FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary end-point in patients with renal impairment Consistent with the overall population, the proportion of patients with mild to moderate renal impairment (eCrCL 30-89 mL/min) who achieved target serum uric acid levels at Month 6 was 56% for lesinurad 200 mg versus 29% for placebo when added to allopurinol at doses ranging from 200 mg to 900 mg.
Danish: Primært endepunkt hos patienter med nedsat nyrefunktion I overensstemmelse med den samlede population var andelen af patienter med let til moderat nedsat nyrefunktionen (eCrCL 30-89 ml/min), som opnåede det tilsigtede serumurinsyreniveau efter måned 6, 56 % for lesinurad 200 mg versus 29 % for placebo, ved administration af allopurinol i doser fra 200 mg til 900 mg.
English: Furuncle
Danish: Furunkel
English: Testing for the target serum uric acid level can be performed after 4 weeks to consider treatment adjustment to target serum uric acid level.Gout flare prophylaxis needs to be considered (see section 4.4).
Danish: Test af serumurinsyreniveauet kan udføres efter 4 uger for at vurdere behandlingsjustering til det tilstræbte serumurinsyreniveau.
English: In these studies, kidney stone adverse reactions (nephrolithiasis being the most frequent) were reported in patients treated with lesinurad 200 mg (0.5%) and placebo (1.2%).
Danish: I disse studier blev nyrestensbivirkninger (med nefrolithiasis som den hyppigste) rapporteret hos 0,5 % af patienterne, der blev behandlet med lesinurad 200 mg og hos 1,2 % af patienterne, der fik placebo.
English: The signs may include: Uncommon - may affect up to 1 in 100 people - pain in your side (below your ribs and above your hipbone), - feeling sick (nausea), - being sick (vomiting), - changes in urination or difficulty urinating, - feeling tired or unwell or loss of appetite.
Danish: Ikke almindelig - kan forekomme hos op til 1 ud af 100 personer - smerter i siden (under dine ribben og over dit hofteben), - kvalme, - opkastning, - ændringer i vandladning eller besvær med at lade vandet, - træthed, utilpashed eller appetitløshed.
English: Additional signs to look for include: o ulcers of the mouth, throat, nose, genitals, conjunctivitis (red and swollen eyes) o widespread blisters or peeling of the skin o flu-like symptoms Very rare - may affect up to 1 in 10,000 people - swelling of the lips, tongue, face, throat, difficulty swallowing or breathing or red-raised itchy skin/hives (angioedema) - Duzallo may affect your blood, which can cause bruising more easily than usual, or you may get a sore throat or other signs of an infection.
Danish: Andre tegn, som du bør være opmærksom på, er: o sår i munden, svælget, næsen, kønsorganerne samt bindehindekatar (røde og hævede øjne) o udbredt forekomst af vabler og afskallende hud o influenza-lignende symptomer Meget sjælden - kan forekomme hos op til 1 ud af 10.000 personer - hævelse af læber, tunge, ansigt og svælg, synkebesvær, vejrtrækningsbesvær, kløende, rød og hævet hud/nældefeber (angioødem) - Duzallo kan påvirke dit blod, så du får blå mærker oftere end sædvanligt, eller du kan få ondt i halsen eller andre tegn på en infektion.
English: Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9.
Danish: Lesinurads eksponering øges, når det administreres sammen med CYP2C9-hæmmere.
English: Hormonal contraception (this includes oral, injectable, transdermal, and implantable forms) might not be reliable when taking Duzallo at the same time.
Danish: Hormonelle præventionsmidler, herunder orale, injicerbare, transdermale og implanterbare former, er muligvis ikke pålidelige, når de anvendes samtidigt med Duzallo.
English: Female patients of childbearing potential should not rely on hormonal contraception alone (including oral, injectable, transdermal, and implantable forms) when taking Duzallo (see sections 4.4 and 4.5).
Danish: Fertile kvindelige patienter bør ikke stole på hormonal antikonception alene (herunder orale, injicerbare, transdermale og implanterbare former), når de tager Duzallo (se pkt.
English: Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production.
Danish: Farmakoterapeutisk klassifikation: Midler mod artritis urica, midler der hæmmer urinsyreproduktionen.
English: Months 4, 5, 6 48 (12%)
Danish: 4.5 og 4.8).
English: Clinical outcomes - renal events
Danish: Kliniske resultater - nyrerelaterede bivirkninger
English: For allopurinol, undesirable effects may vary in their incidence depending on the dose received and also when given in combination with other medicinal products.
Danish: For allopurinol kan bivirkninger variere i forekomst alt efter den administrerede dosis.
English: The other ingredients are: - tablet core: hydroxypropylcellulose, microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate - film-coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), iron oxide red (E172)
Danish: crospovidon, magnesiumstearat - filmovertræk: hypromellose, titandioxid (E171), triacetin, jernoxid gul (E172), jernoxid rød
English: Duzallo and all additional doses of allopurinol should be discontinued immediately at the first appearance of allopurinol-induced skin rash or other signs which may indicate an allergic reaction and additional medical care should be provided as needed.
Danish: Ved første tegn på allopurinol-induceret hududslæt eller andre tegn, der kan tyde på en allergisk reaktion, skal Duzallo og alle supplerende doser af allopurinol øjeblikkeligt seponeres og patienten skal have relevant lægebehandling efter behov.
English: Metabolites are not known to contribute to the uric acid lowering effects of lesinurad.
Danish: Så vidt vides, bidrager metabolitterne ikke til lesinurads urinsyresænkende effekt.
English: Patients who are known or suspected to be CYP2C9 poor metabolisers based on previous history or experience with other CYP2C9 substrates should use Duzallo with caution (see section 4.4).
Danish: Duzallo skal anvendes med forsigtighed hos patienter, der vides eller formodes at være dårlige omsættere af CYP2C9, baseret på tidligere historik eller erfaring med andre CYP2C9-substrater (se pkt.
English: Rash and skin symptoms
Danish: Udslæt og hudsymptomer
English: Duzallo is contraindicated in patients with severe renal impairment (CrCL less than 30 ml/min), with end-stage renal disease, in patients on dialysis or in kidney transplant recipients (see sections 4.3 and 4.4).
Danish: Duzallo er kontraindiceret hos patienter med svært nedsat nyrefunktion (CrCL < 30 ml/min), med nyresygdom i terminalstadiet, hos patienter i dialyse eller hos nyretransplanterede patienter (se pkt.
English: Duzallo 300 mg / 200 mg tablets are available in blister packs of 10, 30 and 100 tablets.
Danish: Duzallo 300 mg / 200 mg tabletter fås i blisterpakninger med 10, 30 og 100 tabletter.
English: Duzallo 200 mg / 200 mg tablets are available in blister packs of 10, 30 and 100 tablets.
Danish: Duzallo 200 mg / 200 mg tabletter fås i blisterpakninger med 10, 30 og 100 tabletter.
English: In male and female rats, there was no effect on mating or fertility with lesinurad.
Danish: Hos han- og hunrotter havde lesinurad ingen indvirkning på parring og fertilitet.
English: Grünenthal Norway AS C.J. Hambros Plass 2C 0164 Oslo
Danish: Grünenthal Norway AS C.J. Hambros Plass 2C N-0164 Oslo Tlf: + 47 22996054
English: Tel.: +49-241-569-0
Danish: Tlf.: + 49-241-569-0
English: Uncommon - may affect up to 1 in 100 people - kidney stones, - kidney stop working properly, - skin reactions, including redness, itchy skin, lumpy rash (hives) and skin rash on exposure to sunshine, - dehydration (loss of too much fluid from your body), - feeling sick (nausea) or being sick (vomiting), - diarrhoea, - abnormal liver tests.
Danish: Ikke almindelig - kan forekomme hos op til 1 ud af 100 personer - nyresten, - nyreproblemer, - hudreaktioner, herunder rødme, kløende hud, udslæt med hævelse (nældefeber) og hududslæt ved udsættelse for solskin, - dehydrering (tab af for meget væske fra kroppen).
English: How to take Duzallo
Danish: Sådan skal du tage Duzallo
English: Very rare - may affect up to 1 in 10,000 people - chest pain, slow heartbeat, high blood pressure or a slow pulse, - vomiting blood (recurrent hematemesis), presence of excess fat in the stool (steatorrhea), - inflammation of the mucous membranes of the mouth (stomatitis), changed stool frequency (changed bowel motions), - hair loss or discoloration, - abnormal glucose metabolism (diabetes; your doctor may wish to measure the level of sugar in your blood to check if this is happening), - high levels of cholesterol in your blood (hyperlipidaemia), - depression, - coma, - weakness, numbness, unsteadiness on your feet, unable to move muscles (paralysis) or loss of consciousness, - not able to control muscle movements (ataxia), - sensation of tingling, tickling, pricking or burning of skin (paraesthesia), - headache, dizziness, drowsiness or disturbance of your vision, - cloudiness of the eye (cataract), - a change in taste, - blood in your urine (haematuria), - male infertility or erectile dysfunction, - enlargement of the breasts, in men as well as in women, - build-up of fluid leading to swelling (oedema) particularly of your ankles, - muscle aches, - painful skin boil, - damage to the nerves which can cause numbness, pain and weakness.
Danish: Meget sjælden - kan forekomme hos op til 1 ud af 10.000 personer - smerter i brystet, langsom hjerterytme, højt blodtryk eller langsom puls, - blodigt opkast (tilbagevendende hæmatemese), for meget fedt i afføringen (steatorré), - betændelse i mundslimhinden (stomatitis), ændret afføringsmønster (ændrede tarmbevægelser), - hårtab eller ændret hårfarve, - unormal glucoseomsætning (diabetes; lægen vil måske måle sukkerniveauet i blodet for at kontrollere for dette), - høje kolesterolniveauer i blodet (hyperlipidæmi), - depression, - koma, - svækkelse, følelsesløshed, usikker balance, manglende evne til at bevæge muskler (paralyse)
English: Consistent serum uric acid lowering was observed in patients who were receiving thiazide diuretics in the placebo-controlled clinical studies in combination with allopurinol.
Danish: Kliniske resultater - samtidig anvendelse af thiazider Der blev observeret konsistent reduktion i serumurinsyre hos patienter, som fik thiaziddiuretika i kombination med allopurinol i de placebokontrollerede kliniske studier.
English: with lesinurad in combination with allopurinol - Pooled data from CLEAR1 and CLEAR2 studies
Danish: Andelen af patienter, som nåede det ønskede målniveau for serumurinsyre (< 6 mg/dl) med lesinurad i kombination med allopurinol - Puljede data fra CLEAR1- og CLEAR2-studier
English: The signs may include: Uncommon - may affect less than 1 in 100 people - flaking skin, boils or sore lips and mouth - very rarely signs may include sudden wheeziness, fluttering or tightness in the chest and collapse.
Danish: Symptomerne kan omfatte: Ikke almindelig - kan forekomme hos op til 1 ud af 100 personer - afskallende hud, bylder eller ømhed i læber og mund.
English: In the randomised, double-blind, placebo-controlled combination therapy clinical studies, the incidences of patients with adjudicated Major Adverse Cardiovascular Events (MACE; cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) per 100 patient-years of exposure were 0.60 (95% confidence interval (C.I.)
Danish: I de randomiserede, dobbeltblindede, placebokontrollerede, kliniske studier med kombinationsbehandling var forekomsten af patienter med vurderede alvorlige kardiovaskulære bivirkninger (kardiovaskulær død, ikke-fatalt myokardieinfarkt eller ikke-fatal apopleksi) pr. 100 patienteksponeringsår 0,60 (95 %-KI 0,15; 2,41) for placebo og 0,61 (95 % KI 0,15; 2,43) for lesinurad 200 mg ved kombination med allopurinol (CLEAR1 og CLEAR2).
English: Concurrent use of allopurinol and ACE inhibitors may lead to an increased risk of hypersensitivity, especially if there is pre-existing renal impairment.
Danish: Hæmmere af angiotensinkonverterende enzym (ACE-hæmmere) Samtidig anvendelse af allopurinol og ACE-hæmmere kan give øget risiko for overfølsomhed, især hos patienter med nedsat nyrefunktion.
English: Each Duzallo 300 mg / 200 mg film-coated tablet contains 300 mg of allopurinol and 200 mg of lesinurad.
Danish: Hver Duzallo 300 mg / 200 mg filmovertrukket tablet indeholder 300 mg allopurinol og 200 mg lesinurad.
English: Each Duzallo 200 mg / 200 mg film-coated tablet contains 200 mg of allopurinol and 200 mg of lesinurad.
Danish: Hver Duzallo 200 mg / 200 mg filmovertrukket tablet indeholder 200 mg allopurinol og 200 mg lesinurad.
English: Time from Baseline in Months placebo (4.2%), resulting in discontinuation of treatment in 1.0% for both treatment setups (see section
Danish: Der blev rapporteret nyrerelaterede bivirkninger hos 4,9 % af patienterne, der blev behandlet med lesinurad 200 mg sammenlignet med 4,2 % af placebopatienterne, hvilket resulterede i seponering af behandlingen hos 1,0 % for begge behandlingstyper (se pkt.
English: What Duzallo looks like and contents of the pack Duzallo 300 mg/200 mg film-coated tablets are orange and slightly brownish oblong tablets and engraved with “LES200” and “ALO300” on one side.
Danish: Duzallo 300 mg/200 mg filmovertrukne tabletter er orange og let brunlige, aflange tabletter og er mærket med “LES200” og “ALO300” på den ene side.
English: Based on literature and following ingestion of one single dose of 20 g allopurinol symptoms such as nausea, vomiting, diarrhoea and dizziness occurred in one patient.
Danish: Der er rapporteret om symptomer såsom kvalme, opkastning, diarré og svimmelhed hos en patient, der indtog 20 g allopurinol, jf. også litteraturen.
English: Duzallo contains lactose
Danish: Duzallo indeholder lactose
English: Evidence suggests that the plasma half-life of adenine arabinoside is increased in the presence of allopurinol and hence when these two active substances are administered concomitantly, extra vigilance is required to recognize enhanced toxic effects.
Danish: Når disse to aktive stoffer administreres samtidigt, er det derfor nødvendigt med særlig opmærksomhed for at identificere en stigning i toksiske virkninger.
English: What Duzallo looks like and contents of the pack Duzallo 200 mg/200 mg film-coated tablets are pale pink oblong tablets and engraved with “LES200” and “ALO200” on one side.
Danish: Duzallo 200 mg/200 mg filmovertrukne tabletter er svagt lyserøde, aflange tabletter og er mærket med “LES200” og “ALO200” på den ene side.
English: Hepatic impairment
Danish: Unormale leverfunktionstests Hepatitis
English: particularly in individuals with impaired renal and/or hepatic function ** Photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria.
Danish: Undersøgelser Forhøjet thyroid stimulerende hormon i blodet****, forhøjet kreatinin i blodet * Der er i meget sjældne tilfælde rapporteret om thrombocytopeni, agranulocytose og aplastisk anæmi, især hos patienter med nedsat nyre- og/eller leverfunktion ** Fotodermatitis, fotosensibilitetsreaktion, allergisk dermatitis, pruritus og urticaria.
English: Treatment Group:
Danish: Hjælpestof, som behandleren skal være opmærksom på:
English: Lesinurad when added to allopurinol caused a reduction of the mean serum uric acid levels, as compared to placebo, which was sustained in the long term in those patients who continued treatment (see Figure 1).
Danish: Da lesinurad blev tilføjet til allopurinol, medførte det en reduktion af det gennemsnitlige serumurinsyreniveau, sammenlignet med placebo.
English: If aluminium hydroxide is taken concomitantly, allopurinol-containing medicinal products may have an attenuated effect.
Danish: Effekten af lægemidler som indeholder allopurinol kan mindskes ved samtidig administration af aluminiumhydroxid.
English: - medicines to treat AIDS/HIV e.g. didanosine, efavirenz - chlorpropamide, used for the treatment of diabetes - theophylline, used for the treatment of breathing problems - medicines used to reduce your immune response (immunosuppressants) e.g. ciclosporin,
Danish: - medicin til behandling af forhøjet kolesterol, f.eks. simvastatin - fluconazol - til behandling af svampeinfektioner - amiodaron - til behandling af problemer med hjerterytmen - valproinsyre, valpromid, phenytoin eller carbamazepin - til forebyggelse af krampeanfald,
English: What you need to know before you take Duzallo 3.
Danish: Det skal du vide, før du begynder at tage Duzallo Sådan skal du tage Duzallo Bivirkninger
English: azathioprine - vidarabine, used to treat herpes or chickenpox - cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents, mercaptopurine), used to treat cancer or rheumatic diseases - aluminium hydroxide, used to treat heartburn and acid indigestion (you should leave an interval of at least 3 hours between taking the two medicines)
Danish: - cytostatika (f.eks. cyclophosphamid, doxorubicin, bleomycin, procarbazin, alkylerende stoffer, mercaptopurin) - til behandling af cancer eller rheumatiske sygdomme.
English: Duzallo 200 mg/200 mg film-coated tablets
Danish: Duzallo 200 mg/200 mg filmovertrukne tabletter
English: Gout flare prophylaxis needs to be considered (see section 4.2).
Danish: Det er nødvendigt at tage profylakse mod udbrud af urinsyregigt i betragtning (se pkt.
English: Duzallo 300 mg/200 mg film-coated tablets
Danish: Duzallo 300 mg/200 mg filmovertrukne tabletter
English: Duzallo is not recommended during breastfeeding.
Danish: Behandling med Duzallo frarådes under amning.
English: Your doctor will check how well your kidneys are working before starting with Duzallo and during the Duzallo treatment.
Danish: Før og under behandlingen med Duzallo vil lægen undersøge, hvor godt dine nyrer virker.
English: Over time, your gout attacks will occur less often if you keep taking Duzallo as advised by your doctor.
Danish: Hvis du bliver ved med at tage Duzallo, sådan som lægen har forklaret dig, vil dine anfald af urinsyregigt med tiden komme sjældnere.
English: Duzallo contains lactose.
Danish: Duzallo indeholder lactose.
English: Classification
Danish: Opbevaring
English: Each film-coated tablet contains 200 mg allopurinol and 200 mg lesinurad
Danish: Én filmovertrukket tablet indeholder 200 mg allopurinol og 200 mg lesinurad
English: Acute gouty attacks (gout flares)
Danish: Akut anfald af urinsyregigt (udbrud af urinsyregigt)
English: Each film-coated tablet contains 300 mg allopurinol and 200 mg lesinurad
Danish: Én filmovertrukket tablet indeholder 300 mg allopurinol og 200 mg lesinurad
English: Adverse reactions related to renal function can occur after initiating Duzallo (see section 4.8)
Danish: Efter start på behandling med Duzallo kan der opstå bivirkninger, som er forbundet med nyrefunktionen (se pkt.
English: Renal failure***, renal impairment, nephrolithiasis
Danish: Nyresvigt***, nedsat nyrefunktion, nyresten
English: - you have thyroid disorders
Danish: - hvis du har sygdomme i skjoldbruskkirtlen.
English: Each film-coated tablet contains 200 mg of allopurinol and 200 mg of lesinurad.
Danish: En filmovertrukket tablet indeholder 200 mg allopurinol og 200 mg lesinurad.
English: Each film-coated tablet contains 300 mg of allopurinol and 200 mg of lesinurad.
Danish: En filmovertrukket tablet indeholder 300 mg allopurinol og 200 mg lesinurad.
English: Duzallo 200 mg / 200 mg film-coated tablets allopurinol/lesinurad
Danish: Duzallo 200 mg / 200 mg filmovertrukne tabletter allopurinol/lesinurad
English: - acetylsalicylic acid - to relieve fever and pain at doses above 325 mg per day - medicines to treat high blood pressure such as ACE inhibitors, water tablets (diuretics medicines that increase the passing of urine) and calcium channel blockers e.g. amlodipine - medicines to treat high cholesterol levels, e.g. simvastatin - fluconazole - to treat fungal infections - amiodarone - to treat heart rhythm problems - valproic acid, valpromide, phenytoin or carbamazepine - to prevent fits (seizures), mood disorders and prevent migraines - bupropion - for treating depression or to help stop smoking - sildenafil - to treat erectile problems in men - contraceptives - used to prevent pregnancy, including oral contraception (such as ‘the pill'), injections, patches and implants - coumarin anticoagulants - to prevent and treat blood clots - antibiotics like ampicillin or amoxicillin
Danish: eller bevidsthedstab, - ingen kontrol af muskelbevægelser (ataksi), - snurrende, kildrende, prikkende eller brændende fornemmelse i huden (paræstesi), - hovedpine, svimmelhed, døsighed eller synsforstyrrelse, - sløret syn (katarakt), - ændret smagssans, - blod i urinen (hæmaturi), - mandlig infertilitet eller erektil dysfunktion (impotens), - forstørrede bryster, både hos mænd og kvinder, - ophobning af væske, som fører til hævelse (ødem), især i anklerne, - muskelsmerter, - smertefulde bylder på huden, - nerveskader, der kan medføre følelsesløshed, smerter eller svaghed.
English: Duzallo 300 mg / 200 mg film-coated tablets allopurinol/lesinurad
Danish: Duzallo 300 mg/200 mg filmovertrukne tabletter allopurinol/lesinurad
English: Duzallo 300 mg/200 mg film-coated tablets allopurinol/lesinurad
Danish: Duzallo 300 mg / 200 mg filmovertrukne tabletter allopurinol/lesinurad
English: If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital immediately.
Danish: Kontakt straks læge eller nærmeste skadestue, hvis du har taget mere af denne medicin, end du skal.
English: If you take more Duzallo than you should
Danish: Hvis du har taget for meget Duzallo
English: Tablet core
Danish: Tabel 3
English: This summary was last updated in November 2013.
Danish: Dette sammendrag blev sidst ajourført i november 2013.
English: EMA/464656/2009 EMA/V/C/154
Danish: EMA/464656/2009 EMEA/V/C/154
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zolvix on 4 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zolvix den 4. november 2009.
English: The oral solution is given directly on the back of the tongue.
Danish: Den orale opløsning gives direkte bagerst på tungen.
English: A number of laboratory studies and field trials in various countries were performed.
Danish: Der blev gennemført en række laboratorieundersøgelser og feltundersøgelser i flere forskellige lande.
English: The amount to use is calculated based on the weight of the sheep.
Danish: Den nødvendige mængde beregnes på grundlag af fårets vægt.
English: The user must not eat, drink or smoke whilst handling the product and hands and exposed skin should be washed after handling the product.
Danish: Brugeren må hverken spise, drikke eller ryge, mens denne håndterer produktet, og hænder og udsat hud skal vaskes efter håndtering af produktet.
English: Two main studies were carried out, one in Europe and one in New Zealand, in sheep suffering from a range of nematode infections.
Danish: Der blev gennemført to hovedundersøgelser - én i Europa og én i New Zealand - hos får med forskellige nematodeinfektioner.
English: Zolvix is given as a single dose of 2.5 mg per kilogram bodyweight.
Danish: Zolvix gives som en enkeltdosis på 2,5 mg pr. kg kropsvægt.
English: Other information about Zolvix:
Danish: Andre oplysninger om Zolvix:
English: The effectiveness of Zolvix has not been established in sheep weighing less than 10 kg and safety has not been established in sheep weighing less than 10 kg or under two weeks of age.
Danish: Virkningen af Zolvix er endnu ikke fastlagt for får på under 10 kg, og sikkerheden er ikke fastlagt for får, som enten vejer under 10 kg eller er under to uger gamle.
English: Zolvix is available as an oral solution (25 mg/ml).
Danish: Det fås som en oral opløsning (25 mg/ml).
English: The withdrawal period for sheep for meat and offal is seven days.
Danish: Tilbageholdelsestiden for fårekød ogslagteaffald er syv dage.
English: Zolvix is a medicine that contains the active substance monepantel.
Danish: Zolvix er et lægemiddel, der indeholder det aktive stof monepantel.