FrancophonIA/ELRC3.0 huggingface dataset:
English: Fluconazole, a moderate CYP2C9 inhibitor, increased lesinurad AUC (56%) and Cmax (38%), as well as the amount of lesinurad excreted unchanged in urine.
Maltese: L-espożizzjoni għal Lesinurad tiżdied meta jingħata flimkien ma' inibituri ta' CYP2C9. Fluconazole, inibitur moderat ta' CYP2C9, żid l-AUC (56 %) u s-Cmax (38 %) ta' lesinurad, kif ukoll l-ammont ta' lesinurad eliminat kif inhu mal-awrina.
English: Lesinurad exposure is expected to decrease when it is co-administered with inducers of CYP2C9 (e.g. carbamazepine, a moderate CYP2C9 inducer).
Maltese: L-espożizzjoni għal lesinurad hija mistennija li tonqos meta jingħata ma' indutturi ta' CYP2C9 (eż. carbamazepine, induttur moderat ta' CYP2C9).
English: EU/1/15/1080/004 98 film-coated tablets
Maltese: EU/1/15/1080/004 98 pillola miksijin b'rita
English: Zurampic should be used with caution in patients with a CrCL of 30 to less than 45 mL/min (see section 4.4).
Maltese: Zurampic għandu jintuża b'kawtela f'pazjenti b'CrCL ta' 30 jew inqas minn 45 mL/min (ara sezzjoni 4.4).
English: The target serum uric acid level is less than 6 mg/dL (360 µmol/L).
Maltese: Il-livell fil-mira ta' uric acid fis-serum huwa inqas minn 6 mg/dL (360 µmol/L).
English: Figure 1 Mean serum uric acid levels in pooled clinical studies with Zurampic in combination with allopurinol in patients with inadequate response (sUA ≥6 mg/dL) to allopurinol alone
Maltese: Figura 1 Livelli medji ta' uric acid fis-serum fi studji kliniċi miġbura b'Zurampic f'kombinazzjoni ma' allopurinol f'pazjenti b'rispons inadegwat (sUA ≥6 mg/dL) għal monoterapija waħdu
English: In an interaction study conducted in healthy subjects with multiple doses of Zurampic 400 mg and single dose warfarin (25 mg), lesinurad led to a decrease in exposure of R-warfarin (the less active enantiomer) and had no effect on the exposure of S-warfarin (the more active enantiomer).
Maltese: Fi studju tal-interazzjoni mwettaq f'individwi b'saħħithom b'dożi multipli ta' Zurampic 400 mg u warfarin f'doża waħda (25 mg), lesinurad wassal għal tnaqqis fl-espożizzjoni ta' R-warfarin (lenantiomer inqas attiv) u ma kellu ebda effett fuq l-esponiment ta' S-warfarin (l-enantiomer iktar attiv).
English: Post-hoc analyses in a subgroup of patients with high cardiovascular risk at baseline (as defined by transient ischemic attack, angina pectoris, heart failure, myocardial infarction, peripheral vascular disease and/or stroke), showed that the incidence of Major Adverse Cardiovascular Events was 1/52 for placebo and 4/53 for Zurampic 200 mg, when used in combination with a xanthine oxidase inhibitor.
Maltese: Analiżijiet post-hoc f'sottogrupp ta' pazjenti b'riskju kardjovaskulari għoli fillinja bażi (kif iddefinit minn attakk iskemiku temporanju, anġina pectoris, insuffiċjenza tal-qalb, infart mijokardijaku, mard vaskulari periferali, u/jew puplessija), urew li l-inċidenza ta' Avvenimenti Kardjovaskulari Avversi
English: No overall differences in safety of Zurampic were observed in patients with mild or moderate renal impairment (eCrCL of30-89 mL/min) compared to patients with normal renal function (see sections 4.2 and 5.2).
Maltese: Ebda differenza ġenerali fis-sigurtà ta' Zurampic ma ġiet osservata f'pazjenti b'indeboliment ħafif jew moderat tal-kliewi (eCrCL ta' 30-89 mL/min) meta mqabbel ma' pazjenti b'funzjoni tal-kliewi normali (ara sezzjonijiet 4.2 u 5.2).
English: Rare - may affect up to 1 in 1000 people - skin reactions, including redness, itchy skin, lumpy rash (hives) and skin rash on exposure to sunshine.
Maltese: Rari - jistgħu jaffettwaw sa persuna 1 minn kull 1000 - reazzjonijiet tal-ġilda, inkluża ħmura, ħakk fil-ġilda, raxx bil-boċoċ (ħorriqija)u raxx fil-ġilda ma'
English: (200 mg) in patients with mild renal impairment (eCrCL 60 to 89 mL/min), 20% and 73% higher (200 mg) and 3% and 50% higher (400 mg) in patients with moderate renal impairment (eCrCL 30 to 59 mL/min), and 13% higher and 113% higher (400 mg) in patients with severe renal impairment (eCrCL <30 mL/min).
Maltese: Wara għoti ta' doża waħdanija ta' lesinurad lil individwi b'indeboliment renali meta mqabbla ma' dawk b'funzjoni renali normali, is-Cmax u l-AUC ta' lesinurad, rispettivament, kienu 36 % u 30 % ogħla (200 mg) f'pazjenti b'indeboliment renali ħafif (eCrCL 60 sa 89 mL/min), 20 % u 73 % ogħla (200 mg) u 3 % u 50 % ogħla (400 mg) f'pazjenti b'indeboliment renali moderat (eCrCL 30 sa 59 mL/min), u 13 % ogħla u 113 % ogħla (400 mg) f'pazjenti b'indeboliment renali sever (eCrCL <30 mL/min).
English: In these studies, kidney stone adverse reactions (nephrolithiasis being the most frequent) were reported in patients treated with Zurampic 200 mg (0.6%), Zurampic 400 mg (2.5%) and placebo (1.7%).
Maltese: F'dawn l-istudji, ġew irrapportati reazzjonijiet avversi minħabba ġebel fil-kliewi (b'nefrolitijasi tkun l-aktar waħda frekwenti) f'pazjenti kkurati b'Zurampic (200 mg (0.6 %), Zurampic 400 mg (2.5 %) u plaċebo (1.7 %).
English: Metabolites are not known to contribute to the uric acid lowering effects of lesinurad.
Maltese: Il-metaboliti mhumiex magħrufa li jikkontribwixxu għall-effetti ta' tnaqqis tal-uric acid minn lesinurad.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma'prodotti mediċinali oħra u forom oħra ta'interazzjoni
English: However, the in vivo activity of OATP1B1, OAT1, OAT3 and OCT1 was not affected by lesinurad.
Maltese: Madankollu, l-attività in vivo ta' OATP1B1, OAT1, OAT3 u OCT1 ma kinitx affettwata minn lesinurad.
English: Zurampic may cause serious kidney problems (see section 4), which occur more frequently if Zurampic is taken alone (see section 3).
Maltese: Zurampic jista' jikkawża problemi serji bil-kliewi (ara sezzjoni 4), li jseħħu b'mod aktar frekwenti jekk Zurampic jittieħed waħdu (ara sezzjoni 3).
English: Zurampic as add-on to allopurinol in inadequate responders CLEAR1 and CLEAR2 enrolled patients with gout who were on a stable dose of allopurinol of at least 300 mg (or 200 mg for moderate renal impairment), had serum uric acid levels greater than 6.5 mg/dL and reported at least 2 gout flares in the previous 12 months.
Maltese: Zurampic bħala żieda ma' allopurinol f'pazjenti li ma rrispondewx b'mod adegwat Il-pazjenti rreġistrati għal CLEAR1 u CLEAR2 b'gotta li kienu fuq doża stabbli ta' allopurinol ta' mill-inqas 300 mg (jew 200 mg għal indeboliment renali moderat), kellhom livelli ta' uric acid fisserum ta' aktar minn 6.5 mg/dL u rrapportaw tal-inqas żewġ każijiet ta' rkadar tal-gotta fit-12-il xahar ta' qabel.
English: DD month YYYY
Maltese: Fih il-lattożju
English: The serious adverse reactions renal failure, renal impairment and nephrolithiasis have occurred uncommonly (less than 1 case per 100 patients) (see Table 1).
Maltese: Ir-reazzjonijiet avversi serji, insuffiċjenza renali, indeboliment renali u nefrolitijasi seħħew b'mod mhux komuni (inqas minn każ f'kull 100 pazjent) (ara t-Tabella 1).
English: Gout flares may occur after initiation of therapy with Zurampic.
Maltese: Jista' jseħħ irkadar tal-gotta wara li tinbeda terapija b'Zurampic.
English: In the fed state, after a single dose of lesinurad 200 mg, geometric mean lesinurad Cmax and AUC were 6 μg/mL and 29 μg/hr/mL, respectively.
Maltese: Fl-istat sajjem, wara doża waħda ta' lesinurad 200 g, il-medja ġeometrika tas-Cmax u lAUC ta' lesinurad kienet 6 μg/mL u 29 μg/hr/mL, rispettivament.
English: In patients with moderate renal impairment, the incidence of renalrelated adverse reactions was similar across all treatment groups: Zurampic 200 mg (12.7%), Zurampic 400 mg (16.3%) and placebo (13.3%).
Maltese: Zurampic 200 mg (12.7 %), Zurampic 400 mg (16.3 %) u plaċebo (13.3 %).
English: The effect of CYP2C9 genotype on the pharmacokinetics of lesinurad was studied in 8 healthy subjects and 59 patients with gout following daily dosing of lesinurad ranging from 200 mg to 600 mg in the absence or presence of a xanthine oxidase inhibitor.
Maltese: L-effett talġenotip CYP2C9 fuq il-farmakokinetika ta' lesinurad kien studjat fi 8 individwi b'saħħithom u 59 pazjent b'gotta li jsegwu dożaġġ ta' kuljum ta' lesinurad li jvarja minn 200 mg sa 600 mg finnuqqas jew il-preżenza tal-inibitur ta' xanthine oxidase.
English: In three 12-month placebo-controlled trials of Zurampic in combination with a xanthine oxidase inhibitor versus a xanthine oxidase inhibitor alone (placebo), serum creatinine elevations between 1.5fold and 2-fold over baseline occurred in 3.9% of patients on Zurampic 200 mg, 10.0% of patients on Zurampic 400 mg and 2.3% on placebo; serum creatinine elevations 2-fold or greater over baseline occurred in 1.8% of patients on Zurampic 200 mg, 6.7% of patients on Zurampic 400 mg and 0% on placebo.
Maltese: 0% tal-pazjenti fuq Zurampic 400 mg u 2.3% fuq plaċebo; kien hemm żidiet fil-kreatinina fisserum ta' darbtejn jew iktar fuq il-linja bażi f'1.8 % tal-pazjenti fuq Zurampic 200 mg, 6.7 % talpazjenti fuq Zurampic 400 mg u 0 % fuq plaċebo.
English: Primary end-point in patients with renal impairment Consistent with the overall population, the proportion of patients with mild to moderate renal impairment (eCrCL 30-89 mL/min) who achieved target serum uric acid levels at Month 6 was 56% for Zurampic 200 mg versus 29% for placebo when added to allopurinol, and 40% for Zurampic 200 mg versus 26% for placebo when added to febuxostat in patients with baseline sUA ≥5.0 mg/dL.
Maltese: Xhur kien 56% għal Zurampic 200 mg meta mqabbel ma' 29% għal plaċebo meta miżjuda ma' allopurinol, u 40% għal Zurampic 200 mg meta mqabbel ma' 26% għal plaċebo meta miżjud ma' febuxostat f'pazjenti b'sUA fil-linja bażi ≥5.0 mg/dL.
English: Patients received febuxostat 80 mg once daily for 3 weeks and then were randomised 1:1:1 to once daily doses of Zurampic 200 mg, Zurampic 400 mg, or placebo in combination with febuxostat.
Maltese: Il-pazjenti ngħataw febuxostat 80 mg darba kuljum għal 3 ġimgħat u mbagħad kienu randomizzati 1:1:1 għal dożi ta' darba kuljum ta' Zurampic 200 mg, Zurampic 400 mg, jew plaċebo flimkien ma' febuxostat.
English: Your doctor may give you other medicines such as ‘colchicine' and ‘nonsteroidal anti-inflammatory drugs (NSAIDs)'.
Maltese: It-tabib tiegħek jista' jagħtik mediċini oħra bħal ‘colchicine' u ‘mediċini għal kontra l-infjammazzjoni li mhumiex sterojdi (NSAIDs)'.
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when Zurampic is co-administered.
Maltese: Kontraċettivi ormonali inkluż forom orali, injettabbli, li jgħaddu minn ġol-ġilda u impjantabbli, jaf ma jkunux affidabbli meta jingħataw flimkien ma' Zurampic.
English: This is also the maximum dose (see section 4.4).
Maltese: Din hija wkoll id-doża massima (ara sezzjoni 4.4).
English: Additional monitoring of lipids and blood pressure is recommended in patients using sensitive CYP3A substrate lipid lowering medicines (such as lovastatin or simvastatin) or antihypertensive medicines (such as amlodipine, felodipine or nisoldipine), since their efficacy may be reduced (see section 4.5).
Maltese: Monitoraġġ addizzjonali tal-lipidi u l-pressjoni tad-demm huwa rrakkomandat f'pazjenti li jużaw mediċini sensittivi li jbaxxu l-lipidi fis-sottostrati ta' CYP3A (bħal lovastatin jew simvastatin) jew mediċini kontra l-pressjoni (bħal amlodipine, felodipine jew nisoldipine), peress li l-effikaċja tagħhom tista' titnaqqas (ara sezzjoni 4.5 u 4.6).
English: The lack of an observed interaction could be due to the combination of the induction of CYP2C9 and inhibition of OATP1B1 and 1B3.
Maltese: In-nuqqas ta' interazzjoni osservata tista' tkun minħabba l-kombinazzjoni tal-induzzjoni ta' CYP2C9 u linibizzjoni ta' OATP1B1 u 1B3.
English: Across both studies, 61% of patients had mild or moderate renal impairment and 19% had tophi at baseline.
Maltese: Fiż-żewġ studji, 61 % tal-pazjenti kellhom indeboliment renali ħafif jew moderat u 19 % kellhom tofi fil-linja bażi.
English: After continued treatment of up to 24 months on Zurampic 200 mg in combination with febuxostat, the proportion of subjects who experienced complete resolution of at least one target tophus increased to 53% of subjects.
Maltese: Wara kura kontinwa għal sa 24 xhur fuq Zurampic 200 mg flimkien ma' febuxostat, il-proporzjon ta' individwi li esperjenzaw għajbien komplet ta' mill-inqas tofus wieħed fil-mira żdied għal 53% tal-individwi.
English: The most frequent renal-related adverse reaction was blood creatinine increased (4.3% with Zurampic 200 mg and 7.8% with Zurampic 400 mg compared to 2.3% with placebo).
Maltese: L-iktar reazzjoni avversa relatata mal-kliewi frekwenti kienet żieda fil-kreatinina fid-demm (4.3% b'Zurampic 200 mg u 7.8% b'Zurampic 400 mg meta mqabbel ma' 2.3% bi plaċebo).
English: Lesinurad is a mild to moderate inducer of CYP3A and therefore may lower plasma concentrations of some hormonal contraceptives, thereby decreasing contraceptive effectiveness (see sections 4.4 and
Maltese: Lesinurad huwa induttur ħafif sa moderat ta' CYP3A u għaldaqstant jista' jbaxxi l-konċentrazzjonijiet fil-plażma ta' xi kontraċettivi ormonali, u b'hekk inaqqas l-effikaċja kontraċettiva (ara sezzjonijiet 4.4 u 4.6).
English: In the pivotal clinical trials, a greater proportion of patients using lipid lowering or antihypertensive medicines that were CYP3A substrates required concomitant medicinal product change when treated with Zurampic 200 mg in combination with a xanthine oxidase inhibitor, compared with patients treated with placebo in combination with a xanthine oxidase inhibitor (35% versus 28%, respectively).
Maltese: Fil-provi kliniċi, proporzjon akbar ta' pazjenti li użaw mediċini li jnaqqsu l-lipidi jew kontra pressjoni għolja li kienu sottostrati ta' CYP3A, kellhom bżonn ta' bidla fil-prodott mediċinali konkomitanti meta ġew ikkurati b'Zurampic 200 mg fimkien ma' inibitur ta' xanthine oxidase, meta mqabbla ma' pazjenti kkurati bi plaċebo flimkien ma' inibitur ta' xanthine oxidase (35 % meta mqabbla ma' 28 %, rispettivament).
English: EU/1/15/1080/002 28 film-coated tablets
Maltese: EU/1/15/1080/002 28 pillola miksijin b'rita
English: EU/1/15/1080/003 30 film-coated tablets
Maltese: EU/1/15/1080/003 30 pillola miksijin b'rita
English: The population pharmacokinetic analysis of clinical data in gout patients treated for up to 12 months estimated increases in lesinurad exposure of approximately 12%, 31% and 65% in patients with mild, moderate, and severe renal impairment, respectively, compared with patients with normal renal function.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni tad-dejta klinika f'pazjenti b'gotta kkurati sa 12-il xahar stmat żidiet fl-espożizzjoni għal lesinurad ta' madwar 12 %, 31 % u 65 % f'pazjenti b'indeboliment renali ħafif, moderat u sever, rispettivament, meta mqabbel ma' pazjenti b'funzjoni renali normali.
English: Common - may affect up to 1 in 10 people - flu (influenza), - headache, - increase in the amount of creatinine in your blood -shown in tests, - heartburn(acid reflux).
Maltese: Komuni - jistgħu jaffettwaw sa persuna 1 minn kull 10 - influwenza, - uġigħ ta'ras, - żieda fl-ammont ta'kreatinina fid-demm tiegħek -murija fit-testijiet, - ħruq ta'stonku (rifluss tal-aċidu).
English: No dose adjustment is necessary based on age (see section 5.2); however, elderly patients are more likely to have decreased renal function (see dosing recommendations for renal impairment).
Maltese: M'hemm bżonn ta' ebda aġġustament fid-doża abbażi tal-età (ara sezzjoni 5.2); madankollu, ilpazjenti anzjani għandhom aktar probabbiltà li jkollhom tnaqqis fil-funzjoni renali (ara rakkomandazzjonijiet dwar id-dożaġġ għal indeboliment renali).
English: EU/1/15/1080/001 10 film-coated tablets
Maltese: EU/1/15/1080/001 10 pilloli miksijin b'rita
English: Consistent serum uric acid lowering was observed in patients who were receiving low dose acetylsalicylic acid in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
Maltese: Tnaqqis konsistenti fl-uric acid fisserum kien osservat f'pazjenti li kienu qegħdin jirċievu doża baxxa tal-acetylsalicylic acid fl-istudji kliniċi kkontrollati bi plaċebo flimkien ma' allopurinol jew febuxostat.
English: In the subgroup of patients with a baseline sUA ≥5.0 mg/dL, after 3 weeks of febuxostat therapy, a significant difference was achieved at all study visits for Zurampic 200 mg in combination with febuxostat compared with placebo in combination with febuxostat (see Table 3).
Maltese: Fis-sottogrupp ta' pazjenti b'sUA fil-linja bażi ≥5.0 mg/dL, wara 3 ġimgħat ta' terapija b'febuxostat, intlaħqet differenza sinifikanti fil-visti ta' studju kollha għal Zurampic 200 mg flimkien ma' febuxostat meta mqabbel ma' plaċebo flimkien ma' febuxostat (ara Tabella 3).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattozju, iddefiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glukożju-gallatożju ma għandhomx jieħdu din ilmediċina.
English: Other medicines and Zurampic
Maltese: Mediċini oħra u Zurampic
English: Experience with Zurampic in patients with an estimated CrCL (eCrCL) less than 45 mL/min is limited; therefore, Zurampic should be used with caution in patients with a CrCL from 30 mL/min to less than 45 mL/min.
Maltese: L-esperjenza b'Zurampic f'pazjenti b'CrCL stmata (eCrCL) inqas minn 45 mL/min hija limitata; għalhekk, Zurampic għandu jintuża b'kawtela f'pazjenti b'CrCL minn 30 mL/min sa inqas minn 45 mL/min.
English: In each of the studies, a greater proportion of patients treated with Zurampic 200 mg in combination with allopurinol compared with placebo in combination with allopurinol achieved a serum uric acid less than 5 mg/dL by Month 6 (CLEAR1: 29% versus 10%; CLEAR2: 35% versus 5%).
Maltese: F'kull wieħed minn dawn l-istudji, proporzjon akbar ta' pazjenti kkurati b'Zurampic 200 mg flimkien ma' allopurinol meta mqabbel ma' plaċebo flimkien ma' allopurinol laħqu uric acid fis-serum ta' inqas minn 5 mg/dL sa Xahar 6 (CLEAR1: 29 % meta mqabbel ma' 10 %; CLEAR2: 35 % meta mqabbel ma' 5 %).
English: Cmax and AUC exposures of lesinurad increased proportionally with single doses of lesinurad from 5 to 1,200 mg.
Maltese: Is-Cmax u lespożizzjonijiet AUC ta' lesinurad żdiedu b'mod proporzjonali b'dożi waħdiena ta' lesinurad minn 5 sa 1200 mg.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Maltese: Kemm għandek tieħu
English: There are no restrictions for doses of salicylates of 325 mg or less per day (i.e. for cardiovascular protection).
Maltese: M'hemm ebda restrizzjoni għal dożi ta' saliċilati ta' 325 mg jew inqas kuljum (jiġifieri għal protezzjoni kardjovaskulari).
English: Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.
Maltese: Zurampic, f'kombinazzjoni ma' inibitur ta' xanthine oxidase huwa indikat fl-adulti għall-kura aġġuntiva ta' iperuriċemija f'pazjenti b'gotta (bi jew mingħajr tofi) li ma jkunux kisbu livelli fil-mira ta' uric acid fis-serum ma' doża adegwata ta' inibitur ta' xanthine oxidase waħdu.
English: Based on in vitro data, lesinurad may be a mild inducer of CYP2B6 but this interaction has not been studied clinically.
Maltese: Abbażi ta' dejta in vitro, lesinurad jista' jkun induttur ħafif ta' CYP2B6 iżda din l-interazzjoni ma ġietx studjata klinikament.
English: Treatment Group:
Maltese: Grupp ta' kura:
English: Zurampic must not be initiated in patients with severe renal impairment (CrCL less than 30 mL/min), with end-stage renal disease or in patients on dialysis (see sections 4.3 and 4.4).
Maltese: Zurampic ma għandux jinbeda f'pazjenti b'indeboliment renali sever (CrCL inqas minn 30 mL/min), bil-marda renali fl-istadju finali jew f'pazjenti fuq dijaliżi (ara sezzjonijiet 4.3 u 4.4).
English: - the other ingredients are: - tablet core: hypromellose, microcrystalline cellulose, lactose monohydrate (see section 2),
Maltese: X'fih Zurampic - is-sustanza attiva hija lesinurad. - kull pillola miksija b'rita (pillola) ta'Zurampic 200mg fiha 200mg ta'lesinurad. - is-sustanzi l-oħra huma: - qalba tal-pillola: hypromellose, microcrystalline cellulose, lactose monohydrate (ara sezzjoni2),
English: injections, patches and implants - rifampin - to treat tuberculosis - warfarin - to prevent and treat blood clots forming in the legs, lungs, brain and heart.
Maltese: irqajja' u impjanti - rifampin -biex tiġikkurata tuberkolożi - warfarina -għall-prevenzjoni u għall-kura ta' emboli tad-demm li jiffurmaw fis-saqajn, fil pulmuni, fil-moħħ u fil-qalb.
English: 28 film-coated tablets
Maltese: 28 pillola miksijin b'rita
English: CYP2C9 inhibitors and inducers
Maltese: Inibituri u indutturi ta' CYP2C9
English: Approximately half of an oral dose of lesinurad is cleared via CYP2C9 metabolism.
Maltese: Madwar nofs id-doża orali ta' lesinurad titneħħa permezz tal-metaboliżmu ta' CYP2C9.
English: Consistent serum uric acid lowering was observed in patients who were receiving thiazide diuretics in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
Maltese: Tnaqqis konsistenti fl-uric acid kien osservat f'pazjenti li kienu qegħdin jirċievu dijuretiċi ta' thiazide fl-istudji kliniċi kkontrollati bi plaċebo flimkien ma' allopurinol jew febuxostat.
English: Zurampic must never be taken without a ‘xanthine oxidase inhibitor' medicine.
Maltese: Effetti ta' lesinurad fuq prodotti mediċinali oħrajn:
English: Since the incidence of severe renal-related adverse events was increased with the monotherapy as compared to the combination therapy with a xanthine oxidase inhibitor, Zurampic should not be used as monotherapy (see sections 4.2 and 5.1).
Maltese: Peress li l-inċidenza ta' avvenimenti avversi relatati malkliewi żdiedet bil-monoterapija meta mqabbel ma' terapija kkombinata b'inibitur ta' xanthine oxidase, Zurampic ma għandux jintuża bħala monoterapija (ara sezzjonijiet 4.2 u 5.1).
English: Zurampic is not recommended in patients with unstable angina, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or with a recent event of myocardial infarction, stroke, or deep venous thrombosis within the last 12 months, due to insufficient data.
Maltese: Zurampic mhuwiex rakkomandat f'pazjenti b'anġina mhux stabbli, b'insuffiċjenza tal-qalb tal-klassi II jew IV tan-New York Heart Association (NYHA), bi pressjoni għolja mhux ikkontrollata jew b'avveniment riċenti ta' infart mijokardijaku, puplesija, jew trombożi fil-vini fil-fond fl-aħħar 12il xahar, minħabba dejta insuffiċjenti.
English: In the long-term uncontrolled extension trials, the rates of gout flares requiring treatment further decreased in the 60% of subjects who entered the extension studies and continued treatment with Zurampic 200 mg in combination with allopurinol or febuxostat for up to an additional year of treatment.
Maltese: Filprovi ta' estensjoni mhux ikkontrollati fit-tul, ir-rati ta' rkadar tal-gotta li jeħtieġu kura naqsu iktar fis60% tal-individwi li daħlu l-istudji ta' estensjoni u komplew l-kura b'Zurampic 200 mg flimkien ma' allopurinol jew febuxostat sa sena addizzjonali ta' kura.
English: Within 7 days following single dosing of radiolabelled lesinurad, 63% of administered radioactive dose was recovered in urine and 32% of administered radioactive dose was recovered in faeces.
Maltese: Fi żmien 7 ijiem wara dożaġġ waħdieni ta' lesinurad radjutikkettat, 63 % tad-doża radjuattiva mogħtija kienet irkuprata fl-awrina u 32 % tad-doża radjuattiva mogħtija kienet irkuprata fl-ippurgar.
English: URAT1 is responsible for the majority of the reabsorption of filtered uric acid from the renal tubular lumen.
Maltese: URAT1 huwa responsabbli għall-maġġoranza tar-riassorbiment ta' uric acid iffiltrat millumen tubulari tal-kliewi.