FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical phase II studies, 88.9% (8/9) of patients with late first relapse as defined in the individual studies achieved CR/CRh* within the first 2 treatment cycles with 62.5% (6/9) achieving MRD response and 37.5% (3/9) undergoing allogeneic HSCT after treatment with BLINCYTO.
Maltese: Fl-istudji kliniċi ta'fażi II, 88.9% (8/9) tal-pazjenti bl-ewwel rikaduta li tkun seħħet tard, kif definit fl-istudji individwali, kisbu CR/CRh* fl-ewwel 2 ċikli ta' trattament, bi 62.5% (6/9) li kisbu rispons ta' MRD u 37.5% (3/9) li kellhom HSCT alloġeneiku wara t-trattament bi BLINCYTO.
English: • swollen lymph nodes (lymphadenopathy)
Maltese: • glandoli limfatiċi minfuħin (limfadenopatija)
English: One vial of powder contains 38.5 micrograms blinatumomab.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' trab fih 38.5 mikrogrammi blinatumomab.
English: BLINCYTO 271
Maltese: BLINCYTO 271 Kimoterapija SOC 134
English: • if you have an active infection.
Maltese: • jekk għandek infezzjoni attiva.
English: To mitigate the risk of CRS, it is important to initiate BLINCYTO (cycle 1, days 1-7) at the recommended starting dose in section 4.2.
Maltese: Biex jitnaqqas ir-riskju ta' CRS, huwa importanti li tibda BLINCYTO (ċiklu 1, jiem 1-7) bid-doża tal-bidu rakkomandata fissezzjoni 4.2.
English: In the randomised, open-label, multicentre, phase III study, 70% (7/10) of post-transplant patients in late first relapse treated with BLINCYTO compared to 20% (1/5) treated with SOC chemotherapy achieved CR/CRh* within the first 2 treatment cycles.
Maltese: III randomised, open-label u b'aktar minn ċentru wieħed, 70% (7/10) tal-pazjenti li jkunu għaddew minn trapjant bl-ewwel rikaduta li tkun seħħet tard trattati bi BLINCYTO meta mqabbla ma' 20% (1/5) ittrattati b'kimoterapija SOC kisbu CR/CRh* fl-ewwel żewġ ċikli tattrattament.
English: Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities.
Maltese: Ir-riżultati minn test in vitro fiċ-ċelluli tal-fwied tal-bniedem jissuġġerixxu li blinatumomab ma kellux effett fuq l-attivitajiet tal-enzimi CYP450.
English: BLINCYTO can cause neurological problems such as dizziness, seizures, confusion, coordination and balance disorders.
Maltese: BLINCYTO jista' jikkawża problemi newroloġiċi bħal sturdament, aċċessjonijiet, konfużjoni, disturbi fil-koordinazzjoni u l-bilanċ.
English: BLINCYTO dose calculations are based on a usual overfill volume of 265 to 275 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Il-kalkoli tad-dożi ta' BLINCYTO huma bbażati fuq volum żejjed tas-soltu ta' 265 sa 275 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Sepsis Pneumonia
Maltese: Sepsi Pulmonite
English: Infusion reactions may be clinically indistinguishable from manifestations of CRS (see section 4.8).
Maltese: Ir-reazzjonijiet għall-infużjoni jistgħu ma jingħarfux klinikament minn manifestazzjonijiet ta' CRS (ara sezzjoni 4.8).
English: • Description of the main signs and / or symptoms of neurologic events and the importance of notifying the treating physician or nurse immediately if symptoms occur
Maltese: • Deskrizzjoni tas-sinjali u / jew sintomi ewlenin ta' avvenimenti newroloġiċi u l-importanza li jinnotifikaw immedjatament lit-tabib li qed jittrattahom jew lill-infermier jekk iseħħu sintomi
English: The type and frequency of adverse events were similar across different paediatric sub-groups (gender, age, geographic region).
Maltese: It-tip u l-frekwenza tar-reazzjonijiet avversi kienu simili fost sottogruppi pedjatriċi differenti (sess, età, reġjun ġeografiku).
English: For reinitiation, premedicate with a 24 mg dose of dexamethasone.
Maltese: Għal bidu mill-ġdid, immedika minn qabel b'doża ta' 24 mg ta' dexamethasone.
English: The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 30 mcg/m2/day in paediatric patients.
Maltese: Il-farmakokinetika ta' blinatumomab tidher lineari fuq medda tad-doża minn 5 sa 30 mcg/m2/jum f'pazjenti adulti.
English: Patients with the highest tumour burden as measured by the percentage of bone marrow blast cells at baseline (≥ 90%) still had a clinically meaningful response with a CR/CRh* rate of 21.6% (CI 12.9 - 32.7) (see figure 2).
Maltese: Il-pazjenti bl-ogħla piż ta' tumur kif imkejjel bil-perċentwal ta' ċelluli blast fil-mudullun fil-linja bażi (≥ 90%) xorta kellhom rispons b'rilevanza klinika b'rata ta' CR/CRh* ta' 21.6% (CI 12.9 - 32.7) (ara figura 2).
English: When administering via a multi-lumen venous catheter, BLINCYTO should be infused through a dedicated lumen.
Maltese: Meta tagħtih permezz ta' kateter fil-vina multi-lumen, BLINCYTO għandu jiġi infuż minn ġo lumen dedikat.
English: SOC chemotherapy (N = 134)
Maltese: Kimoterapija SOC (N=134)
English: Haemophagocytic histiocytosis/macrophage activation syndrome (MAS) has been uncommonly reported in the setting of CRS.
Maltese: L-istoċitożi emofagoċitika/sindrome ta' attivazzjoni ta' makrofaġi (MAS - macrophage activation syndrome) kienet irrappurtata b'mod mhux komuni f'każ ta' CRS.
English: Neutropenia Thrombocytopenia Leukopenia
Maltese: Bidla tal-borża tal-infużjoni
English: • Data from clinical trials, causes of ME, frequency, severity and outcomes.
Maltese: • Dejta mill-provi kliniċi, il-kawżi tal-ME, il-frekwenza, is-severità u r-riżultati.
English: Patients with a medical history of neurologic signs and symptoms (such as dizziness, hypoaesthesia, hyporeflexia, tremor, dysaesthesia, paraesthesia, memory impairment) demonstrated a higher rate of neurologic events (such as tremor, dizziness, confusional state, encephalopathy and ataxia).
Maltese: Pazjenti bi storja medika ta' sinjali u sintomi newroloġiċi (bħal sturdament, ipoestesija, iporiflessija, rogħda, disasteżija, parasteżija, indeboliment tal-memorja) urew rata ogħla ta' avvenimenti newroloġiċi (bħal rogħda, sturdament, stat konfuż, enċefalopatija u atassija).
English: Ataxia
Maltese: Interrompi
English: Ελλάδα
Maltese: Uġigħ ta' ras Rogħda
English: This medicinal product provides less than 1 mmol (23 mg) sodium over a 24 hour infusion i.e. “essentially sodium-free”.
Maltese: Dan il-prodott mediċinali jagħti inqas minn 1 mmol (23 mg) sodium matul infużjoni ta' 24 siegħa jiġifieri huwa “essenzjalment mingħajr sodium”.
English: Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with BLINCYTO.
Maltese: B'mod ġenerali, is-sigurtà kienet simili bejn pazjenti anzjani (≥ 65 sena) u pazjenti li kellhom inqas minn 65 sena ttrattati bi BLINCYTO.
English: - Once at room temperature (up to 27°C) the solution will be infused within 96 hours.
Maltese: - Meta tilħaq it-temperatura ambjentali (sa 27°C) is-soluzzjoni tiġi infuża fi żmien 96 siegħa.
English: Grade 4 Discontinue BLINCYTO permanently.
Maltese: Waqqaf BLINCYTO b'mod permanenti.
English: • Contact details of the BLINCYTO prescriber
Maltese: • Id-data tal-bidu tat-trattament bi BLINCYTO
English: Cognitive disorder Memory impairment Dizziness
Maltese: Parestesija Aċċessjoni Disturb konoxxittiv Indeboliment talmemorja
English: Prior alloHSCT ECOG status - n (%)
Maltese: alloHSCT wara l-linja bażi - n (%) Individwi kollha
English: The median overall survival (OS) was 17.7 months (CI 3.1 - not estimable).
Maltese: Is-sopravivenza globali (OS - overall survival) medjana kienet ta' 17.7 xhur (CI 3.1mhux estimabbli).
English: • Physician educational material
Maltese: • Materjal edukattiv għall-ispiżjara
English: 9 mcg/day
Maltese: 9 mcg/jum
English: Incomplete depletion of B-cells occurred at doses of 0.5 mcg/m 2/day and 1.5 mcg/m 2/day and in a few non-responders at higher doses.
Maltese: It-tnaqqis mhux komplut ta' ċelluli B seħħ f'dożi ta' 0.5 mcg/m2/jum u 1.5 mcg/m2/jum u fi ftit pazjenti mingħajr rispons f'dożi ogħla.
English: Hepatobiliary disorders
Maltese: Trehalose dihydrate
English: Blinatumomab is associated with transient upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, and results in elimination of CD19+ cells.
Maltese: Blinatumomab huwa assoċjat ma' żieda temporanja fl-għadd ta' molekuli ta' adeżjoni taċ-ċelluli, il-produzzjoni ta' proteini ċitolitiċi, ir-reħa ta' ċitokini infjammatorji, u l-proliferazzjoni ta' ċelluli T, u jirriżulta fl-eliminazzjoni taċ-ċelluli CD19+.
English: Six of those patients had anti-blinatumomab antibodies with in vitro neutralising activity.
Maltese: Sitta minn dawn il-pazjenti kellhom antikorpi anti-blinatumomab b'attività newtralizzanti in vitro.
English: Patients with low tumour burden (< 50%) responded best to BLINCYTO treatment with CR/CRh* rate of 72.9% (CI 59.7 - 83.6).
Maltese: Il-pazjenti b'piż ta' tumur baxx (< 50%) kellhom l-aħjar rispons għat-trattament bi BLINCYTO b'rata ta' CR/CRh* ta' 72.9% (CI 59.7 - 83.6).
English: BLINCYTO was administered as a continuous intravenous infusion.
Maltese: BLINCYTO ngħata bħala infużjoni kontinwa ġol-vini.
English: Grade 3 and serious events were reported for 1.5% each of adult patients with MRD positive B-precursor ALL; no grade ≥ 4 events were reported.
Maltese: Avvenimenti ta' grad 3 u serji ġew irrapportati għal 1.5% kull wieħed millpazjenti adulti b'ALL bi prekursur B pożittiva għal MRD; l-ebda avvenimenti tal-grad ≥ 4 ma ġew irrapportati.
English: Characteristic
Maltese: Karatteristiċi
English: 6.3 Shelf life
Maltese: 6.1 xhur
English: Non-interventional post-authorisation safety study (PASS): Study 20150136: an observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices*
Maltese: Studju 20150136: studju ta' osservazzjoni dwar is-sigurtà u l-effikaċja, l-użu u l-prattiki ta' trattament ta' blinatumomab*
English: 1/Complete remission with partial haematological recovery (CRh*) CR
Maltese: Persuni li rrispondew b'mod ematoloġiku (CR/CRh*/CRi)
English: Consistent results were observed after censoring at the time of HSCT; median OS, censored at the time of HSCT, was 6.9 months (95% CI: 5.3, 8.8) in the BLINCYTO group and 3.9 months (95% CI: 2.8, 4.9) in the SOC group (HR, 0.66; 95% CI: 0.50, 0.88; p value = 0.004).
Maltese: Riżultati konsistenti kienu osservati wara ċ-ċensura fil-ħin ta' HSCT; l-OS medjana, iċċensurata filħin ta' HSCT, kienet 6.9 xhur (CI ta' 95%: 5.3, 8.8) fil-grupp ta' BLINCYTO u 3.9 xhur (CI ta' 95%:
English: For clinical management of pancreatitis, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' pankreatite, ara sezzjoni 4.4.
English: MRD (minimum residual disease) response was defined as MRD by PCR or flow cytometry < 1 x 10 f. Patients who achieved CR/CRh*/CRi and had an evaluable post baseline MRD assessment.
Maltese: Rispons ta' MRD (marda residwa minima) kien definit bħala MRD permezz ta' PCR jew flow cytometry < 1 x 10-4. f. Pazjenti li kisbu CR/CRh*/CRi u kellhom stima ta' MRD li setgħet tiġi evalwata wara l-linja bażi.
English: The most common adverse reactions were: pyrexia (69.2%), infusion-related reactions (43.4%), infections - pathogen unspecified (42.1%), headache (32.9%), anaemia (22.8%), thrombocytopenia (20.9%), febrile neutropenia (20.2%), oedema (20.0%), neutropenia (19.7%), rash (16.7%), increased liver hepatic enzymes (16.1%), bacterial infectious disorders (15.4%), tremor (15.2%), cough (15.1%), leukopenia (13.4%), back pain (13.3%), chills (13.0%), hypotension (12.8%), viral infectious disorders (12.7%), decreased immunoglobulins (12.5%), cytokine release syndrome (11.6%), tachycardia (11.3%), insomnia (10.7%), fungal infectious disorders (10.6%) and pain in extremity (10.2%).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni kienu: deni (69.2%), reazzjonijiet relatati mal-infużjoni (43.4%), infezzjonijiet - patoġenu mhux speċifikat (42.1%), uġigħ ta' ras (32.9%), anemija (22.8%), tromboċitopenija (20.9%), newtropenija bid-deni (20.2%), edima (20.0%), newtropenija (19.7%), raxx (16.
English: • low levels of antibodies called “immunoglobulins” which help the immune system fight infection (decreased immunoglobulins)
Maltese: • livelli baxxi ta' antikorpi msejħa “immunoglobulini” li jgħinu s-sistema immuni tiġġieled l-infezzjonijiet (tnaqqis fl-immunoglobulini)
English: BSA = body surface area
Maltese: BSA = erja tas-superfiċje tal-ġisem
English: The median OS was 4.0 months (95% CI: 2.9, 5.3) in the SOC chemotherapy arm compared with 7.7 months (95% CI: 5.6, 9.6) in the BLINCYTO arm.
Maltese: 2.9, 5.3) fil-grupp ta' kimoterapija SOC meta mqabbel ma' 7.7 xhur (CI ta' 95%: 5.6, 9.6) fil-grupp ta' BLINCYTO.
English: In the dose-finding part of the study, doses of up to 30 mcg/m 2/day were evaluated.
Maltese: Fil-parti tal-istudju fejn tinstab id-doża, ġew evalwati dożi ta' mhux aktar minn 30 mcg/m2/jum.
English: Dyspnoea exertional Acute respiratory failure
Maltese: Qtugħ ta' nifs meta wieħed jistrapazza Insuffiċjenza respiratorja akuta
English: Neurologic events were reported for 71.5% of adult patients with MRD positive B-precursor ALL (N = 137) of which 22.6% were considered serious.
Maltese: Ġew irrapportati avvenimenti newroloġiċi għal 71.5% tal-pazjenti adulti b'ALL bi prekursur B pożittiva għal MRD (N = 137) li minnhom 22.6% kienu kkunsidrati bħala serji.
English: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
Maltese: BLINCYTO huwa indikat bħala monoterapija għat-trattament ta' adulti b'lewkimja limfoblastika akuta (ALL - acute lymphoblastic leukaemia) bi prekursur B li reġgħet feġġet jew reżistenti, pożittiva għal CD19 u negattiva għall-kromosoma ta' Philadelphia.
English: Talk to your doctor or nurse about suitable methods of contraception.
Maltese: Kellem lit-tabib jew l-infermier tiegħek dwar metodi adattati ta' kontraċezzjoni.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 4 hours at or below 27°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2°C - 8°C jew għal 4 sigħat f'temperatura ta' 27°C jew inqas.
English: Using a syringe, aseptically transfer reconstituted BLINCYTO into the infusion bag (refer to table 7 to table 9 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 7 sat-tabella 9 għall-volum speċifiku ta' BLINCYTO rikostitwit).
English: To coat the infusion bag, using a syringe, aseptically transfer 5.5 mL of the solution (stabiliser) to the infusion bag.
Maltese: Sabiex tiksi l-borża tal-infużjoni, bl-użu ta' siringa, ittrasferixxi b'mod asettiku 5.5 mL tassoluzzjoni (stabbilizzanti) fil-borża tal-infużjoni.
English: 72 hours
Maltese: 72 siegħa
English: • Information on treatment with BLINCYTO, administration and posology, duration of hospitalisation, interruption and / or permanent discontinuation of the treatment Medication errors (ME)
Maltese: • Informazzjoni dwar it-trattament bi BLINCYTO, l-amministrazzjoni u l-pożoloġija, id-dewmien taż-żmien fl-isptar, l-interruzzjoni u / jew il-waqfien permanenti tattrattament Żbalji fl-għoti tal-mediċina (ME - medication errors)
English: Adverse reactions are presented below by system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma ppreżentati hawn taħt skont il-klassi tas-sistemi u tal-organi u l-kategorija tal-frekwenza.
English: The anti-tumour activity of blinatumomab immunotherapy is not dependent on T-cells bearing a specific TCR or on peptide antigens presented by cancer cells, but is polyclonal in nature and independent of human leukocyte antigen (HLA) molecules on target cells.
Maltese: L-attività kontra t-tumuri talimmunoterapija bi blinatumomab ma tiddependix fuq ċelluli T li għandhom TCR speċifiku jew fuq antiġeni tal-peptidi ppreżentati miċ-ċelluli tal-kanċer, iżda hija ta' natura poliklonali u indipendenti mill-molekoli ta' antiġeni tal-lewkoċiti tal-bniedem (HLA - human leukocyte antigen) fuq ċelluli filmira.
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion blinatumomab
Maltese: BLINCYTO 38.5 mikrogrammi trab għall-konċentrat u soluzzjoni għal soluzzjoni għallinfużjoni blinatumomab
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: BLINCYTO powder (powder for concentrate): White to off-white powder.
Maltese: BLINCYTO trab (trab għall-konċentrat):Trab abjad sa abjad fil-griż.
English: Use an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection that usually contains a total volume of 265 to 275 mL.
Maltese: Uża borża tal-infużjoni mimlija għal-lest b'250 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride li normalment ikun fiha volum totali ta' 265 sa 275 mL.
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u n-nutrizzjoni
English: Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Maltese: Immaniġġjar tal-pankreatite tista' teħtieġ interruzzjoni temporanja jew waqfien ta' BLINCYTO (ara sezzjoni 4.2).
English: Powder: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 and sodium hydroxide.
Maltese: Trab: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 u sodium hydroxide.
English: Dose adjustment was possible in the case of adverse events.
Maltese: Aġġustament fiddoża kien possibbli f'każ ta' avvenimenti avversi.
English: Chest pain Pain
Maltese: Popolazzjoni pedjatrika
English: Lymphadenopathy Histiocytosis haematophagic
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.
Maltese: Il-pazjenti li qed jirċievu prodotti mediċinali li huma sustrati ta' CYP450 u ta' trasportaturi b'indiċi terapewtiku dejjaq għandhom ikunu mmonitorjati għal effetti avversi (eż. warfarin) jew konċentrazzjonijiet ta' mediċini (eż. cyclosporine) matul dan iż-żmien.
English: Most patients had a high tumour burden (≥ 50% leukaemic blasts in bone marrow) at baseline with a median of 75.5% bone marrow blasts.
Maltese: Il-maġġoranza tal-pazjenti kellhom piż tat-tumur għoli (≥ 50% blasts lewkemiċi fil-mudullun) fil-linja bażi b'medjan ta' 75.5% blasts filmudullun.
English: MRD response rates by age and MRD level at baseline subgroups were consistent with the results in the overall population.
Maltese: MRD skont l-età u llivell ta' MRD fis-sottogruppi tal-linja bażi kienu konsistenti mar-riżultati fil-popolazzjoni ġenerali.
English: Store at 2°C - 8°C if not used immediately.
Maltese: Aħżen f'temperatura ta' 2°C - 8°C jekk ma tużax minnufih.
English: Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL.
Maltese: Ir-rikostituzzjoni b'ilma għall-injezzjonijiet tirriżulta f'konċentrazzjoni finali ta' blinatumomab ta' 12.5 mikrogrammi/mL.
English: Leukocytosis Lymphopenia
Maltese: Iperċitokinemija
English: For clinical management of CRS, see section 4.4.
Maltese: Għall-immaniġġjar kliniku tas-CRS, ara sezzjoni 4.4.
English: Frequency categories were determined from the crude incidence rate reported for each adverse reaction in clinical studies of patients with B-precursor ALL (N = 843).
Maltese: Il-kategoriji tal-frekwenzi kienu determinati mir-rata ta' inċidenza għal kull elf persuna rrappurtata għal kull reazzjoni avversa fl-istudji kliniċi ta' pazjenti b'ALL bi prekursur B (N = 843).
English: Non-interventional post-authorisation safety study (PASS): The applicant should submit the final results of a follow-up observational study to further characterise the long-term safety of BLINCYTO including developmental aspects, HSCT and secondary malignancy in high-risk paediatric patients enrolled in Study 20120215*.
Maltese: L-applikant għandu jissottometti r-riżultati finali ta' studju ta' osservazzjoni ta' segwitu biex ikompli jikkaratterizza s-sigurtà fit-tul ta' BLINCYTO inklużi laspetti ta' żvilupp, HSCT u malinn sekondarju f'pazjenti pedjatriċi b'riskju għoli rreġistrati fl-Istudju 20120215*.
English: • 38.5 micrograms blinatumomab powder in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium) and a flip off cap and
Maltese: • 38.5 mikrogrammi ta' trab ta' blinatumomab f'kunjett (ħġieġ tat-tip I) b'tapp (tal-lastku elastomeriku), siġill (tal-aluminju) u għatu li jinfetaħ b'daqqa ta' saba' u
English: Each pack of BLINCYTO contains:
Maltese: Kull pakkett ta' BLINCYTO fih:
English: Reconstitution and preparation of BLINCYTO solution for infusion using an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection
Maltese: Rikostituzzjoni u preparazzjoni ta' soluzzjoni għall-infużjoni ta' BLINCYTO bl-użu ta' borża għallinfużjoni mimlija għal-lest b'250 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride
English: • The addition of water for injections to the powder for concentrate results in a total volume of 3.08 mL for a final BLINCYTO concentration of 12.5 mcg/mL.
Maltese: 3.08 mL għal konċentrazzjoni finali ta' BLINCYTO ta' 12.5 mcg/mL.
English: d. n1: number of patients who achieved MRD response and the respective remission status; n2: number of patients who achieved the respective remission status.
Maltese: d. n1: numru ta' pazjenti li kisbu rispons MRD u l-istatus ta' remissjoni rispettiv; n2: numru ta' pazjenti li kisbu l-istatus ta'
English: Patients should be closely monitored for signs and symptoms of pancreatitis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' pankreatite.
English: Viral infectionsa, b Infections - pathogen unspecified a, b
Maltese: Infezzjonijiet batteriċia, b Infezzjonijiet fungalia, b Infezzjonijiet viralia, b Infezzjonijietb'patoġenu mhux speċifikata, b
English: Serious and grade ≥ 3 neurologic adverse reactions were observed in 11.6% and 12.1% of patients respectively, of which the most common serious adverse reactions were encephalopathy, tremor, aphasia, and confusional state.
Maltese: Reazzjonijiet avversi newroloġiċi serji u ta' grad ≥ 3 kienu osservati fi 11.6% u 12.1% tal-pazjenti rispettivament, li minnhom l-aktar reazzjonijiet avversi serji komuni kienu enċefalopatija, rogħda, afasja u stat ta' konfużjoni.
English: Interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Maltese: BLINCYTO sakemm tonqos sa grad 1 (ħafifa) u għal tal-inqas 3 ijiem, imbagħad ibda BLINCYTO mill-ġdid b'5 mcg/m2/jum.
English: Grade 3 (CTCAE version 4.0) or higher (severe or life-threatening) neurologic events following initiation of blinatumomab administration included encephalopathy, seizures, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders.
Maltese: Avvenimenti newroloġiċi ta' grad 3 (CTCAE verżjoni 4.0) jew ogħla (severi jew ta' periklu għall-ħajja) wara l-bidu tal-għoti ta' blinatumomab kienu jinkludu enċefalopatija, aċċessjonijiet, disturbi fit-taħdit, disturbi filkoxjenza, konfużjoni u diżorjentazzjoni, u disturbi fil-koordinazzjoni u l-bilanċ.
English: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Maltese: BLINCYTO huwa indikat bħala monoterapija għat-trattament ta' adulti b'ALL bi prekursur B pożittiva għal CD19 u negattiva għall-kromosoma ta' Philadelphia fl-ewwel jew it-tieni remissjoni kompleta bil-marda residwa minima (MRD) akbar jew ugwali għal 0.1 %.
English: Capillary leak syndrome
Maltese: Sindrome ta' tnixxija kapillari
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents, ATC code: L01XC19.
Maltese: Sustanzi antineoplastiċi, sustanzi Antineoplastiċi oħrajn, Kodiċi ATC: