FrancophonIA/ELRC3.0 huggingface dataset:
English: Peripheral B-cell counts decreased rapidly to an undetectable level during treatment at doses ≥ 5 mcg/m 2/day or ≥ 9 mcg/day in the majority of patients.
Maltese: L-għadd ta' ċelluli B periferali naqas rapidament sa livell mhux traċċabbli matul it-trattament b'dożi ta' ≥ 5 mcg/m2/jum jew ≥ 9 mcg/jum fil-maġġoranza tal-pazjenti.
English: 1 mL (1) 0.86 mL (1) 0.72 mL (1) 0.59 mL (1)
Maltese: 72 mL (1) 0.59 mL (1)
English: For patients with ≥ 50% leukaemic blasts in bone marrow or > 15,000/microlitre peripheral blood leukaemic blast counts treat with dexamethasone (not to exceed 24 mg/day).
Maltese: Għal pazjenti b'≥ 50% blasts lewkemiċi fil-mudullun jew għadd ta' blasts lewkemiċi fid-demm periferali ta' > 15,000/mikrolitru ttratta b'dexamethasone (li m'għandux jaqbeż 24 mg/jum).
English: The type of adverse events observed in infants were similar to those observed in the overall paediatric population.
Maltese: It-tip ta' reazzjonijiet avversi osservati fit-tfal kien simili għal dawk osservati filpopolazzjoni pedjatrika inġenerali.
English: For clinical management of infections, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' infezzjonijiet, ara sezzjoni 4.4.
English: Like other protein therapeutics, blinatumomab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Maltese: Bħal terapewtiċi tal-proteini oħrajn, blinatumomab huwa mistenni li jiġi metabolizzat f'peptidi żgħar u aċidi amminiċi permezz ta' rotot kataboliċi.
English: The treated population included 116 patients who received at least one infusion of BLINCYTO; the mean number of completed treatment cycles was 1.8 (range: 1 to 4).
Maltese: Il-popolazzjoni ttrattata kienet tinkludi 116-il pazjent li rċevew tal-anqas infużjoni waħda ta' BLINCYTO; in-numru medju ta' ċikli tat-trattament kompluti kien ta' 1.8 (medda: 1 sa 4).
English: Due to the potential for progressive multifocal leukoencephalopathy (PML), patients should be monitored for signs and symptoms.
Maltese: Minħabba l-potenzjal ta' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy) il-pazjenti għandhom ikunu mmonitorjati għal sinjali u sintomi.
English: BLINCYTO permanently.
Maltese: BLINCYTO b'mod permanenti.
English: The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 2.92 (2.83) L/hour.
Maltese: It-tneħħija sistemika medja (SD) stmata b'infużjoni kontinwa ġol-vini f'pazjenti li qed jirċievu blinatumomab fi studji kliniċi kienet ta' 2.92 (2.83) L/siegħa.
English: Sodium chloride 9 mg/mL (0.9%) solution for injection (starting volume)
Maltese: Sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni (volum talbidu)
English: Serious and grade ≥ 3 adverse reactions (such as ALT increased, AST increased, and blood bilirubin increased) were observed in 1.5% and 13.6% of patients respectively.
Maltese: Reazzjonijiet avversi serji u ta' grad ≥ 3 (bħal żieda fl-ALT, żieda fl-AST u żieda fil-bilirubina fid-demm) kienu osservati f'1.5% u 13.6% tal-pazjenti rispettivament.
English: Although there is a potential for the development of progressive multifocal leukoencephalopathy (PML), no confirmed case of PML has been reported in the clinical studies.
Maltese: Għalkemm hemm il-potenzjal li tiżviluppa lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy), l-ebda każ ikkonfermat ta' PML ma kien irrappurtat fl-istudji kliniċi.
English: Using a syringe, aseptically transfer reconstituted BLINCYTO into the infusion bag (refer to table 1 to table 3 for the specific volume of reconstituted BLINCYTO).
Maltese: Bl-użu ta' siringa, ittrasferixxi b'mod asettiku BLINCYTO rikostitwit fil-borża tal-infużjoni (irreferi għat-tabella 1 sat-tabella 3 għall-volum speċifiku ta' BLINCYTO rikostitwit).
English: The elevated cytokine levels returned to baseline within 24 to 48 hours during the infusion.
Maltese: Il-livelli għoljin ta' ċitokini reġgħu lura għal-linja bażi fi żmien 24 sa 48 siegħa matul l-infużjoni.
English: POWDER VIAL
Maltese: Piż talPazjent
English: Of the 267 patients who received BLINCYTO, the mean number of completed treatment cycles was 2.0; of the 109 patients who received SOC chemotherapy, the mean number of treatment cycles was 1.3.
Maltese: Mill-267 pazjent li rċevew BLINCYTO, in-numru medju ta' ċikli ta' trattament kompluti kien 2.0; mil-109 pazjenti li rċivew kimoterapija SOC, l-għadd medju ta' ċikli ta' trattament kien 1.3.
English: Neutropenia and febrile neutropenia
Maltese: Disturbi fis-sistema nervużaa
English: BLINCYTO is used to treat adults with acute lymphoblastic leukaemia.
Maltese: BLINCYTO jintuża biex jittratta adulti b'lewkimja limfoblastika akuta.
English: • feeling sleepy (somnolence), numbness, dizziness
Maltese: • tħossok bi ngħas (ngħas), tnemnim, sturdament
English: Patients in 3
Maltese: Grade 3
English: Efficacy results in patients ≥ 18 years of age with MRD positive B-precursor ALL
Maltese: Riżultati tal-effikaċja f'pazjenti b'età ta' ≥ 18-il sena b'ALL bi prekursur B pożittiva għal MRD
English: Due to the potential depletion of B-cells in newborns following exposure to blinatumomab during pregnancy, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered (see section 4.6).
Maltese: Minħabba t-tnaqqis potenzjali ta' ċelluli B fit-trabi tat-twelid wara esponiment għal blinatumomab waqt it-tqala, it-trabi tat-twelid għandhom jiġu mmonitorjati għal tnaqqis taċ-ċelluli B, u t-tilqim b'vaċċini li jkun fihom virus ħaj għandu jiġi pospost sakemm l-għadd taċ-ċelluli B tat-tarbija jkun irkupra (ara sezzjoni 4.6).
English: Pancreatitis a
Maltese: 96 siegħa
English: Eligible patients were ≥ 18 years of age with no prior HSCT, had received at least 3 blocks of standard ALL induction therapy, were in complete haematologic remission (defined as < 5% blasts in bone marrow, absolute neutrophil count ≥ 1,000/microlitres, platelets ≥ 50,000/microlitres, and haemoglobin level ≥ 9 g/dL) and had molecular failure or molecular relapse (defined as MRD ≥ 10
Maltese: mudullun, għadd assolut ta' newtrofili ≥ 1,000/mikrolitri, plejtlits ≥ 50,000/mikrolitri, u livell ta' emoglobina ≥ 9 g/dL) u kellhom insuffiċjenza molekulari jew rikaduta molekulari (definita bħala MRD ≥ 10-3), ara tabella 4.
English: The treated population included 189 patients who received at least 1 infusion of BLINCYTO; the mean number of cycles per patient was 1.6.
Maltese: Il-popolazzjoni ttrattata kienet tinkludi 189 pazjent li rċevew tal-anqas infużjoni waħda ta' BLINCYTO; in-numru medju ta' ċikli għal kull pazjent kien ta' 1.6.
English: The safety and efficacy of BLINCYTO were evaluated in an open-label, multicentre, single-arm study in 93 paediatric patients with relapsed or refractory B-precursor ALL (second or later bone marrow relapse, in any marrow relapse after allogeneic HSCT, or refractory to other treatments, and also with > 25% blasts in bone marrow).
Maltese: Is-sigurtà u l-effikaċja ta' BLINCYTO kienu evalwati fi studju open-label, multiċentriku u bi grupp wieħed f'93 pazjent b'ALL bi prekursur B li reġgħet feġġet jew reżistenti (it-tieni jew aktar rikaduta tal-mudullum, fi kwalunkwe rikaduta tal-mudullun wara HSCT alloġeniku, jew rikaduta għal trattamenti oħra, u anke b' >25% blasts fil-mudullun.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri hija essenzjalment ‘mingħajr sodium'.
English: The CR/CRh* for patients less than 2 years of age was 40% (4/10), for patients 2 to 6 years was 30.0% (6/20); and for patients aged 7 to 17 years was 25% (10/40).
Maltese: Is-CR/CRh* għal pazjenti ta' età ta' inqas minn sentejn kien ta' 40% (4/10), għal pazjenti bl-età ta' 2 sa 6 snin kien ta' 30.0% (6/20); u għal pazjenti bl-età ta' 7 sa 17-il sena kien ta' 25% (10/40). 3 pazjenti bl-età ta' inqas minn sena reżistenti għal trattament preċedenti u mingħajr alloHSCT preċedenti rċevew ċiklu wieħed ta' Blincyto b'doża ta' 5-15 µg/m2/jum.
English: Eighty-one of 189 (42.9%) patients achieved CR/CRh* within the first 2 treatment cycles with the majority of responses (64 of 81) occurring within 1 cycle of treatment.
Maltese: Wieħed u tmenin minn 189 (42.9%) pazjent kisbu CR/CRh* fl-ewwel 2 ċikli ta' trattament u l-maġġoranza tar-risponsi (64 minn 81) seħħew fl-ewwel ċiklu ta' trattament.
English: Primary refractory
Maltese: Ċikli sussegwenti
English: • cough
Maltese: Xhur
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Maltese: BLINCYTO 38.5 mikrogrammi trab għall-konċentrat u soluzzjoni għal soluzzjoni għall-infużjoni.
English: Rate and 95% Confidence Interval (CI)
Maltese: Rata u Intervall ta' Kunfidenza (Confidence Interval- Cl) ta' 95% n/N Rata (Cl ta' 95%)
English: Median, years (min, max) Mean, years (SD) ≥ 65 years, n (%) Males, n (%) Race, n (%) Asian Other (mixed) White Unknown Relapse history n (%) Patients in 1
Maltese: Medjan, snin (min, max) Medja, snin (SD) ≥ 65 sena, n (%) Irġiel, n (%) Razza, n (%) Asjatika Oħra (imħallta) Bajda Mhux magħrufa Storja ta' rikaduta n (%) Pazjenti fl-ewwel CR Pazjenti fit-tieni CR Pazjenti fit-tielet CR Livell ta' MRD fil-linja bażi* n (%) ≥ 10-1 u < 1 ≥ 10-2 u < 10-1 ≥ 10-3 u < 10-2
English: Recommended dose (for patients at least 45 kg in weight):
Maltese: Doża rakkomandata (għal pazjenti li jiżnu mill-inqas 45 kg):
English: Tachycardia
Maltese: Rimettar
English: nd
Maltese: SN
English: Consolidation Cycles 2-4 Days 1-28
Maltese: Ċikli ta' Konsolidazzjoni 2-4
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), 66.0% of patients experienced one or more neurologic adverse reactions (including psychiatric disorders), primarily involving the central nervous system.
Maltese: II (N = 189), 66.0% tal-pazjenti esperjenzaw reazzjoni avversa newroloġika waħda jew iżjed (li jinkludu disturbi psikjatriċi), li jinvolvu primarjament is-sistema nervuża ċentrali.
English: During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterised by T-cell activation and initial redistribution, rapid peripheral B-cell depletion, and transient cytokine elevation.
Maltese: Matul l-infużjoni kontinwa fil-vini fuq 4 ġimgħat, ir-rispons farmakodinamiku kien ikkaratterizzat mill-attivazzjoni u rridistribuzzjoni inizjali taċ-ċelluli T, it-tnaqqis rapidu taċ-ċelluli B periferali, u ż-żieda temporanja fiċċitokini.
English: 15 mcg/m2/da y via continuous infusion (not to exceed 28 mcg/day)
Maltese: 15 mcg/m2/jum permezz ta' infużjoni kontinwa (li m'għandhiex taqbeż
English: Results suggest that age (7 months to 80 years) and gender do not influence the pharmacokinetics of blinatumomab.
Maltese: Ir-riżultati jissuġġerixxu li l-età (7 xhur sa 80 sena) u s-sess ma jinfluwenzawx il-farmakokinetika ta' blinatumomab.
English: Patients who have achieved complete remission (CR/CRh*) after 2 treatment cycles may receive up to 3 additional cycles of BLINCYTO consolidation treatment, based on an individual benefits-risks assessment.
Maltese: 2 ċikli ta' trattament jistgħu jirċievu sa 3 ċikli addizzjonali ta' trattament ta' konsolidazzjoni bi BLINCYTO, abbażi ta' valutazzjoni tal-benefiċċji u r-riskji individwali.
English: For instructions on the handling and preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-immaniġġjar u l-preparazzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Based on pharmacokinetic analyses, dose adjustment is not necessary in patients with mild to moderate renal dysfunction (see section 5.2).
Maltese: Abbażi ta' analiżi farmakokinetika, mhux meħtieġ aġġustament fid-doża f'pazjenti b'disfunzjoni talkliewi minn ħafifa għal moderata (ara sezzjoni 5.2).
English: Confusion and disorientation, coordination and balance disorders, risk of seizures and disturbances in consciousness can occur (see section 4.4).
Maltese: Jistgħu jseħħu konfużjoni u diżorjentazzjoni, disturbi fil-koordinazzjoni u l-bilanċ, ir-riskju ta' aċċessjonijiet u disturbi fil-koxjenza (ara sezzjoni 4.4).
English: Peripheral lymphocytes were not measured in paediatric subjects.
Maltese: Limfoċiti periferali ma ġewx imkejla f'individwi pedjatriċi.
English: Eligible patients were ≥ 18 years of age and ECOG status ≤ 2 with relapsed or refractory B-cell precursor ALL (had > 5% blasts in the bone marrow and either relapse at any time after allogeneic HSCT, untreated first relapse with first remission duration < 12 months, or refractory to last therapy).
Maltese: Pazjenti eliġibbli kellhom età ta' ≥ 18-il sena u stat ta' ECOG ta' ≤ 2 b'ALL b'prekursur taċ-ċellula B li reġgħet feġġet jew reżistenti (kellhom > 5% tal-blasts fil-mudullun u jew marda li reġgħet feġġet fi kwalunkwe ħin wara HSCT alloġeniku, marda mhux ittrattata li reġgħet feġġet għall-ewwel darba blewwel remissjoni b'tul ta' < 12-il xahar, jew li ma rrispondietx għall-aħħar terapija).
English: (thrombocytopenia), decreased levels of certain white blood cells (leukopenia)
Maltese: (tromboċitopenija), tnaqqis fil-livelli ta' ċerti ċelluli bojod tad-demm (lewkopenija)
English: For clinical management of neurologic events, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' avvenimenti newroloġiċi, ara sezzjoni 4.4.
English: b/CRi c, n (%) [95% CI] Treatment difference [95% CI] p-value CR, n (%) [95% CI] Treatment difference [95% CI] p-value Event-free survival d
Maltese: Remissjoni sħiħa (CR - complete remission) CRa/CRh*b/CRic, n (%) [CI ta' 95%] Differenza fit-trattament [CI ta' 95%] Valur p CR, n (%)[CI ta' 95%] Differenza fit-trattament [CI ta' 95%] Valur p Sopravivenza mingħajr avvenimentd Estimu ta' 6 xhur % [CI ta' 95%] Estimu ta' 18-il xahar % [CI ta' 95%] HR [CI ta' 95%] Tul ta' żmien ta' rispons ematoloġikuŻmien medjan għall-avveniment [CI ta' 95%] CR CR/CRh*/CRi Rispons
English: uric acid, and phosphate and decreased blood levels of calcium (tumour lysis syndrome)
Maltese: potassju fid-demm, aċidu uriku u fosfat u tnaqqis fil-livelli ta' kalċju fid-demm (sindrome ta'
English: • serious infection which can result in organ failure, shock or can be fatal (sepsis)
Maltese: • infezzjoni serja li tista' tirriżulta f'insuffiċjenza tal-organi, xokk jew li tista' tkun fatali (sepsi)
English: 12 Pyrexia includes body temperature increased and pyrexia.
Maltese: 12 Deni jinkludi żieda fit-temperatura tal-ġisem u deni.
English: Confusional state Disorientation
Maltese: Stat ta' konfużjonia Diżorjentazzjoni
English: Intrathecal chemotherapy prophylaxis is recommended before and during BLINCYTO therapy to prevent central nervous system ALL relapse.
Maltese: Kimoterapija ġot-teka bħala profilassi hija rakkomandata qabel u matul it-terapija bi BLINCYTO sabiex tipprevjeni rikaduta ta' ALL tas-sistema nervuża ċentrali.
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Maltese: Evalwazzjoni tal-pazjent tista' tinkludi eżaminazzjoni fiżika, valutazzjoni tal-laboratorju għall-amylase fis-serum u lipase fis-serum, u immaġini addominali, bħal ultrasound u miżuri dijanjostiċi xierqa oħra.
English: CR Duration of complete MRD response [95% CI]
Maltese: Sopravivenza globali medjana [Cl ta' 95%]
English: For clinical management of elevated liver enzymes, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' żieda fl-enzimi tal-fwied, ara sezzjoni 4.4.
English: Patients may receive 1 cycle of induction treatment followed by up to 3 additional cycles of BLINCYTO consolidation treatment.
Maltese: Il-pazjenti jistgħu jirċievu ċiklu wieħed ta' trattament ta' induzzjoni segwit minn mhux aktar minn 3 ċikli addizzjonali ta' trattament ta' konsolidazzjoni bi BLINCYTO.
English: 5.9 months
Maltese: 5.9 xhur
English: CRh* was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Maltese: CRh* kienet definita bħala ≤ 5% ta' blasts fil-mudullun, ebda evidenza ta' mard, u rkupru parzjali tal-għadd taċ-ċelluli tad-demm periferali (plejtlits > 50,000/mikrolitru u ANC > 500/mikrolitru).
English: Other side effects include:
Maltese: Nota Importanti:
English: The demographics and baseline characteristics were well-balanced between the two arms (see table 1).
Maltese: Id-demografiċi u lkaratteristiċi fil-linja bażi kienu bbilanċjati sew bejn iż-żewġ gruppi (ara tabella 1).
English: Grade 3 is severe, and grade 4 is life-threatening.
Maltese: Grad 3 huwa sever, u Grad 4 huwa ta' periklu għall-ħajja.
English: The adverse reactions described in this section were identified in clinical studies of patients with B-precursor ALL (N = 843).
Maltese: Ir-reazzjonijiet avversi deskritti f'din is-sezzjoni kienu identifikati fl-istudji kliniċi ta' pazjenti b'ALL bi prekursur B (N = 843).
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)
Maltese: Tabella 3. Ir-riżultati tal-effikaċja f'pazjenti ≥ 18-il sena b'lewkimja limfoblastika akuta (ALLacute lymphoblastic leukaemia) b'prekursur B li reġgħet feġġet jew reżistenti u negattiva għallkromosoma ta' Philadelphia n (%) n = 189
English: Discontinue BLINCYTO permanently if more than one convulsion occurs.
Maltese: Waqqaf BLINCYTO b'mod permanenti jekk iseħħu iżjed minn konvulżjoni waħda.
English: • Description on patient's monitoring and management of early signs and symptoms of neurological events
Maltese: • Deskrizzjoni dwar il-monitoraġġ tal-pazjent u l-immaniġġjar ta' sinjali u sintomi bikrin ta' avvenimenti newroloġiċi
English: CRh* (complete remission with partial haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Maltese: b. CRh* (Remissjoni sħiħa b'irkupru ematoloġiku parzjali) kienet definita bħala ≤ 5% ta' blasts fil-mudullun, l-ebda evidenza ta' mard, u rkupru parzjali tal-għadd ta' ċelluli tad-demm periferali (plejtlits > 50,000/mikrolitru u ANC > 500/mikrolitru).
English: The metabolic pathway of blinatumomab has not been characterised.
Maltese: Ir-rotta metabolika ta' blinatumomab ma ġietx ikkaratterizzata.
English: In a prespecified exploratory analysis, 60 of 73 MRD evaluable patients with CR/CRh* (82.2%) also had a MRD response (defined as MRD by PCR < 1 x 10
Maltese: (MRD - minimal residual disease) b'CR/CRh* (82.2%) kellhom ukoll rispons ta' MRD (definit bħala MRD b'reazzjoni katina tal-polymerase [PCR - polymerase chain reaction] < 1 x 10-4).
English: Patients with brain MRI/CT findings consistent with leukoencephalopathy experienced concurrent serious adverse events including confusional state, tremor, cognitive disorder, encephalopathy, and convulsion.
Maltese: Il-pazjenti b'sejbiet tal-MRI/CT tal-moħħ konsistenti ma' lewkoenċefalopatija esperjenzaw avvenimenti avversi serji fl-istess żmien li jinkludu stat ta' konfużjoni, rogħda, disturb konoxxittiv, enċefalopatija, u konvulżjoni.
English: Relapse was defined as haematological relapse (blasts in bone marrow greater than 5% following CR) or an extramedullary relapse.
Maltese: Rikaduta kienet definita bħala irkadar ematoloġiku (blasts fil-mudullun akbar minn 5% wara CR) jew rikaduta ekstramedullari.
English: 5 mcg/m2/day via continuous infusion (not to exceed 9 mcg/day)
Maltese: 5 mcg/m2/jum permezz ta' infużjoni kontinwa (li m'għandhiex taqbeż
English: Pre-filled bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
Maltese: Tikkargax b'soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: e for CR /CRh* [95% CI]
Maltese: MRD komplut [95% CI]
English: Hyperbilirubinaemia a,
Maltese: Newtropenija bid-deni Enemija1
English: Serious adverse events that may be signs and symptoms of CRS included pyrexia, asthenia, headache, hypotension, total bilirubin increased, and nausea; uncommonly, these events led to BLINCYTO discontinuation.
Maltese: Avvenimenti avversi serji li jistgħu jkunu sinjali u sintomi ta' CRS jinkludu deni, astenja, uġigħ ta' ras, pressjoni baxxa, żieda fl-għadd totali ta' bilirubina, u nawsja; f'każijiet mhux komuni, dawn l-avvenimenti wasslu għal waqfien ta' BLINCYTO.
English: • low blood pressure
Maltese: • pressjoni baxxa
English: b.
Maltese: c.
English: Infusion-related reactions is a composite term that includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion and event lasted <=2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, rash, tachypnea, swelling face, face oedema and rash erythematous.
Maltese: 16 Tnaqqis fl-immunoglobulini jinkludi tnaqqis fl-immunoglobulina G fid-demm, tnaqqis fil-globulini, ipogammaglobulinemija, ipoglobulinemija u tnaqqis fl-immunoglobulini 17 Reazzjonijiet relatati mal-infużjoni huwa terminu kompost li jinkludi t-terminu reazzjoni relatata mal-infużjoni u l-avvenimenti li ġejjin li jseħħu fl-ewwel 48 siegħa wara l-infużjoni u avveniment li dam <=jumejn: deni, sindrome ta' reħa ta' ċitokini, pressjoni baxxa, uġigħ fil-muskoli, ħsara akuta fil-kliewi, pressjoni għolja, raxx, takipneja, nefħa fil-wiċċ, edima fil-wiċċ u raxx eritematuż.
English: Elastomeric pumps should not be used.
Maltese: Ma għandhomx jintużaw pompi elastomeriċi.
English: For patients with Philadelphia chromosome negative relapsed or refractory B-precursor ALL and patients with MRD positive B-precursor ALL receiving BLINCYTO, consideration to discontinue BLINCYTO temporarily or permanently as appropriate should be made in the case of the following severe (grade 3) or life-threatening (grade 4) toxicities (see section 4.4): cytokine release syndrome,
Maltese: Għal pazjenti b'ALL bi prekursur B li reġgħet feġġet jew reżistenti u negattiva għall-kromosoma ta' Philadelphia, u pazjenti b'ALL bi prekursur B pożittiva għal MRD li jirċievu BLINCYTO, għandu jitqies il-waqfien temporanju jew permanenti ta' BLINCYTO skont kif meħtieġ f'każ tat-tossiċitajiet severi (grad 3) jew perikolużi għall-ħajja (grad 4) li ġejjin (ara sezzjoni 4.4): sindrome ta' reħa ta' ċitokini, sindrome ta' lisi ta' tumur, tossiċità newroloġika, żieda fl-enzimi tal-fwied u kull tossiċità oħra li għandha sinifikant kliniku.
English: Grade 3 Interrupt BLINCYTO until no more than grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 9 mcg/day.
Maltese: BLINCYTO sakemm tonqos sa grad 1 (ħafifa) u għal tal-inqas 3 ijiem, imbagħad ibda BLINCYTO mill-ġdid b'9 mcg/jum.
English: • if you have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
Maltese: • jekk ikollok uġigħ sever u persistenti fl-istonku, flimkien ma' dardir u rimettar jew mingħajrhom, għax dawn jistgħu jkunu sintomi ta' kondizzjoni serja u potenzjalment fatali magħrufa bħala pankreatite (infjammazzjoni tal-frixa).
English: Median, years (min, max) Mean, years (SD) ≥ 65 Years, n (%) Prior salvage therapy
Maltese: Medjan, snin (min, max) Medja, snin (SD) ≥ 65
English: Consider discontinuing BLINCYTO permanently.
Maltese: Ikkunsidra li twaqqaf BLINCYTO b'mod permanenti.
English: • nausea, diarrhoea, vomiting, constipation, abdominal pain
Maltese: • nawsja, dijarea, rimettar, stitikezza, uġigħ addominali
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 15 mcg/m2/day dose
Maltese: Għal pazjenti li jiżnu inqas minn 45 kg: volumi ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, soluzzjoni (stabbilizzanti), u BLINCYTO rikostitwit biex jiżdied mal-borża tal-infużjoni għal doża ta' 15 mcg/m2/jum.