FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from long-term extension studies until 52 months revealed a renal safety profile consistent with that observed in the placebo-controlled studies.
Maltese: Dejta minn studji ta' estensjoni fit-tul sa 52 xahar żvelaw profil tas-sigurtà renali konsistenti ma' dak osservat fl-istudji kkontrollati bi plaċebo.
English: Duzallo may cause serious kidney problems (see section 4).
Maltese: Duzallo jista' jikkawża problemi serji bil-kliewi (ara sezzjoni 4).
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza totali tal-lactase jew malassoribment tal-glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: No increased incidences for adjudicated Major Adverse Cardiovascular Events (MACE) were observed in the randomised, double-blind, placebo-controlled combination therapy clinical studies (CLEAR1 and CLEAR2) (see section 5.1).
Maltese: Ebda żieda fl-inċidenzi ta' Avvenimenti Kardjovaskulari Avversi Ewlenin aġġuntivi (MACE, Major Adverse Cardiovascular Events) ma kienu osservati fl-istudji kliniċi, b'terapija kkombinata kkontrollati bi plaċebo, double-blind, randomizzati (CLEAR1 u CLEAR2) (ara sezzjoni 5.1).
English: EU/1/18/1300/001 30 film-coated tablets EU/1/18/1300/002 100 film-coated tablets EU/1/18/1300/005 10 film-coated tablets
Maltese: EU/1/18/1300/001 30 pillola miksijin b'rita EU/1/18/1300/002 100 pillola miksijin b'rita EU/1/18/1300/005 10 pillola miksijin b'rita
English: In two 12-month placebo-controlled trials of lesinurad in combination with allopurinol versus allopurinol alone (placebo), serum creatinine elevations between 1.5-fold and 2-fold over baseline occurred in 4.4% of patients on lesinurad 200 mg and 2.2% on placebo; serum creatinine elevations 2fold or greater over baseline occurred in 1.5% of patients on lesinurad 200 mg and 0% on placebo.
Maltese: F'żewġ provi kkontrollati bi plaċebo ta' 12-il xahar ta' lesinurad flimkien ma' allopurinol meta mqabbel ma' allopurinol waħdu (plaċebo), kien hemm żidiet fil-kreatinina fis-serum ta' bejn 1.5 u darbtejn fuq il-linja bażi f'4.4% tal-pazjenti fuq lesinurad 200 mg u 2.2% fuq plaċebo; kien hemm żidiet fil-kreatinina fis-serum ta' darbtejn jew iktar fuq il-linja bażi f'1.5% tal-pazjenti fuq lesinurad 200 mg u 0% fuq plaċebo.
English: Pale pink oblong film-coated tablets with 7 x 17 mm in size.
Maltese: Pilloli miksijin b'rita oblungi roża ċar b'daqs ta' 7 x 17 mm.
English: Allopurinol and its main metabolite oxypurinol lower the level of uric acid in plasma and urine by inhibition of xanthine oxidase, the enzyme catalyzing the oxidation of hypoxanthine to xanthine and xanthine to uric acid.
Maltese: Allopurinol u l-metabolit ewlieni tiegħu oxypurinol jbaxxu l-livell ta' uric acid fil-plażma u l-awrina billi jinibixxu l-xanthine oxidase, l-enzima li tikkatalizza l-ossidazzjoni ta' hypoxanthine f'xanthine u ta' xanthine f'uric acid.
English: The most common adverse reaction leading to discontinuation of lesinurad was blood creatinine increased (frequency 0.8%).
Maltese: L-aktar reazzjoni avversa komuni li twassal għat-twaqqif ta' lesinurad kienet żieda fil-kreatinina fid-demm (frekwenza ta' 0.8%).
English: The apparent volume of distribution of allopurinol is approximately 1.6 litre/kg which, suggests relatively extensive uptake by tissues.
Maltese: Il-volum apparenti tad-distribuzzjoni ta' allopurinol huwa madwar 1.6 litru/kg li jissuġġerixxi teħid relattivament estensiv mit-tessuti.
English: Patients continued their allopurinol dose and were randomised 1:1:1 to receive lesinurad 200 mg, lesinurad 400 mg, or placebo once daily.
Maltese: Il-pazjenti komplew id-doża tagħhom ta' allopurinol u kienu randomizzati 1:1:1 biex jirċievu lesinurad 200 mg, lesinurad 400 mg, jew plaċebo darba kuljum.
English: Proportion of patients who met serum uric acid target (<6.0 mg/dL)
Maltese: Proporzjon ta' pazjenti li laħqu l-mira ta' uric acid fis-serum (< 6.0 mg/dL)
English: The safety and efficacy of Duzallo in children and adolescents under 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Duzallo fi tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Duzallo should be used with caution in patients with a CrCL of 30 to less than 45 mL/min (experience with lesinurad in patients with an estimated CrCL (eCrCL) less than 45 mL/min is limited).
Maltese: Duzallo għandu jintuża b'kawtela f'pazjenti b'CrCL ta' 30 għal inqas minn 45 mL/min (l-esperjenza b'lesinurad f'pazjenti b'CrCL stmata (eCrCL, estimated CrCL) ta' inqas minn 45 mL/min hija limitata).
English: Duzallo 200 mg / 200 mg tablets are available in blister packs of 10, 30 and 100 tablets.
Maltese: Il-pilloli ta' Duzallo 200 mg / 200 mg huma disponibbli f'pakketti bil-folji ta' 10, 30 u 100 pillola.
English: Inhibition of the metabolism of theophylline by allopurinol has been reported.
Maltese: Ġiet irrapportata inibizzjoni minn allopurinol tal-metaboliżmu ta' theophylline.
English: Figure 1 Mean serum uric acid levels in pooled clinical studies with lesinurad 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'lesinurad f'kombinazzjoni ma' allopurinol f'pazjenti b'rispons inadegwat (sUA ≥ 6 mg/dL) għal allopurinol waħdu
English: Extensive studies of high oral doses of allopurinol in mice up to 100 mg/kg/day, rats up to 200 mg/kg/day and rabbits up to 150 mg/kg/day during days 8 to 16 of gestation produced no teratogenic effects
Maltese: Studji estensivi ta' dożi orali għoljin ta' allopurinol fil-ġrieden ta' sa 100 mg/kg/jum, fil-firien ta' sa 200 mg/kg/jum u fil-fniek ta' sa 150 mg/kg/jum matul jiem 8 sa 16 tal-ġestazzjoni ma pproduċew l-ebda effett teratoġeniku.
English: Coma, paralysis, ataxia, neuropathy, paraesthesia, drowsiness/somnolence, dysgeusia
Maltese: Koma, paraliżi, atassja, newropatija, paraesteżija, ħedla/ngħas, tibdil fis-sens tat-togħma
English: Duzallo 300 mg / 200 mg tablets are available in blister packs of 10, 30 and 100 tablets.
Maltese: Il-pilloli ta' Duzallo 300 mg / 200 mg huma disponibbli f'pakketti bil-folji ta' 10, 30 u 100 pillola.
English: Lesinurad also inhibits OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia.
Maltese: Lesinurad jinibixxi wkoll OAT4, trasportatur ta' uric acid involut f'iperuriċemija kkaġunata minn dijuretiċi.
English: An increased risk of hypersensitivity has been reported when allopurinol is given with diuretics, in particular thiazides, especially in renal impairment (see section 4.4 and section 5.1).
Maltese: Ġiet irrapportata żieda fir-riskju ta' sensittività eċċessiva meta allopurinol ingħata ma' dijuretiċi, b'mod partikolari thiazides, speċjalment f'indeboliment renali (ara sezzjoni 4.4 u sezzjoni 5.1).
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 lesinurad 200 mg versus 29% for placebo when added to allopurinol at doses ranging from 200 mg to 900 mg.
Maltese: B'mod konsistenti mal-popolazzjoni globali, il-proporzjon ta' pazjenti b'indeboliment renali ħafif sa moderat (eCrCL 30-89 mL/min) li laħqu l-livelli fil-mira ta' uric acid fis-serum f'Xahar 6 kien 56% għal lesinurad 200 mg meta mqabbel ma' 29% għal plaċebo meta miżjuda ma' allopurinol f'dożi li jvarjaw minn 200 mg għal 900 mg.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu n-nutrizzjoni
English: Each film-coated tablet contains 102.6 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 102.6 mg ta' lattożju (bħala monohydrate).
English: Duzallo is contraindicated in patients with severe renal impairment (CrCL less than 30 ml/min), with end-stage renal disease, in patients on dialysis or in kidney transplant recipients (see sections 4.3 and 4.4).
Maltese: Duzallo huwa kontraindikat f'pazjenti b'indeboliment renali sever (CrCL inqas minn 30 mL/min), bil-marda renali fl-istadju finali, f'pazjenti fuq dijaliżi jew f'pazjenti li jingħataw trapjant tal-kliewi (ara sezzjonijiet 4.3 u 4.4).
English: The efficacy of lesinurad 200 mg once daily was studied in 2 multicentre, randomised, double-blind, placebo-controlled clinical studies in 812 adult patients (11% of these patients were elderly, ≥65 years old) with hyperuricaemia and gout in combination with allopurinol (CLEAR1 and CLEAR2).
Maltese: L-effikaċja ta' lesinurad 200 mg darba kuljum ġiet studjata f'2 studji kliniċi, ikkontrollati bi plaċebo, double-blind, randomizzati, multiċentriċi f'812-il pazjent adult (11% minn dawn il-pazjenti kienu anzjani, li għandhom aktar minn 65 sena) b'iperuriċemija u gotta flimkien ma' allopurinol (CLEAR1 u CLEAR2).
English: Serious renal-related adverse reactions, e.g. acute renal failure and renal impairment, were reported in patients treated with placebo (0.2%) and in no patients on lesinurad 200 mg.
Maltese: Reazzjonijiet avversi serji relatati mal-kliewi, eż. insuffiċenza renali akuta u indeboliment renali, ġew irrapportati f'pazjenti ttrattati bi plaċebo (0.2%) u fl-ebda pazjent fuq lesinurad 200 mg.
English: Based on pharmacokinetic modelling simulations, patients with moderate renal impairment and reduced CYP2C9 activity (co-administration of a CYP2C9 inhibitor or a CYP2C9 poor metabolizer) are predicted to have an increase in AUC of approximately 200% in comparison to normal renal function and unimpaired CYP2C9 activity.
Maltese: Abbażi tas-simulazzjonijiet tal-mudell farmakokinetiku, il-pazjenti b'indeboliment renali moderat u tnaqqis fl-attività ta' CYP2C9 (l-għoti flimkien ta' inibitur ta' CYP2C9 jew metabolizzatur ħażin ta' CYP2C9) huwa mbassar li jkollhom żieda fl-AUC ta' madwar 200% meta mqabbel ma' funzjoni renali normali u attività ta' CYP2C9 mhux imfixkla.
English: This is also the maximum daily dose of Duzallo (see section 4.4).
Maltese: Din hija wkoll id-doża massima ta' kuljum ta' Duzallo (ara sezzjoni 4.4).
English: Patients with renal impairment, where creatinine clearance values were between 10 and 20 ml/min, showed plasma oxypurinol concentrations of approximately 30 mg/litre after prolonged treatment with 300 mg allopurinol per day.
Maltese: Pazjenti b'indeboliment renali, fejn il-valuri tal-eliminazzjoni tal-kreatinina kienu bejn 10 u 20 mL/min, kellhom konċentrazzjonijiet ta' oxypurinol fil-plażma ta' madwar 30 mg/litru wara trattament fit-tul b'300 mg allopurinol kuljum.
English: Lesinurad, when combined with a xanthine oxidase inhibitor, increases uric acid excretion and decreases uric acid production resulting in greater sUA lowering.
Maltese: Lesinurad, meta jingħata ma' inibitur ta' xanthine oxidase, iżid l-eliminazzjoni ta' uric acid u jnaqqas il-produzzjoni ta' uric acid li tirriżulta fi tnaqqis akbar ta' sUA.
English: The active substances are allopurinol and lesinurad.
Maltese: Is-sustanzi attivi huma allopurinol u lesinurad.
English: The recommended dose is one tablet of Duzallo (200 mg/200 mg or 300 mg/200 mg) once daily.
Maltese: Id-doża rakkomandata hija pillola waħda ta' Duzallo (200 mg/200 mg jew 300 mg/200 mg) darba kuljum.
English: In the pivotal clinical trials, a greater proportion of patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 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 prinċipali, proporzjon akbar ta' pazjenti li użaw prodotti mediċinali li jnaqqsu l-lipidi jew kontra pressjoni għolja li kienu sottostrati ta' CYP3A, kellhom bżonn ta' bidla fil-prodott mediċinali konkomitanti meta ġew ittrattati b'lesinurad 200 mg flimkien ma' inibitur ta' xanthine oxidase, meta mqabbla ma' pazjenti ttrattati bi plaċebo flimkien ma' inibitur ta' xanthine oxidase (35% meta mqabbla ma' 28%, rispettivament).
English: The kinetics of allopurinol are not likely to be altered other than due to deterioration in renal function (see section 5.2 renal impairment).
Maltese: Huwa improbabbli li l-farmakokinetika ta' allopurinol tinbidel ħlief minħabba deterjorazzjoni fil-funzjoni renali (ara sezzjoni 5.2 Indeboliment renali).
English: Hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function receiving diuretics (in particular thiazides) and Duzallo concurrently (see sections 4.5 and 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva għal allopurinol jistgħu jiżdiedu f'pazjenti bi tnaqqis fil-funzjoni renali li jirċievu dijuretiċi (b'mod partikolari thiazides) u Duzallo fl-istess ħin (ara sezzjonijiet 4.5 u 4.8).
English: Approximately 20% of the ingested allopurinol is excreted in the faeces.
Maltese: Madwar 20% ta' allopurinol inġestit huwa eliminat fl-ippurgar.
English: In the randomised, double-blind, placebo-controlled combination therapy clinical studies, the incidences of patients with adjudicated Major Adverse Cardiovascular Events (MACE; cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) per 100 patient-years of exposure were 0.60 (95% confidence interval (C.I.)
Maltese: Fi studji kliniċi, b'terapija kkombinata kkontrollati bi plaċebo, double-blind, randomizzati, l-inċidenzi ta' pazjenti b'Avvenimenti Kardjovaskulari Avversi Ewlenin aġġuntivi (MACE: mewta kardjovaskulari, infart mijokardijaku mhux fatali jew puplesija mhux fatali) għal kull 100 sena tal-pazjent ta' espożizzjoni kienu 0.60
English: The possibility of reduced efficacy of concomitant medicinal products that are CYP3A substrates should be considered and their efficacy (e.g. blood pressure and cholesterol levels) should be monitored (see section 4.4).
Maltese: Il-possibbiltà ta' tnaqqis fl-effikaċja ta' prodotti mediċinali konkomitanti li huma sottostrati ta' CYP3A għandha tiġi kkunsidrata u l-effikaċja tagħhom (eż. pressjoni tad-demm u livelli ta' kolesterol) għandha tiġi ssorveljata (ara sezzjoni 4.4).
English: One study in mice receiving intraperitoneal doses of 50 or 100 mg/kg on days 10 or 13 of gestation resulted in foetal abnormalities, however in a similar study in rats at 120 mg/kg on day 12 of gestation no abnormalities were observed.
Maltese: Studju wieħed fil-ġrieden li rċevew dożi intraperitonjali ta' 50 jew 100 mg/kg fil-jiem 10 jew 13 talġestazzjoni rriżultaw f'anormalitajiet fil-fetu, madankollu, fi studju simili fil-firien b'120 mg/kg fil-jum 12 ta' ġestazzjoni ma ġiet osservata l-ebda anormalità.
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 fin-nuqqas jew il-preżenza tal-inibitur ta' xanthine oxidase.
English: The most frequent renal-related adverse reaction was blood creatinine increased (3.7% with lesinurad 200 mg compared to 2.2% with placebo).
Maltese: L-iktar reazzjoni avversa relatata mal-kliewi frekwenti kienet żieda fil-kreatinina fid-demm (3.7% b'lesinurad 200 mg meta mqabbel ma'2.2% bi plaċebo).
English: In clinical trials, lesinurad was administered with food, because the serum uric acid lowering was improved under fed conditions (see section 4.2).
Maltese: Fi provi kliniċi, lesinurad ingħata mal-ikel, peress li t-tnaqqis ta' uric acid fis-serum ittejjeb f'kundizzjonijiet mitmugħa (ara sezzjoni 4.2).
English: Such patients, taking 300 mg of allopurinol per day will generally have plasma oxypurinol concentrations of 5-10 mg/litre.
Maltese: Pazjenti bħal dawn, li qed jieħdu 300 mg ta' allopurinol kuljum ġeneralment se jkollhom konċentrazzjonijiet ta' oxypurinol fil-plażma ta' 5-10 mg/litru.
English: Salicylates and non-selective uricosuric active substances such as probenecid Salicylates at doses higher than 325 mg per day may decrease the serum uric acid lowering activity of lesinurad and should not be co-administered with Duzallo.
Maltese: Salicylates u sustanzi attivi urikosuriċi mhux selettivi bħal probenicid Salicylates f'dożi ogħla minn 325 mg kuljum jistgħu jnaqqsu l-attività ta' tnaqqis ta' uric acid fis-serum ta' lesinurad u ma għandhomx jingħataw flimkien ma' Duzallo.
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: 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: Patients known to be CYP2C9 poor metabolisers should be treated with caution, as the potential risk of lesinurad renal-related adverse reactions may be increased (see sections 4.8 and 5.2).
Maltese: Il-pazjenti magħrufin li huma metabolizzaturi dgħajfin ta' CYP2C9 għandhom jiġu ttrattati b'kawtela, peress li r-riskju potenzjali ta' reazzjonijiet avversi relatati mal-kliewi għal lesinurad jista' jiżdied (ara sezzjonijiet 4.8 u 5.2).
English: 1 Stokenchurch Business Park Ibstone Road, HP14 3FE - UK Tel: +44 (0)870 351 8960 medicalinformationuk@grunenthal.com
Maltese: 3FE - UK Tel: + 44 (0)870 351 8960 medicalinformationuk@grunenthal.com
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletr iċi u tat-tessuti konnettivi
English: Impaired liver function tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: A possible interaction should be taken into account when a patient on oral anticoagulants is given Duzallo.
Maltese: Għandha tiġi kkunsidrata l-possibbiltà ta' interazzjoni meta pazjent fuq antikoagulanti orali jingħata Duzallo.
English: Lesinurad is highly protein bound and renal clearance is high (as compared to typical human glomerular filtration rate), indicating that active secretion plays an important role in the renal excretion of lesinurad.
Maltese: Lesinurad jeħel ħafna mal-proteina u t-tneħħija mill-kliewi hija għolja (meta mqabbel ma' rata ta' filtrazzjoni glomerulari tal-bniedem tipika), li tindika li s-sekrezzjoni attiva għandha rwol importanti fit-tneħħija mill-kliewi ta' lesinurad.
English: Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN.
Maltese: Reazzjonijiet ta' sensittività eċċessiva għal allopurinol jistgħu jseħħu f'ħafna modi differenti, inkluż eksantema makulopapulari, sindrome ta' sensittività eċċessiva (magħrufa wkoll bħala DRESS) u SJS/TEN.
English: How to take Duzallo
Maltese: X'fih Duzallo
English: In healthy volunteers and HIV patients receiving didanosine, plasma didanosine maximum plasma concentration (Cmax ) and area under the curve (AUC) values were approximately doubled with concomitant allopurinol treatment (300 mg daily) without affecting terminal half-life.
Maltese: F'voluntiera b'saħħithom u pazjenti b'HIV li ngħataw didanosine, il-valuri tal-konċentrazzjoni massima fil-plażma (Cmax) u l-erja taħt il-kurva (AUC) ta' didanosine bejn wieħed u ieħor rdoppjaw bit-trattament fl-istess ħin ma' allopurinol (300 mg kuljum) mingħajr ma affettwaw il-half-life terminali.
English: Oxypurinol is a less potent inhibitor of xanthine oxidase than allopurinol, but the plasma half-life of oxypurinol is far more prolonged.
Maltese: Oxypurinol huwa inibitur inqas potenti ta' xanthine oxidase minn allopurinol, iżda l-half-life fil-plażma ta' oxypurinol hija ferm itwal.
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 fil-uric acid fis- serum 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: Patients with normal renal function will gradually accumulate oxypurinol until a steadystate plasma oxypurinol concentration is reached.
Maltese: Pazjenti b'funzjoni renali normali se jakkumulaw gradwalment oxypurinol sakemm tintlaħaq konċentrazzjoni ta' oxypurinol fil-plażma fi stat stabbli.
English: SJS/TEN can still occur in patients who are found to be negative for HLA-B*5801 irrespective of their ethnic origin.
Maltese: SJS/TEN xorta tista' sseħħ f'pazjenti li jinstabu li huma negattivi għal HLA-B*5801 irrispettivament mill-oriġini etnika tagħhom.
English: Patients taking Duzallo which contains the active substance allopurinol and 6mercaptopurine or azathioprine must reduce their dose to 25 % of the intended dose of 6
Maltese: Pazjenti li jieħdu Duzallo, li fih is-sustanza attiva allopurinol u 6-mercaptopurine jew azathioprine, għandhom inaqqsu d-doża tagħhom għal 25% tad-doża intenzjonata ta' 6-mercaptopurine jew azathioprine.
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 ttrattati 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: Gastrooesophageal reflux disease
Maltese: Mard ta' rifluss gastro-esofagali
English: azathioprine - vidarabine, used to treat herpes or chickenpox - cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents, mercaptopurine), used to treat cancer or rheumatic diseases - aluminium hydroxide, used to treat heartburn and acid indigestion (you should leave an interval of at least 3 hours between taking the two medicines)
Maltese: - mediċini użati biex inaqqsu r-rispons immunitarju tiegħek (immunosoppressanti) eż. ciclosporin, azathioprine - vidarabine, użat għat-trattament tal-herpes jew ġidri r-riħ - ċitostatiċi (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, aġenti alkilanti, mercaptopurine), użati għat-trattament tal-kanċer jew mard remwatiku - aluminium hydroxide, użat għat-trattament ta' ħruq tal-istonku u indiġestjoni ta' aċidu (għandek tħalli intervall ta' mill-inqas 3 sigħat bejn iż-żewġ mediċini)
English: OUTER CARTON for 10, 30 and 100 film-coated tablets
Maltese: KARTUNA TA' BARRA għal 10, 30 u 100 pillola miksijin b'rita
English: Female patients of childbearing age should practice additional methods of contraception and not rely on hormonal contraception alone when taking Duzallo (see sections 4.5 and 4.6).
Maltese: Il-pazjenti nisa f'età li jista' jkollhom it-tfal għandhom jipprattikaw metodi addizzjonali ta' kontraċezzjoni u ma għandhomx jiddependu fuq kontraċezzjoni ormonali biss meta jieħdu Duzallo (ara sezzjonijiet 4.5 u 4.6).
English: The film-coated tablets are engraved with “LES200” and “ALO300” on one side.
Maltese: Il-pilloli miksijin b'rita għandhom imnaqqax “LES200” u “ALO300” fuq naħa waħda.