FrancophonIA/ELRC3.0 huggingface dataset:
English: The elimination half-life (t½) of lesinurad was approximately 5 hours following a single dose.
Danish: Eliminationshalveringstiden (T½) for lesinurad var ca. 5 timer efter en enkelt dosis.
English: In another patient the intake of 22.5 g allopurinol caused no adverse reactions.
Danish: Hos en anden patient gav et indtag på 22,5 g allopurinol ingen bivirkninger.
English: Therefore effective inhibition of xanthine oxidase is maintained over a 24 hour period with a single daily dose of allopurinol.
Danish: Derfor opretholdes en effektiv hæmning af xanthinoxidase over en 24-timers periode med en enkelt daglig dosis af allopurinol.
English: Oxypurinol AUC and Cmax was not affected by food.
Danish: Oxypurinols AUC og Cmax blev ikke påvirket af føde.
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 farmakokinetisk populationsanalyse har alder, køn, race og etnicitet ingen klinisk betydningsfuld indvirkning på lesinurads farmakokinetik.
English: The safety and efficacy of Duzallo in children and adolescents under 18 years of age have not yet been established.
Danish: Sikkerhed og virkning af Duzallo hos børn og unge under 18 år er endnu ikke klarlagt.
English: Table 1 Adverse reactions by System Organ Class and frequency
Danish: Tabel 1Bivirkninger efter systemorganklasse og hyppighed
English: Hypromellose Titanium dioxide (E171) Triacetin
Danish: Hypromellose Titandioxid (E171) Triacetin
English: Duzallo may cause serious kidney problems (see section 4).
Danish: Duzallo kan forårsage alvorlige nyreproblemer (se afsnit 4).
English: If concomitant use is unavoidable, a dose reduction of didanosine may be required, and patients should be closely monitored.
Danish: Hvis samtidig anvendelse ikke kan undgås, kan det være nødvendigt at nedsætte dosis af didanosin, og patienterne skal monitoreres nøje.
English: **** The occurrence of increased thyroid stimulating hormone (TSH) in the relevant studies did not report any impact on free T4 levels or had TSH levels indicative of subclinical hypothyroidism.
Danish: **** Ved øget thyroid stimulerende hormon (TSH) i de pågældende studier, blev der ikke rapporteret om nogen indvirkning på frit T4, ligesom TSH-niveauet ikke tydede på subklinisk hypothyroidisme.
English: Hypersensitivity*
Danish: Overfølsomhed**
English: Your doctor may give you other medicines to help prevent or treat the symptoms of gout attacks.
Danish: Din læge kan give dig anden medicin til at forebygge eller behandle symptomer på anfald af urinsyregigt.
English: A specific antidote is unknown.
Danish: Der kendes ingen specifik modgift.
English: This is because Duzallo can affect the way some other medicines work.
Danish: Dette skyldes, at Duzallo kan påvirke den måde, hvorpå anden medicin virker.
English: Allopurinol can increase the plasma concentration of ciclosporin when concomitantly administered.
Danish: Allopurinol kan øge plasmakoncentrationen af ciclosporin ved samtidig administration.
English: Vidarabine (Adenine Arabinoside)
Danish: Vidarabin (adeninarabinosid)
English: These effects usually occur in people with liver or kidney problems (agranulocytosis).
Danish: Disse bivirkninger forekommer normalt hos personer med lever- eller nyreproblemer (agranulocytose).
English: Data from long-term extension studies until 52 months revealed a renal safety profile consistent with that observed in the placebo-controlled studies.
Danish: Data fra de langvarige udvidelsesstudier i op til 52 måneder afslørede en renal sikkerhedsprofil, der var i overensstemmelse med den, der blev observeret i de placebokontrollerede studier.
English: The rash may cover large parts of the body with blistering and peeling of the skin.
Danish: Udslættet kan dække store dele af kroppen med blærer og afskalning af huden.
English: • people who have problems with their kidneys and take this medicine and a diuretic (a medicine that increases urine) at the same time
Danish: • personer, der har problemer med nyrerne, og som tager denne medicin og et vanddrivende lægemiddel (et lægemiddel, der øger urinen) på samme tid.
English: Children and adolescents Duzallo is not recommended for use in children and adolescents below 18 years of age.
Danish: Børn og unge Duzallo anbefales ikke til børn og unge under 18 år.
English: If this happens, keep taking Duzallo and talk to your doctor or pharmacist.
Danish: Hvis dette sker, skal du blive ved med at tage Duzallo og tale med din læge eller apotekspersonalet.
English: Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions.
Danish: Kortikosteroider kan være gavnlige til at lindre overfølsomhedsreaktioner i huden.
English: If an overdose is suspected, patients should be managed by symptomatic and supportive care including adequate hydration.
Danish: Ved mistanke om overdosering skal patienten behandles symptomatisk og understøttende, herunder med tilstrækkelig hydrering.
English: In vitro and in vivo studies conducted to date showed no evidence of mutagenic or carcinogenic potential.
Danish: Hidtil gennemførte in vitro- og in vivo-studier har ikke vist evidens for mutagent eller carcinogent potentiale.
English: Serum concentrations of 6-mercaptopurine and azathioprine can reach toxic levels unless dose reduction is undertaken.
Danish: Serumkoncentrationer af 6-mercaptopurin og azathioprin kan nå toksiske niveauer, medmindre dosis reduceres.
English: Some people may have more gout attacks (sudden or severe pain and swelling in a joint, also called a gout flare) when they start using Duzallo and during the first weeks or months of treatment.
Danish: Nogle mennesker kan få flere anfald af urinsyregigt (pludselige eller voldsomme smerter og hævelse i et led, også kaldet et udbrud af urinsyregigt), når de begynder at bruge Duzallo og under de første uger eller måneder af behandlingen.
English: HLA-B*5801 allele
Danish: HLA-B*5801-allel
English: If you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
Danish: Hvis du får udslæt eller nogen af disse hudsymptomer, skal du stoppe med at tage denne medicin og kontakte lægen med det samme.
English: As a precautionary measure, it is preferable to avoid the use of Duzallo during pregnancy.
Danish: Som forholdsregel anbefales det at undgå anvendelse af Duzallo under graviditet.
English: The effect of lesinurad and allopurinol on fertility in humans has not been studied.
Danish: Lesinurads og allopurinols indvirkning på fertiliteten hos mennesker er ikke undersøgt.
English: Allopurinol is negligibly bound by plasma proteins and therefore variations in protein binding are not thought to significantly alter clearance.
Danish: Allopurinol bindes ubetydeligt af plasmaproteiner, og derfor anses variationer i proteinbinding ikke for at ændre clearance signifikant.
English: Other organs may also be affected (e.g. liver, lungs, kidneys, pancreas, myocardium, and colon).
Danish: Andre organer kan også blive påvirket (f.eks. lever, lunger, nyrer, pancreas, myokardium og kolon).
English: The apparent volume of distribution of allopurinol is approximately 1.6 litre/kg which, suggests relatively extensive uptake by tissues.
Danish: Det tilsyneladende fordelingsvolumen for allopurinol er ca. 1,6 l/kg og antyder et relativt stort optag i væv.
English: These serious skin rashes often come after flu-like symptoms such as fever, headache, body ache.
Danish: Disse alvorlige hududslæt kommer ofte efter influenzalignende symptomer, f.eks. feber, hovedpine, smerter i kroppen.
English: Oxypurinol is eliminated unchanged in the urine but has a long elimination half-life because it undergoes tubular reabsorption.
Danish: Oxypurinol elimineres uændret i urinen, men har en lang eliminationshalveringstid, fordi det undergår tubulær reabsorption.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Duzallo if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Duzallo:
English: Agranulocytosis*, aplastic anaemia*, thrombocytopenia*
Danish: Agranulocytose*, aplastisk anæmi*, thrombocytopeni*
English: Hence, medicinal products with known non-selective uricosuric activity such as probenecid or large doses of salicylates may accelerate the excretion of oxypurinol.
Danish: Derfor kan lægemidler med kendt ikke-selektiv urikosurisk aktivitet, f.eks. probenecid, eller høje doser salicylater fremskynde udskillelsen af oxypurinol.
English: In transplant patients frequent measurement of ciclosporin levels and, if necessary, ciclosporin dosage adjustment is required, particularly during the introduction or withdrawal of Duzallo.
Danish: Der kræves hyppig måling af ciclosporin-niveauet hos transplanterede patienter og om nødvendigt dosisjustering af ciclosporin, især ved start eller seponering af Duzallo.
English: Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN is required and the patient should be informed of the need to stop treatment immediately at the first appearance of symptoms.
Danish: Der skal udvises særlig opmærksomhed for tegn på overfølsomhedssyndrom eller SJS/TEN og patienten bør informeres om, at behandlingen skal stoppes straks i tilfælde af symptomer.
English: Hypersensitivity If you have a hypersensitivity (allergic) reaction, stop taking Duzallo and see a doctor immediately.
Danish: Overfølsomhed Hvis får en overfølsomhedsreaktion (allergisk reaktion), skal du stoppe med at tage Duzallo og straks gå til lægen.
English: Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with lesinurad.
Danish: Derfor anbefales det, at patienter overvåges for reduceret virkning af CYP2B6-substrater (f.eks. bupropion, efavirenz) ved samtidig administration med lesinurad.
English: Mean plasma-to-blood ratios of lesinurad AUC and Cmax were approximately 1.8, indicating that it did not penetrate or partition extensively into red blood cells.
Danish: De gennemsnitlige plasma:blod-ratioer for lesinurad-AUC og -Cmax var ca. 1,8, hvilket indikerer, at det ikke penetrerede eller fordeltes til de røde blodlegemer i udstrakt grad.
English: Opaque (PVC/PVdC/Aluminium) blister.
Danish: Uigennemsigtig blister (PVC/PVdC/aluminium).
English: This is approximately the concentration which would be achieved by doses of 600 mg/day in those with normal renal function.
Danish: Dette er omtrent den koncentration, som kunne opnås ved doser på 600 mg/dag hos patienter med normal nyrefunktion.
English: Your doctor may stop Duzallo if your blood tests show changes in how your kidneys are working or if you have symptoms of kidney problems.
Danish: Lægen kan overveje at stoppe behandlingen med Duzallo, hvis dine blodprøver viser ændringer i, hvordan dine nyrer virker, eller hvis du får symptomer på nyreproblemer.
English: Duzallo tablets contain lactose (a type of sugar).
Danish: Duzallo indeholder lactose (en slags sukker).
English: A causal relationship with lesinurad has not been established.
Danish: En årsagssammenhæng med lesinurad er ikke blevet dokumenteret.
English: Rare - may affect up to 1 in 1000 people - disorder of the liver (hepatitis).
Danish: Sjælden - kan forekomme hos op til 1 ud af 1.000 personer - leversygdom (hepatitis).
English: Duzallo should not be restarted without another explanation for the serum creatinine abnormalities.
Danish: Duzallo må ikke startes igen, medmindre der er en anden forklaring på de abnorme serumkreatininværdier.
English: However, it is recommended that in patients receiving Duzallo which contains the active substance allopurinol an alternative to ampicillin or amoxicillin is used where available.
Danish: Det anbefales dog, at patienter, der får Duzallo, som indeholder det aktive stof allopurinol, anvender et alternativ til ampicillin eller amoxicillin, hvis det er muligt.
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 mikromol/l).
English: Diabetes mellitus, hyperlipidaemia
Danish: Diabetes mellitus, hyperlipidæmi
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 en mere ekstensiv metabolisering end atropisomer 2, hvorfor atropisomer 1 har lavere plasmaeksponering end atropisomer 2.
English: These serum creatinine elevations generally resolved, most without treatment interruption.
Danish: Disse serumkreatininstigninger fortog sig generelt og for de flestes vedkommende uden behandlingsafbrydelse.
English: In addition, lesinurad is an in vitro inducer of CYP2B6 and CYP3A via constitutive androstane receptor (CAR)/pregnane X receptor (PXR).
Danish: Derudover inducerer lesinurad CYP2B6 og CYP3A via konstitutiv androstanreceptor (CAR)/pregnan-X-receptor (PXR) in vitro.
English: Coma, paralysis, ataxia, neuropathy, paraesthesia, drowsiness/somnolence, dysgeusia
Danish: Koma, paralyse, ataksi, neuropati, paræstesi, døsighed/somnolens, dysgeusi
English: Tumour lysis syndrome or Lesch-Nyhan syndrome.
Danish: Tumorlysesyndrom eller Lesch-Nyhans syndrom.
English: Such patients, taking 300 mg of allopurinol per day will generally have plasma oxypurinol concentrations of 5-10 mg/litre.
Danish: Sådanne patienter, der tager 300 mg allopurinol pr. dag, vil generelt have plasmaoxypurinolkoncentrationer på 5-10 mg/l.
English: You may feel sick or be sick, feel dizzy or have diarrhoea.
Danish: Du kan få kvalme, kaste op, føle dig svimmel eller få diarré.
English: Do not stop taking Duzallo without talking to your doctor first even if you feel better.
Danish: Du må ikke stoppe med at tage Duzallo uden at tale med lægen først.
English: Duzallo should be interrupted if serum creatinine is elevated to more than 2 times the pre-treatment value or in case of an absolute serum creatinine value greater than 4.0 mg/dL.
Danish: Behandling med Duzallo skal afbrydes, hvis serumkreatinin stiger til mere end 2 gange værdien før behandling eller i tilfælde af absolut serumkreatininværdi > 4,0 mg/dl.
English: Chlorpropamide
Danish: Chlorpropamid
English: Haematuria, azotemia
Danish: Hæmaturi, azotæmi
English: The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol related hypersensitivity syndrome and SJS/TEN.
Danish: HLA-B*5801-allelen har vist sig at være associeret med en risiko for at udvikle allopurinolrelateret overfølsomhedssyndrom og SJS/TEN.
English: Duzallo in inadequate responders
Danish: Duzallo hos patienter med utilstrækkeligt respons
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption bør ikke anvende dette lægemiddel.
English: Continuous treatment with Duzallo decreases the frequency of gout flares.
Danish: Kontinuerlig behandling med Duzallo mindsker hyppigheden af udbrud af urinsyregigt.
English: Renal function should be evaluated prior to initiation of Duzallo 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 medicinal products.
Danish: Nyrefunktionen skal måles inden start med Duzallo og monitoreres regelmæssigt derefter (f.eks. 4 gange om året), baseret på kliniske overvejelser, såsom baseline-nyrefunktion, hypovolæmi, samtidig sygdom eller anden samtidig medicin.
English: Clinical outcomes - cardiovascular safety
Danish: Kliniske resultater - kardiovaskulær sikkerhed
English: In clinical trials, most adverse reactions were mild or moderate in intensity and resolved while continuing lesinurad therapy.
Danish: I kliniske forsøg var de fleste bivirkninger lette eller moderate i intensitet og forsvandt ved fortsat behandling med lesinurad.
English: Duzallo has not been studied in patients with severe hepatic impairment; therefore, no dose recommendations can be given for Duzallo.
Danish: Duzallo er ikke undersøgt hos patienter med svært nedsat leverfunktion; derfor kan der ikke gives dosisanbefalinger for Duzallo.
English: The safety of lesinurad 200 mg was evaluated in the Phase 3 combination therapy clinical trials (including extension studies).
Danish: Sikkerheden af lesinurad 200 mg blev evalueret i kliniske fase-3 studier (herunder udvidede studier) med kombinationsbehandling.
English: In animal studies, long-term use of high allopurinol doses resulted in formation of xanthine precipitates, which led to changes in the urinary tract.
Danish: I dyrestudier resulterede langtidsbrug af høje doser af allopurinol i dannelse af xanthinpræcipitater, som førte til ændringer i urinvejene.
English: In addition to the inhibition of purine catabolism in some but not all hyperuricaemic patients, de novo purine biosynthesis is depressed via feedback inhibition of hypoxanthine-guanine phosphoribosyltransferase.
Danish: Ud over hæmning af purinkatabolisme hos nogle, men ikke alle hyperurikæmiske patienter, hæmmes de-novo-purinbiosyntesen via feedback-hæmning af hypoxanthin-guanin phosphoribosyltransferase.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Duzallo 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 Duzallo i alle undergrupper af den pædiatriske population ved behandling og forebyggelse af hyperurikæmi (se pkt.
English: Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN.
Danish: Overfølsomhedsreaktioner overfor allopurinol kan manifestere sig på mange forskellige måder, herunder makulopapulær exanthem, overfølsomhedssyndrom (også kendt som DRESS) og SJS/TEN.
English: Based on interaction studies in healthy subjects or gout patients, lesinurad does not have clinically significant interactions with NSAIDs (naproxen and indomethacin) or colchicine.
Danish: På baggrund af interaktionsstudier hos raske forsøgspersoner eller patienter med urinsyregigt har lesinurad ikke klinisk signifikante interaktioner med NSAID (naproxen og indomethacin) eller colchicin.
English: Based on its mechanism of action, lesinurad may not be effective in these patients (see section
Danish: Baseret på lesinurads virkningsmekanisme er det ikke nødvendigvis effektivt hos disse patienter (se pkt.
English: Hypersensitivity reactions may present themselves as fever, skin reactions, chills and arthralgia.
Danish: Overfølsomhedsreaktioner kan vise sig som feber, hudreaktioner, kulderystelser og arthralgi.
English: This is also the maximum daily dose of Duzallo (see section 4.4).
Danish: Dette er også den maksimale, daglige dosis (se pkt.
English: If Duzallo which contains the active substance allopurinol is given concomitantly with chlorpropamide when renal function is poor, there may be an increased risk of prolonged hypoglycaemic activity.
Danish: Hvis Duzallo, som indeholder det aktive stof allopurinol, administreres samtidigt med chlorpropamid ved dårlig nyrefunktion, kan der være en øget risiko for forlænget hypoglykæmisk aktivitet.
English: Approximately 20% of the ingested allopurinol is excreted in the faeces.
Danish: Ca. 20 % af den indtagne allopurinol udskilles i fæces.
English: Patients with normal renal function will gradually accumulate oxypurinol until a steadystate plasma oxypurinol concentration is reached.
Danish: Patienter med normal nyrefunktion vil gradvist akkumulere oxypurinol, indtil steady-state plasmakoncentrationen af oxypurinol er nået.
English: 6-mercaptopurine and azathioprine
Danish: 6-mercaptopurin og azathioprin
English: 52078 Aachen
Danish: D-52078 Aachen
English: Patients continued their allopurinol dose and were randomised 1:1:1 to receive lesinurad 200 mg, lesinurad 400 mg, or placebo once daily.
Danish: Patienterne fortsatte deres dosis af allopurinol og blev randomiserede 1:1:1 til at få lesinurad 200 mg, lesinurad 400 mg eller placebo én gang dagligt.
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: Fluconazole, a moderate CYP2C9 inhibitor, increased lesinurad AUC (56%) and Cmax (38%), as well as the amount of lesinurad excreted unchanged in urine.
Danish: Fluconazol, som er en moderat CYP2C9-hæmmer, øgede lesinurad AUC (56 %) og Cmax (38 %), samt den mængde lesinurad, der blev udskilt uomdannet i urinen.
English: In interaction studies conducted in healthy subjects with lesinurad and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine.
Danish: I interaktionsstudier hos raske forsøgspersoner med lesinurad og CYP3A-substrater reducerede lesinurad plasmakoncentrationerne af sildenafil og amlodipin.
English: The possibility of reduced efficacy of concomitant medicinal products that are CYP3A substrates should be considered and their efficacy (e.g. blood pressure and cholesterol levels) should be monitored (see section 4.4).
Danish: Risikoen for nedsat effekt af samtidige lægemidler, der er CYP3A-substrater, bør tages i betragtning, og deres virkning (f.eks. blodtryk og kolesterolniveau) bør monitoreres (se pkt.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Duzallo.
Danish: Hvis noget af ovenstående gælder for dig (eller du er i tvivl), skal du kontakte lægen eller apotekspersonalet, inden du tager Duzallo.
English: Nausea, vomiting and diarrhoea
Danish: Kvalme, opkastning og diarré
English: Also some other medicines can affect the way Duzallo works.
Danish: Anden medicin kan også påvirke den måde, hvorpå Duzallo virker.
English: Allopurinol is rapidly absorbed from the gastrointestinal tract and is reported to have a plasma half-life of about one hour.
Danish: Allopurinol absorberes hurtigt fra mave-tarmkanalen og har ifølge rapporteringen en plasmahalveringstid på ca. en time.
English: Hydroxypropylcellulose Microcrystalline cellulose Lactose monohydrate Crospovidone Magnesium stearate
Danish: Hydroxypropylcellulose Mikrokrystallinsk cellulose Lactosemonohydrat Crospovidon
English: Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with allopurinol (5.8%) in a long term open label extension study.
Danish: Forhøjede TSH-værdier (> 5,5 mikroIE/ml) er observeret hos patienter i langvarig behandling med allopurinol (5,8 %) i et langvarigt, ikke-blindet, forlængelsesstudie.
English: Allopurinol and its metabolite oxypurinol are excreted in human breast milk.
Danish: Allopurinol og dets metabolit oxypurinol udskilles i human modermælk.
English: Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9.
Danish: Derfor anbefales det, at Duzallo anvendes med forsigtighed hos patienter, der tager moderate CYP2C9-hæmmere.
English: Duzallo contains lesinurad and allopurinol, two anti-hyperuricemic active substances with complimentary mechanisms of actions.
Danish: Duzallo indeholder lesinurad og allopurinol, to anti-hyperurikæmiske aktive stoffer med komplementære virkningsmekanismer.
English: Dose titration with allopurinol to an adequate dose must be done before the patient is switched to Duzallo.
Danish: Der skal foretages dosistitrering af allopurinol til en optimal dosis, inden patienten skifter til Duzallo.