FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of neurological events, patients should be diagnostically worked up and managed depending on the underlying pathophysiology and in accordance with local standard of care.
Croatian: U slučaju neuroloških događaja bolesnike je potrebno dijagnostički obraditi i zbrinuti ovisno o temeljnoj patofiziologiji te u skladu s lokalnom standardnom skrbi.
English: Other manifestations included seizures, aphasia and speech disorder.
Croatian: Druge manifestacije uključivale su napadaje, afaziju i poremećaj govora.
English: Prior to Kymriah infusion, infection prophylaxis should follow standard guidelines based on the degree of preceding immunosuppression.
Croatian: Prije infuzije lijeka Kymriah, profilaksa infekcije treba slijediti standardne smjernice ovisno o stupnju prethodne imunosupresije.
English: • Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.
Croatian: • Krvarenje ili nastanak podljeva lakše nego inače, što mogu biti simptomi niskih razina stanica u krvi koje se nazivaju trombociti.
English: • Plan to stay within 2 hours' travel from the hospital where you were treated for at least 4 weeks after you have been given Kymriah.
Croatian: • Planirajte ostati u krugu bolnice u kojoj ste se liječili na udaljenosti od najviše 2 sata tijekom najmanje 4 tjedna nakon što primite lijek Kymriah.
English: • You have had hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
Croatian: • ste imali hepatitis B, hepatitis C ili infekciju virusom humane imunodeficijencije (HIV).
English: Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
Croatian: Bolesnike s medicinski značajnom srčanom disfunkcijom potrebno je zbrinuti prema standardima skrbi za kritične pacijente te razmotriti mjere kao što je ehokardiografija.
English: The median time to onset of neurological events was 7 days in B-cell ALL and DLBCL.
Croatian: Medijan vremena do nastupa neuroloških događaja bio je 7 dana za ALL B-stanica i DLBCL.
English: Kymriah is not recommended if the patient has relapsed with CD19-negative leukaemia after prior anti-CD19 therapy.
Croatian: Kymriah se ne preporučuje ako bolesnik ima recidiv s CD19-negativnom leukemijom nakon prethodne anti-CD19 terapije.
English: Arrhythmia includes atrial fibrillation and supraventricular tachycardia.
Croatian: Aritmija uključuje fibrilaciju atrija i supraventrikularnu tahikardiju.
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.
Croatian: Komponenta CD3 zeta od ključne je važnosti za pokretanje aktivacije T-stanica i protutumorske aktivnosti, dok 4-1BB pojačava ekspanziju i perzistentnost tisagenlekleucela.
English: Age (years) Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <65 years ≥65 years Sex - n (%) Male Female Prior haematopoietic stem cell transplant (SCT) - n (%) No Yes Stage III/IV disease at study entry - n (%) No Yes Number of prior lines of antineoplastic therapy - n (%)
Croatian: Dob (godine) Srednja vrijednost (standardna devijacija) Medijan (minimum - maksimum) Dobna kategorija (godine) - n (%) <65 godina ≥65 godina Spol - n (%) Muški Ženski Prethodna transplantacija krvotvornih matičnih stanica - n (%) Ne Da Stadij bolesti III/IV prilikom uključivanja u ispitivanje - n (%) Ne Da Broj prethodnih linija antineoplastične terapije - n (%)
English: Approximately 30% of patients discontinued the study prior to Kymriah administration.
Croatian: Otprilike 30% bolesnika prekinulo je ispitivanje prije primjene lijeka Kymriah.
English: All material that has been in contact with Kymriah (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Croatian: Sa svim materijalom koji je bio u doticaju s lijekom Kymriah (kruti i tekući otpad) potrebno je rukovati te ga zbrinuti kao potencijalno zarazan otpad u skladu s nacionalnim smjernicama za biološku sigurnost.
English: The T cells are taken from your blood and a new gene is put into the T cells so that they can then find the cells causing your cancer.
Croatian: Iz Vaše krvi prikupe se T-stanice i u T-stanice se unosi novi gen kako bi one mogle pronaći one stanice koje uzrokuju rak.
English: If you have lymphoma, this might include unexplained fever, feeling weak, night sweats, sudden weight loss.
Croatian: Ako imate limfom, to može uključivati neobjašnjivu vrućicu, osjećaj slabosti, noćno znojenje, iznenadni gubitak tjelesne težine.
English: • Administer tocilizumab.
Croatian: • Primijeniti tocilizumab.
English: No pharmacokinetic or pharmacodynamic drug interaction studies with tisagenlecleucel have been performed.
Croatian: Nisu provedena farmakokinetička ili farmakodinamička ispitivanja interakcije lijekova s tisagenlekleucelom.
English: Your doctor will check if you have signs or symptoms of graft-versus-host disease.
Croatian: Liječnik će provjeriti imate li znakove ili simptome reakcije presatka protiv primatelja.
English: The scatter plots of cellular kinetic parameters versus age (22-76 years) revealed no relevant relationship between cellular kinetic parameters (AUC0-28d and Cmax) with age.
Croatian: Raspršeni grafikoni parametara kinetike stanica u odnosu na dob (22-76 godina) nisu otkrili nikakav relevantan odnos između parametara kinetike stanica (AUC0-28d i Cmax) i dobi.
English: cells dispersion for infusion tisagenlecleucel (CAR+ viable T cells)
Croatian: stanica disperzija za infuziju tisagenlekleucel (CAR+ vijabilne T-stanice)
English: If more than one infusion bag has been received for the treatment dose, the next bag should only be thawed after the contents of the preceding bag have been infused.
Croatian: Ako je više od jedne vrećice za infuziju potrebno za dozu liječenja, sljedeća se vrećica smije odmrznuti tek nakon što se infundira sadržaj prethodne vrećice.
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).
Croatian: ORR je udio bolesnika s najboljim ukupnim odgovorom (engl. best overall response, BOR) koji je bio potpuni odgovor (CR) ili djelomični odgovor (PR) na temelju Lugano kriterija za odgovor (Cheson 2014); neinfundiranim bolesnicima dodijeljeno je BOR=Nepoznato (tj. bolesnici bez odgovora).
English: • If you become pregnant or think you may be pregnant after treatment with Kymriah, talk your doctor immediately.
Croatian: • Ako zatrudnite ili mislite da biste mogli biti trudni nakon liječenja lijekom Kymriah, odmah se obratite svom liječniku.
English: • Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
Croatian: • Izraziti umor, slabost ili nedostatak zraka, što mogu biti simptomi nedostatka crvenih krvnih stanica.
English: Leukapheresis for Kymriah manufacturing should be performed at least 12 weeks after allogeneic SCT.
Croatian: Leukaferezu za proizvodnju lijeka Kymriah potrebno je obaviti najmanje 12 tjedana nakon alogenog TMS-a.
English: Non-clinical safety assessment of Kymriah addressed the safety concerns of potential uncontrolled cell growth of transduced T cells in vitro and in vivo as well as dose-related toxicity, biodistribution and persistence.
Croatian: Neklinička procjena sigurnosti lijeka Kymriah bavila se sigurnosnim pitanjima potencijalnog nekontroliranog staničnog rasta transduciranih T-stanica in vitro i in vivo kao i toksičnošću povezanom s dozom, biodistribucijom i perzistentnošću.
English: Tisagenlecleucel continues to expand and persist following administration of tocilizumab and corticosteroids.
Croatian: Tisagenlekleucel se nastavlja ekspandirati i perzistirati nakon primjene tocilizumaba i kortikosteroida.
English: • If no clinical improvement within 12 to 18 hours of the first tocilizumab dose, or worsening at any time, administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg per day until vasopressors and high-flow oxygen are no longer needed, then taper.
Croatian: • Ako ne dođe do kliničkog poboljšanja u roku od 12 do 18 sati od prve doze tocilizumaba ili ako u bilo kojem trenutku dođe do pogoršanja, primijeniti metilprednizolon 2 mg/kg kao početnu dozu, zatim 2 mg/kg na dan dok više ne budu potrebni vazopresori i visoko protočni kisik, a zatim postupno smanjivati dozu.
English: Cerebral haemorrhage** Neuralgia
Croatian: Krvarenje u mozgu** Neuralgija
English: Delirium includes agitation, delirium, hallucination, hallucination visual, irritability and restlessness.
Croatian: Delirij uključuje agitaciju, delirij, halucinacije, vizualne halucinacije, razdražljivost i nemir.
English: 103/111 patients (93%) received lymphodepleting chemotherapy prior to Kymriah infusion.
Croatian: 103/111 bolesnika (93%) primilo je kemoterapiju za limfocitnu depleciju prije infuzije lijeka Kymriah.
English: DOR was defined as time from achievement of CR or PR, whichever occurs first, to relapse or death due to DLBCL.
Croatian: DOR je bio definiran kao vrijeme od postignuća CR-a ili PR-a, štogod je bilo prvo, do recidiva ili smrti zbog DLBCL-a.
English: These may be symptoms of a serious condition called cytokine release syndrome.
Croatian: To mogu biti simptomi ozbiljnog stanja pod nazivom sindrom otpuštanja citokina.
English: For autologous use only.
Croatian: Samo za autolognu primjenu.
English: You should not be given Kymriah:
Croatian: Ne smijete primiti lijek Kymriah:
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.
Croatian: Među bolesnicima s odgovorom (n=48), srednja vrijednost (SD) promjene u odnosu na početnu vrijednost ukupnog rezultata za PedsQL bila je 13,5 (13,5) u 3. mjesecu, 16,9 (17,6) u 6. mjesecu i 27,2 (21,7) u 12. mjesecu, a srednja vrijednost (SD) promjene u odnosu na početnu vrijednost rezultata za EQ-5D VAS bila je 16,5 (17,5) u 3. mjesecu, 15,9 (20,1) u 6. mjesecu i 24,7 (18,6) u 12. mjesecu, što ukazuje na ukupno klinički značajno poboljšanje HRQoL-a nakon infuzije lijeka Kymriah.
English: In almost all cases, development of cytokine release syndrome occurred between 1 to 10 days (median onset 3 days) after Kymriah infusion.
Croatian: U gotovo svim slučajevima do razvoja sindroma otpuštanja citokina došlo je između 1. i 10. dana (medijan pojave 3 dana) nakon infuzije lijeka Kymriah.
English: • Do not donate blood, organs, tissues or cells for transplants.
Croatian: • Nemojte donirati krv, organe, tkiva ili stanice za presađivanje.
English: Kymriah must be administered in a qualified treatment centre.
Croatian: Lijek Kymriah se mora primijeniti u kvalificiranom centru za liječenje.
English: Of 165 patients enrolled, 111 patients received infusion with Kymriah (4 infusions were pending at the time of analysis); for 12 patients (7%) Kymriah could not be manufactured.
Croatian: Od 165 uključenih bolesnika, 111 bolesnika primilo je infuziju lijeka Kymriah (4 infuzije su se očekivale u vrijeme analize); za 12 bolesnika (7%) nije bilo moguće proizvesti lijek Kymriah.
English: Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Kymriah tijekom trudnoće, niti u žena reproduktivne dobi koje ne koriste kontracepciju.
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.
Croatian: U bolesnika s DLBCL-om, u svim rasponima težine (38,4 do 186,7 kg), raspršeni grafikoni qPCR parametara kinetike stanica u odnosu na težinu nisu otkrili nikakav očigledan odnos između parametara kinetike stanica i težine.
English: Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <10 years ≥10 years and <18 years ≥18 years
Croatian: Srednja vrijednost (standardna devijacija) 12,0 (5,43) Medijan (minimum - maksimum) Dobna kategorija (godine) - n (%) <10 godina ≥10 godina i <18 godina ≥18 godina
English: Influenza-like illness Multiple organ dysfunction syndrome
Croatian: Sindrom višestruke disfunkcije organa
English: Patients should be closely monitored for signs or symptoms of these events, including fever.
Croatian: Bolesnike je potrebno pažljivo nadzirati ne bi li se uočili mogući znakovi i simptomi tih događaja, uključujući vrućicu.
English: The concentration of CAR-positive viable T cells is dependent on indication and patient body weight (for B-cell acute lymphoblastic leukaemia [ALL]).
Croatian: Koncentracija CAR-pozitivnih vijabilnih T-stanica ovisi o indikaciji i bolesnikovoj tjelesnoj težini (za akutnu limfoblastičnu leukemiju [ALL] B-stanica).
English: Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.
Croatian: Bolesnike koji nisu ranije bili izloženi dekstranu i DMSO-u potrebno je pažljivo promatrati tijekom prvih minuta primjene infuzije.
English: Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of cytokine release syndrome and/or neurological events.
Croatian: Liječnici trebaju razmotriti hospitalizaciju prvih 10 dana nakon infuzije ili kod pojave prvih znakova/simptoma sindroma otpuštanja citokina i/ili neuroloških događaja.
English: Corticosteroids may be administered in cases of life-threatening emergencies.
Croatian: Kortikosteroidi se mogu primijeniti u hitnim, po život opasnim stanjima.
English: The median time to resolution was 7 days for B-cell ALL and 12 days for DLBCL.
Croatian: Medijan vremena do povlačenja bio je 7 dana za ALL B-stanica i 12 dana za DLBCL.
English: This medicinal product contains 10 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL.
Croatian: Ovaj lijek sadrži 10 mg dekstrana 40 i 82,5 mg dimetilsulfoksida (DMSO) po mL.
English: • during Kymriah treatment.
Croatian: • tijekom liječenja lijekom Kymriah.
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.
Croatian: Razlozi za prekid prije infuzije lijeka Kymriah uključivali su smrt (n=16; 10%), liječnikovu odluku/progresiju primarne bolesti (n=16; 10%), bolesnikovu odluku (n=3; 2%) ili štetne događaje (n=2; 1%) dok su čekali da se proizvede Kymriah u kliničkom ispitivanju.
English: Low-grade fever, fatigue, anorexia
Croatian: Vrućica niskog stupnja, umor, anoreksija
English: Kymriah is prepared from autologous blood of the patient collected by leukapheresis.
Croatian: Kymriah se priprema iz autologne krvi bolesnika koja se prikuplja leukaferezom.
English: The bag should be removed immediately from the thawing device and kept at room temperature (20°C-25°C) until infusion.
Croatian: Vrećicu treba odmah ukloniti iz uređaja za odmrzavanje te se mora držati na sobnoj temperaturi (20°C-25°C) do infundiranja.
English: Monitoring after infusion - Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities.
Croatian: Praćenje nakon infuzije - Bolesnike je potrebno pratiti svakodnevno tijekom prvih 10 dana nakon infuzije radi uočavanja znakova i simptoma mogućeg sindroma otpuštanja citokina, neuroloških događaja i drugih toksičnosti.
English: Before you are given Kymriah your doctor will:
Croatian: Prije nego Vam da lijek Kymriah, Vaš će liječnik:
English: Kymriah is indicated for the treatment of:
Croatian: Kymriah je indiciran za liječenje:
English: It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B-cell lymphocytopenia.
Croatian: Nije poznato može li se lijek Kymriah prenijeti na fetus putem posteljice i može li uzrokovati fetalnu toksičnost, uključujući limfocitopeniju B-stanica.
English: • feeling warm, fever, chills or shivering, sore throat or mouth ulcers may be signs of an infection.
Croatian: • osjećaj topline, vrućica, zimica ili drhtanje, grlobolja ili afte u ustima - mogu biti znakovi infekcije.
English: • No formal studies have been performed in paediatric patients below 3 years of age in B-cell ALL.
Croatian: • Nisu provedena formalna ispitivanja u pedijatrijskih bolesnika mlađih od 3 godine s ALL-om B-stanica.
English: Patients treated with Kymriah should not donate blood, organs, tissues and cells for transplantation.
Croatian: Bolesnici liječeni lijekom Kymriah ne smiju donirati krv, organe, tkiva i stanice za transplantaciju.
English: A colourless to slightly yellow dispersion.
Croatian: Bezbojna do blago žuta disperzija.
English: Seizure includes seizure, generalised tonic-clonic seizures and status epilepticus.
Croatian: Napadaj uključuje napadaj, generalizirane toničko-kloničke napadaje i epileptički status.
English: Kymriah is recommended to be infused 2 to 14 days after completion of the lymphodepleting chemotherapy.
Croatian: Lijek Kymriah preporučuje se infundirati 2 do 14 dana nakon završetka kemoterapije za limfocitnu depleciju.
English: In Studies B2202 and B2205J there were 79.8% Caucasian, 7.7% Asian and 12.5% other ethnic patients.
Croatian: U ispitivanjima B2202 i B2205J bilo je 79,8% bijelaca, 7,7% Azijata i 12,5% bolesnika drugih etničkih skupina.
English: • Shortness of breath, laboured breathing, rapid breathing, fluid in the lungs
Croatian: • Nedostatak zraka, otežano disanje, ubrzano disanje, tekućina u plućima
English: Final report of study results: December 2038
Croatian: Završno izvješće o rezultatima ispitivanja: prosinac 2038.
English: Prior to Kymriah infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the infusion bag(s).
Croatian: Prije infuzije lijeka Kymriah mora se potvrditi da bolesnikov identitet odgovara ključnim jedinstvenim podacima bolesnika navedenim na vrećici (vrećicama) za infuziju.
English: • Leakage of fluids from blood vessels into surrounding tissue.
Croatian: • Curenje tekućina iz krvnih žila u okolno tkivo.
English: • Tingling or numbness, also in fingers and toes
Croatian: • Trnci ili utrnulost, i u prstima na rukama i nogama
English: A total of 72 out of 75 patients who received Kymriah infusion also received lymphodepleting chemotherapy after enrolment and prior to infusion of a single dose of Kymriah (see section 4.2 for condition of lymphodepleting chemotherapy).
Croatian: Ukupno je 72 od 75 bolesnika koji su primili infuziju lijeka Kymriah također primilo kemoterapiju za limfocitnu depleciju nakon uključenja, a prije infuzije jednokratne doze lijeka Kymriah (vidjeti dio 4.2. za kondicioniranje kemoterapijom za limfocitnu depleciju).
English: The co-administration of agents known to stimulate T-cell function has not been investigated and the effects are unknown.
Croatian: Istodobna primjena tvari za koje je poznato da stimuliraju funkciju T-stanica nije bila ispitivana i učinci nisu poznati.
English: • Excessive or prolonged bleeding or bruising
Croatian: • Prekomjerno ili produljeno krvarenje ili stvaranje modrica
English: Efficacy analysis set (EAS) includes patients infused with Kymriah at least 3 months prior to data cutoff date.
Croatian: Skup za analizu djelotvornosti (engl. efficacy analysis set, EAS) uključuje bolesnike koji su primili infuziju lijeka Kymriah barem 3 mjeseca prije isključnog datuma za podatke.
English: This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium-free”.
Croatian: Ova lijek sadrži kalij, manje od 1 mmol (39 mg) po dozi, tj. zanemarive količine kalija.
English: The infusion bag should be placed inside a second, sterile bag during thawing to protect ports from contamination and avoid spills in the unlikely event of the bag leaking.
Croatian: Vrećica za infuziju treba se staviti u drugu, sterilnu vrećicu za vrijeme odmrzavanja kako bi se ulazi u vrećicu zaštitili od kontaminacije te kako bi se izbjeglo curenje u malo vjerojatnom slučaju da vrećica propušta.
English: If the infusion bag appears to have been damaged or to be leaking, it should not be infused and should be disposed of according to local biosafety procedures (see section 4.2.
Croatian: Ako vrećica za infuziju izgleda kao da je oštećena ili da curi, ne smije se infundirati, već se mora zbrinuti sukladno nacionalnim smjernicama za biološku sigurnost (vidjeti dio 4.2).
English: • Before you are given Kymriah, your doctor may give you a type of treatment called lymphodepleting chemotherapy for a few days to prepare your body.
Croatian: Vam se da Kymriah, Vaš liječnik možda će Vam dati jednu vrstu terapije pod nazivom kemoterapija za limfocitnu depleciju tijekom nekoliko dana kako bi se Vaše tijelo pripremilo.
English: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer.
Croatian: U bolesnika liječenih lijekom Kymriah mogle bi se razviti sekundarne zloćudne bolesti ili bi se rak mogao vratiti.
English: How does Kymriah work?
Croatian: Kako Kymriah djeluje?
English: • Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
Croatian: • pedijatrijskih i mladih odraslih bolesnika u dobi do 25 godina s akutnom limfoblastičnom leukemijom B-stanica (ALL) koja je refraktorna, u recidivu nakon transplantacije ili u drugom ili kasnijem recidivu.
English: This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.
Croatian: To se događa kada presađene stanice napadnu Vaše tijelo, što uzrokuje simptome poput osipa, mučnine, povraćanja, proljeva i krvavih stolica.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego
English: Infections and febrile neutropenia
Croatian: Infekcije i febrilna neutropenija
English: Blood, organ, tissue and cell donation
Croatian: Doniranje krvi, organa, tkiva i stanica
English: • Administer high-dose or multiple vasopressors, oxygen, mechanical ventilation and/or other supportive care as needed.
Croatian: • Primijeniti vazopresor u visokoj dozi ili više vazopresora, kisik, mehaničku ventilaciju i/ili drugu suportivnu skrb prema potrebi.
English: Seven patients who achieved CR/CRi after Kymriah infusion went to transplant while in remission.
Croatian: Sedam bolesnika koji su postigli CR/CRi nakon infuzije lijeka Kymriah podvrgnuto je transplantaciji tijekom remisije.
English: Enrolled patients N=92
Croatian: Uključeni bolesnici N=92
English: • Involuntary tremor
Croatian: • Nevoljno drhtanje
English: Patient educational programme
Croatian: Edukacijski program za bolesnike
English: • Nausea, vomiting
Croatian: • Mučnina, povraćanje
English: - Significant clinical worsening of leukaemia burden or lymphoma following lymphodepleting chemotherapy.
Croatian: - Značajno kliničko pogoršanje opterećenjem tumorskih stanica u leukemiji ili limfomu nakon kemoterapije za limfocitnu depleciju.
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).
Croatian: Nuspojave opisane u ovom dijelu bile su utvrđene u 75, odnosno 111 bolesnika u multicentričnim pivotalnim kliničkim ispitivanjima koja su u tijeku (CCTL019B2202 i CCTL019C2201).