FrancophonIA/ELRC3.0 huggingface dataset:
English: 3.8 months (1.9, 19.0)
Croatian: 3,8 mjeseca (1,9, 19,0)
English: Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities.
Croatian: Rezultati in vitro testiranja na ljudskim hepatocitima ukazuju da blinatumomab ne utječe na aktivnosti enzima CYP450.
English: Infusion rate (mL/hour)
Croatian: Brzina infuzije (ml/sat)
English: Gently mix the contents of the bag to avoid foaming.
Croatian: Nježno izmiješajte sadržaj vrećice kako bi se izbjeglo stvaranje pjene.
English: Overdoses have been observed including one patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration.
Croatian: Opažena su predoziranja uključujući i jednog bolesnika u kojeg je primijenjena 133 puta veća doza od preporučene terapijske doze lijeka BLINCYTO u kratkom vremenskom razdoblju.
English: • if the infusion pump stops unexpectedly.
Croatian: • infuzijska pumpa odjednom prestane raditi.
English: What BLINCYTO is and what it is used for What you need to know before you use BLINCYTO How to use BLINCYTO
Croatian: Što je BLINCYTO i za što se koristi Što morate znati prije nego počnete primjenjivati BLINCYTO
English: Efficacy results from other key endpoints in the study are summarised in table 2.
Croatian: Rezultati djelotvornosti prema drugim ključnim mjerama ishoda u ispitivanju sažeti su u tablici 2.
English: To mitigate the risk of CRS, it is important to initiate BLINCYTO (cycle 1, days 1-7) at the recommended starting dose in section 4.2.
Croatian: Kako bi se smanjio rizik od CRS-a, važno je liječenje lijekom BLINCYTO započeti (1. ciklus, 1. - 7. dan) s preporučenom početnom dozom u dijelu 4.2.
English: In patients with a history or presence of clinically relevant central nervous system (CNS) pathology (see section 4.4), hospitalisation is recommended at a minimum for the first 14 days of the first cycle.
Croatian: U bolesnika s anamnezom prisutnosti klinički relevantne patologije središnjeg živčanog sustava (SŽS) (vidjeti dio 4.4), preporučuje se hospitalizacija tijekom najmanje prvih 14 dana prvog ciklusa.
English: BLINCYTO is used to treat children (≥ 1 year old), teenagers and young adults with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Croatian: BLINCYTO se primjenjuje za liječenje djece (u dobi ≥ 1 godine), tinejdžera i mladih odraslih osoba s akutnom limfoblastičnom leukemijom (ALL) ako prethodna liječenja nisu djelovala ili su prestala djelovati.
English: Fifty percent (5/10) compared to 0% (0/5) achieved MRD response and 20% (2/10) compared to 40% (2/5) underwent allogeneic HSCT after treatment.
Croatian: Pedeset posto (5/10) u usporedbi s 0% (0/5) postiglo je MRB odgovor i u 20% (2/10) u usporedbi s 40% (2/5) proveden je alogeni HSCT nakon liječenja.
English: A single cycle of treatment of BLINCYTO induction or consolidation is 28 days (4 weeks) of continuous intravenous infusion followed by a 14 day (2 week) treatment-free interval (total 42 days).
Croatian: Jedan ciklus indukcijskog ili konsolidacijskog liječenja lijekom BLINCYTO čini 28 dana (4 tjedna) kontinuirane intravenske infuzije nakon čega slijedi period bez liječenja u trajanju od 14 dana (2 tjedna) (ukupno 42 dana).
English: In case of exposure during pregnancy, depletion of B-cells may be expected in newborns due to the pharmacological properties of the product.
Croatian: U slučaju izlaganja tijekom trudnoće može se očekivati deplecija B limfocita u novorođenčadi zbog farmakoloških svojstava lijeka.
English: Premedication, BLINCYTO dose per treatment cycle and route of administration were identical to those in the phase III study.
Croatian: Premedikacija, doza lijeka BLINCYTO po ciklusu liječenja i put primjene bili su identični onima iz ispitivanja faze III.
English: The median OS was 15.6 months (CI 5.5 - not estimable) for the BLINCYTO group and 5.3 months (CI 1.1 - not estimable) for the SOC chemotherapy group.
Croatian: Medijan sveukupnog preživljenja bio je 15,6 mjeseci (CI 5,5 - nije procjenjivo) za BLINCYTO skupinu i 5,3 mjeseci (CI 1,1 - nije procjenjivo) za skupinu liječenu SOC kemoterapijom.
English: Reconstituted solution (BLINCYTO solution): - When refrigerated, the reconstituted solution must be used within 24 hours.
Croatian: Rekonstituirana otopina (BLINCYTO otopina): - Kada je u hladnjaku, rekonstituirana otopina mora se primijeniti unutar 24 sata.
English: Sodium hydroxide (for pH-adjustment) Water for injections
Croatian: Natrijev hidroksid (za podešavanje pH) Voda za injekcije
English: The estimated mean (SD) volume of distribution based on terminal phase (Vz) was 4.52 (2.89) L with the continuous intravenous infusion of blinatumomab.
Croatian: Procijenjena srednja vrijednost (SD) volumena distribucije bazirana na terminalnoj fazi (Vz) bila je 4,52 (2,89) l, uz kontinuiranu intravensku infuziju blinatumomaba.
English: • Do not refrigerate or freeze the package.
Croatian: • Ne zamrzavajte pakiranje i ne stavljajte ga u hladnjak.
English: Tell your doctor, pharmacist or nurse immediately if you experience any of the following reactions whilst receiving BLINCYTO as these may need to be treated and your dose adjusted:
Croatian: Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koju od sljedećih reakcija dok se liječite lijekom BLINCYTO, jer će se one možda morati liječiti, a Vaša doza prilagoditi:
English: • serious infection which can result in organ failure, shock or can be fatal (sepsis)
Croatian: • ozbiljna infekcija koja može rezultirati zatajenjem organa, šokom ili može imati smrtan ishod
English: You must not breast-feed during and for at least 48 hours after your last treatment.
Croatian: Ne smijete dojiti tijekom liječenja i najmanje 48 sati nakon Vašeg posljednjeg liječenja.
English: The primary endpoint was overall survival (OS).
Croatian: Primarna mjera ishoda bila je ukupno preživljenje (OS, od eng. overall survival).
English: Patients may receive 1 cycle of induction treatment followed by up to 3 additional cycles of BLINCYTO consolidation treatment.
Croatian: Bolesnici mogu primiti 1 ciklus indukcijskog liječenja, nakon čega slijede do 3 dodatna ciklusa konsolidacijskog liječenja lijekom BLINCYTO.
English: Do not use this solution (stabiliser) for reconstitution of BLINCYTO powder for concentrate.
Croatian: Nemojte koristiti ovu otopinu (stabilizator) za rekonstituciju BLINCYTO praška za koncentrat.
English: Monitoring of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to the start of and during BLINCYTO treatment especially during the first 48 hours of the first 2 cycles should be performed.
Croatian: Potrebno je pratiti alanin aminotransferazu (ALT), aspartat aminotransferazu (AST), gama-glutamil transferazu (GGT) i ukupni bilirubin u krvi prije početka i tijekom primjene lijeka BLINCYTO, pogotovo tijekom prvih 48 sati u prva dva ciklusa.
English: In the second cycle, hospitalisation is recommended at a minimum for 2 days, and clinical judgment should be based on tolerance to BLINCYTO in the first cycle.
Croatian: U drugom ciklusu hospitalizacija se preporučuje tijekom najmanje 2 dana, a klinička procjena se mora temeljiti ovisno o podnošljivosti lijeka BLINCYTO u prvom ciklusu.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP -a.
English: It is also used in patients with acute lymphoblastic leukaemia who still have a small number of cancer cells remaining after previous treatment (referred to as minimal residual disease).
Croatian: Također se koristi u bolesnika s akutnom limfoblastičnom leukemijom u kojih još uvijek postoji mali broj stanica karcinoma preostalih nakon prethodnog liječenja (naziva se minimalna rezidualna bolest).
English: 7.5 months [4.0 to 11.8 months]
Croatian: 7,5 mjeseci [4,0 to 11,8 mjeseci]
English: What you need to know before you use BLINCYTO
Croatian: Što morate znati prije nego počnete primjenjivati BLINCYTO
English: • 1 glass vial containing a white to off-white powder.
Croatian: • 1 staklenu bočicu koja sadrži bijeli do gotovo bijeli prašak.
English: Tell your doctor immediately if you get any of the following or combination of the following side effects:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava ili njihovu kombinaciju:
English: 9 Hypertension includes blood pressure increased and hypertension.
Croatian: 9 Hipertenzija uključuje povišeni krvni tlak i hipertenziju.
English: Patients must be advised that they may experience neurologic events.
Croatian: Bolesnike se mora obavijestiti o mogućnosti pojave neuroloških događaja.
English: Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses.
Croatian: Zanemarive količine blinatumomaba izlučile su se u urinu pri testiranim kliničkim dozama.
English: Patients who responded to BLINCYTO but later relapsed had the option to be retreated with BLINCYTO.
Croatian: Bolesnici koji su odgovorili na BLINCYTO, ali u kojih je kasnije došlo do recidiva, imali su mogućnost ponovnog liječenja lijekom BLINCYTO.
English: Due to the potential for neurologic events, patients receiving blinatumomab should refrain from driving, engaging in hazardous occupations or activities such as driving or operating heavy or potentially dangerous machinery while blinatumomab is being administered.
Croatian: Zbog mogućnosti neuroloških događaja, bolesnici liječeni blinatumomabom trebaju se tijekom primjene blinatumomaba suzdržavati od upravljanja vozilima, obavljanja rizičnih zanimanja ili aktivnosti poput rada sa teškim ili potencijalno opasnim strojevima.
English: Forest plot of CR/CRh* rate during the first two cycles for study MT103-211 (primary analysis set)
Croatian: Slika 2. Grafikon raspona pouzdanosti za stope CR/CRh* tijekom prva dva ciklusa u ispitivanju MT103-211 (Primarni skup podataka za analizu)
English: The median time to onset to the first event was 4 days from the start of BLINCYTO treatment initiation.
Croatian: Medijan vremena do pojave prvog događaja bio je 4 dana od započinjanja liječenja lijekom BLINCYTO.
English: • lung infection (pneumonia)
Croatian: • infekcija pluća (upala pluća)
English: Hyperbilirubinaemia a,
Croatian: Hiperbilirubinemija a, 10
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Croatian: Procjena bolesnika može uključivati fizički pregled, određivanje laboratorijske vrijednosti serumske amilaze i serumske lipaze, te snimanje abdomena metodama poput ultrazvuka i drugih odgovarajućih dijagnostičkih mjera.
English: If the toxicity takes more than 14 days to resolve, discontinue BLINCYTO permanently, except if described differently in the table below.
Croatian: Ako je potrebno više od 14 dana za oporavak od toksičnosti, trajno prekinite primjenu lijeka BLINCYTO, osim ako nije drugačije navedeno u niže navedenoj tablici.
English: If your body weight is less than 45 kilograms, the recommended initial dose in your first cycle will be based on your weight and height.
Croatian: Ako je Vaša tjelesna težina manja od 45 kilograma, preporučena početna doza u prvom ciklusu temeljit će se na Vašoj težini i visini.
English: Partial remission was defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.
Croatian: 4 Djelomična remisija je definirana kao blasti u koštanoj srži 6% do 25% uz najmanje 50% redukcije od početne vrijednosti.
English: It is not known whether BLINCYTO is excreted in breast milk but a risk for suckling baby cannot be excluded.
Croatian: Nije poznato izlučuje li se lijek BLINCYTO u majčino mlijeko, ali ne može se isključiti rizik za dojenče.
English: 12 Pyrexia includes body temperature increased and pyrexia.
Croatian: Pireksija uključuje povišenu tjelesnu temperaturu i pireksiju.
English: Infusion duration (hours)
Croatian: Trajanje infuzije (sati)
English: BLINCYTO was administered as a continuous intravenous infusion.
Croatian: BLINCYTO je primjenjivan kao kontinuirana intravenska infuzija.
English: Peripheral T-cell redistribution (i.e. T-cell adhesion to blood vessel endothelium and/or transmigration into tissue) occurred after start of blinatumomab infusion or dose escalation.
Croatian: Redistribucija perifernih T limfocita (tj. adhezija T limfocita na endotel krvnih žila i/ili transmigracija u tkivo) dogodila se nakon početka infuzije blinatumomaba ili eskalacije doze.
English: • 21-23 gauge needle(s) (recommended)
Croatian: • Igle od 21-23 G (preporučeno)
English: Consequently, as a precautionary measure, breast-feeding is contraindicated during and for at least 48 hours after treatment with blinatumomab.
Croatian: Posljedično, kao mjera predostrožnosti, dojenje je kontraindicirano tijekom i kroz najmanje 48 sati nakon liječenja blinatumomabom.
English: Before each infusion cycle of BLINCYTO, you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells.
Croatian: Prije svakog infuzijskog ciklusa lijeka BLINCYTO, dobit ćete lijekove koji pomažu smanjiti potencijalnu komplikaciju koja može biti opasna po život, poznatu kao sindrom lize tumora, koja uzrokuje kemijsku neravnotežu u krvi nastalu radi raspada umirućih stanica raka.
English: Add to the sodium chloride bag only.
Croatian: Dodati samo u vrećicu s natrijevim kloridom.
English: Then reduce dexamethasone step-wise over 4 days.
Croatian: Zatim postepeno smanjite dozu deksametazona tijekom 4 dana.
English: Remove air from the infusion bag and prime the intravenous infusion line only with the prepared solution for infusion.
Croatian: Uklonite zrak iz infuzijske vrećice i pripremite cjevčicu za intravensku infuziju samo s pripremljenom otopinom za infuziju.
English: Cytokine release syndrome (CRS)
Croatian: Sindrom otpuštanja citokina (CRS)
English: The duration of hepatic adverse reactions has generally been brief and with rapid resolution, often when continuing uninterrupted treatment with BLINCYTO.
Croatian: Trajanje jetrenih nuspojava bilo je općenito kratko i uz brz oporavak, često bez trajnog prekida kontinuiranog liječenja lijekom BLINCYTO.
English: Subjects who fail to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation are considered treatment failures and assigned an EFS duration of 1 day.
Croatian: Ispitanici koji ne uspiju postići CR/CRh*/CRi unutar 12 tjedana od početka liječenja smatraju se neuspjehom liječenja i pripisuje im se trajanje preživljenja bez događaja od 1 dana.
English: BLINCYTO will be given to you through a vein (intravenous) continuously for 4 weeks using an infusion pump (this is 1 treatment cycle).
Croatian: BLINCYTO će u Vas biti primijenjen kroz venu (intravenski), kontinuirano tijekom 4 tjedna, primjenom infuzijske pumpe (to je 1 ciklus liječenja).
English: Hepatic enzyme increased a, 15
Croatian: Povišeni jetreni enzimi a, 15
English: Treatment should be initiated under the direction of and supervised by physicians experienced in the treatment of haematological malignancies.
Croatian: Liječenje se mora započeti prema nalogu i provoditi pod nadzorom liječnika specijalista s iskustvom u liječenju hematoloških zloćudnih bolesti.
English: Using a syringe, reconstitute each vial of BLINCYTO powder for concentrate using 3 mL of water for injections.
Croatian: Koristeći štrcaljku, rekonstituirajte svaku bočicu BLINCYTO praška za koncentrat primjenom 3 ml vode za injekcije.
English: Oedema includes face oedema, generalised oedema, oedema and oedema peripheral.
Croatian: Edem uključuje edem lica, generalizirani edem, edem i periferni edem.
English: Important note: Do not flush the BLINCYTO infusion line or intravenous catheter, especially when changing infusion bags.
Croatian: Važna napomena: Ne ispirite infuzijsku cjevčicu ili intravenski kateter lijeka BLINCYTO, osobito prilikom promjene infuzijskih vrećica.
English: Median, years (min, max) Mean, years (SD) ≥ 65 Years, n (%) Prior salvage therapy
Croatian: Medijan, godine (min, maks) Srednja vrijednost, godine (SD) ≥ 65 godina, n (%) Prethodna spasonosna terapija
English: Consolidation Cycles 2-4 Days 1-28
Croatian: Konsolidacijski ciklusi 2-4 Dani 1-28
English: Four patients achieved CR during consolidation cycles, resulting in a cumulative CR rate of 35.4% (67/189; 95% CI: 28.6% - 42.7%).
Croatian: Četiri su bolesnika postigla CR tijekom konsolidacijskih ciklusa, što rezultira kumulativnom stopom CR-a od 35,4% (67/189; 95% CI: 28,6% - 42,7%).
English: Each cycle of treatment is separated by a 14 day (2 week) treatment-free interval.
Croatian: Svaki ciklus liječenja je razdvojen periodom bez liječenja u trajanju od 14 dana (2 tjedna).
English: The elevated cytokine levels returned to baseline within 24 to 48 hours during the infusion.
Croatian: Povišene razine citokina vratile su se na početne vrijednosti unutar 24 do 48 sati tijekom infuzije.
English: 250 mL (usual overfill volume of 265 to 275 mL)
Croatian: 250 ml (uobičajeno sadrži veći volumen, tj. 265 do 275 ml)
English: Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Croatian: Blinatumomab se proizvodi u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNA.
English: The majority of the events were observed within the first week of treatment initiation and did not require interruption or discontinuation of BLINCYTO (see section 4.8).
Croatian: Većina događaja opažena je unutar prvog tjedna od započinjanja liječenja i nije zahtijevala privremeni ili trajni prekid primjene lijeka BLINCYTO (vidjeti dio 4.8).
English: In case of suspicious events consider consultation with a neurologist, brain MRI and examination of cerebral spinal fluid (CSF), see section 4.8.
Croatian: U slučaju sumnje na događaj razmotrite konzultaciju s neurologom, MR mozga i pretragu cerebrospinalne tekućine (CST), vidjeti dio 4.8.
English: Your doctor or nurse will show you how to care for your catheter site.
Croatian: Vaš liječnik ili medicinska sestra će Vam pokazati kako da održavate mjesto oko katetera.
English: It is recommended that immunoglobulin levels are monitored in elderly patients during treatment with BLINCYTO.
Croatian: Preporuča se praćenje razine imunoglobulina u starijih bolesnika tijekom liječenja lijekom BLINCYTO.
English: • a condition which causes fluid to leak from the small blood vessels into your body (capillary leak syndrome)
Croatian: • stanje koje uzrokuje curenje tekućine iz malih krvnih žila u Vašem tijelu (sindrom propusnosti kapilara)
English: The target therapeutic dose of BLINCYTO delivered does not change.
Croatian: Dostavljena ciljana terapijska doza lijeka BLINCYTO se ne mijenja.
English: In clinical studies of adult ALL patients treated with BLINCYTO, less than 3% tested positive for anti-blinatumomab antibodies.
Croatian: U kliničkim ispitivanjima odraslih bolesnika s ALL-om liječenih lijekom BLINCYTO, manje od 3% bolesnika bilo je pozitivno na anti-blinatumomab antitijela.
English: 1/Complete remission with partial haematological recovery (CRh*) CR
Croatian: 1/Potpuna remisija uz djelomičan hematološki oporavak (CRh*) CR
English: • rapid heart rate (tachycardia)
Croatian: • ubrzani srčani ritam (tahikardija)
English: What BLINCYTO contains
Croatian: Što BLINCYTO sadrži
English: Population pharmacokinetic analysis suggested that there was no association between ALT or AST levels and the clearance of blinatumomab.
Croatian: Populacijske farmakokinetičke analize ukazuju da nije bilo povezanosti između razina ALT-a ili AST-a i klirensa blinatumomaba.
English: Do not shake the reconstituted solution.
Croatian: Ne tresite rekonstituiranu otopinu.
English: Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above.
Croatian: U tablici iznad, pojmovi za događaje koji predstavljaju isti medicinski koncept ili stanje združeni su i prijavljeni kao jedna nuspojava.
English: Premedication and additional medication recommendations
Croatian: Preporuke za premedikaciju i dodatno liječenje
English: No formal drug interaction studies have been performed.
Croatian: Nisu provedena službena ispitivanja interakcija.
English: Infuse BLINCYTO solution according to the instructions on the pharmacy label on the prepared bag at one of the following constant infusion rates:
Croatian: Primijenite infuziju BLINCYTO otopine u skladu s uputama na naljepnici lijeka na pripremljenoj vrećici pri jednoj od sljedećih konstantnih brzina infuzije:
English: In the event of a seizure, secondary prophylaxis with appropriate anticonvulsant medicinal products (e.g. levetiracetam) is recommended.
Croatian: U slučaju napadaja, preporučuje se sekundarno profilaktičko liječenje odgovarajućim antikonvulzivima (npr. levetiracetamom).
English: Intrathecal chemotherapy prophylaxis is recommended before and during BLINCYTO therapy to prevent central nervous system ALL relapse.
Croatian: Profilaktičko liječenje intratekalnom kemoterapijom preporučuje se prije i tijekom terapije lijekom BLINCYTO kako bi se spriječio recidiv ALL-a u središnjem živčanom sustavu.
English: Bone Marrow Blast Infiltration (Central Lab)
Croatian: Infiltracija blasta u koštanu srž (Središnji laboratorij)
English: 48 hours
Croatian: 48 sati
English: Somnolence Hypoaesthesia Cranial nerve disorder b
Croatian: Somnolencija Hipoestezija Poremećaj kranijalnog živca b
English: It is recommended that a neurological examination be performed in patients prior to starting BLINCYTO therapy and that patients be clinically monitored for signs and symptoms of neurologic events (e.g. writing test).
Croatian: Preporučuje se provođenje neurološkog pregleda bolesnika prije započinjanja terapije lijekom BLINCYTO, te kliničko praćenje bolesnika radi znakova i simptoma neuroloških događaja (npr. pismeni test).
English: Of the 267 patients who received BLINCYTO, the mean number of completed treatment cycles was 2.0; of the 109 patients who received SOC chemotherapy, the mean number of treatment cycles was 1.3.
Croatian: Od 267 bolesnika koji su primili BLINCYTO, srednja vrijednost broja završenih ciklusa liječenja iznosila je 2,0; od 109 bolesnika koji su primili SOC kemoterapiju, srednja vrijednost broja ciklusa liječenja bila je 1,3.
English: There were no effects on male or female reproductive organs in toxicity studies with the murine surrogate.
Croatian: Nije bilo učinka na reproduktivne organe mužjaka ili ženki u ispitivanjima toksičnosti s mišjim surogatom.
English: Randomisation was stratified by age (< 35 years versus ≥ 35 years of age), prior salvage therapy (yes versus no), and prior allogeneic HSCT (yes versus no) as assessed at the time of consent.
Croatian: Randomizacija je stratificirana prema dobi (< 35 godina naspram ≥ 35 godina), prethodnoj spasonosnoj terapiji (da naspram ne) i prethodnom alogenom HSCT-u (da naspram ne) sukladno procjeni u trenutku pristanka.
English: It is unknown whether blinatumomab or metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se blinatumomab ili njegovi metaboliti u majčino mlijeko u ljudi.
English: 96 hours
Croatian: 96 sati
English: Four patients achieved M1 bone marrow but did not meet the peripheral blood count recovery criteria for CR or CRh*.
Croatian: Četiri bolesnika postigla su koštanu srž M1, ali nisu ispunjavali kriterije za oporavak broja stanica u perifernoj krvi za CR ili CRh*.
English: Recommended daily dose is by patient weight.
Croatian: Preporučena dnevna doza je ovisna o tjelesnoj težini bolesnika.