FrancophonIA/ELRC3.0 huggingface dataset:
English: In animals, the primary target organs included the liver, bone marrow and lymphoid organs with associated haematological changes, kidney, and nervous system.
Croatian: U životinja, primarni ciljni organi uključuju jetru, koštanu srž i limfoidne organe s povezanim hematološkim promjenama, bubrege i živčani sustav.
English: Cycle 1 is 3 weeks in duration but may be extended to 4 weeks if the patient achieves a CR or CRi, and/or to allow recovery from toxicity.
Croatian: Prvi ciklus traje 3 tjedna, ali se može produljiti na 4 tjedna ako je u bolesnika postignut CR ili CRi, i/ili kako bi se omogućio oporavak od toksičnosti.
English: The median time to onset of hyperbilirubinaemia and increased transaminases was 73 days and 29 days, respectively.
Croatian: Medijan vremena do pojave hiperbilirubinemije i povećane razine transaminaza bio je 73 dana, odnosno 29 dana.
English: Hypersensitivity (1%)
Croatian: Preosjetljivost (1%)
English: This condition may occur during treatment with BESPONSA or after subsequent treatment with a stem cell transplant.
Croatian: Ovo se stanje može javiti tijekom liječenja lijekom BESPONSA ili nakon naknadnog liječenja transplantacijom matičnih stanica.
English: VOD/SOS was reported up to 56 days after the last dose of inotuzumab ozogamicin without an intervening HSCT.
Croatian: VOD/SOS je bio zabilježen do 56 dana nakon zadnje doze inotuzumab ozogamicina bez HSCT intervencije.
English: Other observed changes included male and female reproductive organ effects (see below) and preneoplastic and neoplastic liver lesions
Croatian: Druge primijećene promjene su uključivale učinke na reproduktivne organe mužjaka i ženki (vidjeti u nastavku) i preneoplastične i neoplastične lezije jetre (vidjeti u nastavku).
English: The reconstituted solution must be clear to slightly cloudy, colourless, and essentially free of visible foreign matter.
Croatian: Rekonstituirana otopina mora biti bistra do neznatno zamućena, bezbojna i u biti bez vidljivih čestica.
English: Patients should be monitored closely during and for at least 1 hour after the end of infusion for the potential onset of infusion related reactions, including symptoms such as hypotension, hot flush, or breathing problems.
Croatian: Potrebno je pažljivo pratiti bolesnike tijekom i barem 1 sat nakon završetka infuzije kako bi se otkrila moguća pojava reakcija povezanih s infuzijom, uključujući simptome kao što su hipotenzija, navala vrućine ili problemi s disanjem.
English: Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition.
Croatian: Na osnovi populacijske farmakokinetičke analize, dob, rasa i spol nisu značajno utjecali na dispoziciju inotuzumab ozogamicina.
English: Signs and symptoms of VOD/SOS should be monitored closely in all patients, especially post HSCT.
Croatian: Treba obratiti posebnu pažnju na znakove i simptome VOD/SOS-a u svih bolesnika, osobito nakon provedenog HSCT-a.
English: VOD/SOS was also reported in 18 patients after a subsequent HSCT.
Croatian: VOD/SOS je isto tako zabilježen u 18 bolesnika nakon naknadnog HSCT-a.
English: In vitro, the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins is approximately 97%.
Croatian: In vitro vezanje N-acetil-gama-kalikeamicindimetilhidrazida na proteine ljudske plazme je približno 97%.
English: Dose modification of BESPONSA may be required based on individual safety and tolerability (see section 4.4).
Croatian: Prilagodba doze lijeka BESPONSA može biti potrebna ovisno o individualnoj sigurnosti i podnošljivosti (vidjeti dio 4.4).
English: Men and women should seek advice regarding fertility preservation before treatment.
Croatian: Muškarci i žene bi trebali potražiti savjet o očuvanju plodnosti prije terapije.
English: Before your treatment with BESPONSA, you will be given other medicines (pre-medications) to help reduce infusion reactions and other possible side effects.
Croatian: Prije Vašeg liječenja lijekom BESPONSA primit ćete druge lijekove (premedikacija) koji pomažu ublažiti reakcije povezane s infuzijom i druge moguće nuspojave.
English: a Platelet count used for dosing must be independent of blood transfusion.
Croatian: Broj trombocita koji se koristi za doziranje ne smije ovisiti o transfuziji krvi.
English: Increased amylase and lipase
Croatian: Povišene razine amilaze i lipaze
English: Among all 326 randomised patients (ITT population), 215 (66%) patients had received 1 prior treatment regimen and 108 (33%) patients had received 2 prior treatment regimens for ALL.
Croatian: Od svih 326 randomiziranih ispitanika (ITT populacija), 215 (66%) bolesnika je primilo 1 prethodni režim liječenja i 108 (33%) bolesnika je primilo 2 prethodna režima liječenja za ALL.
English: Dose (mg/m2)
Croatian: Doza (mg/m
English: Vaccination with live viral vaccines is not recommended for at least 2 weeks prior to the start of BESPONSA treatment, during treatment, and until recovery of B lymphocytes following the last treatment cycle.
Croatian: Cijepljenje živim virusnim cjepivima ne preporučuje se u razdoblju od najmanje 2 tjedna prije početka liječenja lijekom BESPONSA, tijekom liječenja i sve do oporavka Blimfocita nakon posljednjeg ciklusa liječenja.
English: Signs may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Croatian: Znakovi mogu uključivati povećanja ukupne razine bilirubina, hepatomegaliju (koja može biti bolna), nagli porast tjelesne težine i ascites.
English: HIDAC, FLAG, or MXN/Ara-C (N=162)
Croatian: HIDAC, FLAG ili MXN/Ara-C (N=162)
English: The QT interval should be monitored in case of combinations of such medicinal products (see sections 4.4, 4.8, and 5.2).
Croatian: Treba pratiti QT-interval u slučaju kombinacije takvih lijekova (vidjeti dijelove 4.4, 4.8 i 5.2).
English: • Excess of uric acid in the blood
Croatian: • Višak mokraćne kiseline u krvi
English: HIDAC, FLAG, or MXN/Ara-C (N=109)
Croatian: HIDAC, FLAG ili MXN/Ara-C (N=109)
English: Overdoses may result in adverse reactions that are consistent with the reactions observed at the recommended therapeutic dose (see section 4.8).
Croatian: Predoziranja mogu rezultirati nuspojavama koje se podudaraju s reakcijama primijećenim pri preporučenoj terapijskoj dozi (vidjeti dio 4.8).
English: Both men and women must seek advice for fertility preservation before treatment.
Croatian: I muškarac i žena moraju potražiti savjet o očuvanju plodnosti prije liječenja.
English: • Raised bilirubin level which may result in a yellowish colour in the skin, eyes, and other tissues
Croatian: • Povišene razine bilirubina koje mogu dovesti do pojave žućkaste boje kože, žućkaste boje u očima i drugim tkivima
English: BESPONSA doses within a treatment cycle (i.e. Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-haematological toxicities.
Croatian: Nije potrebno prekidati doziranje lijeka BESPONSA unutar ciklusa liječenja (odnosno 8. i/ili 15. dana) zbog neutropenije ili trombocitopenije, ali se preporučuju prekidi doziranja unutar ciklusa za nehematološke toksičnosti.
English: Adverse reactions included treatment-emergent, all-causality events that commenced on, or after Cycle 1 Day 1 within 42 days after the last dose of BESPONSA, but prior to the start of a new anticancer treatment (including HSCT).
Croatian: Nuspojave su uključivale događaje bilo kojeg uzroka koji su se pojavili tijekom liječenja, na 1.dan 1.ciklusa ili nakon njega, unutar 42 dana nakon zadnje doze lijeka BESPONSA, ali prije početka novog antitumorskog liječenja (uključujući HSCT).
English: The median (upper bound of the 95% CI) for the change in QTcF at a supratherapeutic Cmax concentration was 3.87 msec (7.54 msec).
Croatian: Medijan (gornja granica 95% CI) promjene QTcF-a pri supraterapijskoj koncentraciji Cmax iznosio je 3,87 ms (7,54 ms).
English: • The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine.
Croatian: • Drugi sastojci su saharoza, polisorbat 80, natrijev klorid i trometamin.
English: If a 25% decrease in the total dose followed by a decrease to 2 doses per cycle is not tolerated, then permanently discontinue treatment.
Croatian: U slučaju nepodnošenja 25%-tnog smanjenja ukupne doze nakon kojeg je uslijedilo smanjenje na 2 doze po ciklusu, trajno prekinuti liječenje.
English: • Your doctor may change your dose, interrupt, or completely stop treatment with BESPONSA
Croatian: • Vaš liječnik može promijeniti Vašu dozu, privremeno prekinuti ili potpuno zaustaviti liječenje lijekom BESPONSA ako imate određene nuspojave.
English: CR/CRi and MRD negativity findings in the initial 218 randomised patients were consistent with those seen in all 326 randomised patients.
Croatian: CR/CRi i negativni nalazi MRD-a u prvih 218 randomiziranih bolesnika su bili u skladu s onima zabilježenim u svih 326 randomiziranih bolesnika.
English: Do not mix BESPONSA or administer as an infusion with other medicinal products.
Croatian: BESPONSA se ne smije miješati ili primjenjivati kao infuzija s drugim lijekovima.
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agent, monoclonal antibodies, ATC code: L01XC26.
Croatian: Farmakoterapijska skupina: Antineoplastici, ostali antineoplastici, monoklonska protutijela, ATK oznaka: L01XC26.
English: What BESPONSA contains
Croatian: Što BESPONSA sadrži
English: a +/- 2 days (maintain a minimum of 6 days between doses).
Croatian: +/- 2 dana (potreban je razmak od minimalno 6 dana između doza).
English: Toxicity and dose modification(s)
Croatian: Toksičnost i prilagodba(-e) doze
English: One Grade 5 bleeding/haemorrhagic event (intra-abdominal haemorrhage) was reported.
Croatian: Prijavljen je jedan slučaj krvarenja/hemoragije 5. stupnja (intraabdominalna hemoragija).
English: Talk to your doctor, pharmacist or nurse before using BESPONSA if you:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene lijeka BESPONSA ako:
English: Before your treatment with BESPONSA, you may be given medicines and be hydrated to prevent tumour lysis syndrome from occurring.
Croatian: Prije Vašeg liječenja lijekom BESPONSA možda ćete dobiti lijekove i biti hidrirani kako bi se spriječila pojava sindroma lize tumora.
English: Instructions for reconstitution, dilution, and administration
Croatian: Upute za rekonstituciju, razrjeđivanje i primjenu
English: As appropriate, prophylactic anti-infectives should be administered and surveillance testing should be employed during and after treatment.
Croatian: Po potrebi, profilaktički primijeniti antiinfektivne lijekove i provjeravati krvnu sliku tijekom i nakon liječenja.
English: If severe VOD/SOS occurs, the patient should be treated according to standard medical practice.
Croatian: Ako se pojavi teški VOD/SOS, treba provesti liječenje u skladu sa standardnom medicinskom praksom.
English: The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Croatian: Sigurnost i djelotvornost lijeka BESPONSA su ocijenjeni u otvorenom, multicentričnom ispitivanju Faze 1/2 s jednom skupinom (Ispitivanje 2).
English: Potential hepatobiliary disease should be evaluated and treated according to standard medical practice.
Croatian: Potrebno je procijeniti moguću pojavu hepatobilijarne bolesti te je liječiti u skladu sa standardnom medicinskom praksom.
English: Women of childbearing potential should avoid becoming pregnant while receiving BESPONSA.
Croatian: Žene reproduktivne dobi moraju izbjegavati trudnoću dok primaju lijek BESPONSA.
English: d VOD/SOS includes 1 additional patient with Venoocclusive liver disease that occurred at Day 56 with no intervening HSCT.
Croatian: VOD/SOS uključuje 1 dodatnog bolesnika s venookluzivnom bolesti jetre koja se pojavila 56. dana bez interveniranja HSCT-om.
English: For full information on dosage and dose modifications please refer to the Summary of Product Characteristics.
Croatian: Za potpune informacije o doziranju i prilagodbi doze molimo vidjeti sažetak opisa svojstava lijeka.
English: Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
Croatian: Febrilna neutropenija, koja može biti opasna po život, bila je zabilježena u 43 (26%) bolesnika.
English: • High levels of liver enzymes (which can be indicators of liver injury) in the blood
Croatian: • Visoke razine jetrenih enzima (koje mogu biti pokazatelji oštećenja jetre) u krvi
English: BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
Croatian: BESPONSA se koristi za liječenje odraslih osoba koji boluju od akutne limfoblastične leukemije.
English: All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Croatian: Svi bolesnici su trebali imati ≥ 5% blasta u koštanoj srži i već primiti 1 do 2 režima indukcijske kemoterapije za ALL.
English: BESPONSA is for single use only.
Croatian: BESPONSA je namijenjena samo za jednokratnu primjenu.
English: What you need to know before you are given BESPONSA
Croatian: Što morate znati prije nego počnete primjenjivati lijek BESPONSA
English: • If the medicine works well and you are going to receive a stem cell transplant (see section 2),
Croatian: • Ako lijek dobro djeluje i Vi trebate ići na transplantaciju matičnih stanica (vidjeti dio 2),
English: [6.0 to 9.2]
Croatian: [6,0 do 9,2]
English: Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity.
Croatian: Tablica 4 prikazuje smjernice za prilagodbu doze ovisno o trajanju prekida doziranja zbog toksičnosti.
English: Infusion related reactions generally occurred in Cycle 1 and shortly after the end of the inotuzumab ozogamicin infusion and resolved spontaneously or with medical management.
Croatian: Reakcije povezane s infuzijom su se uglavnom javljale u 1. ciklusu i ubrzo nakon završetka infuzije inotuzumab ozogamicina te su bile riješene spontano ili uz medicinsko zbrinjavanje.
English: c Haemorrhage also includes other types of haemorrhage (17%).
Croatian: Hemoragija uključuje i druge vrste hemoragija (17%).
English: Hepatotoxicity, including venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS)
Croatian: Hepatotoksičnost, uključujući venookluzivnu bolest jetre/sindrom sinusoidalne opstrukcije (VOD/SOS)
English: Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Croatian: Tablica 2 i Tablica 3 prikazuju smjernice za prilagodbu doze za hematološke i nehematološke toksičnosti.
English: Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of infection during treatment and after HSCT (see section 5.1), bleeding/haemorrhage, and other effects of myelosuppression should be monitored during treatment.
Croatian: Potrebno je kontrolirati kompletnu krvnu sliku prije primjene svake doze lijeka BESPONSA te obratiti pažnju na znakove i simptome infekcije tijekom liječenja i nakon HSCT-a (vidjeti dio 5.1), krvarenja/hemoragije i druge učinke mijelosupresije tijekom liječenja.
English: By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
Croatian: U testiranju u lokalnom i središnjem laboratoriju 231/253 (91,3%) bolesnika i 130/253 (51,4% bolesnika) imalo je ≥ 70% CD22-pozitivnih leukemijskih blasta na početku.
English: BESPONSA should not be administered as an intravenous push or bolus.
Croatian: BESPONSA se ne smije primijeniti kao brza intravenska injekcija ili bolus.
English: The most common reasons for treatment discontinuation were: disease progression/relapse (30 [41.7%)], resistant disease (4 [5.6%]); HSCT (18 [25.0%]), and adverse events
Croatian: Najčešći razlozi prekida liječenja bili su: progresija bolesti/recidiv (30 [41,7%], ustrajna bolest (4 [5,6%], HSCT (18 [25,0%] i štetni događaji (13 [18,1%]).
English: Patients should be observed during, and for at least 1 hour after the end of infusion for symptoms of infusion related reactions (see section 4.4).
Croatian: Bolesnike treba promatrati tijekom infuzije i najmanje 1 sat nakon završetka infuzije zbog moguće pojave simptoma reakcija povezanih s primanjem infuzije (vidjeti dio 4.4).
English: This is consistent with the known induction of DNA breaks by calicheamicin.
Croatian: Ovo je u skladu s poznatom indukcijom DNK lomova od strane kalikeamicina.
English: Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
Croatian: Od 79 bolesnika u kojih je naknadno napravljen HSCT (od kojih je 8 primilo dodatnu „terapiju spasa“ nakon liječenja lijekom BESPONSA prije HSCT-a), VOD/SOS je prijavljen u 18 (23%) bolesnika.
English: Abbreviation: ANC=absolute neutrophil count.
Croatian: Skraćenica: ABN=apsolutni broj neutrofila.
English: If further dose modification is required, then reduce the number of doses to 2 per cycle for subsequent cycles.
Croatian: Ako je potrebna daljnja prilagodba doze, u sljedećim ciklusima smanjiti broj doza na 2 po ciklusu.
English: Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
Croatian: Fatalne infekcije, uključujući upalu pluća, neutropeničnu sepsu, sepsu, septični šok i sepsu povezanu s bakterijama Pseudomonas, su zabilježene u 8 (5%) bolesnika.
English: In patients who tested positive for anti-inotuzumab ozogamicin antibodies, no effect on clearance of BESPONSA was detected based on population-pharmacokinetic analysis.
Croatian: U bolesnika koji su imali pozitivne nalaze testa na protutijela protiv inotuzumab ozogamicin nije primijećen nikakav učinak na klirens lijeka BESPONSA na temelju populacijske farmakokinetičke analize.
English: Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition.
Croatian: Na temelju populacijske farmakokinetičke analize u 765 bolesnika, zaključeno je da tjelesna površina značajno utječe na dispoziciju inotuzumab ozogamicina.
English: • QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms.
Croatian: • produljenja QT-intervala (vidjeti dio 2); znakovi i simptomi uključuju promjenu električne aktivnosti srca koja može uzrokovati ozbiljne nepravilne srčane ritmove.
English: Permanently discontinue treatment (see section 4.4).
Croatian: Trajno prekinuti liječenje (vidjeti dio 4.4)
English: Following administration of multiple doses, a 5.3 times accumulation of inotuzumab ozogamicin was observed between Cycles 1 and 4.
Croatian: Nakon primjene višestrukih doza zabilježena je 5,3 puta veća akumulacija inotuzumab ozogamicina između 1. i 4. ciklusa.
English: Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with BESPONSA and for at least 2 months after the final dose (see section 5.3).
Croatian: Zbog mogućih nuspojava u dojenčadi, žene ne smiju dojiti tijekom liječenja lijekom BESPONSA i najmanje 2 mjeseca nakon zadnje doze (vidjeti dio 5.3).
English: A third cycle may be considered for those patients who do not achieve a CR/CRi and MRD negativity after 2 cycles.
Croatian: Treći ciklus može se uzeti u obzir u onih bolesnika koji ne postignu CR/CRi i negativan status MRD-a nakon 2 ciklusa.
English: - Protect from light.
Croatian: - Zaštititi od svjetlosti.
English: Protect from light and do not freeze.
Croatian: Zaštititi od svjetlosti i ne zamrzavati.
English: Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Croatian: Bolesnike je potrebno pratiti radi znakova i simptoma TLS-a te liječiti u skladu sa standardnom medicinskom praksom.
English: Based on non-clinical safety findings, inotuzumab ozogamicin can cause embryo-foetal harm when administered to a pregnant woman.
Croatian: Na temelju nekliničkih sigurnosnih rezultata, inotuzumab ozogamicin može imati štetan učinak na embrio-fetalni razvoj kada se daje trudnici.
English: Of 93 screened patients, 72 patients were assigned to study drug and treated with BESPONSA.
Croatian: Od 93 bolesnika u probiru, 72 bolesnika je dodijeljeno na ispitivani lijek i liječeno lijekom BESPONSA.
English: Careful consideration is required before administering BESPONSA to patients who have had a prior HSCT.
Croatian: Potrebno je pažljivo razmatranje prije primjene lijeka BESPONSA u bolesnika u kojih je već proveden HSCT.
English: Common Increased lipase (9%)
Croatian: Povećane razine lipaze (9%)
English: Dosing regimen for Cycle 1 All patients: Dose (mg/m2) Cycle length
Croatian: Režim doziranja za 1. ciklus Svi bolesnici: Doza (mg/m Trajanje ciklusa
English: Alternatively, CD22 expression was assessed using immunohistochemistry in patients with an inadequate bone marrow aspirate and insufficient circulating blasts.
Croatian: Alternativno se ekspresija CD22 procjenjivala imunohistokemijski u bolesnika s nedostatnim uzorkom aspirata koštane srži i nedostatnim cirkulirajućim blastima.
English: Due to the risk of VOD/SOS, for patients proceeding to HSCT, the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles (see section 4.2).
Croatian: Zbog rizika od VOD/SOS-a, u bolesnika koji nastavljaju s HSCT-om preporučeno trajanje liječenja inotuzumab ozogamicinom je 2 ciklusa; treći ciklus se može uzeti u obzir u onih bolesnika koji ne postignu CR ili CRi i negativan status MRD-a nakon 2 ciklusa (vidjeti dio 4.2).
English: • Gently invert the infusion container to mix the diluted solution.
Croatian: • Nježno preokrenite spremnik za infuziju kako bi se promiješala razrijeđena otopina.
English: No patients with relapsed or refractory ALL who were treated with BESPONSA in clinical trials had undergone HSCT within the previous 4 months.
Croatian: Nijedan bolesnik s recidivirajućom ili refraktornom ALLliječen lijekom BESPONSA u kliničkim ispitivanjima nije podvgrnut HSCT-u u zadnja 4 mjeseca.
English: Bleeding/haemorrhage
Croatian: Krvarenje/hemoragija
English: Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Croatian: Liječenje lijekom BESPONSA može produljiti QT interval (promjena električne vodljivosti srca koja može uzrokovati ozbiljne nepravilne srčane ritmove).
English: Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Croatian: Zbrinjavanje teške infekcije, krvarenja/hemoragije i drugih učinaka mijelosupresije, uključujući tešku neutropeniju ili trombocitopeniju, može zahtijevati privremeni prekid doziranja, smanjenje doze ili prekid liječenja (vidjeti dio 4.2).
English: Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines.
Croatian: Ovisno o težini reakcije povezane s infuzijom, razmotriti prekid infuzije ili primjenu steroida i antihistaminika.
English: Patients with Ph+ B-cell precursor ALL were required to have failed treatment with at least 1 second or third generation TKI and standard chemotherapy.
Croatian: Bolesnici s Ph+ ALL prekursora B limfocita su trebali imati neuspjelo liječenje s barem 1 TKI-om druge ili treće generacije i standardnom kemoterapijom.