FrancophonIA/ELRC3.0 huggingface dataset:
English: Pre-treatment conditioning (lymphodepleting chemotherapy)
Croatian: Kondicioniranje prije terapije (kemoterapija za limfocitnu depleciju)
English: Neurological events, in particular encephalopathy, confusional state or delirium, occur frequently with Kymriah and can be severe or life-threatening (see section 4.8).
Croatian: Neurološki događaji, osobito encefalopatija, stanje konfuzije ili delirij učestalo se javljaju uz lijek Kymriah i mogu biti teški ili opasni po život (vidjeti dio 4.8).
English: Kymriah contains human blood cells.
Croatian: Kymriah sadrži ljudske krvne stanice.
English: What Kymriah is used for Kymriah is used to treat:
Croatian: Za što se Kymriah koristi Kymriah se koristi za liječenje:
English: The maximal expansion (Cmax) was approximately 2-fold higher in CR/CRi patients (n=79) compared with non-responding (NR) patients (n=10) as measured by qPCR.
Croatian: Maksimalna ekspanzija (Cmax) bila je približno 2 puta veća u bolesnika koji su imali CR/CRi (n=79) nego u bolesnika bez odgovora (engl. non-responding, NR) (n=10) izmjereno pomoću qPCR-a.
English: • Low urine output, dark urine
Croatian: • Niska proizvodnja mokraće, tamna mokraća
English: Two deaths occurred within 30 days of Kymriah infusion: one patient died with cytokine release syndrome and progressive leukaemia and the second patient had resolving cytokine release syndrome with abdominal compartment syndrome, coagulopathy and renal failure when death occurred due to an intracranial haemorrhage.
Croatian: Došlo je do dvije smrti u roku od 30 dana od infuzije lijeka Kymriah: jedan je bolesnik umro sa sindromom otpuštanja citokina i progresivnom leukemijom, a drugi je bolesnik imao sindrom otpuštanja citokina koji se povlačio uz sindrom abdominalnog odjeljka, koagulopatiju i zatajivanje bubrega kad je došlo do smrti zbog intrakranijalnog krvarenja.
English: The overall incidence (all grades) was 54% (unspecified 44%, bacterial 10%, fungal 10% and viral 8%) (see section 4.4).
Croatian: Ukupna incidencija (svih stupnjeva) bila je 54% (neodređene 44%, bakterijske 10%, gljivične 10% i virusne 8%) (vidjeti dio 4.4).
English: If any of the above apply to you (or you are not sure), talk to your doctor before being given Kymriah.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku prije nego Vam da lijek Kymriah.
English: The patient's identity should be matched with the patient identifiers on the infusion bag.
Croatian: Bolesnikov identitet mora odgovarati bolesnikovim identifikacijskim podacima na vrećici za infuziju.
English: Contains genetically-modified cells.
Croatian: Sadrži genetički modificirane stanice.
English: • Your doctor will check that the individual patient identifiers on the Kymriah infusion bag match up to you.
Croatian: • Vaš će liječnik provjeriti podudaraju li se identifikacijski podaci pojedinačnog bolesnika na vrećici za infuziju lijeka Kymriah s Vašima.
English: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV.
Croatian: Trenutačno nema iskustva s proizvodnjom lijeka Kymriah za bolesnike s pozitivnim testom na HBV, HCV i HIV.
English: What Kymriah is
Croatian: Što je Kymriah
English: Infused patients N=75
Croatian: Infundirani bolesnici N=75
English: Before you are given Kymriah you should tell your doctor if:
Croatian: Vam se da Kymriah obavijestite svog liječnika ako:
English: Patients may continue to exhibit cytopenias for several weeks following Kymriah infusion and should be managed according to standard guidelines.
Croatian: Bolesnici mogu nastaviti biti citopenični nekoliko tjedana nakon infuzije lijeka Kymriah pa ih je potrebno zbrinuti sukladno standardnim smjernicama.
English: The full analysis set (FAS) includes all patients infused with Kymriah.
Croatian: Skup za cjelokupnu analizu (engl. full analysis set, FAS) uključuje sve bolesnike koji su primili lijek Kymriah.
English: Immunoglobulin levels should be monitored after treatment with Kymriah.
Croatian: Razine imunoglobulina potrebno je pratiti nakon liječenja lijekom Kymriah.
English: Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10-30 mL (50 mL bags) or 30-50 mL (250 mL bags) cell dispersion.
Croatian: Vrećica za infuziju od etilenvinilacetata (EVA), s cijevi od polivinilklorida (PVC) i priključkom s plastičnom luer iglom zatvorenim luer-lock poklopcem, koja sadrži 10-30 mL (vrećice od 50 mL) ili 30-50 mL (vrećice od 250 ml) disperzije stanica.
English: The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.
Croatian: Nužno je potvrditi dostupnost lijeka Kymriah prije nego što se započne režim za limfocitnu depleciju.
English: Diffuse large B-cell lymphoma (DLBCL)
Croatian: Difuzni B-velikostanični limfom (DLBCL)
English: The infusion bag(s) should be examined for any breaks or cracks prior to thawing.
Croatian: Vrećicu (vrećice) za infuziju potrebno je pregledati zbog mogućih oštećenja ili puknuća prije odmrzavanja.
English: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: - Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies.
Croatian: Zbog rizika povezanih s liječenjem lijekom Kymriah, infuziju je potrebno odgoditi ako bolesnik ima bilo koje od stanja navedenih u nastavku: - Neriješene ozbiljne nuspojave (osobito plućne nuspojave, srčane nuspojave ili hipotenziju)
English: The elimination profile of Kymriah includes a bi-exponential decline in peripheral blood and bone marrow.
Croatian: Profil eliminacije lijeka Kymriah uključuje bieksponencijalno opadanje u perifernoj krvi i koštanoj srži.
English: The adverse reactions described in this section were identified in 111 patients infused with Kymriah in one global multicentre international study, i.e. the ongoing pivotal clinical study CCTL019C2201.
Croatian: Nuspojave opisane u ovom dijelu utvrđene su u 111 bolesnika koji su primili infuziju lijeka Kymriah u jednom globalnom multicentričnom međunarodnom ispitivanju, tj. pivotalnom kliničkom ispitivanju CCTL019C2201 koje je u tijeku.
English: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function were excluded from the studies.
Croatian: Bolesnici s aktivnim poremećajem SŽS-a u anamnezi ili nedostatnom bubrežnom, jetrenom, plućnom ili srčanom funkcijom bili su isključeni iz ispitivanja.
English: The availability of tocilizumab at all hospitals and associated centres must be ensured by the MAH until an authorised treatment for CRS is available in the EU.
Croatian: Nositelj odobrenja dužan je osigurati dostupnost tocilizumaba u svim bolnicama i povezanim centrima dok neka odobrena terapija za sindrom otpuštanja citokina ne postane dostupna u EU.
English: Precautions to be taken before handling or administering the medicinal product This medicinal product contains genetically modified human blood cells.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja ili primjene lijeka Ovaj lijek sadrži genetički modificirane ljudske krvne stanice.
English: Overall survival (OS)3 % survival probability at 6 months % survival probability at 12 months Median (months) (95% CI)
Croatian: Ukupno preživljenje (OS) % vjerojatnosti preživljenja u 6. mjesecu % vjerojatnosti preživljenja u 12. mjesecu Medijan (mjeseci) (95% CI)
English: In clinical studies, humoral immunogenicity of tisagenlecleucel was measured by determination of anti-murine CAR19 antibodies (anti-mCAR19) in serum pre- and post-administration.
Croatian: U kliničkim ispitivanjima, humoralna imunogenost tisagenlekleucela bila je mjerena određivanjem protutijela protiv mišjeg CAR19 (anti-mCAR19) u serumu prije i nakon primjene.
English: Febrile neutropenia and infections
Croatian: Febrilna neutropenija i infekcije
English: Following infusion of Kymriah into paediatric and young adult r/r B-cell ALL and r/r DLBCL patients, Kymriah typically exhibited an initial rapid expansion followed by a slower bi-exponential decline.
Croatian: Nakon infuzije lijeka Kymriah pedijatrijskim i mladim odraslim bolesnicima s r/r ALL-om B-stanica i r/r DLBCL-om, Kymriah je obično pokazivao početnu brzu ekspanziju nakon koje je slijedilo sporije bieksponencijalno opadanje.
English: A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome and emergency equipment must be available prior to infusion.
Croatian: Najmanje četiri doze tocilizumaba za primjenu u slučaju sindroma otpuštanja citokina i oprema za hitne slučajeve moraju biti dostupni prije infuzije.
English: • Convulsion, fits (seizures)
Croatian: • Konvulzije, napadaji (epileptički napadaji)
English: In Study B2202, 43% female and 57% male patients and in Study C2201 39% female and 61% male patients received Kymriah.
Croatian: U ispitivanju B2202, 43% bolesnica i 57% bolesnika, a u ispitivanju C2201 39% bolesnica i 61% bolesnika primilo je lijek Kymriah.
English: Store and transport below -120°C, e.g. in a container for cryogenic storage (Dewar) in the vapour phase of liquid nitrogen.
Croatian: Čuvati i transportirati na temperaturi ispod -120°C, npr. u spremniku za kriogeno čuvanje (Dewarovoj posudi) u plinovitoj fazi tekućeg dušika.
English: • Blue lips, hands and feet
Croatian: • Plavilo usana, šaka i stopala
English: Myeloid growth factors, particularly granulocyte macrophage-colony stimulating factor (GM-CSF), have the potential to worsen cytokine release syndrome symptoms and are not recommended during the first 3 weeks after Kymriah infusion or until cytokine release syndrome has resolved.
Croatian: Mijeloidni čimbenici rasta, osobito čimbenik stimulacije granulocitno-makrofagnih kolonija (engl. granulocyte macrophage-colony stimulating factor, GM-CSF), mogli bi pogoršati simptome sindroma otpuštanja citokina i ne preporučuju se tijekom prva 3 tjedna nakon infuzije lijeka Kymriah ili dok se sindrom otpuštanja citokina ne povuče.
English: • Check for hepatitis B, hepatitis C or HIV infection.
Croatian: • provjeriti imate li hepatitis B, hepatitis C ili HIV infekciju.
English: Confirm the infusion time in advance, and adjust the start time for thaw so that Kymriah is available for infusion when the recipient is ready.
Croatian: Unaprijed potvrdite vrijeme davanja infuzije te prilagodite vrijeme početka odmrzavanja tako da Kymriah bude dostupan za infuziju kad je primatelj spreman.
English: Tumour lysis syndrome (TLS)
Croatian: Sindrom lize tumora (TLS)
English: There is limited experience with Kymriah in patients exposed to prior CD19-directed therapy.
Croatian: Postoji ograničeno iskustvo s lijekom Kymriah u bolesnika ranije izloženih terapiji usmjerenoj protiv CD19.
English: Of 92 patients enrolled, 75 received infusion with Kymriah; for 7 patients (8%) Kymriah could not be manufactured; reasons for discontinuation prior to Kymriah infusion included death (n=7; 8%) or adverse events (n=3; 3%) while awaiting Kymriah manufacturing in the clinical study.
Croatian: Od 92 uključena bolesnika, 75 je primilo infuziju s lijekom Kymriah; za 7 bolesnika (8%) nije bilo moguće proizvesti lijek Kymriah; razlozi prekida ispitivanja prije infuzije lijeka Kymriah uključivali su smrt (n=7; 8%) ili štetne događaje (n=3; 3%) dok su bolesnici čekali da se proizvede Kymriah u kliničkom ispitivanju.
English: Median [min;max], n 9.83 [0.0111;27.8], 79 20.0 [0.0278;62.7], 10
Croatian: Medijan [min; max], n 9,83 [0,0111; 27,8], 79 20,0 [0,0278; 62,7], 10
English: • Stroke causing, for example, weakness, loss of balance, difficulty with speech, visual disturbance, difficulty swallowing
Croatian: • Moždani udar koji uzrokuje, primjerice, slabost, gubitak ravnoteže, poteškoće s govorom,
English: Precautions to be taken for transport and disposal of the medicinal product
Croatian: Mjere opreza koje je potrebno poduzeti prilikom transporta i zbrinjavanja lijeka
English: Therefore the risk/benefit of Kymriah has not been established in these populations.
Croatian: Stoga omjer koristi i rizika lijeka Kymriah u tim populacijama nije ustanovljen.
English: Hypogammaglobulinaemia was reported in 47% of patients treated with Kymriah for r/r ALL and 14% of patients with r/r DLBCL.
Croatian: Hipogamaglobulinemija je bila prijavljena u 47% bolesnika liječenih lijekom Kymriah za r/r ALL te u 14% bolesnika s r/r DLBCL-om.
English: Dispose of as per local biosafety guideline.
Croatian: Zbrinuti u skladu s nacionalnim smjernicama za biološku sigurnost.
English: The majority of neurological events occurred within 8 weeks following Kymriah infusion and were transient.
Croatian: Većina neuroloških događaja pojavila se unutar 8 tjedana nakon infuzije lijeka Kymriah i bila je prolazna.
English: • Heart failure, stopped heart beat
Croatian: • Zatajivanje srca, prestanak otkucaja srca
English: DOR was defined as time since onset of CR or CRi to relapse or death due to underlying indication, whichever is earlier (N=61).
Croatian: DOR je bio definiran kao vrijeme od nastupa odgovora CR ili CRi do relapsa ili smrti zbog osnovne indikacije, štogod se dogodi prije (N=61).
English: Ensure that a minimum of four doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
Croatian: Osigurajte dostupnost najmanje četiri doze tocilizumaba i opreme za hitne slučajeve prije infuzije te tijekom razdoblja oporavka.
English: There are no data from the use of Kymriah in pregnant women.
Croatian: Nema podataka o primjeni lijeka Kymriah u trudnica.
English: In patients with low immunoglobulin levels pre-emptive measures such as infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be taken according to age and standard guidelines.
Croatian: U bolesnika s niskim razinama imunoglobulina potrebno je poduzeti preventivne mjere poput mjera opreza za infekcije, profilakse antibioticima i nadomjestka imunoglobulina sukladno dobi i standardnim smjernicama.
English: OS was defined as time from date of Kymriah infusion to the date of death due to any cause for infused patients and from time of date of enrolment to the date of death due to any cause for enrolled patients.
Croatian: OS je bio definiran kao vrijeme od datuma infuzije lijeka Kymriah do datuma smrti zbog bilo kojeg uzroka za infundirane bolesnike te od datuma uključenja do datuma smrti zbog bilo kojeg uzroka za uključene bolesnike.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Neurological adverse reactions The majority of neurological events occurred within 8 weeks following infusion and were transient.
Croatian: Neurološke nuspojave Većina neuroloških događaja pojavila se unutar 8 tjedana nakon infuzije i bila je prolazna.
English: Infections may also occur during cytokine release syndrome and may increase the risk of a fatal event.
Croatian: Infekcije se mogu pojaviti i tijekom sindroma otpuštanja citokina te povećati rizik od smrtnog ishoda.
English: OS was defined as time from date of Kymriah infusion to the date of death due to any cause on FAS (N=111) and time from date of enrolment to the date of death due to any cause for enrolled patients (N=165).
Croatian: OS je bio definiran kao vrijeme od datuma infuzije lijeka Kymriah do datuma smrti zbog bilo kojeg uzroka u FAS-u (N=111) te vrijeme od datuma uključivanja do datuma smrti zbog bilo kojeg uzroka za uključene bolesnike (N=165).
English: Patients with T-cell rich/histiocyte-rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV-positive DLBCL of the elderly, Richter's transformation, and Burkitt lymphoma were not enrolled in study C2201.
Croatian: T-cell rich/histiocyte rich large B-cell lymphoma, THRBCL), primarnim kutanim B-velikostaničnim limfomom, primarnim medijastinalnim B-staničnim limfomom (PMBCL), EBV-pozitivnim DLBCL-om starijih osoba, Richterovom transformacijom te Burkittovim limfomom nisu bili uključeni u ispitivanje C2201.
English: Upon binding to CD19-expressing cells, the CAR transmits a signal promoting T-cell expansion and persistence of tisagenlecleucel.
Croatian: Nakon vezanja za stanice koje eksprimiraju CD19, CAR odašilje signal koji potiče ekspanziju T-stanica i perzistentnost tisagenlekleucela.
English: The CAR is comprised of a murine single chain antibody fragment which recognises CD19 and is fused to intracellular signalling domains from 4-1BB (CD137) and CD3 zeta.
Croatian: CAR se sastoji od jednolančanog fragmenta mišjeg protutijela koji prepoznaje CD19 i spojen je s intracelularnim signalnim domenama iz 4-1BB (CD137) i CD3 zeta.
English: In adult DLBCL patients (Study C2201), tisagenlecleucel has been detected for up to 2 years in peripheral blood and up to month 9 in bone marrow for complete responder patients.
Croatian: U odraslih bolesnika s DLBCL-om (ispitivanje C2201), tisagenlekleucel je bio dokazan u razdoblju do 2 godine u perifernoj krvi te do 9. mjeseca u koštanoj srži bolesnika s potpunim odgovorom.
English: Of four patients with active CNS leukaemia (i.e. CNS-3) included in study B2101J, three experienced cytokine release syndrome (Grade 2-4) and transient neurological abnormalities (Grade 1-3) that resolved within 1-3 months of infusion.
Croatian: Od četvero bolesnika s aktivnom leukemijom SŽS-a (tj. SŽS-3) uključenih u ispitivanje B2101J, u troje se razvio sindrom otpuštanja citokina (2.-4. stupnja) i prolazni neurološki poremećaji (1.-3. stupnja) koji su se povukli u roku od 1-3 mjeseca od infuzije.
English: Patient leukapheresis material and Kymriah may carry a risk of transmitting infectious viruses to healthcare professionals handling the product.
Croatian: Bolesnikov pripravak dobiven leukaferezom i Kymriah mogu uključivati rizik prenošenja zaraznih virusa zdravstvenim radnicima koji rukuju lijekom.
English: Cytokine release syndrome was graded with the Penn scale as follows: Grade 1: mild reactions, e.g. reactions requiring supportive care; Grade 2: moderate reactions, e.g. reactions requiring intravenous therapies; Grade 3: severe reactions, e.g. reactions requiring low-dose vasopressors or supplemental oxygen; Grade 4: life-threatening reactions, e.g. those requiring high-dose vasopressors or intubation; Grade 5: death.
Croatian: 1. stupanj: blage reakcije, npr. reakcije koje zahtijevaju suportivnu skrb; 2. stupanj: umjerene reakcije, npr. reakcije koje zahtijevaju intravenske terapije; 3. stupanj: teške reakcije, npr. reakcije koje zahtijevaju vazopresore u niskoj dozi ili dodatni kisik; 4. stupanj: reakcije opasne po život, npr. one koje zahtijevaju vazopresore u visokoj dozi ili intubaciju; 5. stupanj: smrt.
English: The blood to bone marrow partitioning of tisagenlecleucel in bone marrow was 47.2% of that present in blood at day 28 while at months 3 and 6 it distributes at 68.3% and 69%, respectively (Studies B2202 and B2205J).
Croatian: Tisagenlekleucel se raspodijelio između krvi i koštane srži tako da je u koštanoj srži 28. dana bilo 47,2% tisagenlekleucela prisutnog u krvi, dok je u 3., odnosno 6. mjesecu iznosio 68,3%, odnosno 69% (ispitivanja B2202 i B2205J).
English: - Active graft-versus-host disease (GVHD).
Croatian: - Aktivna reakcija presatka protiv primatelja (engl. graft-versus-host disease, GVHD).
English: In the event of febrile neutropenia, infection should be evaluated and managed appropriately with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
Croatian: U slučaju febrilne neutropenije, infekciju je potrebno evaluirati i primjereno zbrinuti antibioticima širokog spektra, infuzijskim otopinama i drugom suportivnom skrbi, sukladno medicinskim indikacijama.
English: Management of cytokine release syndrome associated with Kymriah Cytokine release syndrome is managed solely based on clinical presentation and according to the cytokine release syndrome management algorithm provided in Table 1.
Croatian: Zbrinjavanje sindroma otpuštanja citokina povezanog s lijekom Kymriah Sindrom otpuštanja citokina se zbrinjava isključivo na temelju kliničke prezentacije i prema algoritmu za zbrinjavanje sindroma otpuštanja citokina navedenom u Tablici 1.
English: The safety and efficacy of Kymriah treatment in paediatric and young adult patients with relapsed or refractory (r/r) B-cell ALL were evaluated in one pivotal (B2202) and two supportive (B2205J and B2101J) open-label, single-arm studies (160 patients in total, up to 25 years of age).
Croatian: Sigurnost i djelotvornost terapije lijekom Kymriah u pedijatrijskih i mladih odraslih bolesnika s recidivirajućim ili refraktornim (r/r) ALL-om B-stanica bile su ocijenjene u jednom pivotalnom (B2202) i dva potporna (B2205J i B2101J) otvorena ispitivanja s jednom skupinom (ukupno 160 bolesnika u dobi do 25 godina).
English: Kymriah is for intravenous use only.
Croatian: Način primjene Kymriah je namijenjen samo za intravensku primjenu.
English: In the ongoing clinical study in DLBCL (N=111), cytokine release syndrome was reported in 58% of patients, (22% with Grade 3 or 4).
Croatian: U kliničkom ispitivanju koje je u tijeku za DLBCL (N=111), sindrom otpuštanja citokina je bio prijavljen u 58% bolesnika, (22% s 3. ili 4. stupnjem).
English: Treatment-induced anti-mCAR19 antibodies were shown in 34.6% of paediatric and young adult ALL and 5% of adult DLBCL patients.
Croatian: Liječenjem inducirana anti-mCAR19 protutijela dokazana su u 34,6% pedijatrijskih i mladih odraslih bolesnika s ALL-om te u 5% odraslih bolesnika s DLBCL-om.
English: • Pale skin, weakness, breathlessness
Croatian: • Blijeda koža, slabost, nedostatak zraka
English: Kymriah has major influence on the ability to drive and use machines.
Croatian: Lijek Kymriah značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The MAH shall ensure that in each Member State where KYMRIAH is marketed, all HCPs who are expected to prescribe, dispense annd administer KYMRIAH shall be provided with a guidance document to: - facilitate identification of CRS and serious neurological adverse reactions - facilitate management of the CRS and serious neurological adverse reactions - ensure adequate monitoring of CRS and serious neurological adverse reactions - facilitate provision of all relevant information to patients - ensure that adverse reactions are adequately and appropriately reported - ensure that detailed instructions about the thawing procedure are provided - before treating a patient, ensure that 4 doses of tocilizumab for each patient are available on site
Croatian: Nositelj odobrenja dužan je osigurati da u svakoj državi članici u kojoj je KYMRIAH u prometu, svi zdravstveni radnici za koje se očekuje da će propisivati, izdavati i primjenjivati lijek KYMRIAH dobiju dokument sa smjernicama kako bi se: - olakšalo prepoznavanje sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava - olakšalo zbrinjavanje sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava - osiguralo odgovarajuće praćenje sindroma otpuštanja citokina i ozbiljnih neuroloških nuspojava - olakšalo davanje svih relevantnih informacija bolesnicima - osiguralo da se nuspojave primjereno i pravilno prijave - osiguralo da se daju detaljne upute o postupku odmrzavanja - prije liječenja bolesnika, u bolničkoj ustanovi osigurala dostupnost 4 doze tocilizumaba za svakog bolesnika
English: CRi (complete remission with incomplete blood count recovery) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and without full recovery of peripheral blood counts with or without blood transfusion.
Croatian: CRi (potpuna remisija s nepotpunim oporavkom krvne slike) bio je definiran kao <5% blasta u koštanoj srži, cirkulirajući blasti u krvi trebaju biti <1%, bez dokaza ekstramedularne bolesti te bez potpunog oporavka periferne krvne slike s transfuzijom ili bez nje.