det til?
English: It is given as an injection under the skin of the thigh, the upper arm or the abdomen (belly).
Danish: Det gives som en indsprøjtning under huden i låret, overarmen eller maveskindet.
English: Why is Xultophy approved?
Danish: Hvorfor er Xultophy godkendt?
English: The most common side effect with Xultophy (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Danish: Den hyppigste bivirkning ved Xultophy (som optræder hos mere end 1 ud af 10 patienter) er hypoglykæmi (lavt blodsukker).
English: The company that markets Xultophy will provide educational materials for healthcare professionals, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Danish: Den virksomhed, der markedsfører Xultophy, skal udlevere oplysningsmateriale til sundhedspersoner og patienter med instruktioner i sikker anvendelse af lægemidlet, for at nedsætte risikoen for fejlbehandling.
English: It acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
Danish: Det virker på samme måde som inkretiner (hormoner, der produceres i tarmen) ved at få bugspytkirtlen til at afgive mere insulin som reaktion på fødeindtagelse.
English: Adding this medicine to other diabetes medicines offers better control of blood glucose and having an alternative treatment option is valuable in individualising treatment.
Danish: Tilføjelse af dette lægemiddel til andre sukkersygelægemidler giver bedre kontrol af blodsukkeret, og det er værdifuldt at råde over en ekstra behandlingsmulighed for at kunne tilpasse behandlingen til den enkelte patient.
English: What are the risks associated with Xultophy?
Danish: Hvilke risici er der forbundet med Xultophy?
English: Type 2 diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose, or the body is unable to use insulin effectively.
Danish: Ved type 2-sukkersyge producerer kroppen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet effektivt.
English: One of the active substances in Xultophy, insulin degludec, is a replacement insulin that acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Det ene aktive stof i Xultophy, insulin degludec, er et erstatningsinsulin, der virker på samme måde som naturligt produceret insulin, og som får glukose til at trænge ind i cellerne fra blodet.
English: The other active substance in Xultophy, liraglutide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Danish: Det andet aktive stof i Xultophy, liraglutid, tilhører en gruppe sukkersygelægemidler, der er kendt som GLP-1-agonister.
English: For the full list of side effects and restrictions with Xultophy, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Xultophy fremgår af indlægssedlen.
English: Treatment with Xultophy and metformin was compared with treatment using insulin degludec and metformin.
Danish: Behandling med Xultophy og metformin blev sammenlignet med behandling med insulin degludec og metformin.
English: The average HbA1c level, which was 8.3% at the start, fell to 6.4% after 26 weeks of treatment with Xultophy, compared with 6.9% and 7.0% respectively with insulin degludec and liraglutide.
Danish: Det gennemsnitlige indhold af HbA1c var i begyndelsen 8,3 %, men faldt til 6,4 % efter 26 ugers behandling med Xultophy, sammenlignet med henholdsvis 6,9 % og 7,0 % med insulin degludec og liraglutid.
English: The active substances in Xultophy are insulin degludec and liraglutide.
Danish: De aktive stoffer i Xultophy er insulin degludec og liraglutid.
English: • The third study involved 438 patients whose blood glucose was not adequately controlled by a combination of a GLP-1 agonist (liraglutide or exenatide) and metformin with or without other diabetes medicines taken by mouth.
Danish: • Den tredje undersøgelse omfattede 438 patienter, hvis blodsukker ikke var tilfredsstillende reguleret med en kombination af en GLP-1-agonist (liraglutid eller exenatid) og metformin med eller uden andre sukkersygelægemidler indtaget gennem munden.
English: • The first study involved 1,663 patients whose diabetes was not adequately controlled with the diabetes medicines metformin or metformin and pioglitazone taken by mouth.
Danish: • Den første undersøgelse omfattede 1 663 patienter, hvis sukkersyge ikke var tilfredsstillende reguleret med sukkersygelægemidlerne metformin eller metformin og pioglitazon indtaget gennem munden.
English: In all studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Danish: I alle undersøgelserne blev virkningen hovedsagelig bedømt på ændringen i blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c) efter 6 måneders behandling.
English: Together with diet and exercise, Xultophy is added to treatment with diabetes medicines taken by mouth when these medicines, alone or with other injections, have not controlled blood glucose (sugar) levels.
Danish: Xultophy anvendes i tillæg til kost og motion til behandling med sukkersygelægemidler indtaget gennem munden hos patienter, hvis blodsukker (glukose) ikke kan kontrolleres tilstrækkeligt med disse lægemidler alene eller andre indsprøjtninger.
English: Xultophy is available as pre-filled disposable pens and can only be obtained with a prescription.
Danish: Xultophy leveres som fyldte penne til engangsbrug, og lægemidlet udleveres kun på recept.
English: Average HbA1c was 7.8% before patients started to receive Xultophy, and fell after 26 weeks of treatment to 6.4%.
Danish: Det gennemsnitlige indhold af HbA1c lå på 7,8 %, inden patienterne begyndte at få Xultophy, og faldt efter 26 ugers behandling til 6,4 %.
English: How is Xultophy used?
Danish: Hvordan anvendes Xultophy?
English: What benefits of Xultophy have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xultophy?
English: • The second study involved 413 patients whose blood glucose was not adequately controlled by insulin and metformin with or without other diabetes medicines taken by mouth.
Danish: • Den anden undersøgelse omfattede 413 patienter, hvis blodsukker ikke var tilfredsstillende reguleret med insulin og metformin med eller uden andre sukkersygelægemidler indtaget gennem munden.
English: Adding Xultophy to their treatment was compared with adding either of its active substances, insulin degludec or liraglutide.
Danish: Tilføjelse af Xultophy til behandlingen blev sammenlignet med tilføjelse af de aktive stoffer i Xultophy, insulin degludec eller liraglutid.
English: How does Xultophy work?
Danish: Hvordan virker Xultophy?
English: Average HbA1c at the start was 8.7% in the Xultophy group, and fell after 26 weeks of treatment to 6.9%.
Danish: Det gennemsnitlige indhold af HbA1c i Xultophy-gruppen var først 8,7 %, men faldt efter 26 ugers behandling til 6,9 %.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xultophy have also 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 Xultophy.
English: The vaccination schedule depends on the age of the child and should be based on official recommendations:
Danish: Vaccinationsprogrammet afhænger af barnets alder og bør være baseret på officielle anbefalinger:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar 13 on 9 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prevenar 13 den 9. december 2009.
English: This is a summary of the European public assessment report (EPAR) for Prevenar 13.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prevenar 13.
English: The full EPAR for Prevenar 13 can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Prevenar 13 findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This was true for five of the six additional polysaccharides in the second study.
Danish: Dette gjaldt også for fem af de seks øvrige polysaccharider i den anden undersøgelse.
English: The first three doses are given with an interval of one month between each dose.
Danish: De første tre doser gives med én måneds interval mellem hver dosis.
English: The studies compared the immune responses one month after vaccination with the two vaccines.
Danish: I undersøgelserne blev immunresponserne én måned efter vaccinationen sammenlignet med de to vacciner.
English: Prevenar 13 is a vaccine.
Danish: Prevenar 13 er en vaccine.
English: Prevenar 13 contains the polysaccharides from 13 different types of S. pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Danish: Prevenar 13 indeholder polysaccharider fra 13 forskellige typer af S. pneumoniae (serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F og 23F).
English: A risk management plan has been developed to ensure that Prevenar 13 is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Prevenar 13 anvendes så sikkert som muligt.
English: People who have a severe fever should not receive the vaccine until they have recovered, but they can still be given the vaccine if they have a mild infection such as a cold.
Danish: Personer, som har høj feber, bør ikke vaccineres, før de er blevet raske igen, men de kan godt vaccineres, hvis de har en mild infektion såsom en forkølelse.
English: Other information about Prevenar 13
Danish: Andre oplysninger om Prevenar 13
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det udsættes for samme bakterie.
English: The fourth dose, the booster, is given between 11 and 15 months of age.
Danish: Den fjerde dosis, boostervaccinationen, gives i alderen 11 til 15 måneder.
English: In Europe, it is estimated that these are responsible for between 73 and 100% of the cases of invasive disease in children under the age of five years, and at least 50 - 76% of the cases of invasive disease in adults, depending on the country.
Danish: I Europa anslås det, at disse er ansvarlige for mellem 73 og 100 % af tilfældene af invasiv sygdom hos børn under fem år og mindst 50-76 % af tilfælde af invasiv sygdom hos voksne, afhængigt af det pågældende land.
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 Prevenar 13.
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 Prevenar 13.
English: In adults, Prevenar 13 was investigated in four main studies.
Danish: Hos voksne blev Prevenar 13 blev undersøgt i fire hovedundersøgelser.
English: Where the response to Prevenar 13 was lower than the comparator, the differences were considered to be small.
Danish: I de tilfælde, hvor responsen på Prevenar 13 var lavere end sammenligningspræparatet, ansås forskellene for at være små.
English: In the first two studies they were compared directly, and in the third study the results for Prevenar 13 were compared to those obtained for Prevenar in a previous study.
Danish: I de første to undersøgelser blev de sammenlignet direkte, og i den tredje undersøgelse blev de resultater, der blev opnået med Prevenar 13, sammenlignet med dem, der blev opnået med Prevenar i en tidligere undersøgelse.
English: For more information about treatment with Prevenar 13, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Prevenar 13, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Prevenar 13 was compared with Prevenar.
Danish: Prevenar 13 blev sammenlignet med Prevenar.
English: Alternatively, when Prevenar 13 is given as part of a routine immunisation programme, two doses can be given at the ages of two and four months, followed by a booster at 11 to 15 months of age;
Danish: Alternativt kan der, når Prevenar 13 gives inden for et almindeligt immuniseringsprogram, gives to doser i alderen to måneder og fire måneder, efterfulgt af en booster i alderen 11 til 15 måneder.
English: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Danish: konjugeret polysaccharid pneumokokvaccine (13-valent, adsorberet)
English: • children aged between six weeks and six months are normally given four doses.
Danish: • Børn i alderen mellem seks uger og seks måneder gives normalt fire doser.
English: Invasive disease occurs when the bacterium spreads through the body causing serious infections such as septicaemia (blood infection) and meningitis (infection of the membranes around the brain and spine).
Danish: Invasiv sygdom optræder, når bakterien spreder sig i kroppen og forårsager alvorlige infektioner såsom septikæmi (blodforgiftning) og meningitis (betændelse i hinderne rundt om hjernen og rygmarven).
English: Adults and children aged two years and above should receive one single dose of Prevenar 13 into the shoulder muscle.
Danish: Hos voksne og børn over to år bør der gives en enkelt dosis Prevenar 13 i skuldermusklen.
English: When prescribing Prevenar 13, consideration should be given to the risk of invasive disease and pneumonia in the different age groups, other diseases the vaccinees may have and the type of bacteria in the different geographical areas.
Danish: Ved ordinering af Prevenar 13 bør der tages hensyn til risikoen for invasiv sygdom og lungebetændelse i de forskellige aldersgrupper, eventuelle sygdomme i vaccinen samt bakterietypen i de forskellige geografiske områder.
English: In children below two years of age, the vaccine is given by injection into the thigh muscle.
Danish: Hos børn under to år gives vaccinationen ved injektion i lårmusklen.
English: Prevenar 13 was not shown to affect the immunogenicity of other vaccines routinely given to children.
Danish: Det blev ikke påvist, at Prevenar 13 indvirkede på immunogeniciteten af andre vacciner, som rutinemæssigt gives til børn.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prevenar 13, 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 Prevenar 13, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Prevenar 13 is very similar to Prevenar but contains six additional polysaccharides from serotypes which are responsible for between 16 and 60% of the cases.
Danish: Prevenar 13 har meget stor lighed med Prevenar, men indeholder yderligere 6 polysakkarider fra serotyper, der er årsag til mellem 16 og 60 % af sygdomstilfældene.
English: For the prevention of pneumonia, although the use of Prevenar 13 was only investigated in adults over 65 years of age, the CHMP considered that the results could also be applied to younger adults as studies have shown that their immune response is similar or higher than that among adults older than 65.
Danish: Vedrørende forebyggelse af lungebetændelse fandt CHMP, at skønt Prevenar 13 kun var blevet undersøgt hos voksne over 65 år, kunne resultaterne også anvendes på yngre voksne, da undersøgelser har vist, at immunreaktionen er den samme eller kraftigere end hos voksne over 65 år.
English: What measures are being taken to ensure the safe and effective use of Prevenar 13?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Prevenar 13?
English: It is also used to protect adults and the elderly against invasive disease and pneumonia caused by S. pneumoniae.
Danish: Den anvendes endvidere til beskyttelse af voksne og ældre mod invasiv sygdom og lungebetændelse forårsaget af S. pneumoniae.
English: The vaccine is also ‘adsorbed' (fixed) onto an aluminium compound to enhance the immune response.
Danish: Vaccinen er også "adsorberet" (bundet til overfladen) af en aluminiumholdig forbindelse, hvorved immunreaktionen forstærkes.
English: Prevenar 13 contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Danish: Prevenar 13 indeholder små mængder polysaccharider (en form for sukker), som udvindes af den "kapsel", der omgiver bakterien S. pneumoniae.
English: Prevenar 13 can be used in children who have started vaccination with Prevenar (another vaccine authorised in the European Union for S. pneumoniae, which contains parts of seven of the 13 types of S. pneumoniae included in Prevenar 13).
Danish: Prevenar 13 kan anvendes til børn, som har påbegyndt vaccinationen med Prevenar (en anden vaccine, der er godkendt i Den Europæiske Union for S. pneumoniae, og som indeholder dele af syv af de 13 typer af S. pneumoniae, der indgår i Prevenar 13).
English: In children, the ability of Prevenar 13 to trigger the production of antibodies (immunogenicity) was assessed in two main studies involving 1,266 healthy children who were vaccinated between the ages of two and 15 months and in a third study involving 598 children aged between five and 17 years old who had previously been vaccinated with Prevenar or who had never been vaccinated for invasive pneumococcal disease.
Danish: Hos børn blev Prevenar 13's evne til at udløse dannelse af antistoffer (immunogenicitet) vurderet i to hovedundersøgelser, der omfattede 1 266 raske børn, som blev vaccineret i alderen to til 15 måneder, samt i en tredje undersøgelse af 598 børn mellem fem og 17 år, der tidligere var blevet vaccineret med Prevenar, eller som aldrig var blevet vaccineret mod invasiv pneumokoksygdom.
English: • children aged between seven months and 11 months should first receive two doses with an interval of at least one month followed by a third dose in the second year;
Danish: • Børn mellem syv måneder og 11 måneder bør først få to doser med et interval på mindst én måned, efterfulgt af en tredje dosis i det andet år.
English: Further information on the use of Prevenar 13 in people at increased risk of pneumococcal infections (such as patients with HIV or people who have received a haematopoietic stem cell transplant) and on how to switch from Prevenar to Prevenar 13 can be found in the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelse af Prevenar 13 hos personer med forhøjet risiko for pneumokokinfektioner (såsom personer, der har hiv eller har fået en transplantation med bloddannende stamceller), og om, hvordan skift fra Prevenar til Prevenar 13 finder sted, fremgår af produktresuméet (der ligeledes er en del af EPAR).
English: These polysaccharides have been purified, then ‘conjugated' (attached) to a carrier to help them to be recognised by the immune system.
Danish: Polysacchariderne er blevet renset og derefter "konjugeret" (fastgjort) til en bærer, så immunsystemet bedre kan genkende dem.
English: The CHMP noted that in children the immune system's response to Prevenar 13 was comparable to that of Prevenar, which is already authorised for the protection of children against S. pneumoniae in the EU.
Danish: CHMP bemærkede, at hos børn var immunsystemets respons på Prevenar 13 sammenlignelig med responsen på Prevenar, der allerede er godkendt i EU til beskyttelse af børn mod S. pneumoniae.
English: Prevenar 13 is used to protect children aged between six weeks and 17 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Danish: Prevenar 13 anvendes til beskyttelse af børn i alderen seks uger til 17 år mod invasiv sygdom, pneumoni (lungebetændelse) og akut otitis media (mellemørebetændelse) forårsaget af S. pneumoniae.
English: Prevenar 13 must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients or to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Danish: Prevenar 13 må ikke anvendes til personer, der er overfølsomme (allergiske) over for de aktive stoffer, over for andre af indholdsstofferne eller over for difteritoksoid (et svækket toksin fra bakterien, der forårsager difteri).
English: • children between two and 17 years of age should receive a single dose.
Danish: • Børn i alderen to til 17 år bør have en enkelt dosis.
English: The Committee also noted that Prevenar 13 contains additional polysaccharides from the types of S. pneumoniae that are responsible for causing disease in children in Europe.
Danish: Udvalget bemærkede også, at Prevenar 13 indeholder yderligere polysaccharider fra de typer af S. pneumoniae, som forårsager sygdomme hos børn i Europa.
English: In adults and the elderly, the Committee noted that community-acquired pneumonia and invasive pneumococcal disease may be an important health problem and that the benefit in terms of protection outweighed the risk of adverse reactions.
Danish: Udvalget bemærkede, at samfundserhvervet lungebetændelse og invasiv pneumokoksygdom kan udgøre et væsentligt helbredsproblem hos voksne og ældre, og at fordelene hvad angår beskyttelse opvejede risiciene for bivirkninger.
English: What is the risk associated with Prevenar 13?
Danish: Hvilken risiko er der forbundet med Prevenar 13?
English: In both studies, Prevenar 13 was compared with a similar vaccine containing the polysaccharides from 23 different types of S. pneumoniae (23-valent polysaccharide vaccine).
Danish: I begge undersøgelser blev Prevenar 13 sammenlignet med en tilsvarende vaccine, der indeholdt polysaccharider fra 23 forskellige typer af S. pneumoniae (23-valent polysaccharidvaccine).
English: The additional studies showed that Prevenar 13 led to an increase in antibody production following booster vaccinations and supported a switch to Prevenar 13 in children who had started vaccination with Prevenar.
Danish: De yderligere undersøgelser viste, at Prevenar 13 førte til en forøget dannelse af antistoffer efter boostervaccinationer, og understøttede således et skift til Prevenar 13 hos børn, som var begyndt at blive vaccineret med Prevenar.
English: Adults aged 18 to 49 had an immune response with Prevenar 13 which was as good as the response in adults aged 60 to 64.
Danish: Voksne i alderen 18 til 49 år havde en immunrespons med Prevenar 13, som var lige så god som responsen hos voksne i alderen 60 til 64 år.