FrancophonIA/ELRC3.0 huggingface dataset:
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Danish: • at reducere varigheden af neutropeni hos patienter, der er i behandling for at ødelægge knoglemarvsceller før en knoglemarvstransplantation (f.eks. hos nogle patienter med leukæmi), hvis de har en risiko for at få længerevarende alvorlig neutropeni
English: What benefits of Grastofil have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Grastofil?
English: How is Grastofil used?
Danish: Hvordan anvendes Grastofil?
English: How does Grastofil work?
Danish: Hvordan virker Grastofil?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Grastofil have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Grastofil.
English: It is used in the following groups:
Danish: Det anvendes til følgende grupper:
English: This summary was last updated in 07-2009.
Danish: Dette sammendrag blev sidst ajourført i 07-2009
English: The marketing authorisation was renewed on 1 July 2004 and on 1 July 2009.
Danish: Markedsføringstilladelsen blev fornyet den 1. juli 2004 og den 1. juli 2009.
English: A similar benefit was seen in the second study.
Danish: Der sås en lignende virkning i den anden undersøgelse.
English: Other information about Integrilin:
Danish: Andre oplysninger om Integrilin:
English: The recommended dose is a single injection of 180 micrograms per kilogram body weight given as soon as possible after diagnosis.
Danish: Den anbefalede dosis er en enkelt injektion på 180 mikrogram pr. kg legemsvægt, givet hurtigst muligt efter diagnosticering.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Integrilin on 1 July 1999.
Danish: Europa-kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Integrilin den 1. juli 1999.
English: The full EPAR for Integrilin can be found here.
Danish: Den fuldstændige EPAR for Integrilin findes her.
English: In both studies, patients also received other medicines to prevent the blood clotting.
Danish: I begge undersøgelser fik patienterne desuden andre lægemidler til forebyggelse af blodpropper.
English: The Committee recommended that Integrilin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Integrilin.
English: Integrilin is a medicine that contains the active substance eptifibatide.
Danish: Integrilin er et lægemiddel, der indeholder det aktive stof eptifibatid.
English: The main measure of effectiveness was the number of patients who had a heart attack or who died within 30 days of treatment.
Danish: Det primære effektmål var antallet af patienter, som fik et hjertetilfælde, eller som døde inden for 30 dages behandling.
English: The main benefit was in the reduction in further heart attacks.
Danish: Den vigtigste fordel var reduktionen i antallet af yderligere hjertetilfælde.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Integrilin's benefits are greater than its risks when used to prevent early myocardial infarction.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Integrilin er større end risiciene, når det anvendes til forebyggelse af tidlig myokardieinfarkt.
English: In the first study, Integrilin was more effective than placebo in preventing death or a heart attack during the 30 days after it was given.
Danish: I den første undersøgelse var Integrilin mere effektivt end placebo til at forebygge dødsfald eller et hjertetilfælde i de første 30 dage efter, at det blev indgivet.
English: This means that it helps to prevent blood clots from forming.
Danish: Dette betyder, at det hjælper med til at forhindre, at der dannes blodpropper.
English: This is followed by a continuous infusion of 2.0 microgram/kg per minute which is continued for up to 72 hours, until the start of surgery, or until discharge from the hospital, whichever occurs first.
Danish: Dette efterfølges af en kontinuerlig infusion med 2,0 mikrogram/kg pr. minut, som fortsættes i op til 72 timer, indtil operationen påbegyndes, eller indtil patienten udskrives fra hospitalet, afhængigt af, hvad der sker først.
English: Integrilin greatly reduces the risk of a blood clot forming and helps prevent another heart attack.
Danish: Integrilin reducerer i stor udstrækning risikoen for, at der dannes en blodprop, og hjælper dermed til med at forhindre endnu et hjertetilfælde.
English: Patients who have moderate problems with their kidneys should receive a lower dose during the infusion.
Danish: Patienter med moderate nyreproblemer skal have en lavere dosis under infusionen.
English: Integrilin is used to prevent a myocardial infarction (heart attack) in adults.
Danish: Integrilin anvendes til forebyggelse af myokardieinfarkt (hjertetilfælde) hos voksne.
English: Integrilin must not be used in patients with severe kidney problems.
Danish: Integrilin må ikke anvendes til patienter med alvorlige nyreproblemer.
English: Integrilin is given with aspirin and unfractionated heparin (other medicines that prevent blood clots).
Danish: Integrilin gives sammen med aspirin og ufraktioneret heparin (andre lægemidler, der forhindrer dannelse af blodpropper).
English: The most common side effect with Integrilin (seen in more than 1 patient in 10) is bleeding, which may be severe.
Danish: Den hyppigste bivirkning ved Integrilin (som optræder hos flere end 1 ud af 10 patienter) er blødninger, som kan være alvorlige.
English: It must not be used in patients who have bleeding problems or have a disease that may cause bleeding (such as stroke or severe high blood pressure), or in patients with severe liver or kidney problems.
Danish: Det må ikke anvendes til patienter, som har blødningsproblemer eller har en sygdom, der kan forårsage blødning (såsom et slagtilfælde eller meget forhøjet blodtryk), eller hos patienter med svære lever- eller nyreproblemer.
English: Integrilin should not be used in people who may be hypersensitive (allergic) to eptifibatide or any of the other ingredients.
Danish: Integrilin må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for eptifibatid eller et eller flere af de øvrige indholdsstoffer.
English: The active substance in Integrilin, eptifibatide, stops the platelets aggregating by blocking a protein called glycoprotein IIb/III on their surface that helps make them sticky.
Danish: Det aktive stof i Integrilin, eptifibatid, forhindrer, at blodpladerne aggregerer, ved at blokere et protein kaldet glykoprotein IIb/III på blodpladernes overflade, som bidrager til at gøre dem klæbrige.
English: The patients most likely to benefit from a treatment with Integrilin are those at high risk of myocardial infarction in the three to four days after the start of acute (sudden) angina.
Danish: De patienter, der med stor sandsynlighed vil få gavn af en behandling med Integrilin, er patienter med høj risiko for at få myokardieinfarkt inden for tre-fire dage efter starten på akut (pludselig) angina.
English: Integrilin should be given into a vein by a doctor who has experience in the management of heart conditions.
Danish: Integrilin skal indgives i en vene af en læge, der har erfaring med behandling af hjertesygdomme.
English: Integrilin has been compared with placebo (dummy treatment) in a study involving 11,000 patients who were in hospital and had signs that they may soon develop a heart attack, or who had already had a small heart attack.
Danish: Integrilin er blevet sammenlignet med placebo (virkningsløs behandling) i en undersøgelse med deltagelse af 11.000 patienter, som var indlagt på hospitalet og udviste tegn på, at de snart kunne udvikle et hjertetilfælde, eller som allerede havde haft et mindre hjertetilfælde.
English: When the blood clots, this is due to special cells in the blood called platelets sticking together (aggregating).
Danish: Når blodet danner blodpropper, skyldes det, at specielle celler i blodet, kaldet blodplader, klæber sig fast til hinanden (de aggregerer).
English: If the patient undergoes a percutaneous coronary intervention (PCI or angioplasty, a surgical procedure that is used to unblock narrowed coronary arteries), the treatment can be continued for up to 24 hours after surgery, with a maximum treatment duration of 96 hours.
Danish: Hvis patienten gennemgår en perkutan koronar intervention (PCI eller angioplastik, en kirurgisk procedure til udvidelse af forsnævrede koronararterier), kan behandlingen fortsættes i op til 24 timer efter operationen, med en behandlingsperiode på maksimalt 96 timer.
English: • patients who have unstable angina (a severe type of chest pain that varies in intensity);
Danish: • patienter med ustabil angina (en alvorlig type brystsmerte, der varierer i intensitet)
English: • patients who have already had a non-Q-wave myocardial infarction (a type of heart attack), with chest pain in the last 24 hours and with abnormalities on the electrocardiogram (ECG) or signs of heart problems in the blood.
Danish: • patienter, som allerede har haft myokardieinfarkt uden forekomst af Q-takker (en slags hjertetilfælde), med brystsmerter inden for de seneste 24 timer og med uregelmæssigheder i deres elektrokardiogram (EKG) eller tegn på hjerteproblemer i blodet.
English: What is the risk associated with Integrilin?
Danish: Hvilken risiko er der forbundet med Integrilin?
English: It is available as a solution for infusion (drip into a vein) and a solution for injection.
Danish: Det fås som opløsning til infusion (drop i en vene) og opløsning til injektion.
English: An additional study compared Integrilin with placebo in 2,000 patients who were having PTCA to remove a blood clot from the coronary arteries and insert a stent (a short tube that remains in the artery to stop it closing).
Danish: I en anden undersøgelse sammenlignedes Integrilin med placebo hos 2.000 patienter, som var ved at få foretaget PTCA for at få fjernet en blodprop fra kranspulsåren og få indført en stent (et kort rør, der indsættes i arterien for at forhindre, at den lukker).
English: For the full list of all side effects reported with Integrilin, see the Package Leaflet.
Danish: Den fuldstændige liste over samtlige bivirkninger ved Integrilin fremgår af indlægssedlen.
English: Why has Integrilin been approved?
Danish: Hvorfor blev Integrilin godkendt?
English: This includes patients who are having percutaneous transluminal coronary angiography (PTCA, a type of surgery to clear the arteries supplying the heart).
Danish: Dette omfatter patienter, som skal have foretaget perkutan transluminal koronarangioplastik (PTCA, en speciel type operation, der renser blodårerne, som går til hjertet).
English: Integrilin eptifibatide EPAR summary for the public
Danish: Integrilin eptifibatid
English: What is Integrilin?
Danish: Hvad er Integrilin?
English: How has Integrilin been studied?
Danish: Hvordan blev Integrilin undersøgt?
English: What benefit has Integrilin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Integrilin?
English: What is Integrilin used for?
Danish: Hvad anvendes Integrilin til?
English: Integrilin is an inhibitor of platelet aggregation.
Danish: Integrilin hæmmer blodpladeaggregation.
English: How is Integrilin used?
Danish: Hvordan anvendes Integrilin?
English: How does Integrilin work?
Danish: Hvordan virker Integrilin?
English: Cattle: subcutaneous or intravenous use Pigs: intramuscular use Horses: intravenous use
Danish: Kvæg: Intravenøs eller subkutan Svin: intramuskulær
English: HDPE bottle polypropylene measuring syringe
Danish: Peroral brug High density polyethylene flaske, polypropylendoseringssprøjte farveløse hætteglas med gummiprop og
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelfor m
English: Meat and offal: 15 days (Cattle), Milk: 5 days
Danish: Mælk: 5 dage (Kvæg)
English: (Horses) Meat and offal: 5 days (Pigs)
Danish: Kød og indvolde: 5 dage (Heste) Kød og indvolde: 5 dage (Svin)
English: Target species
Danish: Anvendelse i foderet.
English: Previously known as Anoro.
Danish: Tidligere kendt som Anoro.
English: Further information on Anoro Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Anoro Ellipta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Anoro Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Danish: Anoro Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 8. maj 2014.
English: (umeclidinium bromide / vilanterol)
Danish: (umeclidiniumbromid/vilanterol)
English: In all 5 studies, involving over 5,600 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: I alle fem studier, hvori der deltog flere end 5.600 patienter, blev virkningen hovedsagelig bedømt på ændringerne i patienternes forcerede ekspirationsvolumen (FEV1, som er den maksimale luftmængde, en person kan udånde på et sekund).
English: As for all medicines, data on the use of Anoro Ellipta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Anoro Ellipta løbende overvåget.
English: The Agency also noted that there were no major safety concerns with Anoro Ellipta, with side effects being manageable, although the long-term safety data so far are limited.
Danish: Agenturet bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Anoro Ellipta, da bivirkningerne kan behandles, selvom dataene for langsigtet sikkerhed indtil videre er begrænsede.
English: As medicines of the same class as Anoro Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Danish: Da lægemidler af samme klasse som Anoro Ellipta kan påvirke hjertet og blodkarrene i hjernen, skal virksomheden, der markedsfører lægemidlet, gennemføre et langtidsstudie med patienter for at indsamle yderligere oplysninger om lægemidlets sikkerhed sammenholdt med tiotropium.
English: For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet or contact your doctor or pharmacist.
Danish: For information om korrekt brug af inhalatoren se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Anoro Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Anoro Ellipta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Umeclidinium is a muscarinic receptor antagonist.
Danish: Umeclidinium er en såkaldt muskarinreceptor-antagonist.
English: Vilanterol is a long-acting beta-2 adrenergic agonist.
Danish: Vilanterol er en langtidsvirkende adrenerg beta-2-agonist.
English: This causes the muscles of the airways to relax.
Danish: Dette får musklerne i luftvejene til at slappe af.
English: Anoro Ellipta is used for maintenance (regular) treatment.
Danish: Anoro Ellipta anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: It works by attaching to beta-2 adrenergic receptors found in the muscle cells of many organs including the airways in the lungs.
Danish: Det virker ved at binde til adrenerge beta-2-receptorer i muskelcellerne i mange organer, herunder luftvejene i lungerne.
English: The European Medicines Agency decided that Anoro 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 Anoro Ellipta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Anoro Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Anoro Ellipta?
English: When umeclidinium is inhaled, it also relaxes the muscles of the airways.
Danish: Når umeclidinium inhaleres, virker det også afslappende på musklerne i luftvejene.
English: The most common side effects with Anoro Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Danish: De hyppigste bivirkninger ved Anoro Ellipta (som optræder hos op til 1 ud af 10 patienter) er infektioner i de øvre luftveje (næse og svælg), urinvejsinfektioner, halsbetændelse, bihulebetændelse, betændelse i næse og svælg, hovedpine, hoste, smerter i mund og svælg, forstoppelse og mundtørhed.
English: Anoro Ellipta contains the active substances umeclidinium bromide and vilanterol.
Danish: Anoro Ellipta indeholder de aktive stoffer umeclidiniumbromid og vilanterol.
English: An overview of Anoro Ellipta and why it is authorised in the EU
Danish: En oversigt over Anoro Ellipta, og hvorfor det er godkendt i EU
English: Anoro Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Anoro Ellipta er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Each inhalation provides 55 micrograms of umeclidinium (as umeclidinium bromide) and 22 micrograms of vilanterol.
Danish: Hver inhalation indeholder 55 mikrogram umeclidinium (i form af umeclidiniumbromid) og 22 mikrogram vilanterol.
English: The average increase in FEV1 with Anoro Ellipta was 60, 90 and 112 ml more than with tiotropium after 24 weeks of treatment in the three studies where Anoro Ellipta was compared with tiotropium.
Danish: Den gennemsnitlige stigning i FEV1 med Anoro Ellipta var 60, 90 og 112 ml højere end med tiotropium efter 24 ugers behandling i de tre studier, hvor Anoro Ellipta blev sammenlignet med tiotropium.
English: The higher dose combination of umeclidinium and vilanterol did not consistently lead to better improvements in lung function than Anoro Ellipta to justify its use.
Danish: Kombinationen af umeclinidium og vilanterol i den højere dosis medførte ikke tilstrækkeligt større forbedringer af lungefunktionen end Anoro Ellipta til at retfærdiggøre dens anvendelse.
English: Anoro Ellipta also increased FEV1 by an average of up to 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Danish: Anoro Ellipta medførte også en gennemsnitlig stigning i FEV1 på op til 95 ml mere end vilanterol alene og 52 ml mere end umeclidiniumbromid alene.
English: What is Anoro Ellipta and what is it used for?
Danish: Hvad er Anoro Ellipta, og hvad anvendes det til?
English: Anoro Ellipta can only be obtained with a prescription.
Danish: Anoro Ellipta udleveres kun efter recept.
English: Anoro Ellipta and a higher-dose combination of umeclidinium and vilanterol (113 micrograms/22 micrograms) were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium alone or another COPD medicine called tiotropium in 5 main studies.
Danish: Anoro Ellipta og en kombination af umeclinidium og vilanterol i en højere dosis (113 mikrogram/22 mikrogram) blev sammenlignet med placebo (en uvirksom behandling), vilanterol alene, umeclinidium alene og tiotropium (et andet KOL-middel) i fem hovedstudier.
English: Why is Anoro Ellipta authorised in the EU?
Danish: Hvorfor blev Anoro Ellipta godkendt i EU?
English: When inhaled, vilanterol reaches the receptors in the airways and activates them.
Danish: Når Anoro Ellipta inhaleres, når vilanterol frem til receptorerne i luftvejene og aktiverer dem.
English: Other information about Anoro Ellipta
Danish: Andre oplysninger om Anoro Ellipta
English: Results showed that Anoro Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Danish: Resultaterne viste, at behandling med Anoro Ellipta medførte en forbedring af lungefunktionen med en gennemsnitlig stigning i FEV1 på 167 ml mere end placebo efter 24 ugers behandling.
English: The active substances in Anoro Ellipta, umeclidinium and vilanterol, work in different ways to widen the airways and improve breathing in COPD.
Danish: De aktive stoffer i Anoro Ellipta, umeclidiniumbromid og vilanterol, udvider på forskellig vis luftvejene og forbedrer vejrtrækningen ved KOL.
English: It is available as an inhalation powder in a portable inhaler device.
Danish: Anoro Ellipta fås som et inhalationspulver i en bærbar inhalator.
English: Anoro Ellipta was also shown to improve breathlessness when compared with placebo.
Danish: Det blev også påvist, at Anoro Ellipta lindrer åndenød, ved sammenligning med placebo.
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Danish: Kombinationen af muskarinreceptorantagonister og langtidsvirkende beta-2-agonister er almindelig ved behandling af KOL.
English: What are the risks associated with Anoro Ellipta?
Danish: Hvilke risici er der forbundet med Anoro Ellipta?
English: The Agency concluded that Anoro Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Danish: Agenturet fandt, at det er påvist, at Anoro Ellipta er effektivt til at forbedre lungefunktionen og lindre symptomerne på KOL, sammenholdt med placebo, indholdsstofferne hver for sig og tiotropium.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anoro 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 Anoro Ellipta.
English: How is Anoro Ellipta used?
Danish: Hvordan anvendes Anoro Ellipta?
English: What benefits of Anoro Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Anoro Ellipta?
English: How does Anoro Ellipta work?
Danish: Hvordan virker Anoro Ellipta?
English: (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging
Danish: Styrke Lægemiddelform Administration Emballage
English: Pack size bottle (HDPE)
Danish: Oral anvendelse Flaske (HDPE)
English: In Italy: Nubriveo
Danish: I Italien: Nubriveo
English: Briviact received a marketing authorisation valid throughout the EU on 14 January 2016.
Danish: Briviact fik en markedsføringstilladelse med gyldighed i hele EU den 14. januar 2016.
English: Further information on Briviact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Briviact findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore Briviact is expected to work in children in the same way.
Danish: Briviact forventes derfor at virke på samme måde hos børn.
English: This was shown in three main studies involving a total of 1,558 patients aged 16 years and above.
Danish: Dette er påvist i tre hovedstudier med i alt 1.558 patienter på 16 år og derover.
English: This compares with 20% in those adding placebo.
Danish: Dette skal sammenholdes med 20 % af dem, der fik tilføjet placebo.