FrancophonIA/ELRC3.0 huggingface dataset:
English: After one year of study therapy, patients on concurrent chelation therapy had experienced a significantly greater reduction in serum ferritin (1574 µg/l to 598 µg/l with concurrent therapy vs. 1379 µg/l to 1146 µg/l with deferoxamine monotherapy, p<0.001), significantly greater reduction in myocardial iron overload, as assessed by an increase in MRI T2* (11.7 ms to 17.7 ms with concurrent therapy vs. 12.4 ms to 15.7 ms with deferoxamine monotherapy, p=0.02) and significantly greater reduction in liver iron concentration, also assessed by an increase in MRI T2* (4.9 ms to 10.7 ms with concurrent therapy vs. 4.2 ms to 5.0 ms with deferoxamine monotherapy, p< 0.001).
Maltese: Wara sena ta' studju, pazjenti fuq it-terapija attwali ta' kelazzjoni kienu esperjenzaw tnaqqis sinifikanti akbar fil-ferritin fis-serum (1574 µg/l għal 598 µg/l b'terapija attwali kontra 1379 µg/l għal 1146 µg/l b'monoterapija b'deferoxamine, p<0.001), tnaqqis sinifikanti akbar fl-ikkargar eċċessiv ta' ħadid mijokardjali, kif assessjat b'żieda fl-MRI T2* (11.7 ms għal 17.7 ms b'terapija konġunta kontra 12.4 ms għal 15.7 ms b'monoterapija ta' deferoxamine, p=0.02) u tnaqqis sinifikanti akbar fil-konċentrazzjoni ta' ħadid fil-fwied, assessjat ukoll b'żieda flMRI T2* (4.9 ms għal 10.7 ms b'terapija konġunta kontra 4.2 ms għal 5.0 ms b'monoterapija ta'
English: The influence of severe hepatic impairment on the pharmacokinetics of deferiprone and deferiprone 3-O-glucuronide has not been evaluated.
Maltese: L-influwenza ta' indeboliment epatiku sever fuq il-farmakokinetiċi ta' deferiprone u 3-O-glucuronide ma ġietx valutati.
English: Pack size of 100 tablets.
Maltese: Daqs tal-pakkett ta' 100 pillola.
English: Doses of Ferriprox in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Maltese: 50 sa 100 mg/kg/jum u dożi ta' deferoxamine minn 40 sa 60 mg/kg/jum.
English: Hydroxypropyl cellulose
Maltese: USP/EP Hydroxylpropyl cellulose Macrogol
English: Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement, have been reported in children in the post-marketing setting with standard doses of deferiprone.
Maltese: Episodji ta' ipotonja, instabilità, inkapaċità biex timxi, u ipertonja b'inkapaċità fiċ-ċaqlieq ta' parti, ġew rapportati fi tfal fl-ambjent ta' wara t-tqegħid fis-suq b'dożi standard ta' deferiprone.
English: Pack size of 50 tablets.
Maltese: Daqs tal-pakkett ta' 50 pillola.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriki u tat-tessuti konnetivi
English: BOTTLE OF 50 TABLETS
Maltese: FLIXKUN TA' 50 PILLOLA
English: A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Maltese: Metodu ta' magnetic resonance imaging (MRI), T2*, intuża wkoll biex jikkwantifika l-livell ta' ħadid mijokardjali.
English: Study LA12-9907 compared survival, incidence of cardiac disease, and progression of cardiac disease in 129 patients with thalassaemia major treated for at least 4 years with Ferriprox (N=54) or deferoxamine (N=75).
Maltese: L-istudju LA12-9907 qabbel is-sopravivenza, l-inċidenza ta' mard kardijaku, u l-progressjoni ta' mard kardijaku f'129 pazjent b'talassimja maġġuri li ġew ikkurati għal tal-anqas 4 snin b'Ferriprox (N=54) jew deferoxamine (N=75).
English: Ferriprox was concluded to produce no significant prolongation of the QT interval.
Maltese: Ġie konkluż li Ferriprox ma jipproduċix prolongament sinifikanti tal-intervall ta' QT.
English: Less severe episodes of neutropenia were reported in approximately 5% of patients.
Maltese: Episodji inqas severi ta' newtropenija kienu rapportati f'madwar 5% tal pazjenti.
English: The incidences of adverse reactions experienced by 18 children and 97 adults treated with combination therapy were not significantly different between the two age groups except in the incidence of arthropathy (11.1% in children vs. none in adults, p=0.02).
Maltese: L-inċidenzi ta' reazzjonijiet avversi esperjenzati minn 18-il tifel jew tifla u 97 adult ittrattati b'terapija ta' kombinazzjoni ma kinux differenti b'mod sinifikanti bejn iż-żewġ gruppi ta' etajiet ħlief flinċidenza ta' artropatija (11.1% fi tfal kontra xejn f'adulti, p=0.02).
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
Maltese: Kull ml ta' soluzzjoni orali fih 100 mg deferiprone (25 g deferiprone f'250 ml).
English: The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Maltese: Id-doża li ssoltu tingħata hija 25 mg/kg, 3 darbiet kuljum, għal doża totali ta' 75 mg/kg.
English: No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Maltese: L-ebda effett sinjifikanti ta' indeboliment renali ma ntwera b'esponiment sistemiku ta' deferiprone.
English: Archimedesweg 25
Maltese: FLIEXKEN TA' 250
English: Midday
Maltese: Dardir
English: Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Maltese: Disturbi newroloġiċi (bħal sintomi ċerebellari, diplopja, nistagmu laterali, psychomotor slowdown, movimenti tal-idejn u ipotonija assjali) kienu osservati fi tfal li, b'mod voluntarju, ingħataw riċetta li kienet 2.5 darbiet aktar mid-doża massima rakkomandata ta' 100 mg/kg/jum għal diversi snin.
English: Mild arthropathies are generally transient.
Maltese: Artropatiji ħfief ġeneralment huma temporanji.
English: There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs. 16% for deferoxamine).
Maltese: Ma kien hemm ebda differenza sinifikanti fil-perċentwali ta' pazjenti b'funzjoni mhix tajba tal-qalb fl-ewwel stima (13% għal Ferriprox kontra 16% għal deferoxamine).
English: ((Back Cover))
Maltese: ((Qoxra ta' wara))
English: Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
Maltese: Kull ml ta' soluzzjoni orali fih 100 mg deferiprone (50 g deferiprone f'500 ml).
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
Maltese: Aġenti kelanti tal-ħadid, Kodiċi ATC:
English: A fatal outcome was observed in 8.3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience.
Maltese: Eżitu fatali ġie osservat fi 8.3% tal-episodji rapportati ta' agranuloċitożi minn provi kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: There are no reports of acute overdose with Ferriprox.
Maltese: M'hemmx rapporti ta' doża eċċessiva akuta b'Ferriprox.
English: A randomized, placebo-controlled, double-blind trial evaluated the effect of concurrent therapy with Ferriprox and deferoxamine in patients with thalassaemia major, who previously received the standard chelation monotherapy with subcutaneous deferoxamine and had mild to moderate cardiac iron loading (myocardial T2* from 8 to 20 ms).
Maltese: Prova każwali, bil-plaċebo bħala kontroll, double-blind evalwat l-effett ta' terapija konġunta ma' Ferriprox u deferoxamine f'pazjenti b'talassimja maġġuri, li qabel kienu rċevew il-monoterapija ta' kelazzjoni standard taħt il-ġilda ta' deferoxamine u b'ikkargar moderat tal-ħadid kardijaku (mijokardjali T2* minn 8 sa 20 ms).
English: The median time to onset of the first episode of agranulocytosis was 190 days (ranged 22 days- 17.6 years) and median duration was 10 days in clinical trials.
Maltese: agranuloċitożi kien ta' 190 jum (li kien ivarja minn 22 jum- 17.6 snin) u tul medjan kien ta' 10 ijiem fil-provi kliniċi.
English: Other medicines and Ferriprox
Maltese: Mediċini oħra u Ferriprox
English: Ferriprox is packaged in bottles of 50 tablets.
Maltese: Ferriprox huwa ppakkettat fi fliexken ta' 50 pillola.
English: The patient's absolute neutrophil count (ANC) should be monitored every week during the first year of therapy.
Maltese: (ANC, absolute neutrophil count) għandu jiġi monitorat waqt l-ewwel sena ta' terapija.
English: The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterized for monotherapy.
Maltese: Il-profil tas-sigurtà ta' terapija ta' kombinazzjoni (deferiprone u deferoxamine) osservat mill-provi kliniċi, esperjenza ta' wara t-tqegħid fis-suq jew fil-letteratura medika ppubblikata kienet konsistenti ma' dik karatterizzata għal monoterapija.
English: Systemic exposure to the inactive 3-O-glucuronide increased with decreasing eGFR.
Maltese: Esponiment sistemiku ta' 3-O-glucuronide inattiv żdied bi tnaqqis fil-eGFR.
English: Hydroxyethylcellulose
Maltese: taħt il-ġilda
English: Glycerol (E422)
Maltese: Ilma purifikat Hydroxyethylcellulose Glycerol (E422)
English: Do not take Ferriprox
Maltese: Tiħux Ferriprox
English: If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Maltese: Jekk ikun hemm żjieda persistenti fil-livelli ta' serum alanine aminotransferase (ALT), l-interruzzjoni tat-terapija b'deferiprone għandha tkun ikkunsidrata.
English: Evaluation of rate of reactions per 100 patient-years of exposure showed that only the rate of diarrhoea was significantly higher in children (11.1) than in adults (2.0, p=0.01).
Maltese: reazzjonijiet kull 100 sena ta' esponiment ta' pazjenti wriet li hija biss ir-rata ta' dijarea li kienet b'mod sinifikanti ogħla fi tfal (11.1) milli f'adulti (2.0, p=0.01).
English: Hydrochloric acid, concentrated, for pH adjustment Artificial cherry flavour
Maltese: Hydrochloric acid, konċentrat (għal aġġustament fil-pH) Benna artifiċjali taċ-ċirasa
English: Cardiac endpoints were assessed by echocardiogram, electrocardiogram, the New York Heart Association classification and death due to cardiac disease.
Maltese: elettrokardijogramm, il klassifikazzjoni tan-New York Heart Association u mewt dovuta minn mard tal-qalb.
English: The other ingredients are: purified water; hydroxyethylcellulose; glycerol (E422); hydrochloric acid, concentrated (for pH adjustment); artificial cherry flavour; peppermint oil; Sunset Yellow (E110); sucralose (E955).
Maltese: Is-sustanzi mhux attiva l-oħra huma: ilma purifikat; hydroxyethylcellulose; glycerol (E422);
English: Each ml of oral solution contains 100 mg deferiprone.
Maltese: Kull ml ta' soluzzjoni orali fih 100 mg deferiprone.
English: 500 ml oral solution
Maltese: ML SOLUZZJONI ORALI
English: If treatment is unavoidable, breast-feeding must be stopped (see section 4.3).
Maltese: Jekk ittrattament ma jistax jiġi evitat, it-treddigħ għandu jitwaqqaf (ara sezzjoni 4.3).
English: − Keep this leaflet.
Maltese: - Passat ta' agranuloċitosi.
English: Adverse reaction frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Maltese: 5x109/l), b'inċidenza ta' 1.1% (0.6 każijiet għal kull 100 sena ta' kura lill-pazjenti) (ara sezzjoni 4.4).
English: An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Ferriprox.
Maltese: funzjoni renali indebolita fuq is-sikurezza, it-tolerabilità u l-farmakokinetiċi ta' doża orali waħda ta' 33 mg/kg ta' Ferriprox.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1. - Passat ta' episodji rikorrenti ta' newtropenija.
English: Each 1000 mg tablet contains 1000 mg deferiprone.
Maltese: Kull pillola ta' 1000 mg fiha 1000 mg deferiprone
English: Number of 1000 mg tablets* Morning
Maltese: Għadd ta' pilloli ta' 1000 mg*
English: Each pack contains one bottle of 250 ml or 500 ml oral solution.
Maltese: Kull pakkett fih flixkun wieħed ta' 250 ml jew 500 ml soluzzjoni orali.
English: A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
Maltese: Doża totali 'l fuq minn 100 mg/kg piż korporali mhix rakkomandata minħabba r-risku potenzjali ogħla ta' reazzjonijiet avversi (ara sezzjonijiet 4.4, 4.8, u 4.9).
English: Ferriprox and deferoxamine were equivalent in promoting a net stabilization or reduction of body iron load, despite the continuous transfusional iron administration in those patients (no difference in proportion of patients with a negative trend in serum ferritin between the two treatment groups by regression analysis; p >0.05).
Maltese: Ferriprox u deferoxamine kienu ekwivalenti biex iwasslu għal stabilità netta jew tnaqqis fil-livell ta' ħadid filġisem, minkejja l għoti trasfużjonali kontinwu ta' ħadid f'dawk il pazjenti (ebda differenza fil proporzjon ta' pazjenti b'xejra negattiva fil-ferritin fis-serum bejn iż-żewġ gruppi ta' kura b'analiżi ta' rigressjoni; p > 0.05).
English: Immediately interrupt deferiprone if the patient experience infection.
Maltese: Waqqaf minnufih deferiprone jekk il-pazjent jesperjenza infezzjoni.
English: Following randomization, 32 patients received deferoxamine (34.9 mg/kg/day for 5 days/week) and Ferriprox (75 mg/kg/day) and 33 patients received deferoxamine monotherapy (43.4 mg/kg/day for 5 days/week).
Maltese: Wara l-għażla każwali, 32 pazjent irċevew deferoxamine (34.9 mg/kg/jum għal 5 ijiem/ġimgħa) u 33 pazjent li rċevew monoterapija b'deferoxamine (43.4 mg/kg/jum għal 5 ijiem/ġimgħa).
English: Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients.
Maltese: L-ogħla konċentrazzjoni fis-serum isseħħ minn 45 sa 60 minuta wara t-teħid ta' doża waħda f'pazjenti sajmin.
English: The most common findings in non-iron-loaded animals at doses of 100 mg/kg/day and above were hematologic effects such as bone marrow hypocellularity, and decreased WBC, RBC and/or platelet counts in peripheral blood.
Maltese: L-aktar riżultati komuni f'annimali li ma kellhomx ħadid, f'dożi ta' 100 mg/kg/jum u iżjed, kienu effetti ematoloġiċi bħal ipoċellularità tal-mudullun, u tnaqqis fl-għadd tal-WBC, tar-RBC u/jew tal plejtlits fid-demm periferali.
English: Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys.
Maltese: Studji mhux kliniċi saru fuq speċi ta' annimali inklużi ġrieden, firien, fniek, klieb u xadini.
English: Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Maltese: Il-monitoraġġ tal-konċentrazzjoni taż-Zn2+ fil-plażma, u li jingħata suppliment f'każ ta' defiċjenza,
English: The higher rate of “Cardiac disorders" reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy.
Maltese: Qalb” irrapportata waqt it-terapija ta' kombinazzjoni kienet possibilment dovuta għall-inċidenza ogħla ta' disturbi kardijaċi eżistenti minn qabel f'pazjenti li rċevew terapija kombinata.
English: Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in animals.
Maltese: Deferiprone ma wriex karatteristiċi mutaġeniċi diretti; madankollu wera karatteristiċi klastoġeniċi f'assaġġi in vitro u fl-annimali.
English: Provide protective isolation and if clinically indicated, admit patient to the hospital.
Maltese: Ipprovdi iżolament protettiv u jekk klinikament indikat, daħħal il-pazjent l-isptar.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Maltese: Ferriprox 500 mg pilloli miksija b'rita Ferriprox 1000 mg pilloli miksija b'rita
English: The incidences of “Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders" were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders" was higher during combination therapy than monotherapy.
Maltese: L-inċidenzi ta' “Disturbi Muskoluskeletriċi u tat-Tessuti Konnettivi” u “Disturbi fil-Kliewi u fis-Sistema Urinarja” kienu inqas waqt it-terapija b'kombinazzjoni milli bil-monoterapija, filwaqt li l-inċidenza ta' “Disturbi fil-Qalb” kienet ogħla waqt it-terapija ta' kombinazzjoni milli fil-monoterapija.
English: Arthralgia
Maltese: Rimettar
English: Ferriprox 500 mg film-coated tablets deferiprone
Maltese: Ferriprox 500 mg pilloli miksija b'rita deferiprone
English: The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Maltese: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
English: You must use effective contraception while you are taking Ferriprox.
Maltese: Għandek tuża kontraċezzjoni effettiva waqt li tkun qed tieħu Ferriprox.
English: In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
Maltese: F'każ ta' insuffiċjenza tal-qalb imqanqla mill-ħadid, Ferriprox b'madwar 75-100 mg/kg/jum għandu jiġi miżjud mat-terapija ta' deferoxamine.
English: Iron overload causes concentration-dependent MRI T2* signal loss, thus, increased myocardial iron reduces myocardial MRI T2* values.
Maltese: Livelli eċċessivi ta' ħadid jikkawża telf fis-sinjal tal-MRI T2* li hu dipendenti millkonċentrazzjoni, u b'hekk il-ħadid mijokardjali jnaqqas il-valuri ta' MRI T2*.
English: Ferriprox 500 mg film-coated tablets
Maltese: Ferriprox 500 mg pilloli miksija b'rita
English: The total daily dose should not exceed 100 mg/kg.
Maltese: Iddoża totali ta' kuljum m'għandhiex taqbeż 100 mg/kg.
English: MARKETING AUTHORISATION NUMBER EU/1/99/108/002
Maltese: EU/1/99/108/002 EU/1/99/108/003
English: Sample body weights at 10 kg increments are listed.
Maltese: Kampjuni ta' piżijiet korporali f'inkrimenti ta' 10 kg huma elenkati.
English: A positive correlation between MRI T2* values and cardiac function (as measured by Left Ventricular Ejection Fraction (LVEF)) has been documented.
Maltese: T2* u l-funzjoni tal-qalb (kif imkejjel bil-Porzjon li Jitneħħa mill-Ventrikola tax-Xellug,LVEF) ġie ddokumentat.
English: Since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
Maltese: Peress illi deferiprone jeħel ma' ketajins metalliċi, jeżisti l-potenzjal għal interazzjonijiet bejn deferiprone u l-prodotti mediċinali trivalenti li huma dipendenti fuq il-ketajins, bħall-antaċidi bbażati fuq l-aluminju.
English: Ferriprox 1000 mg film-coated tablets
Maltese: Ferriprox 1000 mg pilloli miksija b'rita
English: Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Maltese: Livelli baxxi ta' żingu fil-plażma kienu assoċjati ma' deferiprone, f'minoranza ta' pazjenti.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
Maltese: Ferriprox 100 mg/ml soluzzjoni orali
English: Ferriprox 1000 mg film-coated tablets deferiprone
Maltese: Ferriprox 1000 mg pilloli miksija b'rita deferiprone
English: Following a dose of 25 mg/kg, lower peak serum concentrations have been detected in patients in the fed state (85 µmol/l) than in the fasting state (126 µmol/l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Maltese: Wara doża ta' 25 mg/kg, konċentrazzjonijiet massimi iktar baxxi fis-serum kienu osservati fil-pazjenti li jkunu kielu (85 µmol/l) milli f'dawk fl-istat sajjem (126 µmol/l), għalkemm ma kienx hemm tnaqqis fl-ammont ta' deferiprone assorbit meta dan ingħata ma' l-ikel.
English: Mechanism of action
Maltese: SISTEMA
English: In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
Maltese: Fil-bniedem, deferiprone jiġi eliminat prinċipalment mill-kliewi; minn 75% sa 90% tad-doża li tittieħed hi rrappurtata li tiġi rkuprata fl-awrina fl-ewwel 24 siegħa, fil-forma ta' deferiprone liberu,
English: The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients.
Maltese: L-aktar reazzjonijiet avversi komuni rrapportati waqt it-terapija b'deferiprone fil-provi kliniċi kienu dardir, remettar, uġigħ ta' żaqq u kromaturja li kienu rapportati f'aktar minn 10% tal-pazjenti.
English: Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Maltese: Għandu jiġi kkonsidrat li t-terapija b'deferiprone titwaqqaf, jekk il-ferritin fis-serum jaqa' taħt 500 μg/l.
English: Renal or hepatic impairment and liver fibrosis
Maltese: Indeboliment renali jew epatiku u fibrożi tal-fwied
English: What Ferriprox looks like and contents of the pack Ferriprox 1000 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Maltese: Il-pilloli ta' Ferriprox 1000 mg huma ta' lewn abjad għal off-white, f'għamla ta' kapsula, miksija b'rita, li għandhom stampat fuqhom “APO” b'qasma fin-nofs u “1000” fuq naħa waħda, u xejn fuq innaħa l-oħra.
English: Body weight
Maltese: Artralġja
English: Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fliexken ambra tal-polyethylene terephthalate (PET) b'għotjien (polypropylene) reżistenti għal ftuħ mit-tfal, u kikkra gradata tal-kejl (polypropylene).
English: How to take Ferriprox
Maltese: B'FERRIPROX
English: The other ingredients are:
Maltese: Frekwenzi ta' reazzjonijiet avversi:
English: STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 1000 mg deferiprone.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 1000 mg ta' deferiprone.
English: Neutropenia Agranulocytosis
Maltese: TQEGĦID FIS-SUQ
English: Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/kg/day or greater in non-iron-loaded animals.
Maltese: kienu osservati fi tfal li, b'mod voluntarju, ingħataw riċetta li kienet 2.5 darbiet aktar mid-doża massima rakkomandata ta' 100 mg/kg/jum għal diversi snin.
English: Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Maltese: Aġġustament fid-doża mhux meħtieġ f'pazjenti b'indeboliment renali ħafif, moderat, jew sever (ara sezzjoni 5.2).
English: The risk of agranulocytosis and neutropenia is higher if the baseline ANC is less than 1.5x109/l.
Maltese: Ir-riskju ta' agranuloċitosi u ta' newtropenija hu ogħla, jekk il-kownt ta' l-ANC fil-linja bażi jkun inqas minn 1.5x109/l.
English: MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX
Maltese: Jekk tinsa tieħu Ferriprox
English: Sunset Yellow (E110)
Maltese: Is-soluzzjoni orali Ferriprox fiha Sunset Yellow (E110)