FrancophonIA/ELRC3.0 huggingface dataset:
English: • Open the mouthpiece again, and remove the empty capsule by tipping it out of the capsule chamber.
Danish: • Åbn mundstykket igen, og fjern den tomme kapsel ved at hælde den ud af kapselkammeret.
English: Insert capsule: Place the capsule into the capsule chamber.
Danish: Ilæggelse af en kapsel: Læg kapslen i kapselkammeret.
English: When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs.
Danish: Når stoffet inhaleres, afslappes musklerne i væggene i bronkierne (lungernes små luftpassager).
English: There was a rapid onset of action within 5 minutes after inhalation, with an increase in FEV1 relative to baseline of 110-160 ml, comparable to the effect of the fast-acting beta2-agonist salbutamol 200 microgram and statistically significantly faster compared to salmeterol/fluticasone 50/500 microgram.
Danish: Der sås en hurtig indsættende virkning, inden for 5 minutter efter inhalation med en øget FEV1 på 110-160 ml relativt i forhold til baseline, tilsvarende virkningen af den hurtigtvirkende beta2-agonist salbutamol 200 mikrogram og statistisk set hurtigere i forhold til 50/500 mikrogram salmeterol/fluticason.
English: Immediate hypersensitivity reactions have been reported after administration of Oslif Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af Oslif Breezhaler.
English: Tiotropium once a day
Danish: Tiotropium én gang dagligt
English: No dose adjustment is required for patients with mild and moderate hepatic impairment.
Danish: Der kræves ikke dosisjustering hos patienter med mildt og moderat nedsat leverfunktion.
English: Pull off the cap.
Danish: Fjern hætten.
English: Before placing the mouthpiece in your mouth, breathe out fully.
Danish: Inden mundstykket tages i munden, skal du tage en dyb udånding.
English: Salmeterol twice a day
Danish: Salmeterol to gange dagligt
English: See “How to clean your inhaler”.
Danish: Se "Rengøring af inhalatoren".
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 Oslif 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 Oslif Breezhaler én gang dagligt.
English: Paediatric population There is no relevant use of Oslif Breezhaler in the paediatric population (under 18 years).
Danish: Pædiatrisk population Det er ikke relevant at anvende Oslif Breezhaler hos den pædiatriske population (under 18 år).
English: Oslif Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Danish: Oslif Breezhaler-kapsler skal altid opbevares i blisteren og må først trykkes ud lige før brug.
English: Effects on cardiac electrophysiology
Danish: Virkninger på hjerteelektrofysiologi
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Oslif 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 beta2-adrenergic agonists.
Danish: Selvom der sædvanligvis ikke observeres klinisk relevante virkninger på det kardiovaskulære system efter anvendelse af Oslif 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 Oslif Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Danish: Det kliniske fase III-udviklingsprogram for Oslif Breezhaler omfattede patienter med klinisk diagnose af moderat til svær KOL.
English: Oslif Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Danish: Oslif Breezhaler er ikke undersøgt hos patienter med ukontrolleret diabetes mellitus.
English: An overdose of indacaterol is likely to 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.
Danish: En overdosis af indacaterol vil sandsynligvis medføre en forstærket virkning, som er typisk for beta2adrenerge stimulerende midler, dvs. takykardi, tremor, palpitationer, hovedpine, kvalme, opkast, døsighed, ventrikulære arytmier, metabolisk acidose, hypokaliæmi og hyperglykæmi.
English: Upon initiation of treatment with Oslif Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved påbegyndelse af behandling med Oslif Breezhaler skal plasmaglukose monitoreres tættere hos diabetespatienter.
English: Cough is a common symptom in COPD.
Danish: Hoste er et typisk symptom på KOL.
English: Oslif Breezhaler has no or negligible influence on the ability to drive and use machines.
Danish: Oslif Breezhaler påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Like other beta2-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.
Danish: Ligesom andre beta2-adrenerge agonister kan indacaterol medføre klinisk signifikante kardiovaskulære virkninger hos nogle patienter, hvilket ses ved øget pulsfrekvens, blodtryk og/eller andre symptomer.
English: Indacaterol has not been shown to cause interactions with medicinal products administered concomitantly.
Danish: Det er ikke påvist, at indacaterol interagerer med lægemidler, som gives samtidig.
English: Infections and infestations Nasopharyngitis
Danish: Infektioner og parasitære sygdomme Nasopharyngitis
English: At the recommended doses, the adverse reaction profile of Oslif Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Danish: Ved de anbefalede doser viser bivirkningsprofilen for Oslif Breezhaler hos patienter med KOL klinisk ubetydelige systemiske virkninger af beta2-adrenerg stimulation.
English: • if you get irregular heart beat (uncommon).
Danish: • hvis du får uregelmæssig hjerterytme (ikke almindelig bivirkning).
English: Prepare capsule:
Danish: Forberedelse af en kapsel:
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 Oslif 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 Oslif Breezhaler og de patienter, der fik placebo eller behandling med tiotropium.
English: These include: o steroids (e.g. prednisolone), o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, o medicines for breathing problems such as theophylline.
Danish: Dette gælder: o steroider (fx prednisolon), o diuretika (vanddrivende tabletter), som bruges mod for højt blodtryk, såsom hydrochlorthiazid, o medicin mod åndedrætsbesvær, som fx theofyllin.
English: Your Oslif Breezhaler pack: Each Oslif Breezhaler pack contains: one Oslif Breezhaler inhaler one or more blister containing Oslif Breezhaler capsules to be used in the inhaler.
Danish: Din Oslif Breezhaler-pakning: Hver Oslif Breezhaler-pakning indeholder: én Oslif Breezhaler-inhalator en eller flere blistere med Oslif Breezhaler-kapsler, som skal bruges i inhalatoren.
English: Driving and using machines It is unlikely that Oslif Breezhaler will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Oslif Breezhaler vil påvirke din evne til at køre bil eller betjene maskiner.
English: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Oslif Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i én kapsel på 150 mikrogram en gang dagligt ved hjælp af Oslif Breezhaler-inhalatoren.
English: Oslif Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Danish: Oslif Breezhaler må ikke anvendes sammen med andre langtidsvirkende beta2-adrenerge agonister eller lægemidler, der indeholder langtidsvirkende beta2-adrenerge agonister.
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 openlabel tiotropium på 18 mikrogram én gang dagligt (150 mikrogram, p=0,004; 300 mikrogram, p=0,01).
English: If you use more Oslif Breezhaler than you should If you have inhaled too much Oslif 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 Oslif 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: The powder in the capsules is for you to inhale.
Danish: Pulveret i kapslerne skal inhaleres.
English: Oslif Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Danish: Oslif Breezhaler er ikke indiceret til behandling af akutte tilfælde af bronkospasmer, dvs. som anfaldsbehandling.
English: In the event of deterioration of COPD during treatment with Oslif Breezhaler, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Ved forværring af KOL under behandling med Oslif 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 Oslif 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 Oslif Breezhaler skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Renal impairment No dose adjustment is required for patients with renal impairment.
Danish: Nedsat nyrefunktion Der kræves ikke dosisjustering hos patienter med nedsat nyrefunktion.
English: Wipe the mouthpiece inside and outside to remove any powder with a clean, dry lint-free cloth.
Danish: Tør mundstykket indvendigt og udvendigt med en ren, tør og fnugfri klud for at fjerne eventuelle pulverrester.
English: The inhalation of the content of one 300 microgram capsule once a day, using the Oslif 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 Oslif Breezhaler-inhalatoren giver en yderligere klinisk virkning, hvad angår åndenød, særligt hos patienter med svær KOL.
English: See package leaflet for how to use this medicine.
Danish: Se i indlægssedlen, hvordan du skal bruge denne medicin.
English: • if you get symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
Danish: • hvis du får symptomer på en allergisk reaktion, som fx udslæt, kløe, nældefeber, svært ved at trække vejret eller synke, svimmelhed (ikke almindelig bivirkning).
English: A double-blind, placebo- and active (moxifloxacin)-controlled study for 2 weeks in 404 healthy volunteers demonstrated maximum mean (90% confidence intervals) prolongations of the QTcF interval (in milliseconds) of 2.66 (0.55, 4.77) 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) following multiple doses of 150 microgram, 300 microgram and 600 microgram, respectively.
Danish: Et dobbeltblindet, placebo- og aktivkontrolleret (moxifloxacin) forsøg over 2 uger hos 404 raske frivillige viste maksimal gennemsnitlig (90 % konfidensintervaller) forlængelse af QTcF-intervallet (i millisekunder) på 2,66 (0,55; 4,77), 2,98 (1,02; 4,93) og 3,34 (0,86; 5,82) efter flere doser på henholdsvis 150 mikrogram, 300 mikrogram og 600 mikrogram.
English: • Open the inhaler and carefully loosen the capsule by tapping the base of the inhaler.
Danish: • Åbn inhalatoren, og frigør forsigtigt kapslen ved at banke let på inhalatorens underdel.
English: Formoterol twice a day
Danish: Formoterol to gange dagligt
English: Oslif Breezhaler is a single-dose inhalation device.
Danish: Oslif Breezhaler er en inhalator til enkeltdosering.
English: Indacaterol serum concentrations increased with repeated once-daily administration.
Danish: Serumkoncentrationer af indacaterol forøges ved fortsat anvendelse én gang dagligt.
English: Do not blow into the mouthpiece.
Danish: Du må ikke puste i mundstykket.
English: Due to the very low contribution of the urinary pathway to total body elimination, a study in renally impaired subjects was not performed.
Danish: Da urinvejene spiller en meget lille rolle af den samlede udskillelse, er der ikke udført undersøgelser med forsøgspersoner med nedsat nyrefunktion.
English: Inhale the medicine: To breathe the medicine deeply into your airways:
Danish: Inhaler medicinen: Sådan indånder du medicinen dybt ned i luftvejene:
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Oslif 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 Oslif Breezhaler i kliniske studier (se pkt.
English: medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol).
Danish: Medicin, som kaldes betablokkere, som bruges mod for højt blodtryk eller andre hjerteproblemer (fx propranolol), eller mod øjensygdommen kaldet grøn stær (glaukom) (fx timolol).
English: • Ask your pharmacist how to dispose of medicines and inhalers no longer required.
Danish: • Spørg på apoteket, hvordan du skal bortskaffe medicinrester og brugte inhalatorer.
English: There are no data available for use of Oslif Breezhaler in patients with severe hepatic impairment.
Danish: Der er ingen tilgængelige data for brug af Oslif Breezhaler til patienter med stærkt nedsat leverfunktion.
English: On the inside of the pack there is a daily dose tracker.
Danish: På indersiden af pakningen findes en kalender, hvor du kan afkrydse din daglige dosis.
English: If the capsule is not empty then inhale again as directed.
Danish: Hvis kapslen ikke er tom, skal du inhalere igen i henhold til brugsanvisningen.
English: Oslif Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Danish: Anvendelse af Oslif Breezhaler én gang dagligt ved doser på 150 mikrogram og 300 mikrogram viste klinisk betydningsfulde forbedringer af lungefunktionen.
English: Oslif 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: Oslif Breezhaler bruges til at lette vejrtrækningen hos voksne patienter, som lider af åndedrætsbesvær pga. en lungesygdom, som kaldes kronisk obstruktiv lungesygdom (KOL).
English: How to use your inhaler
Danish: Sådan bruger du din inhalator
English: You should not use Oslif Breezhaler unless your doctor tells you so.
Danish: Du må ikke tage Oslif Breezhaler, medmindre du har aftalt det med din læge.
English: Oslif 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 Oslif 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: Oslif Breezhaler contains lactose
Danish: Oslif Breezhaler indeholder lactose
English: Treatment comparison compared to placebo showed a ratio of rates of 0.68 (95% CI [ 0.47, 0.98]; p-value 0.036) and 0.74 (95% CI [0.56, 0.96]; pvalue 0.026) for 150 microgram and 300 microgram, respectively.
Danish: Frekvensforholdet sammenlignet med placebo var 0,68 (95 % konfidensinterval [0,47; 0,98]; p-værdi=0,036) og 0,74 (95 % konfidensinterval [0,56; 0,96]; pværdi=0,026) for henholdsvis 150 mikrogram og 300 mikrogram.
English: • Dispose of each inhaler after 30 days of use.
Danish: • Smid hver inhalator ud efter 30 dages brug.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Oslif 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 Oslif Breezhaler i alle undergrupper af den pædiatriske population med kronisk obstruktiv lungesygdom (KOL) (se pkt.
English: The 300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml increase compared to formoterol 12 microgram twice a day (p<0.001).
Danish: Dosisen på 300 mikrogram medførte en forøgelse på 170-180 ml sammenlignet med placebo (p<0,001) og en forøgelse på 100 ml sammenlignet med 12 mikrogram formoterol to gange dagligt (p<0,001).
English: Your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment.
Danish: Din læge vil fortælle dig, om du skal tage kapslen med 150 mikrogram eller kapslen med 300 mikrogram.
English: Show the pack of Oslif Breezhaler.
Danish: Vis dem pakningen med Oslif Breezhaler.
English: • if you have difficulty breathing with wheezing or coughing (uncommon).
Danish: • hvis du har besværet vejrtrækning med hvæsen eller hoste (ikke almindelig bivirkning).
English: General disorders and administration site conditions Chest pain
Danish: Almene symptomer og reaktioner på administrationsstedet Brystsmerter
English: Put the empty capsule in your household waste.
Danish: Smid kapslen ud sammen med almindeligt husholdningsaffald.
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, når de anvendes til behandling af astma, forøge risikoen for alvorlige, astmarelaterede bivirkninger inklusive astmarelateret død.
English: How to clean your inhaler
Danish: Rengøring af din inhalator
English: After you have inhaled the medicine:
Danish: Efter inhalation af medicinen:
English: if you have thyroid gland problems (thyrotoxicosis).
Danish: hvis du har problemer med skjoldbruskkirtlen (tyrotoksikose).
English: In addition, patients treated with Oslif 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 get crushing chest pain, (common).
Danish: • hvis du får stærke brystsmerter (almindelig bivirkning).
English: This medicine contains lactose (milk sugar).
Danish: Dette lægemiddel indeholder lactose.
English: Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Oslif Breezhaler er indiceret til bronkodilaterende vedligeholdelsesbehandling af luftvejsobstruktion hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Each inhaler should be disposed of after 30 days of use.
Danish: Hver inhalator skal smides ud efter 30 dages brug.
English: During treatment with Oslif Breezhaler,
Danish: Under behandling med Oslif Breezhaler:
English: Like other beta2-adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Danish: Indacaterol kan, som andre beta2-agonister, hæmme veer ved fødslen pga. en afslappende virkning på den glatte muskulatur i uterus.
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled doses between 150 microgram and 600 microgram.
Danish: Efter inhalation én gang dagligt var indacaterols gennemsnitlige akkumulationsforhold (dvs. AUC målt over et 24 timers doseringsinterval, på dag 14 sammenlignet med dag 1) i intervallet 2,9 til 3,5 for doser mellem 150 mikrogram og 600 mikrogram inhaleret en gang dagligt.
English: Do not use Oslif Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Oslif Breezhaler - hvis du er allergisk over for indacaterol eller et af de øvrige indholdsstoffer i Oslif Breezhaler
English: At the 12-week primary endpoint (24-hour trough FEV1), the 150 microgram dose resulted in a 130-180 ml increase compared to placebo (p<0.001) and a 60 ml increase compared to salmeterol 50 microgram twice a day (p<0.001).
Danish: Ved det primære endepunkt efter 12 uger (24 timers dal-FEV1) medførte en dosis på 150 mikrogram en forøgelse på 130-180 ml sammenlignet med placebo (p<0,001) og en forøgelse på 60 ml sammenlignet med salmeterol på 50 mikrogram to gange dagligt (p<0,001).
English: The Oslif Breezhaler inhaler provided with each new prescription should be used.
Danish: Oslif Breezhalerinhalatoren, der er i hver ny ordination, skal anvendes.
English: Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Oslif Breezhaler.
Danish: Efter markedsføring er der modtaget rapporter om overfølsomhed i forbindelse med brug af Oslif Breezhaler.
English: Do not use Oslif Breezhaler capsules with any other inhaler, and do not use Oslif Breezhaler inhaler to take any other capsule medicine.
Danish: Breezhaler-kapsler sammen med andre inhalatorer, og brug ikke Oslif Breezhaler-inhalatoren til at tage anden medicin i kapsler.
English: Oslif 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: Oslif Breezhaler 150 mikrogram kapsler har påtrykt en sort produktkode "IDL 150" over en sort bjælke og et sort virksomhedslogo ( ) påtrykt under den sorte bjælke.