FrancophonIA/ELRC3.0 huggingface dataset:
English: Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Maltese: Omeprazole (80 mg) mogħti darba kuljum jew fl-istess ħin ma' clopidogrel jew b'differenza ta' 12-il siegħa bejn it-teħid taż-żewġ mediċini naqqas l-espożizzjoni tal-metabolit attiv b'45 % ( id-doża ta' kkargar) u b'40 % (id-doża ta' manteniment).
English: Blood and the lymphatic system disorders
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: 5.3 Preclinical safety data
Maltese: GĦAMLA KWALITATTIVA
English: In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
Maltese: Fis-sottogrupp tal-infart mijokardijaku, il-maġġoranza tal-pazjenti ngħataw ASA għall-ewwel jiem wara infart mijokardijaku akut.
English: Common***
Maltese: Komuni***
English: 117 Allee des Parcs 69 800 Saint Priest France
Maltese: 117 Allee des Parcs 69 800 Saint Priest Franza
English: Rare Tinnitus
Maltese: Rari Tinnitus
English: BL=baseline SEM=standard error of the mean
Maltese: BL = baseline (linja bażi), SEM = standard error of the mean (żball standard tal-medja)
English: Desipramine/CYP2D6 substrates
Maltese: Desipramine/substrati ta' CYP2D6
English: APEX (28 weeks)
Maltese: APEX (28 ġimgħa)
English: FACT (52 weeks)
Maltese: FACT (52 ġimgħa)
English: Atrial fibrillation, palpitations, ECG abnormal Rare
Maltese: Fibrillazzjoni atrijali, palpitazzjonijiet, ECG anormali Rari
English: Syndrome/Toxic epidermal necrolysis)
Maltese: Johnson/nekrolisi epidermali tossika)
English: [Bottles]
Maltese: [Fliexken]
English: Multipack: 84 (2 packs of 42) film-coated tablets
Maltese: Pakkett multiplu: 84 (2 pakketti ta' 42) pillola miksija b'rita
English: Rosiglitazone/CYP2C8 substrates
Maltese: Rosiglitazone/sottostrati ta' CYP2C8
English: H-2900 Komárom Hungary
Maltese: H-2900
English: Manufacturer Mylan Hungary Kft Mylan utca 1
Maltese: Manifattur Mylan Hungary Kft Mylan utca 1
English: [Blisters]
Maltese: [Folji]
English: Hypromellose Titanium dioxide (E171) Ethylcellulose Iron oxide yellow (E172) Triacetin
Maltese: Hypromellose Titanium dioxide(E171) Ethylcellulose Iron oxide isfar (E172) Triacetin
English: The active substance is febuxostat.
Maltese: Is-sustanza attiva hija febuxostat.
English: Film-coating: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin and iron oxide black (E172).
Maltese: Kisja bir-rita: hypromellose, titanium dioxide (E171), ethylcellulose, iron oxide yellow (E172), triacetin u iron oxide black (E172).
English: * p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
Maltese: * p < 0.001 vs allopurinol,
English: Incidence of overall treatmentemergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with febuxostat and allopurinol respectively.
Maltese: L-inċidenza globali ta' sinjali u sintomi li jitfaċċaw waqt it-trattament u reazzjonijiet avversi tal-mediċina kienu 67.6% vs 64.7% u 6.4% vs 6.4% b'febuxostat u allopurinol rispettivament.
English: 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l­identifikatur uniku inkluż.
English: Mean (±SEM) Serum Uric Acid Level (mg/dL)
Maltese: Medja (±SEM) tal-Livell tal-Uric Acid fis-Serum (mg/dL)
English: Salomone Pharma Ltd Tel: + 356 21 22 01 74
Maltese: V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
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.
Maltese: Qalba tal-pillola: lactose (ara sezzjoni 2, “Kontenut tal-Lactose u tas-Sodium”), microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica u colloidal anhydrous silica.
English: Carcinogenesis, mutagenesis, impairment of fertility
Maltese: Karċinoġeniċità, mutaġenesi, indeboliment fil-fertilità
English: Nervousness
Maltese: Nervi
English: There is no appreciable accumulation when doses of 10 mg to 240 mg are administered every 24 hours.
Maltese: M'hemmx akkumulazzjoni notevoli meta dożi ta' 10 mg sa 240 mg jingħataw kull 24 siegħa.
English: Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Maltese: Febuxostat huwa metabolizzat b'mod estensiv permezz ta' konjugazzjoni permezz tas-sistema talenżima uridine diphosphate glucuronosyltransferase (UDPGT) u ta' ossidazzjoni permezz tas-sistema taċ-ċitokromju P450 (CYP).
English: Inducers of glucuronidation
Maltese: Indutturi tal-glukuronidazzjoni
English: The Cmax and AUC of active metabolites increased up to 2- and 4-fold, respectively.
Maltese: Cmax u l-AUC tal-metaboliti attivi żdiedu sa darbtejn u 4 darbiet, rispettivament.
English: Xanthine deposition
Maltese: Depożizzjoni ta' xanthine
English: Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes.
Maltese: Il-metaboliżmu ta' febuxostat jiddependi fuq l-enzimi Uridine Glucuronosyl Transferase (UGT) .
English: Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria Rare
Maltese: Insuffiċjenza renali, nefrolitajasi, ematurja, pollakurja, protejnurja Rari
English: Febuxostat is rapidly (tmax of 1.0-1.5 h) and well absorbed (at least 84%).
Maltese: Febuxostat huwa assorbit malajr (tmax ta' 1.0-1.5 h) u tajjeb (mill-inqas 84%).
English: • nervousness
Maltese: • nervi
English: Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis Rare
Maltese: Artralġja, artrite, mijalġja, bugħawwieġ, djgħufija fil-muskoli, spażmi fil-muskoli, ebusija fil-muskoli, bursite Rari
English: • anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”)
Maltese: • reazzjonijiet anafilattiċi, sensittività eċċessiva għall-mediċina (ara wkoll sezzjoni 2 “Avviżi u prekawzjonijiet”)
English: Prophylaxis against gout flares was obligatory over the 26-week period.
Maltese: Profilassi kontra l-aggravar talgotta kien obbligatorju fuq il-perijodu ta' 26-ġimgħa.
English: After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.05.3 µg/mL, respectively.
Maltese: Wara doża waħda jew dożi multipli orali kuljum ta' 80 u 120 mg, Cmax ikun madwar 2.8-3.2 µg/mL, u 5.0-5.3 µg/mL, rispettivament.
English: • If you have thyroid problems.
Maltese: • Jekk għandek problemi tat-tirojde.
English: Febuxostat Mylan is indicated in adults.
Maltese: Febuxostat Mylan huwa indikat fl-adulti.
English: Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Maltese: Uric acid huwa l-prodott finali tal-metaboliżmu ta' purine fil-bnedmin u huwa ġenerat fil-kaskata ta' hypoxanthine → xanthine → uric acid.
English: Medicinal product allergy / hypersensitivity
Maltese: Allerġija/sensittività eċċessiva għall-prodott mediċinali
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).
Maltese: Kienu osservati valuri miżjuda ta' TSH (>5.5 µIU/mL) f'pazjenti fuq kura fit-tul b'febuxostat (5.5%) u f'pazjenti b'allopurinol (5.8%) fl-istudji ta' estensjoni open label fit-tul (ara sezzjoni 4.4).
English: Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn.
Maltese: Pazjenti li kellhom 3 livelli sUA >6.0 mg/dL kienu rtirati.
English: • Risk Management Plan (RMP)
Maltese: Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Febuxostat was shown to be a weak inhibitor of CYP2C8 in vitro.
Maltese: Intwera li febuxistat huwa inibitur dgħajjef ta' CYP2C8 in vitro.
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: Nekrolisi epidermali tossika*, Sindrome Stevens-Johnson*, anġjoedema*, reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi*, raxx mal-ġisem kollu (serju)*, ħmura, raxx bil-qxur, raxx follikulari, raxx vesikulari, raxx pustulari, raxx bil-ħakk*, raxx bi ħmura, raxx morbilliforme, alopeċja, iperidrożi
English: Gout flare prophylaxis is recommended (see section 4.2 and 4.4).
Maltese: Il-profilassi tal-aggravar talgotta hija rakkomandata (ara sezzjoni 4.2 u 4.4).
English: No significant difference in mean serum creatinine change (%) occurred between febuxostat and allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 respectively; least square means difference: 4.0970 [95% confidence interval: -0.6467 ; 8.8406]; p=0.0903).
Maltese: Ma kienx hemm ebda differenza sinifikanti fil-bidla medja (%) ta' kreatinina fis-serum bejn febuxostat u allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 rispettivament; l-inqas kwadru jfisser differenza ta': 4.0970 [95% intervall ta' kunfidenza: -0.6467 ; 8.8406]; p=0.0903).
English: Tabulated list of adverse reactions
Maltese: Lista f'tabella tar-reazzjonijet avversi
English: Tablet coating
Maltese: Riżultati Kombinati
English: FACT Study: The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study.
Maltese: L-Istudju ta' Febuxostat Ikkontrollat b'Allopurinol (FACT) kien studju ta' 52 ġimgħa, ta' Fażi 3, randomised, double-blind u multicenter.
English: Pharmacotherapeutic group: Antigout preparation, preparations inhibiting uric acid production, ATC code: M04AA03
Maltese: Preparazzjoni kontra l-gotta, preparazzjonijiet li jinibixxu lproduzzjoni ta' uric acid, Kodiċi ATC:
English: Febuxostat has been shown to potently inhibit both the oxidized and reduced forms of XO. At therapeutic concentrations febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, namely, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase or purine nucleoside phosphorylase.
Maltese: F'konċentrazzjonijiet terapewtiċi febuxostat ma jinibixxix enżimi oħra involuti fil-metaboliżmu ta' purine jew ta' pyrimidine, jiġifieri, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase jew purine nucleoside phosphorylase.
English: Primary endpoint in the sub-group of patients with renal impairment The APEX Study evaluated efficacy in 40 patients with renal impairment (i.e., baseline serum creatinine > 1.5 mg/dL and ≤2.0 mg/dL).
Maltese: L-Istudju APEX ivvaluta l-effikaċja f'40 pazjent b'indeboliment renali (i.e., linja bażi tal-krejatinina fis-serum > 1.5 mg/dL u 2.0 mg/dL).
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: Studji in vitro b'mikrożomi tal-fwied uman urew li dawk il-metaboliti ossidattivi ġew iffurmati primarjament minn CYP1A1, CYP1A2, CYP2C8 jew CYP2C9 u febuxostat glucuronide kien iffurmat primarjament minn UGT 1A1, 1A8, u 1A9
English: • Azathioprine (used to reduce immune response)
Maltese: • Azathioprine (użat biex inaqqas ir-rispons immuni)
English: In healthy subjects concomitant use of febuxostat and naproxen 250 mg twice daily was associated with an increase in febuxostat exposure (Cmax 28%, AUC 41% and t1/2 26%).
Maltese: F'individwi b'saħħithom l-użu fl-istess waqt ta' febuxostat u naproxen 250 mg darbtejn kuljum kien assoċjat ma' żjieda fl-esponiment ta' febuxostat (Cmax 28%, AUC 41% u t1/2 26%).
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).
Maltese: Livelli ta' urate fis-serum inżammu maż-żmien (i.e. 91% u 93% tal-pazjenti fuq il-kura inizzjali b'febuxostat 80 mg u 120 mg, rispettivament, kellhom sUA <6 mg/dL f'Xahar 36).
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.
Maltese: Il-mira primarja fis-sottogrupp ta' pazjenti b'sUA ≥ 10 mg/dL Madwar 40% tal-pazjenti (APEX u FACT kombinati) kellhom linja bażi ta' sUA ta' ≥ 10 mg/dL.
English: APEX Study: The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study.
Maltese: L-Istudju tal-Effikaċja Kkontrollat b'Allopurinol u bil-Plaċebo ta' Febuxostat (APEX) kien studju ta' 28 ġimgħa, ta' Fażi 3, randomised, double-blind u multicenter.
English: One thousand and seventy-two (1072) patients were randomized: placebo (n=134), febuxostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 240 mg QD (n=134) or allopurinol (300 mg QD [n=258] for patients with a baseline serum creatinine ≤1.5 mg/dL or 100 mg QD [n=10] for patients with a baseline serum creatinine >1.5 mg/dL and ≤2.0 mg/dL).
Maltese: Elf u tnejn u sebgħin (1072) pazjent kienu randomised: plaċebo (n=134), febuxostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 240 mg QD (n=134) jew allopurinol (300 mg QD [n=258] għall-pazjenti b'linja bażi ta' krejatinina fis-serum 1.5 mg/dL jew 100 mg QD [n=10] għall-pazjenti b'linja bażi ta' krejatinina fis-serum >1.5 mg/dL u 2.0 mg/dL).
English: Gout flares
Maltese: TAGĦRIF
English: Libido decreased, insomnia Rare
Maltese: Tnaqqis fil-libido, nuqqas ta' rqad Rari
English: Febuxostat Mylan film-coated tablets are yellow, capsule shaped, biconvex tablets.
Maltese: Febuxostat Mylan pilloli miksija b'rita huma pilloli sofor, b'forma ta' kapsula u bikonvessi.
English: Febuxostat has an apparent mean terminal elimination half-life (t1/2) of approximately 5 to 8 hours.
Maltese: Febuxostat għandu medja tal-half-life terminali tal-eliminazzjoni (t1/2) ta' madwar 5 sa 8 sigħat.
English: [For calendar blisters only]: MON
Maltese: [Għal folji bil-kalendarju biss]: TNE
English: • rash (including various types of rash, please see below under “uncommon” and “rare”
Maltese: • uġigħ ta' ras raxx (inklużi tipi differenti ta' raxx, jekk jogħġbok ara hawn taħt fis-sezzjonijiet “mhux komuni” u “rari”)
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.
Maltese: Pillola safra, b'forma ta' kapsula, bikonvessa, b'daqs ta' madwar 18 × 8 mm, imnaqqxa b'M fuq naħa waħda tal-pillola, u FX4 fuq in-naħa l-oħra.
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: Il-proporzjon ta' pazjenti b'livelli ta' urate fis-serum ta' < 6.0 mg/dL (357 µmol/L) fl-aħħar żjara, kien 45% għal 40 mg febuxostat, 67% għal febuxostat 80 mg u 42% għal allopurinol 300/200 mg, rispettivament.
English: EXCEL Study (C02-021): The Excel study was a three years Phase 3, open label, multicenter, randomised, allopurinol-controlled, safety extension study for patients who had completed the pivotal Phase 3 studies (APEX or FACT).
Maltese: Studju EXCEL (C02-021): L-istudju EXCEL kien studju ta' sigurtà ta' estensjoni ikkontrollat b'allopurinol, randomized, multiċentriku, open label ta' Fażi 3 li dam 3 snin għall-pazjenti li kienu temmew l-istudji pivitali ta' Fażi 3 (APEX jew FACT).
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.
Maltese: Folji (PVC/oPA/Alu)/Alu (dessikant integrat) ta '14, 28, 84 Pillola, folji bil-kalendarju ta '28, 84 Pillola u folji perforati b'doża waħda ta' 28 × 1 Pillola.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Both steps in the above transformations are catalyzed by xanthine oxidase (XO).
Maltese: Iż-żewġ passi fit-trasformazzjonijiet ta' hawn fuq huma katalizzati minn xanthine oxidase (XO).
English: In the randomized, double-blind, Phase 3 pivotal FLORENCE (FLO-01) study comparing febuxostat with allopurinol (346 patients undergoing chemotherapy for haematologic malignancies and at intermediate-to-high risk of TLS), only 22 (6.4%) patients overall experienced adverse reactions, namely 11 (6.4%) patients in each treatment group.
Maltese: Fl-istudju każwali double-blind, ewlieni, ta' Fażi 3 FLORENCE (FLO-01) li qabbel febuxostat ma' allopurinol (346 pazjent li kienu qed jieħdu kimoterapija għal malinni ematoloġiċi u f'riskju intermedju għal għoli ta' TLS, kienu biss 22 (6.4%) pazjent globali li esperjenzaw reazzjonijiet avversi, jiġifieri 11-il pazjent (6.4%) f'kull grupp ta' trattament.
English: Liver function abnormalities** Uncommon
Maltese: Anormalitajiet fit-testijiet tal-funzjoni tal-fwied** Mhux komuni
English: The apparent steady state volume of distribution (Vss/F) of febuxostat ranges from 29 to 75 L after oral doses of 10-300 mg.
Maltese: Il-volum ta' distribuzzjoni apparenti fi stat stabbli (Vss/F) ta' febuxostat ivarja minn 29 sa 75 l wara dożi orali ta' 10-300 mg.
English: Febuxostat achieved the primary efficacy endpoint in 44% (80 mg QD), 45% (120 mg QD), and 60% (240 mg QD) of patients compared to 0% in the allopurinol 100 mg QD and placebo groups.
Maltese: Febuxostat laħaq il-mira primarja tal-effikaċja f'44% (80 mgQD), 45% (120 mg QD), u 60% (240 mg QD) tal-pazjenti meta mqabbel ma' 0% filgruppi ta' allopurinol 100 mg QD u tal-plaċebo.
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:
Maltese: Fir-rigward ta' punti aħħarin sekondarji, ma ġiet osservata l-ebda differenza sinifikanti f'termini ta' inċidenza ta' TLS tal-laboratorju (8.1% u 9.2% fil-grupp ta' Febuxostat u Allopurinol, rispettivament; riskju relattiv: 0.875 [95% intervall ta' kunfidenza : 0.4408: 1.7369]; p=0.8488u lanqas ta' TLS kliniku (1.7% u 1.2% fil-gruppi ta' Febuxostat u Allopurinol rispettivament; riskju relattiv: 0.994 [95% intervall ta' kunfidenza 0.9691; 1.0199]; p=1.0000).
English: Febuxostat Mylan 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: Febuxostat Mylan huwa 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 (Tumor Lysis Syndrome, TLS) .
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.
Maltese: Il-pilloli miksija b'rita Febuxostat Mylan 80 mg u 120 mg huma disponibbli f'pakketti bil-folji ta' 14, 28, 42 u 84 Pillola, pakketti ta' folji bil-kalendarju ta' 28 u 84 Pillola, u pakketti ta' folji perforati b'doża waħda ta' 28 × 1 Pillola u f'pakketti multipli ta' 84 pillola miksija b'rita li jkun fihom 2 pakketti, kull wieħed bi 42 pillola miksija b'rita.
English: • Theophylline (used to treat asthma)
Maltese: • Theophylline (użat biex jikkura l-ażżma)
English: Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate/high risk of Tumor Lysis Syndrome were included.
Maltese: Globalment, 346 pazjent b'malinni ematoloġiċi li jkunu qed jieħdu kimoterapija u f'riskju intermedjarju / għoli għal Sindrome tal-Lisi tat-Tumur kienu inklużi.
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.
Maltese: Pillola safra, b'forma ta' kapsula, bikonvessa, b'daqs ta' madwar 16 × 7 mm, imnaqqxa b'M fuq naħa waħda tal-pillola, u FX3 fuq in-naħa l-oħra.
English: Uncommon Erectile dysfunction
Maltese: Mhux komuni Disfunzjoni erettili
English: The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 µg⋅h/mL in the normal renal function group to 13.2 µg.h/mL in the severe renal dysfunction group.
Maltese: L-AUC totali medja ta' febuxostat żdiedet b'madwar 1.8 darbiet minn 7.5 gh/mL fil-grupp b'funzjoni renali normali għal 13.2 g.h/mL fil-grupp b'indeboliment renali severi.
English: Following multiple oral doses of febuxostat, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Maltese: Wara dożi orali multipli ta' febuxostat, Cmax u l-AUC kienu 24% u 12% ogħla fin-nisa milli fl-irġiel, rispettivament.
English: Acute gouty attacks (gout flare)
Maltese: Attakki ta' gotta akuta (aggravar tal-gotta)
English: However, weight-corrected Cmax and AUC were similar between the genders.
Maltese: Madankollu, Cmax u l-AUC ikkoreġuti għall-piż kienu simili bejn is-sessi.
English: A total of 1,086 patients were enrolled: Febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145).
Maltese: Totali ta' 1086 pazjent kienu ingaġġati: Febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) u allopurinol 300mg/100mg QD (n=145).
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 kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1 (ara wkoll sezzjoni 4.8).
English: No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Ma twettqux studji f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ).
English: The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Maltese: Il-mira terapewtika hija li l-uric acid fis-serum jitnaqqas u jinżamm taħt 6 mg/dL (357 μmol/L).
English: (n=519) 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: (n=519) 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: Absolute bioavailability of the febuxostat tablet formulation has not been studied.
Maltese: Il-biodisponibiltà assoluta tal-formulazzjoni tal-pillola ta' febuxostat ma ġietx studjata.
English: Following multiple doses of 80 mg of febuxostat 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: Wara dożi multipli ta' 80 mg ta' febuxostat f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh 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: (PVC/oPA/Alu)/Alu blisters of 14, 28, 42 tablets, calendar blisters of 28 tablets and perforated unit dose blisters of 28 x 1 tablets and multipacks of 84 (2 packs of 42) tablets.
Maltese: Folji (PVC/oPA/Alu)/Alu ta' 14, 28, 84 pillola, folji bil-kalendarju ta' 28 pillola u folji perforati b'doża waħda ta' 28 × 1 pillola u pakketti multipli ta' 84 (2 pakketti ta' 42) pillola.