FrancophonIA/ELRC3.0 huggingface dataset:
English: All affected products from Castlebar were eventually recalled in stages across the EU.
Danish: Til sidst blev alle de berørte produkter fra Castlebar trin for trin tilbagekaldt i hele EU.
English: As part of the future risk management plan the Committee adopted proposals for a period of intense monitoring of any reports of aseptic peritonitis during the initial months of marketing new products from CastleBar.
Danish: Som led i den fremtidige risikostyringsplan vedtog udvalget, at nye produkter fra CastleBar skal underkastes intensiv overvågning af indberetninger om aseptisk peritonitis i de første måneder efter at være bragt på markedet.
English: It also cleaned the other tanks and pipework involved in the production.
Danish: Virksomheden rensede desuden de øvrige tanke og rørsystemer i produktionen.
English: It was believed that the endotoxins were being produced by ‘biofilms' (layers of bacteria that adhere to each other), which are very resistant to cleaning processes.
Danish: Det blev antaget, at endotoksinerne blev produceret af “biofilm” (lag af indbyrdes sammenhængende bakterier), som er meget modstandsdygtige mod rengøringsprocesser.
English: These include: Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; Monosol and a sodium chloride solution for haemodialysis.
Danish: Det drejer sig om følgende: Dianeal, Extraneal og Nutrineal, peritonealdialysevæske, Monosol og en natriumchloridopløsning til hæmodialyse.
English: The CHMP started the current review to investigate fully the issues related to the endotoxin contamination and to make recommendations to help protect public health and to prevent future supply shortages.
Danish: CHMP har iværksat denne gennemgang for at undersøge endotoksinforureningen til bunds og fremsætte anbefalinger til beskyttelse af folkesundheden og sikring af forsyningerne i fremtiden.
English: In order to facilitate this, the CHMP had earlier during the investigation made recommendations to formally include the production sites in Canada, USA, Turkey and Poland in the products' marketing authorisations in Europe.
Danish: Til dette formål havde CHMP tidligere i løbet af undersøgelsen anbefalet, at de europæiske markedsføringstilladelser for produkterne blev ændret med formel tilføjelse af fremstillingsstederne i Canada, USA, Tyrkiet og Polen.
English: Dialysis solutions are used in patients with kidney problems to help clear waste substances (such as urea) from the blood.
Danish: Dialysevæsker anvendes hos patienter med nyreproblemer til at rense blodet for affaldsstoffer (såsom urinstof).
English: The Agency was made aware of the presence of endotoxins in batches of Dianeal, Extraneal and Nutrineal made in the Castlebar plant in December 2010.
Danish: Agenturet blev i december 2010 gjort opmærksom på tilstedeværelsen af endotoksiner i batcher af Dianeal, Extraneal og Nutrineal fremstillet på anlægget i Castlebar.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised recommendations to ensure the adequate supply of these dialysis solutions in the EU while measures are being put in place at Castlebar to enable the production of endotoxin-free solutions.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) har udarbejdet anbefalinger, der skal sikre tilstrækkelige leverancer af sådanne dialysevæsker i EU, så længe man i Castlebar er i færd med at indføre foranstaltninger til at fremstille endotoksinfrie væsker.
English: The CHMP noted that improvements are being made to Castlebar plant to ensure future production of endotoxin-free dialysis solutions.
Danish: CHMP konstaterede, at der på anlægget i Castlebar er ved at blive indført forbedringer for at sikre endotoksinfrie dialysevæsker.
English: Symptoms of aseptic peritonitis include cloudy effluent (the solution in the drainage bag), abdominal pain, nausea (feeling sick), vomiting and sometimes fever.
Danish: Symptomerne på aseptisk peritonitis er uklar væske i dialyseposen, mavesmerter, kvalme, opkastning og undertiden feber.
English: The investigation follows the detection in December 2010 of endotoxins in dialysis solutions produced at the plant.
Danish: Forud for undersøgelsen blev der i december 2010 fundet endotoksiner i dialysevæsker fremstillet på anlægget.
English: Despite these measures, endotoxins were still detected in new batches of solutions produced at the plant, causing the manufacture of these solutions to be shut down at the plant.
Danish: Trods disse foranstaltninger blev der igen fundet endotoksiner i nye batcher af væsker, der var fremstillet på anlægget.
English: The products affected by this review are some of the dialysis solutions produced at Baxter's Castlebar plant.
Danish: Denne gennemgang berører nogle at de dialysevæsker, der fremstilles på Baxters anlæg i Castlebar.
English: • Patients who suspect they have aseptic peritonitis or notice any relevant symptoms (cloudy effluent in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and fever) should contact their doctor.
Danish: • Patienterne skal kontakte lægen, hvis de har mistanke om at have aseptisk peritonitis eller bemærker relevante symptomer (uklar væske i dialyseposen efter endt dialyse, mavesmerter,
English: Due to the lack of sufficient alternative sources for dialysis solutions, the CHMP could not recall all affected products from the Castlebar plant at that time.
Danish: Derfor kunne CHMP på daværende tidspunkt ikke tilbagekalde alle de pågældende produkter fra anlægget i Castlebar.
English: In particular, endotoxins in solutions used in peritoneal dialysis can cause ‘aseptic peritonitis', an inflammation of the peritoneum that may affect the way it filters the blood.
Danish: Herved forstås inflammation af bughinden (peritoneum), som kan påvirke bughindens evne til at filtrere blodet.
English: Aseptic peritonitis can force the patient to stop dialysis until it is resolved.
Danish: Det kan være nødvendigt at standse dialysen, indtil den aseptiske peritonitis er svundet.
English: At the time, the company identified endotoxin-producing bacteria in two tanks as the root cause of the problem and removed the tanks from the production line.
Danish: Dengang konstaterede virksomheden, at den tilgrundliggende årsag til problemet var endotoksinproducerende bakterier i to tanke.
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Danish: Virksomheden gennemfører desuden et observationsstudie af lægemidlets langsigtede sikkerhed.
English: Daxas received a marketing authorisation valid throughout the EU on 5 July 2010.
Danish: Daxas fik en markedsføringstilladelse med gyldighed i hele EU den 5. juli 2010.
English: This benefit was seen on top of the effects of the treatments that the patients were already receiving.
Danish: Denne fordel sås i tillæg til virkningen af de behandlinger, som patienterne i forvejen fik.
English: The tablets should be taken at the same time each day.
Danish: Tabletterne skal tages på samme klokkeslæt hver dag.
English: Further information on Daxas can be found on the Agency's website: ema.europa/Find medicine/Human medicine/European public assessment reports.
Danish: Yderligere information om Daxas findes på agenturets websted under: ema.europa/Find medicine/Human medicine/European public assessment reports.
English: At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Danish: Ved begyndelsen af undersøgelserne havde begge patientgrupper et FEV1 på ca. 1 liter (1 000 ml).
English: Patients started on the lower dose had fewer side effects.
Danish: Patienter, der var begyndt med lavere dosis, fik færre bivirkninger.
English: The patients could continue to receive treatment with a bronchodilator during the study.
Danish: Patienterne kunne fortsætte behandlingen med en bronkodilator i studiets varighed.
English: Daxas contains the active substance roflumilast.
Danish: Daxas indeholder det aktive stof roflumilast.
English: As for all medicines, data on the use of Daxas are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Daxas løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Daxas?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Daxas?
English: For more information about using Daxas, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Daxas, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: An overview of Daxas and why it is authorised in the EU
Danish: En oversigt over Daxas, og hvorfor det er godkendt i EU
English: Patients may need to take Daxas 500 micrograms for several weeks before it starts to have an effect.
Danish: Patienterne vil muligvis skulle tage Daxas 500 µg i flere uger, før det begynder at virke.
English: The doctor may stop treatment with Daxas if the patient loses too much weight.
Danish: Lægen kan afbryde behandlingen med Daxas, hvis patienten får for stort vægttab.
English: These involved over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Danish: Studierne omfattede over 3.000 voksne med svær KOL, som havde haft mindst én episode af forværring af sygdommen i det forløbne år.
English: After considering all of the available data on the effects of the medicine, the Agency decided that Daxas's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: På baggrund af alle foreliggende data om lægemidlets virkninger konkluderede agenturet, at fordelene ved Daxas opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Daxas are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Daxas vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Daxas must not be used in patients who have moderate or severe problems with their liver.
Danish: Daxas må ikke anvendes hos patienter med moderate eller svære leverproblemer.
English: By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.
Danish: Ved at blokere virkningen af PDE4 nedsætter roflumilast inflammationen i lungerne, hvilket mindsker patientens symptomer eller forhindrer forværring af dem.
English: The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Danish: Virksomheden, der fremstiller Daxas, skal sikre, at sundhedspersoner, der ordinerer lægemidlet i alle EU's medlemsstater, får udleveret uddannelsesmateriale, der indeholder oplysninger om lægemidlets bivirkninger og om, hvordan det skal bruges.
English: Other information about Daxas:
Danish: Andre oplysninger om Daxas
English: Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies.
Danish: Daxas (500 µg) er påvist at være mere effektivt end placebo (en uvirksom behandling) til behandling af KOL i to hovedstudier.
English: The European Medicines Agency noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at der er behov for nye typer behandling af KOL, og at hovedstudierne viste en beskeden fordel af ved Daxas 500 µg hos patienter med svær KOL.
English: Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily.
Danish: Ca. 18 % (81 af 441 patienter) af de patienter, der begyndte med 250 µg dagligt, udgik af studiet sammenlignet med 25 % (109 af 443) af de patienter, der begyndte med 500 µg dagligt.
English: It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD.
Danish: Det blokerer virkningen af enzymet PDE4, som medvirker til den inflammationsproces, der fører til KOL.
English: The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Danish: De hyppigste bivirkninger ved Daxas (som optræder hos mellem 1 og 10 ud af 100 patienter) er vægttab, nedsat appetit, søvnbesvær, hovedpine, diarré, kvalme og mavesmerter.
English: Why is Daxas authorised in the EU?
Danish: Hvorfor blev Daxas godkendt i EU?
English: The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.
Danish: Fordelene i form af forbedret FEV1 var ens i begge grupper i slutningen af studiet, men patienter, der ikke kunne tage 500 µg dagligt, og som da kun fik 250 µg dagligt, udviste ingen bedring i lungefunktionen.
English: Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.
Danish: Daxas fås som tabletter (250 µg og 500 µg) og udleveres kun efter recept.
English: What is Daxas and what is it used for?
Danish: Hvad er Daxas, og hvad anvendes det til?
English: The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på bedringen i forceret ekspiratorisk volumen (FEV1) og reduktionen i antallet af tilfælde af moderat eller svær opblussen af patienternes KOL i løbet af et års behandling.
English: After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Danish: Efter et år oplevede de patienter, der blev behandlet med Daxas, en gennemsnitlig stigning på 40 ml, mens de patienter, der fik placebo, oplevede en gennemsnitligt nedgang på 9 ml.
English: Although a dose of 250 micrograms daily does not improve lung function it was useful in preventing patients from dropping out because of side effects when starting treatment.
Danish: Selvom en dosis på 250 µg dagligt ikke forbedrer lungefunktionen, var den nyttig til at forhindre patienter i af afbryde behandlingen på grund af bivirkninger i starten af behandlingen.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Danish: KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så indånding og udånding besværliggøres.
English: What are the risks associated with Daxas?
Danish: Hvilke risici er der forbundet med Daxas?
English: In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Danish: Desuden oplevede de patienter, der blev behandlet med Daxas, i gennemsnit 1,1 moderat eller svært tilfælde af sygdomsopblussen sammenlignet med 1,4 hos de patienter, der fik placebo.
English: The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Danish: Det aktive stof i Daxas, roflumilast, tilhører lægemiddelgruppen fosfodiesterase 4-hæmmere (PDE4hæmmere).
English: The recommended dose of Daxas for treatment is one 500-microgram tablet once a day, but treatment is started with one 250-microgram tablet daily to reduce side effects that might make patients stop taking the medicine.
Danish: Den anbefalede behandlingsdosis af Daxas er én 500 µg-tablet én gang dagligt, men behandlingen begyndes med én 250 µg-tablet én gang dagligt for at mindske bivirkninger, der kan få patienterne til at holde op med at tage lægemidlet.
English: Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas 250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with starting at the higher dose.
Danish: Et andet 12-ugers studie med 1.323 patienter omhandlede virkningen af at begynde behandlingen med Daxas 250 µg dagligt i 4 uger, før dosis blev hævet til 500 µg dagligt, sammenlignet med at begynde med den højere dosis.
English: Daxas is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Danish: Daxas anvendes ikke alene, men som tillæg til behandling med medicin, der udvider luftvejene i lungerne (bronkodilatorer).
English: Daxas is a medicine used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Danish: Daxas er et lægemiddel til behandling af svær KOL (kronisk obstruktiv lungesygdom) hos voksne med kronisk bronkitis (langvarig betændelse (inflammation) af luftvejene), som har hyppige episoder med forværring af deres KOL.
English: After taking 250 micrograms daily for 4 weeks, the dose is increased to 500 micrograms daily.
Danish: Når man har fået 250 µg dagligt i 4 uger, sættes dosis op til 500 µg dagligt.
English: The company will also provide cards for patients, telling them what information about their symptoms and past illnesses they need to give their doctor to help the doctor determine whether Daxas is appropriate for them.
Danish: Virksomheden skal desuden sørge for, at patienterne får udleveret kort, der indeholder oplysninger om deres symptomer og tidligere sygdomme, og at de viser kortet til lægen, for at denne lettere kan afgøre, om Daxas er hensigtsmæssigt for dem. På kortet vil der være et felt, hvor patienten kan angive sin vægt.
English: For the full list of side effects of Daxas, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger med Daxas fremgår af indlægssedlen.
English: Because patients taking Daxas may lose weight, they are advised to weigh themselves on a regular basis.
Danish: Eftersom Daxas kan forårsage vægttab, rådes patienter, som tager Daxas, til at veje sig med jævne mellemrum.
English: How is Daxas used?
Danish: Hvordan anvendes Daxas?
English: What benefit of Daxas have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Daxas?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daxas 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 Daxas.
English: How does Daxas work?
Danish: Hvordan virker Daxas?
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere information findes i resuméet af risikostyringsplanen.
English: It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Danish: Det anvendes til behandling af astma hos voksne, når et kombinationsprodukt anses for egnet.
English: The full EPAR and risk management plan summary for Vylaer Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Vylaer Spiromax 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 Vylaer Spiromax on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vylaer Spiromax den 19. november 2014.
English: Vylaer Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Danish: Vylaer Spiromax anvendes desuden til dæmpe symptomerne på svær kronisk obstruktiv lungesygdom (KOL) hos voksne, der tidligere har haft anfald med forværring af sygdommen trods regelmæssig behandling.
English: Vylaer Spiromax budesonide / formoterol
Danish: Vylaer Spiromax budesonid / formoterol
English: The two active substances in Vylaer Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Danish: De to aktive stoffer i Vylaer Spiromax er velkendte og findes i flere lægemidler, der anvendes til behandling af astma og KOL, enten alene eller i kombination med andre lægemidler.
English: Vylaer Spiromax 160/4.5 microgram can be used for the regular treatment of asthma.
Danish: Vylaer Spiromax 160/4,5 µg kan anvendes til regelmæssig behandling af astma.
English: This is a summary of the European public assessment report (EPAR) for Vylaer Spiromax.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vylaer Spiromax.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Danish: Det kan dels anvendes hos patienter, hvis sygdom ikke kan kontrolleres tilfredsstillende ved inhalation af andre astmalægemidler af typen binyrebarkhormoner og “korttidsvirkende beta-2-stimulerende midler”, og dels hos patienter, hvis sygdom kan kontrolleres tilfredsstillende ved inhalation af binyrebarkhormoner og “langtidsvirkende beta-2-stimulerende midler”.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Vylaer Spiromax is given using a different inhaler.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stoffer, men til Vylaer Spiromax anvendes en anden inhalator.
English: If patients need to take more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Danish: Patienter, der behøver mere end 8 inhalationer af anfaldsmedicin dagligt, rådes til at henvende sig til lægen for at få astmabehandlingen revurderet.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
Danish: KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så vejrtrækningen vanskeliggøres.
English: A risk management plan has been developed to ensure that Vylaer Spiromax is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vylaer Spiromax anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det er påvist, at Vylaer Spiromax, 160/4,5 µg og 320/9 µg, har en kvalitet som Symbicort Turbohaler og en virkning som de tilsvarende styrker af Symbicort Turbohaler.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vylaer Spiromax, 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 Vylaer Spiromax, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.