FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose for the PK expansion and efficacy parts of the study was determined to be 5 mcg/m 2/day on days 1-7 and 15 mcg/m 2/day on days 8-28 for cycle 1, and 15 mcg/m2/day on days 1-28 for subsequent cycles.
Slovenian: Za priporočeni odmerek za drugi del študije, ki je določala farmakokinetične razširitve in učinkovitost, so določili 5 µg/m2/dan za 1. ciklus za 1.-7. dan in 15 µg/m2/dan za 1. ciklus za 8.-28. dan, za vse nadaljnje cikluse za 1.-28. dan pa 15 µg/m2/dan.
English: Consequently, as a precautionary measure, breast-feeding is contraindicated during and for at least 48 hours after treatment with blinatumomab.
Slovenian: Posledično, kot previdnostni ukrep, je dojenje kontraindicirano med obdobjem zdravljenja z blinatumomabom in vsaj še 48 ur po zdravljenju.
English: It is very important that the instructions for preparation (including reconstitution and dilution) and administration are strictly followed to minimise medication errors (including underdose and overdose) (see section 4.2).
Slovenian: Zelo pomembno je strogo upoštevanje navodil za pripravo (vključno z navodili za rekonstitucijo in razredčenje) in dajanje, da bi bilo napak pri uporabi zdravila čim manj (vključno s prevelikim in premajhnim odmerjanjem) (glejte poglavje 4.2).
English: If you have minimal residual disease acute lymphoblastic leukaemia, your dose of BLINCYTO will be 28 micrograms per day throughout the first cycle.
Slovenian: Če imate akutno limfoblastno levkemijo z minimalno rezidualno boleznijo, bo vaš odmerek zdravila BLINCYTO 28 mikrogramov na dan med prvim ciklusom.
English: • Recommendation to monitor patients for signs and symptoms of neurotoxicity
Slovenian: • Priporočilo za spremljanje bolnikov glede znakov in simptomov nevrotoksičnosti.
English: Refractory to salvage therapy Maximum of central/local bone marrow blasts - n (%)
Slovenian: Odporni proti reševalnemu zdravljenju Največji delež centralnih/lokalnih blastov v kostnem mozgu - n (%)
English: No formal drug interaction studies have been performed.
Slovenian: Formalnih študij medsebojnega delovanja niso izvedli.
English: In the elderly population (≥ 65 years of age) 11 of 25 patients (44.0%) achieved CR/CRh* within the first 2 treatment cycles (see section 4.8 for safety in elderly).
Slovenian: V starejši populaciji (starost ≥ 65 let) je 11 od 25 bolnikov (44,0 %) doseglo CR/CRh* v prvih 2 ciklusih zdravljenja (glejte poglavje 4.8 za informacije o varnosti pri starejših osebah).
English: Do not use this solution (stabiliser) for reconstitution of BLINCYTO powder for concentrate.
Slovenian: Ne uporabljajte te raztopine (stabilizatorja) za rekonstitucijo praška za koncentrat zdravila BLINCYTO.
English: • high blood pressure (hypertension)
Slovenian: • visok krvni tlak (hipertenzijo)
English: - Breast-feeding (see section 4.6).
Slovenian: - Dojenje (glejte poglavje 4.6).
English: Patients who have achieved complete remission (CR/CRh*) after 2 treatment cycles may receive up to 3 additional cycles of BLINCYTO consolidation treatment, based on an individual benefits-risks assessment.
Slovenian: Bolniki, ki po 2 ciklusih zdravljenja dosežejo popolno remisijo (CR/CRh* - complete remission), lahko dobijo 3 dodatne cikluse konsolidacijskega zdravljenja z zdravilom BLINCYTO; odločitev za to mora temeljiti na individualni oceni koristi in tveganj.
English: Contact details are provided in section 6 of the package leaflet.
Slovenian: Kontaktni podatki so navedeni v poglavju 6 Navodila za uporabo.
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%).
Slovenian: Štirje bolniki so dosegli CR med konsolidacijskimi ciklusi, tako da je bil kumulativni delež CR 35,4 % (67/189, 95 % IZ: 28,6-42,7 %).
English: • disturbances of brain function (encephalopathy) such as difficulty in communicating (aphasia),
Slovenian: • motnje delovanja možganov (encefalopatija), na primer težave s sporazumevanjem (afazija),
English: Adverse reactions that were observed more frequently (≥ 10% difference) in the paediatric population compared to the adult population were anaemia, thrombocytopenia, leukopenia, pyrexia, infusion-related reactions, weight increase, and hypertension.
Slovenian: Neželeni učinki, ki so jih opazili pogosteje (≥ 10 % razlika) pri pediatrični populaciji kot pri odrasli populaciji, so bili anemija, trombocitopenija, levkopenija, pireksija, z infuzijo povezane reakcije, povečanje telesne mase in hipertenzija.
English: What BLINCYTO is and what it is used for What you need to know before you use BLINCYTO How to use BLINCYTO
Slovenian: Kaj je zdravilo BLINCYTO in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo BLINCYTO Kako uporabljati zdravilo BLINCYTO Možni neželeni učinki
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.
Slovenian: Pred začetkom zdravljenja in med zdravljenjem z zdravilom BLINCYTO je treba spremljati alanin-aminotransferazo (ALT), aspartat-aminotransferazo (AST), gamaglutamil-transferazo (GGT) in celokupni bilirubin, zlasti v prvih 48 urah prvih 2 ciklusov.
English: Subsequent cycles Days 1-7 Days 8-28 Days 29-42 Days 1-28 Days 29-42
Slovenian: Nadaljnji ciklusi 1.-7. dan 8.-28. dan 29.-42. dan 1.-28. dan 29.-42. dan
English: The safety of immunisation with live viral vaccines during or following BLINCYTO therapy has not been studied.
Slovenian: Varnost cepljenj z živimi virusnimi cepivi med zdravljenjem z zdravilom BLINCYTO ali po njem ni raziskana.
English: In the event of a seizure, secondary prophylaxis with appropriate anticonvulsant medicinal products (e.g. levetiracetam) is recommended.
Slovenian: V primeru konvulzij je priporočljiva sekundarna profilaksa z ustreznimi antiepileptiki (npr. z levetiracetamom).
English: 9 mcg/day via continuous infusion
Slovenian: 9 µg/dan v kontinuirani infuziji
English: BLINCYTO is used when acute lymphoblastic leukaemia has come back or has not responded to previous treatment (referred to as relapsed/refractory acute lymphoblastic leukaemia).
Slovenian: Zdravilo BLINCYTO se uporablja, ko se je akutna limfoblastna levkemija vrnila ali ni bilo odziva na predhodno zdravljenje (imenovano recidivna/refraktarna akutna limfoblastna levkemija).
English: MRD status at screening was determined from bone marrow aspirations using flow cytometry or polymerase chain reaction (PCR) at a minimum sensitivity of 10
Slovenian: presejanju so stanje MRD določili iz aspiracij kostnega mozga z uporabo pretočne citometrije ali verižne reakcije s polimerazo (PCR) pri minimalni občutljivosti 10
English: • Do not refrigerate or freeze the package.
Slovenian: • Pakiranja ne shranjujte v hladilniku in ne zamrzujte.
English: See table 6 for the efficacy results.
Slovenian: Za rezultate učinkovitosti glejte preglednico 6.
English: You must not breast-feed during and for at least 48 hours after your last treatment.
Slovenian: Med zdravljenjem in vsaj še 48 ur po zadnjem zdravljenju ne smete dojiti.
English: The active ingredient in BLINCYTO is blinatumomab.
Slovenian: Učinkovina v zdravilu BLINCYTO je blinatumomab.
English: Bone Marrow Blast Infiltration (Central Lab)
Slovenian: Infiltracija kostnega mozga z blasti (centralni laboratorij)
English: based on local site evaluations.
Slovenian: na podlagi vrednotenj centrov, vključenih v študijo.
English: • When preparing an infusion bag, remove all air from infusion bag.
Slovenian: • Med pripravo infuzijske vrečke iz vrečke odstranite ves zrak.
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents, ATC code: L01XC19.
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XC19.
English: The treated population (in the dose-finding, PK expansion, and efficacy parts) included 70 patients who received at least 1 infusion of BLINCYTO at the recommended dose; the mean number of treatment cycles was 1.5.
Slovenian: V zdravljeno populacijo (v delih študije za ugotavljanje odmerka, za določitev farmakokinetične razširitve in učinkovitosti) je bilo vključenih 70 bolnikov, ki so prejeli vsaj eno infuzijo zdravila BLINCYTO v priporočenem odmerku; povprečno število ciklusov zdravljenja je bilo 1,5.
English: • Sterile single-use disposable syringes
Slovenian: • sterilne brizge za enkratno uporabo
English: Remove air from the infusion bag and prime the intravenous infusion line only with the prepared solution for infusion.
Slovenian: Iz infuzijske vrečke odstranite zrak in pripravite sistem za intravensko infundiranje le s pripravljeno raztopino za infundiranje.
English: Most patients had a high tumour burden (≥ 50% leukaemic blasts in bone marrow) at baseline with a median of 75.5% bone marrow blasts.
Slovenian: Večina bolnikov je imela v izhodišču visoko tumorsko breme (≥ 50 % levkemičnih blastov v kostnem mozgu) z mediano 75,5 % blastov v kostnem mozgu.
English: One CR /CRh*responder with missing MRD data was considered as a MRDnonresponder.
Slovenian: En bolnik z odzivom CR/CRh* z manjkajočimi podatki o MRD je bil upoštevan kot bolnik, ki ni dosegel MRD odziva.
English: Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.
Slovenian: Bolnike, zdravljene z zdravili, ki so substrati CYP450 in prenašalcev ter imajo ozek terapevtski indeks, je treba med tem časom spremljati glede neželenih učinkov (npr. med uporabo varfarina) ali koncentracije zdravila (npr. med uporabo ciklosporina).
English: The safety and efficacy of BLINCYTO in children < 1 year of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila BLINCYTO pri otrocih, mlajših od 1 leta, še nista dokazani.
English: Treatment with BLINCYTO was associated with transient elevations in liver enzymes.
Slovenian: Zdravljenje z zdravilom BLINCYTO je bilo povezano s prehodnimi zvišanji jetrnih encimov.
English: Consistent immune-pharmacodynamic responses were observed in patients studied.
Slovenian: Pri proučevanih bolnikih so opažali konsistentne imunofarmakodinamične odzive.
English: Partial remission was defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.
Slovenian: Delna remisija je bila opredeljena kot 6 do 25 % blastov v kostnem mozgu in vsaj 50 % zmanjšanje od izhodišča.
English: • rapid heart rate (tachycardia)
Slovenian: • hitro bitje srca (tahikardija)
English: Like other protein therapeutics, blinatumomab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Slovenian: Verjetno se blinatumomab, podobno kot druga beljakovinska zdravila, po kataboličnih poteh razgradi v majhne peptide in aminokisline.
English: 3 patients < 1 year of age refractory to prior treatment and without prior alloHSCT received one cycle of Blincyto at a dose of 5-15 µg/m2/day.
Slovenian: Trije bolniki, mlajši od 1 leta, ki so bili refraktarni na predhodno zdravljenje in jim pred tem niso opravili alogenske presaditve krvotvornih matičnih celic, so prejeli en ciklus zdravila BLINCYTO v odmerku 5-15 µg/m2/dan.
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.
Slovenian: Med 267 bolniki, ki so prejemali zdravilo BLINCYTO, je bilo povprečno število dokončanih ciklusov zdravljenja 2,0; med 109 bolniki, ki so prejemali standardno kemoterapijo, je bilo povprečno število ciklusov zdravljenja 1,3.
English: Unopened vials:
Slovenian: Neodprte viale:
English: If formation of anti-blinatumomab antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Slovenian: V primeru suma o nastajanju protiteles proti blinatumomabu s klinično pomembnim učinkom se za pogovor o testiranju za protitelesa obrnite na imetnika dovoljenja za promet z zdravilom.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar pomeni, da je praktično "brez natrija".
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).
Slovenian: Pred uvedbo zdravila BLINCYTO je priporočljivo opraviti nevrološki pregled, bolnike pa klinično spremljati glede znakov in simptomov nevroloških učinkov (npr. s testom pisanja).
English: Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal dysfunction and normal renal function.
Slovenian: Farmakokinetične analize so pokazale približno 2-kratno razliko povprečnega očistka blinatumomaba med bolniki z zmerno motenim delovanjem ledvic in bolniki z normalnim delovanjem ledvic.
English: Repeat-dose toxicity studies conducted with blinatumomab and the murine surrogate revealed the expected pharmacologic effects (including release of cytokines, decreases in leukocyte counts, depletion of B-cells, decreases in T-cells, decreased cellularity in lymphoid tissues).
Slovenian: Študije toksičnosti ponavljajočih se odmerkov, izvedene z blinatumomabom in mišjim nadomestkom, so pokazale pričakovane farmakološke učinke (vključno s sproščanjem citokinov, zmanjšanjem števila levkocitov, izčrpanjem celic B, zmanjšanjem števila celic T in zmanjšano celularnostjo v limfnem tkivu).
English: Acute lymphoblastic leukaemia is a cancer of the blood in which a particular kind of white blood cell called “B-lymphocyte” is growing out of control.
Slovenian: Akutna limfoblastna levkemija je krvni rak, pri katerem se nenadzorovano razraste posebna vrsta belih krvnih celic, ki jih imenujemo "limfociti B".
English: • nerve problems affecting the head and neck such as visual disturbances, drooping eyelid and/or sagging muscles on one side of the face, difficulty hearing or trouble swallowing
Slovenian: • težave z živčevjem, ki prizadenejo glavo in vrat, kot so motnje vida, viseče veke in/ali tresenje mišic na eni strani obraza, težave s sluhom ali težave pri požiranju (motnje v kranialnem živčevju)
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).
Slovenian: Posledično je treba novorojenčke spremljati glede izčrpanja celic B in cepljenja z živimi virusnimi cepivi odložiti, dokler se število celic B pri dojenčku ne povrne v normalno območje (glejte poglavje 4.4).
English: The treated population included 116 patients who received at least one infusion of BLINCYTO; the mean number of completed treatment cycles was 1.8 (range: 1 to 4).
Slovenian: Zdravljena populacija je obsegala 116 bolnikov, ki so dobili vsaj eno infuzijo zdravila BLINCYTO; povprečno število dokončanih ciklusov zdravljenja je bilo 1,8 (razpon: od 1 do 4).
English: The adverse reactions in BLINCYTO-treated paediatric patients were similar in type to those seen in adult patients.
Slovenian: Neželeni učinki pri pediatričnih bolnikih, zdravljenih z zdravilom BLINCYTO, so bili podobni tistim, ki so jih opazili pri odraslih bolnikih.
English: The nurse educational material should contain:
Slovenian: Izobraževalno gradivo za medicinske sestre mora vsebovati:
English: e for CR /CRh* [95% CI]
Slovenian: e za CR/CRh* [95 % IZ]
English: • Description on patient's monitoring and management of early signs and symptoms of neurological events
Slovenian: • Opis za spremljanje bolnikov in obvladovanje zgodnjih znakov in simptomov nevroloških učinkov.
English: Complete remission (CR) CR a/CRh*
Slovenian: Popolna remisija (CR - Complete Remission) CR a/CRh*
English: From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the reconstituted solution should be diluted immediately.
Slovenian: Z mikrobiološkega stališča je treba rekonstituirano raztopino razredčiti takoj, razen če postopek rekonstitucije preprečuje tveganje za mikrobno kontaminacijo.
English: Do not use if the solution is cloudy or has precipitated.
Slovenian: Ne uporabite, če je raztopina motna ali je precipitirala.
English: Hepatic enzyme increased includes alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased and transaminases increased.
Slovenian: Zvišanje jetrnih encimov obsega zvišanje alanin-aminotransferaze, zvišanje aspartat-aminotransferaze, zvišanje gama-glutamiltransferaze, zvišanje jetrnih encimov in zvišanje transaminaz.
English: The pharmacokinetics of blinatumomab in patients with MRD positive B-precursor ALL was similar to patients with relapsed or refractory ALL.
Slovenian: Farmakokinetika blinatumomaba pri MRD-pozitivnih bolnikih z ALL predhodniških celic B je bila podobna kot pri bolnikih z recidivno ali refraktarno ALL.
English: The treated population included 189 patients who received at least 1 infusion of BLINCYTO; the mean number of cycles per patient was 1.6.
Slovenian: Zdravljena populacija je obsegala 189 bolnikov, ki so dobili vsaj 1 infuzijo zdravila BLINCYTO; povprečno število ciklusov na bolnika je bilo 1,6.
English: Patients should be closely monitored for signs and symptoms of pancreatitis.
Slovenian: Bolnike je treba natančno kontrolirati glede znakov in simptomov pankreatitisa.
English: • The addition of water for injections to the powder for concentrate results in a total volume of 3.08 mL for a final BLINCYTO concentration of 12.5 mcg/mL.
Slovenian: • Z dodatkom vode za injekcije prašku za koncentrat nastane celotna količina 3,08 ml za končno koncentracijo zdravila BLINCYTO 12,5 µg/ml.
English: The adverse reactions described in this section were identified in clinical studies of patients with B-precursor ALL (N = 843).
Slovenian: Neželene učinke, opisane v tem poglavju, so ugotovili v kliničnih študijah pri bolnikih, ki so imeli ALL predhodniških celic B (N = 843).
English: Induction Cycle 1 Days 1-28
Slovenian: Indukcijski ciklus 1 1.-28. dan
English: In clinical studies of adult ALL patients treated with BLINCYTO, less than 3% tested positive for anti-blinatumomab antibodies.
Slovenian: V kliničnih študijah odraslih bolnikov z ALL, zdravljenih z zdravilom BLINCYTO, je imelo pozitiven izvid protiteles proti blinatumomabu manj kot 3 % bolnikov.
English: BLINCYTO will be given to you through a vein (intravenous) continuously for 4 weeks using an infusion pump (this is 1 treatment cycle).
Slovenian: Zdravilo BLINCYTO boste z infuzijsko črpalko dobivali v veno (intravensko) neprekinjeno 4 tedne (to je 1 ciklus zdravljenja).
English: For patients with ≥ 50% leukaemic blasts in bone marrow or > 15,000/microlitre peripheral blood leukaemic blast counts treat with dexamethasone (not to exceed 24 mg/day).
Slovenian: Bolnike, ki imajo ≥ 50 % levkemičnih blastov v kostnem mozgu ali > 15.000 levkemičnih blastov/mikroliter v periferni krvi, zdravite z deksametazonom (odmerek naj ne preseže 24 mg/dan).
English: • Reminder to counsel the patients on how to reduce the risk of ME while using the infusion pump.
Slovenian: • Opomnik, da se je treba z bolnikom pogovoriti o načinu zmanjšavanja tveganja za napake pri uporabi zdravila, med uporabo infuzijske črpalke.
English: Due to the potential depletion of B-cells in newborns following exposure to blinatumomab during pregnancy, 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 4.6).
Slovenian: Zato ker pri novorojenčkih obstaja možnost izčrpanja celic B po izpostavljenosti blinatumomabu med nosečnostjo, je treba novorojenčke spremljati glede izčrpanja celic B in cepljenja z živimi virusnimi cepivi odložiti, dokler se število celic B pri dojenčku ne povrne v normalno območje (glejte poglavje 4.6).
English: This belongs to a group of medicines called antineoplastic agents which target cancer cells.
Slovenian: Blinatumomab spada v skupino zdravil, ki jih imenujemo antineoplastična zdravila in so usmerjena proti rakavim celicam.
English: Recommended daily dose is by patient weight.
Slovenian: Priporočeni dnevni odmerek se določi glede na bolnikovo telesno maso.
English: Treatment with BLINCYTO can cause a decrease in the levels of certain white blood cells with or without fever (febrile neutropenia or neutropenia) or can lead to increased blood levels of potassium, uric acid, and phosphate and decreased blood levels of calcium (tumour lysis syndrome).
Slovenian: Zdravljenje z zdravilom BLINCYTO lahko povzroči zmanjšanje števila določenih belih krvnih celic z zvišano telesno temperaturo ali brez nje (febrilna nevtropenija ali nevtropenija) ali lahko zviša koncentracijo kalija, sečne kisline in fosfata in zniža koncentracijo kalcija v krvi (sindrom lize tumorja).
English: Patients experiencing capillary leak syndrome should be managed promptly.
Slovenian: Bolnike s sindromom povečane prepustnosti kapilar je treba nemudoma zdraviti.
English: No dose adjustment is necessary in elderly patients (≥ 65 years of age), see section 5.1.
Slovenian: Starejšim bolnikom (≥ 65 let) odmerka ni treba prilagoditi (glejte poglavje 5.1).
English: Intravenous use after reconstitution and dilution.
Slovenian: Intravenska uporaba po rekonstituciji in razredčitvi.
English: • if you have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
Slovenian: • če imate hude in trdovratne bolečine v trebuhu, s slabostjo v želodcu (siljenjem na bruhanje) in bruhanjem ali brez njiju, ker so to lahko simptomi resne bolezni, imenovane pankreatitis (vnetje trebušne slinavke), ki je lahko smrtna.
English: Greater than or equal to 45 kg (fixed-dose)
Slovenian: 45 kg ali več (fiksni odmerek)
English: Leukoencephalopathy has been reported.
Slovenian: Poročali so o primerih levkoencefalopatije.
English: Complete MRD response a, n/N (%), [95% CI]
Slovenian: Popoln MRD odziv a, n/N (%), [95 % IZ]
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).
Slovenian: Kategorije pogostnosti so določene na podlagi grobih incidenčnih deležev, poročanih za vsakega od neželenih učinkov v kliničnih študijah pri bolnikih, ki so imeli ALL predhodniških celic B (N = 843).
English: 4.5 months (3.6, 9.0)
Slovenian: 4,5 mesecev (3,6; 9,0)
English: BLINCYTO is usually given for 2 treatment cycles if you have relapsed/refractory acute lymphoblastic leukaemia, or for 1 treatment cycle if you have minimal residual disease acute lymphoblastic leukaemia.
Slovenian: Zdravilo BLINCYTO se po navadi uporablja 2 ciklusa zdravljenja, če imate recidivno/refraktarno akutno limfoblastno levkemijo, ali 1 ciklus zdravljenja, če imate akutno limfoblastno levkemijo z minimalno rezidualno boleznijo.
English: Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Slovenian: Blinatumomab je pridobljen iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
English: If you have relapsed/refractory acute lymphoblastic leukaemia and your body weight is greater than or equal to 45 kilograms the recommended initial dose in your first cycle is 9 micrograms per day for 1 week.
Slovenian: Če imate recidivno/refraktarno akutno limfoblastno levkemijo in je vaša telesna masa enaka 45 kg ali večja, je priporočeni začetni odmerek v prvem ciklusu 9 mikrogramov na dan 1 teden.
English: Neurologic events
Slovenian: Nevrološki učinki