FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing 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: 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 (Serum Uric Acid) inqas minn 6 mg/dL, id-doża ta' febuxostat żdiedet bil-mod ilmod 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: Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience Blood and lymphatic system disorders
Maltese: Tabella 1: Reazzjonijiet avversi kombinati fil-Fazi 3 fl-istudji estiżi fit-tul u esperjenza ta' wara ttqegħid fis-suq Disturbi tad-demm u tas-sistema limfatika
English: Hepatitis, jaundice*, liver injury*
Maltese: Epatite, suffejra*, ġerħa fil-fwied*
English: Febuxostat Mylan 120 mg film-coated tablets febuxostat
Maltese: Febuxostat Mylan 120 mg pilloli miksija b'rita febuxostat
English: CONFIRMS Study: The CONFIRMS study was a Phase 3, randomized, controlled, 26-week study to evaluate the safety and efficacy of febuxostat 40 mg and 80 mg, in comparison with allopurinol 300 mg or 200 mg, in patients with gout and hyperuricaemia.
Maltese: L-istudju CONFIRMS kien studju ta' Fażi 3, randomized, kontrollat, ta' 26ġimgħa biex jevalwa s-sigurtà u l-effikaċja ta' febuxostat 40 mg u 80 mg, meta mqabbel ma' allopurinol 300 mg jew 200 mg, f'pazjenti bil-gotta u iperuriċemija.
English: In healthy subjects, maximum plasma concentrations (Cmax) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg to 120 mg. For doses between 120 mg and 300 mg, a greater than dose proportional increase in AUC is observed for febuxostat.
Maltese: F'individwi b'saħħithom, konċentrazzjonijiet massimi fil-plażma (Cmax) u l-erja taħt il-kurva talkonċentrazzjoni fil-plażma u l-ħin (AUC) ta' febuxostat żdiedu f'mod proporzjonali mad-doża wara doża waħda u dożi multipli ta' 10 mg sa 120 mg.
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 section 4.8 and 5.1).
Maltese: Jista' jseħħ irkadar tal-gotta waqt il-bidu tal-kura minħabba tibdil fil-livelli ta' uric acid fis-serum li jwassal għal mobilizzazzjoni ta' urate mid-depożiti fit-tessut (ara sezzjoni 4.8 u 5.1).
English: Gout flares during the last 4 weeks of the study (Weeks 49-52) were observed in 6-8% (febuxostat 80 mg, 120 mg) and 11% (allopurinol 300 mg) of subjects.
Maltese: L-aggravar tal-gotta waqt l-aħħar 4 ġimgħat (Ġimgħat 49-52) deher f'6-8% (febuxostat 80 mg, 120 mg) u 11% (allopurinol 300 mg) tal-individwi.
English: Excipient with known effect Each tablet contains 236.0 mg of lactose.
Maltese: Kull pillola fiha 236.0 mg ta' lactose.
English: In this subgroup febuxostat 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 febuxostat 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% filgrupp ta' allopurinol 300 mg/100 mg QD u 0 % fil-grupp tal-plaċebo.
English: Rare Pancytopenia, thrombocytopenia, agranulocytosis*
Maltese: Rari Panċitopenija, tromboċitopenija, agranuloċitożi*
English: Common*** Gout flares Uncommon
Maltese: • riżultati tat-test tal-fwied mhux normali
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.
Maltese: Febuxostat f'dożi orali sa 48 mg/kg/kuljum instab li ma għandu l-ebda effett fuq il-fertilità u l-ħila riproduttiva ta' firien maskili u femminili.
English: Where the combination cannot be avoided, a reduction of the dose of mercaptopurine/azathioprine is recommended.
Maltese: Meta l-użu fl-istess waqt ma jkunx jista' jiġi evitat, huwa rakkomandat tnaqqis tad-doża ta' mercaptopurine/azathioprine.
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).
Maltese: 2.3% tal-pazjenti; HR 1.01; 95% CI 0.73-1.41) u rivaskularizzazzjoni urġenti minħabba anġina mhux stabbli (1.6% vs. 1.8% tal-pazjenti; HR 0.86; 95% CI 0.59-1.26).
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).
Maltese: Ir-rata ta' mortalità minn kull kawża kienet ukoll ogħla b'febuxostat milli b'allopurinol (7.8% vs. 6.4% tal-pazjenti; HR 1.22; 95% CI 1.01-1.47), li kienet ġejja prinċipalment mir-rati ogħla ta' mwiet CV f'dak il-grupp (ara sezzjoni 4.4).
English: Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome)
Maltese: Pressjoni għolja, ħmura fil-wiċċ, fwawar ta' sħana, emorraġija (ara sezzjoni Sindrome tal-Lisi tat-Tumur)
English: Febuxostat Mylan 80 mg film-coated tablets febuxostat
Maltese: Febuxostat Mylan 80 mg pilloli miksija b'rita febuxostat
English: • weight decrease, increased appetite, uncontrolled loss of appetite (anorexia)
Maltese: • tnaqqis fil-piż , żjieda fl-aptit, nuqqas fl-aptit bla kontroll (anoressija)
English: Tumor Lysis Syndrome
Maltese: Sindrome tal-Lisi tat-Tumur
English: EU/1/17/1194/009 EU/1/17/1194/010 EU/1/17/1194/011 EU/1/17/1194/012 EU/1/17/1194/013
Maltese: EU/1/17/1194/011 EU/1/17/1194/012 EU/1/17/1194/013 EU/1/17/1194/014
English: Abdominal pain, abdominal distension, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort Rare
Maltese: Uġigħ addominali, nefħa fl-addome marda ta' rifluss gastroesofagali, rimettar, ħalq xott, dispepsja, stitikezza, purgar ta' spiss, gass, skomdità gastro-intestinali
English: In male rats, a statistically significant increase in urinary bladder tumours (transitional cell papilloma and carcinoma) was found only in association with xanthine calculi in the high dose group, at approximately 11 times human exposure.
Maltese: F'firien maskili, żjieda statistikament sinifikanti fit-tumuri tal-bużżieqa tal-awrina (papilloma taċċellula transitorja u karċinoma) nstabet biss f'assoċjazzjoni ma' kalkuli ta' xanthine fil-grupp b'doża għolja, ta' madwar 11-il darba l-esponiment uman.
English: Rare Blood glucose increased, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
Maltese: Żjieda tal-glucose fid-demm, jittawwal il-ħin tat-tromboplastin parzjali attivat, jonqos il-għadd taċ-ċelluli ħomor fid-demm, żjieda tal-alkaline phosphatase fid-demm, żieda fil-creatine phosphokinase fid-demm* * Reazzjonijiet avversi ġejjin minn esperjenza ta' wara t-tqegħid fis-suq ** Dijarea mhux infettiva li toħroġ mal-kura u testijiet anormali tal-funzjoni tal-fwied fl-istudji talFażi 3 kombinati huma aktar frekwenti f'pazjenti kkurati fl-istess waqt b'colchicine *** Ara sezzjoni 5.1 għall-frekwenzi tal-aggravar tal-gotta fl-istudji kontrollati randomized ta' Fażi 3 individwali.
English: Clinical Outcomes: proportion of patients requiring treatment for a gout flare 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: • blurred vision, change in vision
Maltese: • vista mċajpra, bidla fil-vista
English: Other medicines and Febuxostat Mylan
Maltese: Kif taħżen Febuxostat Mylan
English: Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis.
Maltese: Il-kura b'febuxostat għandha titwaqqaf minnufih jekk reazzjonijiet serji ta' allerġija/sensittività eċċessiva, inkluża Sindrome ta' Stevens-Johnson, jseħħu peress li t-twaqqif bikri huwa assoċjat ma' pronjosi aħjar.
English: Each tablet contains 120 mg of febuxostat.
Maltese: Kull Pillola fiha 120 mg ta 'febuxostat.
English: The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were < 6.0 mg/dL (357 µmol/L).
Maltese: Il-fini ewlieni tal-effikaċja flistudji APEX u FACT kien il-proporzjon ta' pazjenti li kellhom l-aħħar 3 livelli ta' kull xahar ta' uric acid fis-serum < 6.0 mg/dL (357 µmol/L).
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: Atrial fibrillation, palpitations, ECG abnormal, left bundle branch block (see section Tumor Lysis Syndrome), sinus tachycardia (see section Tumor Lysis Syndrome)
Maltese: Fibrillazzjoni atrijali, palpitazzjonijiet, ECG anormali, blokk fil-fergħa tal-qabda tax-xellug (ara s-sezzjoni Sindrome tal-Lisi tat-Tumur), takikardja sinusali (ara sezzjoni Sindrome tal-Lisi tat-Tumur)
English: No data is available for febuxostat 120 mg.
Maltese: M'hemmx dejta għal febuxostat 120 mg.
English: 0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000).
Maltese: -238.600; -154.988]; p < .0001).
English: Film-coated tablet.
Maltese: Kisja tal-pillola
English: Febuxostat Mylan 80 mg and 120 mg film-coated tablets are available in plastic bottles of 28
Maltese: Febuxostat Mylan 80 mg u 120 mg pilloli miksija b'rita huma disponibbli fi fliexken tal-plastik ta' 28 u 84 pillolla.
English: • muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm
Maltese: • bugħawwieġ, dgħjufija tal-muskoli, uġigħ/weġgħat fil-muskoli/ġogi, borżite jew artrite (infjammazzjoni tal-ġogi ġeneralment b'uġigħ, nefħa u/jew ebusija), uġigħ fit-truf, uġigħ fiddahar, spażmi fil-muskoli
English: 240 mg febuxostat was used to evaluate the safety of febuxostat at twice the recommended highest dose.
Maltese: Intużat 240 mg febuxostat biex tiġi vvalutata s-sigurtà ta' febuxostat f'doża d-doppju tal-ogħla doża rrakkomandata.
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, nonpurine 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: 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.
Maltese: Ir-riżultati tal-istudju wrew li meta febuxostat 80 mg QD ingħata ma' doża waħda ta' theophylline 400 mg ma kienx hemm effett fuq il-farmakokinetika jew sigurtà ta' theophylline. .
English: The primary endpoint in CARES was the time to first occurrence of MACE, a composite of nonfatal MI, non-fatal stroke, CV death and unstable angina with urgent coronary revascularization.
Maltese: L-iskop finali primarju f'CARES kien iż-żmien għall-ewwel okkorrenza ta' MACE, kompost ta' MI mhux fatali, puplesija mhux fatali, mewt CV u anġina mhux stabbli b'rivaskularizzazzjoni urġenti talqalb.
English: Febuxostat Mylan 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: Febuxostat Mylan huwa 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: If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat Mylan 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 Febuxostat Mylan 120 mg darba kuljum.
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 karatteristiċi dettaljati tal-istudju) irrata tal-avvenimenti MACE (major adverse cardiovascular events - avvenimenti kardjovaskulari avversi maġġuri) 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% talpazjenti;
English: The FACT study showed the statistically significant superiority of both febuxostat 80 mg and febuxostat 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' febuxostat 80 mg u ta' febuxostat 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: If you stop taking Febuxostat Mylan
Maltese: Mediċini oħra u Febuxostat Mylan
English: Gout: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Maltese: Huwa disponibbli tagħrif limitat f'pazjenti b'indeboliment epatiku moderat.
English: In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events.
Maltese: Fi studji kliniċi l-użu ta' naproxen jew NSAIDs/inibituri Cox-2 oħra ma kien relatat mal-ebda żjieda ta' sinifikanza klinika fl-avvenimenti avversi.
English: The efficacy of febuxostat 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' febuxostat 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: Headache
Maltese: ĠIM
English: In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Maltese: Fil-prova ewlenija tas-Sindrome tal-Lisi tat-Tumur febuxostat 120 mg kuljum kien mogħti lil pazjenti b'diversi programmi ta' kura kimoterapewtika, li jinkludu antikorpi monoklonali, mingħajr tħassib dwar is-sigurtà.
English: The requirements for submission of periodic safety update 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: Ir-rekwiżiti biex jiġu ppreżentati 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 kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: No statistically significant differences were found and no causal relationship with febuxostat was established.
Maltese: Ma nstabux differenzi statistikament sinifikanti u ma ġietx stabbilita relazzjoni li febuxostat seta' ikkawżhom.
English: Febuxostat Mylan works by reducing uric acid levels.
Maltese: Febuxostat Mylan jaħdem billi jnaqqas il-livelli ta' uric acid.
English: There was no evidence of impaired fertility, teratogenic effects, or harm to the foetus due to febuxostat.
Maltese: Ma kien hemm l-ebda evidenza ta' indeboliment fil-fertilità, effetti teratoġeniċi, jew ħsara lill-fetu minħabba febuxostat.
English: 28 film-coated tablets 84 film-coated tablets
Maltese: 28 pillola miksija b'rita 84 pillola miksija b'rita
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: BGP Products UAB
English: Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed.
Maltese: It-teħid mill-ħalq fl-istess waqt ta' antaċidu li fih magnesium hydroxide u aluminium hydroxide intwera li jittardja l-assorbiment ta' febuxostat (madwar siegħa) u li jikkawża tnaqqis ta' 32% fis-Cmax, iżda ma kien osservat l-ebda tibdil sinifikanti fl-AUC.
English: Naproxen and other inhibitors of glucuronidation
Maltese: Naproxen u inibituri oħra tal-glukuronidazzjoni
English: The 120 mg tablets are marked with M on one side of the tablet and FX4 on the other side.
Maltese: Il-pilloli ta' 120 mg huma mmarkati fuq naħa waħda b'FX4.
English: SAT
Maltese: TIKKETTAR
English: Mean AUC sUA1-8 (mgxh/dl) was significantly lower with febuxostat (514.0 ± 225.71 vs 708.0 ± 234.42; least square means difference: -196.794 [95% confidence interval: -238.600 ; -154.988]; p < .0001).
Maltese: 71 vs 708.0 ± 234.42; l-inqas kwadru jfisser differenza: -196.794 [95% intervall ta' kunfidenza:
English: THU
Maltese: SIB
English: Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of febuxostat.
Maltese: Ngħas, sturdament, parasteżija, u vista mċajpra kienu rrappurtati bl-użu ta' febuxostat.
English: Fatigue, chest pain, chest discomfort Rare
Maltese: Għeja, uġigħ fis-sider, skumdità fis-sider Rari
English: Uncommon:
Maltese: Gotta:
English: Marketing Authorisation Holder Mylan S.A.S.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Mylan S.A.S.
English: For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100 mg QD.
Maltese: Għall-individwi b'indeboliment renali li kienu randomised għal allopurinol, id-doża kienet mgħollija sa 100 mg QD.
English: The incidence of investigator-reported cardiovascular APTC events in the combined Phase 3 studies (APEX, FACT and CONFIRMS studies) was 0.7 vs. 0.6 events per 100 PYs.
Maltese: Il-frekwenzi ta' episodji APTC kardjovaskulari irrappurtati mill-investigatur flistudji ta' Fażi 3 kombinati (studji APEX, FACT u CONFIRMS) kienu 0.7 kontra 0.6 episodju kull 100 PYs. Fl-istudji estiżi għal tul ta' żmien, il-frekwenzi tal-episodji APTC irrappurtati millinvestigatur kienu 1.2 u 0.6 episodji f'kull 100 PYs għal febuxostat u allopurinol, rispettivament.
English: Clinical Outcomes: proportion of patients requiring treatment for a gout flare 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' individwi fil-grupp ta' kura b'febuxostat 120 mg (36%) kellhom bżonn kura għall-aggravar tal-gotta meta mqabbla malgruppi ta' kura b' febuxostat 80 mg (22%) u allopurinol 300 mg (21%).
English: Febuxostat Mylan 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.
Maltese: Pilloli Febuxostat Mylan fihom is-sustanza attiva febuxostat u jintuzaw għall-kura tal-gotta, li hija assoċjata ma' kimika żejda msejħa uric acid (urate) fil-ġisem.
English: Febuxostat Mylan is available as either an 80 mg tablet or a 120 mg tablet.
Maltese: Febuxostat Mylan huwa disponibbli bħala pillola ta' 120 mg.
English: Cardiac disorders: Uncommon: Left bundle branch block, sinus tachycardia
Maltese: Mhux komuni: blukkar tan-nervituri tal-ventrikolu xellugi , sinus takikardija.
English: • abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation)
Maltese: • traċċar tal-qalb b'ECG mhux normali, tħabbit irregolari jew mgħaġġel tal-qalb, tħoss qalbek tħabbat (palpitazzjoni)
English: During the CONFIRMS study, the percentages of patients who required treatment for gout flares (Day 1 through Month 6) were 31% and 25% for the febuxostat 80 mg and allopurinol groups, respectively.
Maltese: Waqt l-istudju CONFIRMS, il-perċentwali tal-pazjenti li kellhom bżonn kura għall-aggravar tal-gotta (Jum 1 sa Xahar 6) kienu 31% u 25% tal-gruppi fuq febuxostat 80 mg u allopurinol, rispettivament.
English: The 80 mg tablets are marked with M on one side of the tablet and FX3 on the other side.
Maltese: Il-pilloli ta' 80 mg huma mmarkati b'M fuq naħa waħda u b'FX3 fuq in-naħa l-oħra.
English: Study
Maltese: LISTA
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.
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 taleffetti tossiċi.
English: • fatigue, chest pain, chest discomfort
Maltese: • għeja, uġigħ fis-sider, skumdità fis-sider
English: Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation.
Maltese: Sindrome ta' Stevens-Johnson u nekrolisi epidermali tossika huma karatterizzati minn raxxijiet tal-ġilda li javvanzaw, assoċjati ma' bżieżaq jew feriti fil-mukuża u irritazzjoni fl-għajn.