FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare (<1/10,000).
Danish: Kategorierne for hyppighed er defineret efter følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: The effect of lesinurad on fertility in humans has not been studied.
Danish: Lesinurads påvirkning af fertiliteten hos mennesker er ikke undersøgt.
English: No studies have been conducted in patients with secondary hyperuricaemia (including organ transplant recipients).
Danish: Der er ikke udført studier hos patienter med sekundær hyperurikæmi (herunder organtransplanterede patienter).
English: Zurampic is administered as a 50:50 mixture of lesinurad atropisomers.
Danish: Zurampic administreres som en 50:50-blanding af lesinurad-atropisomerer.
English: An induction effect of lesinurad should be anticipated after 2 to 3 weeks of continuous co-administration of Zurampic.
Danish: En inducerende effekt af lesinurad må forventes efter 2-3 ugers kontinuerlig samtidig administration af Zurampic.
English: There are no restrictions for doses of salicylates of 325 mg or less per day (i.e. for cardiovascular protection).
Danish: Der er ingen restriktioner for salicylatdoser på 325 mg eller derunder pr. dag (dvs. til kardiovaskulær beskyttelse).
English: Clinically relevant interactions with other medicinal products
Danish: Klinisk relevante interaktioner med andre lægemidler
English: This is also the maximum dose (see section 4.4).
Danish: Dette er også den maksimale dosis (se pkt.
English: Very elderly (≥75 years)
Danish: Meget ældre (≥75 år)
English: Across both studies, 61% of patients had mild or moderate renal impairment and 19% had tophi at baseline.
Danish: I begge studier havde 61 % af patienterne let eller moderat nedsat nyrefunktion, og 19 % havde tofi ved baseline.
English: In case of overdose, patients should be managed by symptomatic and supportive care including adequate hydration.
Danish: I tilfælde af overdosering skal patienten behandles symptomatisk og understøttende, herunder tilstrækkelig hydrering sikres.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines as they may interact with Zurampic and your doctor will need to know:
Danish: Du skal især fortælle det til lægen eller apotekspersonalet, hvis du tager nogle af følgende lægemidler, da de kan interagere med Zurampic, og lægen har brug for at vide det:
English: Following multiple once daily dosing of Zurampic, there was no evidence of time dependent changes in pharmacokinetic properties and dose proportionality was preserved.
Danish: Efter gentagen dosering af Zurampic én gang dagligt var der ingen tegn på tidsafhængige ændringer i de farmakokinetiske egenskaber, og dosisproportionaliteten var bevaret.
English: Patients should be instructed to stay well hydrated (e.g. 2 litres of liquid per day).
Danish: Patienterne skal instrueres i at være velhydrerede (fx 2 liter væske pr. dag).
English: Based on population pharmacokinetic analysis, age, gender, race and ethnicity do not have a clinically meaningful effect on the pharmacokinetics of lesinurad.
Danish: Med udgangspunkt i en populationsfarmakokinetisk analyse har alder, køn, race og etnicitet ingen klinisk betydningsfuld indvirkning på lesinurads farmakokinetik.
English: Your doctor will prescribe Zurampic if your current medicine is not controlling your gout.
Danish: Lægen vil udskrive Zurampic, hvis din nuværende medicin ikke kan kontrollere din urinsyregigt.
English: Some people may have more gout attacks (gout flares) when they start using Zurampic and during the first weeks or months of treatment.
Danish: Nogle mennesker kan få flere anfald af urinsyregigt (udbrud af urinsyregigt), når de begynder at tage Zurampic og i de første uger eller måneder af behandlingen.
English: If you miss a dose of Zurampic, do not take a double dose to make up for a forgotten dose.
Danish: Hvis du glemmer at tage en Zurampic-dosis, må du ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Unchanged lesinurad in urine accounted for approximately 30% of the dose.
Danish: Uomdannet lesinurad i urin udgjorde ca. 30 % af dosis.
English: The elimination half-life (t½) of lesinurad was approximately 5 hours following a single dose.
Danish: Lesinurads eliminationshalveringstid (t½) var ca. 5 timer efter en enkelt dosis.
English: Ask your doctor or pharmacist if you are not sure about how to take your next dose.
Danish: Spørg din læge eller apotekspersonalet, hvis du ikke er sikker på, hvornår du skal tage din næste dosis.
English: Oval, 5.7 x 12.9 mm, blue tablets.
Danish: Ovale 5,7 x 12,9 mm blå tabletter.
English: URAT1 is responsible for the majority of the reabsorption of filtered uric acid from the renal tubular lumen.
Danish: URAT1 er ansvarlig for hovedparten af reabsorptionen af filtreret urinsyre fra det renale tubulære lumen.
English: Pack sizes of 10, 28, 30, 98 in non-perforated blisters.
Danish: Pakningsstørrelser a 10, 28, 30, 98 i ikke-perforerede blistere.
English: Patients with serum creatinine elevations to greater than 1.5 times the pre-treatment value should be closely monitored.
Danish: Patienter, hvis serumkreatinin stiger til mere end 1,5 gange værdien før behandling, bør monitoreres nøje.
English: Following administration of a single oral dose of lesinurad in either the fed or fasted state, maximum plasma concentrations (Cmax) were attained within 1 to 4 hours.
Danish: Efter administration af en enkelt oral dosis lesinurad enten efter fødeindtagelse eller fastende blev maksimal plasmakoncentration (Cmax) nået inden for 1 til 4 timer.
English: Zurampic should not be used as monotherapy or at doses above the recommended dose.
Danish: Zurampic bør ikke anvendes som monoterapi eller i højere dosis end den anbefalede.
English: Lesinurad at doses up to 1,600 mg did not demonstrate an effect on ECG parameters (including QTc interval) in healthy subjects.
Danish: Lesinurad i doser op til 1.600 mg viste ingen effekt på EKG-parametre (herunder QTc-interval) hos raske forsøgspersoner.
English: The safety of Zurampic 200 mg was evaluated in the Phase 3 combination therapy clinical trials (including extension studies).
Danish: Sikkerheden ved Zurampic 200 mg blev vurderet i kliniske fase 3-studier med kombinationsbehandling (herunder udvidede studier).
English: Zurampic may cause serious kidney problems (see section 4), which occur more frequently if Zurampic is taken alone (see section 3).
Danish: Zurampic kan forårsage alvorlige nyreproblemer (se punkt 4), som kan forekomme hyppigere, hvis Zurampic tages alene (se punkt 3).
English: As a precautionary measure, it is preferable to avoid the use of Zurampic during pregnancy.
Danish: Som forholdsregel anbefales det at undgå at anvende Zurampic under graviditet.
English: Serious side effects - Uncommon - may affect up to 1 in 100 people Stop taking Zurampic and see a doctor straight away if you notice any of the following side effects, as these may be signs of a problem with your kidneys - you may need urgent medical treatment:
Danish: Alvorlige bivirkninger - Ikke almindelige - kan forekomme hos op til 1 ud af 100 personer Stop med at tage Zurampic og gå straks til lægen, hvis du får nogen af følgende bivirkninger, da de kan være tegn på nyreproblemer - du kan have brug for lægehjælp omgående:
English: Available pharmacodynamic/toxicological data in rats have shown excretion of lesinurad in milk.
Danish: Tilgængelige farmakodynamiske/toksikologiske data hos rotter har vist, at lesinurad udskilles i mælk.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier tyder ikke på direkte eller indirekte skadelige virkninger med hensyn til reproduktionstoksicitet (se pkt.
English: The safety and efficacy of Zurampic in children under 18 years of age have not yet been established.
Danish: Zurampics sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: If you forget to take Zurampic
Danish: Hvis du har glemt at tage Zurampic
English: Your doctor may consider stopping Zurampic if your blood tests indicate changes in how your kidneys are working (blood creatinine levels increase) or if you experience symptoms of kidney problems.
Danish: Lægen kan overveje at stoppe behandlingen med Zurampic, hvis dine blodprøver viser ændringer i, hvordan dine nyrer virker (stigning i kreatinin i blodet), eller hvis du får symptomer på nyreproblemer.
English: Your doctor may ask you to have tests to check how your kidneys are working.
Danish: Lægen kan bede om, at du får taget nogle prøver for at se, hvordan dine nyrer virker.
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the cardiovascular risk in association with lesinurad exposure, mainly in patients with a history of cardiovascular disorders, the MAH shall conduct and submit the results of an observational prospective study according to an agreed protocol.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): Med det formål at undersøge den kardiovaskulære risiko i forbindelse med eksponering for lesinurad, hovedsageligt hos patienter med kardiovaskulære sygdomme i anamnesen, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af et prospektivt observationsstudie i overensstemmelse med
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when Zurampic is co-administered.
Danish: Hormonelle præventionsmidler, herunder orale, injicerbare, transdermale og implanterbare former, er muligvis ikke pålidelige, når de anvendes sammen med Zurampic.
English: Your doctor may tell you to restart treatment with Zurampic when your kidney function improves.
Danish: Lægen kan fortælle dig, at du skal starte behandlingen med Zurampic igen, når din nyrefunktion er blevet bedre.
English: The mean steady state volume of distribution of lesinurad was approximately 20 L following intravenous dosing.
Danish: Det gennemsnitlige steady state-distributionsvolumen for lesinurad var ca. 20 l efter intravenøs administration.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitetspotentiale samt reproduktions- og udviklingstoksicitet.
English: Cmax and AUC exposures of lesinurad increased proportionally with single doses of lesinurad from 5 to 1,200 mg.
Danish: Lesinurad-Cmax og AUC steg proportionalt med enkeltdoser fra 5 til 1.200 mg.
English: These are to help prevent or treat the symptoms of gout attacks (a sudden or severe pain and swelling in a joint).
Danish: Du får dem som hjælp til at forebygge eller behandle dine symptomer på anfald af urinsyregigt (en pludselig eller stærk smerte og hævelse i et led).
English: However, individual values were well within the range observed in the extensive metaboliser subjects.
Danish: De individuelle værdier lå imidlertid pænt inden for det interval, der blev observeret for ekstensive omsættere.
English: For cardiovascular patients in a stable condition, the benefit/risk balance should be assessed for each individual patient on an ongoing basis, taking into account the benefits of lowering urate levels versus a potential increase in cardiac risk (see section 4.8).
Danish: Til kardiovaskulære patienter i stabil tilstand skal benefit/risk-forholdet løbende vurderes for hver enkelt patient, idet der tages højde for fordelene ved at sænke uratniveauet i forhold til en potentielt øget kardiel risiko (se pkt.
English: These serum creatinine elevations generally resolved, most without treatment interruption.
Danish: Disse serumkreatininstigninger forsvandt generelt af sig selv og for de flestes vedkommende uden behandlingsafbrydelse.
English: crospovidone, magnesium stearate - film-coating:hypromellose, titanium dioxide, triacetin, indigo carmine, brilliant blue FCF.
Danish: crospovidon, magnesiumstearat - filmovertræk: hypromellose, titandioxid, triacetin, indigocarmin, brilliant blue FCF.
English: Table 1 Adverse reactions by System Organ Class and frequency
Danish: Tabel 1 Bivirkninger efter systemorganklasse og hyppighed Systemorganklasse
English: Lesinurad is highly protein bound and renal clearance is high (as compared to typical human glomerular filtration rate), indicating that active secretion plays an important role in the renal excretion of lesinurad.
Danish: Lesinurad er i høj grad proteinbundet og renal clearance er høj (i sammenligning med den typiske humane glomerulære filtrationsrate), hvilket indikerer, at aktiv udskillelse spiller en vigtig rolle ved renal udskillelse af lesinurad.
English: The gout flare should be managed concurrently as appropriate for the individual patient.
Danish: Udbruddet bør håndteres sideløbende på hensigtsmæssig vis for den enkelte patient.
English: Lesinurad does not accumulate following multiple doses.
Danish: Lesinurad akkumuleres ikke efter gentagne doser.
English: BLISTER NON-PERFORATED (10 TABLETS) BLISTER PERFORATED UNIT DOSE CALENDAR BLISTER (14 TABLETS)
Danish: BLISTER IKKE-PERFORERET (10 TABLETTER) BLISTER PERFORERET ENKELTDOSIS KALENDERBLISTER (14 TABLETTER)
English: Lesinurad has no or negligible influence on the ability to drive and use machines.
Danish: Lesinurad påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Pre-existing cardiovascular disease
Danish: Eksisterende kardiovaskulær sygdom
English: **Includes the preferred terms: renal failure, renal failure chronic and renal failure acute.
Danish: ** Inkluderer de foretrukne termer: nyresvigt, kronisk nyresvigt og akut nyresvigt.
English: *Photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria.
Danish: * Fotodermatit, fotosensibilitetsreaktion, allergisk dermatitis, pruritus og urticaria.
English: Sixty-six percent of patients had mild or moderate renal impairment.
Danish: 66 % af patienterne havde let eller moderat nedsat nyrefunktion.
English: Also some other medicines can affect the way Zurampic works.
Danish: Anden medicin kan også påvirke den måde, hvorpå Zurampic virker.
English: The ratio of atropisomer 1 to atropisomer 2 AUC(0-24) was 44:56 because atropisomer 1 undergoes more extensive metabolism than atropisomer 2, causing atropisomer 1 to have lower plasma exposure than atropisomer 2.
Danish: Forholdet mellem atropisomer 1- og atropisomer 2-AUC(0-24) var 44:56, fordi atropisomer 1 gennemgår mere ekstensiv metabolisering end atropisomer 2, hvorfor atropisomer 1 har lavere plasmaeksponering end atropisomer 2.
English: Zurampic should be interrupted if serum creatinine is elevated to greater than 2 times the pre-treatment value or in case of an absolute serum creatinine value greater than 4.0 mg/dL.
Danish: Behandlingen med Zurampic skal afbrydes, hvis serumkreatinin stiger til mere end to gange værdien før behandling eller i tilfælde af en absolut serumkreatinin > 4,0 mg/dl.
English: Based on in vitro data, lesinurad may be a mild inducer of CYP2B6 but this interaction has not been studied clinically.
Danish: På baggrund af in vitro-data kan lesinurad være en let CYP2B6-induktor, men denne interaktion er ikke undersøgt klinisk.
English: Mean plasma-to-blood ratios of lesinurad AUC and Cmax were approximately 1.8, indicating that radioactivity was largely contained in the plasma space and did not penetrate or partition extensively into red blood cells.
Danish: Gennemsnitlige plasma:blod-ratioer for lesinurad-AUC og -Cmax var ca. 1,8, hvilket indikerer, at radioaktiviteten for størstedelen blev indeholdt i plasma og ikke penetrerede eller fordeltes til de røde blodlegemer i udstrakt grad.
English: Approximately half of an oral dose of lesinurad is cleared via CYP2C9 metabolism.
Danish: Omtrent halvdelen af en oral dosis lesinurad elimineres via CYP2C9-metabolisme.
English: Zurampic has not been studied in patients with severe hepatic impairment; therefore, dose recommendations cannot be given.
Danish: Zurampic er ikke undersøgt hos patienter med svært nedsat leverfunktion, og der kan derfor ikke gives dosisanbefalinger.
English: Patients with tumour lysis syndrome or Lesch-Nyhan syndrome.
Danish: Patienter med tumorlysesyndrom eller Lesch-Nyhans syndrom.
English: Renal function should be evaluated prior to initiation of Zurampic and monitored periodically thereafter, e.g. 4 times per year, based on clinical considerations, such as baseline renal function, volume depletion, concurrent illness or concomitant medications.
Danish: Nyrefunktionen skal måles inden start med Zurampic og monitoreres regelmæssigt derefter, dvs. 4 gange om året, baseret på kliniske overvejelser, såsom baseline-nyrefunktion, hypovolæmi, samtidig sygdom eller anden samtidig medicin.
English: Tablet coat hypromellose titanium dioxide triacetin
Danish: Tabletovertræk hypromellose titandioxid triacetin
English: Other moderate CYP2C9 inhibitors, such as amiodarone, would also be expected to affect lesinurad pharmacokinetics to a similar degree.
Danish: Det forventes, at andre moderate CYP2C9-hæmmere, såsom amiodaron, også påvirker farmakokinetikken for lesinurad i lignende grad.
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA <PC: {nummer}
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Danish: Plasmaproteinbindingen ændres ikke betydeligt hos patienter med nedsat nyre- eller leverfunktion.
English: Zurampic should not be restarted without another explanation for the serum creatinine abnormalities.
Danish: Zurampic-behandlingen bør ikke startes igen, medmindre der er en anden forklaring på de abnorme serumkreatininværdier.
English: You should avoid taking Zurampic during pregnancy or if you are breast-feeding.
Danish: Du skal undgå at tage Zurampic under graviditet, og hvis du ammer.
English: In patients with tophi or persistent symptoms, the target is less than 5 mg/dL (300 µmol/L).
Danish: Hos patienter med tofi eller vedvarende symptomer er målet under 5 mg/dl (300 µmol/l).
English: Tablet core hypromellose microcrystalline cellulose lactose monohydrate crospovidone type A magnesium stearate
Danish: Tabletkerne hypromellose mikrokrystallinsk cellulose lactosemonohydrat crospovidon type A magnesiumstearat
English: Experience in very elderly (≥75 years) is limited (see section 4.4).
Danish: Erfaringen med meget ældre (≥75 år) er begrænset (se pkt.
English: If this happens, keep taking Zurampic and talk to your doctor or pharmacist.
Danish: Hvis dette sker, skal du blive ved med at tage Zurampic og tale med din læge eller apotekspersonalet.
English: Fifty percent of patients had a baseline sUA ≥5.0 mg/dL, which was after 3 weeks of treatment with febuxostat alone.
Danish: 50 % af patienterne havde sUA ≥5,0 mg/dl ved baseline, hvilket var efter 3 ugers behandling med febuxostat alene.
English: After continued treatment of up to 24 months on Zurampic 200 mg in combination with febuxostat, the proportion of subjects who experienced complete resolution of at least one target tophus increased to 53% of subjects.
Danish: Efter fortsat behandling i op til 24 måneder med Zurampic 200 mg i kombination med febuxostat steg andelen af forsøgspersoner, som oplevede fuldstændig resolution af mindst ét target-tophus, til 53 %.
English: Treatment should be interrupted in patients who report symptoms that may indicate acute uric acid nephropathy including flank pain, nausea or vomiting, and measure serum creatinine promptly.
Danish: Behandlingen bør afbrydes hos patienter, som melder om symptomer, der kan tyde på akut urinsyrenefropati, herunder flankesmerter, kvalme eller opkastning, og serumkreatinin skal straks måles.
English: Inhibitors of microsomal Epoxide Hydrolase (mEH) (e.g. valproic acid, valpromide) may interfere with the metabolism of lesinurad.
Danish: Hæmmere af mikrosomal epoxidhydrolase (mEH) (fx valproinsyre, valpromid) kan interferere med metaboliseringen af lesinurad.
English: Driving and using machines Zurampic is not expected to affect you being able to drive a car or use any tools or machines.
Danish: Trafik- og arbejdssikkerhed Zurampic forventes ikke at påvirke din evne til at køre bil eller bruge værktøj eller maskiner.
English: In interaction studies conducted in healthy subjects with Zurampic and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine.
Danish: I interaktionsstudier udført hos raske forsøgspersoner med Zurampic og CYP3A-substrater reducerede lesinurad plasmakoncentrationen af sildenafil og amlodipin.
English: Continuous treatment with Zurampic decreases the frequency of gout flares.
Danish: Kontinuerlig behandling med Zurampic mindsker hyppigheden af udbrud af urinsyregigt.
English: All studies were of 12 months duration and patients received prophylaxis for gout flares with colchicine or NSAIDs during the first 5 months of lesinurad treatment.
Danish: Alle studier var af 12 måneders varighed, og patienterne fik profylakse mod udbrud af urinsyregigt med colchicin eller NSAID i de første 5 måneder med lesinurad.
English: Within 7 days following single dosing of radiolabelled lesinurad, 63% of administered radioactive dose was recovered in urine and 32% of administered radioactive dose was recovered in faeces.
Danish: Inden for 7 dage efter en enkelt dosis radioaktivt mærket lesinurad blev 63 % af den administrerede radioaktive dosis genfundet i urin og 32 % i fæces.
English: If you stop taking your xanthine oxidase inhibitor medicine, you must also stop taking Zurampic.
Danish: Hvis du stopper med at tage din xanthinoxidasehæmmer, skal du også stoppe med at tage Zurampic.
English: Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with Zurampic.
Danish: Derfor anbefales det, at patienterne monitoreres for nedsat effekt af CYP2B6-substrater (fx bupropion, efavirenz) ved administration sammen med Zurampic.
English: There is no clinical experience in patients with severe (Child-Pugh class C) hepatic impairment.
Danish: Der er ingen klinisk erfaring hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zurampic in all subsets of the paediatric population for the treatment and prevention of hyperuricaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Zurampic i alle undergrupper af den pædiatriske population ved behandling og forebyggelse af hyperurikæmi (se pkt.
English: In an interaction study conducted in healthy subjects with multiple doses of Zurampic 400 mg and single dose warfarin (25 mg), lesinurad led to a decrease in exposure of R-warfarin (the less active enantiomer) and had no effect on the exposure of S-warfarin (the more active enantiomer).
Danish: I et interaktionsstudie udført hos raske forsøgspersoner, der fik multiple doser Zurampic 400 mg og en enkelt dosis warfarin (25 mg), medførte lesinurad et fald i eksponeringen for R-warfarin (den mindst aktive enantiomer) og havde ingen indvirkning på eksponeringen for S-warfarin (den mest aktive enantiomer).
English: Excipient with known effect: Each tablet contains 52.92 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: En tablet indeholder 52,92 mg lactose (som monohydrat).