FrancophonIA/ELRC3.0 huggingface dataset:
English: For major depression, Cymbalta has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Maltese: Għal episodji ta' dipressjoni qawwija, Cymbalta tqabbel ma' plaċebo (trattament finta) fi tmien studji ewlenin li involvew total ta' 2,544 pazjent.
English: For generalised anxiety disorder, Cymbalta has been compared with placebo in five studies involving a total of 2,337 patients.
Maltese: Għad-disturb tal-ansjetà ġeneralizza, Cymbalta tqabbel ma' plaċebo f‘ħames studji li involvew total ta' 2,337 pazjent.
English: What is Cymbalta?
Maltese: X'inhu Cymbalta?
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Cymbalta.
Maltese: Il-ħames studju ffoka fuq kemm damu s-sintomi biex reġgħu ġew lura f'429 pazjent li inizjalment kienu rrispondew tajjeb għal Cymbalta.
English: Why has Cymbalta been approved?
Maltese: Għaliex ġiet approvata Cymbalta?
English: For neuropathic pain, Cymbalta has been compared with placebo in two 12-week studies in 809 diabetic adults.
Maltese: Għall-uġigħ newropatiku, Cymbalta tqabbel ma' plaċebo f'żewġ studji ta' tnax-il ġimgħa fi 809 adult dijabetiku.
English: For generalised anxiety disorder, Cymbalta was also more effective than placebo at treating the disorder and preventing symptoms returning.
Maltese: Għad-disturb tal-ansjetà ġeneralizzat, Cymbalta rriżulta aktar effikaċi mill-plaċebo fit-trattament taddisturb u fil-prevenzjoni ta' rkaduti.
English: The most common side effects with Cymbalta (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Cymbalta (li dehru f'aktar minn pazjent 1 minn 10) huma nawżea (dardir), uġigħ ta' ras, ħalq xott, ħedla tan-ngħas u sturdament.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Maltese: • uġigħ minħabba newropatija periferika dijabetika (ħsara lin-nervituri tal-estremitajiet li tista'
English: Other information about Cymbalta:
Maltese: Aktar tagħrif dwar Cymbalta:
English: What is the risk associated with Cymbalta?
Maltese: X'inhu r-riskju assoċjat ma' Cymbalta?
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Cymbalta, including 288 patients with a history of repeated episodes of depression for up to five years.
Maltese: Iż-żewġ studji l-oħra ffukaw fuq kemm għadda żmien biex issintomi reġgħu lura f'pazjenti li kienu inizjalment irrispondew tajjeb għal Cymbalta, fosthom 288 pazjent li fil-passat kellhom episodji ripetittivi ta' dipressjoni għal ħames snin.
English: How has Cymbalta been studied?
Maltese: Kif ġiet studjata Cymbalta?
English: As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Cymbalta, particularly in the first few weeks of treatment for depression.
Maltese: Bħal għall-antidepressivi l-oħra, filpazjenti f'terapija b'Cymbalta ġew osservati każijiet iżolati ta' ħsibijiet u mġiba ta' suwiċidju, partikolarment fl-ewwel ġimgħat ta' trattament tad-depressjoni.
English: For the treatment of diabetic neuropathic pain, Cymbalta was more effective at reducing pain than placebo.
Maltese: Minkejja li r-riżultati tal-istudji fuq id-dipressjoni varjaw, Cymbalta kien aktar effettiv mill-plaċebo f'erba' mill-istudji.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Numru tal-MA (EU)
English: Coating: hypromellose, macrogol 6000, titanium dioxide
Maltese: Kisja: hypromellose, macrogol 6000, titanium dioxide
English: Electronic mail: lipomed@lipomed.com
Maltese: Email: lipomed@lipomed.com
English: COMMON (≥1/100 to <1/10)
Maltese: KOMUNI (≥1/100 SA
English: Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein GERMANY
Maltese: Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein Il-Ġermanja
English: Tablet core: hypromellose, croscarmellose sodium, silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate
Maltese: Il-qalba tal-pillola: hypromellose, croscarmellose sodium, silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate
English: Subjects were categorized into 4 groups based on estimated glomerular filtration rate (eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR 60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Maltese: Individwi kienu kategorizzati f'4 gruppi abbażi tar-rata ta' filtrazzjoni glomerulari stmata (eGFR - estimated glomerular filtration rate): voluntiera f'saħħithom (eGFR ≥ 90 mL/min/1.73 m2), indeboliment renali ħafif (eGFR 60-89 mL/min/1.73 m2), indeboliment renali moderat (eGFR 30-59 mL/min/1.73 m2), u indeboliment renali sever (eGFR 15-29 mL/min/1.73 m2).
English: • History of recurrent episodes of neutropenia.
Maltese: • Passat ta' episodji rikorrenti ta' newtropenija.
English: INFORMATION IN BRAILLE Deferiprone Lipomed 500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Deferiprone Lipomed 500 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2018
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1310/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1310/001
English: The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds to iron in a 3:1 molar ratio.
Maltese: Is-sustanza attiva hi deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), ligand bidentate li jeħel malħadid fi proporzjon molari ta' 3:1.
English: Limited information is available regarding re-challenge.
Maltese: Informazzjoni limitata hi disponibbli dwar ir-rechallenge.
English: Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Maltese: Individwi kienu kategorizzati fi 3 gruppi abbażi tal-punteġġ ta' klassifikazzjoni Child-Pugh: voluntiera f'saħħithom, indeboliment epatiku ħafif (Klassi A: 5- 6 punti), indeboliment epatiku moderat (Klassi B: 7-9 punti).
English: Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of deferiprone with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Maltese: L-istudji LA16-0102, LA-01 u LA08-9701 qabblu l-effikaċja ta' deferiprone ma' dik ta' deferoxamine biex jikkontrollaw il-ferritin fis serum f'pazjenti bit-talassimja dipendenti mit-trasfużjoni.
English: Dose (mg, three times/day)
Maltese: Doża (mg, tliet darbiet/jum)
English: Data from the pooled safety database from clinical trials (1343 patient-years exposure to deferiprone monotherapy and 244 patient-years exposure to deferiprone and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders”, “Musculoskeletal and connective tissue disorders” and “Renal and urinary disorders”.
Maltese: Tagħrif mid-database ta' sikurezza ppuljat minn provi kliniċi (1343 sena ta' esponiment ta' pazjenti għal monoterapija b'deferiprone u 244 sena ta' esponiment ta' pazjenti b'deferiprone u deferoxamine) wera differenzi statistikament sinifikanti (p<0.05) fl-inċidenza ta' reazzjonijiet avversi abbażi tasSistema tal-Klassifikazzjoni tal-Organi għal “Disturbi fil-Qalb”, “Disturbi Muskoluskeletriċi u tatTessuti Konnettivi” u “Disturbi fil-Kliewi u fis-Sistema Urinarja”.
English: Study LA37-1111 was conducted to evaluate the effect of single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral doses of deferiprone on the cardiac QT interval duration in healthy subjects.
Maltese: L-istudju LA37-1111 sar biex jivvaluta l-effetti ta' dożi orali terapewtiċi uniċi (33 mg/kg) u sopraterapewtiċi (50 mg/kg) ta' deferiprone fuq it-tul tal-intervall QT kardijaku f'individwi b'saħħithom.
English: The observed incidence of the less severe form of neutropenia (neutrophils <1.5 x 109/l) is 4.9% (2.5 cases per 100 patient-years).
Maltese: L-inċidenza osservata tal-forma inqas serja ta' newtropenija (newtrofili <1.5 x 109/l) hi ta' 4.9% (2.5 każijiet għal kull 100 sena ta' kura lill-pazjenti).
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l minn 25°C.
English: Important Safety Reminders for Patients Taking Deferiprone Lipomed Prescribing doctor:________________________ Phone no:_______________________________
Maltese: Tfakkiriet Importanti dwar is-Sigurtà għal Pazjenti Li Jieħdu Deferiprone Lipomed Tabib li jippreskrivi:________________________ Nru tat
English: Deferiprone Lipomed contains sodium
Maltese: Deferiprone Lipomed fih is-sodium
English: Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Maltese: Deferiprone hu assorbit malajr mill-parti ta' fuq tal-apparat gastrointestinali.
English: Phone number: +49 7621 1693 472
Maltese: Numru tat-telefon: +49 7621 1693 472
English: Phone number: +49 7621 1693 472 Fax number: +49 7621 1693 474 Electronic mail: lipomed@lipomed.com
Maltese: Numru tat-telefon: +49 7621 1693 472 Numru tal-fax: +49 7621 1693 474 Email: lipomed@lipomed.com
English: In the event of neutropenia:
Maltese: F'każ ta' newtropenija:
English: Other medicines and Deferiprone Lipomed
Maltese: Mediċini oħra u Deferiprone Lipomed
English: How to take Deferiprone Lipomed
Maltese: Tiħux Deferiprone Lipomed
English: Phone number: +49 7621 1693 472 Fax number: +49 7621 1693 474 lipomed@lipomed.com
Maltese: Numru tat-telefon: +49 7621 1693 472 Numru tal-fax: +49 7621 1693 474 lipomed@lipomed.com
English: Fax number: +49 7621 1693 474
Maltese: Numru tal-fax: +49 7621 1693 474
English: ((Back Cover))
Maltese: ((Qoxra ta' Wara))
English: Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
Maltese: L-AUC ta' deferiprone-3-O-glucuronide naqset b'10% u Cmax b'20% f'individwi indeboliti b'mod ħafif jew moderat meta mqabbla ma' voluntieri f'saħħithom.
English: Systemic exposure to deferiprone and to its metabolite deferiprone 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.
Maltese: Esponiment sistemiku għal deferiprone u l-metabolit tiegħu deferiprone 3-O-glucuronide kien evalwat permezz tal-parametri farmakokinetiċi Cmax u AUC.
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: The total daily dose should not exceed 100 mg/kg.
Maltese: Id-doża totali ta' kuljum m'għandhiex taqbeż 100 mg/kg.
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-farmakokinetika ta' deferiprone u deferiprone 3-Oglucuronide ma ġietx evalwata.
English: No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Maltese: L-ebda effett sinifikanti ta' indeboliment renali ma ntwera b'esponiment sistemiku għal deferiprone.
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, metabolit glucuronide u kumpless ħadid-deferiprone.
English: Doses of deferiprone in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Maltese: Id-dożi ta' Ferriprox f'dawn l-istudji kien ivarja minn 50 sa 100 mg/kg/jum u dożi ta' deferoxamine minn 40 sa 60 mg/kg/jum.
English: What Deferiprone Lipomed contains The active substance is deferiprone.
Maltese: Deferiprone Lipomed fih is-sustanza attiva deferiprone.
English: If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Maltese: Jekk ikun hemm żieda persistenti fil-livelli ta' serum alanine aminotransferase (ALT), l-interruzzjoni tat-terapija b'deferiprone għandha tkun ikkunsidrata.
English: Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Maltese: Hu meħtieġ monitoraġġ b'attenzjoni ta' każijiet kardijaċi f'pazjenti fuq terapija ta' kombinazzjoni (ara sezzjoni 4.4).
English: Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in vivo in animals.
Maltese: Deferiprone ma weriex karatteristiċi mutaġeniċi diretti; madankollu wera karatteristiċi klastoġeniċi f'assaġġi in vitro u in vivo fl-annimali.
English: The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5 x 109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Maltese: L-aktar effett serju mhux mixtieq irrappurtat fi provi kliniċi b'deferiprone hu l-agranuloċitosi (newtrofili <0.5 x 109/l), b'inċidenza ta' 1.1% (0.6 każijiet għal kull 100 sena ta' kura lill-pazjenti) (ara sezzjoni 4.4).
English: Systemic exposure to the inactive 3-Oglucuronide increased with decreasing eGFR.
Maltese: Esponiment sistemiku għal 3-O-glucuronide inattiv żdied bi tnaqqis fl-eGFR.
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 deferiprone.
Maltese: Sar studju kliniku, bit-tikketta tingħaraf, mhux każwali fi grupp parallel biex jivvaluta l-effett ta' funzjoni epatika indebolita fuq is-sigurtà, it-tolerabilità u l-farmakokinetika ta'doża orali waħda ta' 33 mg/kg ta' deferiprone.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 pillola miksija b'rita
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet and that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) għal kull pillola u jiġifieri essenzjalment ‘mingħajr sodium'.
English: Even though agranulocytosis only affects 1 to 2 out of 100 users, it is important to monitor your blood on a regular basis.
Maltese: Anke jekk l-agranuloċitosi taffettwa biss utent 1 sa 2 minn 100, huwa importanti li timmonitorja ddemm tiegħek regolarment.
English: Each 500 mg film-coated tablet contains 500 mg deferiprone.
Maltese: Kull pillola miksija b'rita ta' 500 mg fiha 500 mg deferiprone.
English: Plasma Zn2+ concentration 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: Common side effects (may affect up to 1 in 10 people): - low white blood cell count (agranulocytosis and neutropenia) - headache - diarrhoea - increase in liver enzymes - fatigue - increase in appetite
Maltese: Effetti kollaterali komuni (jistgħu jaffettwaw minn 1 f'10 persuni): - għadd baxx ta' ċelluli bojod tad-demm (agranuloċitosi u newtropenija) - uġigħ ta' ras - dijarea - żieda fl-enzimi tal-fwied - għeja - żieda fl-aptit
English: The risk of agranulocytosis and neutropenia is higher if the baseline absolute neutrophil count (ANC) is less than 1.5 x 109/l.
Maltese: Ir-riskju ta' agranuloċitosi u ta' newtropenija hu ogħla, jekk l-għadd tal-ANC fil-linja bażi jkun inqas minn 1.5 x 109/l.
English: Deferiprone Lipomed 500 mg film-coated tablets deferiprone
Maltese: Deferiprone Lipomed 500 mg pilloli miksija b'rita deferiprone
English: Dose table for Deferiprone Lipomed 500 mg film-coated tablets Body weight (kg)
Maltese: Tabella tad-dożi għal Deferiprone Lipomed 500 mg pilloli miksija b'rita Piż tal-Ġisem (kg)
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 talplejtlits fid-demm periferali.
English: Aluminium/PVC-PVDC blisters in cartons of 100 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-aluminju/PVC-PVDC f'pakketti ta' 100 pillola miksija b'rita.
English: Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and 4.9).
Maltese: L-użu ta' deferiprone għandu jitwaqqaf jekk jiġu osservati disturbi newroloġiċi (ara sezzjonijiet 4.8 u 4.9).
English: Deferiprone AUCs did not differ between treatment groups, but Cmax was decreased by 20% in mildly or moderately hepatically impaired subjects compared with healthy volunteers.
Maltese: L-AUCs ta' deferiprone ma varjawx fi gruppi ta' trattament differenti, imma Cmax naqset b'20% f'individwi b'indeboliment ħafif jew moderat tal-fwied meta mqabbla ma' voluntieri f'saħħithom.
English: Deferiprone Lipomed in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction (see section 4.2).
Maltese: Deferiprone Lipomed f'kombinazzjoni ma' kelatur ieħor (ara sezzjoni 4.4) hu indikat f'pazjenti b'talassimja maġġuri meta l-monoterapija bi kwalunkwe kelatur ieħor tal-ħadid tkun ineffettiva, jew meta l-prevenzjoni jew konsegwenzi li jistgħu jkunu ta' theddida għall-ħajja ta' kkargar eċċessiv ta' ħadid jiġġustifika korrezzjoni rapida jew intensiva (ara sezzjoni 4.2).
English: Croscarmellose sodium Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Maltese: Silica, colloidal anhydrous
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 itterapija b'kombinazzjoni milli bil-monoterapija, filwaqt li l-inċidenza ta' “Disturbi fil-Qalb“ kienet ogħla waqt it-terapija ta' kombinazzjoni milli fil-monoterapija.
English: Marketing Authorisation Holder and Manufacturer Lipomed GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Lipomed GmbH
English: • To increase patient awareness of the importance of regular monitoring of the neutrophil count during treatment with Deferiprone Lipomed
Maltese: • Biex jiżdied l-għarfien tal-pazjent dwar l-importanza ta' monitoraġġ regolari tal-għadd ta' newtrofili matul il-kura b'Deferiprone Lipomed
English: Deferiprone 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: Deferiprone 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 filproporzjon ta' pazjenti b'xejra negattiva fil-ferritin fis-serum bejn iż-żewġ gruppi ta' kura b'analiżi ta' rigressjoni; p > 0.05).
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: L-evalwazzjoni tar-rata ta' 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: You must use effective contraception while you are taking Deferiprone Lipomed.
Maltese: Għandek tuża kontraċezzjoni effettiva waqt li tkun qed tieħu Deferiprone Lipomed.
English: Very common side effects (may affect more than 1 in 10 people): - abdominal pain - nausea - vomiting - reddish/brown discoloration of urine
Maltese: Effetti kollaterali komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 f'10): - uġigħ addominali - dardir - remettar - awrina b'kulur ħamrani/kannella
English: In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Maltese: Minħabba r-riżultati tal-ġenotossiċità, il-potenzjal karċinoġeniku ta' deferiprone ma jistax jiġi eskluż (ara sezzjoni 5.3).
English: Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Maltese: Aġġustament fid-doża mhux meħtieġ f'pazjenti b'indeboliment ħafif jew moderat fil-funzjoni epatika (ara sezzjoni 5.2).
English: In post-marketing experience with deferiprone, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years.
Maltese: Fl-esperjenza b'deferiprone ta' wara t-tqegħid fis-suq, disturbi newroloġiċi (bħal rogħda, disturbi filmod kif timxi, tara doppju, kontrazzjonijiet involontarji tal-muskoli, problemi fil-koordinazzjoni talmoviment) kienu rrappurtati fi tfal li, b'mod voluntarju, ingħataw riċetta li kienet aktar mid-doppju tad-doża massima rrakkomandata ta' 100 mg/kg/jum għal diversi snin.
English: The tablet is scored.
Maltese: huma rakkomandati.
English: Data from the published literature on iron balance studies in patients with thalassaemia major show that the use of deferiprone concurrently with deferoxamine (co-administration of both chelators during the same day, either simultaneously or sequentially, e.g., deferiprone during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Maltese: Dejta ristretta hija disponibbli fuq l-użu kkombinat ta' deferiprone u deferasirox, u kawtela għandha tiġi applikata meta jiġi kkonsidrat l-użu ta' din ilkombinazzjoni.
English: Fatalities and life-threatening situations (caused by agranulocytosis) have been reported with deferiprone in combination with deferoxamine.
Maltese: Fatalitajiet u sitwazzjonijiet li jkunu ta' theddida għall-ħajja (ikkaġunati minn agranuloċitożi) ġew irrapportati b'deferipone f'kombinazzjoni ma' deferoxamine.
English: Deferiprone was concluded to produce no significant prolongation of the QT interval.
Maltese: Ġie konkluż li Deferiprone ma jipproduċix prolongament sinifikanti tal-intervall ta' QT.
English: Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Deferiprone Lipomed may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
Maltese: Aġġustamenti fid-doża meta jintuża ma' kelaturi oħra tal-ħadid F'pazjenti li għalihom il-monoterapija hija inadegwata, Deferiprone Lipomed jista' jintuża ma' deferoxamine fid-doża standard (75 mg/kg/jum) imma m'għandux jaqbeż 100 mg/kg/jum.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Lipomed GmbH
Maltese: FIS-SUQ Lipomed GmbH