FrancophonIA/ELRC3.0 huggingface dataset:
English: Extensive studies of high oral doses of allopurinol in mice up to 100 mg/kg/day, rats up to 200 mg/kg/day and rabbits up to 150 mg/kg/day during days 8 to 16 of gestation produced no teratogenic effects
Croatian: Opsežna ispitivanja visokih oralnih doza alopurinola na miševima do 100 mg/kg/dan, štakorima do 200 mg/kg/dan i kunićima do 150 mg/kg/dan tijekom 8. do 16. dana gestacije nisu proizvela teratogene učinke.
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).
Croatian: Kada se lesinurad primijenio zajedno s alopurinolom uzrokovao je smanjenje srednje razine mokraćne kiseline u serumu, u usporedbi s placebom, koje je bilo dugoročno održano u onih bolesnika koji su nastavili liječenje (vidjeti Sliku 1).
English: Patients with normal renal function will gradually accumulate oxypurinol until a steadystate plasma oxypurinol concentration is reached.
Croatian: Bolesnici s normalnom funkcijom bubrega postepeno će nakupljati oksipurinol sve dok se ne postigne stanje dinamičke ravnoteže za koncentraciju oksipurinola u plazmi.
English: Patients continued their allopurinol dose and were randomised 1:1:1 to receive lesinurad 200 mg, lesinurad 400 mg, or placebo once daily.
Croatian: Bolesnici su nastavili uzimati svoju dozu alopurinola i randomizirani su u omjeru 1:1:1 za primjenu lesinurada 200 mg, lesinurada 400 mg ili placeba jedanput dnevno.
English: If you forget to take Duzallo
Croatian: Ako ste zaboravili uzeti Duzallo
English: Tissue concentrations of allopurinol have not been reported in humans, but it is likely that allopurinol and oxypurinol will be present in the highest concentrations in the liver and intestinal mucosa where xanthine oxidase activity is high.
Croatian: Koncentracije alopurinola u tkivima nisu zabilježene u ljudi, ali je vjerojatno da su alopurinol i oksipurinol u najvećim koncentracijama prisutni u jetri i sluznici tankog crijeva gdje je visoka aktivnost ksantin oksidaze.
English: Hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function receiving diuretics (in particular thiazides) and Duzallo concurrently (see sections 4.5 and 4.8).
Croatian: Reakcije preosjetljivosti na alopurinol mogu se povećati u bolesnika sa smanjenom funkcijom bubrega koji istodobno primaju diuretike (naročito tiazide) i Duzallo (vidjeti dijelove 4.5 i 4.8).
English: 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Croatian: 10 filmom obloženih tableta 30 filmom obloženih tableta 100 filmom obloženih tableta
English: Cataract, vision disorders (visual impairment and blurred vision), maculopathy
Croatian: Katarakta, poremećaji vida (oštećenje vida i mutan vid), makulopatija
English: Treatment with lesinurad 200 mg in combination with allopurinol was associated with an increased incidence of serum creatinine elevations, which are related to increased renal uric acid excretion.
Croatian: Kombinirano liječenje lesinuradom u dozi od 200 mg i alopurinolom bilo je povezano s povećanom incidencijom povišenja serumskog kreatinina, koje je povezano s povećanim izlučivanjem mokraćne kiseline bubrezima.
English: Particularly in the case of a co-administration with azathioprine or 6mercaptopurine, absorption-reducing or elimination-increasing measures such as haemodialysis are indicated (haemodialysis may be considered in patients with severe renal or hepatic impairment).
Croatian: Naročito u slučaju istodobne primjene azatioprina ili 6-merkaptopurina, indicirane su mjere za smanjenje apsorpcije ili povećanje eliminacije poput hemodijalize (hemodijaliza se može razmotriti u bolesnika s teškim oštećenjem funkcije bubrega ili jetre).
English: Oxypurinol, the major metabolite of allopurinol and itself therapeutically active, is excreted by the kidney in a similar way to urate.
Croatian: Oksipurinol, glavni metabolit alopurinola i terapijski djelatna tvar, izlučuje se putem bubrega na sličan način kao urat.
English: Pack sizes of 10, 30 or 100 film-coated tablets.
Croatian: Veličine pakiranja od 10, 30 ili 100 filmom obloženih tableta.
English: Elimination of allopurinol is mainly by metabolic conversion to oxypurinol by xanthine oxidase and aldehyde oxidase, with less than 10% of the unchanged active substance excreted in the urine.
Croatian: Eliminacija alopurinola uglavnom se odvija metaboličkom konverzijom u oksipurinol pomoću ksantin oksidaze i aldehid oksidaze pri čemu se manje od 10% nepromijenjene djelatne tvari izlučuje putem mokraće.
English: Allopurinol and its metabolite oxypurinol are excreted in human breast milk.
Croatian: Alopurinol i njegov metabolit oksipurinol se izlučuju u mlijeko liječenih žena.
English: Gout flares may occur after initiation of therapy with Duzallo.
Croatian: Akutni napadaji gihta mogu se javiti nakon započinjanja terapije lijekom Duzallo.
English: Patients with serum creatinine elevations to greater than 1.5 times the pre-treatment value should be closely monitored.
Croatian: Potrebno je pomno pratiti bolesnike u kojih je povišenje serumskog kreatinina veće od 1,5 puta u odnosu na vrijednost prije liječenja.
English: Patients who are currently treated with allopurinol doses higher than 300 mg can be switched to Duzallo 200 mg/200 mg or Duzallo 300 mg/200 mg and should receive complementary doses of allopurinol to cover the total dose of allopurinol taken before switching to Duzallo.
Croatian: Bolesnici koji se trenutno liječe alopurinolom u dozama višim od 300 mg, mogu prijeći na Duzallo 200 mg/200 mg ili Duzallo 300 mg/200 mg i moraju primiti komplementarne doze alopurinola radi pokrivanja ukupne doze alopurinola koji se uzimao prije prijelaza na Duzallo.
English: The efficacy of lesinurad 200 mg once daily was studied in 2 multicentre, randomised, double-blind, placebo-controlled clinical studies in 812 adult patients (11% of these patients were elderly, ≥65 years old) with hyperuricaemia and gout in combination with allopurinol (CLEAR1 and CLEAR2).
Croatian: Djelotvornost lesinurada u dozi od 200 mg jedanput dnevno ispitana je u 2 multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja u 812 odraslih bolesnika (11% ovih bolesnika bili su starije osobe, u dobi od ≥ 65 godina) s hiperuricemijom i gihtom, u kombinaciji s alopurinolom (CLEAR1 i CLEAR2).
English: 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).
Croatian: Prijavljen je povećani rizik od preosjetljivosti kada se alopurinol daje s diureticima, naročito tiazidima, osobito u slučaju oštećenja funkcije bubrega (vidjeti dio 4.4 i dio 5.1).
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B) (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (Child-Pugh stadij A ili B) (vidjeti dio 5.2).
English: The choice of the dose strength of Duzallo depends on the allopurinol dose taken as individual tablet(s).
Croatian: Odabir jačine doze lijeka Duzallo ovisi o dozi alopurinola koji se uzima kao pojedinačna(e) tableta(e).
English: Other metabolites of allopurinol include allopurinol-riboside and oxypurinol-7-riboside.
Croatian: Drugi metaboliti alopurinola uključuju alopurinol-ribozid i oksipurinol-7-ribozid.
English: Hormonal contraception (this includes oral, injectable, transdermal, and implantable forms) might not be reliable when taking Duzallo at the same time.
Croatian: Hormonska kontracepcija (to uključuje oralne, injekcijske, transdermalne oblike i implantate) može biti nepouzdana kada se u isto vrijeme uzima Duzallo.
English: Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.
Croatian: Duzallo je indiciran za liječenje hiperuricemije u bolesnika s gihtom koji nisu postigli ciljne razine mokraćne kiseline u serumu uz liječenje samo alopurinolom u odgovarajućoj dozi.
English: 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.
Croatian: Bolesnici s oštećenjem funkcije bubrega, čije su vrijednosti klirensa kreatinina iznosile između 10 i 20 ml/min, pokazali su koncentracije oksipurinola u plazmi od približno 30 mg/litri nakon produljenog liječenja dozom od 300 mg alopurinola dnevno.
English: Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicinal products that are sensitive substrates of CYP3A.
Croatian: Blaga do umjerena indukcija CYP3A lesinuradom može smanjiti izloženost istodobno primjenjivanim lijekovima u plazmi, koji su osjetljivi supstrati CYP3A.
English: How to take Duzallo
Croatian: Kako uzimati Duzallo
English: Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production.
Croatian: Farmakoterapijska skupina: Pripravci za liječenje gihta, pripravci koji inhibiraju stvaranje mokraćne kiseline.
English: Duzallo which contains lesinurad as active substance causes an increase in renal uric acid excretion, which may lead to transient increases in serum creatinine, renal-related adverse reactions and kidney stones (see section 5.1).
Croatian: Duzallo koji sadrži lesinurad kao djelatnu tvar, uzrokuje pojačano izlučivanje mokraćne kiseline bubrezima, što može dovesti do prolaznih povišenja razine serumskog kreatinina, nuspojava povezanih s bubrezima i bubrežnih kamenaca (vidjeti dio 5.1).
English: Lesinurad is not an in vitro inhibitor of P-glycoprotein, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1, MATE2-K and BSEP.
Croatian: Lesinurad nije in vitro inhibitor P-glikoproteina, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1, MATE2-K i BSEP.
English: Clinical outcomes - concomitant use of thiazides
Croatian: Klinički ishodi - istodobna primjena tiazida
English: Common - may affect up to 1 in 10 people - increased level of thyroid stimulating hormone in the blood, - flu, - headache, - blood tests showing increased creatinine (which may be a sign of kidney problems), - heartburn (acid reflux), - skin rash.
Croatian: Često - mogu se javiti u do 1 na 10 osoba - povećana razina hormona u krvi koji stimulira štitnjaču, - gripa, - glavobolja, - krvne pretrage koje pokazuju povišeni kreatinin (što može biti znak problema s bubrezima), - žgaravica (vraćanje kiseline), - kožni osip.
English: In the long-term uncontrolled extension trials, the rates of gout flares requiring treatment further decreased in the 60% of subjects who entered the extension studies and continued treatment with lesinurad 200 mg in combination with allopurinol or febuxostat for up to an additional year of treatment.
Croatian: U dugotrajnim, nekontroliranim nastavcima ispitivanja, stope akutnih napadaja gihta koje je potrebno liječiti dodatno su se smanjile u 60% ispitanika koji su bili uključeni u nastavke ispitivanja i nastavili liječenje lesinuradom 200 mg u kombinaciji s alopurinolom ili febuksostatom tijekom dodatne godine liječenja.
English: Lesinurad undergoes oxidative metabolism mainly via cytochrome P450 (CYP) 2C9 to intermediate metabolite M3c (not detected in vivo) and is subsequently metabolised by microsomal epoxide hydrolase (mEH) to metabolite M4; there is minimal contribution from CYP1A1, CYP2C19, and CYP3A to the metabolism of lesinurad.
Croatian: Oksidativni metabolizam lesinurada uglavnom se odvija putem citokroma P450 (CYP) 2C9, do intermedijarnog metabolita M3c (nije otkriven in vivo) koji se naknadno metabolizira putem mikrosomalne epoksid hidrolaze (mEH) do metabolita M4; doprinos CYP1A1, CYP2C19 i CYP3A metabolizmu lesinurada je minimalan.
English: Oxypurinol AUC and Cmax was not affected by food.
Croatian: Hrana nije utjecala na AUC i Cmax oksipurinola.
English: One study in mice receiving intraperitoneal doses of 50 or 100 mg/kg on days 10 or 13 of gestation resulted in foetal abnormalities, however in a similar study in rats at 120 mg/kg on day 12 of gestation no abnormalities were observed.
Croatian: Ispitivanje u miševa koji su primili intraperitonealne doze od 50 ili 100 mg/kg na 10. ili 13. dan gestacije, rezultiralo je fetalnim poremećajima, međutim, u sličnom ispitivanju na štakorima s dozom od 120 mg/kg na 12. dan gestacije nisu opaženi poremećaji.
English: 6-mercaptopurine and azathioprine
Croatian: 6-merkaptopurin i azatioprin
English: In patients with moderate renal impairment, the incidence of renal-related adverse reactions was similar across all treatment groups: Lesinurad 200 mg (13.4%) and placebo (12.5%).
Croatian: U bolesnika s umjerenim oštećenjem funkcije bubrega, incidencija nuspojava povezanih s bubrezima bila je slična u svim liječenim skupinama: Lesinurad 200 mg (13,4%) i placebo (12,5%).
English: With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Croatian: Kod primjene alopurinola i citostatika (npr. ciklofosfamida, doksorubicina, bleomicina, prokarbazina, alkilirajućih tvari), krvna diskrazija javlja se češće nego kada se te djelatne tvari primjenjuju pojedinačno.
English: Duzallo is not recommended in patients with unstable angina, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or with a recent event of myocardial infarction, stroke, or deep venous thrombosis within the last 12 months, due to insufficient data with lesinurad.
Croatian: Zbog nedostatka podataka o lesinuradu, Duzallo se ne preporučuje u bolesnika s nestabilnom anginom, zatajenjem srca NYHA (New York Heart Association) stadija III ili IV, nekontroliranom hipertenzijom ili nedavnim infarktom miokarda, moždanim udarom ili dubokom venskom trombozom unutar posljednjih 12 mjeseci.
English: Other organs may also be affected (e.g. liver, lungs, kidneys, pancreas, myocardium, and colon).
Croatian: I drugi organi mogu biti zahvaćeni (npr. jetra, pluća, bubrezi, gušterača, miokard i debelo crijevo).
English: EU/1/18/1300/003 30 film-coated tablets EU/1/18/1300/004 100 film-coated tablets EU/1/18/1300/006 10 film-coated tablets
Croatian: EU/1/18/1300/003 30 filmom obloženih tableta EU/1/18/1300/004 100 filmom obloženih tableta EU/1/18/1300/006 10 filmom obloženih tableta
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).
Croatian: Žene reproduktivne dobi ne smiju se pouzdati samo u hormonsku kontracepciju (uključujući oralne, injekcijske, transdermalne oblike i implantate) tijekom uzimanja lijeka Duzallo (vidjeti dijelove 4.4 i 4.5).
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.
Croatian: U dugotrajnom nastavku otvorenog ispitivanja opažene su povećane vrijednosti TSH (> 5,5 μIU/ml) u bolesnika na dugotrajnom liječenju alopurinolom (5,8%).
English: EU/1/18/1300/001 30 film-coated tablets EU/1/18/1300/002 100 film-coated tablets EU/1/18/1300/005 10 film-coated tablets
Croatian: EU/1/18/1300/001 30 filmom obloženih tableta EU/1/18/1300/002 100 filmom obloženih tableta EU/1/18/1300/005 10 filmom obloženih tableta
English: Haematuria, azotemia
Croatian: Hematurija, azotemija
English: Adequate therapy with allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter.
Croatian: Odgovarajuća terapija alopurinolom dovest će do otapanja velikih uratnih bubrežnih kamenaca uz neznatnu mogućnost njihovog zaglavljivanja u mokraćovodu.
English: Patients with a history of kidney stones were permitted entry into the 12-month studies of lesinurad in combination with allopurinol.
Croatian: Bolesnicima s anamnezom bubrežnih kamenaca bilo je dozvoljeno uključivanje u 12-mjesečna ispitivanja lesinurada u kombinaciji s alopurinolom.
English: Lesinurad is administered as a 50:50 mixture of lesinurad atropisomers.
Croatian: Lesinurad se primjenjuje kao smjesa atropoizomera lesinurada u omjeru 50:50.
English: If no HLA-B*5801 genotyping is available for patients with Han Chinese, Thai or Korean descent, the benefits should be thoroughly assessed and considered to outweigh the possible higher risks before starting therapy.
Croatian: Ako za bolesnike Han kineskog, Thai ili korejskog porijekla nije dostupna genotipizacija za HLA-B*5801, potrebno je prije započinjanja terapije temeljito procijeniti koristi i smatrati da koristi prevladavaju u odnosu na moguće povišene rizike.
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.
Croatian: Vrlo rijetko - mogu se javiti u do 1 na 10 000 osoba - bol u prsnom košu, spori otkucaji srca, visoki krvni tlak ili nizak puls, - povraćanje krvi (opetovana hematemeza), prisutnost viška masti u stolici (steatoreja), - upala sluznica u ustima (stomatitis), promijenjena učestalost stolice (promijenjeno pražnjenje crijeva), - gubitak ili promjena boje kose, - poremećeni metabolizam glukoze (dijabetes, Vaš liječnik će Vam možda izmjeriti razinu šećera u krvi radi provjere događaju li se te promjene), - visoke razine kolesterola u Vašoj krvi (hiperlipidemija), - depresija, - koma, - slabost, utrnulost, nestabilnost na nogama, nemogućnost pokretanja mišića (paraliza) ili gubitak svijesti, - nemogućnost kontroliranja mišićnih pokreta (ataksija), - osjećaj trnaca, golicanja, bockanja ili peckanja u koži (parestezija), - glavobolja, omaglica, omamljenost ili poremećaj Vašeg vida, - zamućenost oka (katarakta), - promjena okusa, - krv u Vašoj mokraći (hematurija), - muška neplodnost ili erektilna disfunkcija, - povećanje grudi u muškaraca i žena, - nakupljanje tekućine koje dovodi do oticanja (edema) naročito u Vašim gležnjevima, - bolovi u mišićima, - bolni gnojni čir na koži, - oštećenje živaca koje može uzrokovati utrnulost, bol i slabost.
English: Screening for HLA-B*5801 should be considered before starting treatment with allopurinol in patient subgroups where the prevalence of this allele is known to be high.
Croatian: Prije započinjanja liječenja alopurinolom potrebno je razmotriti probir na HLA-B*5801 u podskupina bolesnika za koje je poznato da je prevalencija tog alela visoka.
English: Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9.
Croatian: Stoga se preporučuje oprez kada se Duzallo primjenjuje u bolesnika koji uzimaju umjerene inhibitore CYP2C9.
English: Continuous treatment with Duzallo decreases the frequency of gout flares.
Croatian: Kontinuirano liječenje lijekom Duzallo smanjuje učestalost akutnih napadaja gihta.
English: Duzallo contains the active ingredients allopurinol and lesinurad.
Croatian: Duzallo sadrži djelatne tvari alopurinol i lesinurad.
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.
Croatian: Međutim, u bolesnika koji primaju Duzallo, koji sadrži djelatnu tvar alopurinol, preporučuje se umjesto ampicilina ili amoksicilina primijeniti drugo liječenje kada je dostupno.
English: An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both medicinal products.
Croatian: Prijavljeno je povećanje učestalosti kožnog osipa u bolesnika koji su primili ampicilin ili amoksicilin istodobno s alopurinolom u usporedbi s bolesnicima koji nisu primili ta dva lijeka.
English: 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.
Croatian: Sindrom odgođene višeorganske preosjetljivosti (poznat kao sindrom preosjetljivosti ili DRESS) s vrućicom, osipom, vaskulitisom, limfadenopatijom, pseudolimfomom, artralgijom, leukopenijom, eozinofilijom, hepatosplenomegalijom, abnormalnim pretragama funkcije jetre i sindromom nestajanja žučovoda (uništenje i nestanak intrahepatičkih žučovoda) javlja se u različitim kombinacijama.
English: Recurrent haematemesis, steatorrhoea, stomatitis, changed stool frequency
Croatian: Opetovana hematemeza, steatoreja, stomatitis, promijenjena učestalost stolice
English: Duzallo is not recommended during breastfeeding.
Croatian: Ne preporučuje se primjena lijeka Duzallo tijekom dojenja.
English: How to store Duzallo
Croatian: Kako čuvati Duzallo
English: The kinetics of allopurinol are not likely to be altered other than due to deterioration in renal function (see section 5.2 renal impairment).
Croatian: Promjene u farmakokinetici alopurinola nisu vjerojatne, osim u slučaju oslabljene funkcija bubrega (vidjeti dio 5.2 oštećenje funkcije bubrega).
English: Serious skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have occured in patients taking allopurinol.
Croatian: Ozbiljni kožni osipi (sindrom preosjetljivosti, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza) pojavili su se u bolesnika koji uzimaju alopurinol.
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%).
Croatian: U ovim ispitivanjima, nuspojave bubrežnih kamenaca (od kojih je najčešća nefrolitijaza) prijavljene su u bolesnika liječenih lesinuradom u dozi od 200 mg (0,5%) i placebom (1,2%).