FrancophonIA/ELRC3.0 huggingface dataset:
English: Urine tests may show ‘false-positive' results for strong painkillers called ‘opiates' in people taking Tavanic.
Danish: Urinprøver kan vise ”falsk-positive” resultater for stærke smertestillende midler kaldet ”opiater” hos patienter, der tager Tavanic.
English: 3 days
Danish: 3 dage
English: • You are a child or a growing teenager
Danish: • hvis du er barn eller teenager i voksealderen
English: The mean volume of distribution of levofloxacin is approximately 100 l after single and repeated 500 mg doses, indicating widespread distribution into body tissues.
Danish: Den gennemsnitlige distributionsvolumen for levofloxacin er ca. 100 l efter en enkelt eller gentagne 500 mg doser, hvilket indikerer udbredt distribution til legemsvæv.
English: Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body.
Danish: Hæmodialyse, herunder peritonealdialyse og CAPD, er ikke effektivt til at eliminere levofloxacin fra kroppen.
English: Creatinine clearance first dose: 250 mg first dose: 500 mg first dose: 500 mg
Danish: Kreatininclearance første dosis: 250 mg første dosis: 500 mg første dosis: 500 mg
English: In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted.
Danish: Hvis patienten udvikler disse reaktioner, bør levofloxacin seponeres, og der bør tages passende forholdsregler.
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i to lige store doser.
English: 4.7 Effects on ability to drive and use machines
Danish: Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: For the above-mentioned infections Tavanic should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Danish: Tavanic bør kun anvendes ved ovennænvte infektioner, når det er uhensigtsmæssigt at anvende de antibakterielle lægemidler, der almindeligvis anbefales til den initiale behandling af disse infektioner.
English: Psychotic reactions
Danish: Psykotiske reaktioner
English: If the patient is to receive both sucralfate and Tavanic, it is best to administer sucralfate 2 hours after the Tavanic tablet administration (see section 4.2).
Danish: Hvis patienten skal behandles både med sucralfat og Tavanic, er det bedst at administrere sucralfat 2 timer efter Tavanic tabletter (se pkt.
English: • Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest,
Danish: • Unormalt hurtig hjerterytme (puls), livstruende uregelmæssig hjerterytme inklusive hjertestop,
English: alteration of the heart rhythm (called ‘prolongation of QT interval', seen on ECG, electrical activity of the heart)
Danish: ændring i hjerterytmen (kaldet ”forlænget QT-interval”, set på ekg, registrering af hjertets elektriske aktivitet)
English: Levofloxacin may be used in the treatment of Acute Bacterial Sinusitis and Acute Exacerbation of Chronic Bronchitis when these infections have been adequately diagnosed.
Danish: Levofloxacin kan anvendes til behandling af akut bakteriel sinuitis og akutte eksacerbationer af kronisk bronkitis, når disse infektioner er diagnosticeret på tilfredsstillende vis.
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Danish: Der er observeret krydsresistens mellem levofloxacin og andre fluoroquinoloner.
English: swelling of your lips, face, throat, or tongue
Danish: hævede læber, ansigt, hals eller tunge
English: • Corticosteroids, sometimes called steroids - used for inflammation.
Danish: • Kortikosteroider, nogle gange kaldet steroider - bruges til vævsirritation.
English: • Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.
Danish: • Ændret nyrefunktion og lejlighedsvis nyresvigt, som kan skyldes en allergisk reaktion i nyrerne kaldet interstitiel nefritis
English: Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt (see section 4.4)
Danish: Psykotiske forstyrrelser med selvdestruktiv adfærd, inklusive selvmordstanker eller selvmordsforsøg (se pkt.
English: Date of first authorisation: [To be completed nationally] Date of last renewal: [To be completed nationally]
Danish: Dato for første markedsføringstilladelse: [Udfyldes nationalt] Dato for seneste fornyelse: [Udfyldes nationalt]
English: Do not double-up the next dose to make up for the missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Resistance to levofloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also affect susceptibility to levofloxacin.
Danish: Resistens over for levofloxacin udvikles gennem en trinvis proces af mutationer på target i begge type II topoisomeraser, DNA-gyrase og topoisomerase IV. Andre resistensmekanismer som f.eks. permeationsbarrierer (almindelig ved Pseudomonas aeruginosa) og effluksmekanismer kan også påvirke følsomheden for levofloxacin.
English: Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide.
Danish: Levofloxacin metaboliseres i meget lille omfang; metabolitterne er desmethyl-levofloxacin og levofloxacinN-oxid.
English: Pruritus Urticaria Hyperhidrosis
Danish: Udslæt Pruritus Urticaria Hyperhidrose
English: Dosage in patients with normal renal function (creatinine clearance >50 ml/min)
Danish: Dosering til patienter med normal nyrefunktion (kreatininclearance >50 ml/min)
English: Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.
Danish: På grund af virkningsmekanismen er der generelt ingen krydsresistens mellem levofloxacin og andre typerantibiotika.
English: In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour- sometimes after only a single dose of levofloxacin (see section 4.8).
Danish: I meget sjældne tilfælde har disse reaktioner udviklet sig til selvmordstanker og selvdestruktiv adfærd - nogle gange efter en enkelt dosis levofloxacin (se pkt.
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 enkeldosis, toksicitet efter gentagne doser, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Mechanism of resistance
Danish: Resistensmekanisme
English: Commonly susceptible species
Danish: Almindeligt følsomme arter
English: There are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects, except those associated with differences in creatinine clearance.
Danish: Der er ingen signifikant forskel på levofloxacins farmakokinetik hos yngre og ældre patienter bortset fra, hvad der kan tilskrives forskelle i kreatininclearance.
English: Package leaflet: Information for the user Tavanic 250 mg tablets
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Tavanic 250 mg tabletter
English: • Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia)
Danish: • Blodmangel (anæmi): Det kan gøre din hud bleg eller gul på grund af beskadigelse af de røde blodlegemer; lavere antal af alle typer blodlegemer
English: Adults and the elderly
Danish: Voksne og ældre patienter
English: Pain (including pain in back, chest, and extremities)
Danish: Smerter (inklusive smerter i ryg, bryst og ekstremiteter)
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tavanic.
Danish: Hvis du er i tvivl, om noget af ovenstående gælder for dig, så spørg lægen eller på apoteket, inden du tager Tavanic.
English: • Prostate gland, where you have a long lasting infection
Danish: • Prostata (blærehalskirtlen), hvis du har en langvarig infektion
English: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Danish: Fluoroquinoloner, inklusive levofloxacin, har neuromuskulært blokerende aktivitet og kan forværre muskelsvækkelse hos patienter med myasthenia gravis.
English: Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Danish: Forsogtoghed anbefales, hvis levofloxacin anvendes til psykotiske patienter eller til patienter med en psykiatrisk anamnese.
English: This is because it can increase the chance of you getting side effects, when taken with Tavanic:
Danish: Det kan øge risikoen for, at du får bivirkninger, når de tages sammen med Tavanic:
English: Ask your pharmacist how to to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Tavanic is contraindicated in breast-feeding women.
Danish: Tavanic er kontraindiceret til ammende kvinder.
English: Patients treated with Vitamin K antagonists
Danish: Patienter i behandling med K-vitamin-antagonister
English: Staphylococcus aureus methicillin-susceptible Staphylococcus saprophyticus Streptococci, group C and G Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes
Danish: Staphylococcus aureus methicillin-følsom Staphylococcus saprophyticus Streptococci, gruppe C og G Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Danish: Patienter bør rådes til øjenlikkeligt at kontakte deres læge, inden de fortsætter behandlingen, hvis der opstår reaktioner fra huden og/eller slimhinder.
English: Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.
Danish: Tavanic kan også anvendes til at fuldføre et behandlingsforløb hos patienter, der har vist forbedring under den indledende behandling med intravenøs levofloxacin.
English: • Pain and inflammation in your tendons or ligaments, which could lead to rupture.
Danish: • Smerte og inflammation (betændelse eller irritation) i dine sener eller ligamenter, som kan medføre bristning.
English: Do not use this medicine after the expiry date which is stated on the carton and foil after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: eosinophilia)
Danish: eosinofili)
English: Yellow ferric oxide E 172 Red ferric oxide E 172
Danish: Gul jernoxid E 172 Rød jernoxid E 172
English: Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic active substance ofloxacin.
Danish: Levofloxacin er et syntetisk antibakterielt middel fra fluoroquinolongruppen og er S (-) enantiomeren af det racemiske lægemiddelstof ofloxacin.
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 drugs: calcium carbonate, digoxin, glibenclamide, ranitidine.
Danish: Klinisk farmakologiske studier har påvist, at levofloxacins farmakokinetik ikke blev påvirket i klinisk relevant omfang, når levofloxacin blev indgivet sammen med følgende stoffer: calciumcarbonat, digoxin, glibenclamid, ranitidin.
English: Calcium salts have a minimal effect on the oral absorption of levofloxacin.
Danish: Calciumsalte har minimal indvirkning på den orale absorption af levofloxacin.
English: No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Danish: Dosisjustering er ikke nødvendig, da levofloxacin ikke metaboliseres i nævneværdig omfang i leveren, men hovedsageligt udskilles renalt.
English: Benign intracranial hypertension
Danish: Benign interkraniel hypertension
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 agents which lower the seizure threshold.
Danish: En udpræget nedsat cerebral krampetærskel kan dog forekomme, når quinoloner gives samtidigt med theophyllin, non-steroide antiinflammatoriske lægemidler eller andre midler, der sænker krampetærsklen.
English: Vitamin K antagonists
Danish: K-vitamin-antagonister
English: Renal failure acute (e.g. due to interstitial nephritis)
Danish: Akut nyresvigt (f.eks. på grund af interstitiel nefritis)
English: Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.
Danish: Levofloxacin bør seponeres ved symptomer på neuropati for at hindre udvikling af en irreversibel tilstand.
English: • Inflammation of the liver (hepatitis)
Danish: • Leverbetændelse (hepatitis)
English: Anaerobic bacteria Peptostreptococcus
Danish: Anaerobe bakterier Peptostreptococcus
English: Daily dose regimen (according to severity)
Danish: Daglig dosis (alt efter sværhedsgrad)
English: • You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for levofloxacin, andre quinolon-antibiotika, f.eks. moxifloxacin, ciprofloxacin eller ofloxacin eller et af de øvrige indholdsstoffer i Tavanic tabletter (se afsnit.
English: 4.4 Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Caution should be exercised when levofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially in renally impaired patients.
Danish: Forsigtighed bør udvises, når levofloxacin indgives samtidig med lægemidler, der påvirker den renale tubulære sekretion som f.eks. probenicid og cimetidin, især hos patienter med nedsat nyrefunktion.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkel frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
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 det er tilfældet med alle quinoloner er der rapporteret forstyrrelser i blodglucose, både hypo- og hyperglykæmi, sædvanligvis hos diabetespatienter, der er i samtidig behandling med et oralt antidiabetikum (f.eks. glibenclamid) eller med insulin.
English: Postmarketing serious adverse reactions, including deaths and the requirement for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
Danish: Alvorlige bivirkninger efter markedsføring, herunder letale tilfælde og tilfælde med behov for understøttelse af respirationen, er blevet associeret med anvendelse af fluoroquinoloner hos patienter med myasthenia gravis.
English: Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations.
Danish: Der bør udvises forsigtighed, når fluoroquinoloner, inklusive levofloxacin, anvendes til disse populationer (se pkt.
English: Infection of skin and underneath the skin, including muscles
Danish: Betændelsei huden og under huden, inklusive musklerne
English: Non-species related breakpoints 4 ≤1 mg/l
Danish: Ikke-artsrelaterede grænseværdier 4 ≤1 mg/l
English: Effect of other medicinal products on Tavanic
Danish: Andre lægemidlers virkning på Tavanic
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: For at forebygge fotosensibilisering anbefales det, at patienter ikke unødvendigt udsætter sig for stærkt sollys eller kunstige UV-stråler (f.eks. sollamper, solarium) under behandlingen og i 48 timer efter behandlingsophør.
English: Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Danish: 6) Tegn på en allergisk reaktion inkluderer udslæt, besvær med at synke eller trække vejret, hævede læber, ansigt, hals eller tunge
English: However, levofloxacin has poor penetration intro cerebro-spinal fluid.
Danish: Levofloxacin har imidlertid ringe penetration til cerebrospinalvæsken.
English: This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine,), for psychiatric disorders (antipsychotics), and for bacterial infections (‘macrolide' antibiotics such as erythromycin, azithromycin and clarithromycin)
Danish: Dette inkluderer medicin, der bruges mod unormal hjerterytme (antiarytmika, som f.eks. quinidin, hydroquinidin, disopyramid, sotalol, dofetilid, ibutilid og amiodaron), mod depression (tricykliske antidepressiva, som f.eks. amitriptylin og imipramin), til psykiske lidelser (antipsykotika) og mod bakterieinfektioner (”makrolid”antibiotika, som f.eks. erythromycin, azitromycin og claritromycin)
English: • Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
Danish: • Nedtrykthed, psykiske problemer, rastløshed (agitation), unormale drømme eller mareridt
English: Coagulase negative Staphylococcus spp
Danish: Koagulase negative Staphylococcus spp
English: Tendon disorders (see sections 4.3 and 4.4) including tendinitis (e.g. Achilles tendon) Muscular weakness which may be of special importance in patients with myasthenia gravis (see section 4.4 )
Danish: 4.3 og 4.4), inklusive tendinitis (f.eks. akillessene) Muskelsvaghed, hvilket kan være af særlig relevans hos patienter med myasthenia gravis (se pkt.
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats and its only effect on fetuses was delayed maturation as a result of maternal toxicity.
Danish: Levofloxacin påvirkede ikke fertiliteten eller reproduktionsevnen hos rotter, og den eneste virkning på fostre var forsinket modning som følge af maternel toksicitet.
English: ClR [ml/min] 13 t1/2 [h]
Danish: ClR [ml/min] 13
English: Drugs known to prolong QT interval
Danish: Stoffer, der vides at forlænge QT-intervallet
English: • Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin.
Danish: • Non-steroide antiinflammatoriske medicin (NSAID'er) - bruges til smerter og gigt, f.eks. acetylsalicylsyre, ibuprofen, fenbufen, ketoprofen og indometacin.
English: EUCAST clinical MIC breakpoints for levofloxacin (version 2.0, 2012-01-01):
Danish: EUCAST-kliniske MIC-grænseværdier for levofloxacin (version 2.0, 2012-01-01): Patogen
English: What you need to know before you take Tavanic tablets 3.
Danish: Det skal du vide, før du begynder at tage Tavanic tabletter 3.
English: Summary of product characteristics, labelling and package leaflets
Danish: Bilag III Produktresume, etikettering og indlægsseddel
English: No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study.
Danish: Der blev ikke fundet farmakokinetiske interaktioner mellem levofloxacin og theophyllin i et klinisk studie.
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 fremkaldte ikke genmutationer i bakterier eller pattedyrceller, men fremkaldte kromosomafvigelser i lungeceller fra kinesisk hamster in vitro.
English: Cases of hypoglycaemic coma have been reported.
Danish: Der er rapporteret tilfælde med hypoglykæmisk koma.
English: Steady state conditions are reached within 48 hours following a 500 mg once or twice daily dosage regimen.
Danish: Steady-state nås i løbet af 48 timer efter en dosis på 500 mg én eller to gange dagligt.
English: Stop taking Tavanic and see a doctor or go to a hospital straight away if you notice the following side effect:
Danish: Stop med at tage Tavanic og søg læge eller skadestue med det samme, hvis du bemærker nogen af følgende bivirkninger:
English: Tavanic tablets contain a medicine called levofloxacin.
Danish: Tavanic tabletter indeholder et aktivt stof kaldet levofloxacin.
English: The EUCAST recommended MIC breakpoints for levofloxacin, separating susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms are presented in the below table for MIC testing (mg/l).
Danish: De af EUCAST anbefalede MIC-grænseværdier for levofloxacin, der adskiller følsomme fra intermediært følsomme organismer og intermediært følsomme fra resistente organismer, præsenteres i nedenstående tabel for MIC-værdier (mg/l).
English: Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).
Danish: Levofloxacin frarådes derfor til behandling af infektioner forårsaget af methicillin-resistent S. aureus eller ved mistanke herom, medmindre laboratorieresultater har bekræftet, at patogenet er følsomt over for levofloxacin (og de antibakterielle lægemidler, der almindeligvis anbefales til behandling af MRSAinfektioner, anses for uhensigtsmæssige).
English: The following effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems - leading to uneven heart beats as well as feeling sick (nausea) or having stomach burning.
Danish: Følgende virkninger kan opstå: krampeanfald, forvirring, svimmelhed, mindre bevidsthed, rysten (tremor) og hjerteproblemer - hvilket fører til uregelmæssige hjerteslag og kvalme eller en brændende fornemmelse i maven.
English: • Probenecid - used for gout and cimetidine - used for ulcers and heartburn.
Danish: • Probenecid - bruges til urinsyregigt og cimetidin - bruges til mavesår og halsbrand.
English: Food has little effect on the absorption of levofloxacin.
Danish: Føde har kun en lille indflydelse på absorptionen af levofloxacin.
English: Ligament rupture Muscle rupture Arthritis
Danish: Ligamentruptur Muskelruptur Artritis
English: • Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis)
Danish: • Betændelse i de kar, der fører blodet rundt i kroppen, på grund af en allergisk reaktion
English: Penetration into tissues and body fluids
Danish: Penetration til væv og legemsvæsker
English: Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption.
Danish: Samtidig administration af fluoroquinoloner med multivitaminer indeholdende zink ser ud til at reducere fluoroquinoloners orale absorption.
English: Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.
Danish: Patienter skal straks ophøre med behandlingen og kontakte deres læge eller skadestuen ogpassende behandling initieres.
English: • Tingly feeling in your hands and feet (paraesthesia)
Danish: • Prikkende fornemmelse i hænderne og fødderne