FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/l) (see section 4.5).
Maltese: 9/l) (ara sezzjoni 4.5).
English: Linearity / non-linearity
Maltese: Linearità/nuqqas ta' linearità
English: Twice (2×)
Maltese: Darbtejn (2×)
English: 1, anaemia aggravated
Maltese: 1, anemija aggravata
English: 2900 Komarom HUNGARY
Maltese: 2900 Komarom L-UNGERIJA
English: The study enrolled 145 adult and 21 paediatric patients.
Maltese: L-istudju inkluda 145 adult u 21 pazjent pedjatriku.
English: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, France
Maltese: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, Franza
English: Cataract, maculopathy
Maltese: Katarretti, makulopatija
English: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Maltese: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, L-Ungerija
English: Adult patients
Maltese: Pazjenti adulti
English: Value 1
Maltese: Valur 1
English: The active substance is deferasirox.
Maltese: Is-sustanza attiva hi deferasirox.
English: Cellulose, microcrystalline Crospovidone (Type A) Povidone (K30) Magnesium stearate Silica, colloidal anhydrous Poloxamer (P188)
Maltese: Cellulose, microcrystalline Crospovidone (Tip A) Povidone (K30) Magnesium stearate Silica, colloidal anhydrous Poloxamer (P188)
English: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Maltese: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, L-Irlanda
English: [Bottles]:
Maltese: [Fliexken]:
English: Manufacturer Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Maltese: Manifattur Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1 TL, Ir-Renju Unit
English: or >1,000μg/l
Maltese: jew >1,000μg/l
English: Serum transaminases, bilirubin, alkaline phosphatase
Maltese: Transaminases, bilirubin, alkaline phosphatase fis-serum
English: LLN: lower limit of the normal range
Maltese: LLN: l-inqas limitu tal-firxa normali ULN: l-ogħla limitu tal-firxa normali
English: Value 2
Maltese: Valur 2
English: Contraindicated
Maltese: Kontraindikat
English: The tablet coating material contains: hypromellose, titanium dioxide (E171), macrogol/PEG (6000), talc, iron oxide yellow (E172), iron oxide red (E172).
Maltese: Il-materjal tar-rita fih: hypromellose, titanium dioxide (E171), macrogol/PEG (6000), talc, iron oxide yellow (E172), iron oxide red (E172).
English: and Once (1×)
Maltese: u Darba (1×)
English: The transporters MRP2 and MXR (BCRP) are involved in the biliary excretion of deferasirox.
Maltese: It-trasportaturi MRP2 u MXR (BCRP) huma nvoluti fl-eskrezzjoni ta' deferasirox mill-marrara.
English: Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Maltese: Emorraġija gastrointestinali, ulċera fl-istonku (inklużi ħafna ulċeri), ulċera fid-duwodenu, gastrite
English: For adults not assessed and ≤2,000 µg/l
Maltese: Għall-adulti mhux evalwat u ≤2,000 µg/l
English: Gastrointestinal disorders
Maltese: Perforazzjoni gastrointestinali
English: Approximate tablet dimensions 12.8 mm × 6.00 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 12.8 mm × 6.00 mm.
English: Elderly patients (≥65 years of age)
Maltese: Pazjenti anzjani (≥65 sena)
English: Table 4 Summary of safety monitoring recommendations
Maltese: Tabella 4 Sommarju ta' rakkomandazzjonijiet ta' monitoraġġ tas-sigurtà
English: Marketing Authorisation Holder Mylan S.A.S, 117 Allée des Parcs, Saint-Priest, 69800, France
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, Franza
English: 2D barcode carrying the unique identifier included
Maltese: barcode 2D li jkollu lidentifikatur uniku inkluż.
English: Approximate tablet dimensions 17 mm × 6.7 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 17 mm × 6.7 mm.
English: Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3.
Maltese: Wara ħafna dużaġġi lesponiment żdied b'fattur ta' akkumulazzjoni ta' bejn 1.3 sa 2.3.
English: 1, thrombocytopenia
Maltese: 1, tromboċitopenija
English: No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro.
Maltese: Ma deherx li kien hemm impediment ta' metaboliżmu ta' deferasirox minn hydroxyurea in vitro.
English: Approximate tablet dimensions 10.00 mm × 4.5 mm.
Maltese: mm × 4.5 mm.
English: After 20 units (about 100 ml/kg) of PRBC
Maltese: Wara 20 unita (madwar 100 mL/kg) ta' PRBC
English: Proteinuria
Maltese: Proteinurja
English: - ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis), - simvastatin (used to lower cholesterol), - certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), - oral bisphosphonates (used to treat osteoporosis), - anticoagulant medicines (used to prevent or treat blood clotting), - hormonal contraceptive agents (birth control medicines), - bepridil, ergotamine (used for heart problems and migraines), - repaglinide (used to treat diabetes), - rifampicin (used to treat tuberculosis), - phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), - ritonavir (used in the treatment of HIV infection), - paclitaxel (used in cancer treatment), - theophylline (used to treat respiratory diseases such as asthma), - clozapine (used to treat psychiatric disorders such as schizophrenia), - tizanidine (used as a muscle relaxant), - cholestyramine (used to lower cholesterol levels in the blood).
Maltese: kortikosterojdi), - bisfosfonati orali (użati għall-kura ta' osteoporożi), - mediċini antikoagulanti (użati għall-prevenzjoni jew għall-kura tal-għaqid tad-demm), - sustanzi li jintuzaw bħala kontraċettivi ormonali (mediċini li jikkontrollaw it-twelid), - bepridil, ergotamine (użati għall-problemi tal-qalb u emigranja), - repaglinide (użat għall-kura tad-dijabete), - rifampicin (użat għall-kura ta' tuberkolożi), - phenytoin, phenobarbital, carbamazepine (użati għall-kura tal-epilessija), - ritonavir (użat għall-kura ta' infezzjoni b'HIV), - paclitaxel (użat għall-kura tal-kanċer), - theophylline (użat biex jikkura mard respiratorju bħall-ażma), - clozapine (użat biex jikkura disturbi psikjatriċi bħal skizofrenja), - tizanidine (użat bħala rilassant tal-muskoli), - cholestyramine (użat biex ibaxxi llivelli tal-kolesterol fid-demm).
English: The mean elimination half-life (t½) ranged from 8 to 16 hours.
Maltese: Ilmedja tal-half-life tal-eliminazzjoni (t½) kienet bejn 8 u 16-il siegħa.
English: Adverse reactions are ranked below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi huma kklassifikati hawn taħt skont il-konvenzjoni li ġejja: 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); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: ≥5 mg Fe/g dw or >800 µg/l
Maltese: ≥5 mg Fe/g dw jew >800 µg/l
English: , tubulointerstitial nephritis
Maltese: , nefropatija tubulointerstizjali nefrolitijażi
English: <3 mg Fe/g dw or <300 µg/l
Maltese: <3 mg Fe/g dw jew <300 µg/l
English: Abnormal serum creatinine and creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively.
Maltese: Kienu rrappurtati valuri mhux normali ta' kreatinina tas-serum u ta' tneħħija tal-kreatinina f'5.5% u 1.8%, rispettivament, talpazjenti.
English: However, a contributory or aggravating role cannot be excluded.
Maltese: Madankollu, ma jistax jiġi eskluż rwol kontributorju jew aggravanti.
English: Interaction with midazolam and other agents metabolised by CYP3A4
Maltese: Interazzjoni ma' midazolam u aġenti oħrajn metabolizzati b'CYP3A4
English: Serum creatinine
Maltese: Kreatinina tas-serum
English: Interaction with theophylline and other agents metabolised by CYP1A2
Maltese: Interazzjoni ma' theophylline u aġenti oħrajn metabolizzati b'CYP1A2
English: In duplicate prior to therapy.
Maltese: Duplikati qabel it-terapija.
English: The other ingredients are microcrystalline cellulose, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica and poloxamer.
Maltese: Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica u poloxamer.
English: Single events of increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 145 patients who completed the study.
Maltese: Kienu rrappurtati episodji individwali ta' żieda tal-ALT u tal-aspartat aminotrasferasi f'20.0% u fi 8.3%, rispettivament, mill-145 pazjent li temmew listudju.
English: Deferasirox Mylan may decrease the efficacy of hormonal contraceptives (see section 4.5).
Maltese: Deferasirox Mylan jista' jnaqqas leffikaċja ta' kontraċettivi ormonali (ara sezzjoni 4.5).
English: In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four open label studies of up to five years' duration, a mean creatinine clearance decrease of 13.2% in adult patients (95% CI: −14.4% to −12.1%; n=935) and 9.9% (95% CI: −11.1% to −8.6%; n=1,142) in paediatric patients was observed during the first year of treatment.
Maltese: F'meta-analiżi retrospettiva ta' 2,102 adulti u pazjenti pedjatriċi b'beta-talessimja b'trasfużjoni b'tagħbija żejda ta' ħadid ittrattati b'deferasirox pilloli li jinxterdu f'żewġ studji randomizzati u f'erba' studji open label li damu għaddejjin sa ħames snin, tnaqqis ta' 13.2% fil-medja li biha titneħħa l-kreatinina f'pazjenti adulti (95% CI: −14.4% sa −12.1%; n=935) u 9.9% (95% CI: −11.1% sa −8.6%; n=1,142) f'pazjenti pedjatriċi osservati matul l-ewwel sena mit-trattament.
English: 3.5 - 7 mg/kg/day
Maltese: 3.5 - 7 mg/kg/jum
English: >14 ml/kg/month of PRBC (approx. >4 units/month for an adult)
Maltese: >14 ml/kg/xahar ta' PRBC (madwar >4 unitajiet/xahar għal adult)
English: In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor (repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 73% to 95%).
Maltese: Fi studju fuq volontiera b'saħħithom, l-użu konkomitanti ta' deferasirox bħala inibitur ta' CYP1A2 (dożi ripetuti ta' 30 mg/kg/kuljum, formulazzjoni ta' pillola li tinxtered) u s-substrat CYP1A2 theophylline (doża singola ta' 120 mg) irriżulta f'żieda ta' theophylline AUC bi 84% (90% CI: minn 73% sa 95%).
English: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Deferasirox Mylan (see section 4.4).
Maltese: Reazzjonijiet avversi qawwija fil-ġilda (SCARs), inklużi ssindrome ta' Stevens-Johnson (SJS), nekrolisi tossika tal-epidermide (TEN) u reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi (DRESS) kienu rrapportati bl-użu ta' Deferasirox Mylan (ara sezzjoni 4.4).
English: >33% above pretreatment average and Decreases <LLN
Maltese: >33% ogħla mill-medja ta' qabel it-trattament u Tnaqqis ta' <LLN
English: 1, neutropenia
Maltese: 1, urtikarja
English: The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose.
Maltese: Il-biodisponibiltà assoluta (AUC) ta' deferasirox (formulazzjoni ta' pillola li tinxtered) hija madwar 70% meta mqabbla ma' doża li tingħata għal ġol-vina.
English: Pyrexia, oedema, fatigue
Maltese: Deni, edema, għeja
English: 1, hypersensitivity vasculitis
Maltese: 1, vaskulite kkawżata minn sensittività eċċessiva
English: The concomitant administration of deferasirox with substances that have known ulcerogenic potential, such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4).
Maltese: għoti fl-istess ħin ta' deferasirox ma' sustanzi li għandhom potenzjal ulċeroġeniku bħal NSAIDs (inkluż acetylsalicylic acid f'dożaġġi għoljin), kortikosterojdi, jew bisfosfonati orali, jista' jżid irriskju ta' tossiċità gastrointestinali (ara sezzjoni 4.4).
English: In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) and 1.6-fold (90% CI [1.42-1.84]), respectively.
Maltese: Fi studju b'voluntiera b'saħħithom, l-għoti f'daqqa ta' deferasirox bħala inibitur moderat ta' CYP2C8 (30 mg/kg kuljum, formulazzjoni ta' pillola li tinxtered), u repaglinide, substrat ta' CYP2C8, mogħti bħala doża waħda ta' 0.5 mg, żied l-AUC u s-Cmax ta' repaglinide b'madwar 2.3 drabi aktar (90% CI [2.03-2.63]) u b'1.6 drabi aktar (90% CI [1.42-1.84]), rispettivament.
English: Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Maltese: Deferasirox Mylan mhuwiex rakkomandat f'pazjenti li jsofru b'indeboliment epatiku serju (ChildPugh Klassi C) (ara sezzjoni 5.2).
English: [Unit dose blisters] 30 × 1 film-coated tablets
Maltese: [Folji b'doża waħda] 30 × 1 pillola miksija b'rita
English: In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of deferasirox in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%).
Maltese: Fi studju ta' 5 snin imsejjes fuq l-osservazzjoni li matulu 267 tifel u tifla li kellhom bejn sentejn u <6 snin (mas-sħubija) b'emosiderożi transfużjonali ngħataw deferasirox, ma kienx hemm differenzi importanti klinikimant fis-sigurtà u ttollerabbiltà ta' deferasirox f'pazjenti pedjatriċi li kellhom bejn sentejn u <6 snin imqabblin mal-popolazzjoni sħiħa adulta u pedjatrika ta' età akbar, inkluż żidiet talkreatinina fis-serum ta' >33% u li qabżu logħla limitu tan-normal f'≥2 okkażjonijiet konsekuttivi (3.1%), u żieda tal-alanina aminotransferasi (ALT) 5 darbiet akbar mill-ogħla limitu tan-normal (4.3%).
English: The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
Maltese: Ilfarmakokinetika ta' deferasirox ma kinitx effettwata minn livelli ta' transaminase tal-fwied sa 5 darbiet l-ogħla limitu tal-medda normali.
English: • Disturbance in liver function tests
Maltese: • Disturb fir-riżultati ta' testijiet tal-funzjoni tal-fwied
English: Interaction with repaglinide and other agents metabolised by CYP2C8
Maltese: Interazzjoni ma' repaglinide u aġenti oħrajn metabolizzati b'CYP2C8
English: Other markers of renal tubular function (such as glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria)
Maltese: Markaturi oħra tal-funzjoni tat-tubuli renali (bħal zokkor fl-awrina f'pazjenti mhux dijabetiċi u livelli baxxi ta' potassium, phosphate, magnesium jew urate fis-serum, fosfaturja, aminoaċidurja)
English: Deferasirox Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Deferasirox Mylan fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The concomitant administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal haemorrhage.
Maltese: L-għoti f'daqqa ta' deferasirox u antikoagulanti jista' jżid ukoll ir-riskju ta' emorraġija gastrointestinali.
English: Film-coated tablets
Maltese: Karatteristiċi fil-pazjenti
English: Diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
Maltese: Dijarea, stitikezza, rimettar, tqalligħ, uġigħ addominali, nefħa addominali, dispepsja
English: Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and has a small volume of distribution of approximately 14 litres in adults.
Maltese: Deferasirox jintrabat bil-qawwa (99%) mal-proteini tal-plażma, kważi esklużivament ma' albumin tasserum, u għandu volum żgħir ta' distribuzzjoni fl-adulti ta' madwar 14-il litru.
English: • Non-compliance of the posology and biological monitoring
Maltese: • Nuqqas ta' kompjaċenza mal-pożoloġija u l-monitoraġġ bijoloġiku
English: 1, urticaria erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 Renal and urinary disorders Very common:
Maltese: 1, nekrolisi tossika tal epidermide (TEN) Disturbi fil-kliewi u fis-sistema urinarja Komuni ħafna:
English: The Cmax was increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Maltese: 3% - 40.0%); madankollu analiżi klinika ta' esponiment/rispons ma wriet l-ebda evidenza ta' effetti klinikament rilevanti ta' din iż-żieda.
English: Deferasirox Mylan is available in clear, transparent PVC/PVdC /aluminium blister packs containing 30 or 90 film-coated tablets, in unit dose blister pack of 30 tablets and in white, plastic bottles with white opaque screw cap with aluminium seal containing 90 and 300 tablets.
Maltese: Deferasirox Mylan huwa disponibbli f'pakketti tal-folji tal-PVC/PVdC/aluminium ċari u trasparenti li fihom 30 jew 90 pillola miksija b'rita, f'pakkett bil-folji b'doża waħda ta' 30 pillola u fi fliexken bojod tal-plastik b'għatu bil-kamin opak abjad b'siġill tal-aluminium li fih 90 u 300 pillola.
English: Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older).
Maltese: Pazjenti anzjani Il-farmakokinetika ta' deferasirox f'pazjenti anzjani ma kinitx studjata (ta' 65 sena jew akbar).
English: • Each film-coated tablet of Deferasirox Mylan 360 mg contains 360 mg deferasirox.
Maltese: • Kull pillola miksija b'rita ta' Deferasirox Mylan 360 mg fiha 360 mg deferasirox.
English: The single dose Cmax was not affected, but an increase of theophylline Cmax is expected to occur with chronic dosing.
Maltese: Id-doża singola Cmax ma kinitx affetwata, iżda huwa mistenni li jkun hemm żieda ta' theophylline Cmax ma' dożaġġ kroniku.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jolqtu sa persuna waħda f'kull 100)
English: Deferasirox Mylan 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: Deferasirox Mylan 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: Anxiety, sleep disorder Nervous system disorders Common:
Maltese: Ansjetà, disturbi fl-irqad Disturbi fis-sistema nervuża Komuni:
English: Gastrointestinal perforation 1, acute pancreatitis
Maltese: 1, pankreatite akuta
English: 21 mg/kg/day
Maltese: 21 mg/kg/jum
English: In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function.
Maltese: Fi studju kliniku li matulu ntużaw dożi singoli ta' 20 mg/kg deferasirox pilloli li jinxterdu, lespożizzjoni medja żdiedet b'16% f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh Klassi A) u b'76% f'pazjenti b'indeboliment moderat tal-fwied (Child-Pugh Klassi B) meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied.
English: <7 ml/kg/month of PRBC (approx. <2 units/month for an adult)
Maltese: <7 ml/kg/xahar ta' PRBC (madwar <2 unitajiet/xahar għal adult)
English: Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose).
Maltese: Eliminazzjoni eskrezzjoni ta' deferasirox u l-metaboli tiegħu sseħħ primarjament fl-ippurgar (84% tad-doża).
English: 14 mg/kg/day
Maltese: 14 mg/kg/jum
English: After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively).
Maltese: Wara ikla b'ħafna xaħam, l-AUC u Cmax żdiedu (bi 18% u 29%, rispettivament).
English: Decrease 3.5 - 7 mg/kg/day
Maltese: Żjieda 3.5 - 7 mg/kg/jum
English: Patients with estimated creatinine clearance <60 ml/min.
Maltese: Pazjenti li jkollhom tneħħija tal-kreatinina stmata <60 ml/min.
English: Laryngeal pain
Maltese: Popolazzjoni pedjatrika
English: Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Maltese: L-espożizzjoni żdiedet bi 2.8 drabi f'pazjent wieħed b'indeboliment qawwi tal-fwied (Child-Pugh Klassi C) (ara sezzjonijiet 4.2 u 4.4).
English: • Each film-coated tablet of Deferasirox Mylan 180 mg contains 180 mg deferasirox.
Maltese: • Kull pillola miksija b'rita ta' Deferasirox Mylan 180 mg fiha 180 mg deferasirox.
English: One third of deferoxamine dose
Maltese: Terz tad-doża ta' deferoxamine
English: Starting dose
Maltese: Doża inizjali
English: In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, deferasirox at daily doses of 10, 20 and 40 mg/kg (dispersible tablet formulation) induced the mean net excretion of 0.119, 0.329 and 0.445 mg Fe/kg body weight/day, respectively.
Maltese: Fi studju dwar il-metaboliżmu tal-bilanċ tal-ħadid f'pazjenti talassemiċi adulti li għandhom tagħbija żejda tal-ħadid, deferasirox bdożi ta' 10, 20 u 40 mg/kg (formulazzjoni ta' pillola li tinxtered) kuljum (formulazzjoni ta' pillola li tinxtered) wasslu għal medja ta' eskrezzjoni netta ta' 0.119, 0.329 u 0.445 mg/Fe/kg piż tal-ġisem kuljum, rispettivament.
English: In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% CI: 8% - 26%).
Maltese: Fi studju b'voluntiera b'saħħithom, l-għotja ta' deferasirox pilloli li jinxterdu flimkien ma' midazolam (sottostrati tal-prowb għal CYP3A4) ikkawżat tnaqqis fl-esponiment għal midazolam bi 17% (90% CI: 8% - 26%).
English: Dizziness
Maltese: Twaqqif
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: (acquired Fanconi syndrome), glycosuria
Maltese: (sindrome Fanconi akkwistat), zokkor fl awrina Mhux magħruf:
English: Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 µg/l).
Maltese: Terapija b'kelatur għandha tinbeda biss meta hemm evidenza ta' tagħbija żejda ta' ħadid (ilkonċentrazzjoni ta' ħadid fil-fwied [LIC] ≥5 mg Fe/g piż xott [dw] jew ferritin fis-serum b'mod konsistenti ta' >800 µg/l).