FrancophonIA/ELRC3.0 huggingface dataset:
English: In a Phase III, 6-month study (DB2113373) Rolufta Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Danish: I et fase III-studie af 6 måneders varighed (DB2113373) viste Rolufta Ellipta klinisk relevant forbedring 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 30 minutter efter administration af den første dosis, med en forbedring på 102 ml (p < 0,001∗) sammenlignet med placebo.
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 Rolufta Ellipta:
Danish: Hvis du under behandling med Rolufta Ellipta får øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR YDRE KARTON (UDEN BLUE BOX - KUN MULTIPAKNING) 55 mikrogram
English: Don't use this medicine if you are pregnant unless your doctor tells you so.
Danish: Brug ikke dette lægemiddel, medmindre lægen siger, at du .
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium is co-administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in CYP2D6 activity (poor metabolisers).
Danish: Der forventes ingen klinisk relevant interaktion på baggrund af størrelsesordenen af disse ændringer, når umeclidinium administreres samtidigt med CYP2D6-hæmmere eller ved administration til patienter, som genetisk mangler CYP2D6-aktivitet (patienter med nedsat metabolisme).
English: Animal studies indicate no effects of umeclidinium bromide on fertility.
Danish: Dyrestudier viste ingen effekt af umeclidiniumbromid på fertiliteten.
English: Treatment should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Danish: Hvis der opstår paradoks bronkospasme, skal behandlingen med umeclidiniumbromid omgående seponeres, og anden behandling iværksættes, hvis det er nødvendigt.
English: If stored in the 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: Urinary elimination accounted for 22% of the administered radiolabelled dose by 168 hours (27% of recovered radioactivity).
Danish: 22 % af den administrerede radioaktivt mærkede dosis var elimineret via urinen efter 168 timer (27 % af genfunden radioaktivitet).
English: 2 years In-use shelf-life after opening the tray: 6 weeks.
Danish: 2 år Holdbarhed efter anbrud af bakken: 6 uger.
English: Don't breathe out into the inhaler.
Danish: Ånd ikke ud i inhalatoren.
English: There are no data on the effects of umeclidinium bromide on human fertility.
Danish: Der foreligger ingen data om virkningen af umeclidiniumbromid på fertilitet hos mennesker.
English: The mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml (p<0.001*) at Week 24.
Danish: De gennemsnitlige forbedringer i FEV1 inden for de første 6 timer efter dosering, i forhold til placebo, var 130 ml (p < 0,001∗) ved uge 24.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 55 micrograms
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERETIKET (MED BLUE BOX - MULTIPAKNING) 55 mikrogram
English: No effect of verapamil was observed on umeclidinium bromide Cmax.
Danish: Der blev ikke observeret nogen effekt af verapamil på Cmax for umeclidiniumbromid.
English: In two 12-week, placebo controlled studies (200109 and 200110), the addition of Rolufta Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001 and 122 mL 95% CI: 91, 152; p<0.001).
Danish: I to 12-ugers placebokontrollerede studier (200109 og 200110) viste tillæg af Rolufta Ellipta til fluticasonfuroat/vilanterol (FF/VI) (92/22 mikrogram) én gang daglig til voksne patienter med en klinisk diagnose af KOL en statistisk signifikant og klinisk relevant forbedring af det primære endepunkt troughFEV1 ved dag 85, sammenlignet med placebo plus FF/VI (124 ml 95 % CI: 93, 154; p < 0,001 og 122 ml 95 % CI: 91, 152; p < 0,001).
English: Common Uncommon Not known
Danish: Almindelig Ikke almindelig Ikke kendt
English: If you stop using Rolufta Ellipta
Danish: Hvis du holder op med at tage Rolufta Ellipta
English: In the 12-week study, Rolufta Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
Danish: I studiet af 12 ugers varighed reducerede Rolufta Ellipta forbruget af anfaldsmedicin (salbutamol) sammenlignet med placebo (gennemsnitligt en reduktion på 0,7 pust pr. dag over uge 1-12, p = 0,025), og der blev set en højere procentdel af dage uden behov for anfaldsmedicin (gennemsnitligt 46,3 %) sammenlignet med placebo (gennemsnitligt 35,2 % - der blev ikke foretaget nogen formel statistisk analyse på dette endepunkt).
English: Don't use Rolufta Ellipta as well as these other medicines.
Danish: Du må ikke tage Rolufta Ellipta, hvis du allerede tager nogen af disse lægemidler.
English: • Obligation to conduct post-authorisation measures
Danish: Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter.
Danish: Hvidt pulver i en grå inhalator (Ellipta) med en lysegrøn beskyttelseshætte over mundstykket og en dosistæller.
English: Rolufta Ellipta is an inhalation powder, pre-dispensed.
Danish: Rolufta Ellipta er inhalationspulver, afdelt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (ENKELTPAKNINGER) 55 mikrogram
English: Multipacks containing 90 (3 inhalers of 30) doses are also available.
Danish: Multipakninger med 90 doser (3 inhalatorer med 30 doser) fås også.
English: The most frequently reported adverse reactions with Rolufta Ellipta were nasopharyngitis and upper respiratory tract infection.
Danish: Sammendrag af sikkerhedsprofilen De hyppigst rapporterede bivirkninger ved Rolufta Ellipta var nasopharyngitis og infektion i de øvre luftveje.
English: In both of the pivotal 12-week and 24-week studies, Rolufta Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Danish: Både i det pivotale studie af 12 ugers varighed og det pivotale studie af 24 ugers varighed viste Rolufta Ellipta statistisk signifikante og klinisk relevante forbedringer af lungefunktionen (defineret som ændring i forhold til baseline i trough-FEV1 ved henholdsvis uge 12 og uge 24, hvilket var det primære effektendepunkt i begge studier) sammenlignet med placebo (se tabel 1).
English: Your Rolufta Ellipta inhaler carton contains
Danish: Din æske med Rolufta Ellipta inhalator indeholder
English: In the 24-week study treatment with Rolufta Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Rolufta Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Danish: I de 24 ugers forsøgsbehandling med Rolufta Ellipta var den gennemsnitlige (SD) ændring i forhold til baseline i antal pust af anfaldsmedicin (salbutamol) over behandlingsperioden på 24 uger -1,4 (0,20) for placebo og -1,7 (0,16) for Rolufta Ellipta (forskel = -0,3, 95 % CI: -0,8, 0,2, p = 0,276).
English: It is packaged in a foil laminate tray with a peelable foil lid.
Danish: Den er pakket i en bakke af laminatfolie med et afriveligt folielåg.
English: No dosage adjustment is required in patients with renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: • irregular heart beat
Danish: • uregelmæssig hjerterytme (puls)
English: Other antimuscarinics
Danish: Andre antimuskarinika
English: How to use Rolufta Ellipta 4.
Danish: Sådan skal du tage Rolufta Ellipta 4.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
English: • constipation.
Danish: • forkølelse
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum
English: Rare side effects
Danish: Sjældne bivirkninger
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 12 was greater for Rolufta Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Danish: Andelen af patienter, der som minimum responderede med MCID i SGRQ-scoren (defineret som et fald på 4 enheder i forhold til baseline) ved uge 12, var større for Rolufta Ellipta 55 mikrogram (44 %) sammenlignet med placebo (26 %) i studiet af 12 ugers varighed.
English: The dose counter counts down by 1 to confirm.
Danish: Dosistælleren har nu talt 1 ned.
English: Rolufta Ellipta also demonstrated a statistically significant 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 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Danish: Rolufta 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 12 sammenlignet med placebo (-7,90 enheder, p < 0,001) i studiet af 12 ugers varighed.
English: c) Close the inhaler
Danish: c) Luk inhalatoren
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Umeclidinium bromide has not been evaluated in subjects with severe hepatic impairment.
Danish: Umeclidiniumbromid er ikke vurderet hos patienter med svært nedsat leverfunktion.
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Danish: Patienten skal rådes til først at åbne bakken, når han eller hun er klar til at inhalere en dosis.
English: The MAH shall complete, within the stated timeframe, the below measure:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Similarly, a greater proportion of patients achieved ≥1 unit TDI focal score for Rolufta Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Danish: Ligeledes opnåede en større andel af patienterne ≥ 1 enhed i TDI fokal score for Rolufta Ellipta (53 %) sammenlignet med placebo (41 %) ved uge 24 i studiet af 24 ugers varighed.
English: Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium bromide is co-administered with P-gp inhibitors.
Danish: Der forventes ingen klinisk relevant interaktion på baggrund af størrelsesordenen af disse ændringer, når umeclidiniumbromid administreres samtidigt med P-gp-hæmmere.
English: In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Rolufta Ellipta (1.0 units, p=0.05).
Danish: I studiet af 12 ugers varighed blev der ikke påvist en statistisk signifikant forbedring sammenlignet med placebo i TDI fokal score ved uge 12 for Rolufta Ellipta (1,0 enheder, p = 0,05).
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Rolufta Ellipta is for inhalation use.
Danish: Rolufta Ellipta er til inhalationsbrug.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Common
Danish: Almindelig
English: 1 inhaler of 30 doses.
Danish: 1 inhalator med 30 doser.
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: The “Discard by” date is 6 weeks from the date you opened the tray.
Danish: Datoen ”Kasseres senest” er 6 uger fra den dag, hvor bakken blev åbnet.
English: When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
Danish: Når bakken er åbnet, skal du skrive datoen for ”Kasseres senest” i det dertil beregnede felt på inhalatorens etiket.
English: The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Danish: Inhalatoren er pakket i en bakke, der indeholder en pose med tørremiddel for at beskytte mod fugt.
English: The tray is sealed with a peelable foil lid.
Danish: Bakken er forseglet med et afriveligt folielåg.
English: Symptomatic outcomes
Danish: Symptomudfald
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Rolufta Ellipta (38%) compared with placebo (15%) in the 12-week study.
Danish: Andelen af patienter, der som minimum responderede med mindste klinisk relevante ændring (MCID) på 1 enhed i TDI fokal score ved uge 12, var større for Rolufta Ellipta (38 %) sammenlignet med placebo (15 %) i studiet af 12 ugers varighed.
English: What you need to know before you use Rolufta Ellipta Do not use Rolufta Ellipta:
Danish: Det skal du vide, før du begynder at tage Rolufta Ellipta Tag ikke Rolufta Ellipta
English: • headache
Danish: • hovedpine
English: Similarly, a greater proportion of patients achieved at least the MCID for Rolufta Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Danish: Ligeledes opnåede en større andel af patienterne som minimum MCID for Rolufta Ellipta ved uge 24 (44 %) sammenlignet med placebo (34 %) i studiet af 24 ugers varighed.
English: Rolufta Ellipta is for inhalation use only.
Danish: Rolufta Ellipta er kun beregnet til inhalation.
English: if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
Danish: - hvis du har forstørret prostata, vandladningsbesvær eller en blokering i blæren - hvis du har alvorlige leverproblemer.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase Deficiency) eller glucose-/galactosemalabsorption.
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Danish: Datoen ”Kasseres senest” er 6 uger efter den dag, hvor bakken åbnes.
English: Immune system disorders
Danish: Immunsystemet
English: In use shelf-life: 6 weeks.
Danish: Holdbarhed efter anbrud: 6 uger.
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Danish: Hver afgivet dosis indeholder 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid).
English: If you do not have a quick-acting inhaler contact your doctor.
Danish: Kontakt din læge hvis du ikke har en hurtigtvirkende inhalator.
English: How to use the inhaler
Danish: Sådan bruges inhalatoren
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I PRODUKTRESUMÉ
English: Use of rescue medicinal product
Danish: Brug af anfaldsmedicin
English: b) How to inhale the medicinal product
Danish: b) Sådan inhaleres medicinen
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: The inhaler should be held away from the mouth breathing out as far as is comfortable.
Danish: Hold inhalatoren væk fra munden, og foretag den dybeste udånding, du finder behagelig.
English: Uncommon Uncommon Uncommon Uncommon Common
Danish: Ikke almindelig Ikke almindelig Ikke almindelig Ikke almindelig Almindelig
English: Inhalation powder, pre-dispensed.
Danish: Inhalationspulver, afdelt.
English: Rolufta Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12-week pivotal study.
Danish: Rolufta Ellipta viste en statistisk signifikant større forbedring i forhold til baseline i vægtet middelværdi for FEV1 over 0-6 timer efter dosering ved uge 12 sammenlignet med placebo (166 ml, p < 0,001) i det pivotale studie af 12 ugers varighed.
English: Do not shake the inhaler.
Danish: Omryst ikke inhalatoren.
English: Lactose monohydrate, Magnesium stearate.
Danish: Lactosemonohydrat Magnesiumstearat
English: Rolufta Ellipta contains lactose
Danish: Rolufta Ellipta indeholder lactose
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Danish: Hver enkelt inhalation leverer en afgivet dosis (den dosis, der afgives fra mundstykket) på 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid).
English: EXPIRY DATE
Danish: UDLØBSDATO
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Rolufta Ellipta (1.0 units, p<0.001) in the 24-week study.
Danish: Der blev påvist en statistisk signifikant forbedring sammenlignet med placebo i TDI fokal score ved uge 24 for Rolufta Ellipta (1,0 enheder, p < 0,001) i studiet af 24 ugers varighed.
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Danish: Rolufta Ellipta 55 mikrogram inhalationspulver, afdelt
English: • sore throat
Danish: • ondt i halsen
English: • faster heart beat
Danish: • hurtigere hjerterytme (puls)
English: Common Common Common Common Uncommon
Danish: Almindelig Almindelig Almindelig Almindelig Ikke almindelig
English: Other medicines and Rolufta Ellipta
Danish: Brug af anden medicin sammen med Rolufta Ellipta
English: Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
Danish: Forbedring af lungefunktionen blev understøttet af et reduceret forbrug af salbutamol i ugerne 1-12 (-0,4 pust pr. dag (95 % CI: -0,7, -0,2; p < 0,001) og -0,3 pust pr. dag (95 % CI: -0,5, -0,1; p = 0,003)), sammenlignet med placebo plus FF/VI.
English: An approximately 1.4-fold increase in umeclidinium bromide AUC was observed.
Danish: AUC for umeclidiniumbromid blev øget ca. 1,4 gange.
English: The tray contains a desiccant packet, to reduce moisture in the packaging.
Danish: Bakken indeholder en pose med tørremiddel for at beskytte mod fugt i pakningen.
English: Rolufta Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Danish: Rolufta Ellipta indeholder det aktivt stof, umeclidiniumbromid.
English: Write the date the inhaler should be discarded on the label in the space provided.
Danish: Skriv datoen for, hvornår inhalatoren skal kasseres, i det dertil beregnede felt på etiketten.
English: Pregnancy and breast-feeding
Danish: Graviditet og amning
English: Pack sizes of 7 and 30 dose inhaler.
Danish: Pakningsstørrelser med inhalator med 7 eller 30 doser.
English: Rolufta Ellipta demonstrated a greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p<0.001*) in the 24-week pivotal study.
Danish: Rolufta Ellipta viste en større forbedring i forhold til baseline i vægtet middelværdi for FEV1 over 0-6 timer efter dosering ved uge 24 sammenlignet med placebo (150 ml, p<0,001∗) i det pivotale studie af 24 ugers varighed.
English: Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Danish: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
English: • Dizziness
Danish: • udslæt
English: The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover and a dose counter.
Danish: Ellipta-inhalatoren er en grå inhalator af plast med en lysegrøn beskyttelseshætte over mundstykket og en dosistæller.
English: Due date
Danish: Tidsfrist
English: Desiccant
Danish: Udslæt
English: Subjects with severe renal impairment (creatinine clearance <30mL/min) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with severe renal impairment and healthy volunteers.
Danish: viste ingen tegn på øget systemisk eksponering over for umeclidiniumbromid (Cmax og AUC), og der var ingen tegn på ændret proteinbinding mellem patienter med svært nedsat nyrefunktion og raske personer.
English: Not known Not known Not known Rare
Danish: Ikke kendt Ikke kendt Ikke kendt Sjælden
English: If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
Danish: Hvis dosistælleren ikke tæller ned, når "klikket" høres, vil inhalatoren ikke afgive en dosis.
English: The air vents should not be blocked with fingers during use.
Danish: Spær ikke for luftkanalerne med fingrene under inhalationen.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: 4) Close the inhaler
Danish: Luk inhalatoren
English: Posology
Danish: Indlægsseddel
English: Wait to open the cover until you are ready to inhale your dose.
Danish: Klargøring af dosis Vent med at åbne beskyttelseshætten, til du er klar til at inhalere din dosis.
English: Versus Placebo mcg = micrograms 1.least squares mean (95% confidence interval)
Danish: 1Middelværdi udregnet med mindste kvadraters metode (95 % konfidensinterval).
English: Hepatic impairment
Danish: Hovedpine Dysgeusi Svimmelhed
English: Glaucoma
Danish: Glaukom
English: At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001).
Danish: for FF/UMEC/VI sammenlignet med FF/VI (gennemsnitlig forskel: +94 ml vs. -3 ml; behandlingsforske: 97 ml; 95 % CI: 85, 109; p < 0,001).
English: No new adverse drug reactions were identified with the addition of Rolufta Ellipta to FF/VI in these studies.
Danish: Tillæg af Rolufta Ellipta til FF/VI i disse studier resulterede ikke i identifikation af nye bivirkninger.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.