FrancophonIA/ELRC3.0 huggingface dataset:
English: Large doses of laxatives (such as macrogol) Increased blood sugar levels MAO inhibitors (such as iproniazide) used to treat depression
Danish: MAO-hæmmere (såsom iproniazid), der anvendes til behandling af depression
English: • Amglidia is available in four different boxes corresponding to four different presentations (four different strengths): One box for the 0.6 mg/mL strength with one 1mL syringe: yellow colour for outer carton and reverse type yellow colour for label One box for the 0.6 mg/mL strength with one 5 mL syringe: yellow colour for outer carton and reverse type yellow colour for label One box for the 6 mg/mL strength with one syringe of 1 mL: purple colour for outer carton and reverse type purple colour for label One box for the 6 mg/mL strength with one syringe of 5 mL: purple colour for outer carton and reverse type purple colour for label
Danish: Én æske til styrken 0,6 mg/ml med én 5 ml-sprøjte: gul farve til yderkartonen, og gul baggrundsfarve til etiketten
English: Fibrates
Danish: Fibrater
English: Potentiation of the blood-glucose lowering
Danish: Potentiering af den blodglukosesænkende virkning
English: Dose adjustment is required in patients with mild to moderate hepatic impairment (refer to section 4.2).
Danish: Dosisjustering er nødvendig for patienter med let til moderat nedsat nyrefunktion (se pkt.
English: Blood sugar levels too low Increased blood sugar levels Incorrect control of plasma sugar
Danish: Ukorrekt kontrol af sukkerindholdet i plasma Ukorrekt kontrol af sukkerindholdet i plasma Forhøjet blodsukker
English: Posology
Danish: Indgivelse
English: Hepatic impairment:
Danish: Nedsat leverfunktion:
English: Probenecid used to treat gout, gouty arthritis Blood sugar levels too low Progestogens (such as desogestrel, dydrogesterone) used for hormonal treatment
Danish: Gestagener (såsom desogestrel, dydrogesteron), der anvendes til hormonbehandling
English: • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsberetninger (PSUR'er)
English: 1) Read this before you start
Danish: 1) Læs dette, inden du starter
English: ONCE DAILY
Danish: ÉN GANG DAGLIGT
English: contact your doctor as soon as possible.
Danish: kontakt lægen så hurtigt som muligt.
English: The pre-specified non-inferiority margin was 50 mL.
Danish: Den forud specificerede non-inferiore margin var 50 ml.
English: Children and adolescents Don't give this medicine to children or adolescents below the age of 18 years.
Danish: Børn og unge Dette lægemiddel må ikke gives til børn og unge under 18 år.
English: You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Danish: Du skal kun inhalere én gang dagligt, da virkningen af dette lægemiddel varer i 24 timer.
English: Hold this breath in for as long as possible (at least 3-4 seconds).
Danish: Hold vejret så længe som muligt (mindst 3-4
English: Not for acute use
Danish: Ikke til akut brug
English: Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data):
Danish: Andre bivirkninger er forekommet, men den præcise hyppighed kendes ikke (kan ikke estimeres ud fra forhåndenværende data):
English: Where adverse reaction frequencies differed between studies, the higher frequency is reported below.
Danish: Hvor hyppigheden af bivirkningerne var forskellige mellem studier, rapporteres den højere hyppighed nedenfor.
English: The dose counter counts down by 1 to confirm.
Danish: Dosistælleren tæller ned med 1 for at bekræfte.
English: The recommended dose is one inhalation every day at the same time of day.
Danish: Den anbefalede dosis er én inhalation hver dag på samme tidspunkt på dagen.
English: A risk to newborns/infants cannot be excluded.
Danish: En risiko for ammede nyfødte/spædbørn kan ikke udelukkes.
English: • painful and frequent urination (may be signs of a urinary tract infection)
Danish: • smertefuld og hyppig vandladning (kan være tegn på en urinvejsinfektion)
English: Systemic exposure to the metabolites is low.
Danish: Den systemiske eksponering for metabolitterne er lav.
English: It counts down by 1 each time you open the cover.
Danish: Tæller ned med 1, hver gang du åbner beskyttelseshætten.
English: • weakening of the bones, leading to fractures.
Danish: • svækkelse af knoglerne, hvilket kan føre til knoglebrud.
English: At this dose, no effects on systemic exposure were observed.
Danish: Ved denne dosis blev der ikke observeret nogen virkning på den systemiske eksponering.
English: It is unlikely that this medicine will affect your ability to drive or use machines.
Danish: Det er usandsynligt, at dette lægemiddel vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.
Danish: Når det bruges regelmæssigt, hjælper det med at holde dine vejrtrækningsproblemer under kontrol og reducere KOL's indvirkning på din dagligdag.
English: What is the inhaler?
Danish: Hvad er inhalatoren?
English: COPD is a longterm condition characterised by breathing difficulties that slowly get worse.
Danish: KOL er en langvarig tilstand, der er karakteriseret ved vejrtrækningsbesvær, som langsomt forværres.
English: This shows how many doses of medicine are left in the inhaler.
Danish: Viser, hvor mange medicindoser, der er tilbage i inhalatoren.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2017
Danish: Dato for første markedsføringstilladelse: 15. november 2017
English: Instructions for use:
Danish: Instruktioner vedrørende anvendelse:
English: It is very important that you use Trelegy Ellipta every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du bruger Trelegy Ellipta hver dag i henhold til lægens anvisninger.
English: Health-Related Quality of Life
Danish: Helbredsrelateret livskvalitet
English: These effects are much less likely to occur than with oral corticosteroids.
Danish: Disse bivirkninger er langt mindre sandsynlige end ved oral kortikosteroidbehandling.
English: Some medicines may affect how this medicine works, or make it more likely that you'll have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af dette lægemiddel eller gøre det mere sandsynligt, at du får bivirkninger.
English: Don't take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: There was no significant increase in systemic exposure to vilanterol.
Danish: Der var ikke nogen signifikant stigning i den systemiske eksponering for vilanterol.
English: Before the inhaler has been used, it shows exactly 30 doses.
Danish: Inden brug af inhalatoren viser den nøjagtigt 30 doser.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Trelegy Ellipta.
Danish: Lægen vil muligvis overvåge dig omhyggeligt, hvis du tager nogen af disse lægemidler, da de kan øge bivirkningerne fra Trelegy Ellipta.
English: • Take one long, steady, deep breath in.
Danish: • Tag en lang, rolig og dyb indånding.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Danish: Der er visse tegn på, at der er en øget risiko for pneumoni, når steroiddosis øges, men dette er ikke blevet endegyldigt vist på tværs af studierne.
English: If you use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Danish: Hvis du har brugt for meget af dette lægemiddel, skal du kontakte lægen eller apotekspersonalet for at få rådgivning med det samme, da du muligvis har brug for lægehjælp.
English: Uncommon side effects These may affect up to 1 in 100 people:
Danish: Ikke almindelige bivirkninger Kan forekomme hos op til 1 ud af 100 personer:
English: See section 4 ‘Possible side effects' for information on symptoms to look out for while you are using this medicine.
Danish: Se punkt 4, "Bivirkninger", for oplysninger om de symptomer, du skal være opmærksom på, mens du tager dette lægemiddel.
English: However, these higher systemic exposures remain below the threshold for FF-induced reduction of serum and urine cortisol and are not considered clinically relevant.
Danish: Disse højere systemiske eksponeringer forbliver dog under tærsklen for FF-induceret reduktion af serum- og urinkortisol og betragtes ikke som klinisk relevante.
English: 14 doses 30 doses
Danish: 14 doser 30 doser
English: The active substances are present as a white powder in separate blister strips inside the inhaler.
Danish: De aktive stoffer findes som et hvidt pulver i separate blisterstrips inde i inhalatoren.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Bivirkningernes hyppighed er defineret ved hjælp af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Danish: Du kan opleve, at dit hjerte slår hurtigere end normalt, at du ryster, at du har synsforstyrrelser, eller at du har mundtørhed eller får hovedpine.
English: Don't block the air vent with your fingers.
Danish: Spær ikke for luftkanalerne med fingrene.
English: Administration of Trelegy Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Danish: Administration af Trelegy Ellipta til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen opvejer enhver mulig risiko for fostret.
English: This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs.
Danish: Dette lægemiddel udvider disse muskler i lungerne, ved at reducere hævelsen og irritationen i de små luftveje i lungerne, hvilket gør det lettere for luften at komme ind og ud af lungerne.
English: Treatment difference (95% CI) Comparison with BUD/FOR
Danish: Behandlingsforskel (95 % CI) Sammenligning med BUD/FOR
English: If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.
Danish: Hvis din vejrtrækning eller hvæsen bliver værre, umiddelbart efter at du har taget dette lægemiddel, skal du stoppe med at bruge det og søge lægehjælp med det samme.
English: • inflammation of the lungs (bronchitis)
Danish: • inflammation i lungerne (bronkitis)
English: The medicinal product is now ready to be inhaled.
Danish: Lægemidlet er nu klar til at blive inhaleret.
English: All three studies were multicentre, randomised, double-blind studies that required patients to be symptomatic with a COPD Assessment Test (CAT) score ≥10 and on daily maintenance treatment for their COPD for at least three months prior to study entry.
Danish: Alle tre studier var multicenter, randomiserede, dobbeltblindede studier, der krævede, at patienterne var symptomatiske med en CAT-score (COPD Assessment Test) ≥ 10 og havde modtaget KOL-vedligeholdelsesbehandling i mindst 3 måneder før indtrædelse i studiet.
English: It is not known whether the ingredients of this medicine can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i dette lægemiddel også kan udskilles i mælk.
English: There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Danish: Det er ikke relevant at anvende Trelegy Ellipta hos den pædiatriske population (under 18 år) til indikationen KOL.
English: • pain in the back of the mouth and throat
Danish: • smerter bagest i mund og svælg
English: Urinary excretion accounted for approximately 2 % of the intravenously administered dose.
Danish: Udskillelse i urin udgjorde ca. 2 % af den intravenøst administrerede dosis.
English: • infection of the nose, sinuses or throat
Danish: • infektion i næse, bihuler eller svælg
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Danish: Stop med at bruge dette lægemiddel, og søg straks lægehjælp, da du kan have en alvorlig tilstand kaldet paradoks bronkospasme.
English: Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Danish: Du må ikke stoppe behandlingen, medmindre lægen siger det, heller ikke selvom du får det bedre, da dine symptomer kan forværres.
English: No clinically relevant effects requiring dose adjustment were observed.
Danish: Der blev ikke observeret nogen klinisk relevante virkninger, der krævede dosisjustering.
English: The patient should be assessed and alternative therapy instituted if necessary.
Danish: Patienten skal vurderes, og en anden behandling skal om nødvendigt iværksættes.
English: Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control.
Danish: Øget brug af korttidsvirkende bronkodilatatorer til symptomlindring kan indikere dårligere sygdomskontrol.
English: If possible, show them the inhaler, the package or this leaflet.
Danish: Vis dem inhalatoren, pakningen eller denne indlægsseddel, hvis det er muligt.
English: These patients may have also been taking other COPD medications (e.g. mucolytics or leukotriene receptor antagonists).
Danish: Disse patienter har muligvis også taget andre KOL-lægemidler (f.eks. mucolytika eller leukotrienreceptorantagonister).
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Danish: Det viser langsom reversibilitet ved den humane muskarine M3-receptorundertype in vitro og er langtidsvirkende in vivo, når det administreres direkte til lungerne i prækliniske modeller.
English: Therefore, caution is advised in moderate to severe hepatic impairment, but no specific dose adjustment based on hepatic function is recommended.
Danish: Der opfordres derfor til forsigtighed ved moderat til svært nedsat leverfunktion, men der anbefales ikke en specifik dosisjustering baseret på leverfunktionen.
English: Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Danish: Efter intravenøs administration var halveringstiden i eliminationsfasen 15,1 timer i gennemsnit.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trelegy Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienterne skal informeres om tegn og symptomer på akut snævervinklet glaukom og om, at de skal stoppe med at bruge Trelegy Ellipta og omgående kontakte deres læge, hvis nogen af disse tegn eller symptomer opstår.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use,
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til inhalation
English: If you open the cover after this, the dose counter will change from half red to completely red.
Danish: Hvis du åbner beskyttelseshætten herefter, vil dosistælleren ændres fra at være halvt rød til at være helt rød.
English: Trelegy Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Danish: Trelegy Ellipta må ikke bruges til patienter med astma, fordi det ikke er blevet undersøgt hos denne patientpopulation.
English: When you take the inhaler out of the sealed tray, it will be in the ‘closed' position.
Danish: Når du tager inhalatoren ud af den forseglede bakke, er den i "lukket" position.
English: There is no specific treatment for an overdose with Trelegy Ellipta.
Danish: Der findes ingen specifik behandling af overdosering med Trelegy Ellipta.
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Danish: Faldet i serumkalium er normalt kortvarigt og kræver ikke supplerende tilskud.
English: Umeclidinium and vilanterol belong to a group of medicines called bronchodilators.
Danish: Umeclidinium og vilanterol tilhører en gruppe lægemidler, der kaldes bronkodilatatorer.
English: Trelegy Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Trelegy Ellipta skal bruges hver dag og ikke kun, når du har problemer med vejrtrækningen eller andre symptomer på KOL.
English: Vilanterol has a low association with red blood cells.
Danish: Vilanterol har lav association med røde blodlegemer.
English: Covariate analysis showed higher FF apparent clearance (42%) when comparing FF/VI to FF/UMEC/VI; however, this is not considered clinically relevant.
Danish: En kovariant analyse viste en højere tilsyneladende clearance (42 %) af FF ved sammenligning af FF/VI med FF/UMEC/VI, dette anses ikke som klinisk relevant.
English: Population PK analyses for FF/UMEC/VI were conducted using a combined PK dataset from three phase III studies in 821 COPD subjects.
Danish: Der blev foretaget PK-populationsanalyser for FF/UMEC/VI ved hjælp af et kombineret PK-datasæt fra tre fase III-studier i 821 KOL-forsøgspersoner.
English: Table 2 - Lung function endpoint in IMPACT
Danish: Tabel 2 - Endepunkt for lungefunktion i IMPACT
English: Each time you open this, you prepare one dose of medicine.
Danish: Beskyttelseshætte Hver gang du åbner denne, klargør du en dosis medicin.
English: One fatal case of pneumonia was reported in a patient who received Trelegy Ellipta.
Danish: Der blev indberettet et tilfælde af dødelig pneumoni hos en patient, der fik Trelegy Ellipta.
English: Eye problems during treatment with Trelegy Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Trelegy Ellipta:
Danish: Øjenproblemer ved behandling med Trelegy Ellipta Hvis du oplever smerter eller ubehag i øjnene, midlertidigt sløret syn, synlige haloer eller farvede billeder såvel som røde øjne ved behandling med Trelegy Ellipta:
English: In COPD the muscles around the airways tighten, making breathing difficult.
Danish: Ved KOL bliver musklerne omkring luftvejene spændt, hvilket gør det svært at trække vejret.
English: Umeclidinium is a long-acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Danish: Umeclidinium er en langtidsvirkende muskarin receptorantagonist (også kaldet et antikolinergikum).
English: Rinsing your mouth out with water immediately after using Trelegy Ellipta may help prevent this side effect.
Danish: Hvis du skyller munden med vand og spytter vandet ud, umiddelbart efter at du har brugt Trelegy Ellipta, kan det være med til at forebygge denne bivirkning
English: Tell your doctor or pharmacist if you are taking any of these.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du tager et eller flere af disse lægemidler.
English: Vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Danish: Vilanterol (som alfaphenylcinnamat) og triphenyleddikesyre var ikke genotoksiske, hvilket indikerer, at vilanterol (som trifenatat) ikke udgør en genotoksisk risiko for mennesker.
English: The most frequently reported adverse reactions with Trelegy Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Danish: De hyppigst indberettede bivirkninger ved brug af Trelegy Ellipta var nasopharyngitis (7 %), hovedpine (5 %) og infektion i de øvre luftveje (2 %).
English: Less than 1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting negligible absorption following oral administration.
Danish: Under 1 % af den oralt administrerede dosis (1 % af den genfundne radioaktivitet) blev udskilt i urinen, hvilket tyder på minimal absorption efter oral administration.
English: There are no clinical data to support the use of Trelegy Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Danish: Der er ingen kliniske data, der understøtter brugen af Trelegy Ellipta til behandling af akutte tilfælde af bronkospasme eller akut eksacerbation af KOL (dvs. som nødbehandling).
English: Adverse reactions detected during these clinical trials are listed by MedDRA system organ class.
Danish: Bivirkninger, der er blevet påvist i disse kliniske studier, er anført efter MedDRA-systemorganklasse.
English: Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Danish: Behandling med Trelegy Ellipta skal stoppes omgående, hvis der opstår paradoks bronkospasme.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Trelegy Ellipta contains lactose') and magnesium stearate.
Danish: De øvrige indholdsstoffer er lactosemonohydrat (se punkt 2 ”Trelegy Ellipta indeholder lactose”) og magnesiumstearat.
English: Tabulated summary of adverse reactions The safety profile of Trelegy Ellipta is based on three phase III clinical studies.
Danish: Tabel over bivirkninger Sikkerhedsprofilen for Trelegy Ellipta er baseret på tre kliniske fase III-studier.
English: Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Danish: Efter oral administration blev fluticasonfuroat primært elimineret hos mennesker via metabolisering, hvor metabolitterne næsten udelukkende blev udskilt med fæces, og < 1 % af den genfundne radioaktive dosis blev elimineret i urinen.
English: Don't use Trelegy Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Trelegy Ellipta: - hvis du er allergisk over for fluticasonfuroat, umeclidinium, vilanterol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate or blood potassium.
Danish: Den øgede eksponering for vilanterol var ikke forbundet med en stigning i beta2-agonistrelaterede systemiske virkninger på hjertefrekvens eller blodkalium.
English: Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines) involved in inflammation.
Danish: Det er vist, at kortikosteroider har en lang række effekter på mange forskellige celletyper (f.eks. eosinofile celler, makrofager og lymfocytter) og på mediatorer (f.eks. cytokiner og kemokiner) involveret i inflammation.
English: • increased mucus production, change in mucus colour
Danish: • øget slimproduktion eller ændring i slimets farve
English: Interaction with CYP2D6 inhibitors/CYP2D6 polymorphism
Danish: Interaktion med CYP2D6-hæmmere/CYP2D6-polymorfi
English: Upon initiation of treatment with Trelegy Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved initiering af behandling med Trelegy Ellipta, bør plasmaglucose monitoreres tættere hos diabetespatienter.
English: Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol.
Danish: Beta2-adrenerge blokkere kan svække eller antagonisere virkningen af beta2-adrenerge agonister som f.eks. vilanterol.