FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents Oslif Breezhaler should not be given to children or adolescents below the age of 18 years
Danish: Børn og unge Oslif Breezhaler må ikke gives til børn eller unge under 18 år.
English: Systemic exposure results from a composite of pulmonary and gastrointestinal absorption; about 75% of systemic exposure was from pulmonary absorption and about 25% from gastrointestinal absorption.
Danish: Systemisk eksponering sker som følge af både pulmonal og gastrointestinal absorption; ca. 75 % af systemisk eksponering stammer fra pulmonal absorption, og ca. 25 % stammer fra gastrointestinal absorption.
English: Indacaterol is a chiral molecule with R-configuration.
Danish: Indacaterol er et chiralt molekyle med R-konfiguration.
English: Never place a capsule directly into the mouthpiece.
Danish: Læg aldrig en kapsel direkte i mundstykket.
English: Absolute bioavailability of indacaterol after an inhaled dose was on average 43% to 45%.
Danish: Indacaterols absolutte biotilgængelighed efter en inhaleret dosis var gennemsnitligt 43 % til 45 %.
English: If you experience coughing briefly after inhaling the medicine, do not worry.
Danish: Hvis du oplever hoste umiddelbart efter inhalation af medicinen, er der ikke grund til bekymring.
English: • Place the mouthpiece in your mouth and close your lips firmly around it.
Danish: • Tag mundstykket i munden, og luk læberne tæt omkring det.
English: The oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Danish: De oxidative metabolitter blev fundet i inkubationer med rekombinant CYP1A1, CYP2D6 og CYP3A4.
English: Use of cardioselective beta blockers may be considered, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
Danish: Brug af kardioselektive betablokkere kan overvejes, men kun under overvågning af en læge og med ekstrem forsigtighed, da brugen af beta-adrenerge blokkere kan udløse bronkospasmer.
English: Both doses demonstrated statistically significant improvements in symptom relief over placebo for dyspnoea and health status (as evaluated by Transitional Dyspnoea Index [TDI] and St. George's Respiratory Questionnaire [SGRQ], respectively).
Danish: Begge doser viste statistisk signifikante forbedringer i forhold til placebo med hensyn til dyspnø og helbredstilstand (evalueret ved hjælp af henholdsvis Transitional Dyspnoea Index [TDI] og St George's Respiratory Questionaire [SGRQ]).
English: In Phase III clinical studies, healthcare providers observed during clinic visits that on average 17-20% of patients experienced a sporadic cough that occurred usually within 15 seconds following inhalation and typically lasted for 5 seconds (about 10 seconds in current smokers).
Danish: I fase III kliniske forsøg observerede sundhedspersonalet ved de kliniske besøg, at gennemsnitlig 17-20 % af patienterne oplevede sporadisk hoste, som almindeligvis forekom inden for 15 sekunder efter inhalation og typisk med en varighed på 5 sekunder (ca. 10 sekunder hos aktive rygere).
English: There was no evidence of a concentration-delta QTc relationship in the range of doses evaluated.
Danish: Der var ikke tegn på en koncentration-delta QTc-relation i intervallet af de evaluerede doser.
English: The other ingredients include lactose and the capsule is made of gelatin.
Danish: Øvrige indholdsstoffer: lactose og kapslen er lavet af gelatine.
English: Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.
Danish: Fortæl det øjeblikkeligt til lægen, hvis dine KOL-symptomer (stakåndethed, hvæsen, hoste) ikke forbedres eller bliver værre.
English: Do not use this medicine if you notice that the pack is damaged or show signs of tampering.
Danish: Brug ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på at have været åbnet.
English: Symptomatic benefits
Danish: Symptomatiske fordele
English: 300 microgram, tiotropium and placebo;
Danish: 300 mikrogram, tiotropium og placebo,
English: Therefore, this shows no concern for a pro-arrhythmic potential related to QT-interval prolongations at recommended therapeutic doses or at twice the maximum recommended dose.
Danish: Der er derfor ikke grund til bekymring vedrørende et proarytmisk potentiale relateret til forlængelserne af QT-intervallet ved anbefalede terapeutiske doser eller ved det dobbelte af maksimal anbefalet dosis.
English: Indacaterol 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: Indacaterol udskilles i human fæces primært som uændret moderstof (54 % af dosis) og i et mindre omfang som hydroxylerede indacaterolmetabolitter (23 % af dosis).
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety database.
Danish: Bivirkningerne i tabel 1 står anført efter systemorganklasser i henhold til MedDRAsikkerhedsdatabasen for KOL.
English: An increase in the daily dose of Oslif Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Danish: En forøgelse af den daglige dosis af Oslif Breezhaler over den maksimale dosis på 300 mikrogram er ikke hensigtsmæssig.
English: 1.0 b a n/e a
Danish: 1,0 b a i/e a
English: Mean heart rate changes were less than one beat per minute, and tachycardia was infrequent and reported at a similar rate as under placebo treatment.
Danish: Middeltal for ændringer i hjertefrekvens var mindre end et slag pr. minut, og takykardi var sjælden og rapporteret til en lignende frekvens under behandling med placebo.
English: Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor agonists, ATC code: R03AC18
Danish: Farmakoterapeutisk klassifikation: Lægemidler til obstruktive luftvejslidelser, selektive beta-2adrenoreceptor agonister, ATC-kode: R03AC18
English: The capsules contain lactose.
Danish: Kapslerne indeholder lactose.
English: This opens the inhaler.
Danish: Dette åbner inhalatoren.
English: Close the inhaler: Close the inhaler until you hear a “click”.
Danish: Luk inhalatoren: Luk inhalatoren, indtil der lyder et "klik".
English: Always release the push buttons before inhalation.
Danish: Slip altid trykknapperne, inden du inhalerer.
English: • Hold the inhaler as shown in the picture.
Danish: • Hold inhalatoren som vist på billedet.
English: This cough experienced post inhalation did not lead to any patient discontinuing from the studies at the recommended doses (cough is a symptom in COPD and only 8.2% of patients reported cough as an adverse event).
Danish: Hosten opstået efter en inhalation medførte ikke, at nogen af patienterne afbrød deres deltagelse i forsøgene ved de anbefalede doser (hoste er et symptom ved KOL, og blot 8,2 % af patienterne rapporterede hoste som en bivirkning).
English: In vitro investigations have indicated that indacaterol has negligible potential to cause metabolic interactions with medicinal products at the systemic exposure levels achieved in clinical practice.
Danish: In vitroundersøgelser har indikeret, at indacaterol har en ubetydeligt mulighed til at forårsage metaboliske interaktioner med lægemidler ved de systemiske eksponeringsniveauer opnået i klinisk praksis.
English: Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Danish: Stop med at tage medicinen og fortæl det øjeblikkeligt til din læge, hvis du oplever trykken for brystet, hoste, hvæsen eller åndenød lige efter, du har taget medicinen.
English: If you have questions about how long to continue your treatment with Oslif Breezhaler, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal fortsætte din behandling med Oslif Breezhaler, skal du tale med din læge eller apoteket.
English: The most common adverse reactions at the recommended doses were nasopharyngitis (14.3%), upper respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle spasms (3.5%).
Danish: De hyppigste bivirkninger ved de anbefalede doser var nasopharyngitis (14,3 %), infektion i øvre luftveje (14,2 %), hoste (8,2 %), hovedpine (3,7 %) og muskelspasmer (3,5 %).
English: The mean of the maximum changes in blood glucose were similar between Oslif Breezhaler and placebo.
Danish: Middeltallet for maksimale ændringer i blodglukose var tilsvarende mellem Oslif Breezhaler og placebo.
English: Study design with a: indacaterol 150 microgram, salmeterol and placebo;
Danish: Forsøgsdesign med a: indacaterol 150 mikrogram, salmeterol og placebo,
English: Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10-50% of the total adrenergic receptors.
Danish: Selvom beta2-receptorer er de fremherskende adrenerge receptorer i den bronkiale glatte muskulatur, og beta1-receptorer er de fremherskende receptorer i det humane hjerte, eksisterer der ligeledes beta2adrenerge receptorer i det humane hjerte, som udgør 10-50 % af den samlede mængde adrenerge receptorer.
English: If you forget to inhale a dose, inhale just one dose at the usual time the next day.
Danish: Hvis du glemmer at inhalere en dosis, skal du blot inhalere en dosis til sædvanlig tid næste dag.
English: • feeling of pressure or pain in the cheeks and forehead (inflammation of the sinuses)
Danish: • følelse af trykken eller smerte i kinderne og panden (bihulebetændelse)
English: Percentage of patients who achieved MCID SGRQ†
Danish: Procentdel af patienter, som opnåede MCID SGRQ
English: As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise.
Danish: Når du tager en indånding gennem inhalatoren roterer kapslen rundt i kammeret, og du bør høre en snurrende lyd.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Oslif Breezhaler.
Danish: Samtidig anvendelse af andre sympatomimetiske lægemidler (alene eller som del af kombinationsbehandling) kan potensere bivirkninger ved Oslif Breezhaler.
English: Beta-adrenergic blockers and beta2-adrenergic agonists may weaken or antagonise the effect of each other when administered concurrently.
Danish: Beta-adrenerge blokkere og beta2-adrenerge agonister kan svække eller modvirke virkningen af hinanden, når de administreres samtidig.
English: Oslif Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory capacity during exercise and at rest, compared to placebo.
Danish: Det er påvist, at Oslif Breezhaler reducerer hyperinflation af lungerne, hvilket resulterede i øget inspiratorisk kapacitet under motion og hvile sammenlignet med placebo.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassiumsparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution is required (see section 4.4).
Danish: Samtidig hypokaliæmisk behandling med methylxanthin-derivater, steroider eller ikkekaliumbesparende diuretika kan potentiere muligheden for hypokaliæmisk virkning af beta2-adrenerge agonister, og derfor er forsigtighed påkrævet (se pkt.
English: Metabolism and nutrition disorders Diabetes mellitus and hyperglycaemia
Danish: Metabolisme og ernæring Diabetes mellitus og hyperglykæmi
English: This helps open up the airways, making it easier to get air in and out.
Danish: Dette hjælper med at åbne luftvejene, hvilket gør det nemmere at trække vejret.
English: In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval.
Danish: Hos KOL-patienter var enkeltdoser på 10 gange den maksimale anbefalede terapeutiske dosis forbundet med moderat forhøjet pulsfrekvens, systolisk blodtryk og QTc-interval.
English: There is no evidence that cough experienced post inhalation is associated with bronchospasm, exacerbations, deteriorations of disease or loss of efficacy.
Danish: Der er ingen tegn på, at hoste efter inhalation er forbundet med bronkospasmer, eksacerbationer, sygdomsforværring eller tab af effekt.
English: Indacaterol once a day
Danish: Indacaterol én gang dagligt
English: After you have finished taking your medicine:
Danish: Når du har taget medicinen:
English: Sympathomimetic medicinal products
Danish: Sympatomimetiske lægemidler
English: In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via urine was generally lower than 2% of the dose.
Danish: Kliniske forsøg, som omfattede urinprøver, har vist, at den udskilte mængde uændret indacaterol i urinen generelt var lavere end 2 % af dosis.
English: The precise function of beta2-adrenergic receptors in the heart is not known, but their presence raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects.
Danish: Den nøjagtige funktion af beta2-adrenerge receptorer i hjertet kendes ikke, men tilstedeværelsen af dem øger sandsynligheden for, at selv meget selektive beta2-adrenerge agonister kan påvirke hjertet.
English: These studies included measures of lung function and of health outcomes such as dyspnoea, exacerbations and health-related quality of life.
Danish: Disse forsøg omfattede målinger af lungefunktion og helbredsresultater, som f.eks. dyspnø, eksacerbation og helbredsrelateret livskvalitet.
English: Systemic exposure to indacaterol increased with increasing dose (150 microgram to 600 microgram) in a dose proportional manner.
Danish: Systemisk eksponering af indacaterol øges proportionalt med øget dosis (150 mikrogram til 600 mikrogram).
English: Pooled efficacy analysis over 6 months' treatment demonstrated that the rate of COPD exacerbations was statistically significantly lower than the placebo rate.
Danish: Samlede effektanalyser over 6 måneders behandling viste, at frekvensen af KOL-eksacerbationer var statistisk signifikant lavere end for placebo.
English: At 600 microgram once-daily, the safety profile of Oslif Breezhaler was overall similar to that of recommended doses.
Danish: Ved 600 mikrogram en gang daglig var sikkerhedsprofilen for Oslif Breezhaler samlet set svarende til den for den anbefalede dosis.
English: if you have diabetes.
Danish: hvis du har sukkersyge.
English: Nevertheless, it is considered unlikely that indacaterol will affect reproductive or fertility performance in humans following inhalation of the maximum recommended dose (see section 5.3).
Danish: Det anses alligevel for usandsynligt, at indacaterol kan påvirke reproduktion eller fertilitet hos mennesker ved inhalation af den maksimale anbefalede dosis (se pkt.
English: In vitro studies have shown that indacaterol, a long-acting beta2-adrenergic agonist, has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3receptors.
Danish: In vitro-forsøg har påvist, at indacaterol, som er en langtidsvirkende beta2-adrenerg agonist, har mere end 24 gange større agonistaktivitet på beta2-receptorer sammenlignet med beta1-receptorer og 20 gange større agonistaktivitet sammenlignet med beta3-receptorer.
English: The clinical development programme included one 12-week, two six-month (one of which was extended to one year to evaluate safety and tolerability) and one one-year randomised controlled studies in patients with a clinical diagnosis of COPD.
Danish: Det kliniske udviklingsprogram omfattede et 12 ugers-forsøg, to 6 måneders-forsøg (hvoraf det ene blev udvidet til et år for at evaluere sikkerhed og tolerabilitet) og et 1-årigt forsøg.
English: The 24-hour bronchodilator effect of Oslif Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis).
Danish: Oslif Breezhalers bronkodilaterende virkning i 24 timer blev opretholdt fra første dosis og gennem en behandlingsperiode på ét år uden tegn på tab af effekt (takyfylaksis).
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (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-bølgen, forlængelse af QT-intervallet og ST-segmentdepression, selvom den kliniske signifikans af disse observationer ikke kendes.
English: You may get all or most of the following: sore throat, runny nose, blocked nose, sneezing, coughing, headache.
Danish: Du kan få alle eller de fleste af følgende symptomer: ondt i halsen, løbende næse, tilstoppet næse, nysen, hoste, hovedpine.
English: • Open the inhaler to see if any powder is left in the capsule.
Danish: • Åbn inhalatoren for at kontrollere, om der er overskydende pulver i kapslen.
English: In this pack, you will find an inhaler and capsules (in blister) 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: • pain in muscles, bones or joints
Danish: • Smerter i muskler, knogler eller led
English: In a human ADME study where indacaterol was given orally, the faecal route of excretion was dominant over the urinary route.
Danish: I et humant ADME-forsøg, hvor indacaterol blev anvendt oralt, var den fækale udskillelsesvej dominerende sammenlignet med udskillelsen via urin.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Oslif Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic 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 Oslif Breezhaler i doser på op til det dobbelte af den maksimale anbefalede terapeutiske dosis.
English: Please read the following instructions carefully to learn how to use and care for your Oslif Breezhaler inhaler.
Danish: Læs følgende brugsanvisning omhyggeligt for at lære, hvordan du bruger og rengør din Oslif Breezhaler-inhalator.
English: As with other inhalation therapy, administration of Oslif Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Danish: Som ved anden inhalationsbehandling kan anvendelse af Oslif Breezhaler medføre paradoks bronkospasme, hvilket kan være livstruende.
English: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Oslif Breezhaler should be discontinued immediately and alternative therapy instituted.
Danish: Hvis der opstår symptomer, som antyder allergiske reaktioner (specielt vejrtrækning- eller synkebesvær, hævet tunge, læber og ansigt, urticaria, hududslæt), skal Oslif Breezhaler seponeres med det samme og alternativ terapi startes.
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 Oslif Breezhaler.
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 Oslif Breezhaler.
English: Talk to your doctor or pharmacist before using Oslif Breezhaler if you have asthma (in this case you should not use Oslif Breezhaler).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Oslif Breezhaler hvis du har astma (hvis dette er tilfældet, må du ikke tage Oslif Breezhaler).
English: Oslif Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Danish: Oslif Breezhaler indeholder det aktive stof indacaterol, som tilhører en gruppe lægemidler, der kaldes bronkodilatorer.
English: In COPD the muscles around the airways tighten.
Danish: Ved KOL trækker musklerne omkring luftvejene sig sammen.
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Oslif Breezhaler (i.e. medicines such as salmeterol and formoterol).
Danish: Fortæl det især til lægen, hvis du tager: medicin mod åndedrætsbesvær, som svarer til Oslif Breezhaler (fx medicin, såsom salmeterol og formoterol).
English: • Pierce the capsule by firmly pressing together both side buttons at the same time.
Danish: • Perforer kapslen ved samtidigt at trykke begge sideknapper helt ind.
English: Each capsule contains 24.6 mg lactose.
Danish: Hver kapsel indeholder 24,6 mg lactose.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Oslif Breezhaler at the recommended doses than on placebo.
Danish: Kliniske studier har vist, at klinisk betydningsfulde ændringer i blodglukose generelt var 1-2 % hyppigere med Oslif Breezhaler end med placebo ved de anbefalede doser.
English: Hold breath: After you have inhaled the medicine:
Danish: Hold vejret: Efter inhalation af medicinen:
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 12-14 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. 12-14 dage.
English: Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk (see section 5.3).
Danish: De tilgængelige farmakokinetiske/toksikologiske data fra dyrestudier viser, at indacaterol/metabolitter udskilles i mælk (se pkt.
English: The median time to reach peak serum concentrations of indacaterol was approximately 15 min after single or repeated inhaled doses.
Danish: Den gennemsnitlige tid til opnåelse af maksimale serumkoncentrationer for indacaterol var ca. 15 min. efter inhalation af en enkelt dosis eller efter inhalation af gentagne doser.
English: The pharmacological effects of beta2-adrenoceptor agonists 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 monophosphate).
Danish: De farmakologiske virkninger af beta2-adrenoceptoragonister kan som minimum delvist tilskrives stimulering af intracellulær adenylcyclase, det enzym, som katalyserer omdannelsen af adenosintrifosfat (ATP) til cyklisk-3', 5'-adenosinmonofosfat (cyklisk monofosfat).
English: Each capsule contains 24.8 mg lactose.
Danish: Hver kapsel indeholder 24,8 mg lactose.
English: In vitro investigations indicated that UGT1A1 is the only UGT isoform that metabolised indacaterol to the phenolic O-glucuronide.
Danish: In vitro-undersøgelser indikerede, at UGT1A1 er den eneste UGT-isoform, som metaboliserede indacaterol til phenol-O-glucuronid.
English: Therefore, long-acting beta2-adrenergic agonists such as Oslif Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Danish: Langtidsvirkende beta2-adrenerge agonister som Oslif Breezhaler skal derfor bruges med forsigtighed hos patienter med kendt, eller hvor der er mistanke om forlænget QTinterval, eller som er i behandling med lægemidler, der påvirker QT-intervallet.