FrancophonIA/ELRC3.0 huggingface dataset:
English: ∗ A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Danish: ∗En statistisk testprocedure med trinvis reduktion blev benyttet i dette studie, og denne sammenligning lå under en sammenligning, hvor der ikke blev opnået statistisk signifikans.
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Laventair Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Danish: Indsendelse af den endelige rapport for det kliniske observationssikkerhedsstudie (kohorte) efter godkendelsen (PAS - Post-Authorisation Safety) efter godkendelsen, der skal kvantificere incidensen og sammenlignende sikkerhed for udvalgte kardiovaskulære og cerebrovaskulære bivirkninger hos KOL-patienter forbundet med Laventair Ellipta i sammenligning med tiotropium (studie 201038), i henhold til den protokol, der er aftalt med PRAC.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with LAVENTAIR
Danish: Lungefunktion, symptomatiske og helbredsrelateret livskvalitets resultater ved uge 24
English: There was no evidence for tachyphylaxis in the effect of LAVENTAIR ELLIPTA over time.
Danish: Der var ingen tegn på takyfylaksi for effekten af Laventair Ellipta over tid.
English: - if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
Danish: - hvis du har forstørret prostata, vandladningsbesvær eller en blokering i blæren
English: LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Danish: Laventair Ellipta indeholder to aktive stoffer umeclidiniumbromid og vilanterol.
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with LAVENTAIR ELLIPTA and tiotropium; 49% and 54% for LAVENTAIR ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Danish: I de to andre studier med aktiv komparator opnåede en tilsvarende andel af patienterne som minimum MCID med Laventair Ellipta og tiotropium; 49 % og 54 % for Laventair Ellipta 55/22 mikrogram og 52 % og 55 % for tiotropium.
English: - ketoconazole or itraconazole, to treat fungal infections - clarithromycin or telithromycin, to treat bacterial infections - ritonavir, to treat HIV infection - medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) - other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
Danish: - ketoconazol eller itraconazol, til behandling af svampeinfektioner - clarithromycin eller telithromycin, til behandling af bakterieinfektioner - ritonavir, til behandling af hiv-infektion - medicin der nedsætter mængden af kalium i dit blod, såsom diuretika (vanddrivende tabletter) eller visse lægemidler til behandling af astma (f.eks. methylxanthine eller steroider) - andre langtidsvirkende lægemidler, som minder om Laventair Ellipta, til behandling af vejrtrækningsproblemer, f.eks. tiotropium eller indacaterol.
English: In the second study, the treatment difference in EET between LAVENTAIR ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Danish: I det andet studie var behandlingsforskellen i EET mellem Laventair Ellipta 55/22 mikrogram og placebo 21,9 sekunder (p = 0,234) ved uge 12.
English: LAVENTAIR ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Danish: Laventair Ellipta viste forbedringer af lungefunktion (defineret som ændring i forhold til baseline i troughFEV1) i flere studier.
English: LAVENTAIR ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Danish: Laventair Ellipta må ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your LAVENTAIR ELLIPTA inhaler:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød, umiddelbart efter at du har brugt din Laventair Ellipta inhalator:
English: The European Medicines Agency has waived the obligation to submit the results of studies with LAVENTAIR ELLIPTA in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Laventair Ellipta i alle undergrupper af den pædiatriske population ved indikationen KOL (se pkt.
English: LAVENTAIR ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Danish: Laventair Ellipta viste også en større stigning fra baseline i antal dage uden behov for anfaldsmedicin i alle tre studier (gennemsnit indenfor intervallet 17,6-21,5 %) sammenlignet med tiotropium (gennemsnit indenfor intervallet 11,7-13,4 %).
English: It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Laventair Ellipta går over i modermælken.
English: Eye problems during treatment with LAVENTAIR ELLIPTA
Danish: Øjenproblemer under behandling med Laventair Ellipta
English: The ELLIPTA inhaler contains pre-dispensed doses and is ready to use.
Danish: Ellipta-inhalatoren indeholder afdelte doser og er klar til brug.
English: The use of LAVENTAIR ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution.
Danish: Anvendelse af Laventair Ellipta er ikke undersøgt hos patienter med svært nedsat leverfunktion og skal derfor anvendes med forsigtighed til disse patienter.
English: LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Laventair Ellipta er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: To use LAVENTAIR ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
Danish: Laventair Ellipta tages ved at indånde medicinen ned i dine lunger gennem munden ved hjælp af Ellipta-inhalatoren.
English: The first time you use LAVENTAIR 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 Laventair Ellipta første gang, den indeholder afdelte doser og er klar til brug med det samme.
English: Package leaflet: Information for the user LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Laventair Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt umeclidinium/vilanterol Dette lægemiddel er underlagt supplerende overvågning.
English: BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 00 info@bial.com
Danish: Portela & Ca. SA. Tel: + 351 22 986 61 00 info@bial.com
English: Use LAVENTAIR ELLIPTA regularly
Danish: Tag Laventair Ellipta regelmæssigt
English: If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA.
Danish: Hvis du ammer, skal du tale med lægen, før du begynder at tage Laventair Ellipta.
English: In the three 6-month active-comparator-controlled studies, LAVENTAIR 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 Laventair Ellipta forbruget af anfaldsmedicin (salbutamol) sammenlignet med tiotropium med statistisk signifikante reduktioner observeret i to af studierne (se tabel 1).
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 LAVENTAIR 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 Laventair Ellipta (49 %) sammenlignet med placebo (34 %) og hver monoterapikomponent (44 % for umeclidinium og 48 % for vilanterol).
English: Inhalation powder, pre-dispensed 1 inhaler of 30 doses
Danish: Inhalationspulver, afdelt 1 inhalator med 30 doser
English: LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Danish: Laventair Ellipta anvendes til behandling af kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: What you need to know before you use LAVENTAIR ELLIPTA 3.
Danish: Det skal du vide, før du begynder at tage Laventair Ellipta 3.
English: those for the LAVENTAIR ELLIPTA dose and provided additional supportive evidence for the efficacy of LAVENTAIR ELLIPTA.
Danish: Resultaterne var sammenlignelige med resultater for Laventair Ellipta dosis og gav yderligere understøttende evidens for virkningen af Laventair Ellipta.
English: In addition, LAVENTAIR 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: Laventair 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: 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: LAVENTAIR ELLIPTA showed a statistically significant reduction in SGRQ total score compared with tiotropium in one of the three activecomparator studies (see Table 1).
Danish: Laventair 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: LAVENTAIR 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: Laventair 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: If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with LAVENTAIR ELLIPTA:
Danish: Hvis du under behandling med Laventair Ellipta får øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne:
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-esacerbation øget med 20 % og 90 % i to studier (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: LAVENTAIR ELLIPTA contains lactose
Danish: Laventair Ellipta indeholder lactose
English: In one active-comparator study, a higher percentage of patients receiving LAVENTAIR 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 SGRQscore ved uge 24, der fik Laventair Ellipta (53 %) sammenlignet med tiotropium (46 %).
English: If you stop using LAVENTAIR ELLIPTA
Danish: Hvis du holder op med at tage Laventair Ellipta
English: Multipack: 90 (3 packs of 30) doses
Danish: Inhalationspulver, afdelt Multipakning: 90 doser (3 pakninger med 30) doser
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 Laventair Ellipta eller gøre det mere sandsynligt, at du får bivirkninger.
English: In the first study, LAVENTAIR 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 Laventair 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: In one 6-month Phase III study, LAVENTAIR 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 Laventair 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: 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 LAVENTAIR 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 Laventair Ellipta (58 %) sammenlignet med placebo (41 %) og hver monoterapikomponent (53 % for umeclidinium og 51 % for vilanterol).
English: The maximum dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Danish: Den maksimale dosis er én inhalation af Laventair Ellipta 55/22 mikrogram én gang daglig.
English: The recommended dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Danish: Den anbefalede dosis er én inhalation af Laventair Ellipta 55/22 mikrogram én gang daglig.
English: LAVENTAIR ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Danish: Laventair Ellipta (N=454) versus tiotropium 18 mikrogram (N=451) (studie ZEP117115)
English: Your LAVENTAIR ELLIPTA inhaler carton contains
Danish: Din æske med Laventair Ellipta inhalator indeholder
English: LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed.
Danish: Laventair Ellipta er inhalationspulver, afdelt.
English: LAVENTAIR ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Danish: Laventair Ellipta 55/22 mikrogram viste desuden statistisk signifikante forbedringer sammenlignet med placebo i ændring fra baseline af lungevolumen, målt ved trough og 3 timer efter dosering ved uge 12 i det første studie (inspiratorisk kapacitet: henholdsvis 237 ml og 316 ml, residualvolumen: henholdsvis -466 ml og -643 ml, samt funktionel residualkapacitet: henholdsvis -351 ml og -522 ml, alle p < 0,001).
English: What you need to know before you use LAVENTAIR ELLIPTA Do not use LAVENTAIR ELLIPTA:
Danish: Det skal du vide, før du begynder at tage Laventair Ellipta Tag ikke Laventair Ellipta
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, LAVENTAIR ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Danish: I et 24 ugers placebo kontrolleret studie hos patienter med symptomatisk KOL, reducerede Laventair Ellipta risikoen for KOL-eksacerbation med 50 % sammenlignet med placebo (baseret på analyse af tiden til første eksacerbation; hazard ratio (HR) 0,5; 95% CI:0,3, 0,8; p = 0,004*), med 20 % sammenlignet med umeclidinium (HR 0,8; 95% CI: 0,5, 1,3; p = 0,391) og med 30 % sammenlignet med vilanterol (HR 0,7; 95% CI: 0,4, 1,1; p = 0,121).
English: Τηλ: + 30 210 8316111-13
Danish: Menarini Hellas A.E. Τηλ: + 30 210 316111-13
English: Renal impairment No dose adjustment is required in patients with renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: LAVENTAIR ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Danish: Laventair Ellipta viste en statisk signifikant og klinisk relevant reduktion i åndenød, ved vurdering ud fra en stigning i TDI (Transition Dyspnea Index) fokal score ved uge 24 (sekundært endepunkt) sammenlignet med placebo (se tabel 1).
English: Contents of the pack and other information What LAVENTAIR ELLIPTA contains
Danish: Pakningsstørrelser og yderligere oplysninger Laventair Ellipta indeholder:
English: - if you have an eye problem called narrow-angle glaucoma
Danish: - hvis du har problemer med øjnene, der kaldes snævervinklet grøn stær
English: In the second study, LAVENTAIR ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Danish: I det andet studie viste Laventair Ellipta 55/22 mikrogram forbedringer sammenlignet med placebo i ændring fra baseline af lungevolumen, målt ved trough og 3 timer efter dosering ved uge 12 (inspiratorisk kapacitet: henholdsvis 198 ml og 238 ml, residualvolumen: henholdsvis -295 ml og -351 ml og funktionel residualkapacitet: henholdsvis -238 ml og -302 ml, alle p < 0,001∗).
English: LAVENTAIR ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360)
Danish: Laventair Ellipta (N=207) versus tiotropium 18 mikrogram (N=203) (studie DB2113360)
English: How to use LAVENTAIR ELLIPTA 4.
Danish: Sådan skal du tage Laventair Ellipta 4.
English: If you do not have a quick-acting inhaler contact your doctor.
Danish: Kontakt din læge hvis du ikke har en hurtigvirkende inhalator.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med heretitær galactoseintolerans, total lactasemangel eller glucose-/galactosemalabsorption.
English: 1 inhaler of 7 doses 1 inhaler of 30 doses
Danish: Inhalationspulver, afdelt 1 inhalator med 7 doser 1 inhalator med 30 doser
English: LAVENTAIR ELLIPTA is for inhalation use.
Danish: Laventair Ellipta er til inhalationsbrug.
English: LAVENTAIR ELLIPTA is for inhalation use only.
Danish: Laventair Ellipta er kun beregnet til inhalation.
English: LAVENTAIR ELLIPTA (N = 217) versus tiotropium 18 mcg (N = 215) (Study DB2113374)
Danish: Laventair Ellipta (N=217) versus tiotropium 18 mikrogram (N=215) (studie DB2113374)
English: LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
Danish: Laventair Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt
English: LAVENTAIR ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Danish: Laventair Ellipta 55/22 mikrog inhalationspulver umeclidinium/vilanterol
English: LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Danish: Laventair Ellipta viste en stigning fra baseline i antal dage uden behov for anfaldsmedicin (gennemsnitligt 11,1 %) sammenlignet med et fald fra baseline med placebo (gennemsnitligt 0,9 %).
English: LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Danish: Laventair Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt umeclidinium/vilanterol
English: Other medicines and LAVENTAIR ELLIPTA
Danish: Brug af anden medicin sammen med Laventair Ellipta
English: LAVENTAIR ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Danish: Laventair Ellipta 55 mikrogram forbedrede fysisk udholdenhed målt ved fysisk anstrengelse sammenlignet med placebo, vurderet ved Endurance Shuttle Walk Test (ESWT) i ét studie, men ikke i det andet.
English: - if you suffer from epilepsy
Danish: - hvis du lider af epilepsi - hvis du har problemer med skjoldbruskkirtlen - hvis du har sukkersyge
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Danish: Hver enkelt inhalation afgiver en leveret dosis (den dosis, der afgives fra mundstykket) på 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid) og 22 mikrogram vilanterol (som trifenatat).
English: Placebo (N = 280) LAVENTAIR ELLIPTA (N = 413) versus
Danish: Placebo (N=280) Laventair Ellipta (N=413) versus umeclidinium 55 mikrogram (N=418) Laventair Ellipta (N=413) versus vilanterol 22 mikrogram (N=421)
English: If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Danish: Kontakt straks lægen eller apoteket, hvis du ved et uheld har taget for meget af Laventair Ellipta, da du kan have brug for lægehjælp.