FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered (see section 4.4).
Croatian: Posljedično, novorođenčad treba pratiti radi deplecije B limfocita te se mora odgoditi cijepljenje živim virusnim cjepivom dok se broj B limfocita novorođenčeta ne oporavi (vidjeti dio 4.4).
English: Patients with the highest tumour burden as measured by the percentage of bone marrow blast cells at baseline (≥ 90%) still had a clinically meaningful response with a CR/CRh* rate of 21.6% (CI 12.9 - 32.7) (see figure 2).
Croatian: Bolesnici s najvišim tumorskim opterećenjem, izmjerenim kao postotak stanica blasta u koštanoj srži na početku liječenja (≥ 90%), i dalje su imali klinički značajan odgovor uz stopu CR/CRh* od 21,6% (CI 12,9 - 32,7) (vidjeti sliku 2).
English: 7 Tachycardia includes sinus tachycardia, supraventricular tachycardia and tachycardia.
Croatian: Tahikardija uključuje sinusnu tahikardiju, supraventrikularnu tahikardiju i tahikardiju.
English: Patients in 2
Croatian: Bolesnici u 2. CR
English: Baseline ALT and AST levels were used to assess the effect of hepatic impairment on the clearance of blinatumomab.
Croatian: Početne vrijednosti razina ALT-a i AST-a korištene su za procjenu učinka oštećenja jetre na klirens blinatumomaba.
English: Uncommon (≥ 1/1,000 to < 1/100)
Croatian: Manje često (≥ 1/1000 do
English: 14 Chest pain includes chest discomfort, chest pain, musculoskeletal chest pain and non-cardiac chest pain.
Croatian: 14 Bol u prsnom košu uključuje nelagodu u prsnom košu, bol u prsnom košu, mišićno-koštanu bol u prsnom košu i bol u prsnom košu nekardiološke etiologije.
English: See method of administration.
Croatian: Vidjeti način primjene.
English: The safety and efficacy of BLINCYTO were evaluated in an open-label, multicentre, single-arm study in 93 paediatric patients with relapsed or refractory B-precursor ALL (second or later bone marrow relapse, in any marrow relapse after allogeneic HSCT, or refractory to other treatments, and also with > 25% blasts in bone marrow).
Croatian: Sigurnost i djelotvornost lijeka BLINCYTO procijenjene su u otvorenom, multicentričnom, ispitivanju s jednom skupinom u 93 pedijatrijska bolesnika s recidivirajućim ili refraktornim ALL-om prekursora limfocita B (drugi ili kasniji recidiv u koštanoj srži, u bilo kojem recidivu koštane srži nakon alogene transplantacije hematopoetskih matičnih stanica (HSCT, od eng. hematopoietic stem cell transplantation) ili refraktoran na druga liječenja, i s > 25% blasta u koštanoj srži).
English: Alternatively the vials can be stored at room temperature (up to 27°C) for up to 4 hours.
Croatian: čuvajte bočice na sobnoj temperaturi (do 27°C) tijekom najviše 4 sata.
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), 66.0% of patients experienced one or more neurologic adverse reactions (including psychiatric disorders), primarily involving the central nervous system.
Croatian: U bolesnika liječenih lijekom BLINCYTO u randomiziranom kliničkom ispitivanju faze III (N = 267) i kliničkom ispitivanju faze II s jednom skupinom (N = 189), 66,0% bolesnika imalo je jednu ili više neuroloških nuspojava (uključujući psihijatrijske poremećaje), primarno uključujući središnji živčani sustav.
English: • Patient alert card
Croatian: • Kartica s upozorenjima za bolesnika
English: • Infusion bag with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection; o To minimise the number of aseptic transfers, use a 250 mL pre-filled infusion bag.
Croatian: • Infuzijska vrećica s 250 ml otopine natrijeva klorida 9 mg/ml (0,9%) za injekcije; o Kako bi se broj aseptičkih prijenosa smanjio na najmanji mogući, koristite gotovu napunjenu infuzijsku vrećicu otopine natrijeva klorida 9 mg/ml od 250 ml.
English: Median, years (min, max) Mean, years (SD) ≥ 65 years, n (%) Males, n (%) Race, n (%) Asian Other (mixed) White Unknown Relapse history n (%) Patients in 1
Croatian: Medijan, godine (min, maks) Srednja vrijednost, godine (SD) ≥ 65 godina, n (%) Muškarci, n (%) Rasa, n (%) Azijati Drugo (miješano) Bijelci Nepoznato Povijest recidiva n (%) Bolesnici u 1. CR Bolesnici u 2. CR Bolesnici u 3. CR Početna razina MRB-a* n (%) i < 1 i < 10 i < 10
English: • nausea, diarrhoea, vomiting, constipation, abdominal pain
Croatian: • mučnine, proljev, povraćanje, zatvor, bol u trbuhu
English: - Store in the original carton in order to protect from light.
Croatian: - Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: 3.1 months (2.6, 4.3) (N = 32)
Croatian: 3,1 mjeseca (2,6, 4,3) (N = 32)
English: 6-month estimate % [95% CI] 18-months estimate % [95% CI] HR [95% CI]
Croatian: 6-mjesečna procjena % [95% CI] 18-mjesečna procjena % [95% CI] Omjer hazarda [95% CI] Trajanje hematološkog odgovoraMedijan vremena do događaja [95% CI] CR
English: Elderly patients may be more susceptible to serious neurologic events such as cognitive disorder, encephalopathy, and confusion.
Croatian: Stariji bolesnici mogu biti podložniji ozbiljnim neurološkim događajima kao što su kognitivni poremećaji, encefalopatija i konfuzija.
English: In a prespecified exploratory analysis, 60 of 73 MRD evaluable patients with CR/CRh* (82.2%) also had a MRD response (defined as MRD by PCR < 1 x 10
Croatian: Minimal Residual Disease) s CR/CRh* (82,2%) također je imalo MRB odgovor (definiran kao MRB po PCR < 1 x 10
English: Grade 3 and serious events were reported for 1.5% each of adult patients with MRD positive B-precursor ALL; no grade ≥ 4 events were reported.
Croatian: Događaji stupnja 3 i ozbiljni događaji prijavljeni su za 1,5% svih odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om; nisu prijavljeni događaji stupnja ≥ 4.
English: 1 Anaemia includes anaemia and haemoglobin decreased.
Croatian: Anemija uključuje anemiju i sniženi hemoglobin.
English: Serious and grade ≥ 3 adverse reactions (such as ALT increased, AST increased, and blood bilirubin increased) were observed in 1.5% and 13.6% of patients respectively.
Croatian: Ozbiljne nuspojave odnosno nuspojave stupnja ≥ 3 (poput povišene razine ALT-a, povišene razine AST-a i povišene razine bilirubina u krvi) opažene su u 1,5%
English: Cytokine release syndrome a
Croatian: Sindrom otpuštanja citokina a
English: The safety and efficacy of BLINCYTO in adult patients with MRD positive B-precursor ALL were evaluated in an open-label, multicentre, single-arm study.
Croatian: Sigurnost i djelotvornost lijeka BLINCYTO u odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om procijenjene su u otvorenom, multicentričnom ispitivanju s jednom skupinom.
English: • Obligation to complete post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: • Polyolefin, PVC non-DEHP, or EVA intravenous tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micrometre in-line filter.
Croatian: • Poliolefinska intravenska cjevčica, PVC intravenska cjevčica bez dietilheksilftalata ili EVA intravenska cjevčica koja sadrži sterilni, nepirogeni filter od 0,2 mikrometra niskog afiniteta za vezanje proteina.
English: Discard the remaining solution (stabiliser) vial.
Croatian: Bacite bočicu s preostalom otopinom (stabilizator).
English: Aseptic handling must be ensured when preparing the infusion.
Croatian: Prilikom pripremanja infuzije mora se osigurati aseptičko rukovanje.
English: Patients in 3
Croatian: Bolesnici u 3. CR
English: Hypotension includes blood pressure decreased and hypotension.
Croatian: 8 Hipotenzija uključuje sniženi krvni tlak i hipotenziju.
English: The pharmacokinetics of blinatumomab in patients with MRD positive B-precursor ALL was similar to patients with relapsed or refractory ALL.
Croatian: Farmakokinetika blinatumomaba u bolesnika s ALL-om prekursora B limfocita s pozitivnom MRB slična je onoj u bolesnika s recidivirajućim ili refraktornim ALL-om.
English: Symptoms may include wheezing, flushing, face swelling, difficulty breathing, low or high blood pressure.
Croatian: Simptomi mogu uključivati piskanje, crvenilo uz osjećaj vrućine, oticanje lica, otežano disanje, nizak ili visok krvni tlak.
English: Patients experiencing capillary leak syndrome should be managed promptly.
Croatian: Bolesnici u kojih je došlo do sindroma povećane propusnosti kapilara trebaju se hitno zbrinuti.
English: Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation section listed below.
Croatian: Potvrdite propisanu dozu i vrijeme infuzije lijeka BLINCYTO i identificirajte odgovarajuće upute za doziranje u dolje navedenom dijelu.
English: The physician educational material should contain: A link to the Summary of Product Characteristics (SmPC) The guide for physicians shall contain the following key elements:
Croatian: Edukacijski materijali za liječnike trebaju sadržavati: Poveznicu na sažetak opisa svojstava lijeka Upute za liječnike će sadržavati sljedeće ključne elemente:
English: This medicinal product provides less than 1 mmol (23 mg) sodium over a 24 hour infusion i.e. “essentially sodium-free”.
Croatian: Ovim lijekom se primjenjuje manje od 1 mmol (23 mg) natrija tijekom 24-satne infuzije, odnosno zanemarive količine natrija.
English: Frequency categories were determined from the crude incidence rate reported for each adverse reaction in clinical studies of patients with B-precursor ALL (N = 843).
Croatian: Kategorije učestalosti određene su prema gruboj stopi incidencije prijavljene za svaku nuspojavu u kliničkim ispitivanjima u bolesnika s ALL-om prekursora B limfocita (N = 843).
English: • Description of the administration procedures of BLINCYTO and how to reduce the risk of ME while using the infusion pump.
Croatian: • Opis postupaka primjene lijeka BLINCYTO i kako smanjiti rizik od medikacijskih pogreški tijekom primjene infuzijske pumpe.
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Croatian: BLINCYTO 38,5 mikrograma prašak za koncentrat i otopina za otopinu za infuziju.
English: Dyspnoea Productive cough Respiratory failure Wheezing
Croatian: Produktivni kašalj Respiratorno zatajenje Piskanje
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), serious CRS reactions were reported in 2.4% of patients with a median time to onset of 2 days.
Croatian: U bolesnika liječenih lijekom BLINCYTO u randomiziranom kliničkom ispitivanju faze III (N = 267) i kliničkom ispitivanju faze II s jednom skupinom (N = 189), ozbiljne reakcije CRS-a prijavljene su u 2,4% bolesnika, uz medijan vremena do pojave od 2 dana.
English: • swollen lymph nodes (lymphadenopathy)
Croatian: • natečeni limfni čvorovi (limfadenopatija)
English: Pyrexia Chills Oedema
Croatian: Pireksija Zimica Edem
English: The median OS was 4.0 months (95% CI: 2.9, 5.3) in the SOC chemotherapy arm compared with 7.7 months (95% CI: 5.6, 9.6) in the BLINCYTO arm.
Croatian: Medijan OS-a bio je 4,0 mjeseci (95% CI: 2,9; 5,3) u skupini koja je primala SOC kemoterapiju u odnosu na 7,7 mjeseci (95% CI: 5,6; 9,6) u skupini koja je primala BLINCYTO.
English: One vial of powder contains 38.5 micrograms blinatumomab.
Croatian: Jedna bočica praška sadrži 38,5 mikrograma blinatumomaba.
English: Fungal infections a, b
Croatian: Gljivične infekcije a, b
English: Reconstituted solution:
Croatian: Rekonstituirana otopina:
English: Eighty-eight out of 113 (77.9%) evaluable patients achieved a complete MRD response after one cycle of treatment; see table 5.
Croatian: Osamdeset i osam od 113 (77,9%) procjenjivih bolesnika postigli su potpuni MRB odgovor nakon jednog ciklusa liječenja; vidjeti tablicu 5. Dva su ispitanika postigla potpuni MRB odgovor s 1 dodatnim ciklusom lijeka BLINCYTO.
English: 11.3 months (5.2, NE) (N = 119)
Croatian: 11,3 mjeseci (5,2, NP) (N = 119)
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: CR Duration of complete MRD response [95% CI]
Croatian: Trajanje potpunog MRB odgovora [95% CI]
English: Dose adjustments
Croatian: Prilagodba doze
English: • Sterile single-use disposable syringes
Croatian: • Sterilne štrcaljke za jednokratnu primjenu
English: • Infusion rate of 3.3 mL/h for a duration of 72 hours
Croatian: • Brzina infuzije od 3,3 ml/h u trajanju od 72 sata
English: Capillary leak syndrome was observed in 1 patient in the phase II clinical study in adult patients with relapsed or refractory B-precursor ALL and in 1 patient in the phase 2 clinical study in adult patients with MRD positive B-precursor ALL.
Croatian: Sindrom povećane propusnosti kapilara opažen je u 1 bolesnika u kliničkom ispitivanju faze II u odraslih bolesnika s recidivirajućim ili refraktornim ALL-om prekursora B limfocita i u 1 bolesnika u kliničkom ispitivanju faze 2 u odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om.
English: • Contact details of the BLINCYTO prescriber
Croatian: • Kontakt podatke liječnika koji propisuje BLINCYTO.
English: Discard any remaining BLINCYTO reconstituted solution.
Croatian: Bacite svu preostalu BLINCYTO rekonstituiranu otopinu.
English: d. n1: number of patients who achieved MRD response and the respective remission status; n2: number of patients who achieved the respective remission status.
Croatian: c. Potpuni MRB odgovor Ne otkriva se signal za leukemijske stanice po PCR-u ili protočnoj citometriji. d. n1: broj bolesnika koji su postigli MRB odgovor i odgovarajući status remisije; n2: broj bolesnika koji su postigli odgovarajući status remisije.
English: • Infusion rate of 10 mL/h for a duration of 24 hours
Croatian: • Brzina infuzije od 10 ml/h u trajanju od 24 sata
English: • Recommendation for patients not to drive while receiving BLINCYTO and to contact immediately the treating physician/nurse if they experience neurological symptoms
Croatian: • Preporuku za bolesnike da ne upravljaju vozilima tijekom liječenja lijekom BLINCYTO i da odmah obavijeste svog liječnika/medicinsku sestru ako osjete neurološke simptome.
English: Follow the steps for reconstituting BLINCYTO and preparing the infusion bag detailed below table 9.
Croatian: Slijedite korake za rekonstituciju lijeka BLINCYTO i pripremu infuzijske vrećice kako je dolje navedeno u tablici 9.
English: 3.6 months (2.3, 7.2) (N = 33)
Croatian: 3,6 mjeseca (2,3, 7,2) (N = 33)
English: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Croatian: BLINCYTO je indiciran kao monoterapija za liječenje odraslih osoba s Philadelphia kromosom negativnim, CD19 pozitivnim, ALL-om prekursora B limfocita u prvoj ili drugoj potpunoj remisiji s minimalnom rezidualnom bolešću (MRB) većom ili jednakom 0,1%.
English: • Recommendation for patients not to drive while receiving BLINCYTO and to contact immediately the treating physician if they experience neurological symptoms
Croatian: • Preporuka za bolesnike da ne upravljaju vozilima tijekom liječenja lijekom BLINCYTO i da odmah obavijeste svog liječnika ako osjete neurološke simptome.
English: • Infusion rate of 5 mL/h for a duration of 48 hours
Croatian: • Brzina infuzije od 5 ml/h u trajanju od 48 sati
English: The BLINCYTO solution for infusion must be administered using intravenous tubing that contains a sterile, non-pyrogenic, low protein-binding 0.2 micrometre in-line filter.
Croatian: BLINCYTO otopina za infuziju mora se primijeniti pomoću intravenske cjevčice koja sadrži sterilni, ne-pirogeni filter od 0,2 mikrometra niskog afiniteta za vezanje proteina.
English: In clinical studies, patients with moderate renal impairment showed an increased incidence of TLS compared with patients with mild renal impairment or normal renal function.
Croatian: U kliničkim je ispitivanjima zapažena povišena incidencija TLS-a u bolesnika s umjerenim oštećenjem bubrega u usporedbi s bolesnicima s blagim oštećenjem bubrega ili normalnom bubrežnom funkcijom.
English: Cognitive disorder Memory impairment Dizziness
Croatian: Kognitivni poremećaji Oštećenje pamćenja Omaglica
English: Percent Achieving CR/CRh*
Croatian: Postotak koji je postigao CR/CRh*
English: Chemical and physical in-use stability has been demonstrated for 10 days at 2°C - 8°C or 96 hours at or below 27°C.
Croatian: Kemijska i fizička stabilnost razrijeđene otopine pokazana je kroz 10 dana na temperaturi od 2°C - 8°C ili 96 sati na temperaturi od 27°C ili nižoj.
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion blinatumomab
Croatian: BLINCYTO 38,5 mikrograma prašak za koncentrat i otopina za otopinu za infuziju blinatumomab
English: For clinical management of elevated liver enzymes, see section 4.4.
Croatian: Za kliničko zbrinjavanje povišenih jetrenih enzima, vidjeti dio 4.4.
English: Store in the original carton in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), 22.4% of patients reported elevated liver enzymes and associated signs/symptoms.
Croatian: U bolesnika liječenih lijekom BLINCYTO u randomiziranom kliničkom ispitivanju faze III (N = 267) i kliničkom ispitivanju faze II s jednom skupinom (N = 189), u 22,4% bolesnika prijavljeni su povišeni jetreni enzimi i povezani znakovi/simptomi.
English: 5 years
Croatian: ≥ 65 godina
English: Sodium hydroxide (for pH-adjustment)
Croatian: Natrijev hidroksid (za podešavanje pH) Otopina (stabilizator)
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 4 hours at or below 27°C.
Croatian: Kemijska i fizička stabilnost pripremljene otopine pokazana je kroz 24 sata na temperaturi od 2°C - 8°C ili 4 sata na temperaturi od 27°C ili nižoj.
English: Peripheral lymphocytes were not measured in paediatric subjects.
Croatian: U pedjatrijskih ispitanika nisu mjereni limfociti periferne krvi.
English: Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation in the relevant table below.
Croatian: Potvrdite propisanu dozu i trajanje infuzije lijeka BLINCYTO i identificirajte odgovarajuće upute za doziranje u odgovarajućoj tablici dolje.
English: BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
Croatian: BLINCYTO je indiciran kao monoterapija za liječenje pedijatrijskih bolesnika u dobi od navršene 1 godine ili starijih s Philadelphia kromosom negativnim, CD19 pozitivnim ALL-om prekursora B limfocita koji je refraktoran ili recidivirajući nakon primanja najmanje dvije prethodne terapije ili recidivirajući nakon prethodnog liječenja alogenom transplantacijom hematopoetskih matičnih stanica.
English: Discontinue BLINCYTO permanently.
Croatian: Trajno prekinite primjenu lijeka BLINCYTO.
English: Each vial of powder contains 38.5 micrograms of blinatumomab.
Croatian: Svaka bočica praška sadrži 38,5 mikrograma blinatumomaba.
English: Dyspnoea exertional Acute respiratory failure
Croatian: Dispneja u naporu Akutno respiratorno zatajenje
English: tingling of skin (paraesthesia), seizure, difficulty thinking or processing thoughts, difficulty remembering, difficulty in controlling movement (ataxia)
Croatian: • poremećaji u funkciji mozga (encefalopatija) poput poteškoća u komuniciranju (afazija), trnaca po koži (parestezija), napadaja, poteškoća u razmišljanju ili procesiranju misli, poteškoća u prisjećanju, poteškoće u kontroliranju pokreta (ataksija)
English: A link to the Summary of Product Characteristics (SmPC) The nurse educational guide, including the following key elements:
Croatian: Poveznicu na sažetak opisa svojstava lijeka Edukacijsku brošuru za medicinske sestre, uključujući sljedeće ključne elemente:
English: Follow the steps for reconstituting BLINCYTO and preparing the infusion bag detailed below table 3.
Croatian: Slijedite korake za rekonstituciju lijeka BLINCYTO i pripremu infuzijske vrećice kako je dolje navedeno u tablici 3.
English: Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 8.0% and 4.4% of adult patients with MRD positive B-precursor ALL.
Croatian: Događaji stupnja ≥ 3 i stupnja ≥ 4 prijavljeni su za 8,0% i 4,4% odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om.
English: • reactions related to infusion may include, wheezing, flushing, face swelling, difficulty breathing, low blood pressure, high blood pressure.
Croatian: • reakcije povezane s infuzijom mogu uključivati piskanje, crvenilo uz osjećaj vrućine, oticanje lica, otežano disanje, nizak krvni tlak, visok krvni tlak.
English: For the treatment of Philadelphia chromosome negative relapsed or refractory B-precursor ALL, hospitalisation is recommended for initiation at a minimum for the first 9 days of the first cycle and the first 2 days of the second cycle.
Croatian: Prilikom liječenja recidivirajućeg ili refraktornog Philadelphia kromosom negativnog ALL-a prekursora B limfocita preporučuje se hospitalizacija kroz najmanje prvih 9 dana prvog ciklusa i prva 2 dana drugog ciklusa.
English: Febrile neutropenia Anaemia
Croatian: Febrilna neutropenija Anemija
English: Grade* Action for patients greater than or equal to 45 kg
Croatian: Stupanj* Postupak za bolesnike tjelesne težine 45 kg ili veće
English: Viral infectionsa, b Infections - pathogen unspecified a, b
Croatian: Infekcije - patogen neodređen a, b
English: Grade 3 is severe, and grade 4 is life-threatening.
Croatian: Common Terminology Criteria for Adverse Events), verzija 4.0. 3. stupanj je teško, a 4. stupanj je po život opasno stanje.
English: • Pharmacist educational material
Croatian: • Edukacijski materijali za ljekarnika
English: Patients with Philadelphia chromosome negative relapsed or refractory B-precursor ALL with ECOG performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of < 2.
Croatian: Incidencija ozbiljnih infekcija u bolesnika s recidivirajućim ili refraktornim Philadelphia kromosom negativnim ALL-om prekursora B limfocita bila je veća u bolesnika početnog ECOG funkcionalnog statusa 2 u usporedbi s bolesnicima ECOG funkcionalnog statusa < 2.
English: For the treatment of Philadelphia chromosome negative MRD positive B-precursor ALL, hospitalisation is recommended at a minimum for the first 3 days of the first cycle and the first 2 days of subsequent cycles.
Croatian: Za liječenje Philadelphia kromosom negativnog ALL-a prekursora B limfocita s pozitivnim MRB-om preporučuje se hospitalizacija kroz najmanje prva 3 dana prvog ciklusa i prva 2 dana sljedećih ciklusa.
English: It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells.
Croatian: Aktivira endogene T limfocite povezujući CD3 u receptorskom kompleksu T limfocita (TCR, od eng.
English: • reactions related to infusion may include face swelling, low blood pressure, high blood pressure (infusion-related reaction)
Croatian: • reakcije povezane s infuzijom mogu uključivati oticanje lica, nizak krvni tlak, visok krvni tlak
English: For clinical management of neurologic events, see section 4.4.
Croatian: Za kliničko zbrinjavanje neuroloških događaja, vidjeti dio 4.4.
English: Elevated liver enzyme events were reported for 12.4% of adult patients with MRD positive B-precursor ALL (N = 137).
Croatian: Događaji s povišenim jetrenim enzimima prijavljeni su za 12,4% odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om (N = 137).