FrancophonIA/ELRC3.0 huggingface dataset:
English: How are hop strobile medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder humlekopper, i EU?
English: In its assessment, the HMPC considered laboratory studies which supported the use of hop strobile for aiding sleep.
Danish: HMPC har i sin vurdering taget hensyn til laboratorieundersøgelser, der understøtter brugen af humlekopper til at gøre det lettere at falde i søvn.
English: Herbal medicines containing these hop strobile preparations are usually available as herbal tea to be drunk or in liquid or solid forms to be taken by mouth.
Danish: Plantelægemidler med humlekopper fås normalt som urtete beregnet til at drikke samt i flydende eller fast form til anvendelse gennem munden.
English: What are the risks associated with hop strobile medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder humlekopper?
English: What evidence supports the use of hop strobile medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af humlekopper?
English: The solvent is then partially or completely evaporated to obtain a dry extract.
Danish: Opløsningsmidlet fordampes herefter for at opnå det tørre ekstrakt.
English: The HMPC conclusions on the use of these hop strobile medicines for relief of mental stress and to aid sleep are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med humlekopper til at lindre lettere symptomer på mental strass samt gøre det lettere at falde i søvn er baseret på lægemidlernes "traditionelle anvendelse" til disse tilstande.
English: For more information about treatment with hop strobile medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder humlekopper, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded that, on the basis of its long-standing use, these hop strobile preparations can be used for relief of mild symptoms of mental stress and to aid sleep.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at humlekopper i disse tilberedninger kan anvendes til at lindrelettere symptomerpå mental stress og gøre det lettere at falde i søvn.
English: For practical information about using hop strobile medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med humlekopper, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC conclusions only cover hop strobile preparations which are obtained by comminuting (reducing into tiny pieces) or by drying and powdering the flowers or as dry or liquid extracts.
Danish: Humlekopper er det almindelige navn for blomsterne af planten Humulus lupulus L. HMPC's konklusioner omfatter kun tilberedninger af humlekopper, som fremstilles ved findeling eller ved tørring og pulverisering af blomsterne, eller som tørre eller flydende ekstrakter.
English: This overview was last updated in 09-2018.
Danish: Denne oversigt blev sidst ajourført i 09-2018.
English: The recommended dose is one inhalation per day at the same time each day.
Danish: Den anbefalede dosis er én inhalation dagligt på samme tidspunkt hver dag.
English: Rolufta Ellipta received a marketing authorisation valid throughout the EU on 20 March 2017.
Danish: Rolufta Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 20. marts 2017.
English: Further information on Rolufta Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Rolufta Ellipta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This helps to keep the airways open and allows the patient to breathe more easily.
Danish: Dette hjælper med at holde luftvejene åbne og gør det lettere for patienten at trække vejret.
English: This authorisation was based on the authorisation granted to Incruse Ellipta in 2014 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Incruse Ellipta i 2014 ("informeret samtykke").
English: Rolufta Ellipta was investigated in four main studies involving over 4,000 patients.
Danish: Rolufta Ellipta blev undersøgt i fire hovedstudier med over 4 000 patienter.
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: The studies also showed an improvement in symptoms such as breathlessness and wheezing.
Danish: Studierne viste desuden en bedring i symptomer som f.eks. åndenød og hvæsende vejrtrækning.
English: changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: Det primære mål for virkning var ændringer i patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, som en person kan udånde på et sekund).
English: It works by blocking the action of so-called muscarinic receptors, which control the contraction of muscles.
Danish: Det virker ved at blokere virkningen af de såkaldte muskarinreceptorer, der styrer musklernes sammentrækning.
English: Rolufta Ellipta1 (umeclidinium bromide)
Danish: Rolufta Ellipta1 (umeclidiniumbromid)
English: Each inhalation provides 65 micrograms of umeclidinium bromide equivalent to 55 micrograms of umeclidinium.
Danish: Hver inhalation indeholder 65 mikrogram umeclidiniumbromid, svarende til 55 mikrogram umeclidinium.
English: Rolufta Ellipta0F (umeclidinium bromide) EMA/595684/2018
Danish: Rolufta Ellipta0F (umeclidiniumbromid) EMA/595684/2018
English: Rolufta Ellipta is used for maintenance (regular) treatment.
Danish: Rolufta Ellipta bruges til (regelmæssig) vedligeholdelsesbehandling.
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.
Danish: KOL er en langvarig sygdom, hvor luftvejene og lungeblærerne bliver beskadiget eller blokeret, så det er vanskeligt at trække vejret.
English: A double dose of Rolufta Ellipta only showed small improvements compared with a single dose, which were not considered relevant.
Danish: En dobbelt dosis Rolufta Ellipta gav i forhold til en enkelt dosis kun små forbedringer, der ikke blev anset for at være klinisk relevante.
English: Side effects reported with Rolufta Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Rolufta Ellipta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: As for all medicines, data on the use of Rolufta Ellipta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Rolufta Ellipta løbende overvåget.
English: Previously known as Rolufta.
Danish: Tidligere kendt som Rolufta.
English: Results showed that Rolufta Ellipta improved lung function by an average FEV1 by 127 ml more than placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment.
Danish: Resultaterne viste, at behandling med Rolufta Ellipta forbedrede lungefunktionen med en gennemsnitlig stigning i FEV1 på 127 ml mere end placebo efter 12 ugers behandling og 115 ml mere end placebo efter 24 ugers behandling.
English: As medicines of the same class as Rolufta Ellipta may have an effect on the heart and blood vessels, the company that markets Rolufta Ellipta 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 Rolufta Ellipta kan påvirke hjertet og blodkarrene, skal den virksomhed, der markedsfører lægemidlet, gennemføre et langtidsstudie med patienter for at indsamle yderligere oplysninger om lægemidlets sikkerhed sammenholdt med tiotropium.
English: The most common side effects with Rolufta Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate).
Danish: De hyppigste bivirkninger ved Rolufta Ellipta (der kan forekomme hos op til 1 ud af 10 patienter) er hovedpine, betændelse i næse og svælg, infektioner i de øvre luftveje (næse og svælg), bihulebetændelse, hoste, urinvejsinfektion og øget hjertefrekvens.
English: In the study comparing Rolufta Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.
Danish: I det studie, hvor Rolufta Ellipta blev sammenlignet med tiotropium, var forbedringen af FEV1 i løbet af 24 uger den samme for begge lægemidler.
English: The European Medicines Agency decided that Rolufta 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 Rolufta Ellipta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: When umeclidinium bromide is inhaled, it relaxes the muscles of the airways.
Danish: Når umeclidiniumbromid inhaleres, får det musklerne i luftvejene til at slappe af.
English: What measures are being taken to ensure the safe and effective use of Rolufta Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rolufta Ellipta?
English: The Agency also noted that there were no major safety concerns with Rolufta Ellipta, with side effects being manageable and similar to other medicines of the same class (antimuscarinic bronchodilators).
Danish: Agenturet bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Rolufta Ellipta, idet bivirkningerne kan behandles og svarer til bivirkningerne ved andre lægemidler af samme klasse (antimuskarine bronkodilatorer).
English: The active substance in Rolufta Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist.
Danish: Det aktive stof i Rolufta Ellipta, umeclidiniumbromid, er en muskarinreceptor-antagonist.
English: An overview of Rolufta Ellipta and why it is authorised in the EU
Danish: En oversigt over Rolufta Ellipta, og hvorfor det er godkendt i EU
English: Other information about Rolufta Ellipta
Danish: Andre oplysninger om Rolufta Ellipta
English: Rolufta Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Rolufta Ellipta er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Rolufta Ellipta contains the active substance umeclidinium bromide.
Danish: Rolufta Ellipta indeholder det aktive stof umeclidiniumbromid.
English: What is Rolufta Ellipta and what is it used for?
Danish: Hvad er Rolufta Ellipta, og hvad anvendes det til?
English: Why is Rolufta Ellipta authorised in the EU?
Danish: Hvorfor blev Rolufta Ellipta godkendt i EU?
English: For the full list of side effects and restrictions with Rolufta Ellipta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Rolufta Ellipta fremgår af indlægssedlen.
English: Rolufta Ellipta is available as an inhalation powder in a portable inhaler device.
Danish: Rolufta Ellipta fås som et inhalationspulver i en bærbar inhalator.
English: What are the risks associated with Rolufta Ellipta?
Danish: Hvilke risici er der forbundet med Rolufta Ellipta?
English: The Agency concluded that Rolufta Ellipta was shown to be effective at improving the lung function and symptoms of COPD.
Danish: CHMP fandt, at det er påvist, at Rolufta Ellipta er effektivt til at forbedre lungefunktionen og lindre symptomerne ved KOL.
English: Three studies compared Rolufta Ellipta with placebo (a dummy treatment), while one study compared Rolufta Ellipta with tiotropium (another medicine for COPD).
Danish: Rolufta Ellipta blev i tre studier sammenlignet med placebo (ikke-aktivt stof) og i ét studie med tiotropium (et andet lægemiddel mod KOL).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rolufta 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 Rolufta Ellipta.
English: How is Rolufta Ellipta used?
Danish: Hvordan anvendes Rolufta Ellipta?
English: What benefits of Rolufta Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rolufta Ellipta?
English: How does Rolufta Ellipta work?
Danish: Hvordan virker Rolufta Ellipta?
English: Translarna has been given ‘conditional authorisation'.
Danish: Translarna har fået en "betinget godkendelse".
English: Translarna received a conditional marketing authorisation valid throughout the EU on 31 July 2014.
Danish: Translarna fik en betinget markedsføringstilladelse med gyldighed i hele EU den 31. juli 2014.
English: Other information about Translarna
Danish: Andre oplysninger om Translarna
English: As for all medicines, data on the use of Translarna are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Translarna løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Translarna?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Translarna?
English: An overview of Translarna and why it is authorised in the EU
Danish: En oversigt over Translarna og hvorfor det er godkendt i EU
English: The main measure of effectiveness was the change in the distance the patient could walk in six minutes after 48 weeks of treatment.
Danish: Det primære effektmål var ændringerne i den distance, patienterne kunne gå på seks minutter efter 48 ugers behandling.
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som virksomheden er blevet pålagt at fremskaffe.
English: The European Medicines Agency decided that Translarna's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Translarna opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For more information about using Translarna, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om anvendelse af Translarna, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: However, data indicated that Translarna had a positive effect on different measures such as time to run or walk 10 metres, time to climb up and down 4 steps and time to loss of walking ability.
Danish: Af dataene fremgik det dog, at Translarna havde en positiv virkning på forskellige effektmål såsom den tid, det tager, at gå eller løbe 10 meter, den tid, det tager at gå op og ned ad fire trin, og tiden frem til tab af gangevne.
English: The beneficial effect of the lower dose was also supported by improvements in other measures of effectiveness, including those directly linked to patients' daily activities.
Danish: Den gavnlige virkning af den lave dosis understøttedes desuden af bedring i andre effektmål, herunder dem, der har direkte betydning for patientens daglige aktiviteter.
English: Translarna seemed effective on an assessment of physical activity in 12 patients when compared with past records of 11 patients of similar age who had not been treated with Translarna.
Danish: Translarna syntes at være effektivt ved en vurdering af den fysiske aktivitet hos 12 patienter i forhold til tidligere journaler for 11 patienter af samme alder, som ikke var blevet behandlet med Translarna.
English: Why is Translarna authorised in the EU?
Danish: Hvorfor er Translarna godkendt i EU?
English: Since Translarna has been given conditional authorisation, the company that markets it will provide results of a new study comparing Translarna with placebo in order to confirm its effectiveness and safety.
Danish: Da Translarna har fået en betinget godkendelse, skal den virksomhed, der markedsfører det, fremlægge resultater af en ny undersøgelse, der sammenligner Translarna med placebo for at bekræfte dets virkning og sikkerhed.
English: A further study in 230 patients aged 7 to 14 years with worsening walking ability was completed after initial approval, but its results were considered inconclusive.
Danish: Endnu en undersøgelse hos 230 patienter i alderen 7 til 14 år, hvis gangevne blev stadig ringere, blev gennemført efter den indledende frigivelse, men resultaterne heraf blev anset for utilstrækkelige.
English: Further information on Translarna can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Translarna findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Side effects reported with Translarna are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Translarna vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: In both studies, the beneficial effects of Translarna seemed more evident in patients with moderate decline of their disease.
Danish: I begge undersøgelser forekom de gavnlige virkninger af Translarna mere åbenbare hos patienter med moderat sygdomsforværring.
English: What is Translarna and what is it used for?
Danish: Hvad er Translarna, og hvad anvendes det til?
English: The most common side effects with Translarna (which may affect more than 5 in 100 people) are vomiting, diarrhoea, nausea (feeling sick), headache, stomach ache and flatulence.
Danish: De hyppigste bivirkninger ved Translarna (som kan forekomme hos flere end 5 ud af 100 patienter) er opkastning, diarré, kvalme, hovedpine, mavesmerter og oppustethed.
English: What information is still awaited for Translarna?
Danish: Hvilke oplysninger afventes der stadig for Translarna?
English: No improvement was seen with the higher dose (80 mg/kg daily).
Danish: Der var ingen forbedring med den højere dosis (80 mg/kg dagligt).
English: Duchenne muscular dystrophy is rare, and Translarna was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Danish: Duchennes muskeldystrofi er sjælden, og Translarna blev udpeget som "lægemiddel til sjældne sygdomme" den 27. maj 2005.
English: Translarna is taken three times a day, and the recommended dose is 10 mg/kg (10 mg per kilogram body weight) in the morning, 10 mg/kg at midday and 20 mg/kg in the evening (making a total daily dose of 40 mg/kg).
Danish: Translarna tages tre gange dagligt, og den anbefalede dosis er 10 mg/kg (10 mg pr. kg legemsvægt) om morgenen, 10 mg/kg ved middagstid og 20 mg/kg om aftenen (svarende til en total daglig dosis på 40 mg/kg).
English: The Agency acknowledged that patients with Duchenne muscular dystrophy have an unmet need for treatment of this serious condition.
Danish: Agenturet anerkendte, at patienter med Duchennes muskeldystrofi har et uopfyldt behov for behandling af denne alvorlige sygdom.
English: Translarna is available as granules (125, 250 and 1,000 mg) to be taken by mouth after mixing them with liquid or semi-solid food (such as yogurt).
Danish: Translarna leveres som granulat (125, 250 og 1 000 mg), der indtages gennem munden efter at være blevet rørt op i et halvflydende fødemiddel (f.eks. yoghurt).
English: Despite the need for further data, the Agency considered that the evidence suggests that Translarna slows the progression of the disease and that its safety profile is not of major concern.
Danish: Trods behovet for yderligere oplysninger var CHMP af den opfattelse, at dokumentationen viser, at Translarna hæmmer sygdommens udvikling, og at dets sikkerhedsprofil ikke giver anledning til større betænkelighed.
English: What are the risks associated with Translarna?
Danish: Hvilke risici er der forbundet med Translarna?
English: Translarna must not be used at the same time as aminoglycoside antibiotics given by injection or infusion (drip) into a vein.
Danish: Translarna må ikke anvendes samtidig med antibiotika af aminoglykosidtypen indgivet ved injektion eller drop (infusion) i en vene.
English: Before starting treatment with Translarna, patients will have a genetic test to confirm that their disease is due to a nonsense mutation and that they are therefore suitable for treatment with Translarna.
Danish: Før påbegyndelse af behandlingen med Translarna vil patienten få foretaget en genetisk test for at sikre, at sygdommen skyldes en nonsensmutation, og at patienten derfor er egnet til behandling med Translarna.
English: Translarna is used in the small group of patients whose disease is caused by a specific genetic defect (called a ‘nonsense mutation') in the dystrophin gene.
Danish: Translarna anvendes hos en lille gruppe patienter, hvis sygdom skyldes en særlig genetisk defekt (en såkaldt "nonsensmutation") i genet for dystrofin.
English: A small study in children aged 2 to 5 years with Duchenne muscular dystrophy found that the usual dose of Translarna 40 mg/kg daily was sufficient.
Danish: En lille undersøgelse hos børn i alderen 2 til 5 år med Duchennes muskeldystrofi viste, at den sædvanlige dosis Translarna, 40 mg/kg dagligt, var tilstrækkelig.
English: For the full list of side effects and restrictions of Translarna, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Translarna fremgår af indlægssedlen.
English: Translarna can only be obtained with a prescription and treatment should be started by a specialist doctor experienced in the management of Duchenne/Becker muscular dystrophy.
Danish: Translarna udleveres kun på recept, og behandlingen bør iværksættes af en speciallæge med erfaring i behandling af Duchenne/Beckers muskeldystrofi.
English: Duchenne muscular dystrophy can be caused by a number of genetic abnormalities.
Danish: Duchennes muskeldystrofi kan skyldes forskellige genetiske anomalier.
English: Translarna is a medicine that is used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk.
Danish: Translarna er et lægemiddel til behandling af patienter over 2 år, der har Duchennes muskeldystrofi og kan gå.
English: Although an initial analysis of the results of all the data from the study did not show a significant difference in the distances patients in the Translarna and placebo groups could walk, further analyses indicated that walking ability worsened to a lesser extent with 40 mg/kg daily Translarna than with placebo: after 48 weeks of treatment patients receiving 40 mg/kg daily Translarna could walk on average 32 metres more than those given placebo.
Danish: Selvom en første gennemgang af alle studiedataenes resultater ikke viste nogen særlig forskel i den distance, patienterne i gruppen på henholdsvis Translarna og placebo kunne gå, påvistes det ved nærmere analyse, at gangevnen forringedes i mindre grad med 40 mg/kg Translarna dagligt end med placebo: Efter 48 ugers behandling kunne de patienter, der fik 40 mg/kg Translarna dagligt, i gennemsnit gå 32 meter længere end dem, der fik placebo.
English: How is Translarna used?
Danish: Hvordan anvendes Translarna?
English: Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function.
Danish: Duchennes muskeldystrofi er en arvelig sygdom med gradvis svækkelse og tab af muskelfunktionen.