natgillin/translations-raw huggingface dataset:
Re-challenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. 
Pri bolnikih s sindromom preobčutljivosti in SJS/TEN zdravila ne smemo ponovno uvesti.
Dose titration with allopurinol to an adequate dose must be done before the patient is switched to Duzallo. 
Alopurinol moramo titrirati do ustreznega odmerka preden uvedemo zdravilo Duzallo.
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). 
Zdravilo Duzallo je kontraindicirano pri bolnikih s hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/min), s končno odpovedjo ledvic, pri bolnikih na dializi ali pri prejemnikih presajene ledvice (glejte poglavji 4.3 in 4.4).
Coma, paralysis, ataxia, neuropathy, paraesthesia, drowsiness/somnolence, dysgeusia 
Bolezni živčevja glavobol koma, paraliza, ataksija, nevropatija, parestezija, zaspanost/somnolenca, motnje okusa
Re-challenge should not be undertaken in patients with SJS/TEN. 
Pri bolnikih s SJS/TEN zdravila ne smemo ponovno uvesti.
Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when Duzallo is co-administered. 
Hormonski kontraceptivi, vključno s peroralnimi, injekcijskimi, transdermalnimi oblikami in vsadki, so med sočasno uporabo z zdravilom Duzallo lahko nezanesljivi.
It is preferable to avoid Duzallo when you are pregnant. 
Bolje se je uporabi zdravila Duzallo med nosečnostjo izogniti.
Serious renal-related adverse reactions, e.g. acute renal failure and renal impairment, were reported in patients treated with placebo (0.2%) and in no patients on lesinurad 200 mg. 
Resne neželene učinke v povezavi z ledvicami, npr. akutno ledvično odpoved in okvaro ledvic so zabeležili pri bolnikih, ki so prejemali placebo (0,2%), ne pa pri bolnikih, ki so prejemali lesinurad 200 mg.
Oxypurinol, the major metabolite of allopurinol and itself therapeutically active, is excreted by the kidney in a similar way to urate. 
Oksipurinol, glavni presnovek alopurinola, ki ima tudi terapevtski učinek, se izloča preko ledvic, podobno kot se izloča urat.
Duzallo contains the active ingredients allopurinol and lesinurad. 
Zdravilo Duzallo vsebuje učinkovini alopurinol in lesinurad.
Adequate therapy with allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter. 
Ustrezno zdravljenje z alopurinolom v ledvičnem mehu povzroči raztapljanje velikih kamnov iz sečne kisline in majhno možnostjo, da se zagozdijo v sečevodih.
- 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, 
- klorpropamid, ki se uporablja za zdravljenje sladkorne bolezni; - teofilin, ki se uporablja za težave z dihanjem; - zdravila, s katerimi zmanjšujemo imunski odziv telesa (imunosupresijska zdravila), npr.
Lesinurad, when combined with a xanthine oxidase inhibitor, increases uric acid excretion and decreases uric acid production resulting in greater sUA lowering. 
Lesinurad v kombinaciji z zaviralcem ksantin-oksidaze poveča izločanje sečne kisline in zmanjša njeno nastajanje ter tako doseže večje znižanje sUA.
Patients with renal impairment, where creatinine clearance values were between 10 and 20 ml/min, showed plasma oxypurinol concentrations of approximately 30 mg/litre after prolonged treatment with 300 mg allopurinol per day. 
Pri bolnikih z okvaro ledvic s kreatininskim očistkom med 10 in 20 ml/min je bila pri dolgotrajnem jemanju alopurinola v odmerku 300 mg na dan plazemska koncentracija oksipurinola približno 30 mg/l.
Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production. 
Farmakoterapevtska skupina: Zdravila za zdravljenje protina, zdravila za zaviranje nastajanja sečne kisline.
The choice of the dose strength of Duzallo depends on the allopurinol dose already taken as individual tablet(s) and will be decided by your doctor. 
Izbira jakosti odmerka zdravila Duzallo je odvisna od odmerka alopurinola, ki ga bolnik jemlje kot samostojno tableto, in jo bo določil zdravnik.
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. 
Dodatni vidni znaki vključujejo: o razjede v ustih, grlu, nosu, spolovilih in konjunktivitis (rdeče in otekle oči) o široko razširjeni mehurji ali luščenje kože o gripi podobni simptomi Zelo redki - pojavijo se lahko pri največ 1 od 10.000 bolnikov - otekanje ustnic, jezika, obraza, grla, oteženo požiranje ali dihanje ali privzdignjena, rdeča, srbeča koža/koprivnica (angioedem) - Zdravilo Duzalloima lahko vpliv na kri, kar lahko privede do lažjega nastajanja modric kot običajno ali vnetja žrela ali drugih znakov okužbe.
Additional monitoring of lipids and blood pressure is recommended in patients using sensitive CYP3A substrate lipid lowering medicinal products (such as lovastatin or simvastatin) or antihypertensive medicinal products (such as amlodipine, felodipine or nisoldipine), since their efficacy may be reduced (see section 4.5). 
Bolnikom, ki se zdravijo s hipolipemiki (npr. lovastatinom ali simvastatinom) ali antihipertenzivi (npr. amlodipinom, felodipinom ali nisoldipinom), ki so občutljivi substrati CYP3A, je priporočljivo dodatno nadzirati lipide oziroma krvni tlak, ker se njihova učinkovitost lahko zmanjša (glejte poglavje 4.5).
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%). 
V teh študijah so neželene učinke z ledvičnimi kamni (med njimi je bila najpogostejša nefrolitiaza) zabeležili pri bolnikih, ki so prejemali lesinurad 200 mg (0,5%), in pri bolnikih, ki so prejemali placebo (1,2%).
Hypersensitivity If you have a hypersensitivity (allergic) reaction, stop taking Duzallo and see a doctor immediately. 
Preobčutljivost Nehajte jemati zdravilo Duzallo in takoj obiščite zdravnika, če imate preobčutljivostno (alergijsko) reakcijo.
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). 
Alopurinolu dodan lesinurad je v primerjavi s placebom povzročil takojšnje znižanje povprečne koncentracije sečne kisline v serumu; pri bolnikih, ki so nadaljevali zdravljenje, je bilo to znižanje stalno in dolgotrajno (glejte sliko 1).
Gout flare prophylaxis needs to be considered (see section 4.2). 
Upoštevati je treba tudi profilakso napadov protina (glejte poglavje 4.2).
Duzallo contains lesinurad and allopurinol, two anti-hyperuricemic active substances with complimentary mechanisms of actions. 
Zdravilo Duzallo vsebuje lesinurad in alopurinol, dve učinkovini, ki zavirata nastajanje sečne kisline in se dopolnjujeta v mehanizmu delovanja.
particularly in individuals with impaired renal and/or hepatic function ** Photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria. 
* Zelo redko so poročali o trombocitopeniji, agranulocitozi in aplastični anemiji, predvsem pri osebah z okvarami v delovanju ledvic in/ali jeter ** Fotodermatoza, fotosenzitivna reakcija, alergijski dermatitis, srbenje in urtikarija.
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). 
Zdravilo Duzallo je treba previdno uporabljati pri bolnikih, za katere je na podlagi anamneze ali izkušenj z drugimi substrati CYP2C9 znano ali obstaja sum, da so slabi presnavljalci s CYP2C9 (glejte poglavje 4.4).
An interaction between allopurinol and coumarins has been seen under experimental conditions. 
Pod eksperimentalnimi pogoj so poročali so o medsebojnem delovanju alopurinola in kumarinov.
Consistent serum uric acid lowering was observed in patients who were receiving low dose acetylsalicylic acid in the placebo-controlled clinical studies in combination with allopurinol or febuxostat. 
V kliničnih študijah, nadzorovanih s placebom, , so opažali dosledno znižanje sečne kisline pri bolnikih, ki so jemali nizke odmerke acetilsalicilne kisline v kombinaciji z alopurinolom ali febuksostatom.
Angioimmunoblastic T-cell lymphoma 
angioimunoblastni limfom T
Duzallo may make you feel sleepy, dizzy or unsteady. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Duzallo lahko povzroči, da ste zaspani, omotični ali nestabilni na nogah.
A delayed multi-organ hypersensitivity disorder (known as hypersensitivity syndrome or DRESS) with fever, rashes, vasculitis, lymphadenopathy, pseudo lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly, abnormal liver function tests and vanishing bile duct syndrome (destruction and disappearance of the intrahepatic bile ducts) occurring in various combinations. 
Zapoznela preobčutljivostna reakcija, ki zajema več organov (znana kot preobčutljivostni sindrom ali DRESS), in vključuje zvišano telesno temperaturo, kožne izpuščaje, vaskulitis, limfadenopatijo, psevdolimfom, bolečine v sklepih, levkopenijo, eozinofilijo, hepatosplenomegalijo, spremenjene rezultate preiskav delovanja jeter in sindrom izginjajočega žolčevoda (uničenje in izginotje žolčnih vodov v jetrih) in se pojavlja v različnih kombinacijah.
Duzallo 200 mg / 200 mg tablets are available in blister packs of 10, 30 and 100 tablets. 
Duzallo 200 mg/200 mg filmsko obložene tablete so na voljo v pretisnih omotih po 10, 30 in 100 tablet.
Duzallo 300 mg / 200 mg tablets are available in blister packs of 10, 30 and 100 tablets. 
Duzallo 300 mg/200 mg filmsko obložene tablete so na voljo v pretisnih omotih po 10, 30 in 100 tablet.
CLEAR1 and CLEAR2 enrolled patients with gout who were on a stable dose of allopurinol of at least 300 mg (or 200 mg for moderate renal impairment), had serum uric acid levels greater than 6.5 mg/dL and reported at least 2 gout flares in the previous 12 months. 
Zdravilo Duzallo pri bolnikih z nezadostnim odzivom Študiji CLEAR1 in CLEAR2 sta zajeli bolnike s protinom, ki so dobivali stabilen odmerek vsaj 300 mg alopurinola (oz. 200 mg v primeru zmerne okvare ledvic), so imeli koncentracijo sečne kisline v serumu več kot 6,5 mg/dl in so imeli v preteklih 12 mesecih vsaj 2 napada protina.
An increased risk of hypersensitivity has been reported when allopurinol is given with diuretics, in particular thiazides, especially in renal impairment (see section 4.4 and section 5.1). 
Ob sočasni uporabi alopurinola z diuretiki, zlasti tiazidi, so poročali o povečanem tveganju za preobčutljivost, predvsem pri okvari ledvic (glejte poglavji 4.4 in 5.1).
Duzallo is a tablet to be taken by mouth. 
Zdravilo Duzallo je tableta, ki jo jemljete peroralno.
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) 
magnezijev stearat - Filmska obloga: hipromeloza, titanov dioksid (E171), triacetin, rumeni železov oksid (E172),
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. 
Nekateri bolniki imajo lahko po začetku uporabe zdravila Duzallo in v prvih tednih ali mesecih zdravljenja več napadov protina (nenadna ali huda bolečina ali otekanje sklepov, kar tudi imenujemo ponovni zagon protina).
The choice of the dose strength of Duzallo depends on the allopurinol dose taken as individual tablet(s). 
Izbira jakosti odmerka zdravila Duzallo je odvisna od odmerka alopurinola, ki ga bolnik jemlje kot samostojno tableto.
They may be pruritic, maculopapular, sometimes scaly, sometimes purpuric and rarely exfoliative, such as SJS/TEN. 
Lahko so srbeče, makulopapulozne, občasno luskaste ali kot purpura in redko kot eksfoliativni izpuščaj, na primer pri Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi (SJS/TEN).
Rare cases of hypersensitivity (photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria) have been reported with lesinurad during the clinical programme. 
V kliničnem programu so bili med uporabo lesinurada opisani redki primeri preobčutljivosti (fotodermatoza, fotosenzitivna reakcija, alergijski dermatitis, srbenje in urtikarija).
In each of the studies, a greater proportion of patients treated with lesinurad 200 mg in combination with allopurinol compared with placebo in combination with allopurinol achieved a serum uric acid level of less than 5 mg/dL by Month 6 (CLEAR1: 29% versus 10%; CLEAR2: 35% versus 5%). 
V obeh študijah je koncentracijo sečne kisline v serumu manj kot 5 mg/dl do 6. meseca dosegel večji delež bolnikov, ki so dobivali kombinacijo 200 mg lesinurada in alopurinola, kot tistih, ki so dobivali kombinacijo placeba in alopurinola (CLEAR1: 29% v primerjavi z 10%, CLEAR2: 35% v primerjavi s 5%).
This leaflet was last revised in 
Navodilo je bilo nazadnjerevidirano dne
Male infertility, erectile dysfunction, gynaecomastia 
Motnje reprodukcije in dojk neplodnost pri moških, erektilna disfunkcija, ginekomastija
What Duzallo contains 
Kaj vsebuje zdravilo Duzallo
Allopurinol and oxypurinol clearance is greatly reduced in patients with poor renal function resulting in higher plasma levels in chronic therapy. 
Pri bolnikih z okvarjenim delovanjem ledvic sta očistka alopurinola in oksipurinola močno zmanjšana, kar ob dolgotrajnem zdravljenju povzroči višje plazemske koncentracije.
The rates of gout flare requiring treatment were low and comparable to placebo in the last 6 months of the randomised trials (after gout flare prophylaxis was discontinued) with median scores of zero. 
Klinični izidi - napadi protina, ki so zahtevali zdravljenje Delež napadov protina, ki so zahtevali zdravljenje, je bil v zadnjih 6 mesecih randomiziranih preskušanj (po prenehanju uporabe profilakse napadov) majhen in podoben kot pri placebu; mediani seštevek je bil nič.
- you have thyroid disorders 
- če imate bolezni ščitnice
Hypersensitivity reactions may present themselves as fever, skin reactions, chills and arthralgia. 
Preobčutljivostne reakcije se lahko kažejo kot zvišana telesna temperatura, spremembe na koži, mrazenje ali bolečine v sklepih.
Agranulocytosis*, aplastic anaemia*, thrombocytopenia* 
Bolezni krvi in limfatičnega sistema agranulocitoza*, aplastična anemija*, trombocitopenija*
Hypersensitivity* 
Bolezni imunskega sistema preobčutljivost**
In both studies, significantly more patients treated with lesinurad 200 mg in combination with allopurinol ≥ 300 mg/day (≥ 200 mg/day in subjects with moderate renal impairment) achieved the target serum uric acid level of less than 6 mg/dL by Month 6 and by Month 12 compared with patients receiving placebo in combination with allopurinol (see Table 3). 
V obeh študijah je ciljno koncentracijo sečne kisline v serumu manj kot 6 mg/dl do 6. in do 12. meseca doseglo značilno več bolnikov, ki so prejemali kombinacijo 200 mg lesinurada in alopurinola ≥ 300 mg/dan (≥ 200 mg/dan pri bolnikih z zmerno okvaro ledvic) kot bolnikov, ki so prejemali kombinacijo placeba in alopurinola (glejte preglednico 3).
No increased incidences for adjudicated Major Adverse Cardiovascular Events (MACE) were observed in the randomised, double-blind, placebo-controlled combination therapy clinical studies (CLEAR1 and CLEAR2) (see section 5.1). 
V randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih študijah kombiniranega zdravljenja (CLEAR1 in CLEAR2) niso poročali o povečani pojavnosti bolnikov s prisojenimi večjimi srčno-žilnimi neželenimi učinki (MACE - Major Adverse Cardiovascular Events) (glejte poglavje 5.1).
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. 
Zelo redki - pojavijo se lahko pri največ 1 od 10.000 bolnikov - bolečina v prsih, upočasnjen srčni utrip, visok krvni tlak in upočasnjen pulz, - bruhanje krvi (ponavljajoča se hematemeza), prisotnost čezmerne maščobe v blatu (steatoreja), - vnetje ustne sluznice (stomatitis), spremenjena pogostnost odvajanja blata, - plešavost in obarvanje las, - nenormalna presnova glukoze (sladkorna bolezen; zdravnik vam bo morda izmeril raven sladkorja v krvi, da bo preveril, če se to dogaja pri vas), - visoka raven holesterola v krvi (hiperlipidemija), - depresija, - koma, - šibkost, odrevenelost, nestabilnost na nogah, občutek nezmožnosti premikanja mišic (paraliza)
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. 
Tako kot v celotni populaciji je bil delež bolnikov z blago do zmerno okvaro ledvic (ocenjeni očistek kreatinina od 30 do 89 ml/min), ki so 6. mesec dosegli ciljno koncentracijo sečne kisline v serumu, 56% z 200 mg lesinurada in 29% s placebom po dodatku alopurinola v odmerkih 200 mg do 900 mg.
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). 
Preverjanje ciljne koncentracije sečne kisline v serumu lahko opravimo po 4 tednih, da po potrebi prilagodimo zdravljenje do ciljne koncentracije sečne kisline v serumu.
OUTER CARTON for 10, 30 and 100 film-coated tablets 
ŠKATLA za 10, 30 in 100 filmsko obloženih tablet
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. 
Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov - bolečine v ledvenem predelu (pod rebri in nad kolčnico), - slabost v želodcu (siljenje na bruhanje), - bruhanje, - spremembe pri odvajanju vode ali težave z odvajanjem vode, - utrujenost, slabo počutje ali izgubo apetita.
Do not stop taking Duzallo without talking to your doctor first even if you feel better. 
Tudi če se počutite bolje, ne prenehajte jemati zdravila Duzallo, če vam tega ne svetuje zdravnik.
Adverse reactions related to renal function can occur after initiating Duzallo (see section 4.8) 
Po uvedbi zdravila Duzallo se lahko pojavijo neželeni učinki povezani z delovanjem ledvic (glejte poglavje 4.8).
Inhibition of the metabolism of theophylline by allopurinol has been reported. 
Poročali so, da alopurinol zavira presnovo teofilina.
- 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 
(konvulzij), motenj razpoloženja in preprečevanje migrene; - bupropion - za zdravljenje depresije ali pomoč pri prenehanju kajenja; - sildenafil - za zdravljenje motenj erekcije; - kontraceptivi - uporabljajo se za preprečevanje nosečnosti in vključujejo peroralne kontraceptive (kontracepcijske tabletke), kontracepcijske injekcije, obliže in vsadke - kumarinski antikoagulanti - za preprečevanje nastanka krvnih strdkov in njihovega zdravljenja; - antibiotiki, kot sta ampicilin in amoksicilin; - zdravila za zdravljenje okužbe z virusom HIV (AIDS), npr. didanozin, efavirenz;
Diabetes mellitus, hyperlipidaemia 
Presnovne in prehranske motnje dehidracija sladkorna bolezen, hiperlipidemija
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletn ega sistema in vezivnega tkiva mialgija
In the pivotal clinical trials, a greater proportion of patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor, compared with patients treated with placebo in combination with a xanthine oxidase inhibitor (35% versus 28%, respectively). 
Zamenjavo sočasnih zdravil je potreboval večji delež bolnikov, ki so obenem jemali kombinacijo lesinurada 200 mg in zaviralca ksantin-oksidaze, kot tistih, ki so jemali kombinacijo placeba in zaviralca ksantin-oksidaze (35% prvih in 28% drugih).
Duzallo is not recommended during breastfeeding. 
Zdravilu Duzallo se je med dojenjem bolje izogibati.
with lesinurad in combination with allopurinol - Pooled data from CLEAR1 and CLEAR2 studies 
Preglednica 3 Delež bolnikov, ki so dosegli ciljno koncentracijo sečne kisline v serumu (< 6 mg/dl) z lesinuradom v kombinaciji z alopurinolom - kumulativni podatki študij CLEAR1 in CLEAR2
Hypromellose Titanium dioxide (E171) Triacetin 
Obloga tablete hipromeloza titanov dioksid (E171) triacetin rumeni železov oksid (E172) rdeči železov oksid (E172)
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.) 
V randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih študijah kombiniranega zdravljenja je bila pojavnost bolnikov s prisojenimi večjimi srčno-žilnimi neželenimi učinki (MACEMajor Adverse Cardiovascular Events: srčno-žilna smrt, miokardni infarkt brez smrtnega izida ali možganska kap brez smrtnega izida) na 100 bolnikov- let izpostavljenosti 0,60 (95% interval zaupanja (IZ): 0,15; 2,41) s placebom in 0,61 (95% IZ 0,15; 2,43) z 200 mg lesinurada, kadar sta bila uporabljena skupaj z alopurinolom (CLEAR1 in CLEAR2).