FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to onset was 5 days (range: 1 to 17 days).
Maltese: Iżżmien medjan sal-bidu kien ta' 5 ijiem (firxa: 1 sa 17-il jum).
English: Ninety-eight percent (98%) of patients recovered from CRS.
Maltese: Tmienja u disgħin fil-mija (98%) tal-pazjenti rkupraw minn CRS.
English: Grade 3 or higher unspecified pathogen, bacterial, and viral infections occurred in 19%, 9%, and 6% of patients respectively.
Maltese: Infezzjonijiet ta' patoġenu mhux speċifikat, batteriċi u virali ta' Grad 3 jew ogħla seħħew f'19%, 9%, u 6% tal-pazjenti rispettivament.
English: Grade 3 or higher prolonged cytopenias following YESCARTA infusion occurred very commonly and included thrombocytopenia, neutropenia, and anaemia.
Maltese: Ċitopeniji fit-tul ta' Grad 3 jew ogħla wara infużjoni ta' YESCARTA seħħew b'mod komuni ħafna u inkludew tromboċitopenija, newtropenija, u anemija.
English: Duration of Responsea, CR, median (range) in months
Maltese: Tul tar-risponsa, CR, medjan (firxa) f'xhur
English: Severe neurologic adverse reactions have been very commonly observed in patients treated with YESCARTA, which could be life-threatening or fatal (see section 4.8).
Maltese: Ġew osservati b'mod komuni ħafna reazzjonijiet avversi newroloġiċi severi f'pazjenti ttrattati b'YESCARTA, li jistgħu jkunu ta' periklu għall-ħajja jew fatali (ara sezzjoni 4.8).
English: In phase 2 of ZUMA-1, after YESCARTA infusion, pharmacodynamic responses were evaluated over a 4-week interval by measuring transient elevation of cytokines, chemokines, and other molecules in blood.
Maltese: Fil-fażi 2 ta' ZUMA-1, wara infużjoni ta' YESCARTA, ġew evalwati r-risponsi farmakodinamiċi fuq intervall ta' 4 ġimgħat bil-kejl taż-żieda temporanja ta' ċitokini, kimokini, u molekuli oħrajn fiddemm.
English: Fatigue Pyrexia Oedema Chills
Maltese: FULJETT TA' TAGĦRIF
English: Among 73 patients with evaluable samples at baseline, 40% had detectable B-cells; the B-cell aplasia observed in the majority of patients at baseline was attributed to prior therapies.
Maltese: Fost 73 pazjent b'kampjuni li setgħu jiġu evalwati fil-linja bażi, 40% kellhom ċelluli B li setgħu jiġu osservati; l-aplasija taċ-ċellula B osservata fil-maġġoranza tal-pazjenti fil-linja bażi kienet attribwita għal terapiji preċedenti.
English: Hypocalcaemia Hypoalbuminaemia
Maltese: Ipokalċemija Ipoalbuminemija
English: Administer methylprednisolone 1000 mg intravenously per day with first dose of tocilizumab and continue methylprednisolone 1000 mg intravenously per day for 2 more days; if improves, then manage as above.
Maltese: Agħti methylprednisolone 1000 mg ġol-vini kuljum malewwel doża ta' tocilizumab u kompli methylprednisolone 1000 mg ġol-vini kuljum għal jumejn oħra; jekk ikun hemm titjib, imbagħad immaniġġja skont hawn fuq.
English: - Low levels of antibodies called immunoglobulins, which may lead to infections.
Maltese: Livelli baxxi ta' antikorpi msejħa immunoglobulini, li jistgħu jwasslu għal infezzjonijiet.
English: Prolonged (still present at Day 30 or with an onset at Day 30 or beyond) Grade 3 or higher neutropenia, thrombocytopenia, and anaemia occurred in 26%, 24%, and 10% of patients, respectively.
Maltese: Newtropenija, tromboċitopenija, u anemija ta' Grad 3 jew ogħla fit-tul (li kienu għadhom preżenti f'Jum 30 jew b'bidu f'Jum 30 jew wara) seħħew f'26%, 24%, u 10% tal-pazjenti, rispettivament.
English: In the primary analysis, based on the mITT population (minimum follow up of 6 months) the ORR was 72% and the complete response (CR) rate was 51%, as determined by an independent review committee.
Maltese: Fl-analiżi primarja, ibbażata fuq il-popolazzjoni mITT (segwitu minimu ta' 6 xhur) l-ORR kienet ta' 72% u r-rata ta' rispons totali (CR - complete response) kienet ta' 51%, kif iddeterminat minn kumitat ta' analiżi indipendenti.
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
English: Concurrent CRS
Maltese: Mard konkomitanti
English: •Final report of study results: December 2038
Maltese: Diċembru 2038
English: Of the 55 patients who achieved CR, 7 patients had SD and 10 had PR at their initial tumour assessment and converted to CR as late as 12 months after YESCARTA infusion.
Maltese: Mill-55 pazjent li kisbu CR, 7 pazjenti kellhom SD u 10 kellhom PR fil-valutazzjoni inizjali tat-tumur tagħhom u qalbu għal CR tard sa 12-il xahar wara l-infużjoni ta' YESCARTA.
English: Following YESCARTA treatment, the proportion of patients with detectable B-cells decreased: 20% had detectable B-cells at Month 3, and 22% had detectable B-cells at Month 6.
Maltese: Wara t-trattament b'YESCARTA, il-proporzjon ta' pazjenti b'ċelluli B li setgħu jiġu osservati naqas: 20% kellhom ċelluli B li setgħu jiġu osservati f'Xahar 3, u 22% kellhom ċelluli B li setgħu jiġu osservati f'Xahar 6.
English: Monitor patients daily for signs and symptoms of CRS for at least 10 days following infusion at the qualified clinical facility.
Maltese: Issorvelja lill-pazjenti kuljum għal sinjali u sintomi ta' CRS għal mill-inqas 10 ijiem wara l-infużjoni f'faċilità klinika kkwalifikata.
English: Date of first authorisation: 23 August 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Awwissu 2018
English: Three patients tested positive for anti-FMC63 prior to being treated with YESCARTA.
Maltese: Tliet pazjenti ttestjaw pożittivi għal anti-FMC63 qabel ġew ittrattati b'YESCARTA.
English: It is used to treat aggressive conditions in adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body.
Maltese: Dan jintuża biex jittratta kondizzjonijiet aggressivi f'adulti b'limfoma taċ-ċellula B kbira diffuża (DLBCL - diffuse large B-cell lymphoma) u limfoma taċ-ċellula B kbira medjastinali primarja (PMBCL - primary mediastinal large B-cell lymphoma) li jaffettwaw it-tessut limfatiku tiegħek (parti mis-sistema immuni) li jaffettwa tip ta' ċelluli bojod tad-demm imsejħa limfoċiti B u organi oħrajn f'ġismek.
English: Diarrhoea Nausea
Maltese: Lewkaferezzati kollha
English: For severe or life-threatening CRS, consider intensive-care supportive therapy.
Maltese: Għal CRS sever jew ta' periklu għall-ħajja, ikkunsidra terapija ta' sostenn ta' kura intensiva.
English: Quadriplegia
Maltese: Kwadripleġja
English: A causal relationship between spinal cord lesions and axicabtagene ciloleucel was confirmed, based on the evidence from two clinical trial cases; one case with an event of quadriplegia (in the setting of myelitis) and second case with events of muscular weakness and leukoencephalopathy, and one spontaneous case report with an event of spinal cord oedema.
Maltese: Relazzjoni kawżali bejn leżjonijiet fis-sinsla tad-dahar u axicabtagene ciloleucel ġiet ikkonfermata abbażi ta' evidenza minn żewġ każijiet minn provi kliniċi; każ wieħed b'avveniment ta' kwadripleġja (f'ambjent ta' majelite) u t-tieni każ b'avvenimenti ta' dgħufija fil-muskoli u lewkoenċefalopatija, u rapport ta' każ spontanju wieħed b'avveniment ta' edima fis-sinsla tad-dahar.
English: • A lymphodepleting chemotherapy regimen consisting of cyclophosphamide 500 mg/m2 intravenous and fludarabine 30 mg/m2 intravenous should be administered on the 5th, 4th, and 3rd day before infusion of YESCARTA.
Maltese: • Kors ta' kimoterapija li tnaqqas il-limfoċiti li jikkonsisti minn cyclophosphamide 500 mg/m2 ġol-vini u fludarabine 30 mg/m2 ġol-vini għandu jingħata fil-ħames, ir-raba', u t-tielet jum qabel l-infużjoni ta' YESCARTA.
English: Severe CRS, including life-threatening and fatal reactions, was very commonly observed with YESCARTA with a time to onset of 1 to 12 days (see section 4.8).
Maltese: CRS sever, li jinkludi reazzjonijiet ta' periklu għall-ħajja u fatali, ġie osservat b'mod komuni ħafna b'YESCARTA bi żmien sal-bidu tagħhom ta' 1 sa 12-il jum (ara sezzjoni 4.8).
English: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells.
Maltese: Riattivazzjoni tal-HBV, fejn f'ċerti każijiet tirriżulta f'epatite fulminanti, falliment tal-fwied, u mewt, tista' sseħħ f'pazjenti ttrattati b'mediċini diretti kontra ċ-ċelluli B.
English: - Skin rash.
Maltese: Ħalq xott.
English: This sequence of events leads to apoptosis and necrosis of CD19-expressing target cells.
Maltese: Din is-sekwenza ta' avvenimenti twassal għal apoptożi u nekrożi taċ-ċelluli fil-mira li jesprimu CD19.
English: One sterile infusion bag.
Maltese: Borża waħda sterili għal infużjoni.
English: The median time to response was 1.0 months (range: 0.8 to 12.2 months).
Maltese: Iż-żmien medjan għar-rispons kien ta' 1.0 xhur (firxa: 0.8 sa 12.2 xhur).
English: • After the entire content of the bag is infused, rinse the tubing at the same infusion rate with 0.9% sodium chloride solution (0.154 mmol sodium per mL) to ensure all YESCARTA is delivered.
Maltese: • Wara li jiġi infuż il-kontenut kollu tal-borża, laħlaħ it-tubu fl-istess rata ta' infużjoni b'soluzzjoni ta' 0.9% sodium chloride (0.154 mmol ta' sodium f'kull mL) biex jiġi żgurat li YESCARTA jkun ingħata kollu.
English: Spinal cord oedema Myelitis
Maltese: Deni Edema Sirdat
English: • Verify that the patient's identity (ID) matches the patient identifiers on the YESCARTA cassette.
Maltese: • Ivverifika li l-identità (ID) tal-pazjent taqbel mal-identifikaturi tal-pazjent fuq il-kasett ta' YESCARTA.
English: Symptoms require and respond to aggressive intervention.
Maltese: Is-sintomi jeħtieġu u jirrispondu għal intervent aggressiv.
English: YESCARTA should not be used in children and adolescents below 18 years of age.
Maltese: YESCARTA m'għandux jintuża fi tfal u adolexxenti taħt it-18-il sena.
English: Motor dysfunction Pain in extremity Back pain Arthralgia Muscle pain
Maltese: Disfunzjoni tal-movimenti Uġigħ fl-estremitajiet Uġigħ fid-dahar Artralġja
English: Of 111 patients who underwent leukapheresis, 101 received YESCARTA.
Maltese: Mill-111-il pazjent li għaddew minn lewkafereżi, 101 irċevew YESCARTA.
English: NE (0.4, 17.3)
Maltese: NE (0.4, 17.3) NE (0.4, 29.5) NE (0.4, 17.3)
English: Summary of demographics for ZUMA-1 phase 2 (12 month analysis)
Maltese: Tabella 4: Sommarju tad-demografika għal ZUMA-1 ta' fażi
English: Analyses performed to identify associations between cytokine levels and incidence of CRS or neurologic events showed that higher levels (peak and AUC at 1 month) of IL-15, as well as IL-6, were associated with Grade 3 or higher neurologic adverse reactions and Grade 3 or higher CRS.
Maltese: Analiżi mwettqa biex jiġu identifikati assoċjazzjonijiet bejn il-livelli ta' ċitokina u l-inċidenza ta' CRS jew avvenimenti newroloġiċi wrew li livelli ogħla (massimu u AUC wara xahar) ta' IL-15, kif ukoll ta' IL-6, kienu assoċjati ma' reazzjonijiet avversi newroloġiċi ta' Grad 3 jew ogħla u ma' CRS ta' Grad 3 jew ogħla.
English: The safety data described in this section reflect exposure to YESCARTA in ZUMA-1, a Phase 1/2 study in which 108 patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) received CAR-positive T cells based on a recommended dose which was weightbased.
Maltese: Id-data dwar is-sigurtà deskritta f'din is-sezzjoni tirrifletti esponiment għal YESCARTA f'ZUMA-1, studju ta' Fażi 1/2 li fih 108 pazjenti b'limfoma mhux ta' Hodgkin (NHL - non-Hodgkin lymphoma) taċ-ċellula B li rkadiet/reżistenti rċevew ċelluli T pożittivi għal CAR abbażi ta' doża rakkomandata li kienet ibbażata fuq il-piż.
English: Monitor patients life-long for secondary malignancies.
Maltese: Immonitorja l-pazjenti tul il-ħajja kollha għal tumuri malinni sekondarji.
English: Patients with CNS lymphoma, a history of allogeneic stem cell transplantation (SCT) or prior anti-CD19 CAR or other genetically modified T-cell therapy were excluded.
Maltese: Pazjenti b'limfoma tas-CNS, b'passat ta' trapjant ta' ċelluli staminali (SCT - stem cell transplantation) alloġeniċi jew CAR anti-CD19 jew terapija oħra taċċelluli T ġenetikament modifikati fil-passat ġew esklużi.
English: (b) Refer to Table 2 for management of neurologic adverse reactions.
Maltese: (b) Irreferi għat-Tabella 2 għall-immaniġġjar ta' reazzjonijiet avversi newroloġiċi.
English: • Thaw YESCARTA at approximately 37 °C using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
Maltese: • Ħoll YESCARTA minn silġ f'madwar 37 °C bl-użu ta' banjumarija jew metodu fejn jinħall fixxott sakemm ma jkun hemm l-ebda silġ viżibbli fil-borża tal-infużjoni.
English: Hypotension Hypertension
Maltese: human immunodeficiency virus).
English: Patients who experience Grade 2 or higher neurologic toxicities should be monitored with continuous cardiac telemetry and pulse oximetry.
Maltese: Pazjenti li jesperjenzaw tossiċitajiet newroloġiċi ta' Grad 2 jew ogħla għandhom jiġu mmonitorjati b'telemetrija kardijaka u ossimetrija tal-polz kontinwi.
English: Dyspnoea Hypoxia Pleural effusion
Maltese: Sensittività eċċessiva Istjoċitożi Ematofaġika
English: This medicine contains 300 mg sodium (main component of cooking/table salt) in each infusion.
Maltese: Din il-mediċina fiha 300 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir/li jintuża mal-ikel) f'kull infużjoni.
English: No studies have been conducted to evaluate the effects of YESCARTA on fertility, reproduction, and development.
Maltese: Ma twettaq l-ebda studju biex jiġu evalwati l-effetti ta' YESCARTA fuq il-fertilità, is-sistema riproduttiva, u l-iżvilupp.
English: Sixty-six patients were evaluable for cell-of-origin classifications (germinal center B-cell type [GCB] or activated B-cell type [ABC]).
Maltese: [ABCactivated B-cell]).
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara li l-prodott mediċinali jinħall minn silġ, ara sezzjoni 6.3.
English: The safety and efficacy of YESCARTA in children and adolescents below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' YESCARTA fit-tfal u l-adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells) For intravenous use only.
Maltese: U MNEJN GĦANDU JINGĦATA YESCARTA 0.4 - 2 x 108 ċelluli dispersjoni għal infużjoni axicabtagene ciloleucel (CAR+ ċelluli T vijabbli) Għal użu ġol-vini biss.
English: Dispersion for infusion.
Maltese: GĦAMLA FARMAĊEWTIKA Dispersjoni għal infużjoni.
English: Eleven percent (11%) of patients experienced Grade 3 or higher (severe, life-threatening, and fatal) CRS.
Maltese: Ħdax fil-mija (11%) tal-pazjenti esperjenzaw CRS ta' Grad 3 jew ogħla (sever, ta' periklu għall-ħajja, u fatali).
English: Limit to a maximum of 3 doses in a 24 hour period; maximum total of 4 doses if no clinical improvement in the signs and symptoms of CRS.
Maltese: Illimita għal massimu ta' 3 dożi f'perjodu ta' 24 siegħa; total massimu ta' 4 dożi jekk ma jkun hemm l-ebda titjib kliniku fis-sinjali u s-sintomi ta' CRS.
English: Febrile neutropenia has been observed in patients after YESCARTA infusion (see section 4.8) and may be concurrent with CRS.
Maltese: Ġiet osservata newtropenija bid-deni f'pazjenti wara infużjoni ta' YESCARTA (ara sezzjoni 4.8) u tista' tkun flimkien ma' CRS.
English: In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.
Maltese: F'każ ta' newtropenija bid-deni, evalwa għal infezzjoni u mmaniġġja b'antibijotiċi ta' spettru wiesa', fluwidi, u kura ta' sostenn oħra kif indikat medikament.
English: Clinical efficacy and safety DLBCL, PMBCL and DLBCL arising from follicular lymphoma (ZUMA-1)
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Febrile neutropenia and infections
Maltese: Infezzjonijiet u infestazzjonijiet
English: - Infections in the blood caused by fungi.
Maltese: Infezzjonijiet fid-demm ikkawżati minn fungi.
English: Adverse reactions Dyscalculia Myoclonus
Maltese: Atassja Newropatija Aċċessjoni Diskalkulja Mijoklonu
English: Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above.
Maltese: Agħti methylprednisolone 1000 mg ġol-vini kuljum għal 3 ijiem; jekk ikun hemm titjib, imbagħad immaniġġja skont hawn fuq.
English: Peak levels of anti-CD19 CAR T cells occurred within the first 8 to 15 days after YESCARTA infusion.
Maltese: Il-livelli massimi ta' ċelluli T CAR anti-CD19 seħħew fl-ewwel 8 sa 15-il jum wara l-infużjoni ta' YESCARTA.
English: Patients should be monitored for signs and symptoms of neurologic adverse reactions (Table 2).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' reazzjonijiet avversi newroloġiċi (Tabella 2).
English: - Decreased levels of sodium, phosphate, or potassium which will show up on blood tests.
Maltese: Tnaqqis fil-livell ta' sodium, phosphate, jew potassium li ser jidhru fit-testijiet tad-demm.
English: Oxygen requirement less than 40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity (b).
Maltese: Ħtieġa ta' ossiġnu ta' inqas minn 40% FiO2 jew pressjoni baxxa li tirrispondi għal fluwidi jew doża baxxa ta' vasopressur wieħed jew tossiċità tal-organi ta' Grad 2 (b).
English: Pre-treatment (lymphodepleting chemotherapy)
Maltese: Qabel it-trattament (kimoterapija li tnaqqas il-limfoċiti)
English: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions, or hypotension) including from preceding chemotherapies.
Maltese: • Reazzjonijiet avversi serji mhux riżolti (speċjalment reazzjonijiet pulmonari, reazzjonijiet kardijaċi, jew pressjoni baxxa) inklużi dawk minn kimoterapiji preċedenti.
English: Contraindications of the lymphodepleting chemotherapy must be considered.
Maltese: Din il-mediċina fiha ċelluli ġenetikament modifikati.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna
English: The ORR was prespecified to be tested in the first 92 treated patients and was significantly higher than the prespecified rate of 20% (P < 0.0001).
Maltese: L-ORR kienet speċifikata minn qabel li trid tiġi ttestjata fl-ewwel 92 pazjent ittrattati u kienet ogħla b'mod sinifikanti mir-rata speċifikata minn qabel ta' 20% (P < 0.0001).
English: Hypersensitivity Histiocytosis Haematophagic
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Educational program - Prior to the launch of YESCARTA in each Member State the MAH must agree the content and format of the educational materials with the National Competent Authority.
Maltese: Programm edukattiv - Qabel it-tqegħid fis-suq ta' YESCARTA f'kull Stat Membru l-MAH irid jaqbel dwar il-kontenut u d-disinn tal-materjal edukattiv mal-Awtorità Nazzjonali Kompetenti.
English: Verify patient ID.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The PRAC considers that the product information of axicabtagene ciloleucel should be amended to reflect the risk of spinal cord oedema, myelitis and quadriplegia associated with axicabtagene ciloleucel therapy.
Maltese: Il-PRAC iqis li l-informazzjoni tal-prodott ta' axicabtagene ciloleucel għandha tiġi emendata biex tirrifletti r-riskju ta' edima fis-sinsla tad-dahar, majelite u kwadripleġja assoċjati ma' terapija b'axicabtagene ciloleucel.
English: INSTRUCTIONS ON USE
Maltese: Testijiet u verifiki
English: A causal relationship between dysphagia and axicabtagene ciloleucel was confirmed, based on the evidence from 15 post-marketing cases and 4 clinical trial cases of dysphagia.
Maltese: Relazzjoni kawżali bejn disfaġja u axicabtagene ciloleucel ġiet ikkonfermata abbażi ta' evidenza minn 15-il każ ta' wara t-tqegħid fis-suq u 4 każijiet minn provi kliniċi ta' disfaġja.
English: Grade 3 or higher neutropenia, thrombocytopenia, and anaemia present after Day 93 occurred in 11%, 7%, and 3% of patients, respectively.
Maltese: Jum 93 seħħew fi 11%, 7%, u 3% tal-pazjenti, rispettivament.
English: Symptoms require and respond to moderate intervention.
Maltese: Is-sintomi jeħtieġu u jirrispondu għal intervent moderat.
English: • Tocilizumab and emergency equipment should be available prior to infusion and during the monitoring period.
Maltese: • Tocilizumab u tagħmir ta' emerġenza għandhom ikunu disponibbli qabel l-infużjoni u matul ilperjodu ta' monitoraġġ.
English: In addition, administer dexamethasone 10 mg intravenously with the first dose of tocilizumab and repeat dose every 6 hours.
Maltese: Barra minn hekk, agħti dexamethasone 10 mg ġol-vini mal-ewwel doża ta' tocilizumab u rrepeti d-doża kull 6 sigħat.
English: • Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
Maltese: • Għeja estrema, debbulizza u qtugħ ta' nifs, li jistgħu jkunu sintomi ta' nuqqas ta' ċelluli ħomor tad-demm.
English: Package leaflet: Information for the patient YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells) This medicine is subject to additional monitoring.
Maltese: Informazzjoni għall-pazjent YESCARTA 0.4 - 2 x 108 ċelluli dispersjoni għal infużjoni axicabtagene ciloleucel (CAR+ ċelluli T vijabbli)
English: Non-sedating, anti-seizure medicines should be considered as clinically indicated for Grade 2 or higher adverse reactions.
Maltese: Mediċini mhux sedattivi kontra laċċessjonijiet għandhom jiġu kkunsidrati bħala klinikament indikati għal reazzjonijiet avversi ta' Grad 2 jew ogħla.
English: Prophylactic anti-microbials should be administered according to standard institutional guidelines.
Maltese: L-antimikrobiċi profilattiċi għandhom jingħataw skont il-linji gwida istituzzjonali standard.
English: Provide intensive-care supportive therapy for severe or lifethreatening neurologic toxicities.
Maltese: Ipprovdi terapija ta' sostenn ta' kura intensiva għal tossiċitajiet newroloġiċi severi jew ta' periklu għall-ħajja.
English: Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
Maltese: Nefħa fir-riġlejn jew id-dirgħajn, fluwidu madwar il-pulmun (effużjoni fil-plewra).
English: Neurologic adverse reactions occurred in 67% of patients.
Maltese: Ir-reazzjonijiet avversi newroloġiċi seħħew f'67% tal-pazjenti.
English: • Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential CRS, neurologic events and other toxicities.
Maltese: • Il-pazjenti għandhom jiġu mmonitorjati kuljum għall-ewwel 10 ijiem wara l-infużjoni għal sinjali u sintomi ta' CRS, avvenimenti newroloġiċi u tossiċitajiet oħra potenzjali.
English: Prolonged cytopenias
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: For patients experiencing severe CRS, consider performing an echocardiogram to assess cardiac function.
Maltese: Għal pazjenti li jesperjenzaw CRS sever, ikkunsidra li tagħmel ekokardjogramma sabiex tivvaluta l-funzjoni kardijaka.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Maltese: 2.1 Deskrizzjoni ġenerali
English: Peak elevation was observed within the first 14 days after infusion, and levels generally returned to baseline within 28 days.
Maltese: Ġiet osservata żieda massima fl-ewwel 14-il jum wara l-infużjoni, u l-livelli ġeneralment reġgħu lura għal-linja bażi fi żmien 28 jum.
English: Age (years) Median (min, max)
Maltese: Sopravivenza Globali, medjan (xhur)
English: It usually takes about 3 to 4 weeks to receive your YESCARTA therapy but the time may vary.
Maltese: Dan normalment jieħu madwar 3 sa 4 ġimgħat biex tirċievi t-terapija ta' YESCARTA tiegħek iżda żżmien jista' jvarja.
English: Further information on Mayzent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Mayzent.
Maltese: ema.europa.eu/medicines/human/EPAR/Mayzent.
English: Other information about Mayzent
Maltese: Informazzjoni oħra dwar Mayzent