FrancophonIA/ELRC3.0 huggingface dataset:
English: • Make sure you use high factor sun cream
Danish: • Sørg for at bruge solcreme med høj faktor
English: Tavanic tablets are administered once or twice daily.
Danish: Tavanic tabletter administreres én eller to gange dagligt.
English: Clostridium difficile-associated disease
Danish: Clostridium difficile associeret sygdom
English: Tendinitis may rarely occur.
Danish: Tendinitis kan forekomme i sjældne tilfælde.
English: Therefore, these SmPCs, labelling and package leaflets may not necessarily represent the current text.
Danish: Derfor repræsenterer disse produktresumeer, etiketteringer og indlægssedler ikke nødvendigvis den aktuelle tekst.
English: Levofloxacin tablets must not be used:
Danish: Levofloxacin tabletter må ikke anvendes:
English: ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Danish: Ekg bør monitorerspå grund af risikoen for forlængelse af QT-intervallet.
English: • Ciclosporin - used after organ transplants.
Danish: • Ciclosporin - bruges efter organtransplantationer.
English: The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Resistensprævalensen kan variere geografisk og med tiden for de enkelte arter, og lokal information om resistens er ønskværdig, særligt ved behandling af svære infektioner.
English: This medicine does not require any special storage conditions but it is best to keep Tavanic tablets in the original strips and box in a dry place.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen, men det er bedst at opbevare Tavanic tabletterne i den originale blisterstrip og æske på et tørt sted.
English: There is no evidence that these gender differences are of clinical relevance.
Danish: Der er ingen evidens for, at disse kønsforskelle har klinisk relevans.
English: In particular, tell your doctor if you are taking any of the following medicines.
Danish: Fortæl det især til lægen, hvis du tager nogen af følgende lægemidler.
English: The use of levofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms.
Danish: Anvendelse af levofloxacin, især langvarig anvendelse, kan resultere i overvækst af ikke-følsomme organismer.
English: Exacerbation of myasthenia gravis
Danish: Forværring af myasthenia gravis
English: Take your dose of these medicines at least 2 hours before or after Tavanic tablets.
Danish: Tag denne medicin mindst 2 timer før eller efter, du tager Tavanic tabletterne
English: The Achilles tendon is affected most often
Danish: Akillessenen påvirkes oftest
English: It is important that you complete the course of tablets that your doctor has prescribed for you.
Danish: Det er vigtigt, at du gennemfører det behandlingsforløb, som lægen har ordineret til dig.
English: • You have ever had epilepsy
Danish: • hvis du har haft epilepsi
English: If your doctor has prescribed a urine test, tell your doctor you are taking Tavanic.
Danish: Hvis din læge ordinerer en urinprøve, skal du fortælle , at du tager Tavanic.
English: Tavanic tablets may therefore be administered regardless of food intake.
Danish: Tavanic tabletter kan derfor administreres uafhængigt af fødeindtagelse.
English: • You are pregnant, might become pregnant or think you may be pregnant
Danish: • hvis du er gravid, planlægger at blive gravid eller har mostanke om, at du er gravid
English: Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t½ : 6 - 8 h).
Danish: Efter oral og intravenøs administration elimineres levofloxacin relativt langsomt fra plasma(t½ : 6-8 timer).
English: These SmPCs, labelling and packages leaflets are the version valid at the time of Commission decision.
Danish: Disse produktresumeer, etiketteringer og indlægssedler er gældende version på tidspunktet for Kommissionens beslutning.
English: The following dose recommendations can be given for Tavanic:
Danish: Følgende doseringsvejledning kan gives for Tavanic:
English: It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with levofloxacin.
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, der får alvorlig diarré under eller efter behandling med levofloxacin.
English: Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Danish: Koncentrationen af levofloxacin var ca. 13 % højere ved tilstedeværelse af fenbufen, end når det blev indgivet alene.
English: Resistance to fluoroquinolones of E. coli - the most common pathogen involved in urinary tract infections - varies across the European Union.
Danish: Resistens over for fluoroquinoloner hos E. coli - det mest almindelige patogen involveret i urinvejsinfektioner - varierer i EU.
English: Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs
Danish: Theophyllin, fenbufen og lignende non-steroide antiinflammatoriske lægemidler
English: All patients should consult their physician if they experience symptoms of tendinitis.
Danish: Alle patienter bør kontakte deres læge, hvis de får symptomer på tendinitis.
English: Tavanic tablets can be used to treat infections of the:
Danish: Tavanic tabletter kan anvendes til at behandle infektioner i:
English: The risk of tendinitis and tendon rupture is increased in patients aged over 60 years, in patients receiving daily doses of 1000 mg and in patients using corticosteroids.
Danish: Risikoen for tendinitis og seneruptur er forøget hos patienter over 60 år, hos patienter, der får en daglig dosis over 1.000 mg og hos patienter, der får kortikosteroider.
English: This may be due to a lowering in the number of white blood cells (agranulocytosis).
Danish: Det kan skyldes et nedsat antal hvide blodlegemer (agranulocytose)
English: • The dose will depend on the type of infection you have and where the infection is in your body.
Danish: • Dosis afhænger af den infektionstype, du har, og hvor infektionen er i din krop.
English: Strains with MIC values above the susceptible breakpoint are very rare or not yet reported.
Danish: Stammer med MIC-værdier over grænseværdien for følsomhed er meget sjældne eller endnu ikke rapporteret.
English: Probenecid and cimetidine
Danish: Probenecid og cimetidin
English: Do not take Tavanic tablets at the same time as the following medicines.
Danish: Tag ikke Tavanic tabletter samtidigt med følgende medicin.
English: The tablets may be taken during meals or between meals.
Danish: Tabletterne kan indtages under eller mellem måltider.
English: Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with levofloxacin and have been reported up to several months after discontinuation of treatment.
Danish: Tendinitis og seneruptur, sommetider bilateral, kan forekomme inden for 48 timer efter behandlingsstart med levofloxacin og er blevet rapporteret op til flere måneder efter behandlingsophør.
English: Other undesirable effects which have been associated with fluoroquinolone administration include: • attacks of porphyria in patients with porphyria
Danish: Andre bivirkninger, der har været associeret med administration af fluoroquinolon inkluderer: • porfyri-anfald hos patienter med porfyri
English: Do not take this medicine if any of the above applies to you.
Danish: • hvis du ammer Tag ikke denne medicin, hvis noget af ovenstående gælder for dig.
English: This is sometimes called ‘soft tissue'
Danish: Det kaldes nogle gange ”bløddele”.
English: These could be signs of a severe bowel problem
Danish: Det kan være tegn på et alvorligt tarmproblem
English: Excretion is primarily by the renal route (>85% of the administered dose).
Danish: Udskillelsen sker primært renalt (>85 % af den indgivne dosis).
English: However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance.
Danish: Ved doser undersøgt i studiet er det dog usandsynligt, at disse statistisk signifikante kinetiske forskelle har nogen klinisk relevans.
English: Tuberculosis tests
Danish: Tuberkuloseprøver
English: • Low number of white blood cells (neutropenia)
Danish: • Lavt antal hvide blodlegemer (neutropeni)
English: • Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia,
Danish: • Ændring i antallet af hvide blodlegemer, som påvises i resultaterne af visse blodprøver (leukopeni,
English: This medicinal product does not require any special storage conditions.
Danish: Særlige opbevaringsforhold Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: <10 ml/min (including haemodialysis and CAPD) 1
Danish: <10 ml/min (inklusive hæmodialyse og CAPD) 1
English: 4.5 Interactions with other medicinal products and other forms of interaction
Danish: Interaktion med andre lægemidler og andre former for interaktion
English: This is because both drugs are capable of blocking the renal tubular secretion of levofloxacin.
Danish: Dette skyldes, at begge lægemidler kan blokere den renale tubulære sekretion af levofloxacin.
English: • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
Danish: • Øget følsomhed af din hud over for sol og ultraviolet lys
English: Inhalation Anthrax: Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data.
Danish: Inhalationsanthrax: Anvendelsen hos mennesker er baseret på data om følsomhed for in vitro Bacillus anthracis og eksperimentelle data hos dyr sammen med begrænsede humane data.
English: • Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
Danish: • Følelse af at se og høre ting, som ikke er der (hallucinationer, paranoia), ændring i din opfattelse og dine tanker (psykotiske reaktioner) med risiko for at få selvmordstanker eller prøve at begå selvmord
English: Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Danish: Levofloxacin er stereokemisk stabilt og undergår ikke chiral inversion.
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Danish: Indtil der er evidens for klinisk respons for bekræftede isolater med MIC over de nuværende grænseværdier for resistens, skal de rapporteres som resistente.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Ekspertrådgivning bør søges efter behov, når den lokale resistensprævalens er sådan, at midlets anvendelighed er tvivlsom til i det mindste nogle typer infektioner.
English: The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen.
Danish: Doseringen afhænger af infektionens type og sværhedsgrad og af følsomheden af det formodede kausale patogen.
English: You may be more likely to get the side effects of ciclosporin
Danish: Du kan have større risiko for at få bivirkninger ved ciclosporin
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid denne medicin nøjagtigt efter lægens anvisning.
English: • Fever, sore throat and a general feeling of being unwell that does not go away.
Danish: • Feber, ondt i halsen og en generel følelse af utilpashed, som ikke forsvinder.
English: You may be more likely to have a bleed.
Danish: Du kan have større risiko for at bløde.
English: This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:
Danish: Dette skyldes, at din hud vil blive mere følsom over for solen og kan blive forbrændt eller, få et alvorligt blæreformer udslæt, eller du kan få en prikkende fornemmelse i huden, hvis du ikke tager følgende forholdsregler:
English: Stop taking Tavanic and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop med at tage Tavanic, og gå straks til lægen, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan have brug for akut lægebehandling:
English: 28 days
Danish: 28 dage
English: This is because it can affect the way Tavanic tablets work:
Danish: Det skyldes, at det kan påvirke den måde, hvorpå Tavanic tabletter virker:
English: Adults and the elderly with kidney problems Your doctor may need to give you a lower dose.
Danish: Voksne og ældre patienter med nyreproblemer Din læge vil muligvis give dig en lavere dosis.
English: Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics.
Danish: Separate analyser på mænd og kvinder påviste små eller marginale kønsforskelle i levofloxacins farmakokinetik.
English: In some special situations, Tavanic tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.
Danish: I særlige situationer kan Tavanic tabletter anvendes til at reducere risikoen for at få en lungesygdom kaldet anthrax eller forværring af denne sygdom, hvis du har været udsat for den bakterie, der forårsager anthrax.
English: There are 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: The bioavailability of Tavanic tablets is significantly reduced when administered together with sucralfate.
Danish: Tavanic tabletternes biotilgængelighed reduceres signifikant, når de administreres samtidigt med sucralfat.
English: • Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated
Danish: • Ændring i antallet af andre bakterier eller svampe, infektion med en svamp kaldet Candida, som eventuelt skal behandles
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 vedbakteriologisk diagnosticering af tuberkulose.
English: The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.
Danish: Ciclosporins halveringstid blev øget med 33 % ved administration sammen med levofloxacin.
English: Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin.
Danish: Probenecid og cimetidin har en statistisk signifikant virkning på eliminationen af levofloxacin.
English: This is important in people with myasthenia gravis (a rare disease of the nervous system).
Danish: Personer med myasthenia gravis (en sjælden sygdom i nervesystemet) skal være opmærksom herpå
English: If you have kidney problems, your doctor may want to give you a lower dose.
Danish: Hvis du har nyreproblemer, vil din læge muligvis give dig en lavere dosis.
English: The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).
Danish: Graden af levofloxacins baktericide aktivitet afhænger af forholdet mellem den maksimale serumkoncentration (Cmax) eller arealet under kurven (AUC) og den mindste hæmmende koncentration (MIC).
English: • You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic'.
Danish: • hvis du har haft problemer med dine sener, f.eks. betændelse i en sene (tendinitis), som havde forbindelse med behandling med et quinolon-antibiotikum.
English: Staphylococcus aureus methicillin-resistant#
Danish: Staphylococcus aureus methicillin-resistent#
English: • in patients with epilepsy,
Danish: • til patienter med epilepsi
English: • Problems with your hearing (tinnitus) or eyesight (blurred vision)
Danish: • Problemer med hørelsen (tinnitus) eller synet (sløret syn)
English: Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses.
Danish: Studier med mus viste, at levofloxacin kun havde fototoksisk aktivitet ved meget høje doser.
English: This leaflet was last revised in MM/YYYY [To be completed nationally]
Danish: Denne indlægsseddel blev senest revideret MM/ÅÅÅÅ [Udfyldes nationalt]
English: Levofloxacin is a ‘quinolone' antibiotic.
Danish: Levofloxacin er et ”quinolon”-antibiotikum.
English: Close monitoring of these patients is therefore necessary if they are prescribed levofloxacin.
Danish: Det er derfor nødvendigt at monitorere disse patienter nøje, hvis de får ordineret levofloxacin.
English: This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis.
Danish: Denne medicin kan give ”falsk negative” resultater af nogle laboratorieprøver for den bakterier, der forårsager tuberkulose.
English: • Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high temperature.
Danish: • Vandig diarré, der kan være blodig, muligvis med mavekramper og høj temperatur.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
English: 1No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Danish: 1Ingen ekstra doser er påkrævet efter hæmodialyse eller kontinuerlig ambulant peritonealdialyse (CAPD).
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, vedvarende og/eller blodig, under eller efter behandling med levofloxacin (indtil flere uger efter behandling), kan være symptomatisk for Clostridium difficile associeret sygdom (CDAD).
English: You may be more likely to have inflammation and/or rupture of your tendons.
Danish: Du kan have større risiko for at få betændelse i og/eller bristning af dine sener
English: Ventricular tachycardia, which may result in cardiac arrest
Danish: Ventrikulær takykardi, som kan medføre hjertestop
English: There are no major differences in the pharmacokinetics of levofloxacin following intravenous and oral administration, suggesting that the oral and intravenous routes are interchangeable.
Danish: Der er ingen væsentlige forskelle på levofloxacins farmakokinetik efter intravenøs og oral indgift, hvilket antyder, at oral og intravenøs administration er substituerbar.
English: • Warfarin - used to thin the blood.
Danish: • Warfarin - bruges til at forebygge blodpropper.
English: Duration of treatment (according to severity)
Danish: Behandlingsvarighed (alt efter sværhedsgrad)
English: They may be divided at the score line to adapt the dose.
Danish: De kan deles ved delekærven for at tilpasse dosis.
English: It most frequently involves the Achilles tendon and may lead to tendon rupture.
Danish: Det involverer hyppigst akillessenen og kan føre til seneruptur.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD / BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON/ÆSKE
English: In vivo tests (micronucleus, sister chromatid exchange, unscheduled DNA synthesis, dominant lethal tests) did not show any genotoxic potential.
Danish: In vivo-test (mikronukleus, søsterkromatidudveksling, ikke-planlagt DNA-syntese, dominant letaltest) udviste ikke nogen genotoksicitet.
English: Low-level fluoroquinolone resistance (ciprofloxacin MICs of 0.12-0.5 mg/l) may occur but there is no evidence that this resistance is of clinical importance in respiratory tract infections with H. influenzae.
Danish: Resistens ved lavfluoroquinolonkoncentration (ciprofloxacin MIC-værdier på 0,12-0,5 mg/l) kan forekomme, men der er ikke evidens for, at denne resistens er klinisk vigtig ved luftvejsinfektioner forårsaget af H. influenzae.
English: Streptococcus A, B, C, G ≤1 mg/l
Danish: Streptococcus A, B, C, G
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: Patienter bør rådes til at stoppe behandlingen og kontakte deres læge, hvis der opstår tegn og symptomer på sygdom i leveren, f.eks. anoreksi, gulsot, mørk urin, pruritus eller ømt abdomen.
English: Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.
Danish: Læger anbefales at tage hensyn til den lokale prævalens af resistens for fluoroquinoloner hos E. coli.
English: If CDAD is suspected or confirmed, levofloxacin should be stopped immediately and appropriate treatment initiated without delay.
Danish: Ved mistanke om eller verificering af CDAD skal behandling med levofloxacin øjeblikkeligt stoppes og passende behandling omgående initieres.
English: Effect of Tavanic on other medicinal products
Danish: Tavanics virkning på andre lægemidler
English: The mean apparent total body clearance of levofloxacin following a 500 mg single dose was 175 +/-29.2 ml/min.
Danish: Den gennemsnitlige tilsyneladende totalelevofloxacin-clearance efter en enkeldosis på 500 mg var 175 +/-29,2 ml/min.
English: • Do not take these medicines at the same time as Tavanic.
Danish: • Tag ikke ovenstående lægemidler samtidigt med Tavanic.
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 af theophyllin (som er et markørsubstrat for CYP1A2), hvilket indikerer, at levofloxacin ikke er en CYP1A2-inhibitor.
English: Severe bullous reactions
Danish: Svære bulløse reaktioner
English: Hypromellose Titanium dioxide E 171 Talc
Danish: Tabletovertræk: Hypromellose Titandioxid E 171 Talcum
English: You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight.
Danish: Du kan få bivirkninger, efter du har taget denne medicin, inklusive svimmelhed, døsighed, en følelse af at dreje rundt (vertigo) eller ændringer i dit syn.
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 reelle defekter i glukose-6-fosfatdehydrogenaseaktiviteten kan have tilbøjelighed til hæmolytiske reaktioner, når de behandles med quinoloner.
English: • Skin and underneath the skin, including muscles.
Danish: • Hud og under huden, inklusive musklerne.
English: Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Danish: Nogle bivirkninger (f.eks. svimmelhed/vertigo, døsighed, synsforstyrrelser) kan påvike patientens koncentrations- og reaktionsevne og kan derfor udgøre en risiko i situationer, hvor disse egenskaber er af særlig vigtighed (f.eks. når patienten fører motorkøretøj eller betjener maskiner).
English: Pharmacotherapeutic group: quinolone antibacterials, fluoroquinolones, ATC code: J01MA12
Danish: Farmakoterapeutisk klassifikation: Quinolon-antibiotika, fluoroquinoloner ATC-kode: J01MA12
English: Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.
Danish: Der er rapporteret om psykotiske reaktioner hos patienter, der får quinoloner, inklusive levofloxacin.
English: • Avoid sun beds
Danish: • Undgå solarier