FrancophonIA/ELRC3.0 huggingface dataset:
English: Onbrez 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 Onbrez Breezhaler reducerer hyperinflation af lungerne, hvilket resulterede i øget inspiratorisk kapacitet under motion og hvile sammenlignet med placebo.
English: The mean of the maximum changes in blood glucose were similar between Onbrez Breezhaler and placebo.
Danish: Middeltallet for maksimale ændringer i blodglukose var tilsvarende mellem Onbrez Breezhaler og placebo.
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: If you have questions about how long to continue your treatment with Onbrez Breezhaler, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal fortsætte din behandling med Onbrez Breezhaler, skal du tale med din læge eller apoteket.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Onbrez Breezhaler.
Danish: Samtidig anvendelse af andre sympatomimetiske lægemidler (alene eller som del af kombinationsbehandling) kan potensere bivirkninger ved Onbrez Breezhaler.
English: At 600 microgram once-daily, the safety profile of Onbrez Breezhaler was overall similar to that of recommended doses.
Danish: Ved 600 mikrogram en gang daglig var sikkerhedsprofilen for Onbrez Breezhaler samlet set svarende til den for den anbefalede dosis.
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Onbrez Breezhaler (i.e. medicines such as salmeterol and formoterol).
Danish: Fortæl det især til lægen, hvis du tager: medicin mod åndedrætsbesvær, som svarer til Onbrez Breezhaler (fx medicin, såsom salmeterol og formoterol).
English: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Onbrez 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 Onbrez Breezhaler seponeres med det samme og alternativ terapi startes.
English: The 24-hour bronchodilator effect of Onbrez Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis).
Danish: Onbrez 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: 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 Onbrez 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 Onbrez Breezhaler.
English: As with other inhalation therapy, administration of Onbrez Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Danish: Som ved anden inhalationsbehandling kan anvendelse af Onbrez Breezhaler 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 Onbrez 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 Onbrez Breezhaler i doser på op til det dobbelte af den maksimale anbefalede terapeutiske dosis.
English: Talk to your doctor or pharmacist before using Onbrez Breezhaler if you have asthma (in this case you should not use Onbrez Breezhaler).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Onbrez Breezhaler hvis du har astma (hvis dette er tilfældet, må du ikke tage Onbrez Breezhaler).
English: Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Danish: Onbrez Breezhaler indeholder det aktive stof indacaterol, som tilhører en gruppe lægemidler, der kaldes bronkodilatorer.
English: Therefore, long-acting beta2-adrenergic agonists such as Onbrez 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 Onbrez Breezhaler skal derfor bruges med forsigtighed hos patienter med kendt, eller hvor der er mistanke om forlænget QT-interval, eller som er i behandling med lægemidler, der påvirker QT-intervallet.
English: Immediate hypersensitivity reactions have been reported after administration of Onbrez Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af Onbrez Breezhaler.
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 Onbrez Breezhaler once a day at a dose of 300 microgram.
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 300 mikrogram Onbrez Breezhaler én gang dagligt.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez 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 Onbrez Breezhaler end med placebo ved de anbefalede doser.
English: Please read the following instructions carefully to learn how to use and care for your Onbrez Breezhaler inhaler.
Danish: Læs følgende brugsanvisning omhyggeligt for at lære, hvordan du bruger og rengør din Onbrez Breezhaler-inhalator.
English: Onbrez Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Danish: Onbrez Breezhaler-kapsler skal altid opbevares i blisteren og må først trykkes ud lige før brug.
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2adrenergic agonists.
Danish: Selvom der sædvanligvis ikke observeres klinisk relevante virkninger på det kardiovaskulære system efter anvendelse af Onbrez Breezhaler ved de anbefalede doser, skal indacaterol, som ved andre beta2adrenerge agonister, anvendes med forsigtighed hos patienter med kardiovaskulære sygdomme (koronar hjertesygdom, akut myokardieinfarkt, hjertearytmier, hypertension), hos patienter med konvulsive sygdomme eller tyrotoksikose og hos patienter, som er usædvanlig responsive over for beta2-adrenerge agonister.
English: The Onbrez Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Danish: Det kliniske fase III-udviklingsprogram for Onbrez Breezhaler omfattede patienter med klinisk diagnose af moderat til svær KOL.
English: At the recommended doses, the adverse reaction profile of Onbrez Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Danish: Ved de anbefalede doser viser bivirkningsprofilen for Onbrez Breezhaler hos patienter med KOL klinisk ubetydelige systemiske virkninger af beta2-adrenerg stimulation.
English: Onbrez Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Danish: Onbrez Breezhaler er ikke undersøgt hos patienter med ukontrolleret diabetes mellitus.
English: Onbrez Breezhaler has no or negligible influence on the ability to drive and use machines.
Danish: Onbrez Breezhaler påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i én kapsel på 150 mikrogram en gang dagligt ved hjælp af Onbrez Breezhaler-inhalatoren.
English: As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Onbrez Breezhaler treatment and those patients who received placebo or treatment with tiotropium.
Danish: Et dobbeltblindet, placebokontrolleret fase III-forsøg over 26 uger med 605 KOL-patienter viste, at der ikke var en klinisk relevant forskel på udviklingen af arytmiske hændelser ved monitorering over 24 timer ved baseline og op til 3 gange i løbet af behandlingsperioden på 26 uger blandt patienter, der fik de anbefalede doser af Onbrez Breezhaler og de patienter, der fik placebo eller behandling med tiotropium.
English: Driving and using machines It is unlikely that Onbrez Breezhaler will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Onbrez Breezhaler vil påvirke din evne til at køre bil eller betjene maskiner.
English: Both doses resulted in an increase of 40-50 ml over open-label tiotropium 18 microgram once a day (150 microgram, p=0.004; 300 microgram, p=0.01).
Danish: Begge doser medførte en forøgelse på 40-50 ml over for open-label tiotropium på 18 mikrogram én gang dagligt (150 mikrogram, p=0,004; 300 mikrogram, p=0,01).
English: Onbrez Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Danish: Onbrez Breezhaler må ikke anvendes sammen med andre langtidsvirkende beta2-adrenerge agonister eller lægemidler, der indeholder langtidsvirkende beta2-adrenerge agonister.
English: Upon initiation of treatment with Onbrez Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved påbegyndelse af behandling med Onbrez Breezhaler skal plasmaglukose monitoreres tættere hos diabetespatienter.
English: Your Onbrez Breezhaler pack: Each Onbrez Breezhaler pack contains: one Onbrez Breezhaler inhaler one or more blisters containing Onbrez Breezhaler capsules to be used in the inhaler.
Danish: Din Onbrez Breezhaler-pakning: Hver Onbrez Breezhaler-pakning indeholder: én Onbrez Breezhaler-inhalator en eller flere blistere med Onbrez Breezhaler-kapsler, som skal bruges i inhalatoren.
English: Onbrez Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Danish: Onbrez Breezhaler er ikke indiceret til behandling af akutte tilfælde af bronkospasmer, dvs. som anfaldsbehandling.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onbrez Breezhaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Onbrez Breezhaler skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: If you use more Onbrez Breezhaler than you should If you have inhaled too much Onbrez Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit.
Danish: Hvis du har inhaleret for meget Onbrez Breezhaler, eller hvis en anden person bruger dine kapsler, skal du straks fortælle det til din læge eller henvende dig på den nærmeste skadestue.
English: In the event of deterioration of COPD during treatment with Onbrez Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Ved forværring af KOL under behandling med Onbrez Breezhaler skal der foretages en reevaluering af patienten og behandlingsregimet for KOL.
English: The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD.
Danish: Det er påvist, at inhalation af indholdet i én 300 mikrogram kapsel en gang daglig ved hjælp af Onbrez Breezhaler-inhalatoren giver en yderligere klinisk virkning, hvad angår åndenød, særligt hos patienter med svær KOL.
English: There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
Danish: Der er ingen tilgængelige data for brug af Onbrez Breezhaler til patienter med stærkt nedsat leverfunktion.
English: Onbrez Breezhaler 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: Onbrez Breezhaler bruges til at lette vejrtrækningen hos voksne patienter, som lider af åndedrætsbesvær pga. en lungesygdom, som kaldes kronisk obstruktiv lungesygdom (KOL).
English: Onbrez Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Danish: Anvendelse af Onbrez Breezhaler én gang dagligt ved doser på 150 mikrogram og 300 mikrogram viste klinisk betydningsfulde forbedringer af lungefunktionen.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see section 5.1).
Danish: Der er ikke observeret klinisk relevante virkninger af QTc-intervallet ved de anbefalede terapeutiske doser af Onbrez Breezhaler i kliniske studier (se pkt.
English: Onbrez Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies.
Danish: Regelmæssig anvendelse af Onbrez Breezhaler én gang dagligt ved doser på 150 mikrogram og 300 mikrogram medførte en klinisk signifikant forbedring af lungefunktionen (målt som forceret eksspirationsvolumen i ét sekund, FEV1) over 24 timer på tværs af flere kliniske farmakodynamiske forsøg og forsøg vedrørende virkning.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onbrez 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 Onbrez Breezhaler i alle undergrupper af den pædiatriske population med kronisk obstruktiv lungesygdom (KOL) (se pkt.
English: Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Onbrez Breezhaler er indiceret til bronkodilaterende vedligeholdelsesbehandling af luftvejsobstruktion hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Breezhaler capsules with any other inhaler, and do not use Onbrez Breezhaler inhaler to take any other capsule medicine.
Danish: Onbrez Breezhaler-kapsler sammen med andre inhalatorer, og brug ikke Onbrez Breezhaler inhalatoren til at tage anden medicin i kapsler.
English: You should not use Onbrez Breezhaler unless your doctor tells you so.
Danish: Du må ikke tage Onbrez Breezhaler, medmindre du har aftalt det med din læge.
English: Onbrez Breezhaler is a single-dose inhalation device.
Danish: Onbrez Breezhaler er en inhalator til enkeltdosering.
English: Show the pack of Onbrez Breezhaler.
Danish: Vis dem pakningen med Onbrez Breezhaler.
English: In addition, patients treated with Onbrez Breezhaler required significantly less rescue medication, had more days when no rescue medication was needed compared to placebo and had a significantly improved percentage of days with no daytime symptoms.
Danish: Desuden havde de flere dage, hvor der ikke var behov for anfaldsmedicin sammenlignet med placebo og en betydelig øget procentdel af dage uden symptomer i dagtimerne.
English: During treatment with Onbrez Breezhaler,
Danish: Under behandling med Onbrez Breezhaler:
English: Onbrez Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo ( ) printed below the black bar.
Danish: Onbrez Breezhaler 150 mikrogram kapsler har påtrykt en sort produktkode "IDL 150" over en sort bjælke og et sort virksomhedslogo ( ) påtrykt under den sorte bjælke.
English: Never wash the Onbrez Breezhaler inhaler with water.
Danish: Vask aldrig Onbrez Breezhaler-inhalatoren med vand.
English: Onbrez Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo ( ) printed below the blue bar.
Danish: Onbrez Breezhaler 300 mikrogram kapsler har påtrykt en blå produktkode "IDL 300" over en blå bjælke og et blåt virksomhedslogo ( ) påtrykt under den blå bjælke.
English: Onbrez Breezhaler contains lactose
Danish: Onbrez Breezhaler indeholder lactose
English: The Onbrez Breezhaler inhaler provided with each new prescription should be used.
Danish: Onbrez Breezhalerinhalatoren, der er i hver ny ordination, skal anvendes.
English: If paradoxical bronchospasm occurs Onbrez Breezhaler should be discontinued immediately and alternative therapy substituted.
Danish: Ved paradoks bronkospasme skal behandlingen straks seponeres og erstattes med alternativ behandling.
English: What Onbrez Breezhaler contains - Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Danish: Onbrez Breezhaler indeholder: - Hver Onbrez Breezhaler 150 mikrogram kapsel indeholder 150 mikrogram indacaterol i form af indacaterolmaleat.
English: If you forget to use Onbrez Breezhaler
Danish: Hvis du har glemt at tage Onbrez Breezhaler
English: Do not use Onbrez Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Onbrez Breezhaler - hvis du er allergisk over for indacaterol eller et af de øvrige indholdsstoffer i Onbrez Breezhaler
English: Onbrez Breezhaler capsules must not be swallowed.
Danish: Onbrez Breezhaler-kapsler må ikke synkes.
English: The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in an Onbrez Breezhaler capsule.
Danish: Onbrez Breezhaler-inhalatoren gør det muligt for dig at inhalere medicinen i en Onbrez Breezhalerkapsel.
English: - Each Onbrez Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Danish: - Hver Onbrez Breezhaler 300 mikrogram kapsel indeholder 300 mikrogram indacaterol i form af indacaterolmaleat.
English: Always use the new Onbrez Breezhaler inhaler that comes with your new pack.
Danish: Brug altid den nye Onbrez Breezhaler-inhalator, som er vedlagt din nye pakning.
English: Always keep the Onbrez Breezhaler inhaler and capsules in a dry place.
Danish: Onbrez Breezhaler-inhalatoren og kapslerne skal altid opbevares på et tørt sted.
English: The capsules must be administered only using the Onbrez Breezhaler inhaler (see section 6.6).
Danish: Kapslerne må kun tages ved hjælp af Onbrez Breezhaler-inhalatoren (se pkt.
English: What you need to know before you use Onbrez Breezhaler
Danish: Det skal du vide, før du begynder at tage Onbrez Breezhaler
English: Common 1 Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Onbrez Breezhaler.
Danish: Efter markedsføring er der modtaget rapporter om overfølsomhed i forbindelse med brug af Onbrez Breezhaler.
English: When you start a new pack, use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Danish: Når du starter på en ny pakning, skal du bruge den nye Onbrez Breezhaler-inhalator, som er vedlagt pakningen.
English: INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER
Danish: BRUGSANVISNING TIL ONBREZ BREEZHALER-INHALATOR
English: Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Danish: Pakning med 30 kapsler og en Onbrez Breezhaler-inhalator.
English: Onbrez Breezhaler inhaler
Danish: Onbrez Breezhaler-inhalator
English: Carton containing 10 capsules and one Onbrez Breezhaler inhaler.
Danish: Pakning med 10 kapsler og en Onbrez Breezhaler-inhalator.
English: • Only use the Onbrez Breezhaler inhaler contained in this pack.
Danish: • Brug kun den Onbrez Breezhaler-inhalator, som er vedlagt denne pakning.
English: • When you start a new pack, only use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Danish: • Når du starter på en ny pakning, skal du bruge den nye Onbrez Breezhaler-inhalator, som medfølger pakningen.
English: Only use the capsules with the inhaler provided in this pack (Onbrez Breezhaler inhaler).
Danish: Brug kun kapslerne sammen med den vedlagte inhalator (Onbrez Breezhaler-inhalator).
English: Never place a Onbrez Breezhaler capsule directly into the mouthpiece of the Onbrez Breezhaler inhaler.
Danish: Læg aldrig en Onbrez Breezhaler-kapsel direkte i mundstykket på Onbrez Breezhalerinhalatoren.
English: Only use the Onbrez Breezhaler inhaler contained in this pack.
Danish: Brug kun den Onbrez Breezhaler-inhalator, som er vedlagt denne pakning.
English: The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Danish: Onbrez Breezhaler-inhalatoren skal du bruge til at inhalere medicinen i kapslen.
English: How much Onbrez Breezhaler to use
Danish: Så meget Onbrez Breezhaler skal du tage
English: You will experience a sweet flavour as the medicine goes into your lungs.
Danish: I takt med, at medicinen når lungerne, vil du opleve en sødlig smag.
English: Never blow into the mouthpiece of the Onbrez Breezhaler inhaler.
Danish: Pust aldrig ned i mundstykket på Onbrez Breezhaler-inhalatoren.
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Danish: Onbrez Breezhaler 150 mikrogram inhalationspulver i kapsler Onbrez Breezhaler 300 mikrogram inhalationspulver i kapsler indacaterol
English: Do not store the capsules in the Onbrez Breezhaler inhaler.
Danish: Kapslerne må ikke opbevares i Onbrez Breezhaler-inhalatoren.
English: What Onbrez Breezhaler is and what it is used for What you need to know before you use Onbrez Breezhaler How to use Onbrez Breezhaler Possible side effects
Danish: Det skal du vide, før du begynder at tage Onbrez Breezhaler Sådan skal du tage Onbrez Breezhaler Bivirkninger
English: Never take the Onbrez Breezhaler inhaler apart.
Danish: Skil aldrig Onbrez Breezhaler-inhalatoren ad.