natgillin/translations-raw huggingface dataset:
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. 
Ker so pa pri bolnikih, ki so jemali alopurinol (glejte poglavje 4.8) poročali o neželenih učinkih, kot so somnolenca, vrtoglavica in ataksija, morajo bolniki biti previdni preden vozijo, upravljajo stroje ali sodelujejo pri nevarnih dejavnostih, dokler se ne prepričajo, da zdravilo Duzallo ne vpliva na njihovo sposobnost vožnje in upravljanja strojev.
Also some other medicines can affect the way Duzallo works. 
Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Duzallo.
If you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately. 
Če pri vas pride do pojava izpuščajev ali teh kožnih simptomov, nemudoma prenehajte z jemanjem tega zdravila in se takoj posvetujte z zdravnikom.
The most commonly reported adverse reactions during treatment with lesinurad 200 mg are influenza, gastro-oesophageal reflux disease, headache and blood creatinine increased. 
Najpogosteje poročani neželeni učinki med zdravljenjem z lesinuradom 200 mg so gripa, gastroezofagealna refluksna bolezen, glavobol in zvišanje kreatinina v krvi.
There are no data from the use of lesinurad and limited amount of data from the use of allopurinol in pregnant women. 
Podatkov o uporabi lesinurada pri nosečnicah ni, podatki o uporabi alopurinola pa so omejeni.
These serious skin rashes often come after flu-like symptoms such as fever, headache, body ache. 
Pogosto se ti resni kožni izpuščaji pojavijo po znakih, ki so podobni simptomom gripe, kot so zvišana telesna temperatura, glavobol in bolečine v telesu.
Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN. 
Preobčutljivostne reakcije, ki jih povzroča alopurinol, se lahko kažejo na mnogo različnih načinov, vključno z makulopapularnim eksantemom, sindromom preobčutljivosti (poznanim tudi kot DRESS) in SJS/TEN.
Kidney problems If you notice any of the following side effects, stop taking Duzallo and see a doctor immediately as these may be signs of a problem with your kidneys - you may need urgent medical treatment. 
Če opazite katerega od naslednjih neželenih učinkov, nehajte jemati zdravilo Duzallo in takoj obiščite zdravnika, kajti to so lahko znaki težav z ledvicami - morda boste potrebovali nujno medicinsko pomoč.
The rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). 
Izpuščaji lahko vključujejo razjede v ustih, grlu, nosu, spolovilih in konjunktivitis (rdeče in otekle oči).
Based on interaction studies in healthy subjects or gout patients, lesinurad does not have clinically significant interactions with NSAIDs (naproxen and indomethacin) or colchicine. 
Na podlagi študij medsebojnega delovanja pri zdravih osebah in bolnikih s protinom, lesinurad nima klinično pomembnih medsebojnih delovanj z NSAID (naproksen in indometacin) in kolhicinom.
Angiotensin-converting-enzyme (ACE) inhibitors 
Zaviralci angiotenzinske konvertaze (ACE)
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. 
Delovanje ledvic je treba oceniti pred uvedbo zdravila Duzallo in ga nadzirati redno (npr. 4-krat na leto) med zdravljenjem glede na klinične okoliščine, kot so izhodiščno delovanje ledvic, zmanjšanje volumna, sočasne bolezni ali sočasna zdravila.
Iron oxide yellow (E172) Iron oxide red (E172) 
rdeči železov oksid (E172)
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. 
Vseeno se priporoča, da bolniki, ki prejemajo zdravilo Duzallo, ki vsebuje učinkovino alopurinol, uporabljajo alternativo za ampicilin ali amoksicilin, kadar je to mogoče.
Clinical outcomes - renal events 
Klinični izidi - ledvični dogodki
Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN is required and the patient should be informed of the need to stop treatment immediately at the first appearance of symptoms. 
Nujno je biti še posebno pozoren na znake sindroma preobčutljivosti in SJS/TEN in bolnika opozoriti, da ob prvem pojavu simptomov nemudoma prekine zdravljenje.
Duzallo tablets contain lactose (a type of sugar). 
Tablete zdravila Duzallo vsebujejo laktozo (vrsto sladkorja).
Your doctor may stop Duzallo if your blood tests show changes in how your kidneys are working or if you have symptoms of kidney problems. 
Zdravnik bo morda ukinil zdravljenja z zdravilom Duzallo, če bodo preiskave krvi pokazale spremenjeno delovanje ledvic ali če se pri vas pojavijo simptomi težav z ledvicami.
The elimination half-life (t½) of lesinurad was approximately 5 hours following a single dose. 
Razpolovni čas izločanja (t½) lesinurada po enkratnem odmerku je bil približno 5 ur.
In interaction studies conducted in healthy subjects with lesinurad and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine. 
V študijah medsebojnih delovanj lesinurada in substratov CYP3A na zdravih osebah je lesinurad zmanjšal koncentracijo sildenafila in amlodipina v plazmi.
Mild to moderate induction of CYP3A by concomitantly administered lesinurad may reduce or eventually reverse this effect. 
Blaga do zmerna indukcija CYP3A, ki jo povzroči sočasno jemanje lesinurada, lahko zmanjša ali sčasoma odpravi ta učinek.
This is approximately the concentration which would be achieved by doses of 600 mg/day in those with normal renal function. 
Ta vrednost približno ustreza koncentraciji, ki bi bila dosežena pri odmerku 600 mg na dan pri bolnikih z normalnim delovanjem ledvic.
Concurrent use of allopurinol and ACE inhibitors may lead to an increased risk of hypersensitivity, especially if there is pre-existing renal impairment. 
Sočasna uporaba alopurinola in zaviralcev ACE lahko privede do povečanega tveganja za preobčutljivost, predvsem ob predhodni okvari ledvic.
Your doctor may tell you to restart treatment with Duzallo when your kidneys improve. 
Zdravnik vam lahko naroči, da ponovno pričnete jemati zdravilo Duzallo, ko se vam delovanje ledvic izboljša.
Data from long-term extension studies until 52 months revealed a renal safety profile consistent with that observed in the placebo-controlled studies. 
Ledvični varnostni profil na podlagi podatkov dolgoročnih podaljšanih študij do 52 mesecev se sklada z varnostnim profilom, ugotovljenim v študijah, nadzorovanih s placebom.
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. 
Pri zdravih prostovoljcih in bolnikih z okužbo HIV, ki so prejemali didanozin, sta bili vrednosti najvišje plazemske koncentracije (Cmax) in področja pod krivulja (AUC) približno podvojeni ob sočasnem zdravljenju z alopurinolom (300 mg na dnevno), ne da bi to vplivalo na končni razpolovni čas.
Caution is required when allopurinol is used in patients with alteration of thyroid function. 
Previdnost je potrebna pri uporabi alopurinola pri bolnikih s spremenjenim delovanjem ščitnice.
In clinical trials, most adverse reactions were mild or moderate in intensity and resolved while continuing lesinurad therapy. 
V kliničnih preskušanjih je bila večina neželenih učinkov blagih ali zmernih in so med nadaljevanjem zdravljenja z lesinuradom izzveneli.
What you need to know before you take Duzallo 
Kaj morate vedeti, preden boste vzeli zdravilo Duzallo
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. 
V dolgoročnih nekontroliranih podaljšanjih preskušanj so se deleži napadov protina, ki so zahtevali zdravljenje, dodatno zmanjšali pri 60% bolnikov, ki so vstopili v podaljšane študije in nadaljevali zdravljenje z 200 mg lesinurada v kombinaciji z alopurinolom ali febuksostatom v obdobju do enega dodatnega leta zdravljenja.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Duzallo. 
Če kaj od naštetega velja za vas (ali če niste prepričani), se pred jemanjem zdravila Duzallo posvetujte z zdravnikom ali farmacevtom.
There should be an interval of at least 3 hours between the concomitant use of those medicinal products. 
Pri sočasni uporabi teh zdravil, moramo pri njunem jemanju upoštevati vsaj 3-urni interval med zdraviloma.
In animal studies, long-term use of high allopurinol doses resulted in formation of xanthine precipitates, which led to changes in the urinary tract. 
V študijah na živalih je dolgotrajna uporaba visokih odmerkov alopurinola povzročila nastanek oborin ksantina, kar je vodilo k spremembam na sečilih.
Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9. 
Zato je priporočljivo zdravilo Duzallo previdno uporabljati pri bolnikih, ki jemljejo zmerne zaviralce CYP2C9.
Serum concentrations of 6-mercaptopurine and azathioprine can reach toxic levels unless dose reduction is undertaken. 
Koncentracije 6-merkaptopurina in azatioprina lahko dosežejo toksične vrednosti, če ne znižamo odmerka.
The recommended dose is one tablet of Duzallo (200 mg/200 mg or 300 mg/200 mg) once daily. 
Priporočeni odmerek je ena tableta zdravila Duzallo (200 mg/200 mg ali 300 mg/200 mg) enkrat dnevno.
Allopurinol has a plasma half-life of about 0.5 to 1.5 hours. 
Razpolovni čas alopurinola je približno 0,5 do 2 uri.
Allopurinol and its metabolite oxypurinol are excreted in human breast milk. 
Alopurinol in njegov presnovek oksipurinol se izločata v materino mleko.
In the same trials, all patients with a MACE treated with lesinurad 200 mg had a history of heart failure, stroke or myocardial infarction. 
V istih preskušanjih so vsi bolniki z MACE, ki so bili zdravljeni z 200 mg lesinurada, imeli v anamnezi srčno popuščanje, možgansko kap ali miokardni infarkt.
If aluminium hydroxide is taken concomitantly, allopurinol-containing medicinal products may have an attenuated effect. 
Pri sočasni uporabi aluminijevega hidroksida imajo lahko zdravila, ki vsebujejo alopurinol, oslabljen učinek.
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 
Bolniki, ki jemljejo zdravilo Duzallo, ki vsebuje učinkovino alopurinol, in 6-merkaptopurin ali azatioprin, morajo odmerek 6-merkaptopurina ali azatioprina zmanjšati na 25% njim prvotno namenjenega odmerka.
Based on its mechanism of action, lesinurad may not be effective in these patients (see section 
Glede na njegov način delovanja, lesinurad pri teh bolnikih morda ni učinkovit (glejte poglavje 5.1).
Hypersensitivity syndrome, Stevens-Johnson-Syndrome (SJS ) and toxic epidermal necrolysis (TEN) 
Sindrom preobčutljivosti, Stevens-Johnsonov sindrom (SJS) in toksična epidermalna nekroliza (TEN)
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. 
Zdravljenje z zdravilom Duzallo in vsemi dodatnimi odmerki alopurinola moramo ob prvem pojavu kožnega izpuščaja, povezanega z alopurinolom, ali drugih znakih alergijske reakcije, nemudoma prekiniti in po potrebi uvesti dodatno zdravljenje.
Duzallo has not been studied in patients with severe hepatic impairment; therefore, no dose recommendations can be given for Duzallo. 
Študij na bolnikih s hudo okvaro jeter z zdravilom Duzallo niso izvedli, zato priporočil za odmerjanje zdravila Duzallo ni mogoče dati.
Hydroxypropylcellulose Microcrystalline cellulose Lactose monohydrate Crospovidone Magnesium stearate 
Jedro tablete hidroksipropilceluloza mikrokristalna celuloza laktoza monohidrat krospovidon magnezijev stearat
Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, medicinal product eruption, alopecia, hair colour changes 
Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, angioedem, medikamentozni izpuščaj, alopecija, spremenjena barva las
Duzallo may cause serious kidney problems (see section 4). 
Zdravilo Duzallo lahko povzroči resne težave z ledvicami (glejte poglavje 4).
Patients continued their allopurinol dose and were randomised 1:1:1 to receive lesinurad 200 mg, lesinurad 400 mg, or placebo once daily. 
Bolniki so še naprej uporabljali svoj odmerek alopurinola in so bili v razmerju 1:1:1 randomizirani na prejemanje 200 mg lesinurada, 400 mg lesinurada ali placeba enkrat na dan.
In clinical trials, lesinurad was administered with food, because the serum uric acid lowering was improved under fed conditions (see section 4.2). 
V kliničnih preskušanjih so lesinurad uporabljali s hrano, ker je bilo znižanje sečne kisline v serumu na poln želodec boljše (glejte poglavje 4.2).
6-mercaptopurine and azathioprine 
6-merkaptopurin in azatioprin
Salicylates and non-selective uricosuric active substances such as probenecid Salicylates at doses higher than 325 mg per day may decrease the serum uric acid lowering activity of lesinurad and should not be co-administered with Duzallo. 
Salicilati in neselektivne urikozurične učinkovine, kot je npr. probenecid Salicilati lahko v odmerkih nad 325 mg na dan oslabijo vpliv lesinurada na znižanje sečne kisline v serumu in se jih ne sme uporabljati skupaj z zdravilom Duzallo.
Hence, medicinal products with known non-selective uricosuric activity such as probenecid or large doses of salicylates may accelerate the excretion of oxypurinol. 
Zdravila, ki imajo neselektiven urikozurični učinek, kot ga imata probenecid ali visoki odmerki salicilatov, lahko pospešijo izločanje oksipurinola.
Allopurinol is rapidly absorbed from the gastrointestinal tract and is reported to have a plasma half-life of about one hour. 
Alopurinol Alopurinol se hitro absorbira iz prebavil in ima razpolovni čas v plazmi približno 1 uro.
If you forget to take Duzallo 
Če ste pozabili vzeti zdravilo Duzallo
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). 
Ženske v rodni dobi morajo uporabljati dodatne načine kontracepcije in se med jemanjem zdravila Duzallo ne smejo zanašati le na hormonsko kontracepcijo (glejte poglavji 4.5 in 4.6).
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. 
Zaviralci epoksid-hidrolaze (npr. valprojska kislina, valpromid) Zaviralci mikrosomalne epoksid-hidrolaze (mEH - microsomal Epoxide Hydrolase) (npr. valprojska kislina, valpromid) lahko ovirajo presnovo lesinurada.
Reproductive studies with allopurinol have been performed in rats and rabbits at doses up to twenty times the usual human dose and it was concluded that there was no impaired fertility. 
Študije vpliva na razmnoževanje z alopurinolom na podganah in kuncih v odmerkih, ki so do dvajsetkrat višji od običajnih odmerkov pri ljudeh, niso pokazali zmanjšanja plodnosti.
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. 
Povečanje pogostnosti kožnega izpuščaja so opazili pri bolnikih, ki so prejemali ampicilin ali amoksicilin sočasno z alopurinolom, v primerjavi z bolniki, ki niso prejemali obeh zdravil sočasno.
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. 
Zdravljenje z lesinuradom 200 mg v kombinaciji z alopurinolom je spremljala večja pogostnost zvišanj kreatinina v serumu; ta so povezana z večjim izločanjem sečne kisline v ledvicah.
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. 
V študiji na miših, ki so prejemale alopurinol intraperitonealno v odmerkih 50 ali 100 mg/kg na 10. ali 13. dan brejosti, je prišlo do pojava fetalnih nenormalnosti, vendar v podobni študiji na podganah pri odmerku 120 mg/kg na 12. dan brejosti niso opazili nenormalnosti.
Mean plasma-to-blood ratios of lesinurad AUC and Cmax were approximately 1.8, indicating that it did not penetrate or partition extensively into red blood cells. 
Povprečno razmerje AUC in Cmax lesinurada v plazmi in krvi je bilo približno 1,8; to kaže, da ni v veliki meri prodiral ali se porazdelil v eritrocite.
If you stop taking Duzallo 
Če ste prenehali jemati zdravilo Duzallo
Oxypurinol is eliminated unchanged in the urine but has a long elimination half-life because it undergoes tubular reabsorption. 
Oksipurinol se v seču izloča nespremenjen, vendar ima zaradi tubularne reabsorpcije daljši razpolovni čas izločanja.
Warnings and precautions Talk to your doctor or pharmacist before taking Duzallo if: 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Duzallo se posvetujte z zdravnikom ali farmacevtom:
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. 
Če je znano, da je bolnik nosilec HLA-B*5801 alela, zlasti če je potomec Han Kitajcev, Tajcev ali Korejcev, se zdravljenje z alopurinolom ne bi smelo pričeti, razen v primerih, kadar ni drugih možnosti zdravljenja in so koristi večje od tveganja.
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. 
Če uporabljamo zdravilo Duzallo, ki vsebuje učinkovino alopurinol, sočasno s klorpropamidom, lahko ob slabem delovanju ledvic pride do tveganja za podaljšan hipoglikemični učinek.
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). 
Bolnike, ki so slabi presnavljalci s CYP2C9, je treba zdraviti previdno, ker imajo lahko večje tveganje za neželene učinke na ledvicah, povezane z lesinuradom (glejte poglavji 4.8 in 5.2).
The kinetics of allopurinol are not likely to be altered other than due to deterioration in renal function (see section 5.2 renal impairment). 
Ni verjetno, da bi bila kinetika alopurinola spremenjena, razen zaradi zmanjšanega delovanja ledvic (glejte poglavje 5.2 Okvara ledvic).
It is used to treat gout in adult patients in case allopurinol alone is not controlling your gout. 
Uporablja se ga za zdravljenje protina pri odraslih bolnikih, če z alopurinolom samim ne nadzorujete protina.
Do not use this medicine after the expiry date which is stated on the carton or blister foil after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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). 
Učinkovitost 200 mg lesinurada enkrat na dan so proučili v 2 multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah pri 812 odraslih bolnikih (11% bolnikov je bilo starejših, starih ≥ 65 let) s hiperurikemijo in protinom, ki so ga prejemali v kombinaciji z alopurinolom (CLEAR1 in CLEAR2).
Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicinal products that are sensitive substrates of CYP3A. 
Blaga do zmerna indukcija CYP3A, ki jo povzroči lesinurad, lahko zmanjša plazemsko izpostavljenost sočasno uporabljenim zdravilom, ki so občutljivi substrati CYP3A.
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. 
Podatkov o koncentraciji alopurinola v tkivih pri ljudeh ni na voljo, vendar je pričakovati, da se alopurinol in oksipurinol v najvišjih koncentracijah nahajata v jetrih in sluznici prebavil, kjer je visoka aktivnost ksantin-oksidaze.
Other metabolites of allopurinol include allopurinol-riboside and oxypurinol-7-riboside. 
Med druge presnovke alopurinola spadata tudi alopurinol-ribozid in oksipurinol-7-ribozid.
Allopurinol is a xanthine-oxidase inhibitor. 
Alopurinol je zaviralec ksantin-oksidaze.
Cataract, vision disorders (visual impairment and blurred vision), maculopathy 
Očesne bolezni katarakta, spremembe vida (motnja vida in zamegljen vid), makulopatija
Re-challenge should not be undertaken in patients with hypersensitivity syndrome. 
Pri bolnikih s preobčutljivostnim sindromom zdravila ne smemo ponovno uvesti.
A causal relationship with lesinurad has not been established. 
Vzročna povezanost z lesinuradom ni ugotovljena.
Therefore effective inhibition of xanthine oxidase is maintained over a 24 hour period with a single daily dose of allopurinol. 
Učinkovito zaviranje ksantin-oksidaze po enem dnevnem odmerku alopurinola je zato ohranjeno preko 24-urnega obdobja.
Allopurinol is negligibly bound by plasma proteins and therefore variations in protein binding are not thought to significantly alter clearance. 
Alopurinol se na plazemske proteine veže v zanemarljivih količinah, zato ni pričakovati, da bi lahko spremembe v vezavi proteinov pomembno vplivale na očistek.
The main metabolite of allopurinol is oxypurinol. 
Glavni presnovek alopurinola je oksipurinol.
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. 
Ugotavljanje HLA-B*5801 alela pred uvedbo zdravljenja z alopurinolom bi bilo smotrno pri podskupinah bolnikov, pri katerih je visoka pojavnost tega alela.
Oxypurinol is a less potent inhibitor of xanthine oxidase than allopurinol, but the plasma half-life of oxypurinol is far more prolonged. 
Oksipurinol je šibkejši zaviralec ksantin-oksidaze kot alopurinol, vendar je razpolovni čas oksipurinola v plazmi mnogo daljši.