FrancophonIA/ELRC3.0 huggingface dataset:
English: You should stop taking PROTELOS if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Danish: - Hvis De skal have antibiotika såsom tetracykliner og quinoloner til indtagelse gennem munden, bør De holde op med at tage PROTELOS.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Hirobriz Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Danish: Hirobriz Breezhaler må kun anvendes under graviditet, hvis de forventede fordele opvejer de mulige risici.
English: Children and adolescents Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years.
Danish: Børn og unge Hirobriz Breezhaler må ikke gives til børn eller unge under 18 år.
English: Hirobriz Breezhaler should be administered at the same time of the day each day.
Danish: Hirobriz Breezhaler bør tages på samme tidspunkt hver dag.
English: Paediatric population There is no relevant use of Hirobriz Breezhaler in the paediatric population (under 18 years).
Danish: Pædiatrisk population Det er ikke relevant at anvende Hirobriz Breezhaler hos den pædiatriske population (under 18 år).
English: An increase in the daily dose of Hirobriz Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Danish: En forøgelse af den daglige dosis af Hirobriz Breezhaler over den maksimale dosis på 300 mikrogram er ikke hensigtsmæssig.
English: If you have questions about how long to continue your treatment with Hirobriz Breezhaler, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal fortsætte din behandling med Hirobriz 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 Hirobriz Breezhaler.
Danish: Samtidig anvendelse af andre sympatomimetiske lægemidler (alene eller som del af kombinationsbehandling) kan potensere bivirkninger ved Hirobriz Breezhaler.
English: The mean of the maximum changes in blood glucose were similar between Hirobriz Breezhaler and placebo.
Danish: Middeltallet for maksimale ændringer i blodglukose var tilsvarende mellem Hirobriz Breezhaler og placebo.
English: Hirobriz 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 Hirobriz Breezhaler reducerer hyperinflation af lungerne, hvilket resulterede i øget inspiratorisk kapacitet under motion og hvile sammenlignet med placebo.
English: At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of recommended doses.
Danish: Ved 600 mikrogram en gang daglig var sikkerhedsprofilen for Hirobriz Breezhaler samlet set svarende til den for den anbefalede dosis.
English: The 24-hour bronchodilator effect of Hirobriz Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis).
Danish: Hirobriz 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: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Hirobriz 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 Hirobriz Breezhaler seponeres med det samme og alternativ terapi startes.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Hirobriz 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 Hirobriz Breezhaler i doser på op til det dobbelte af den maksimale anbefalede terapeutiske dosis.
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 Hirobriz 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 Hirobriz Breezhaler.
English: Please read the following instructions carefully to learn how to use and care for your Hirobriz Breezhaler inhaler.
Danish: Læs følgende brugsanvisning omhyggeligt for at lære, hvordan du bruger og rengør din Hirobriz Breezhaler-inhalator.
English: Talk to your doctor or pharmacist before using Hirobriz Breezhaler if you have asthma (in this case you should not use Hirobriz Breezhaler).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Hirobriz Breezhaler hvis du har astma (hvis dette er tilfældet, må du ikke tage Hirobriz Breezhaler).
English: As with other inhalation therapy, administration of Hirobriz Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Danish: Som ved anden inhalationsbehandling kan anvendelse af Hirobriz Breezhaler medføre paradoks bronkospasme, hvilket kan være livstruende.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Hirobriz 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 Hirobriz Breezhaler end med placebo ved de anbefalede doser.
English: Therefore, long-acting beta2-adrenergic agonists such as Hirobriz 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 Hirobriz 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: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Hirobriz Breezhaler (i.e. medicines such as salmeterol and formoterol).
Danish: Fortæl det især til lægen, hvis du tager: medicin mod åndedrætsbesvær, som svarer til Hirobriz Breezhaler (fx medicin, såsom salmeterol og formoterol).
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 Hirobriz 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 Hirobriz Breezhaler én gang dagligt.
English: Hirobriz Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Danish: Hirobriz Breezhaler-kapsler skal altid opbevares i blisteren og må først trykkes ud lige før brug.
English: Hirobriz Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Danish: Hirobriz Breezhaler indeholder det aktive stof indacaterol, som tilhører en gruppe lægemidler, der kaldes bronkodilatorer.
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Hirobriz 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 Hirobriz Breezhaler ved de anbefalede doser, skal indacaterol, som ved andre beta2-adrenerge 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 Hirobriz Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Danish: Det kliniske fase III-udviklingsprogram for Hirobriz Breezhaler omfattede patienter med klinisk diagnose af moderat til svær KOL.
English: If you use more Hirobriz Breezhaler than you should If you have inhaled too much Hirobriz Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit.
Danish: Hvis du har taget for meget Hirobriz Breezhaler Hvis du har inhaleret for meget Hirobriz 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: Hirobriz Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Danish: Hirobriz Breezhaler er ikke undersøgt hos patienter med ukontrolleret diabetes mellitus.
English: Immediate hypersensitivity reactions have been reported after administration of Hirobriz Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af Hirobriz Breezhaler.
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 Hirobriz 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 Hirobriz Breezhaler og de patienter, der fik placebo eller behandling med tiotropium.
English: At the recommended doses, the adverse reaction profile of Hirobriz Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Danish: Ved de anbefalede doser viser bivirkningsprofilen for Hirobriz Breezhaler hos patienter med KOL klinisk ubetydelige systemiske virkninger af beta2-adrenerg stimulation.
English: Driving and using machines It is unlikely that Hirobriz Breezhaler will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Hirobriz Breezhaler vil påvirke din evne til at køre bil eller betjene maskiner.
English: Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Danish: Hirobriz 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 Hirobriz Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved påbegyndelse af behandling med Hirobriz Breezhaler skal plasmaglukose monitoreres tættere hos diabetespatienter.
English: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Hirobriz Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i én kapsel på 150 mikrogram en gang dagligt ved hjælp af Hirobriz Breezhaler-inhalatoren.
English: Your Hirobriz Breezhaler pack: Each Hirobriz Breezhaler pack contains: one Hirobriz Breezhaler inhaler one or more blister containing Hirobriz Breezhaler capsules to be used in the inhaler.
Danish: Din Hirobriz Breezhaler-pakning: Hver Hirobriz Breezhaler-pakning indeholder: én Hirobriz Breezhaler-inhalator en eller flere blistere med Hirobriz Breezhaler-kapsler, som skal bruges i inhalatoren.
English: Hirobriz Breezhaler has no or negligible influence on the ability to drive and use machines.
Danish: Hirobriz Breezhaler påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In the event of deterioration of COPD during treatment with Hirobriz Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Ved forværring af KOL under behandling med Hirobriz Breezhaler skal der foretages en reevaluering af patienten og behandlingsregimet for KOL.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hirobriz 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 Hirobriz Breezhaler skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Hirobriz Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Danish: Hirobriz Breezhaler er ikke indiceret til behandling af akutte tilfælde af bronkospasmer, dvs. som anfaldsbehandling.
English: The inhalation of the content of one 300 microgram capsule once a day, using the Hirobriz 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 Hirobriz Breezhaler-inhalatoren giver en yderligere klinisk virkning, hvad angår åndenød, særligt hos patienter med svær KOL.
English: Hirobriz Breezhaler is a single-dose inhalation device.
Danish: Hirobriz Breezhaler er en inhalator til enkeltdosering.
English: You should not use Hirobriz Breezhaler unless your doctor tells you so.
Danish: Du må ikke tage Hirobriz Breezhaler, medmindre du har aftalt det med din læge.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Hirobriz 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 Hirobriz Breezhaler i kliniske studier (se pkt.
English: Hirobriz 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: Hirobriz Breezhaler bruges til at lette vejrtrækningen hos voksne patienter, som lider af åndedrætsbesvær pga. en lungesygdom, som kaldes kronisk obstruktiv lungesygdom (KOL).
English: Hirobriz 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 Hirobriz 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: Hirobriz Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Danish: Anvendelse af Hirobriz Breezhaler én gang dagligt ved doser på 150 mikrogram og 300 mikrogram viste klinisk betydningsfulde forbedringer af lungefunktionen.
English: Hirobriz Breezhaler contains lactose
Danish: Hirobriz Breezhaler indeholder lactose
English: There are no data available for use of Hirobriz Breezhaler in patients with severe hepatic impairment.
Danish: Der er ingen tilgængelige data for brug af Hirobriz Breezhaler til patienter med stærkt nedsat leverfunktion.
English: Breezhaler capsules with any other inhaler, and do not use Hirobriz Breezhaler inhaler to take any other capsule medicine.
Danish: Hirobriz Breezhaler-kapsler sammen med andre inhalatorer, og brug ikke Hirobriz Breezhaler inhalatoren til at tage anden medicin i kapsler.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Hirobriz 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 Hirobriz Breezhaler i alle undergrupper af den pædiatriske population med kronisk obstruktiv lungesygdom (KOL) (se pkt.
English: Do not use Hirobriz Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Hirobriz Breezhaler - hvis du er allergisk over for indacaterol eller et af de øvrige indholdsstoffer i Hirobriz
English: Show the pack of Hirobriz Breezhaler.
Danish: Vis dem pakningen med Hirobriz Breezhaler.
English: Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Hirobriz Breezhaler er indiceret til bronkodilaterende vedligeholdelsesbehandling af luftvejsobstruktion hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: The Hirobriz Breezhaler inhaler provided with each new prescription should be used.
Danish: Hirobriz Breezhaler-inhalatoren, der er i hver ny ordination, skal anvendes.
English: In addition, patients treated with Hirobriz 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: If you forget to use Hirobriz Breezhaler
Danish: Hvis du har glemt at tage Hirobriz Breezhaler
English: Hirobriz 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: Hirobriz 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: Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Hirobriz Breezhaler.
Danish: Efter markedsføring er der modtaget rapporter om overfølsomhed i forbindelse med brug af Hirobriz Breezhaler.
English: Hirobriz 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: Hirobriz 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: The Hirobriz Breezhaler inhaler enables you to inhale the medicine contained in an Hirobriz Breezhaler capsule.
Danish: Hirobriz Breezhaler-inhalatoren gør det muligt for dig at inhalere medicinen i en Hirobriz Breezhalerkapsel.
English: If paradoxical bronchospasm occurs Hirobriz Breezhaler should be discontinued immediately and alternative therapy substituted.
Danish: Ved paradoks bronkospasme skal behandlingen straks seponeres og erstattes med alternativ behandling.
English: Never wash the Hirobriz Breezhaler inhaler with water.
Danish: Vask aldrig Hirobriz Breezhaler-inhalatoren med vand.
English: Always use the new Hirobriz Breezhaler inhaler that comes with your new pack.
Danish: Brug altid den nye Hirobriz Breezhaler-inhalator, som er vedlagt din nye pakning.
English: Always keep the Hirobriz Breezhaler inhaler and capsules in a dry place.
Danish: Hirobriz Breezhaler-inhalatoren og kapslerne skal altid opbevares på et tørt sted.
English: What you need to know before you use Hirobriz Breezhaler
Danish: Det skal du vide, før du begynder at tage Hirobriz Breezhaler
English: Hirobriz Breezhaler capsules must not be swallowed.
Danish: Hirobriz Breezhaler-kapsler må ikke synkes.
English: What Hirobriz Breezhaler contains - Each Hirobriz Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Danish: Hirobriz Breezhaler indeholder: - Hver Hirobriz Breezhaler 150 mikrogram kapsel indeholder 150 mikrogram indacaterol i form af indacaterolmaleat.
English: - Each Hirobriz Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Danish: - Hver Hirobriz Breezhaler 300 mikrogram kapsel indeholder 300 mikrogram indacaterol i form af indacaterolmaleat.
English: During treatment with Hirobriz Breezhaler, 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: The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6).
Danish: Kapslerne må kun tages ved hjælp af Hirobriz Breezhaler-inhalatoren (se pkt.
English: When you start a new pack, use the new Hirobriz Breezhaler inhaler that is supplied in the pack.
Danish: Når du starter på en ny pakning, skal du bruge den nye Hirobriz Breezhaler-inhalator, som er vedlagt pakningen.
English: Carton containing 30 capsules and one Hirobriz Breezhaler inhaler.
Danish: Pakning med 30 kapsler og en Hirobriz Breezhaler-inhalator.
English: • Only use the Hirobriz Breezhaler inhaler contained in this pack.
Danish: • Brug kun den Hirobriz Breezhaler-inhalator, som er vedlagt denne pakning.
English: Carton containing 10 capsules and one Hirobriz Breezhaler inhaler.
Danish: Pakning med 10 kapsler og en Hirobriz Breezhaler-inhalator.
English: INSTRUCTIONS FOR USE OF HIROBRIZ BREEZHALER INHALER
Danish: BRUGSANVISNING TIL HIROBRIZ BREEZHALER-INHALATOR
English: • When you start a new pack, only use the new Hirobriz Breezhaler inhaler that is supplied in the pack.
Danish: • Når du starter på en ny pakning, skal du bruge den nye Hirobriz Breezhaler-inhalator, som medfølger pakningen.
English: Hirobriz Breezhaler inhaler
Danish: Hirobriz Breezhaler-inhalator