FrancophonIA/ELRC3.0 huggingface dataset:
English: • high levels of some enzymes including blood enzymes
Maltese: • livelli għoljin ta' xi enzimi inklużi enzimi tad-demm
English: Thirty-two of 189 (17%) patients underwent allogeneic HSCT in CR/CRh* induced with BLINCYTO (see table 3).
Maltese: Tnejn u tletin minn 189 (17%) pazjent kellhom HSCT alloġeniku f'CR/CRh* indotta minn BLINCYTO (ara tabella 1).
English: These may include corticosteroids (e.g. dexamethasone).
Maltese: Dawn jistgħu jinkludu kortikosterojdi (eż. dexamethasone).
English: 5 years
Maltese: 5 snin
English: 100 day mortality after alloHSCT n/N (%), [95% CI]
Maltese: Mortalità 100 jum wara alloHSCT n/N (%), [CI ta' 95%]
English: Sodium hydroxide (for pH-adjustment)
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: 3.6 months (2.3, 7.2) (N = 33)
Maltese: 3.6 xhur (2.3, 7.2) (N = 33)
English: Immunisations
Maltese: Immunoġeniċità
English: The estimated mean (SD) volume of distribution (Vz), clearance (CL) and terminal half-life (t1/2,z) were 3.91 (3.36) L/m2, 1.88 (1.90) L/hr/m and 2.19 (1.53) hours, respectively.
Maltese: Il-volum ta' distribuzzjoni (Vz) medju stmat (SD), it-tneħħija (CL) u l-half-life terminali (t1/2,z) kienu 3.91 (3.36) L/m2, 1.88 (1.90)
English: Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 8.0% and 4.4% of adult patients with MRD positive B-precursor ALL.
Maltese: Avvenimenti ta' grad ≥ 3 u grad ≥ 4, rispettivament, ġew irrapportati għal 8.0% u 4.4% tal-pazjenti adulti b'ALL bi prekursur B pożittiva għal MRD.
English: The most frequently reported serious adverse events were pyrexia (11.4%), febrile neutropenia (11.4%), cytokine release syndrome (5.7%), sepsis (4.3%), device-related infection (4.3%), overdose (4.3%), convulsion (2.9%), respiratory failure (2.9%), hypoxia (2.9%), pneumonia (2.9%), and multi-organ failure (2.9%).
Maltese: Ir-reazzjonijiet avversi serji rrapportati l-aktar kienu deni (11.4%), newtropenija bid-deni (11.4%), sindrome ta' reħa ta' ċitokini (5.7%), sepsi (4.3%), infezzjoni relatata mal-apparat (4.3%), doża eċċessiva (4.3%), konvulżjoni (2.9%), insuffiċjenza respiratorja (2.9%), ipoksja (2.9%), pulmonite (2.9%), u insuffiċjenza ta' ħafna organi (2.9%).
English: • Data from clinical trials, frequency and severity (grade 3 and 4 neurological toxicities were observed)
Maltese: • Dejta mill-provi kliniċi, il-frekwenza u s-severità (kienu osservati tossiċitajiet newroloġiċi ta' grad 3 u 4)
English: • Infusion rate of 2.5 mL/h for a duration of 96 hours
Maltese: • Rata ta' infużjoni ta' 2.5 mL/siegħa għal tul ta' 96 siegħa
English: 1 Anaemia includes anaemia and haemoglobin decreased.
Maltese: 1 Anemija tinkludi anemija u tnaqqis fl-emoglobina.
English: • infections in the blood including bacteria, fungi, viruses, or other types of infection
Maltese: • infezzjonijiet fid-demm inkluż batterji, fungi, viri, jew tipi oħrajn ta' infezzjoni
English: Body surface area (0.37 to 2.70 m2) influences the pharmacokinetics of blinatumomab.
Maltese: L-erja tas-superfiċje talġisem (0.37 sa 2.70 m2) tinfluwenza l-farmakokinetika ta' blinatumomab.
English: Infusion rate (mL/hour)
Maltese: Rata tal-infużjoni (mL/siegħa)
English: At the recommended doses, the mean (SD) steady state concentration (Css) values were 162 (179) and 533 (392) pg/mL at 5 and 15 mcg/m2/day doses, respectively.
Maltese: Fid-dożi rakkomandati, il-valuri tal-konċentrazzjoni medja (SD) fl-istat stabbli (Css) kienu 162 (179) u 533 (392) pg/mL f'dożi ta' 5 u 15 mcg/m2/jum, rispettivament.
English: The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 90 mcg/m2/day (approximately equivalent to 9-162 mcg/day) in adult patients.
Maltese: Il-farmakokinetika ta' blinatumomab tidher lineari fuq medda tad-doża minn 5 sa 90 mcg/m2/jum (ekwivalenti għal madwar 9-162 mcg/jum) f'pazjenti adulti.
English: Cycle 1
Maltese: Ċiklu 1
English: RFS at 18 months not censored at HSCT or postBLINCYTO chemotherapy was 53% (44%, 62%).
Maltese: RFS fi 18-il xahar mhux iċċensurata f'HSCT jew kimoterapija wara BLINCYTO kienet 53% (44%, 62%)
English: Partial remission was defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.
Maltese: Remissjoni parzjali kienet definita bħala blasts tal-mudullun ta' 6% sa 25% b'mill-inqas tnaqqis ta' 50% mil linja bażi.
English: • BLINCYTO is compatible with polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Maltese: • BLINCYTO huwa kompatibbli ma' boroż tal-infużjoni/kasetts tal-pompa tal-polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), jew ethyl vinyl acetate (EVA).
English: 9 mcg/day via continuous infusion
Maltese: 9 mcg/jum permezz ta' infużjoni kontinwa
English: There is limited experience with BLINCYTO in patients ≥ 75 years of age.
Maltese: Hemm esperjenza limitata bi BLINCYTO f'pazjenti li għandhom ≥ 75 sena.
English: The mortality rate following alloHSCT among all responders who did not receive anti-leukemic therapy was 10/38 (26.3%; 95% CI: 13.4, 43.1) in the BLINCYTO group and 3/12 (25%; 95% CI: 5.5, 57.2) in the SOC group; such mortality rate at 100 days post alloHSCT was 4/38 (12.4%; 95% CI: 4.8%, 29.9%) in the BLINCYTO group and 0/12 (0%; 95% CI: not estimable) in the SOC group.
Maltese: Ir-rata ta' mortalità wara alloHSCT fost dawk li rrispondew b'mod komplut li ma rċivewx terapija kontra l-lewkimja kienet 10/38 (26.3%; CI ta' 95%: 13.4, 43.1) fil-grupp ta' BLINCYTO u 3/12 (25%; CI ta' 95%: 5.5, 57.2) fil-grupp ta' SOC; din ir-rata ta' mortalità 100 jum wara alloHSCT kienet 4/38 (12.4%; CI ta' 95%: 4.8%, 29.9%) fil-grupp ta' BLINCYTO u 0/12 (0%; CI ta' 95%: mhux stmat) filgrupp ta' SOC.
English: There is limited experience with blinatumomab in patients with documented active ALL in the CNS or cerebrospinal fluid (CSF).
Maltese: Hemm esperjenza limitata bi blinatumomab f'pazjenti b'ALL attiva dokumentata fis-CNS jew filfluwidu ċerebrospinali (CSF - cerebrospinal fluid).
English: Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 16.1% and 2.2% of adult patients with MRD positive B-precursor ALL.
Maltese: Avvenimenti ta' grad ≥ 3 u grad ≥ 4, rispettivament, ġew irrapportati għal 16.1% u 2.2% tal-pazjenti adulti b'ALL bi prekursur B pożittiva għal MRD.
English: 11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular and rash pruritic.
Maltese: 11 Raxx jinkludi eritema, raxx, raxx eritematuż, raxx ġeneralizzat, raxx makulari, raxx makulo-papulari u raxx bil-ħakk.
English: Adult patients with Eastern Cooperative Oncology Group (ECOG) performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of < 2.
Maltese: Il-pazjenti adulti bi stat ta' esekuzzjoni tal-Eastern Cooperative Oncology Group (ECOG) fil-linja bażi ta' 2 esperjenzaw inċidenza ogħla ta' infezzjonijiet serji meta mqabbla ma' pazjenti bi stat ta' esekuzzjoni tal-ECOG ta' < 2.
English: Randomisation was stratified by age (< 35 years versus ≥ 35 years of age), prior salvage therapy (yes versus no), and prior allogeneic HSCT (yes versus no) as assessed at the time of consent.
Maltese: Randomisation kienet stratifikata skont l-età (età ta' < 35 sena kontra ≥ 35 sena), terapija ta' salvataġġ preċedenti (iva kontra le), u HSCT alloġeniku preċedenti (iva kontra le) kif evalwat fiż-żmien tal-kunsens.
English: • neurologic events: shaking (or tremor), confusion, disturbances of brain function (encephalopathy), difficulty in communicating (aphasia), seizure (convulsion).
Maltese: • każijiet newroloġiċi: rogħda, konfużjoni, disturbi tal-funzjoni tal-moħħ (enċefalopatija), diffikultà biex tikkomunika (afasja), aċċessjoni (konvulżjoni).
English: o Ensure that the tubing is compatible with the infusion pump.
Maltese: o Kun ċert li l-pajp huwa kompatibbli mal-pompa tal-infużjoni.
English: Solution (stabiliser): Colourless-to-slightly yellow, clear solution with a pH of 7.0.
Maltese: Soluzzjoni (stabbilizzanti):Soluzzjoni trasparenti mingħajr kulur sa ftit safranija, b'pH ta' 7.0.
English: Hepatic enzyme increased includes alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased and transaminases increased.
Maltese: Żieda fl-enzimi tal-fwied tinkludi żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda f'gamma-glutamyltransferase, żieda fl-enzimi tal-fwied u zieda fit-transaminases.
English: In the event of a seizure, secondary prophylaxis with appropriate anticonvulsant medicinal products (e.g. levetiracetam) is recommended.
Maltese: Fil-każ ta' aċċessjoni, hija rakkomandata profilassi sekondarja bi prodotti mediċinali xierqa kontra lkonvulżjonijiet (eż. levetiracetam).
English: The estimated mean (SD) volume of distribution based on terminal phase (Vz) was 4.52 (2.89) L with the continuous intravenous infusion of blinatumomab.
Maltese: Il-volum medju (SD) stmat tad-distribuzzjoni bbażat fuq il-fażi terminali (Vz) kien 4.52 (2.89) L bl-infużjoni kontinwa ġol-vini ta' blinatumomab.
English: • Infusion rate of 5 mL/h for a duration of 48 hours
Maltese: • Rata ta' infużjoni ta' 5 mL/siegħa għal tul ta' 48 siegħa
English: • Nurse educational material
Maltese: • Materjal edukattiv għall-infermiera
English: Dyspnoea Productive cough Respiratory failure Wheezing
Maltese: Qtugħ ta' nifs Sogħla produttiva Insuffiċjenza respiratorja Tħarħir
English: a Complete MRD response was defined as the absence of detectable MRD confirmed in an assay with minimum sensitivity of 10-4 b One hundred thirteen patients (97.4%; 113/116) were included in the primary endpoint full analysis set
Maltese: MRD komplut ġie definit bħala n-nuqqas ta' MRD identifikabbli kkonfermata f'assaġġ b'sensittività minima ta' b Mija u tlettax-il pazjent (97.4%; 113/116) kienu inklużi fis-sett tal-analiżi sħiħ tal-punt tat-tmiem primarju
English: Additional information is provided in “Description of selected adverse reactions”.
Maltese: a Informazzjoni addizzjonali hija pprovduta fid-“Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: 28 mcg/day via continuous infusion
Maltese: 28 mcg/jum permezz ta' infużjoni kontinwa
English: A single cycle of treatment is 28 days (4 weeks) of continuous infusion.
Maltese: Ċiklu wieħed ta' trattament huwa 28 ġurnata (4 ġimgħat) ta' infużjoni kontinwa.
English: * Centrally assessed in an assay with minimum sensitivity of 10-4
Maltese: Mhux magħruf * Ivvalutat b'mod ċentrali f'assaġġ b'sensittività minima ta' 10-4
English: BLINCYTO contains sodium
Maltese: BLINCYTO fih is-sodium
English: BLINCYTO was also evaluated in an open-label, multicentre, single-arm phase II study of 189 patients.
Maltese: II, open-label, multiċentriku u bi grupp wieħed ta' 189 pazjent.
English: b MedDRA high level group terms (MedDRA version 18.1).
Maltese: b Termini tal-grupp ta' livell għoli tal-MedDRA (MedDRA verżjoni 16.1).
English: Disseminated intravascular coagulation (DIC) and capillary leak syndrome (CLS, e.g. hypotension, hypoalbuminaemia, oedema and haemoconcentration) have been commonly associated with CRS (see section 4.8).
Maltese: Il-koagulazzjoni intravaskulari mifruxa (DIC - disseminated intravascular coagulation) u s-sindrome ta' tnixxija kapillari (CLS - capillary leak syndrome, eż. pressjoni baxxa, ipoalbuminemija, edima u emokonċentrazzjoni) kienu assoċjati b'mod komuni ma' CRS (ara sezzjoni 4.8).
English: Other medicines and BLINCYTO
Maltese: Mediċini oħra u BLINCYTO
English: The median OS was 15.6 months (CI 5.5 - not estimable) for the BLINCYTO group and 5.3 months (CI 1.1 - not estimable) for the SOC chemotherapy group.
Maltese: L-OS medjana kienet 15.6 xhur (CI 5.5 - ma jistax jiġi stmat) għall-grupp ta' BLINCYTO u 5.3 xhur (CI 1.1 - ma jistax jiġi stmat) għall-grupp ta' kimoterapija SOC.
English: The mean (SD) half-life was 2.11 (1.42) hours.
Maltese: Il-half-life medja (SD) kienet ta' 2.11 (1.42) siegħa.
English: Clinical testing of MRD, regardless of the choice of technique, should be performed by a qualified laboratory familiar with the technique, following well established technical guidelines.
Maltese: L-ittestjar kliniku ta' MRD, irrispettivament mill-għażla tat-teknika, għandu jitwettaq minn laboratorju kwalifikat familjari matteknika, segwit minn linji gwida tekniċi stabbiliti sew.
English: Headache Tremor
Maltese: Tqala u treddigħ
English: 5-free survival (RFS) for CR/CRh*
Maltese: Sopravivenza mingħajr rikaduta5 (RFS - relapse-free survival) għal CR/CRh*
English: Chemical and physical in-use stability has been demonstrated for 10 days at 2°C - 8°C or 96 hours at or below 27°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 10 ijiem f'temperatura ta' 2°C - 8°C jew għal 96 siegħa f'temperatura ta' 27°C jew inqas.
English: In clinical studies of adult ALL patients treated with BLINCYTO, less than 3% tested positive for anti-blinatumomab antibodies.
Maltese: Fi studji kliniċi ta' pazjenti adulti b'ALL ittrattati bi BLINCYTO, anqas minn 3% ittestjaw pożittivi għal antikorpi anti-blinatumomab.
English: b, n (%) [95% CI] CR, n (%) [95% CI] CRh*, n (%) [95% CI] Complete MRD response for CR /CRh*
Maltese: CRa/CRh*b, n (%) [CI ta' 95%] CR, n (%)[CI ta' 95%] CRh*, n (%) [Cl ta' 95%] Rispons MRD komplut għal CR /CRh*c, n1/n2d (%) [Cl ta' 95%] CR, n1/n2d (%) [Cl ta' 95%] CRh*, n1/n2d (%) [Cl ta' 95%] Sopravivenza mingħajr rikaduta medjanae(RFS)e għal CR /CRh* [Cl ta' 95%]
English: Paraesthesia Seizure
Maltese: Prepazzjoni asettika
English: Neurological toxicity
Maltese: Tossiċità newroloġika
English: Table 7 provides instructions for patients weighing greater than or equal to 45 kg, whereas table 8 and table 9 provide instructions for patients weighing less than 45 kg.
Maltese: Tabella 7 tipprovdi istruzzjonijiet għal pazjenti li jiżnu aktar minn 45 kg filwaqt li tabella 8 u tabella 9 jipprovdu istruzzjonijiet għal pazjenti li jiżnu inqas minn 45 kg.
English: Hepatic enzyme increased a, 15
Maltese: Żieda fl-enzimi tal fwieda, 15
English: • Polyolefin, PVC non-DEHP, or EVA intravenous tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micrometre in-line filter.
Maltese: • Pajp għal ġol-vini tal-polyolefin, PVC non-DEHP, jew EVA b'filtru fil-pajp sterili, mhux piroġeniku u li jintrabat b'mod baxx mal-proteini ta' 0.2 mikrometri.
English: A single cycle of treatment of BLINCYTO induction or consolidation is 28 days (4 weeks) of continuous intravenous infusion followed by a 14 day (2 week) treatment-free interval (total 42 days).
Maltese: Ċiklu wieħed ta' trattament ta' induzzjoni jew ta' konsolidazzjoni bi BLINCYTO huwa 28 ġurnata (4 ġimgħat) ta' infużjoni kontinwa fil-vini segwita minn intervall ta' 14-il ġurnata (ġimagħtejn) mingħajr trattament (total ta' 42 jum).
English: Table 1 provides instructions for patients weighing greater than or equal to 45 kg whereas table 2 and table 3 provide instructions for patients weighing less than 45 kg.
Maltese: Tabella 1 tipprovdi istruzzjonijiet għal pazjenti li jiżnu aktar minn 45 kg filwaqt li tabella 2 u tabella 3 jipprovdu istruzzjonijiet għal pazjenti li jiżnu inqas minn 45 kg.
English: Sodium chloride 9 mg/mL (0.9%) (starting volume)
Maltese: Sodium chloride 9 mg/mL (0.9%) (volum tal-bidu)
English: • disturbances of brain function (encephalopathy) such as difficulty in communicating (aphasia),
Maltese: • disturbi fil-funzjoni tal-moħħ (enċefalopatija) bħal diffikultà biex tikkomunika (afasja),
English: Action for patients less than 45 kg
Maltese: Azzjoni għal pazjenti li jiżnu aktar minn 45 kg
English: There is limited experience in patients with a history or presence of clinically relevant central nervous system (CNS) pathology (e.g. epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis) as they were excluded from clinical trials.
Maltese: Hemm esperjenza limitata f'pazjenti bi storja jew bi preżenza ta' patoloġija klinikament rilevanti tassistema nervuża ċentrali (CNS - central nervous system) (eż. epilessija, aċċessjoni, paresi, afasja, puplesija, korrimenti severi tal-moħħ, dimensja, marda ta' Parkinson, mard taċ-ċervellett, sindrome organika tal-moħħ, psikożi) għaliex dawn kienu esklużi mill-provi kliniċi.
English: Percent Achieving CR/CRh*
Maltese: Perċentwal li Kiseb CR/CRh*
English: SOC Chemo (N=134)
Maltese: Kimoterapija SOC (N = 134)
English: In patients with non-CNS/non-testes extramedullary disease (defined as at least 1 lesion ≥ 1.5 cm) at screening (N = 8/189) clinical response rates (25% [95% CI: 3.2-65.1] were lower compared with patients with no evidence of extramedullary disease (N = 181, 43.6% [95% CI: 36.3 - 51.2]) (see figure 2).
Maltese: F'pazjenti b'mard ekstramedullari mhux fit-testikoli/mhux fis-CNS (definit bħala mill-inqas ferita waħda ≥ 1.5 ċm) meta kienu eżaminati (N = 8/189), ir-rati ta' rispons kliniku (25% [CI ta' 95%: 3.2-65.1] kienu aktar baxxi meta mqabbla ma' pazjenti bl-ebda evidenza ta' mard ekstramedullari (N = 181, 43.6% [CI ta' 95%: 36.3 - 51.2]) (ara figura 2).
English: EU/1/15/1047/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1047/001
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Aħżen u ttrasporta fi friġġ (2°C - 8°C).
English: Somnolence Hypoaesthesia Cranial nerve disorder b
Maltese: Ipoestesija Disturb fin-nervituri kranjalib
English: Infusion duration (hours)
Maltese: Tul tal-infużjoni (sigħat)
English: Greater than or equal to 45 kg (fixed-dose)
Maltese: Aktar minn jew ugwali għal 45 kg (doża fissa)
English: In case of suspicious events consider consultation with a neurologist, brain MRI and examination of cerebral spinal fluid (CSF), see section 4.8.
Maltese: F'każ ta' avvenimenti suspettużi kkunsidra li tikkonsulta newrologu, MRI tal-moħħ u eżami tal-fluwidi spinali ċerebrali (CSF - cerebral spinal fluid), ara sezzjoni 4.8.
English: • decreased levels of red blood cells (anaemia), decreased levels of platelets
Maltese: • tnaqqis fil-livelli ta' ċelluli ħomor tad-demm (anemija), tnaqqis fil-livelli ta' plejtlits
English: RFS in patients with Philadelphia chromosome negative B-precursor ALL at 18 months censored at HSCT or postBLINCYTO chemotherapy was 54% (33%, 70%).
Maltese: RFS f'pazjenti b'ALL bi prekursur B negattiva għall-kromosoma ta' Philadelphia fi 18-il xahar iċċensurata f'HSCT jew kimoterapija wara BLINCYTO kienet 54% (33%, 70%).
English: Adverse reactions that were observed more frequently (≥ 10% difference) in the paediatric population compared to the adult population were anaemia, thrombocytopenia, leukopenia, pyrexia, infusion-related reactions, weight increase, and hypertension.
Maltese: Ir-reazzjonijiet avversi li kienu osservati b'mod aktar frekwenti (differenza ta' ≥ 10%) fil-popolazzjoni pedjatrika meta mqabbla mal-popolazzjoni adulta kienu anemija, tromboċitopenija, lewkopenija, deni, reazzjonijiet relatati mal-infużjoni, żieda fil-piż, u pressjoni għolja.
English: • Infusion rate of 10 mL/h for a duration of 24 hours
Maltese: • Rata ta' infużjoni ta' 10 mL/siegħa għal tul ta' 24 siegħa
English: BLINCYTO 38.5 mcg powder for concentrate blinatumomab
Maltese: U MNEJN GĦANDU JINGĦATA BLINCYTO 38.5 mcg trab għall-konċentrat blinatumomab
English: The hazard ratio (95% CI) was 0.71 (0.55, 0.93) between treatment arms favouring BLINCYTO, indicated a 29% reduction in hazard rate in the BLINCYTO arm (p-value = 0.012 (stratified log-rank test)), see figure 1.
Maltese: Il-proporzjon ta' periklu (CI ta' 95%) kien 0.71 (0.55, 0.93) bejn il-gruppi ta' trattament li jiffavorixxi BLINCYTO, li indika tnaqqis ta' 29% fir-rata ta' periklu fil-grupp ta' BLINCYTO (valur p = 0.
English: Complete MRD response a, n/N (%), [95% CI]
Maltese: Rispons MRD kompluta, n/N (%), [95% CI]
English: The recommended dose for the PK expansion and efficacy parts of the study was determined to be 5 mcg/m 2/day on days 1-7 and 15 mcg/m 2/day on days 8-28 for cycle 1, and 15 mcg/m2/day on days 1-28 for subsequent cycles.
Maltese: Id-doża rakkomandata għall-partijiet tal-espansjoni PK u l-effikaċja tal-istudju kienet stabbilita għal 5 mcg/m2/jum fil-jiem 1 - 7 u 15 mcg/m2/jum filjiem 8 - 28 għaċ-ċiklu 1, u 15 mcg/m2/jum fil-jiem 1 - 28 għal ċikli sussegwenti.
English: • Infusion bag with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection; o To minimise the number of aseptic transfers, use a 250 mL pre-filled infusion bag.
Maltese: • Borża tal-infużjoni b'250 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride; o Sabiex tnaqqas in-numru ta' trasferimenti asettiċi uża borża tal-infużjoni mimlija għallest ta' 250 mL.
English: In the elderly population (≥ 65 years of age) 11 of 25 patients (44.0%) achieved CR/CRh* within the first 2 treatment cycles (see section 4.8 for safety in elderly).
Maltese: Fil-popolazzjoni tal-anzjani (≥ 65 sena) 11 minn 25 pazjent (44.0%) kisbu CR/CRh* fl-ewwel 2 ċikli ta' trattament (ara sezzjoni 4.8 għas-sigurtà fl-anzjani).
English: Alternatively the vials can be stored at room temperature (up to 27°C) for up to 4 hours.
Maltese: Alternattivament il-kunjetti jistgħu jinħażnu f'temperatura ambjentali (temperatura sa 27°C) sa 4 sigħat.
English: Elevated liver enzyme events were reported for 12.4% of adult patients with MRD positive B-precursor ALL (N = 137).
Maltese: Avvenimenti ta' żieda fl-enzimi tal-fwied ġew irrapportati għal 12.4% tal-pazjenti adulti b'ALL bi prekursur B pożittiva għal MRD (N = 137).
English: Cytokine release syndrome was reported in 2.9% of adult patients with MRD positive B-precursor ALL (N = 137).
Maltese: Sindrome ta' reħa ta' ċitokini ġie rrapportat f'2.9% tal-pazjenti adulti b'ALL bi prekursur B pożittiva għal MRD (N = 137).
English: Eleven of the 20 patients (55%) who achieved CR/CRh* received an allogeneic HSCT.
Maltese: Ħdax mill-20 pazjent (55%) li kisbu CR/CRh* irċevew HSCT alloġeniku.
English: Twenty out of 70 (28.6%) patients achieved CR/CRh* within the first 2 treatment cycles with 17 out of 20 (85%) occurring within cycle 1 of treatment.
Maltese: Għoxrin minn 70 (28.6%) pazjent irċevew CR/CRh* fl-ewwel 2 ċikli ta' trattament fejn 17 minn 20 (85%) seħħew fl-ewwel ċiklu ta' trattament.
English: Monitoring of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to the start of and during BLINCYTO treatment especially during the first 48 hours of the first 2 cycles should be performed.
Maltese: Għandu jitwettaq monitoraġġ tal-alanine aminotransferase (ALT), l-aspartate aminotransferase (AST), il-gamma-glutamyl transferase (GGT), u tal-għadd totali ta' bilirubina fid-demm qabel jinbeda u waqt it-trattament bi BLINCYTO, b'mod speċjali matul l-ewwel 48 siegħa tal-ewwel 2 ċikli.
English: Survival Probability
Maltese: Probabbiltà ta' Sopravivenza
English: • there is a problem with the pump or the pump alarm sounds
Maltese: • hemm problema bil-pompa jew l-allarm tal-pompa jibda jdoqq
English: Patients received up to 4 cycles of treatment.
Maltese: Pazjenti rċevew sa 4 ċikli tat-trattament.
English: Leukoencephalopathy including progressive multifocal leukoencephalopathy
Maltese: Lewkoenċefalopatija li tinkludi lewkoenċefalopatija multifokali progressiva
English: Diluted solution (prepared infusion bag)
Maltese: Soluzzjoni dilwita (borża tal-infużjoni ppreparata):
English: Oedema includes face oedema, generalised oedema, oedema and oedema peripheral.
Maltese: 13 Edima tinkludi edima fil-wiċċ, edima ġeneralizzata, edima u edima periferali.
English: o Use only polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Maltese: o Uża biss boroż tal-infużjoni/kasetts tal-pompa tal-polyolefin, PVC mhux di-ethylhexylphthalate (non-DEHP), jew ethyl vinyl acetate (EVA).
English: f. Only patients with HSCT in CR/CRh* remission (with no anti-leukemia agents used prior to HSCT) are included.
Maltese: f. Pazjenti b'HSCT f'remissjoni CR/CRh* (mingħajr ebda aġenti antilewkemiċi użati qabel HSCT) biss huma inklużi.