FrancophonIA/ELRC3.0 huggingface dataset:
English: Febuxostat 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels.
Slovenian: Febuksostat 80 mg se pri bolnikih, ki se sočasno zdravijo s teofilinom, lahko uporablja brez tveganja za povečanje plazemskih vrednosti teofilina.
English: In each phase 3 pivotal study, ADENURIC demonstrated superior ability to lower and maintain serum uric acid levels compared to allopurinol.
Slovenian: V vsaki ključni študiji 3. faze je zdravilo ADENURIC dokazalo boljšo sposobnost zmanjšanja in vzdrževanja ravni sečne kisline v serumu v primerjavi z alopurinolom.
English: Excipient(s) with known effects:
Slovenian: Pomožne snovi z znanim učinkom:
English: If you take more ADENURIC than you should
Slovenian: Če ste vzeli večji odmerek zdravila ADENURIC, kot bi smeli
English: It is important to keep taking ADENURIC even if you have a flare, as ADENURIC is still working to lower uric acid.
Slovenian: Pomembno je, da z jemanjem zdravila ADENURIC nadaljujete tudi, če pride do izbruha protina, saj zdravilo ADENURIC še vedno znižuje raven sečne kisline.
English: If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Thus, ADENURIC may be taken without regard to food.
Slovenian: Zato se lahko zdravilo ADENURIC jemlje ne glede na hrano.
English: ADENURIC 120 mg tablets is also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.
Slovenian: Zdravilo ADENURIC 120 mg tablete uporabljamo tudi za zdravljenje in preprečevanje visokih ravni sečne kisline v krvi, ki se lahko pojavijo ob začetku zdravljenja krvnega raka s kemoterapijo.
English: ADENURIC is indicated in adults.
Slovenian: Zdravilo ADENURIC je indicirano pri odraslih.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience
Slovenian: Preglednica 1: Neželeni učinki v kombiniranih študijah 3. faze, dolgoročnih podaljšanih študijah in v obdobju trženja
English: Other medicines and ADENURIC
Slovenian: Druga zdravila in zdravilo ADENURIC
English: This has not been observed in the pivotal clinical study with ADENURIC in the Tumor Lysis Syndrome.
Slovenian: Tega v pilotski klinični študiji z zdravilom ADENURIC pri sindromu tumorske lize ni bilo opaženo.
English: Continue to take ADENURIC every day even when you are not experiencing gout flare or attack.
Slovenian: Z jemanjem zdravila ADENURIC nadaljujte vsak dan, tudi ko pri vas ne pride do izbruha ali poslabšanja protina.
English: • hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, seen only in patients taking chemotherapy for blood disorders)
Slovenian: • vročinski oblivi (npr. pordelost obraza ali vratu), zvišan krvni tlak, krvavitev (hemoragija, opažena samo pri bolnikih, zdravljenih s kemoterapijo zaradi bolezni krvi),
English: No data is available for febuxostat 120 mg.
Slovenian: Na voljo ni podatkov za febuksostat 120 mg.
English: ADENURIC tablets contain lactose (a type of sugar).
Slovenian: Zdravilo ADENURIC vsebuje laktozo (vrsto sladkorja).
English: It is unknown whether febuxostat is excreted in human breast milk.
Slovenian: Ni znano, ali se pri ljudeh febuksostat izloča v materino mleko.
English: Film-coated tablet (tablets).
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta)
English: If you stop taking ADENURIC your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.
Slovenian: Če prenehate jemati zdravilo ADENURIC, se lahko ravni sečne kisline znova povišajo in pride do poslabšanja simptomov zaradi nastajanja novih kristalov urata v sklepih in ledvicah.
English: Each tablet contains 114.75 mg of lactose (as monohydrate)
Slovenian: Ena tableta vsebuje 114,75 mg laktoze (v obliki monohidrata).
English: No dose adjustment is required in the elderly (see section 5.2).
Slovenian: Starejši Pri starostnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Each tablet contains 76.50 mg of lactose (as monohydrate)
Slovenian: Ena tableta vsebuje 76,50 mg laktoze (v obliki monohidrata).
English: ADENURIC 80 mg and 120 mg is packed in clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
Slovenian: Zdravili ADENURIC 80 mg in 120 mg sta na voljo v prozornih (Aclar/PVC/aluminij ali PVC/PE/PVDC/aluminij) pretisnih omotih po 14 tablet.
English: Film-coating: Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172)
Slovenian: Filmska obloga: Opadry II rumena 85F42129, ki vsebuje: polivinil alkohol, titanov dioksid (E171), makrogol 3350, smukec, rumeni železov oksid (E172).
English: What ADENURIC is and what it is used for What you need to know before you take ADENURIC How to take ADENURIC
Slovenian: Kaj je zdravilo ADENURIC in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ADENURIC Kako jemati zdravilo ADENURIC Možni neželeni učinki
English: The primary endpoint in CARES was the time to first occurrence of MACE, a composite of non-fatal MI, non-fatal stroke, CV death and unstable angina with urgent coronary revascularization.
Slovenian: Primarni opazovani dogodek študije CARES je bil čas do prvega pojava MACE, ki je sestavljen iz miokardnega infarkta (MI) brez smrtnega izida, možganske kapi brez smrtnega izida, smrti zaradi srčno-žilnega vzroka in nestabilne angine pektoris z nujno koronarno revaskularizacijo.
English: Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu France or
Slovenian: 40 boulevard de Champaret 38300 Bourgoin Jallieu Francija ali
English: A. MANUFACTURE(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
Slovenian: Če pozabite vzeti odmerek zdravila ADENURIC, ga vzemite takoj, ko se spomnite, razen če je skoraj čas za naslednji odmerek.
English: In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones, even though this has not been observed in patients being treated with ADENURIC for Tumor Lysis Syndrome.
Slovenian: Pri bolnikih, ki imajo zelo visoke vrednosti sečne kisline (npr. tisti, ki prejemajo kemoterapijo zaradi rakavega obolenja), lahko zdravila za zniževanje sečne kisline vodijo v odlaganje ksantina v sečilih, z možnimi kamni, čeprav tega ni bilo opaženo pri bolnikih, ki so se zdravili z zdravilom ADENURIC zaradi sindroma tumorske lize.
English: Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
Slovenian: Prozorni (Aclar/PVC/aluminij ali PVC/PE/PVDC/aluminij) pretisni omot s 14 tabletami.
English: It is not known if ADENURIC may pass into human breast milk.
Slovenian: Ni znano, ali zdravilo ADENURIC prehaja v materino mleko.
English: INR and Factor VII activity were also not affected by the coadministration of febuxostat.
Slovenian: Tudi INR in aktivnost faktorja VII se nista spremenili pri sočasnem dajanju febuksostata.
English: • nervousness
Slovenian: • Živčnost,
English: • rash (including various types of rash, please see below under “uncommon” and “rare” sections)
Slovenian: • izpuščaj (vključno z različnimi tipi izpuščajev, ki so našteti spodaj med »občasnimi« in
English: ADENURIC tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body.
Slovenian: Tablete ADENURIC vsebujejo zdravilno učinkovino febuksostat in jih uporabljamo za zdravljenje protina, ki je povezan z izločanjem substance, ki se imenuje sečna kislina (urati) v telesu.
English: Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Slovenian: Sečna kislina je končni produkt presnove purina pri ljudeh in nastaja v kaskadi hipoksantin  ksantin  sečna kislina.
English: The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day.
Slovenian: • Običajni odmerek je ena tableta na dan. Na hrbtni strani pretisnega omota so oznake z dnevi v tednu, s pomočjo katerih lahko nadzirate vsakodnevno jemanje odmerka.
English: ADENURIC works by reducing uric acid levels.
Slovenian: Zdravilo ADENURIC zmanjšuje ravni sečne kisline.
English: The 120 mg film-coated tablets are marked on one side with ‘120'.
Slovenian: 120 mg filmsko obložene tablete imajo na eni strani vtisnjeno oznako ‘120'.
English: ADENURIC is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
Slovenian: Zdravilo ADENURIC je indicirano za preventivo in zdravljenje hiperurikemije pri odraslih bolnikih, pri katerih poteka zdravljenje hematološkega malignega obolenja s srednje visokim do visokim tveganjem nastanka sindroma tumorske lize (TLS - Tumor Lysis Syndrome) s kemoterapijo.
English: Do not stop taking ADENURIC without the advice of your doctor even if you feel better.
Slovenian: Tudi če se počutite bolje, ne prenehajte jemati zdravila ADENURIC, razen če vam je to svetoval zdravnik.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience in gout patients.
Slovenian: Preglednica 1: Neželeni učinki v kombiniranih študijah 3. faze, dolgoročne podaljšane študije in poročila v obdobju trženja pri bolnikih s protinom.
English: Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy
Slovenian: Preventiva in zdravljenje visokih vrednosti sečne kisline pri bolnikih, ki zdravijo rakava obolenja s kemoterapijo
English: • Do not use this medicine after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.'
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Following multiple oral 80 mg once daily doses or a single 120 mg dose with a high fat meal, there was a 49% and 38% decrease in Cmax and a 18% and 16% decrease in AUC, respectively.
Slovenian: Pri ponavljajočih se peroralnih odmerkih 80 mg enkrat na dan ali enkratnem odmerku 120 mg z obrokom, bogatim z maščobami, se je vrednost Cmax znižala za 49 % oz. 38 %, AUC pa za 18 % oz. 16 %.
English: After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.0-5.3 µg/mL, respectively.
Slovenian: Po enkratnem ali ponavljajočem se peroralnem odmerku 80 mg enkrat na dan je Cmax približno 2,8-3,2 µg/ml, pri odmerku 120 mg pa 5,05,3 µg/ml.
English: In the FLORENCE study ADENURIC demonstrated a superior control of serum uric acid level compared to allopurinol in patients scheduled to receive the latter drug.
Slovenian: Vštudiji FLORENCE se je pri zdravilu ADENURIC pokazalo boljše uravnavanje vrednosti sečne kisline v primerjavi z alopurinolom pri bolnikih, ki so bili predvideni za prejem slednjega zdravila.
English: What you need to know before you take ADENURIC Do not take ADENURIC
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo ADENURIC Ne jemljite zdravila ADENURIC:
English: What ADENURIC looks like and contents of the pack
Slovenian: Izgled zdravila ADENURIC in vsebina pakiranja
English: An analysis in patients with gout and renal impairment was prospectively defined in the CONFIRMS study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied).
Slovenian: Analiza pri bolnikih s protinom in okvaro ledvic je bila nato določena v študiji CONFIRMS in pokazala, da je bil febuksostat statistično pomembno učinkovitejši pri zmanjševanju serumskih ravni sečne kisline na < 6 mg/dl v primerjavi z alopurinolom 300 mg/200 mg pri bolnikih s protinom in blago do zmerno okvaro ledvic (65 % bolnikov).
English: • dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia)
Slovenian: • omotičnost, občutek odrevenelosti ali ščemenja, zmanjšano ali spremenjeno zaznavanje (hipestezija, hemipareza ali parestezija) sprememba čuta za okušanje, zmanjšanje občutka za vonj (hiposmija),
English: The proportion of patients with serum urate levels of <6.0 mg/dL (357 µmol/L) at the final visit was greater than 80% (81-100%) at each febuxostat dose.
Slovenian: Delež bolnikov z vrednostmi uratov v serumu < 6,0 mg/dl (357 mol/l) je bil na zaključnem obisku večji kot 80 % (81-100 %) neodvisno od odmerka febuksostata.
English: Co-administration of febuxostat 80 mg and theophylline 400mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5).
Slovenian: Ob sočasnem jemanju 80 mg febuksostata in 400 mg teofilina v enkratnem odmerku pri zdravih prostovoljcih ni bilo nikakršnih farmakokinetičnih interakcij (glejte poglavje 4.5).
English: In a study in healthy subjects, 120 mg ADENURIC QD resulted in a mean 22% increase in AUC of desipramine, a CYP2D6 substrate indicating a potential weak inhibitory effect of febuxostat on the CYP2D6 enzyme in vivo.
Slovenian: V študiji pri zdravih prostovoljcih, ki so jemali ADENURIC v odmerku 120 mg enkrat na dan, je prišlo do povprečno 22 % povečanja AUC dezipramina, substrata CYP2D6, kar kaže na potencialni šibek zaviralni učinek febuksostata na encim CYP2D6 in vivo.
English: If you forget to take ADENURIC
Slovenian: Če ste pozabili vzeti zdravilo ADENURIC
English: If you stop taking ADENURIC
Slovenian: Če ste prenehali jemati zdravilo ADENURIC
English: Following multiple doses of 80 mg of ADENURIC in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function.
Slovenian: Po večkratnih odmerkih zdravila ADENURIC 80 mg pri bolnikih z blago, zmerno ali hudo ledvično okvaro, se vrednost Cmax febuksostata ni spremenila v primerjavi z osebami z normalnim delovanjem ledvic.
English: The proportion of subjects requiring treatment for a gout flare (APEX and FACT Study) was numerically lower in the groups that achieved an average post-baseline serum urate level <6.0 mg/dL, <5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals).
Slovenian: Delež bolnikov, pri katerih je bilo treba zdraviti izbruh protina (v študijah APEX in FACT), je bil številčno nižji v skupinah, ki so dosegle povprečno vrednost urata v serumu po izhodišču < 6,0 mg/dl, < 5,0 mg/dl ali < 4,0 mg/dl, v primerjavi s skupino, ki je dosegla povprečne vrednosti urata v serumu po izhodišču ≥ 6,0 mg/dl v obdobju zadnjih 32 tednov zdravljenja (v intervalih teden 20-24 do teden
English: Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase
Slovenian: Pogosti zvišanje amilaze v krvi, znižanje števila trombocitov, zmanjšano število belih krvnih celic, zmanjšano število limfocitov, povečane vrednosti kreatina v krvi, povečane vrednosti kreatinina v krvi, znižanje vrednosti hemoglobina, povečanje koncentracije sečnine v krvi, zvišanje vrednosti trigliceridov, zvišanje ravni holesterola v krvi, zmanjšan hematokrit, povečanje laktat dehidrogenaze v krvi, povečanje kalija v krvi
English: Cardio-vascular disorders Treatment of chronic hyperuricaemia
Slovenian: Zdravljenje kronične hiperuikemije
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Slovenian: Preglednica 2: Delež bolnikov s koncentracijo sečne kisline v serumu < 6,0 mg/dl (357 µmol/l) Zadnji trije mesečni obiski
English: There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of ADENURIC, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk.
Slovenian: Redko so se pri jemanju febuksostata pojavili potencialno življenjsko nevarni kožni izpuščaji (Stevens-Johnsonov sindrom), ki so vidni na začetku kot rdečkaste, tarči podobne pike ali krožne lise, pogosto z mehurjem v sredini trupa.
English: The efficacy of ADENURIC was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Slovenian: Učinkovitost zdravila ADENURIC je bila dokazana v treh ključnih študijah 3. faze (dve ključni študiji APEX in FACT ter dodatna študija CONFIRMS, ki so opisane v nadaljevanju) pri 4.101 bolnikih s hiperurikemijo in protinom.
English: Possible symptoms of allergic reactions might be: - rash including severe forms (e.g. blisters, nodules, itchy-, exfoliative rash), itchiness - swelling of limbs or face - difficulties in breathing - fever with enlarged lymph nodes - but also serious life threatening allergic conditions with cardiac and circulatory arrest.
Slovenian: Možni simptomi alergijske reakcije so: - izpuščaj, vključno z resnejšimi oblikami (npr. mehurji, vozliči, srbeč, eksfoliativen izpuščaj), srbenje - otekanje okončin in obraza - oteženo dihanje - zvišana telesna temperatura s povečanimi limfatičnimi vozliči - in tudi resna, življenjsko nevarna alergijska stanja z zastojem srca in s krvožilnim zastojem.
English: Also contains lactose (as monohydrate).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo (v obliki monohidrata).
English: Serum urate levels were maintained over time (i.e. 91% and 93% of patients on initial treatment with febuxostat 80 mg and 120 mg, respectively, had sUA <6 mg/dL at Month 36).
Slovenian: Nivo serumskih uratov se je ohranil skozi celotno obdobje zdravljenja (tj. 91 % in 93 % bolnikov glede na začetno zdravljenje s febuksostatom 80 mg in 120 mg oziroma, je bil nivo sUA < 6 mg/dl na mesec 36).
English: The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357μmol/L).
Slovenian: Terapevtski cilj je zmanjšati in vzdrževati koncentracijo sečne kisline v serumu pod 6 mg/dl (357 /l).
English: At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended (see section 4.2).
Slovenian: Ob začetku zdravljenja s febuksostatom se za preprečitev ponovnega izbruha priporoča preventivno zdravljenje z NSAID ali kolhicinom vsaj 6 mesecev (Glejte poglavje 4.2).
English: ADENURIC is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Slovenian: Zdravilo ADENURIC je indicirano za zdravljenje kronične hiperurikemije v primerih, ko je že prišlo do odlaganja kristalov urata (vključno s primeri, kjer so ali so kdaj prej bili prisotni tofi ali uratni artritis).
English: Patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome treated with ADENURIC should be under cardiac monitoring as clinically appropriate.
Slovenian: Bolnike, ki se zdravijo z zdravilom Adenuric in pri katerih poteka zdravljenje hematološkega malignega obolenja s srednje visokim do visokim tveganjem nastanka sindroma tumorske lize (TLS) s kemoterapijo, je potrebno skrbno spremljati delovanje srca, kot je klinično ustrezno.
English: Therefore no special caution is advised when febuxostat 80 mg and theophylline are given concomitantly.
Slovenian: Zato ob sočasnem jemanju febuksostata 80 mg in teofilina ni potrebna posebna previdnost.
English: Following multiple doses of 80 mg of ADENURIC in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function.
Slovenian: Po večkratnih odmerkih zdravila ADENURIC 80 mg pri bolnikih z blago (razred A po Child-Pughu) ali zmerno (razred B po Child-Pughu) okvaro jeter se Cmax in AUC febuksostata in njegovih presnovkov nista pomembneje spremenili v primerjavi z osebami z normalnim delovanjem jeter.
English: Tabulated list of adverse reactions Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)
Slovenian: Pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in redki ( 1/10.000 do < 1/1.000) neželeni učinki, ki so se pojavili pri bolnikih, ki so bili zdravljeni s febuksostatom, so našteti spodaj.
English: In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Slovenian: V pilotski študiji sindroma tumorske lize so bolniki, pri katerih poteka zdravljenje s kemoterapevtiki z različnim režimom zdravljenja, vključno z monoklonskimi protitelesi, prejemali febuksostat 120 mg dnevno.
English: The proportion of patients with serum urate levels of < 6.0 mg/dL (357 µmol/L) at the final visit, was 45% for 40 mg febuxostat, 67% for febuxostat 80 mg and 42% for allopurinol 300/200 mg, respectively.
Slovenian: Delež bolnikov z nivojem sečne kisline v serumu na končnem pregledu < 6,0 mg/dl (357 µmol/l) je bil 45 % pri odmerku 40 mg febuksostata, 67 % pri 80 mg febuksostata oziroma 42 % pri 300/200 mg alopurinola.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica.
Slovenian: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, magnezijev stearat, hidroksipropilceluloza, premreženi natrijev karmelozat, koloidni hidratirani silicijev dioksid.
English: No data comparing ADENURIC with rasburicase are currently available.
Slovenian: Na voljo ni podatkov, ki bi primerjali zdravilo ADENURIC z razburikazo.
English: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Slovenian: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luksembourg
English: Tumor Lysis Syndrome: The recommended oral dose of ADENURIC is 120 mg once daily without regard to food.
Slovenian: Sindrom tumorske lize: priporočeni peroralni odmerek zdravila ADENURIC je 120 mg enkrat na dan, ne glede na uživanje hrane.
English: With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.875 [95% confidence interval: 0.4408 ; 1.7369]; p=0.8488) nor of clinical TLS (1.7% and 1.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000).
Slovenian: Pri sekundarnih opazovanih dogodkih ni bilo izmerjenih pomembnih razlik glede incidence laboratorijske TLS (8,1 % pri zdravilu ADENURIC oziroma 9,2 % pri alopurinolu; relativno tveganje: 0,875 [95% interval zaupanja: 0,4408; 1,7369]; p=0,8488) in klinične TLS (1,7% pri zdravilu ADENURIC oziroma 1,2 % pri alopurinolu; relativno tveganje: 0,994 [95 % interval zaupanja: 0,9691; 1,0199]; p=1,0000).