FrancophonIA/ELRC3.0 huggingface dataset:
English: What BLINCYTO looks like and contents of the pack
Slovenian: Izgled zdravila BLINCYTO in vsebina pakiranja
English: Grade 4 Consider discontinuing BLINCYTO permanently.
Slovenian: 4. stopnja Razmislite o trajnem prenehanju uporabe zdravila BLINCYTO.
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%.
Slovenian: Zdravilo BLINCYTO je indicirano kot monoterapija za zdravljenje odraslih bolnikov s CD19-pozitivno ALL predhodniških celic B z negativnim Philadelphia kromosomom pri prvi ali drugi popolni remisiji z vrednostjo minimalne rezidualne bolezni (MRD - minimal residual disease), ki je večja ali enaka 0,1 %.
English: Serious adverse events that may be signs and symptoms of CRS included pyrexia, asthenia, headache, hypotension, total bilirubin increased, and nausea; uncommonly, these events led to BLINCYTO discontinuation.
Slovenian: Med resnimi neželenimi učinki, ki so lahko znaki in simptomi sindroma sproščanja citokinov, so zvišana telesna temperatura, astenija, glavobol, hipotenzija, zvišan celokupni bilirubin in navzea; občasno so ti učinki povzročili trajno prenehanje zdravljenja z zdravilom BLINCYTO.
English: The estimated mean (SD) volume of distribution (Vz), clearance (CL) and terminal half-life (t1/2,z) were 3.91 (3.36) L/m2, 1.88 (1.90) L/hr/m and 2.19 (1.53) hours, respectively.
Slovenian: Ocenjeni povprečni (standardni odklon) volumen porazdelitve (Vz) je bil 3,91 (3,36) l/m2, ocenjeni povprečni (standardni odklon) očistek (Cl) je bil 1,88 (1,90) l/h/m in ocenjena povprečna (standardni odklon) končna razpolovna doba (t1/2,z) 2,19 (1,53) ure.
English: CR Duration of complete MRD response [95% CI]
Slovenian: Trajanje popolnega MRD odziva [95 % IZ]
English: Infusion pump and intravenous tubing
Slovenian: Infuzijska črpalka in intravenska cevka
English: However patients have been treated with blinatumomab in clinical studies after clearance of CSF blasts with CNS directed therapy (such as intrathecal chemotherapy).
Slovenian: So pa v kliničnih študijah z blinatumomabom zdravili bolnike po odpravi blastov v cerebrospinalni tekočini z zdravljenjem, usmerjenim na osrednje živčevje (npr. z intratekalno kemoterapijo).
English: • Patient / caregivers educational material
Slovenian: • Izobraževalno gradivo za bolnike/skrbnike
English: 9 Hypertension includes blood pressure increased and hypertension.
Slovenian: Hipertenzija obsega zvišan krvni tlak in hipertenzijo.
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.
Slovenian: Za zdravljenje recidivne ali refraktarne ALL predhodniških celic B z negativnim Philadelphia kromosomom je za uvedbo priporočljiv sprejem v bolnišnico, in sicer vsaj za prvih 9 dni prvega ciklusa in za prva 2 dneva drugega ciklusa.
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.
Slovenian: Za zdravljenje MRD-pozitivne ALL predhodniških celic B z negativnim Philadelphia kromosomom je priporočljiv sprejem v bolnišnico vsaj za prve 3 dni prvega ciklusa in prva 2 dneva nadaljnjih ciklusov.
English: • if you develop a reaction at any time during your infusion, which may include dizziness, feeling faint, nauseated, face swelling, difficulty breathing, wheezing, or rash.
Slovenian: • če se vam kadar koli med infundiranjem zdravila pojavi reakcija, ki lahko obsega omotico, omedlevico, siljenje na bruhanje, oteklost obraza, težko dihanje, piskajoče dihanje ali izpuščaj.
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.
Slovenian: Incidenca resnih okužb je bila večja pri odraslih bolnikih z izhodiščnim stanjem zmogljivosti 2 po ECOG (Eastern Cooperative Oncology Group) kot pri bolnikih z izhodiščnim stanjem zmogljivosti < 2 po ECOG.
English: Consistent results were observed after censoring at the time of HSCT; median OS, censored at the time of HSCT, was 6.9 months (95% CI: 5.3, 8.8) in the BLINCYTO group and 3.9 months (95% CI: 2.8, 4.9) in the SOC group (HR, 0.66; 95% CI: 0.50, 0.88; p value = 0.004).
Slovenian: Konsistentne rezultate so opazili po krnitvi ob času HSCT; mediana celokupnega preživetja, krnjena ob času HSCT, je bila v skupini z zdravilom BLINCYTO 6,9 meseca (95 % IZ: 5,3; 8,8) in v skupini s standardnim zdravljenjem 3,9 meseca (95 % IZ: 2,8 do 4,9) (razmerje ogroženosti 0,66; 95 % IZ: 0,50; 0,88, p-vrednost = 0,004).
English: f. Only patients with HSCT in CR/CRh* remission (with no anti-leukemia agents used prior to HSCT) are included.
Slovenian: f. Vključeni so samo bolniki, ki so jim pred tem opravili presaditev krvotvornih matičnih celic, in so v remisiji CR/CRh* (pri katerih pred presaditvijo krvotvornih matičnih celic niso uporabili antilevkemičnih učinkovin).
English: Infusion-related reactions is a composite term that includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion and event lasted <=2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, rash, tachypnea, swelling face, face oedema and rash erythematous.
Slovenian: Znižanje imunoglobulinov obsega znižanje imunoglobulinov G v krvi, znižanje globulinov, hipogamaglobulinemijo, hipoglobulinemijo in znižanje imunoglobulinov Z infundiranjem povezane reakcije so sestavljen izraz, ki obsega izraz z infundiranjem povezana reakcija in naslednje učinke, ki so se pojavili v prvih 48 urah po infundiranju in so trajali <= 2 dneva: zvišana telesna temperatura, sindrom sproščanja citokinov, hipotenzija, mialgija, akutna okvara ledvic, hipertenzija, izpuščaj, tahipneja, oteklost obraza, edem obraza in eritematozen izpuščaj.
English: Patients in 3
Slovenian: Bolniki v tretji CR
English: Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation in the relevant table below.
Slovenian: Preverite predpisani odmerek in čas infundiranja zdravila BLINCYTO ter izberite ustrezno pripravo odmerka po ustrezni spodnji preglednici.
English: No studies have been conducted to evaluate the effects of blinatumomab on fertility.
Slovenian: Študij za oceno vplivov blinatumomab na plodnost niso izvedli.
English: o Use only polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Slovenian: o Uporabljajte le poliolefinske, PVC ne-dietilheksilftalatne (ne-DEHP) ali etilvinilacetatne (EVA) infuzijske vrečke/kasete za črpalke.
English: For patients with Philadelphia chromosome negative relapsed or refractory B-precursor ALL and patients with MRD positive B-precursor ALL receiving BLINCYTO, consideration to discontinue BLINCYTO temporarily or permanently as appropriate should be made in the case of the following severe (grade 3) or life-threatening (grade 4) toxicities (see section 4.4): cytokine release syndrome,
Slovenian: Pri bolnikih z recidivno ali refraktarno ALL predhodniških celic B z negativnim Philadelphia kromosomom in MRD-pozitivnih bolnikih z ALL predhodniških celic B, ki prejemajo zdravilo BLINCYTO, začasno ali trajno prenehanje (kot je primerno) uporabe zdravila BLINCYTO pride v poštev v primeru naslednjih hudih (3. stopnja) ali smrtno nevarnih (4. stopnja) toksičnih učinkov
English: Disseminated intravascular coagulation (DIC) and capillary leak syndrome (CLS, e.g. hypotension, hypoalbuminaemia, oedema and haemoconcentration) have been commonly associated with CRS (see section 4.8).
Slovenian: Sindrom sproščanja citokinov sta pogosto spremljala diseminirana intravaskularna koagulacija in sindrom povečane prepustnosti kapilar (npr. hipotenzija, hipoalbuminemija, edemi in hemokoncentracija) (glejte poglavje 4.8).
English: A link to the Summary of Product Characteristics (SmPC) The nurse educational guide, including the following key elements:
Slovenian: Povezavo na Povzetek glavnih značilnosti zdravila (SmPC) Vodnik za medicinske sestre, ki vsebuje naslednje ključne točke:
English: Body surface area (0.37 to 2.70 m2) influences the pharmacokinetics of blinatumomab.
Slovenian: Na farmakokinetiko blinatumomaba vpliva telesna površina (od 0,37 do 2,70 m2).
English: RFS in patients with Philadelphia chromosome negative B-precursor ALL at 18 months censored at HSCT or postBLINCYTO chemotherapy was 54% (33%, 70%).
Slovenian: Pri bolnikih z ALL predhodniških celic B z negativnim Philadelphia kromosomom je bilo preživetje brez recidiva pri 18 mesecih, krnjeno ob presaditvi krvotvornih matičnih celic ali kemoterapiji po zdravljenju z zdravilom BLINCYTO, je bilo 54 % (33 %, 70 %).
English: The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 30 mcg/m2/day in paediatric patients.
Slovenian: Farmakokinetika blinatumomaba je pri pediatričnih bolnikih linearna v razponu odmerkov od 5 do 30 µg/m2/dan.
English: Cytokine release syndrome, tumour lysis syndrome
Slovenian: Sindrom sproščanja citokinov, sindrom lize tumorja
English: Using a syringe, aseptically transfer reconstituted BLINCYTO into the infusion bag (refer to table 7 to table 9 for the specific volume of reconstituted BLINCYTO).
Slovenian: Z brizgo aseptično prenesite rekonstituirano zdravilo BLINCYTO v infuzijsko vrečko (za specifični volumen rekonstituiranega zdravila BLINCYTO glejte preglednice od 7 do 9).
English: The potential benefits of treatment should be carefully weighed against the risk of neurologic events and heightened caution should be exercised when administering BLINCYTO to these patients.
Slovenian: Možne koristi zdravljenja je treba skrbno pretehtati v primerjavi s tveganjem za nevrološke učinke.
English: (not to exceed 20 mg) should be administered orally or intravenously 6 to 12 hours prior to the start of BLINCYTO (cycle 1, day 1).
Slovenian: Pri pediatričnih bolnikih je treba dati 10 mg/m deksametazona (ne sme preseči 20 mg) peroralno ali intravensko od 6 do 12 ur pred uvedbo zdravila BLINCYTO (1. ciklus, 1. dan).
English: • Infusion rate of 2.5 mL/h for a duration of 96 hours
Slovenian: • hitrost infundiranja 2,5 ml/uro v trajanju 96 ur
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.
Slovenian: Med zdravljenjem recidivne/refraktarne ALL je bila povprečna Css (standardni odklon) ob kliničnem odmerku 9 µg/dan 230 (359) pg/ml in ob kliničnem odmerku 28 µg/dan 612 (532) pg/ml.
English: AlloHSCT = allogeneic haematopoietic stem cell transplantation SOC = standard of care
Slovenian: AlloHSCT = alogenska presaditev hematopoetskih matičnih celic
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion blinatumomab
Slovenian: BLINCYTO 38,5 mikrogramov prašek za koncentrat in raztopina za raztopino za infundiranje blinatumomab
English: Women of childbearing potential have to use effective contraception during and for at least 48 hours, after treatment with BLINCYTO (see section 4.6).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom BLINCYTO in vsaj še 48 ur po njem (glejte poglavje 4.6).
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Slovenian: BLINCYTO 38,5 mikrogramov prašek za koncentrat in raztopina za raztopino za infundiranje.
English: Oedema includes face oedema, generalised oedema, oedema and oedema peripheral.
Slovenian: 13 Edemi obsegajo edem obraza, generalizirane edeme, edeme in periferne edeme.
English: Recommended dose (for patients at least 45 kg in weight):
Slovenian: Priporočeni odmerek (za bolnike s telesno maso vsaj 45 kg): Ciklus(i) zdravljenja
English: • wheezing or difficulty in breathing (dyspnoea), breathlessness (respiratory failure)
Slovenian: • piskajoče dihanje ali težko dihanje (dispneja), kratka sapa (respiracijska odpoved)
English: Patients received BLINCYTO at a constant dose of 15 mcg/m2/day (equivalent to the recommended dosage of 28 mcg/day) for all treatment cycles.
Slovenian: Bolniki so zdravilo BLINCYTO prejemali v stalnem odmerku 15 µg/m2/dan (enakovredno priporočenemu odmerku
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.
Slovenian: Zdravilo BLINCYTO je indicirano kot monoterapija za zdravljenje pediatričnih bolnikov, starih 1 leto ali več, s CD19-pozitivno ALL predhodniških celic B z negativnim Philadelphia kromosomom, ki je refraktarna ali recidivna po vsaj dveh predhodnih zdravljenjih, ali z recidivom po opravljeni predhodni alogenski presaditvi hematopoetskih matičnih celic.
English: 5 mcg/m 2/day via continuous infusion (not to exceed 9 mcg/day)
Slovenian: 5 µg/m2/dan v kontinuirani infuziji (ne sme preseči 9 µg/dan)
English: Efficacy results in patients ≥ 18 years of age with MRD positive B-precursor ALL
Slovenian: Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, ki so imeli MRD-pozitivno ALL predhodniških celic B
English: Using a syringe, aseptically transfer reconstituted BLINCYTO into the infusion bag (refer to table 1 to table 3 for the specific volume of reconstituted BLINCYTO).
Slovenian: Z brizgo aseptično prenesite rekonstituirano zdravilo BLINCYTO v infuzijsko vrečko (za specifični volumen rekonstituiranega zdravila BLINCYTO glejte preglednice od 1 do 3).
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.
Slovenian: Zdravilo BLINCYTO raztopina za infundiranje je treba dati po intravenskem sistemu, ki ima v liniji sterilen, apirogen 0,2-mikrometrski filter, ki minimalno veže beljakovine.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj
English: When administering via multi-lumen venous catheter, BLINCYTO should be infused through a dedicated lumen.
Slovenian: Pri dajanju po večlumenskem katetru je treba zdravilo BLINCYTO infundirati skozi namensko svetlino.
English: e response for CR/CRh*/CRi MRD evaluable patients (%) [95% CI]
Slovenian: e odziv za CR/CRh*/CRi Bolniki, ocenljivi za MRD (%) [95 % IZ]f
English: 15 mcg/m2/day via continuous infusion (not to exceed 28 mcg/day)
Slovenian: 15 µg/m2/dan v kontinuirani infuziji (ne sme preseči 28 µg/dan)
English: Women of childbearing potential have to use effective contraception during and for at least 48 hours after treatment with blinatumomab (see section 4.4).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z blinatumomabom in vsaj še 48 ur po njem (glejte poglavje 4.4).
English: Medication errors have been observed with BLINCYTO treatment.
Slovenian: Med zdravljenjem z zdravilom BLINCYTO so opažali napake pri uporabi zdravila.
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.
Slovenian: Bolniki so v skladu s smernicami ustanove ali države v obdobju 1 tedna pred začetkom zdravljenja z zdravilom BLINCYTO prejeli obvezno premedikacijo z intratekalnim režimom kot profilakso za cerebrospinalno tekočino.
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.
Slovenian: O učinkih 3. stopnje so poročali pri 1,5 % in o resnih učinkih pri 1,5 % odraslih MRD-pozitivnih bolnikih z ALL predhodniških celic B; o učinkih ≥ 4. stopnje niso poročali.
English: - Store in the original carton in order to protect from light.
Slovenian: - Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: The median time to onset of a CRS event was 2 days.
Slovenian: Mediana časa do pojava sindroma sproščanja citokinov je bila 2 dni.
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.
Slovenian: O učinkih ≥ 3. stopnje so poročali pri 8,0 % in o učinkih ≥ 4. stopnje pri 4,4 % odraslih MRD-pozitivnih bolnikov z ALL predhodniških celic B.
English: In adult patients, dexamethasone 20 mg intravenous should be administered 1 hour prior to initiation of each cycle of BLINCYTO therapy.
Slovenian: Priporočila za premedikacijo in dodatna zdravila Pri odraslih bolnikih je treba eno uro pred začetkom vsakega ciklusa zdravljenja z zdravilom BLINCYTO bolniku dati 20 mg deksametazona intravensko.
English: e. Relapse was defined as haematological relapse (blasts in bone marrow greater than 25% following CR) or an extramedullary relapse.
Slovenian: e. Recidiv je bil opredeljen kot hematološki recidiv (več kot 25 % blastov v kostnem mozgu po CR) ali recidiv zunaj kostnega mozga.
English: • back pain, pain in extremity
Slovenian: • bolečine v hrbtu, bolečina v okončini
English: 3.6 months (2.3, 7.2) (N = 33)
Slovenian: 3,6 mesecev (2,3; 7,2) (N = 33)
English: c. Complete MRD response No detectable signal for leukemic cells either by PCR or flow cytometry.
Slovenian: Brez zaznavnega signala levkemičnih celic glede na PCR ali pretočno citometrijo.
English: Your doctor will take regular blood tests to monitor your blood counts during treatment with BLINCYTO.
Slovenian: Zdravnik bo med zdravljenjem z zdravilom BLINCYTO izvajal redne preiskave krvi, da vam bo kontroliral krvno sliko.
English: Duration of MRD responseMedian time to event [95% CI]
Slovenian: Trajanje MRD odziva Mediana časa do dogodka [95 % IZ]
English: 15 mcg/m2/day
Slovenian: 15 µg/m2/dan
English: 6-month estimate % [95% CI] 18-months estimate % [95% CI] HR [95% CI]
Slovenian: 6-mesečna ocena % [95 % IZ] 18-mesečna ocena % [95 % IZ] Razmerje ogroženosti [95 % IZ] Trajanje hematološkega odziva Mediana časa do dogodka [95 % IZ] CR
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
Slovenian: Starost Mediana, leta (največja in najmanjša vrednost) Povprečje, leta (standardni odklon) ≥ 65 let, n (%) Moški, n (%) Rasa, n (%) Azijska Druga (mešana) Bela Neznana Anamneza recidivov, n (%) Bolniki v prvi CR Bolniki v drugi CR Bolniki v tretji CR Vrednost MRD v izhodišču*, n (%) in < 1 in < 10 in < 10
English: Cytokine release syndrome was reported in 2.9% of adult patients with MRD positive B-precursor ALL (N = 137).
Slovenian: O sindromu sproščanja citokinov so poročali pri 2,9 % odraslih MRD-pozitivnih bolnikih z ALL predhodniških celic B (N = 137).
English: tingling of skin (paraesthesia), seizure, difficulty thinking or processing thoughts, difficulty remembering, difficulty in controlling movement (ataxia)
Slovenian: mravljinčenje v koži (parestezije), napadi krčev, težave z razmišljanjem ali obdelavo misli,
English: 10 mL/hour
Slovenian: 10 ml/uro
English: • the infusion bag empties before the scheduled bag change
Slovenian: • se infuzijska vrečka izprazni pred časom, ki je predviden za zamenjavo vrečke.
English: Do not drive, use heavy machines, or engage in hazardous activities while you are being given BLINCYTO.
Slovenian: Medtem, ko dobivate zdravilo BLINCYTO, ne upravljajte vozil ali težkih strojev in ne izvajajte nevarnih dejavnosti.
English: • Description of the administration procedures of BLINCYTO
Slovenian: • Opis postopkov dajanja zdravila BLINCYTO.
English: Consider discontinuing BLINCYTO permanently.
Slovenian: Razmislite o trajnem prenehanju uporabe zdravila BLINCYTO.
English: Talk to your doctor or nurse about suitable methods of contraception.
Slovenian: O ustreznem načinu kontracepcije se posvetujte z zdravnikom ali medicinsko sestro.
English: • BLINCYTO treatment start date
Slovenian: • Datum začetka zdravljenja z zdravilom BLINCYTO.
English: 5 mcg/m2/day
Slovenian: 5 µg/m2/dan
English: Dose adjustment was possible in the case of adverse events.
Slovenian: V primeru neželenih učinkov je bilo mogoče odmerek prilagoditi.
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).
Slovenian: Za vključitev so bili primerni bolniki, stari ≥ 18 let in s stanjem ECOG ≤ 2, ki so imeli recidivno ali refraktarno ALL predhodniških celic B (> 5 % blastov v kostnem mozgu in ali recidiv kadar koli po alogenski presaditvi hematopoetskih matičnih celic, ali nezdravljen prvi recidiv s trajanjem prve remisije < 12 mesecev, ali so bili odporni proti zadnjemu zdravljenju).
English: ≥ 65 years old Patients in 1
Slovenian: ≥ 65 let
English: Tumour lysis syndrome
Slovenian: Sindrom lize tumorja
English: A censored subject is indicated by a Vertical Bar l.
Slovenian: Krnjenje preiskovancev je označeno z navpično črtico I.
English: Hyperbilirubinaemia a,
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija a, 10
English: Do not prime with sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Ne pripravljajte z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje.
English: • Contact details of the BLINCYTO prescriber
Slovenian: • Kontaktni podatki zdravnika, ki je predpisal zdravilo BLINCYTO.
English: Hypotension includes blood pressure decreased and hypotension.
Slovenian: 8 Hipotenzija obsega znižan krvni tlak in hipotenzijo.
English: At the recommended doses, the mean (SD) steady state concentration (Css) values were 162 (179) and 533 (392) pg/mL at 5 and 15 mcg/m2/day doses, respectively.
Slovenian: Povprečna (standardni odklon) koncentracija v stanju dinamičnega ravnovesja (Css) ob priporočenem odmerku 5 µg/m2/dan je bila 162 (179) pg/ml in ob priporočenem odmerku 15 µg/m2/dan 533 (392) pg/ml.
English: • reactions related to infusion may include, wheezing, flushing, face swelling, difficulty breathing, low blood pressure, high blood pressure.
Slovenian: • z infundiranjem povezane reakcije lahko vključujejo piskajoče dihanje, zardevanje, oteklost obraza, težko dihanje, nizek krvni tlak, visok krvni tlak
English: Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses.
Slovenian: Med uporabo testiranih kliničnih odmerkov se je v urinu izločila zanemarljiva količina blinatumomaba.
English: There is limited experience with BLINCYTO in patients ≥ 75 years of age.
Slovenian: Pri bolnikih, starih ≥ 75 let, je izkušenj z zdravilom BLINCYTO malo.
English: • Infusion rate of 5 mL/h for a duration of 48 hours
Slovenian: • Hitrost infundiranja 5 ml/uro v trajanju 48 ur
English: Neutropenia includes neutropenia and neutrophil count decreased.
Slovenian: 2 Nevtropenija obsega nevtropenijo in zmanjšanje števila nevtrofilcev.
English: Store in the original carton in order to protect from light.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: No formal pharmacokinetic studies of blinatumomab have been conducted in patients with renal impairment.
Slovenian: Formalnih farmakokinetičnih študij blinatumomaba pri bolnikih z okvaro ledvic niso izvedli.
English: Relapse was defined as haematological relapse (blasts in bone marrow greater than 5% following CR) or an extramedullary relapse.
Slovenian: Recidiv je bil opredeljen kot hematološki recidiv (več kot 5 % blastov v kostnem mozgu po CR) ali recidiv zunaj kostnega mozga.
English: BLINCYTO (N=271)
Slovenian: Zdravilo BLINCYTO (N=271)
English: BLINCYTO (N = 271)
Slovenian: Zdravilo BLINCYTO (N = 271)