FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the product is on the market.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq għandu jiżgura li s-sistema ta' farmakoviġilanza, ippreżentata f'Modulu 1.8.1 ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq, hija f'postha u qed tiffunzjona qabel u waqt li l-prodott jitqiegħed fis-suq.
English: Hepatic impairment
Maltese: Magnesium stearate
English: Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4).
Maltese: Wara t-tqegħid fis-suq, ġew irrappurtati fratturi fl-għadam kemm f'pazjenti rġiel u anki f'dawk nisa (ara sezzjoni 4.4).
English: Pioglitazone Accord 15 mg tablets: 3 years Pioglitazone Accord 30 mg/ 45 mg tablets: 4 years
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali Pilloli Pioglitazone Accord 15 mg: 3 snin
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Pioglitazone Accord f'kull sett tal-popolazzjoni pedjatrika f'Diabetes Mellitus Tip 2.
English: • The risk of heart failure and relevant risk minimisation advice.
Maltese: • Ir-riskju ta' kollass tal-qalb u l-parir ta' minimizzazzjoni tar-riskju relevanti.
English: Pioglitazone Accord may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulfonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Maltese: Pioglitazone Accord jista jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformin, u fejn trattament ma' dieta u eżercizzju naqas milli jikkontrolla z-zokkor fid-demm jew jista' jittieħed flimkien ma'terapiji oħra (bħal metformin, sulphonylurea jew insulina) li naqsu milli jipprovdu kontroll biżżejjed taz-zokkor fid-demm.
English: Adults (> 21 and < 65 years old)
Maltese: Adulti (> 21 u < 65 sena)
English: ORPHELIA Pharma 85 boulevard Saint-Michel 75005 PARIS France
Maltese: ORPHELIA Pharma 85 boulevard Saint-Michel 75005 PARIS Franza
English: 75.4 to 124.8
Maltese: 75.4 sa 124.8
English: Common: Hypoacusis
Maltese: Komuni: Hypoacusis
English: CR = Complete remission
Maltese: RK = Remissjoni kompleta
English: MARKETING AUTHORISATION NUMBER EU/1/19/1396/001
Maltese: EU/1/19/1396/001
English: 1.45 to 2.40
Maltese: 1.45 sa 2.40
English: (4.6 to 38.3)
Maltese: (4.6 sa 38.3)
English: Half-life of clofarabine triphosphate
Maltese: Half-life ta' clofarabine triphosphate
English: The active substance is clofarabine.
Maltese: Is-sustanza attiva hi clofarabine.
English: See section 2 “Ivozall contains sodium”.
Maltese: Ara sezzjoni 2 “Ivozall fih sodium”.
English: • Recovery of peripheral counts (platelets ≥ 100 x 109/l and ANC ≥ 1.0 x 109/l)
Maltese: • Rikopru ta' kownts periferali (plejtlits ≥ 100 x 109/l u ANC ≥ 1.0 x 109/l)
English: Overall remission (CR + CRp)
Maltese: Remissjoni totali (RK + RKp)
English: Concentrate (ml)*
Maltese: Konċentrat (ml)*
English: • Ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools.
Maltese: • Inibizzjoni ta' Ribonucleotide reductase bi tnaqqis ta' għadajjar ta' cellular deoxynucleotide triphosphate (dNTP).
English: (7.9 to 18.1)
Maltese: (7.9 sa 18.1)
English: Total diluted volume 100 ml
Maltese: Volum totali dilwit 100 ml
English: (6.7 to 12.6)
Maltese: (6.7 sa 12.6)
English: Estimates based on noncompartmental analysis (n = 14 / n = 14)
Maltese: Estimi bbażati fuq analiżi non-kompartmentali (n = 14 / n = 14)
English: (9.1 to 42)
Maltese: (9.1 sa 42)
English: Clofarabine is a purine nucleoside anti-metabolite.
Maltese: Clofarabine hu anti-metabolit purin nukleosijd.
English: Children weighing < 20 kg
Maltese: Tfal li jiżnu < 20 kg
English: Adult population (including elderly)
Maltese: Popolazzjoni adulta (inkluż l-anzjani)
English: 125.3 to 130.0
Maltese: 125.3 sa 130.
English: Its antitumour activity is believed to be due to 3 mechanisms:
Maltese: L-attività tiegħu ta' kontra t-tumuri hi maħsuba li hi riżultat ta' 3 mekkaniżmi:
English: (58.6 to -)
Maltese: (58.6 sa -)
English: 2.41 to 2.50
Maltese: 2.41 sa 2.50
English: Responses were seen in different immunophenotypes of ALL, including pre-B cell and T-cell.
Maltese: Ir-risponsi kienu investigati f'immunofenotipi differenti ta' ALL, inklużi pre-B cellula u T-cellula.
English: 172 l/m2
Maltese: 172 1/m2
English: (4.0 to 6.1)
Maltese: (4.0 sa 6.1)
English: 10.8 l/h/m2
Maltese: 10.8 1/h/m2
English: 28.8 l/h/m2
Maltese: 28.8 1/h/m2
English: Treatment failure
Maltese: Falliment tattrattament
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċini:http://www.ema.europa.eu.
English: (13.7 to 56.1)
Maltese: (13.7 sa 56.1)
English: (66.6 to -)
Maltese: (66.6 sa -)
English: (15.4 to 56.1)
Maltese: (15.4 sa 56.1)
English: (13.7 to -)
Maltese: (13.7 sa -)
English: The median age of treated patients (37 males, 24 females) was 12 years old.
Maltese: L-età medjana ta' pazjenti li ngħataw it-trattament (37 maskili, 24 feminili) kienet ta' 12-il sena.
English: (42.0 to -)
Maltese: (42.0 sa -)
English: Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Maltese: Xokk settiku*, sepsis, batterimja, pnewmonja, herpes zoster, herpes simplex, kandidijasite tal-ħalq
English: CR + CRp + PR 18
Maltese: RK + RKp + RP
English: • An M1 bone marrow (≤ 5% blasts)
Maltese: M1 (≤ 5% ċelluli primittivi)
English: Of the 17 ALL patients, 2 achieved a complete remission (12%; CR) and 2 a partial remission (12%; PR) at varying doses.
Maltese: pazjent, 2 kellhom remissjoni kompleta (12 %; RK) u 2 remissjoni parzjali (12 % RP) f'dożi varji.
English: (5.0 to -)
Maltese: (5.0 sa -)
English: Each 20 ml vial contains 70.77 mg of sodium .
Maltese: Kull kunjett ta' 20 ml fih 70.77 mg ta' sodium.
English: Those most frequently reported were nausea (61% of patients), vomiting (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Maltese: uġigħ ta' ras (24%), raxx (21%), dijarea (20%), ħakk (20%), deni (19%), sindrome ta' eritrodisestesija palmar-plantar (15%), għeja kbira (14%), ansjetà (12%), infjammazzjoni tal-mukuża (11%), u fwawar
English: Haematuria was observed in 13% of patients overall.
Maltese: L-ematurja kienet osservata fi 13% tal-pazjenti kollha.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100; rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below.
Maltese: (komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: (18.1 to -)
Maltese: (18.1 sa -)
English: Common: Tumour lysis syndrome*
Maltese: Komuni: Sindrome tal-lisi tat-tumur*
English: Common: Hypersensitivity
Maltese: Komuni: Sensittività eċċessiva
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l, free from visible particles.
Maltese: Soluzzjoni ċara prattikament bla kulur b'pH ta' minn 4.5 sa 7.5 u ożmolarità ta' minn 270 sa 310 mOsm/l, mingħajr partikuli viżibbli.
English: Common: Pericardial effusion*, tachycardia*
Maltese: Komuni: Jinġema' likwidu fil-perikardju*, takikardija*
English: (9.7 to 47.9)
Maltese: (9.7 sa 47.
English: The limited data available indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see sections 4.4 and 5.2).
Maltese: Id-dejta limitata disponibbli tindika li clofarabine jista' jakkumula f'pazjenti bi tneħħija mnaqqsa ta' kreatinina (ara sezzjonijiet 4.4 u 5.2).
English: Pericardial effusion and pericarditis were reported as an adverse reaction in 9% (10/115) of patients.
Maltese: Effużjoni perikardjali u perikardite kienu rrapportati bħala reazzjoni avversa f'9% (10/115) talpazjenti.
English: The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade ≥ 3.
Maltese: Fit-testijiet tad-demm fil-laboratorju, l-iktar anormalitajiet frekwenti li kienu osservati f'pazjenti kkurati bi clofarabine kienu anemija (83.3%; 95/114); lewkopenija (87.7%; 100/114); limfopenija
English: A total of 83% of patients experienced at least 1 infection after clofarabine treatment, including fungal, viral and bacterial infections (see section 4.4).
Maltese: Total ta' 83% tal-pazjenti kellhom mill-inqas infezzjoni waħda wara l-kura bi clofarabine, li jinkludu infezzjonijiet fungali, virali u batterjali (ara sezzjoni 4.4).
English: Patients with moderate renal impairment (creatinine clearance 30 - < 60 ml/min) require a 50% dose reduction (see section 5.2).
Maltese: Pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina ta' 30 - < 60 ml/min) jeħtieġu tnaqqis ta' 50% fid-doża (ara sezzjoni 5.2).
English: (7.0 to -)
Maltese: (7.0 sa -)
English: Dose-limiting toxicities in this study were hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash experienced at 70 mg/m2/day (2 ALL patients; see section 4.9).
Maltese: Tossiċitajiet limitati mid-doża f'dan l-istudju kienu iperbilirubinemja, livelli elevati ta' transaminasi u raxx makulo-papulari li nħassu f'70 mg/m2/kuljum (2 ALL pazjenti; ara sezzjoni 4.9).
English: These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (≥ 7.5 mg/m2/day clofarabine).
Maltese: Dawn l-effetti kienu jinkludu deġenerazzjoni bilaterali ta' epiteljum seminiferus bi spermatidi miżmuma u atrofija ta' ċelluli interstitjali fil-firien f'livelli esaġerati ta' esponiment (150 mg/m2/kuljum) u deġenerazzjoni ta' cellula tal-epididimis u deġenerazzjoni tal-epiteljum seminiferus fil-klieb f'livelli ta' esponiment relevanti kliniku (≥ 7.5 mg/m2/kuljum ta' clofarabine).
English: 5.2 hours
Maltese: 5.2 sigħat
English: Delayed ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at the only dose used of 225 mg/m2/day clofarabine.
Maltese: Atrofija ovarjana postposta jew deġenerazzjoni u apoptożi mukosali uterina kienu osservati fi ġrieden feminili fil-livell tal-unika doża li ntużat ta' 225 mg/m2/kuljum ta' clofarabine.
English: PR = Partial remission
Maltese: RP = Remissjoni parzjali
English: No specific antidotal therapy exists.
Maltese: M'hemm l-ebda terapija speċifika antidotali.
English: Pharmacokinetic data indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see section 5.2).
Maltese: Dejta farmakokinetika tindika li clofarabine jista' jakkumula f'pazjenti bi tnaqqis fil-krejatinina fis-serum (ara sezzjoni 5.2).
English: Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2).
Maltese: Pazjenti li fil-passat sarilhom trapjant ematopoietiku ta' ċelluli staminali (HSCT) jistgħu jkunu f'riskju ogħla għal epatotossiċità li hi suġġestiva ta' mard okklużiv tal-vini (VOD) wara l-kura bi clofarabine (40 mg/m2) meta jintuża flimkien ma' etoposide (100 mg/m2) u cyclophosphamide (440 mg/m2).
English: • An M2 bone marrow (≥ 5% and ≤ 25% blasts) and appearance of normal progenitor cells • An M1 marrow that did not qualify for CR or CRp
Maltese: • Mudullun tal-għadma M2 (≥ 5% u ≤ 25% ċelluli primittivi) u d-dehra ta' ċelluli normali proġenitriċi Mudullun M1 li ma jikkwalifikax għal RK jew RKp
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/20 ml
Maltese: INDIVIDWALI 20 mg/20 ml
English: (9.1 to -)
Maltese: (9.1 sa -)
English: In addition, 50/113 patients receiving clofarabine had at least severely (at least US NCI CTC Grade 3) elevated ALT, 36/100 elevated AST and 15/114 elevated bilirubin levels.
Maltese: Barra minn dan, 50/113-il pazjent li ngħataw clofarabine kellhom tal-anqas ALT elevat b'mod qawwi (tal-anqas Grad 3 ta' CTC tal-NCI tal-US), 36/100 AST elevat u 15/114 livelli elevati tal-bilirubin.
English: It was also active against quiescent lymphocytes and macrophages.
Maltese: Kien attiv wkoll kontra limfoċiti passivi u makrofaġi.
English: The threshold for developmental toxicity was considered to be 6 mg/m2/day in rats and 1.2 mg/m2/day in rabbits.
Maltese: 6 mg/m2/kuljum fil-firien u 1.2 mg/m2/kuljum fil-fniek.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB06.
Maltese: Aġenti antineoplastiċi, antimetaboliti, analogi purini, Kodiċi ATC:
English: Thirteen events of tumour lysis syndrome, capillary leak syndrome or SIRS have been reported; SIRS (2 events; both were considered to be serious), capillary leak syndrome (4 events; 3 of which were considered serious and related) and tumour lysis syndrome (7 events; 6 of which were considered related and 3 of which were serious).
Maltese: Tlettax-il avveniment tas-sindrome tal-lisi tat-tumur, sindrome tat-tnixxija kapillari jew SIRS kienu rrappurtati; SIRS (2 każi; it-tnejn kienu meqjusa bħala serji), sindrom ta' nixxija kapillari (4 każi; 3 minnhom kienu kkunsidrati li huma serji u marbuta mal-mediċina), u sindrom ta' lisi ta' tumur (7 każi; 6 minnhom kienu kkunsidrati li kienu marbuta mal-mediċina u 3 minnhom kienu serji).
English: Each 20 ml vial contains 20 mg of clofarabine.
Maltese: Kull kunjett ta' 20 ml fih 20 mg ta' clofarabine.
English: (6.1 to -)
Maltese: (6.1 sa -)
English: (7.6 to 47.9)
Maltese: (7.6 sa 47.
English: However, there are no known clinically significant interactions with other medicinal products or laboratory tests.
Maltese: Imma, m'hemmx interazzjonijiet klinikalment sinifikanti ma' prodotti mediċinali oħra jew ma' testijiet tal-laboratorju.
English: Frequency not known: C. difficile colitis
Maltese: Frekwenza mhux magħrufa: Ċ. kolite difficile
English: Very common: Palmar-plantar erythrodysaesthesia syndrome, pruritus
Maltese: Komuni ħafna: Sindrome tal-eritrodisestesija palmari-plantari, ħakk Komuni:
English: Clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system.
Maltese: Clofarabine mhuwiex metabolizzat b'mod li jingħaraf bis-sistema enżimatika cytochrome P450
English: In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase α and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Maltese: Barra minn dan, clofarabine fih reżistenza akbar għad-degradazzjoni ċellulari b'adenosin deaminejs u suxxettibilità mnaqqsa għal qsim fosforolitiku minn sustanzi attivi oħra fil-klassi tiegħu waqt li laffinità ta' clofarabine triphosphate għad-DNA polymerejs α u ribonukleotijd reduktejs hi simili għal jew akbar minn dik ta' deoxyadenosine triphosphate.
English: Each vial of Ivozall contains 70.77 mg of sodium.
Maltese: Kull kunjett ta' Ivozall fih 70.77 mg ta' sodium.
English: Renal failure or acute renal failure have been observed as a consequence of infections, sepsis and tumour lysis syndrome (see section 4.8).
Maltese: Insuffiċjenza renali jew insuffiċjenza renali akuta ġiet osservata bħala konsegwenza ta' infezzjonijiet, sepsis u sindromu ta' lisi ta' tumur (ara sezzjoni 4.8).
English: How to store Ivozall
Maltese: Tużax Ivozall
English: Other medicines and Ivozall
Maltese: Mediċini oħra u Ivozall
English: The following parameters should be closely monitored in patients undergoing treatment with clofarabine:
Maltese: Il-parametri li ġejjin għandhom jkunu monitorjati bir-reqqa f'pazjenti li jingħataw trattament b'clofarabine:
English: Administration of clofarabine resulted in a dramatic and rapid reduction in peripheral leukaemia cells in 31 of the 33 patients (94%) who had a measurable absolute blast count at baseline.
Maltese: L-għoti ta' clofarabine wassal għal tnaqqis drammatiku u ta' malajr fiċ-ċelluli periferali tal-lewkimja f'31 minn 33 pazjent (94 %) li kellhom kownt taċ-ċelluli primittivi assoluti li kien jista' jitkejjel fillinjabażi.
English: Chemical and physical in-use stability has been demonstrated for seven days at room temperature and under refrigeration (2°C - 8°C) at a concentration range of 0.15 mg/ml to 0.83 mg/ml after dilution with sodium chloride 9 mg/ml (0.9%).
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal sebat ijiem fit-temperatura tal-kamra u meta kien fi friġġ (2°C - 8°C) f'medda tal-konċentrazzjoni ta' 0.15 mg/ml sa 0.83 mg/ml wara d-dilwizzjoni b'sodium chloride 9 mg/ml (0.9%).
English: If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 109/l.
Maltese: Jekk il-lewkimja persistenti mhix evidenti, hu rrakkomandat lid-doża għaċ-ċiklu li jmiss għandha titnaqqas b'25% tad doża preċedenti wara l-irkuprar tal-ANC għal ≥ 0.75 × 109/l.
English: Common: Contusion
Maltese: Komuni: Kontużjoni
English: In addition, clofarabine is unlikely to inhibit any of the major 5 human CYP isoforms (1A2, 2C9, 2C19, 2D6 and 3A4) or to induce 2 of these isoforms (1A2 and 3A4) at the plasma concentrations achieved following intravenous infusion of 52 mg/m2/day.
Maltese: Barra minn dan, mhux probabbli li clofarabine jinibixxi kwalunkwe wieħed mill-5 iżoformi umani maġġuri CYP (1A2, 2C9, 2C19, 2D6 u 3A4) jew iħaffef 2 minn dawn l-iżoformi (1A2 u 3A4) fil-konċentrazzjonijiet tal-plażma li jintlaħqu wara l-infużjoni għal ġol-vini ta' 52 mg/m2/kuljum.
English: Volume of distribution (steady state)
Maltese: Volum ta' distribuzzjoni (rata stabbli)
English: (3.4 to 5.1)
Maltese: (3.4 sa 5
English: Clofarabine is eliminated by a combination of renal and non-renal excretion.
Maltese: Clofarabine jiġi eliminat permezz ta' tneħħija renali u dik mhux renali.
English: Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every 2 to 6 weeks depending on toxicity and response.
Maltese: b'eskalazzjoni għal 15, 30, 40, 52 u 70 mg/m2/kuljum b'infużjoni għal ġol-vini għal 5 ġranet minn kull 2 sa 6 ġimgħat dejjem jiddependi mit-tossiċità u r-rispons.
English: Before Ivozall is given to you, it will be diluted in a sodium chloride solution (salt and water).
Maltese: Qabel ma tingħata Ivozall, ser ikun dilwit f'soluzzjoni ta' sodium chloride (melħ u ilma).
English: Clofarabine AUC0-24 hours by baseline estimated creatinine clearance in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML (n = 11 / n = 12) following administration of multiple doses of clofarabine by intravenous infusion (creatinine clearance estimated using Schwartz formula)
Maltese: Clofarabine AUC 0-24 hours (ng*h/ml) = Clofarabine AUC 0-24 sigħat (ng*h/ml) Estimated creatinine clearance (ml/min) = Tneħħija ta' kreatinina stimata (ml/min)
English: Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m2/day clofarabine.
Maltese: Żidiet fit-telf ta' postimplantazzjoni, nuqqas fil-piż tal-ġisem foetali u tnaqqis fid-daqs tal-boton flimkien ma' żieda fin-numru ta' malformazzjonijiet (esterni grossi, tessuti rotob), tibdil skeletrali (inkluż ossifikazzjoni ritardata) kienu rrapportati filfirien li kienu qed jirċievu dożi li pproduċew madwar bejn 2 sa 3 darbiet ta' esponiment kliniku (54 mg/m2/kuljum) u fi fniek li kienu qed jirċievu 12 mg/m2/kuljum ta' clofarabine.
English: For storage conditions after dilution of the medicinal product, see section 6.3
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3 6.5
English: • The use of prophylactic steroids (e.g., 100 mg/m2 hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
Maltese: • L-użu ta' sterojdi profilattiċi (eż., 100 mg/m2 ta' hydrocortisone f'Jiem 1 sa 3), jista' jkun ta'
English: The toxicities observed in these patients included vomiting, hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash.
Maltese: It-tossiċitajiet osservati f'dawn il-pazjenti kienu jinkludu rramettar, iperbilirubinemja, u livelli elevati ta' transaminasi u raxx makulo-papulari.
English: Sodium chloride Water for injections
Maltese: Sodium chloride u ilma għall-injezzjonijiet.
English: Common: Respiratory distress, epistaxis, dyspnoea, tachypnoea, cough
Maltese: Komuni: Problemi respiratorji, tinfaraġ, qtugħ ta' nifs, nifs mgħaġġel, sogħla
English: * = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Maltese: **Ir-reazzjonijiet avversi kollha li seħħew mill-inqas darbtejn (i.e., 2 reazzjonijiet jew iktar (1.7%)) huma inklużi f'din it-tabella
English: Although transplantation rate was not a study endpoint, 10/61 patients (16%) went on to receive a HSCT after treatment with clofarabine (3 after achieving a CR, 2 after a CRp, 3 after a PR, 1 patient that was considered a treatment failure by the IRRP and 1 that was considered not evaluable by the IRRP).
Maltese: Għalkemm ir-rata ta' trapjanti ma kienx l-għan aħħari tal-istudju, 10/61 pazjenti (16 %) komplew sejrin u rċevew HSCT wara ttrattament bil-clofarabine (3 wara li kisbu RK, 2 wara RKp, 3 wara RP, pazjent 1 li kien meqjus li m'għaddiex mit-trattament mill-IRRP u 1 kien meqjus li ma jistax jiġi evalwat mill-IRRP).
English: • Periodic safety update reports (PSURs)
Maltese: • Rapporti perjodiċi ta' aġġornament dwar is-sikurezza (PSURs)
English: Plasma protein binding Serum albumin Elimination: β half-life of clofarabine
Maltese: Irbit tal-proteina fil-plażma Serum albumin
English: Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).
Maltese: Ġew irrapportati każijiet ta' epatite u ta' insuffiċjenza epatika , inklużi b'riżultati fatali, b'trattament ta' clofarabine (ara sezzjoni 4.8).
English: Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): - infjammazzjoni tal-fwied (epatite).
English: Ivozall may harm both male and female reproductive organs.
Maltese: Ivozall għandu mnejn jagħmel ħsara lill-organi riproduttivi maskili u dawk feminili.
English: Population pharmacokinetic data from adult and paediatric patients suggest that patients with stable moderate renal impairment (creatinine clearance 30 - < 60 ml/min) receiving a 50% dose reduction achieve similar clofarabine exposure to those with normal renal function receiving a standard dose.
Maltese: Dejta farmakokinetika tal-popolazzjoni minn pazjenti adulti u pedjatriċi tissuġġerixxi li pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina ta' 30 - < 60 ml/min) li jkunu qed jirċievu tnaqqis ta' 50% fid-doża jiksbu espożizzjoni simili għal clofarabine bħal dawk b'funzjoni normali talkliewi li jkunu qed jirċievu doża standard.