FrancophonIA/ELRC3.0 huggingface dataset:
English: Consumption of grapefruit juice is associated with inhibition of CYP1A2 and should be avoided during treatment with pirfenidone.
Maltese: Il-konsum tal-meraq tal-grejpfrut huwa assoċjat mal-inibizzjoni ta' CYP1A2 u għandu jkun evitat waqt il-kura b'pirfenidone.
English: Esbriet therapy should not be used in patients with severe hepatic impairment or end stage liver disease (see section 4.3, 4.4 and 5.2).
Maltese: Terapija b'Esbriet m'għandhiex tintuża f'pazjenti b'indeboliment epatiku sever jew b'marda tal-fwied fl-aħħar stadju (ara sezzjoni 4.3, 4.4 u 5.2).
English: Pharmacotherapeutic group: Immunosuppressants, other immunosuppressants, ATC code: L04AX05 The mechanism of action of pirfenidone has not been fully established.
Maltese: Immunosoppressanti, immunosoppressanti oħrajn, Kodiċi ATC:
English: Nervous system disorders Very Common Headache Common
Maltese: Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras
English: ● Severe hepatic impairment or end stage liver disease (see sections 4.2 and 4.4).
Maltese: ● Indeboliment epatiku sever jew mard tal-fwied fl-aħħar stadju (ara sezzjonijiet 4.2 u 4.4).
English: The decline in 6MWT distance from Baseline to Week 72 was significantly reduced compared with placebo in study PIPF-006 (p<0.001, rank ANCOVA).
Maltese: It-tnaqqis fid-distanza ta' 6MWT mil-Linja Bażi sat-72 Ġimgħa kien imnaqqas b'mod sinifikanti meta mqabbel mal-plaċebo fi studju PIPF-006 (p <0.
English: Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with “PFD”.
Maltese: Esbriet 267 mg pilloli miksija b'rita huma pilloli miksija b'rita, sofor, ovali, madwar 1.3 x 0.6 ċm,
English: Dyspnoea; cough; productive cough Gastrointestinal disorders Very Common Dyspepsia; nausea; diarrhoea Common
Maltese: Komuni ħafna Dispepsja; nawsja; dijareja Komuni
English: The recommended maintenance daily dose of Esbriet is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total of 2403 mg/day.
Maltese: Id-doża ta' manteniment rakkomandata kuljum ta' Esbriet hija 801 mg (3 pilloli sofor jew pillola kannella waħda) tliet darbiet kuljum mal-ikel, għal total ta' 2403 mg/jum.
English: The majority of pirfenidone is excreted as the 5-carboxy-pirfenidone metabolite (>95% of that recovered), with less than 1% of pirfenidone excreted unchanged in urine.
Maltese: Il-parti l-kbira ta' pirfenidone jitneħħa bħala l-metabolit 5-carboxy-pirfenidone (>95% minn dak irkuprat), b'inqas minn 1% ta' pirfenidone jitneħħa mingħajr bidla fl-awrina.
English: 42 film-coated tablets.
Maltese: 42 pillola miksija b'rita.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON -2-WEEK TREATMENT INITIATION PACK (7 X 3 CAPSULES AND 7 X 6 CAPSULES CONFIGURATION)
Maltese: TA' 7 X 3 KAPSULI U 7 X 6 KAPSULI)
English: Therefore, patients should know how they react to this medicinal product before they engage in activities requiring mental alertness or coordination (see section 4.7).
Maltese: Għaldaqstant, il-pazjenti għandhom ikunu jafu kif jirreaġixxu għal din il-mediċina qabel ma jagħmlu xi attivitajiet li jkunu jeħtieġu viġilanza mentali jew koordinazzjoni (ara sezzjoni 4.7).
English: ● for the first 7 days take a dose of 267 mg (1 yellow tablet), 3 times a day with food (a total of 801 mg/day)
Maltese: ● għall-ewwel 7 ijiem ħu doża ta' 267 mg (pillola safra waħda), 3 darbiet kuljum mal-ikel (total ta' 801 mg/jum)
English: Film-coated tabet
Maltese: ● tnaqqis fil-piż
English: Two piece capsules with a white to off-white opaque body and white to off-white opaque cap imprinted with “PFD 267 mg” in brown ink and containing a white to pale yellow powder.
Maltese: Kapsula f'biċċtejn bil-parti ta' taħt lewn abjad sa abjad maħmuġ opak u b'kappa lewn abjad sa abjad maħmuġ opak stampata b'“PFD 267 mg” b'linka kannella u li fiha trab bajdani sa isfar ċar.
English: The studies were nearly identical in design, with few exceptions including an intermediate dose group (1,197 mg/day) in PIPF-004.
Maltese: L-istudji kienu kważi identiċi fl-għamla tagħhom, bi ftit eċċezzjonijiet inkluż grupp ta' doża intermedja (1,197 mg/jum) f'PIPF-004.
English: High-Density Polyethylene (HDPE) bottle with a child-resistant and tamper-evident screw cap Pack sizes
Maltese: Flixkun tal-Polyethylene ta' Densità Għolja (HDPE - high-density polyethylene) b'għatu bil-kamin reżistenti għal ftuħ mit-tfal u b'siġill li juri evidenza ta' tbabis
English: Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, debossed with “PFD”.
Maltese: Esbriet 801 mg pilloli miksija b'rita huma kannella, ovali, ibbuzzati fuq iż-żewġ naħat, imnaqqxa b'“PFD”.
English: Pirfenidone showed no indication of mutagenic or genotoxic activity in a standard battery of tests and when tested under UV exposure was not mutagenic.
Maltese: Pirfenidone ma wera l-ebda indikazzjoni ta' attività mutaġenika jew ġenotossika f'sensiela standard ta' testijiet u meta ttestjat taħt espożizzjoni tal-UV ma kienx mutaġeniku.
English: NAME OF THE MEDICINAL PRODUCT Esbriet 534 mg film-coated tablets Pirfenidone
Maltese: Esbriet 534 mg pilloli miksija b'rita Pirfenidone
English: Patients should be monitored closely for signs of toxicity especially if they are concomitantly taking a known CYP1A2 inhibitor (see sections 4.5 and 5.2).
Maltese: Il-pazjenti għandhom jiġu sorveljati mill-qrib għal sinjali ta' tossiċità b'mod speċjali jekk ikunu qegħdin jieħdu inibitur ta' CYP1A2 magħruf fl-istess ħin (ara sezzjonijiet 4.5 u 5.2).
English: Mutlipack: 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) filmcoated tablets
Maltese: Pakkett multiplu: 63 (pakkett wieħed li fih folja waħda ta' 21 u pakkett wieħed li fih 2 folji ta' 21)
English: The use of pirfenidone is contraindicated in patients with severe renal impairment (CrCl <30ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 4.3).
Maltese: L-użu ta' pirfenidone huwa kontraindikat f'pazjenti b'indeboliment renali sever (CrCl <30ml/min) jew b'mard tal-kliewi tal-aħħar stadju li jkun jeħtieġ id-dijalisi (ara sezzjonijiet 4.2 u 4.3).
English: The recommended maintenance daily dose of Esbriet is 3 capsules three times a day with food, for a total of 2403 mg/day.
Maltese: Id-doża ta' manteniment rakkomandata kuljum ta' Esbriet hija 3 kapsuli tliet darbiet kuljum mal-ikel, għal total ta' 2403 mg/jum.
English: Esbriet has not been studied in individuals with severe hepatic impairment and Esbriet must not be used in patients with severe hepatic impairment (see section 4.3).
Maltese: Esbriet ma ġiex studjat f'individwi b'indeboliment epatiku sever u Esbriet m'għandux jintuża f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: Population pharmacokinetic analyses from 4 studies in healthy subjects or subjects with renal impairment and one study in patients with IPF showed no clinically relevant effect of age, gender or body size on the pharmacokinetics of pirfenidone.
Maltese: Analiżi farmakokinetika tal-popolazzjoni minn 4 studji fuq suġġetti f'saħħithom jew suġġetti b'indeboliment renali u studju wieħed f'pazjenti bl-IPF ma urew l-ebda effett klinikament rilevanti taletà, is-sess jew id-daqs tal-ġisem fuq il-farmakokinetika ta' pirfenidone.
English: 1 blister containing 21 film-coated tablets (21 in total) 2 blisters each containing 21 film-coated tablets (42 in total) 4 blisters each containing 21 film-coated tablets (84 in total) 8 blisters each containing 21 Film-coated tablets (168 in total)
Maltese: Folja waħda li fiha 21 pillola miksija b'rita (21 b'kollox) 2 folji li kull waħda fiha 21 pillola miksija b'rita (42 b'kollox) 4 folji li kull waħda fiha 21 pillola miksija b'rita (84 b'kollox) 8 folji li kull waħda fiha 21 pillola miksija b'rita (168 b'kollox)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - BOTTLE 250 ML
Maltese: PAKKETT - FLIXKUN TA' 250
English: Esbriet should be used with caution when ciprofloxacin is used at a dose of 250 mg or 500 mg once or two times a day.
Maltese: Esbriet għandu jintuża b'kawtela meta ciprofloxacin jintuża f'doża ta' 250 mg jew 500 mg darba jew darbtejn kuljum.
English: Esbriet must not be used in patients with a history of angioedema or hypersensitivity due to Esbriet (see section 4.3).
Maltese: Esbriet m'għandux jintuża f'pazjenti b'passat ta' anġjoedima jew ta' sensittività eċċessiva minħabba Esbriet (ara sezzjoni 4.3).
English: Paediatric population There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
Maltese: M'hemm l-ebda użu rilevanti ta' Esbriet fil-popolazzjoni pedjatrika għal indikazzjoni ta' IPF.
English: The clinical efficacy of Esbriet has been studied in four Phase 3, multicentre, randomised, double-blind, placebo-controlled studies in patients with IPF.
Maltese: Effikaċja klinika L-effikaċja klinika ta' Esbriet ġiet studjata f'diversi ċentri f'erba' studji tal-Fażi 3, fortuwiti,
English: ● muscle pain, aching joints/joint pains
Maltese: ● uġigħ fil-muskoli, ġogi juġgħu/uġigħ fil-ġogi
English: Initiation Pack
Maltese: Daqsijiet tal-pakkett
English: 2-week treatment initiation pack: multipack containing 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) film-coated tablets
Maltese: Pakkett ta' trattament inizjali ta' ġimagħtejn: pakkett multiplu li fih 63 (pakkett wieħed li fih folja waħda ta' 21 u pakkett wieħed li fih 2 folji ta' 21) pillola miksija b'rita
English: <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data)] the adverse reactions are presented in order of decreasing seriousness.
Maltese: (SOC - System Organ Class) u f'kull grupp ta' frekwenza [Komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli)] ir-reazzjonijiet avversi l-aktar serji huma mniżżlin l-ewwel, segwiti minn dawk anqas serji.
English: How to store Esbriet
Maltese: X'fih Esbriet
English: Special care should also be exercised if CYP1A2 inhibitors are being used concomitantly with potent inhibitors of one or more other CYP isoenzymes involved in the metabolism of pirfenidone such as CYP2C9 (e.g. amiodarone, fluconazole), 2C19 (e.g. chloramphenicol) and 2D6 (e.g. fluoxetine, paroxetine).
Maltese: (eż. amiodarone, fluconazole), 2C19 (eż. chloramphenicol) u 2D6 (eż. fluoxetine, paroxetine).
English: Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2).
Maltese: It-terapija b'Esbriet m'għandhiex issir fuq pazjenti b'indeboliment renali sever (CrCl <30 ml/min) jew b'mard tal-kliewi fl-aħħar stadju li jkun jeħtieġ id-dijalisi (ara sezzjonijiet 4.3 u 5.2).
English: 801 mg film-coated tablets 1 bottle containing 90 film-coated tablets
Maltese: Flixkun 1 fih 21 pillola miksija b'rita Flixkun 1 fih 90 pillola miksija b'rita
English: Pirfenidone should be used with caution in patients with mild to moderate hepatic impairment and patients should be monitored closely for signs of toxicity especially if they are concomitantly taking a known CYP1A2 inhibitor (see sections 4.2 and 4.4).
Maltese: Pirfenidone għandu jintuża b'kawtela f'pazjenti b'indeboliment epatiku ħafif sa moderat u l-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali ta' tossiċità b'mod speċjali jekk ikunu qegħdin jieħdu inibitur magħruf ta' CYP1A2 fl-istess ħin (ara sezzjonijiet 4.2 u 4.4).
English: More than 170 patients have been investigated in open studies for more than five years and some for up to 10 years.
Maltese: Aktar minn 170 pazjent ġew investigati fi studji miftuħa għal aktar minn ħames snin u xi wħud sa 10 snin.
English: ● for the first 7 days take 1 capsule, 3 times a day with food (a total of 801 mg/day)
Maltese: ● għall-ewwel 7 ijiem ħu kapsula waħda 3 darbiet kuljum mal-ikel (total ta' 801 mg/jum)
English: Angioedema1
Maltese: ANNESS III
English: Concomitant use of strong inducers of CYP1A2 including smoking should be avoided during Esbriet therapy based on the observed relationship between cigarette smoking and its potential to induce CYP1A2.
Maltese: L-użu konkomitanti ta' indutturi qawwija ta' CYP1A2 inkluż it-tipjip għandu jkun evitat waqt terapija b'Esbriet abbażi tar-relazzjoni osservata bejn it-tipjip tas-sigaretti u l-potenzjal tiegħu li jinduċi CYP1A2.
English: ● omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
Maltese: ● omeprazole (użat għall-kura ta' kondizzjonijiet bħall-indiġestjoni, mard ta' rifluss gastroesofagali)
English: The bottle packs contain either one bottle containing 21 tablets or one bottle containing 90 tablets.
Maltese: Il-pakketti bi flixkun fihom jew flixkun wieħed li fih 21 pillola jew flixkun wieħed li fih 90 pillola.
English: ● Photosensitivity reactions and skin rashes
Maltese: ● Reazzjonijiet ta' fotosensittività u raxx tal-ġilda
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets Pirfenidone
Maltese: Esbriet 267 mg pilloli miksija b'rita Pirfenidone
English: Studies in lactating rats indicate that pirfenidone and/or its metabolites are excreted in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk.
Maltese: Fl-annimali t-trasferiment fil-plaċenta ta' pirfenidone u/jew il-metaboliti tiegħu jseħħ bil-possibbiltà ta' akkumulazzjoni ta' pirfenidone u/jew il-metaboliti tiegħu fil-fluwidu amnjotiku.
English: The 267 mg blisters strips containing 63 film-coated tablets are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:
Maltese: L-istrixxi ta' folji ta' 267 mg li fihom 63 pillola miksija b'rita huma kollha mmarkati bis-simboli u t taqsiriet tal-ismijiet tal-ġurnata li ġejjin bħala tfakkira biex tieħu d-doża tliet darbiet kuljum:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 February 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' Frar 2011
English: Weight loss has been reported in patients treated with Esbriet (see section 4.8).
Maltese: Telf ta' piż ġie rrappurtat f'pazjenti kkurati b'Esbriet (ara sezzjoni 4.8).
English: Printing Inks
Maltese: Disturbi gastro-intestinali
English: Co-administration of medicinal products that act as potent inducers of both CYP1A2 and the other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. rifampicin) may result in significant lowering of pirfenidone plasma levels.
Maltese: L-għoti flimkien ta' prodotti mediċinali li jaġixxu bħala indutturi qawwijin kemm ta'CYP1A2 kif ukoll tal-isoenzimi ta' CYP l-oħrajn involuti fil-metaboliżmu ta' pirfenidone (eż. rifampicin) jista'
English: ● You may become more sensitive to sunlight (photosensitivity reaction) when taking Esbriet.
Maltese: ● Tista' ssir aktar sensittiv għad-dawl tax-xemx (reazzjoni ta' fotosensittività) meta tieħu Esbriet.
English: The effect of food on pirfenidone oral AUC was consistent between the tablet and capsule formulations.
Maltese: L-effett tal-ikel fuq l-AUC orali ta' pirfenidone kien konsistenti bejn il-formulazzjonijiet tal-pilloli u l-kapsuli.
English: Each film-coated tablet contains 267 mg of pirfenidone.
Maltese: Kull pillola fiha 267 mg ta' pirfenidone.
English: The results of mechanistic studies indicate that the occurrence of uterine tumours is probably related to a chronic dopamine-mediated sex hormone imbalance involving a species specific endocrine mechanism in the rat which is not present in humans.
Maltese: Ir-riżultati ta' studji mekkanistiċi jindikaw li l-okkorrenza ta' tumuri fl-utru hija aktarx relatata ma' nuqqas ta' bilanċ kroniku tal-ormoni sesswali medjat mid-dopamine li jinvolvi mekkaniżmu tal-endokrina speċifiku għall-ispeċi fil-firien li mhuwiex preżenti fil-bnedmin.
English: Rarely these have been associated with concomitant elevations in total serum bilirubin.
Maltese: żidiet fl-istess waqt tal-bilirubina totali fis-serum.
English: EU/1/11/667/020EU/1/11/667/021
Maltese: EU/1/11/667/001 EU/1/11/667/002 EU/1/11/667/003
English: Further information on Duzallo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The safety profile of Duzallo is similar to the individual components.
Maltese: Il-profil tas-sigurtà ta' Duzallo huwa simili għall-komponenti individwali.
English: Other information about Duzallo
Maltese: Informazzjoni oħra dwar Duzallo
English: The most common side effects with Duzallo (which may affect up to 1 in 10 people) are flu, gastrooesophageal reflux disease (stomach acid coming back to the mouth), headache and blood tests showing increased blood creatinine levels (a marker of kidney function).
Maltese: L-effetti sekondarji l-aktar komuni b'Duzallo (li jistgħu jaffetwaw sa persuna 1 minn kull 10) huma influwenza, rifluss gastroesofagali (aċidu tal-istonku li jerġa' jitla' fil-ħalq), uġigħ ta' ras u testijiet taddemm li juru żieda fil-livelli tal-kreatinina fid-demm (markatur tal-funzjoni tal-kliewi).
English: Lesinurad has been authorized in the EU as Zurampic since 2016.
Maltese: Il-lesinurad ilu awtorizzat fl-UE bħala Zurampic mill-2016.
English: • Lesinurad helps to remove uric acid from the body by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Maltese: • Il-lesinurad jgħin biex ineħħi l-aċidu uriku mill-ġisem billi jimblokka proteina msejħa “trasportatur1 tal-aċidu uriku” (URAT1) fil-kliewi.
English: Adding lesinurad 200 mg once daily to the treatment led to 55% patients having levels below 60 mg/litre after 6 months.
Maltese: Iż-żieda ta' lesinurad 200 mg darba kuljum mal-kura wasslet għal 55 % tal-pazjenti li kellhom livelli inqas minn 60 mg/litru wara 6 xhur.
English: What are the risks associated with Duzallo?
Maltese: X'inhuma r-riskji assoċjati ma' Duzallo?
English: Duzallo is available as tablets containing either 200 or 300 mg of allopurinol in combination with 200 mg of lesinurad.
Maltese: Duzallo jiġi bħala pilloli li fihom jew 200 jew 300 mg ta' allopurinol flimkien ma' 200 mg ta' lesinurad.
English: This compared with 26% of patients who received placebo (a dummy treatment) in addition to allopurinol.
Maltese: Dan tqabbel ma' 26 % tal-pazjenti li rċevew plaċebo (kura finta) flimkien mal-allopurinol.
English: As for all medicines, data on the use of Duzallo are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Duzallo hija ssorveljata kontinwament.
English: The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100.
Maltese: Ir-reazzjonijiet avversi l-aktar serji kienu insuffiċjenza tal-kliewi, tnaqqis fil-funzjoni tal-kliewi, u ġebel fil-kliewi, li affetwaw inqas minn pazjent 1 minn kull 100.
English: Duzallo is a medicine used in adults with gout to reduce high levels of uric acid in the blood.
Maltese: Duzallo huwa mediċina li tintuża fl-adulti bil-gotta sabiex tnaqqas il-livelli għoljin tal-aċidu uriku fiddemm.
English: Duzallo must not be taken by patients with severely reduced kidney function, including those who have severely impaired kidney function, who are on dialysis or have received a kidney transplant.
Maltese: Duzallo m'għandux jittieħed minn pazjenti b'funzjoni tal-kliewi mnaqqsa severament, inkluż dawk li għandhom funzjoni tal-kliewi indebolita severament, li jinsabu fuq dijaliżi jew li rċevew trapjant talkliewi.
English: It must also not be taken in patients with tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or Lesch-Nyhan syndrome (a rare genetic disease).
Maltese: Dan m'għandux jittieħed ukoll f'pazjenti b'sindrome ta' liżi tat-tumur (kumplikazzjoni minħabba t-tkissir rapidu taċ-ċelloli tal-kanċer waqt kura għall-kanċer) jew b'sindrome ta' Lesch-Nyhan (marda ġenetika rari).
English: The two studies involved over 800 adults with gout whose blood level of uric acid was high (above 65 mg/litre) despite allopurinol treatment.
Maltese: Iż-żewġ studji involvew aktar minn 800 adult bil-gotta li l-livell tagħhom tal-aċidu uriku fid-demm kien għoli (‘il fuq minn 65 mg/litru) minkejja kura b'allopurinol.
English: How does Duzallo work?
Maltese: Kif jintuża Duzallo?
English: • Allopurinol reduces the production of uric acid in the body by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Maltese: • L-allopurinol inaqqas il-produzzjoni tal-aċidu uriku fil-ġisem billi jimblokka enzima msejħa ksantinossidażi, li hija meħtieġa għall-produzzjoni tal-aċidu uriku fil-ġisem.
English: The two active substances in Duzallo work in different ways to prevent the build-up of uric acid:
Maltese: Iż-żewġ sustanzi attivi f'Duzallo jaħdmu b'modi differenti sabiex l-akkumulazzjoni tal-aċidu uriku jiġi evitat:
English: The active substances in Duzallo have already been shown to be effective when used as separate tablets.
Maltese: Is-sustanzi attivi f'Duzallo diġà ntwerew li huma effettivi meta jintużaw bħala pilloli separati.
English: For the full list of side effects reported with Duzallo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Duzallo, ara l-fuljett ta' tagħrif.
English: Side effects reported with Duzallo are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Duzallo huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: What measures are being taken to ensure the safe and effective use of Duzallo?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Duzallo?
English: Duzallo contains the active substances allopurinol and lesinurad.
Maltese: Duzallo fih is-sustanzi attivi allopurinol u lesinurad.
English: In addition two studies were carried out to show that Duzallo produced similar levels of active substances in the blood to the active substances given separately.
Maltese: Barra minn hekk, saru żewġ studji biex juru li Duzallo pproduċa livelli simili ta' sustanzi attivi fid-demm għas-sustanzi attivi mogħtija separatament.
English: Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
Maltese: Il-gotta tirriżulta minn akkumulazzjoni ta' kristalli tal-aċidu uriku ġewwa u madwar il-ġogi, speċjalment fis-swaba' tas-saqajn, li tikkawża uġigħ u nefħa.
English: By reducing the production of uric acid, allopurinol can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Maltese: Billi jnaqqas ilproduzzjoni tal-aċidu uriku, l-allopurinol jista' jnaqqas il-livelli tal-aċidu uriku fid-demm u jżommhom baxxi, u jwaqqaf il-kristalli milli jakkumulaw.
English: By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.
Maltese: Billi jimblokka URAT1, jgħaddi aktar aċidu uriku fl-awrina u jibqa' anqas fid-demm.
English: The European Medicines Agency decided that Duzallo's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Duzallo huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.