FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: It belongs to the group of antibiotics called fluoroquinolones.
Danish: Det tilhører gruppen af antibiotika, der kaldes fluorquinoloner.
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Danish: Krydsresistens mellem levofloxacin og andre fluorquinoloner er observeret.
English: Resistance to levofloxacin is most often acquired through a stepwise process by target site mutations in DNA gyrase and topoisomerase IV.
Danish: Resistens over for levofloxacin erhverves som oftest ved en trinvis proces ved målstedsmutationer i DNA-gyrase og topoisomerase IV.
English: In common with other fluoroquinolones, levofloxacin showed effects on cartilage (blistering and cavities) in rats and dogs.
Danish: I lighed med andre fluorquinoloner viste levofloxacin virkninger på brusk (blæredannelse og hulrum) hos rotter og hunde.
English: - Coughing up blood or blood-stained mucus from the airways.
Danish: - Ophostning af blod eller blodfarvet slim fra luftvejene.
English: However if there are more than a few drops left, replace the medicine cap and restart treatment.
Danish: Hvis der er mere end nogle få dråber tilbage, skal medicinlåget dog sættes på igen, og behandlingen genoptages.
English: If you are treated with Quinsair, you may have a severe skin reaction such as blistering or lesions.
Danish: Hvis du behandles med Quinsair, kan du muligvis få en kraftig hudreaktion, som f.eks. blæredannelse eller læsioner.
English: Nausea,
Danish: Kvalme,
English: LS Mean (SE) Treatment Difference at Day 28 [95% CI] b
Danish: Behandlingsforskel på dag 28 [95% CI] b
English: Haemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), are not effective in removing levofloxacin from the body.
Danish: Hæmodialyse, herunder peritoneal dialyse og kontinuerlig ambulant peritoneal dialyse (CAPD), er ikke effektiv til fjernelse af levofloxacin fra kroppen.
English: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Danish: Patienter med latente eller aktuelle defekter i glucose-6-phosphatdehydrogenaseaktiviteten kan have tendens til hæmolytiske reaktioner, når de behandles med quinolon-antibakterielle midler.
English: How much do I use?
Danish: Så meget skal du bruge?
English: Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. including angioedema and anaphylactic shock).
Danish: Levofloxacin kan forårsage alvorlige, potentielt letale overfølsomhedsreaktioner (herunder f.eks. angioødem og anafylaktisk shock).
English: However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Danish: Det er dog usandsynligt, at de statistisk signifikante kinetiske forskelle ved de testede doser i studiet har klinisk relevans.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Danish: Fluorquinoloner, herunder levofloxacin, har neuromuskulær blokerende aktivitet og kan forværre muskelsvaghed hos patienter med myasthenia gravis.
English: 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.
Danish: 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.
English: Quinsair should not be used with any other type of handset or aerosol head.
Danish: Quinsair må ikke anvendes med andre typer af håndsæt eller aerosolhoveder.
English: • Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Danish: • Hjertesygdom (f.eks. hjerteinsufficiens, myokardieinfarkt, bradykardi).
English: The half-life of levofloxacin following inhalation of Quinsair is approximately 5 to 7 hours.
Danish: Halveringstiden for levofloxacin efter inhalation af Quinsair er ca. 5 til 7 timer.
English: Established susceptibility breakpoints for systemic (oral or intravenous) administration of levofloxacin are not applicable to delivery by inhalation.
Danish: Fastlagte breakpoints for følsomhed ved systemisk (oral eller intravenøs) administration af levofloxacin er ikke relevante for fremføring ved hjælp af inhalation.
English: In a pharmacokinetic interaction study, levofloxacin did not affect the pharmacokinetics of theophylline (which is a probe substrate for CYP1A2) indicating that levofloxacin is not a CYP1A2 inhibitor.
Danish: I et farmakokinetisk interaktionsstudie påvirkede levofloxacin ikke farmakokinetikken for theophyllin (som er et probesubstrat for CYP1A2), hvilket indikerer, at levofloxacin ikke er en CYP1A2-hæmmer.
English: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Danish: Tendinitis og seneruptur (især, men ikke begrænset til akillessenen), undertiden bilateral, kan forekomme så tidligt som inden for 48 timer efter start på behandling med quinoloner og fluorquinoloner og er blevet rapporteret til at forekomme selv op til adskillige måneder efter behandlingsafslutning.
English: IV = intravenous; QD = quaque die (once a day); BID = bis in die (twice a day) * Predicted value from population PK analysis in CF patients ** Healthy males 18-53 years old
Danish: IV = intravenøs, QD = quaque die (en gang dagligt), BID = bis in die (to gange dagligt) * Forventet værdi ud fra populations-PK-analyse for CF-patienter ** Raske mænd på 18-53 år
English: The outer carton box also contains one Zirela Nebuliser Handset packaged in its own carton box with the Manufacturer's Instruction for Use.
Danish: Den ydre papæske indeholder endvidere ét Zirelanebulisatorhåndsæt, der er pakket i sin egen papæske med producentens brugsanvisning.
English: Pancytopenia*, Agranulocytosis*, Haemolytic anaemia*
Danish: Pancytopeni*, Agranulocytose*, Hæmolytisk anæmi*
English: Patients who completed Study 209 (Core Phase) could continue in an optional Extension Phase for 3 additional cycles (i.e. 28 days of treatment with Quinsair 240 mg twice daily followed by 28 days off treatment).
Danish: Patienter, der gennemførte studie 209 (kernefase), kunne fortsætte i en valgfri forlængelsesfase med 3 yderligere cyklusser (det vil sige 28 dages behandling med Quinsair 240 mg to gange dagligt, efterfulgt af 28 dage uden behandling).
English: Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt
Danish: Psykotiske forstyrrelser med en adfærd, hvor patienten er til fare for sig selv, herunder selvmordstanker eller selvmordsforsøg
English: Continue to inhale and exhale comfortably until the treatment is finished.
Danish: Fortsæt med at ånde ind og ud afslappet, indtil behandlingen er færdig.
English: Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.
Danish: Der er rapporteret psykotiske reaktioner hos patienter, der får quinoloner, herunder levofloxacin.
English: - Difficulty in breathing which can range from mild to severe (bronchospasm).
Danish: - Vejrtrækningsproblemer, der kan være fra lette til svære (bronkospasme).
English: It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium) during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.
Danish: Det anbefales, at patienter ikke udsætter sig unødigt for kraftigt sollys eller for kunstige UV-stråler (f.eks. højfjeldssol, solarium), mens de er i behandling og i 48 timer efter behandlingsafslutning, for at forhindre lyssensibilisering.
English: Bronchospasm**, Bronchial hyper-reactivity, Obstructive airways disorder
Danish: Bronkospasme**, Bronkial hyperreaktivitet, Obstruktiv luftvejsforstyrrelse
English: * Note: One adolescent randomised to Quinsair 240 mg twice daily did not receive study drug.
Danish: * Bemærk: Én ung, der var randomiseret til Quinsair 240 mg to gange dagligt, fik ikke forsøgslægemiddel.
English: Tell your doctor before using Quinsair if you have or have ever had any of the following: - Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Quinsair, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible.
Danish: Fortæl lægen, før du bruger Quinsair, hvis du har eller har haft et eller flere af følgende: - Langvarige, invaliderende og muligvis varige alvorlige bivirkninger Antibakterielle lægemidler med fluorquinolon/quinolon, herunder Quinsair, er blevet forbundet med meget sjældne, men alvorlige bivirkninger, hvoraf nogle af dem er langvarige (fortsætter i måneder eller år), invaliderende eller muligvis varige.
English: Table 3: Comparison of mean (SD) multiple dose levofloxacin pharmacokinetic parameters following Quinsair administration by inhalation to patients with CF and following oral and intravenous administration of levofloxacin to healthy adult volunteers
Danish: Tabel 3: Sammenligning af gennemsnitlige (SD) farmakokinetiske parametre for flerdosislevofloxacin efter Quinsair-administration ved hjælp af inhalation til patienter med CF og efter oral og intravenøs administration af levofloxacin til raske, voksne frivillige
English: Quinsair is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.
Danish: Quinsair skal tages i skiftende cyklusser af 28 dages behandling efterfulgt af 28 dage uden behandling.
English: Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
Danish: Smerter og hævelse af led og betændelse eller bristning af sener kan opstå i sjældne tilfælde.
English: Taking Quinsair at the same time as these medicines could affect how your kidneys deal with the medicine which is particularly important if you suffer from kidney problems.
Danish: Hvis du tager Quinsair samtidig med disse lægemidler, kan det påvirke måden dine nyrer behandler medicinen på, hvilket er særlig vigtigt, hvis du lider af nyreproblemer.
English: Administration of Quinsair in patients with clinically significant haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Danish: Administration af Quinsair til patienter med klinisk signifikant hæmoptyse bør kun foregå, hvis det vurderes, at fordelen ved behandling opvejer risiciene for at inducere yderligere blødning.
English: Any unused product must be discarded.
Danish: Eventuelt ubrugt produkt skal kasseres.
English: Levofloxacin is an antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic active substance ofloxacin.
Danish: Levofloxacin er et antibakterielt middel fra fluorquinolon-klassen, og det er S(-)-enantiomeren af det racemiske aktive stof ofloxacin.
English: The use of inhaled medicinal products may induce a cough reflex.
Danish: Anvendelse af inhalerede lægemidler kan inducere en hosterefleks.
English: All patients had also received at least 3 courses of TIS in the 12 months prior to entry into the study, but none in the 28 days immediately preceding study entry.
Danish: Alle patienter havde endvidere gennemgået mindst 3 behandlingsforløb med TIS i løbet af de 12 måneder forud for inklusion i studiet, men ingen behandling i de 28 dage umiddelbart forud for inklusion i studiet.
English: Anxiety*, Depression*
Danish: Angst*, Depression*
English: Table 2: Results for the primary and key secondary endpoints in the active-controlled efficacy and safety study of Quinsair in patients with CF
Danish: Tabel 2: Resultater for det primære endepunkt og de sekundære nøgleendepunkter i det aktivkontrollerede effekt- og sikkerhedsstudie med Quinsair til patienter med CF
English: Each treatment cycle included 28 days of treatment with Quinsair 240 mg twice daily or TIS 300 mg twice daily followed by 28 days without inhaled antibiotics.
Danish: Hver behandlingscyklus inkluderede 28 dages behandling med Quinsair 240 mg to gange dagligt eller TIS 300 mg to gange dagligt, efterfulgt af 28 dage uden inhalerede antibiotika.
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats and its only effect on foetuses was delayed maturation as a result of maternal toxicity.
Danish: Levofloxacin forårsagede ingen forringelse af fertilitet eller reproduktionsevne hos rotter, og dets eneste virkning på fostre var forsinket modning som følge af maternal toksicitet.
English: These two placebo-controlled studies showed that 28 days of treatment with Quinsair 240 mg twice daily resulted in significant improvement in relative change from baseline in FEV1 percent predicted compared to placebo (see Table 1).
Danish: Disse to placebokontrollerede studier viste, at 28 dages behandling med Quinsair 240 mg to gange dagligt resulterede i en signifikant forbedring i den relative ændring fra baseline i forventet FEV1-procent sammenlignet med placebo (se tabel 1).
English: a Treatment difference for Quinsair minus TIS, or Hazard ratio for Quinsair/TIS.
Danish: a Behandlingsforskel for Quinsair minus TIS eller risikorate for Quinsair/TIS.
English: Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: a ANCOVA with terms for treatment, region, age (16 to 18 years, > 18 years), and baseline FEV1 percent predicted as quartiles.
Danish: a ANCOVA med betingelser for behandling, område, alder (16 til 18 år, > 18 år) og forventet baseline-FEV1
English: Effect of other medicinal products on levofloxacin
Danish: Virkninger af andre lægemidler på levofloxacin
English: Levofloxacin is primarily excreted unchanged in the urine and metabolism is minimal (see section 5.2).
Danish: Levofloxacin udskilles primært uændret i urinen, og metabolismen er minimal (se pkt.
English: The safety of the recommended dose of Quinsair was evaluated in 472 patients with CF from two double-blind, single-cycle, placebo-controlled trials and from an active-comparator study with an optional uncontrolled extension.
Danish: Sikkerheden ved den anbefalede dosis Quinsair er blevet vurderet hos 472 patienter med CF i to dobbeltblinde, placebokontrollerede enkeltcyklusforsøg og et aktiv komparator-studie med en valgfri ikke-kontrolleret forlængelse.
English: The development of fluoroquinolone-resistant P. aeruginosa and superinfection with fluoroquinolone-insusceptible microorganisms represent potential risks associated with the use of Quinsair.
Danish: Udviklingen af fluorquinolonresistente P. aeruginosa og superinfektion med mikroorganismer, der er ufølsomme over for fluorquinolon, er potentielle risici i forbindelse med anvendelsen af Quinsair.
English: - Inflammation of a tendon causing pain, stiffness and/or swelling in the joints (tendonitis).
Danish: - Betændelse i en sene, der medfører smerte, stivhed og/eller hævelse i leddene (tendonitis).
English: Post-marketing serious adverse reactions, including deaths and the requirements for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
Danish: Alvorlige bivirkninger efter markedsføring, herunder dødsfald og behov for vejrtrækningsstøtte, har været forbundet med brug af fluorquinolon hos patienter med myasthenia gravis.
English: These medicines may interfere with the effects of Quinsair.
Danish: Disse lægemidler kan muligvis have indvirkning på virkningen af Quinsair.
English: However, there is variability in the systemic exposures observed which means that serum levels of levofloxacin following inhalation of Quinsair may sometimes fall within the range of levels observed following systemic administration of comparable doses.
Danish: Der er dog variabilitet i de observerede systemiske eksponeringer, hvilket betyder, at serumniveauer af levofloxacin efter inhalation af Quinsair undertiden kan falde inden for det niveau-interval, der observeres efter systemisk administration af sammenlignelige doser.
English: How do I prepare my Nebuliser System to inhale the medicine?
Danish: Klargøring af nebulisatorsystemet til inhalering af medicinen?
English: If the contents of the ampoule are swallowed, don't worry but tell your doctor as soon as possible.
Danish: Hvis du har slugt indholdet i ampullen, er der ingen grund til bekymring, men du skal fortælle det til lægen så hurtigt som muligt.
English: The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves inhibition of bacterial DNA gyrase and topoisomerase IV enzymes.
Danish: Virkningsmekanismen for levofloxacin og andre fluorquinolon-antimikrobielle midler inddrager hæmning af bakteriel DNA-gyrase og topoisomerase IV-enzymer.
English: - Ciclosporin (used after organ transplants) or medicines that affect your heart beat (such as antiarrhythmics, tricyclic antidepressants, macrolide antibiotics or antipsychotics).
Danish: - Ciclosporin (anvendes efter organtransplantationer) eller lægemidler, der påvirker din hjerterytme (som f.eks. antiarytmika, tricykliske antidepressiva, makrolid-antibiotika eller antipsykotika).
English: On the front of the ampoule tail Quinsair 240 mg
Danish: På forsiden af ampulunderdelen Quinsair 240 mg
English: - Do not use Quinsair if you notice that it is cloudy or there are particles in the solution.
Danish: - Brug ikke Quinsair, hvis du bemærker, at det er uklart, eller der er partikler i opløsningen.
English: Animal studies with levofloxacin do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med levofloxacin indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
English: 2) Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset (Figure 1).
Danish: 2) Tryk alt indholdet fra én ampul ud i medicinbeholderen på Zirela-nebulisatorhåndsættet (figur 1).
English: Following systemic administration, levofloxacin obeys linear pharmacokinetics over a range of 50 to 1000 mg.
Danish: Efter systemisk administration udviser levofloxacin lineær farmakokinetik over et interval fra 50 til 1000 mg.
English: Do not use Quinsair: - if you are allergic to levofloxacin, to any other quinolone antibiotics, such as moxifloxacin,
Danish: Brug ikke Quinsair: - hvis du er allergisk over for levofloxacin, over for et andet antibiotikum af quinolon-typen,
English: Caution is recommended if levofloxacin is used in psychotic patients or in patients with a history of psychiatric disease.
Danish: Forsigtighed anbefales, hvis levofloxacin anvendes til psykotiske patienter eller til patienter med psykiatrisk sygdom i anamnesen.
English: Levofloxacin is systemically absorbed following inhalation of Quinsair and eliminated similarly to levofloxacin following systemic administration.
Danish: Levofloxacin absorberes systemisk efter inhalation af Quinsair og elimineres på tilsvarende måde som levofloxacin efter systemisk administration.
English: OFF Quinsair Do not use it for the next 28 days
Danish: Quinsair - pause Brug det ikke i de næste 28 dage
English: Press down and turn the cap clockwise as far as it will go.
Danish: Tryk ned, og drej låget med uret så langt, som det kan komme.
English: The recommended dosage is 240 mg (one ampoule) administered by inhalation twice daily (see section 5.2).
Danish: Den anbefalede dosis er 240 mg (én ampul), der administreres ved inhalation to gange dagligt (se pkt.
English: More detailed instructions are available in the Package Leaflet and device Manufacturer's Instructions for Use.
Danish: En mere detaljeret anvisning findes i indlægssedlen og brugsanvisningen fra producenten af anordningen.
English: Inner box
Danish: Indre æske
English: If you notice any changes in your eyesight or any other problems with your eyes whilst using Quinsair, contact an eye specialist immediately.
Danish: Hvis du bemærker ændringer i dit syn eller andre problemer med dine øjne, mens du bruger Quinsair, skal du straks kontakte en øjenspecialist.
English: Some adverse reactions (e.g. fatigue, asthenia, visual disturbances, dizziness) may impair patient's ability to concentrate and react.
Danish: Nogle bivirkninger (f.eks. træthed, asteni, synsforstyrrelser, svimmelhed) kan forringe patientens evne til at koncentrere sig og reagere.
English: If you experience any of these side effects after taking Quinsair, contact your doctor immediately prior to continuing treatment.
Danish: Hvis du oplever nogen af disse bivirkninger, efter at have taget Quinsair, skal du straks kontakte lægen, før du fortsætter behandlingen.
English: In vivo tests (micronucleus, sister chromatid exchange, unscheduled DNA synthesis, dominant lethal tests) did not show any genotoxic potential.
Danish: In vivo-tests (mikronukleus-, søsterkromatidudvekslings-, ikke-planlagt DNA-syntese-, dominant letal-tests) viste ingen genotoksicitet.
English: Anorexia*
Danish: Anoreksi*
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin.
Danish: Som ved alle quinoloner er der rapporteret forstyrrelser i blodglucose, herunder både hypoglykæmi og hyperglykæmi, sædvanligvis hos diabetespatienter, der får samtidig behandling med et oralt hypoglykæmisk middel (f.eks. glibenclamid) eller med insulin.