FrancophonIA/ELRC3.0 huggingface dataset:
English: Written explanations were provided by the applicant on 21 May 2013.
Maltese: Spjegazzjonijiet bil-miktub ingħataw millapplikant fil-21 ta' Mejju 2013.
English: France is the reference Member State and Austria, Germany, Hungary, the Netherlands, Poland, Romania, Spain and the United Kingdom are concerned Member States.
Maltese: Franza huwa l-Istat Membru ta' referenza u l-Awstrija, il-Ġermanja, l-Ungerija, il-Pajjiżi l-Baxxi, il-Polonja, ir-Rumanija, Spanja u r-Renju Unit huma l-Istati Membri kkonċernati.
English: Opinion following an Article 33(4)0F referral for Suifertil 4 mg/ml Oral Solution for Pigs and associated names
Maltese: Opinjoni wara riferiment tal-Artikolu 33(4)0F għas-Soluzzjoni Orali ta' 4 mg/ml ta'
English: The applicant, aniMedica GmbH, submitted an application for a decentralised procedure for Suifertil 4 mg/ml Oral Solution for Pigs and associated names.
Maltese: L-applikant, aniMedica GmbH, issottometta applikazzjoni għal proċedura deċentralizzata għasSoluzzjoni Orali ta' 4 mg/ml ta' Suifertil għall-Ħnieżer u l-ismijiet assoċjati.
English: The referral procedure started on 6 March 2013.
Maltese: Il-proċedura ta' riferiment bdiet fis-6 ta' Marzu 2013.
English: On 1 March 2013, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fl-1 ta' Marzu 2013, l-Istat Membru ta' referenza, Franza, innotifika lill-Aġenzija Ewropea għall-Mediċini li s-CMD(v) naqas milli jilħaq ftehim dwar il-prodott u konsegwentement il-kwistjoni ġiet riferuta lisCVMP skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: The decentralised procedure started on 7 October 2011.
Maltese: Il-proċedura deċentralizzata bdiet fis-7 ta' Ottubru 2011.
English: Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.
Maltese: Matul il-proċedura deċentralizzata ġew identifikati riskji potenzjali serji mill-Ġermanja fir-rigward tas-sigurtà ambjentali tal-prodott.
English: Having considered all the overall submitted data in writing the CVMP concluded that there is no product specific concern identified for the Suifertil 4 mg/ml Oral Solution for Pigs that is different from the other, already authorised, altrenogest containing veterinary medicinal products.
Maltese: Wara li kkunsidra d-dejta ġenerali kollha ppreżentata bil-miktub, is-CVMP ikkonkluda li ma hemm lebda tħassib speċifiku għall-prodott, identifikat għal Suifertil 4 mg/ml Soluzzjoni Orali għall-Majjali, li huwa differenti mill-prodotti mediċinali veterinarji l-oħra diġà awtorizzati, li fihom altrenogest.
English: Suifertil 4 mg/ml Oral Solution for Pigs contains altrenogest as active ingredient and is intended for use in pigs for the synchronisation of oestrous in sexually mature gilts.
Maltese: Is-Soluzzjoni Orali ta' 4 mg/ml ta' Suifertil għall-Ħnieżer fiha alternogest bħala sustanza attiva u hija maħsuba għall-użu fil-ħnieżer għas-sinkronizzazzjoni tal-estru fil-ħnieżer nisa żgħar sesswalment maturi.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 17 December 2012.
Maltese: Fil-jum 210, dawn il-kwistjonijiet baqgħu mhux solvuti u għalhekk, fis-17 ta' Diċembru 2012 inbeda riferiment skont l-Artikolu 33(1) tad-Direttiva 2001/82/KE lill-grupp ta' Koordinazzjoni għal proċeduri ta' Rikonoxximent reċiproku u Proċeduri deċentralizzati (veterinarju) (CMD(v)).
English: Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: Il-jum 60 tal-proċedura CMD(v) kien l-14 ta' Frar 2013, u minħabba li l-Istati Membri kkonċernati ma waslux għal ftehim dwar il-prodott, il-proċedura ġiet riferuta lis-CVMP.
English: Therefore, the Committee adopted by consensus a positive opinion on 18 July 2013 recommending the granting of a marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs and associated names.
Maltese: Għaldaqstant, il-Kumitat b'kunsens adotta opinjoni pożittiva fit 18 ta' Lulju 2013 li tirrakkomanda lgħoti ta' awtorizzazzjoni għat-tqegħid fis-suq għas-Soluzzjoni Orali ta' 4 mg/ml ta' Suifertil għallĦnieżer u l-ismijiet assoċjati.
English: Ampoule (LDPE) 2.4 ml (100 mg/ml) 56 Ampoules + 1 Nebuliser Handset
Maltese: Ampulla (LDPE) 2.4 ml (100 mg/ml) 56 Ampulla + 1 Sett tal-Idejn tan-Nebulizzatur
English: 240 mg Nebuliser solution Inhalation use
Maltese: 240 mg Soluzzjoni għan-nebulizzatur
English: Initiation pack: 49 tablets (42 x 15 mg + 7 x 20 mg)
Maltese: 49 pillola (42 x 15 mg + 7 x 20 mg)
English: 100 (10 x 10 x 1) tablets (unitdose) (multipack)
Maltese: 100 (10 x 10 x 1) pillola (doża waħda)
English: Film-coated tablet Oral use
Maltese: Pakkett biex tibda:
English: June 2021
Maltese: Ġunju 2021
English: 1, alopecia
Maltese: 1, alopeċja
English: Titanium dioxide (E171) Macrogol (4000)
Maltese: Titanium dioxide (E171) Macrogal (4000)
English: Twice (2x)
Maltese: Darbtejn (2x)
English: *LLN: lower limit of the normal range **ULN: upper limit of the normal range
Maltese: *LLN: l-inqas limitu tal-firxa normali **ULN: l-ogħla limitu tal-firxa normali
English: and Once (1x)
Maltese: Darba (1x)
English: > age appropriate ULN**
Maltese: > xieraq skont l-età ULN**
English: 1, anaemia aggravated neutropenia
Maltese: 1, anemija aggravata
English: “NVR” on the other.
Maltese: “NVR” fuq in-naħa l-oħra.
English: The tablet coating material contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; indigo carmine aluminium lake (E132).
Maltese: Il-materjal tal-kisja tal-pillola fih: hypromellose; titanium dioxide (E171); macrogol (4000); talc; indigo carmine aluminium lake (E132).
English: 1, urticaria erythema multiforme
Maltese: 1, eritema multiforme
English: Date of first authorisation: 28 August 2006 Date of latest renewal: 18 April 2016
Maltese: Data tal-aħħar tiġdid: 18 ta' April 2016
English: Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Qratas bil-fojl tal-polyethylene terephthalate (PET)/Aluminju/polyethylene (PE).
English: Sodium laurilsulfate Silica, colloidal anhydrous
Maltese: Sodium laurilsulfate Silica, colloidal anhydrous Magnesium stearate
English: Other medicines and EXJADE
Maltese: Mediċini oħra u EXJADE
English: Table 4 Summary of safety monitoring recommendations
Maltese: Tabella 4 Sommarju ta' rakkomandazzjonijiet ta' monitoraġġ tas-sigurtà Test
English: and/or Decreases <LLN* (<90 ml/min)
Maltese: u/jew Tnaqqis ta' <LLN* (<90 ml/min)
English: The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium laurilsulfate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, crospovidone type A, povidone, sodium laurilsulfate, microcrystalline cellulose, colloidal anhydrous silica u magnesium stearate.
English: EXJADE may decrease the efficacy of hormonal contraceptives (see section 4.5).
Maltese: EXJADE jista' jnaqqas l-effikaċja ta' kontraċettivi ormonali (ara sezzjoni 4.5).
English: (acquired Fanconi syndrome), glycosuria
Maltese: (sindrome Fanconi akkwistat), zokkor fl-awrina
English: Hepatitis, cholelithiasis
Maltese: Epatite, kolelitijażi
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi (DRESS)
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: Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3.
Maltese: Wara ħafna dużaġġi l-esponiment żdied b'fattur ta' akkumulazzjoni ta' bejn 1.3 sa 2.3.
English: Approximate tablet dimensions 10.7 mm x 4.2 mm.
Maltese: 7 mm x 4.2 mm.
English: 300 (10 packs of 30) film-coated tablets
Maltese: 300 (10 pakketti ta' 30) pillola miksija b'rita
English: Interaction with theophylline and other agents metabolised by CYP1A2
Maltese: Interazzjoni m'a theophylline u aġenti oħrajn metabolizzati b'CYP1A2
English: Hypersensitivity reactions (including anaphylactic reactions and angioedema) Metabolism and nutrition disorders Not known:
Maltese: Reazzjonijiet ta' sensittività eċċessiva (inkluż reazzjonijiet anafilattiċi u anġjoedima) Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux magħruf:
English: This includes in particular: - other iron chelators, which must not be taken with EXJADE, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as EXJADE, - 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), - busulfan (used as a treatment prior to transplantation in order to destroy the original bone marrow before the transplant).
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 l-livelli tal-kolesterol fid-demm), - busulfan (użat bħala trattament qabel it-trapjant sabiex jinqered il-mudullun oriġinali qabel it trapjant).
English: Laryngeal pain Gastrointestinal disorders Common:
Maltese: Uġigħ fil-larinġi Disturbi gastro-intestinali Komuni:
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 l-istudju.
English: EXP.
Maltese: EXP/JIS.
English: Unit packs containing 30 sachets.
Maltese: Kull pakkett fih 30 qartas.
English: Approximate tablet dimensions 17 mm x 6.7 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 17 mm x 6.7 mm.
English: ≥7 mg Fe/g dw or >2,000 µg/l
Maltese: ≥7 mg Fe/g dw jew >2,000 µg/l
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: L-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: <7 mg Fe/g dw or ≤2,000 µg/l
Maltese: <7 mg Fe/g dw jew ≤2,000 µg/l
English: Alternative starting doses
Maltese: Dożi alternattivi talbidu
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-sustrat CYP1A2 theophylline (doża singola ta' 120 mg) irriżulta f'żieda ta' theophylline AUC bi 84% (90% CI:-73% sa 95%).
English: Approximate tablet dimensions 14 mm x 5.5 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 14 mm x 5.5 mm.
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 Exjade 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 t-tollerabbiltà ta' Exjade 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 l-ogħla 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: 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: Tneħħija tal-kreatinina f'trasfużjoni b'tagħbija żejda ta' ħadid 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 lkreatinina 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: 14 mg/kg/day 20 mg/kg/day
Maltese: 14 mg/kg/jum 20 mg/kg/jum
English: Creatinine clearance and/or plasma cystatin C
Maltese: Tneħħija tal-kreatinina u/jew cystatin C fil-plażma
English: Approximate tablet dimensions 20 mm x 5.6 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 20 mm x 5.6 mm.
English: EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Maltese: EXJADE mhuwiex rakkomandat f'pazjenti li jsofru b'indeboliment epatiku serju (Child-Pugh Klassi C) (ara sezzjoni 5.2).
English: The multipacks contain 300 (10 packs of 30) film-coated tablets.
Maltese: Il-pakketti multipli fihom 300 (10 pakketti ta' 30) pillola miksija b'rita.
English: The absolute bioavailability of the granule formulation has not been determined.
Maltese: Il-bijodisponibilità assoluta tal-formulazzjoni tal-granijiet ma ġietx determinata.
English: The safety profile was consistent with previous studies in adult MDS patients.
Maltese: Il-profil ta' sigurtà kien konsistenti ma' studji mgħoddija fost pazjenti adulti b'MDS.
English: • 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: Approximate tablet dimensions 12 mm x 3.6 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 12 mm x 3.6 mm.
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 EXJADE (see section 4.4).
Maltese: Reazzjonijiet avversi qawwija fil-ġilda (SCARs), inklużi s-sindrome ta' Stevens-Johnson (SJS), nekrolisi tossika tal-epidermide (TEN) u reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi (DRESS) kienu rrapportati bl-użu ta' EXJADE (ara sezzjoni 4.4).
English: • EXJADE 125 mg tablets are stamped “J 125” on one side and “NVR” on the other.
Maltese: • Il-pilloli EXJADE 125 mg huma ttimbrati b'“J 125” fuq naħa minnhom u “NVR” fuq in-naħa l oħra.
English: or >1,000 µg/l
Maltese: jew >1,000 µg/l
English: EXJADE 180 mg granules EU/1/06/356/021
Maltese: EXJADE 180 mg granijiet EU/1/06/356/021
English: The bioavailability (AUC) of deferasirox was moderately (approx. 13-25%) elevated when taken 30 minutes before meals with normal or high fat content.
Maltese: Il-biodisponibiltà (AUC) ta' deferasirox kienet moderatament (madwar 13-25%) għolja meta ttieħed 30 minuta qabel l-ikel ma' kontenut normali jew għoli ta' xaħam.
English: The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica and poloxamer.
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica u poloxamer.
English: Approximate tablet dimensions 15 mm x 4.7 mm.
Maltese: Id-daqs bejn wieħed u ieħor tal-pillola hu ta' 15 mm x 4.7 mm.
English: 5-10 mg/kg/day Up to 40 mg/kg/day Decrease 3.5 - 7 mg/kg/day 5-10 mg/kg/day
Maltese: 5-10 mg/kg/jum Sa 40 mg/kg/jum Tnaqqis 3.5 - 7 mg/kg/jum 5-10 mg/kg/jum
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, 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: 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l
Maltese: Doża tal-bidu 7 mg/kg/jum 10 mg/kg/jum ≥5 mg Fe/g dw jew >800 µg/l Monitoraġġ
English: EXJADE 360 mg granules EU/1/06/356/022
Maltese: EXJADE 360 mg granijiet EU/1/06/356/022
English: Liver iron concentration (LIC)*
Maltese: Konċentrazzjoni ta' ħadid filfwied (LIC)*
English: EXJADE 125 mg, 250 mg and 500 mg dispersible tablets are available in unit packs containing 28, 84 or 252 dispersible tablets.
Maltese: EXJADE 125 mg, 250 mg u 500 mg pilloli li jinxterdu huma disponibbli f'pakketti waħedhom li fihom 28, 84 jew 252 pillola li jinxterdu.
English: • Drop the tablet(s) into a glass of water, or apple or orange juice (100 to 200 ml).
Maltese: • Waqqa' l-pillola(i) f'tazza ilma, jew meraq tat-tuffieħ jew tallarinġ (100 sa 200 ml).
English: The mean elimination half-life (t1/2) ranged from 8 to 16 hours.
Maltese: Il-medja tal-half-life tal-eliminazzjoni (t½) kienet bejn 8 u 16-il siegħa.
English: EXJADE contains lactose
Maltese: EXJADE fih lactose
English: Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose).
Maltese: L-eskrezzjoni ta' deferasirox u l-metaboli tiegħu sseħħ primarjament fl-ippurgar (84% tad-doża).
English: Excipient with known effect: Each dispersible tablet contains 544 mg lactose.
Maltese: Kull pillola li tinxtered fiha 544 mg lactose.
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: EXJADE 125 mg dispersible tablets EXJADE 250 mg dispersible tablets EXJADE 500 mg dispersible tablets
Maltese: EXJADE 125 mg pilloli li jinxterdu EXJADE 250 mg pilloli li jinxterdu EXJADE 500 mg pilloli li jinxterdu
English: 3.5 - 7 mg/kg/day 5-10 mg/kg/day
Maltese: 3.5 - 7 mg/kg/jum 5-10 mg/kg/jum
English: • EXJADE 250 mg tablets are stamped “J 250” on one side and “NVR” on the other.
Maltese: • Il-pilloli EXJADE 250 mg huma ttimbrati b'“J 250” fuq naħa minnhom u “NVR” fuq in-naħa l oħra.
English: 28 dispersible tablets 84 dispersible tablets 252 dispersible tablets
Maltese: 28 pilloli li jinxterdu 84 pilloli li jinxterdu 252 pillola li jinxterdu
English: • EXJADE 500 mg tablets are stamped “J 500” on one side and “NVR” on the other.
Maltese: • Il-pilloli EXJADE 500 mg huma ttimbrati b'“J 500” fuq naħa minnhom u “NVR” fuq in-naħa l oħra.
English: A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and transfusional iron overload.
Maltese: Studju randomizzat ikkontrollat bil-plaċebo twettaq fost 225 pazjent b'MDS (riskju Baxx/Int-1) u bi trasfużjoni b'tagħbija żejda ta' ħadid.
English: 3.5 - 7 mg/kg/day Up to 28 mg/kg/day
Maltese: 3.5 - 7 mg/kg/jum Sa 28 mg/kg/jum
English: EXJADE contains an active substance called deferasirox.
Maltese: EXJADE fih sustanza attiva li jisimha deferasirox.
English: If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should be considered (see section 4.4).
Maltese: Jekk illivelli ta' ferritin fis-serum jaqaw taħt 500 µg/l b'mod konsistenti, wieħed għandu jqis li jwaqqaf ilkura għal kollox (ara sezzjoni 4.4).
English: Renal excretion of deferasirox and its metabolites is minimal (8% of the dose).
Maltese: Leskrezzjoni ta' deferasirox u l-metaboli tiegħu permezz tal-kliewi hija minima (8% tad-doża).
English: In patients treated with doses >21 mg/kg/day
Maltese: F'pazjenti ttrattati b'dożi ta' >21 mg/kg/jum