FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Orkambi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Orkambi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Orkambi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Orkambi?
English: The children's growth (measured in terms of the body mass index, weight and height) also improved.
Danish: Børnenes vækst blev også forbedret (målt via kropsmasseindeks, vægt og højde).
English: The European Medicines Agency decided that Orkambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Orkambi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: An overview of Orkambi and why it is authorised in the EU
Danish: En oversigt over Orkambi og hvorfor det er godkendt i EU
English: The effects of Orkambi in children aged 2 to 5 years were considered to be similar to those in older children and a long-term study will be carried out to confirm this.
Danish: Virkningerne af Orkambi hos børn i alderen 2-5 år blev anset for at være de samme som for ældre børn, og der vil blive gennemført et langtidsstudie for at bekræfte dette.
English: Orkambi is used in patients who have inherited the mutation from both parents.
Danish: Orkambi anvendes til patienter, der har arvet mutationen fra begge forældre.
English: The most common side effects with Orkambi (which may affect more than 1 in 10 people) are dyspnoea (shortness of breath), diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Orkambi (som kan forekomme hos mere end 1 ud af 10 personer) er stakåndethed (dyspnø), diarré og kvalme.
English: Side effects reported with Orkambi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Orkambi vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Stopping treatment with Orkambi caused chloride levels to rise again.
Danish: Når behandlingen med Orkambi blev standset, steg chloridniveauerne igen.
English: In the studies, Orkambi was compared with placebo (a dummy treatment), both added to patients' usual therapy.
Danish: I studierne blev Orkambi sammenlignet med placebo (en virkningsløs behandling), begge anvendt som tillægsbehandling til patienternes sædvanlige behandling.
English: Why is Orkambi authorised in the EU?
Danish: Hvorfor blev Orkambi godkendt i EU?
English: What is Orkambi and what is it used for?
Danish: Hvad er Orkambi, og hvad anvendes det til?
English: What are the risks associated with Orkambi?
Danish: Hvilke risici er der forbundet med Orkambi?
English: Treatment with Orkambi also reduced the number of exacerbations (flares-up) requiring hospital admission or antibiotic therapy.
Danish: Behandlingen med Orkambi mindskede også antallet af forværringer (eksacerbationer), der krævede indlæggelse eller antibiotikabehandling.
English: Orkambi is available as tablets and granules.
Danish: Orkambi fås som tabletter og granulat.
English: However, as cystic fibrosis caused by F508del mutation is particularly severe, the observed effects were considered clinically relevant for patients with no other option.
Danish: Cystisk fibrose forårsaget af F508del-mutationen er imidlertid særlig alvorlig, og det blev derfor konkluderet, at de observerede virkninger var klinisk relevante for patienter uden andre behandlingsmuligheder.
English: One of the active substances in Orkambi, lumacaftor, increases the amount of CFTR protein on the cell and the other, ivacaftor, increases the activity of the defective CFTR protein.
Danish: Det ene aktive stof i Orkambi, lumacaftor, øger mængden af CFTR-proteiner på cellen, og det andet, ivacaftor, øger aktiviteten af det defekte CFTR-protein.
English: Orkambi's side effects mainly affected the gut and breathing and were generally considered mild to moderate and manageable.
Danish: Bivirkningerne ved Orkambi vedrørte hovedsageligt tarm og luftveje og blev sædvanligvis anset for at være lette til moderate og at kunne håndteres.
English: Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection.
Danish: Ophobning af tykt og klæbrigt sekret i lungerne fører til betændelse og langvarig infektion.
English: Patients with cystic fibrosis have high levels of chloride in sweat due to CFTR not working properly.
Danish: Patienter med cystisk fibrose har et højt indhold af chlorid i sved, fordi CFTR ikke fungerer korrekt.
English: Orkambi contains the active substances lumacaftor and ivacaftor.
Danish: Orkambi indeholder de aktive stoffer lumacaftor og ivacaftor.
English: After 24 weeks of treatment, LCI2.5 decreased by 1.01 in patients treated with Orkambi compared with an increase of 0.08 in patients treated with placebo.
Danish: Efter 24 ugers behandling faldt LCI2.5 med 1,01 hos de patienter, der blev behandlet med Orkambi, sammenlignet med en stigning på 0,08 hos de patienter, der blev behandlet med placebo.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system.
Danish: Cystisk fibrose er en arvelig sygdom med svære virkninger på lungerne og fordøjelsessystemet.
English: Orkambi can only be prescribed by a doctor with experience in the treatment of cystic fibrosis.
Danish: Orkambi kan kun ordineres af en læge med erfaring i behandling af cystisk fibrose.
English: The mutations reduce the amount of CFTR protein on the cell surface or affect the way the protein works.
Danish: Disse mutationer nedsætter mængden af CFTR-proteiner på celleoverfladen eller påvirker den måde, som proteinet virker på.
English: Serious side effects include liver problems such as raised liver enzymes, cholestatic hepatitis (build-up of bile leading to inflammation of the liver) and hepatic encephalopathy (a brain disease caused by liver problems).
Danish: Til de alvorlige bivirkninger hørte leverproblemer såsom forhøjede leverenzymer, ophobning af galde, der medfører betændelse af leveren (kolestatisk hepatitis) og en hjernesygdom forårsaget af leverproblemerne (hepatisk encefalopati).
English: Orkambi improved lung function in two main studies involving 1,108 cystic fibrosis patients aged 12 years and above, and one study involving 204 children aged from 6 to 11 years.
Danish: Orkambi forbedrede lungefunktionen i to hovedstudier med 1 108 patienter med cystisk fibrose i alderen 12 år og derover og i et studie med 204 børn i alderen 6-11 år.
English: Orkambi is used in patients who have a genetic mutation (change) called the F508del mutation.
Danish: Orkambi anvendes hos patienter, der har en genetisk mutation (ændring), som hedder F508del.
English: The company that markets Orkambi is required to conduct a 5-year study in patients with cystic fibrosis to evaluate the long-term effects of the medicine.
Danish: Den virksomhed, der markedsfører Orkambi, skal gennemføre et 5-årigt studie hos patienter med cystisk fibrose med henblik på at evaluere langtidsvirkningerne af lægemidlet.
English: For the full list of all side effects and restrictions with Orkambi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Orkambi fremgår af indlægssedlen.
English: In cystic fibrosis, the secretions become thick and cause blockage.
Danish: Ved cystisk fibrose bliver sekreterne tykke, så de medfører blokering.
English: In the two studies in patients aged 12 years and above, the main measure of effectiveness was based on improvement in patients' predicted FEV1 which is a measure of how well the lungs work.
Danish: I de to studier med patienter i alderen 12 år og derover var det primære mål for virkningen baseret på forbedringen af patienternes forventede FEV1, der er et mål for, hvor godt lungerne virker.
English: A further long-term study in children aged 2 to 5 years with cystic fibrosis is also required to compare those who have the F508del mutation in the CFTR gene and are treated with Orkambi with those who have not been treated with Orkambi.
Danish: Et yderligere langtidsstudie med børn i alderen 2-5 år med cystisk fibrose skal endvidere sammenligne dem, der har F508del-mutationen i CFTR-genet, og som behandles med Orkambi, med dem, der ikke er blevet behandlet med Orkambi.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Danish: Cystisk fibrose skyldes mutationer i CFTR-genet.
English: In the study in children aged 6 to 11 years, the main measure of effectiveness was a decrease in the lung clearance index (LCI2.5), which indicates an improvement in lung ventilation.
Danish: I studiet med børn i alderen 6-11 år var det primære mål for virkningen et fald i det såkaldt lungeclearanceindeks (LCI2,5), der indikerer en forbedring af lungeventilationen.
English: Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above.
Danish: Orkambi er et lægemiddel, der anvendes til behandling af cystisk fibrose hos patienter i alderen 2 år og derover.
English: Results from the first study showed that after 24 weeks of treatment patients who took Orkambi had an average improvement in FEV1 of 2.41 percentage points more than those who took placebo; this figure was 2.65 in the second study.
Danish: Det første studie viste, at den gennemsnitlige forbedring af FEV1 blandt de Orkambi-behandlede patienter efter 24 ugers behandling var 2,41 procentpoint højere end blandt de placebo-behandlede patienter; i det andet studie var det tilsvarende tal 2,65.
English: A further study involved 60 children aged 2 to 5 years with cystic fibrosis who had the F508del mutation in the CFTR gene.
Danish: Et yderligere studie omfattede 60 børn i alderen 2-5 år med cystisk fibrose, som havde F508delmutationen i CFTR-genet.
English: How is Orkambi used?
Danish: Hvordan anvendes Orkambi?
English: It affects the cells that produce mucus and digestive juices.
Danish: Den angriber de celler, der producerer slim og fordøjelsesvæsker.
English: There was improvement in CFTR protein activity as measured by a decrease in the amount of chloride in sweat after 24 weeks of treatment.
Danish: Efter 24 ugers behandling var der sket en forbedring af CFR-proteinaktiviteten målt ved et fald i chloridmængden i sved.
English: These actions make mucus and digestive juices less thick.
Danish: Dermed bliver slimet og fordøjelsesvæskerne tyndere.
English: What benefits of Orkambi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Orkambi?
English: All patients had the F508del mutation in the CFTR gene.
Danish: Alle patienterne havde F508delmutationen i CFTR-genet.
English: This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices.
Danish: Denne mutation berører genet for proteinet "cystisk fibrose transmembranøs konduktansregulator" (CFTR), som medvirker ved produktionen af slim og fordøjelsesvæsker.
English: This gene makes the CFTR protein, which is involved in regulating the production of mucus and digestive juices.
Danish: Dette gen fremstiller CFTR-proteinet, som medvirker ved reguleringen af produktionen af slim og fordøjelsesvæsker.
English: Orkambi has been shown to improve lung function and lung ventilation in patients with cystic fibrosis from 6 years of age.
Danish: Det er påvist, at Orkambi forbedrer lungefunktionen og lungeventilationen hos patienter med cystisk fibrose i alderen 6 år og derover.
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Danish: I tarmen medfører blokering af kanalerne fra bugspytkirtlen langsom fordøjelse og ringe vækst.
English: How does Orkambi work?
Danish: Hvordan virker Orkambi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orkambi 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 Orkambi.
English: It should be prescribed only to patients confirmed to have the F508del mutation in both copies of the CFTR gene.
Danish: Det bør kun ordineres til patienter med påvist F508del-mutation i begge kopier af CFTR-genet.
English: 22 March 2013 EMA/402540/2013
Danish: Den 22. marts 2013 EMA/402540/2013
English: Patients were followed for a median of 3.9 years.
Danish: Patienterne blev fulgt op i en median periode på 3,9 år.
English: Of those enrolled, 14,741 were from Europe and 10,932 were from China.
Danish: 14 741 af de indrullerede patienterne var fra Europa, og 10 932 var fra Kina.
English: In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
Danish: I højere doser nedsætter det fedtindholdet i blodet ved en mekanisme, der endnu ikke er fuldt forstået.
English: They were available as modified release tablets (meaning that the two active substances are released at different rates over a few hours).
Danish: Disse stoffer blev leveret som en tablet med modificeret udløsning (herved forstås, at de to aktive stoffer udløses med forskellig hastighed i løbet af nogle timer).
English: Tredaptive, Pelzont and Trevaclyn suspended across the EU
Danish: Tredaptive, Pelzont og Trevaclyn er suspenderet i EU
English: • The review of Tredaptive, Pelzont and Trevaclyn was initiated at the request of the European Commission on 19 December 2012, under Article 20 of Regulation (EC) No 726/2004 following the procedural steps laid out in Article 107j and 107k of Directive 2001/83/EC.
Danish: • Gennemgangen af Tredaptive, Pelzont og Trevaclyn blev indledt den 19. december 2012 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004 efter gennemførelse af de proceduremæssige skridt, der er fastlagt i artikel 107j og 107k i direktiv 2001/83/EF.
English: The medicine has been marketed under one of these trade names by Merck Sharp & Dohme Ltd in all EU Member States, except Bulgaria, France and Romania.
Danish: Merck Sharp & Dohme Ltd har under et af disse handelsnavne markedsført lægemidlet i alle EU's medlemsstater bortset fra Bulgarien, Frankrig og Rumænien.
English: In addition, a higher frequency of non-fatal but serious side effects was seen in patients taking these medicines.
Danish: Desuden var der større hyppighed af ikke-dødelige, men alvorlige bivirkninger hos patienter, der tog disse lægemidler.
English: • The two active substances, nicotinic acid and laropiprant, have different functions.
Danish: • De to aktive stoffer nicotinsyre og laropiprant har forskellig funktion.
English: • A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: • Disse data blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: The European Commission asked the Agency to assess the impact of the new data from the HPS2-THRIVE study, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Danish: Europa-Kommissionen anmodede CHMP om at vurdere betydningen af de nye data fra HPS2-THRIVE-undersøgelsen og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg to achieve a total cholesterol level of less than 3.5 mmol/l, and were then randomised to nicotinic acid / laropiprant or placebo.
Danish: Patienterne blev behandlet med simvastatin 40 mg plus ezetimib 10 mg for at bringe totalkolesterol under 3,5 mmol/l, hvorefter de blev randomiseret til nicotinsyre/laropiprant eller placebo.
English: It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
Danish: Det blev først anvendt som et lægemiddel til at modificere blodets fedtindhold i midten af 1950'erne, men har haft begrænset anvendelse på grund af sine bivirkninger, navnlig rødme af huden.
English: • An increase in the incidence of non-fatal but serious adverse events was seen.
Danish: • Der sås en stigning i forekomsten af ikke-fatale, men alvorlige bivirkninger.
English: These included bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes.
Danish: Disse bestod i blødning (intrakraniel og gastrointestinal), myopati, infektioner og debuterende diabetes.
English: • You should make a non-urgent appointment with your doctor to review your treatment.
Danish: • Du skal få en ikke-akut tid hos lægen for at få gennemgået din behandling.
English: • The HPS2-THRIVE study was a large, long-term study involving 25,673 patients considered to be at high risk for cardiovascular events due to a history of occlusive vascular disease.
Danish: • HSP2-THRIVE-undersøgelsen var en stor langtidsundersøgelse med 25 673 patienter med formodet høj risiko for kardiovaskulære hændelser på grund af okklusiv karsygdom i anamnesen.
English: The Agency's recommendations are based on the new data from the HPS2-THRIVE study:
Danish: Agenturets anbefalinger er baseret på de nye data fra HPS2-THRIVE-undersøgelsen:
English: The CHMP opinion was based on a recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines.
Danish: CHMP's udtalelse var baseret på en anbefaling af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC) om at suspendere disse lægemidler.
English: Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3).
Danish: Nicotinsyre er et naturligt forekommende stof, der i lave doser anvendes som et vitamin (under navnet niacin eller vitamin B3).
English: Having reviewed the results of the study, the CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorisations should be suspended.
Danish: Efter gennemgang af undersøgelsens resultater konkluderede CHMP, at fordelene ved Tredaptive, Pelzont og Trevaclyn ikke længere overstiger risiciene, og at markedsføringstilladelserne bør suspenderes.
English: • The Agency recommended the suspension of Tredaptive, Pelzont or Trevaclyn following the review of new evidence which indicated that the benefits of these medicines no longer outweigh their risks for patients.
Danish: • Agenturet anbefalede suspendering af Tredaptive, Pelzont eller Trevaclyn efter gennemgang af nye forskningsresultater, der viste, at fordelene ved disse lægemidler ikke længere overstiger risiciene for patienterne.
English: • Tredaptive, Pelzont and Trevaclyn contain two active substances: nicotinic acid (1,000 mg) and laropiprant (20 mg).
Danish: • Tredaptive, Pelzont og Trevaclyn indeholder to aktive stoffer: Nicotinsyre (1 000 mg) og laropiprant (20 mg).
English: • The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 22 March 2013.
Danish: • CHMP's udtalelse blev overgivet til Europa-Kommissionen, som vedtog en retligt bindende afgørelse den 22. marts 2013.
English: • Tredaptive, Pelzont and Trevaclyn are identical medicines authorised throughout the EU on 3 July 2008 for the treatment of dyslipidaemia in combination with a statin when statin treatment alone is not sufficient, or alone in patients unable to take statins.
Danish: • Tredaptive, Pelzont og Trevaclyn er identiske lægemidler, der blev godkendt i hele EU den 3. juli 2008 til behandling af dyslipidæmi i kombination med et statin, når statinbehandling alene ikke er tilstrækkelig eller ikke kan anvendes.
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 22 March 2013.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og vedtog en retligt bindende afgørelse den 22. marts 2013.
English: The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available.
Danish: I december 2012 blev der indledt en gennemgang af Tredaptive, Pelzont og Trevaclyn, efter at der var kommet nye data frem fra en stor langtidsundersøgelse (HPS2-THRIVE).
English: On 17 January 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Danish: Den 17. januar 2013 bekræftede Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til Mennesker (CHMP) anbefalingen om suspendering af markedsføringstilladelserne for Tredaptive, Pelzont og Trevaclyn (nicotinsyre/laropiprant), der anvendes til behandling af voksne med dyslipidæmi (unormalt højt indhold i blodet af fedtstoffer såsom triglycerider og kolesterol).
English: Such treatment is ultimately aimed to reduce the risk of heart attacks, strokes and other conditions affecting the heart and blood vessels.
Danish: Formålet med denne behandling er i sidste instans at nedsætte risikoen for hjerteslag, slagtilfælde og andre hjerte-karsygdomme.
English: Doctors should no longer prescribe these medicines and should review patients' treatment options
Danish: Læger skal ikke længere ordinere disse lægemidler, men gennemgå patientens behandlingsmuligheder
English: Laropiprant has no effect on cholesterol but it reduces flushing, by blocking the receptors for a substance called ‘prostaglandin D2' which is released when nicotinic acid is taken and which dilates (widens) the blood vessels in the skin.
Danish: Laropiprant har ingen indvirkning på kolesterol, men nedsætter rødme ved at blokere receptorerne for stoffet prostaglandin D2, der frigives ved indtagelse af nicotinsyre og udvider blodkarrene i huden.
English: The CHMP encouraged patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment.
Danish: Patienter, der tager disse lægemidler, blev af CHMP opfordret til at få en ikke-akut tid hos lægen for at få gennemgået behandlingen.
English: • Doctors should review their patients' treatment in order to discontinue treatment with these medicines, which are no longer available in the EU.
Danish: • Lægen bør gennemgå patienternes behandling og seponere behandlingen med disse lægemidler, der ikke længere er på markedet i EU.
English: More information on the HPS2-THRIVE study is available below.
Danish: Nedenfor er der givet flere detaljer om HPS2-THRIVE-undersøgelsen.
English: As taking Tredaptive, Pelzont and Trevaclyn together with a statin has no additional benefit in reducing the risk of major vascular events compared with statin therapy alone and taking into account the increased risk of serious side effects, the CHMP recommended the suspension of these medicines.
Danish: I betragtning af, at anvendelse af Tredaptive, Pelzont og Trevaclyn sammen med et statin ikke har nogen ekstra fordel i form af nedsat risiko for større vaskulære hændelser frem for statinbehandling alene, og at der er øget risiko for alvorlige bivirkninger, anbefalede CHMP suspendering af disse lægemidler.
English: • Tredaptive, Pelzont and Trevaclyn are identical medicines used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Danish: • Tredaptive, Pelzont og Trevaclyn er identiske lægemidler, der anvendes til behandling af voksne med dyslipidæmi (unormalt højt indhold i blodet af fedtstoffer såsom triglycerider og kolesterol).