FrancophonIA/ELRC3.0 huggingface dataset:
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Quinsair therapy.
Danish: Der kan opstå betændelse og bristning af sener i løbet af de første 48 timers behandling, og endda op til flere måneder efter du er stoppet behandlingen med Quinsair.
English: - Glucose-6-phosphate dehydrogensae deficiency Quinolone antibiotics, such as Quinsair, can cause patients with glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease) to be prone to blood complications leading to a sudden rise in body temperature, yellowing of the skin and mucous membranes, dark coloured urine, paleness, tiredness, heavy, fast breathing and a weak, rapid pulse.
Danish: - Glucose-6-phosphatdehydrogenasemangel Quinolon-antibiotika, som f.eks. Quinsair, kan forårsage, at patienter med glucose-6-phosphatdehydrogenasemangel (en sjælden arvelig sygdom) har en tilbøjelighed til at få komplikationer i blodet, der fører til en pludselig stigning i kropstemperaturen, gulfarvning af huden og slimhinderne, mørkfarvet urin, bleghed, træthed, tung, hurtig vejrtrækning og en svag, hurtig puls.
English: Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following active substances: calcium carbonate, digoxin, glibenclamide and ranitidine.
Danish: Kliniske farmakologistudier har vist, at farmakokinetikken for levofloxacin ikke blev påvirket i klinisk relevant grad, når levofloxacin blev administreret sammen med følgende aktive stoffer: calciumcarbonat, digoxin, glibenclamid og ranitidin.
English: The maximal plasma concentration (Cmax) of levofloxacin following administration by inhalation occurred at approximately 0.5-1 hour post-dose.
Danish: Den maksimale plasmakoncentration (Cmax) af levofloxacin efter administration ved hjælp af inhalation forekom ca. 0,5-1 time efter dosering.
English: Figure 1 3) Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir (a).
Danish: Figur 1 3) Luk medicinbeholderen ved at rette tappene på medicinlåget ind i forhold til rillerne på beholderen (a).
English: Caution should be exercised when levofloxacin is coadministered with active substances that affect the tubular renal secretion such as probenecid and cimetidine, especially in patients with renal impairment.
Danish: Der skal udvises forsigtighed, når levofloxacin administereres sammen med aktive stoffer, der påvirker den renale tubulære sekretion, såsom probenecid og cimetidin, især hos patienter med nedsat nyrefunktion.
English: The safety and efficacy of Quinsair in elderly patients with CF have not been established.
Danish: Quinsairs sikkerhed og virkning hos ældre patienter med CF er ikke klarlagt.
English: Talk to your doctor if you have any concerns or questions about this.
Danish: Tal med lægen, hvis du har bekymringer eller spørgsmål i forhold til dette.
English: In diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).
Danish: Hos diabetespatienter anbefales en nøje overvågning af blodglucose (se pkt.
English: ON Quinsair Use it twice a day for 28 days
Danish: Quinsair - behandling Brug det to gange dagligt i 28 dage
English: Tabulated list of adverse reactions reported with Quinsair
Danish: Skematisk oversigt over bivirkninger, der er rapporteret med Quinsair
English: After it has completely turned itself off and when you are ready to restart, press and hold the on/off button for one second again.
Danish: Efter at den er helt slukket, skal du, når du er klar til at starte igen, trykke på afbryderknappen igen og holde den nede i ét sekund.
English: Inhale the contents of one ampoule (240 mg) twice a day using the Zirela Nebuliser System.
Danish: Inhalér inholdet af én ampul (240 mg) to gange dagligt ved anvendelse af Zirelanebulisatorsystemet.
English: If you forget a dose, use it as soon as you remember as long as there is an 8-hour interval before inhaling the next dose.
Danish: Hvis du har glemt en dosis, skal du bruge den, så snart du kommer i tanker om det, når blot der er mindst 8 timer, til du skal inhalere den næste dosis.
English: - Theophylline (used to treat breathing problems) or non-steroidal anti-inflammatory medicines (NSAIDs) such as fenbufen, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting) or ibuprofen.
Danish: - Theophyllin (anvendes til at behandle vejrtrækningsproblemer) eller ikke-steroide antiinflammatoriske lægemidler (NSAIDer), som f.eks. fenbufen, acetylsalicylsyre (et stof, der findes i mange lægemidler, der anvendes til smertelindring og sænkning af feber samt til forebyggelse af blodpropper) eller ibuprofen.
English: If you forget to use Quinsair
Danish: Hvis du har glemt at bruge Quinsair
English: Therefore, doses of Quinsair do not need to be adjusted in patients with mild to moderate renal impairment.
Danish: En dosisjustering af Quinsair er derfor ikke nødvendig til patienter med let til moderat nedsat nyrefunktion.
English: Quinolone antibiotics, including Quinsair, may cause levels of glucose in the blood to be either too high or too low.
Danish: Quinolon-antibiotika, herunder Quinsair, kan forårsage, at niveauerne af sukker i blodet enten bliver for høje eller for lave.
English: The Zirela Nebuliser System was used to administer Quinsair in the clinical studies described in section 5.1.
Danish: Zirela-nebulisatorsystemet blev anvendt til administrering af Quinsair i de kliniske studier, der er beskrevet i pkt.
English: • Hypersensitivity to the active substance, other quinolones or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof, andre quinoloner eller over for et eller flere af hjælpestofferne anført i pkt.
English: Clinical efficacy was demonstrated in two placebo-controlled studies and one active-comparator study in 448 patients randomised to receive Quinsair 240 mg twice daily.
Danish: Klinisk virkning er blevet vist i to placebokontrollerede studier og ét aktiv komparator-studie med 448 patienter randomiseret til at få Quinsair 240 mg to gange dagligt.
English: However, a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, or other substances which lower the seizure threshold.
Danish: Der kan imidlertid forekomme en markant sænkning af den cerebrale krampetærskel, når quinoloner gives samtidig med theophyllin, ikke-steroide anti-inflammatoriske lægemidler eller andre stoffer, der sænker krampetærsklen.
English: The adverse drug reactions are ranked by frequency with the most serious reactions first.
Danish: Bivirkningerne er inddelt efter hyppighed med de mest alvorlige bivirkninger først.
English: If this becomes severe or persistent, or you notice blood in your stools, you should stop using Quinsair immediately and talk to your doctor.
Danish: Hvis den bliver kraftig eller vedvarende, eller du bemærker blod i afføringen, skal du straks holde op med at bruge Quinsair og tale med lægen.
English: Do not inhale the contents of more than one ampoule to make up for a missed dose.
Danish: Du må ikke inhalere indholdet af mere end én ampul som erstatning for den glemte dosis.
English: If this happens, stop taking Quinsair and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Danish: Hvis dette forekommer, skal du stoppe med at tage Quinsair og straks informere lægen for at forhindre, at der udvikles en muligvis varig tilstand.
English: If aerosol mist does not begin to flow, please refer to the Zirela Manufacturer's Instructions for Use for help.
Danish: Hvis aerosoltågen ikke begynder at strømme, henvises til Zirelabrugsanvisning for hjælp.
English: Each 28-day pack of Quinsair contains one box of 56 (14 sachets of 4) ampoules and one box holding a Zirela Nebuliser Handset with the Manufacturer's Instructions for Use.
Danish: Hver 28 dages-pakning af Quinsair indeholder én æske med 56 (14 breve med hver 4) ampuller og én æske, der indeholder et Zirela-nebulisatorhåndsæt med producentens brugsanvisning.
English: and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Danish: IA og III antiarytmika, tricykliske antidepressiva, makrolider, antipsykotika).
English: Levofloxacin did not induce gene mutations in bacterial or mammalian cells but did induce chromosome aberrations in Chinese hamster lung cells in vitro.
Danish: Levofloxacin inducerede ikke genmutationer i bakterie- eller mammaliaceller, men inducerede kromosomafvigelser i lungeceller fra kinesisk hamster in vitro.
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Danish: Tilfælde af sensorisk eller sensomotorisk polyneuropati, der medførte paræstesi, hypæstesi, dysæstesi eller svaghed, er blevet rapporteret hos patienter, der fik quinoloner og fluorquinoloner.
English: During the Extension Phase, the LS Mean change for FEV1 percent predicted ranged between 4.83% to 1.46% across the 3 additional treatment cycles.
Danish: I løbet af forlængelsesfasen lå ændringen af LS-middelværdien for forventet FEV1-procent i intervallet mellem 4,83% og 1,46% over de 3 yderligere behandlingscyklusser.
English: 3) After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Danish: 3) Efter nogle få sekunder begynder en aerosoltåge at strømme ind i aerosolkammeret på Zirela-nebulisatorhåndsættet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Quinsair in one or more subsets of the paediatric population in cystic fibrosis patients with P. aeruginosa pulmonary infection/colonisation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Quinsair i en eller flere undergrupper af den pædiatriske population for patienter med cystisk fibrose med P. aeruginosa-lungeinfektion/kolonisering (se pkt.
English: How do I use the Zirela Nebuliser System?
Danish: Sådan skal du bruge Zirela-nebulisatorsystemet?
English: This comprises an inner carton box containing 56 ampoules and a Package Leaflet.
Danish: Denne omfatter en indre papæske, der indeholder 56 ampuller og en indlægsseddel.
English: Inhaled steroids.
Danish: Inhalerede steroider.
English: Patients weighing 22 to 30 kg received 180 mg levofloxacin/day and patients weighing ˃ 30 kg received 240 mg levofloxacin/day.
Danish: Patienter, der vejede 22 til 30 kg, fik 180 mg levofloxacin/dag, og patienter, der vejede ˃ 30 kg, fik 240 mg levofloxacin/dag.
English: The weight-based dosing scheme resulted in consistent serum and sputum PK exposure across the range of ages (7 to 16 years old) and weights (22 to 61 kg) observed in the study.
Danish: Den vægtbaserede dosisplan resulterede i ensartet PK-eksponering i serum og spyt på tværs af aldersintervallet (7 til 16 år) og vægtintervallet (22 til 61 kg), der observeredes i studiet.
English: If you have used more Quinsair than you should, tell your doctor as soon as possible.
Danish: Hvis du har brugt for meget Quinsair, skal du fortælle det til lægen så hurtigt som muligt.
English: Hepatitis*, Hyperbilirubinaemia*
Danish: Hepatitis*, Hyperbilirubinæmi*
English: Resistance to levofloxacin, other antibacterial agents and treatment-emergent microorganisms
Danish: Resistens over for levofloxacin, andre antibakterielle midler og mikroorganismer, der fremkommer under behandlingen
English: - Diarrhoea
Danish: - Diarré
English: The adverse drug reactions are ranked by frequency with the most frequent reactions first.
Danish: Bivirkningerne er inddelt efter hyppighed med de hyppigste bivirkninger først.
English: If for any reason you must stop the treatment before it's finished, press and hold the controller's on/off button for one second.
Danish: Hvis du af en eller anden grund må standse behandlingen, før du er færdig, skal du trykke på afbryderknappen på styreenheden, og holde den nede i ét sekund.
English: Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide.
Danish: Levofloxacin metaboliseres i meget ringe grad. Metabolitterne er desmethyl-levofloxacin og levofloxacin-N-oxid.
English: Jaundice and severe liver injury, including cases with fatal acute liver failure
Danish: Gulsot og svær leverskade, herunder tilfælde med letal akut leverinsufficiens
English: Levofloxacin did not show any genotoxic potential in a photomutagenicity assay.
Danish: Levofloxacin viste ingen genotoksicitet i et fotomutagenicitetsassay.
English: Ventricular tachycardia, Ventricular arrhythmia and torsade de pointes
Danish: Ventrikulær takykardi, Ventrikulær arytmi og torsade de pointes
English: Active substances known to prolong the QT interval Levofloxacin should be used with caution in patients receiving active substances known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Danish: Aktive stoffer, der er kendte for at forlænge QT-intervallet Levofloxacin bør anvendes med forsigtighed til patienter, der får aktive stoffer, der er kendte for at forlænge QT-intervallet (f.eks. klasse IA og III antiarytmika, tricykliske antidepressiva, makrolider, antipsykotika).
English: In very rare cases, these have progressed to suicidal thoughts and self-endangering behavioursometimes after only a single dose of levofloxacin (see section 4.8).
Danish: I meget sjældne tilfælde har disse udviklet sig til selvmordstanker og en adfærd, hvor patienten har været til fare for sig selv, undertiden efter blot en enkelt dosis levofloxacin (se pkt.
English: ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6) - if you have ever had a problem with your tendons (inflammation of a tendon or a ruptured tendon) during treatment with a quinolone or fluoroquinolone antibiotic - if you suffer from epilepsy - if you are pregnant or breast-feeding
Danish: såsom moxifloxacin, ciprofloxacin eller ofloxacin, eller over for et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6) - hvis du nogensinde har haft et problem med dine sener (betændelse i en sene eller en bristet sene) under behandling med et quinolon- eller fluorquinolon-antibiotikum - hvis du lider af epilepsi - hvis du er gravid eller ammer
English: Arthralgia, Myalgia*
Danish: Artralgi, Myalgi*
English: Serious haematological adverse reactions such as pancytopenia, agranulocytosis and haemolytic anaemia have been reported following systemic administration of levofloxacin.
Danish: Alvorlige hæmatologiske bivirkninger, såsom pancytopeni, agranulocytose og hæmolytisk anæmi, er blevet rapporteret efter systemisk administration af levofloxacin.
English: An in vitro study indicated a low potential for interaction between levofloxacin and CYP2C9 substrates.
Danish: CYP2C9-substrater Et in vitro-forsøg viste et lavt potentiale for interaktion mellem levofloxacin og CYP2C9-substrater.
English: 8) Once treatment is complete, disconnect the controller and take apart the Zirela Nebuliser Handset for cleaning and disinfecting.
Danish: 8) Når behandlingen er færdig, afmonteres styreenheden, og Zirela-nebulisatorhåndsættet skilles ad til rengøring og desinfektion.
English: The mean apparent total body clearance of levofloxacin following systemic administration of a 500 mg single dose was 175 +/- 29.2 ml/min.
Danish: Den gennemsnitlige, tilsyneladende, totale kropsclearance af levofloxacin efter systemisk administration af en 500 mg enkeltdosis var 175 ± 29,2 ml/minut.
English: Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Danish: Patienterne skal informeres om at standse behandlingen og kontakte deres læge, hvis de udvikler tegn og symptomer på leversygdom, såsom anoreksi, gulsot, mørk urin, pruritus eller ømhed i abdomen.
English: The apparent clearance (CL/F) of levofloxacin following inhalation of Quinsair 240 mg twice daily is 31.8 +/- 22.4 L/hour.
Danish: Den tilsyneladende clearance (CL/F) af levofloxacin efter inhalation af Quinsair 240 mg to gange dagligt er 31,8 ± 22,4 l/time.
English: - Vision problems
Danish: - Synsproblemer
English: Due to the limited extent of levofloxacin metabolism in the liver, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.
Danish: På grund af den begrænsede grad af levofloxacin-metabolisme i leveren forventes farmakokinetikken for levofloxacin ikke at påvirkes af nedsat leverfunktion.
English: Tell your doctor if you notice any skin reactions after using Quinsair.
Danish: Fortæl lægen, hvis du bemærker hudreaktioner efter brug af Quinsair.
English: If you experience breathing difficulties after using Quinsair, your doctor may prescribe you an inhaler containing a bronchodilator medicine (e.g. salbutamol).
Danish: Hvis du oplever vejrtrækningsproblemer efter brug af Quinsair, kan din læge ordinere en inhalator til dig, der indeholder et bronkodilator-lægemiddel (f.eks. salbutamol) (udvider bronkierne i lungerne).
English: It reduced tumour development in a photocarcinogenicity study.
Danish: Levofloxacin reducerede tumorudviklingen i et fotokarcinogenicitetsstudie.
English: Anaemia*, Neutropenia*
Danish: Anæmi*, Neutropeni*
English: Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter en enkelt dosis, toksicitet efter gentagne doser, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Median time to pulmonary exacerbation
Danish: Mediantid til pulmonal eksacerbation
English: Oral fungal infection
Danish: Oral svampeinfektion
English: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin).
Danish: Forhøjede koagulationstests (PT/INR) og/eller blødning, som kan være svær, er blevet rapporteret hos patienter, der er i behandling med levofloxacin i kombination med en vitamin K-antagonist (f.eks. warfarin).
English: Bronchospasm is a complication associated with inhaled therapies including Quinsair (see section 4.8).
Danish: Bronkospasme er en komplikation, der er forbundet med inhalerede behandlinger, herunder Quinsair (se pkt.
English: Efficacy was not evaluated in the 14 children with CF (≥ 6 to < 12 years old) and 13 adolescents with CF (≥ 12 to < 17 years old) who participated in Study 206.
Danish: Virkningen er ikke evalueret hos de 14 børn med CF (≥ 6 til < 12 år) og 13 unge med CF (≥ 12 til < 17 år), der deltog i studie 206.
English: The pharmacokinetics of levofloxacin following inhalation of Quinsair 240 mg twice daily were investigated in paediatric patients with CF aged 12 years and older and weighing ≥ 30 kg. A population PK model based on sparse sampling determined that levofloxacin serum concentrations were comparable between paediatric and adult patients following 28 days of treatment.
Danish: Farmakokinetikken for levofloxacin efter inhalation af Quinsair 240 mg to gange dagligt er blevet undersøgt for pædiatriske patienter med CF i alderen 12 år og derover, som vejede ≥ 30 kg. En PKpopulationsmodel baseret på sparsomt prøvemateriale har vist, at serumkoncentrationerne af levofloxacin var sammenlignelige mellem pædiatriske og voksne patienter efter 28 dages behandling.
English: When do I use it?
Danish: På disse tidspunkter skal du bruge det?
English: - Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers).
Danish: - Lægemidler, som f.eks. probenecid (anvendes til forebyggelse af urinsyregigt) eller cimetidin (anvendes til behandling af mavesår).
English: Symptoms include: - Loss of appetite - Yellowing of the skin and eyes (jaundice) - Dark coloured urine - Itching - Tenderness (pain) around the stomach (abdomen)
Danish: Symptomerne omfatter: - Tab af appetit - Gulfarvning af hud og øjne (gulsot) - Mørkfarvet urin - Kløe - Ømhed (smerter) i maven (abdomen)
English: Taking these medicines with Quinsair may lead to an increase in bleeding.
Danish: Hvis du tager disse lægemidler samtidig med Quinsair, kan det medføre forøget blødning.
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including Quinsair, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Danish: Du må ikke tage antibakterielle lægemidler med fluorquinolon/quinolon, herunder Quinsair, hvis du tidligere har oplevet alvorlig(e) bivirkning(er) ved indtagelse af quinolon eller fluorquinolon.
English: If you experience palpitations or an irregular heart beat whilst using Quinsair you should tell your doctor immediately.
Danish: Hvis du oplever hjertebanken eller en uregelmæssig hjerterytme, mens du bruger Quinsair, skal du straks fortælle det til lægen.
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Pulmonary function test decreased*, Blood glucose increased and decreased*, Blood creatinine increased* Breath sounds abnormal*
Danish: Forhøjet alaninaminotransferase, Forhøjet aspartataminotransferase, Nedsat lungefunktionstest*, Forhøjet og reduceret blodglucose*, Forhøjet blodkreatinin*, Abnorme vejrtrækningslyde*
English: Quinsair 240 mg once daily.
Danish: Quinsair 240 mg to gange dagligt
English: if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Danish: hvis du er diagnosticeret med en udposning på en stor blodåre (aortaaneurisme eller perifer aneurisme i en stor blodåre).
English: Tendinitis, Costochondritis, Joint stiffness
Danish: Tendinitis, Costochondritis, Ledstivhed
English: Carefully read the Manufacturer's Instructions for Use, provided with your Zirela Nebuliser Handset.
Danish: Læs omhyggeligt producentens brugsanvisning, der følger med dit Zirela-nebulisatorhåndsæt.
English: Due to possible increases in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these active substances are given concomitantly (see section 4.5).
Danish: På grund af risikoen for forhøjede koagulationstests (PT/INR) og/eller blødning hos patienter, der behandles med levofloxacin i kombination med en vitamin K-antagonist (f.eks. warfarin), bør koagulationtests overvåges, når disse aktive stoffer gives samtidigt (se pkt.
English: Studies using systemic administration of levofloxacin show that the pharmacokinetics of levofloxacin are affected by renal impairment; with decreasing renal function (estimated creatinine clearance < 50 ml/min), renal elimination and clearance are decreased, and elimination half-life increased.
Danish: Studier med systemisk administration af levofloxacin viser, at farmakokinetikken for levofloxacin påvirkes af nedsat nyrefunktion, idet faldende nyrefunktion (estimeret kreatininclearance < 50 ml/minut) medfører faldende renal elimination og clearance og stigende eliminationshalveringstid.
English: If you stop using Quinsair Do not stop using Quinsair without first talking to your doctor as your lung infection may worsen.
Danish: Du må ikke holde op med at bruge Quinsair uden først at tale med lægen, da din lungeinfektion kan blive forværret.
English: Do not use this medicine after the expiry date which is stated on the ampoule, the foil sachet and the boxes after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på ampullen, foliebrevet og æskerne efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.