FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common serious adverse reactions included encephalopathy (22%), unspecified pathogen infections (16%), bacterial infections (6%), febrile neutropenia (6%), viral infections (5%), and pyrexia (5%).
Maltese: Ir-reazzjonijiet avversi serji l-aktar komuni inkludew enċefalopatija (22%), infezzjonijiet ta' patoġenu mhux speċifikat (16%), infezzjonijiet batteriċi (6%), newtropenija bid-deni (6%), infezzjonijiet virali (5%), u deni (5%).
English: Active graft-versus-host disease (GVHD).
Maltese: • Marda tat-trapjant kontra l-ospitant (GVHD - graft-versus-host disease) attiva.
English: Efficacy was based on 101 patients in phase 2, including histologically confirmed DLBCL (N = 77), PMBCL (N = 8), or DLBCL arising from follicular lymphoma, (N = 16) based on the 2008 WHO-classification.
Maltese: L-effikaċja ġiet ibbażata fuq 101 pazjent f'fażi 2, inkluża DLBCL ikkonfermata istoloġikament (N = 77), PMBCL (N = 8), jew DLBCL li tirriżulta minn limfoma follikulari, (N = 16) abbażi tal-klassifikazzjoni tad-WHO tal-2008.
English: Cumulatively, 33 (31%) of 108 subjects received intravenous immunoglobulin therapy at the time of the 24-month analysis.
Maltese: B'mod kumulattiv, 33 (31%) minn 108 individwi rċivew terapija b'immunoglobulini ġol-vini waqt l-analiżi ta' 24 xahar.
English: In the 12-month follow-up analysis (Table 5), the ORR was 72% and the CR rate was 51%.
Maltese: Fl-analiżi ta' segwitu ta' 12-il xahar (Tabella 5), l-ORR kienet ta' 72% u r-rata ta' CR kienet ta' 51%.
English: The median duration of follow up was 27.4 months.
Maltese: It-tul medjan ta' segwitu kien ta' 27.4 xhur.
English: •Update reports:
Maltese: • Aġġorna r-rapporti:
English: The immunogenicity of YESCARTA has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the anti-CD19 CAR.
Maltese: L-immunoġeniċità ta' YESCARTA ġiet evalwata bl-użu ta' assaġġ ta' immunoassorbiment enzimatiku (ELISA - enzyme-linked immunosorbent assay) għall-iskoperta ta' antikorpi li jeħlu kontra FMC63, l-antikorp oriġinarju tas-CAR anti-CD19.
English: The median peak level of anti-CD19 CAR T cells in the blood (Cmax) was 38.3 cells/µL (range: 0.8 to 1513.7 cells/μL), which decreased to a median of 2.1 cells/µL by 1 month (range: 0 to 167.4 cells/μL) and to a median of 0.4 cells/µL by 3 months (range: 0 to 28.4 cells/μL) after YESCARTA infusion.
Maltese: Il-livell massimu medjan ta' ċelluli T CAR anti-CD19 fid-demm (Cmax) kien ta' 38.3 ċelluli/µL (firxa: 0.8 sa 1513.7 ċelluli/μL), li tnaqqas għal medjan ta' 2.1 ċellula/µL fi żmien xahar (firxa: 0 sa 167.4 ċelluli/μL) u għal medjan ta' 0.4 ċelluli/µL fi żmien 3 xhur (firxa: 0 sa 28.4 ċelluli/μL) wara l-infużjoni ta' YESCARTA.
English: These events were considered as syndromes of neurologic toxicity, an important identified risk of axicabtagene ciloleucel use.
Maltese: Dawn l-avvenimenti kienu meqjusa bħala sindromi ta' tossiċità newroloġika, riskju importanti identifikat bl-użu ta' axicabtagene ciloleucel.
English: Median AUCDay 0-28 in responding patients (N = 71) was 253% of the corresponding level in nonresponders (N = 25) (562.0 days x cells/μL versus 222.0 days x cells/μL).
Maltese: L-AUCJum 0-28 medjana f'pazjenti li rrispondew (N = 71) kienet 253% tal-livell korrispondenti f'pazjenti li ma rrispondewx (N = 25) (562.0 jum x ċelluli/μL kontra 222.0 jum x ċelluli/μL).
English: The anticipated metabolic products are typical cellular degradation products resulting from normal cellular clearance mechanisms.
Maltese: Il-prodotti metaboliċi antiċipati huma prodotti tipiċi ta' degradazzjoni ċellulari li jirriżultaw minn mekkaniżmi normali ta' tneħħija ċellulari.
English: Serious adverse reactions that may be associated with CRS included acute kidney injury, atrial fibrillation, ventricular tachycardia, cardiac arrest, cardiac failure, capillary leak syndrome, hypotension, hypoxia, and HLH/MAS.
Maltese: Ir-reazzjonijiet avversi serji li jistgħu jiġu assoċjati ma' CRS inkludew korriment akut tal-kliewi, fibrillazzjoni atrijali, takikardija ventrikulari, waqfien tal-qalb, falliment tal-qalb, sindrome ta' tnixxija kapillari, pressjoni baxxa, ipossja, u HLH/MAS.
English: Administer tocilizumab (c) 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Maltese: Agħti tocilizumab (c) 8 mg/kg ġolvini fuq perjodu ta' siegħa (li ma taqbiżx 800 mg).
English: A retrospective, patient-level, pooled analysis of outcomes in refractory aggressive NHL (N = 636) was conducted (Crump et al., 2017) to provide confirmation of the prespecified control response rate of 20% and historical context for interpreting the ZUMA-1 results.
Maltese: Twettqet analiżi miġbura, fil-livell tal-pazjent u retrospettiva tar-riżultati f'NHL aggressiva reżistenti (N = 636) (Crump et al., 2017) biex tipprovdi konferma tar-rata ta' rispons ta' kontroll speċifikata minn qabel ta' 20% u l-kuntest storiku għall-interpretazzjoni tar-riżultati ta' ZUMA-1.
English: Other neurologic adverse reactions have been reported less frequently in clinical trials and included dysphagia (5%), myelitis (0.2%), and quadriplegia (0.2%).
Maltese: Reazzjonijiet avversi newroloġiċi oħra ġew irrappurtati b'mod inqas frekwenti fi provi kliniċi u kienu jinkludu disfaġja (5%), majelite (0.2%), u kwadripleġja (0.2%).
English: The primary endpoint was objective response rate (ORR).
Maltese: L-iskop finali primarju kien rata ta' rispons oġġettiv (ORR - objective response rate).
English: 6 month OS (%) [95% CI] 9 month OS (%) [95% CI] 12 month OS (%) [95% CI]
Maltese: OS ta' 6 xhur (%) [CI ta' 95%] OS ta' 9 xhur (%) [CI ta' 95%] OS ta' 12-il xahar (%) [CI ta' OS ta' 24 xahar (%) [CI ta' 95%]
English: This can take 3 to 6 hours and may need to be repeated.
Maltese: Dan jista' jieħu 3 sa 6 sigħat u jista' jkun jeħtieġ li jiġi repetut.
English: Administer dexamethasone 10 mg intravenously every 6 hours.
Maltese: Agħti dexamethasone 10 mg ġol-vini kull 6 sigħat.
English: Immunoglobulin levels should be monitored after treatment with YESCARTA and managed using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
Maltese: Il-livelli tal-immunoglobulina għandhom jiġu mmonitorjati wara trattament b'YESCARTA u għandhom jiġu mmaniġġjati bl-użu ta' prekawzjonijiet għall-infezzjoni, profilassi antibijotiċi, u sostituzzjoni tal-immunoglobulina.
English: The most significant and frequently occurring adverse reactions were CRS (93%), encephalopathy (58%), and infections (39%).
Maltese: Ir-reazzjonijiet avversi l-aktar sinifikanti u li jseħħu bl-aktar mod frekwenti kienu CRS (93%), enċefalopatija (58%), u infezzjonijiet (39%).
English: For special precautions for disposal, see section 6.6.
Maltese: Għal prekawzjonijiet speċjali għar-rimi, ara sezzjoni 6.6.
English: EXP:
Maltese: Pereżempju:
English: • You will be given a pregnancy test before treatment starts.
Maltese: • Int ser isirlek test tat-tqala qabel jibda t-trattament.
English: Other medicines and YESCARTA
Maltese: Mediċini oħra u YESCARTA
English: Requirements for ventilator support or continuous veno-venous haemodialysis or Grade 4 organ toxicity (excluding transaminitis).
Maltese: Ħtiġijiet ta' sostenn b'ventilatur jew emodijalisi veno-venuża kontinwa jew tossiċità tal-organi ta' Grad 4 (minbarra transaminite).
English: The median dose was 2.0 x 106 anti-CD19 CAR T cells/kg.
Maltese: Id-doża medjana kienet ta' 2.0 x 106 ċelluli T CAR anti-CD19 għal kull kg.
English: Grade 3 or higher neutropenia (including febrile neutropenia), anaemia, and thrombocytopenia occurred in 80%, 45%, and 40% of patients, respectively.
Maltese: Newtropenija (inkluża newtropenija bid-deni), anemija, u tromboċitopenija ta' Grad 3 jew ogħla seħħew fi 80%, 45%, u 40% tal-pazjenti, rispettivament.
English: All treated (mITT) Cohort 1 + 2 (N = 101)
Maltese: Ittrattati kollha (mITT) Koorti 1 + 2
English: • Once thawed, YESCARTA is stable at room temperature (20 ˚C-25 ˚C) for up to 3 hours.
Maltese: • Ladarba jinħall minn silġ, YESCARTA jkun stabbli f'temperatura ambjentali (20 ˚C-25 ˚C) għal sa 3 sigħat.
English: Dizziness Aphasia
Maltese: Disturbi vaskulari
English: Serious adverse reactions including encephalopathy (22%), aphasia (4%), delirium (4%), and seizures (1%) have been reported in patients administered YESCARTA.
Maltese: Reazzjonijiet avversi serji li jinkludu enċefalopatija (22%), afasja (4%), thewdin (4%), u aċċessjonijiet (1%) ġew irrappurtati f'pazjenti li ngħataw YESCARTA.
English: All leukapheresed (ITT) Cohort 1 + 2 (N = 111)
Maltese: Lewkaferezzati kollha (ITT) Koorti 1 + 2
English: Forty-seven patients were evaluable for MYC, BCL-2, and BCL-6 status.
Maltese: Sebgħa u erbgħin pazjent setgħu jiġu evalwati għall-istat ta' MYC, BCL-2, u BCL-6.
English: In the 24-month follow-up analysis, based on the mITT population (results from an independent review committee), the ORR and the CR rate were 74% and 54%, respectively.
Maltese: Fl-analiżi ta' segwitu ta' 24 xahar, ibbażata fuq il-popolazzjoni mITT (riżultati minn kumitat ta' analiżi indipendenti), ir-rata ta' ORR u ta' CR kienu 74% u 54%, rispettivament.
English: - Muscle spasms.
Maltese: Spażmi fil-muskoli.
English: The most common signs or symptoms associated with CRS included pyrexia (83%), hypotension (44%), tachycardia (24%), hypoxia (23%), and chills (20%).
Maltese: Is-sinjali jew is-sintomi l-aktar komuni assoċjati ma' CRS inkludew deni (83%), pressjoni baxxa (44%), takikardija (24%), ipossja (23%), u sirdat (20%).
English: The ORR results within PMBCL and DLBCL arising from follicular lymphoma were both 88%.
Maltese: Ir-riżultati tal-ORR fi ħdan PMBCL u DLBCL li tirriżulta minn limfoma follikulari t-tnejn kienu 88%.
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells)
Maltese: YESCARTA 0.4 - 2 x 108 ċelluli, dispersjoni għal infużjoni axicabtagene ciloleucel (CAR+ ċelluli T vijabbli)
English: Serious adverse reactions occurred in 56% of patients.
Maltese: Reazzjonijiet avversi serji seħħew f'56% tal-pazjenti.
English: Thirty were found to have double expressor DLBCL (overexpression of both MYC and BCL-2 protein); 5 were found to have HGBCL with MYC, BCL-2 or BCL-6 gene rearrangement (double- and triple-hit); and 2 were found to have HGBCL not otherwise specified.
Maltese: Tletin instabu li kellhom DLBCL b'espressjoni doppja (espressjoni żejda kemm ta' MYC kif ukoll talproteina BCL-2); 5 nstabu li kellhom HGBCL b'arranġament mill-ġdid tal-ġeni MYC, BCL-2 jew BCL-6 (hit doppja u tripla); u 2 instabu li kellhom HGBCL li ma ġietx speċifikata b'xi mod ieħor.
English: Store frozen in vapour phase of liquid nitrogen ≤ -150˚C.
Maltese: Aħżen iffriżat f'fażi ta' fwar tan-nitroġenu likwidu ≤ -150˚C.
English: - Keep this leaflet.
Maltese: Preparazzjoni ta' YESCARTA
English: The MAH shall ensure that in each Member State where YESCARTA is marketed, all HCPs who are expected to prescribe, dispense, and administer YESCARTA shall be provided with a guidance document to: - facilitate identification of CRS and serious neurologic adverse reactions - facilitate management of the CRS and serious neurologic adverse reactions - ensure adequate monitoring of CRS and serious neurologic adverse reactions - facilitate provision of all relevant information to patients - ensure that adverse reactions are adequately and appropriately reported - ensure that detailed instructions about the thawing procedure are provided - before treating a patient, ensure that 4 doses of tocilizumab for each patient are available on site
Maltese: L-MAH għandu jiżgura li f'kull Stat Membru fejn YESCARTA jitqiegħed fis-suq, l-HCPs kollha li huma mistennija jippreskrivu, jagħtu u jamministraw YESCARTA għandhom jiġu pprovduti b'dokument ta' gwida biex: jiffaċilita l-identifikazzjoni ta' CRS u ta' reazzjonijiet avversi newroloġiċi serji jiffaċilita l-immaniġġjar ta' CRS u ta' reazzjonijiet avversi newroloġiċi serji jiżgura monitoraġġ adegwat ta' CRS u ta' reazzjonijiet avversi newroloġiċi serji jiffaċilita l-għoti tal-informazzjoni relevanti kollha lill-pazjenti jiżgura li reazzjonijiet avversi jiġu rrappurtati b'mod adegwat u xieraq jiżgura li jingħataw istruzzjonijiet dettaljati dwar il-proċedura ta' kif jinħall minn silġ qabel ma jiġi ttrattat pazjent, jiġi żgurat li jkun hemm disponibbli fuq il-post 4 dożi ta' tocilizumab għal kull pazjent
English: - Decreased levels of albumin which will show up on blood tests.
Maltese: Livelli mnaqqsa ta' albumin li jiġu osservati fit-testijiet tad-demm.
English: Serious infections have been very commonly observed with YESCARTA (see section 4.8).
Maltese: Ġew osservati b'mod komuni ħafna infezzjonijiet serji b'YESCARTA (ara sezzjoni 4.8).
English: • Check for hepatitis B, hepatitis C or HIV infection.
Maltese: • Jiċċekkja għal infezzjoni tal-epatite B, tal-epatite Ċ jew tal-HIV.
English: - Lung infection.
Maltese: - għandek infezzjoni.
English: Summary of efficacy results for ZUMA-1 phase 2
Maltese: Sommarju tar-riżultati tal-effikaċja għall-fażi 2 ta' ZUMA-1
English: To prepare YESCARTA, patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.
Maltese: Biex jiġi ppreparat YESCARTA, iċ-ċelluli T tal-pazjent stess jiġu miġbura u ġenetikament modifikati ex vivo permezz ta' transduzzjoni retrovirali biex jiġi espress riċettur ta' antiġene kimeriku (CAR - chimeric antigen receptor) li jinkludi framment varjabbli ta' katina singola anti-CD19 tal-ġrieden marbut ma' dominju kostimulanti CD28 u dominju ta' sinjalar CD3-zeta.
English: Tumour necrosis factor (TNF) antagonists are not recommended for management of YESCARTA-associated CRS.
Maltese: Antagonisti talfattur tan-nekrożi tat-tumur (TNF - tumour necrosis factor) mhumiex rakkomandati għall-immaniġġjar ta' CRS assoċjat ma' YESCARTA.
English: - Dehydration.
Maltese: Deidratazzjoni.
English: YESCARTA was administered as a single infusion at a target dose of 2 x 106 anti-CD19 CAR T cells/kg after lymphodepleting chemotherapy regimen of 500 mg/m2 intravenous cyclophosphamide and 30 mg/m2 intravenous fludarabine on the 5th, 4th, and 3rd day before YESCARTA.
Maltese: YESCARTA ngħata bħala infużjoni waħda f'doża fil-mira ta' 2 x 106 ċelluli T CAR anti-CD19 għal kull kg wara kors ta' kimoterapija li tnaqqas il-limfoċiti ta' 500 mg/m2 cyclophosphamide ġol-vini u 30 mg/m2 fludarabine ġol-vini fil-ħames, ir-raba', u t-tielet jum qabel YESCARTA.
English: - Extreme tiredness.
Maltese: Għeja estrema.
English: Each patient specific single infusion bag of YESCARTA contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg body weight (range: 1 x 106 - 2 x 106 cells/kg), with a maximum of 2 x 108 anti-CD19 CAR T cells.
Maltese: Kull borża tal-infużjoni waħda ta' YESCARTA speċifika għall-pazjent fiha dispersjoni ta' ċelluli T CAR anti-CD19 f'madwar 68 mL għal doża fil-mira ta' 2 x 106 ċelluli T vijabbli pożittivi għal CAR anti-CD19 għal kull kg ta' piż tal-ġisem (firxa: 1 x 106 - 2 x 106 ċelluli/kg), b'massimu ta' 2 x 108 ċelluli T CAR anti-CD19.
English: • Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, or rapid heartbeat, which may be symptoms of a condition known as cytokine release syndrome.
Maltese: • Sirdat, għeja estrema, debbulizza, sturdament, uġigħ ta' ras, sogħla, qtugħ ta' nifs, jew taħbit tal-qalb mgħaġġel, li jistgħu jkunu sintomi ta' kondizzjoni magħrufa bħala sindrome ta' rilaxx ta' ċitokina.
English: The median time from leukapheresis to product delivery was 17 days (range: 14 to 51 days), and the median time from leukapheresis to infusion was 24 days (range: 16 to 73 days).
Maltese: Iż-żmien medjan mil-lewkafereżi sal-għoti tal-prodott kien ta' 17-il jum (firxa: 14 sa 51 jum), u ż-żmien medjan mil-lewkafereżi sal-infużjoni kien ta' 24 jum (firxa: 16 sa 73 jum).
English: Following anti-CD19 CAR T-cell engagement with CD19 expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signalling cascades that lead to T-cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines.
Maltese: Wara li ċ-ċellula T CAR anti-CD19 teħel maċ-ċelluli filmira li jesprimu CD19, id-dominji kostimulanti CD28 u CD3-zeta jattivaw kaskati ta' sinjalar downstream li jwasslu għal attivazzjoni taċ-ċelluli T, proliferazzjoni, kisba ta' funzjonijiet ta' effettur, u sekrezzjoni taċ-ċitokini u l-kimokini infjammatorji.
English: The most common signs or symptoms associated with neurologic adverse reactions included encephalopathy (58%), headache (40%), tremor (31%), dizziness (21%), aphasia (18%), and delirium (17%).
Maltese: Is-sinjali jew is-sintomi l-aktar komuni assoċjati ma' reazzjonijiet avversi newroloġiċi inkludew enċefalopatija (58%), uġigħ ta' ras (40%), rogħda (31%), sturdament (21%), afasja (18%), u thewdin (17%).
English: CRS Grade (a)
Maltese: NUMRU(I)
English: Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.
Maltese: Borża tal-ħażna krijoġenika tal-ethylene-vinyl acetate b'tubu ssiġillat imnejn iżżid u żewġ spike ports disponibbli, li fiha madwar 68 mL ta' dispersjoni ta' ċelluli.
English: The DOR was longer in patients who achieved CR compared to patients with a best response of PR (Table 5).
Maltese: Id-DOR kien itwal f'pazjenti li kisbu CR imqabbel ma' pazjenti bl-aħjar rispons ta' PR (Tabella 5).
English: A summary of the patient demographics is provided in Table 4.
Maltese: Sommarju tad-demografika tal-pazjenti huwa pprovdut fit-Tabella 4.
English: YESCARTA, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells and normal B cells.
Maltese: YESCARTA, prodott ta' immunoterapija taċ-ċelluli T awtologi mmanifatturati, jeħel maċ-ċelluli talkanċer li jesprimu CD19 u ċelluli B normali.
English: The stability of YESCARTA upon completion of thawing is up to 3 hours at room temperature (20 ˚C to 25 °C).
Maltese: L-istabbiltà ta' YESCARTA wara li jinħall minn silġ hija sa 3 sigħat f'temperatura ambjentali (20 ˚C sa 25 C).
English: Contents: approximately 68 mL of cell dispersion.
Maltese: Kontenut: madwar 68 mL ta' dispersjoni ta' ċelluli.
English: This medicinal product contains 300 mg sodium per infusion, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 300 mg sodium għal kull infużjoni, ekwivalenti għal 15% tal-ammont massimu rakkomandat mid-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: • Prophylactic use of systemic corticosteroids is not recommended as it may interfere with the activity of YESCARTA.
Maltese: • Użu profilattiku ta' kortikosterojdi sistemiċi mhuwiex rakkomandat peress li jista' jinterferixxi mal-attività ta' YESCARTA.
English: Ensure that a minimum of 4 doses of tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, are available for each patient prior to infusion of YESCARTA.
Maltese: Ara li tiżgura li jkun hemm minimu ta' 4 dożi ta' tocilizumab, inibitur tar-riċettur ta' interleukin-6 (IL-6), disponibbli għal kull pazjent qabel l-infużjoni ta' YESCARTA.
English: The median anti-CD19 CAR T cell Cmax level in responders (N = 71) was 216% higher compared to the corresponding level in nonresponders (N = 25) (43.6 cells/μL versus 20.2 cells/μL).
Maltese: Il-livell tas-Cmax medjan taċ-ċelluli T CAR anti-CD19 f'pazjenti li rrispondew (N = 71) kien 216% ogħla meta mqabbel mal-livell korrispondenti f'pazjenti li ma rrispondewx (N = 25) (43.6 ċelluli/μL kontra 20.2 ċelluli/μL).
English: YESCARTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
Maltese: YESCARTA huwa indikat għat-trattament ta' pazjenti adulti b'limfoma taċ-ċellula B kbira diffuża (DLBCL - diffuse large B-cell lymphoma) li rkadiet jew reżistenti u limfoma taċ-ċellula B kbira medjastinali primarja (PMBCL - primary mediastinal large B-cell lymphoma), wara żewġ għażliet jew aktar ta' terapija sistemika.
English: Tachycardia Arrhythmia
Maltese: Takikardija Arritmija
English: Kite Patient ID:
Maltese: Kategorija farmakoterapewtika:
English: No clinical data on the effect of YESCARTA on fertility are available.
Maltese: M'hemm l-ebda data klinika disponibbli dwar l-effett ta' YESCARTA fuq il-fertilità.
English: • During YESCARTA treatment.
Maltese: • Waqt it-trattament b'YESCARTA.
English: During the 30 to 60 minutes before you are given YESCARTA you may be given other medicines.
Maltese: Mediċini li jingħataw qabel it-trattament ta' YESCARTA Matul it-30 sa 60 minuta qabel ma tingħata YESCARTA tista' tingħata mediċini oħrajn.
English: Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise).
Maltese: Is-sintomi jeħtieġu trattament sintomatiku biss (eż., deni, dardir, għeja, uġigħ ta' ras, mijalġja, telqa kbira).
English: Anti-CD19 CAR T cell levels decreased toward background levels by Month 3 after infusion.
Maltese: Il-livelli ta' ċelluli T CAR anti-CD19 naqsu u ġew viċin il-livelli fl-isfond sa Xahar 3 wara infużjoni.
English: YESCARTA must be administered in a qualified clinical setting.
Maltese: YESCARTA jrid jingħata f'ambjent kliniku kkwalifikat.
English: - Fluid in the lungs.
Maltese: Fluwidu fil-pulmun.
English: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (CAR) with a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Ċelluli T awtologi transdotti b'vettur retrovirali li jikkodifika riċettur ta' antiġene kimeriku (CAR) CD28/CD3-zeta anti-CD19 b'doża fil-mira ta' 2 x 106 ċelluli T vijabbli pożittivi għal CAR anti-CD19
English: Cytokine Release Syndrome Hypogammaglobulinaemia
Maltese: Trombożi Sindrome ta' tnixxija kapillari
English: (c) Refer to tocilizumab summary of product characteristics for details.
Maltese: (c) Irreferi għas-sommarju tal-karatteristiċi tal-prodott ta' tocilizumab għal dettalji.
English: YESCARTA is intended for autologous use only (see section 4.4).
Maltese: YESCARTA huwa maħsub għal użu awtologu biss (ara sezzjoni 4.4).
English: Age (range: 23 to 76 years) and sex had no significant impact on AUC and Cmax of YESCARTA.
Maltese: L-età (firxa: 23 sa 76 sena) u s-sess ma kellhom l-ebda impatt sinifikanti fuq l-AUC u s-Cmax ta' YESCARTA.
English: Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva inkluż anafilassi, jistgħu jseħħu minħabba dimethyl sulfoxide (DMSO) jew gentamicin residwu f'YESCARTA.
English: Neurologic adverse reaction grading and management guidance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: In ZUMA-1, hypogammaglobulinaemia occurred in 16% of patients.
Maltese: F'ZUMA-1, ipogammaglobulinemija seħħet f'16% tal-pazjenti.
English: Of the 52 patients who achieved CR, 7 patients had SD and 9 had PR at their initial tumour assessment and converted to CR as late as 6.5 months.
Maltese: Mit-52 pazjent li kisbu CR, 7 pazjenti kellhom SD u 9 kellhom PR fil-valutazzjoni inizjali tagħhom tat-tumur u qalbu għal CR anki sa 6.5 xhur wara.
English: The most common site of infection was in the respiratory tract.
Maltese: Is-sit laktar komuni ta' infezzjoni kien is-sistema respiratorja.
English: This is the equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 15% tal-ammont massimu rakkomandat ta' sodium li għandu jittieħed kuljum mad-dieta minn adult.
English: CRS has been known to be associated with end organ dysfunction (e.g., hepatic, renal, cardiac, and pulmonary).
Maltese: CRS huwa magħruf li huwa assoċjat ma' disfunzjoni tal-organu fil-mira (eż., tal-fwied, tal-kliewi, talqalb, u tal-pulmun).
English: Leukopenia Neutropenia Anaemia
Maltese: Lewkopenija Newtropenija Anemija