FrancophonIA/ELRC3.0 huggingface dataset:
English: In a human ADME study, indacaterol given orally was excreted into human faeces primarily as unchanged parent substance (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% of the dose).
Danish: I et humant ADME-forsøg blev indacaterol, givet oralt, udskilt i human fæces primært som uændret moderstof (54 % af dosis) og i et mindre omfang som hydroxylerede indacaterol-metabolitter (23 % af dosis).
English: In vitro the UGT1A1 isoform is a major contributor to the metabolic clearance of indacaterol.
Danish: In-vitro er UGT1A1-isoformen en stor bidragyder til den metaboliske clearance af indacaterol.
English: The elimination pattern suggests sustained lung absorption and/or transfer of glycopyrronium into the systemic circulation at and beyond 24 h after inhalation.
Danish: Elimineringsmønstret tyder på vedvarende absorption i lungerne og/eller overførelse af glycopyrronium i den systemiske cirkulation ved og efter 24 timer efter inhalation.
English: Inhalation powder, hard capsule
Danish: Inhalationspulver, hård kapsel
English: Administration of Ultibro Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Danish: Anvendelse af Ultibro Breezhaler kan medføre paradoks bronkospasme, hvilket kan være livstruende.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with indacaterol in clinical studies of up to one year at doses up to twice the maximum recommended indacaterol dose.
Danish: Størrelsesordenen på eksponeringsforhøjelserne, som skyldes interaktioner, giver ikke grund til bekymringer vedrørende sikkerheden, taget i betragtning, at der er erfaringer med sikkerhed fra kliniske forsøg på op til ét år med indacaterol i doser på op til det dobbelte af den maksimalt anbefalede indacaterol dosis.
English: A population pharmacokinetic analysis of data in COPD patients identified body weight and age as factors contributing to inter-patient variability in systemic exposure.
Danish: En farmakokinetisk populationsanalyse af data fra KOL-patienter klarlagde kropsvægt og alder som de faktorer, der bidrager til variation i systemisk eksponering.
English: The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator and a short-acting beta2-agonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%).
Danish: Effektgraden var afhængig af graden af reversibilitet af besværet vejrtrækning ved baseline (undersøgt ved administration af en korttidsvirkende muskarin-antagonist bronkodilatator og en hurtigvirkende beta2-agonist bronkodilatator): Patienter med den laveste grad af reversibilitet ved baseline (<5 %) udviste generelt et lavere bronkodilatator-respons end patienter med en højere grad af reversibilitet ved baseline (≥5 %).
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.2 litres/hour.
Danish: Renal clearance af indacaterol var gennemsnitlig mellem 0,46 og 1,2 liter/time.
English: No specific interaction studies were conducted with Ultibro Breezhaler.
Danish: Der er ikke udført specifikke interaktionsstudier med Ultibro Breezhaler.
English: The pharmacological effects of beta2-adrenoceptor agonists, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP).
Danish: De farmakologiske virkninger af beta2-adrenoceptoragonister, inklusive indacaterol, kan som minimum delvist tilskrives stimulering af intracellulær adenylcyclase, det enzym, som katalyserer omdannelsen af adenosintrifosfat (ATP) til cyklisk-3', 5'-adenosinmonofosfat (cyklisk AMP).
English: Improvements versus indacaterol and glycopyrronium were 0.26 and 0.21, respectively.
Danish: Forbedringer sammenlignet med indacaterol og glycopyrronium var henholdsvis 0,26 og 0,21.
English: In Phase III studies, bronchodilator effects were seen within 5 minutes after the first dose and were maintained over the 24-hour dosing interval from the first dose.
Danish: I Fase III-studier sås bronkodilaterende virkning inden for 5 minutter efter første dosis, og denne blev opretholdt i løbet af doserings-intervallet på 24 timer fra første dosis.
English: In four of these studies patients were enrolled who had a clinical diagnosis of moderate to severe COPD.
Danish: I fire af disse studier blev der inkluderet patienter med den kliniske diagnose moderat til svær KOL.
English: • painful and frequent urination - these may be signs of a urinary tract infection called cystitis.
Danish: • smertefuld og hyppig vandladning- dette kan være tegn på en urinvejsinfektion, som kaldes cystitis.
English: An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding.
Danish: En overdosis kan medføre en forstærket virkning, som er typisk for beta2-adrenerge stimulerende midler, dvs. takykardi, tremor, palpitationer, hovedpine, kvalme, opkast, døsighed, ventrikulære arytmier, metabolisk acidose, hypokaliæmi og hyperglykæmi eller den kan inducere antokolinergisk virkning såsom øget intraokulært tryk (forårsager smerte, synsforstyrrelse eller rødt øje), obstipation eller udtømningsbesvær.
English: Instructions for handling and use
Danish: Anvisninger i håndtering og brug
English: Patients with mild and moderate hepatic impairment showed no relevant changes in Cmax or AUC of indacaterol, nor did protein binding differ between mild and moderate hepatic impaired subjects and their healthy controls.
Danish: Patienter med mildt og moderat nedsat leverfunktion viste ingen relevante ændringer i Cmax eller AUC for indacaterol, og proteinbindingen mellem forsøgspersoner med mildt og moderat nedsat leverfunktion og disses raske kontrolgruppe adskilte sig ligeledes ikke.
English: After intravenous dosing, the steady-state volume of distribution of glycopyrronium was 83 litres and the volume of distribution in the terminal phase was 376 litres.
Danish: Efter intravenøs dosering var fordelingsvolumen af glycopyrronium ved steady state 83 liter, og fordelingsvolumen i den terminale fase var 376 liter.
English: Pierce capsule by firmly pressing both side buttons at the same time.
Danish: Perforer kapslen ved samtidig at trykke begge sideknapper helt ind.
English: Due to the differential density of beta2-adrenoceptors and M3-receptors in central versus peripheral airways, beta2-agonists should be more effective in relaxing peripheral airways, whilst an anticholinergic compound may be more effective in central airways.
Danish: Grundet forskellen i tæthed af beta2-adrenoceptorer og M3-receptorer i centrale versus perifere luftveje, bør beta2-agonister have større virkning på afslappelse af de perifere luftveje, mens en antikolinerg komponent kan være mere effektiv i de centrale luftveje.
English: Cimetidine or other inhibitors of organic cation transport In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%.
Danish: Cimetidin eller andre hæmmere af organisk kationtransport I en klinisk undersøgelse med raske frivillige forårsagede cimetidin, en hæmmer af organisk kationtransport, som menes at bidrage til renal udskillelse af glycopyrronium, en stigning i den samlede eksponering (AUC) for glycopyrronium på 22 % og en reduktion i renal clearance på 23 %.
English: You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit, or you may notice visual disturbances, feel constipated or have difficulty when passing urine.
Danish: Du kan muligvis opleve, at dit hjerte slår hurtigere end normalt, og kan have hovedpine, føle dig døsig, have kvalme eller blive nødt til at kaste op. Du kan også opleve synsforstyrrelser, føle dig forstoppet eller have problemer med at lade vandet.
English: Ultibro Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Danish: Ultibro Breezhaler må ikke anvendes til behandling af astma, da der ikke foreligger data for denne indikation.
English: The components of Ultibro Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Danish: Komponenterne i Ultibro Breezhaler er ikke kendt for at have et QT-forlængende potentiale ved kliniske dosisniveauer.
English: Beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists.
Danish: Beta-adrenerge blokkere kan svække eller modvirke virkningen af beta2-adrenerge agonister.
English: Gender, smoking status and baseline FEV1 had no apparent effect on systemic exposure.
Danish: Køn, rygevaner og baseline FEV1 havde ingen åbenlys virkning på systemisk eksponering.
English: This medicine is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Danish: Dette lægemiddel anvendes til at lette vejrtrækning hos voksne patienter, som lider af åndedrætsbesvær pga. en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL).
English: Oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Danish: Oxidative metabolitter blev fundet i inkubationer med rekombinant CYP1A1, CYP2D6 og CYP3A4.
English: Pre-clinical studies included in vitro and in vivo safety pharmacology assessments, repeated-dose inhalation toxicity studies in rats and dogs and an inhalation embryo-foetal development study in rats.
Danish: Prækliniske studier omfatter in vitro og in vivo farmakologiske sikkerhedsvurderinger, toksicitetsstudier med inhalation af gentagne doser hos rotter og hunde og et embryoføtalt udviklingsinhalationsstudie hos rotter.
English: Mild irritancy or adaptive changes in the respiratory tract were seen in rats.
Danish: Der er set mild irritation eller adaptive ændringer i luftvejene hos rotter.
English: • fever.
Danish: • feber.
English: Concomitant administration of orally inhaled indacaterol and glycopyrronium, under steady-state conditions of both active substances, did not affect the pharmacokinetics of either active substance.
Danish: Samtidig administration af oralt inhaleret indacaterol og glycopyrronium ved steady-state for begge aktive stoffer påvirkede ikke farmakokinetikken for nogle af de aktive stoffer.
English: Ultibro Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Danish: Ultibro Breezhaler kan bruges ved den anbefalede dosis til ældre patienter (75 år eller ældre).
English: In vitro metabolism studies showed consistent metabolic pathways for glycopyrronium bromide between animals and humans.
Danish: In vitro-metabolismeforsøg har vist overensstemmende metaboliske signalveje for glycopyrroniumbromid mellem dyr og mennesker.
English: Ultibro Breezhaler should be used with caution in these patient groups.
Danish: Ultibro Breezhaler bør anvendes med forsigtighed til disse patientgrupper.
English: Their presence in the heart raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects.
Danish: Deres tilstedeværelse i hjertet øger sandsynligheden for, at selv meget selektive beta2-adrenerge agonister kan påvirke hjertet.
English: The effective half-life, calculated from the accumulation of indacaterol after repeated dosing ranged from 40 to 52 hours which is consistent with the observed time-to-steady state of approximately 12-15 days.
Danish: Den effektive halveringstid udregnet fra akkumuleringen af indacaterol efter gentagen dosering, var i intervallet fra 40 til 52 timer, hvilket er i overensstemmelse med den observerede tid til steady-state på ca. 12-15 dage.
English: - you have severe liver problems.
Danish: - hvis du har alvorlige leverproblemer.
English: tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine - these may be signs of a condition called paradoxical bronchospasm.
Danish: trykken for brystet, hoste, hvæsen eller åndenød umiddelbart efter, du har taget dette lægemiddel - dette kan være tegn på en tilstand kaldet paradoks bronkospasme.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassiumsparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).
Danish: Samtidig hypokaliæmisk behandling med methylxanthin-derivater, steroider eller ikkekaliumbesparende diuretika kan potensere muligheden for hypokaliæmisk virkning af beta2-adrenerge agonister, og skal derfor anvendes med forsigtighed (se pkt.
English: Systemic exposure to indacaterol increased with increasing (delivered) dose (120 micrograms to 480 micrograms) in a dose proportional manner.
Danish: Systemisk eksponering af indacaterol øgedes med stigende (leveret) dosis (120 mikrogram til 480 mikrogram) og var dosisproportional.
English: Check capsule is empty Open the inhaler to see if any powder is left in the capsule.
Danish: Tjek at kapslen er tom Åbn inhalatoren for at kontrollere, om der er overskydende pulver i kapslen.
English: 3H]-labelled glycopyrronium bromide, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Danish: 3H]-mærket glycopyrroniumbromid udgjorde middelværdien for urinudskillelse af radioaktivitet over 48 timer 85 % af dosis.
English: If this happens, carefully loosen the capsule by tapping the base of the inhaler.
Danish: Hvis dette er tilfældet, skal du forsigtigt løsne kapslen ved banke let på inhalatorens underdel.
English: During long-term clinical studies, more patients on Ultibro Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Danish: Kliniske langtidsstudier har vist, at flere patienter på Ultibro Breezhaler har oplevet klinisk betydningsfulde ændringer i blodglukose (4,9 %) ved den anbefalede dosis end ved placebo (2,7 %).
English: In particular, please tell your doctor or pharmacist if you are using: - any medicines that may be similar to Ultibro Breezhaler (contain similar active substances).
Danish: Fortæl det især til lægen, hvis du tager: medicin som kan være tilsvarende Ultibro Breezhaler (indeholder lignende aktive stoffer).
English: Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency.
Danish: Indacaterol er en partiel agonist på den humane beta2-adrenerg receptor med nanomolær styrke.
English: 6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler 90 x 1 capsules + 1 inhaler
Danish: 6 x 1 kapsler + 1 inhalator 10 x 1 kapsler + 1 inhalator 12 x 1 kapsler + 1 inhalator 30 x 1 kapsler + 1 inhalator 90 x 1 kapsler + 1 inhalator
English: Do not use Ultibro Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Ultibro Breezhaler - hvis du er allergisk over for indacaterol eller glycopyrronium eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: In vitro studies have shown that indacaterol has multi-fold greater agonist activity at beta2-receptors compared to beta1 and beta3-receptors.
Danish: In vitroforsøg har påvist, at indacaterol har flere gange større agonistaktivitet på beta2-receptorer sammenlignet med beta1- og beta3-receptorer.
English: CYP3A4 is concluded to be the predominant isoenzyme responsible for hydroxylation of indacaterol.
Danish: Det konkluderes, at CYP3A4 er det fremherskende isoenzym, som er ansvarlig for hydroxylering af indacaterol.
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ultibro Breezhaler contains lactose”).
Danish: - Øvrige indholdsstoffer i inhalationspulveret: lactosemonohydrat og magnesiumstearat (se afsnit 2 under ”Ultibro Breezhaler indeholder lactose”).
English: Hydroxylation resulting in a variety of mono- and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Danish: Der sås hydroxylering, som medførte en række mono- og bis-hydroxylerede metabolitter, og direkte hydrolyse, som medførte dannelsen af et carboxylsyrederivat (M9).
English: Over 64 weeks, this reduction was 0.76 puffs per day (p<0.001) compared to tiotropium.
Danish: Over 64 uger var denne reduktion 0,76 sug per dag (p<0,001) sammenlignet med tiotropium.
English: It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk.
Danish: Det vides ikke om indacaterol, glycopyrronium og deres metabolitter udskilles i human mælk.
English: In COPD the muscles around the airways tighten.
Danish: Ved KOL trækker musklerne sig sammen omkring luftvejene.
English: • Do not push the capsule through the foil to remove it from the blister.
Danish: • Tryk ikke kapslen gennem folien for at fjerne den fra blisterkortet.
English: Multiple CYP isoenzymes contribute to the oxidative biotransformation of glycopyrronium.
Danish: Adskillige CYP-isoenzymer medvirker til den oxidative biotransformation af glycopyrronium.
English: - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Danish: - Denne pakning indeholder en inhalator og kapsler (i blister), som indeholder medicinen i form af et inhalationspulver.
English: Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with indacaterol.
Danish: Selvom indacaterol ikke påvirkede den generelle reproduktionsevne i fertilitetsforsøg på rotter, blev der observeret et nedsat antal af gravide F1 afkom i peri- og postnatal udviklingsforsøg med rotter ved eksponeringer 14 gange højere end hos mennesker behandlet med indacaterol.
English: Increased incidences of benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent with similar findings reported for other beta2-adrenergic agonists.
Danish: Forøget forekomst af benign ovarie leiomyom og fokal hyperplasi af den glatte ovariemuskulatur hos rotter var i overensstemmelse med lignende resultater for andre beta2-adrenerge agonister.
English: There were no major differences in total systemic exposure (AUC) for both compounds between Japanese and Caucasian subjects.
Danish: Der var ingen betydende forskel i total systemisk eksponering (AUC) for nogen af komponenterne mellem japanere og kaukasiere.
English: Not for acute use Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Danish: Ikke til akut brug Ultibro Breezhaler er ikke indiceret til behandling af akutte tilfælde af bronkospasmer.
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Danish: Desuden er der rapporteret ekg-ændringer ved brug af beta-adrenerge agonister, såsom udfladning af T-tak, forlængelse af QT-intervallet og ST-segmentdepression, selvom den kliniske signifikans af disse observationer ikke kendes.
English: The safety experience with Ultibro Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Danish: Erfaringer vedrørende sikkerhed af Ultibro Breezhaler er baseret på data fra op til 15 måneders eksponering ved den anbefalede terapeutiske dosis.
English: Indacaterol administered to dogs alone or in Ultibro Breezhaler was associated with a similar incidence and severity of myocardial lesions.
Danish: Indacaterol administreret til hunde alene eller i Ultibro Breezhaler var forbundet med sammenlignelig forekomst og sværhedsgrad af myokardielæsioner.
English: • pain that affects the muscles, ligaments, tendons, joints and bones.
Danish: • smerte, der mærkes i muskler, ledbånd, sener, led og knogler.
English: Beta-adrenergic blockers
Danish: Beta-adrenerge blokkere
English: There are no data from the use of Ultibro Breezhaler in pregnant women available.
Danish: Der er utilstrækkelige data fra anvendelse af Ultibro Breezhaler til gravide kvinder.
English: Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms) were excluded from the clinical trials, and therefore there is no experience in these patient groups.
Danish: Patienter med ustabil iskæmisk hjertesygdom, venstreventrikulær dysfunktion, tidligere myokardieinfarkt, arytmi (eksklusive kronisk stabil atrieflimren), tidligere langt QT-syndrom eller hvis QTc (Fridericia metode) var forlænget (>450 ms) blev ekskluderet fra de kliniske studier, og der er derfor ingen erfaring med disse patientgrupper.
English: Treatment for 90 days [90 x 1 capsules + 1 inhaler only].
Danish: Behandling i 90 dage [90 x 1 kapsler + kun 1 inhalator].
English: Do not push the capsule through the foil.
Danish: Tryk ikke kapslen gennem folien.
English: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Danish: Langtidsvirkende beta2-adrenerge agonister kan øge risikoen for alvorlige astma-relaterede bivirkninger, inklusive astma-relaterede dødsfald, hvis det bruges til behandling af astma.
English: Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved påbegyndelse af behandling med Ultibro Breezhaler skal plasmaglukose monitoreres tættere hos diabetespatienter.
English: What Ultibro Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Danish: Ultibro Breezhaler indeholder - Aktive stoffer: indacaterol (som maleat) og glycopyrroniumbromid.
English: If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face) urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Danish: Hvis der opstår symptomer, som antyder allergiske reaktioner, specielt angioødem (vejrtræknings- eller synkebesvær, hævet tunge, læber og ansigt), urticaria eller hududslæt, skal behandlingen seponeres med det samme og alternativ terapi startes.
English: • swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).
Danish: • Hævelse, hovedsageligt af tungen, læber, ansigt eller hals (muligvis tegn på angioødem).
English: Increased cyclic AMP levels cause relaxation of bronchial smooth muscle.
Danish: Forøgede cykliske AMP-niveauer medfører afslapning af den bronkiale glatte muskulatur.
English: When inhaled, indacaterol acts locally in the lung as a bronchodilator.
Danish: Når indacaterol inhaleres, virker det lokalt i lungen som en bronkodilator.
English: • Ultibro Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Danish: • Ultibro Breezhaler kapsler skal altid opbevares i den originale blister og må først tages ud umiddelbart inden anvendelse.