FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconstitute each 500 mg vial with 20 mL of 9 mg/mL (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/mL pemetrexed.
Danish: Hvert hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion
Danish: Pemetrexed Lilly 500 mg pulver til koncentrat til infusionsvæske, opløsning
English: Reconstitute 100-mg vials with 4.2 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/mL pemetrexed.
Danish: Hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion
Danish: Pemetrexed Lilly 100 mg pulver til koncentrat til infusionsvæske, opløsning
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/ radiation therapy.
Danish: Betændelse i spiserørets overflade er forekommet med pemetrexed i kombination med strålebehandling.
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Danish: hvis De ammer, skal De afbryde amningen under behandlingen med Pemetrexed Lilly.
English: The doctor will decide which inhaler the patient should use.
Danish: Lægen afgør, hvilken inhalator patienten bør anvende.
English: The dose is one inhalation (‘puff') into the mouth once a day at the same time each day.
Danish: Dosis er én inhalation (ét drag) i munden én gang dagligt på samme tidspunkt hver dag.
English: COPD
Danish: KOL
English: Further information on Relvar Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Relvar Ellipta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Relvar Ellipta received a marketing authorisation valid throughout the EU on 13 November 2013.
Danish: Relvar Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 13. november 2013.
English: In asthma, it is used for regular treatment of patients from 12 years of age:
Danish: Ved astma anvendes det til regelmæssig behandling af patienter over 12 år:
English: It works on various types of immune cells, blocking the release of substances involved in inflammation.
Danish: Det virker på forskellige typer immunceller ved at blokere frigivelsen af stoffer, der medvirker til inflammation.
English: This reduces inflammation in the airways and improves the patient's breathing.
Danish: Dette nedsætter inflammation i luftvejene og forbedrer patientens vejrtrækning.
English: These patients were already well controlled with the comparator medicine and Relvar Ellipta treatment was able to maintain their FEV1.
Danish: Disse patienter var i forvejen velkontrollerede med sammenligningslægemidlet, og behandlingen med Relvar Ellipta var i stand til at opretholde deres FEV1.
English: As for all medicines, data on the use of Relvar Ellipta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Relvar Ellipta løbende overvåget.
English: For more information about using Relvar Ellipta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Relvar Ellipta, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency concluded that Relvar Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Relvar Ellipta opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Other information about Relvar Ellipta
Danish: Andre oplysninger om Relvar Ellipta
English: Relvar Ellipta (fluticasone furoate / vilanterol)
Danish: Relvar Ellipta (fluticasonfuroat/vilanterol)
English: What measures are being taken to ensure the safe and effective use of Relvar Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Relvar Ellipta?
English: It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Danish: Det bindes til beta-2 receptorer i luftvejene, så musklerne i luftvejene slapper af og udvider sig, så patienten lettere kan trække vejret.
English: In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).
Danish: Ved KOL anvendes det hos voksne, der har episoder med forværring af sygdommen trods regelmæssig behandling med et lægemiddel, der udvider luftvejene (en bronkodilator).
English: An overview of Relvar Ellipta and why it is authorised in the EU
Danish: En oversigt over Relvar Ellipta og hvorfor det er godkendt i EU
English: Relvar Ellipta can only be obtained with a prescription.
Danish: Relvar Ellipta udleveres kun efter recept.
English: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Danish: Relvar Ellipta leveres som en inhalator i to styrker (92/22 µg og 184/22 µg).
English: The most common side effects with Relvar Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Danish: De hyppigste bivirkninger ved Relvar Ellipta (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine og betændelse i næse og svælg (nasofaryngitis).
English: Side effects reported with Relvar Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Relvar Ellipta vurderes nøje, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Vilanterol is a long-acting beta-2 agonist.
Danish: Vilanterol er et langtidsvirkende beta-2-stimulerende middel.
English: More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma.
Danish: Mere alvorlige bivirkninger er lungebetændelse og knoglebrud (optræder hos op til 1 ud af 10 patienter), som oftere blev indberettet hos patienter med KOL end hos patienter med astma.
English: In two further studies, Relvar Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.
Danish: I to yderligere studier reducerede Relvar Ellipta antallet af episoder med forværring med mellem 13 og 34 % mere end vilanterol alene.
English: Why is Relvar Ellipta authorised in the EU?
Danish: Hvorfor blev Relvar Ellipta godkendt i EU?
English: What is Relvar Ellipta and what is it used for?
Danish: Hvad er Relvar Ellipta, og hvad anvendes det til?
English: In a third study, fewer patients taking Relvar Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
Danish: I et tredje studie havde færre patienter, der fik Relvar Ellipta 92/22, mindst én alvorlig episode med forværring efter et års behandling, end de, der fik fluticasonfuroat alene (13 % mod 16 %).
English: A fourth study in 1,522 patients showed that Relvar Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
Danish: Et fjerde studie hos 1.522 patienter viste, at Relvar Ellipta var lige så effektiv som et andet lægemiddel indeholdende et binyrebarkhormon (fluticasonpropionat) og et langtidsvirkende beta-2-stimulerende middel (salmeterol).
English: Relvar Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Danish: Relvar Ellipta 184/22 forbedrede desuden FEV1 med 193 ml mere end fluticasonfuroat og 210 ml mere end en anden inhalator indeholdende fluticasonpropionat.
English: Relvar Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Danish: Relvar Ellipta er et inhalationslægemiddel til behandling af astma og kronisk obstruktiv lungesygdom (KOL).
English: What are the risks associated with Relvar Ellipta?
Danish: Hvilke risici er der forbundet med Relvar Ellipta?
English: The first study showed that Relvar Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Relvar Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
Danish: Det første studie viste, at Relvar Ellipta, 92/22, forbedrede det gennemsnitlige FEV1 med 115 ml mere end placebo, mens et andet studie viste, at Relvar Ellipta, 184/22, forbedrede det gennemsnitlige FEV1 med 131 ml mere end placebo.
English: Relvar Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Danish: Relvar Ellipta indeholder to aktive stoffer, der på hver sin måde forbedrer vejrtrækningen hos patienter med astma og KOL.
English: Relvar Ellipta contains the active substances fluticasone furoate and vilanterol.
Danish: Relvar Ellipta er et lægemiddel, der indeholder de aktive stoffer fluticasonfuroat og vilanterol.
English: • whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting
Danish: • hvis symptomer ikke er kontrolleret med et inhaleret binyrebarkhormon og et inhaleret korttidsvirkende beta-2-stimulerende middel
English: Three studies in over 3,200 patients showed that Relvar Ellipta improves breathing and reduces flareups in patients with asthma.
Danish: Tre studier hos over 3.200 patienter har vist, at Relvar Ellipta forbedrer vejrtrækningen og reducerer episoder med forværring hos patienter med astma.
English: In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
Danish: I to af studierne øgede Relvar Ellipta 92/22 den mængde luft, som en patient kunnet udånde på et sekund (FEV1), med 36 ml mere end fluticasonfuroat alene og 172 ml mere end virkningsløs behandling (placebo).
English: For the full list of side effects of Relvar Ellipta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger med Relvar Ellipta fremgår af indlægssedlen.
English: Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flareups of symptoms in patients with COPD.
Danish: Fire studier hos over 5.500 patienter har vist, at Relvar Ellipta forbedrer vejrtrækningen og reducerer episoder med forværring af symptomer hos patienter med KOL.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relvar Ellipta 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 Relvar Ellipta.
English: Relvar Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD.
Danish: Relvar Ellipta giver bedre vejrtrækning og færre episoder med forværring af symptomerne hos patienter med astma og KOL.
English: Regarding its safety, the most frequent side effects reported with Relvar Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
Danish: Med hensyn til sikkerheden svarer de hyppigste bivirkninger, der er indberettet med Relvar Ellipta, til dem, der ses med andre KOL- og astmabehandlinger.
English: • whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting
Danish: • hvis symptomer er tilstrækkeligt kontrolleret med både et inhaleret binyrebarkhormon og et langtidsvirkende beta-2-stimulerende middel.
English: How is Relvar Ellipta used?
Danish: Hvordan anvendes Relvar Ellipta?
English: What benefits of Relvar Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Relvar Ellipta?
English: How does Relvar Ellipta work?
Danish: Hvordan virker Relvar Ellipta?
English: What is VeraSeal?
Danish: Hvad er VeraSeal?
English: There are no consequences for patients in the three ongoing clinical trials.
Danish: Der er ingen konsekvenser for patienterne i de tre igangværende kliniske undersøgelser.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med VeraSeal og har behov for mere information om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: The Committee was concerned that the main study had not been carried out in accordance with the guidelines for Good Clinical Practice (GCP).
Danish: Udvalget havde betænkeligheder ved, at hovedundersøgelsen ikke var udført efter retningslinjerne for god klinisk praksis (GCP).
English: The applicant presented data from one main study involving 167 patients who underwent vascular surgery.
Danish: Ansøgeren fremlagde data fra én hovedundersøgelse, hvori der deltog 167 patienter, som fik foretaget karoperation.
English: VeraSeal is a medicine that contains the active substances human fibrinogen and human thrombin.
Danish: VeraSeal er et lægemiddel, der indeholder de aktive stoffer humant fibrinogen og humant trombin.
English: What was VeraSeal expected to be used for?
Danish: Hvad forventedes VeraSeal anvendt til?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/679015/2015 EMEA/H/C/003914
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The main measure of effectiveness was the ability to stop bleeding during a 10-minute observation period, after applying the method to stop the bleeding.
Danish: Det vigtigste mål for virkningen var evnen til at standse blødningen i en 10-minutters observationsperiode efter at metoden til standsning af blødning var taget i anvendelse.
English: It was to be available as two separate solutions that are mixed together to prepare a sealant that is applied to the surface of blood vessels.
Danish: Det forventedes at kunne fås som to særskilte opløsninger, der blandes sammen til en tætningsmasse til påføring på overfladen af blodkar.
English: The active substances in VeraSeal, human fibrinogen and human thrombin, are natural proteins in the blood and are obtained from blood donors.
Danish: De aktive stoffer i VeraSeal, humant fibrinogen og humant trombin, er naturlige blodproteiner, der fås fra donorblod.
English: In this study, bleeding during surgery was managed either by applying VeraSeal or by
Danish: I denne undersøgelse blev blødning under operation behandlet enten ved påføring af
English: When applied to a moist surface, the thrombin is activated and cuts fibrinogen up into smaller units called fibrin.
Danish: Når trombinet påføres på en fugtig overflade, aktiveres det og spalter fibrinogen til mindre enheder, der kaldes fibrin.
English: On 29 September 2015, Instituto Grifols S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for marketing authorisation of VeraSeal, which was intended to help stop bleeding during vascular (blood vessel) surgery when standard surgical methods for controlling bleeding are insufficient.
Danish: Den 29. september 2015 meddelte Instituto Grifols S.A. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for VeraSeal til standsning af blødning under en operation på blodkar, når sædvanlige kirurgiske metoder til blødningskontrol er utilstrækkelige.
English: How is VeraSeal expected to work?
Danish: Hvordan forventes VeraSeal at virke?
English: In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to not being able to gather the additional data required by the CHMP, including data from three ongoing clinical studies with the product, within the available timeframe.
Danish: I brevet til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes, at det inden for den foreliggende frist ikke var muligt at fremskaffe de nødvendige supplerende data, som CHMP havde forlangt, herunder data fra tre igangværende kliniske undersøgelser med produktet.
English: The fibrin then aggregates (sticks together) and forms fibrin clots on the surface of blood vessels.
Danish: Fibrinet klæber derefter sammen (aggregerer) og danner en fibrinklump på overfladen af blodkarrene.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for VeraSeal.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om VeraSeal.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med VeraSeal eller i programmer for anvendelse af VeraSeal med særlig udleveringstilladelse?
English: applying manual pressure (a standard way of stopping bleeding during surgery).
Danish: VeraSeal eller ved påføring af manuelt tryk (en standardmetode til at standse blødning under operation).
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had concerns and was of the provisional opinion that VeraSeal could not have been approved to help stop bleeding during vascular surgery.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at VeraSeal ikke kunne være blevet godkendt til standsning af blødning ved karoperationer.
English: Findings from a GCP inspection of the study sites raised serious questions about the data from the main study submitted in support of the application.
Danish: Resultaterne af en GCP-inspektion på forsøgsstedet rejste alvorlig tvivl ved de data, der var forelagt til dokumentation af ansøgningen.
English: VeraSeal was expected to be used to help stop bleeding during vascular surgery when standard surgical methods for controlling bleeding are insufficient.
Danish: VeraSeal forventedes anvendt til at standse blødning under karoperationer, hvor sædvanlige kirurgiske metoder til blødningskontrol er utilstrækkelige.
English: The company informed the CHMP that there are currently no ongoing compassionate use programmes for VeraSeal.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres programmer for anvendelse med særlig udleveringstilladelse for VeraSeal.
English: This helps prevent bleeding and seals the blood vessels.
Danish: Dette modvirker blødning og tætner blodkarrene.
English: This summary was last updated in 05-2008.
Danish: Dette sammendrag blev sidst ajourført i 05-2008.
English: The tablets must be swallowed whole, and should not be split, broken, crushed or chewed.
Danish: Tabletterne skal sluges hele og må ikke deles, brydes, knuses eller tygges.
English: The Committee recommended that Pelzont be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Pelzont.
English: Other information about Pelzont:
Danish: Andre oplysninger om Pelzont:
English: The starting dose of Pelzont is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Danish: Startdosis for Pelzont er én tablet én gang dagligt i fire uger, hvorefter dosis øges til to tabletter én gang dagligt.
English: ‘Modified-release' means that the two active substances are released at different rates from the tablet over a few hours.
Danish: "Modificeret udløsning" betyder, at de to aktive stoffer frigives fra tabletten med forskellige hastigheder over nogle timer.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pelzont to Merck Sharp & Dohme Ltd. on 3 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pelzont til Merck Sharp & Dohme Ltd.
English: The effects of Pelzont were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Pelzont blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Pelzont is used on its own only in patients who cannot take statins.
Danish: Pelzont anvendes alene hos patienter, der ikke tåler statiner.
English: The full EPAR for Pelzont can be found here.
Danish: Den fuldstændige EPAR for Pelzont findes her.
English: Pelzont is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Danish: Pelzont anbefales ikke til patienter under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning hos denne aldersgruppe.
English: This study also looked at the symptoms of flushing using a specially designed questionnaire.
Danish: Denne undersøgelse så også nærmere på flushingsymptomerne ved hjælp af et specielt udformet spørgeskema.
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 sænker det blodets fedtindhold via en mekanisme, der ikke kendes nøjagtigt.
English: Laropiprant blocks the receptors to which PGD2 normally attaches.
Danish: Laropiprant blokerer de receptorer, som PGD2 normalt binder sig til.
English: It is available as modified-release tablets.
Danish: Det findes som tabletter med modificeret udløsning.
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 ændre fedtindholdet i blodet i midten af 1950'erne, men brugen har været begrænset på grund af stoffets bivirkninger, navnlig flushing (rødmen af huden).
English: It is taken by mouth, with food, in the evening or before going to bed.
Danish: Tabletterne tages sammen med mad om aftenen eller ved sengetid.
English: They included a total of 2,349 patients who were taking either Pelzont or nicotinic acid.
Danish: De omfattede i alt 2 349 patienter, som tog enten Pelzont eller nikotinsyre.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PELZONT EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PELZONT EPAR - sammendrag for offentligheden
English: Nicotinic acid is a naturally occurring substance that is used in low doses as a vitamin.
Danish: Nikotinsyre er et naturligt forekommende stof, der anvendes i lave doser som et vitamin.
English: What is the risk associated with Pelzont?
Danish: Hvilken risiko er der forbundet med Pelzont?
English: The most common side effect with Pelzont (seen in more than 1 patient in 10) is flushing.
Danish: Den mest almindelige bivirkning ved Pelzont (som optræder hos flere end 1 ud af 10 patienter) er flushing.
English: The two active substances in Pelzont, nicotinic acid and laropiprant, have different modes of action.
Danish: De to aktive stoffer i Pelzont, nikotinsyre og laropiprant, har forskellige virkemåder.
English: When the receptors are blocked, PGD2 cannot dilate the vessels in the skin, reducing the frequency and intensity of flushing.
Danish: Når receptorerne blokeres, kan PGD2 ikke udvide blodkarrene i huden, hvorved hyppigheden og intensiteten af flushing reduceres.