FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively.
Maltese: Fl-istudju CONFIRMS, il-proporzjon ta' pazjenti li kisbu l-fini ewlieni tal-effikaċja (sUA < 6.0 mg/dL fl-aħħar żjara) għall-pazjenti b'livell ta' urate fis-serum mal-linja bażi ta' ≥ 10 mg/dL ikkurati b'febuxostat 40 mg QD kien 27% (66/249), b'febuxostat 80 mg QD 49% (125/254) u b'allopurinol 300 mg/200 mg QD 31% (72/230), rispettivament.
English: Pharmaprim AB Tlf: +468355933
Maltese: Tlf: +468355933
English: ADENURIC 80 mg and 120 mg is available in packs containing 14, 28, 42, 56, 84 and 98 film-coated tablets.
Maltese: ADENURIC 80 mg u 120 mg jiġu f'pakketti li jkun fihom 14, 28, 42, 56, 84 u 98 pilloli miksijin b'rita.
English: 1 results from subjects receiving either 100 mg QD (n=10: patients with serum creatinine >1.5 and ≤2.0 mg/dL) or 300 mg QD (n=509) were pooled for analyses.
Maltese: 1 riżultati minn individwi li rċievew 100 mg QD (n=10: pazjenti bi krejatinina fis-serum >1.5 u ≤2.0 mg/dL) jew 300 mg QD (n=509) inġabru għall-analiżi.
English: Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience.
Maltese: Reazzjonijiet rari u serji għal febuxostat, inkluża Sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika u ta' reazzjoni/xokk anafilattiku, seħħew fl-esperjenza ta' wara t-tqegħid fis-suq.
English: In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively.
Maltese: PYs. Fl-istudji estiżi għal tul ta' żmien, il-frekwenzi tal-episodji APTC irrappurtati mill investigatur kienu 1.2 u 0.6 episodji f'kull 100 PYs għal febuxostat u allopurinol, rispettivament.
English: ADENURIC is for adults.
Maltese: ADENURIC huwa għall-adulti.
English: EU/1/08/447/001 28 film-coated tablets EU/1/08/447/002 84 film-coated tablets EU/1/08/447/005 14 film-coated tablets EU/1/08/447/006 42 film-coated tablets EU/1/08/447/007 56 film-coated tablets EU/1/08/447/008 98 film-coated tablets EU/1/08/447/013 14 film-coated tablets EU/1/08/447/014 28 film-coated tablets EU/1/08/447/015 42 film-coated tablets EU/1/08/447/016 56 film-coated tablets EU/1/08/447/017 84 film-coated tablets EU/1/08/447/018 98 film-coated tablets
Maltese: EU/1/08/447/001 28 pillola miksija b'rita EU/1/08/447/002 84 pillola miksija b'rita EU/1/08/447/005 14-il pillola miksija b'rita EU/1/08/447/006 42 pillola miksija b'rita EU/1/08/447/007 56 pillola miksija b'rita EU/1/08/447/008 98 pillola miksija b'rita EU/1/08/447/013 14-il pillola miksija b'rita EU/1/08/447/014 28 pillola miksija b'rita EU/1/08/447/015 42 pillola miksija b'rita EU/1/08/447/016 56 pillola miksija b'rita EU/1/08/447/017 84 pillola miksija b'rita EU/1/08/447/018 98 pillola miksija b'rita
English: ADENURIC works by reducing uric acid levels.
Maltese: ADENURIC jaħdem billi jnaqqas il-livelli ta' uric acid.
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.
Maltese: Fi studju f'individwi b'saħħithom, 120 mg ADENURIC QD wassal għal żjieda medja ta' 22% fl-AUC ta' desipramine, substrat ta' CYP2D6 u dan jindika l-potenzjal ta' effett inibitorju dgħajjef ta' febuxostat fuq l-enżima CYP2D6 in vivo.
English: To achieve sUA less than 6 mg/dL, the dose of febuxostat was titrated from 40 mg up to 80 mg (regardless of renal function) and the dose of allopurinol was titrated in 100 mg increments from 300 to 600 mg in patients with normal renal function and mild renal impairment and from 200 to 400 mg in patients with moderate renal impairment.
Maltese: Biex tinkiseb sUA inqas minn 6 mg/dL, id-doża ta' febuxostat żdiedet bil-mod il-mod minn 40 mg sa 80 mg (irrispettivament mill-funzjoni tal-kliewi) u d-doża ta' allopurinol żdiedet b'żidiet ta' 100 mg minn 300 sa 600 mg f'pazjenti b'funzjoni normali tal-kliewi u indeboliment ħafif tal-kliewi u minn 200 sa 400 mg f'pazjenti b'indeboliment moderat talkliewi.
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.
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod komuni fi provi kliniċi (4,072 individwi ikkurati b'mill-anqas 10 mg sa' 300 mg) u esperjenza ta' wara t-tqegħid fis-suq f'pazjenti bil-gotta huma aggravar tal-gotta, anormalitajiet fil-funzjoni tal-fwied, dijarea, tqalligħ, uġigħ ta' ras, raxx, u edima.
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Maltese: Fil-prova CARES ta' wara r-reġistrazzjoni (ara sezzjoni 5.1 għal karattersistiċi dettaljati tal-istudju) irrata tal-avvenimenti MACE kienet tixxiebah fil-pazjenti ttrattati b'febuxostat versus allopurinol (HR 1.03; 95% CI 0.87-1.23), iżda ġiet osservata rata aktar għolja ta' mwiet kardjovaskulari (4.3% vs. 3.2% tal-pazjenti; HR 1.34; 95% CI 1.03-1.73).
English: A total of 1,086 patients were enrolled: ADENURIC 80 mg QD (n=649), Adenuric 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145).
Maltese: ADENURIC 80 mg QD (n=649), Adenuric 120 mg QD (n=292) u allopurinol 300mg/100mg QD
English: EU/1/08/447/003 28 film-coated tablets EU/1/08/447/004 84 film-coated tablets EU/1/08/447/009 14 film-coated tablets EU/1/08/447/010 42 film-coated tablets EU/1/08/447/011 56 film-coated tablets EU/1/08/447/012 98 film-coated tablets EU/1/08/447/019 14 film-coated tablets EU/1/08/447/020 28 film-coated tablets EU/1/08/447/021 42 film-coated tablets EU/1/08/447/022 56 film-coated tablets EU/1/08/447/023 84 film-coated tablets EU/1/08/447/024 98 film-coated tablets
Maltese: EU/1/08/447/003 28 pillola miksija b'rita EU/1/08/447/004 84 pillola miksija b'rita EU/1/08/447/009 14 pillola miksija b'rita EU/1/08/447/010 42 pillola miksija b'rita EU/1/08/447/011 56 pillola miksija b'rita EU/1/08/447/012 98 pillola miksija b'rita EU/1/08/447/019 14-il pillola miksija b'rita EU/1/08/447/020 28 pillola miksija b'rita EU/1/08/447/021 42 pillola miksija b'rita EU/1/08/447/022 56 pillola miksija b'rita EU/1/08/447/023 84 pillola miksija b'rita EU/1/08/447/024 98 pillola miksija b'rita
English: In vitro studies with human liver microsomes showed that those oxidative metabolites were formed primarily by CYP1A1, CYP1A2, CYP2C8 or CYP2C9 and febuxostat glucuronide was formed mainly by UGT 1A1, 1A8, and 1A9.
Maltese: CYP2C9 u febuxostat glucuronide kien iffurmat primarjament minn UGT 1A1, 1A8, u 1A9 Eliminazzjoni
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.
Maltese: 45% għal 40 mg febuxostat, 67% għal febuxostat 80 mg u 42% għal allopurinol 300/200 mg,
English: 46% and 38%, of patients on final stable treatment of febuxostat 80 or 120 mg QD, respectively, had complete resolution of the primary palpable tophus from baseline to the Final Visit.
Maltese: 46% u 38% tal-pazjenti fuq il-kura finali stabbli ta' febuxostat 80 jew 120 mg QD, rispettivament,
English: • reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)
Maltese: • tiħmar il-ġilda (eritema), diversi tipi ta' raxx(eż. bil-ħakk, b'tikkek bojod, bil-ponot, bil-ponot bil-materja, bil-ġilda titqaxxar, raxx bħal tal-ħosba), eritema mifruxa, nekrosi, u nfafet maqlugħa tal-epidermi u r-riti mukużi, li jirriżultaw fi tqaxxir u possibbilment f'sepsis (Sindrome ta'
English: Rare Anaphylactic reaction*, drug hypersensitivity*
Maltese: Reazzjoni anafilattika*, sensittività eċċessiva għall-mediċina*
English: The APEX study showed statistically significant superiority of both the ADENURIC 80 mg QD and the ADENURIC 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n = 258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 µmol/L) (see Table 2 and Figure 1).
Maltese: 80 mg QD u ta' ADENURIC 120 mg QD versus il-grupp ta' kura ta' dożi konvenzjonali ta' allopurinol 300 mg (n = 258) /100 mg (n = 10), biex inaqqsu l-sUA taħt 6 mg/dL (357 µmol/L) (ara Tabella 2 u Figura 1).
English: Also contains lactose (as monohydrate).
Maltese: Fih ukoll lactose (bhala monohydrate).
English: Each tablet contains 120 mg of febuxostat.
Maltese: Kull pillola fiha 120 mg febuxostat.
English: Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Maltese: hypoxanthine → xanthine → uric acid.
English: ADENURIC is available as a 120 mg tablet.
Maltese: ADENURIC huwa disponibbli bħala pillola ta' 120 mg.
English: BL=baseline SEM=standard error of the mean
Maltese: BL= linja bażi
English: See the package leaflet for further information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Rare Pancytopenia, thrombocytopenia, agranulocytosis*
Maltese: Rari Nefrite fit-tubuli tal-interstizzju*, urġenza biex tgħaddi l-awrina
English: APEX (28 weeks)
Maltese: (28 ġimgħa)
English: ADENURIC is available as either an 80 mg tablet or a 120 mg tablet.
Maltese: ADENURIC huwa disponibbli bħala pillola ta' 80 mg jew bħala pillola ta' 120 mg.
English: Based on modelling and simulation analysis of data from a pre-clinical study in rats, when coadministered with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.5 and 5.3).
Maltese: Abbażi ta' analiżi tad-dejta b'immudellar u simulazzjoni minn studju ta' qabel l-użu kliniku fil-firien, meta tingħata flimkien ma' febuxostat, id-doża ta' mercaptopurine/azathioprine għandha titnaqqas għall-20% jew anqas tad-doża li kienet ġiet ordnata qabel sabiex jiġu evitati effetti ematoloġiċi possibbli (ara sezzjoni 4.5 u 5.3).
English: Excipient(s) with known effects:
Maltese: Eċċipjent(i) b'effett magħruf:
English: Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis Rare
Maltese: spażmi fil-muskoli, ebusija fil-muskoli, bursite Rari
English: The FACT study showed the statistically significant superiority of both ADENURIC 80 mg and ADENURIC 120 mg QD treatment arms versus the conventionally used dose of allopurinol 300 mg treatment arm in reducing and maintaining sUA below 6 mg/dL (357 µmol/L).
Maltese: L-istudju FACT wera superjorità statistikament sinifikanti taż-żewġ gruppi ta' kura ta' ADENURIC 80 mg u ta' ADENURIC 120 mg QD versus il-grupp ta' kura ta' doża konvenzjonali ta' allopurinol 300 mg, biex inaqqsu u jżommu l-sUA taħt 6 mg/dL (357 µmol/L).
English: Film-coated tablet (tablets).
Maltese: Pillola miksija b'rita (pillola).
English: Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o
Maltese: Menarini Distribution Slovakia s.r.o
English: APEX study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%).
Maltese: Waqt il-perijodu ta' 8-ġimgħat ta' profilassi, proporzjon akbar ta' pazjenti fil-grupp ta' kura b'120 mg febuxostat (36%) kienu jeħtieġu kura għall-aggravar tal-gotta meta mqabbla ma' febuxostat 80 mg (28%), allopurinol 300 mg (23%) u plaċebo (20%).
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.
Maltese: kien hemm tnaqqis ta' 49% u ta' 38% f'Cmax u tnaqqis ta' 18% u 16% fl-AUC, rispettivament.
English: However, no clinically significant change in the percent decrease in serum uric acid concentration was observed where tested (80 mg multiple dose).
Maltese: uric acid fis-serum fejn ġie ttestjat (doża multipla ta' 80 mg).
English: FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study.
Maltese: ta' Fażi 3, randomised, double-blind u multicenter.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati f'sezzjoni 6.1 (ara wkoll sezzjoni 4.8).
English: Hypersensitivity reactions to febuxostat can be associated to the following symptoms: skin reactions characterised by infiltrated maculopapular eruption, generalised or exfoliative rashes, but also skin lesions, facial oedema, fever, haematologic abnormalities such as thrombocytopenia and eosinophilia, and single or multiple organ involvement (liver and kidney including tubulointerstitial nephritis) (see section 4.4).
Maltese: Reazzjonijiet ta' sensittività eċċessiva għal febuxostat jistgħu jiġu assoċjati mas-sintomi li ġejjin: reazzjonijiet tal-ġilda karatterizzata b'eruzzjoni ta' infiltrazzjoni makulopapulari, raxxijiet mal-ġisem kollu jew bi qxur, iżda wkoll feriti fil-ġilda, edima fil-wiċċ, deni, anormalitajiet tad-demm bħal tromboċitopenija u eosinofilja, u l-involviment ta' wieħed jew aktar organi (fwied u kliewi inkluża nefrite fit-tubuli tal interstizzju)
English: The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357μmol/L).
Maltese: Il-mira terapewtika hija li l-uric acid fis-serum jitnaqqas u jinżamm taħt 6 mg/dL (357μmol/L).
English: In this subgroup ADENURIC achieved the primary efficacy endpoint (sUA < 6.0 mg/dL at the last 3 visits) in 41% (80 mg QD), 48% (120 mg QD), and 66% (240 mg QD) of patients compared to 9% in the allopurinol 300 mg/100 mg QD and 0 % in the placebo groups.
Maltese: F'dan is-sottogrupp ADENURIC laħaq l-mira primarja tal-effikaċja (sUA < 6.0 mg/dL fl-aħħar 3 żjajar) f'41% (80 mg QD), 48% (120 mg QD), u 66% (240 mg QD) tal-pazjenti meta mqabbel ma' 9% fil-grupp ta' allopurinol 300 mg/100 mg QD u 0 % fil-grupp tal-plaċebo.
English: Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Febuxostat is a potent, non-purine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar.
Maltese: Febuxostat huwa derivattiv ta' 2-arylthiazole li jilħaq l-effett terapewtiku tiegħu li jnaqqas il-uric acid fis-serum billi jinibixxi b'mod selettiv lil XO.
English: Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with febuxostat, the clinical dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.4 and 4.5).
Maltese: jew anqas tad-doża li kienet ġiet ordnata qabel sabiex jiġu evitati effetti ematoloġiċi possibbli (ara sezzjoni 4.4 u 4.5).
English: labeled febuxostat, approximately 49% of the dose was recovered in the urine as unchanged febuxostat (3%), the acyl glucuronide of the active substance (30%), its known oxidative metabolites and their conjugates (13%), and other unknown metabolites (3%).
Maltese: Wara doża orali ta' 80 mg ta' febuxostat tikkettjat b'14C, madwar 49% tad-doża kienet irkuprata fl-awrina bħala febuxostat mhux mibdul (3%), l-acyl glucuronide tas-sustanza attiva (30%), il-metaboliti ossidattivi magħrufa tiegħu u l-konjugati tagħhom (13%), u metaboliti mhux magħrufa oħra (3%).
English: • feeling thirsty
Maltese: Tqala u Treddigħ
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.
Maltese: Klassi A) jew moderat (Child-Pugh Klassi B), Cmax u l-AUC ta' febuxostat u l-metaboliti tiegħu ma nbidlux b'mod sinifikanti meta mqabbel ma' individwi b'funzjoni epatika normali.
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).
Maltese: ADENURIC hu indikat għal trattament ta' iperuriċimja kronika f'kundizzjonijiet fejn diġà seħħet depożizzjoni ta' urate (inkluż passat, jew preżenza ta' artrite tofus u/jew tal-gotta).
English: • blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly
Maltese: • demm fl-awrina, awrina frekwenti aktar mis-soltu, testijiet tal-awrina mhux normali (żjieda fil livell ta' proteini fl-awrina), tnaqqis fil-ħila tal-kliewi li jaħdmu kif suppost
English: Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity.No interaction studies have been performed in humans.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib u d-doża ta' mercaptopurine/azathioprine għandha sussegwentement tiġi aġġustata abbażi tal-evalwazzjoni tar-rispons terapewtiku u l-bidu eventwali tal effetti tossiċi.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience in gout patients.
Maltese: Tabella 1: Reazzjonijiet avversi kombinati fil-Fazi 3 fl-istudji estiżi fit-tul u esperjenza ta' wara ttqegħid fis-suq bil-gotta.
English: ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped.
Maltese: ADENURIC, pilloli miksija b'rita huma ta' kulur isfar ċar għal isfar u b'forma ta' kapsula.
English: • Do not use this medicine after the expiry date which is stated on the carton and the tablet blister foil after ‘EXP.'
Maltese: • Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna u fuq il-kisja tal-folja bilpilloli wara ‘JIS'.
English: Toxic epidermal necrolysis*, Stevens-Johnson Syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalized rash (serious)*, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic*, rash erythematous, rash morbillifom, alopecia, hyperhidrosis
Maltese: anġjoedema*, reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi*, raxx mal-ġisem kollu (serju)*, ħmura, raxx bil-qxur,
English: Pharmaprim AB Sími: +468355933
Maltese: Sími: +468355933
English: Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular Rare
Maltese: petekje, raxx makulari, raxx makulopapulari, raxx papulari Rari
English: Antacids
Maltese: Anzjani
English: *** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies.
Maltese: *** Ara sezzjoni 5.1 għall-frekwenzi tal-aggravar tal-gotta fl-istudji kontrollati randomized ta'
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.
Maltese: L-effikaċja ta' ADENURIC intweriet f'tlett studji pivotali ta' Fażi 3 (iż-żewġ studji pivitali APEX u FACT, u l-istudju ieħor addizzjonali CONFIRMS deskritti hawn taħt) li twettqgħu f'4101 pazjent b'iperuriċimja u gotta.
English: The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornamenti sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Two thousand and two hundred-sixty nine (2269) patients were randomized: ADENURIC 40 mg QD (n=757), ADENURIC 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756).
Maltese: QD (n=756), jew allopurinol 300/200 mg QD (n=756).
English: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2).
Maltese: krejatinina <30 mL/min, ara sezzjoni 5.2).
English: What ADENURIC looks like and contents of the pack
Maltese: Id-dehra ta' ADENURIC u l-kontenuti tal-pakkett
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).
Maltese: ADENURIC hu indikat għal prevenzjoni u trattament ta' iperuriċemija f'pazjenti adulti fuq kimoterapija għal malinni ematoloġiċi f'riskju intermedjarju sa għoli ta' Sindrome ta' Lisi ta' Tumur
English: If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, ADENURIC 120 mg once daily may be considered.
Maltese: Jekk wara 2-4 ġimgħat il-uric acid fis-serum ikun > 6 mg/dL (357 µmol/L), jista' jiġi kkunsidrat ADENURIC 120 mg darba kuljum.
English: ADENURIC 80 mg film-coated tablets Febuxostat
Maltese: ADENURIC 80 mg pilloli miksija b'rita Febuxostat
English: Pharmaprim AB Tel: +468355933
Maltese: Tel: +468355933
English: Package leaflet: Information for the user ADENURIC 80 mg film-coated tablets ADENURIC 120 mg film-coated tablets
Maltese: ADENURIC 80 mg pilloli miksija b'rita ADENURIC 120 mg pilloli miksija b'rita
English: There were no clinically significant differences in the percent decrease in serum uric acid concentration in healthy subjects irrespective of their renal function (58% in the normal renal function group and 55% in the severe renal dysfunction group).
Maltese: (58 % fil-grupp b'funzjoni tal-kliewi normali u 55% fil-grupp b'indeboliment sever tal-funzjoni talkliewi).
English: In general, febuxostat pharmacokinetic parameters estimated by these analyses are consistent with those obtained from healthy subjects, indicating that healthy subjects are representative for pharmacokinetic/pharmacodynamic assessment in the patient population with gout.
Maltese: Ġeneralment, il-parametri farmakokinetiċi ta' febuxostat stmati minn dawn l-analiżi huma konsistenti ma' dawk miksuba minn individwi b'saħħithom, u dan jindika li individwi b'saħħithom huma rappreżentattivi għall-valutazzjoni farmakokinetika /
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.
Maltese: Sintomi ta' reazzjonijiet allerġiċi li jista' jkun hemm jistgħu jinkludu: - raxx inklużi forom ħarxa (eż bżieżaq, noduli, raxx bil-ħakk, bil-qxur), ħakk - nefħa tar-riġlejn, dirgħajn jew wiċċ - tbatija biex tieħu n-nifs - deni bl-għenieqed limfatiċi minfuħa - iżda wkoll kondizzjonijiet allerġiċi li jistgħu jkunu ta' theddida għall-ħajja b'arrest kardijaku jew ċirkolatorju.