FrancophonIA/ELRC3.0 huggingface dataset:
English: Patient guide should contain the following key elements: o Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin o Information that renal biopsy may be considered if significant renal abnormalities occur o 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: Il-gwida għall-pazjent għandu jkollha l-elementi importanti li ġejjin: o Informazzjoni fuq il-bżonn ta' monitoraġġ regolari, u ta' meta għandu jsir, talkreatinina fis-serum, tneħħija tal-kreatinina, proteina fl-awrina, enzimi tal-fwied, ferritin o Informazzjoni li tista' tiġi kkunsidrata bijopsija tal-kliewi jekk ikun hemm anormalità sinifikanti fil-kliewi o 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: • EXJADE 360 mg film-coated tablets are dark blue and stamped “360” on one side and “NVR”
Maltese: • Il-pilloli miksija b'rita EXJADE 360 mg huma blu skuri u ttimbrati b'“360” fuq naħa minnhom u “NVR” fuq in-naħa l-oħra.
English: 10 mg/kg/day For adults not assessed and ≤2,000 µg/l
Maltese: 7 mg/kg/jum 10 mg/kg/jum Għall-adulti mhux evalwat u ≤2,000 µg/l
English: 28 mg/kg/day 40 mg/kg/day
Maltese: Doża massima 28 mg/kg/jum 40 mg/kg/jum
English: Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds).
Maltese: Tagħrif kliniku limitat (29 pazjent b'funzjoni kardijaka normali mal-linja bażika) bl-użu ta' MRI jindika li kura b'deferasirox 10-30 mg/kg/jum (formulazzjoni ta' pillola li tinxtered) għal sena tista' tnaqqas ukoll il-livelli tal-ħadid fil-qalb (medja, MRI T2* żieda minn 18.3 għal 23.0 millisekondi).
English: EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance <60 ml/min (see sections 4.3 and 4.4).
Maltese: EXJADE ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi u huwa kontraindikat f'pazjenti li jkollhom tneħħija tal-kreatinina stmata <60 ml/min (ara sezzjonijiet 4.3 u 4.4).
English: EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: EXJADE mhuwiex irrakkomandat għal pazjenti b'indeboliment qawwi tal-fwied (Child-Pugh Klassi C).
English: When to take EXJADE
Maltese: X'inhu EXJADE
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 EXJADE 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 EXJADE għandu jintuża b'attenzjoni f'dawn il-pazjenti.
English: The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes [MDS], Diamond-Blackfan 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 [MDS], sindrome ta' Diamond-Blackfan, anemija aplastika, u anemiji oħrajn rari ħafna).
English: • Description of available deferasirox formulations (e.g. dispersible tablets, film-coated tablets and granules) o Different posology regimen o Different conditions of administration o Dose conversion table when switching from one formulation to another
Maltese: • Deskrizzjoni tal-formulazzjonijiet disponibbli ta' deferasirox (eż. pilloli li jinxterdu, pilloli miksija b'rita u granijiet) o Korsijiet ta' pożoloġija differenti o Kundizzjonijiet differenti ta' għoti o Tabella ta' konverżjoni tad-doża meta wieħed jaqleb minn formulazzjoni għal oħra
English: Therefore, the concomitant use of EXJADE with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in EXJADE efficacy.
Maltese: Għalhekk, l-użu ta' EXJADE flimkien ma' indutturi qawwija ta' UGT (eż. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) jista' jwassal għal tnaqqis fl-effikaċja ta' EXJADE.
English: The Cmax was increased by 34% (90% CI: 27.9% - 40.3%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Maltese: Is-Cmax żdiedet bi 34% (CI ta' 90%: 27.9% - 40.
English: Unit packs containing 28, 84 or 252 dispersible tablets and multipacks containing 294 (3 packs of 98) dispersible tablets.
Maltese: Pakketti ta' unitajiet li fihom 28, 84 jew 252 pillola li tinxtered u pakketi multipli li fihom 294
English: • Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox.
Maltese: • Kull qartas ta' EXJADE 90 mg granijiet fih 90 mg deferasirox.
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, ilkonċentrazzjoni 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: Optic neuritis
Maltese: Mhux irrakkomandat
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-iron-loaded 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: Exjade 360 mg granules deferasirox
Maltese: Exjade 360 mg granijiet deferasirox
English: EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Maltese: EXJADE pilloli miksija b'rita juru bijodisponibilità ogħla meta mqabbla mal-formulazzjoni ta' EXJADE pillola li tinxtered (ara sezzjoni 5.2).
English: Excipient with known effect: Each dispersible tablet contains 136 mg lactose.
Maltese: Kull pillola li tinxtered fiha 136 mg lactose.
English: Deferasirox has been studied only in patients with baseline serum creatinine within the age-appropriate 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: • Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min)
Maltese: >33% fuq il-linja bażika u t-tneħħija tal-kreatinina <LLN (90 ml/min)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: • Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox.
Maltese: • Kull qartas ta' EXJADE 180 mg granijiet fih 180 mg deferasirox.
English: Exjade 180 mg granules deferasirox
Maltese: Exjade 180 mg granijiet deferasirox
English: • Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox.
Maltese: • Kull qartas ta' EXJADE 360 mg granijiet fih 360 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: Exjade 90 mg granules deferasirox
Maltese: Exjade 90 mg granijiet deferasirox
English: Each pack contains 30 sachets.
Maltese: Pakketti ta' unitajiet li fihom 30 qartas.
English: Excipient with known effect: Each dispersible tablet contains 272 mg lactose.
Maltese: Kull pillola li tinxtered fiha 272 mg lactose.
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: After adjustment of the strength, the granules formulation (4 x 90 mg strength) was equivalent to EXJADE 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-granijiet (qawwa ta' 4 x 90 mg) kienet ekwivalenti għal EXJADE pilloli li jinxterdu (qawwa ta' 500 mg) fir-rigward tal-erja medja taħt ilkurva tal-konċentrazzjoni fil-plażma ħin (AUC) f'kundizzjonijiet ta' sawm.
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 millmediċina b'eosinofilija u sintomi sistemiċi (DRESS), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, kienu rrappurtati.
English: EU/1/06/356/022 30 sachets
Maltese: EU/1/06/356/022 30 qartas
English: EXJADE 125 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
Maltese: EXJADE 125 mg pilloli li jinxterdu Pakketti li fihom 28, 84 jew 252 pillola li jinxterdu.
English: EXJADE 250 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
Maltese: EXJADE 250 mg pilloli li jinxterdu Pakketti li fihom 28, 84 jew 252 pillola li tinxtered.
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Maltese: EXJADE granijiet juru bijodisponibilità ogħla meta mqabbla mal-formulazzjoni ta' EXJADE pillola li tinxtered (ara sezzjoni 5.2).
English: EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets Deferasirox
Maltese: Informazzjoni għall-utent EXJADE 90 mg pilloli miksija b'rita EXJADE 180 mg pilloli miksija b'rita EXJADE 360 mg pilloli miksija b'rita Deferasirox
English: , tubulointerstitial nephritis
Maltese: Qabel it-tnedija tatterapija
English: OUTER CARTON OF MULTIPACK (including blue box)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA TA' PAKKETT MULTIPLU (INKLUŻ KAXXA BLU)
English: • Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome).
Maltese: • Ikun hemm ukoll xi markatur ieħor tal-funzjoni tal-kliewi li b'mod persistenti ma jkunx f'livell normali (eż. proteina fl-awrina, Sindrome Fanconi).
English: EXJADE 90 mg film-coated tablets EU/1/06/356/011
Maltese: EXJADE 90 mg pilloli miksija b'rita EU/1/06/356/011
English: After adjustment of the strength, the film-coated tablet formulation (360 mg strength) was equivalent to EXJADE 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 EXJADE pilloli li jinxterdu (qawwa ta' 500 mg) firrigward tal-erja medja taħt il-kurva tal-konċentrazzjoni fil-plażma ħin (AUC) f'kundizzjonijiet ta' sawm.
English: EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Maltese: EXJADE granijiet juru bijodisponibilità ogħla meta mqabbla mal-formulazzjoni ta' EXJADE pillola li tinxtered.
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 lplaċebo korrispondenti (56 pazjent).
English: EXJADE 125 mg dispersible tablets EU/1/06/356/001
Maltese: EXJADE 125 mg pilloli li jinxterdu EU/1/06/356/001
English: How to store EXJADE
Maltese: X'fih EXJADE
English: EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets
Maltese: EXJADE 90 mg pilloli miksija b'rita EXJADE 180 mg pilloli miksija b'rita EXJADE 360 mg pilloli miksija b'rita
English: Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other).
Maltese: Pillola miksija b'rita, blu medju, ovali u bbuzzata fuq iż-żewġ naħat bi xfar imżerżqa u timbri (NVR fuq naħa u 180 fuq in-naħa l-oħra).
English: EU/1/06/356/020 30 sachets
Maltese: EU/1/06/356/020 30 qartas
English: EU/1/06/356/021 30 sachets
Maltese: EU/1/06/356/021 30 qartas
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: EXJADE 500 mg dispersible tablets EU/1/06/356/005
Maltese: EXJADE 500 mg pilloli li jinxterdu EU/1/06/356/005
English: EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox.
Maltese: EXJADE 250 mg pilloli li jinxterdu Kull pillola li tinxtered fiha 250 mg deferasirox.
English: EXJADE 360 mg film-coated tablets EU/1/06/356/017
Maltese: EXJADE 360 mg pilloli miksija b'rita EU/1/06/356/017
English: EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox.
Maltese: EXJADE 500 mg pilloli li jinxterdu Kull pillola li tinxtered fiha 500 mg deferasirox.
English: For deferasirox granules, a dose ratio of 3:1 can be considered (i.e. a dose of deferasirox granules that is numerically one third of the deferoxamine dose).
Maltese: Għal deferasirox granijiet, jista' jiġi kkunsidrat proporzjon tad-doża ta' 3:1 (jiġifieri. doża ta' deferasirox granijiet li hija numerikament terz tad-doża ta' deferoxamine).
English: Each tablet contains 180 mg of deferasirox.
Maltese: Kull pillola fiha 180 mg ta' deferasirox.
English: • Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
Maltese: Kull pillola li tinxtered EXJADE 250 mg fiha 250 mg deferasirox.
English: In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia.
Maltese: Minbarra hekk, f'pazjenti b'konċentrazzjoni tal-ħadid fil-fwied ta' 7 mg Fe/g piż niexef li kellhom diversi anemiji rari jew marda tas-sickle cell, meta ngħataw sa 20 u 30 mg/kg deferasirox pilloli li jinxterdu kien hemm tnaqqis fil-konċentrazzjoni tal-ħadid fil-fwied u tal-ferritin fis-serum li jikkumpara ma' dak li nkiseb f'pazjenti b'beta-talessimja.
English: EXJADE 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: EXJADE 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 il-gruppi 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: Clinical efficacy and safety Clinical efficacy studies were conducted with deferasirox dispersible tablets.
Maltese: Effikaċja klinika u sigurtà Twettqu studji dwar l-effikaċja klinika b'deferasirox pilloli li jinxterdu.
English: EXJADE 180 mg film-coated tablets EU/1/06/356/014
Maltese: EXJADE 180 mg pilloli miksija b'rita EU/1/06/356/014
English: EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet Deferasirox
Maltese: Informazzjoni għall-utent EXJADE 90 mg granijiet f'qartas EXJADE 180 mg granijiet f'qartas EXJADE 360 mg granijiet f'qartas Deferasirox
English: Each dispersible tablet contains 125 mg of deferasirox.
Maltese: Kull pillola li tinxtered fiha 125 mg deferasirox.
English: Clinical study in patients with non-transfusion-dependent thalassaemia syndromes 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), l-aktar episodji avversi b'rabta mal-mediċina studjata kienu d-dijarrea (9.1%), raxx (9.1%) u dardir (7.3%).
English: EXJADE 360 mg granules Each sachet contains 360 mg deferasirox.
Maltese: EXJADE 360 mg granijiet Kull qartas fih 360 mg deferasirox.
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: Aġenti li jistgħu jnaqqsu l-espożizzjoni sistemika ta' EXJADE Il-metaboliżmu ta' deferasirox jiddependi fuq l-enzimi UGT. Fi studju b'voluntiera b'saħħithom, lgħotja 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 dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Maltese: Kull pillola li tinxtered EXJADE 125 mg fiha 125 mg deferasirox.
English: EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox.
Maltese: U KWANTITATTIVA EXJADE 125 mg pilloli li jinxterdu Kull pillola li tinxtered fiha 125 mg deferasirox.
English: • Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox.
Maltese: Kull pillola li tinxtered EXJADE 500 mg fiha 500 mg deferasirox.
English: EXJADE 250 mg dispersible tablets EU/1/06/356/003
Maltese: EXJADE 250 mg pilloli li jinxterdu EU/1/06/356/003
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 l-LIC hu <7 mg Fe/g dw jew il-ferritin fis-serum hu ≤2000 µg/l.
English: EXJADE 125 mg dispersible tablets deferasirox
Maltese: EXJADE 125 mg pilloli li jinxterdu deferasirox
English: EXJADE 180 mg granules Each sachet contains 180 mg deferasirox.
Maltese: EXJADE 180 mg granijiet Kull qartas fih 180 mg deferasirox.
English: Bioavailability of deferasirox granules was 52% greater than that with dispersible tablets.
Maltese: Bijodisponibilità ta' deferasirox granijiet kienet 52% ogħla minn dik bil-pilloli li jinxterdu.
English: Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other).
Maltese: Pillola miksija b'rita, blu skur, ovali u bbuzzata fuq iż-żewġ naħat bi xfar imżerżqa u timbri (NVR fuq naħa u 360 fuq in-naħa l-oħra).
English: Maximum dose
Maltese: Doża massima
English: For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 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 >10 mg/kg, huwa rrakkomandat tnaqqis fid-doża għal 10 mg/kg jew anqas meta l-LIC hu <7 mg Fe/g dw jew il-ferritin fis-serum hu ≤2000 µg/l.
English: EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet
Maltese: EXJADE 90 mg granijiet f'qartas EXJADE 180 mg granijiet f'qartas EXJADE 360 mg granijiet f'qartas
English: Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units (about 100 ml/kg) of PRBC
Maltese: Doża tal-bidu 14 mg/kg/jum 20 mg/kg/jum Wara 20 unità (madwar
English: Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) film-coated tablets.
Maltese: Pakketti ta' unitajiet li fihom 30 jew 90 pillola miksija b'rita jew pakketi multipli li fihom 300 (10 pakketti ta' 30) pillola miksija b'rita.
English: Serum creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to therapy, weekly in the first month after initiation or modification of therapy with EXJADE (including switch of formulation), and monthly thereafter.
Maltese: Kreatinina fis-serum, tneħħija tal-kreatinina (stmat bil-formula Cockcroft-Gault jew MDRD f'adulti u bil-formula Schwartz fit-tfal) u/jew livelli ta' cystatin C fil-plasma għandhom ikunu monitorati qabel it-terapija, kull ġimgħa fl-ewwel xahar wara li tibda jew tinbidel it-terapija b'EXJADE (inkluż il-bidla fil-formulazzjoni), u kull xahar minn hemm 'il quddiem.
English: Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
Maltese: Pillola miksija b'rita, blu ċara, ovali u bbuzzata fuq iż-żewġ naħat bi xfar imżerżqa u timbri (NVR fuq naħa u 90 fuq in-naħa l-oħra).
English: *LIC is the preferred method of iron overload determination.
Maltese: *LIC hu l-metodu ppreferu biex tiddetermina t-tagħbija tal-ħadid.
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg.
Maltese: F'pazjenti li l-LIC tagħhom ma ġiex evalwat u l-ferritin fis-serum hu ta' ≤2000 µg/l, id-doża m'għandhiex taqbeż 7 mg/kg.