FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult patients with Eastern Cooperative Oncology Group (ECOG) performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of < 2.
Croatian: Eastern Cooperative Oncology Group) funkcionalnog stanja na početku liječenja bila 2, incidencija ozbiljnih infekcija bila je veća u odnosu na bolesnike s ECOG funkcionalnim statusom < 2. Iskustvo s lijekom BLINCYTO u bolesnika s aktivnom nekontroliranom infekcijom je ograničeno.
English: • BLINCYTO treatment start date
Croatian: • Datum početka liječenja lijekom BLINCYTO.
English: Confusional state Disorientation
Croatian: Stanje konfuzije Dezorijentacija
English: BLINCYTO solution for infusion is administered as a continuous intravenous infusion delivered at a constant flow rate using an infusion pump over a period of up to 96 hours.
Croatian: BLINCYTO otopina za infuziju primjenjuje se kao kontinuirana intravenska infuzija pri konstantnoj brzini protoka pomoću infuzijske pumpe tijekom perioda u trajanju do 96 sati.
English: Contact details are provided in section 6 of the package leaflet.
Croatian: Kontakt podaci nalaze se u dijelu 6 Upute o lijeku.
English: Cytokine release syndrome was reported in 2.9% of adult patients with MRD positive B-precursor ALL (N = 137).
Croatian: Sindrom otpuštanja citokina prijavljen je u 2,9% odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om (N = 137).
English: Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 16.1% and 2.2% of adult patients with MRD positive B-precursor ALL.
Croatian: Događaji stupnja ≥ 3 i stupnja ≥ 4 prijavljeni su za 16,1% i 2,2% odraslih bolesnika s ALL-om prekursora B limfocita s pozitivnim MRB-om.
English: How BLINCYTO is given
Croatian: Kako se BLINCYTO primjenjuje
English: BLINCYTO solution for infusion is administered as a continuous intravenous infusion delivered at a constant flow rate using an infusion pump, over a period of up to 96 hours.
Croatian: BLINCYTO otopina za infuziju primjenjuje se kao kontinuirana intravenska infuzija pri konstantnoj brzini protoka, pomoću infuzijske pumpe tijekom perioda u trajanju do 96 sati.
English: Sodium chloride 9 mg/mL (0.9%) solution for injection (starting volume)
Croatian: Otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju (početni volumen)
English: Patients with a medical history of neurologic signs and symptoms (such as dizziness, hypoaesthesia, hyporeflexia, tremor, dysaesthesia, paraesthesia, memory impairment) demonstrated a higher rate of neurologic events (such as tremor, dizziness, confusional state, encephalopathy and ataxia).
Croatian: U bolesnika s anamnezom neuroloških znakova i simptoma (poput omaglice, hipoestezije, hiporefleksije, tremora, dizestezije, parestezije, oštećenja pamćenja) stopa neuroloških događaja
English: BLINCYTO (N = 116)
Croatian: (N = 116)
English: Consider discontinuing BLINCYTO permanently.
Croatian: Razmotrite trajni prekid primjene lijeka BLINCYTO.
English: Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor ALL (relapsed with first remission duration of ≤ 12 months in first salvage, or relapsed or refractory after first salvage therapy, or relapsed within 12 months of allogeneic HSCT, and had ≥ 10% blasts in bone marrow).
Croatian: Podobni bolesnici bili su u dobi od ≥ 18 godina, s recidivirajućim ili refraktornim Philadelphia kromosom negativnim ALL-om prekursora limfocita B (recidivirajući uz trajanje prve remisije ≤ 12 mjeseci kod prvog spasonosnog liječenja, ili recidivirajući ili refraktorni nakon prve spasonosne terapije, ili recidivirajući unutar 12 mjeseci od alogene transplantacije hematopoetskih matičnih stanica (HSCT, od eng. hematopoietic stem cell transplantation) i uz ≥ 10% blasta u koštanoj srži).
English: n/N Rate (95% CI)
Croatian: Stopa (95% CI)
English: Patients were premedicated with a mandatory cerebrospinal fluid prophylaxis consisting of an intrathecal regimen according to institutional or national guidelines within 1 week prior to start of BLINCYTO treatment.
Croatian: Unutar tjedan dana prije započinjanja liječenja lijekom BLINCYTO, bolesnici su primili premedikaciju obavezne profilakse cerebrospinalne tekućine koju je činio intratekalni režim usklađen s nacionalnim ili institucionalnim smjernicama.
English: No adverse effects on male or female mouse reproductive organs in 13 week toxicity studies with the murine surrogate molecule (see section 5.3).
Croatian: U ispitivanjima toksičnosti s mišjom surogatnom molekulom, u trajanju od 13 tjedana nije bilo nuspojava na reproduktivne organe mužjaka ili ženki miševa (vidjeti dio 5.3).
English: For instructions on administration, see Summary of Product Characteristics section 4.2.
Croatian: Za upute o primjeni, vidjeti dio 4.2 u Sažetku opisa svojstava lijeka.
English: Consistent immune-pharmacodynamic responses were observed in patients studied.
Croatian: U ispitivanih bolesnika opažen je nepromjenjiv imuno-farmakodinamički odgovor.
English: 5-free survival (RFS) for CR/CRh*
Croatian: Preživljenje bez recidiva za CR/CRh*
English: Eligible patients were ≥ 18 years of age and ECOG status ≤ 2 with relapsed or refractory B-cell precursor ALL (had > 5% blasts in the bone marrow and either relapse at any time after allogeneic HSCT, untreated first relapse with first remission duration < 12 months, or refractory to last therapy).
Croatian: Podobni bolesnici bili su u dobi od ≥ 18 godina i s ECOG funkcionalnim statusom ≤ 2 s recidivirajućim ili refraktornim ALL-om prekursora B limfocita (> 5% blasta u koštanoj srži i nešto od sljedećeg: recidiv u bilo kojem trenutku nakon alogene transplantacije hematopoetskih matičnih stanica (HSCT, od eng. hematopoietic stem cell transplantation), ili neliječen prvi recidiv uz trajanje prve remisije < 12 mjeseci, ili refraktorni na zadnju terapiju).
English: The resulting solution should be clear to slightly opalescent, colourless-to-slightly yellow.
Croatian: Konačna otopina treba biti bistra do blago opalescentna, bezbojna do žućkasta.
English: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
Croatian: BLINCYTO je indiciran kao monoterapija za liječenje odraslih osoba s recidivirajućom ili refraktornom Philadelphia kromosom negativnom, CD19 pozitivnom, akutnom limfoblastičnom leukemijom (ALL) prekursora B limfocita.
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may become severe - these may be signs of a so-called cytokine release syndrome.
Croatian: • vrućica, oticanje, zimica, snižen ili povišen krvni tlak i tekućina u plućima, što može postati teško stanje - ovo mogu biti znakovi takozvanog sindroma otpuštanja citokina.
English: Bacterial infections a, b
Croatian: Virusne infekcije a, b
English: Do not prime with sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Ne pripremajte cjevčicu koristeći otopinu natrijevog klorida 9 mg/ml (0,9%) za injekciju.
English: How to store BLINCYTO
Croatian: Kako čuvati BLINCYTO
English: The mortality rate following alloHSCT among all responders who did not receive anti-leukemic therapy was 10/38 (26.3%; 95% CI: 13.4, 43.1) in the BLINCYTO group and 3/12 (25%; 95% CI: 5.5, 57.2) in the SOC group; such mortality rate at 100 days post alloHSCT was 4/38 (12.4%; 95% CI: 4.8%, 29.9%) in the BLINCYTO group and 0/12 (0%; 95% CI: not estimable) in the SOC group.
Croatian: Stopa smrtnosti nakon aloHSCT-a kod svih bolesnika s odgovorom koji nisu primili terapiju za leukemiju bila je 10/38 (26,3%; 95% CI: 13,4; 43,1) u BLINCYTO skupini i 3/12 (25%; 95% CI: 5,5; 57,2) u SOC skupini.
English: Store the vials in the original package in order to protect from light.
Croatian: Bočice čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: HR (BLINCYTO/SOC Chemo) (95% CI) p-value (2-sided)
Croatian: Medijan sveukupnog preživljenja, mjeseci Omjer hazarda (BLINCYTO/SOC kemoterapija) (95% CI) p-vrijednost (dvostrana)
English: Haemophagocytic histiocytosis/macrophage activation syndrome (MAS) has been uncommonly reported in the setting of CRS.
Croatian: Manje često je u slučaju CRS-a prijavljena hemofagocitna histiocitoza/sindrom aktivacije makrofaga (MAS, od eng. macrophage activation syndrome).
English: No dose adjustment is necessary in elderly patients (≥ 65 years of age), see section 5.1.
Croatian: Nije potrebna prilagodba doze u starijih bolesnika (u dobi od ≥ 65 godina), vidjeti dio 5.1. Iskustvo s primjenom lijeka BLINCYTO u osoba u dobi od ≥ 75 godina je ograničeno.
English: Psychiatric disorders a
Croatian: Psihijatrijski poremećaji a
English: No recovery of peripheral B-cell counts was observed during the 2-week treatment-free period between treatment cycles.
Croatian: U dvotjednom periodu između ciklusa liječenja, u kojem nije primjenjivano liječenje, nije opažen oporavak broja perifernih B limfocita.
English: Incomplete depletion of B-cells occurred at doses of 0.5 mcg/m 2/day and 1.5 mcg/m 2/day and in a few non-responders at higher doses.
Croatian: Do nepotpune deplecije B limfocita došlo je pri dozama od 0,5 µg/m2/dan i 1,5 µg/m2/dan,
English: A central laboratory subsequently confirmed MRD levels by PCR.
Croatian: Središnji laboratorij naknadno je potvrdio
English: 5 mL/hour
Croatian: 5 ml/sat
English: • Nurse educational material
Croatian: • Edukacijski materijali za medicinsku sestru
English: 3 Thrombocytopenia includes platelet count decreased and thrombocytopenia.
Croatian: 3 Trombocitopenija uključuje snižen broj trombocita i trombocitopeniju.
English: Results suggest that age (7 months to 80 years) and gender do not influence the pharmacokinetics of blinatumomab.
Croatian: godina) i spol ne utječu na farmakokinetiku blinatumomaba.
English: Life-threatening or fatal (grade ≥ 4) viral, bacterial and fungal infections have been reported in patients treated with BLINCYTO.
Croatian: U bolesnika liječenih lijekom BLINCYTO prijavljene su virusne, bakterijske ili gljivične infekcije opasne po život ili sa smrtnim ishodom (stupanj ≥ 4).
English: If the toxicity occurred at 9 mcg/day, or if the toxicity takes more than 7 days to resolve, discontinue
Croatian: Ako se toksičnost javi pri dozi od 9 µg/dan ili je potrebno više od 7 dana za oporavak, trajno prekinite primjenu lijeka BLINCYTO.
English: 15 mcg/m2/day
Croatian: 15 µg/m2/dan
English: < 1 year old achieved a CR/CRh
Croatian: 3 ispitanika u dobi < 1 godine nije postigao CR/CRh
English: In adult patients, dexamethasone 20 mg intravenous should be administered 1 hour prior to initiation of each cycle of BLINCYTO therapy.
Croatian: U odraslih bolesnika sat vremena prije započinjanja svakog ciklusa terapije lijekom BLINCYTO mora se intravenski primijeniti 20 mg deksametazona.
English: Back pain Pain in extremity
Croatian: Bol u leđima Bol u udovima
English: 11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular and rash pruritic.
Croatian: 11 Osip uključuje eritem, osip, eritemski osip, generalizirani osip, makularni osip, makulo-papularni osip i pruritički osi.
English: For clinical management of pancreatitis, see section 4.4.
Croatian: Za kliničko zbrinjavanje pankreatitisa, vidjeti dio 4.4.
English: No formal pharmacokinetic studies of blinatumomab have been conducted in patients with renal impairment.
Croatian: Nisu provedena službena farmakokinetička ispitivanja blinatumomaba u bolesnika s oštećenjem bubrega.
English: How to use BLINCYTO
Croatian: Kako primjenjivati BLINCYTO
English: 10 mL/hour
Croatian: 10 ml/sat
English: Powder for concentrate and solution for solution for infusion 1 vial of powder.
Croatian: Prašak za koncentrat i otopina za otopinu za infuziju: 1 bočica praška.
English: Postbaseline alloHSCT - n (%) Overall subjects Hematological responders (CR/CRh*/CRi) Time to alloHSCT among all transplanted patients Median time to event (Interquartile range)
Croatian: Vrijeme do aloHSCT-a među svim transplantiranim bolesnicima Medijan vremena do događaja (Interkvartilni raspon)
English: Store at 2°C - 8°C if not used immediately.
Croatian: Ako se ne primjenjuje odmah, čuvati na temperaturi od 2°C - 8°C.
English: Direct the water for injections toward the side of the vial during reconstitution.
Croatian: Tijekom rekonstitucije usmjerite vodu za injekcije na stijenku bočice.
English: • Physician educational material
Croatian: • Edukacijski materijali za liječnika
English: Philadelphia chromosome negative relapsed or refractory B-precursor ALL
Croatian: Recidivirajući ili refraktorni Philadelphia kromosom negativni ALL prekursora B limfocita
English: For clinical management of infections, see section 4.4.
Croatian: Za kliničko zbrinjavanje infekcija, vidjeti dio 4.4.
English: No formal pharmacokinetic studies of blinatumomab have been conducted in patients with hepatic impairment.
Croatian: Nisu provedena službena farmakokinetička ispitivanja blinatumomaba u bolesnika s oštećenjem jetre.
English: SOC Chemo
Croatian: SOC kemoterapija
English: Solution (stabiliser)
Croatian: Otopina (stabilizator)
English: 5 mcg/m2/day
Croatian: 5 µg/m2/dan
English: None of the 3 subjects
Croatian: Nijedan od
English: Unopened vials:
Croatian: Neotvorene bočice:
English: No anti-blinatumomab antibodies were detected in clinical studies of paediatric patients with relapsed or refractory ALL treated with blinatumomab.
Croatian: U kliničkim ispitivanjima pedijatrijskih bolesnika s recidivirajućim ili refraktornim ALL-om liječenih blinatumomabom nisu otkrivena anti-blinatumomab antitijela.
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may be severe and can be fatal (cytokine storm)
Croatian: • vrućica, oticanje, zimica, snižen ili povišen krvni tlak i tekućina u plućima, što može biti ozbiljno i smrtonosno (citokinska oluja)
English: Anti-pyretic use (e.g. paracetamol) is recommended to reduce pyrexia during the first 48 hours of each treatment cycle.
Croatian: Za smanjenje pireksije tijekom prvih 48 sati svakog ciklusa liječenja preporučuje se primjena antipiretika (npr. paracetamol).
English: Cytokine release syndrome (CRS) which may be life-threatening or fatal (grade ≥ 4) has been reported in patients receiving BLINCYTO (see section 4.8).
Croatian: Sindrom otpuštanja citokina i reakcije povezane s infuzijom U bolesnika u kojih se primjenjuje BLINCYTO prijavljen je sindrom otpuštanja citokina (CRS, od eng. cytokine release syndrome), koji može biti opasan po život ili imati smrtan ishod (stupanj ≥ 4) (vidjeti dio 4.8).
English: - performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Croatian: Priprema lijeka BLINCYTO treba biti: - provedena u aseptičkim uvjetima od strane educiranog osoblja, u skladu s pravilima dobre kliničke prakse, posebno u skladu s aseptičkom pripremom parenteralnih lijekova. - provedena u komori s laminarnim protokom zraka ili biološki sigurnosnoj komori primjenom standardnih mjera predostrožnosti za sigurno rukovanje intravenskim lijekovima.
English: Blast free hypoplastic or aplastic bone marrow was defined as bone marrow blasts ≤ 5%, no evidence of disease, insufficient recovery of peripheral blood counts: platelets ≤ 50,000/microlitre and/or ANC ≤ 500/microlitre.
Croatian: Hipoplastična ili aplastična koštana srž bez blasta je definirana kao blasti u koštanoj srži ≤ 5%, bez dokaza bolesti, nedovoljan oporavak broja stanica u perifernoj krvi: trombociti ≤ 50,000/mikrolitar i/ili apsolutni broj neutrofila ≤ 500/mikrolitar.
English: Blast free hypoplastic or aplastic bone marrow Partial remission
Croatian: Hipoplastična ili aplastična koštana srž bez blasta Djelomična remisija
English: MRD
Croatian: MRB
English: Anti-pyretic use (e.g. paracetamol) is recommended to help reduce pyrexia during the first 48 hours of each cycle.
Croatian: Za smanjenje pireksije tijekom prvih 48 sati svakog ciklusa preporučuje se primjena antipiretika (npr. paracetamola).
English: Management of these signs and symptoms to resolution may require either temporary interruption or permanent discontinuation of BLINCYTO (see section 4.2).
Croatian: Zbrinjavanje ovih znakova i simptoma do oporavka može zahtijevati bilo privremeni prekid bilo trajni prekid primjene lijeka BLINCYTO (vidjeti dio 4.2).
English: A total of 456 patients aged ≥ 18 years of age with relapsed or refractory B-precursor ALL were exposed to BLINCYTO during the phase II and phase III clinical studies described below.
Croatian: Tijekom kliničkih ispitivanja faze II i faze III opisanih niže, ukupno je 456 bolesnika u dobi od ≥ 18 godina s recidivirajućim ili refraktornim ALL-om prekursora B limfocita bilo izloženo lijeku BLINCYTO.
English: BLINCYTO 271
Croatian: BLINCYTO 271 SOC kemoterapija 134
English: MRD positive B-precursor ALL
Croatian: ALL prekursora B limfocita s pozitivnim MRB-om
English: Solution (stabiliser).
Croatian: Otopina (stabilizator).
English: Infusion catheter
Croatian: Kateter za infuziju
English: • 1 glass vial containing a colourless-to-slightly yellow, clear solution.
Croatian: • 1 staklenu bočicu koja sadrži bezbojnu do žućkastu, bistru otopinu.
English: 3.3 mL/hour
Croatian: 3,3 ml/h
English: For clinical management of CRS, see section 4.4.
Croatian: Za kliničko zbrinjavanje CRS-a, vidjeti dio 4.4.
English: At the clinical doses of 9 mcg/day and 28 mcg/day for the treatment of relapsed/refractory ALL, the mean (SD) Css was 230 (359) pg/mL and 612 (532) pg/mL, respectively.
Croatian: Css-a bila je 230 (359) pg/ml odnosno 612 (532) pg/ml.
English: • complications occurring after cancer treatment leading to increased blood levels of potassium,
Croatian: • komplikacije nakon liječenja raka koje dovode do povišene razine kalija u krvi, mokraćne kiseline i fosfata u krvi, te snižene razine kalcija u krvi (sindrom lize tumora)
English: Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and anti-leukaemic chemotherapy (including systemic high dose methotrexate or intrathecal cytarabine).
Croatian: U bolesnika u kojih se primjenjuje BLINCYTO, pogotovo u bolesnika prethodno liječenih zračenjem glave i kemoterapijom protiv leukemije (uključujući sistemsku primjenu visokih doza metotreksata ili intratekalnu primjenu citarabina), opažene su promjene nalaza MR-a glave (magnetska rezonancija) koje pokazuju leukoencefalopatiju.
English: Prednisone 100 mg intravenously or equivalent (e.g. dexamethasone 16 mg) should be administered 1 hour prior to initiation of each cycle of BLINCYTO therapy.
Croatian: Sat vremena prije započinjanja svakog ciklusa terapije lijekom BLINCYTO mora se intravenski primijeniti 100 mg prednizona ili ekvivalenta (npr. 16 mg deksametazona).
English: Pre-filled bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
Croatian: Vrećica napunjena otopinom natrijeva klorida 9 mg/ml (0,9%) za injekcije
English: Neutropenia and febrile neutropenia, including life-threatening cases, have been observed in patients receiving BLINCYTO.
Croatian: U bolesnika u kojih se primjenjuje BLINCYTO opažene su neutropenija i febrilna neutropenija, uključujući i slučajeve opasne po život.
English: The safety and efficacy of BLINCYTO have not been studied in patients with severe hepatic impairment.
Croatian: Sigurnost i djelotvornost lijeka BLINCYTO nisu ispitane u bolesnika s teškim oštećenjem bubrega.
English: 28 mcg/day
Croatian: 28 µg/dan
English: The safety of BLINCYTO has not been studied in patients with severe renal impairment.
Croatian: Sigurnost lijeka BLINCYTO nije ispitana u bolesnika s teškim oštećenjem bubrega.
English: Lymphopenia includes lymphocyte count decreased and lymphopenia.
Croatian: 6 Limfopenija uključuje snižen broj limfocita i limfopeniju.
English: Efficacy results in patients ≥ 18 years of age with MRD positive B-precursor ALL
Croatian: Tablica 5. Rezultati djelotvornosti u bolesnika u dobi od ≥ 18 godina s ALL-om prekursora B limfocita s pozitivnom MRB-om
English: Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80
Croatian: Citratna kiselina hidrat (E330) Trehaloza dihidrat Lizinklorid
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may become severe (cytokine release syndrome)
Croatian: • vrućica, oticanje, zimica, snižen ili povišen krvni tlak i tekućina u plućima, što može postati teško stanje (sindrom otpuštanja citokina)
English: Paraesthesia Seizure
Croatian: Prijavljivanje nuspojava
English: • cough
Croatian: • kašalj
English: Powder for concentrate and solution for solution for infusion.
Croatian: Prašak za koncentrat i otopina za otopinu za infuziju.
English: This should be followed by dexamethasone 5 mg/m orally or intravenously within 30 minutes prior to the start of
Croatian: Potom se treba oralno ili intravenski primijeniti 5 mg/m deksametazona unutar 30 minuta prije početka primjene lijeka BLINCYTO (1. ciklus, 1. dan).
English: If clinically relevant, interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Croatian: Ako je klinički značajno, prekinite primjenu lijeka BLINCYTO dok se ne postigne barem 1. stupanj (blago), zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 5 µg/m2/dan.
English: • Recommendation for patients not to drive while receiving BLINCYTO A link to the package leaflet
Croatian: • Preporuku za bolesnike da ne upravljaju vozilima tijekom liječenja lijekom BLINCYTO.
English: Diarrhoea Vomiting Constipation Abdominal pain
Croatian: Mučnina Proljev Povraćanje Zatvor Bol u trbuhu
English: • back pain, pain in extremity
Croatian: • bolovi u leđima, bolovi u udovima
English: • Patient / caregivers educational material
Croatian: • Edukacijski materijali za bolesnika/njegovatelja
English: • Description of the administration procedures of BLINCYTO
Croatian: • Opis postupaka primjene lijeka BLINCYTO.
English: - The other ingredients in the powder are citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80, and sodium hydroxide.
Croatian: - Drugi sastojci u prašku su citratna kiselina hidrat (E330), trehaloza dihidrat, lizinklorid, polisorbat 80 i natrijev hidroksid.
English: Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Croatian: Zbrinjavanje pankreatitisa može zahtijevati ili privremeni ili trajni prekid liječenja lijekom BLINCYTO (vidjeti dio 4.2).
English: Infusion rate
Croatian: Brzina infuzije
English: 9 mcg/day.
Croatian: 9 µg/dan
English: Chest pain Pain
Croatian: Bol u prsnom košu Bol
English: Interrupt BLINCYTO until resolved, then restart BLINCYTO at 5 mcg/m2/day.
Croatian: Prekinite primjenu lijeka BLINCYTO do oporavka, zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 5 µg/m2/dan.
English: Powder: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 and sodium hydroxide.
Croatian: Prašak: citratna kiselina hidrat (E330), trehaloza dihidrat, lizinklorid, polisorbat 80 i natrijev hidroksid.
English: Ataxia
Croatian: Cijepljenje
English: 15 mcg/m2/day via continuous infusion (not to exceed 28 mcg/day)
Croatian: 15 µg/m2/dan putem kontinuirane infuzije (ne smije se prekoračiti 28 µg/dan)
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Efficacy results in patients < 18 years of age with relapsed or refractory B-cell precursor ALL
Croatian: Tablica 6. Rezultati djelotvornosti u bolesnika < 18 godina s recidivirajućim ili refraktornim ALL-om prekursora B limfocita
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA PRAŠKA