FrancophonIA/ELRC3.0 huggingface dataset:
English: Gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits (see sections 4.8 and 5.1).
Slovenian: Ob začetku zdravljenja se lahko pojavi izbruh protina zaradi spremenjene ravni sečne kisline v serumu, kar povzroči mobilizacijo urata iz depozitov v tkivih (glejte poglavje 4.8 in 5.1).
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 z 80 mg in 120 mg febuksostata oziroma, je bil nivo sUA <6 mg/dl na mesec 36).
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in blister packs of 14, 28, 42 and 84 tablets, calendar blister packs of 28 and 84 tablets, and perforated unit dose blister packs of 28 x 1 tablets and in multipacks of 84 film-coated tablets comprising 2 packs, each containing 42 film-coated tablets.
Slovenian: 80-miligramske in 120-miligramske filmsko obložene tablete Febuksostat Mylan so na voljo v pretisnih omotih s po 14, 28, 42 in 84 tabletami, koledarskih pretisnih omotih s po 28 in 84 tabletami in v perforiranih pretisnih omotih za posamezne odmerke z 28 × 1 tableto ter v večkratnih pakiranjih s po 84 filmsko obloženimi tabletami, ki vključujejo 2 pakiranji; vsako vsebuje 42 filmsko obloženih tablet.
English: Naproxen and other inhibitors of glucuronidation
Slovenian: Naproksen in drugi zaviralci glukuronidacije
English: Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1).
Slovenian: Pri uporabi febuksostata pri bolnikih s spremenjenim delovanjem ščitnice je potrebna previdnost (glejte poglavje 5.1).
English: How to store Febuxostat Mylan Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Febuksostat Mylan Vsebina pakiranja in dodatne informacije
English: There was high dose maternal toxicity accompanied by a reduction in weaning index and reduced development of offspring in rats at approximately 4.3 times human exposure.
Slovenian: Visoki odmerki (približno 4,3-kratna izpostavljenost človeka) so bili toksični za mater, kar je vplivalo tudi na zmanjšanje indeksa odstavljanja in slabši razvoj podganjih mladičev.
English: If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat Mylan 120 mg once daily may be considered.
Slovenian: Če je po 2-4 tednih koncentracija sečne kisline v serumu > 6 mg/dl (357 µmol/l), je smiselno razmisliti o jemanju zdravila Febuksostat Mylan v odmerku 120 mg enkrat na dan.
English: The results of the study showed that the co-administration of febuxostat 80 mg QD with theophylline 400 mg single dose has no effect on the pharmacokinetics or safety of theophylline.
Slovenian: Rezultati študije na zdravih prostovoljcih so pokazali, da sočasno jemanje 80 mg febuksostata štirikrat na dan in 400 mg teofilina v enkratnem odmerku, nima učinka na farmakokinetiko ali varnost teofilina.
English: The 80 mg tablets are marked with M on one side of the tablet and FX3 on the other side.
Slovenian: 80-miligramske tablete so označene z »M« na eni strani in »FX3« na drugi strani.
English: Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome)
Slovenian: Občasni atrijska fibrilacija, palpitacije, nenormalni EKG, levokračni blok, (glejte poglavje Sindrom tumorske lize), sinusna tahikardija (glejte poglavje Sindrom tumorske lize) Redki nenadna kardialna smrt*
English: An interaction study in healthy subjects has been performed with febuxostat to evaluate whether the inhibition of XO may cause an increase in the theophylline circulating levels as reported with other XO inhibitors.
Slovenian: Študijo medsebojnega delovanja na zdravih prostovoljcih s febuksostatom so izvedli z namenom ugotoviti ali zaviranje ksantinske oksidaze poviša raven teofilina, o čemer so poročali pri drugih zaviralcih ksantinske oksidaze.
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Slovenian: Občasni neželeni učinki (pojavijo se pri 1 od 100 bolnikov) so:
English: Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that febuxostat does not adversely affect performance.
Slovenian: Po uporabi febuksostata so poročali o neželenih učinkih, kot so zaspanost, omotica, parestezija in zamegljen vid. Bolniki morajo biti pred vožnjo, uporabo strojev ali udeležbo v tveganih dejavnostih previdni, dokler niso povsem prepričani, da febuksostat ne vpliva negativno na opravljanje teh dejavnosti.
English: Febuxostat at oral doses up to 48 mg/kg/day was found to have no effect on fertility and reproductive performance of male and female rats.
Slovenian: Ugotovili so, da peroralni odmerki do 48 mg/kg/dan febuksostata ne vplivajo na plodnost ali sposobnost razmnoževanja podganjih samcev ali samic.
English: Do not stop taking Febuxostat Mylan without the advice of your doctor even if you feel better.
Slovenian: Če ste prenehali jemati zdravilo Febuksostat Mylan Tudi če se počutite bolje, ne prenehajte jemati zdravila Febuksostat Mylan, razen če vam je to svetoval zdravnik.
English: • stones in the gallbladder or in bile ducts (cholelithiasis)
Slovenian: • žolčni kamni v žolčniku in žolčnih vodih (holelitiaza),
English: • increase in gout symptoms
Slovenian: • povečano pojavljanje znakov protina,
English: On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended.
Slovenian: Na podlagi poznavanja mehanizma delovanja febuksostata na zaviranje ksantinske oksidaze se sočasnega jemanja ne priporoča.
English: 62% of patients required no dose adjustment to maintain sUA <6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose.
Slovenian: Vključenih je bilo 116 bolnikov, ki so prejemalo prvotni odmerek 80 mg febuksostata enkrat na dan. 62 % bolnikov ni potrebovalo prilagajanja odmerka za vzdrževanje sUA <6 mg/dl, 38 % bolnikov pa je potrebovalo prilagoditev odmerjanja, za dosego končnega ciljnega stabilnega odmerka.
English: Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase*
Slovenian: Redki povečanje koncentracije glukoze v krvi, podaljšan aktiviran delni tromboplastinski čas, zmanjšano število rdečih krvnih celic, zvišanje ravni alkalne fosfataze v krvi, povečane vrednosti kreatin fosfokinaze v krvi* * Neželeni učinki iz obdobja trženja.
English: Therefore no special caution is advised when febuxostat 80 mg and theophylline are given concomitantly.
Slovenian: Zato ob sočasnem jemanju 80 mg febuksostata in teofilina ni potrebna posebna previdnost.
English: Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro.
Slovenian: Pokazalo se je, da je febuksostat in vitro šibek zaviralec CYP2D6.
English: It is not known if febuxostat may pass into human breast milk.
Slovenian: Ni znano, ali febuksostat prehaja v materino mleko.
English: Tablet core: lactose (see section 2, “Febuxostat Mylan contains lactose”), microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica, colloidal anhydrous silica, crospovidone and talc.
Slovenian: Jedro tablete: laktoza (glejte poglavje 2, »Vsebnost laktoze in natrija«), mikrokristalna celuloza, magnezijev stearat, hidroksipropilceluloza, premreženi natrijev karmelozat, koloidni hidratirani silicijev dioksid in brezvodni koloidni silicijev dioksid.
English: EXP For bottles: After first opening use within 180 days
Slovenian: EXP: Za plastenke: Po odprtju porabite v roku 180 dni.
English: If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylactic reaction/shock, febuxostat must not be re-started in this patient at any time.
Slovenian: Pri bolnikih, kjer pride do nastanka alergijske/preobčutljivostne reakcije, vključno s Stevens-Johnsonovim sindromom in akutno anafilaktično reakcijo/šokom, se febuksostata ne sme nikoli ponovno uvajati.
English: Organ transplant recipients
Slovenian: Bolniki po presaditvi organa
English: Primary endpoint in the sub group of patients with sUA ≥ 10 mg/dL Approximately 40% of patients (combined APEX and FACT) had a baseline sUA of ≥ 10 mg/dL.
Slovenian: Primarni opazovani dogodek v podskupini bolnikov z vrednostmi sečne kisline v serumu ≥ 10 mg/dl Približno 40 % bolnikov (iz obeh študij APEX in FACT) je imelo izhodiščno vrednost sečne kisline v serumu ≥ 10 mg/dl.
English: Increased TSH values (>5.5 µIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) and patients with allopurinol (5.8%) in the long term open label extension studies (see section 4.4).
Slovenian: V dolgoročnih odprtih podaljšanih študijah so povišane vrednosti TSH (> 5,5 µi.e./ml) opazili pri bolnikih, ki so se dolgoročno zdravili s febuksostatom (5,5 %), in pri bolnikih, ki so se zdravili z alopurinolom (5,8 %) (glejte poglavje 4.4).
English: FLORENCE was a randomized (1:1), double blind, phase III, pivotal trial comparing febuxostat 120 mg once daily with allopurinol 200 to 600 mg daily (mean allopurinol daily dose [± standard deviation]: 349.7 ± 112.90 mg) in terms of control of serum uric acid level.
Slovenian: V študiji FLORENCE, ki je bila randomizirana (1:1), dvojno slepa, pilotska študija 3. faze, so primerjali, kako 120 mg febuksostata enkrat na dan in 200 do 600 mg alopurinola dnevno (povprečni dnevni odmerek alopurinola [± standardna deviacija]: 349,7 ± 112,90 mg), vplivata na serumske vrednosti sečne kisline.
English: The rate of all-cause mortality was also higher with febuxostat than allopurinol (7.8% vs. 6.4% of patients; HR 1.22; 95% CI 1.01-1.47), which was mainly driven by the higher rate of CV deaths in that group (see section 4.4).
Slovenian: Stopnja umrljivosti zaradi kateregakoli vzroka je bil prav tako značilno višja pri uporabi febuksostata kot pri alopurinolu (7,8% v primerjavi z 6,4% bolnikov; HR 1,22; 95% IZ 1,01-1,47), kar je predvsem posledica višje stopnje srčno-žilnih smrti v tej skupini (glejte poglavje 4.4).
English: * p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
Slovenian: p < 0,001 v primerjavi z 80 mg
English: Fatigue, chest pain, chest discomfort Rare
Slovenian: Občasni utrujenost, bolečina v prsnem košu, nelagodje v prsnem košu Redki žeja
English: The rates of the other MACE events were similar in the febuxostat and allopurinol groups, i.e. non-fatal MI (3.6% vs. 3.8% of patients; HR 0.93; 95% CI 0.72-1.21), non-fatal stroke (2.3% vs. 2.3% of patients; HR 1.01; 95% CI 0.73-1.41) and urgent revascularization due to unstable angina (1.6% vs. 1.8% of patients; HR 0.86; 95% CI 0.59-1.26).
Slovenian: Stopnje drugih dogodkov MACE so bile v skupini, ki je prejemala febuksostat podobne kot v skupini, ki je prejemala alopurinol, in sicer: MI brez smrtnega izida (3,6% v primerjavi z 3,8% bolnikov; HR 0,93; 95% IZ 0,72-1,21), možganska kap brez smrtnega izida (2,3% v primerjavi z 2,3% bolnikov; HR 1,01; 95% IZ 0,73-1,41) in nujna revaskularizacija zaradi nestabilne angine pektoris (1,6% v primerjavi z 1,8% bolnikov; HR 0,86; 95% IZ 0,59-1,26).
English: Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
Slovenian: Zavedajte se, da lahko med jemanjem zdravila postanete omotični, zaspani, imate moten vid in začutite otrplost ali ščemenje.
English: Dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia
Slovenian: Občasni omotica, parestezija, hemipareza, somnolenca, spremenjeno okušanje, hipoestezija, zmanjšana sposobnost voha
English: It is unknown whether febuxostat is excreted in human breast milk.
Slovenian: Ni znano, ali se febuksostat izloča v materino mleko pri ljudeh.
English: BOTTLE LABEL
Slovenian: NALEPKA ZA PLASTENKO
English: • increase in blood thyroid stimulating hormone (TSH) level
Slovenian: • povišana raven spodbujevalnega hormona ščitnice (TSH) v krvi,
English: Febuxostat can be co-administered with colchicine or indomethacin with no dose adjustment of febuxostat or the co-administered active substance being necessary.
Slovenian: Febuksostat se lahko daje sočasno s kolhicinom ali indometacinom brez prilagoditve odmerka febuksostata ali zdravilne učinkovine, ki se daje hkrati.
English: • cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis
Slovenian: • kašelj, težko dihanje, nelagodje ali bolečina v prsnem košu, vnetje nosne sluznice ali/in žrela (vnetje zgornjih dihalnih poti), bronhitis,
English: During the phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%).
Slovenian: V kliničnih študijah 3. faze so opazili blage nenormalnosti rezultatov pri testih delovanja jeter pri bolnikih, zdravljenih s febuksostatom (5,0 %).
English: The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali v kliničnem preskušanju (4.072 bolnikov, zdravljenih z odmerkom zdravila od 10 mg do 300 mg) in v obdobju trženja pri bolnikih s protinom so zagoni putike, nenormalnosti delovanja jeter, driska, navzea, glavobol, izpuščaj in edem.
English: A yellow, capsule shaped, biconvex tablet, approximately 18 x 8 mm, debossed with M on one side of the tablet and FX4 on the other side.
Slovenian: Rumene bikonveksne tablete v obliki kapsul, velikosti približno18 × 8 mm, z vtisnjeno oznako »M« na eni in »FX4« na drugi strani.
English: A yellow, capsule shaped, biconvex tablet approximately 16 x 7 mm, debossed with M on one side of the tablet and FX3 on the other side.
Slovenian: Rumene bikonveksne tablete v obliki kapsul, velikosti približno 16 × 7 mm, z vtisnjeno oznako »M« na eni in »FX3« na drugi strani.
English: During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%).
Slovenian: V kombiniranih kliničnih študijah 3. faze so opazili blage nenormalnosti pri rezultatih testov delovanja jeter pri bolnikih, zdravljenih s febuksostatom (5,0 %).
English: The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali v kliničnem preskušanju (4.072 bolnikov, zdravljenih z odmerkom zdravila od 10 mg do 300 mg) in v obdobju trženja so zagoni putike, nenormalnosti delovanja jeter, driska, navzea, glavobol, izpuščaj in edem.
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 120 mg febuksostata dnevno.
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 postbaseline 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: In the analysis of the individual components of MACE, the rate of CV deaths was higher with febuxostat than allopurinol (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Slovenian: Pri analizi posameznih sestavnih elementov MACE je bila stopnja srčno-žilnih smrti značilno višja pri uporabi febuksostata kot pri alopurinolu (4,3% v primerjavi s 3,2% bolnikov; HR 1,34; 95% IZ 1,031,73).
English: Thus, co-administration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Slovenian: Zato ni pričakovati, da bi bilo treba pri sočasnem dajanju febuksostata z drugimi substrati za CYP2D6 prilagoditi odmerek učinkovin.
English: Febuxostat should not be used while breastfeeding.
Slovenian: Febuksostata med dojenjem ne smete uporabljati.
English: Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological, renal or hepatic involvement in some cases.
Slovenian: Resnim preobčutljivostnim reakcijam, vključno z reakcijami na zdravilo z eozinofilijo in sistemskimi simptomi (sindrom DRESS), je v nekaterih primerih pridružena zvišana telesna temperatura, hematološke nepravilnosti in prizadetost ledvic ali jeter.
English: In addition to the urinary excretion, approximately 45% of the dose was recovered in the faeces as the unchanged febuxostat (12%), the acyl glucuronide of the active substance (1%), its known oxidative metabolites and their conjugates (25%), and other unknown metabolites (7%).
Slovenian: Približno 45 % odmerka se je izločilo z blatom, 12 % v obliki nespremenjenega febuksostata, 1 % v obliki acilglukuronida, 25 % v obliki znanih oksidativnih presnovkov in njihovih konjugatov in 7 % v obliki drugih neznanih presnovkov.
English: In patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Slovenian: V redkih primerih lahko absolutna koncentracija ksantina v urinu pri bolnikih z zelo povišano stopnjo nastajanja urata (npr. maligna bolezen in njeno zdravljenje, Lesch-Nyhanov sindrom) naraste toliko, da se pojavi odlaganje v sečilih.
English: However, drugdrug and drug-disease interactions were not explored during this study.
Slovenian: Med študijo ni bilo opravljene raziskave o medsebojnem delovanju med zdravili ter med zdravilom in boleznijo.
English: In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
Slovenian: V dodatni študiji 3. faze CONFIRMS, za katero so bili rezultati na voljo po prvi pridobitvi dovoljenja za promet s febuksostatom, je bil primarni opazovani dogodek učinkovitosti delež bolnikov, pri katerih je bil nivo sečne kisline v serumu na končnem pregledu < 6,0 mg/dl. Bolniki s presajenimi organi niso bili vključeni v študiji (glejte poglavje 4.2).
English: Febuxostat Mylan 80 mg
Slovenian: Febuksostat Mylan 80 mg
English: What Febuxostat Mylan looks like and contents of the pack
Slovenian: Izgled zdravila Febuksostat Mylan in vsebina pakiranja
English: Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms and rare events of sudden cardiac death, have occurred in the post-marketing experience.
Slovenian: V obdobju trženja so poročali o redkih resnih preobčutljivostnih reakcijah na febuksostat, pri čemer so bile nekatere povezane s sistemskimi simptomi, in redkih dogodkih nenadne kardialne smrti.
English: Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Colloidal hydrated silica Colloidal anhydrous silica Crospovidone Talc
Slovenian: 6.1 Seznam pomožnih snovi Jedro tablete laktoza mikrokristalna celuloza magnezijev stearat hidroksipropilceluloza premreženi natrijev karmelozat koloidni hidratirani silicijev dioksid brezvodni koloidni silicijev dioksid krospovidon smukec
English: Note: 509 patients received allopurinol 300 mg QD; 10 patients with serum creatinine >1.5 and ≤2.0 mg/dL were dosed with 100 mg QD.
Slovenian: Opomba: 509 bolnikov je prejemalo alopurinol v odmerku 300 mg enkrat na dan; 10 bolnikov s serumskim kreatininom > 1,5 in ≤ 2,0 mg/dl je prejemalo odmerek 100 mg enkrat na dan (10 od 268 bolnikov v študiji APEX).
English: (PVC/oPA/Alu)/Alu (desiccant embedded) blisters of 14, 28, 84 tablets, calendar blisters of 28, 84 tablets and perforated unit dose blisters of 28 x 1 tablets.
Slovenian: Pretisni omoti iz (PVC/oPA/Alu)/Alu (sušilno sredstvo vdelano) s po 14, 28, 84 tabletami, koledarski pretisni omoti s po 28, 84 tabletami in perforirani pretisni omoti za posamezne odmerke z 28 × 1 tableto.
English: Acute gouty attacks (gout flare)
Slovenian: Akutni zagon protina (izbruhi protina)
English: Each tablet contains 80 mg or 120 mg of febuxostat.
Slovenian: Ena tableta vsebuje 80 mg ali 120 mg febuksostata.
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 an 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: • inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
Slovenian: • vnetje trebušne slinavke: običajni simptomi so bolečina v trebuhu, občutek siljenja na bruhanje in bruhanje,
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: Febuxostat Mylan works by reducing uric acid levels.
Slovenian: Zdravilo Febuksostat Mylan zmanjšuje ravni sečne kisline.
English: • high fever in combination with measles-like skin rash, enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood
Slovenian: • zvišana telesna temperatura v kombinaciji z noricam podobnimi kožnimi izpuščaji, povečani limfatični vozliči, povečanje jeter, hepatitis (vse do jetrne odpovedi), povečano število belih krvničk v krvi (levkociti, z ali brez eozinofilije).
English: With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in febuxostat 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 febuxostat and allopurinol arm, respectively; relative risk:
Slovenian: Pri sekundarnih opazovanih dogodkih ni bilo izmerjenih pomembnih razlik glede incidence laboratorijske TLS (8,1 % pri febuksostatu 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 febuksostatu oziroma 1,2 % pri alopurinolu; relativno tveganje: 0,994 [95 % interval zaupanja: 0,9691; 1,0199]; p=1,0000).
English: Uncommon Hypertension, flushing, hot flush
Slovenian: Občasni hipertenzija, zardevanje, navali vročine