FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with Trelegy Ellipta also reported improved health compared with those treated with the comparator treatment.
Danish: Patienter, der blev behandlet med Trelegy Ellipta, rapporterede også et forbedret helbred sammenholdt med dem, der blev behandlet med sammenligningspræparatet.
English: Trelegy Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Danish: Trelegy Ellipta (fluticasonfuroat/umeclidiniumbromid/vilanterol)
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells.
Danish: Det virker ligesom naturligt binyrebarkhormon, idet det dæmper immunsystemets aktivitet ved at binde til receptorer (mål) på forskellige typer immunceller.
English: It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.
Danish: Det indeholder de aktive stoffer fluticasonfuroat, umeclidiniumbromid og vilanterol.
English: Regarding the safety profile of the medicine, the most frequent side effects reported with Trelegy Ellipta were similar to those with the individual active substances of the medicine and are well known.
Danish: Hvad angår lægemidlets sikkerhedsprofil, var de hyppigste bivirkninger ved Trelegy Ellipta de samme som ved de enkelte aktive stoffer i lægemidlet, og de er velkendte.
English: The European Medicines Agency therefore decided that Trelegy Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Trelegy Ellipta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Trelegy Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Danish: De hyppigste bivirkninger ved Trelegy Ellipta (som kan forekomme hos op til 1 ud af 10 personer) er betændelse i næse og svælg, hovedpine og infektion i næse og svælg.
English: Side effects reported with Trelegy Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Trelegy Ellipta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Trelegy Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trelegy Ellipta?
English: It works by attaching to beta-2 receptors in some types of muscle cells.
Danish: Det virker ved at binde sig til beta-2-receptorerne i nogle typer muskelceller.
English: This reduces the release of substances involved in the inflammation process, such as histamine, thereby reducing inflammation and helping to keep the airways clear and allowing the patient to breathe more easily.
Danish: Dette mindsker frigivelsen af stoffer, der medvirker i inflammationsprocessen, som f.eks. histamin, hvorved betændelsen reduceres, og luftvejene bedre kan holdes frie, så patienten får lettere ved at trække vejret.
English: Umeclidinium bromide is a muscarinic receptor antagonist.
Danish: Umeclidiniumbromid er en såkaldt muskarin receptor-antagonist.
English: It works by blocking muscarinic receptors, which are involved in the contraction of muscles.
Danish: Det virker ved at blokere de muskarine receptorer, der er involveret i muskulaturens sammentrækning.
English: Trelegy Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
Danish: Trelegy Ellipta indeholder tre aktive stoffer, der på forskellig vis udvider luftvejene og forbedrer vejrtrækningen ved KOL.
English: When inhaled, vilanterol activates the beta-2 receptors in the airways.
Danish: Når vilanterol inhaleres, aktiverer det beta-2-receptorerne i luftvejene.
English: Other information about Trelegy Ellipta
Danish: Andre oplysninger om Trelegy Ellipta
English: After 24 weeks, patients taking Trelegy Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml.
Danish: Efter 24 uger var FEV1 (den maksimale luftmængde, som en person kan udånde på et sekund) hos de patienter, der fik Trelegy Ellipta, forbedret med 142 ml.
English: An overview of Trelegy Ellipta and why it is authorised in the EU
Danish: En oversigt over Trelegy Ellipta, og hvorfor det er godkendt i EU
English: Long-acting beta-2 agonists widen the airways; corticosteroids reduce inflammation in the airways and lungs; and muscarinic receptor antagonists cause the muscles of the airways to relax.
Danish: Langtidsvirkende beta-2-agonister udvider luftvejene, binyrebarkhormon mindsker betændelse i luftvejene og lungerne, og muskarine receptor-antagonister får musklerne i luftvejene til at slappe af.
English: Trelegy Ellipta can only be obtained with a prescription.
Danish: Trelegy Ellipta udleveres kun efter recept.
English: Vilanterol is a long-acting beta-2 agonist.
Danish: Vilanterol er en langtidsvirkende beta-2-antagonist.
English: Trelegy Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Danish: Trelegy Ellipta anvendes hos voksne, hvis sygdom ikke er tilstrækkeligt reguleret med en kombination af inhalerede lægemidler bestående af en langtidsvirkende beta-2-agonist plus enten et binyrebarkhormon eller en langtidsvirkende muskarin antagonist.
English: Trelegy Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Danish: Trelegy Ellipta er et lægemiddel, der anvendes til at lindre symptomerne på moderat til svær kronisk obstruktiv lungesygdom (KOL).
English: A study compared Trelegy Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
Danish: Trelegy Ellipta blev i et studie sammenlignet med enten vilanterol givet med fluticasonfuroat eller vilanterol givet med umeclidiniumbromid, hos 10.355 patienter med fremskreden KOL, hvis sygdom var i fare for at forværres og ikke var tilstrækkeligt reguleret med daglig vedligeholdelsesbehandling.
English: Trelegy Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Danish: Trelegy Ellipta forbedrer lungefunktionen samt livskvaliteten hos patienter med moderat til svær KOL.
English: When umeclidinium bromide is inhaled, it causes the muscles of the airways to relax.
Danish: Når umeclidiniumbromid inhaleres, virker det afslappende på musklerne i luftvejene.
English: Why is Trelegy Ellipta authorised in the EU?
Danish: Hvorfor blev Trelegy Ellipta godkendt i EU?
English: What is Trelegy Ellipta and what is it used for?
Danish: Hvad er Trelegy Ellipta, og hvad anvendes det til?
English: Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Trelegy Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Danish: Af et andet hovedstudie med 1.810 patienter, hvis KOL ikke var tilstrækkeligt reguleret med en daglig vedligeholdelsesbehandling, fremgik det, at Trelegy Ellipta var mere effektivt til at forbedre patienternes vejrtrækning end en inhaleret kombination af budesonid, et binyrebarkhormon, og formoterol, en langtidsvirkende beta-2-agonist.
English: For the full list of side effects and restrictions with Trelegy Ellipta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Trelegy Ellipta fremgår af indlægssedlen.
English: Trelegy Ellipta was shown to improve patients' breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.
Danish: Trelegy Ellipta blev i to hovedstudier påvist at forbedre patienternes vejrtrækning og reducere forværringer (opblussen) af sygdommen.
English: What are the risks associated with Trelegy Ellipta?
Danish: Hvilke risici er der forbundet med Trelegy Ellipta?
English: Fluticasone furoate is a corticosteroid.
Danish: Fluticasonfuroat er et binyrebarkhormon.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trelegy Ellipta 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 Trelegy Ellipta.
English: How is Trelegy Ellipta used?
Danish: Hvordan anvendes Trelegy Ellipta?
English: What benefits of Trelegy Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Trelegy Ellipta?
English: How does Trelegy Ellipta work?
Danish: Hvordan virker Trelegy Ellipta?
English: These reactions are potentially serious and occasionally life threatening.
Danish: Disse reaktioner er potentielt alvorlige og undertiden livstruende.
English: Speak to your doctor if this is the case.
Danish: Tal med lægen, hvis det er tilfældet.
English: <[Invented name] contains lactose.
Danish: <[Særnavn] indeholder lactose.
English: Your doctor will review and decide if you must stop the medication.
Danish: Lægen vil foretage en vurdering og beslutte, om du skal stoppe med medicinen.
English: The initial dose is one tablet (1-1.65 mg) per day at mealtime.
Danish: Initialdosis er én tablet (1-1,65 mg) om dagen i forbindelse med et måltid.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante afsnit i produktresuméet og indlægssedlen
English: The duration of continuous administration must not exceed six months because of the risk of fibrosis (see section 4.8).
Danish: Varigheden af kontinuerlig administration må ikke overstige seks måneder på grund af risikoen for fibrose (se afsnit 4.8).
English: The need to continue treatment should be re-assessed, and the optimal timing for reintroduction discussed with the patient.
Danish: Behovet for fortsat behandling skal revurderes, og det optimale tidspunkt for genstart skal diskuteres med patienten.
English: Then increase the dose gradually according to your doctor's instructions.
Danish: Dosis kan derefter øges gradvist i henhold til lægens anvisninger.
English: The medication must be stopped as soon as one of these symptoms or signs has been established.
Danish: Medicinen skal seponeres, så snart et af disse symptomer eller tegn er konstateret.
English: Discontinuation of the treatment should be done gradually (in 2 or 3 weeks).
Danish: Behandlingen skal afbrydes gradvist (over 2 eller 3 uger).
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Danish: Hvis du oplever bivirkninger, bør du tale med <lægen>, <apoteket> <eller sygeplejersken>.
English: In between two treatments there should be an interval of 3-4 weeks in order to check whether you still need to take [Invented name].
Danish: Mellem to behandlinger skal der være et interval på 3-4 uger for at kontrollere, om du stadig har brug for at tage [Særnavn].
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the newly agreed wording as provided below.
Danish: Den eksisterende produktinformation skal ændres (der skal indsættes, erstattes eller slettes tekst, hvor det er relevant), så den reflekterer den nye, godkendte formulering som angivet nedenfor.
English: The treatment should be stopped in patients who have not responded adequately in the first 2-3 months.
Danish: Behandlingen skal afbrydes hos patienter, som ikke har responderet tilfredsstillende inden for de første 2-3 måneder.
English: [Invented name] should not be used to stop a headache once it has started.
Danish: [Særnavn] kan ikke bruges til at standse en hovedpine, når den først er startet.
English: An abrupt cessation of treatment is necessary in the event of a fibrotic reaction.
Danish: Brat afbrydelse af behandlingen er nødvendig i tilfælde af en fibrotisk reaktion.
English: Nausea and vomiting, particularly if [Invented name] is taken outside meals.
Danish: Kvalme og opkastning, særligt hvis [Særnavn] tages uden for måltiderne.
English: [Invented name] should not be used in the paediatric population.
Danish: [Særnavn] bør ikke anvendes til den pædiatriske population.
English: [Invented name] should not be used in children.
Danish: [Særnavn] må ikke anvendes til børn.
English: Patients should be informed on the risk of fibrosis with methysergide therapy and should accept the need for periodic investigations as described below.
Danish: Patienterne skal informeres om risikoen for fibrose ved behandling med methysergid, og de skal acceptere nødvendigheden af periodiske undersøgelser som nedenfor beskrevet.
English: • Prophylactic treatment of episodic and chronic cluster headache in adults.
Danish: • Profylaktisk behandling af episodisk og kronisk klyngehovedpine hos voksne.
English: Serious intolerance or contra-indication to a first line drug is regarded as treatment failure.
Danish: Alvorlig intolerans over for eller kontraindikation mod et førstevalgspræparat betragtes som behandlingssvigt.
English: What you need to know before you take [Invented name]
Danish: Det skal du vide, før du begynder at tage [Særnavn]
English: Section 4.4 Special warnings and precautions for use [This section should be amended to reflect the following wording] Because of the potential serious safety concerns (in particular fibrotic reactions), methysergide should only be used after other treatment have failed.
Danish: Afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Dette afsnit skal ændres, så det afspejler følgende formulering] På grund af de potentielt alvorlige sikkerhedsproblemer (især fibrotiske reaktioner) bør methysergid kun anvendes efter svigt af anden behandling.
English: The minimal duration of treatment before concluding failure is 2 months.
Danish: Den minimale behandlingsvarighed, inden der kan konkluderes behandlingssvigt, er 2 måneder.
English: [Invented name] belong to a group of medicines called antimigraine drugs.
Danish: [Særnavn] tilhører gruppen af lægemidler mod migræne.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Danish: Dette produktresumé og denne indlægsseddel er resultatet af referral-proceduren.
English: To start, take one tablet daily.
Danish: Tag én tablet om dagen i starten.
English: [This section should be amended to reflect the following wording] Like all medicines, [Invented name] can cause side effects, although not everybody gets them.
Danish: [Dette afsnit skal ændres, så det reflekterer følgende formulering] [Særnavn] kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Treatment must not begin until after the patient has been examined for any pre-existing fibrotic conditions.
Danish: Behandling må ikke påbegyndes, før patienten er undersøgt for eksisterende fibrotiske tilstande.
English: However, it should only be used after at least two other types of medication for treating this type of headache have been tried for at least 2 months and failed to adequately treat the cluster headaches.
Danish: Det må imidlertid kun bruges, hvis mindst to andre typer medicin til behandling af denne type hovedpine har været prøvet i mindst 2 måneder uden at have været i stand til at behandle klyngehovedpinerne tilfredsstillende.
English: [Invented name] is taken by people who get severe migraines, with or without an aura, that affect their ability to go about their normal lives.
Danish: [Særnavn] tages af mennesker, der får alvorlige migræneanfald med eller uden aura, som påvirker deres evne til at leve normalt.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem, der er anført i Appendiks V.
English: Edema and vasoconstriction of the large and small arteries can occur.
Danish: Der kan forekomme ødem og vasokonstriktion af de store og små arterier.
English: Although symptoms may sometimes improve after cessation of therapy in some cases, fibrotic reactions may also persist.
Danish: Skønt symptomerne undertiden bedres efter behandlingsophør, kan de fibrotiske reaktioner også persistere.
English: Patients should have failed at least 2 classes of drugs before starting methysergide (see section 4.4).
Danish: Patienterne skal have prøvet mindst 2 lægemiddelklasser uden succes, inden de starter på methysergid (se afsnit 4.4).
English: You notice numbness or tingling in your fingers and toes.
Danish: Du oplever følelsesløshed eller prikken i fingre eller tæer.
English: For chronic cluster headache, the therapeutic dose would normally be 6 mg but a higher dose may sometimes be required.
Danish: Ved kronisk klyngehovedpine vil den terapeutiske dosis normalt være 6 mg, men en højere dosis kan undertiden være nødvendig.
English: Your doctor will perform some tests before the start of treatment and then every 6 months to ensure that you do not have or develop fibrosis (scarring within body organs).
Danish: Lægen vil foretage nogle test, inden behandlingen startes og derefter hver 6. måned for at kontrollere, at du ikke har eller er ved at udvikle fibrose (ardannelse i kroppens organer).
English: [Invented name] is not effective for treating a migraine attack that is already present.
Danish: [Særnavn] er ikke effektivt til behandling af et igangværende migræneanfald.
English: Nausea and vomiting may occur, but these undesirable effects are often less severe if [Invented name] is taken at mealtime.
Danish: Der kan forekomme kvalme og opkastning, men disse bivirkninger er ofte mindre alvorlige, hvis [Særnavn] tages i forbindelse med et måltid.
English: Take the tablets during a meal with some drink.
Danish: Tag tabletterne sammen med væske i forbindelse med et måltid.
English: (see section 4.4 regarding the need for specialist monitoring requirements)
Danish: 4.4 for nødvendig overvågning hos speciallæge)
English: Fibrotic reactions have been reported, especially of the pleura and retro-peritoneum, and also of the pericardium and cardiac valves.
Danish: Der er rapporteret om fibrotiske reaktioner, navnlig i pleura og retroperitoneum samt i pericardium og hjerteklapperne.
English: Cardiac and vascular disorders
Danish: Hjerte og vaskulære sygdomme
English: [Invented name] is also taken by people who have episodes or regular ‘cluster' headaches.
Danish: [Særnavn] tages også af mennesker, der periodevist eller jævnligt har "klyngehovedpiner".
English: An initial screen must be performed prior to commencing methysergide therapy to exclude patients with pre-existent fibrosis or any other pathology that might put them at increased risk of developing fibrosis.
Danish: Inden behandling med methysergid påbegyndes, skal der udføres en indledende screening for at udelukke patienter med allerede eksisterende fibrose eller enhver anden patologi, som kan indebære højere risiko for at udvikle fibrose.
English: The dosage may be gradually increased in divided daily dose until the optimal dose is reached.
Danish: Dosis kan gradvist øges, til den optimale daglige dosis er nået; døgndosis fordeles på flere doser,.
English: It is taken regularly as a preventative measure to reduce how often they get the migraines.
Danish: Det tages jævnligt som en forebyggende foranstaltning for at nedsætte hyppigheden af migræneanfald.
English: Heart valve fibrosis may cause increased heart rate, swelling in the hands and feet and can be identified by clinical examination.
Danish: Fibrose i hjerteklapperne kan forårsage hurtigere hjerterytme samt hævede hænder og fødder og kan identificeres ved klinisk undersøgelse.
English: It is taken regularly as a preventative measure to reduce how often they get these headaches.
Danish: Det tages regelmæssigt som en forebyggende foranstaltning for at nedsætte hyppigheden af disse hovedpiner.
English: If symptoms suggestive of a fibrosis occur, treatment with methysergide should be discontinued unless an alternative aetiology is confirmed.
Danish: Hvis der opstår symptomer, som tyder på en fibrose, skal behandlingen med methysergid seponeres, medmindre en anden ætiologi bekræftes.
English: It is recommended to taper the dosage gradually over the last two to three weeks of a course of treatment, so as to prevent a rebound effect on headaches.
Danish: Det anbefales at reducere dosis gradvist over de sidste 2-3 uger af en behandlingsperiode for at forebygge et rebound-fænomen på hovedpinerne.
English: You must not take methysergide continuously (without a break) for longer than six months.
Danish: Du må ikke tage methysergid uden pause i mere end seks måneder.
English: Valvular fibrosis may cause changes in cardiac function.
Danish: Hjerteklapfibrose kan forårsage ændringer i hjertefunktionen.
English: The maximum dose should not exceed 6 mg per day.
Danish: Den maksimale daglige dosis bør ikke overstige 6 mg.
English: Methysergide treatment should be initiated and supervised by specialised physicians with experience in the treatment of migraine and cluster headache.
Danish: Behandling med methysergid skal indledes og superviseres af speciallæger med erfaring i behandling af migræne og klyngehovedpine (se pkt.
English: A treatment-free interval of at least 4 weeks must be allowed between courses.
Danish: Et behandlingsfrit interval på mindst 4 uger mellem behandlingsperioderne skal overholdes.
English: • Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Danish: • Profylaktisk behandling hos voksne med alvorlig, intraktabel migræne (med eller uden aura), der indebærer funktionelt handicap.
English: Always take [Invented name] exactly as your doctor has told you to.
Danish: Tag altid [Særnavn] nøjagtigt efter lægens anvisning.
English: - For prophylactic treatment of episodic and chronic cluster headache at least two other classes of treatment should be considered first (e.g. verapamil, topiramate or lithium).
Danish: - Til profylaktisk behandling af episodisk og kronisk klyngehovedpine skal mindst to andre lægemiddelklasser overvejes først (fx verapamil, topiramat eller lithium).
English: There have been isolated reports of myocardial infarct, especially in patients who do not pay attention to the contraindications regarding coronary disorders or the use of vasoconstrictive medications.
Danish: Der har været enkelte rapporter om myokardieinfarkt, navnlig hos patienter, som ikke er opmærksomme på kontraindikationerne vedrørende koronare lidelser eller brugen af vasokonstriktiv medicin.
English: Once treatment is commenced the patient must be examined for occurrence of fibrosis at 6-monthly intervals, this examination should include a reassessment of the benefit: risk balance in the individual patient.
Danish: Efter behandlingsstart skal patienten undersøges for forekomst af fibrose hver 6. måned; undersøgelsen skal omfatte en ny individuel vurdering af risk/benefit-forholdet.
English: The following investigations should be performed prior to initiation of treatment with methysergide and at 6-monthly intervals thereafter: cardiac ultrasound, pulmonary function tests, abdominal MRI.
Danish: Følgende undersøgelser skal udføres inden start af behandling med methysergid og efterfølgende hver 6. måned: Ekkokardiografi, lungefunktionstests, MR-scanning af abdomen.