FrancophonIA/ELRC3.0 huggingface dataset:
English: Ultibro Breezhaler is recommended to be administered at the same time of the day each day.
Danish: Det anbefales at tage Ultibro Breezhaler på samme tidspunkt hver dag.
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential for glycopyrronium bromide.
Danish: Genotoksicitetsforsøg viste ikke mutagent eller klastogent potentiale for glycopyrroniumbromid.
English: Glycopyrronium at the recommended dose can be safely used in all age and body weight groups.
Danish: Glycopyrronium kan anvendes sikkert i alle alders- og vægtgrupper i den anbefalede dosis.
English: In the 52-week activecontrolled study, patients were enrolled who had moderate to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
Danish: I det 52-ugers aktiv-kontrolleret studie blev der inkluderet patienter med moderat til meget svær KOL med en anamnese ≥1 moderat eller svær KOL-eksacerbationer i det foregående år.
English: The inhaler provided with each new prescription should be used.
Danish: Inhalatoren, der medfølger ved hver ny ordination, skal anvendes.
English: Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Danish: Indacaterol kan hæmme veer ved fødslen pga. en afslappende virkning på den glatte muskulatur i uterus.
English: Keep the inhaler dry.
Danish: Hold inhalatoren tør.
English: Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ultibro Breezhaler and indacaterol monotherapy product.
Danish: På grundlag af in vitro performancedata forventes dosis af indacaterol leveret til lungerne at være den samme for Ultibro Breezhaler og indacaterol monoterapiproduktet.
English: The effects on heart rate for Ultibro Breezhaler increased in magnitude and duration when compared with the changes observed for each component alone consistent with an additive response.
Danish: Ultibro Breezhaler havde en både kraftigere og længere varende virkning på hjertefrekvensen sammenlignet med ændringerne observeret for hver af komponenterne alene, hvilket er i overensstemmelse med en additiv virkning.
English: Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients.
Danish: Ultibro Breezhaler er ikke undersøgt hos patienter med ukontrolleret diabetes mellitus, og derfor anbefales forsigtighed og passende monitorering af denne patientgruppe.
English: Only use the capsules with the inhaler provided in this pack (Ultibro
Danish: Brug kun kapslerne sammen med den vedlagte inhalator (Ultibro
English: INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF MULTIPACK
Danish: INDERSIDE AF LÅGET PÅ YDERKARTON TIL ENKELTPAKNING OG PÅ DELPAKNING AF MULTIPAKNING
English: Blister card
Danish: Blisterkort
English: Renal impairment has an impact on the systemic exposure to glycopyrronium bromide.
Danish: Nedsat nyrefunktion har en indvirkning på systemisk eksponering for glycopyrroniumbromid.
English: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
Danish: Inhalation af høje doser beta2-adrenerge agonister kan medføre forhøjet plasmaglukose.
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on day 14 or day 15 compared to day 1, was in the range of 2.9 to 3.8 for once-daily inhaled doses between 60 micrograms and 480 micrograms (delivered dose).
Danish: Indacaterols gennemsnitlige akkumulationsforhold (dvs. AUC målt over et 24 timers doseringsinterval på dag 14 eller dag 15 sammenlignet med dag 1) var i intervallet 2,9 til 3,8 for doser mellem 60 mikrogram and 480 mikrogram inhaleret en gang dagligt (leveret dosis).
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Danish: Beta2-adrenerge agonister kan medføre signifikant hypokaliæmi hos visse patienter, hvilket potentielt kan medføre kardiovaskulære bivirkninger.
English: Systemic exposures (AUC) in rats and mice at the no-observed-adverse-effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with indacaterol once a day at the maximum recommended therapeutic dose.
Danish: Systemisk eksponering (AUC) hos rotter og mus i disse forsøg ved dosisniveauer, hvor ingen skadelig virkning kunne observeres, var henholdsvis mindst 7 og 49 gange større end hos mennesker, som behandles med indacaterol en gang dagligt med den maksimalt anbefalede terapeutiske dosis.
English: Glycopyrronium is cleared predominantly from the systemic circulation by renal excretion.
Danish: Glycopyrronium cleares hovedsageligt fra systemisk cirkulation ved renal udskillelse.
English: The mean terminal elimination half-life was much longer after inhalation (33 to 57 hours) than after intravenous (6.2 hours) and oral (2.8 hours) administration.
Danish: Plasmakoncentrationer af glycopyrronium faldt på multifasisk vis. Middeltallet for terminal eliminationshalveringstid var meget længere efter inhalation (33 til 57 timer) end efter intravenøs (6,2 timer) og oral (2,8 timer) administration.
English: Time to first pneumonia was prolonged with Ultibro Breezhaler compared to fluticasone/salmeterol (p=0.013).
Danish: Tid til første pneumoni blev forlænget med Ultibro Breezhaler sammenlignet med fluticason/salmeterol (p=0,013).
English: • headache.
Danish: • hovedpine.
English: At week 26, Ultibro Breezhaler produced statistically significant improvement in peak FEV1 compared to placebo in the first 4 hours post dose (LS mean treatment difference 330 ml) (p<0.001).
Danish: Ved uge 26 medførte Ultibro Breezhaler statistisk signifikant forbedring af peak FEV1 sammenlignet med placebo i de første 4 timer post dosis (LS gennemsnitlig behandlingsforskel 330 ml) (p<0,001).
English: Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Ultibro Breezhaler.
Danish: Rygevaner og baseline FEV1 havde ingen åbenlys virkning på systemisk eksponering af indacaterol og glycopyrronium efter inhalation af Ultibro Breezhaler.
English: Ultibro Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Danish: Ultibro Breezhaler forlængede tiden til første moderate eller svære eksacerbation med en 22 % risikoreduktion for en eksacerbation (p<0,001) og forlængede tiden til første svære eksacerbation med en 19 % risikoreduktion for en eksacerbation (p=0,046).
English: Show the pack of Ultibro Breezhaler.
Danish: Vis dem pakken med Ultibro Breezhaler.
English: • Do not use the Ultibro Breezhaler inhaler to take any other capsule medicine.
Danish: • Brug ikke Ultibro Breezhaler inhalatoren til at tage anden kapselmedicin.
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist.
Danish: Glycopyrroniumbromid er en muskarinreceptorantagonist med høj affinitet.
English: Impairment of the hepatic metabolism of glycopyrronium is not thought to result in a clinically relevant increase of systemic exposure.
Danish: Nedsættelse af glycopyrroniums metabolisme i leveren menes ikke at medføre en klinisk relevant forøgelse af systemisk eksponering.
English: The incidence of pneumonia was 3.2% in the Ultibro Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Danish: Hyppigheden af pneumoni var 3,2 % i Ultibro Breezhaler-armen sammenlignet med 4,8 % i fluticason/salmeterol-armen (p=0,017).
English: Renal and urinary disorders Bladder obstruction and urinary retention
Danish: Nyrer og urinveje Blæreobstruktion og urinretention
English: On the first day of treatment, inspiratory capacity under exercise was significantly improved (LS mean treatment difference 250 ml, p<0.001) compared to placebo.
Danish: På første behandlingsdag var den inspiratoriske indåndingskapacitet under fysisk aktivitet signifikant forbedret (LS gennemsnitlig behandlingsforskel 250 ml, p<0,001) sammenlignet med placebo.
English: Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ultibro Breezhaler at the recommended therapeutic dose (see section 5.1).
Danish: Der er ikke set klinisk relevante virkninger af hypokaliæmi i kliniske studier med Ultibro Breezhaler ved den anbefalede terapeutiske dosis (se pkt.
English: Step 1b: Open inhaler
Danish: Trin 1b: Åbn inhalatoren
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Danish: Ved klinisk relevante eksponeringer indikerer dyrestudier hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: No effects on the embryo or foetus were seen at any dose level of Ultibro Breezhaler during an embryo-foetal development study in rats.
Danish: Der blev ikke set virkning på embryo eller foster ved noget dosisniveau i et embryoføtalt udviklingsstudie hos rotter.
English: Ultibro Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Danish: Yderligere viste Ultibro Breezhaler superioritet i reduktion af den årlige hyppighed af alle eksacerbationer med 11 % versus fluticason/salmeterol (p=0,003).
English: Serum potassium and blood glucose
Danish: Serumkalium og blodglukose
English: A statistically significantly higher percentage of patients receiving Ultibro Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (68.1% and 57.5% respectively, p=0.004).
Danish: En statistisk signifikant højere procentdel patienter, som fik Ultibro Breezhaler, responderede med en 1 point eller større forbedring i TDI fokal score ved uge 26 sammenlignet med placebo (henholdsvis 68,1 % og 57,5 %, p=0,004).
English: - you have an eye problem called narrow-angle glaucoma.
Danish: - hvis du har en øjenlidelse, som kaldes snævervinklet glaukom.
English: Systemic exposures (AUC) at the no-observed-adverse-effect level (NOAEL) for myocardial lesions were 64- and 59-fold higher than in humans, for each component respectively.
Danish: Systemisk eksponering (AUC) ved no-observed-adverse-effect level (NOAEL) for myokardielæsioner var for hver komponent henholdsvis 64 og 59 gange højere end hos mennesker.
English: The capsules must be administered only using the Ultibro Breezhaler inhaler (see section 6.6).
Danish: Kapslerne må kun tages ved hjælp af Ultibro Breezhaler-inhalatoren (se pkt.
English: The effects of Ultibro Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Ultibro Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour.
Danish: Virkningen af Ultibro Breezhaler på QTc-intervallet blev undersøgt hos raske frivillige forsøgspersoner efter inhalation af Ultibro Breezhaler i op til 4 gange den anbefalede terapeutiske dosis i fire dosistrin med en times mellemrum mellem hver dosis.
English: General disorders and administration site conditions Pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Pyreksi1
English: In this pack, you will find a device called an inhaler together with capsules in blister strips.
Danish: Denne pakning indeholder en inhalator, samt kapsler i blister.
English: • crushing chest pain with increased sweating - this may be a serious heart problem (ischaemic heart disease).
Danish: • dundrende brystsmerte med øget svedproduktion - dette kan være et alvorligt hjerteproblem
English: Step 2a:
Danish: Trin 2a:
English: • sore throat.
Danish: • ondt i halsen.
English: • palpitations - signs of abnormal heart beat.
Danish: • hjertebanken - tegn på unormale hjerteslag.
English: Compared to fluticasone/salmeterol, Ultibro Breezhaler reduced the annualised rate of both moderate or severe exacerbations by 17% (p<0.001), and of severe exacerbations (requiring hospitalisation) by 13% (not statistically significant, p=0.231).
Danish: Sammenlignet med fluticason/salmeterol reducerede Ultibro Breezhaler den årlige hyppighed af både moderate eller svære eksacerbationer med 17 % (p<0,001), og af de svære eksacerbationer (som kræver hospitalisering) var reduktionen 13 % (ikke statistisk signifikant, p=0,231).
English: In the 64-week study patients were enrolled who had severe to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
Danish: I 64-ugers-studiet blev der inkluderet patienter med svær til meget svær KOL med en anamnese ≥1 moderat eller svær KOL-eksacerbationer i det foregående år.
English: Ultibro Breezhaler also statistically significantly reduced the annualised rate of all COPD exacerbations (mild, moderate or severe) by 15% as compared to glycopyrronium (p=0.001) and 14% as compared to tiotropium (p=0.002).
Danish: Ultibro Breezhaler reducerede også den årlige rate af alle KOL-eksacerbationer (milde, moderate eller svære) statistisk signifikant med 15 % sammenlignet med glycopyrronium (p=0,001) og 14 % sammenlignet med tiotropium (p=0,002).
English: • Do not blow into the mouthpiece.
Danish: • Pust ikke ind i mundstykket.
English: In vivo, M9 is formed from the swallowed dose fraction of inhaled glycopyrronium bromide.
Danish: M9 dannes in vivo fra den slugte dosisfraktion af inhaleret glycopyrroniumbromid.
English: difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of an allergic reaction).
Danish: besvær med at trække vejret eller synke, hævelse af tunge, læber eller ansigt, hududslæt, kløe og nældefeber (tegn på en allergisk reaktion).
English: To be taken into account with concomitant use
Danish: Overvejelser ved samtidig brug
English: In the 52-week study comparing Ultibro Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Ultibro Breezhaler met the primary study objective of non-inferiority in rate of all COPD exacerbations (mild, moderate or severe) compared to fluticasone/salmeterol.
Danish: I det 52 ugers studie, der sammenligner Ultibro Breezhaler (n=1.675) og fluticason/salmeterol (n=1.679), opnåede Ultibro Breezhaler studiets primære mål om non-inferioritet i reduktion af hyppigheden af alle KOL-eksacerbationer (let, moderat eller svær) sammenlignet med fluticason/salmeterol.
English: Each capsule contains 110 microgram indacaterol and 50 microgram glycopyrronium.
Danish: Hver kapsel indeholder 110 mikrogram indacaterol og 50 mikrogram glycopyrronium.
English: In a 64-week study comparing Ultibro Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ultibro Breezhaler reduced the annualised rate of moderate or severe COPD exacerbations by 12% compared to glycopyrronium (p=0.038) and by 10% compared to tiotropium (p=0.096).
Danish: I et 64 ugers studie, der sammenligner Ultibro Breezhaler (n=729), glycopyrronium (n=739) og tiotropium (n=737), reducerede Ultibro Breezhaler den årlige hyppighed for moderate til svære KOLeksacerbationer med 12 % sammenlignet med glycopyrronium (p=0,038) og med 10 % sammenlignet med tiotropium (p=0,096).
English: Use of rescue medication
Danish: Brug af anfaldsmedicin
English: Over 52 weeks, Ultibro Breezhaler reduced the use of rescue medication by 0.25 puffs per day compared to fluticasone/salmeterol (p<0.001).
Danish: Over 52 uger reducerede Ultibro Breezhaler brugen af anfaldsmedicin med 0,25 sug per dag sammenlignet med fluticason/salmeterol (p<0,001).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ultibro Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (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 Ultibro Breezhaler i alle undergrupper af den pædiatriske population med kronisk obstruktiv lungesygdom (KOL) (se pkt.
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed på under 30 ml/min/1,73 m2), herunder patienter med slutstadiet af nyresygdom, hvor dialyse er påkrævet, må Ultibro Breezhaler kun bruges, hvis den forventede fordel opvejer den potentielle risiko (se punkt 5.2).
English: Indacaterol is a long-acting beta2-adrenergic agonist for once-daily administration.
Danish: Indacaterol er en langtidsvirkende beta2-adrenerg agonist beregnet til administration én gang dagligt.
English: The following pack sizes are available: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Danish: Følgende pakningsstørrelser er tilgængelige: Enkeltpakninger med 6x1, 10x1, 12x1, 30x1 eller 90x1 kapsler og 1 inhalator.
English: Peel open the blister and remove the capsule.
Danish: Åbn blisteren og fjern kapslen.
English: Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD.
Danish: Glycopyrronium er en langtidsvirkende muskarinreceptorantagonist (antikolinergt lægemiddel) til inhalation én gang dagligt til bronkodilaterende vedligeholdelsesbehandling af KOL.
English: No data are available for subjects with severe hepatic impairment.
Danish: Der er ingen data tilgængelige for personer med svært nedsat leverfunktion.
English: At 64 weeks, the reduction compared to tiotropium was statistically significant (LS mean treatment difference -2.69, p<0.001).
Danish: Efter 64 uger var reduktionen statistisk signifikant sammenlignet med tiotropium (LS gennemsnitlig behandlingsforskel -2,69, p<0,001).
English: Uncommon Adverse reaction observed with Ultibro Breezhaler, but not with the individual components.
Danish: Ikke almindelig Bivirkning observeret for Ultibro Breezhaler, men ikke for de individuelle komponenter.
English: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Danish: Enkelt pakning, som indeholder 6x1, 10x1, 12x1, 30x1 eller 90x1 kapsler og 1 inhalator.
English: Ultibro Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol.
Danish: Ultibro Breezhaler forøgede post-dosis FEV1 AUC0-12 (primært endepunkt) med 140 ml efter 26 uger (p<0,001) sammenlignet med fluticason/salmeterol.
English: The capsules must always be stored in the original blister to protect from moisture and only removed immediately before use.
Danish: Kapslerne skal altid opbevares i den originale blister for at beskytte mod fugt og må først tages ud umiddelbart inden anvendelse.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk.
Danish: Hos patienter med svært nedsat nyrefunktion eller slutstadiet af nyresygdom, som kræver dialyse, må Ultibro Breezhaler kun anvendes, hvis den forventede fordel opvejer den potentielle risiko.
English: At week 64, Ultibro Breezhaler showed numerical improvement over glycopyrronium (LS mean treatment difference 1.95%; p=0.175) and statistical improvement over tiotropium (LS mean treatment difference 4.96%; p=0.001).
Danish: Ved uge 64 viste Ultibro Breezhaler numerisk forbedring i forhold til glycopyrronium (LS gennemsnitlig behandlingsforskel 1,95 %; p=0,175) og statistisk forbedring i forhold til tiotropium (LS gennemsnitlig behandlingsforskel 4,96 %; p=0,001).
English: At 26 weeks (primary endpoint), Ultibro Breezhaler increased trough FEV1 by 80 ml in patients (Ultibro Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Ultibro Breezhaler n=392, placebo n=190) with a higher degree of reversibility at baseline (≥5%) compared to placebo (p<0.001).
Danish: Efter 26 uger (primært endepunkt) øgede Ultibro Breezhaler dal-FEV1 med 80 ml hos patienter (Ultibro Breezhaler n=82; placebo n=42) med den laveste grad af reversibilitet (<5 %) (p=0,053) og med 220 ml hos patienterne (Ultibro Breezhaler n=392, placebo n=190), med en højere grad af reversibilitet ved baseline (≥5 %) sammenlignet med placebo (p<0,001).
English: The safety and efficacy of Ultibro Breezhaler in children have not been established.
Danish: Ultibro Breezhalers sikkerhed og virkning hos børn er ikke klarlagt.
English: In another study comparing Ultibro Breezhaler (n=258) and fluticasone/salmeterol (n=264), for 26 weeks, the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
Danish: I et andet studie, der sammenligner Ultibro Breezhaler (n=258) og fluticason/salmeterol (n=264) i 26 uger, var antallet af moderate til svære KOL-eksacerbationer/patient-år henholdsvis 0,15 versus 0,18 (18 tilfælde versus 22 tilfælde) (p=0,512), og antallet af alle KOL-eksacerbationer/patient-år (milde, moderate og svære) var henholdsvis 0,72 versus 0,94 (86 tilfælde versus 113 tilfælde) (p=0,098).
English: Ultibro Breezhaler demonstrated a statistically superior improvement versus tiotropium in the percentage of “days able to perform usual daily activities” over 26 weeks (LS mean treatment difference 8.45%, p<0.001).
Danish: Ultibro Breezhaler viste en signifikant overlegen forbedring versus tiotropium i andel af ”dage med evne til at udføre daglige aktiviteter” i løbet af 26 uger (LS gennemsnitlig behandlingsforskel 8,45 %, p<0,001).
English: Insert capsule Never place a capsule directly into the mouthpiece.
Danish: Læg kapslen i kapselkammeret Læg aldrig en kapsel direkte i mundstykket.
English: In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Ultibro Breezhaler showed a higher proportion of patients with QTcF increases vs. baseline between 30 ms and 60 ms (ranging from 16.0% to 21.6% vs. 1.9% for placebo), but there were no QTcF increases >60 ms from baseline.
Danish: Hos KOL-patienter medførte supraterapeutiske doser af Ultibro Breezhaler på mellem 116 mikrogram/86 mikrogram og 464 mikrogram/86 mikrogram en højere andel af patienter med QTcF-stigning versus baseline på mellem 30 ms og 60 ms (rangerende fra 16,0 % til 21,6 % versus 1,9 % for placebo), men der var ingen QTcF-stigninger >60 ms i forhold til baseline.
English: Oropharyngeal pain including throat irritation
Danish: Orofaryngeale smerter, inklusive halsirritation
English: After three weeks of treatment, the improvement in inspiratory capacity with Ultibro Breezhaler was greater (LS mean treatment difference 320 ml, p<0.001) and exercise endurance time increased (LS mean treatment difference 59.5 seconds, p=0.006) compared to placebo.
Danish: Efter tre ugers behandling var forbedringen i inspiratorisk kapacitet med Ultibro Breezhaler større (LS gennemsnitlig behandlingsforskel 320 ml, p<0,001) og varigheden af udholdenhed under fysisk aktivitet øget (LS gennemsnitlig behandlingsforskel 59,5 sekunder, p=0,006) sammenlignet med placebo.
English: The largest time-matched heart rate increase compared to placebo was +5.69 bpm (90% CI [2.71, 8.66]), the largest decrease was -2.51 bpm (90% CI [-5.48, 0.47]).
Danish: Den største tidsmæssige øgning i hjertefrekvens sammenlignet med placebo var +5,69 slag/minut (90 % [CI 2,71, 8,66]), og det største fald var -2,51 slag/minut (90 % [CI -5,48, 0,47]).
English: Ultibro Breezhaler contains lactose
Danish: Ultibro Breezhaler indeholder lactose
English: Psychiatric disorders Insomnia
Danish: Psykiske forstyrrelser Søvnløshed