FrancophonIA/ELRC3.0 huggingface dataset:
English: Because you are using this medicine for COPD, you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Danish: Da du bruger dette lægemiddel mod KOL, kan du have øget risiko for at få lungebetændelse.
English: The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity.
Danish: De primære metaboliske ruter for vilanterol er O-dealkylering til en række forskellige metabolitter med signifikant reduceret beta1- og beta2-adrenerg agonistaktivitet.
English: Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6).
Danish: Umeclidinium er et substrat af cytokrom P450 2D6 (CYP2D6).
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød umiddelbart efter at have brugt Trelegy Ellipta-inhalatoren:
English: The effects of haemodialysis have not been studied.
Danish: Virkningen af hæmodialyse er ikke blevet undersøgt.
English: Following oral administration of radiolabelled vilanterol, 70% of the radiolabel was excreted in urine and 30% in faeces.
Danish: Efter oral administration af radioaktivt mærket vilanterol blev 70 % af det radioaktivt mærkede stof udskilt i urinen og 30 % med fæces.
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (LABA).
Danish: Vilanterol er en selektiv, langtidsvirkende beta2-adrenerg receptoragonist (LABA).
English: Slide the cover upwards as far as it will go, to cover the mouthpiece.
Danish: Skub beskyttelseshætten så langt op som muligt, så den dækker for mundstykket.
English: Caution should be exercised when Trelegy Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Danish: Der bør udvises forsigtighed, når Trelegy Ellipta anvendes sammen med andre lægemidler, der også potentielt kan forårsage hypokalæmi (se pkt.
English: Use Trelegy Ellipta regularly
Danish: Brug Trelegy Ellipta regelmæssigt
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Astma
English: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively.
Danish: Der kan ses kardiovaskulære effekter såsom hjertearytmi, f.eks. atrieflimmer og takykardi, efter administration af muskarine receptorantagonister og sympatomimetika, inklusive henholdsvis umeclidinium og vilanterol.
English: An approximately 1.4-fold increase in umeclidinium AUC was observed with no effect on vilanterol AUC.
Danish: Der blev observeret en stigning på ca. 1,4 gange i AUC af umeclidinium uden effekt på AUC af vilanterol.
English: It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk.
Danish: Det vides ikke, om fluticasonfuroat, umeclidinium, vilanterol eller deres metabolitter udskilles i human mælk.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Trelegy Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Trelegy Ellipta skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
Danish: I inhalationsstudier med kaniner medførte vilanterol virkninger, der lignede dem, der ses med andre beta2-adrenerge agonister (ganespalte, åbne øjenlåg, sammenvoksning ved sternum og abnormt bøjede lemmer/malrotation).
English: No clinically relevant effects on the QTc interval were observed on review of centrally read ECGs from 911 subjects with COPD exposed to fluticasone furoate/umeclidinium/vilanterol for up to 24 weeks, or in the subset of 210 subjects exposed for up to 52 weeks.
Danish: Der blev ikke observeret klinisk relevante virkninger på QTc-intervallet ved gennemgang af centralt aflæste EKG'er fra 911 forsøgspersoner med KOL, som blev eksponeret for fluticasonfuroat/umeclidinium/vilanterol i op til 24 uger, eller i undergruppen på 210 forsøgspersoner, der blev eksponeret i op til 52 uger.
English: Throw this desiccant sachet away - don't open, eat or inhale it.
Danish: Smid posen med tørremiddel ud - du må ikke åbne, spise eller inhalere tørremidlet.
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Trelegy Ellipta and budesonide/formoterol arms was equal at 2%.
Danish: I undergruppen med 430 patienter i op til 52 uger var forekomsten af indberettet pneumoni for både Trelegy Ellipta- og budesonid/formoterol-gruppen 2 %.
English: At screening, the mean post-bronchodilator percent predicted FEV1 was 46% and over 99% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Danish: Ved screening var den gennemsnitlige postbronkodilator FEV1 på 46 % af det forventede, og over 99 % af patienterne indberettede en eller flere moderate/svære eksacerbationer inden for det seneste år.
English: other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
Danish: - andre langtidsvirkende lægemidler, der minder om dette lægemiddel, og som bruges til at behandle vejrtrækningsproblemer, f.eks. tiotropium eller indacaterol.
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose.
Danish: Der er ikke observeret klinisk relevante hypokalæmieffekter i kliniske studier med Trelegy Ellipta ved den anbefalede terapeutiske dosis.
English: Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver afgivet dosis indeholder ca. 25 mg lactose (som monohydrat).
English: The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Danish: Umeclidiniums farmakokinetik ved steady-state er blevet vurderet hos frivillige raske forsøgspersoner, der mangler CYP2D6 (har nedsat stofskifte).
English: After you have used the last dose, half of the dose counter shows red and the number 0 is displayed.
Danish: Når du har taget den sidste dosis, vises halvdelen af dosistælleren i rødt, og tallet 0 vises.
English: Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively.
Danish: Samtidig administration øgede det gennemsnitlige AUC(0-t) og Cmax af vilanterol med henholdsvis 65 % og 22 %.
English: Other medicines and Trelegy Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Trelegy Ellipta Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Administration of combined fluticasone furoate, umeclidinium and vilanterol to dogs did not result in any significant new toxicity or any major exacerbation of expected findings associated with fluticasone furoate, umeclidinium or vilanterol alone.
Danish: Administration af kombineret fluticasonfuroat, umeclidinium og vilanterol til hunde medførte ikke signifikant ny toksicitet eller markante eksacerbationer af forventede resultater associeret med enkeltstående fluticasonfuroat, umeclidinium eller vilanterol.
English: INFORMATION IN BRAILLE trelegy ellipta
Danish: INFORMATION I BRAILLESKRIFT trelegy ellipta
English: For further instructions for use and handling, see section 4.2.
Danish: For yderligere instruktioner vedrørende brug og håndtering se pkt.
English: The incidence of pneumonia with Trelegy Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Danish: Forekomsten af pneumoni ved brug af Trelegy Ellipta er sammenlignelig med den forekomst, der blev observeret i fluticasonfuroat/vilanterol (FF/VI) 100/25-gruppen i kliniske FF/VI-studier af KOL.
English: A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor).
Danish: Der blev udført et studie med gentaget dosering til raske forsøgspersoner af kombinationen fluticasonfuroat/vilanterol (184/22 mikrogram) og ketoconazol (400 milligram, en potent CYP3A4-hæmmer).
English: No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle, der kræver dosisjustering baseret på race, køn eller vægt, ved systemisk eksponering for fluticasonfuroat, umeclidinium eller vilanterol.
English: Hypokalaemia
Danish: Hypokalæmi
English: Use of Rescue Medication
Danish: Brug af akutmedicin
English: The absolute bioavailability of inhaled umeclidinium was on average 13%, with negligible contribution from oral absorption.
Danish: Den absolutte biotilgængelighed for inhaleret umeclidinium var 13 % i gennemsnit med en ubetydelig andel fra oral absorption.
English: When fluticasone furoate, umeclidinium and vilanterol were administered in combination by the inhaled route from a single inhaler in healthy subjects, the pharmacokinetics of each component were similar to those observed when each active substance was administered either as fluticasone furoate/vilanterol combination or as an umeclidinium/vilanterol combination or umeclidinium monotherapy.
Danish: Når fluticasonfuroat, umeclidinium og vilanterol blev administreret sammen via inhalation fra en enkelt inhalator til raske forsøgspersoner, svarede farmakokinetikken i hver komponent til den farmakokinetik, der blev observeret, når hvert af de aktive stoffer blev administreret enten som kombination af fluticasonfuroat/vilanterol eller som en kombination af umeclidinium/vilanterol eller umeclidinium monoterapi.
English: The precise mechanism through which fluticasone furoate affects COPD symptoms is not known.
Danish: Den præcise mekanisme bag fluticasonfuroats effekt på KOL-symptomer kendes ikke.
English: The inhaler contains two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply).
Danish: Inhalatoren indeholder to blistere i aluminiumfolielaminat, der i alt leverer 14 eller 30 doser (til 14 eller 30 dages forbrug).
English: The excretion of the drug-related material in the faeces following intravenous dosing indicated secretion into the bile.
Danish: Udskillelsen af det lægemiddelrelaterede materiale med fæces efter intravenøs administration indikerede galdesekretion.
English: Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres.
Danish: Efter intravenøs administration af umeclidinium til frivillige raske forsøgspersoner var den gennemsnitlige fordelingsvolumen 86 liter.
English: If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Danish: Hvis beskyttelseshætten på inhalatoren åbnes og lukkes, uden at lægemidlet inhaleres, vil dosis gå tabt.
English: Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Danish: Trough FEV1 (l) i uge 24, gennemsnitlig LS-ændring fra baseline (SE)a
English: Following oral administration, 92% of the administered radiolabelled dose was excreted primarily in faeces.
Danish: Efter oral administration blev 92 % af den administrerede radioaktivt mærkede dosis udskilt primært med fæces.
English: The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study.
Danish: Virkningen af fluticasonfuroat/umeclidinium/vilanterol på QT-intervallet er ikke blevet evalueret i et grundigt QT-studie (TQT).
English: How to use the inhaler
Danish: Sådan bruger du inhalatoren
English: Cardiac electrophysiology
Danish: Hjerteelektrofysiologi
English: Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a
Danish: Trough FEV1 (l) i uge 52, gennemsnitlig LS-ændring fra baseline (SE) a
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Danish: Patienten skal informeres om, at bakken ikke må åbnes, før patienten er klar til at inhalere en dosis.
English: If you are breast-feeding, you must check with your doctor before you use Trelegy Ellipta.
Danish: Hvis du ammer, skal du tale med lægen, før du bruger Trelegy Ellipta.
English: Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA).
Danish: Fluticasonfuroat/umeclidinium/vilanterol er en kombination af inhaleret syntetisk kortikosteroid, langtidsvirkende muskarin receptorantagonist og langtidsvirkende beta2-adrenerg agonist (ICS/LAMA/LABA).
English: Trelegy Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Danish: Trelegy Ellipta bør bruges med forsigtighed hos patienter med krampelidelser eller tyreotoksikose og hos patienter, der reagerer i usædvanlig høj grad på beta2-adrenerge agonister.
English: An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax.
Danish: Der blev observeret en stigning på ca. 1,3 gange i AUC af umeclidinium ved en dosis, der var 16 gange højere, uden effekt på Cmax af umeclidinium.
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Danish: Inhalatoren er i "lukket" position, når den tages ud af den forseglede bakke.
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Danish: Den absolutte biotilgængelighed for inhaleret vilanterol var 27 % med en ubetydelig andel fra oral absorption.
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Danish: • Hvis dosistælleren ikke tæller ned, når du hører klikket, afgiver inhalatoren ikke lægemidlet.
English: Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions.
Danish: Samtidig administration bør undgås, medmindre fordelen opvejer den øgede risiko for systemiske bivirkninger relateret til kortikosteroider.
English: Fluticasone furoate had no adverse effect on pre- or post-natal development in rats.
Danish: Fluticasonfuroat havde ingen negative virkninger på den præ- eller postnatale udvikling hos rotter.
English: At screening, the mean post-bronchodilator percent predicted FEV1 was 45% and 65% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Danish: Ved screening var den gennemsnitlige postbronkodilator FEV1 på 45 % af det forventede, og 65 % af patienterne indberettede én eller flere moderate/svære eksacerbationer inden for det seneste år.
English: • infection of the upper airways
Danish: • infektion i de øvre luftveje
English: Other long acting antimuscarinics and long acting beta2- adrenergic agonists
Danish: Andre langtidsvirkende antimuskarine stoffer og langtidsvirkende beta2-adrenerge agonister
English: Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Danish: Trelegy Ellipta er indiceret til vedligeholdelsesbehandling hos voksne patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), som ikke er velkontrolleret med en kombination af inhalationssteroid og en langtidsvirkende beta2-agonist eller en kombination af en langtidsvirkende beta2-agonist og en langtidsvirkende muskarin-antagonist (for effekt på symptomkontrol og forebyggelse af eksacerbationer, se pkt.
English: No effect on umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose.
Danish: Der blev ikke observeret nogen virkning på AUC eller Cmax af umeclidinium ved en dosis, der var 8 gange højere end den terapeutiske dosis.
English: Trelegy Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Danish: Trelegy Ellipta indeholder tre aktive stoffer ved navn fluticasonfuroat, umeclidinium og vilanterol.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers).
Danish: Ud fra disse ændringers betydning forventes der ingen klinisk relevante lægemiddelinteraktioner, når fluticasonfuroat/umeclidinium/vilanterol administreres sammen med CYP2D6-hæmmere, eller når de administreres til patienter med genetisk nedsat CYP2D6-aktivitet (nedsat stofskifte).
English: However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol that showed no evidence of an increase in systemic exposure to fluticasone furoate, umeclidinium or vilanterol.
Danish: Der er dog foretaget studier med fluticasonfuroat/vilanterol og umeclidinium/vilanterol, der ikke viste nogen evidens for stigning i den systemiske eksponering for fluticasonfuroat, umeclidinium eller vilanterol.
English: • constipation.
Danish: • forstoppelse.
English: If you open and close the cover without inhaling the medicine, you will lose the dose.
Danish: Hvis du åbner og lukker beskyttelseshætten, uden at lægemidlet inhaleres, vil dosis gå tabt.
English: Nighttime awakenings
Danish: Natlige opvågninger
English: Trelegy Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Danish: Trelegy Ellipta kan ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
English: Deterioration of disease
Danish: Eksacerbation af sygdom
English: In vitro plasma protein binding in human plasma was on average 89%.
Danish: In vitro-plasmaproteinbindingen i humant plasma var i gennemsnit 89 %.
English: Fractures
Danish: Frakturer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERETIKET (MED BLUE BOX-MULTIPAKNING)
English: Fluticasone furoate/umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
Danish: Fluticasonfuroat/umeclidinium/vilanterol påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
Danish: I et præ- og postnatalt studie medførte subkutan administration af umeclidinium til rotter lavere maternel kropsvægtsøgning og madindtag samt en lidt lavere kropsvægt hos ungerne før ophør af diegivning for moderdyr, der fik en dosis på 180 mikrogram/kg/dag (ca. 61 gange højere end det, der opnås hos mennesker ved en daglig dosis på 55 mikrogram umeclidinium, baseret på AUC).
English: • Don't shake the inhaler at any time.
Danish: • Inhalatoren må ikke omrystes på noget tidspunkt.
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Trelegy Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Danish: Letal pneumoni forekom hos 12 af 4.151 patienter (3,5 pr. 1.000 patientår), som fik Trelegy Ellipta, 5 af 4.134 patienter (1,7 pr. 1.000 patientår), som fik fluticasonfuroat/vilanterol og 5 af 2.070 patienter (2.9 pr. 1.000 patientår), som fik umeclidinium/vilanterol.
English: • sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
Danish: • ømme, hævede pletter i munden eller svælget på grund af en svampeinfektion
English: Don't use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen, bakken og inhalatoren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women.
Danish: Der er begrænsede data fra anvendelse af fluticasonfuroat/umeclidinium/vilanterol til gravide kvinder.
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Danish: Efter gentaget inhalation af umeclidinium blev der opnået steady-state inden for 7-10 dage med en akkumulering på 1,5-2 gange.
English: TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI.
Danish: TQT-studier af FF/VI og umeclidinium/vilanterol (UMEC/VI) viste ikke klinisk relevante virkninger på QT-intervallet ved kliniske doser af FF, UMEC og VI.
English: Pack sizes of 14 or 30 dose inhalers.
Danish: Pakningsstørrelser med inhalator med 14 eller 30 doser.
English: Contents of the pack and other information Step-by-step instructions
Danish: Pakningsstørrelser og yderligere oplysninger Brugervejledning
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Danish: Beta2-adrenerge agonister kan, hos nogle patienter medføre signifikant hypokalæmi, som kan give kardiovaskulære bivirkninger.
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Danish: Når du er klar til at bruge inhalatoren, skal du trække låget af for at åbne bakken.
English: Patients with moderate to severe hepatic impairment receiving Trelegy Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Danish: Patienter med moderat til svært nedsat leverfunktion, som får Trelegy Ellipta, bør monitoreres for bivirkninger relateret til kortikosteroiders systemiske virkninger (se pkt.
English: Wait to open the cover until you are ready to take your dose.
Danish: Vent med at åbne beskyttelseshætten, til du er klar til at tage din dosis.
English: 1 inhaler of 14 doses
Danish: 1 inhalator med 14 doser
English: However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol.
Danish: Der er dog foretaget studier med fluticasonfuroat/vilanterol og umeclidinium/vilanterol.
English: If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
Danish: Hvis du får hvæsende vejrtrækning eller åndenød, skal du inhalere et lægemiddel med hurtig virkning (f.eks. salbutamol) og derefter søge lægehjælp.