FrancophonIA/ELRC3.0 huggingface dataset:
English: **** The occurrence of increased thyroid stimulating hormone (TSH) in the relevant studies did not report any impact on free T4 levels or had TSH levels indicative of subclinical hypothyroidism.
Maltese: **** L-okkorrenza taż-żieda fl-ormon li jistimula t-tirojde (TSH, thyroid stimulating hormone) fl-istudji rilevanti ma rrapportatx xi impatt fuq il-livelli ta' T4 ħielsa jew kellha livelli ta' TSH li jindikaw ipotirojdiżmu subkliniku.
English: Months 4, 5, 6 48 (12%)
Maltese: Xahar 4, 5, 6
English: Very rare - may affect up to 1 in 10,000 people - chest pain, slow heartbeat, high blood pressure or a slow pulse, - vomiting blood (recurrent hematemesis), presence of excess fat in the stool (steatorrhea), - inflammation of the mucous membranes of the mouth (stomatitis), changed stool frequency (changed bowel motions), - hair loss or discoloration, - abnormal glucose metabolism (diabetes; your doctor may wish to measure the level of sugar in your blood to check if this is happening), - high levels of cholesterol in your blood (hyperlipidaemia), - depression, - coma, - weakness, numbness, unsteadiness on your feet, unable to move muscles (paralysis) or loss of consciousness, - not able to control muscle movements (ataxia), - sensation of tingling, tickling, pricking or burning of skin (paraesthesia), - headache, dizziness, drowsiness or disturbance of your vision, - cloudiness of the eye (cataract), - a change in taste, - blood in your urine (haematuria), - male infertility or erectile dysfunction, - enlargement of the breasts, in men as well as in women, - build-up of fluid leading to swelling (oedema) particularly of your ankles, - muscle aches, - painful skin boil, - damage to the nerves which can cause numbness, pain and weakness.
Maltese: jew tintilef minn sensik, - ma tkunx tista' tikkontrolla l-movimenti tal-muskoli (atassja), - sensazzjoni ta' tnemnim, tagħrix, tingiż jew ħruq tal-ġilda (paraesteżija), - uġigħ ta' ras, sturdament, ħedla jew problemi bil-vista, - għajn imċajpra (katarretti), - bidla fis-sens tat-togħma, - demm fl-awrina tiegħek, (ematurja), - infertilità fl-irġiel jew disfunzjoni erettili fl-irġiel, - tkabbir tas-sider, fl-irġiel kif ukoll fin-nisa, - akkumulazzjoni ta' fluwidu li jwassal għal nefħa (edema) b'mod partikolari tal-għekiesi, - uġigħ fil-muskoli, - msiemer fil-ġilda li jweġġgħu, - ħsara lin-nervituri li tista' tikkawża tnemnim, uġigħ u dgħufija.
English: 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: Duzallo 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 fis-serum ta' aktar minn 6.5 mg/dL u rrapportaw tal-inqas żewġ każijiet ta' rkadar tal-gotta fit-12-il xahar ta' qabel.
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.
Maltese: Tnaqqis konsistenti fil-uric acid kien osservat f'pazjenti li kienu qegħdin jirċievu dijuretiċi ta' thiazide fl-istudji kliniċi kkontrollati bi plaċebo flimkien ma' allopurinol.
English: Orange and slightly brownish oblong film-coated tablets with 8 x 19 mm in size.
Maltese: Pilloli miksijin b'rita oblungi oranġjo għal kemxejn kannella b'daqs ta' 8 x 19 mm.
English: Gastrointestinal disorders
Maltese: Disturbi gastro-intestina li
English: Duzallo which contains lesinurad as active substance causes an increase in renal uric acid excretion, which may lead to transient increases in serum creatinine, renal-related adverse reactions and kidney stones (see section 5.1).
Maltese: Duzallo li fih lesinurad bħala sustanza attiva jikkawża żieda fl-eliminazzjoni renali ta' uric acid, li jista' jwassal għal żieda temporanja fil-kreatinina fis-serum, reazzjonijiet avversi relatati mal-kliewi u ġebel fil-kliewi (ara sezzjoni 5.1).
English: - acetylsalicylic acid - to relieve fever and pain at doses above 325 mg per day - medicines to treat high blood pressure such as ACE inhibitors, water tablets (diuretics medicines that increase the passing of urine) and calcium channel blockers e.g. amlodipine - medicines to treat high cholesterol levels, e.g. simvastatin - fluconazole - to treat fungal infections - amiodarone - to treat heart rhythm problems - valproic acid, valpromide, phenytoin or carbamazepine - to prevent fits (seizures), mood disorders and prevent migraines - bupropion - for treating depression or to help stop smoking - sildenafil - to treat erectile problems in men - contraceptives - used to prevent pregnancy, including oral contraception (such as ‘the pill'), injections, patches and implants - coumarin anticoagulants - to prevent and treat blood clots - antibiotics like ampicillin or amoxicillin
Maltese: (dijuretiċi - mediċini li jżidu l-ammont ta' awrina li tgħaddi) u mediċini li jimblokkaw il-kanal tal-kalċju eż. amlodipine - mediċini biex jiġu kkurati livelli għoljin ta' kolesterol, eż. simvastatin - fluconazole - biex jiġu kkurati infezzjonijiet tal-moffa - amiodarone - biex jiġu kkurati problemi fir-ritmu tat-taħbit tal-qalb - valproic acid, valpromide, phenytoin, jew carbamazepine - biex jiġu evitati aċċessjonijiet
English: Each film-coated tablet contains 300 mg allopurinol and 200 mg lesinurad
Maltese: Kull pillola miksija b'rita fiha 300 mg allopurinol u 200 mg lesinurad
English: In each of the studies, a greater proportion of patients treated with lesinurad 200 mg in combination with allopurinol compared with placebo in combination with allopurinol achieved a serum uric acid level of 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 ttrattati b'lesinurad 200 mg flimkien ma' allopurinol meta mqabbel ma' plaċebo flimkien ma' allopurinol laħqu livell ta' 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: 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' salicylates ta' 325 mg jew inqas kuljum (jiġifieri għal protezzjoni kardjovaskulari).
English: Each Duzallo 300 mg / 200 mg film-coated tablet contains 300 mg of allopurinol and 200 mg of lesinurad.
Maltese: Kull Duzallo 300 mg / 200 mg pillola miksija b'rita fiha 300 mg ta' allopurinol u 200 mg ta' lesinurad.
English: A delayed multi-organ hypersensitivity disorder (known as hypersensitivity syndrome or DRESS) with fever, rashes, vasculitis, lymphadenopathy, pseudo lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly, abnormal liver function tests and vanishing bile duct syndrome (destruction and disappearance of the intrahepatic bile ducts) occurring in various combinations.
Maltese: Disturb ta' sensittività eċċessiva ttardjata f'diversi organi (magħruf bħala sindrome ta' sensittività eċċessiva jew DRESS) b'deni, raxx, vaskulite, limfadenopatija, psewdolimfoma, artralġja, lewkopenja, eosinofilja, epatosplenomegalija, testijiet tal-funzjoni tal-fwied mhux normali u sindrome tal-kanal tal-bile li jisparixxi (qerda u għajbien tal-kanali tal-bile intraepatiċi) li jseħħ f'diversi kombinazzjonijiet.
English: The most commonly reported adverse reactions during treatment with lesinurad 200 mg are influenza, gastro-oesophageal reflux disease, headache and blood creatinine increased.
Maltese: L-iktar reazzjonijiet avversi rrapportati b'mod komuni matul it-trattament b'lesinurad 200 mg huma influwenza, marda ta' rifluss gastro-esofagali, uġigħ ta' ras u żieda fil-kreatinina fid-demm.
English: Gout flare prophylaxis needs to be considered (see section 4.2).
Maltese: Għandha tiġi kkunsidrata profilassi għal irkadar tal-gotta (ara sezzjoni 4.2).
English: Adverse reactions related to renal function can occur after initiating Duzallo (see section 4.8)
Maltese: Jistgħu jseħħu reazzjonijiet avversi relatati mal-funzjoni renali wara li jinbeda Duzallo (ara sezzjoni 4.8).
English: In both studies, significantly more patients treated with lesinurad 200 mg in combination with allopurinol ≥ 300 mg/day (≥ 200 mg/day in subjects with moderate renal impairment) achieved the target serum uric acid level of less than 6 mg/dL by Month 6 and by Month 12 compared with patients receiving placebo in combination with allopurinol (see Table 3).
Maltese: Fiż-żewġ studji, numru ferm akbar ta' pazjenti ttrattati b'lesinurad 200 mg flimkien ma' allopurinol ≥ 300 mg/jum (≥ 200 mg/jum f'individwi b'indeboliment renali moderat) laħqu l-livell fil-mira ta' uric acid fis-serum ta' inqas minn 6 mg/dL sa Xahar 6 u sa Xahar 12 meta mqabbla ma' pazjenti li rċevew plaċebo flimkien ma' allopurinol (ara Tabella 3).
English: Duzallo 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 with lesinurad.
Maltese: Duzallo mhuwiex rakkomandat f'pazjenti b'anġina mhux stabbli, b'insuffiċjenza tal-qalb tal-klassi III jew IV tan-New York Heart Association (NYHA), bi pressjoni għolja mhux ikkontrollata jew b'avveniment riċenti ta' infart mijokardijaku, puplesija, jew trombożi profonda fil-vini fl-aħħar 12-il xahar, minħabba dejta insuffiċjenti b'lesinurad.
English: The film-coated tablets are engraved with “LES200” and “ALO200” on one side.
Maltese: Il-pilloli miksijin b'rita għandhom imnaqqax “LES200” u “ALO200” fuq naħa waħda.
English: In interaction studies conducted in healthy subjects with lesinurad and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine.
Maltese: Fi studji ta' interazzjoni li saru f'individwi b'saħħithom b'lesinurab u sottostrati ta' CYP3A, lesinurad naqqas il-konċentrazzjonijiet fil-plażma ta' sildenafil u amlodipine.
English: Additional monitoring of lipids and blood pressure is recommended in patients using sensitive CYP3A substrate lipid lowering medicinal products (such as lovastatin or simvastatin) or antihypertensive medicinal products (such as amlodipine, felodipine or nisoldipine), since their efficacy may be reduced (see section 4.5).
Maltese: Huwa rrakkomandat li jsir monitoraġġ addizzjonali tal-lipidi u tal-pressjoni tad-demm f'pazjenti li jużaw prodotti mediċinali sensittivi li jbaxxu l-lipidi fis-sottostrati ta' CYP3A (bħal lovastatin jew simvastatin) jew prodotti mediċinali kontra l-pressjoni għolja (bħal amlodipine, felodipine jew nisoldipine), peress li l-effikaċja tagħhom tista' titnaqqas (ara sezzjoni 4.5).
English: Each Duzallo 200 mg / 200 mg film-coated tablet contains 200 mg of allopurinol and 200 mg of lesinurad.
Maltese: Kull Duzallo 200 mg / 200 mg pillola miksija b'rita fiha 200 mg ta' allopurinol u 200 mg ta' lesinurad.
English: However, it is recommended that in patients receiving Duzallo which contains the active substance allopurinol an alternative to ampicillin or amoxicillin is used where available.
Maltese: Madankollu, huwa rrakkomandat li f'pazjenti li jingħataw Duzallo li fih is-sustanza attiva allopurinol, tintuża alternattiva għal ampicillin jew amoxicillin meta din tkun disponibbli.
English: Serious skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have occured in patients taking allopurinol.
Maltese: Raxx serju fil-ġilda (sindrome ta' sensittività eċċessiva, sindrome ta' Stevens-Johnson, nekroliżi epidermika tossika) seħħ f'pazjenti li kienu qed jieħdu allopurinol.
English: 0.15, 2.41) for placebo and 0.61 (95% C.I.
Maltese: (intervall ta' kunfidenza (C.I., confidence interval) ta' 95% 0.15, 2.41) għal plaċebo u 0.61 (C.I. ta' 95% 0.15, 2.43) għal lesinurad 200 mg, meta użat flimkien ma' allopurinol (CLEAR1 u CLEAR2).
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 lesinurad 200 mg in combination with allopurinol or febuxostat for up to an additional year of treatment.
Maltese: Fil-provi ta' estensjoni mhux ikkontrollati fit-tul, ir-rati ta' rkadar tal-gotta li jeħtieġu trattament naqsu iktar fis-60% tal-individwi li daħlu fl-istudji ta' estensjoni u komplew it-trattament b'lesinurad 200 mg flimkien ma' allopurinol jew febuxostat għal massimu ta' sena addizzjonali ta' trattament.
English: Angioimmunoblastic T-cell lymphoma
Maltese: Farmakokinetika f'pazjenti anzjani
English: Pack sizes of 10, 30 or 100 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 10, 30 jew 100 pillola miksijin b'rita.
English: Oxypurinol is eliminated unchanged in the urine but has a long elimination half-life because it undergoes tubular reabsorption.
Maltese: Oxypurinol huwa eliminat kif inhu fl-awrina iżda għandu half-life ta' eliminazzjoni twila minħabba li jgħaddi minn riassorbiment tubulari.
English: If the patient is a known carrier of HLA-B*5801, especially in those who are of Han Chinese, Thai or Korean descent, allopurinol should not be started unless there are no other reasonable therapeutic options and the benefits are thought to exceed risks.
Maltese: Jekk ma jkun hemm l-ebda ġenotipar ta' HLA-B*5801 disponibbli għal pazjenti b'dixxendenza Ċiniża tal-Han, Tajlandiża jew Koreana, il-benefiċċji għandhom jiġu vvalutati sew u jridu jitqiesu li dawn jegħlbu r-riskji ogħla possibbli qabel ma tinbeda t-terapija.
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: System Organ
Maltese: Sistema tal-Klassifika tal-Organi
English: They may be pruritic, maculopapular, sometimes scaly, sometimes purpuric and rarely exfoliative, such as SJS/TEN.
Maltese: Dawn jistgħu jkunu bil-ħakk, makulopapulari, kultant bil-qxur, kultant purpuriċi u rarament esfoljattivi, bħal SJS/TEN.
English: In another patient the intake of 22.5 g allopurinol caused no adverse reactions.
Maltese: F'pazjent ieħor, it-teħid ta' 22.5 g allopurinol ma kkawża l-ebda reazzjoni avversa.
English: Patients who are currently treated with allopurinol doses higher than 300 mg can be switched to Duzallo 200 mg/200 mg or Duzallo 300 mg/200 mg and should receive complementary doses of allopurinol to cover the total dose of allopurinol taken before switching to Duzallo.
Maltese: Pazjenti li attwalment qed jiġu ttrattati b'dożi ta' allopurinol ogħla minn 300 mg jistgħu jaqilbu għal Duzallo 200 mg/200 mg jew Duzallo 300 mg/200 mg u għandhom jingħataw dożi kumplimentari ta' allopurinol biex ikopru d-doża totali ta' allopurinol li jieħdu qabel ma jaqilbu għal Duzallo.
English: What Duzallo looks like and contents of the pack Duzallo 200 mg/200 mg film-coated tablets are pale pink oblong tablets and engraved with “LES200” and “ALO200” on one side.
Maltese: Duzallo 200 mg/200 mg pilloli miksijin b'rita huma pilloli oblongi roża ċari u għandhom imnaqqax “LES200” u “ALO200” fuq naħa waħda.
English: Common - may affect up to 1 in 10 people - increased level of thyroid stimulating hormone in the blood, - flu, - headache, - blood tests showing increased creatinine (which may be a sign of kidney problems), - heartburn (acid reflux), - skin rash.
Maltese: Komuni - jistgħu jaffettwaw sa persuna 1 minn kull 10 - żieda fil-livell tal-ormon li jistimula t-tirojde fid-demm, - influwenza, - uġigħ ta' ras, - testijiet tad-demm li juru żieda fil-kreatinina (li jista' jkun sinjal ta' problemi bil-kliewi), - ħruq ta' stonku (rifluss tal-aċidu), - raxx fil-ġilda.
English: - fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder) Rare - may affect up to 1 in 1000 people - potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Maltese: Rari - jistgħu jaffettwaw sa persuna 1 minn kull 1000 - raxx fil-ġilda potenzjalment ta' theddid għall-ħajja (sindrome ta' Stevens-Johnson, nekroliżi epidermika tossika) li jidher fil-bidu bħala ponot jew irqajja' ċirkolari qishom bersall ħomor ħafna drabi b'infafet ċentrali fuq it-tronk.
English: Gout flares may occur after initiation of therapy with Duzallo.
Maltese: Irkadar tal-gotta jista' jseħħ wara l-bidu tat-terapija b'Duzallo.
English: When generalised hypersensitivity reactions have occurred, renal and/or hepatic disorder has usually been present particularly when the outcome has been fatal.
Maltese: Meta jseħħu reazzjonijiet ta' sensittività eċċessiva ġeneralizzati, normalment kien hemm preżenti disturb renali u/jew epatiku b'mod partikolari meta r-riżultat kien fatali.
English: The mechanism of the interaction may be explained by xanthine oxidase being involved in the biotransformation of theophylline in man. Theophylline levels should be monitored in patients undergoing Duzallo therapy.
Maltese: Il-mekkaniżmu ta' interazzjoni jista' jiġi spjegat mill-involviment ta' xanthine oxidase fil-bijotrasformazzjoni ta' theophylline fil-bniedem.
English: Duzallo 200 mg/200 mg film-coated tablets allopurinol/lesinurad
Maltese: Duzallo 200 mg / 200 mg pilloli miksijn b'rita allopurinol/lesinurad
English: Duzallo 300 mg/200 mg film-coated tablets allopurinol/lesinurad
Maltese: Duzallo 300 mg / 200 mg pilloli miksijn b'rita allopurinol/lesinurad
English: Duzallo should not be restarted without another explanation for the serum creatinine abnormalities.
Maltese: Duzallo ma għandux jerġa' jinbeda mingħajr spjegazzjoni oħra għall-anormalitajiet ta' kreatinina fis-serum.
English: Each film-coated tablet contains 200 mg allopurinol and 200 mg lesinurad
Maltese: Kull pillola miksija b'rita fiha 200 mg allopurinol u 200 mg lesinurad
English: In vitro and in vivo studies conducted to date showed no evidence of mutagenic or carcinogenic potential.
Maltese: Studji in vitro u in vivo li twettqu sal-lum ma wrew l-ebda evidenza ta' potenzjal mutaġeniku jew karċinoġeniku.
English: Classification
Maltese: LISTA
English: Rash and skin symptoms
Maltese: Raxx u sintomi tal-ġilda
English: In patients with moderate renal impairment, the incidence of renal-related adverse reactions was similar across all treatment groups: Lesinurad 200 mg (13.4%) and placebo (12.5%).
Maltese: Lesinurad 200 mg (13.4%) u plaċebo (12.5%).
English: Patients with serum creatinine elevations to greater than 1.5 times the pre-treatment value should be closely monitored.
Maltese: Il-pazjenti b'żidiet fil-kreatinina fis-serum ta' iktar minn 1.5 drabi l-valur qabel it-trattament għandhom jiġu ssorveljati mill-qrib.
English: Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.
Maltese: Duzallo huwa indikat f'adulti għat-trattament tal-iperuriċemija f'pazjenti bil-gotta li ma jkunux kisbu l-livelli ta' uric acid fis-serum fil-mira b'doża adegwata ta' allopurinol waħdu.
English: 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Maltese: 10 pillola miksijin b'rita 30 pillola miksijin b'rita 100 pillola miksijin b'rita
English: What Duzallo looks like and contents of the pack Duzallo 300 mg/200 mg film-coated tablets are orange and slightly brownish oblong tablets and engraved with “LES200” and “ALO300” on one side.
Maltese: Duzallo 300 mg/200 mg pilloli miksijin b'rita huma pilloli oblongi oranġjo u jagħtu fil-kannella u għandhom imnaqqax “LES200” u “ALO300” fuq naħa waħda.
English: Treatment with lesinurad 200 mg in combination with allopurinol was associated with an increased incidence of serum creatinine elevations, which are related to increased renal uric acid excretion.
Maltese: It-trattament b'lesinurad 200 mg flimkien ma' allopurinol kien assoċjat ma' inċidenza ikbar ta' żidiet fil-kreatinina fis-serum, li huma relatati ma' żieda fl-eliminazzjoni renali ta' uric acid.
English: If Duzallo which contains the active substance allopurinol is given concomitantly with chlorpropamide when renal function is poor, there may be an increased risk of prolonged hypoglycaemic activity.
Maltese: Jekk Duzallo li fih is-sustanza attiva allopurinol jingħata fl-istess ħin ma' chlorpropamide meta l-funzjoni renali tkun batuta, jista' jkun hemm riskju miżjud ta' attività ipogliċemika mtawla.
English: In addition to the inhibition of purine catabolism in some but not all hyperuricaemic patients, de novo purine biosynthesis is depressed via feedback inhibition of hypoxanthine-guanine phosphoribosyltransferase.
Maltese: Minbarra l-inibizzjoni tal-kataboliżmu ta' purine f'uħud mill-pazjenti b'iperuriċemija iżda mhux kollha kemm huma, il-bijosinteżi mill-ġdid ta' purine titnaqqas minħabba l-inibizzjoni ta' feedback tal-hypoxanthine-guanine phosphoribosyltransferase.
English: Uncommon - may affect up to 1 in 100 people - kidney stones, - kidney stop working properly, - skin reactions, including redness, itchy skin, lumpy rash (hives) and skin rash on exposure to sunshine, - dehydration (loss of too much fluid from your body), - feeling sick (nausea) or being sick (vomiting), - diarrhoea, - abnormal liver tests.
Maltese: Mhux komuni - jistgħu jaffettwaw sa persuna 1 minn kull 100 - ġilda titqaxxar, infafet jew ulċeri fix-xofftejn u l-ħalq - sinjali rari ħafna jistgħu jinkludu tħarħir f'daqqa waħda, palpitazzjonijiet jew għafis fis-sider li jfeġġu f'daqqa u kollass. - deni, raxx fil-ġilda, uġigħ fil-ġogi, u riżultati mhux normali fit-testijiet tad-demm u tal-funzjoni tal-fwied (dawn jistgħu jkunu sinjali ta' disturb ta' sensittività f'diversi organi).
English: Lesinurad is a mild to moderate inducer of CYP3A (see section 4.5).
Maltese: Għandha tiġi kkunsidrata profilassi għal irkadar tal-gotta (ara sezzjoni 4.4).
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, il-pazjenti anzjani għandhom aktar probabbiltà li jkollhom tnaqqis fil-funzjoni renali (ara rakkomandazzjonijiet dwar id-dożaġġ għal indeboliment renali).
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 mil-lumen tubulari tal-kliewi.
English: The stability of the sustained response was demonstrated with a greater proportion of patients treated with lesinurad 200 mg in combination with allopurinol achieving the target serum uric acid level at each visit for 3 consecutive months (Months 4, 5 and 6) compared to patients treated with placebo in combination with allopurinol (see Table 3).
Maltese: L-istabbiltà tar-rispons sostnut intweriet bi proporzjon akbar ta' pazjenti ttrattati b'lesinurad 200 mg f'kombinazzjoni ma' allopurinol li laħqu l-livell fil-mira ta' uric acid fis-serum f'kull vista għal 3 xhur konsekuttivi (Xahar 4, 5 u 6) meta mqabbla mal-pazjenti ttrattati bi plaċebo flimkien ma' allopurinol (ara Tabella 3).
English: A causal relationship with lesinurad has not been established.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Allopurinol is rapidly absorbed from the gastrointestinal tract and is reported to have a plasma half-life of about one hour.
Maltese: Allopurinol jiġi assorbit rapidament mill-passaġġ gastro-intestinali u huwa rrapportat li għandu half-life fil-plażma ta' madwar siegħa.