FrancophonIA/ELRC3.0 huggingface dataset:
English: Other symptoms of cytokine release syndrome are difficulty breathing, nausea, vomiting, diarrhoea, muscle pain, joint pain, low blood pressure, or dizziness/light-headedness.
Croatian: Drugi simptomi sindroma otpuštanja citokina su otežano disanje, mučnina, povraćanje, proljev, bol u mišićima, bol u zglobovima, nizak krvni tlak ili omaglica/ošamućenost.
English: Table 6 Study C2201: Efficacy results in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Croatian: Tablica 6 Ispitivanje C2201: Rezultati za djelotvornost u odraslih bolesnika s recidivirajućim ili refraktornim difuznim B-velikostaničnim limfomom (DLBCL) nakon dvije ili više linija sistemske terapije
English: The infusion start time should be confirmed in advance and adjusted for thaw so that Kymriah is available for infusion when the recipient is ready.
Croatian: Vrijeme početka infuzije mora se potvrditi unaprijed te prilagoditi u odnosu na odmrzavanje kako bi lijek Kymriah bio dostupan za infuziju kad je primatelj spreman.
English: Precautions to be taken before handling or administering Kymriah Kymriah contains genetically-modified human blood cells.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja lijekom Kymriah ili njegove primjene Kymriah sadrži genetički modificirane ljudske krvne stanice.
English: Content of dextran 40 and dimethyl sulfoxide (DMSO)
Croatian: Sadržaj dekstrana 40 i dimetilsulfoksida (DMSO)
English: This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose.
Croatian: Ovaj lijek sadrži 2,43 mg natrija po mL i 24,3 do 121,5 mg natrija po dozi.
English: T-cell immunogenicity responses were not observed in paediatric and young adult B-cell ALL and adult r/r DLBCL patients.
Croatian: Odgovori imunogenosti T-stanica nisu bili opaženi u pedijatrijskih i mladih odraslih bolesnika s B-staničnim ALL-om te u odraslih bolesnika s r/r DLBCL-om.
English: Infections - pathogen unspecified Viral infections
Croatian: Infekcije - neodređeni patogen Virusne infekcije Bakterijske infekcije Gljivične infekcije
English: Secondary malignancies
Croatian: Sekundarne zloćudne bolesti
English: If you have any questions about how Kymriah works or why this medicine has been prescribed for you, ask your doctor.
Croatian: Ako imate dodatnih pitanja o tome kako Kymriah djeluje ili o tome zašto
English: The most common Grade 3 and 4 non-haematological adverse reactions were infections (32%) and cytokine release syndrome (22%).
Croatian: Najčešće nehematološke nuspojave 3. i 4. stupnja bile su infekcije (32%) i sindrom otpuštanja citokina (22%).
English: Kymriah contains genetically-modified human blood cells.
Croatian: Kymriah sadrži genetički modificirane ljudske krvne stanice.
English: Infused N=111 n (%)
Croatian: Infundirani N=111 n (%)
English: This medicinal product contains 24.3 to 121.5 mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 24,3 do 121,5 mg natrija po dozi, što odgovara 1 do 6% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah (see section 4.5).
Croatian: Cijepljenje živim virusnim cjepivima ne preporučuje se barem 6 tjedana prije početka kemoterapije za limfocitnu depleciju, tijekom liječenja lijekom Kymriah te do imunološkog oporavka nakon liječenja lijekom Kymriah (vidjeti dio 4.5).
English: Symptoms of cytokine release syndrome may include high fever, rigors, myalgia, arthralgia, nausea, vomiting, diarrhoea, diaphoresis, rash, anorexia, fatigue, headache, hypotension, encephalopathy, dyspnoea, tachypnoea, and hypoxia.
Croatian: Simptomi sindroma otpuštanja citokina mogu uključivati visoku temperaturu, tresavicu, mijalgiju, artralgiju, mučninu, povraćanje, proljev, dijaforezu, osip, anoreksiju, umor, glavobolju, hipotenziju, encefalopatiju, dispneju, tahipneju i hipoksiju.
English: Neurological events can be concurrent with cytokine release syndrome, following resolution of cytokine release syndrome or in the absence of cytokine release syndrome.
Croatian: Neurološki događaji mogu se pojaviti istodobno sa sindromom otpuštanja citokina, nakon povlačenja sindroma otpuštanja citokina ili u odsutnosti sindroma otpuštanja citokina.
English: When the full volume of Kymriah has been infused, the infusion bag should be rinsed with 10 to 30 mL sodium chloride 9 mg/mL (0.9%) solution for injection by back priming to ensure as many cells as possible are infused into the patient.
Croatian: Kad je infundiran cjelokupni volumen lijeka Kymriah, vrećicu za infuziju potrebno je isprati s 10 do 30 mL otopine natrijevog klorida 9 mg/mL (0,9%) za injekciju kojom će se ispuniti cijevi seta kako bi se osiguralo da je bolesniku infundirano što je više moguće stanica.
English: Accordingly, healthcare professionals should employ appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or Kymriah to avoid potential transmission of infectious diseases.
Croatian: Sukladno tome, zdravstveni radnici moraju poduzeti odgovarajuće mjere opreza (nositi rukavice i naočale) kad rukuju pripravkom dobivenim leukaferezom ili lijekom Kymriah kako bi se izbjegao mogući prijenos zaraznih bolesti.
English: Fluid overload Hypermagnesaemia Hyponatraemia Hyperphosphataemia Tumour lysis syndrome
Croatian: Preopterećenje tekućinom Hipermagnezijemija Hiponatrijemija Hiperfosfatemija Sindrom lize tumora
English: It is supplied as an infusion bag containing a cloudy to clear, colourless to slightly yellow dispersion of cells.
Croatian: Dostavlja se u obliku vrećice za infuziju koja sadrži zamućenu do bistru, bezbojnu do žućkastu disperziju stanica.
English: In some cases, disseminated intravascular coagulation (DIC), with low fibrinogen levels, capillary leak syndrome (CLS), and haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) have been reported in the setting of cytokine release syndrome.
Croatian: U nekim slučajevima uz sindrom otpuštanja citokina prijavljena je diseminirana intravaskularna koagulacija (DIK) s niskom razinom fibrinogena, sindrom kapilarnog curenja (engl. capillary leak syndrome, CLS) i hemofagocitna limfohistiocitoza/sindrom aktivacije makrofaga (HLH/MAS).
English: Your doctor handling Kymriah will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Croatian: Vaš liječnik koji rukuje lijekom Kymriah zato će poduzeti odgovarajuće mjere opreza (nositi rukavice i naočale) kako bi se izbjegao mogući prijenos zaraznih bolesti.
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).
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): kako bi se dodatno ocijenila djelotvornost lijeka Kymriah u bolesnika s recidivirajućim/refraktornim DLBCL-om, podnositelj zahtjeva treba provesti i predati rezultate prospektivnog opservacijskog ispitivanja u bolesnika s r/r DLBCL-om na temelju podataka iz registra s mjerama ishoda u pogledu djelotvornosti u skladu s ispitivanjem C2201, uključujući pojedinosti o vremenu potrebnom za proizvodnju (tj. vremenu od zadnjeg relapsa ili potvrđenog refraktornog statusa, vremenu od odluke o liječenju i vremenu od leukafereze do infuzije).
English: Table 5 Study C2201: Baseline information across the enrolled and the infused patient populations
Croatian: Tablica 5 Ispitivanje C2201: Informacije s početka ispitivanja o uključenoj i infundiranoj populaciji bolesnika
English: Pregnancy after Kymriah therapy should be discussed with the treating physician.
Croatian: O trudnoći nakon liječenja lijekom Kymriah treba razgovarati s liječnikom koji provodi liječenje.
English: Decreased appetite Hypokalaemia Hypophosphataemia Hypocalcaemia Hypomagnesaemia Hypoalbuminaemia Hyperuricaemia Hyperglycaemia
Croatian: Smanjeni apetit Hipokalijemija Hipofosfatemija Hipokalcijemija Hipomagnezijemija Hipoalbuminemija
English: Other secondary endpoint
Croatian: Druga mjera sekundarnog ishoda
English: Post-authorisation efficacy study (PAES): In order to further characterise the long-term efficacy and safety of Kymriah in relapsed/refractory DLBCL, the applicant should submit the 24 months follow-up for patients in the main Cohort and 24 months follow-up of all infused patients from study C2201.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): kako bi se dodatno okarakterizirale dugoročna djelotvornost i sigurnost primjene lijeka Kymriah kod recidivirajućeg/refraktornog DLBCL-a, podnositelj zahtjeva treba predati podatke o 24-mjesečnom kontrolnom praćenju za bolesnike u glavnoj kohorti i 24-mjesečnom kontrolnom praćenju svih infundiranih bolesnika iz ispitivanja C2201.
English: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.
Croatian: Cijepljenje živim virusnim cjepivima ne preporučuje se barem 6 tjedana prije početka kemoterapije za limfocitnu depleciju, tijekom liječenja lijekom Kymriah te do imunološkog oporavka nakon liječenja lijekom Kymriah.
English: Preparation of the infusion bag
Croatian: Priprema vrećice za infuziju
English: Patients should be monitored for signs and symptoms of infection and treated appropriately.
Croatian: Bolesnike je potrebno motriti zbog mogućih znakova i simptoma infekcije te primjereno liječiti.
English: Table 3 Study B2202: Baseline information across the enrolled and the infused patient population
Croatian: Tablica 3 Ispitivanje B2202: Informacije s početka ispitivanja o uključenoj i infundiranoj populaciji bolesnika
English: Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is ≤1,000 cells/μL.
Croatian: Preporučuje se primijeniti kemoterapiju za limfocitnu depleciju prije infuzije lijeka Kymriah, osim ako je broj leukocita (Lkc) unutar tjedan dana prije infuzije ≤1000 stanica/μL.
English: Autologous human T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Croatian: Autologne humane T-stanice genetički modificirane ex vivo koristeći lentivirusni vektor koji kodira anti-CD19 kimerični antigenski receptor (CAR).
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: - Bendamustine (90 mg/m2 intravenous daily for 2 days).
Croatian: Ako je bolesnik prethodno uz ciklofosfamid imao hemoragijski cistitis 4. stupnja ili je postao rezistentan na kemoterapijski protokol koji sadrži ciklofosfamid primijenjen nedugo prije kemoterapije za limfocitnu depleciju, potrebno je primijeniti sljedeće: - bendamustin (90 mg/m intravenski dnevno tijekom 2 dana).
English: Pregnancy status for females of child-bearing age should be verified prior to starting treatment with Kymriah.
Croatian: Kod žena reproduktivne dobi mora se provjeriti jesu li trudne prije početka terapije lijekom Kymriah.
English: Dosage in paediatric and young adult B-cell ALL patients - For patients 50 kg and below: 0.2 to 5 x 106 CAR-positive viable T cells/kg body weight.
Croatian: Doziranje kod pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica - Za bolesnike težine od 50 kg i manje: 0,2 do 5 x 10
English: Not reached (10.0, NE4) Not reached (10.0, NE4)
Croatian: Nije postignut (10,0; NE
English: It is unknown whether Kymriah cells are excreted in human milk.
Croatian: Nije poznato izlučuje li se lijek Kymriah (stanice) u majčino mlijeko.
English: Non-interventional post-authorisation safety study (PASS): In order to further characterise the safety - including long-term safety - of Kymriah, the applicant should conduct and submit a study based on data from a disease registry in ALL and DLBCL patients.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): kako bi se dodatno okarakterizirala sigurnost - uključujući dugoročnu sigurnostprimjene lijeka Kymriah, podnositelj zahtjeva treba provesti i predati rezultate ispitivanja na temelju podataka iz registra bolesti u bolesnika s ALL-om i DLBCL-om.
English: In adult DLBCL, patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included thrombocytopenia (41%), lymphopenia (28%), neutropenia (24%), leukopenia (21%) and anaemia (14%).
Croatian: U odraslih bolesnika s DLBCL-om, citopenije 3. i 4. stupnja koje se nisu povukle do 28. dana bile su prijavljene na temelju laboratorijskih nalaza i uključivale su trombocitopeniju (41%), limfopeniju (28%), neutropeniju (24%), leukopeniju (21%) i anemiju (14%).
English: Kymriah should be transported within the facility in closed, break-proof, leak-proof containers.
Croatian: Kymriah je potrebno prenositi unutar objekta u zatvorenim spremnicima otpornim na lomove i curenje.
English: Also contains: glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, water for injections.
Croatian: Također sadrži: glukozu, natrijev klorid, otopinu ljudskog albumina, dekstran 40 za injekciju, dimetilsulfoksid, natrijev glukonat, natrijev acetat, kalijev klorid, magnezijev klorid, natrijev N-acetiltriptofanat, natrijev kaprilat, aluminij, vodu za injekcije.
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.
Croatian: Raspodjela lijeka između krvi i koštane srži bila je takva da je 28. dan od primitka terapije u koštanoj srži bilo gotovo 70% one količine lijeka koja je pronađena u krvi, a nakon 3 mjeseca količina lijeka u koštanoj srži odgovarala je 50% one količine koja je pronađena u krvi, što je vrijedilo i za bolesnike s odgovorom i one bez odgovora.
English: Vascular disorders Hypotension Hypertension
Croatian: Hipotenzija Hipertenzija
English: Prior transplantation did not impact the expansion/persistence of Kymriah in paediatric and young adult B-Cell ALL patients or DLBCL patients.
Croatian: Prethodna transplantacija nije utjecala na ekspanziju/perzistentnost lijeka Kymriah u pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica ili u bolesnika s DLBCL-om.
English: • in the 6 weeks before you are given the short course of chemotherapy (called lymphodepleting chemotherapy) to prepare your body for the Kymriah cells.
Croatian: Vam se da kratki ciklus kemoterapije (pod nazivom kemoterapija za limfocitnu depleciju) da se Vaše tijelo pripremi za stanice lijeka Kymriah.
English: Hypogammaglobulinaemia includes immunoglobulins decreased, blood immunoglobulin A decreased, blood immunoglobulin G decreased, blood immunoglobulin M decreased, immunodeficiency common variable and hypogammaglobulinaemia.
Croatian: A u krvi, sniženi imunoglobulin G u krvi, sniženi imunoglobulin M u krvi, običnu varijabilnu imunodeficijenciju i hipogamaglobulinemiju.
English: • Flu-like illness
Croatian: • Bolest nalik gripi
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.
Croatian: Tisagenlekleucel je terapija raka autolognim imunosnim stanicama koja uključuje reprogramiranje bolesnikovih vlastitih T-stanica transgenom koji kodira kimerični antigenski receptor (CAR) kako bi identificirale i eliminirale stanice koje eksprimiraju CD19.
English: ‡ (day)
Croatian: (dan)
English: The most common non-haematological adverse reactions were cytokine release syndrome (77%), infections (65%), hypogammaglobulinaemia (47%), pyrexia (40%) and decreased appetite (39%).
Croatian: Najčešće nehematološke nuspojave bile su sindrom otpuštanja citokina (77%), infekcije (65%), hipogamaglobulinemija (47%), pireksija (40%) i smanjeni apetit (39%).
English: The MAH must ensure on-site, immediate access to 4 doses of tocilizumab for each patient as CRS management medication prior to treating patients.
Croatian: Nositelj odobrenja dužan je u bolničkoj ustanovi za svakog bolesnika osigurati neposrednu dostupnost 4 doze tocilizumaba kao lijeka za zbrinjavanje sindroma otpuštanja citokina prije liječenja bolesnika.
English: Table 4 Study B2202: Efficacy results in paediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukaemia (ALL)
Croatian: Tablica 4 Ispitivanje B2202: Rezultati za djelotvornost u pedijatrijskih i mladih odraslih bolesnika s recidivirajućom/refraktornom akutnom limfoblastičnom leukemijom (ALL) B-stanica
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).
Croatian: U pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica pokazalo se da je tisagenlekleucel prisutan u krvi i koštanoj srži i nakon 2 godine (ispitivanje B2101J).
English: Kymriah was administered in a qualified Kymriah treatment centre in an inpatient and outpatient setting.
Croatian: Kymriah je primijenjen u kvalificiranom centru za liječenje lijekom Kymriah u bolničkom i u ambulantnom okruženju.
English: Post-authorisation efficacy study (PAES): In order to further characterise the long-term efficacy and safety of Kymriah in relapsed/refractory DLBCL, the applicant should submit the results of study CCTL019H2301 - open-label, Phase III study of Kymriah versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): kako bi se dodatno okarakterizirale dugoročna djelotvornost i sigurnost primjene lijeka Kymriah kod recidivirajućeg/refraktornog DLBCL-a, podnositelj zahtjeva treba predati rezultate ispitivanja CCTL019H2301 - otvorenog ispitivanja faze III u kojem se ispituje Kymriah u odnosu na standardnu skrb u odraslih bolesnika s recidivirajućim ili refraktornim agresivnim B-staničnim ne-Hodgkinovim limfomom.
English: The pivotal study (C2201) is a multicentre, single-arm phase II study in adult patients with relapsed or refractory DLBCL.
Croatian: Pivotalno ispitivanje (C2201) multicentrično je ispitivanje faze II s jednom skupinom u odraslih bolesnika s recidivirajućim ili refraktornim DLBCL-om.
English: • The other ingredients are glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, and water for injections.
Croatian: • Drugi sastojci su glukoza, natrijev klorid, otopina ljudskog albumina, dekstran 40 za injekciju, dimetilsulfoksid, natrijev glukonat, natrijev acetat, kalijev klorid, magnezijev klorid, natrijev N-acetiltriptofanat, natrijev kaprilat, aluminij i voda za injekcije.
English: % event free probability at 6 months Median (months) (95% CI)
Croatian: % vjerojatnosti izostanka događaja u 6. mjesecu 79,5 Medijan (mjeseci) (95% CI)
English: The most common Grade 3 and 4 non-haematological adverse reaction was cytokine release syndrome (47%).
Croatian: Najčešća nehematološka nuspojava 3. i 4. stupnja bio je sindrom otpuštanja citokina (47%).
English: Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Croatian: Zdravstveni radnici koji rukuju lijekom Kymriah zato trebaju poduzeti odgovarajuće mjere opreza (nositi rukavice i naočale) kako bi se izbjegao mogući prijenos zaraznih bolesti.
English: This will show if you are likely to develop a condition called tumour lysis syndrome.
Croatian: Time će se utvrditi postoji li vjerojatnost da se razvije stanje pod nazivom sindrom raspadanja
English: • Bloating (abdominal distension), accumulation of fluid in the abdomen
Croatian: • Nadutost (nadimanje trbuha), nakupljanje tekućine u trbuhu
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy and safety of Kymriah in ALL patients below the age of 3 years, the applicant should conduct and submit a study based on data from a disease registry in ALL patients.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): kako bi se dodatno ocijenile djelotvornost i sigurnost primjene lijeka Kymriah u bolesnika s ALL-om mlađih od 3 godine, podnositelj zahtjeva treba provesti i predati rezultate ispitivanja na temelju podataka iz registra bolesti u bolesnika s ALL-om.
English: A summary of cellular kinetic parameters of tisagenlecleucel in paediatric and young adult B-cell ALL patients is provided in Table 7 below.
Croatian: Sažetak parametara kinetike stanica tisagenlekleucela u pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica naveden je u Tablici 7 u nastavku.
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).
Croatian: Ako je bolesnik prethodno uz ciklofosfamid imao hemoragijski cistitis 4. stupnja ili je postao rezistentan na kemoterapijski protokol koji sadrži ciklofosfamid primijenjen nedugo prije kemoterapije za limfocitnu depleciju, potrebno je primijeniti sljedeće: - citarabin (500 mg/m intravenski dnevno tijekom 2 dana) i etopozid (150 mg/m intravenski dnevno tijekom 3 dana počevši s prvom dozom citarabina).
English: INFUSION BAG LABEL
Croatian: NALJEPNICA VREĆICE ZA INFUZIJU
English: Dyspnoea includes dyspnoea, dyspnoea exertional, respiratory distress and respiratory failure.
Croatian: Dispneja uključuje dispneju, dispneju uzrokovanu naprezanjem, respiratorni distres i respiratorno zatajivanje.
English: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied.
Croatian: Sigurnost imunizacije živim virusnim cjepivima tijekom ili nakon terapije lijekom Kymriah nije bila ispitivana.
English: Enrolled N=92 n (%)
Croatian: Uključeni N=92 n (%)
English: In paediatric and young adult B-cell ALL patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included leukopenia (55%), neutropenia (53%), lymphopenia (43%), thrombocytopenia (41%) and anaemia (12%).
Croatian: U pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica, citopenije 3. i 4. stupnja koje se nisu povukle do 28. dana bile su prijavljene na temelju laboratorijskih nalaza i uključivale su leukopeniju (55%), neutropeniju (53%), limfopeniju (43%), trombocitopeniju (41%) i anemiju (12%).
English: Abdominal pain includes abdominal pain, abdominal pain upper and abdominal discomfort.
Croatian: Bol u abdomenu uključuje bol u abdomenu, bol u gornjem dijelu abdomena i nelagodu u abdomenu.