FrancophonIA/ELRC3.0 huggingface dataset:
English: Bacteria can become resistant to treatment with an antibiotic over time.
Danish: Bakterier kan over tid blive resistente over for behandling med et antibiotikum.
English: 4) Keeping the handset level, place the mouthpiece in your mouth and close your lips around it (Figure 3).
Danish: 4) Hold fortsat håndsættet vandret, anbring mundstykket i munden, og luk dine læber omkring det (figur 3).
English: The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne defineres ved anvendelse af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: For patients taking multiple inhaled therapies, the recommended order of administration is as follows: 1.
Danish: For patienter, der tager flere inhalerede behandlinger, er den anbefalede rækkefølge for administration følgende:
English: Reduced bacterial permeability (common in P. aeruginosa) and efflux mechanisms may also confer or contribute to resistance.
Danish: Reduceret bakteriel permeabilitet (almindeligt hos P. aeruginosa) og udstrømningsmekanismer kan også bibringe eller bidrage til resistens.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der forekommer superinfektion under behandlingen, skal der iværksættes passende foranstaltninger.
English: - Do not swallow the liquid in the ampoule.
Danish: - Undlad at sluge væsken i ampullen.
English: Effect of levofloxacin on other medicinal products
Danish: Virkninger af levofloxacin på andre lægemidler
English: Median time to administration of anti-pseudomonal antimicrobials
Danish: Mediantid til administration af antipseudomonale antimikrobielle midler
English: The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Danish: Nyreclearance af levofloxacin blev reduceret ved hjælp af cimetidin (24%) og probenecid (34%).
English: * See paragraph below for further details.
Danish: * Se afsnit nedenfor for yderligere oplysninger.
English: Sputum PK exposure in children aged 7 to 16 years old was approximately one-third of adult exposure.
Danish: PK-eksponering i spyt hos børn i alderen 7 til 16 år var ca. en tredjedel af eksponeringen hos voksne.
English: Treatment of these patients with levofloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Danish: Behandling af disse patienter med levofloxacin bør kun påbegyndes, hvis der ikke findes alternative behandlingsmuligheder, og efter en nøje vurdering af benefit/risk-forholdet (se også pkt.
English: Press down and turn the cap clockwise as far as it will go (b, Figure 2).
Danish: Tryk ned, og drej låget med uret så langt, som det kan komme (b, figur 2).
English: 1) Make sure that the Zirela Nebuliser Handset is on a flat and stable surface.
Danish: 1) Sørg for, at Zirela-nebulisatorhåndsættet er placeret på en plan og stabil overflade.
English: One nebuliser handset should be used for one 28-day treatment course.
Danish: Ét nebulisatorhåndsæt skal anvendes til ét 28 dages behandlingsforløb.
English: Get urgent medical treatment immediately if you notice a severe allergic reaction after inhaling Quinsair.
Danish: Få straks akut medicinsk behandling, hvis du oplever en kraftig allergisk reaktion efter inhalering af Quinsair.
English: Changes in bronchial secretions (volume and viscosity)*, Haemoptysis*
Danish: Ændringer i bronkiale sekretioner (volumen og viskositet)*, Hæmoptyse*
English: Exacerbation of myasthenia gravis
Danish: Eksacerbation af myasthenia gravis
English: Following oral and intravenous administration, levofloxacin is eliminated relatively slowly from the plasma (t1/2: 6 to 8 hours).
Danish: Efter oral og intravenøs administration elimineres levofloxacin relativt langsomt fra plasmaet (t1/2: 6 til 8 timer).
English: • Epilepsy.
Danish: • Epilepsi.
English: Based on these limited data, there does not appear to be any clinically relevant difference in the safety profile of Quinsair in these subsets of the paediatric population compared to adults.
Danish: På baggrund af disse begrænsede data ser der ikke ud til at være nogen klinisk relevant forskel på Quinsairs sikkerhedsprofil for disse undergrupper af den pædiatriske population i forhold til voksne.
English: These effects can be attributed to inhibition of topoisomerase II.
Danish: Disse virkninger kan tilskrives hæmning af topoisomerase II.
English: Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
Danish: Levofloxacin kan hæmme væksten af Mycobacterium tuberculosis og kan derfor give falsk negative resultater ved bakteriologisk diagnosticering af tuberkulose.
English: Inhaling Quinsair at the same time each day will help you remember when to take your medicine.
Danish: Hvis du inhalerer Quinsair på samme tid hver dag, vil det være en hjælp for dig til at huske, hvornår du skal tage din medicin.
English: Certain tests (e.g. to confirm tuberculosis or screening for strong painkillers) may give false results whilst you are being treated with Quinsair.
Danish: Visse tests (f.eks. til bekræftelse af tuberkulose eller screening for kraftige smertestillende midler) kan give forkerte resultater, mens du behandles med Quinsair.
English: CDAD may range in severity from mild to life-threatening, the most severe form of which is pseudomembranous colitis.
Danish: CDAD kan spænde i sværhedsgrad fra let til livstruende, hvor den sværeste form er pseudomembranøs colitis.
English: Weight decrease was reported as an adverse event during clinical studies, but was primarily thought to be disease rather than drug-related.
Danish: Vægttab et rapporteret som en utilsigtet hændelse i kliniske studier, men det blev primært betragtet som sygdomsrelateret og ikke lægemiddelrelateret.
English: Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Danish: Farmakoterapeutisk klassifikation: antibakterielle midler til systemisk anvendelse, fluorquinoloner, ATC-kode: J01MA12
English: You must inhale and exhale through the mouthpiece as before.
Danish: Du skal ånde ind og ud gennem mundstykket som før.
English: The Manufacturer's Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.
Danish: Producentens brugsanvisning til Zirela-nebulisatorsystemet bør læses før første anvendelse af Quinsair.
English: It is important that you keep using the medicine twice a day during your 28 days on treatment and that you keep to the 28-days on, 28-days off cycle for as long as your doctor tells you to.
Danish: Det er vigtigt, at du fortsætter med at bruge medicinen to gange dagligt i de 28 dage med behandling, og at du fortsætter med cyklussen med 28 dages behandling og 28 dages pause, så længe som lægen fortæller dig, du skal gøre det.
English: A few drops of medicine may remain at the bottom of the reservoir at the end of treatment.
Danish: Der kan være nogle få dråber medicin tilbage i bunden af beholderen efter endt behandling.
English: There is a limited amount of data from the use of levofloxacin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af levofloxacin til gravide kvinder.
English: 7) Once complete, open the medicine cap to ensure all of the medicine has been used.
Danish: 7) Åbn medicinlåget, når behandlingen er færdig, for at sikre, at al medicinen er brugt.
English: Sometimes lengthy treatment with antibiotics can mean that you get another infection caused by other bacteria which are not affected by the antibiotic (superinfection).
Danish: Undertiden kan man under en langvarig behandling med et antibiotikum få en anden infektion, der skyldes en anden bakterie, der ikke påvirkes af det pågældende antibiokum (superinfektion).
English: Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses.
Danish: Studier med mus har vist, at levofloxacin kun har fototoksisk aktivitet ved meget høje doser.
English: Furthermore, clinical data do not suggest interaction with P-glycoprotein (P-gp) substrates such as digoxin.
Danish: Ydermere tyder kliniske data ikke på interaktion med P-glycoprotein (P-gp)-substrater, såsom digoxin.
English: When the treatment is complete, the controller will ‘beep' twice.
Danish: Når behandlingen er gennemført, “bipper” styreenheden to gange.
English: To conduct a non-interventional post-authorisation safety study in a registry of patients with cystic fibrosis to investigate the long term safety profile of Quinsair in normal clinical practice in the European Union.
Danish: Udføre et ikke-inventionsstudie af sikkerheden efter markedsføring i et register over patienter med cystisk fibrose til undersøgelse af langtidssikkerhedsprofilen for Quinsair i normal klinisk praksis i EU.
English: Quinsair can interfere with the effects of these medicines.
Danish: Quinsair kan påvirke virkningerne af disse lægemidler.
English: • Uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia).
Danish: • Ukorrigeret elektrolyt-ubalance (f.eks. hypokaliæmi, hypomagnesiæmi).
English: Each ampoule is for single use only.
Danish: Hver ampul er udelukkende til engangsbrug.
English: Weight decreased**, Forced expiratory volume decreased*
Danish: Reduceret vægt**, Reduceret forceret ekspiratorisk volumen*
English: Quinsair is supplied as a 28-day pack.
Danish: Quinsair leveres som en 28 dages-pakning.
English: Psychotic reactions (e.g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares
Danish: Psykotiske reaktioner (f.eks. hallucination, paranoia), Agitation, Abnorme drømme, Mareridt
English: The parameters associated with the antibacterial effects of levofloxacin are the Cmax/MIC and AUC/MIC ratios (Cmax = maximum concentration at the site of infection, AUC = area under the curve and MIC = minimal inhibitory concentration).
Danish: Parametrene, der er forbundet med de antibakterielle virkninger af levofloxacin, er Cmax/MIC- og AUC/MIC-forholdene (Cmax = maksimal koncentration på infektionsstedet, AUC = areal under kurven og MIC = minimal hæmmende koncentration).
English: Inhale your medicine as follows: - 1 ampoule in the morning using the Zirela Nebuliser - 1 ampoule in the evening using the Zirela Nebuliser It is best to leave close to 12 hours between your doses.
Danish: Inhalér din medicin som følger: - 1 ampul om morgenen ved anvendelse af Zirela-nebulisatoren - 1 ampul om aftenen ved anvendelse af Zirela-nebulisatoren Det er bedst, hvis der er ca. 12 timer mellem dine doser.
English: Ask the patient to inhale and exhale through the mouthpiece until the treatment is finished.
Danish: Bed patienten om at inhalere og ekshalere gennem mundstykket, indtil behandlingen er færdig.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den oprindelige pakning for at beskytte mod lys.
English: Patients treated with vitamin K antagonists
Danish: Patienter, der behandles med vitamin K-antagonister
English: Vulvovaginal mycotic infection
Danish: Vulvovaginal mykotisk infektion
English: Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations.
Danish: Der bør derfor udvises forsigtighed, når fluorquinoloner, herunder levofloxacin, anvendes i disse populationer.
English: The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%).
Danish: De hyppigst rapporterede bivirkninger var hoste/produktiv hoste (54%), dysgeusi (30%) og træthed/asteni (25%).
English: In addition to study drug, patients remained on standard of care treatment for chronic pulmonary infection.
Danish: Foruden forsøgslægemidlet forblev patienterne på standardbehandling mod kronisk lungeinfektion.
English: Quinsair can cause changes to your heart rhythm, especially if you are taking any medicines to treat heart problems or low levels of potassium or magnesium in the blood.
Danish: Quinsair kan medføre ændringer i din hjerterytme, især hvis du tager medicin til behandling af hjerteproblemer eller lave niveauer af kalium eller magnesium i blodet.
English: Following systemic administration, there were no significant differences in levofloxacin pharmacokinetics between young and elderly subjects except those associated with age-related decreases in creatinine clearance.
Danish: Efter systemisk administration var der ingen signifikante forskelle i levofloxacinfarmakokinetikken mellem unge og ældre personer bortset fra de, der er forbundet med aldersrelaterede fald i kreatininclearance.
English: Prevention of photosensitisation
Danish: Forebyggelse af lyssensibilisering
English: At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quinsair, contact your doctor and rest the painful area.
Danish: Ved det første tegn på smerter eller betændelse i en sene (for eksempel i anklen, håndleddet, albuen, skulderen eller knæet) skal du holde op med at tage Quinsair, kontakte din læge og hvile det smertefulde område.
English: The mean post-dose sputum concentrations were approximately 500-1900 µg/ml and were approximately 400-1700 times higher than those observed in serum.
Danish: De gennemsnitlige spytkoncentrationer efter dosering var ca. 500-1900 µg/ml og var ca. 400-1700 gange højere end de koncentrationer, der blev observeret i serum.
English: Reduced susceptibility to levofloxacin can also result from acquisition of plasmids encoding proteins that protect these targets from inhibition.
Danish: Reduceret følsomhed over for levofloxacin kan også skyldes erhvervelse af plasmider, der koder for proteiner, der beskytter disse mål mod hæmning.
English: b LS Mean difference for Quinsair minus placebo.
Danish: b LS-middelværdiforskel for Quinsair minus placebo.
English: Basic instructions for use are given below.
Danish: Nedenfor er anført en grundlæggende brugsanvisning.
English: Any unused product must be thrown away.
Danish: Eventuelt ubrugt produkt skal smides væk.
English: At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered.
Danish: Ved det første tegn på tendinitis (f.eks. smertefuld hævelse, inflammation) skal behandlingen med levofloxacin seponeres, og der skal overvejes alternativ behandling.
English: Pneumonitis allergic
Danish: Allergisk pneumoni
English: INFORMATION IN BRAILLE Quinsair
Danish: INFORMATION I BRAILLESKRIFT Quinsair
English: * Adverse events with uncertain relatedness to Quinsair but which are known to be associated with systemic administration of levofloxacin and/or are plausibly associated with Quinsair and were reported more frequently than with placebo in clinical studies.
Danish: * Bivirkninger med usikker forbindelse til Quinsair, men som er kendt for at være forbundet med systemisk administration af levofloxacin, og/eller hvor det er sandsynligt, at de er forbundet med Quinsair, og som er rapporteret hyppigere ved brug af Quinsair end placebo i kliniske studier.
English: Keep the Zirela Instructions for Use in a safe place as they give full details on assembling the device.
Danish: Opbevar Zirela-brugsanvisningen på et sikkert sted, da den indeholder alle detaljer om samling af anordningen.
English: - Superinfections
Danish: - Superinfektioner
English: Tell your doctor if you are taking any of the following medicines: - Vitamin K antagonists such as warfarin (used to prevent blood clots).
Danish: Fortæl lægen, hvis du tager et eller flere af følgende lægemidler: - Vitamin K-antagonister, som f.eks. warfarin (anvendes til forebyggelse af blodpropper).
English: Pharmacokinetic parameter
Danish: Farmakokinetisk parameter
English: A total of 88 patients received at least 1 dose of Quinsair in Study 209 (Extension Phase), 32 of these had received TIS and 56 of these had received Quinsair in the Core Phase.
Danish: I alt 88 patienter fik mindst 1 dosis Quinsair i studie 209 (forlængelsesfase), 32 af disse havde fået TIS, og 56 af disse havde fået Quinsair i kernefasen.
English: Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD).
Danish: Diarré, især hvis den er svær, persistent og/eller blodig, under eller efter behandling med levofloxacin (herunder adskillige uger efter behandling), kan være symptom på Clostridium difficile-forbundet sygdom (CDAD).
English: Stop using Quinsair and tell your doctor immediately: - if you experience pain, stiffness and/or swelling in your joints - if you develop problems with your liver.
Danish: Hold straks op med at bruge Quinsair og fortæl det til lægen: - hvis du oplever smerter, stivhed og/eller hævelse i dine led - hvis du får problemer med din lever.
English: Following systemic administration, the effect of race on levofloxacin pharmacokinetics was examined through a covariate analysis performed on data from 72 subjects: 48 white and 24 non-white.
Danish: Virkningen af race på farmakokinetikken for levofloxacin efter systemisk administration er blevet undersøgt ved hjælp af en kovariansanalyse udført på data fra 72 personer: 48 hvide og 24 ikke-hvide.
English: Study 209 (Core Phase) was a randomised, open-label, parallel group, active-controlled, non-inferiority study comparing Quinsair to tobramycin inhalation solution (TIS) over 3 treatment cycles.
Danish: Studie 209 (kernefase) var et randomiseret, åbent, parallelgruppe, aktiv-kontrolleret, non-inferioritetsstudie, der sammenlignede Quinsair med tobramycin-inhalationsopløsning (TIS) over 3 behandlingscyklusser.
English: Patients should not inhale the contents of more than one ampoule to compensate for the missed dose.
Danish: Patienter må ikke inhalere indholdet af mere end én ampul for at kompensere for den manglende dosis.
English: What if I am using several different inhalers and other therapies for cystic fibrosis?
Danish: Hvis du bruger flere forskellige inhalatorer og andre behandlinger mod cystisk fibrose?
English: It should only be used to treat lung infections caused by Pseudomonas aeruginosa.
Danish: Det bør kun anvendes til at behandle lungeinfektioner, der skyldes Pseudomonas aeruginosa.
English: Ciclosporin The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.
Danish: Halveringstiden for ciclosporin blev forøget med 33%, når det blev administreret sammen med levofloxacin.
English: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Danish: Der er i epidemiologiske studier rapporteret en øget risiko for aortaaneurisme og -dissektion efter indtagelse af fluorquinoloner, især hos den ældre population.
English: The medicine comes in small 3 ml plastic ampoules.
Danish: Lægemidlet leveres i små 3 ml plastampuller.
English: if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Danish: hvis du tidligere har haft et tilfælde af aortadissektion (en rift i aortavæggen).
English: If you are using several different inhaled treatments and other therapies for cystic fibrosis, it is recommended that you use your medicines in the following order: 1st
Danish: Hvis du bruger flere forskellige inhalerede behandlinger og andre behandlinger mod cystisk fibrose, anbefales det, at du tager din medicin i følgende rækkefølge:
English: Talk to your doctor if you have any questions about this.
Danish: Tal med lægen, hvis du har spørgsmål om dette.
English: Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Danish: Levofloxacin er stereokemisk stabil og gennemgår ikke chiral inversion.
English: Talk to your doctor if you have any concerns or questions about this and using Quinsair.
Danish: Tal med lægen, hvis du har bekymringer eller spørgsmål i forhold til dette og brugen af Quinsair.
English: • Concomitant use of active substances that are known to prolong the QT interval (e.g. Class IA
Danish: • Samtidig anvendelse af aktive stoffer, der er kendte for at forlænge QT-intervallet (f.eks. klasse
English: Hyposmia*, Somnolence*
Danish: Hyposmi*, Somnolens*
English: This means that Quinsair should not be used to prevent lung infections.
Danish: Dette betyder, at Quinsair ikke bør anvendes til at forebygge lungeinfektioner.
English: These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
Danish: Disse metabolitter udgør < 5% af dosen efter systemisk administration og udskilles i urin.
English: Insomnia*
Danish: Insomni*
English: Please refer to the Manufacturer's Instructions for Use for cleaning and storage advice.
Danish: Der henvises til producentens brugsanvisning for råd vedrørende rengøring og opbevaring.
English: - A disease causing muscle weakness and fatigue called myasthenia gravis.
Danish: - En sygdom, der medfører muskelsvaghed og træthed, som kaldes myasthenia gravis.
English: The Manufacturer's Instructions for Use will give full details on cleaning and disinfecting.
Danish: Producentens brugsanvisning giver alle detaljer om rengøring og desinfektion.
English: Store in the original package in order to protect from light.
Danish: Opbevares i den oprindelige pakning for at beskytte mod lys.
English: You use Quinsair every day for 28 days, then take a 28-day break, during which you do not inhale any Quinsair.
Danish: Du skal bruge Quinsair hver dag i 28 dage, hvorefter du holder en pause på 28 dage, hvor du ikke inhalerer Quinsair.
English: Once an ampoule is opened, the contents should be used immediately.
Danish: Når en ampul er åbnet, skal indholdet bruges straks.
English: Patients with glucose-6-phosphate dehydrogenase deficiency
Danish: Patienter med glucose-6-phosphatdehydrogenasedeficiens
English: Two randomised, double-blind, single-cycle, placebo-controlled clinical trials (Studies 204 and 207) in patients with CF chronically infected with P. aeruginosa were conducted.
Danish: Der er udført to randomiserede, dobbeltblinde, placebokontrollerede kliniske enkeltcyklusstudier (studie 204 og 207) med patienter med CF, der var kronisk inficeret med P. aeruginosa.
English: However, two cases of arthralgia have been observed in children in clinical studies with Quinsair and long-term safety data are missing especially considering the effects on cartilage observed in animals.
Danish: Der er imidlertidobserveret to tilfælde af artralgi hos børn i kliniske studier med Quinsair, og der mangler data om sikkerheden på langt sigt, især i relation til de virkninger på brusk, der er observeret hos dyr (se pkt.
English: Ensure that you completely empty the ampoule, gently tapping it against the side of the reservoir if necessary.
Danish: Sørg for, at du tømmer ampullen helt ved om nødvendigt at banke den forsigtigt mod siden af beholderen.
English: Population pharmacokinetic analysis results showed no differences in systemic exposure of levofloxacin due to gender following administration of Quinsair.
Danish: Populationsfarmakokinetiske analyseresultater viste ingen forskelle i systemisk eksponering for levofloxacin på grund af køn efter administration af Quinsair.
English: Four ampoules are sealed in a foil sachet and each box contains 14 sachets.
Danish: Fire ampuller er forseglet i et foliebrev, og hver æske indeholder 14 breve.