FrancophonIA/ELRC3.0 huggingface dataset:
English: Clear transparent PVC/PVDC/Aluminium blisters containing 30 or 90 film-coated tablets and unit dose blisters of 30 × 1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PVDC/Aluminium trasparenti ċari li fihom 30 jew 90 pillola miksija b'rita u folji b'doża waħda ta' 30 × 1 pillola.
English: • If you notice a marked decrease in your urine output (sign of kidney problem),
Maltese: • Jekk tinnota li l-awrina li tgħaddi naqset b'mod sostanzjali (sinjal ta' problema fil-kliewi),
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Truxija Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni:
English: 7 mg/kg/day
Maltese: 7 mg/kg/jum
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life- threatening or fatal, have been reported.
Maltese: Reazzjonijiet avversi qawwija fil-ġilda (SCARs) li jinkludu s-Sindrome ta' Stevens-Johnson (SJS), nekrolisi tossika tal-epidermide (TEN) u reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi (DRESS), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, kienu rrappurtati.
English: Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in indicators of total body iron; liver iron concentration was reduced by about −0.4 and −8.9 mg Fe/g liver (biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about −36 and −926 µg/l on average, respectively.
Maltese: L-indikaturi tal-ħadid totali fil-ġisem urew tnaqqis meta pazjenti adulti u pedjatriċi li jsofru minn betatalessimja u li kellhom trasfużjonijiet frekwenti ngħataw kura b'deferasirox formulazzjoni ta' pillola li tinxtered b'dożi ta' 20 u 30 mg/kg kuljum għal sena; il-konċentrazzjoni tal-ħadid fil-fwied tnaqqset b'medja ta' madwar −0.4 u −8.9 mg Fe/g fwied (piż niexef tal-bijopsija (dw)) rispettivament, u l-ferritin fis-serum tnaqqas b'medja ta' madwar −36 u −926 µg/l rispettivament.
English: On average, serum ferritin decreased by 222.0 µg/l in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in patients treated with placebo (p<0.001).
Maltese: Bħala medja, il-ferritin fis-serum niżel b'222.0 µg/l f'pazjenti ttrattati b'deferasirox pilloli li jinxterdu (doża inizjali ta' 10 mg/kg/kuljum) u żdied b'115 µg/l f'pazjenti ttrattati bi plaċebo (p<0.
English: Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving deferasirox.
Maltese: Ulċerazzjoni tal-parti ta' fuq tas-sistema gastrointestinali u fsada kienu rrapurtati f'pazjenti, inklużi tfal u adoloxxenti, li kienu qed jirċievu deferasirox.
English: • Each film-coated tablet of Deferasirox Mylan 90 mg contains 90 mg deferasirox.
Maltese: • Kull pillola miksija b'rita ta' Deferasirox Mylan 90 mg fiha 90 mg deferasirox.
English: If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should be considered (see section 4.4).
Maltese: Jekk il-livelli ta' ferritin fis-serum jaqaw taħt 500 µg/l b'mod konsistenti, wieħed għandu jqis li jwaqqaf il-kura għal kollox (ara sezzjoni 4.4).
English: Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%).
Maltese: Żidiet ta' transaminase tal-fwied akbar minn 10 darbiet il-limitu ta' fuq tal-medda normali, li jindika li hemm epatite, ma kienux komuni (0.3%).
English: Alternative starting doses
Maltese: Dożi alternattivi tal-bidu
English: EU/1/19/1386/011 EU/1/19/1386/012 EU/1/19/1386/013 EU/1/19/1386/014 EU/1/19/1386/015 EU/1/19/1386/016
Maltese: EU/1/19/1386/011 EU/1/19/1386/012 EU/1/19/1386/013 EU/1/19/1386/014
English: After adjustment of the strength, the film-coated tablet formulation (360 mg strength) was equivalent to deferasirox dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Maltese: Wara li tkun aġġustata l-qawwa, il-formulazzjoni tal-pillola miksija b'rita (qawwa ta' 360 mg) kienet ekwivalenti għal deferasirox pilloli li jinxterdu (qawwa ta' 500 mg) fir-rigward tal-erja medja taħt il-kurva tal-konċentrazzjoni fil-plażma ħin (AUC) f'kundizzjonijiet ta' sawm.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03
Maltese: Aġenti tal-kelatur tal-ħadid, Kodiċi ATC:
English: 1, renal tubular necrosis General disorders and administration site conditions Uncommon:
Maltese: 1, nekrożi tubulari renali Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux komuni:
English: On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in patients treated with placebo (p<0.001).
Maltese: Bħala medja, il-konċentrazzjoni ta' ħadid fil-fwied naqset bi 3.80 mg Fe/g dw f'pazjenti ttrattati b'deferasirox pilloli li jinxterdu (doża inizjali ta' 10mg/kg/kuljum) u żdiedet b'0.38 mg Fe/g dw f'pazjenti ttrattati bi plaċebo (p<0.
English: Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 4.8).
Maltese: Kien hemm rapporti ta' disturbi fis-smigħ (nuqqas ta' smigħ) u fl-għajnejn (opaċità tal-lenti) (ara sezzjoni 4.8).
English: Coating material:
Maltese: Materjal fil-kisja:
English: Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Deferasirox Mylan mhuwiex irrakkomandat għal pazjenti b'indeboliment qawwi tal-fwied (ChildPugh Klassi C).
English: It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Maltese: Huwa ligand tridentat li jeħel mal-molekula tal-ħadid b'affinità għolja f'proporzjon ta' 2:1.
English: In patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and Deferasirox Mylan must be used with caution in such patients.
Maltese: F'pazjenti b'indeboliment moderat tal-fwied (Child-Pugh Klassi B), id-doża għandha titnaqqas b'mod konsiderevoli u tkun segwita b'żieda progresssiva sa limitu ta' 50% (ara sezzjonijiet 4.4 u 5.2), u Deferasirox Mylan għandu jintuża b'attenzjoni f'dawn il-pazjenti.
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulation (see section 5.2).
Maltese: Deferasirox pilloli miksija b'rita juru bijodisponibilità ogħla meta mqabbla mal-formulazzjonijiet ta' pillola li tinxtered ta' deferasirox (ara sezzjoni 5.2).
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jistgħu jolqtu persuna waħda f'kull 10)
English: Acute pancreatitis has been reported, particularly in children and adolescents.
Maltese: Kienet irrappurtata pankreatite akuta, speċjalment fi tfal u adolexxenti.
English: Hypersensitivity reactions (including anaphylactic reactions and angioedema) Metabolism and nutrition disorders Not known:
Maltese: Disturbi fis-sistema immuni Mhux magħruf: Reazzjonijiet ta' sensittività eċċessiva (inkluż reazzjonijiet anafilattiċi u anġjoedima) Disturbi fil-metaboliżmu u nnutrizzjoni Mhux magħruf: Aċidożi metabolika Disturbi psikjatriċi Mhux komuni:
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations.
Maltese: Deferasirox pilloli miksija b'rita juru bijodisponibilità ogħla meta mqabbla mal-formulazzjoni ta' deferasirox pillola li tinxtered.
English: Rash, pruritus
Maltese: Vista u smigħ
English: Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC).
Maltese: Dekonjugazzjoni ta' glukoronidati fl-intestini u wara dan, huwa probabbli li jseħħ riassorbiment (riċiklaġġ enteroepatiku): fi studju ta' voluntiera b'saħħithom, l-għoti ta' cholestyramine wara doża waħda ta' deferasirox wassal għal tnaqqis ta' 45% fl-esponiment (AUC) ta' deferasirox.
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets deferasirox
Maltese: Deferasirox Mylan 90 mg pilloli miksija b'rita Deferasirox Mylan 180 mg pilloli miksija b'rita Deferasirox Mylan 360 mg pilloli miksija b'rita deferasirox
English: The study compared the efficacy of two different deferasirox dispersible tablet regimens (starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients).
Maltese: L-istudju qabbel l-effikaċja taż-żewġ reġimi differenti ta' deferasirox pillola li tinxtered (dożi inizjali ta' 5 u 10 mg/kg/kuljum, 55 pazjent f'kull grupp) u l-plaċebo korrispondenti (56 pazjent).
English: Deferasirox Mylan is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older.
Maltese: Deferasirox Mylan huwa indikat ukoll għall-kura ta' tagħbija żejda kronika tal-ħadid minħabba trasfużjonijiet tad-demm meta terapija b'deferoxamine tkun kontraindikata jew inadegwata f'dawn ilgruppi ta' pazjenti: - f'pazjenti pedjatriċi li għandhom beta talessimja maġġuri b'tagħbija żejda ta' ħadid minħabba trasfuzjonijiet frekwenti tad-demm (≥7 mL/kg/xahar ta' ċelloli ħomor tad-demm ippakkjati) li għandhom bejn 2 u 5 snin, - f'pazjenti adulti u pedjatriċi li għandhom beta talessimja maġġuri b'tagħbija żejda ta' ħadid minħabba trasfużjonijiet tad-demm mhux frekwenti (<7 mL/kg/xahar ta' ċelluli ħomor tad demm ippakkjati) li għandhom sentejn u aktar, - f'pazjenti adulti u pedjatriċi li jkollhom anemiji oħrajn li għandhom sentejn jew aktar.
English: EU/1/19/1386/001 EU/1/19/1386/002 EU/1/19/1386/003 EU/1/19/1386/004 EU/1/19/1386/005
Maltese: EU/1/19/1386/001 EU/1/19/1386/002 EU/1/19/1386/003 EU/1/19/1386/004
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets
Maltese: Deferasirox Mylan 90 mg pilloli miksija b'rita Deferasirox Mylan 180 mg pilloli miksija b'rita Deferasirox Mylan 360 mg pilloli miksija b'rita
English: Transaminases increased
Maltese: Żieda fit-transaminases
English: Other medicines and Deferasirox Mylan
Maltese: Mediċini oħra u Deferasirox Mylan
English: It is recommended that serum creatinine be assessed in duplicate before initiating therapy.
Maltese: Huwa rakkomandat li l-kreatinina fis-serum tiġi stmata b'duplikat qabel ma tinbeda t-terapija.
English: Creatinine clearance and/or plasma cystatin C Prior to therapy.
Maltese: Tneħħija tal-kreatinina u/jew cystatin C filplażma
English: When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).
Maltese: Jekk il-kreatinina fis-serum jiġi għoli u tkun instabet xi anormalità oħra (eż. proteina fl-awrina, sinjali tas-sindrome Fanconi).
English: Optic neuritis Ear and labyrinth disorders Uncommon:
Maltese: Newrite ottika Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni:
English: Non-transfusion-dependent thalassaemia syndromes:
Maltese: Sindromi ta' talessimja mhux dipendenti fuq trasfużjoni:
English: Each film-coated tablet contains 180 mg deferasirox.
Maltese: Kull pillola miksija b'rita fiha 180 mg deferasirox.
English: Deferasirox has been investigated in 411 adult (age ≥16 years) and 292 paediatric patients (aged 2 to <16 years) with chronic iron overload due to blood transfusions.
Maltese: Saru investigazzjonijiet dwar deferasirox f'411 pazjenti adulti (≥16-il sena) u 292 pazjent pedjatriku (minn 2 sa <16-il sena) b'tagħbija żejda kronika tal-ħadid minħabba trasfużjonijiet tad-demm. 52 talpazjenti pedjatriċi kellhom bejn 2 u 5 snin.
English: Cases of serious acute pancreatitis were observed without documented underlying biliary conditions.
Maltese: Kienu osservati każijiet ta' pankreatite akuta serja mingħajr kondizzjonijiet sottostanti dokumentati filmarrara.
English: Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median time to maximum plasma concentration (tmax) of about 1.5 to 4 hours.
Maltese: Deferasirox (formulazzjoni ta' pillola li tinxtered) jiġi assorbit wara li jittieħed mill-ħalq u tintlaħaq logħla konċentrazzjoni fil-plażma (tmax) f'ħin medju ta' madwar 1.5 sa 4 sigħat.
English: Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes
Maltese: Tabella 2 Dożi rrakkomandati f'każ ta' sindromi ta' talessimja mhux dipendenti fuq trasfużjoni
English: Deferasirox Mylan contains an active substance called deferasirox.
Maltese: Deferasirox Mylan fih sustanza attiva li jisimha deferasirox.
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
Maltese: b'forma ta' kapsula modifikata, bikonvessa b'“ ” imnaqqxa fuq naħa tal-pillola u ‘DF 1' fuq l-oħra.
English: • Disturbance in kidney function tests.
Maltese: • Tibdil fit-testijiet tal-funzjoni tal-kliewi.
English: Gastrointestinal disorders Common:
Maltese: Uġigħ fil-larinġi Disturbi gastro-intestinali Komuni:
English: In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea (7.3%) were the most frequent study drug-related adverse events.
Maltese: Fi studju klinku ta' sena fost pazjenti b'sindromi ta' talessimja mhux dipendenti fuq trasfużjoni u b'tagħbija ta' ħadid (pilloli li jinxterdu b'doża ta' 10 mg/kg/kuljum), laktar episodji avversi b'rabta mal-mediċina studjata kienu ddijarrea (9.1%), raxx (9.1%) u dardir (7.3%).
English: Prior to therapy.
Maltese: Qabel it-terapija.
English: EU/1/19/1386/015 EU/1/19/1386/016
Maltese: EU/1/19/1386/015
English: Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of non-ironloaded rats at lethal doses.
Maltese: Testijiet tal-effett tossiku fuq il-ġeni in vitro kienu negattivi (test Ames, test ta' aberrazzjoni talkromożomi) filwaqt li deferasirox ikkawża l-formazzjoni ta' mikronukleji in vivo fil-mudullun talgħadam, imma mhux fil-fwied, ta' firien li ma kellhomx tagħbija tal-ħadid meta ngħataw dożi letali.
English: Cases of acute renal failure have been reported following post-marketing use of deferasirox (see section 4.8).
Maltese: Każijiet ta' insuffiċjenza tal-kliewi akuta kienu rrappurtati wara t-tqegħid fis-suq ta' deferasirox (ara sezzjoni 4.8).
English: Patient guide should contain the following key elements: ◦ Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin ◦ Information that renal biopsy may be considered if significant renal abnormalities occur ◦ Availability of several oral formulations (e.g. dispersible tablets, film-coated tablets and granules) and the main differences associated with these formulations (i.e., different posology regimen, different conditions of administration notably with food)
Maltese: ◦ Informazzjoni fuq il-bżonn ta' monitoraġġ regolari, u ta' meta għandu jsir, tal-kreatinina fis-serum, tneħħija tal-kreatinina, proteina fl-awrina, enzimi tal-fwied, ferritin ◦ Informazzjoni li tista' tiġi kkunsidrata bijopsija tal-kliewi jekk ikun hemm anormalità sinifikanti fil-kliewi ◦ Disponibilità ta' diversi formulazzjonijiet orali (eż. pilloli li jinxterdu, pilloli miksija b'rita u granijiet) u d-differenzi ewlenin assoċjati ma' dawn il-formulazzjonijiet (jiġifieri, korsijiet ta' pożoloġija differenti, kondizzjonijiet differenti ta' għoti l-aktar mal-ikel)
English: • Severe upper stomach pain (pancreatitis)
Maltese: • Uġigħ sever fin-naħa ta' fuq tal-istonku (pankreatite)
English: Therefore, due to a possible decrease in efficacy, caution should be exercised when deferasirox is combined with substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive agents, bepridil, ergotamine).
Maltese: (eż. ciclosporin, simvastatin, sustanzi kontraċettivi ormonali, bepridil, ergotamine).
English: The overall exposure of adolescents (12 to ≤17 years) and children (2 to <12 years) to deferasirox after single and multiple doses was lower than that in adult patients.
Maltese: L-esponiment totali tal-adolexxenti (12 sa ≤17-il sena) u tfal (2 sa <12-il sena) għal deferasirox wara doża waħda jew dożi multipli, kien aktar baxx minn dak f'pazjenti adulti.
English: Show them the pack of tablets.
Maltese: Urihom il-pakkett tal-pilloli.
English: ◦ The need to interrupt treatment after a dose reduction if serum creatinine rises: Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min)
Maltese: Adulti u Pedjatriċi: jibqa' >33% fuq il-linja bażika jew it-tneħħija tal-kreatinina < LLN (90 ml/min)
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Maltese: b'forma ta' kapsula modifikata, bikonvessa b'“ ” imnaqqxa fuq naħa tal-pillola u ‘DF 2' fuq l-oħra.
English: An interaction between deferasirox and other CYP1A2 substrates cannot be excluded.
Maltese: Interazzjoni bejn deferasirox u sustrati oħra ta' CYP1A2 ma tistax tiġi eskluża.
English: Deferasirox Mylan 360 mg film-coated tablets deferasirox
Maltese: Deferasirox Mylan 360 mg pilloli miksija b'rita deferasirox
English: Deferasirox has been studied only in patients with baseline serum creatinine within the ageappropriate normal range.
Maltese: Deferasirox ġie studjat biss f'pazjenti li għandhom linja bażi tal-kreatinina fis-serum li taqa' skont ilmedda normali tal-età adattata.
English: ◦ The need to reduce by 10 mg/kg the dose if serum creatinine rises: Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits.
Maltese: ◦ Il-bżonn li d-doża titnaqqas b'10 mg/kg jekk il-kreatinina fis-serum togħla: Adulti: >33% fuq il-linja bażika u t-tneħħija tal-kreatinina < LLN (90 ml/min) Pedjatriċi: jew > ULN jew it-tneħħija tal-kreatinina taqa' għal < LLN f'żewġ żjajjar wara xulxin.
English: Renal tubular disorder
Maltese: Mhux applikabbli.
English: • Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.
Maltese: • Disturb fir-riżultat tat-test tal-awrina (proteina fl-awrina) Jekk xi waħda minn dawn tolqtok bil-qawwi, għid lit-tabib tiegħek.
English: There is no specific antidote for deferasirox.
Maltese: M'hemmx antidotu speċifiku għal deferasirox.
English: For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Maltese: Għall-pazjenti li żdiditilhom id-doża għal >7 mg/kg, huwa rrakkomandat tnaqqis fid-doża għal 7 mg/kg jew anqas meta lLIC hu <7 mg Fe/g dw jew il-ferritin fis-serum hu ≤2000 µg/l.
English: However, in patients with liver iron concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Maltese: Madankollu, f'pazjenti li kellhom konċentrazzjoni talħadid fil-fwied <7mg Fe/g piż niexef ikkurati b'deferasirox pilloli li jinxterdu (5 u 10 mg/kg) jew deferoxamine (20 sa 35 mg/kg), ma ġiex stabbilit jekk ma kienx inferjuri minħabba żbilanċ fiddużaġġi taż-żewġ kelaturi.
English: • The need to monitor serum ferritin monthly
Maltese: • Il-bżonn li ferritin fis-serum ikun monitorat kull xahar
English: The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes, DiamondBlackfan syndrome, aplastic anaemia and other very rare anaemias).
Maltese: Il-kundizzjonijiet li kienu jinħtieġu trasfużjonijiet kienu jinkludu beta-talessimja, mard tas-sickle cell u mard ieħor konġenitu u anemiji akkwiżiti (sindromi majlodisplastiċi, sindrome ta' Diamond-Blackfan, anemija aplastika, u anemiji oħrajn rari ħafna).
English: Deferasirox Mylan 360 mg film-coated tablets are also available in blister pack of 300 tablets.
Maltese: Deferasirox Mylan 360 mg pilloli miksija b'rita huma disponibbli wkoll f'pakketti tal-folji ta' 300 pillola.
English: Stevens-Johnson syndrome
Maltese: Reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi (DRESS) Mhux magħruf: Sindrome ta' Stevens-Johnson
English: Therefore, the concomitant use of Deferasirox Mylan with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in Deferasirox Mylan efficacy.
Maltese: Għalhekk, l-użu fl-istess ħi ta' Deferasirox Mylan flimkien ma' indutturi qawwija ta' UGT (eż. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) jista' jwassal għal tnaqqis fl-effikaċja ta' Deferasirox Mylan.
English: Clinical study in patients with non-transfusion-dependent thalassaemia syndromes
Maltese: Sindromi ta' talessimja mhux dipendenti fuq trasfużjoni
English: In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated for 24 weeks.
Maltese: Fi studju biex jevalwa s-sigurtà ta' deferasirox f'pilloli miksija b'rita u li jinxterdu, 173 pazjent adulti u pedjatriċi b'talissimja dipendenti fuq trasfużjoni jew sindrome mijelodiplastika kienu ttrattati għal 24 ġimgħa.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with Deferasirox Mylan.
Maltese: Tubulopatija tal-kliewi kienet irrappurtata l-aktar fi tfal u adoloxxenti bit-talassemija beta kkurati b'Deferasirox Mylan.
English: In a healthy volunteer study, the concomitant administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent UGT inducer, rifampicin, (repeated dose of 600 mg/day) resulted in a decrease of deferasirox exposure by 44% (90% CI: 37% - 51%).
Maltese: Il-metaboliżmu ta' deferasirox jiddependi fuq lenzimi UGT. Fi studju b'voluntiera b'saħħithom, l-għotja fl-istess ħin ta' deferasirox (doża waħda ta' 30 mg/kg, formulazzjoni ta' pillola li tinxtered) u linduttur qawwi ta' UGT, rifampicin (doża ripetuta ta' 600 mg/jum) irriżultat fi tnaqqis tal-esponiment għal deferasirox b'44% (90% CI: 37% - 51%).
English: Each film-coated tablet contains 90 mg deferasirox.
Maltese: Kull pillola miksija b'rita fiha 90 mg deferasirox.
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF' on the other side.
Maltese: b'forma ta' kapsula modifikata, bikonvessa b'“ ” imnaqqxa fuq naħa tal-pillola u ‘DF' fuq l-oħra.
English: Deferasirox Mylan 90 mg film-coated tablets deferasirox
Maltese: Deferasirox Mylan 90 mg pilloli miksija b'rita deferasirox