FrancophonIA/ELRC3.0 huggingface dataset:
English: tumour lysis syndrome, neurological toxicity, elevated liver enzymes and any other clinically relevant toxicities.
Slovenian: (glejte poglavje 4.4): sindroma sproščanja citokinov, sindroma lize tumorja, nevrotoksičnosti, zvišanja jetrnih encimov ali kakršnih koli drugih klinično pomembnih toksičnih učinkov.
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.
Slovenian: • zvišana telesna temperatura, oteklost, mrzlica, znižanje ali zvišanje krvnega tlaka in tekočina v pljučih, ki lahko postanejo hudi - to so lahko znaki tako imenovanega sindroma sproščanja citokinov.
English: leukopenia), decreased levels of red blood cells, decreased levels of platelets
Slovenian: ((febrilna) nevtropenija, levkopenija), zmanjšano števila rdečih krvnih celic, zmanjšanje števila krvnih ploščic
English: The patient (including caregivers) educational material should contain: The patient information guide, including the following key elements:
Slovenian: Izobraževalno gradivo za bolnike (vključno s skrbniki) mora vsebovati:
English: One vial of powder contains 38.5 micrograms blinatumomab.
Slovenian: Ena viala s praškom vsebuje 38,5 mikrogramov blinatumomaba.
English: < 1 year old achieved a CR/CRh
Slovenian: 3 bolnikov, mlajših od 1 leta, ni dosegel CR/CRh
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).
Slovenian: Med zdravljenjem z zdravilom BLINCYTO so poročali o sindromu sproščanja citokinov (CRScytokine release syndrome), ki je lahko smrtno nevaren ali smrten (≥ 4. stopnja) (glejte poglavje 4.8).
English: For all subsequent cycle starts and reinitiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalisation is recommended.
Slovenian: Nadzor zdravnika ali sprejem v bolnišnico sta priporočljiva na začetku vseh nadaljnjih ciklusov in za vse ponovne začetke (npr. po prekinitvi zdravljenja, ki je trajala 4 ure ali več).
English: • Nurse educational material
Slovenian: • Izobraževalno gradivo za medicinske sestre
English: • Remarks on the importance of reporting ADRs
Slovenian: • Pojasnilo o pomembnosti poročanja neželenih učinkov zdravila.
English: Talk to your doctor, pharmacist or nurse before using BLINCYTO if any of these apply to you.
Slovenian: Pred začetkom uporabe zdravila BLINCYTO se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če kar koli od naslednjega velja za vas.
English: Transient elevation of cytokines was observed in the first two days following start of blinatumomab infusion.
Slovenian: V prvih dveh dneh po začetku infundiranja blinatumomaba so opažali prehodno zvišanje citokinov.
English: • Infusion rate of 3.3 mL/h for a duration of 72 hours
Slovenian: • Hitrost infundiranja 3,3 ml/uro v trajanju 72 ur
English: 5 mL/hour
Slovenian: 5 ml/uro
English: One vial of powder contains 38.5 micrograms of blinatumomab.
Slovenian: Ena viala praška vsebuje 38,5 mikrogramov blinatumomaba.
English: 5-free survival (RFS) for CR/CRh*
Slovenian: Preživetje brez recidiva pri CR/CRh*
English: Elevated liver enzyme events were reported for 12.4% of adult patients with MRD positive B-precursor ALL (N = 137).
Slovenian: O učinkih zvišanja jetrnih encimov so poročali pri 12,4 % odraslih MRD-pozitivnih bolnikih z ALL predhodniških celic B (N = 137).
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.
Slovenian: Zdravilo BLINCYTO raztopina za infundiranje se uporablja v kontinuirani intravenski infuziji z infuzijsko črpalko in stalno hitrostjo dotoka v obdobju do 96 ur.
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.
Slovenian: O učinkih ≥ 3. stopnje so poročali pri 16,1 % in o učinkih ≥ 4. stopnje pri 2,2 % odraslih MRD-pozitivnih bolnikih z ALL predhodniških celic B.
English: • nausea, diarrhoea, vomiting, constipation, abdominal pain
Slovenian: • siljenje na bruhanje, driska, bruhanje, zaprtje, bolečine v trebuhu
English: Infusion catheter
Slovenian: Infuzijski kateter
English: Always use this medicine exactly as your doctor, pharmacist or nurse have told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
English: No anti-blinatumomab antibodies were detected in clinical studies of paediatric patients with relapsed or refractory ALL treated with blinatumomab.
Slovenian: V kliničnih študijah pri pediatričnih bolnikih z recidivno ali refraktarno ALL, zdravljenih z blinatumomabom, niso zaznali protiteles proti blinatumomabu.
English: Solution (stabiliser)
Slovenian: Raztopina (stabilizator)
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.
Slovenian: faze z eno samo skupino (N = 189), je 66,0 % bolnikov imelo enega ali več nevroloških neželenih učinkov (vključno s psihiatričnimi motnjami), predvsem na osrednjem živčevju.
English: Use an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection that usually contains a total volume of 265 to 275 mL.
Slovenian: Uporabite napolnjeno infuzijsko vrečko z 250 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, ki običajno vsebuje celoten volumen od 265 do 275 ml. Za oblogo infuzijske vrečke z uporabo brizge aseptično prenesite 5,5 ml raztopine (stabilizatorja) v infuzijsko vrečko.
English: Percent Achieving CR/CRh*
Slovenian: Odstotek bolnikov, ki so dosegli CR/CRh*
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).
Slovenian: Zdravilo BLINCYTO je indicirano kot monoterapija za zdravljenje odraslih bolnikov s CD19-pozitivno recidivno ali refraktarno akutno limfoblastno levkemijo (ALL - acute lymphoblastic leukaemia) predhodniških celic B z negativnim Philadelphia kromosomom.
English: Convulsion Discontinue BLINCYTO permanently if more than one convulsion occurs.
Slovenian: Nevrotoksičnost Konvulzije Če se pojavi več kot en napad konvulzij, trajno prenehajte uporabljati zdravilo
English: IV after reconstitution and dilution
Slovenian: uporaba po rekonstituciji in razredčitvi
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).
Slovenian: V 13 tedenskih študijah toksičnosti z mišjo nadomestno molekulo niso ugotovili neželenih učinkov na reproduktivne organe samic in samcev (glejte poglavje 5.3).
English: 5 Leukocytosis includes leukocytosis and white blood cell count increased.
Slovenian: Levkocitoza obsega levkocitozo in povečanje števila belih krvnih celic.
English: • Recommendation for patients not to drive while receiving BLINCYTO A link to the package leaflet
Slovenian: • Priporočilo za bolnike, da v času prejemanja zdravila BLINCYTO, ne vozijo.
English: Headache Tremor
Slovenian: • vročinski oblivi
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.
Slovenian: Med 2-tedenskim obdobjem brez zdravila med ciklusi zdravljenja niso opazili porasta števila perifernih celic B. Nepopolno izčrpanje celic B se je pojavilo pri odmerkih 0,5 µg/m 2/dan in 1,5 µg/m 2/dan in pri maloštevilnih neodzivnih bolnikih pri večjih odmerkih.
English: BLINCYTO contains sodium
Slovenian: Zdravilo BLINCYTO vsebuje natrij
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).
Slovenian: Za vključitev so bili primerni bolniki, stari ≥ 18 let, ki so imeli recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom (recidiv s trajanjem prve remisije ≤ 12 mesecev med prvim rešilnim, ali recidiv ali refraktarnost po prvem rešilnem zdravljenju, ali recidiv v 12 mesecih po alogenski presaditvi krvotvornih matičnih celic ter ≥ 10 % blastov v kostnem mozgu).
English: • Pharmacist educational material
Slovenian: • Izobraževalno gradivo za farmacevte
English: Median, years (min, max) Mean, years (SD) ≥ 65 Years, n (%) Prior salvage therapy
Slovenian: Mediana, leta (največja in najmanjša vrednost) Povprečje, leta (standardni odklon) ≥ 65 let, n (%)
English: No formal pharmacokinetic studies of blinatumomab have been conducted in patients with hepatic impairment.
Slovenian: Formalnih farmakokinetičnih študij blinatumomaba pri bolnikih z okvaro jeter niso izvedli.
English: • Infusion rate of 10 mL/h for a duration of 24 hours
Slovenian: • Hitrost infundiranja 10 ml/uro v trajanju 24 ur
English: For clinical management of elevated liver enzymes, see section 4.4.
Slovenian: Za informacije o kliničnem obvladovanju zvišanja jetrnih encimov glejte poglavje 4.4.
English: Medicines given before each cycle of BLINCYTO
Slovenian: Pred vsakim ciklusom zdravila BLINCYTO boste dobili zdravila
English: BLINCYTO powder (powder for concentrate): White to off-white powder.
Slovenian: prašek za koncentrat in raztopina za raztopino za infundiranje Prašek BLINCYTO (prašek za koncentrat): Bel ali skoraj bel prašek.
English: Table 9.
Slovenian: Preglednica 9.
English: Weight increased Blood alkaline phosphatase increased
Slovenian: znižanje imunoglobulinov povečanje telesne mase zvišana alkalna fosfataza v krvi
English: If clinically relevant, interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Slovenian: Če je klinično primerno, prekinite uporabo zdravila BLINCYTO, dokler učinek ni največ 1. stopnje (blag), nato začnite zdravilo znova uporabljati v odmerku 5 µg/m2/dan.
English: SOC chemotherapy (N = 134)
Slovenian: Standardna kemoterapija (N=134)
English: 3.3 mL/hour
Slovenian: 3,3 ml/uro
English: Discard any remaining BLINCYTO reconstituted solution.
Slovenian: Ves preostanek rekonstituirane raztopine zdravila BLINCYTO zavrzite.
English: This should be followed by dexamethasone 5 mg/m orally or intravenously within 30 minutes prior to the start of
Slovenian: Temu mora slediti 5 mg/m deksametazona peroralno ali intravensko v roku 30 minut pred začetkom dajanja zdravila BLINCYTO (1. ciklus, 1. dan).
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.
Slovenian: faze z eno samo skupino (N = 189), so pri 22,4 % bolnikov poročali o zvišanju jetrnih encimov in s tem povezanimi znaki/simptomi.
English: Discontinue BLINCYTO permanently.
Slovenian: Trajno prenehajte uporabljati zdravilo BLINCYTO.
English: Table 7 provides instructions for patients weighing greater than or equal to 45 kg, whereas table 8 and table 9 provide instructions for patients weighing less than 45 kg.
Slovenian: V preglednici 7 so navodila za bolnike, ki tehtajo 45 kg ali več, v preglednicah 8 in 9 pa so navodila za bolnike, ki tehtajo manj kot 45 kg. Sledite korakom za rekonstitucijo zdravila BLINCYTO in pripravo infuzijske vrečke, kot je opisano pod preglednico 9.
English: What BLINCYTO contains
Slovenian: Kaj vsebuje zdravilo BLINCYTO
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.
Slovenian: faze in III. faze je bilo zdravilu BLINCYTO izpostavljenih skupaj 456 bolnikov, starih ≥ 18 let, z recidivno ali refraktarno ALL predhodniških celic B.
English: The metabolic pathway of blinatumomab has not been characterised.
Slovenian: Pot presnove blinatumomaba ni ugotovljena.
English: • 1 glass vial containing a colourless-to-slightly yellow, clear solution.
Slovenian: • 1 stekleno vialo, ki vsebuje brezbarvno do rumenkasto, bistro raztopino.
English: Sodium chloride 9 mg/mL (0.9%) (starting volume)
Slovenian: Natrijev klorid 9 mg/ml (0,9 %) (začetni volumen)
English: Management of these signs and symptoms to resolution may require either temporary interruption or permanent discontinuation of BLINCYTO (see section 4.2).
Slovenian: Obvladovanje teh znakov in simptomov, tako da minejo, lahko zahteva začasno prekinitev ali trajno prenehanje uporabe zdravila BLINCYTO (glejte poglavje 4.2).
English: Patients in 2
Slovenian: Bolniki v drugi CR
English: Increase of T-cell counts above baseline (T-cell expansion) was observed in few patients.
Slovenian: Pri nekaj bolnikih so opazili povečanje števila celic T nad izhodiščno število (ekspanzija celic T).
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.
Slovenian: Mediana celokupnega preživetja je bila v skupini s standardno kemoterapijo 4,0 mesece (95 % IZ: 2,9; 5,3) in v skupini z zdravilom BLINCYTO 7,7 meseca (95 % IZ: 5,6; 9,6).
English: • decreased levels of red blood cells (anaemia), decreased levels of platelets
Slovenian: • znižano raven rdečih krvnih celic (anemijo), znižano raven trombocitov (trombocitopenijo),
English: 28 mcg/day
Slovenian: 28 µg/dan
English: Grade 3 If clinically relevant, interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 9 mcg/day.
Slovenian: 3. stopnja Če je klinično primerno, prekinite uporabo zdravila BLINCYTO, dokler učinek ni največ 1. stopnje (blag), nato začnite zdravilo znova uporabljati v odmerku 9 µg/dan.
English: Life-threatening or fatal (grade ≥ 4) viral, bacterial and fungal infections have been reported in patients treated with BLINCYTO.
Slovenian: Pri bolnikih, zdravljenih z zdravilom BLINCYTO, so poročali o smrtno nevarnih ali smrtnih (≥ 4. stopnje ) virusnih, bakterijskih in glivnih okužbah.
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may be severe and can be fatal (cytokine storm)
Slovenian: • zvišana telesna temperatura, oteklost, mrzlica, znižan ali zvišan krvni tlak in tekočina v pljučih, ki so lahko hudi in so lahko smrtni (t.i. citokinski vihar)
English: For clinical management of pancreatitis, see section 4.4.
Slovenian: Za klinično obravnavo pankreatitisa glejte poglavje 4.4.
English: Your next cycles
Slovenian: Naslednji ciklusi zdravljenja
English: Lymphopenia includes lymphocyte count decreased and lymphopenia.
Slovenian: 6 Limfopenija obsega zmanjšanje števila limfocitov in limfocitopenijo.
English: • reactions related to infusion may include face swelling, low blood pressure, high blood pressure (infusion-related reaction)
Slovenian: • reakcije, povezane z infundiranjem, lahko vključujejo otekanje obraza, nizek krvni tlak,
English: The safety and efficacy of BLINCYTO have not been studied in patients with severe renal impairment.
Slovenian: Varnost in učinkovitost zdravila BLINCYTO pri bolnikih s hudo okvaro ledvic nista raziskani.
English: How BLINCYTO is given
Slovenian: Kako se daje zdravilo BLINCYTO
English: 9 mcg/day.
Slovenian: 9 µg/dan
English: Table 1 provides instructions for patients weighing greater than or equal to 45 kg whereas table 2 and table 3 provide instructions for patients weighing less than 45 kg.
Slovenian: V preglednici 1 so navodila za bolnike, ki tehtajo 45 kg ali več, v preglednicah 2 in 3 pa so navodila za bolnike, ki tehtajo manj kot 45 kg. Sledite korakom za rekonstitucijo zdravila BLINCYTO in pripravo infuzijske vrečke, kot je opisano pod preglednico 3.
English: Infusion duration Infusion rate BSA (m
Slovenian: Telesna površina (BSA) (m
English: Extramedullary Disease at Baseline
Slovenian: Ekstramedularna bolezen v izhodišču Da
English: b/CRi c, n (%) [95% CI] Treatment difference [95% CI] p-value CR, n (%) [95% CI] Treatment difference [95% CI] p-value Event-free survival d
Slovenian: b/CRi c, n (%) [95 % IZ] Razlika med zdravljenjema [95 % IZ] p-vrednost
English: BLINCYTO 38.5 mcg powder for concentrate blinatumomab
Slovenian: BLINCYTO 38,5 µg prašek za koncentrat blinatumomab i.v.
English: Unopened vials
Slovenian: Neodprte viale
English: The safety and efficacy of BLINCYTO have not been studied in patients with severe hepatic impairment.
Slovenian: Varnost in učinkovitost zdravila BLINCYTO pri bolnikih s hudo okvaro jeter nista raziskani.
English: Additional information is provided in “Description of selected adverse reactions”.
Slovenian: Poškodbe, zastrupitve in zapleti postopkov z infundiranjem povezane reakcije a Dodatne informacije so navedene pod naslovom "Opis izbranih neželenih učinkov".
English: Patient weight
Slovenian: Bolnikova telesna masa
English: Efficacy results in patients < 18 years of age with relapsed or refractory B-cell precursor ALL
Slovenian: Rezultati učinkovitosti pri bolnikih, starih < 18 let, ki so imeli recidivno ali refraktarno ALL predhodniških celic B
English: Table 7.
Slovenian: Preglednica 7.
English: Pancreatitis, life-threatening or fatal, has been reported in patients receiving BLINCYTO in clinical trials and the post-marketing setting.
Slovenian: V kliničnih preskušanjih in po prihodu zdravila BLINCYTO na trg so pri bolnikih, ki so prejemali to zdravilo, poročali o pankreatitisu, ki je bil smrtno nevaren ali se je končal s smrtnim izidom.
English: The safety of BLINCYTO has not been studied in patients with severe renal impairment.
Slovenian: Varnost zdravila BLINCYTO pri bolnikih s hudo okvaro ledvic ni raziskana.
English: Postbaseline alloHSCT - n (%) Overall subjects Hematological responders (CR/CRh*/CRi) Time to alloHSCT among all transplanted patients Median time to event (Interquartile range)
Slovenian: Čas do alloHSCT med vsemi bolniki s presaditvijo Mediana časa do dogodka (interkvartilni obseg)
English: For clinical management of neurologic events, see section 4.4.
Slovenian: Za informacije o kliničnem obvladovanju nevroloških učinkov glejte poglavje 4.4.
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).
Slovenian: Opažali so jih zlasti pri bolnikih, predhodno zdravljenih z obsevanjem lobanje in antilevkemično kemoterapijo (vključno z visokimi sistemskimi odmerki metotreksata ali intratekalnega citarabina).
English: The anti-tumour activity of blinatumomab immunotherapy is not dependent on T-cells bearing a specific TCR or on peptide antigens presented by cancer cells, but is polyclonal in nature and independent of human leukocyte antigen (HLA) molecules on target cells.
Slovenian: Blinatumomab je bispecifičen T-celični povezovalec, konstrukt protiteles, ki se specifično veže na CD19, izražen na površini celic z izvorom v liniji B, ter na CD3, izražen na površini celic T. Aktivira endogene celice T, in sicer tako, da poveže CD3 v receptorskem kompleksu celic T (TCR) s CD19 na benignih in malignih celicah B. Protitumorska aktivnost imunoterapije z blinatumomabom ni odvisna od specifičnega TCR na celicah T in tudi ne od peptidnih antigenov, ki jih predstavijo rakave celice, temveč je po svoji naravi poliklonska in neodvisna od molekul humanega levkocitnega antigena (HLA) na ciljnih celicah.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC
English: Pre-filled bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
Slovenian: Napolnjena vrečka z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje
English: b. CRh*was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre) and no relapse within 28 days.
Slovenian: b. CRh* je bila opredeljena kot kostni mozeg M1 (≤ 5 % blastov v kostnem mozgu), brez znakov blastov v obtoku ali ekstramedularne bolezni, ter delno okrevanje periferne krvne slike (trombociti > 50.000/mikroliter in ANC > 500/mikroliter) ter brez relapsa v roku 28 dni.
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.
Slovenian: Incidenca resnih okužb je bila pri bolnikih z recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom z izhodiščnim stanjem zmogljivosti 2 po ECOG večja kot pri bolnikih s stanjem zmogljivosti < 2 po ECOG. Za informacije o kliničnem obvladovanju okužb glejte poglavje 4.4.
English: POWDER VIAL
Slovenian: VIALA S PRAŠKOM
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.
Slovenian: faze pri odraslih bolnikih z recidivno ali refraktarno ALL predhodniških celic B in pri 1 bolniku v klinični študiji II.
English: - The other ingredients in the powder are citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80, and sodium hydroxide.
Slovenian: - Druge sestavine v prašku so citronska kislina monohidrat (E330), trehaloza dihidrat, lizinijev klorid, polisorbat 80 in natrijev hidroksid.
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)
Slovenian: Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, ki so imeli recidivno ali refraktarno akutno limfoblastno levkemijo (ALL) predhodniških celic B z negativnim Philadelphia kromosomom n (%) n = 189
English: Sodium chloride 9 mg/mL (0.9%) solution for injection (starting volume)
Slovenian: Natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje (začetni volumen)
English: - Do not freeze.
Slovenian: - Ne zamrzujte.
English: Visually inspect the reconstituted solution for particulate matter and discolouration during reconstitution and prior to infusion.
Slovenian: Med rekonstitucijo in pred infundiranjem preglejte rekonstituirano raztopino glede delcev in spremembe barve.
English: BLINCYTO 271
Slovenian: zdravilo BLINCYTO 271 Standardna kemoterapija
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.
Slovenian: faze z eno samo skupino (N = 189), so pri 2,4 % bolnikov poročali o resnih reakcijah sindroma sproščanja citokinov z mediana časom do njihovega pojava 2 dni.
English: There were no effects on male or female reproductive organs in toxicity studies with the murine surrogate.
Slovenian: V študijah toksičnosti z mišjim nadomestkom niso ugotovili učinkov na reproduktivne organe samcev ali samic.
English: (thrombocytopenia), decreased levels of certain white blood cells (leukopenia)
Slovenian: znižano raven nekaterih belih krvnih celic (levkopenijo)
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may become severe (cytokine release syndrome)
Slovenian: • zvišana telesna temperatura, oteklost, mrzlica, zvišan ali znižan krvni tlak in tekočina v pljučih, ki lahko postanejo hudi (sindrom sproščanja citokinov)
English: Diarrhoea Vomiting Constipation Abdominal pain
Slovenian: Žilne bolezni hipotenzija hipertenzija vročinski oblivi sindrom povečane prepustnosti kapilar