FrancophonIA/ELRC3.0 huggingface dataset:
English: However, since adverse reactions such as somnolence, vertigo and ataxia have been reported in patients receiving allopurinol (see section 4.8), patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Duzallo does not adversely affect their ability to drive and use machines.
Croatian: Međutim, budući da su u bolesnika koji su primili alopurinol (vidjeti dio 4.8) prijavljene nuspojave poput somnolencije, vrtoglavice i ataksije, bolesnici moraju biti oprezni prije upravljanja vozilima, rada sa strojevima ili sudjelovanja u opasnim aktivnostima sve dok nisu u razumnoj mjeri sigurni da Duzallo ne utječe štetno na njihovu sposobnost upravljanja vozilima i rada sa strojevima.
English: What you need to know before you take Duzallo
Croatian: Što morate znati prije nego počnete uzimati Duzallo
English: Children and adolescents Duzallo is not recommended for use in children and adolescents below 18 years of age.
Croatian: Ne preporučuje se primjena lijeka Duzallo u djece i adolescenata mlađih od 18 godina.
English: Ampicillin/amoxicillin
Croatian: Ampicilin/amoksicilin
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.
Croatian: Dokazi upućuju na to da se poluvijek adenin arabinozida u plazmi povećava u prisutnosti alopurinola i stoga je kod istodobne primjene tih dviju djelatnih tvari potrebno naročito praćenje radi prepoznavanja pojačanih toksičnih učinaka.
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.
Croatian: Na temelju ispitivanja interakcija u zdravih ispitanika ili bolesnika s gihtom, lesinurad ne stupa u klinički značajne interakcije s NSAIL-ovima (naproksenom i indometacinom) ili kolhicinom.
English: Duzallo is not recommended during breastfeeding, as allopurinol passes into the breast milk.
Croatian: Ne preporučuje se primjena lijeka Duzallo tijekom dojenja, jer alopurinol prolazi u majčino mlijeko.
English: In clinical trials, lesinurad was administered with food, because the serum uric acid lowering was improved under fed conditions (see section 4.2).
Croatian: U kliničkim ispitivanjima, lesinurad je primjenjivan s hranom jer je sniženje razine mokraćne kiseline u serumu bilo poboljšano u uvjetima sitosti (vidjeti dio 4.2).
English: This is approximately the concentration which would be achieved by doses of 600 mg/day in those with normal renal function.
Croatian: To je približno koncentracija koja bi se postigla dozama od 600 mg/dan u bolesnika s normalnom funkcijom bubrega.
English: Clinical outcomes - cardiovascular safety
Croatian: Klinički ishodi - kardiovaskularna sigurnost
English: Duzallo should not be administered with inhibitors of mEH.
Croatian: Duzallo se ne smije primjenjivati istodobno s inhibitorima mEH.
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.
Croatian: Ako se Duzallo, koji sadrži djelatnu tvar alopurinol, istodobno daje s klorpropamidom kada je funkcija bubrega loša, mogući je povećani rizik od produljene hipoglikemijske aktivnosti.
English: Duzallo has not been studied in patients with severe hepatic impairment; therefore, no dose recommendations can be given for Duzallo.
Croatian: Duzallo nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre; stoga se ne mogu dati preporuke za doziranje lijeka Duzallo.
English: Serum concentrations of 6-mercaptopurine and azathioprine can reach toxic levels unless dose reduction is undertaken.
Croatian: Koncentracije 6-merkaptopurina i azatioprina u serumu mogu doseći toksične razine, osim ako se ne smanji doza.
English: Mild to moderate induction of CYP3A by concomitantly administered lesinurad may reduce or eventually reverse this effect.
Croatian: Blaga do umjerena indukcija CYP3A putem istodobne primjene lesinurada može smanjiti ili eventualno poništiti taj učinak.
English: The recommended dose is one tablet of Duzallo (200 mg/200 mg or 300 mg/200 mg) once daily.
Croatian: Preporučena doza je jedna tableta lijeka Duzallo (200 mg/200 mg ili 300 mg/200 mg) jedanput dnevno.
English: Approximately 20% of the ingested allopurinol is excreted in the faeces.
Croatian: Približno 20% progutanog alopurinola izlučuje se putem fecesa.
English: Agranulocytosis*, aplastic anaemia*, thrombocytopenia*
Croatian: Agranulocitoza*, aplastična anemija*, trombocitopenija*
English: The rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Croatian: Osip može uključivati vrijed u ustima, grlu, nosu, na spolnim organima te konjunktivitis (crvene i otečene oči).
English: A causal relationship with lesinurad has not been established.
Croatian: Uzročna povezanost s lesinuradom nije ustanovljena.
English: Coumarin anticoagulants
Croatian: Kumarinski antikoagulansi
English: In healthy volunteers and HIV patients receiving didanosine, plasma didanosine maximum plasma concentration (Cmax ) and area under the curve (AUC) values were approximately doubled with concomitant allopurinol treatment (300 mg daily) without affecting terminal half-life.
Croatian: U zdravih dobrovoljaca i bolesnika s HIV-om koji primaju didanozin, vrijednosti maksimalne plazmatske koncentracije (Cmax) i površine ispod krivulje (AUC) za didanozin u plazmi približno su se udvostručile pri istodobnom liječenju alopurinolom (300 mg dnevno) bez utjecaja na terminalni poluvijek.
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.
Croatian: Primjenu lijeka Duzallo potrebno je privremeno prekinuti ako razina serumskog kreatinina poraste više od 2 puta u odnosu na vrijednost prije početka liječenja ili u slučaju apsolutne vrijednosti serumskog kreatinina veće od 4,0 mg/dl.
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.
Croatian: Na temelju literature nakon gutanja jedne jednokratne doze od 20 g alopurinola javili su se simptomi poput mučnine, povraćanja, dijareje i omaglice u jednog bolesnika.
English: Such patients, taking 300 mg of allopurinol per day will generally have plasma oxypurinol concentrations of 5-10 mg/litre.
Croatian: Takvi bolesnici koji uzimaju 300 mg alopurinola dnevno, općenito će imati koncentracije oksipurinola u plazmi 5-10 mg/litra.
English: Duzallo should be used with caution in patients with a CrCL of 30 to less than 45 mL/min (experience with lesinurad in patients with an estimated CrCL (eCrCL) less than 45 mL/min is limited).
Croatian: Duzallo je potrebno primijeniti s oprezom u bolesnika s CrCL-om od 30 do manje od 45 ml/min (iskustvo s lesinuradom u bolesnika s procijenjenim CrCL-om (eCrCL) manjim od 45 ml/min je ograničeno).
English: Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with lesinurad.
Croatian: Prema tome, preporučuje se pratiti bolesnike zbog smanjene djelotvornosti supstrata CYP2B6 (npr. bupropion, efavirenz) prilikom istodobne primjene s lesinuradom.
English: Allopurinol is rapidly absorbed from the gastrointestinal tract and is reported to have a plasma half-life of about one hour.
Croatian: Alopurinol se brzo apsorbira iz probavnog sustava te je za njega prijavljen poluvijek u plazmi od približno jednog sata.
English: Hypersensitivity syndrome, Stevens-Johnson-Syndrome (SJS ) and toxic epidermal necrolysis (TEN)
Croatian: Sindrom preosjetljivosti, Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN)
English: The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol related hypersensitivity syndrome and SJS/TEN.
Croatian: Za alel HLA-B*5801 je kod primjene alopurinola dokazana povezanost s rizikom razvoja sindroma preosjetljivosti i SJS/TEN.
English: The most commonly reported adverse reactions during treatment with lesinurad 200 mg are influenza, gastro-oesophageal reflux disease, headache and blood creatinine increased.
Croatian: Najčešće prijavljivane nuspojave tijekom liječenja lesinuradom u dozi od 200 mg su gripa, gastroezofagealna refluksna bolest, glavobolja i povišen kreatinin u krvi.
English: There is no clinical experience in patients with severe (Child-Pugh class C) hepatic impairment.
Croatian: Nema kliničkog iskustva u bolesnika s teškim (Child-Pugh stadij C) oštećenjem funkcije jetre.
English: It is preferable to avoid Duzallo when you are pregnant.
Croatian: Poželjno je izbjegavati primjenu lijeka Duzallo kada ste trudni.
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).
Croatian: Potrebno je uzeti u obzir mogućnost smanjene djelotvornosti istodobno primjenjivanih lijekova koji su supstrati CYP3A te je potrebno pratiti njihovu djelotvornost (npr. krvni tlak i razinu kolesterola) (vidjeti dio 4.4).
English: Hypersensitivity reactions may present themselves as fever, skin reactions, chills and arthralgia.
Croatian: Reakcije preosjetljivosti mogu se javiti kao vrućica, kožne reakcije, zimica i artralgija.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Croatian: Benigne, maligne i nespecificirane neoplazme (uklj. ciste i polipe)
English: Allopurinol is negligibly bound by plasma proteins and therefore variations in protein binding are not thought to significantly alter clearance.
Croatian: Alopurinol se neznatno veže na proteine u plazmi i stoga se ne smatra da varijacije u vezanju na proteine značajno mijenjaju klirens.
English: Your doctor may tell you to restart treatment with Duzallo when your kidneys improve.
Croatian: Vaš liječnik Vam može reći da ponovno počnete uzimati Duzallo kada se poboljša stanje Vaših bubrega.
English: Epoxide hydrolase inhibitors (e.g. valproic acid, valpromide) Inhibitors of microsomal Epoxide Hydrolase (mEH) (e.g. valproic acid, valpromide) may interfere with the metabolism of lesinurad.
Croatian: Inhibitori epoksid hidrolaze (npr. valproatna kiselina, valpromid) Inhibitori mikrosomalne epoksid hidrolaze (mEH) (npr. valproatna kiselina, valpromid) mogu utjecati na metabolizam lesinurada.
English: The most common adverse reaction leading to discontinuation of lesinurad was blood creatinine increased (frequency 0.8%).
Croatian: Najčešća nuspojava koja je dovela do prekida primjene lesinurada bila je povišen kreatinin u krvi (učestalost 0,8%).
English: Gout is a type of arthritis caused by the build-up of uric acid crystals around the joints.
Croatian: Giht je vrsta artritisa uzrokovana nakupljanjem kristala mokraćne kiseline u zglobovima.
English: If the patient is a known carrier of HLA-B*5801, especially in those who are of Han Chinese, Thai or Korean descent, allopurinol should not be started unless there are no other reasonable therapeutic options and the benefits are thought to exceed risks.
Croatian: Ako je poznato da je bolesnik nositelj alela HLA-B*5801, pogotovo u bolesnika Han kineskog, Thai ili korejskog porijekla, liječenje alopurinolom ne smije se započeti osim ako ne postoje druge razumne terapijske mogućnosti i smatra se da koristi premašuju rizike.
English: There are no data from the use of lesinurad and limited amount of data from the use of allopurinol in pregnant women.
Croatian: Nema podataka o primjeni lesinurada u trudnica, a podaci o primjeni alopurinola u trudnica su ograničeni.
English: Hydroxypropylcellulose Microcrystalline cellulose Lactose monohydrate Crospovidone Magnesium stearate
Croatian: Jezgra tablete hidroksipropilceluloza mikrokristalična celuloza laktoza hidrat krospovidon magnezijev stearat
English: Inhibition of the metabolism of theophylline by allopurinol has been reported.
Croatian: Prijavljena je inhibicija metabolizma teofilina alopurinolom.
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.
Croatian: Za alopurinol, nuspojave mogu varirati u svojoj incidenciji ovisno o primljenoj dozi te također kada se taj lijek daje u kombinaciji s drugim lijekovima.
English: Therefore effective inhibition of xanthine oxidase is maintained over a 24 hour period with a single daily dose of allopurinol.
Croatian: Stoga se djelotvorna inhibicija ksantin oksidaze održava tijekom 24-satnog razdoblja pomoću jedne doze alopurinola jedanput dnevno.
English: Male infertility, erectile dysfunction, gynaecomastia
Croatian: Muška neplodnost, erektilna disfunkcija, ginekomastija
English: 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).
Croatian: Preporučuje se dodatno praćenje lipida i krvnog tlaka u bolesnika koji uzimaju lijekove koji su osjetljivi supstrati CYP3A za sniženje lipida (poput lovastatina ili simvastatina) ili sniženje krvnog tlaka (poput amlodipina, felodipina ili nisoldipina), s obzirom da njihova djelotvornost može biti smanjena (vidjeti dio 4.5).
English: In male and female rats, there was no effect on mating or fertility with lesinurad.
Croatian: U mužjaka i ženki štakora, primjena lesinurada nije imala učinak na parenje ili plodnost.
English: 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.
Croatian: Odabir jačine doze lijeka Duzallo ovisi o dozi alopurinola koji se već uzima kao pojedinačna(e) tableta(e), a o odabiru će odlučiti Vaš liječnik.
English: In clinical trials, most adverse reactions were mild or moderate in intensity and resolved while continuing lesinurad therapy.
Croatian: U kliničkim ispitivanjima, većina je nuspojava bila blagog do umjerenog intenziteta i razriješena je uz nastavak liječenja lesinuradom.
English: In the same trials, all patients with a MACE treated with lesinurad 200 mg had a history of heart failure, stroke or myocardial infarction.
Croatian: U istim ispitivanjima svi bolesnici koji su imali MACE i liječeni su lesinuradom u dozi od 200 mg, imali su u anamnezi zatajenje srca, moždani udar ili infarkt miokarda.
English: Allopurinol can increase the plasma concentration of ciclosporin when concomitantly administered.
Croatian: Alopurinol može povećati koncentraciju ciklosporina u plazmi kod istodobne primjene.
English: Chlorpropamide
Croatian: Klorpropamid
English: Rash and skin symptoms
Croatian: Osip i kožni simptomi
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)
Croatian: Drugi sastojci su: - jezgra tablete: hidroksipropilceluloza, mikrokristalična celuloza, laktoza hidrat, krospovidon, magnezijev stearat - film-ovojnica: hipromeloza, titanijev dioksid (E171), triacetin, željezov oksid žuti (E172), željezov oksid crveni (E172)
English: Vidarabine (Adenine Arabinoside)
Croatian: Vidarabin (adenin arabinozid)
English: Lesinurad is a mild to moderate inducer of CYP3A and therefore may lower plasma concentrations of some hormonal contraceptives, thereby decreasing contraceptive effectiveness (see sections 4.4 and
Croatian: Lesinurad je blagi do umjereni induktor CYP3A i prema tome može sniziti koncentracije nekih hormonskih kontraceptiva u plazmi te time smanjiti učinkovitost kontracepcije (vidjeti dijelove 4.4 i 4.6).
English: If aluminium hydroxide is taken concomitantly, allopurinol-containing medicinal products may have an attenuated effect.
Croatian: Ako se istodobno uzima aluminijev hidroksid, lijekovi koji sadrže alopurinol mogu imati oslabljen učinak.
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.
Croatian: Potrebno je procijeniti funkciju bubrega prije početka primjene lijeka Duzallo, te je redovito pratiti tijekom liječenja (npr. 4 puta godišnje), na temelju kliničkih okolnosti poput početne vrijednosti funkcije bubrega, deplecije volumena, istodobno prisutne bolesti ili istodobno primjenjivanih lijekova.
English: Patients taking Duzallo which contains the active substance allopurinol and 6mercaptopurine or azathioprine must reduce their dose to 25 % of the intended dose of 6
Croatian: Bolesnici koji uzimaju Duzallo, koji sadrži djelatnu tvar alopurinol, i 6-merkaptopurin ili azatioprin moraju smanjiti njihovu dozu na 25% namijenjene doze 6-merkaptopurina ili azatioprina.
English: Iron oxide yellow (E172) Iron oxide red (E172)
Croatian: Ovojnica tablete hipromeloza titanijev dioksid (E171) triacetin željezov oksid žuti (E172) željezov oksid crveni (E172)
English: Pale pink oblong film-coated tablets with 7 x 17 mm in size.
Croatian: Blijedo ružičaste, duguljaste, filmom obložene tablete veličine 7 x 17 mm.
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.
Croatian: U ispitivanjima na životinjama dugotrajna primjena visokih doza alopurinola rezultirala je stvaranjem precipitata ksantina, koji je doveo do promjena u mokraćnom sustavu.
English: Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, medicinal product eruption, alopecia, hair colour changes
Croatian: Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, angioedem, izbijanje kožnih promjena uzrokovano lijekom, alopecija, promjene boje kose
English: The main metabolite of allopurinol is oxypurinol.
Croatian: Glavni metabolit alopurinola je oksipurinol.
English: It is used to treat gout in adult patients in case allopurinol alone is not controlling your gout.
Croatian: Primjenjuje se za liječenje gihta u odraslih bolesnika ako alopurinol koji uzimate samog, ne kontrolira Vaš giht.
English: Nausea, vomiting and diarrhoea
Croatian: Mučnina, povraćanje i dijareja
English: A possible interaction should be taken into account when a patient on oral anticoagulants is given Duzallo.
Croatian: Potrebno je uzeti u obzir moguću interakciju, kada se Duzallo daje bolesniku koji prima oralne antikoagulanse.
English: Duzallo may cause serious kidney problems (see section 4).
Croatian: Duzallo može uzrokovati ozbiljne probleme s bubrezima (vidjeti dio 4).
English: The most frequent renal-related adverse reaction was blood creatinine increased (3.7% with lesinurad 200 mg compared to 2.2% with placebo).
Croatian: Najčešća nuspojava povezana s bubrezima bila je povišena razina kreatinina u krvi (3,7% za lesinurad u dozi od 200 mg u usporedbi s 2,2% za placebo).
English: --o-- Placebo + Allopurinol,
Croatian: Terapijska skupina: --o-- placebo + alopurinol,
English: Do not take Duzallo if: - you are allergic to allopurinol, lesinurad or any of the other ingredients of this medicine (listed in section 6) - you have tumour lysis syndrome - a fast breakdown of cancer cells which can cause high uric acid levels - you have Lesch-Nyhan syndrome - a rare inherited illness that starts in childhood where there is too much uric acid in the blood - your kidneys work very poorly or you have end stage kidney disease (when the kidneys no longer work well enough to meet the body's need) - you have received a kidney transplant - you are on kidney dialysis.
Croatian: Nemojte uzimati Duzallo: - ako ste alergični na alopurinol, lesinurad ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako imate sindrom lize tumora - brzi raspad stanica raka koji može uzrokovati visoke razine mokraćne kiseline - ako imate Lesch-Nyhanov sindrom - rijetku nasljednu bolest koja počinje u djetinjstvu kada postoji previše mokraćne kiseline u krvi - ako Vaši bubrezi rade jako slabo ili imate završni stadij bolesti bubrega (kada bubrezi više ne rade dovoljno dobro za odgovaranje na potrebe tijela) - ako Vam je transplantiran bubreg - ako ste na dijalizi bubrega.
English: The serious adverse reactions renal failure, renal impairment and nephrolithiasis have occurred uncommonly (less than 1 case per 100 patients) (see Table 1).
Croatian: Ozbiljne nuspojave: zatajenje bubrega, oštećenje funkcije bubrega i nefrolitijaza javile su se manje često (manje od jedan slučaj na 100 bolesnika) (vidjeti Tablicu 1).
English: Female patients of childbearing age should practice additional methods of contraception and not rely on hormonal contraception alone when taking Duzallo (see sections 4.5 and 4.6).
Croatian: Bolesnice reproduktivne dobi moraju koristiti dodatne metode kontracepcije i ne smiju se pouzdati samo na hormonsku kontracepciju tijekom uzimanja lijeka Duzallo (vidjeti dijelove 4.5 i 4.6).
English: Allopurinol and oxypurinol clearance is greatly reduced in patients with poor renal function resulting in higher plasma levels in chronic therapy.
Croatian: Klirens alopurinola i oksipurinola značajno je smanjen u bolesnika sa slabom funkcijom bubrega što rezultira višim razinama u plazmi tijekom kronične terapije.
English: Duzallo contains lesinurad and allopurinol, two anti-hyperuricemic active substances with complimentary mechanisms of actions.
Croatian: Duzallo sadrži lesinurad i alopurinol, dvije djelatne tvari protiv hiperuricemije i s komplementarnim mehanizmima djelovanja.
English: Post-hoc analyses in a subgroup of patients with high cardiovascular risk at baseline (as defined by transient ischemic attack, angina pectoris, heart failure, myocardial infarction, peripheral vascular disease and/or stroke), showed that the incidence of MACE was 0/39 for placebo and 2/43 for lesinurad 200 mg.
Croatian: Post-hoc analiza u podskupini bolesnika s visokim kardiovaskularnim rizikom na početku ispitivanja (definirano kao prolazni ishemijski napad, angina pektoris, zatajenje srca, infarkt miokarda, periferna vaskularna bolest i/ili moždani udar), pokazala je da je incidencija MACE bila 0/39 za placebo i 2/43 za lesinurad 200 mg.
English: Allopurinol is a xanthine-oxidase inhibitor.
Croatian: Alopurinol je inhibitor ksantin oksidaze.
English: Oxypurinol is a less potent inhibitor of xanthine oxidase than allopurinol, but the plasma half-life of oxypurinol is far more prolonged.
Croatian: Oksipurinol je manje potentan inhibitor ksantin oksidaze od alopurinola, ali je poluvijek oksipurinola u plazmi puno duži.
English: The effect of lesinurad and allopurinol on fertility in humans has not been studied.
Croatian: Nije ispitan učinak lesinurada i alopurinola na plodnost u ljudi.
English: Allopurinol and its main metabolite oxypurinol lower the level of uric acid in plasma and urine by inhibition of xanthine oxidase, the enzyme catalyzing the oxidation of hypoxanthine to xanthine and xanthine to uric acid.
Croatian: Alopurinol i njegov glavni metabolit oksipurinol snizuju razinu mokraćne kiseline u plazmi i urinu putem inhibicije ksantin oksidaze, enzima koji katalizira oksidaciju hipoksantina u ksantin i ksantina u mokraćnu kiselinu.
English: Patients known to be CYP2C9 poor metabolisers should be treated with caution, as the potential risk of lesinurad renal-related adverse reactions may be increased (see sections 4.8 and 5.2).
Croatian: Potrebno je s oprezom liječiti bolesnike za koje je poznato da su spori CYP2C9 metabolizatori, jer mogući rizik od nuspojava lesinurada povezanih s bubrezima može biti povećan (vidjeti dijelove 4.8 i 5.2).