FrancophonIA/ELRC3.0 huggingface dataset:
English: V.J.
Maltese: U L-UŻU
English: During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%).
Maltese: Waqt studji kliniċi kombinati ta' fażi 3, kienu osservati anormalitajiet ħfief fit-test tal-funzjoni talfwied f'pazjenti kkurati b'febuxostat (5.0%).
English: The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Maltese: L-effikaċja u s-sigurtà ta' febuxostat ma ġewx studjati f'pazjenti b'indeboliment epatiku sever (Child Pugh Klassi Ċ).
English: Reproductive system and breast disorder
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: Each tablet contains 80 mg of febuxostat.
Maltese: Kull pillola fiha 80 mg febuxostat.
English: Continuous treatment with febuxostat decreases frequency and intensity of gout flares.
Maltese: Kura kontinwa b'febuxostat tnaqqas il-frekwenza u l-intensità tal-irkadar tal-gotta.
English: Figure 1 Mean Serum Uric Acid Levels in Combined Pivotal Phase 3 Studies
Maltese: Figura 1 Livelli Medji Kombinati ta' Uric Acid fis-Serum fl-Istudji Pivitali ta' Fażi 3
English: Thyroid disorders
Maltese: Disturbi fit-tirojde
English: Plasma protein binding of the active metabolites ranges from about 82% to
Maltese: It-twaħħil mal-proteini fil-plażma tal-metaboliti attivi jvarja minn madwar 82% sa 91%.
English: Vascular disorders: Uncommon: haemorrhage
Maltese: Mhux komuni: Emorraġija
English: FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004.
Maltese: L-istudju FOCUS (TMX-01-005) kien studju ta' 5 snin ta' Fażi 2, open-label, multiċentriku, ta' estenzjoni dwar is-sigurtà għall-pazjenti li kienu temmew l-istudju TMX-00-004 ta' 4 ġimgħat b'febuxostat b'dużaġġ double blind.
English: The other ingredients are:
Maltese: Effetti vaskulari:
English: Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness
Maltese: Rabdomajelosi*, ebusija tal-ġogi, ebusija muskolu-skeletrali
English: FRI
Maltese: Tqala
English: Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro.
Maltese: Intwera li febuxostat huwa inibitur dgħajjef ta' CYP2D6 in vitro.
English: • Mercaptopurine (used to treat cancer)
Maltese: • Mercaptopurine (użat biex jikkura l-kanċer)
English: Two thousand and two hundred-sixty nine (2269) patients were randomized: febuxostat 40 mg QD (n=757), febuxostat 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756).
Maltese: Elfejn mitejn u disgħa u sittin (2269) pazjent kienu mgħażulin għall-għarrieda: febuxostat 40 mg QD (n=757), febuxostat 80 mg QD (n=756), jew allopurinol 300/200 mg QD (n=756).
English: A standard battery of test for genotoxicity did not reveal any biologically relevant genotoxic effects for febuxostat.
Maltese: Sensiela ta' testijiet standard għall-ġenotossiċità ma wrew l-ebda effetti ġenotossiċi rilevanti bioloġikament għal febuxostat.
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 talinterstizzju) (ara sezzjoni 4.4).
English: Date of first authorisation: 15 June 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 Ġunju 2017
English: EU/1/17/1194/007 EU/1/17/1194/008 EU/1/17/1194/017 EU/1/17/1194/018 EU/1/17/1194/019 EU/1/17/1194/020 EU/1/17/1194/021 EU/1/17/1194/022
Maltese: EU/1/17/1194/007 EU/1/17/1194/008 EU/1/17/1194/017 EU/1/17/1194/018 EU/1/17/1194/019 EU/1/17/1194/020
English: Each tablet contains 80 mg or 120 mg of febuxostat.
Maltese: Kull pillola fiha 80 mg jew 120 mg ta' febuxostat.
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: Wara dożi orali multipli ta' 80 mg darba kuljum jew doża waħda ta' 120 mg ma' ikla b'ħafna xaħam, kien hemm tnaqqis ta' 49% u ta' 38% f'Cmax u tnaqqis ta' 18% u 16% fl-AUC, rispettivament.
English: Overall 56.6% of patients discontinued trial treatment prematurely and 45% of patients did not complete all trial visits.
Maltese: Globalment 56.6% tal-pazjenti waqqfu t-trattament tal-prova qabel iż-żmien u 45% tal-pazjenti ma temmewx il-visti kollha tal-prova.
English: At least 65% of the patients had mild-moderate renal impairment (with creatinine clearance of 30-89 mL/min).
Maltese: Mill-anqas 65% tal-pazjenti kellhom indeboliment renali ħafif-moderat (bi tneħħija tal-krejatinina ta' 30-89 mL/min).
English: Rare reports of serious allergic/hypersensitivity reactions, including life-threatening StevensJohnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
Maltese: Rapporti rari ħafna ta' reazzjonijiet serji ta' allerġija/sensittività eċċessiva, inkluża s-Sindrome Stevens-Johnson, nekrolisi epidermali tossika, li kienu ta' theddida għall-ħajja u reazzjoni anafilattika akuta/ xokk, kienu miġbura waqt l-esperjenza ta' wara t-tqegħid fis-suq.
English: Primary endpoints were serum uric acid area under the curve (AUC sUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8.
Maltese: Il-punti aħħarin prinċipali kienu l-erja taħt il-kurva (AUC sUA1-8) ta' uric acid fis-serum u l-bidla fil-livell ta' kreatinina fis-serum (serum creatinine, sC) it-tnejn mil-linja ta' riferiment bażi sa Jum 8.
English: Lactose and Sodium content
Maltese: Kontenut tal-Lactose u tas-Sodium
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: Ma kien hemm l-ebda differenza ta' sinifikanza klinika fil-perċentwali ta' tnaqqis fil-konċentrazzjoni ta' uric acid fis-serum f'individwi b'saħħithom irrispettivament mill-funzjoni tal-kliewi tagħhom (58 % fil-grupp b'funzjoni tal-kliewi normali u 55% fil-grupp b'indeboliment sever tal-funzjoni talkliewi).
English: Gout
Maltese: Gotta
English: The ability of febuxostat to lower serum uric acid levels was prompt and persistent.
Maltese: Il-ħila ta' febuxostat biex ibaxxi l-livelli ta' uric acid fis-serum kienet immedjata u persistenti.
English: Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular Rare
Maltese: Dermatite, urtikarja, ħakk, ġilda titlef il-kulur, ferita fil-ġilda, petekje, raxx makulari, raxx makulopapulari, raxx papulari Rari
English: The primary MACE endpoint occurred at similar rates in the febuxostat and allopurinol treatment groups (10.8% vs. 10.4% of patients, respectively; hazard ratio [HR] 1.03; two-sided repeated 95% confidence interval [CI] 0.87-1.23).
Maltese: 4% tal-pazjenti, rispettivament; proporzjon ta' periklu [HR, hazard ratio] 1.03; intervall ta' kunfidenza ta' 95% ripetut, two-sided [CI, confidence interval] 0.87-1.23).
English: • yellowing of the skin (jaundice)
Maltese: • tisfar il-ġilda (suffejra)
English: Following an 80 mg oral dose of C-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: C, 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: 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).
Maltese: Fl-analiżi tal-komponenti individwali ta' MACE, ir-rata ta' mwiet CV kienet ogħla b'febuxostat milli b'allopurinol (4.3% vs. 3.2% tal-pazjenti; HR 1.34; 95% CI 1.03-1.73).
English: Febuxostat Mylan tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Febuxostat Mylan fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the postmarketing 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: The APEX study showed statistically significant superiority of both the febuxostat 80 mg QD and the febuxostat 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: L-istudju APEX wera superjorità statistikament sinifikanti taż-żewġ gruppi ta' kura ta' febuxostat 80 mg QD u ta' febuxostat 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: Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below.
Maltese: Reazzjonijiet avversi komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) u rari (1/10,000 sa <1/1000) li seħħew f'pazjenti ikkurati b'febuxostat huma mniżżla hawn taħt.
English: Febuxostat Mylan tablets contain lactose (a type of sugar).
Maltese: Pilloli Febuxostat Mylan fihom lactose (tip ta' zokkor).
English: Medicinal products that inhibit glucuronidation, such as NSAIDs and probenecid, could in theory affect the elimination of febuxostat.
Maltese: Prodotti mediċinali li jinibixxu l-glukuronidazzjoni, bħal NSAIDs u probenecid, teoretikament jistgħu jaffettwaw l-eliminazzjoni ta' febuxostat.
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.
Maltese: Nota: 509 pazjent irċievew allopurinol 300 mg QD; 10 pazjenti bi krejatinina fis-serum >1.5 u ≤ 2.0 mg/dL kienu dożati b'100 mg QD. (10 pazjenti minn 268 fl-istudju APEX).
English: Should you experience allergic reactions to Febuxostat Mylan, stop taking this medicine (see also section 4).
Maltese: Jekk ikollok reazzjonijiet allerġiċi għal Febuxostat Mylan, waqqaf din il-mediċina (ara wkoll sezzjoni 4).
English: Teratology studies, performed in pregnant rats at approximately 4.3 times and pregnant rabbits at approximately 13 times human exposure did not reveal any teratogenic effects.
Maltese: Studji teratoloġiċi, li twettqu f'firien tqal f'madwar 4.3 darbiet u fi fniek tqal f'madwar 13-il darba lesponiment uman ma wrew l-ebda effetti teratoġeniċi.
English: Long-term, open label extension Studies
Maltese: Studji ta' estenzjoni fit-tul open label
English: In a study in healthy subjects, 120 mg febuxostat 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 febuxostat 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: Oedema
Maltese: Edima
English: During the phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%).
Maltese: Waqt l-istudji kliniċi ta' fażi 3, kienu osservati anormalitajiet ħfief fit-test tal-funzjoni tal-fwied f'pazjenti kkurati b'febuxostat (5.0%).
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 84 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets (calendar) 84 film-coated tablets (calendar)
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksija b'rita 84 pillola miksija b'rita 28 × 1 pillola miksija b'rita 28 pillola miksija b'rita (kalendarju) 84 pillola miksija b'rita (kalendarju)
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, irriżultaw għal fejqan komplut tat-tofus palpabbli mill-linja bażi fl-Aħħar
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 fillivell ta' proteini fl-awrina), tnaqqis fil-ħila tal-kliewi li jaħdmu kif suppost
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%).
Maltese: Barra mit-tneħħija fl-awrina, madwar 45% tad-doża kienet irkuprata fl-ippurgar bħala febuxostat mhux mibdul (12%), l-acyl glucuronide tas-sustanza attiva (1%), il-metaboliti ossidattivi magħrufa tiegħu u l-konjugati tagħhom (25%), u metaboliti mhux magħrufa oħra (7%).
English: In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA <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: Cholelithiasis
Maltese: Kolelitijasi
English: Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat C 120 mg QD (n=251), or allopurinol 300 mg QD (n=253).
Maltese: Seba' mija u sittin (760) pazjent kienu randomised: febuxostat 80 mg QD (n=256), febuxostat C 120 mg QD (n=251), jew allopurinol 300 mg QD (n=253).
English: EXPIRY DATE
Maltese: DATA TA 'SKADENZA
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Febuxostat Mylan is for adults.
Maltese: Febuxostat Mylan huwa għall-adulti.
English: EXP
Maltese: ERB
English: Febuxostat Mylan tablets contain lactose.
Maltese: Pilloli Febuxostat Mylan fihom lactose.
English: Seven hundred sixty (760) patients were randomized: febuxostat 80 mg QD (n=256), febuxostat 120 mg QD (n=251), or allopurinol 300 mg QD (n=253).
Maltese: Seba' mija u sittin (760) pazjent kienu randomised: febuxostat 80 mg QD (n=256), febuxostat 120 mg QD (n=251), jew allopurinol 300 mg QD (n=253).
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 huma aggravar tal-gotta, anormalitajiet fil-funzjoni tal-fwied, dijarea, tqalligħ, uġigħ ta' ras, raxx, u edima.
English: Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Maltese: Tabella 2 Proporzjon ta' Pazjenti b'Livelli ta' Uric Acid fis-Serum <6.0 mg/dL (357µmol/L)
English: Following multiple doses of 80 mg of febuxostat in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function.
Maltese: Wara dożi multipli ta' 80 mg ta' febuxostat f'pazjenti b'indeboliment renali ħafif, moderata jew severa, Cmax ta' febuxostat ma nbidilx, relattivament għall-individwi b'funzjoni renali normali.
English: • headache
Maltese: • dardir
English: Febuxostat Mylan 80 mg film-coated tablets Febuxostat Mylan 120 mg film-coated tablets febuxostat
Maltese: Informazzjoni għall-pazjent Febuxostat Mylan 80 mg pilloli miksija b'rita Febuxostat Mylan 120 mg pilloli miksija b'rita febuxostat
English: Gout flares during the last 4 weeks of the study (Weeks 24-28) were observed in 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) and 20% (placebo) of subjects.
Maltese: L-aggravar tal-gotta fl-aħħar 4 ġimgħat tal-istudju (Ġimgħat 24-28) deher fi 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) u 20% (plaċebo) tal-individwi.
English: A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
Maltese: Frekwenza numerikament akbar ta'episodji APTC kardjovaskulari irrappurtati mill-investigatur (fini definiti mill-Kollaborazzjoni tat-Trijalisti Kontra l-Plejtlits (APTC) li kienu jinkludu mewt kardjovaskulari, infart mijokardijaku mhux fatali, puplesija mhux fatali) dehru fil-grupp totali fuq febuxostat meta mqabbla mal-grupp fuq allopurinol fl-istudji APEX u FACT (1.3 vs 0.3 episodji f'kull 100
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: Immudellar farmakokinetiku u simulazzjoni farmakokinetika ta' dejta mill-firien tindika li, meta jingħata flimkien ma' febuxostat, id-doża ta' mercaptopurine/azathioprine għandha titnaqqas għal 20% jew anqas tad-doża li kienet ġiet ordnata qabel sabiex jiġu evitati effetti ematoloġiċi possibbli (ara sezzjoni 4.4 u 4.5).
English: Posology
Maltese: Antaċidi
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 0.87-1.23), 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: CARES Study was a multicenter, randomized, double-blind, non inferiority trial comparing CV outcomes with febuxostat versus allopurinol in patients with gout and a history of major CV disease including MI, hospitalization for unstable angina, coronary or cerebral revascularization procedure, stroke, hospitalized transient ischemic attack, peripheral vascular disease, or diabetes mellitus with evidence of microvascular or macrovascular disease.
Maltese: L-istudju CARES kien prova b'ħafna ċentri, arbitrarja, ta' nuqqas ta' inferjorità, fejn la linvestigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, li qabbel riżultati CV (cardiovascular - kardjovaskulari) b'febuxostat versus allopurinol f'pazjenti bil-gotta u storja ta' mard CV serju inklużi MI (myocardial infarction - infart mijokardijaku), rikoverar lisptar għal anġina mhux stabbli, proċedura ta' vaskularizzazzjoni mill-ġdid ta' arterja fil-qalb jew fil-moħħ, puplesija, rikoverar l-isptar għal attakk iskemiku temporanju, mard vaskulari periferali, jew dijabete mellitus b'xhieda ta' mard mikrovaskulari jew makrovaskulari.
English: These rates were similar to the rates reported on allopurinol (4.2%) (see section 4.4).
Maltese: Dawn ir-rati kienu simili għar-rati rrapportati b'allopurinol (4.2%) (ara sezzjoni 4.4).
English: In a study in healthy subjects, coadministration of 120 mg febuxostat QD with a single 4 mg oral dose of rosiglitazone had no effect on the pharmacokinetics of rosiglitazone and its metabolite N-desmethyl rosiglitazone, indicating that febuxostat is not a CYP2C8 enzyme inhibitor in vivo.
Maltese: Fi studju fuq individwi b'saħħithom, meta febuxostat 120 mg ingħata QD ma' doża waħda orali ta' rosiglitazone ma kienx hemm effett fuq il-farmakokinetika ta' rosiglitazone u l-metabolu tiegħu N-desmethyl rosiglitazone, li juri li febuxostat mhuwiex inibitur tal-enzima CYP2C8 in vitro.
English: A risk to a suckling infant cannot be excluded.
Maltese: Irriskju gћat-trabi tat-twelid mhux eskluż.
English: EU/1/17/1194/001 EU/1/17/1194/002 EU/1/17/1194/003 EU/1/17/1194/004 EU/1/17/1194/005 EU/1/17/1194/006
Maltese: EU/1/17/1194/001 EU/1/17/1194/002 EU/1/17/1194/003 EU/1/17/1194/004
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.
Maltese: Il-proporzjon ta' pazjenti b'livelli ta' urate fis-serum ta' <6.0 mg/dL (357 µmol/L) fl-aħħar żjara kien akbar minn 80% (81-100%) ma' kull doża ta' febuxostat.
English: Diarrhoea**, nausea
Maltese: Dijarea**, tqalligħ
English: Rare side effects (may affect up to 1 in 1,000 people) are:
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa'1 f'kull 1,000 persuna) huma:
English: • potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens- Johnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2)
Maltese: • raxxijiet li jistgħu jkunu ta' theddida għall-ħajja li għandhom karatteristika li jiffurmaw ponot u titqaxxar il-ġilda u s-superfiċji interni tad-daħliet fil-ġisem, eż ħalq u ġenitali, ulċeri bl-uġigħ filħalq u/jew partijiet ġenitali, flimkien ma' deni, grieżem misluħin u għeja (Sindrome ta' Stevens Johnsons/Nekrolisi Epidermali Tossika), jew b'għenieqed limfatiċi minfuħa, fwied minfuħ, epatite (sa insuffiċjenza tal-fwied), għadd aktar għoli taċ-ċelluli bojod tad-demm (reazzjoni talmediċina b'eosinofilja u sintomi sistemiċi -DRESS) (ara sezzjoni 2)