FrancophonIA/ELRC3.0 huggingface dataset:
English: The secondary endpoints included MRD negativity, duration of remission (DoR), HSCT rate, and progression-free survival (PFS).
Maltese: Il-punti tat-tmiem sekondarji kienu jinkludu n-negattività tal-MRD, ittul ta' remissjoni (DoR, duration of remission), ir-rata tal-HSCT u s-sopravivenza mingħajr progressjoni (PFS, progression-free survival).
English: One Grade 5 bleeding/haemorrhagic event (intra-abdominal haemorrhage) was reported.
Maltese: Ġie rrappurtat episodju wieħed ta' fsada/emorraġija ta' Grad 5 (emorraġija intraaddominali).
English: Administer diluted solution as a 1-hour infusion at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Maltese: Agħti ssoluzzjoni dilwita bħala infużjoni ta' siegħa b'rata ta' 50 mL/h f'temperatura ambjentali (20°C-25°C).
English: Five of the 18 VOD/SOS events that occurred post-HSCT were fatal (see section 5.1).
Maltese: Ħamsa mit-18-il episodju ta' VOD/SOS li seħħew wara l-HSCT kienu fatali (ara sezzjoni 5.1).
English: Consider permanent discontinuation of BESPONSA.
Maltese: Ikkunsidra t-twaqqif permanenti ta' BESPONSA.
English: Among the initial 218 randomised patients, 64/88 (73%) and 21/88 (24%) of responding patients per EAC achieved a CR/CRi in Cycles 1 and 2, respectively, in the BESPONSA arm. No additional patients achieved CR/CRi after Cycle 3 in the BESPONSA arm.
Maltese: Fost il-218-il pazjent inizjali li ntgħażlu b'mod każwali, 64/88 (73%) u 21/88 (24%) tal-pazjenti li rrispondew għal kull EAC kisbu CR/CRi f'Ċikli 1 u 2, rispettivament, fil-parti tal-istudju dwar BESPONSA.
English: f In the standard definition of PFS, defined as the time from date of randomisation to earliest date of the following events: death, progressive disease (including objective progression and relapse from CR/CRi), the HR was 0.568 (2-sided p-value=0.0002) and median PFS was 5.6 months and 3.7 months in the BESPONSA and Investigator's choice of chemotherapy arm, respectively.
Maltese: Fid-definizzjoni standard ta' PFS, definita bħala l-ħin mid-data tal-għażla b'mod każwali sal-aktar data bikrija tal-episodji li ġejjin: mewt, mard progressiv (li jinkludi progressjoni oġġettiva u rikaduta minn CR/ CRI), l-HR kien 0.568 (2-sided valur p=0.0002) u medjan PFS kien 5.6 xhur u 3.7 xhur fil-parti ta' l-istudja b'BESPONSA u f'dik bil-kimoterapija li kienet l-għażla tal-Investigatur.
English: Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.2).
Maltese: Hija rakkomandata premedikazzjoni b'kortikosterojde, antipiretiku u antistamini qabel id-dożaġġ (ara sezzjoni 4.2).
English: The median time from HSCT to onset of VOD/SOS was 15 days (range: 3-57 days).
Maltese: Il-ħin medjan mill-HSCT sal-bidu tal-VOD/SOS kien 15-il jum (firxa: 3-57 jum).
English: In a randomised clinical study in patients with relapsed or refractory ALL (Study 1), maximum increases in QTcF interval of ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patients in the inotuzumab ozogamicin arm, respectively, versus18/124 (15%) and 3/124 (2%) in the Investigator's choice of chemotherapy arm, respectively.
Maltese: Fi studju kliniku li fih il-parteċipanti ntgħażlu b'mod każwali f'pazjenti b'ALL li tirkadi jew refrattarja (Studju 1) tkejlu ż-żidiet massimi fl-intervall tal-QTcF ta'  30msec u ≥ 60 msec mil-linja bażi fi 30/162 (19%) u f'4/162 (3%) pazjenti fil-parti tal-istudju dwar inotuzumab ozogamicin rispettivament, kontra 18/124 (15%) u 3/124 (2%) fil-parti tal-istudju dwar il-kimoterapija li kienet l-għażla talInvestigatur, rispettivament.
English: Table 5 shows the adverse reactions reported in patients with relapsed or refractory ALL who received BESPONSA.
Maltese: Tabella 5 turi r-reazzjonijiet avversi rrappurtati f'pazjenti b'ALL li tirkadi jew refrattarja li rċevew BESPONSA.
English: Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN (see Table 3 and section 4.4).
Maltese: Waqqaf il-kura b'mod permanenti jekk il-bilirubina totali ma tirkuprax għal ≤ 1.5 × ULN jew AST/ALT ma jirkuprax għal ≤ 2.5 × ULN (ara Tabella 3 u sezzjoni 4.4).
English: Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.4).
Maltese: Hija rakkomandata premedikazzjoni b'kortikosterojde, antipiretiku u antistamini qabel id-dożaġġ (ara sezzjoni 4.4).
English: Furthermore, at month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) for patients who underwent a follow-up HSCT compared to 8.0% (95% CI: 3.3, 15.3) for patients who did not undergo a follow-up HSCT in the BESPONSA arm.
Maltese: Barra minn hekk, f'xahar 24, il-probabbiltà tas-sopravivenza kienet 38 % (95% CI: 27.4, 48.5) għal pazjenti li kellhom HSCT ta' segwitu meta mqabbel ma' 8.0% (95% CI: 3.3, 15.3) għal pazjenti li ma sarilhomx HSCT ta' segwitu fil-parti tal-istudju ta' BESPONSA.
English: The NOAEL was not identified for the effects on male reproductive organs, which were observed at approximately 0.3 times the human clinical exposure based on AUC.
Maltese: InNOAEL ma ġiex identifikat għall-effetti fuq l-organi riproduttivi maskili, li ġew osserveti f'madwar 0.3 darbiet tal-esponiment kliniku tal-bniedem abbażi tal-AUC.
English: For clinical management of TLS, see section 4.4.
Maltese: Għall-ġestjoni klinika ta' TLS, ara sezzjoni 4.4.
English: However, if the diluted solution is filtered, polyethersulphone (PES)-, polyvinylidene fluoride (PVDF)-, or hydrophilic polysulphone (HPS)-based filters are recommended.
Maltese: Madankollu, jekk is-soluzzjoni dilwita tiġi ffiltrata, filtri bbażati fuq polyethersulphone (PES), polyvinylidene fluoride (PVDF), jew hydrophilic polysulphone (HPS) huma rakkomandati.
English: In the pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%) and 43 (26%) patients, respectively.
Maltese: Fl-istudju importanti ħafna (N=164), iperbilirubinemija u transaminases miżjuda ġew irrappurtati f'35 (21%) pazjent u f'43 (26%) pazjent, rispettivament.
English: Powder for concentrate for solution for infusion 1 vial
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni kunjett 1
English: The no observed adverse effect level (NOAEL) for the effects on female reproductive organs in rats and monkeys was approximately 2.2 and 3.1 times the human clinical exposure based on AUC, respectively.
Maltese: Il-livell bla effett ħażin osservat (NOAEL, no observed adverse effect level) għall-effetti fuq l-organi riproduttivi femminili fil-firien u x-xadini kien madwar 2.2 u 3.1 darbiet tal-esponiment kliniku tal-bniedem abbażi tal-AUC, rispettivament.
English: In clinical studies of BESPONSA in patients with relapsed or refractory ALL, 7/236 (3%) patients tested positive for anti-inotuzumab ozogamicin antibodies.
Maltese: Fi studji kliniċi ta' BESPONSA f''pazjenti b'ALL li tirkadi jew refrattarja, 7/236 (3%) pazjent ttestjaw pożittivi għal antikorpi ta' anti-inotuzumab ozogamicin.
English: The median age was 47 years (range: 18-79 years), 206 (63%) patients had a duration of first remission < 12 months, and 55 (17%) patients had undergone an HSCT prior to receiving BESPONSA or Investigator's choice of chemotherapy.
Maltese: L-età medjana kienet TA' 47 sena (medda: 18-79 snin), 206 (63%) pazjent kellhom tul ta' l-ewwel remissjoni <12-il xahar, u 55 (17%) pazjent kienu għaddew minn HSCT qabel ma jrċevew BESPONSA jew il-kimoterapija ta' l-għażla ta' l-Investigatur.
English: Headache (28%)
Maltese: Iperurikemija (4%)
English: BESPONSA improved OS versus Investigator's choice of chemotherapy for all stratification factors including duration of first remission ≥12 months, Salvage 1 status, and age at randomisation <55 years.
Maltese: BESPONSA tejjeb l-OS kontra l-kimoterapja tal-għażla tal-Investigatur għall-fatturi ta' stratifikazzjoni kollha inkluż durata tal-ewwel remissjoni 12-il xahar, status ta' Salvataġġ 1, u età meta saret ir-randomizzazzjoni <55 sena.
English: Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative (Ph-) or Ph+ relapsed or refractory B-cell CD22-positive precursor ALL.
Maltese: Il-pazjenti eliġibbli kienu ta' età ta' ≥ 18-il sena b'ALL prekursura taċ-ċelluli B pożittiva għas-CD22 li tirkadi jew refrattarja (Ph) negattiva jew Ph+ għall-kromożma ta' Philadelphia .
English: There was also a trend for better OS with BESPONSA for patients with other prognostic factors (Ph-, no prior HSCT, ≥ 90% leukaemic blasts CD22-positive at baseline, no baseline peripheral blasts, and baseline haemoglobin ≥ 10 g/dL, based on exploratory analyses).
Maltese: -, l-ebda HSCT minn qabel,  90% ta' blasts lewkemiċi pożittivi għas-CD22 fil-linja bażi, l-ebda blast periferali fil-linja bażi, u emoglobina fil-linja bażi ≥ 10 g/dL, abbażi tal-analiżi esploratorji).
English: Patients who have not achieved a CRc or CRid: Dose (mg/m2)
Maltese: Pazjenti li ma kisbux CR jew CRi: Doża (mg/m
English: In the Phase 1 portion of the study, 37 patients received BESPONSA at a total dose of 1.2 mg/m2 (n=3), 1.6 mg/m2 (n=12), or 1.8 mg/m2 (n=22).
Maltese: (n=12) jew 1.8 mg/m 2 (n=22).
English: Infusion lines made of PVC (DEHP or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended.
Maltese: Huma rakkomandati linji tal-infużjoni magħmula minn PVC (DEHP jew li ma jkunx fih DEHP), polyolefin (polypropylene u/jew polyethylene), jew polybutadiene.
English: Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, l-età, ir-razza, u s-sess ma affettwawx b'mod sinifikanti d-dispożizzjoni ta' inotuzumab ozogamicin.
English: • Calculate the dose (mg) and number of vials of BESPONSA required.
Maltese: • Ikkalkula d-doża (mg) u n-numru ta' kunjetti ta' BESPONSA meħtieġa.
English: ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La
Maltese: 9/L u/jew lgħadd tal-plejtlits tad-demm kien < 50 × 10
English: What you need to know before you are given BESPONSA
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: BESPONSA acts by attaching to cells with a protein called CD22.
Maltese: BESPONSA jaħdem billi jeħel ma' ċelluli bi proteina li tissejjaħ CD22.
English: In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
Maltese: 0333 L/h, u l-half-life terminali tal-eliminazzjoni (t½) fit-tmiem iċ-Ċiklu 4 kienet madwar 12.3 jiem.
English: In patients with relapsed or refractory ALL treated with inotuzumab ozogamicin at the recommended starting dose of 1.8 mg/m2/cycle (see section 4.2), steady-state exposure was achieved by Cycle 4.
Maltese: Fil-pazjenti b'ALL li tirkadi jew refrattarja kkurati b'inotuzumab ozogamicin fid-doża tal-bidu rakkomandata ta' 1.8 mg/m2/ċiklu (ara sezzjoni 4.2), inkiseb l-esponiment fi stat fiss sa Ċiklu 4.
English: BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22positive B cell precursor acute lymphoblastic leukaemia (ALL).
Maltese: BESPONSA huwa indikat bħala monoterapija għall-kura ta' adulti b'lewkimja limfoblastika akuta (ALL, acute lymphoblastic leukaemia) prekursura taċ-ċelluli B pożittiva għas-CD22 li tirkadi jew refrattarja.
English: These medicines are called antineoplastic agents.
Maltese: Dawn il-mediċini jissejħu aġenti antineoplastiċi.
English: After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Maltese: Wara r-rikostituzzjoni, 1 mL tas-soluzzjoni jkun fiha 0.25 mg inotuzumab ozogamicin.
English: For subsequent cycles, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle given as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR/CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR/CRi.
Maltese: 3 dożi maqsuma f'Jiem 1 (0.5 mg/m 2), 8 (0.5 mg/m 2), u 15 (0.5 mg/m 2) għal pazjenti li jiksbu CR/CRi jew ta'1.8 mg/m 2 għal kull ċiklu mogħtija bħala 3 dożi maqsuma f'Jiem 1 (0.8 mg/m 2), 8 (0.5 mg/m u 15 (0.5 mg/m 2) għal pazjenti li ma jiksbux CR/CRi.
English: progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi.
Maltese: mewt, marda progressiva (inkluż progressjoni oġġettiva, li tirkadi minn CR/CRi, twaqqif tal-kura minħabba d-deterjorament globali tal-istatus tas-saħħa), u l-bidu ta' HSCT ġdid tat-terapija tal-induzzjoni jew ta' wara t-terapija mingħajr ma jinkisbu CR/CRi.
English: In clinical studies in patients with relapsed or refractory ALL, the maximum single and multiple doses of inotuzumab ozogamicin were 0.8 mg/m2 and 1.8 mg/m2, respectively, per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) (see section 4.2).
Maltese: Fi studji kliniċi f'pazjenti b'ALL li tirkadi jew refrattarja, id-dożi uniċi u multipli massimi ta' inotuzumab ozogamicin kienu ta' 0.8 mg/m 2 u 1.8 mg/m 2, rispettivament, għal kull ċiklu, mogħtija bħala 3 dożi maqsuma f'Jiem 1 (0.8 mg/m 2), 8 (0.5 mg/m 2), u 15 (0.5 mg/m 2) (ara sezzjoni 4.2).
English: In patients receiving inotuzumab ozogamicin, infusion related reactions were reported (see section 4.8).
Maltese: F'pazjenti li kienu qed jirċievu inotuzumab ozogamicin, ġew irrappurtati infużjonijiet relatati malinfużjoni (ara sezzjoni 4.8).
English: Of 93 screened patients, 72 patients were assigned to study drug and treated with BESPONSA.
Maltese: Fost it-93 pazjenti skrinjati, 72 pazjent kienu assenjati għall-istudju tad-droga u kkurati b'BESPONSA.
English: CD22 expression was assessed using flow cytometry based on bone marrow aspirate.
Maltese: L-espressjoni tas-CD22 ġiet ivvalutata bl-użu ta' ċitometrija tal-fluss abbażi ta' aspirat tal-mudullun.
English: CRib; n (%) [95% CI]
Maltese: CRi b; n (%) [95% CI]
English: Based on in vitro data, coadministration of inotuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate-glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Maltese: Abbażi ta' data in vitro, l-għoti flimkien ta' inotuzumab ozogamicin ma' inibituri jew indutturi taċċitokroma P450 (CYP) jew uridine diphosphate-glucuronosyltransferase (UGT) l-enzimi li jimmetabolizzaw il-mediċina x'aktarx li mhux se jbiddlu l-esponiment għal N-acetyl-gammacalicheamicin dimethylhydrazide.
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD/SOS=venoocclusive disease/sinusoidal obstruction syndrome.
Maltese: ULN=limitu ta' fuq tannormal; VOD/SOS=marda venookklużiva/sindrome ta' ostruzzjoni sinusojdali.
English: • QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms.
Maltese: • titwil fl-intervall tal-QT (ara sezzjoni 2); sinjali u sintomi jinkludu bidla fl-attività elettrika talqalb li jista' jikkawża ritmi serji u rregolari tal-qalb.
English: This is consistent with the known induction of DNA breaks by calicheamicin.
Maltese: Dan huwa konsistenti mal-induzzjoni magħrufa tat-tkissir tad-DNA minn calicheamicin.
English: • Swelling of the abdomen
Maltese: • Nefħa tal-addome
English: g Duration of remission was defined as the time since first response of CRa or CRib per Investigator's assessment to the date of a PFS event or censoring date if no PFS event was documented.
Maltese: Investigatur sad-data ta' episodju ta' PFS jew id-data taċ-ċensura jekk ma jkun ġie ddokumentat l-ebda episodju ta' PFS.
English: CRa/CRib; n (%) [95% CI]
Maltese: CR a/CRi b; n (%) [95% CI]
English: • Reconstitute each 1 mg vial with 4 mL of water for injection, to obtain a single-use solution of 0.25 mg/mL of BESPONSA.
Maltese: • Irrikostitwixxi kull kunjett ta' 1 mg b'4 mL ta' ilma għall-injezzjoni, biex tikseb soluzzjoni li tintuża darba ta' 0.25 mg/mL ta' BESPONSA.
English: Inotuzumab ozogamicin (which has a density of 1.02 g/mL at 20 °C/68 °F) is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration.
Maltese: Inotuzumab ozogamicin (li għandu densità ta' 1.02 g/mL f'temperatura ta' 20°C/68°F) huwa sensittiv għad-dawl u għandu jiġi protett minn dawl ultravjola waqt ir-rikostituzzjoni, id-dilwizzjoni u l-għoti.
English: Each pack of BESPONSA contains:
Maltese: Kull pakkett ta' BESPONSA fih:
English: For periodic monitoring of increased amylase and lipase, see section 4.4.
Maltese: Għall-monitoraġġ perjodiku tal-amylase u l-lipase miżjuda, ara sezzjoni 4.4.
English: Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Maltese: Inotuzumab ozogamicin huwa ADC magħmul minn antikorp monoklonali dirett lejn CD22 li huwa marbut b'mod kovalenti ma' N-acetyl-gamma-calicheamicin dimethylhydrazide.
English: Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Maltese: Il-pazjenti għandhom ikunu mmonitorjati għal sinjali u sintomi ta' TLS u kkurati skont il-prattika medika standard.
English: In 3 patients with hepatic impairment defined by NCI ODWG category C (total bilirubin > 1.5-3 × ULN and AST any level) and 1 patient with hepatic impairment defined by NCI ODWG category D (total bilirubin > 3 × ULN and AST any level), inotuzumab ozogamicin clearance did not appear to be reduced.
Maltese: ODWG kategorija Ċ (bilirubina totali > 1.5-3 × ULN u AST kwalunkwe livell) u pazjent 1 b'indeboliment tal-fwied definit mill-NCI
English: The median time to onset of hyperbilirubinaemia and increased transaminases was 73 days and 29 days, respectively.
Maltese: Il-ħin medjan għall-bidu tal-iperbilirubinemija u tat-transaminases miżjuda kien ta' 73 jum u 29 jum, rispettivament.
English: The safety and efficacy of BESPONSA in children aged 0 to <18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' BESPONSA fit-tfal minn età ta' 0 sa <18-il senama ġewx determinati s'issa.
English: Immunogenicity
Maltese: • Infezzjonijiet
English: Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Maltese: Tabella 2 u Tabella 3 juru l-linji gwida ta' modifikazzjoni fid-doża għal tossiċitajiet ematoloġiċi u mhux ematoloġiċi, rispettivament.
English: • Infuse the diluted solution for 1 hour at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Maltese: • Agħti l-infużjoni tas-soluzzjoni dilwita għal siegħa b'rata ta' 50 mL/h f'temperatura ambjentali (20°C-25°C).
English: If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L.
Maltese: Jekk l-ANC jonqos, interrompi ċ-ċiklu tal-kura li jmiss salirkupru ta' ANC għal ≥ 1 × 10
English: - Patients with a serum bilirubin ≥ ULN prior to HSCT.
Maltese: - Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: These may include corticosteroids (e.g., dexamethasone), antipyretics (medicines to reduce fever), and antihistamines (medicines to reduce allergic reactions).
Maltese: Dawn jistgħu jinkludu kortikosterojdi (eż. dexamethasone), antipiretiċi (mediċini biex inaqqsu d-deni) u antiistaminiċi (mediċini biex inaqqsu r-reazzjonijet allerġiċi).
English: • Abnormally high levels of lipase (an enzyme needed to process dietary fat) in the blood
Maltese: • Livelli għolja b'mod anormali ta' lipase (enzima meħtieġa biex tipproċessa xaħam fid-dieta)
English: Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN (see section 4.4).
Maltese: Waqqaf il-kura b'mod permanenti jekk il-bilirubina totali ma tirkuprax għal ≤ 1.5 × ULN jew l-AST/ALT ma jirkuprax għal ≤ 2.5 × ULN (ara sezzjoni 4.4).
English: In patients receiving inotuzumab ozogamicin, complications associated with neutropenia and thrombocytopenia (including infections and bleeding/haemorrhagic events, respectively) were reported in some patients (see section 4.8).
Maltese: F'pazjenti li kienu qed jirċievu inotuzumab ozogamicin, f'xi wħud minnhom ġew irrappurtati kumplikazzjonijiet assoċjati ma' newtropenija u tromboċitopenija (inklużi infezzjonijiet u fsada/episodji emorraġiċi, rispettivament) (ara sezzjoni 4.8).
English: Of the 49 (15%) patients with Ph+ ALL, 4 patients did not receive a prior TKI, 28 patients received 1 prior TKI, and 17 patients received 2 prior TKIs.
Maltese: Mid-49 (15%) pazjent b'Ph + ALL, 4 pazjenti ma jrċevewx TKI minn qabel, 28 pazjent irċevew 1 TKI minn qabel, u 17- il pazjent irċevew 2 TKIs minn qabel.
English: In patients receiving inotuzumab ozogamicin, increases in amylase and lipase have been reported (see section 4.8).
Maltese: F'pazjenti li kienu qed jirċievu inotuzumab ozogamicin, ġew irrappurtati żidiet fl-amylase u fil-lipase (ara sezzjoni 4.8).
English: For clinical management of infusion related reactions, see section 4.4.
Maltese: Għall-ġestjoni klinika ta' reazzjonijiet relatati mal-infużjoni, ara sezzjoni 4.4.
English: Inotuzumab ozogamicin is considered to have the potential to impair reproductive function and fertility in men and women based on non-clinical findings (see section 4.6).
Maltese: Skont is-sejbiet mhux kliniċi inotuzumab ozogamicin huwa meqjus li għandu l-potenzjal li jfixkel ilfunzjoni riproduttiva u l-fertilità fl-irġiel u n-nisa (ara sezzjoni 4.6).
English: Administration:
Maltese: Rikostituzzjoni:
English: Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice.
Maltese: Inotuzumab ozogamicin kien klastoġeniku in vivo fil-mudullun tal-ġrieden maskili.
English: Patient-reported outcomes measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), were significantly better for BESPONSA by estimated mean postbaseline scores (BESPONSA and Investigator's choice of chemotherapy, respectively) for role functioning (64.7 versus 53.4, improvement grade small), physical functioning (75.0 versus 68.1, improvement grade small), social functioning (68.1 versus 59.8, improvement grade medium), and appetite loss (17.6 versus 26.3, improvement grade small) compared to Investigator's choice of chemotherapy.
Maltese: Riżultati rrappurtati mill-pazjenti mkejla bl-użu tal-Kwestjonarju Ewlieni tal-Kwalità tal-Ħajja talOrganizzazzjoni Ewropea għar-Riċerka u l-Kura tal-Kanċer (EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30), kienu aħjar b'mod sinifikanti għal BESPONSA permezz ta' punteġġi ta' wara l-linja bażi medji stmati (BESPONSA u l-kimoterapija li kienet l-għażla tal-Investigatur, rispettivament) għall-funzjonament tar-rwol (64.7 kontra 53.4, grad ta' titjib żgħir), fil-funzjonament fiżiku (75.
English: Interrupt dosing until recovery of total bilirubin to ≤ 1.5 × ULN and AST/ALT to ≤ 2.5 × ULN prior to each dose unless due to Gilbert's syndrome or haemolysis.
Maltese: Interrompi d-dożaġġ sal-irkupru tal-bilirubina totali għal ≤ 1.5 × ULN u AST/ALT sa ≤ 2.5 × ULN qabel kull doża sakemm mhux minħabba s-sindromu ta' Gilbert jew l-emolisi.
English: Use diluted solution immediately or after being stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Maltese: Is-soluzzjoni dilwita għandha tintuża immedjatament jew tinħażen f'temperatura ambjentali (20°C-25°C) jew fi friġġ (2°C-8°C).
English: After reconstitution each vial contains 0.25 mg/mL of inotuzumab ozogamicin.
Maltese: Wara r-rikostituzzjoni kull kunjett fih 0.25 mg/mL ta' inotuzumab ozogamicin.
English: Type I amber glass vial with chlorobutyl rubber stopper and crimp seal with flip off cap containing 1 mg of powder.
Maltese: Flixkun tal-ħgieġ kulur l-ambra ta' Tip I b'tapp tal-gomma chlorobutyl u b'siġill irbattut b'għatu tattip flip off li jkun fih 1 mg ta' trab.