FrancophonIA/ELRC3.0 huggingface dataset:
English: ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Anoro Ellipta er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours in healthy volunteers, with 3% to 4% excreted unchanged in urine at steady-state.
Danish: Halveringstiden for elimination af umeclidinium i plasma efter dosering via inhalation i 10 dage, var i gennemsnit 19 timer hos raske personer, med 3-4 % udskilt uomdannet i urinen ved steady state.
English: Hyperglycaemia Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.
Danish: Hyperglykæmi Beta2-adrenerge agonister kan medføre forbigående hyperglykæmi hos visse patienter.
English: A higher dose of umeclidinium/vilanterol (113/22 micrograms) was also studied in a 24-week placebo controlled clinical study and in two of the three 24-week active-controlled studies.
Danish: En højere dosis af umeclidinium/vilanterol (113/22 mikrogram) blev desuden undersøgt i et klinisk placebokontrolleret studie af 24 ugers varighed og i to ud af de tre studier med aktiv komparator, der varede 24 uger.
English: Use ANORO ELLIPTA regularly
Danish: Tag Anoro Ellipta regelmæssigt
English: Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4).
Danish: Vilanterol er et substrat for cytochrom P450 3A4 (CYP3A4).
English: The primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Danish: Umeclidinium metaboliseres primært via oxidation (hydroxylering, O-dealkylering) efterfulgt af konjugering (glucuronidering, osv.), hvilket resulterer i en række metabolitter med enten nedsat farmakologisk effekt, eller metabolitter hvor den farmakologiske effekt ikke er klarlagt.
English: Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease.
Danish: Umeclidinium/vilanterol bør derfor anvendes med forsigtighed hos patienter med svær kardiovaskulær sygdom.
English: The first time you use ANORO ELLIPTA you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Danish: Det er ikke nødvendigt at kontrollere, om inhalatoren virker korrekt, før du bruger Anoro Ellipta første gang, den indeholder afdelte doser og er klar til brug med det samme.
English: 2 years In-use shelf-life after opening the tray: 6 weeks
Danish: 2 år Holdbarhed efter anbrud af bakken: 6 uger
English: An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Danish: En overdosis af umeclidinium/vilanterol vil sandsynligvis medføre tegn og symptomer som følge af de enkelte indholdsstoffers virkninger, der stemmer overens med de kendte bivirkninger ved inhalerede muskarinantagonister (f.eks. mundtørhed, visuelle akkommodationsforstyrrelser og takykardi) eller med bivirkningerne ved overdosering af andre beta2-agonister (f.eks. arytmier, tremor, hovedpine, palpitationer, kvalme, hyperglykæmi og hypokaliæmi).
English: Caution should be exercised when umeclidinium/vilanterol is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Danish: Der bør udvises forsigtighed ved anvendelse af umeclidinium/vilanterol sammen med andre lægemidler, der også kan medføre hypokaliæmi (se pkt.
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).
Danish: Vilanterol er en selektiv, langtidsvirkende beta2-adrenerg receptoragonist (beta2-adrenerg agonist).
English: The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Danish: Farmakokinetikken af umeclidinium ved steady state blev bestemt hos raske personer, der manglede CYP2D6 (personer med nedsat metabolisme).
English: Excipient with known effect 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: In the event of deterioration of COPD during treatment with umeclidinium/vilanterol, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Forværres KOL under behandlingen med umeclidinium/vilanterol, skal der foretages en revurdering af patienten og af KOL behandlingsregimet.
English: In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which were evident at 15 minutes following administration of the first dose (improvement over placebo by 112 ml (p <0.001*).
Danish: I fase III-studier af 6 måneders varighed viste umeclidinium/vilanterol klinisk relevante forbedringer af lungefunktionen i forhold til placebo (målt ved forceret eksspiratorisk volumen i første sekund [FEV1]) over 24 timer efter administration én gang daglig, som var tydelig 15 minutter efter administration af den første dosis, med en forbedring på 112 ml (p < 0,001*) sammenlignet med placebo.
English: Package leaflet: Information for the user ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Anoro Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt umeclidinium/vilanterol Dette lægemiddel er underlagt supplerende overvågning.
English: • combination of sore throat and runny nose
Danish: • kombination af ømhed i halsen og løbende næse
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 26 or ≥ 22-fold, times the human clinical exposure of umeclidinium 55 micrograms, based on AUC, respectively.
Danish: Umeclidinium var ikke genotoksisk i en række standardstudier og ikke karcinogent ved livslang inhalationsbehandling af mus og rotter ved eksponeringer på henholdsvis ≥ 26 og ≥ 22 gange human klinisk eksponering for umeclidinium 55 mikrogram, baseret på AUC.
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Danish: In vitro-studier viste, at umeclidinium primært metaboliseres via cytochrom P450 2D6 (CYP2D6) og er et substrat for transportproteinet P-glykoprotein (P-gp).
English: The clinical efficacy of umeclidinium/vilanterol administered once daily was evaluated in eight Phase III clinical studies in 6,835 adult patients with a clinical diagnosis of COPD; 5,618 patients from five 6-month studies (two placebo-controlled and three active [tiotropium]-comparator controlled), 655 patients from two 3-month exercise endurance/lung function studies and 562 patients from a 12-month supportive study.
Danish: Den kliniske virkning af umeclidinium/vilanterol administreret én gang daglig blev vurderet i otte kliniske fase III-studier hos 6.835 voksne patienter med en klinisk diagnose på KOL; 5.618 patienter fra fem studier af 6 måneders varighed (to placebokontrollerede og tre aktiv komparator [tiotropium]-kontrollerede), 655 patienter fra to studier af 3 måneders varighed til vurdering af fysisk udholdenhed/lungefunktion, og 562 patienter fra et studie af 12 måneders varighed.
English: If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with ANORO ELLIPTA:
Danish: Hvis du under behandling med Anoro Ellipta får øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne:
English: In the three 6-month active-comparator-controlled studies, ANORO ELLIPTA reduced the use of rescue medication with salbutamol compared with tiotropium, with statistically significant reductions observed in two of the studies (see Table 1).
Danish: I de tre aktiv komparator-kontrollerede studier af 6 måneders varighed reducerede Anoro Ellipta forbruget af anfaldsmedicin (salbutamol) sammenlignet med tiotropium med statistisk signifikante reduktioner observeret i to af studierne (se tabel 1).
English: ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Danish: Anoro Ellipta anvendes til behandling af kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: The active substances are umeclidinium bromide and vilanterol.
Danish: Aktive stoffer: umeclidiniumbromid og vilanterol.
English: If you stop using ANORO ELLIPTA
Danish: Hvis du holder op med at tage Anoro Ellipta
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for ANORO ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Danish: Andelen af patienter, der som minimum responderede med MCID i SGRQ-score (defineret som et fald på 4 enheder i forhold til baseline) ved uge 24, var større for Anoro Ellipta (49 %) sammenlignet med placebo (34 %) og hver monoterapikomponent (44 % for umeclidinium og 48 % for vilanterol).
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Danish: Der forventes ingen klinisk relevant lægemiddelinteraktion på baggrund af størrelsesordenen af disse ændringer, når umeclidinium/vilanterol administreres samtidigt med CYP2D6hæmmere eller ved administration til patienter, som genetisk mangler CYP2D6-aktivitet (patienter med nedsat metabolisme).
English: Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Danish: Umeclidinium/vilanterol bør i overensstemmelse med dets antimuskarine aktivitet anvendes med forsigtighed hos patienter med urinretention eller med snævervinklet glaukom.
English: • pain and irritation in the back of the mouth and throat
Danish: • smerte og irritation i svælget
English: ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution.
Danish: Anvendelse af Anoro Ellipta er ikke undersøgt hos patienter med svært nedsat leverfunktion og skal derfor anvendes med forsigtighed til disse patienter.
English: In addition, ANORO ELLIPTA demonstrated clinically meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in two of the three 6-month active-comparator studies and numerically greater improvements from tiotropium in the third active-comparator study (see Table 1).
Danish: Anoro Ellipta viste desuden klinisk relevante og statistisk signifikante forbedringer i trough-FEV1 sammenlignet med tiotropium i to ud af de tre studier af 6 måneders varighed med aktiv komparator og numerisk større forbedringer end tiotropium i det tredje studie med aktiv komparator (se tabel 1).
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Danish: Efter intravenøs administration var plasmaclearance af vilanterol 108 liter/time.
English: ANORO ELLIPTA has also shown an improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 24 compared with placebo and each monotherapy component (see Table 1).
Danish: Anoro Ellipta viste desuden en forbedring af den helbredsrelaterede livskvalitet målt ved St. George's Respiratory Questionnaire (SGRQ), indikeret ved en reduktion i den samlede SGRQ-score ved uge 24 sammenlignet med placebo og hver monoterapikomponent (se tabel 1).
English: In the other two studies, the risk of a moderate/severe COPD exacerbation was increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 respectively).
Danish: I de andre to studier var risikoen for moderat/svær KOL-eksacerbation øget med 20 % og 90 % (HR 1,2; 95% CI: 0,5, 2,6; p = 0,709 og HR 1,9; 95% CI: 1,0, 3,6; p = 0,062).
English: White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter.
Danish: Hvidt pulver i en lysegrå inhalator (Ellipta) med en rød beskyttelseshætte over mundstykket og en dosistæller.
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 Anoro Ellipta eller gøre det mere sandsynligt, at du får bivirkninger.
English: An approximately 1.4-fold increase in umeclidinium AUC was observed with no effect on vilanterol AUC.
Danish: AUC for umeclidinium blev øget ca. 1,4 gange, uden at der blev set nogen effekt på AUC for vilanterol.
English: ANORO ELLIPTA showed a statistically significant reduction in SGRQ total score compared with tiotropium in one of the three activecomparator studies (see Table 1).
Danish: Anoro Ellipta viste statistisk signifikant reduktion af samlet SGRQ-score sammenlignet med tiotropium i et af de tre studier med aktiv komparator (se tabel 1).
English: Following inhaled administration of vilanterol in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Danish: Efter administration af vilanterol som inhalation hos raske personer indtraf Cmax efter 5 til 15 minutter.
English: What you need to know before you use ANORO ELLIPTA Do not use ANORO ELLIPTA:
Danish: Det skal du vide, før du begynder at tage Anoro Ellipta Tag ikke Anoro Ellipta
English: The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Danish: Nedenstående brugervejledning til inhalatoren kan både bruges til inhalator med 30 doser (30 dages forbrug) og inhalator med 7 doser (7 dages forbrug).
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol (FF/VI 92/22 micrograms) administered once daily as a single inhaler.
Danish: I et randomiseret, dobbeltblindet 52-ugers studie (CTT116855, IMPACT) blev 10.355 voksne patienter med symptomatisk KOL med 1 eller flere moderate eller svære eksacerbationer i anamnesen inden for de forudgående 12 måneder randomiseret (1:2:2) til behandling med umeclidinium/vilanterol (UMEC/VI 55/22 mikrogram), fluticasonfuroat/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 mikrogram) eller fluticasonfuroat/vilanterol (FF/VI 99/22 mikrogram) administreret én gang dagligt som en enkelt inhalator.
English: There was no increase in tumour incidence in rats or mice at exposures 0.5- or 13-fold, times the human clinical exposure of vilanterol 22 micrograms based on AUC, respectively.
Danish: Der var ingen stigning i forekomsten af tumorer hos rotter eller mus ved eksponeringer på henholdsvis 0,5 og 13 gange human klinisk eksponering over for vilanterol 22 mikrogram, baseret på AUC.
English: An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax.
Danish: AUC for umeclidinium blev øget ca. 1,3 gange ved en 16 gange højere dosis, uden at der blev set nogen effekt på Cmax for umeclidinium.
English: In one active-comparator study, a higher percentage of patients receiving ANORO ELLIPTA responded with a clinically meaningful improvement in SGRQ score at Week 24 (53%) compared to tiotropium (46%).
Danish: I et studie med aktiv komparator var der en højere procentandel af patienter med klinisk relevant forbedring af SGRQ-score ved uge 24, der fik Anoro Ellipta (53 %) sammenlignet med tiotropium (46 %).
English: If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Danish: Hvis inhalatoren opbevares på køl, skal den ligge ved stuetemperatur i mindst én time før brug.
English: No effect on umeclidinium AUC or Cmax was observed at a 8-fold higher dose.
Danish: Der blev ikke observeret nogen effekt på AUC eller Cmax af umeclidinium ved en dosis, der var 8 gange højere.
English: Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
Danish: Ikke almindelig Ikke almindelig Ikke almindelig Ikke almindelig Ikke almindelig Ikke almindelig
English: Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Danish: Efter administration af umeclidinium som inhalation hos raske personer indtraf Cmax efter 5 til 15 minutter.
English: If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek medical advice.
Danish: Hvis du får hvæsende vejrtrækning eller åndenød, så skal du inhalere et lægemiddel med hurtig virkning (f.eks. salbutamol), og herefter søge lægehjælp.
English: ANORO ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Danish: Anoro Ellipta (N=454) versus tiotropium 18 mikrogram (N=451) (studie ZEP117115)
English: Consistent with findings for other beta2-adrenergic agonists, in lifetime inhalation studies, vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and in the rat pituitary gland.
Danish: I overensstemmelse med resultater med andre beta2-agonister viste livstidsstudier med inhaleret vilanteroltrifenatat proliferative virkninger i reproduktionskanalen hos hunrotter og hunmus og i hypofysen hos rotter.
English: By Q3 2024
Danish: Inden udgangen af tredje kvartal 2024
English: Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA).
Danish: Umeclidinium/vilanterol er en kombination af en inhaleret langtidsvirkende muskarinreceptorantagonist og en langtidsvirkende beta2-agonist (LAMA/LABA).
English: In one 6-month Phase III study, ANORO ELLIPTA demonstrated statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo and each monotherapy component treatment arm.
Danish: I et fase III-studie af 6 måneders varighed viste Anoro Ellipta statistisk signifikante forbedringer i trough-FEV1 (primært endepunkt) ved uge 24 sammenlignet med placebo og med hver behandlingsarm med én komponent alene (monoterapi).
English: In the first study, ANORO ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]).
Danish: I det første studie viste Anoro Ellipta 55/22 mikrogram statistisk signifikant og klinisk relevante forbedring (baseret på mindste klinisk relevante ændring (MCID) mellem 45-85 sekunder) i forhold til placebo i fysisk udholdenhed (EET) målt 3 timer efter dosering ved uge 12 (69,4 sekunder [p = 0,003]).
English: The maximum dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Danish: Den maksimale dosis er én inhalation af Anoro Ellipta 55/22 mikrogram én gang daglig.
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for ANORO ELLIPTA (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Danish: Andelen af patienter, der som minimum responderede med den mindste klinisk relevante ændring (MCID) på 1 enhed i TDI fokal score ved uge 24, var større for Anoro Ellipta (58 %) sammenlignet med placebo (41 %) og hver monoterapikomponent (53 % for umeclidinium og 51 % for vilanterol).
English: The recommended dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Danish: Den anbefalede dosis er én inhalation af Anoro Ellipta 55/22 mikrogram én gang daglig.
English: Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see sections 4.4 and 4.9).
Danish: Samtidig administration af umeclidinium/vilanterol med andre langtidsvirkende muskarinantagonister, langtidsvirkende beta2-adrenerge agonister eller lægemidler, der indeholder nogen af disse stoffer, er ikke undersøgt og anbefales ikke, da det kan forstærke kendte bivirkninger ved inhalerede muskarinantagonister eller beta2-adrenerge agonister (se pkt.
English: From the three active-comparator studies in patients with symptomatic COPD, the risk of a moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 95% CI: 0.3, 1.0; p=0.044).
Danish: Ud fra de tre studier med aktiv komparator hos patienter med symptomatisk KOL, blev risikoen for en moderat/svær KOL-eksacerbation reduceret med 50 % i et studie (HR 0,5; 95% CI: 0,3, 1,0; p = 0,044) sammenlignet med tiotropium.
English: Anaphylaxis, angioedema, and urticaria
Danish: Anafylaksi, angioødem og urticaria
English: No dose adjustment is required in patients with renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: See ‘Step-by-step instructions' in this leaflet for full information.
Danish: Se 'Brugervejledning' i denne indlægsseddel for yderligere oplysninger.
English: Your ANORO ELLIPTA inhaler carton contains
Danish: Din æske med Anoro Ellipta inhalator indeholder
English: ANORO ELLIPTA is an inhalation powder, pre-dispensed.
Danish: Anoro Ellipta er inhalationspulver, afdelt.
English: Frequency not known
Danish: Bivirkninger, hvor hyppigheden ikke er kendt
English: The maximum mean difference in heart rate from placebo after baseline-correction was 8.4 (90% CI=7.0 to 9.8) beats/minute and 20.3 (90% CI=18.9 to 21.7) beats/minute seen 10 minutes after administration of umeclidinium/vilanterol 113/22 micrograms and 500/100 micrograms respectively.
Danish: Den maksimale middelforskel i hjertefrekvens i forhold til placebo, efter baseline-korrektion, var 8,4 slag/minut (90 % CI = 7,0 til 9,8) og 20,3 slag/minut (90 % CI = 18,9 til 21,7) set 10 minutter efter administration af umeclidinium/vilanterol henholdsvis 113/22 mikrogram og 500/100 mikrogram.
English: Common Common Uncommon Rare
Danish: Almindelig Almindelig Ikke almindelig Sjælden
English: Exercise endurance and lung volumes
Danish: Fysisk udholdenhed og lungevolumen