FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients weighing greater than or equal to 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag
Maltese: Għal pazjenti li jiżnu aktar minn jew 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
English: Patients received BLINCYTO at a constant dose of 15 mcg/m2/day (equivalent to the recommended dosage of 28 mcg/day) for all treatment cycles.
Maltese: Pazjenti rċevew BLINCYTO b'doża kostanti ta' 15 mcg/m2/jum (ekwivalenti għad-dożaġġ rakkomandat ta' 28 mcg/jum) għaċ-ċikli kollha tattrattament.
English: Follow the steps for reconstituting BLINCYTO and preparing the infusion bag detailed below table 9.
Maltese: Segwi l-passi għar-rikostituzzjoni ta' BLINCYTO, u pprepara l-borża tal-infużjoni deskritta hawn taħt fit-tabella 9.
English: Do not shake.
Maltese: nonresponder e.
English: 5 mcg/m2/day
Maltese: 5 mcg/m2/jum24 siegħa
English: Median OS, mo
Maltese: OS Medjana, xhur
English: Neurologic events
Maltese: Disturbi psikjatriċia
English: • Remarks on the importance of reporting ADRs
Maltese: • Kummenti dwar l-importanza tar-rappurtar tal-ADRs
English: CR was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
Maltese: CR kienet iddefinita bħala ≤ 5% ta' blasts fil-mudullun, l-ebda evidenza ta' mard, u rkupru sħiħ tal-għadd ta' ċelluli tad-demm periferali (plejtlits > 100,000/mikrolitru u għadd assolut ta' newtrofili [ANC - absolute neutrophil counts] > 1,000/mikrolitru).
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 5 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' 5 mcg/m2/jum.
English: Among treated patients, the median age was 39 years (range: 18 to 79 years, including 25 patients ≥ 65 years of age), 64 of 189 (33.9%) had undergone HSCT prior to receiving BLINCYTO and 32 of 189 (16.9%) had received more than 2 prior salvage therapies.
Maltese: Il-pazjenti li kellhom rispons għal BLINCYTO iżda li l-ALL tagħhom reġgħet feġġet, kellhom l-għażla li jerġgħu jingħataw it-trattament bi BLINCYTO. Fost il-pazjenti ttrattati, l-età medjana kienet ta' 39 sena (medda: 18 sa 79 sena, li kienu jinkludu 25 pazjent ta' ≥ 65 sena) 64 minn 189 (33.9%) kienu sottoposti għal HSCT qabel ma rċevew BLINCYTO u 32 minn 189 (16.9%) kienu rċevew iżjed minn 2 terapiji ta' salvataġġ preċedenti.
English: BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
Maltese: BLINCYTO huwa indikat bħala monoterapija għat-trattament ta' pazjenti pedjatriċi bl-età ta' sena jew aktar b'ALL bi prekursur B pożittiva għal CD19 u negattiva għall-kromosoma ta' Philadelphia, li hija reżistenti jew reġgħet feġġet wara li jirċievu tal-inqas żewġ terapiji preċedenti jew li reġgħet feġġet wara li jirċievu trapjant ta' ċelluli staminali ematopoetiċi alloġeniċi preċedenti.
English: There is limited experience with BLINCYTO in patients with an active uncontrolled infection.
Maltese: Hemm esperjenza limitata bi BLINCYTO f'pazjenti b'infezzjoni attiva mhux ikkontrollata.
English: Management of infections may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Maltese: L-immaniġġjar ta' infezzjonijiet jista' jeħtieġ l-interruzzjoni temporanja jew il-waqfien ta' BLINCYTO (ara sezzjoni 4.2).
English: Demographics and baseline characteristics in MRD study
Maltese: Demografija u Karatteristiċi fil-Linja
English: A total of 456 patients aged ≥ 18 years of age with relapsed or refractory B-precursor ALL were exposed to BLINCYTO during the phase II and phase III clinical studies described below.
Maltese: Total ta' 456 pazjent b'età ta' ≥ 18-il sena b'ALL bi prekursur B li reġgħet feġġet jew reżistenti kienu esposti għal BLINCYTO matul l-istudji kliniċi ta' fażi
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), 22.4% of patients reported elevated liver enzymes and associated signs/symptoms.
Maltese: II (N = 189), 22.4% tal-pazjenti rrappurtaw żieda fl-enzimi tal-fwied u sinjali/sintomi assoċjati.
English: • Recommendation to monitor patients for signs and symptoms of neurotoxicity
Maltese: • Rakkomandazzjoni biex il-pazjenti jiġu mmonitorjati għal sinjali u sintomi ta' newrotossiċità
English: BLINCYTO has been evaluated in paediatric patients with relapsed or refractory B-precursor ALL in a phase I/II dose escalation/evaluation study, in which 70 paediatric patients, aged 7 months to 17 years, were treated with the recommended dosage regimen.
Maltese: BLINCYTO kien evalwat f'pazjenti pedjatriċi b'ALL bi prekursur B li reġgħet feġġet jew reżistenti fi studju tal-fażi I/II ta' eskalazzjoni/evalwazzjoni tad-doża, li fih 70 pazjent pedjatriku, bl-età ta' 7 xhur sa 17-il sena, ġew ittrattati bir-reġim tad-dożaġġ speċifikat.
English: Follow the steps for reconstituting BLINCYTO and preparing the infusion bag detailed below table 3.
Maltese: Segwi l-passi għar-rikostituzzjoni ta' BLINCYTO, u pprepara l-borża tal-infużjoni deskritta hawn taħt fit-tabella 3.
English: Unopened vials:
Maltese: Tel/Tél:
English: The most serious adverse reactions that may occur during blinatumomab treatment include: infections (24.8%), neurologic events (13.8%), neutropenia/febrile neutropenia (10.1%), cytokine release syndrome (3.3%), and tumour lysis syndrome (0.7%).
Maltese: Ir-reazzjonijiet avversi l-aktar serji li jistgħu jseħħu matul it-trattament bi blinatumomab jinkludu: infezzjonijiet (24.8%), avvenimenti newroloġiċi (13.8%), newtropenija/newtropenija bid-deni (10.
English: Postbaseline alloHSCT - n (%) Overall subjects Hematological responders (CR/CRh*/CRi) Time to alloHSCT among all transplanted patients Median time to event (Interquartile range)
Maltese: Żmien għal alloHSCT fost persuni li kellhom rispons ta' CR/CRh*/CRi Żmien medjan għall-avveniment [CI ta' 95%] (stima KM)
English: Cytokine release syndrome (CRS) which may be life-threatening or fatal (grade ≥ 4) has been reported in patients receiving BLINCYTO (see section 4.8).
Maltese: Is-sindrome ta' reħa ta' ċitokini (CRS - cytokine release syndrome) li tista' tkun ta' periklu għall-ħajja jew fatali (grad ≥ 4) kienet irrappurtata f'pazjenti li qed jirċievu BLINCYTO (ara sezzjoni 4.8).
English: Reconstituted solution:
Maltese: Kunjetti mhux miftuħin:
English: BLINCYTO solution for infusion is administered as a continuous intravenous infusion delivered at a constant flow rate using an infusion pump over a period of up to 96 hours.
Maltese: BLINCYTO soluzzjoni għall-infużjoni jingħata bħala infużjoni kontinwa fil-vini mogħtija b'rata ta' fluss kostanti bl-użu ta' pompa tal-infużjoni fuq perjodu sa 96 siegħa.
English: The safety and efficacy of BLINCYTO in adult patients with MRD positive B-precursor ALL were evaluated in an open-label, multicentre, single-arm study.
Maltese: Is-sigurtà u l-effikaċja ta' BLINCYTO f'pazjenti adulti b'ALL bi prekursur B pożittiva għal MRD ġew evalwati fi studji open-label, b'aktar minn ċentru wieħed u bi grupp wieħed.
English: If the toxicity occurred at 5 mcg/m2/day, or if the toxicity takes more than 7 days to resolve, discontinue BLINCYTO permanently
Maltese: Jekk it-tossiċità seħħet b'5 mcg/m2/jum, jew jekk ittossiċità ddum iżjed minn 7 ijiem biex tgħaddi, waqqaf BLINCYTO b'mod permanenti.
English: Dose adjustments
Maltese: Sopravivenza globali
English: Hyperbilirubinaemia includes blood bilirubin increased and hyperbilirubinaemia.
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata.
English: • increased bilirubin in the blood
Maltese: • sogħla bil-bili
English: Solution (stabiliser): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Maltese: Soluzzjoni (stabbilizzanti): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide u ilma għall-injezzjonijiet.
English: Decreased immunoglobulins
Maltese: Ilma għall-injezzjonijiet
English: The primary endpoint was the complete remission/complete remission with partial haematological recovery (CR/CRh*) rate within 2 cycles of treatment with BLINCYTO.
Maltese: Il-punt ta' tmiem primarju kien ir-rata ta' remissjoni sħiħa/remissjoni sħiħa b'irkupru ematoloġiku parzjali (CR/CRh* - complete remission/complete remission with partial haematological recovery) fi żmien 2 ċikli ta' trattament bi BLINCYTO.
English: 15 mcg/m2/day
Maltese: 15 mcg/m2/jum24 siegħa
English: 2.1 mL (1) 2.0 mL (1) 1.8 mL (1) 1.7 mL (1) 1.6 mL (1) 1.4 mL (1) 1.3 mL (1) 1.1 mL (1) 1.00 mL (1) 0.86 mL (1) 0.72 mL (1) 0.59 mL (1)
Maltese: 2.1 mL (1) 2.0 mL (1) 1.8 mL (1) 1.7 mL (1) 1.6 mL (1) 1.4 mL (1) 1.3 mL (1) 1.1 mL (1) 1.00 mL (1) 0.86 mL (1) 0.
English: Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor ALL (relapsed with first remission duration of ≤ 12 months in first salvage, or relapsed or refractory after first salvage therapy, or relapsed within 12 months of allogeneic HSCT, and had ≥ 10% blasts in bone marrow).
Maltese: Il-pazjenti eliġibbli kellhom ≥ 18-il sena u kellhom ALL bi prekursur B negattiva għallkromosoma ta' Philadelphia li reġgħet feġġet jew reżistenti (li reġgħet feġġet mal-ewwel perjodu ta' remissjoni ta' ≤ 12-il xahar fl-ewwel terapija ta' salvataġġ, jew li reġgħet feġġet jew saret reżistenti wara l-ewwel terapija ta' salvataġġ, jew li reġgħet feġġet fi żmien 12-il xahar ta' trapjant ta' ċelluli staminali ematopojetiċi (HSCT - hematopoietic stem cell transplantation) alloġeniku, u kellha ≥ 10% blasts fil-mudullun).
English: e. Relapse was defined as haematological relapse (blasts in bone marrow greater than 25% following CR) or an extramedullary relapse.
Maltese: Rikaduta kienet definita bħala irkadar ematoloġiku (blasts fil-mudullun akbar minn 25% wara CR) jew rikaduta ekstramedullari.
English: - The other ingredients in the powder are citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80, and sodium hydroxide.
Maltese: - Is-sustanzi l-oħra fit-trab huma citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80, u sodium hydroxide.
English: Under aseptic conditions, attach the intravenous tubing to the infusion bag with the sterile 0.2 micron in-line filter.
Maltese: 9 Pressjoni għolja tinkludi żieda fil-pressjoni u pressjoni għolja.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużawx minnufih, iż-żmien tal-ħżin waqt l-użu u l-kondizzjonijiet ta' qabel l-użu ikunu firresponsabbiltà tal-utent u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C - 8°C, sakemm id-dilwizzjoni ma sseħħx f'kondizzjonijiet asettiċi kkontrollati u validati.
English: Cytokine release syndrome, tumour lysis syndrome
Maltese: Sindrome ta' reħa ta' ċitokini, sindrome ta' lisi ta' tumur
English: In addition, reactivations of virus infection (e.g. Polyoma (BK)) have been observed in the phase II clinical study in adults with Philadelphia chromosome negative relapsed or refractory B-precursor ALL.
Maltese: II kienu osservati riattivazzjonijiet ta' infezzjoni virali (eż. Polyoma (BK)) f'adulti b'ALL bi prekursur B li reġgħet feġġet jew reżistenti u negattiva għall-kromosoma ta' Philadelphia.
English: • if you have ever had neurological problems, for example, shaking (or tremor), abnormal sensations, seizures, memory loss, confusion, disorientation, loss of balance, or difficulty in speaking.
Maltese: • jekk qatt kellek problemi newroloġiċi, pereżempju, rogħda, sensazzjonijiet mhux normali, aċċessjonijiet, telf ta' memorja, konfużjoni, diżorjentazzjoni, telf ta' bilanċ, jew diffikultà fittaħdit.
English: After reconstitution with water for injections each vial contains 12.5 micrograms/mL of blinatumomab.
Maltese: Wara r-rikostituzzjoni bl-ilma għall-injezzjonijiet, kull kunjett ikun fih 12.5 mikrogrammi/mL ta' blinatumomab.
English: The majority of patients who respond to blinatumomab achieve a response after 1 cycle (see section 5.1).
Maltese: Ilmaġġoranza tal-pazjenti li jirrispondu għal blinatumomab jiksbu rispons wara ċiklu wieħed (ara sezzjoni 5.1).
English: Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and anti-leukaemic chemotherapy (including systemic high dose methotrexate or intrathecal cytarabine).
Maltese: Kienu osservati bidliet fl-immaġni bir-riżonanza manjetika (MRI - magnetic resonance imaging) talkranju li juru lewkoenċefalopatija f'pazjenti li qed jirċievu BLINCYTO, b'mod speċjali f'pazjenti li ngħataw trattament preċedenti bl-irradjazzjoni kranjali u kimoterapija kontra l-lewkimja (li jinkludi dożi sistemiċi għoljin ta' methotrexate jew cytarabine ġot-teka).
English: Your doctor will take regular blood tests to monitor your blood counts during treatment with BLINCYTO.
Maltese: • Deskrizzjoni dettaljata tal-proċeduri ta' rikostituzzjoni u preparazzjoni ta' BLINCYTO
English: Patients were randomised 2:1 to receive BLINCYTO or 1 of 4 prespecified, investigator-selected, SOC backbone chemotherapy regimens.
Maltese: Il-pazjenti kienu randomised 2:1 biex jirċievu BLINCYTO jew 1 minn 4 korsijiet ta' kimoterapija SOC ewlenija, speċifikata minn qabel u magħżula mill-investigatur.
English: Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal dysfunction and normal renal function.
Maltese: L-analiżi farmakokinetika wriet differenza kważi doppja fil-valuri medji tat-tneħħija ta' blinatumomab bejn pazjenti b'disfunzjoni tal-kliewi moderata u dawk b'funzjoni tal-kliewi normali.
English: 3 Thrombocytopenia includes platelet count decreased and thrombocytopenia.
Maltese: Inti tista' tgħin billi tirrapporta kwalunkwe effett sekondarju li jista' jkollok.
English: Treatment with BLINCYTO was associated with transient elevations in liver enzymes.
Maltese: It-trattament bi BLINCYTO kien assoċjat ma' żidiet temporanji fl-enzimi tal-fwied.
English: The patient alert card should contain:
Maltese: Il-kartuna ta' twissija għall-pazjent għandu jkun fiha:
English: Blast free hypoplastic or aplastic bone marrow was defined as bone marrow blasts ≤ 5%, no evidence of disease, insufficient recovery of peripheral blood counts: platelets ≤ 50,000/microlitre and/or ANC ≤ 500/microlitre.
Maltese: 3. Il-mudullun ipoplastiku jew aplastiku ħieles minn blasts kien definit bħala blasts tal-mudullun ta' ≤ 5%, ebda evidenza ta' mard, irkupru insuffiċjenti tal-għadd taċ-ċelluli tad-demm periferali: plejtlits ≤ 50,000/mikrolitru u/jew ANC ≤ 500/mikrolitru.
English: Citric acid monohydrate (E330) Lysine hydrochloride Polysorbate 80
Maltese: Citric acid monohydrate (E330)
English: Following continuous intravenous infusion, the steady state serum concentration (Css) was achieved within a day and remained stable over time.
Maltese: Wara infużjoni kontinwa ġol-vini, il-konċentrazzjoni fis-serum fi stat fiss (Css - steady state serum concentration) inkisbet fi żmien ġurnata u baqgħet stabbli maż-żmien.
English: Nausea
Maltese: Pożoloġija
English: At a dose higher than the recommended dose, a case of fatal cardiac failure occurred in the setting of life-threatening cytokine release syndrome (CRS) and tumour lysis syndrome (TLS), see section 4.4.
Maltese: F'doża ogħla mid-doża rakkomandata, seħħ każ ta' insuffiċjenza tal-qalb fatali fil-preżenza ta' sindrome ta' reħa ta' ċitokini (CRS - cytokine release syndrome) u sindrome ta' lisi ta' tumur (TLStumour lysis syndrome) ta' periklu għall-ħajja, ara sezzjoni 4.4.
English: c. CRi (complete remission with incomplete haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microlitre or ANC > 1,000/microlitre).
Maltese: CRi (Remissjoni sħiħa b'irkupru ematoloġiku mhux sħiħ) kienet definita bħala ≤ 5% ta' blasts fil-mudullun, lebda evidenza ta' mard, u rkupru mhux komplut tal-għadd ta' ċelluli tad-demm periferali (plejtlits > 100,000/mikrolitru jew ANC > 1,000/mikrolitru).
English: Your next cycles
Maltese: DATA TA' SKADENZA
English: If clinically relevant, interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Maltese: Jekk ta' sinifikat kliniku, interrompi BLINCYTO sakemm tonqos għal livell 1 (ħafifa), imbagħad ibda BLINCYTO millġdid b'5 mcg/m2/jum.
English: The target dose of 28 mcg/day was administered in cycle 2 and subsequent cycles starting on day 1 of each cycle.
Maltese: Id-doża mmirata ta' 28 mcg/jum ingħatat f'ċiklu 2 u f'ċikli sussegwenti b'bidu f'jum 1 ta' kull ċiklu.
English: Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient's body surface area (BSA).
Maltese: Pazjenti li jiżnu aktar minn 45 kg jirċievu doża fissa u għal pazjenti li jiżnu inqas minn 45 kg, id-doża hija kkalkulata permezz tal-erja tas-superfiċje talġisem (BSA) tal-pazjent.
English: Pyrexia Chills Oedema
Maltese: Lysine hydrochloride
English: Life-threatening or fatal (grade ≥ 4) viral, bacterial and fungal infections have been reported in patients treated with BLINCYTO.
Maltese: Infezzjonijiet virali, batteriċi u fungali ta' periklu għall-ħajja jew fatali (grad ≥ 4) kienu rrappurtati f'pazjenti ittrattati bi BLINCYTO.
English: • BLINCYTO treatment start date
Maltese: • diffikultà biex titkellem
English: Cytokine storm
Maltese: Rata talinfużjoni
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1. - Treddigħ (ara sezzjoni 4.6).
English: BLINCYTO is used when acute lymphoblastic leukaemia has come back or has not responded to previous treatment (referred to as relapsed/refractory acute lymphoblastic leukaemia).
Maltese: BLINCYTO jintuża meta lewkimja limfoblastika akuta terġa' tfeġġ jew ma tkunx irrispondiet għal trattament preċedenti (imsejħa lewkimija limfoblastika akuta li reġgħet feġġet jew reżistenti).
English: • coughing with phlegm
Maltese: • żieda ta' bilirubina fid-demm
English: Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur.
Maltese: Żid għal 15 mcg/m2/jum wara 7 ijiem jekk it-tossiċità ma terġax isseħħ.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara EXP.
English: 14-day treatment-free interval
Maltese: TAL-PRODOTT MEDIĊINALI
English: BLINCYTO solution for infusion is administered as a continuous intravenous infusion delivered at a constant flow rate using an infusion pump, over a period of up to 96 hours.
Maltese: BLINCYTO soluzzjoni għall-infużjoni jingħata bħala infużjoni kontinwa fil-vini mogħtija b'rata ta' fluss kostanti bl-użu ta' pompa tal-infużjoni, fuq perjodu sa 96 siegħa.
English: Posology
Maltese: Sími:
English: • chills, shivering, fever, rapid heart rate, decreased blood pressure, aching muscles, feeling tired, coughing, difficulty breathing, confusion, redness, swelling or discharge in the affected area or at the site of the infusion line - these may be signs of an infection.
Maltese: • sirdat, tertir, deni, rata tal-qalb mgħaġġla, pressjoni baxxa, uġigħ fil-muskoli, tħossok għajjien, sogħla, diffikultà biex tieħu n-nifs, konfużjoni, ħmura, nefħa jew tnixxija fis-sit affettwat jew fis-sit tal-pajp tal-infużjoni - dawn jistgħu jkunu sinjali ta' infezzjoni.
English: However patients have been treated with blinatumomab in clinical studies after clearance of CSF blasts with CNS directed therapy (such as intrathecal chemotherapy).
Maltese: Pazjenti li qed jirċievu BLINCYTO għandhom ikunu mmonitorjati klinikament għal sinjali u sintomi ta' infezzjoni u jiġu ttrattati kif xieraq.
English: • 21-23 gauge needle(s) (recommended)
Maltese: • Labra(ar) bi ħxuna ta' 21-23 (rakkomandat)
English: Among treated patients, the median age was 8 years (range: 7 months to 17 years), 40 out of 70 (57.1%) had undergone allogeneic HSCT prior to receiving BLINCYTO, and 39 out of 70 (55.7%) had refractory disease.
Maltese: Il-popolazzjoni trattata (fil-partijiet tas-sejbien tad-doża, l-espansjoni PK u l-effikaċja) inkludiet 70 pazjent li rċevew mill-inqas infużjoni waħda ta' BLINCYTO, fid-doża rakkomandata; in-numru medju ta' ċikli tat-trattament kien 1.5. Fost il-pazjenti ttrattati, l-età medjana kienet ta' 8 snin (medda: 7 xhur sa 17-il sena), 40 minn 70 (57.1%) kienu għaddew minn HSCT alloġeniku qabel ma ngħataw BLINCYTO, u 39 minn 70 (55.7%) kellhom marda refrattorja.
English: Philadelphia chromosome negative relapsed or refractory B-precursor ALL
Maltese: diffikultà biex tiftakar, diffikultà biex tikkontrolla l-moviment (atassja)
English: Rash
Maltese: Trab
English: MRD status at screening was determined from bone marrow aspirations using flow cytometry or polymerase chain reaction (PCR) at a minimum sensitivity of 10
Maltese: L-istatus ta' MRD fl-iskrining kien determinat minn aspirazzjonijiet talmudullun permezz ta' ċitometrija tal-fluss jew reazzjoni katina tal-polimerażi (PCR) f'sensittività baxxa ta' 10-4 abbażi ta' evalwazzjonijiet lokali fuq il-post.
English: CR was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
Maltese: ċelluli tad-demm periferali (plejtlits > 100,000/mikrolitru u għadd assolut ta' newtrofili [ANC - absolute neutrophil counts] > 1,000/mikrolitru).
English: From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the reconstituted solution should be diluted immediately.
Maltese: Mil-lat mikrobijoloġiku, sakemm il-metodu tar-rikostituzzjoni ma jipprekludix ir-riskji ta' kontaminazzjoni mikrobika, is-soluzzjoni rikostitwita għandha tiġi dilwita minnufih.
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: • Description of the administration procedures of BLINCYTO and how to reduce the risk of ME while using the infusion pump.
Maltese: • Tfakkira biex jingħata parir lill-pazjenti dwar kif inaqqsu r-riskju ta' ME waqt li jkunu qed jużaw il-pompa tal-infużjoni.
English: Your doctor will take regular blood tests during treatment with BLINCYTO.
Maltese: It-tabib tiegħek se jieħu testijiet tad-demm regolari matul it-trattament bi BLINCYTO.
English: It is recommended that a neurological examination be performed in patients prior to starting BLINCYTO therapy and that patients be clinically monitored for signs and symptoms of neurologic events (e.g. writing test).
Maltese: Huwa rakkomandat li jitwettaq eżami newroloġiku fil-pazjenti qabel ma tinbeda t-terapija bi BLINCYTO u li l-pazjenti jiġu mmonitorjati klinikament għal sinjali u sintomi ta' avvenimenti newroloġiċi (eż. test tal-kitba).
English: PC SN NN
Maltese: Pazjenti fit-tielet CR
English: Pre-phase treatment for patients with high tumour burden
Maltese: Reżistenti għal terapija primarja