FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available in patients with urinary retention, therefore Ultibro Breezhaler should be used with caution in these patients.
Danish: Der foreligger ingen data for patienter med urinretention, Ultibro Breezhaler bør derfor anvendes med forsigtighed hos disse patienter.
English: Systemic exposures (AUC) at the no-observed-adverse-effect level (NOAEL) were 79- and 126-fold higher than in humans, for indacaterol and glycopyrronium respectively.
Danish: Systemisk eksponering (AUC) ved no-effect-adverse-effect level (NOAEL) var for indacaterol og glycopyrronium henholdsvis 79 og 126 gange højere end hos mennesker.
English: In the 52-week active-controlled study, the mean pre-dose FEV1 was statistically significant in favour of Ultibro Breezhaler at all visits up to week 52 compared to fluticasone/salmeterol (LS mean treatment difference 62-86 ml, p<0.001).
Danish: I det 52-ugers aktiv-kontrolleret studie var den gennemsnitlige før-dosis FEV1 statistisk signifikant til fordel for Ultibro Breezhaler ved alle besøg op til uge 52 sammenlignet med fluticason/salmeterol (LS gennemsnitlig behandlingsforskel 62-86 ml, p<0,001).
English: • One Ultibro Breezhaler inhaler
Danish: • En Ultibro Breezhaler inhalator
English: Anticholinergic effects related to glycopyrronium
Danish: Antikolinerge virkninger relateret til glycopyrronium Snævervinklet glaukom
English: At 52 weeks, the reduction compared to fluticasone/salmeterol was statistically significant (LS mean treatment difference -1.3, p=0.003).
Danish: Efter 52 uger var reduktionen statistisk signifikant sammenlignet med fluticason/salmeterol (LS gennemsnitlig behandlingsforskel -1,3, p=0,003).
English: Steady-state exposure to indacaterol after Ultibro Breezhaler inhalation was either similar or slightly lower than systemic exposure after indacaterol monotherapy product inhalation.
Danish: Eksponering ved steady state af indacaterol efter inhalation af Ultibro Breezhaler var enten den samme eller en anelse lavere end systemisk eksponering efter inhalation af indacaterol monoterapiprodukt.
English: A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease.
Danish: En moderat gennemsnitlig forøgelse af total systemisk eksponering (AUClast) på op til 1,4 gange blev set hos forsøgspersoner med mildt og moderat nedsat nyrefunktion og op til 2,2 gange hos forsøgspersoner med svært nedsat nyrefunktion og slutstadiet af nyresygdom.
English: The number of all COPD exacerbations/patient-years was 3.34 for Ultibro Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Danish: Antallet af alle KOL-eksacerbationer/patient-år var 3,34 for Ultibro Breezhaler (2.893 tilfælde), 3,92 for glycopyrronium (3.294 tilfælde) og 3,89 for tiotropium (3.301 tilfælde).
English: The largest time-matched difference versus placebo was 4.62 ms (90% CI 0.40, 8.85 ms), the largest time-matched decrease was -2.71 ms (90% CI -6.97, 1.54 ms), indicating that Ultibro Breezhaler had no relevant impact on the QT interval, as was expected by the properties of its components.
Danish: Den største tidsmæssige forskel sammenlignet med placebo var 4,62 ms (90 % CI 0,40, 8,85 ms), og den største tidsmæssige nedsættelse var -2,71 ms (90 % CI -6,97, 1,54 ms), hvilket indikerer at Ultibro Breezhaler ikke har nogen relevant indvirkning på QT-intervallet.
English: • muscle pain, aches or tenderness.
Danish: • muskelsmerte, ømhed eller trykken.
English: • fast heart beat.
Danish: • hurtig hjerterytme.
English: • difficulty breathing with wheezing or coughing.
Danish: • vejrtrækningsbesvær med hvæsen eller hoste.
English: diuretics (water tablets) used for high blood pressure (such as hydrochlorothiazide),
Danish: Dette gælder: steroider (fx prednisolon), diuretika (vanddrivende tabletter), som bruges mod for højt blodtryk, såsom hydrochlorthiazid, medicin mod åndedrætsbesvær, som fx theofyllin.
English: Steady-state exposure to glycopyrronium after Ultibro Breezhaler inhalation was similar to systemic exposure after glycopyrronium monotherapy product inhalation.
Danish: Steady state eksponering af glycopyrronium efter inhalation af Ultibro Breezhaler var den samme som systemisk eksponering efter inhalation af glycopyrronium monoterapiproduktet.
English: A moderate mean increase in total system exposure (AUClast) to glycopyrronium of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease.
Danish: En moderat, gennemsnitlig forøgelse i den samlede systemiske eksponering (AUClast) af glycopyrronium på op til 1,4 gange er set hos forsøgspersoner med let og moderat nedsat nyrefunktion, og op til 2,2 gange hos forsøgspersoner med svært nedsat nyrefunktion og i slutstadiet af nyresygdom.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glukose/galactosemalabsorption.
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Danish: Udseende af Ultibro Breezhaler og pakningsstørrelser Ultibro Breezhaler 85 mikrogram/43 mikrogram inhalationspulver, hårde kapsler, er gennemsigtige og gule og indeholder et hvidt til næsten hvidt pulver.
English: Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.
Danish: Opbevar kapslerne i den originale blister for at beskytte mod fugt og må først tages ud lige før brug.
English: Due to the very low contribution of the urinary pathway to total body elimination of indacaterol maleate, a study in renal impaired subjects was not performed.
Danish: Da urinvejene spiller en meget lille rolle af den samlede udskillelse, er der ikke udført undersøgelser med forsøgspersoner med nedsat nyrefunktion.
English: Each inhaler should be disposed of after all capsules have been used.
Danish: Hver inhalator skal bortskaffes efter alle kapslerne er brugt.
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Danish: Knogler, led, muskler og bindevæv Muskuloskeletale smerter
English: If you forget to use Ultibro Breezhaler
Danish: Hvis du har glemt at tage Ultibro Breezhaler
English: In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ultibro Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo).
Danish: Hos raske, frivillige forsøgspersoner var virkningen på serumkalium meget lille efter indgift af en dosis, der var 4 gange højere end den anbefalede terapeutiske dosis af Ultibro Breezhaler (maksimal forskel sammenlignet med placebo var -0,14 mmol/l).
English: Breezhaler inhaler).
Danish: Breezhaler-inhalator).
English: Step 1e: Close inhaler
Danish: Trin 1e: Luk inhalatoren
English: Step 2b: Release side buttons
Danish: Trin 2b: Slip sideknapperne helt
English: Step 3b:
Danish: Trin 3b:
English: For use only with the inhaler provided in the pack.
Danish: Må kun bruges sammen med den vedlagte inhalator.
English: No data are available in patients with narrow-angle glaucoma, therefore Ultibro Breezhaler should be used with caution in these patients.
Danish: Der foreligger ingen data for patienter med snævervinklet glaukom, Ultibro Breezhaler bør derfor anvendes med forsigtighed hos disse patienter.
English: Effects on heart rate
Danish: Virkninger på hjertefrekvensen
English: Step 1c:
Danish: Trin 1c:
English: The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Ultibro Breezhaler (1,265 events) and 1.19 for fluticasone/salmeterol (1,452 events).
Danish: Antallet af moderate eller svære KOL-eksacerbationer/patientår var 0,98 for Ultibro Breezhaler (1.265 tilfælde) og 1,19 for fluticason/salmeterol (1.452 tilfælde).
English: It is not harmful.
Danish: Dette kan forekomme, og det er ikke farligt.
English: - you have seizure or fits.
Danish: - hvis du har kramper eller anfald.
English: Skin and subcutaneous tissue disorders Pruritus/rash
Danish: Hud og subkutane væv Kløe/udslæt
English: The number of all COPD exacerbations/patient-years was 3.59 for Ultibro Breezhaler (4,531 events) and 4.03 for fluticasone/salmeterol (4,969 events).
Danish: Antallet af alle KOL-eksacerbationer/patientår var 3,59 for Ultibro Breezhaler (4.531 tilfælde) og 4,03 for fluticason/salmeterol (4.969 tilfælde).
English: Ultibro Breezhaler has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at 26 weeks compared to placebo (LS mean treatment difference -3.01, p=0.002) and tiotropium (LS mean treatment difference -2.13, p=0.009) and reductions versus indacaterol and glycopyrronium were -1.09 and -1.18, respectively.
Danish: Ultibro Breezhaler har også vist en statistisk signifikant virkning på helbredsrelateret livskvalitet målt ved hjælp af St. George's Respiratory Questionnaire (SGRQ) udtrykt ved en reduktion i SGRQ totalscore efter 26 uger sammenlignet med placebo (LS gennemsnitlig behandlingsforskel -3,01, p=0,002) og tiotropium (LS gennemsnitlig behandlingsforskel -2,13, p=0,009) og reduktioner sammenlignet med indacaterol og glycopyrronium var henholdsvis -1,09 og -1,18.
English: There are no data available for the use of Ultibro Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).
Danish: Der er ingen tilgængelige data for brug af Ultibro Breezhaler til patienter med stærkt nedsat leverfunktion, der skal derfor iagttages forsigtighed hos disse patienter (se pkt.
English: A higher proportion of patients demonstrated clinically meaningful response at week 26 on Ultibro Breezhaler as compared to tiotropium (68.1% Ultibro Breezhaler versus 59.2% tiotropium, p=0.016) and fluticasone/salmeterol (65.1% Ultibro Breezhaler versus 55.5% fluticasone/salmeterol, p=0.088).
Danish: En signifikant højere andel af patienterne på Ultibro Breezhaler viste klinisk betydningsfuldt respons ved uge 26 sammenlignet med patienter på tiotropium (68,1 % Ultibro Breezhaler versus 59,2 % tiotropium, p=0,016) og patienter på fluticason/salmeterol (65,1 % Ultibro Breezhaler versus 55,5 % fluticason/salmeterol, p=0,088).
English: Over 26 weeks, Ultibro Breezhaler statistically significantly reduced the use of rescue medication (salbutamol) by 0.96 puffs per day (p<0.001) compared to placebo, 0.54 puffs per day (p<0.001) compared to tiotropium and 0.39 puffs per day (p=0.019) compared to fluticasone/salmeterol.
Danish: Ultibro Breezhaler nedsatte over 26 uger brugen af anfaldsmedicin (salbutamol) statistisk signifikant med 0,96 sug per dag (p<0,001) sammenlignet med placebo, 0,54 sug per dag (p<0,001) sammenlignet med tiotropium og 0,39 sug per dag (p=0,019) sammenlignet med fluticason/salmeterol.
English: How to inhale Ultibro Breezhaler - Ultibro Breezhaler is for inhalation use.
Danish: Sådan skal du inhalere Ultibro Breezhaler - Ultibro Breezhaler tages ved indånding.
English: The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Ultibro Breezhaler (812 events), 1.07 for glycopyrronium (900 events) and 1.06 for tiotropium (898 events).
Danish: Antallet af moderate til svære KOL-eksacerbationer/patientår var 0,94 for Ultibro Breezhaler (812 tilfælde), 1,07 for glycopyrronium (900 tilfælde) og 1,06 for tiotropium (898 tilfælde).
English: A higher percentage of patients receiving Ultibro Breezhaler responded with a clinically meaningful improvement in SGRQ score (defined as a decrease of at least 4 units from baseline) at week 26 compared to placebo (63.7% and 56.6% respectively, p=0.088) and tiotropium (63.7% Ultibro Breezhaler vs. 56.4% tiotropium, p=0.047), at week 64 compared to glycopyrronium and tiotropium (57.3% Ultibro Breezhaler versus 51.8% glycopyrronium, p=0.055; versus 50.8% tiotropium, p=0.051, respectively), and at week 52 compared to fluticasone/salmeterol (49.2% Ultibro Breezhaler vs. 43.7% fluticasone/salmeterol, odds ratio: 1.30, p<0.001).
Danish: En højere procentdel af patienter, som fik Ultibro Breezhaler, responderede med en klinisk betydningsfuld forbedring i SGRQ-score (defineret som et fald på mindst 4 enheder fra udgangsværdien) ved uge 26 sammenlignet med placebo (henholdsvis 63,7 % og 56,6 %, p=0,088) og tiotropium (63,7 % Ultibro Breezhaler versus 56,4 % tiotropium, p=0,047), ved uge 64 sammenlignet med glycopyrronium og tiotropium (henholdsvis 57,3 % Ultibro Breezhaler versus 51,8 % glycopyrronium, p=0,055; versus 50,8 % tiotropium, p=0,051), og ved uge 52 sammenlignet med fluticason/salmeterol (49,2 % Ultibro Breezhaler versus 43,7 % fluticason/salmeterol, odds ratio: 1,30, p<0,001).
English: Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp), raises the systemic exposure of indacaterol up to two-fold.
Danish: CYP3A4 og P-glycoprotein (P-gp) er centrale komponenter i udskillelsen af indacaterol.
English: It is unlikely that this medicine will affect your ability to drive and use machines.
Danish: Dette lægemiddel menes ikke at påvirke evnen til at køre bil eller betjene maskiner.
English: What you need to know before you use Ultibro Breezhaler
Danish: Det skal du vide, før du begynder at tage Ultibro Breezhaler
English: Mild irritancy of the nasal cavity and larynx were seen in rodents.
Danish: Mild irritation af næsehulen og svælget blev observeret hos gnavere.
English: The mean pre-dose FEV1 (average of the values taken at -45 and -15 minutes prior to the morning dose of study medication) was statistically significant in favour of Ultibro Breezhaler at week 26 compared to fluticasone/salmeterol (least squares [LS] mean treatment difference 100 ml, p<0.001), at week 52 compared to placebo (LS mean treatment difference 189 ml, p<0.001) and at all visits up to week 64 compared to glycopyrronium (LS mean treatment difference 70-80 ml, p<0.001) and tiotropium (LS mean treatment difference 60-80 ml, p<0.001).
Danish: Den gennemsnitlige før-dosis FEV1 (gennemsnittet af værdierne målt ved -45 og -15 minutter før morgendosis af studiemedicin) var statistisk signifikant til fordel for Ultibro Breezhaler sammenlignet med fluticason/salmeterol (least squares [LS] gennemsnitlig behandlingsforskel 100 ml, p<0,001) ved uge 26, sammenlignet med placebo (LS gennemsnitlig behandlingsforskel 189 ml, p<0,001) efter uge 52 og ved alle besøg op til uge 64 sammenlignet med glycopyrronium (LS gennemsnitlig behandlingsforskel 70-80 ml, p<0,001) og tiotropium (LS gennemsnitlig behandlingsforskel 60-80 ml, p<0,001).
English: Respiratory, thoracic and mediastinal disorders Cough
Danish: Luftveje, thorax og mediastinum Hoste
English: Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Ultibro Breezhaler.
Danish: Generelt sås ingen konsistent farmakodynamisk virkning af Ultibro Breezhaler på hjertefrekvensen over tid.
English: Step 3c:
Danish: Trin 3c:
English: • upset stomach, indigestion.
Danish: • maveonde, fordøjelsesproblemer.
English: COPD is a long-term disease and you should use Ultibro Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Fortsæt med at bruge Ultibro Breezhaler så længe din læge siger du skal gøre det. - KOL er en kronisk sygdom, og du skal tage Ultibro Breezhaler hver dag og ikke blot, når du har åndedrætsbesvær eller andre symptomer på KOL.
English: A thorough QT (TQT) study in healthy volunteers with high doses of inhaled indacaterol (up to twice the maximum recommended therapeutic dose) did not demonstrate a clinically relevant effect on the QT interval.
Danish: Der blev ikke vist klinisk relevant virkning på QT-intervallet i et omhyggeligt QT (TQT)-studie hos raske frivillige forsøgspersoner med inhalation af en høj dosis indacaterol (op til to gange den maksimalt anbefalede terapeutiske dosis).
English: Do not press the side buttons.
Danish: Tryk ikke på sideknapperne.
English: Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Udfra de kliniske farmakokinetiske karakteristika af dets monoterapikomponenter kan Ultibro Breezhaler anvendes i de anbefalede doser til patienter med mildt til moderat nedsat leverfunktion.
English: Close the inhaler and replace the cap.
Danish: Luk inhalatoren, og sæt hætten på igen.
English: Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Ultibro Breezhaler kan bruges i den anbefalede dosis til patienter med mildt til moderat nedsat leverfunktion.
English: Step 3a:
Danish: Trin 3a:
English: Inhalation use only
Danish: Kun til inhalation
English: • difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention.
Danish: • vanskelig og smertefuld vandladning - dette kan skyldes en forhindring i urinrøret eller akut vandladningsstop.
English: The capsules must not be swallowed.
Danish: Kapslerne må ikke synkes.
English: Gastrointestinal disorders Dyspepsia
Danish: Mave-tarm-kanalen Dyspepsi
English: • dental caries.
Danish: • huller i tænderne.
English: Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Danish: Hver kapsel indeholder 143 mikrogram indacaterolmaleat svarende til 110 mikrogram indacaterol og 63 mikrogram glycopyrroniumbromid svarende til 50 mikrogram glycopyrronium.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion eller slutstadiet af nyresygdom, som kræver dialyse, må det udelukkende bruges, hvis den forventede fordel opvejer den potentielle risiko (se pkt.
English: Breathe out fully Do not blow into the inhaler.
Danish: Tag en dyb udånding Du må ikke puste i mundstykket.
English: 6 or 10 Ultibro Breezhaler capsules to be used in the inhaler
Danish: • Et eller flere blisterkort, som hver indeholder enten 6 eller 10 Ultibro Breezhaler kapsler til brug i inhalatoren
English: • chest pain.
Danish: • brystsmerte.
English: Dysphonia
Danish: Dyspfoni
English: Cardiac disorders Ischaemic heart disease
Danish: Hjerte Iskæmisk hjertesygdom
English: Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.
Danish: Multipakning bestående af 96 (4 pakninger af 24x1) hårde kapsler og 4 inhalatorer.
English: Ultibro Breezhaler statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI); it demonstrated a statistically significant improvement in the TDI focal score at week 26 compared to placebo (LS mean treatment difference 1.09, p<0.001), tiotropium (LS mean treatment difference 0.51, p=0.007) and fluticasone/salmeterol (LS mean treatment difference 0.76, p=0.003).
Danish: Ultibro Breezhaler medførte statistisk signifikant reduktion af åndenød evalueret ved hjælp af Transitional Dyspnoea Index (TDI); og viste en statistisk signifikant forøgelse i TDI fokal score ved uge 26 sammenlignet med placebo (LS gennemsnitlig behandlingsforskel 1,09, p<0,001), tiotropium (LS gennemsnitlig behandlingsforskel 0,51, p=0,007) og fluticason/salmeterol (LS gennemsnitlig behandlingsforskel 0,76, p=0,003).
English: Multipack: 96 (4 packs of 24 x 1) capsules + 4 inhalers.
Danish: Multipakning: 96 (4 pakninger af 24 x 1) kapsler + 4 inhalatorer.
English: Ultibro Breezhaler increased post-dose trough FEV1 by 200 ml compared to placebo at the 26-week primary endpoint (p<0.001) and showed statistically significant increases compared to each monotherapy component treatment arm (indacaterol and glycopyrronium) as well as the tiotropium treatment arm, as shown in the below table.
Danish: Som vist i tabellen nedenfor forøgede Ultibro Breezhaler post-dosis dal-FEV1 med 200 ml sammenlignet med placebo ved det primære endepunkt (p<0,001) efter 26 uger, og viste statistisk signifikant forøgelse sammenlignet med såvel hver monoterapikomponent-behandlingsarm (indacaterol og glycopyrronium) som tiotropiumbehandlingsarmen.
English: Multipack comprising 4 packs (24 capsules + 1 inhaler)
Danish: Multipakning bestående af 4 pakninger (24 kapsler + 1 inhalator)
English: • tiredness.
Danish: • træthed.
English: Ultibro Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment.
Danish: Ultibro Breezhaler kan bruges ved den anbefalede dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Multipack comprising 25 packs (6 capsules + 1 inhaler)
Danish: Multipakning bestående af 25 pakninger (6 kapsler + 1 inhalator)
English: • dizziness.
Danish: • svimmelhed.
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
Danish: Ultibro Breezhaler 85 mikrogram/43 mikrogram inhalationspulver, hårde kapsler
English: 24 x 1 capsules + 1 inhaler.
Danish: 24 x 1 kapsler + 1 inhalator.
English: How to store Ultibro Breezhaler Contents of the pack and other information Instructions for use of Ultibro Breezhaler inhaler
Danish: Pakningsstørrelser og yderligere oplysninger Brugsanvisning til Ultibro Breezhaler-inhalator
English: Multipack comprising 15 packs (10 capsules + 1 inhaler)
Danish: Multipakning bestående af 15 pakninger (10 kapsler + 1 inhalator)
English: • combination of sore throat and runny nose - these may be signs of nasopharyngitis.
Danish: • kombination af ondt i halsen og løbende næse - dette kan være tegn på forkølelse
English: - you have kidney problems.
Danish: - hvis du har nyreproblemer.
English: Urinary tract infection
Danish: Urinvejsinfektioner
English: EXP The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Danish: EXP Inhalatoren i hver pakning skal smides ud efter alle kapsler i pakningen er brugt.
English: Ultibro Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium
Danish: Ultibro Breezhaler 85 mikrog/43 mikrog inhalationspulver indacaterol/glycopyrronium
English: Multipack: 150 (25 packs of 6 x 1) capsules + 25 inhalers.
Danish: Multipakning: 150 (25 pakninger af 6 x 1) kapsler + 25 inhalatorer.
English: Indacaterol and its metabolites transferred rapidly into the milk of lactating rats.Indacaterol was not embryotoxic or teratogenic in rats or rabbits.
Danish: Indacaterol var ikke embryotoksisk eller teratogent hos rotter eller kaniner.
English: 6 x 1 capsules + 1 inhaler.
Danish: 6 x 1 kapsler + 1 inhalator.
English: Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Danish: Multipakning bestående af 150 (25 pakninger af 6x1) hårde kapsler og 25 inhalatorer.
English: Insert
Danish: Indsæt
English: Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Danish: Multipakning bestående af 150 (15 pakninger af 10x1) hårde kapsler og 15 inhalatorer.
English: Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.
Danish: Multipakning: 150 (15 pakninger af 10 x 1) kapsler + 15 inhalatorer.
English: - you have thyroid gland problems (thyrotoxicosis).
Danish: - hvis du har problemer med skjoldbruskkirtlen (tyrotoksikose).
English: The amount of indacaterol and glycopyrronium inhaled is 85 micrograms (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms (equivalent to 54 micrograms of glycopyrronium bromide), respectively.
Danish: Mængden af indacaterol og glycopyrronium som inhaleres er henholdsvis 85 mikrogram (svarende til 110 mikrogram indacaterolmaleat) og 43 mikrogram (svarende til 54 mikrogram glycopyrroniumbromid).