FrancophonIA/ELRC3.0 huggingface dataset:
English: Active graft-versus-host disease (GVHD).
Croatian: • aktivnu reakciju presatka protiv primatelja (engl. graft-versus-host disease, GVHD).
English: Thus, the infused CAR T cells are expected to be cleared over time.
Croatian: Stoga se očekuje da će CAR T-stanice dane infuzijom s vremenom biti uklonjene.
English: Administer methylprednisolone 1 mg/kg intravenously twice daily or equivalent dexamethasone (e.g., 10 mg intravenously every 6 hours).
Croatian: Intravenski primijeniti 1 mg/kg metilprednizolona dva puta dnevno ili ekvivalentnu količinu deksametazona (npr. 10 mg intravenski svakih 6 sati).
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.
Croatian: Od 52 bolesnika koji su postigli CR, 7 bolesnika imalo je SD dok je 9 bolesnika imalo PR na početnoj procjeni tumora te su postigli CR tek nakon 6,5 mjeseci.
English: Thirty-two percent (32%) of patients experienced Grade 3 or higher (severe or life-threatening) adverse reactions.
Croatian: Trideset dva posto (32%) bolesnika imalo je nuspojave 3. ili višeg stupnja (teške ili opasne po život).
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.
Croatian: Kod trideset bolesnika pronađen je dvostruki ekspresor DLBCL-a (prekomjerna ekspresija i proteina MYC i proteina BCL-2); kod 5 bolesnika utvrđen je HGBCL s restrukturiranjem gena MYC, BCL-2 ili BCL-6 (s dvostrukom i trostrukom translokacijom); a kod 2 bolesnika zapažen je HGBCL koji nije drugačije specificiran.
English: - the risks of CRS and serious neurologic adverse reactions, associated with YESCARTA - the need to report the symptoms to their treating doctor immediately - the need to remain in the proximity of the location where YESCARTA was received for at least 4 weeks following YESCARTA infusion - the need to carry the patient alert card at all times
Croatian: Program treba bolesnike informirati i objasniti im: rizike za pojavu CRS-a i ozbiljnih neuroloških nuspojava povezanih s lijekom YESCARTA potrebu da simptome odmah prijave svom liječniku potrebu da ostanu u blizini ustanove u kojoj su primili lijek YESCARTA najmanje 4 tjedna nakon infuzije lijeka YESCARTA potrebu da sa sobom uvijek nose karticu s upozorenjima za bolesnika.
English: The DOR was longer in patients who achieved CR, as compared to patients with a best response of partial response (PR).
Croatian: DOR je bio dulji u bolesnika koji su postigli CR u usporedbi s bolesnicima kojima je najbolji odgovor bio djelomičan odgovor (engl. partial response, PR).
English: It is not known if YESCARTA has the potential to be transferred to the foetus.
Croatian: Nije poznato ima li lijek YESCARTA potencijal prijenosa u fetus.
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.
Croatian: Podaci o sigurnosti primjene prikazani u ovom dijelu odnose se na izloženost lijeku YESCARTA u ispitivanju faze 1/2, ZUMA-1, u kojem je 108 bolesnika s relapsnim/refraktornim ne-Hodgkinovim limfomom (NHL) B-stanica primilo CAR-pozitivne T-stanice u preporučenoj dozi određenoj na temelju tjelesne težine.
English: Note: The 12-month analysis had a median follow-up of 15.1 months.
Croatian: U analizi nakon 12 mjeseci medijan praćenja iznosio je 15,1 mjesec.
English: Allergic reactions may occur with the infusion of YESCARTA.
Croatian: Alergijske reakcije moguće su kod primjene infuzije lijeka YESCARTA.
English: The median duration was 13 days (range: 1 to 191 days).
Croatian: Medijan trajanja bio je 13 dana (raspon: od 1 do 191 dana).
English: All patients were hospitalized for observation for a minimum of 7 days after YESCARTA infusion.
Croatian: Svi su bolesnici bili hospitalizirani najmanje 7 dana nakon infuzije lijeka YESCARTA radi promatranja.
English: 6229 EV Maastricht The Netherlands
Croatian: 6229 EV Maastricht Nizozemska
English: YESCARTA contains genetically modified human blood cells.
Croatian: YESCARTA sadrži genetički modificirane ljudske krvne stanice.
English: No clinical data on the effect of YESCARTA on fertility are available.
Croatian: Nema dostupnih kliničkih podataka o učinku lijeka YESCARTA na plodnost.
English: Summary of efficacy results for ZUMA-1 phase 2
Croatian: Tablica 5: Sažetak rezultata djelotvornosti za fazu 2 ispitivanja ZUMA-1
English: Precautions to be taken for the disposal of the medicinal product
Croatian: Mjere koje treba provesti za zbrinjavanje lijeka
English: YESCARTA contains sodium
Croatian: Lijek YESCARTA sadrži natrij
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.
Croatian: Nakon djelovanja anti-CD19 CAR T-stanica s ciljanim stanicama koje izražavaju CD19, kostimulacijske domene CD28 i CD3-zeta aktiviraju signalne kaskade koje dalje vode do aktivacije T-stanica, proliferacije, preuzimanja efektorske funkcije i izlučivanja upalnih citokina i kemokina.
English: Patients with active CNS disorder or inadequate renal, hepatic, pulmonary, or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions described below and require special attention.
Croatian: Bolesnici s aktivnim poremećajem središnjeg živčanog sustava ili neodgovarajućom bubrežnom, jetrenom, plućnom ili srčanom funkcijom osjetljiviji su na posljedice nuspojava opisanih u nastavku i zahtijevaju posebnu pozornost.
English: What you need to know before you are given YESCARTA
Croatian: Što morate znati prije nego primite lijek YESCARTA
English: Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
Croatian: Razmotriti primjenu lijekova protiv napadaja koji nemaju sedacijsko djelovanje (npr. levetiracetam) radi profilakse napadaja.
English: In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.
Croatian: U slučaju febrilne neutropenije potrebno je provjeriti je li prisutna infekcija i primijeniti terapiju antibioticima širokog spektra, tekućine i druge mjere potporne skrbi kako je medicinski indicirano.
English: 6229EV Maastricht The Netherlands
Croatian: 6229EV Maastricht Nizozemska
English: Oxygen requirement less than 40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity (b).
Croatian: Potreba za kisikom manja od 40% FiO2, ili hipotenzija koja odgovara na tekućine ili malu dozu jednog vazopresora, ili toksično oštećenje organa 2. stupnja (b).
English: CRS has been known to be associated with end organ dysfunction (e.g., hepatic, renal, cardiac, and pulmonary).
Croatian: Poznato je da je CRS povezan s poremećajem funkcije ciljnih organa (npr. jetre, bubrega, srca i pluća).
English: The median time to onset was 2 days (range: 1 to 12 days) and the median duration was 7 days (range: 2 to 29 days).
Croatian: Medijan vremena do početka bio je 2 dana (raspon: od 1 do 12 dana), a medijan trajanja 7 dana (raspon: od 2 do 29 dana).
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Samo za autolognu primjenu.
English: Some people may feel tired, dizzy or have some shaking after being given YESCARTA.
Croatian: Neki ljudi mogu osjetiti umor, omaglicu ili malo drhtanje nakon što prime lijek YESCARTA.
English: Eleven percent (11%) of patients experienced Grade 3 or higher (severe, life-threatening, and fatal) CRS.
Croatian: Jedanaest posto (11%) bolesnika imalo je CRS 3. ili višeg stupnja (teški, opasan po život i smrtonosan).
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.
Croatian: • Nakon što je cjelokupni sadržaj vrećice primijenjen infuzijom, isperite cijevi 0,9%-tnom otopinom natrijeva klorida (0,154 mmol natrija po ml) pri istoj brzini infuzije kako bi se osiguralo da je primijenjena sva količina lijeka YESCARTA.
English: Gently mix the contents of the bag to disperse clumps of cellular material.
Croatian: Sadržaj vrećice pažljivo promiješajte kako bi se raspršile nakupine staničnog materijala.
English: Oxygen requirement greater than or equal to 40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis.
Croatian: Potreba za kisikom veća od ili jednaka 40% FiO2, ili hipotenzija koja zahtijeva visoku dozu ili više vazopresora, ili toksično oštećenje organa 3. stupnja ili transaminitis 4. stupnja.
English: Healthcare professionals handling YESCARTA should take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Croatian: Pri rukovanju lijekom YESCARTA zdravstveni radnici moraju poduzeti odgovarajuće mjere opreza (nositi rukavice i naočale) kako bi izbjegli moguće prenošenje zaraznih bolesti.
English: Duration of Responsea, CR, median (range) in months
Croatian: Trajanje odgovoraa, CR, medijan (raspon) u mjesecima NP (0,4; 17,3)
English: Hypogammaglobulinaemia has been very commonly observed in patients treated with YESCARTA.
Croatian: Hipogamaglobulinemija je vrlo često bila zabilježena u bolesnika liječenih lijekom YESCARTA.
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.
Croatian: Intravenski primijeniti 1000 mg metilprednizolona dnevno s prvom dozom tocilizumaba i nastaviti intravensku primjenu 1000 mg metilprednizolona dnevno tijekom dodatna 2 dana; ako dođe do poboljšanja, liječiti prema prethodno navedenim smjernicama.
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.
Croatian: Nakon liječenja lijekom YESCARTA smanjio se udio bolesnika u kojih su se mogle ustanoviti B-stanice: nakon 3 mjeseca B-stanice mogle su se pronaći u njih 20%, a nakon 6 mjeseci u njih 22%.
English: This trend of B-cell recovery continued over time, as 64% of patients had detectable B-cells at Month 18, and 77% of patients had detectable B-cells at Month 24.
Croatian: Taj trend oporavka B-stanica nastavio se i kasnije, pa su se tako B-stanice mogle ustanoviti u 64% bolesnika nakon 18 mjeseci te 77% bolesnika nakon 24 mjeseca.
English: • Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.
Croatian: • krvarenje ili stvaranje modrica, što mogu biti simptomi niske razine krvnih stanica pod nazivom trombociti.
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.
Croatian: Imunogeničnost lijeka YESCARTA procijenjena je pomoću imunoenzimskog testa (engl. enzymelinked immunosorbent assay, ELISA) za detekciju vezivanja protutijela protiv FMC63, protutijela koje nastaje iz anti-CD19 CAR.
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%).
Croatian: Najčešće ozbiljne nuspojave uključivale su encefalopatiju (22%), infekcije neodređenim patogenima (16%), bakterijske infekcije (6%), febrilnu neutropeniju (6%), virusne infekcije (5%) i pireksiju (5%).
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).
Croatian: Teške neurološke nuspojave vrlo su često opažene u bolesnika liječenih lijekom YESCARTA i mogu biti opasne po život ili smrtonosne (vidjeti dio 4.8).
English: Immunoglobulin levels should be monitored after treatment with YESCARTA and managed using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
Croatian: Nakon liječenja lijekom YESCARTA potrebno je nadzirati razine imunoglobulina i zbrinjavati ih primjenom mjera opreza u slučaju infekcije, antibiotske profilakse i nadomjestka imunoglobulina.
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.
Croatian: Medijan vršne razine anti-CD19 CAR T-stanica u krvi (Cmax) bio je 38,3 stanica/µl (raspon: 0,8-1513,7 stanica/μl), što se smanjilo na medijan od 2,1 stanica/µl do 1 mjeseca (raspon: 0-167,4 stanica/μl) i na medijan od 0,4 stanice/µl do 3 mjeseca (raspon 0-28,4 stanica/μl) nakon infuzije lijeka YESCARTA.
English: YESCARTA is not recommended if the patient has relapsed with CD19-negative disease after prior anti-CD19 therapy.
Croatian: Primjena lijeka YESCARTA ne preporučuje se ako se kod bolesnika ponovno pojavi bolest negativna na CD19 nakon prethodne terapije protiv CD19.
English: These include the use of tocilizumab (if concurrent CRS) and/or corticosteroids for moderate, severe, or life-threatening neurologic adverse reactions as summarised in Table 2.
Croatian: Oni uključuju primjenu tocilizumaba (uz istodobni CRS) i/ili kortikosteroida za umjerene, teške ili opasne po život neurološke nuspojave kako je sažeto prikazano u tablici 2.
English: Tell your doctor immediately if you get any of the side effects listed above.
Croatian: Odmah se obratite svom liječniku ako se u Vas pojavi bilo koja od prethodno navedenih nuspojava.
English: Grade 3 or higher prolonged cytopenias following YESCARTA infusion occurred very commonly and included thrombocytopenia, neutropenia, and anaemia.
Croatian: Produljene citopenije 3. ili višeg stupnja zabilježene su vrlo često nakon infuzije lijeka YESCARTA te su uključivale trombocitopeniju, neutropeniju i anemiju.
English: This will show if you are likely to develop a condition called tumour lysis syndrome.
Croatian: Ova će provjera pokazati koliko je vjerojatna pojava stanja koje se naziva sindrom tumorske lize.
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.
Croatian: • Režim kemoterapije za limfocitnu depleciju koji se sastoji od 500 mg/m2 ciklofosfamida intravenski i 30 mg/m2 fludarabina intravenski treba primijeniti 5., 4. i 3. dana prije infuzije lijeka YESCARTA.
English: The median time to response was 1.0 months (range: 0.8 to 6.3 months).
Croatian: Medijan vremena do odgovora bio je 1,0 mjeseci (raspon: od 0,8 do 6,3 mjeseca).
English: NE= Not estimable (not reached) a Duration of response was censored at the time of SCT for subjects who received SCT while in response.
Croatian: NP = nije procjenjivo (nije postignuto) a Trajanje odgovora bilo je cenzurirano u vrijeme transplantacije matičnih stanica za ispitanike u kojih je transplantacija matičnih stanica provedena dok su imali odgovor.
English: At the 24-month follow-up analysis, these 3 patients remained in CR at 30 to 35 months after YESCARTA infusion.
Croatian: U analizi podataka nakon 24 mjeseca praćenja, u ta se 3 bolesnika CR zadržao 30 do 35 mjeseci nakon infuzije lijeka YESCARTA.
English: There are no data regarding the signs of overdose with YESCARTA.
Croatian: Nema podataka o znakovima predoziranja lijekom YESCARTA.
English: Accordingly, healthcare professionals should take appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or YESCARTA to avoid potential transmission of infectious diseases.
Croatian: U skladu s tim, zdravstveni radnici trebaju provoditi odgovarajuće mjere opreza (nositi rukavice i naočale) prilikom rukovanja materijalom iz leukafereze ili lijekom YESCARTA kako bi izbjegli moguće prenošenje zaraznih bolesti.
English: • For autologous use only.
Croatian: • Samo za autolognu primjenu.
English: NE (0.4, 17.3)
Croatian: NP (0,4; 17,3)
English: - Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to hospital.
Croatian: - Karticu s upozorenjima za bolesnika uvijek pokažite liječniku ili medicinskoj sestri pri svakom posjetu liječniku ili odlasku u bolnicu.
English: YESCARTA is stable for 1 year when stored frozen in the vapour phase of liquid nitrogen (≤ -150 ˚C).
Croatian: Lijek YESCARTA stabilan je 1 godinu kad se čuva zamrznut u plinovitoj fazi tekućeg dušika (≤ -150 °C).
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).
Croatian: Medijan vrijednosti AUCdan 0 - 28 u bolesnika s odgovorom (N = 71) bio je 253% odgovarajuće razine u bolesnika bez odgovora (N = 25) (562,0 dana x stanice/μl naspram 222,0 dana x stanice/μl).
English: Lonza Netherlands B.V. Oxfordlaan 70
Croatian: Lonza Netherlands B.V.
English: 6 month OS (%) [95% CI] 9 month OS (%) [95% CI] 12 month OS (%) [95% CI]
Croatian: 6 mjeseci ukupno preživljenje (%) [95% CI] 9 mjeseci ukupno preživljenje (%) [95% CI] 12 mjeseci ukupno preživljenje (%) [95% CI] 24 mjeseca ukupno preživljenje (%) [95% CI]
English: Grade 3 or higher unspecified pathogen, bacterial, and viral infections occurred in 19%, 9%, and 6% of patients respectively.
Croatian: Infekcije neodređenim patogenima, bakterijske i virusne infekcije 3. ili višeg stupnja imalo je 19%, 9% odnosno 6% bolesnika.
English: Before infusion, the patient's identity must match the patient identifiers on the YESCARTA infusion bag and cassette.
Croatian: Prije infuzije potrebno je potvrditi da identitet bolesnika odgovara identifikacijskim oznakama bolesnika na vrećici za infuziju i kazeti lijeka YESCARTA.
English: This medicine contains genetically modified human blood cells.
Croatian: Ovaj lijek sadrži genetički modificirane ljudske krvne stanice.
English: To minimise risk of TLS, patients with elevated uric acid or high tumour burden should receive allopurinol, or an alternative prophylaxis, prior to YESCARTA infusion.
Croatian: Kako bi se rizik od pojave STL-a sveo na najmanju moguću mjeru, bolesnici s povišenom vrijednosti mokraćne kiseline ili velikim tumorskim opterećenjem trebaju primiti alopurinol ili drugu profilaksu prije primjene infuzije lijeka YESCARTA.
English: Gently mix the contents of the bag while thawing.
Croatian: Pažljivo promiješajte sadržaj vrećice tijekom odmrzavanja.
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.
Croatian: Pobrinite se da prije infuzije lijeka YESCARTA za svakog bolesnika budu dostupne za infuziju minimalno 4 doze tocilizumaba, inhibitora receptora interleukina-6 (IL-6).
English: YESCARTA continues to expand and persist following administration of tocilizumab and corticosteroids.
Croatian: Lijek YESCARTA nastavlja se širiti u tijelu i ostaje nakon primjene tocilizumaba i kortikosteroida.
English: There are no available data with YESCARTA use in pregnant women.
Croatian: Nema dostupnih podataka o primjeni lijeka YESCARTA u trudnica.
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.
Croatian: U primarnoj analizi, na temelju modificirane populacije planirane za liječenje (praćenje u trajanju od najmanje 6 mjeseci) stopa objektivnog odgovora iznosila je 72%, a stopa potpunog odgovora (engl. complete response, CR) 51%, kako je utvrdilo nezavisno povjerenstvo za procjenu.
English: Patients who were refractory to chemotherapy or who relapsed after two or more lines of systemic therapy were generally ineligible for haematopoietic stem cell transplantation.
Croatian: Bolesnici refraktorni na kemoterapiju ili s relapsom nakon dvije ili više linija sistemske terapije u pravilu nisu bili podobni za transplantaciju krvotvornih matičnih stanica (engl. haematopoietic stem cell transplantation, HSCT).
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.
Croatian: Primjenjuje se za liječenje agresivnih bolesti u odraslih osoba s difuznim B-velikostaničnim limfomom i primarnim medijastinalnim B-velikostaničnim limfomom koji zahvaćaju limfno tkivo (dio imunosnog sustava), koje utječe na vrstu leukocita naziva B-limfociti i druge organe u tijelu.
English: In addition worsening of underlying organ pathologies can occur in the setting of CRS.
Croatian: Osim toga, u okolnostima CRS-a može doći i do pogoršanja postojećih patologija organa.
English: The most common signs or symptoms associated with CRS included pyrexia (83%), hypotension (44%), tachycardia (24%), hypoxia (23%), and chills (20%).
Croatian: Najčešći znakovi ili simptomi povezani s CRS-om uključivali su pireksiju (83%), hipotenziju (44%), tahikardiju (24%), hipoksiju (23%) i zimicu (20%).
English: NE (12.8, NE)
Croatian: NP (12,8; NP)
English: Pregnancy after YESCARTA therapy should be discussed with the treating physician.
Croatian: O trudnoći nakon terapije lijekom YESCARTA potrebno je razgovarati s liječnikom.
English: Adverse reactions reported from clinical trials and post-marketing setting are presented below.
Croatian: U nastavku su prikazane prijavljene nuspojave iz kliničkih ispitivanja i nakon stavljanja lijeka u promet.
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.
Croatian: Lijek YESCARTA indiciran je za liječenje odraslih bolesnika s difuznim B-velikostaničnim limfomom (engl. diffuse large B-cell lymphoma, DLBCL) koji je refraktoran ili u relapsu i primarnim medijastinalnim B-velikostaničnim limfomom (engl. primary mediastinal large B-cell lymphoma, PMBCL), nakon dvije ili više linija sistemske terapije.
English: Tumour necrosis factor (TNF) antagonists are not recommended for management of YESCARTA-associated CRS.
Croatian: Primjena antagonista faktora tumorske nekroze (engl. tumour necrosis factor, TNF) ne preporučuje se za liječenje CRS-a povezanog s lijekom YESCARTA.
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.
Croatian: Od 55 bolesnika koji su postigli CR, 7 bolesnika imalo je SD, dok je 10 bolesnika imalo PR na početnoj procjeni tumora te su postigli CR tek 12 mjeseci nakon infuzije lijeka YESCARTA.
English: YESCARTA is to be administered via intravenous infusion.
Croatian: Lijek YESCARTA treba primijeniti putem intravenske infuzije.
English: NE (0.0, 29.5)
Croatian: NP (0,0; 29,5)