FrancophonIA/ELRC3.0 huggingface dataset:
English: Bacterial infections Fungal infections
Maltese: Infezzjoni virali Infezzjoni batterika Infezzjoni fungali
English: Patients with T-cell rich/histiocyte-rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV-positive DLBCL of the elderly, Richter's transformation, and Burkitt lymphoma were not enrolled in study C2201.
Maltese: Pazjenti b'limfoma b'ammont għoli taċ-ċellula T/ b'ammont għoli taċ-ċellula B istjoċitojdi (THRBCL), b'limfoma kutanja primarja b'ammont għoli taċ-ċellula B, b'limfoma medjastinali primarja taċ-ċellula B (PMBCL), b'DLBCL pożittiva għal EBV tal-anzjani, bit-trasformazzjoni skont Richter, u bil-limfoma Burkitt ma ddaħħlux fl-istudju CC201.
English: The most common (>25%) Grade 3 and 4 haematological laboratory abnormalities were lymphocyte count decreased (95%), neutrophil count decreased (81%), white blood cell count decreased (77%), haemoglobin decreased (59%) and platelet count decreased (55%).
Maltese: L-aktar anormalitajiet ematoloġiċi komuni (>25%) fil-laboratorju fi Grad 3 u 4 kienu tnaqqis fl-għadd tal-limfoċiti (95%), tnaqqis fl-għadd tan-newtrofili (81%), tnaqqis fl-għadd taċ-ċelluli bojod tad-demm (77%), tnaqqis tal-emoglobina (59%) u tnaqqis fl-għadd tal-platelets (55%).
English: Grade 3 and 4 adverse reactions were reported in 88% of patients.
Maltese: Kienu rrappurtati reazzjonijiet avversi fi Grad 3 u 4 fi 88% tal-pazjenti.
English: Blood, organ, tissue and cell donation
Maltese: Donazzjoni ta' demm, organu, tessut u ċellula
English: HBV reactivation
Maltese: Riattivazzjoni tal-HBV
English: Acute kidney injury includes acute kidney injury, anuria, azotaemia, blood creatinine increased, renal failure, renal tubular dysfunction and renal tubular necrosis.
Maltese: Il-ħsara gravi fil-kliewi tinkludi ħsara gravi fil-kliewi, anurija, azotemija, żieda tal-kreatinina fiddemm, insuffiċjenza renali, disfunzjoni tubulari tal-kliewi u nekrożi tubulari tal-kliewi.
English: The most common Grade 3 and 4 haematological laboratory abnormalities were white blood cells decreased (99%), neutrophils decreased (95%), lymphocytes decreased (95%), platelets decreased (77%) and haemoglobin decreased (53%).
Maltese: L-aktar anormalitajiet ematoloġiċi komuni fil-laboratorju fi Grad 3 u 4 kienu tnaqqis taċ-ċelluli bojod tad-demm (99%), tnaqqis fin-newtrofili (95%), tnaqqis tal-limfoċiti (95%), tnaqqis tal-platelets (77%) u tnaqqis tal-emoglobina (53%).
English: Other secondary endpoint
Maltese: Endpoint sekondarju ieħor
English: The maximal expansion (Cmax) was approximately 2-fold higher in CR/CRi patients (n=79) compared with non-responding (NR) patients (n=10) as measured by qPCR.
Maltese: L-espansjoni massima (Cmax) kienet ta' madwar darbtejn ogħla fil-pazjenti b'CR/CRi (n=79) imqabbla mal-pazjenti li ma kellhomx rispons (NR) (n=10) kif imkejjel bi qPCR.
English: The CAR is comprised of a murine single chain antibody fragment which recognises CD19 and is fused to intracellular signalling domains from 4-1BB (CD137) and CD3 zeta.
Maltese: Il-CAR hu magħmul minn fdal tal-antikorp li jikkorrispondi għall-katina singola tal-murin li jagħraf is-CD19 u jintiseġ mad-dominji ta' senjalazzjoni intraċellulari minn 4-1BB (CD137) u CD3 zeta.
English: The adverse reactions described in this section were identified in 111 patients infused with Kymriah in one global multicentre international study, i.e. the ongoing pivotal clinical study CCTL019C2201.
Maltese: Ir-reazzjonijiet avversi mfissra f'din it-taqsima kienu identifikati f'111-il pazjent mogħtija Kymriah bħala infużjoni waqt wieħed mill-istudji multiċentriċi dinjija internazzjonali, i.e. l-istudju kliniku pivotali kontinwu CCTL019C2201.
English: The median time to onset of neurological events was 7 days in B-cell ALL and DLBCL.
Maltese: Iż-żmien medju sakemm żviluppaw episodji newroloġiċi kien ta' 7 ijiem f'każ ta' pazjenti b'ALL taċ-ċellula B u b'DLBCL.
English: Grade 3 and 4 adverse reactions were reported in 89% of patients.
Maltese: Kienu rrappurtati reazzjonijiet avversi fi Grad 3 u 4 f'89% tal-pazjenti.
English: 1-3 bags contain a total of 1.2 x 106 - 6 x 108 CAR+ viable T cells.
Maltese: 1-3 boroż bl-infużjoni li fihom total ta' 1.2 x 106 sa 6 x 108 ċelluli T vijabbli pożittivi għal CAR.
English: The most common Grade 3 and 4 non-haematological adverse reactions were infections (32%) and cytokine release syndrome (22%).
Maltese: L-aktar reazzjonijiet avversi mhux ematoloġiċi komuni fi Grad 3 u 4 kienu infezzjonijiet (32%) u sindrome ta' rilaxx taċ-ċitokini
English: Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support.
Maltese: Osserva fil-persuna; eskludi infezzjoni; agħti antibjotiċi skont il-linji gwida lokali jekk newtropeniċi; agħti għajnuna sintomatika.
English: Delirium includes agitation, delirium, hallucination, hallucination visual, irritability and restlessness.
Maltese: It-thewdin jinkludi aġitazzjoni, thewdin, alluċinazzjoni, alluċinazzjoni viżiva, irritabbiltà, u nuqqas ta' kwiet.
English: Pregnancy
Maltese: Ipoksja
English: • Jaundice
Maltese: • Suffejra
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kymriah in one or more subsets of the paediatric population in the following conditions: a) treatment of B-cell lymphoblastic lymphoma, and b) treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Kymriah f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kundizzjonijiet li ġejjin: a) trattament tal-limfoma limfoblastika taċ-ċellula B, u b) trattament tan-neoplażmi taċ-ċellula B maturi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: This is equivalent to 1 to 6% of the recommended maximum daily dietary intake of 2 g sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1 sa 6% talammont massimu rakkomandat ta' sodium ta' 2 mg li għandu jittieħed kuljum mad-dieta minn adult.
English: There are no data on the effect of Kymriah on fertility.
Maltese: M'hemmx data dwar l-effett ta' Kymriah fuq il-fertilità.
English: The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2
Maltese: Ir-reġim irrakkomadat ta' kimoterapija ta' limfodeplezzjoni hu ta': - Fludarabine (30 mg/m2 fil-vina kuljum għal 4 ijiem) u cyclophosphamide (500 mg/m2 fil-vina kuljum għal jumejn billi tibda bl-ewwel doża ta' fludarabine).
English: MRD (minimal residual disease) negative was defined as MRD by flow cytometry <0.01%.
Maltese: 01% b'ċitometrija tal-fluss (MRD-negattiva).
English: Overall survival (OS)8 % survival probability at 6 months % survival probability at 12 months Median (months) (95% CI)
Maltese: Probabbiltà f'% ta' sopravivenza f'6 xhur Probabbiltà f'% ta' sopravivenza fi 12-il xahar Medjan (xhur) (95% CI)
English: Cardiac disorders Tachycardiaj)
Maltese: Disturbi fil-qalb Takikardijaj)
English: Cough includes cough, productive cough and upper-airway cough syndrome.
Maltese: Is-sogħla tinkludi sogħla, sogħla produttiva u sindrome tas-sogħla tal-passaġġ ta' fuq.
English: Sex - n (%)
Maltese: Sesss - n (%)
English: T-cell immunogenicity responses were not observed in paediatric and young adult B-cell ALL and adult r/r DLBCL patients.
Maltese: Ir-risponsi tal-immunoġeniċità taċ-ċellula T ma kinux osservati f'pazjenti pedjatriċi u adult żgħażagħ b'ALL taċ-ċellula B u f'pazjenti adulti b'DLBCL b'r/r.
English: • Abnormal blood test results (high level of: uric acid, glucose; low level of: phosphorus, calcium,
Maltese: • Riżultati tat-testijiet tad-demm mhux normali (livell għoli ta': aċidu uriku, glucose; livell baxx ta': fosfru, kalċju, potassju, manjeżju)
English: Relapsed disease2
Maltese: Pazjenti msieħba
English: Cellular kinetics in paediatric and young adult B-cell ALL patients
Maltese: Kinetika ċellullari f'pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B
English: • problems such as altered or decreased consciousness, delirium, confusion, agitation, seizures, difficulty speaking and understanding speech, loss of balance.
Maltese: • problemi newroloġiċi bħalma huma tnaqqis jew tibdil fil-ħila li tkun konxju ta' x'qed jiġri madwarek, thewdin, konfużjoni, aġitazzjoni, aċċessjonijiet, diffikultà biex titkellem u tifhem ittaħdit, nuqqas ta' bilanċ.
English: Seizure includes seizure, generalised tonic-clonic seizures and status epilepticus.
Maltese: L-aċċessjoni tinkludi aċċessjoni u aċċessjonijiet toniċi-kloniċi ġġeneralizzati u qagħda epilettika.
English: - For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based).
Maltese: - Għal pazjenti li jiżnu aktar minn 50 kg: 0.1 to 2.5 x 108 ċelluli T vijabbli pożittivi għal CAR
English: The majority of patients tested positive for pre-dose anti-mCAR19 antibodies in paediatric and young adult ALL (B2202 and B2205J, 84.6%) and adult DLBCL (C2201, 91.4%).
Maltese: 6%) u adulti b'DLBCL (C2201, 91.4%).
English: The safety and efficacy of Kymriah treatment in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who received ≥2 lines of chemotherapy, including rituximab and anthracycline, or relapsed following autologous haematopoietic stem cell transplantation (HSCT), was evaluated in an open-label, pivotal, single-arm study.
Maltese: Is-sigurtà u l-effikaċja tat-trattament b'Kymriah fost pazjenti adulti b'limfoma kbira mifruxa taċċellula B (DLBCL) b'rikaduta jew refrattorja (r/r) li ngħataw ≥2 linji ta' kimoterapija, li kienet tinkludi rituximab u anthracycline, jew li kellhom rikaduta wara trapjant taċ-ċellula staminali awtologa ematopoetika (HSCT), kienu evalwati fi studju open-label, pivotali fost grupp wieħed ta' pazjenti.
English: Other medicines and Kymriah
Maltese: Mediċini oħra u Kymriah
English: • Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.
Maltese: • Fsada jew tbenġil b'aktar faċilità, li jistgħu jkunu sintomi ta' livelli baxxi ta' ċelluli fid-demm magħrufin bħala platelets.
English: A risk to the breast-fed infant cannot be excluded.
Maltese: Ir-riskju għat-trabi mreddgħa mhux eskluż.
English: Pyrexia Fatigue Oedemar) Pains) Chills
Maltese: Studju dwar l-effikaċja wara l-awtorizzazzjoni (PAES):
English: Prolonged cytopenias
Maltese: Popolazzjoni anzjana
English: In the ongoing clinical studies in paediatric and young adult B-cell ALL (N=75), cytokine release syndrome was reported in 77% of patients (47% with Grade 3 or 4).
Maltese: Fl-istudji kliniċi kontinwi fost pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B (N=75), issindrome ta' rilaxx taċ-ċitokini kienet irrappurtata f'77% tal-pazjenti (47% bi Grad 3 jew 4).
English: • Look for signs of infection; any infection will be treated before you are given Kymriah.
Maltese: • Jara hemmx sinjali ta' infezzjoni; kull infezzjoni se tkun ittrattata qabel ma tieħu Kymriah.
English: Diarrhoea Nausea
Maltese: Disturbi vaskulari
English: Dosage in adult DLBCL patients - 0.6 to 6 x 108 CAR-positive viable T cells (non-weight based).
Maltese: Doża li trid tingħata lil pazjenti adulti b'DLBCL - 0.6 to 6 x 108 ċelluli T vijabbli pożittivi għal CAR (mhux skont il-piż).
English: Cytokine release syndrome Hypogammaglobulinaemiab)
Maltese: Is-sindrome ta' rilaxx taċ-ċitokini Ipogammaglobulinemijab)
English: In paediatric and young adult B-cell ALL patients, tisagenlecleucel has been shown to be present in the blood and bone marrow beyond 2 years (study B2101J).
Maltese: F'pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B, intwera li tisagenlecleucel jibqa' preżenti fid-demm u l-mudullun wara sentejn (studju B2101J).
English: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma.
Maltese: Teżisti esperjenza limitata dwar l-użu ta' Kymriah f'pazjenti b'lewkimja tas-CNS attiva u b'limfoma tas-CNS attiva.
English: In DLBCL patients, manifestations of encephalopathy and/or delirium occurred in 21% of patients (12% were Grade 3 or 4) within 8 weeks after Kymriah infusion.
Maltese: Fost pazjenti b'DLBCL, kien hemm manifestazzjonijiet ta' enċefalopatija u/jew thewdin f'21% tal-pazjenti (12% kellhom Grad 3 jew 4) fi żmien 8 ġimgħat mill-infużjoni ta' Kymriah.
English: This is because Kymriah has not been studied in this age group.
Maltese: Dan minħabba li Kymriah ma ġiex studjat fost dan il-grupp ta' età.
English: Cytokine release syndrome was graded with the Penn scale as follows: Grade 1: mild reactions, e.g. reactions requiring supportive care; Grade 2: moderate reactions, e.g. reactions requiring intravenous therapies; Grade 3: severe reactions, e.g. reactions requiring low-dose vasopressors or supplemental oxygen; Grade 4: life-threatening reactions, e.g. those requiring high-dose vasopressors or intubation; Grade 5: death.
Maltese: Grad 3: reazzjonijiet gravi, eż. reazzjonijiet li jeħtieġu doża baxxa ta' vażopressuri jew ossiġnu supplimentari; Grad 4: reazzjonijiet ta' theddida għall-ħajja, eż. dawk li jeħtieġu doża għolja ta' vażopressuri jew intubazzjoni;
English: Immunoglobulin levels should be monitored after treatment with Kymriah.
Maltese: Il-livelli tal-immunoglobulina għandhom ikunu mmonitorati wara t-trattament b'Kymriah.
English: ORR is the proportion of patients with best overall response (BOR) of CR or PR based on the Lugano response criteria (Cheson 2014); non-infused patients were assigned BOR=Unknown (i.e. non-responders).
Maltese: L-ORR hi l-proporzjon ta' pazjenti li kisbu l-aħjar rispons sħiħ (BOR) ta' CR jew PR skont il-kriterji ta' rispons Lugano (Cheson 2014); pazjenti li ma ngħatawx l-infużjoni ngħataw BOR=Mhux magħruf (i.e. ma rrispondewx).
English: Table 3 Study B2202: Baseline information across the enrolled and the infused patient population
Maltese: Tabella 3 Studju B2202:
English: Table 1 Cytokine release syndrome management algorithm
Maltese: Tabella 1 Algorittmu ta' kontroll ta' sindrome ta' rilaxx taċ-ċitokini
English: Infections may also occur during cytokine release syndrome and may increase the risk of a fatal event.
Maltese: Jista' jkun hemm ukoll infezzjonijiet matul is-sindrome ta' rilaxx taċ-ċitokini u jistgħu jżidu r-riskju ta' episodju fatali.
English: There is no evidence that the presence of pre-existing and treatment-induced anti-mCAR19 antibodies impacts the safety or effectiveness of Kymriah.
Maltese: M'hemmx evidenza li l-preżenza ta' antikorpi anti-mCAR19 eżistenti diġà u mqanqla mit-trattament iħallu impatt fuq is-sigurtà jew l-effettività ta' Kymriah.
English: B-cell ALL: No formal studies have been performed in paediatric patients below 3 years of age.
Maltese: All taċ-ċellula B: Ma twettaq l-ebda studju formali fost pazjenti pedjatriċi taħt it-3 snin.
English: Tisagenlecleucel is an autologous, immunocellular cancer therapy which involves reprogramming a patient's own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19 expressing cells.
Maltese: Tisagenlecleucel hu terapija awtologa u immunoċellulari għal kontra l-kanċer li tinvolvi programmazzjoni mill-ġdid taċ-ċelluli T tal-pazjent innifsu b'transġenu b'kodifikazzjoni ta' riċettur antiġenu kimeriku (CAR) li jidentifika u jelimina ċ-ċelluli li jesprimu s-CD19.
English: • Nerve pain
Maltese: • Uġigħ fin-nervituri
English: The most common Grade 3 and 4 non-haematological adverse reaction was cytokine release syndrome (47%).
Maltese: L-aktar reazzjoni avversa mhux ematoloġika komuni fi Grad 3 u 4 kienet sindrome ta' rilaxx taċ-ċitokini (47%).
English: In paediatric and young adult B-cell ALL patients, manifestations of encephalopathy and/or delirium occurred in 40% of patients (13% were Grade 3 or 4) within 8 weeks after Kymriah infusion.
Maltese: Fost pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B, kien hemm manifestazzjonijiet ta' enċefalopatija u/jew thewdin f'40% tal-pazjenti (13% kellhom Grad 3 jew 4) fi żmien 8 ġimgħat millinfużjoni ta' Kymriah.
English: If the patient experienced a previous Grade 4 haemorrhagic cystitis with cyclophosphamide, or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen administered shortly before lymphodepleting chemotherapy, then the following should be used: - Cytarabine (500 mg/m2 intravenous daily for 2 days) and etoposide (150 mg/m2 intravenous daily for 3 days starting with the first dose of cytarabine).
Maltese: Jekk il-pazjent kellu ċistite emorraġika fi Grad 4 b'cyclophosphamide, jew wera stat kimorefrattorju għal reġim li fih cyclophosphamide mogħti minnufih qabel il-kimoterapija ta' limfodeplezzjoni, allura għandu jintuża dan li ġej: - Cytarabine (500 mg/m2 fil-vina kuljum għal jumejn) u etoposide (150 mg/m2 fil-vina kuljum għal 3 ijiem billi tibda bl-ewwel doża ta' cytarabine).
English: What Kymriah is
Maltese: X'inhu Kymriah
English: Histiocytosis haematophagic Pancytopenia
Maltese: tocilizumab għal kull pazjent
English: Kymriah was administered in a qualified Kymriah treatment centre in an inpatient and outpatient setting.
Maltese: Kymriah ingħata f'ċentru kkwalifikat għat-trattament b'Kymriah f'qafas ta' inpatient u outpatient.
English: Tisagenlecleucel also traffics and persists in cerebrospinal fluid in paediatric and young adult B-cell ALL patients (Study B2101J) for up to 1 year.
Maltese: Tisagenlecleucel jgħaddi wkoll għall-fluwidu ċelebrospinali f'pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B (Studju B2101J) u jibqa' hemm sa sena.
English: Of 92 patients enrolled, 75 received infusion with Kymriah; for 7 patients (8%) Kymriah could not be manufactured; reasons for discontinuation prior to Kymriah infusion included death (n=7; 8%) or adverse events (n=3; 3%) while awaiting Kymriah manufacturing in the clinical study.
Maltese: II fost pazjenti pedjatriċi u adulti żgħażagħ b'lewkimja limfoblastiku akuta b'r/r taċ-ċellula B. Minn 92 pazjent imsieħba, 75 irċevew l-infużjoni ta' Kymriah; għal 7 pazjenti (8%) Kymriah ma setax jinħadem; raġunijiet għala twaqqfu qabel l-infużjoni ta' Kymriah kienu jinkludu mewt (n=7; 8%) jew episodji avversi (n=3; 3%) huma u jistennew sabiex jinħadem Kymriah waqt l-istudju kliniku.
English: • Cough
Maltese: • Ħakk
English: Attention to signs and symptoms of infection should be implemented according to age and standard specific guidelines.
Maltese: Għandha tkun implimentata attenzjoni minnufih għal sinjali u sintomi ta' infezzjoni skont l-età u l-linji gwida standard speċifiċi.
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of Kymriah in patients with relapsed/refractory DLBCL, the applicant should conduct and submit a prospective, observational study in patients with r/r DLBCL based on data from registry with efficacy outcome measures in line with study C2201, including details of the manufacturing turnaround time (i.e. time from last relapse or confirmed refractory status, time from decision to treat, and time from leukapheresis to infusion).
Maltese: Sabiex tissokta l-evalwazzjoni tal-effikaċja ta' Kymriah f'pazjenti b'DLBC b'rikaduta/refrattorja, l-applikant għandu jwettaq u jissottometti studju prospettiv u osservazzjonali f'pazjenti b'DLBCL b'r/r imsejjes fuq iddata mir-reġistru tal-mard skont l-istudju C2201, li jinkludi detallji tażżmien meħtieġ għall-manifattura (i.e. żmien mill-aħħar rikaduta jew qagħda refrattorja kkonfermata, żmien mid-deċiżjoni sat-trattament, u żmien mill-lewkafereżi sal-infużjoni).
English: Special populations No differences in efficacy or safety were observed between different age subgroups.
Maltese: Ma dehru ebda differenzi fl-effikaċja u s-sigurtà bejn sottogruppi ta' etajiet differenti.
English: Pre-treatment conditioning (lymphodepleting chemotherapy)
Maltese: Insuffiċjenza tal-qalbk) Arritmijal)
English: TLS, which may be severe, has occasionally been observed.
Maltese: Kultant kien hemm it-TLS, li tista' tkun gravi.
English: See section 4.4 for the management of febrile neutropenia before and after Kymriah infusion.
Maltese: Ara sezzjoni 4.4 għall-immaniġġar tannewtropenija febbrili qabel u wara l-infużjoni ta' Kymriah.
English: B-cell ALL
Maltese: ALL taċ-ċellula B
English: The blood to bone marrow partitioning in bone marrow was nearly 70% of that present in blood at day 28 and 50% at month 3 in both responder and non-responder patients.
Maltese: It-tqassim bejn id-demm u lmudullun fil-mudullun kien ta' kważi 70% ta' dak preżenti fid-demm fit-28 jum u ta' 50% fit3et xahar kemm fil-pazjenti li rrispondew u dawk li ma rrispondewx.
English: • Muscle and joint aches, muscle spasms, back pain
Maltese: • Uġigħ fil-muskoli u fil-ġogi, spażmi fil-muskoli, uġigħ fid-dahar
English: Back pain Myalgia Arthralgia
Maltese: Uġigħ fid-dahar Mijalġja Artralġja
English: Serious infections, including life-threatening or fatal infections, occurred frequently in patients after Kymriah infusion (see section 4.8).
Maltese: Spiss kien hemm infezzjonijiet serji, inkluż infezzjonijiet ta' theddida għall-ħajja jew fatali, f'pazjenti wara l-infużjoni ta' Kymriah (ara sezzjoni 4.8).
English: Risk factors for severe cytokine release syndrome in paediatric and young adult B-cell ALL patients are: high pre-infusion tumour burden, uncontrolled or accelerating tumour burden following lymphodepleting chemotherapy, active infection and early onset of fever or cytokine release syndrome following Kymriah infusion.
Maltese: Il-fatturi ta' riskju għal pazjenti b'ALL taċ-ċellula B pedjatriċi u adulti żgħażagħ b'sindrome ta' rilaxx taċ-ċitokini gravi huma: il-massa tumurali għolja ta' qabel l-infużjoni, il-massa tumurali mhux ikkontrollata jew b'żieda qawwija wara kimoterapija ta' limfodeplezzjoni, infezzjoni attiva u episodju bikri ta' deni jew sindrome ta' rilaxx taċ-ċitokini wara l-infużjoni ta' Kymriah.
English: INSTRUCTIONS ON USE
Maltese: Iperidratazzjoni Ipermanjeżemija Iponatremija
English: Once Kymriah has been thawed and is at room temperature (20°C -25°C), it should be infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Maltese: Wara li ma jibqax iffriżat, il-prodott għandu jinżamm f'temperatura ambjentali (20°C-25°C) u jingħata bħala infujoni sa 30 minuta sabiex tinżamm l-ogħla vijabbiltà tal-prodott, inkluż kull interruzzjoni waqt l-infużjoni.
English: Hypogammaglobulinaemia includes immunoglobulins decreased, blood immunoglobulin A decreased, blood immunoglobulin G decreased, blood immunoglobulin M decreased, immunodeficiency common variable and hypogammaglobulinaemia.
Maltese: F'pazjenti b'livelli baxxi ta' immunoglobulina għandhom jittieħdu miżuri preventivi bħalma huma prekawzjonijiet għall-infezzjoni, jintużaw profilassi antibjotiċi u sostitut talimmunoglubilina skont l-età u l-linji gwida standard.
English: Graft-versus-host disease
Maltese: Disturbi fil-fwied u fil-marrara
English: Sterile sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion as well as rinse it afterwards.
Maltese: Għandha tintuża soluzzjoni għal injezzjoni ta' 9 mg/mL (0.9%) sodium chloride sabiex jitħejja t-tubu qabel ma sseħħ linfużjoni u sabiex jitlaħlaħ wara l-infużjoni.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2)
English: • Skin rash
Maltese: • Għatx
English: Juvenile toxicity studies were not conducted.
Maltese: Ma twettqux studji dwar it-tossiċità fost annimali mhux adulti.
English: Cellular kinetics in adult DLBCL patients
Maltese: Studji fost annimali mhux adulti
English: In DLBCL patients, across the weight ranges (38.4 to 186.7 kg), the scatter plots of qPCR cellular kinetic parameters versus weight revealed no apparent relationship between cellular kinetic parameters with weight.
Maltese: F'pazjenti b'DLBCL, fost il-meded differenti ta' piż (minn 38.4 sa 186.7 kg), id-dijagrammi bil-firxa tal-parametri tal-kinetika ċellulari qPCR kontra l-piż ma wrew l-ebda relazzjoni relevanti bejn ilparametri tal-kinetika ċellulari mal-piż.