FrancophonIA/ELRC3.0 huggingface dataset:
English: Type I glass vial with grey chlorobutyl fluoropolymer coated rubber stopper, polypropylene flip-off cap and aluminium overseal.
Maltese: Tip I kunjett tal-ħġieġ b'tapp tal-lastiku griż tal-chlorobutyl miksi bi fluoropolymer, għatu tal polipropijlene li tiflippjah u siġill sekondarju tal-aluminju.
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletriċi tat-tessuti konnettivi u tal-għadam
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ivozall 1 mg/ml sterile concentrate clofarabine
Maltese: Ivozall 1 mg/ml konċentrat sterili clofarabine
English: Most patients received conditioning regimens that included busulfan, melphalan, and/or the combination of cyclophosphamide and total body irradiation.
Maltese: Il-biċċa l-kbira mill-pazjenti rċevew tipi ta' kura ta' kondizzjonament li kienu jinkludu busulfan, melphan, u/jew it-teħid flimkien ta' cyclophosphamide u l-irradazzjoni totali tal-ġisem.
English: Intravenous infusion of 52 mg/m2 clofarabine produced equivalent exposure across a wide range of weights.
Maltese: Infużjoni għal ġol-vini ta' 52 mg/m2 ta' clofarabine ipproduċiet esponiment ekwivalenti li kien mifrux fuq firxa wiesgħa ta' piżijiet.
English: Best Response
Maltese: MANIFATTUR RESPONSABBLI
English: It is then recommended that clofarabine be administered at a 25% dose reduction.
Maltese: tingħata bi tnaqqis fid-doża ta' 25%.
English: Clinical efficacy: To enable systematic evaluation of the responses seen in patients, an unblinded Independent Response Review Panel (IRRP) determined the following response rates based on definitions produced by the Children's Oncology Group:
Maltese: Reviżjoni tar-Rispons Indipendenti (IRRP) mhux għami, iddetermina dawn ir-rati ta' risponsi li ġejjin ibbażati fuq id-definizzjonijiet ipproduċuti mill-Grupp tal-Onkoloġija tat-Tfal:
English: Four renal adverse reactions in 115 patients were considered to be related to clofarabine, none of which were serious; haematuria (3 events) and acute renal failure (1 event) (see sections 4.3 and 4.4).
Maltese: Erba' reazzjonijiet avversi tal-kliewi f'115-il pazjent kienu meqjusa li kienu marbuta ma' clofarabine, fejn l-ebda wieħed minnhom ma kien serju; ematurja (3 każi) u insuffiċjenza akut talkliewi (każ 1) (ara sezzjonijiet 4.3 u 4.4).
English: The majority of the cases were associated with thrombocytopaenia (see section 4.8).
Maltese: tromboċitopinja (ara sezzjoni 4.8).
English: Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Maltese: Reazzjonijiet avversi meqjusa bħala marbuta ma' clofarabine irrapportati fi frekwenzi ≥ 1/100 (eż. f'> 1/115 pazjenti) fi studji kliniċi u wara t-tqegħid fis-suq
English: Very common: Flushing* Common: Hypotension*, capillary leak syndrome, haematoma
Maltese: Komuni: Pressjoni baxxa*, sindrome tat-tnixxija kapillari, ematoma
English: Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non-activated chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells and in the in vivo rat micronucleus assay.
Maltese: Studji ta' ġenotossiċità wrew li clofarabine ma kienx mutaġeniku fl-analiżi tal-mutazzjoni riversibbli tal-bakterja, imma induċa effetti klastoġeniċi fl'aberrazzjoni tal-analiżi tal-kromożomi mhux attivati fiċ-ċelluli tal-Ovarji tal-Hamster Ċiniż (CHO) u f'analiżi in vivo mikronuklejuż fil-far.
English: Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse reaction.
Maltese: Disturbi vaskulari Erba' u sittin pazjent minn 115 (55.7 %) kellhom tal-anqas reazzjoni avversa waħda ta' disturbi vaskulari.
English: 200 ml *Each ml of concentrate contains 1 mg of clofarabine.
Maltese: 200 ml * Kull ml ta' konċentrat fih 1 mg ta' clofarabine.
English: Nephrotoxic medicinal products, tumour lysis, and tumour lysis with hyperuricemia may contribute to renal toxicity (see sections 4.3 and 4.4).
Maltese: Prodotti mediċinali nefrotossiċi, lisi tat-tumur, u lisi tat-tumur b'iperurikemija jistgħu jikkontribwixxu għal tossiċità tal-kliewi (ara sezzjonijiet 4.3 u 4.4).
English: Very common: Fatigue, pyrexia, mucosal inflammation Common: Multi-organ failure, systemic inflammatory response syndrome*, pain, chills, irritability, oedema, peripheral oedema, feeling hot, feeling abnormal
Maltese: Insuffiċjenza ta' diversi organi, sindrome tarrispons infjammatorju sistemiku*, uġigħ, tertir ta' bard, irritabilità, edema, edema periferali, tħoss is-sħana, ma tħossokx f'siktek
English: Clofarabine has high affinity for one of the activating phosphorylating enzymes, deoxycytidine kinase, which exceeds that of the natural substrate, deoxycytidine.
Maltese: deoxycytidine kinase, li hu akbar mis-sottostrat naturali, deoxycytidine.
English: Very common: Febrile neutropenia Common: Neutropenia
Maltese: Komuni ħafna: Newtropenija bid-deni Komuni: Newtropenija
English: Patients should be monitored for signs and symptoms of enterocolitis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' enterokolite.
English: If a patient develops a clinically significant infection, clofarabine treatment may be withheld until the infection is clinically controlled.
Maltese: Jekk pazjent jiżviluppa infezzjoni klinikalment sinifikanti, it-trattament b'clofarabine jista' jitwaqqaf sakemm l-infezzjoni tkun ikkontrollata klinikalment.
English: The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML.
Maltese: Il-farmakokinetiċi ta' clofarabine kienu studjati f'40 pazjent ta' bejn 2 sa 19-il sena li kellhom ALL jew AML rikadut jew refrattorju.
English: Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment: - if you get a fever or high temperature - because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections; - if you have breathing difficulties, rapid breathing, or breathlessness; - if you feel a change in your heart rate; - if you suffer from dizziness (light-headedness) or fainting - it may be a symptom of low blood pressure; - if you feel sick or have diarrhoea (loose bowels); - if your urine is darker than usual - it is important to drink plenty of water to avoid dehydration; - if you get a rash with blisters or mouth ulcers; - if you lose your appetite, have nausea (feeling sick), vomiting, diarrhea, dark-colored urine and light-coloured stools, stomach pain, jaundice (yellowing of the skin and eyes), or if you feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure); - if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (these may be signs of acute kidney failure / kidney failure).
Maltese: Għid lit-tabib tiegħek jew min jieħu ħsiebek minnufih jekk tħoss kwalunkwe waħda minn dawn ilkondizzjonijiet li ġejjin għax għandek mnejn ikollok bżonn twaqqaf it-trattament: - jekk ikollok id-deni jew temperatura għolja - għax clofarabine inaqqas in-numru ta' ċelluli tad demm li jsiru fil-mudullun, int għandek ċans akbar li timbokka infezzjonijiet; - jekk issibha bi tqila biex tieħu n-nifs, tieħu nifs malajr, jew tbagħti minn qtugħ ta' nifs;
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 ml vial contains 20 mg of clofarabine
Maltese: Kull kunjett ta' 20 ml fih 20 mg ta' clofarabine
English: Ivozall 1 mg/ml concentrate for solution for infusion clofarabine
Maltese: Ivozall 1 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Six events were considered to be related to clofarabine of which acute cholecystitis (1 event), cholelithiasis (1 event), hepatocellular damage (1 event; patient died (see above)) and hyperbilirubinaemia (1 event; the patient discontinued therapy (see above)) were considered to be serious.
Maltese: kolelitijasi (każ 1), ħsara epatoċelluri (każ 1; il-pazjent miet (ara hawn fuq)) u iperbilirubinemja (każ 1; il-pazjent ma kompliex it-terapija (ara hawn fuq) kienu meqjusa serji.
English: Clofarabine was teratogenic in rats and rabbits.
Maltese: Clofarabine kien teratoġeniku fil-firien u l-fniek.
English: Cardiac effects were observed in rats consistent with cardiomyopathy and contributed to signs of cardiac failure after repeated cycles of treatment.
Maltese: L-effetti kardijaċi kienu osservati f'firien konsistenti ma' kardjomijopatija u kkontribwew għal sinjali ta' falliment kardijaku wara ċikli rripetuti ta' trattament.
English: Ivozall is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Maltese: Ivozall jintuża biex jikkura tfal (≥ sena), teenagers u żgħażagħ sa 21 sena li jbatu minn lewkimja akuta limfoblastika (ALL) meta trattamenti oħra li ntużaw qabel ma ħadmux jew ma baqgħux jaħdmu.
English: Each ml contains 1 mg of clofarabine.
Maltese: Kull ml fih 1 mg ta' clofarabine.
English: Adverse reactions reported during the post-marketing period are also included in the table under the frequency category “not known” (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi rrappurtati matul il-perijodu ta' wara t-tqegħid fis-suq huma inklużi wkoll fit-tabella t'hawn taħt, taħt il-kategorija ta' frekwenza “mhux magħrufa” (ma tistax tittieħed stima mid-data disponibbli).
English: • Patients should receive intravenous fluids throughout the 5 day clofarabine administration period to reduce the effects of tumour lysis and other events.
Maltese: • Il-pazjenti għandhom jirċievu fluwidi fil-vina matul il-perijodu ta' 5 ijiem tal-għoti ta' clofarabine biex jitnaqqsu l-effetti tal-lisi tat-tumur u avvenimenti oħra.
English: Systemic inflammatory response syndrome (SIRS) or capillary leak syndrome SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse reaction in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
Maltese: takikardija, pressjoni baxxa, edema pulmonari) kienu rrapportati bħala reazzjoni avversa f'5% (6/115) tal-pazjenti pedjatriċi (5
English: Glomerulonephropathy was reported in rats at exposure levels 3 to 5 fold higher than the clinical AUC after 6 dosing cycles of clofarabine.
Maltese: Kien hemm rapporti ta' glomerulonefropatija fi firien fil-livell ta' esponiment li kienu minn 3 sa 5 darbiet ogħla mill-AUC klinikali wara 6 ċikli ta' dożaġġ ta' clofarabine.
English: Patients who met each of the following criteria:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) and then diluted in sodium chloride 9 mg/ml (0.9%) intravenous transparent PVC or polyolefine (polypropylene) infusion bags to produce a total volume according to the examples given in the table below.
Maltese: filter ta' siringa PVDF idrofiliku) u mbagħad dilwit f'boroż tal-infuzjoni għal ġol-vina ta' sodium chloride ta' 9 mg/ml (0.9%) ta' PVC trasparenti jew polyolefine (polypropylene) biex tjipproduċi volum totali skont l-eżempji li ngħataw fit-tabella t'hawn taħt.
English: Hepatic effects were observed in rats following chronic administration of clofarabine.
Maltese: Effetti epatiċi kienu osservati fil-firien wara l-għoti kroniku ta' clofarabine.
English: Dose related toxicities on male reproductive organs have been observed in mice, rats and dogs, and toxicities on female reproductive organs have been observed in mice (see section 5.3).
Maltese: Tossiċitajiet marbuta mad-doża fuq organi riproduttivi maskili kienu osservati fil-ġrieden, firien u klieb, u tossiċitajiet fuq organi riproduttivi femminili kienu osservati fil-ġrieden (ara sezzjoni 5.3).
English: Common: Maculo-papular rash, petechiae, erythema, pruritic rash, skin exfoliation, generalised rash, alopecia, skin hyperpigmentation, generalised erythema, erythematous rash, dry skin, hyperhidrosis Frequency not known: Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Maltese: - falliment fl-organi, uġigħ, żieda fit-tensjoni tal-muskoli, żamma tal-ilma u nefħa f'partijiet talġisem, inkluż id-dirgħajn u r-riġlejn, tibdil fl-istat mentali, tħoss sħana, tħoss il-kesħa jew tħossok anormali; - clofarabine għandu mnejn jolqot il-livelli ta' ċerti sustanzi fid-demm.
English: Very common: Headache Common: Somnolence, peripheral neuropathy, paraesthesia, dizziness, tremor
Maltese: Komuni ħafna: Uġigħ ta' ras Komuni: Ngħas tqil, newropatija periferali, parestesija, mejt, rogħda
English: No apparent difference in pharmacokinetics was observed between patients with ALL or AML, or between males and females.
Maltese: Ma ġiet osservata l-ebda differenza apparenti fil-farmakokinetiċi bejn pazjenti bil-ALL jew AML; jew bejn maskili u feminili.
English: Nine of 17 ALL patients were treated with clofarabine 52 mg/m2/day.
Maltese: Disa' mis-17 ilpazjent ALL kienu kkurati bi clofarabine b'doża ta' 52 mg/m2/kuljum ta' clofarabine.
English: It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) ) and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Maltese: filtru ta' siringa PVDF idrofiliku) u mbagħad għandu jiġi dilwit f'boroż tal-infuzjoni għal ġol-vina ta' sodium chloride ta' 9 mg/ml (0.9%) biex jipproduċi volum totali skont l-eżempji li ngħataw fit-tabella t'hawn taħt.
English: However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m2 clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m2 clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Maltese: Imma, il-farmakokinetiċi ta' clofarabine fl-adulti b'AML rikadut jew refrattarju wara l-għoti ta' doża waħda ta' 40 mg/m2 ta' clofarabine permezz ta' infużjoni għal ġol-vini fuq perijodu ta' siegħa kienu komparabbli ma' dawk deskritti hawn fuq f'pazjenti ta' bejn is-sentejn u 19-il sena b'ALL jew AML rikadut jew refrattarju wara l-għoti ta' 52 mg/m2 ta' clofarabine permezz ta' infużjoni għal ġol-vini fuq perijodu ta' sagħtejn għal 5 ġranet konsekuttivi.
English: Clofarabine must first diffuse or be transported into target cells where it is sequentially phosphorylated to the mono- and bi-phosphate by intracellular kinases, and then finally to the active conjugate, clofarabine 5'-triphosphate.
Maltese: L-ewwelnettt clofarabine irid jinxtered jew ikun trasportat f'ċelluli bersall fejn ikun b'mod sekwenzjali fosforilatat għal mono- u bi-fosfat bil-kinasi intraċellulari, u fl-aħħar għal konjugat attiv, clofarabine 5'-triphosphate.
English: During the post-marketing period prolonged cytopaenias (thrombocytopaenia, anaemia, neutropaenia and leukopaenia) and bone marrow failure have been reported.
Maltese: Trażżin sever tal-funzjoni tal-mudullun, li jinkludi newtropenija, anemija, u tromboċitopenija,
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Maltese: M'hemmx esperjenza dwar l-użu f'pazjenti li jbatu minn indeboliment epatiku (serum bilirubin > 1.5 x ULN kif ukoll AST u ALT > 5 x ULN) u l-fwied hu organu potenzjali bersall għat-tossiċità.
English: Eleven events in 115 patients were considered to be related to clofarabine, none of which were serious and the most frequently reported cardiac disorder was tachycardia (35%) (see section 4.4); 6.1% (7/115) patient's tachycardia were considered to be related to clofarabine.
Maltese: Ħdaxil avveniment f'115-il pazjent kienu meqjusa marbutin ma' clofarabine, l-ebda wieħed minnhom ma kien serju, u l-aktar disturb kardijaku komuni rrappurtat kienet it-takikardija (35 %) (ara sezzjoni 4.4); 6.1 % (7/115) tat-takikardija tal-pazjenti kienet ikkunsidrata li hi marbuta ma' clofarabine.
English: Should patients experience an ANC < 0.5 × 109/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%.
Maltese: ANC < 0.5 × 109/l għal aktar minn 4 ġimgħat mill-bidu tal-aħħar ċiklu, hu rrakkomandat lid-doża għaċ-ċiklu li jmiss titnaqqas b'25%.
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine Body surface area (m2)
Maltese: clofarabine fid-doża rrakkomandata ta' 52 mg/m2 kuljum x 5.
English: CRp = Complete remission in the Absence of Total Platelet Recovery
Maltese: RKp - Remissjoni kompleta finNuqqas ta' Rkupru Komplet ta' Pjastrini
English: Each vial contains 70.77mg sodium (main component of cooking/table salt).
Maltese: Ivozall fih sodium Kull kunjett fih 70.77 mg sodium (il-komponent ewlieni ta' melħ tat-tisjir/tal-ikel).
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported (see section 4.8).
Maltese: Is-sindrome ta' StevensJohnson (SJS), nekrolisi epidermali ossika (TEN)
English: The reference medicine for Ivozall has been authorised under ‘exceptional circumstances'.
Maltese: Il-prodott mediċinali ta' referenza għal Ivozall ġie awtorizzat taħt “ċirkustanzi eċċezzjonali”.
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse reaction (see sections 4.3 and 4.4).
Maltese: 2% tal-pazjenti batew minn tal-anqas reazzjoni avversa waħda ta' disturbi fil-fwied u fil-marrara (ara sezzjonijiet 4.3 u 4.4).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: LIST OF EXCIPIENTS Excipients: Sodium chloride and water for injections.
Maltese: 6.1 Lista ta' eċċipjenti Sodium chloride Ilma għall-injezzjonijiet
English: Disposal
Maltese: Iponatrimja
English: Ivozall contains sodium
Maltese: Kif jidher Ivozall u l-kontenut tal-pakkett
English: Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported in patients who were receiving or had recently been treated with clofarabine.
Maltese: Is-sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN), li jinkludu każijiet fatali, ġew irrappurtati f'pazjenti li kienu qed jirċievu jew li dan l-aħħar ġew ikkurati bi clofarabine.
English: Thus, the concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period (see sections 4.4, 4.8 and 5.2).
Maltese: immunosoppressanti (cyclosporin, tacrolimus), acyclovir u valganciclovir, għandhom ikunu evitati partikularment matul il-perijodu ta' għoti ta' 5 ijiem ta' clofarabine (ara sezzjonijiet 4.4, 4.8 u 5.2).
English: The no-observable effect level for maternal toxicity in rats was 18 mg/m2/day and in rabbits was more than 12 mg/m2/day.
Maltese: Il-livell tal-effett mhux osservat fit-tossiċità maternali fil-firien kien 18 mg/m2/kuljum, fil-fniek kien aktar minn 12 mg/m2/kuljum.
English: Any patient who experiences a severe non-hematologic toxicity (US NCI CTC Grade 3 toxicity) on a third occasion, a severe toxicity that does not recover within 14 days (excluding nausea/vomiting) or a life-threatening or disabling non-infectious non-hematologic toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.2).
Maltese: Kwalunkwe pazjent li jkollu tossiċità mhux ematoloġika severa għat-tielet darba (tossiċità Grad 3 ta' CTC tal-NCI tal-US), tossiċità severa li ma tirkuprax fi żmien 14-il ġurnata (ħlief għal dardir/rimettar) jew tossiċità mhux infettiva u mhux ematoloġika li tirriżulta f'diżabilita` jew tkun potenzjalment fatali (tossiċità Grad 4 ta' CTC tal-NCI tal-US) m'għandux jibqa' jingħata trattament bi clofarabine (ara sezzjoni 4.2).
English: Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropenic colitis, caecitis
Maltese: Pankreatite, żidiet fil-livelli ta' amylase u lipase fis-serum, enterokolite, kolite newtropenika, keċite
English: Three patients died of adverse events considered by the study investigator to be related to treatment with clofarabine: one patient died from respiratory distress, hepatocellular damage, and capillary leak syndrome; one patient from VRE sepsis and multi-organ failure; and one patient from septic shock and multi-organ failure.
Maltese: Tliet pazjenti mietu minħabba avvenimenti avversi li kienu kkunsidrati mill-investigatur tal-istudju li kienu marbuta mal-kura bi clofarabine: wieħed bi problemi respiratorji, ħsara epatoċellulari, u sindrome tat-tnixxija kapillari; pazjent wieħed minn infezzjoni VRE u insuffiċjenza ta' diversi organi; u pazjent wieħed minn xokk settiku u insuffiċjenza ta' diversi organi.
English: In the majority of patients (8/10), the pericardial effusion and pericarditis were deemed to be asymptomatic and of little or no clinical significance on echocardiographic assessment.
Maltese: Fil-każ tal-biċċa l-kbira tal-pazjenti (8/10), l-effużjoni perikardjali u l-perikardite kienu meqjusa li kienu asimptomatiċi u ta' importanza żgħira jew tal-ebda sinifikat kliniku skont assessjament ekocardjografiku.
English: An infusion time of > 2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine (see section 5.2).
Maltese: Ħin ta' infużjoni ta' > 2 sigħat għandu jkun meqjus biex jgħin fit-tnaqqis ta' sintomi ta' ansjetà u irritabilità, u biex jiġu evitati konċentrazzjonijiet għoljin massimi ta' clofarabine (ara sezzjoni 5.2).
English: breathlessness, cough; - vomiting blood, stomach ache, pain in the bottom; - bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflamed mouth lining; - yellowing of the skin and eyes (also called jaundice), or other liver disorders; - bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems; - pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, or joints; - blood in urine; - failure of organs, pain, increased muscle tension, water retention and swelling in parts of the body, including the arms and legs, changes in mental state, feeling hot, cold or abnormal; - clofarabine may affect the levels of certain substances in the blood.
Maltese: ansjetà, uġigħ ta' ras, deni, għeja; tħossok u tkun marid, dijarea (tagħmel imsarnek); ħmura fil-wiċċ, ħakk, ġilda infjammata, infjammazzjoni tal-linji mukużi (niedjin) bħal ħalq u partijiet oħra; int għandek mnejn ikollok aktar infezzjonijiet minn normal għax Ivozall jista' jbaxxi n-numru ta' ċerti tipi ta' celluli tad-demm; raxx tal-ġilda, li jista' jkun bil-ħakk, aħmar u bl-uġigħ jew tistelaħ il-ġilda, li jinkludi l kefef tal-idejn u l-qiegħ tas-saqajn, jew tikek żgħar ħomor jew vjola taħt il-ġilda;