FrancophonIA/ELRC3.0 huggingface dataset:
English: • The other ingredients are glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, and water for injections.
Maltese: • L-ingredjenti l-oħra huma glucose, sodium chloride, soluzzjoni bl-albumina umana, dextran 40 għall-injezzjoni, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, ilma għallinjezzjonijiet.
English: Name:
Maltese: ISEM
English: • Abdominal pain, constipation, diarrhoea
Maltese: • Uġigħ fl-addome, konstipazzjoni, dijarrea
English: The adverse reactions described in this section were identified in 75 and 111 patients in the ongoing multicentre pivotal clinical studies (CCTL019B2202 and CCTL019C2201).
Maltese: Lista ttabulata ta' reazzjonijiet avversi tal-mediċina Ir-reazzjonijiet avversi deskritti f'din it-taqsima kienu identifikati f'75 u 111-il pazjent waqt l-istudji kliniċi pivotali multiċentriċi kontinwi (CCTL019B2202 u CCTL019C2201).
English: Among patients responding (n=48), the mean (SD) change from baseline in the PedsQL total score was 13.5 (13.5) at month 3, 16.9 (17.6) at month 6 and 27.2 (21.7) at month 12, and the mean (SD) change from baseline in the EQ-5D VAS score was 16.5 (17.5) at month 3, 15.9 (20.1) at month 6 and 24.7 (18.6) at month 12, indicating overall clinically meaningful improvement in HRQoL following Kymriah infusion.
Maltese: Fost il-pazjenti li wieġbu (n=48), il-bidla medja (SD) mil-linja bażi fl-iskor totali ta' PedsQL kienet ta' 13.5 (13.5) fit-3et xahar, 16.9 (17.6) fis-6t xahar u 27.2 (21.7) fit-12-il xahar, u l-bidla medja (SD) mil-linja bażi fl-iskor ta' EQ-5D VAS kienet ta' 16.5 (17.5) fit-3et xahar, 15.
English: The CD3 zeta component is critical for initiating T-cell activation and antitumour activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel.
Maltese: Il-komponent tas-CD3 zeta hu kritiku għat-tnedija tal-attivazzjoni taċ-ċellula T u l-attività antitumurali, filwaqt li 4-1BB isaħħaħ l-espansjoni u l-persistenza ta' tisagenlecleucel.
English: Cerebral haemorrhage** Neuralgia
Maltese: Emorraġija ċelebrali** Newralaġja
English: NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion
Maltese: Kymriah 1.2 x 106 - 6 x 108 ċelluli dispersjoni għall-infużjoni
English: Reasons for discontinuation prior to Kymriah infusion included death (n=16; 10%), physician decision/primary disease progression (n=16; 10%), patient decision (n=3; 2%) or adverse events (n=2; 1%) while awaiting Kymriah manufacturing in the clinical study.
Maltese: Raġunijiet għala twaqqfu għal kollox qabel l-infużjoni ta' Kymriah kienu mewt (n=16; 10%), deċiżjoni tat-tabib/progressjoni tal-marda primarja (n=16; 10%), deċiżjoni talpazjent (n=3; 2%) jew episodji avversi (n=2; 1%) huma u jistennew sabiex jinħadem Kymriah waqt listudju kliniku.
English: Kymriah contains sodium, dimethylsulfoxide (DMSO) and dextran 40.
Maltese: Kymriah fih is-sodju, dimethylsulfoxide (DMSO) u dextran 40
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Lîmited Vista Building
English: • Blue lips, hands and feet
Maltese: • Xofftejn, idejn, riġlejn blu
English: Annual safety reports and 5-yearly interim reports
Maltese: Rapporti aġġornati Rapporti annwali dwar issigurtà u rapporti interim kull 5 snin
English: Worsening respiratory distress, including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen and/or need for mechanical ventilation Rapid clinical deterioration
Maltese: Skumdità respiratorja aggravata, inkluż infiltrati pulmonari, żieda talbżonn ta' ossiġnu inkluż ossiġnu b'livell għoli ta' fluss u/jew ħtieġa ta' ventilazzjoni mekkanika Deterjorazzjoni klinika mgħaġġla
English: For clinical management of cytokine release syndrome, see section 4.4 and Table 1.
Maltese: Għall-immaniġġar kliniku tas-sindrome ta' rilaxx taċ-ċitokini, ara sezzjoni 4.4 u Tabella 1.
English: HCP educational programme
Maltese: Programm edukattiv għall-pazjent
English: The blood to bone marrow partitioning of tisagenlecleucel in bone marrow was 47.2% of that present in blood at day 28 while at months 3 and 6 it distributes at 68.3% and 69%, respectively (Studies B2202 and B2205J).
Maltese: 2% ta' dak preżenti fid-demm fit-28 jum filwaqt li fit-3et u s-6t xhur jinfirex bi 68.3% u b'69%, rispettivament (Studji B2202 u B2205J).
English: Bag x of y
Maltese: Borża x ta' y
English: Of four patients with active CNS leukaemia (i.e. CNS-3) included in study B2101J, three experienced cytokine release syndrome (Grade 2-4) and transient neurological abnormalities (Grade 1-3) that resolved within 1-3 months of infusion.
Maltese: Minn erba' pazjenti b'lewkimja tas-CNS attiva (i.e. CNS-3) inklużi fl-istudju B2101J, tlieta esperjenzaw sindrome ta' rilaxx taċ-ċitokini (Grad 2-4) u anormalitajiet newroloġiċi tranżitorji (Grad 1-3) li għaddew fi żmien xahar sa 3 xhur mill-infużjoni.
English: Febrile neutropenia Leukopenia Lymphopenia Anaemia
Maltese: Newtropenija febbrili Lewkopenija Limfopenija Anemija
English: One individual treatment dose comprises 1 to 3 infusion bags.
Maltese: Doża waħda ta' trattament tinkludi minn 1 sa 3 boroż bl-infużjoni.
English: The most common non-haematological adverse reactions were cytokine release syndrome (58%), infections (54%), pyrexia (35%), diarrhoea (32%), nausea (29%), hypotension (26%) and fatigue
Maltese: L-aktar reazzjonijiet avversi mhux ematoloġiċi komuni kienu sindrome ta' rilaxx taċ-ċitokini (58%), infezzjonijiet (54%), deni (35%), dijarrea (32%), dardir (29%), pressjoni baxxa (26%) u għeja (26%).
English: Nominal one-sided exact p-value based on H0: Rate of MRD negative remission ≤15% vs. Ha: >15%.
Maltese: Valur-p nominali bl-eżatt fuq naħa waħda fuq H0: Ir-rata ta' remissjoni tal-MRD negattiva ta' ≤15% vs.
English: Hypogammaglobulinaemia was reported in 47% of patients treated with Kymriah for r/r ALL and 14% of patients with r/r DLBCL.
Maltese: L-ipogammaglobulinemija kienet irrappurtata fi 47% tal-pazjenti ttrattati b'Kymriah għal ALL b'r/r u f'14% għal pazjenti b'DLBCL b'r/r.
English: Diffuse large B-cell lymphoma (DLBCL)
Maltese: Kinetika ċellulari f'pazjenti adulti b'DLBCL
English: This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium-free”.
Maltese: Dan il-prodott mediċinali fih il-potassium, anqas minn 1 mmol (39 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mill-potassium'.
English: Table 8 Cellular kinetic parameters of tisagenlecleucel in r/r DLBCL patients by clinical response at month 3
Maltese: Tabella 8 Il-parametri tal-kinetika ċellulari ta' tisagenlecleucel f'pazjenti b'DLBCL b'r/r skont rispons kliniku fit-3et xahar
English: Requires remission status to be maintained for at least 28 days without clinical evidence of relapse.
Maltese: Ħtieġa li l-qagħda ta' remissjoni tinżamm għal mill-inqas 28 jum mingħajr evidenza klinika ta' rikaduta.
English: Infections and febrile neutropenia
Maltese: Infezzjonijiet u newrtopenija febbrili
English: This usually takes less than 1 hour.
Maltese: Dan normalment jieħu anqas minn siegħa.
English: Treatment-induced anti-mCAR19 antibodies were shown in 34.6% of paediatric and young adult ALL and 5% of adult DLBCL patients.
Maltese: L-antikorpi anti-mCAR19 imqanqla mit-trattament dehru f'34.6% tal-pazjenti pedjatriċi u adulti żgħażagħ b'ALL u f'5% tal-adulti b'DLBCL.
English: Key secondary endpoint
Maltese: Endpoint sekondarju ewlieni
English: • Bloating (abdominal distension), accumulation of fluid in the abdomen
Maltese: • Nefħa (distensjoni addominali), tiġmigħ ta' fluwidu fl-addome
English: Infused N=75 n (%)
Maltese: Mogħtija l-infużjoni N=75 n (%)
English: This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose.
Maltese: Dan il-prodott mediċinali fih 2.43 mg ta' sodju f'kull mL u 24.3 sa 121.5 mg sodju f'kull doża.
English: Severe febrile neutropenia (Grade 3 or 4) was observed in 36% of paediatric and young adult B-cell ALL patients and 15% of DLBCL patients.
Maltese: Kienet osservata newtropenija febbrili gravi (Grad 3 jew 4) f'36% tal-pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B u fi 15% tal-pazjenti b'DLBCL.
English: Tachycardia includes sinus tachycardia and tachycardia.
Maltese: It-takikardija tinkludi takikardija tas-sinus u takikardija.
English: This medicine contains 24.3 to 121.5 mg sodium per dose.
Maltese: Din il-mediċina fiha 24.3 sa 121.5 mg sodju f'kull doża.
English: Non-responding patients (NR) N=11
Maltese: Pazjenti li ma rrispondewx (NR) N=11
English: % relapse free probability at 6 months % relapse free probability at 12 months Other secondary endpoints
Maltese: Probabbiltà f'% ta' rikaduta ħielsa f'6 xhur Probabbiltà f'% ta' rikaduta ħielsa fi 12-il xahar Endpoints sekondarji oħra
English: Final report: December 2023
Maltese: Diċembru 2023
English: Coughm)
Maltese: Sogħlam)
English: Key elements:
Maltese: Elementi ewlenin:
English: Influenza-like illness Multiple organ dysfunction syndrome
Maltese: Mard jixbah lill-influwenza Sindrome tad-disfunzjoni multipla talorgani
English: Dyspnoea includes dyspnoea, dyspnoea exertional, respiratory distress and respiratory failure.
Maltese: Id-dispnea tinkludi dispnea, dispnea minħabba sforz, disturb respiratorju u kollass respiratorju.
English: Febrile neutropenia and infections
Maltese: Newtropenija febbrili u infezzjonijiet
English: Prolonged neutropenia has been associated with increased risk of infection.
Maltese: Newtropenija mtawla kienet assoċjata ma' żieda fir-riskju ta' infezzjoni.
English: Haemoglobin decreased* Lymphocyte count decreased* White blood cell count decreased* Neutrophil count decreased* Platelet count decreased* Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubin increased International normalised ratio increased
Maltese: Tnaqqis fl-għadd tan-newtrofili* Tnaqqis fl-għadd tal-platelets* Żieda tal-aspartat aminotransferażi Żieda tal-alanina aminotransferażi Żieda tal-bilirubina fid-demm Żieda tal-proporzjon normalizzat internazzjonali
English: Autologous human T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Maltese: Ċelluli T awtologi mmodifikati ġenetikament ex vivo bl-użu ta' vettur lentivirali b'kodifikazzjoni ta' riċettur ta' antiġen kimeriku anti-CD19 (CAR).
English: The most common non-haematological adverse reactions were cytokine release syndrome (77%), infections (65%), hypogammaglobulinaemia (47%), pyrexia (40%) and decreased appetite (39%).
Maltese: L-iktar reazzjonijiet avversi mhux ematoloġiċi komuni kienu s-sindrome ta' rilaxx taċ-ċitokini (77%), infezzjonijiet (65%), ipogammaglobulinemija (47%), deni (40%) u tnaqqis tal-aptit (39%).
English: % event free probability at 6 months Median (months) (95% CI)
Maltese: Probabbiltà f'% ta' episodji ħielsa f'6 xhur Medjan (xhur) (95% CI)
English: Cardiac failure includes cardiac failure, left ventricular dysfunction, cardiac failure congestive and right ventricular dysfunction.
Maltese: L-insuffiċjenza kardijaka tinkludi insuffiċjenza kardijaka, disfunzjoni tal-ventrikulu tax-xellug, insuffiċjenza konġestiva tal-qalb u disfunzjoni tal-ventrikulu tal-lemin.
English: Each ethylene vinyl acetate (EVA) infusion bag of Kymriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells) (see section 4.2).
Maltese: Kull borża bl-infużjoni ta' ethylene vinyl acetate (EVA) ta' Kymriah fiha dispersjoni taċ-ċellula ta' tisagenlecleucel f'konċentrazzjoni dipendenti mil-lott ta' ċelluli T awtologi ġenetikament immodifikati biex jesprimu r-riċettur ta' antiġen kimeriku (ċelluli T vijabbli pożittivi għal CAR) anti-CD19 (ara sezzjoni 4.2).
English: During the 30 to 60 minutes before you are given Kymriah you may be given other medicines.
Maltese: Mediċini mogħtija qabel it-trattament b'Kymriah Minn 30 sa 60 minuta qabel ma tieħu Kymriah jaf tingħata mediċini oħrajn.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: F'kull sistema tal-klassifika tal-organu, r-reazzjonijiet avversi tal-mediċina qed jidhru skont il-frekwenza, bl-aktar reazzjonijiet frekwenti jidhru l-ewwel, billi ntużat il-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma jistax ikun stmat mid-data disponibbli).
English: In adult DLBCL, patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included thrombocytopenia (41%), lymphopenia (28%), neutropenia (24%), leukopenia (21%) and anaemia (14%).
Maltese: F'pazjenti adulti b'DLBCL, kienu rrappurtati ċitopeniji fi Grad 3 u 4 mhux solvuti sat- 28 jum skont is-sejbiet li saru fil-laboratorju u kienu jinkludu tromboċitopenija (41%), limfopenija (28%), newtropenija (21%), lewkopenija (20%) u anemija (14%).
English: ‡ (day)
Maltese: (jum)
English: Nominal one-sided exact p-value based on H0: ORR ≤20% vs. Ha: ORR >20% CR (complete remission) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and full recovery of peripheral blood counts (platelets >100,000/μL and absolute neutrophil counts [ANC] >1,000/μL) without blood transfusion.
Maltese: Ha: ORR >20% CR (remissjoni sħiħa) kienet iddefinita bħala <5% ta' ċelluli mhux maturi fil-mudullun, iċċirkolazzjoni taċ-ċelluli mhux maturi fid-demm għandha tkun ta' <1%, ebda evidenza ta' mard ekstramedullari, u rkupru sħiħ tal-għadd tad-demm periferali (platelets >100,000/μL u l-għadd assolut ta' newtrofili [ANC] >1,000/μL) mingħajr trasfużjoni tad-demm.
English: In paediatric and young adult B-cell ALL patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included leukopenia (55%), neutropenia (53%), lymphopenia (43%), thrombocytopenia (41%) and anaemia (12%).
Maltese: Fost pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B, kienu rrappurtati ċitopeniji fi Grad 3 u 4 mhux solvuti sat-28 jum skont is-sejbiet li saru fil-laboratorju u kienu jinkludu lewkopenija (55%), newtropenija (53%), limfopenija (43%), tromboċitopenija (41%) u anemija (12%).
English: A genomic insertion site analysis of the lentiviral vector was performed on Kymriah products from 14 individual donors (12 patients and 2 healthy volunteers).
Maltese: Twettqet analiżi tas-sit ta' inserzjoni ġenomika tal-vettur lentivirali b'rabta mal-prodotti Kymriah minn 14-il donatur individwali (12-il pazjent u 2 voluntiera b'saħħithom).
English: • Take your temperature twice a day for 3-4 weeks after treatment with Kymriah.
Maltese: • Iċċekkja t-temperatura tiegħek darbtejn kuljum għal 3-4 ġimgħat wara li tingħata Kymriah.
English: This medicinal product contains 24.3 to 121.5 mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 24.3 sa 121.5 mg ta' sodju f'kull doża, ekwivalenti għal 1 sa 6% tal-ammont massimu rakkomandat mill-WHO ta' 2 g li għandu jittieħed kuljum minn adult.
English: • Abnormal blood test results (high level of: phosphorus, magnesium, an enzyme called alkaline phosphatase to help detect liver disease, fibrin d-dimer, serum ferritin; low level of: sodium)
Maltese: • Riżultati mhux normali tat-test tad-demm (livell għoli ta': fosfru, manjeżju, enzima msejħa fosfat tal-alkalina li tgħin issib mard tal-fwied, fibrin d-dimer, serum ferritin; livell baxx ta':
English: Encephalopathy includes depressed level of consciousness, mental status changes, automatism, cognitive disorder, confusional state, disturbance in attention, encephalopathy, posterior reversible encephalopathy syndrome, somnolence, lethargy, memory impairment, metabolic encephalopathy and thinking abnormal.
Maltese: L-enċefalopatija tinkludi livell imnaqqas fil-ħila li tkun konxju ta' x'qed jiġri madwarek, tibdil fil-qagħda mentali, awtomatiżmu, disturb konjittiv, qagħda konfużjonali, disturb fl-attenzjoni, enċefalopatija, sindrome ta' enċefalopatija riversibbli posterjuri, nuqqas ta' rqad, telqa, diffikultà fil-memorja, enċefalopatija metabolika u taħseb b'mod mhux normali.
English: In adult DLBCL patients (Study C2201), tisagenlecleucel has been detected for up to 2 years in peripheral blood and up to month 9 in bone marrow for complete responder patients.
Maltese: F'pazjenti adulti b'DLBCL (Studju C2201), tisagenlecleucel baqa' jidher sa sentejn fid-demm periferali u sa 9 xhur fil-mudullun f'pazjenti li rrispondew b'mod sħiħ.
English: Symptoms of cytokine release syndrome may include high fever, rigors, myalgia, arthralgia, nausea, vomiting, diarrhoea, diaphoresis, rash, anorexia, fatigue, headache, hypotension, encephalopathy, dyspnoea, tachypnoea, and hypoxia.
Maltese: Is-sintomi tas-sindrome ta' rilaxx taċ-ċitokini jistgħu jinkludu deni għoli, ebusija tal-ġisem, uġigħ filmuskoli, artralġja, rimettar, dijarrea, djaforesi, raxx, anoressija, għeja, uġigħ ta' ras, pressjoni baxxa, enċefalopatija, dispnea, takipnea, u ipoksja.
English: • Check for hepatitis B, hepatitis C or HIV infection.
Maltese: • Jiċċekkja għall-epatite B, epatite C jew l-infezzjoni bl-HIV.
English: Repeat tocilizumab as needed at a minimum interval of 8 hours if there is no clinical improvement.
Maltese: Irrepeti tocilizumab skont il-bżonn b'intervall minimu ta' 8 sigħat jekk m'hemmx titjib kliniku.
English: Patients with active CNS leukaemia
Maltese: Pazjenti b'lewkimija tas-CNS attiva
English: The MAH shall ensure that in each Member State where KYMRIAH is marketed, all HCPs who are expected to prescribe, dispense annd administer KYMRIAH shall be provided with a guidance document to: - facilitate identification of CRS and serious neurological adverse reactions - facilitate management of the CRS and serious neurological adverse reactions - ensure adequate monitoring of CRS and serious neurological 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 jara li f'kull Stat Membru fejn jinsab fis-suq KYMRIAH, il-PKS kollha li huma mistennija jippreskrivu, jagħtu u jamministraw KYMRIAH għandhom jingħataw dokument ta' gwida li: - iħaffef l-identifikazzjoni tas-CRS u tar-reazzjonijiet avversi newroloġiċi serji - iħaffef l-amministrazzjoni tas-CRS u tar-reazzjonijiet avversi newroloġiċi serji - jiżgura monitoraġġ xieraq tas-CRS u tar-reazzjonijiet avversi newroloġiċi serji - iħaffef l-għoti tat-tagħrif kollu relevanti lill-pazjenti - jiżgura li r-reazzjonijiet avversi huma rrappurtati kif jixraq u kif suppost - jiżgura li jingħataw istruzzjonijiet iddetaljati dwar il-proċedura biex il-prodott jinħall mis-silġ - jiżgura li qabel it-trattament ta' pazjent, ikun hemm disponibbli fuq il-post 4 dożi ta'
English: There is limited evidence that race/ethnicity impact the expansion of Kymriah in paediatric and young adult ALL and DLBCL patients.
Maltese: Hemm evidenza limitata li r-razza/l-etniċità taffettwa l-espansjoni ta' Kymriah f'pazjenti pedjatriċi u adulti żgħażagħ b'ALL u f'pazjenti b'DLBCL.
English: Table 6 Study C2201: Efficacy results in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Maltese: Tabella 6 Studju C2201: Riżultati tal-effikaċja f'pazjenti adulti b'limfoma kbira mifruxa taċċellula B (DLBCL) wara żewġ linji jew aktar ta' terapija sistemika.
English: - Active graft-versus-host disease (GVHD).
Maltese: - Marda attiva kronika tat-trapjant kontra r-riċevitur (GVHD).
English: Mouth haemorrhage Stomatitis
Maltese: Trapjant li seħħ qabel
English: The majority of patients (101/111, 91%) received bridging therapy for disease stabilisation.
Maltese: Il-biċċa l-kbira tal-pazjenti (101/111, 91%) ingħataw terapija ta' tranżizzjoni għallistabilizzazzjoni tal-marda.
English: The safety and efficacy of Kymriah treatment in paediatric and young adult patients with relapsed or refractory (r/r) B-cell ALL were evaluated in one pivotal (B2202) and two supportive (B2205J and B2101J) open-label, single-arm studies (160 patients in total, up to 25 years of age).
Maltese: Is-sigurtà u l-effikaċja tat-trattament b'Kymriah fost pazjenti pedjatriċi u adulti żgħażagħ b'ALL b'rikaduta jew refrattorja (r/r) taċ-ċellula B kienu evalwati fi studju wieħed pivotali (B2202) u żewġ studji supportivi (B2205J u B2101J) open-label bi grupp wieħed ta' pazjenti (160 pazjent b'kollox, li għandhom sa 25 sena).
English: Enrolled patients N=92
Maltese: Pazjenti msieħba N=92
English: Overall remission rate (ORR)
Maltese: Sopravivenza globali (OS)8
English: In clinical studies, humoral immunogenicity of tisagenlecleucel was measured by determination of anti-murine CAR19 antibodies (anti-mCAR19) in serum pre- and post-administration.
Maltese: Fi studji kliniċi, l-immunoġeniċità umorali ta' tisagenlecleucel tkejlet permezz tad-determinazzjoni talantikorpi antimurin CAR19 (anti-mCAR19) fis-serum qabel ma ngħata u wara li ngħata.
English: • Nausea, vomiting
Maltese: • Konvulżjoni, aċċessjonijiet
English: Infused patients N=75
Maltese: Pazjenti mogħtija l-infużjoni N=75
English: Adverse drug reactions from these clinical studies (Table 2) are listed by MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi tal-mediċina minn dawn l-istudji kliniċi (Tabella 2) huma elenkati skont is-sistema ta' klassifika talorgani tal-MedDRA.
English: Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Maltese: Kymriah hu terapija immunoċellulari li fiha tisagenleclueucel, ċelluli T awtologi mmodifikati ġenetikament ex vivo bl-użu ta' vettur lentivirali b'kodifikazzjoni ta' riċettur ta' antiġen kimeriku (CAR) anti-CD19.
English: In some cases, disseminated intravascular coagulation (DIC), with low fibrinogen levels, capillary leak syndrome (CLS), and haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) have been reported in the setting of cytokine release syndrome.
Maltese: F'xi każijiet, kienu rrappurtati koagulazzjoni intravaskulari mifruxa (DIC), b'livelli baxxi ta' fibrinogen, sindrome ta' tnixxija kapillari (CLS), u limfoistjoċitożi emofagoċitika/sindrome ta' attivazzjoni ta' makrofaġi (HLH/MAS) fil-każijiet ta' sindrome ta' rilaxx taċ-ċitokini.
English: Not reached (8.6, NE9) Not reached (8.6, NE)
Maltese: Mhux milħuqa (8.6, NE9)
English: The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (25 mg/m2 intravenous daily for 3 days) and cyclophosphamide (250 mg/m2
Maltese: Ir-reġim irrakkomadat ta' kimoterapija ta' limfodeplezzjoni hu ta': - Fludarabine (25 mg/m2 fil-vina kuljum għal 3 ijiem) u cyclophosphamide (250 mg/m2 fil-vina kuljum għal 3 ijiem billi tibda bl-ewwel doża ta' fludarabine).
English: Store and transport below -120°C, e.g. in a container for cryogenic storage (Dewar) in the vapour phase of liquid nitrogen.
Maltese: Aħżen u ttrasporta l-prodott taħt -120°C f'kontenitur għall-ħażna krijoġenika (Dewar) fil-fażi ta' fwar tan-nitroġenu likwidu.
English: • during Kymriah treatment.
Maltese: • Kymriah hu trattament ta' darba.
English: Oedema includes oedema peripheral, generalised oedema, localised oedema and face oedema.
Maltese: L-edima tinkludi edima periferali, edima ġeneralizzata, edima lokalizzata u edima fil-wiċċ.