natgillin/translations-raw huggingface dataset:
Disse virkninger kan tilskrives hæmning af topoisomerase II. 
These effects can be attributed to inhibition of topoisomerase II.
Levofloxacin kan hæmme væksten af Mycobacterium tuberculosis og kan derfor give falsk negative resultater ved bakteriologisk diagnosticering af tuberkulose. 
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
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. 
Inhaling Quinsair at the same time each day will help you remember when to take your medicine.
Visse tests (f.eks. til bekræftelse af tuberkulose eller screening for kraftige smertestillende midler) kan give forkerte resultater, mens du behandles med Quinsair. 
Certain tests (e.g. to confirm tuberculosis or screening for strong painkillers) may give false results whilst you are being treated with Quinsair.
CDAD kan spænde i sværhedsgrad fra let til livstruende, hvor den sværeste form er pseudomembranøs colitis. 
CDAD may range in severity from mild to life-threatening, the most severe form of which is pseudomembranous colitis.
Vægttab et rapporteret som en utilsigtet hændelse i kliniske studier, men det blev primært betragtet som sygdomsrelateret og ikke lægemiddelrelateret. 
Weight decrease was reported as an adverse event during clinical studies, but was primarily thought to be disease rather than drug-related.
Farmakoterapeutisk klassifikation: antibakterielle midler til systemisk anvendelse, fluorquinoloner, ATC-kode: J01MA12 
Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC code: J01MA12
Du skal ånde ind og ud gennem mundstykket som før. 
You must inhale and exhale through the mouthpiece as before.
Producentens brugsanvisning til Zirela-nebulisatorsystemet bør læses før første anvendelse af Quinsair. 
The Manufacturer's Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.
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. 
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.
Der kan være nogle få dråber medicin tilbage i bunden af beholderen efter endt behandling. 
A few drops of medicine may remain at the bottom of the reservoir at the end of treatment.
Der er utilstrækkelige data fra anvendelse af levofloxacin til gravide kvinder. 
There is a limited amount of data from the use of levofloxacin in pregnant women.
7) Åbn medicinlåget, når behandlingen er færdig, for at sikre, at al medicinen er brugt. 
7) Once complete, open the medicine cap to ensure all of the medicine has been used.
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). 
Sometimes lengthy treatment with antibiotics can mean that you get another infection caused by other bacteria which are not affected by the antibiotic (superinfection).
Studier med mus har vist, at levofloxacin kun har fototoksisk aktivitet ved meget høje doser. 
Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses.
Ydermere tyder kliniske data ikke på interaktion med P-glycoprotein (P-gp)-substrater, såsom digoxin. 
Furthermore, clinical data do not suggest interaction with P-glycoprotein (P-gp) substrates such as digoxin.
Når behandlingen er gennemført, “bipper” styreenheden to gange. 
When the treatment is complete, the controller will ‘beep' twice.
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. 
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.
Quinsair kan påvirke virkningerne af disse lægemidler. 
Quinsair can interfere with the effects of these medicines.
• Ukorrigeret elektrolyt-ubalance (f.eks. hypokaliæmi, hypomagnesiæmi). 
• Uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia).
Hver ampul er udelukkende til engangsbrug. 
Each ampoule is for single use only.
Reduceret vægt**, Reduceret forceret ekspiratorisk volumen* 
Weight decreased**, Forced expiratory volume decreased*
Quinsair leveres som en 28 dages-pakning. 
Quinsair is supplied as a 28-day pack.
Psykotiske reaktioner (f.eks. hallucination, paranoia), Agitation, Abnorme drømme, Mareridt 
Psychotic reactions (e.g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares
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). 
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).
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. 
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.
Bed patienten om at inhalere og ekshalere gennem mundstykket, indtil behandlingen er færdig. 
Ask the patient to inhale and exhale through the mouthpiece until the treatment is finished.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den oprindelige pakning for at beskytte mod lys. 
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Patienter, der behandles med vitamin K-antagonister 
Patients treated with vitamin K antagonists
Vulvovaginal mykotisk infektion 
Vulvovaginal mycotic infection
Der bør derfor udvises forsigtighed, når fluorquinoloner, herunder levofloxacin, anvendes i disse populationer. 
Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations.
De hyppigst rapporterede bivirkninger var hoste/produktiv hoste (54%), dysgeusi (30%) og træthed/asteni (25%). 
The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%).
Foruden forsøgslægemidlet forblev patienterne på standardbehandling mod kronisk lungeinfektion. 
In addition to study drug, patients remained on standard of care treatment for chronic pulmonary infection.
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. 
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.
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. 
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.
Forebyggelse af lyssensibilisering 
Prevention of photosensitisation
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. 
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.
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. 
The mean post-dose sputum concentrations were approximately 500-1900 µg/ml and were approximately 400-1700 times higher than those observed in serum.
Reduceret følsomhed over for levofloxacin kan også skyldes erhvervelse af plasmider, der koder for proteiner, der beskytter disse mål mod hæmning. 
Reduced susceptibility to levofloxacin can also result from acquisition of plasmids encoding proteins that protect these targets from inhibition.
b LS-middelværdiforskel for Quinsair minus placebo. 
b LS Mean difference for Quinsair minus placebo.
Nedenfor er anført en grundlæggende brugsanvisning. 
Basic instructions for use are given below.
Eventuelt ubrugt produkt skal smides væk. 
Any unused product must be thrown away.
Ved det første tegn på tendinitis (f.eks. smertefuld hævelse, inflammation) skal behandlingen med levofloxacin seponeres, og der skal overvejes alternativ behandling. 
At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered.
Allergisk pneumoni 
Pneumonitis allergic
INFORMATION I BRAILLESKRIFT Quinsair 
INFORMATION IN BRAILLE Quinsair
* 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. 
* 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.
Opbevar Zirela-brugsanvisningen på et sikkert sted, da den indeholder alle detaljer om samling af anordningen. 
Keep the Zirela Instructions for Use in a safe place as they give full details on assembling the device.
- Superinfektioner 
- Superinfections
Fortæl lægen, hvis du tager et eller flere af følgende lægemidler: - Vitamin K-antagonister, som f.eks. warfarin (anvendes til forebyggelse af blodpropper). 
Tell your doctor if you are taking any of the following medicines: - Vitamin K antagonists such as warfarin (used to prevent blood clots).
Farmakokinetisk parameter 
Pharmacokinetic parameter
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. 
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.
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). 
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).
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. 
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.
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. 
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.
Studie 209 (kernefase) var et randomiseret, åbent, parallelgruppe, aktiv-kontrolleret, non-inferioritetsstudie, der sammenlignede Quinsair med tobramycin-inhalationsopløsning (TIS) over 3 behandlingscyklusser. 
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.
Patienter må ikke inhalere indholdet af mere end én ampul for at kompensere for den manglende dosis. 
Patients should not inhale the contents of more than one ampoule to compensate for the missed dose.
Hvis du bruger flere forskellige inhalatorer og andre behandlinger mod cystisk fibrose? 
What if I am using several different inhalers and other therapies for cystic fibrosis?
Det bør kun anvendes til at behandle lungeinfektioner, der skyldes Pseudomonas aeruginosa. 
It should only be used to treat lung infections caused by Pseudomonas aeruginosa.
Halveringstiden for ciclosporin blev forøget med 33%, når det blev administreret sammen med levofloxacin. 
Ciclosporin The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.
Der er i epidemiologiske studier rapporteret en øget risiko for aortaaneurisme og -dissektion efter indtagelse af fluorquinoloner, især hos den ældre population. 
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Lægemidlet leveres i små 3 ml plastampuller. 
The medicine comes in small 3 ml plastic ampoules.
hvis du tidligere har haft et tilfælde af aortadissektion (en rift i aortavæggen). 
if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Hvis du bruger flere forskellige inhalerede behandlinger og andre behandlinger mod cystisk fibrose, anbefales det, at du tager din medicin i følgende rækkefølge: 
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
Tal med lægen, hvis du har spørgsmål om dette. 
Talk to your doctor if you have any questions about this.
Levofloxacin er stereokemisk stabil og gennemgår ikke chiral inversion. 
Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Tal med lægen, hvis du har bekymringer eller spørgsmål i forhold til dette og brugen af Quinsair. 
Talk to your doctor if you have any concerns or questions about this and using Quinsair.
• Samtidig anvendelse af aktive stoffer, der er kendte for at forlænge QT-intervallet (f.eks. klasse 
• Concomitant use of active substances that are known to prolong the QT interval (e.g. Class IA
Hyposmi*, Somnolens* 
Hyposmia*, Somnolence*
Dette betyder, at Quinsair ikke bør anvendes til at forebygge lungeinfektioner. 
This means that Quinsair should not be used to prevent lung infections.
Disse metabolitter udgør < 5% af dosen efter systemisk administration og udskilles i urin. 
These metabolites account for ˂ 5% of the dose following systemic administration and are excreted in urine.
Insomni* 
Insomnia*
Der henvises til producentens brugsanvisning for råd vedrørende rengøring og opbevaring. 
Please refer to the Manufacturer's Instructions for Use for cleaning and storage advice.
- En sygdom, der medfører muskelsvaghed og træthed, som kaldes myasthenia gravis. 
- A disease causing muscle weakness and fatigue called myasthenia gravis.
Producentens brugsanvisning giver alle detaljer om rengøring og desinfektion. 
The Manufacturer's Instructions for Use will give full details on cleaning and disinfecting.
Opbevares i den oprindelige pakning for at beskytte mod lys. 
Store in the original package in order to protect from light.
Du skal bruge Quinsair hver dag i 28 dage, hvorefter du holder en pause på 28 dage, hvor du ikke inhalerer Quinsair. 
You use Quinsair every day for 28 days, then take a 28-day break, during which you do not inhale any Quinsair.
Når en ampul er åbnet, skal indholdet bruges straks. 
Once an ampoule is opened, the contents should be used immediately.
Patienter med glucose-6-phosphatdehydrogenasedeficiens 
Patients with glucose-6-phosphate dehydrogenase deficiency
Der er udført to randomiserede, dobbeltblinde, placebokontrollerede kliniske enkeltcyklusstudier (studie 204 og 207) med patienter med CF, der var kronisk inficeret med P. aeruginosa. 
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.
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. 
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.
Sørg for, at du tømmer ampullen helt ved om nødvendigt at banke den forsigtigt mod siden af beholderen. 
Ensure that you completely empty the ampoule, gently tapping it against the side of the reservoir if necessary.
Populationsfarmakokinetiske analyseresultater viste ingen forskelle i systemisk eksponering for levofloxacin på grund af køn efter administration af Quinsair. 
Population pharmacokinetic analysis results showed no differences in systemic exposure of levofloxacin due to gender following administration of Quinsair.
Fire ampuller er forseglet i et foliebrev, og hver æske indeholder 14 breve. 
Four ampoules are sealed in a foil sachet and each box contains 14 sachets.
Risikoen for tendinitis og seneruptur er forøget hos ældre patienter, patienter med nedsat nyrefunktion, patienter, der har fået transplanteret solide organer, patienter, der får daglige doser af 1000 mg levofloxacin, og dem, der samtidigt bliver behandlet med kortikosteroider. 
The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, patients receiving daily doses of 1000 mg levofloxacin, and those treated concurrently with corticosteroids.
Du bør undgå langvarig udsættelse for sollys eller kraftigt sollys og bør ikke anvende solarier eller andre UV-lamper, mens du behandles med Quinsair og i 48 timer, efter du er standset med behandlingen. 
You should avoid prolonged exposure to sunlight or strong sunlight and should not use sunbeds or any other UV lamps whilst using Quinsair and for 48 hours after stopping treatment.
Det tilhører gruppen af antibiotika, der kaldes fluorquinoloner. 
It belongs to the group of antibiotics called fluoroquinolones.
Krydsresistens mellem levofloxacin og andre fluorquinoloner er observeret. 
Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Resistens over for levofloxacin erhverves som oftest ved en trinvis proces ved målstedsmutationer i DNA-gyrase og topoisomerase IV. 
Resistance to levofloxacin is most often acquired through a stepwise process by target site mutations in DNA gyrase and topoisomerase IV.
I lighed med andre fluorquinoloner viste levofloxacin virkninger på brusk (blæredannelse og hulrum) hos rotter og hunde. 
In common with other fluoroquinolones, levofloxacin showed effects on cartilage (blistering and cavities) in rats and dogs.
- Ophostning af blod eller blodfarvet slim fra luftvejene. 
- Coughing up blood or blood-stained mucus from the airways.
Hvis der er mere end nogle få dråber tilbage, skal medicinlåget dog sættes på igen, og behandlingen genoptages. 
However if there are more than a few drops left, replace the medicine cap and restart treatment.
Hvis du behandles med Quinsair, kan du muligvis få en kraftig hudreaktion, som f.eks. blæredannelse eller læsioner. 
If you are treated with Quinsair, you may have a severe skin reaction such as blistering or lesions.
Kvalme, 
Nausea,
Behandlingsforskel på dag 28 [95% CI] b 
LS Mean (SE) Treatment Difference at Day 28 [95% CI] b
Hæmodialyse, herunder peritoneal dialyse og kontinuerlig ambulant peritoneal dialyse (CAPD), er ikke effektiv til fjernelse af levofloxacin fra kroppen. 
Haemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), are not effective in removing levofloxacin from the body.
Patienter med latente eller aktuelle defekter i glucose-6-phosphatdehydrogenaseaktiviteten kan have tendens til hæmolytiske reaktioner, når de behandles med quinolon-antibakterielle midler. 
Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Så meget skal du bruge? 
How much do I use?
Levofloxacin kan forårsage alvorlige, potentielt letale overfølsomhedsreaktioner (herunder f.eks. angioødem og anafylaktisk shock). 
Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. including angioedema and anaphylactic shock).
Det er dog usandsynligt, at de statistisk signifikante kinetiske forskelle ved de testede doser i studiet har klinisk relevans. 
However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Interaktioner medieret af virkninger på transportører In vitro-forsøg har vist, at hæmning af nøgletransportører, der er forbundet med lægemiddelfjernelse i nyren (organisk aniontransporterende polypeptid-1B1 (OATP1B1), OATP1B3, organisk aniontransportør-1 (OAT1), OAT3 og organisk kationisk transportør-2 (OCT2)) ved eksponeringer efter inhalation af 240 mg levofloxacin to gange dagligt, er lav. 
In vitro studies demonstrated that inhibition of the key transporters associated with drug disposition in the kidney (organic anion-transporting polypeptide-1B1 (OATP1B1), OATP1B3, organic anion transporter-1 (OAT1), OAT3 and organic cationic transporter-2 (OCT2)) at exposures following inhalation of 240 mg levofloxacin twice daily is low.
Levofloxacin skal omgående seponeres ved de første tegn eller symptomer på en alvorlig bivirkning, og patienterne skal rådes til at kontakte deres ordinerende læge for rådgivning. 
Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Fluorquinoloner, herunder levofloxacin, har neuromuskulær blokerende aktivitet og kan forværre muskelsvaghed hos patienter med myasthenia gravis. 
Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Der observeredes højere spytkoncentrationer hos voksne sammenlignet med pædiatriske patienter i studie 207, mens der i studie 209 observeredes tilsvarende spytkoncentrationer hos voksne og pædiatriske patienter. 
Higher sputum concentrations were observed in adults compared to paediatric patients in Study 207; similar sputum concentrations were observed in adult and paediatric patients in Study 209.
Quinsair må ikke anvendes med andre typer af håndsæt eller aerosolhoveder. 
Quinsair should not be used with any other type of handset or aerosol head.
• Hjertesygdom (f.eks. hjerteinsufficiens, myokardieinfarkt, bradykardi). 
• Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Halveringstiden for levofloxacin efter inhalation af Quinsair er ca. 5 til 7 timer. 
The half-life of levofloxacin following inhalation of Quinsair is approximately 5 to 7 hours.
Fastlagte breakpoints for følsomhed ved systemisk (oral eller intravenøs) administration af levofloxacin er ikke relevante for fremføring ved hjælp af inhalation. 
Established susceptibility breakpoints for systemic (oral or intravenous) administration of levofloxacin are not applicable to delivery by inhalation.