FrancophonIA/ELRC3.0 huggingface dataset:
English: Other instructions
Slovenian: Dodatna navodila
English: Infusion duration
Slovenian: Trajanje infuzije
English: Initiation of BLINCYTO treatment causes transient release of cytokines during the first days of treatment that may suppress CYP450 enzymes.
Slovenian: Uvedba zdravila BLINCYTO lahko v prvih dneh zdravljenja povzroči prehodno sproščanje citokinov, ki lahko zavrejo encime CYP450.
English: The choice of the infusion duration should be made by the treating physician considering the frequency of the infusion bag changes.
Slovenian: Trajanje infundiranja mora določiti lečeči zdravnik ob upoštevanju pogostnosti menjav infuzijskih vrečk.
English: Subsequent cycles
Slovenian: Nadaljnji ciklusi
English: - The package will be opened by your nurse and the infusion bags will be stored in a refrigerator until infusion.
Slovenian: - Pakiranje bo odprla medicinska sestra in bo infuzijske vrečke shanila v hladilnik za čas do infundiranja.
English: The majority of the events were observed within the first week of treatment initiation and did not require interruption or discontinuation of BLINCYTO (see section 4.8).
Slovenian: Večino teh primerov so opazili v prvem tednu po začetku zdravljenja in niso zahtevali prekinitve ali prenehanja zdravljenja z zdravilom BLINCYTO (glejte poglavje 4.8).
English: Patients who responded to BLINCYTO but later relapsed had the option to be retreated with BLINCYTO.
Slovenian: Bolniki, ki so se odzvali na zdravilo BLINCYTO, a se jim je pozneje pojavil recidiv, so imeli možnost ponovnega zdravljenja z zdravilom BLINCYTO.
English: Diluted solution (prepared infusion bag): If your infusion bag is changed at home: - Infusion bags containing BLINCYTO solution for infusion will arrive in special packaging containing cooling packs.
Slovenian: Razredčena raztopina (pripravljena infuzijska vrečka): Če bo zamenjava infuzijske vrečke potekala doma: - Infuzijske vrečke, ki vsebujejo raztopino zdravila BLINCYTO, so na voljo v posebnem pakiranju, ki vsebuje hladilna telesa.
English: • A warning message for HCPs treating the patient at any time, including emergency conditions, that the patient is using BLINCYTO
Slovenian: • Opozorilo za zdravstvene delavce, ki kadar koli zdravijo bolnika, vključno v nujnih primerih, da bolnik uporablja zdravilo BLINCYTO.
English: • fever (pyrexia)
Slovenian: • vročino (pireksijo)
English: The effects of BLINCYTO in pregnant women are not known but based on its mechanism of action, BLINCYTO may harm your unborn baby.
Slovenian: Učinki zdravila BLINCYTO pri nosečnicah niso znani, vendar bi zdravilo BLINCYTO zaradi njegovega mehanizma delovanja lahko škodovalo nerojenemu otroku.
English: Change of infusion bag
Slovenian: Zamenjava infuzijske vrečke
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Blinatumomab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Slovenian: Blinatumomaba ne smete uporabljati med nosečnostjo, razen če možne koristi odtehtajo možna tveganja za plod.
English: A single cycle of treatment of BLINCYTO induction or consolidation is 28 days (4 weeks) of continuous intravenous infusion followed by a 14 day (2 week) treatment-free interval (total 42 days).
Slovenian: En ciklus indukcijskega ali konsolidacijskega zdravljenja z zdravilom BLINCYTO obsega 28 dni (4 tedne) kontinuiranega intravenskega infundiranja, ki mu sledi 14-dnevni (2-tedenski) premor brez zdravljenja (skupno 42 dni).
English: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO treatment, during treatment, and until recovery of B-lymphocytes to normal ranges following last treatment cycle.
Slovenian: Cepljenje z živimi virusnimi cepivi ni priporočljivo vsaj 2 tedna pred začetkom zdravljenja z zdravilom BLINCYTO, med zdravljenjem in do normalizacije števila limfocitov B po zadnjem ciklusu zdravljenja.
English: • Pump specifications: The infusion pump to administer BLINCYTO solution for infusion should be programmable, lockable and have an alarm.
Slovenian: • Specifikacije črpalke: Infuzijska črpalka za dajanje zdravila BLINCYTO raztopina za infundiranje mora biti programabilna, imeti mora možnost zaklepanja in imeti mora alarm.
English: Refractory status - n (%)
Slovenian: Status odpornosti - n (%)
English: 3.8 months (1.9, 19.0)
Slovenian: 3,8 mesecev (1,9; 19,0)
English: Do not shake the reconstituted solution.
Slovenian: Rekonstituirane raztopine ne pretresajte.
English: Reconstituted solution (BLINCYTO solution): - When refrigerated, the reconstituted solution must be used within 24 hours.
Slovenian: Rekonstituirana raztopina (raztopina zdravila BLINCYTO): - Če je rekonstituirana raztopina shranjena v hladilniku, jo je treba uporabiti v roku 24 ur.
English: 96 hours
Slovenian: 96 ur
English: Your infusion catheter will be attached to you at all times during each cycle of your treatment.
Slovenian: Kateter za infundiranje boste imeli vstavljen ves čas med vsakim ciklusom zdravljenja.
English: Peripheral T-cell redistribution (i.e. T-cell adhesion to blood vessel endothelium and/or transmigration into tissue) occurred after start of blinatumomab infusion or dose escalation.
Slovenian: Redistribucija perifernih celic T (tj. adhezija celic T na žilni endotelij in/ali transmigracija v tkiva) se je pojavila po začetku infundiranja blinatumomaba ali povečanju odmerka.
English: Due to the potential for neurologic events, patients receiving blinatumomab should refrain from driving, engaging in hazardous occupations or activities such as driving or operating heavy or potentially dangerous machinery while blinatumomab is being administered.
Slovenian: Zaradi možnosti za nevrološke učinke bolniki med zdravljenjem z blinatumomabom ne smejo voziti in izvajati nevarnih poklicev ali dejavnosti (kot so upravljanje vozil ali težkih ali potencialno nevarnih strojev).
English: Six of those patients had anti-blinatumomab antibodies with in vitro neutralising activity.
Slovenian: Šest od teh bolnikov je imelo protitelesa proti blinatumomabu, ki so in vitro delovala nevtralizirajoče.
English: Reinitiation of BLINCYTO at the correct therapeutic dose should be considered when all toxicities have resolved and no earlier than 12 hours after interruption of the infusion (see section 4.2).
Slovenian: Ponovna uvedba zdravila BLINCYTO v pravilnem terapevtskem odmerku pride v poštev, ko vsi toksični učinki minejo, in se ne sme začeti prej kot 12 ur po prekinitvi infundiranja (glejte poglavje 4.2).
English: • if you experience seizures, difficulty in speaking or slurred speech, confusion and disorientation, or loss of balance.
Slovenian: • če se vam pojavijo napadi krčev, težave z govorjenjem ali nejasen govor, zmedenost in dezorientiranost ali izguba ravnotežja.
English: The type of adverse events observed in infants were similar to those observed in the overall paediatric population.
Slovenian: Opaženi neželeni učinki pri dojenčkih so bili podobni tistim, ki so jih opazili na splošno pri pediatrični populaciji.
English: 1/Complete remission with partial haematological recovery (CRh*) CR
Slovenian: 1/popolna remisija z delnim hematološkim okrevanjem (CRh*) CR
English: Patients with prior allogeneic HSCT had similar response rates to those without prior HSCT, older patients had similar response rates to younger patients, and no substantial difference was observed in remission rates based on the number of lines of prior salvage treatment.
Slovenian: Bolniki s predhodno alogensko presaditvijo krvotvornih matičnih celic so imeli podobne deleže odzivov kot tisti brez nje, starejši bolniki so imeli podobne deleže odzivov kot mlajši in deleži remisij se niso bistveno razlikovali glede na število linij predhodnega rešilnega zdravljenja.
English: Prior alloHSCT ECOG status - n (%)
Slovenian: Predhodna alloHSCT Stanje ECOG - n (%)
English: High-dose steroid therapy may have contributed, in some cases, to the pancreatitis.
Slovenian: V nekaterih primerih je k pankreatitisu lahko pripomoglo zdravljenje z visokimi odmerki steroidov.
English: Some vaccines must not be given within two weeks before, at the same time as or in the months after you receive treatment with BLINCYTO.
Slovenian: Nekaterih cepiv se ne sme dati v dveh tednih pred zdravljenjem, med zdravljenjem ali v mesecih po zdravljenju z zdravilom BLINCYTO.
English: • Detailed description of the reconstitution and preparation procedures of BLINCYTO infusion solution for intravenous administration under aseptic conditions, using aseptic techniques.
Slovenian: • Podroben opis postopkov za rekonstitucijo in pripravo zdravila BLINCYTO infuzijske raztopine za intravensko uporabo, v aseptičnih pogojih, z uporabo aseptičnih tehnik.
English: • there is a problem with the pump or the pump alarm sounds
Slovenian: • je kakšna težava s črpalko, ali se oglasi alarm črpalke.
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Slovenian: Ocena bolnikov lahko obsega klinični pregled, laboratorijske preiskave amilaze v serumu in lipaze v serumu, slikovni pregled trebuha, na primer z ultrazvokom, in druge ustrezne diagnostične ukrepe.
English: • 21-23 gauge needle(s) (recommended)
Slovenian: • igla/igle št. 21-23 (priporočeno)
English: To mitigate the risk of CRS, it is important to initiate BLINCYTO (cycle 1, days 1-7) at the recommended starting dose in section 4.2.
Slovenian: Za zmanjšanje tveganja za sindrom sproščanja citokinov je pomembno, da se zdravljenje z zdravilom BLINCYTO (1. do 7. dan 1. ciklusa) začne z začetnim odmerkom, priporočenim v poglavju 4.2.
English: Infuse BLINCYTO solution according to the instructions on the pharmacy label on the prepared bag at one of the following constant infusion rates:
Slovenian: Raztopino zdravila BLINCYTO infundirajte skladno z navodili na lekarniški etiketi na pripravljeni vrečki pri eni od naslednjih stalnih hitrosti infundiranja:
English: The recommended dose of BLINCYTO throughout each 4-week treatment cycle is 28 mcg/day.
Slovenian: Priporočeni odmerek zdravila BLINCYTO med vsakim 4-tedenskim ciklusom zdravljenja je 28 µg/dan.
English: • lung infection (pneumonia)
Slovenian: • okužba pljuč (pljučnica)
English: a Complete MRD response was defined as the absence of detectable MRD confirmed in an assay with minimum sensitivity of 10-4 b One hundred thirteen patients (97.4%; 113/116) were included in the primary endpoint full analysis set
Slovenian: a Popoln MRD odziv je bil opredeljen kot odsotnost zaznavne MRD, potrjena s preiskavo z minimalno občutljivostjo 10-4. b Stotrinajst bolnikov (97,4 %; 113/116) je bilo vključenih v nabor za celovito analizo primarnega opazovanega dogodka.
English: The starting volume (270 mL) is more than the volume administered to the patient (240 mL) to account for the priming of the intravenous tubing and to ensure that the patient will receive the full dose of BLINCYTO.
Slovenian: Začetni volumen (270 ml) je večji od volumna, danega bolniku (240 ml), s čimer se upošteva črpanje v intravenski sistem, in zagotovi, da bo bolnik prejel celotni odmerek zdravila BLINCYTO.
English: Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient's body surface area (BSA).
Slovenian: Bolniki, ki tehtajo 45 kg ali več, prejmejo fiksen odmerek, pri bolnikih, ki tehtajo manj kot 45 kg, pa se odmerek izračuna glede na telesno površino bolnika (BSA - Body Surface Area).
English: • Information on treatment with BLINCYTO, administration and posology, duration of hospitalisation, interruption and / or permanent discontinuation of the treatment Medication errors (ME)
Slovenian: • Informacije o zdravljenju z zdravilom BLINCYTO, dajanju in odmerjanju, trajanju hospitalizacije, prekinitvi in / ali trajnem prenehanju zdravljenja.
English: Elderly patients with MRD-positive ALL treated with BLINCYTO may have an increased risk of hypogammaglobulinaemia compared to younger patients.
Slovenian: Starejši MRD-pozitivni bolniki z ALL, zdravljeni z zdravilom BLINCYTO, imajo lahko povečano tveganje za hipogamaglobulinemijo v primerjavi z mlajšimi bolniki.
English: Fifty percent (5/10) compared to 0% (0/5) achieved MRD response and 20% (2/10) compared to 40% (2/5) underwent allogeneic HSCT after treatment.
Slovenian: Petdeset odstotkov (5/10), v primerjavi z 0 % (0/5), jih je doseglo MRD odziv in 20 % (2/10), v primerjavi s 40 % (2/5), jih je po zdravljenju opravilo alogensko presaditev krvotvornih matičnih celic.
English: Among patients that experienced a neurologic event, the median time to the first event was within the first two weeks of treatment and the majority of events resolved after treatment interruption and infrequently led to BLINCYTO treatment discontinuation.
Slovenian: Med bolniki, ki se jim je pojavil kakšen nevrološki učinek, je bila mediana časa do prvega učinka v prvih dveh tednih zdravljenja, večina učinkov je minila po prekinitvi zdravljenja in redki so povzročili trajno prenehanje zdravljenja z zdravilom BLINCYTO.
English: The primary endpoint was the proportion of patients who achieved a complete MRD response within one cycle of BLINCYTO treatment.
Slovenian: Primarni opazovani dogodek je bil delež bolnikov, ki so dosegli popoln MRD odziv v enem ciklusu zdravljenja z zdravilom BLINCYTO.
English: • headache, shaking (or tremor)
Slovenian: • glavobol, tresenje (ali tremor)
English: • Data from clinical trials, causes of ME, frequency, severity and outcomes.
Slovenian: • Podatki iz kliničnih preskušanj, vzroki za napake pri uporabi zdravila, pogostnost, resnost in izidi.
English: Hepatic enzyme increased a, 15
Slovenian: Preiskave zvišanje jetrnih encimov a, 15
English: If the toxicity takes more than 14 days to resolve, discontinue BLINCYTO permanently, except if described differently in the table below.
Slovenian: Če traja več kot 14 dni, da toksični učinek mine, trajno prenehajte uporabljati zdravilo BLINCYTO, razen če je v spodnji preglednici navedeno drugače.
English: In patients with a history or presence of clinically relevant central nervous system (CNS) pathology (see section 4.4), hospitalisation is recommended at a minimum for the first 14 days of the first cycle.
Slovenian: Pri bolnikih s preteklo ali trenutno klinično pomembno patologijo osrednjega živčevja (glejte poglavje 4.4) je priporočljiv sprejem v bolnišnico vsaj za prvih 14 dni prvega ciklusa.
English: Using a syringe, reconstitute each vial of BLINCYTO powder for concentrate using 3 mL of water for injections.
Slovenian: Z brizgo rekonstituirajte vsako vialo zdravila BLINCYTO prašek za koncentrat s 3 ml vode za injekcije.
English: Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 1 treatment cycle should be assessed by the treating physician.
Slovenian: Zato mora lečeči zdravnik oceniti možne koristi in tveganja, povezane z nadaljevanjem zdravljenja, pri bolnikih, ki ne kažejo hematološkega in/ali kliničnega izboljšanja po 1 ciklusu zdravljenja.
English: Tell your doctor, pharmacist or nurse immediately if you experience any of the following reactions whilst receiving BLINCYTO as these may need to be treated and your dose adjusted:
Slovenian: Zdravniku, farmacevtu ali medicinski sestri takoj povejte, če se vam med prejemanje zdravila BLINCYTO pojavi katera koli naslednja reakcija, ker jo bo morda treba zdraviti in vam prilagoditi odmerek zdravila:
English: Median overall survival [95% CI]
Slovenian: Mediana celokupnega preživetja [95 % IZ]
English: However some patients reported delayed onset of infusion reactions or in later cycles.
Slovenian: A pri nekaterih bolnikih so se infuzijske reakcije pojavile z zakasnjenim začetkom ali v poznejših ciklusih.
English: It is recommended that immunoglobulin levels are monitored in elderly patients during treatment with BLINCYTO.
Slovenian: Priporočljivo je, da se pri starejših bolnikih med zdravljenjem z zdravilom BLINCYTO spremlja ravni imunoglobulinov.
English: The CR/CRh* for patients less than 2 years of age was 40% (4/10), for patients 2 to 6 years was 30.0% (6/20); and for patients aged 7 to 17 years was 25% (10/40).
Slovenian: CR/CRh* je doseglo 40 % (4/10) bolnikov, mlajših od 2 let, 30,0 % (6/20) bolnikov, starih od 2 do 6 let, in 25 % (10/40) bolnikov, starih od 7 do 17 let.
English: If your body weight is less than 45 kilograms, the recommended initial dose in your first cycle will be based on your weight and height.
Slovenian: Če je vaša telesna masa manjša od 45 kilogramov, bo priporočeni začetni odmerek v prvem ciklu odvisen od vaše telesne mase in višine.
English: It is very important that the instructions for preparation and administration provided in this section are strictly followed to minimise medication errors (including underdose and overdose).
Slovenian: Zelo pomembno je strogo upoštevanje navodil za pripravo in dajanje, navedenih v tem poglavju, da bi zmanjšali napake pri uporabi zdravila (vključno s premajhnim in prevelikim odmerjanjem).
English: Women who are able to become pregnant have to use effective contraception during treatment and for at least 48 hours after your last treatment.
Slovenian: Ženske, ki lahko zanosijo, morajo med zdravljenjem in vsaj še 48 ur po zadnjem zdravljenju uporabljati učinkovito kontracepcijo.
English: • Obligation to complete post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterised by T-cell activation and initial redistribution, rapid peripheral B-cell depletion, and transient cytokine elevation.
Slovenian: Med stalnim intravenskim infundiranjem v obdobju 4 tednov so bile značilnosti farmakodinamičnega odziva aktivacija in začetna redistribucija celic T, hitro izčrpanje perifernih celic B in prehodno zvišanje citokinov.
English: Add to the sodium chloride bag only.
Slovenian: Dodati le vrečki z natrijevim kloridom.
English: Eighty-eight out of 113 (77.9%) evaluable patients achieved a complete MRD response after one cycle of treatment; see table 5.
Slovenian: Oseminosemdeset od 113 (77,9 %) bolnikov, ki so bili primerni za analizo, je doseglo popoln MRD odziv po enem ciklusu zdravljenja; glejte preglednico 5.
English: Although there is a potential for the development of progressive multifocal leukoencephalopathy (PML), no confirmed case of PML has been reported in the clinical studies.
Slovenian: Kljub možnosti za pojav progresivne multifokalne levkoencefalopatije pa v kliničnih študijah niso poročali o potrjenem primeru multifokalne levkoencefalopatije.
English: The median time to onset to the first event was 4 days from the start of BLINCYTO treatment initiation.
Slovenian: Mediana časa do pojava prvega učinka je bila 4 dni po uvedbi zdravljenja z zdravilom BLINCYTO.
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Pri vsakem organskem sistemu so neželeni učinki zdravila navedeni po padajoči resnosti.
English: Subjects who fail to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation are considered treatment failures and assigned an EFS duration of 1 day.
Slovenian: Pri preiskovancih, ki v 12 tednih po začetku zdravljenja niso dosegli CR/CRh*/CRi, je zdravljenje veljalo za neuspešno in takšnim preiskovancem je bila dodeljeno trajanje EFS 1 dan.
English: Patients should be closely monitored for signs or symptoms of these events.
Slovenian: Bolnike je treba skrbno spremljati glede znakov ali simptomov teh učinkov.
English: In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the initial 48 hours of the first treatment cycle.
Slovenian: Med nadaljnjimi ciklusi zdravljenja se je zvišanje citokinov pojavilo pri manj bolnikih in z manjšo izrazitostjo kot v uvodnih 48 urah prvega ciklusa zdravljenja.
English: Neurologic events including events with a fatal outcome have been observed.
Slovenian: Zabeležili so nevrološke učinke, tudi takšne s smrtnim izidom.
English: Days 29-42
Slovenian: 29.-42. dan
English: Peripheral lymphocytes were not measured in paediatric subjects.
Slovenian: Perifernih limfocitov pri pediatričnih bolnikih niso merili.
English: A single cycle of treatment is 28 days (4 weeks) of continuous infusion.
Slovenian: En ciklus zdravljenja obsega 28 dni (4 tedne) kontinuiranega infundiranja.
English: Other medicines and BLINCYTO
Slovenian: Druga zdravila in zdravilo BLINCYTO
English: Your doctor may need to take special care of you during your treatment with BLINCYTO.
Slovenian: Zdravnik bo morda moral med zdravljenjem z zdravilom BLINCYTO še posebej paziti na vas.
English: The target dose of 28 mcg/day was administered in cycle 2 and subsequent cycles starting on day 1 of each cycle.
Slovenian: Ciljni odmerek 28 µg/dan so v 2. in nadaljnjih ciklusih uporabljali od 1. dne vsakega ciklusa.
English: Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with BLINCYTO.
Slovenian: Na splošno je bila varnost zdravljenja z zdravilom BLINCYTO pri starejših bolnikih (≥ 65 let) podobna kot pri mlajših od 65 let.
English: * Based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Slovenian: * Na podlagi NCI CTCAE (Common Terminology Criteria for Adverse Events), različica 4.0. 3. stopnja je huda, 4. stopnja je smrtno nevarna.
English: Consolidation Cycles 2-4 Days 1-28
Slovenian: Konsolidacijski ciklusi 2-4 1.-28. dan
English: Medication errors
Slovenian: Napake pri uporabi zdravila
English: 48 hours
Slovenian: 48 ur
English: Gently mix the contents of the bag to avoid foaming.
Slovenian: Previdno premešajte vsebino vrečke, da boste preprečili penjenje.
English: BLINCYTO is used to treat adults with acute lymphoblastic leukaemia.
Slovenian: Zdravilo BLINCYTO se uporablja za zdravljenje odraslih z akutno limfoblastno levkemijo.
English: 100 day mortality after alloHSCT n/N (%), [95% CI]
Slovenian: 100-dnevna umrljivost po alloHSCT n/N (%), [95 % IZ]
English: This was a two-part study, a dose-finding part to determine the appropriate dosing regimen, followed by a single-arm efficacy part using this regimen.
Slovenian: To je bila dvodelna študija, s prvim delom za ugotavljanje odmerka za določitev ustrezne sheme odmerjanja, čemur je v drugem delu sledilo določanje učinkovitosti uporabe te sheme pri eni sami skupini bolnikov.
English: The primary endpoint was the complete remission/complete remission with partial haematological recovery (CR/CRh*) rate within 2 cycles of treatment with BLINCYTO.
Slovenian: Primarni opazovani dogodek je bil delež popolna remisija/popolna remisija z delnim hematološkim okrevanjem (CR/CRh*) v 2 ciklusih zdravljenja z zdravilom BLINCYTO.
English: The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 2.92 (2.83) L/hour.
Slovenian: Ocenjeni povprečni (standardni odklon) sistemski očistek pri bolnikih, ki so prejemali blinatumomab v stalni intravenski infuziji v kliničnih študijah, je bil 2,92 (2,83) l/uro.
English: Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):
Slovenian: Eno pakiranje zdravila BLINCYTO vsebuje 1 vialo praška za koncentrat za raztopino za infuzijo in 1 vialo raztopine (stabilizatorja):
English: 28 mcg/day via continuous infusion
Slovenian: 28 µg/dan v kontinuirani infuziji