natgillin/translations-raw huggingface dataset:
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".
It is recommended that a neurological examination be performed in patients prior to starting BLINCYTO therapy and that patients be clinically monitored for signs and symptoms of neurologic events (e.g. writing test). 
Pred uvedbo zdravila BLINCYTO je priporočljivo opraviti nevrološki pregled, bolnike pa klinično spremljati glede znakov in simptomov nevroloških učinkov (npr. s testom pisanja).
Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal dysfunction and normal renal function. 
Farmakokinetične analize so pokazale približno 2-kratno razliko povprečnega očistka blinatumomaba med bolniki z zmerno motenim delovanjem ledvic in bolniki z normalnim delovanjem ledvic.
Repeat-dose toxicity studies conducted with blinatumomab and the murine surrogate revealed the expected pharmacologic effects (including release of cytokines, decreases in leukocyte counts, depletion of B-cells, decreases in T-cells, decreased cellularity in lymphoid tissues). 
Študije toksičnosti ponavljajočih se odmerkov, izvedene z blinatumomabom in mišjim nadomestkom, so pokazale pričakovane farmakološke učinke (vključno s sproščanjem citokinov, zmanjšanjem števila levkocitov, izčrpanjem celic B, zmanjšanjem števila celic T in zmanjšano celularnostjo v limfnem tkivu).
Acute lymphoblastic leukaemia is a cancer of the blood in which a particular kind of white blood cell called “B-lymphocyte” is growing out of control. 
Akutna limfoblastna levkemija je krvni rak, pri katerem se nenadzorovano razraste posebna vrsta belih krvnih celic, ki jih imenujemo "limfociti B".
• nerve problems affecting the head and neck such as visual disturbances, drooping eyelid and/or sagging muscles on one side of the face, difficulty hearing or trouble swallowing 
• težave z živčevjem, ki prizadenejo glavo in vrat, kot so motnje vida, viseče veke in/ali tresenje mišic na eni strani obraza, težave s sluhom ali težave pri požiranju (motnje v kranialnem živčevju)
Consequently, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered (see section 4.4). 
Posledično je treba novorojenčke spremljati glede izčrpanja celic B in cepljenja z živimi virusnimi cepivi odložiti, dokler se število celic B pri dojenčku ne povrne v normalno območje (glejte poglavje 4.4).
The treated population included 116 patients who received at least one infusion of BLINCYTO; the mean number of completed treatment cycles was 1.8 (range: 1 to 4). 
Zdravljena populacija je obsegala 116 bolnikov, ki so dobili vsaj eno infuzijo zdravila BLINCYTO; povprečno število dokončanih ciklusov zdravljenja je bilo 1,8 (razpon: od 1 do 4).
The adverse reactions in BLINCYTO-treated paediatric patients were similar in type to those seen in adult patients. 
Neželeni učinki pri pediatričnih bolnikih, zdravljenih z zdravilom BLINCYTO, so bili podobni tistim, ki so jih opazili pri odraslih bolnikih.
The nurse educational material should contain: 
Izobraževalno gradivo za medicinske sestre mora vsebovati:
e for CR /CRh* [95% CI] 
e za CR/CRh* [95 % IZ]
• Description on patient's monitoring and management of early signs and symptoms of neurological events 
• Opis za spremljanje bolnikov in obvladovanje zgodnjih znakov in simptomov nevroloških učinkov.
Complete remission (CR) CR a/CRh* 
Popolna remisija (CR - Complete Remission) CR a/CRh*
From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the reconstituted solution should be diluted immediately. 
Z mikrobiološkega stališča je treba rekonstituirano raztopino razredčiti takoj, razen če postopek rekonstitucije preprečuje tveganje za mikrobno kontaminacijo.
Do not use if the solution is cloudy or has precipitated. 
Ne uporabite, če je raztopina motna ali je precipitirala.
Hepatic enzyme increased includes alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased and transaminases increased. 
Zvišanje jetrnih encimov obsega zvišanje alanin-aminotransferaze, zvišanje aspartat-aminotransferaze, zvišanje gama-glutamiltransferaze, zvišanje jetrnih encimov in zvišanje transaminaz.
The pharmacokinetics of blinatumomab in patients with MRD positive B-precursor ALL was similar to patients with relapsed or refractory ALL. 
Farmakokinetika blinatumomaba pri MRD-pozitivnih bolnikih z ALL predhodniških celic B je bila podobna kot pri bolnikih z recidivno ali refraktarno ALL.
The treated population included 189 patients who received at least 1 infusion of BLINCYTO; the mean number of cycles per patient was 1.6. 
Zdravljena populacija je obsegala 189 bolnikov, ki so dobili vsaj 1 infuzijo zdravila BLINCYTO; povprečno število ciklusov na bolnika je bilo 1,6.
Patients should be closely monitored for signs and symptoms of pancreatitis. 
Bolnike je treba natančno kontrolirati glede znakov in simptomov pankreatitisa.
• The addition of water for injections to the powder for concentrate results in a total volume of 3.08 mL for a final BLINCYTO concentration of 12.5 mcg/mL. 
• Z dodatkom vode za injekcije prašku za koncentrat nastane celotna količina 3,08 ml za končno koncentracijo zdravila BLINCYTO 12,5 µg/ml.
The adverse reactions described in this section were identified in clinical studies of patients with B-precursor ALL (N = 843). 
Neželene učinke, opisane v tem poglavju, so ugotovili v kliničnih študijah pri bolnikih, ki so imeli ALL predhodniških celic B (N = 843).
Induction Cycle 1 Days 1-28 
Indukcijski ciklus 1 1.-28. dan
In clinical studies of adult ALL patients treated with BLINCYTO, less than 3% tested positive for anti-blinatumomab antibodies. 
V kliničnih študijah odraslih bolnikov z ALL, zdravljenih z zdravilom BLINCYTO, je imelo pozitiven izvid protiteles proti blinatumomabu manj kot 3 % bolnikov.
BLINCYTO will be given to you through a vein (intravenous) continuously for 4 weeks using an infusion pump (this is 1 treatment cycle). 
Zdravilo BLINCYTO boste z infuzijsko črpalko dobivali v veno (intravensko) neprekinjeno 4 tedne (to je 1 ciklus zdravljenja).
For patients with ≥ 50% leukaemic blasts in bone marrow or > 15,000/microlitre peripheral blood leukaemic blast counts treat with dexamethasone (not to exceed 24 mg/day). 
Bolnike, ki imajo ≥ 50 % levkemičnih blastov v kostnem mozgu ali > 15.000 levkemičnih blastov/mikroliter v periferni krvi, zdravite z deksametazonom (odmerek naj ne preseže 24 mg/dan).
• Reminder to counsel the patients on how to reduce the risk of ME while using the infusion pump. 
• Opomnik, da se je treba z bolnikom pogovoriti o načinu zmanjšavanja tveganja za napake pri uporabi zdravila, med uporabo infuzijske črpalke.
Due to the potential depletion of B-cells in newborns following exposure to blinatumomab during pregnancy, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered (see section 4.6). 
Zato ker pri novorojenčkih obstaja možnost izčrpanja celic B po izpostavljenosti blinatumomabu med nosečnostjo, je treba novorojenčke spremljati glede izčrpanja celic B in cepljenja z živimi virusnimi cepivi odložiti, dokler se število celic B pri dojenčku ne povrne v normalno območje (glejte poglavje 4.6).
This belongs to a group of medicines called antineoplastic agents which target cancer cells. 
Blinatumomab spada v skupino zdravil, ki jih imenujemo antineoplastična zdravila in so usmerjena proti rakavim celicam.
Recommended daily dose is by patient weight. 
Priporočeni dnevni odmerek se določi glede na bolnikovo telesno maso.
Treatment with BLINCYTO can cause a decrease in the levels of certain white blood cells with or without fever (febrile neutropenia or neutropenia) or can lead to increased blood levels of potassium, uric acid, and phosphate and decreased blood levels of calcium (tumour lysis syndrome). 
Zdravljenje z zdravilom BLINCYTO lahko povzroči zmanjšanje števila določenih belih krvnih celic z zvišano telesno temperaturo ali brez nje (febrilna nevtropenija ali nevtropenija) ali lahko zviša koncentracijo kalija, sečne kisline in fosfata in zniža koncentracijo kalcija v krvi (sindrom lize tumorja).
Patients experiencing capillary leak syndrome should be managed promptly. 
Bolnike s sindromom povečane prepustnosti kapilar je treba nemudoma zdraviti.
No dose adjustment is necessary in elderly patients (≥ 65 years of age), see section 5.1. 
Starejšim bolnikom (≥ 65 let) odmerka ni treba prilagoditi (glejte poglavje 5.1).
Intravenous use after reconstitution and dilution. 
Intravenska uporaba po rekonstituciji in razredčitvi.
• if you have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas). 
• če imate hude in trdovratne bolečine v trebuhu, s slabostjo v želodcu (siljenjem na bruhanje) in bruhanjem ali brez njiju, ker so to lahko simptomi resne bolezni, imenovane pankreatitis (vnetje trebušne slinavke), ki je lahko smrtna.
Greater than or equal to 45 kg (fixed-dose) 
45 kg ali več (fiksni odmerek)
Leukoencephalopathy has been reported. 
Poročali so o primerih levkoencefalopatije.
Complete MRD response a, n/N (%), [95% CI] 
Popoln MRD odziv a, n/N (%), [95 % IZ]
Frequency categories were determined from the crude incidence rate reported for each adverse reaction in clinical studies of patients with B-precursor ALL (N = 843). 
Kategorije pogostnosti so določene na podlagi grobih incidenčnih deležev, poročanih za vsakega od neželenih učinkov v kliničnih študijah pri bolnikih, ki so imeli ALL predhodniških celic B (N = 843).
4.5 months (3.6, 9.0) 
4,5 mesecev (3,6; 9,0)
BLINCYTO is usually given for 2 treatment cycles if you have relapsed/refractory acute lymphoblastic leukaemia, or for 1 treatment cycle if you have minimal residual disease acute lymphoblastic leukaemia. 
Zdravilo BLINCYTO se po navadi uporablja 2 ciklusa zdravljenja, če imate recidivno/refraktarno akutno limfoblastno levkemijo, ali 1 ciklus zdravljenja, če imate akutno limfoblastno levkemijo z minimalno rezidualno boleznijo.
Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology. 
Blinatumomab je pridobljen iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
If you have relapsed/refractory acute lymphoblastic leukaemia and your body weight is greater than or equal to 45 kilograms the recommended initial dose in your first cycle is 9 micrograms per day for 1 week. 
Če imate recidivno/refraktarno akutno limfoblastno levkemijo in je vaša telesna masa enaka 45 kg ali večja, je priporočeni začetni odmerek v prvem ciklusu 9 mikrogramov na dan 1 teden.
Neurologic events 
Nevrološki učinki
• if you develop chills or shivering, or feel warm; you should take your temperature as you may have a fever - these may be symptoms of an infection. 
• če se vam pojavi mrzlica ali drgetanje, ali če vam je toplo; izmeriti si morate telesno temperaturo, ker gre lahko za zvišanje telesne temperature - vse to so lahko simptomi okužbe.
The most serious adverse reactions that may occur during blinatumomab treatment include: infections (24.8%), neurologic events (13.8%), neutropenia/febrile neutropenia (10.1%), cytokine release syndrome (3.3%), and tumour lysis syndrome (0.7%). 
Med najresnejšimi neželenimi učinki, ki se lahko pojavijo med zdravljenjem z blinatumomabom, so: okužbe (24,8 %), nevrološki učinki (13,8 %), nevtropenija/febrilna nevtropenija (10,1 %), sindrom sproščanja citokinov (3,3 %) in sindrom lize tumorja (0,7 %).
Anti-pyretic use (e.g. paracetamol) is recommended to help reduce pyrexia during the first 48 hours of each cycle. 
Priporočljiva je uporaba antipiretika (npr. paracetamola) za znižanje zvišane telesne temperature v prvih 48 urah vsakega ciklusa.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
- performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products. 
Priprava zdravila BLINCYTO mora biti: - opravljena v aseptičnih pogojih in jo mora opraviti usposobljeno osebje v skladu s pravili dobre prakse, še zlasti glede aseptične priprave parenteralnih zdravil.
Unopened vials: - Store and transport refrigerated (2°C - 8°C). 
Neodprte viale: - Shranjujte in prevažajte na hladnem (2 °C - 8 °C).
Blinatumomab mediates the formation of a cytolytic synapse between the T-cell and the tumour cell, releasing proteolytic enzymes to kill both proliferating and resting target cells. 
Blinatumomab posreduje nastanek citolitične sinapse med celico T in tumorsko celico in sprosti proteolitične encime, ki uničijo tako proliferirajoče kot mirujoče ciljne celice.
Serious and grade ≥ 3 neurologic adverse reactions were observed in 11.6% and 12.1% of patients respectively, of which the most common serious adverse reactions were encephalopathy, tremor, aphasia, and confusional state. 
Resne nevrološke neželene učinke so zabeležili pri 11,6 % bolnikov, nevrološke neželene učinke ≥ 3. stopnje pa pri 12,1 % bolnikov; najpogostejši resni neželeni učinki so bili encefalopatija, tremor, afazija in stanje zmedenosti.
• Do not reconstitute BLINCYTO powder for concentrate with the solution 
• Zdravila BLINCYTO prašek za koncentrat ne rekonstituirajte z raztopino
Hyperbilirubinaemia includes blood bilirubin increased and hyperbilirubinaemia. 
10 Hiperbilirubinemija obsega zvišanje bilirubina v krvi in hiperbilirubinemijo.
Storage conditions and shelf life 
Pogoji shranjevanja in rok uporabnosti
f n/N (%), [95% CI] 
f n/N (%), [95 % IZ]
In patients receiving blinatumomab, serious infections, including sepsis, pneumonia, bacteraemia, opportunistic infections and catheter site infections have been observed, some of which were lifethreatening or fatal. 
Med zdravljenjem z blinatumomabom so opažali resne okužbe, vključno s sepso, pljučnico, bakteriemijo, oportunistične okužbe in okužbe na mestu katetra; nekatere okužbe so bile smrtno nevarne in nekatere so bile smrtne.
• chills, shivering, fever, rapid heart rate, decreased blood pressure, aching muscles, feeling tired, coughing, difficulty breathing, confusion, redness, swelling or discharge in the affected area or at the site of the infusion line - these may be signs of an infection. 
• mrzlica, drgetanje, zvišana telesna temperatura, hitro bitje srca, znižanje krvnega tlaka, boleče mišice, utrujenost, kašelj, težko dihanje, zmedenost, pordelost, oteklost ali izcedek na prizadetem predelu ali na mestu infuzijske linije - to so lahko znaki okužbe.
EFS time was calculated from the time of randomisation until the date of disease assessment indicating a relapse after achieving a CR/CRh*/CRi or death, whichever is earlier. 
d Čas preživetja brez dogodkov (EFS - Event-Free Survival) je bil izračunan kot čas od randomizacije do datuma ocene bolezni, ki je pokazala recidiv po doseženi CR/CRh*/CRi, ali do smrti, kar se je zgodilo prej.
If you have minimal residual disease acute lymphoblastic leukaemia, it is recommended that the first 3 days of treatment and the first 2 days of subsequent cycles will be given to you in a hospital or clinic under the supervision of a doctor or nurse experienced in the use of anti-cancer medicines. 
Če imate akutno limfoblastno levkemijo z minimalno rezidualno boleznijo, je priporočljivo, da prve 3 dni zdravljenja in prva 2 dni nadaljnjih ciklusov zdravljenje dobivate v bolnišnici ali v ambulanti pod nadzorstvom zdravnika ali medicinske sestre, ki imata izkušnje z uporabo zdravil proti raku.
• if you have ever had neurological problems, for example, shaking (or tremor), abnormal sensations, seizures, memory loss, confusion, disorientation, loss of balance, or difficulty in speaking. 
• če ste kdaj imeli nevrološke težave, na primer tresenje (tremor), nenormalne zaznave, napade krčev (konvulzije), izgubo spomina, zmedenost, dezorientiranost, izgubo ravnotežja ali težave z govorjenjem.
Population pharmacokinetic analysis suggested that there was no association between ALT or AST levels and the clearance of blinatumomab. 
Populacijska farmakokinetična analiza je pokazala, da med vrednostjo ALT ali AST ter očistkom blinatumomaba ni povezave.
MRD (minimum residual disease) response was defined as MRD by PCR or flow cytometry < 1 x 10 f. Patients who achieved CR/CRh*/CRi and had an evaluable post baseline MRD assessment. 
Odziv MRD (MRD - Minimum Residual Disease) je bil opredeljen kot MRD glede na PCR ali pretočno citometrijo < 1 x 10 f Bolniki, ki so dosegli CR/CRh*/CRi in so bili po izhodišču ocenljivi za MRD.
However high inter-patient variability was discerned (CV% up to 95.6%), and clearance values in renal impaired patients were essentially within the range observed in patients with normal renal function, no clinically meaningful impact of renal function on clinical outcomes is expected. 
Toda opazna je bila velika variabilnost med bolniki (KV % do 95,6 %) in očistek pri bolnikih z okvaro ledvic je bil v bistvu znotraj razpona, ugotovljenega pri bolnikih z normalnim delovanjem ledvic.
Store and transport refrigerated (2°C - 8°C). 
Shranjujte in prevažajte na hladnem (2 °C - 8 °C).
GRH0358 v1 
GRH0243SL v1
There is limited experience in patients with a history or presence of clinically relevant central nervous system (CNS) pathology (e.g. epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis) as they were excluded from clinical trials. 
Malo izkušenj je pri bolnikih z anamnestično ali trenutno klinično pomembno patologijo osrednjega živčevja (npr. z epilepsijo, konvulzijami, parezo, afazijo, možgansko kapjo, hudimi poškodbami možganov, demenco, Parkinsonovo boleznijo, cerebelarno boleznijo, psihoorganskim sindromom, psihozo), ker ti bolniki niso bili vključeni v klinična preskušanja.
• 38.5 micrograms blinatumomab powder in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium) and a flip off cap and 
• 38,5 mikrogramov praška blinatumomaba v viali (steklo tipa I) z zamaškom (elastomerna guma), zaporo (aluminij) in snemno zaporko, in
The elevated cytokine levels returned to baseline within 24 to 48 hours during the infusion. 
Zvišana koncentracija citokinov se je med infundiranjem vrnila na izhodiščno v 24 do 48 urah.
Patients with low tumour burden (< 50%) responded best to BLINCYTO treatment with CR/CRh* rate of 72.9% (CI 59.7 - 83.6). 
Bolniki z majhnim tumorskim bremenom (< 50 %) so se na zdravljenje z zdravilom BLINCYTO odzvali najbolje in so imeli delež CR/CRh* 72,9 % (IZ 59,7-83,6).
Patients were randomised 2:1 to receive BLINCYTO or 1 of 4 prespecified, investigator-selected, SOC backbone chemotherapy regimens. 
Bolnike so v razmerju 2:1 randomizirali na prejemanje zdravila BLINCYTO ali na eno od 4 vnaprej določenih shem standardne temeljne kemoterapije po izbiri raziskovalca.
GRH0148v2 
GRH0488SL v1
The resulting solution should be clear to slightly opalescent, colourless-to-slightly yellow. 
Nastala raztopina mora biti bistra do rahlo opalescentna, brezbarvna do rumenkasta.
Recommended daily dose by patient weight. 
Priporočeni dnevni odmerek glede na bolnikovo telesno maso.
Infusion reactions may be clinically indistinguishable from manifestations of CRS (see section 4.8). 
Infuzijske reakcije se klinično lahko ne razlikujejo od manifestacij sindroma sproščanja citokinov (glejte poglavje 4.8).
Baseline ALT and AST levels were used to assess the effect of hepatic impairment on the clearance of blinatumomab. 
Izhodiščni vrednosti ALT in AST sta bili uporabljeni za oceno vpliva okvare jeter na očistek blinatumomaba.
The most frequently reported serious adverse events were pyrexia (11.4%), febrile neutropenia (11.4%), cytokine release syndrome (5.7%), sepsis (4.3%), device-related infection (4.3%), overdose (4.3%), convulsion (2.9%), respiratory failure (2.9%), hypoxia (2.9%), pneumonia (2.9%), and multi-organ failure (2.9%). 
Najpogosteje poročani resni neželeni dogodki so bili pireksija (11,4 %), febrilna nevtropenija (11,4 %), sindrom sproščanja citokinov (5,7 %), sepsa (4,3 %), s pripomočkom povezana okužba (4,3 %), preveliko odmerjanje (4,3 %), konvulzija (2,9 %), dihalna odpoved (2,9 %), hipoksija (2,9 %), pljučnica (2,9 %) in odpoved več organov (2,9 %).
Discard the remaining solution (stabiliser) vial. 
Preostanek raztopine (stabilizatorja) v viali zavrzite.
In an embryo-foetal developmental toxicity study performed in mice, the murine surrogate crossed the placenta to a limited extent (foetal-to-maternal serum concentration ratio < 1%) and did not induce embryo-foetal toxicity or teratogenicity. 
V študiji embrio-fetalne razvojne toksičnosti, izvedeni na miših, je mišji nadomestek v omejenem obsegu prehajal skozi placento (razmerje med koncentracijo v serumu pri plodu v primerjavi s koncentracijo v serumu pri materi < 1 %) in ni povzročil embrio-fetalne toksičnosti ali teratogenosti.