natgillin/translations-raw huggingface dataset:
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
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.
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.
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.
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).
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).
• Information on treatment with BLINCYTO, administration and posology, duration of hospitalisation, interruption and / or permanent discontinuation of the treatment Medication errors (ME)
• Informacije o zdravljenju z zdravilom BLINCYTO, dajanju in odmerjanju, trajanju hospitalizacije, prekinitvi in / ali trajnem prenehanju zdravljenja.
Elderly patients with MRD-positive ALL treated with BLINCYTO may have an increased risk of hypogammaglobulinaemia compared to younger patients.
Starejši MRD-pozitivni bolniki z ALL, zdravljeni z zdravilom BLINCYTO, imajo lahko povečano tveganje za hipogamaglobulinemijo v primerjavi z mlajšimi bolniki.
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.
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.
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.
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.
The primary endpoint was the proportion of patients who achieved a complete MRD response within one cycle of BLINCYTO treatment.
Primarni opazovani dogodek je bil delež bolnikov, ki so dosegli popoln MRD odziv v enem ciklusu zdravljenja z zdravilom BLINCYTO.
• headache, shaking (or tremor)
• glavobol, tresenje (ali tremor)
• Data from clinical trials, causes of ME, frequency, severity and outcomes.
• Podatki iz kliničnih preskušanj, vzroki za napake pri uporabi zdravila, pogostnost, resnost in izidi.
Hepatic enzyme increased a, 15
Preiskave zvišanje jetrnih encimov a, 15
If the toxicity takes more than 14 days to resolve, discontinue BLINCYTO permanently, except if described differently in the table below.
Če traja več kot 14 dni, da toksični učinek mine, trajno prenehajte uporabljati zdravilo BLINCYTO, razen če je v spodnji preglednici navedeno drugače.
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.
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.
Using a syringe, reconstitute each vial of BLINCYTO powder for concentrate using 3 mL of water for injections.
Z brizgo rekonstituirajte vsako vialo zdravila BLINCYTO prašek za koncentrat s 3 ml vode za injekcije.
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.
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.
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:
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:
Median overall survival [95% CI]
Mediana celokupnega preživetja [95 % IZ]
However some patients reported delayed onset of infusion reactions or in later cycles.
A pri nekaterih bolnikih so se infuzijske reakcije pojavile z zakasnjenim začetkom ali v poznejših ciklusih.
It is recommended that immunoglobulin levels are monitored in elderly patients during treatment with BLINCYTO.
Priporočljivo je, da se pri starejših bolnikih med zdravljenjem z zdravilom BLINCYTO spremlja ravni imunoglobulinov.
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).
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.
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.
Če je vaša telesna masa manjša od 45 kilogramov, bo priporočeni začetni odmerek v prvem ciklu odvisen od vaše telesne mase in višine.
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).
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).
Women who are able to become pregnant have to use effective contraception during treatment and for at least 48 hours after your last treatment.
Ženske, ki lahko zanosijo, morajo med zdravljenjem in vsaj še 48 ur po zadnjem zdravljenju uporabljati učinkovito kontracepcijo.
• Obligation to complete post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
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.
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.
Add to the sodium chloride bag only.
Dodati le vrečki z natrijevim kloridom.
Eighty-eight out of 113 (77.9%) evaluable patients achieved a complete MRD response after one cycle of treatment; see table 5.
Oseminosemdeset od 113 (77,9 %) bolnikov, ki so bili primerni za analizo, je doseglo popoln MRD odziv po enem ciklusu zdravljenja; glejte preglednico 5.
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.
Kljub možnosti za pojav progresivne multifokalne levkoencefalopatije pa v kliničnih študijah niso poročali o potrjenem primeru multifokalne levkoencefalopatije.
The median time to onset to the first event was 4 days from the start of BLINCYTO treatment initiation.
Mediana časa do pojava prvega učinka je bila 4 dni po uvedbi zdravljenja z zdravilom BLINCYTO.
Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Pri vsakem organskem sistemu so neželeni učinki zdravila navedeni po padajoči resnosti.
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.
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.
Patients should be closely monitored for signs or symptoms of these events.
Bolnike je treba skrbno spremljati glede znakov ali simptomov teh učinkov.
In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the initial 48 hours of the first treatment cycle.
Med nadaljnjimi ciklusi zdravljenja se je zvišanje citokinov pojavilo pri manj bolnikih in z manjšo izrazitostjo kot v uvodnih 48 urah prvega ciklusa zdravljenja.
Neurologic events including events with a fatal outcome have been observed.
Zabeležili so nevrološke učinke, tudi takšne s smrtnim izidom.
Days 29-42
29.-42. dan
Peripheral lymphocytes were not measured in paediatric subjects.
Perifernih limfocitov pri pediatričnih bolnikih niso merili.
A single cycle of treatment is 28 days (4 weeks) of continuous infusion.
En ciklus zdravljenja obsega 28 dni (4 tedne) kontinuiranega infundiranja.
Other medicines and BLINCYTO
Druga zdravila in zdravilo BLINCYTO
Your doctor may need to take special care of you during your treatment with BLINCYTO.
Zdravnik bo morda moral med zdravljenjem z zdravilom BLINCYTO še posebej paziti na vas.
The target dose of 28 mcg/day was administered in cycle 2 and subsequent cycles starting on day 1 of each cycle.
Ciljni odmerek 28 µg/dan so v 2. in nadaljnjih ciklusih uporabljali od 1. dne vsakega ciklusa.
Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with BLINCYTO.
Na splošno je bila varnost zdravljenja z zdravilom BLINCYTO pri starejših bolnikih (≥ 65 let) podobna kot pri mlajših od 65 let.
* Based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
* Na podlagi NCI CTCAE (Common Terminology Criteria for Adverse Events), različica 4.0. 3. stopnja je huda, 4. stopnja je smrtno nevarna.
Consolidation Cycles 2-4 Days 1-28
Konsolidacijski ciklusi 2-4 1.-28. dan
Medication errors
Napake pri uporabi zdravila
48 hours
48 ur
Gently mix the contents of the bag to avoid foaming.
Previdno premešajte vsebino vrečke, da boste preprečili penjenje.
BLINCYTO is used to treat adults with acute lymphoblastic leukaemia.
Zdravilo BLINCYTO se uporablja za zdravljenje odraslih z akutno limfoblastno levkemijo.
100 day mortality after alloHSCT n/N (%), [95% CI]
100-dnevna umrljivost po alloHSCT n/N (%), [95 % IZ]
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.
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.
The primary endpoint was the complete remission/complete remission with partial haematological recovery (CR/CRh*) rate within 2 cycles of treatment with BLINCYTO.
Primarni opazovani dogodek je bil delež popolna remisija/popolna remisija z delnim hematološkim okrevanjem (CR/CRh*) v 2 ciklusih zdravljenja z zdravilom BLINCYTO.
The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 2.92 (2.83) L/hour.
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.
Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):
Eno pakiranje zdravila BLINCYTO vsebuje 1 vialo praška za koncentrat za raztopino za infuzijo in 1 vialo raztopine (stabilizatorja):
28 mcg/day via continuous infusion
28 µg/dan v kontinuirani infuziji
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.
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.
Consequently, as a precautionary measure, breast-feeding is contraindicated during and for at least 48 hours after treatment with blinatumomab.
Posledično, kot previdnostni ukrep, je dojenje kontraindicirano med obdobjem zdravljenja z blinatumomabom in vsaj še 48 ur po zdravljenju.
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).
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).
If you have minimal residual disease acute lymphoblastic leukaemia, your dose of BLINCYTO will be 28 micrograms per day throughout the first cycle.
Če imate akutno limfoblastno levkemijo z minimalno rezidualno boleznijo, bo vaš odmerek zdravila BLINCYTO 28 mikrogramov na dan med prvim ciklusom.
• Recommendation to monitor patients for signs and symptoms of neurotoxicity
• Priporočilo za spremljanje bolnikov glede znakov in simptomov nevrotoksičnosti.
Refractory to salvage therapy Maximum of central/local bone marrow blasts - n (%)
Odporni proti reševalnemu zdravljenju Največji delež centralnih/lokalnih blastov v kostnem mozgu - n (%)
No formal drug interaction studies have been performed.
Formalnih študij medsebojnega delovanja niso izvedli.
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).
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).
Do not use this solution (stabiliser) for reconstitution of BLINCYTO powder for concentrate.
Ne uporabljajte te raztopine (stabilizatorja) za rekonstitucijo praška za koncentrat zdravila BLINCYTO.
• high blood pressure (hypertension)
• visok krvni tlak (hipertenzijo)
- Breast-feeding (see section 4.6).
- Dojenje (glejte poglavje 4.6).
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.
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.
Contact details are provided in section 6 of the package leaflet.
Kontaktni podatki so navedeni v poglavju 6 Navodila za uporabo.
Four patients achieved CR during consolidation cycles, resulting in a cumulative CR rate of 35.4% (67/189; 95% CI: 28.6% - 42.7%).
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 %).
• disturbances of brain function (encephalopathy) such as difficulty in communicating (aphasia),
• motnje delovanja možganov (encefalopatija), na primer težave s sporazumevanjem (afazija),
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.
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.
What BLINCYTO is and what it is used for What you need to know before you use BLINCYTO How to use BLINCYTO
Kaj je zdravilo BLINCYTO in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo BLINCYTO Kako uporabljati zdravilo BLINCYTO Možni neželeni učinki
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.
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.
Subsequent cycles Days 1-7 Days 8-28 Days 29-42 Days 1-28 Days 29-42
Nadaljnji ciklusi 1.-7. dan 8.-28. dan 29.-42. dan 1.-28. dan 29.-42. dan
The safety of immunisation with live viral vaccines during or following BLINCYTO therapy has not been studied.
Varnost cepljenj z živimi virusnimi cepivi med zdravljenjem z zdravilom BLINCYTO ali po njem ni raziskana.
In the event of a seizure, secondary prophylaxis with appropriate anticonvulsant medicinal products (e.g. levetiracetam) is recommended.
V primeru konvulzij je priporočljiva sekundarna profilaksa z ustreznimi antiepileptiki (npr. z levetiracetamom).
9 mcg/day via continuous infusion
9 µg/dan v kontinuirani infuziji
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).
Zdravilo BLINCYTO se uporablja, ko se je akutna limfoblastna levkemija vrnila ali ni bilo odziva na predhodno zdravljenje (imenovano recidivna/refraktarna akutna limfoblastna levkemija).
MRD status at screening was determined from bone marrow aspirations using flow cytometry or polymerase chain reaction (PCR) at a minimum sensitivity of 10
presejanju so stanje MRD določili iz aspiracij kostnega mozga z uporabo pretočne citometrije ali verižne reakcije s polimerazo (PCR) pri minimalni občutljivosti 10
• Do not refrigerate or freeze the package.
• Pakiranja ne shranjujte v hladilniku in ne zamrzujte.
See table 6 for the efficacy results.
Za rezultate učinkovitosti glejte preglednico 6.
You must not breast-feed during and for at least 48 hours after your last treatment.
Med zdravljenjem in vsaj še 48 ur po zadnjem zdravljenju ne smete dojiti.
The active ingredient in BLINCYTO is blinatumomab.
Učinkovina v zdravilu BLINCYTO je blinatumomab.
Bone Marrow Blast Infiltration (Central Lab)
Infiltracija kostnega mozga z blasti (centralni laboratorij)
based on local site evaluations.
na podlagi vrednotenj centrov, vključenih v študijo.
• When preparing an infusion bag, remove all air from infusion bag.
• Med pripravo infuzijske vrečke iz vrečke odstranite ves zrak.
Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents, ATC code: L01XC19.
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XC19.
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.
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.
• Sterile single-use disposable syringes
• sterilne brizge za enkratno uporabo
Remove air from the infusion bag and prime the intravenous infusion line only with the prepared solution for infusion.
Iz infuzijske vrečke odstranite zrak in pripravite sistem za intravensko infundiranje le s pripravljeno raztopino za infundiranje.
Most patients had a high tumour burden (≥ 50% leukaemic blasts in bone marrow) at baseline with a median of 75.5% bone marrow blasts.
Večina bolnikov je imela v izhodišču visoko tumorsko breme (≥ 50 % levkemičnih blastov v kostnem mozgu) z mediano 75,5 % blastov v kostnem mozgu.
One CR /CRh*responder with missing MRD data was considered as a MRDnonresponder.
En bolnik z odzivom CR/CRh* z manjkajočimi podatki o MRD je bil upoštevan kot bolnik, ki ni dosegel MRD odziva.
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.
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).
The safety and efficacy of BLINCYTO in children < 1 year of age have not yet been established.
Varnost in učinkovitost zdravila BLINCYTO pri otrocih, mlajših od 1 leta, še nista dokazani.
Treatment with BLINCYTO was associated with transient elevations in liver enzymes.
Zdravljenje z zdravilom BLINCYTO je bilo povezano s prehodnimi zvišanji jetrnih encimov.
Consistent immune-pharmacodynamic responses were observed in patients studied.
Pri proučevanih bolnikih so opažali konsistentne imunofarmakodinamične odzive.
Partial remission was defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.
Delna remisija je bila opredeljena kot 6 do 25 % blastov v kostnem mozgu in vsaj 50 % zmanjšanje od izhodišča.
• rapid heart rate (tachycardia)
• hitro bitje srca (tahikardija)
Like other protein therapeutics, blinatumomab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Verjetno se blinatumomab, podobno kot druga beljakovinska zdravila, po kataboličnih poteh razgradi v majhne peptide in aminokisline.
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.
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.
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.
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.
Unopened vials:
Neodprte viale:
If formation of anti-blinatumomab antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar pomeni, da je praktično "brez natrija".