natgillin/translations-raw huggingface dataset:
The MAH shall ensure that in each Member State where BLINCYTO is marketed, all healthcare professionals (HCP) and patients / caregivers who are expected to prescribe, dispense and use BLINCYTO are provided with the following educational packages: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, v kateri se zdravilo BLINCYTO trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo zdravilo BLINCYTO predpisovali, izdajali in uporabljali, prejeli paket sledečih izobraževalnih gradiv:
Your doctor or nurse will advise you on how to manage your daily activities around your infusion pump. 
Zdravnik ali medicinska sestra vam bo svetoval, kako opravljati vsakodnevne dejavnosti v zvezi z infuzijsko črpalko.
The majority of neurologic events (80.5 %) were clinically reversible and resolved following interruption of BLINCYTO. 
Večina nevroloških učinkov (80,5 %) je bilo klinično reverzibilnih in so po prekinitvi zdravila BLINCYTO minili.
If your leukaemia has spread to your brain and/or spinal cord, your doctor may have to treat this first before you can start treatment with BLINCYTO. 
Če se vam je levkemija razširila v možgane in/ali hrbtni mozeg, bo zdravnik morda moral najprej moral zdraviti to, preden boste lahko začeli zdravljenje z zdravilom BLINCYTO.
Blinatumomab has major influence on the ability to drive and use machines. 
Blinatumomab ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions. 
Če niso uporabljene takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika in čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C - 8 °C, razen če ni razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
Do not adjust the settings on the pump, even if there is a problem or the pump alarm sounds. 
Ne spreminjajte nastavitev na črpalki, niti če so z njo kakšne težave ali če se oglasi alarm črpalke.
Patients must be advised that they may experience neurologic events. 
Bolnikom je treba povedati, da se jim lahko pojavijo nevrološki učinki.
Demographics and baseline characteristics in MRD study 
Demografske in izhodiščne značilnosti v študiji MRD
The median time to the first event was within the first two weeks of treatment. 
Mediana časa do prvega učinka je bila v prvih dveh tednih zdravljenja.
Due to the potential for progressive multifocal leukoencephalopathy (PML), patients should be monitored for signs and symptoms. 
Zaradi možnosti za pojav progresivne multifokalne levkoencefalopatije je treba bolnike spremljati glede njenih znakov in simptomov.
Clinical testing of MRD, regardless of the choice of technique, should be performed by a qualified laboratory familiar with the technique, following well established technical guidelines. 
Ne glede na izbiro tehnike mora klinično testiranje MRD opraviti usposobljen laboratorij, ki je seznanjen s tehniko, z upoštevanjem dobro uveljavljenih tehničnih smernic.
In the second cycle, hospitalisation is recommended at a minimum for 2 days, and clinical judgment should be based on tolerance to BLINCYTO in the first cycle. 
V drugem ciklusu je priporočljiv sprejem v bolnišnico vsaj za 2 dneva, klinična presoja pa mora temeljiti na toleranci na zdravilo BLINCYTO v prvem ciklusu.
Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α and IFN-γ were measured and, IL-6, IL-10 and IFN-γ were most elevated. 
Merili so citokine IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α in IFN-γ; najbolj so se zvišali IL-6, IL-10 in IFN-γ.
Your doctor will determine when your BLINCYTO infusion bag will be changed, which may range from every day to every 4 days. 
Zdravnik bo odločil, kdaj je treba zamenjati vrečko za infundiranje zdravila BLINCYTO, kar se lahko naredi vsak dan do vsake 4 dni.
A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics on blinatumomab pharmacokinetics. 
S populacijsko farmakokinetično analizo so ovrednotili vpliv demografskih značilnosti na farmakokinetiko blinatumomaba.
14-day treatment-free interval 
14-dnevni interval brez zdravljenja
Prior to launch of BLINCYTO in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila BLINCYTO na trg v vsaki državi članici, mora imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom uskladiti vsebino in obliko izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
Tell your doctor immediately if you get any of the following or combination of the following side effects: 
Zdravniku morate nemudoma povedati, če se vam pojavi kateri koli od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov:
The number of treatment cycles and the dose which you will be given will depend on how you tolerate and respond to BLINCYTO. 
Število prejetih ciklusov zdravljenja in odmerek bodo odvisni od tega, kako prenašate in kako se odzovete na zdravilo BLINCYTO.
Gently swirl contents to avoid excess foaming. 
Previdno zavrtite vsebino, da boste preprečili prekomerno penjenje.
• excessive activation of white blood cells associated with inflammation (hemophagocytic histiocytosis) 
• prekomerna aktivacija belih krvnih celic, povezanih z vnetjem (hemofagocitna histiocitoza)
The mean (SD) half-life was 2.11 (1.42) hours. 
Povprečni (standardni odklon) razpolovni čas je bil 2,11 (1,42) ure.
If you have or had neurological problems, it is recommended that the first 14 days of treatment will be given to you in a hospital or clinic. 
Če imate ali ste imeli nevrološke težave, je priporočljivo, da prvih 14 dni zdravljenje dobivate v bolnišnici ali ambulanti.
Neutropenia and febrile neutropenia 
Nevtropenija in febrilna nevtropenija
Your treatment may also be interrupted depending on how you tolerate BLINCYTO. 
Vaše zdravljenje lahko tudi prekine glede na to, kako prenašate zdravilo BLINCYTO.
If you are still suffering from active neurological problems or conditions, tell your doctor. 
Če imate še vedno prisotne nevrološke težave ali motnje, morate to povedati zdravniku.
6.8 months [2.2 to 12.0 months] 
6,8 mesecev [2,2 do 12,0 mesecev]
For reinitiation, premedicate with a 24 mg dose of dexamethasone. 
Ob ponovnem začetku uporabite premedikacijo s 24 mg odmerkom deksametazona.
T-cell counts initially declined within 1 to 2 days and then returned to baseline levels within 7 to 14 days in the majority of patients. 
Število celic T se je uvodoma v 1 do 2 dneh zmanjšalo, nato pa se je pri večini bolnikov v 7 do 14 dneh vrnilo na izhodiščno.
• Store the package at room temperature (up to 27°C). 
• Pakiranje shranjujte na sobni temperaturi (do 27 °C).
Your doctor or nurse will show you how to care for your catheter site. 
Zdravnik ali medicinska sestra vam bosta pokazala, kako poskrbeti za mesto, kjer je kateter.
This is to account for intravenous infusion line loss and to assure that the patient will receive the full dose of BLINCYTO. 
Namen tega je upoštevanje izgube v intravenskem sistemu za infundiranje in zagotovitev, da bolnik dobi celotni odmerek zdravila BLINCYTO.
Action for patients less than 45 kg 
Ukrepanje pri bolnikih, lažjih od 45 kg
5.9 months 
5,9 mesecev
In this open-label study, Health related quality of life (HRQoL) reported by patients were measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). 
V tej študiji z odprtim načrtom zdravljenja so z zdravjem povezano kakovost življenja (HRQoLHealth related quality of life) po navedbi bolnikov merili z vprašalnikom o kakovosti življenja EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30).
o Ensure that the tubing is compatible with the infusion pump. 
o Poskrbite, da je sistem kompatibilen z infuzijsko črpalko.
• infections in the blood including bacteria, fungi, viruses, or other types of infection 
• okužbe krvi, vključno z bakterijskimi, glivnimi, virusnimi in drugimi vrstami okužb
• low blood pressure 
• nizek krvni tlak
Common (≥ 1/100 to < 1/10) 
Pogosti (≥ 1/100 do < 1/10)
Then reduce dexamethasone step-wise over 4 days. 
Potem postopoma zmanjšujte deksametazon v teku 4 dni.
Your doctor may decide to then increase your dose for weeks 2, 3, and 4 of your treatment. 
Zdravnik se nato lahko odloči za povečanje odmerka za 2., 3. in 4. teden zdravljenja.
BSA = body surface area 
BSA = telesna površina bolnika
- Once at room temperature (up to 27°C) the solution will be infused within 96 hours. 
- Ko je raztopina na sobni temperaturi (do 27 °C), bo za infundiranje uporabljena v 96 urah.
Patients should be closely monitored for signs or symptoms of TLS, including renal function and fluid balance in the first 48 hours after the first infusion. 
Bolnike je treba skrbno spremljati glede znakov in simptomov sindroma lize tumorja, vključno z delovanjem ledvic in ravnovesjem tekočin v prvih 48 urah po prvem infundiranju.
Diluted solution (prepared infusion bag) 
Razredčena raztopina (pripravljena infuzijska vrečka)
Specific reconstitution and dilution instructions are provided for each dose and infusion time. 
Navedena so specifična navodila za rekonstitucijo in redčenje za vsak odmerek in čas infundiranja.
MRD positive B-precursor ALL 
MRD-pozitivna ALL predhodniških celic B
There are no data for children < 7 months of age. 
Podatki pri otrocih, mlajših od 7 mesecev, niso na voljo.
Infusion rate (mL/hour) 
Hitrost infundiranja (ml/uro)
Premedication, BLINCYTO dose per treatment cycle and route of administration were identical to those in the phase III study. 
Premedikacija, odmerek zdravila BLINCYTO na ciklus zdravljenja in pot uporabe so bili enaki kot v študiji III. faze.
Four patients achieved M1 bone marrow but did not meet the peripheral blood count recovery criteria for CR or CRh*. 
Štirje bolniki so dosegli kostni mozeg M1, vendar niso izpolnili meril obnove periferne krvne slike za CR ali CRh*.
[4.2 to 7.5 months] 
[4,2 do 7,5 mesecev]
The patient alert card should contain: 
Opozorilna kartica za bolnika mora vsebovati:
Patients receiving BLINCYTO should be clinically monitored for signs and symptoms of infection and treated appropriately. 
Bolnike, ki prejemajo zdravilo BLINCYTO, je treba klinično spremljati glede znakov in simptomov okužb in jih ustrezno zdraviti.
n = number of patients who achieved CR or CRh* in the first two cycles of treatment in the specified subgroup. 
n = število bolnikov, ki so v opredeljeni podskupini v prvih dveh ciklusih zdravljenja dosegli CR ali CRh*.
Uncommon (≥ 1/1,000 to < 1/100) 
Občasni (≥ 1/1.000 do < 1/100)
Adverse reactions are presented below by system organ class and frequency category. 
Spodaj so prikazani neželeni učinki po organskih sistemih in kategoriji pogostnosti.
It is not known whether BLINCYTO is excreted in breast milk but a risk for suckling baby cannot be excluded. 
Ni znano, ali se zdravilo BLINCYTO izloča v materino mleko, vendar tveganja za dojenega otroka ne moremo izključiti.
Days 1-7 
1.-7. dan
The duration of hepatic adverse reactions has generally been brief and with rapid resolution, often when continuing uninterrupted treatment with BLINCYTO. 
Jetrni neželeni učinki so bili na splošno kratkotrajni in so hitro minili, pogosto med neprekinjenim nadaljevanjem zdravljenja z zdravilom BLINCYTO.
BLINCYTO is used to treat children (≥ 1 year old), teenagers and young adults with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working. 
Zdravilo BLINCYTO se uporablja za zdravljenje otrok (starih ≥ 1 leto), najstnikov in mladih odraslih z akutno limfoblastno levkemijo (ALL), kadar predhodna zdravljenja niso delovala ali so prenehala delovati.
The infusion bag must be changed at least every 96 hours by a healthcare professional for sterility reasons. 
Infuzijsko vrečko je treba zamenjati vsaj na 96 ur; zaradi sterilnosti jo mora zamenjati zdravstveni delavec.
Excipients with known effect 
Pomožne snovi z znanim učinkom
Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above. 
Izrazi za učinke, ki predstavljajo isti medicinski koncept ali stanje, so v zgornji preglednici razvrščeni skupaj in zabeleženi kot en neželen učinek.
[4.8 to 8.3 months] 
[4,8 do 8,3 mesecev]
In the dose-finding part of the study, doses of up to 30 mcg/m 2/day were evaluated. 
V delu za ugotavljanje odmerka, so ocenjevali odmerke do 30 µg/m2/dan.
7.5 months [4.0 to 11.8 months] 
7,5 mesecev [4,0 do 11,8 mesecev]
Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities. 
Rezultati testiranj v človeških hepatocitih in vitro kažejo, da blinatumomab ne vpliva na aktivnost encimov CYP450.
What BLINCYTO is and what it is used for 
Kaj je zdravilo BLINCYTO in za kaj ga uporabljamo
Among these patients, the median time to the first neurologic event was within the first cycle of treatment. 
Med temi bolniki je bila mediana časa do prvega nevrološkega učinka znotraj prvega ciklusa zdravljenja.
The target therapeutic dose of BLINCYTO delivered does not change. 
Ciljni terapevtski odmerek danega zdravila BLINCYTO se ne spremeni.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Important note: Do not flush the BLINCYTO infusion line or intravenous catheter, especially when changing infusion bags. 
Pomembna opomba: Infuzijske linije zdravila BLINCYTO ali intravenskega katetra ne izpirajte, zlasti ne pri zamenjavi infuzijskih vrečk.
What you need to know before you use BLINCYTO 
Kaj morate vedeti, preden boste uporabili zdravilo BLINCYTO
These may include corticosteroids (e.g. dexamethasone). 
Med temi zdravili so lahko kortikosteroidi (npr. deksametazon).
Patients may receive 1 cycle of induction treatment followed by up to 3 additional cycles of BLINCYTO consolidation treatment. 
Bolniki lahko prejmejo 1 ciklus indukcijskega zdravljenja, ki mu sledijo do 3 dodatni ciklusi konsolidacijskega zdravljenja z zdravilom BLINCYTO.
In case of suspicious events consider consultation with a neurologist, brain MRI and examination of cerebral spinal fluid (CSF), see section 4.8. 
V primeru sumljivih manifestacij razmislite o posvetu z nevrologom, MRI možganov in pregledu cerebrospinalne tekočine, glejte poglavje 4.8.
Your doctor may decide to then increase your dose to 28 micrograms per day for weeks 2, 3, and 4 of your treatment. 
Zdravnik se nato lahko odloči za povečanje odmerka na 28 mikrogramov na dan v 2., 3. in 4. tednu zdravljenja.
Overdoses have been observed including one patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration. 
Zabeleženi so bili primeri prevelikega odmerjanja, vključno z enim bolnikom, ki je prejel 133-kraten priporočeni terapevtski odmerek zdravila BLINCYTO, apliciran v kratkem času.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
For instructions on the handling and preparation of the medicinal product before administration, see section 6.6. 
Za navodila o ravnanju z zdravilom in njegovi pripravi pred dajanjem glejte poglavje 6.6.
It is also used in patients with acute lymphoblastic leukaemia who still have a small number of cancer cells remaining after previous treatment (referred to as minimal residual disease). 
Uporablja se tudi pri bolnikih z akutno limfoblastno levkemijo, ki imajo še preostanek manjšega števila rakavih celic po predhodnem zdravljenju (imenovano minimalna rezidualna bolezen).
Before each infusion cycle of BLINCYTO, you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells. 
Pred vsakim ciklusom infundiranja zdravila BLINCYTO boste dobili zdravilo, ki bo pomagalo zmanjšati možnost za potencialno smrtno nevaren zaplet, imenovan sindrom lize tumorja; vzrok tega zapleta so kemične motnje v krvi, ki nastanejo zaradi razgradnje odmirajočih rakavih celic.
Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. 
Izpiranje pri zamenjavi vrečk ali po koncu infundiranja lahko povzroči povečanje odmerka in s tem povezane zaplete.
Other instructions 
Dodatna navodila
Initiation of BLINCYTO treatment causes transient release of cytokines during the first days of treatment that may suppress CYP450 enzymes. 
Uvedba zdravila BLINCYTO lahko v prvih dneh zdravljenja povzroči prehodno sproščanje citokinov, ki lahko zavrejo encime CYP450.
The choice of the infusion duration should be made by the treating physician considering the frequency of the infusion bag changes. 
Trajanje infundiranja mora določiti lečeči zdravnik ob upoštevanju pogostnosti menjav infuzijskih vrečk.
Subsequent cycles 
Nadaljnji ciklusi
- The package will be opened by your nurse and the infusion bags will be stored in a refrigerator until infusion. 
- Pakiranje bo odprla medicinska sestra in bo infuzijske vrečke shanila v hladilnik za čas do infundiranja.
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). 
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).
Patients who responded to BLINCYTO but later relapsed had the option to be retreated with BLINCYTO. 
Bolniki, ki so se odzvali na zdravilo BLINCYTO, a se jim je pozneje pojavil recidiv, so imeli možnost ponovnega zdravljenja z zdravilom BLINCYTO.
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. 
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.
• A warning message for HCPs treating the patient at any time, including emergency conditions, that the patient is using BLINCYTO 
• Opozorilo za zdravstvene delavce, ki kadar koli zdravijo bolnika, vključno v nujnih primerih, da bolnik uporablja zdravilo BLINCYTO.
• fever (pyrexia) 
• vročino (pireksijo)
The effects of BLINCYTO in pregnant women are not known but based on its mechanism of action, BLINCYTO may harm your unborn baby. 
Učinki zdravila BLINCYTO pri nosečnicah niso znani, vendar bi zdravilo BLINCYTO zaradi njegovega mehanizma delovanja lahko škodovalo nerojenemu otroku.
Change of infusion bag 
Zamenjava infuzijske vrečke
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. 
• 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.
Blinatumomab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. 
Blinatumomaba ne smete uporabljati med nosečnostjo, razen če možne koristi odtehtajo možna tveganja za plod.
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). 
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).
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. 
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.
• Pump specifications: The infusion pump to administer BLINCYTO solution for infusion should be programmable, lockable and have an alarm. 
• Specifikacije črpalke: Infuzijska črpalka za dajanje zdravila BLINCYTO raztopina za infundiranje mora biti programabilna, imeti mora možnost zaklepanja in imeti mora alarm.
Refractory status - n (%) 
Status odpornosti - n (%)
3.8 months (1.9, 19.0) 
3,8 mesecev (1,9; 19,0)
Do not shake the reconstituted solution. 
Rekonstituirane raztopine ne pretresajte.
Reconstituted solution (BLINCYTO solution): - When refrigerated, the reconstituted solution must be used within 24 hours. 
Rekonstituirana raztopina (raztopina zdravila BLINCYTO): - Če je rekonstituirana raztopina shranjena v hladilniku, jo je treba uporabiti v roku 24 ur.
96 hours 
96 ur
Your infusion catheter will be attached to you at all times during each cycle of your treatment. 
Kateter za infundiranje boste imeli vstavljen ves čas med vsakim ciklusom zdravljenja.
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. 
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.
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. 
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).
Six of those patients had anti-blinatumomab antibodies with in vitro neutralising activity. 
Šest od teh bolnikov je imelo protitelesa proti blinatumomabu, ki so in vitro delovala nevtralizirajoče.
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). 
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).
• if you experience seizures, difficulty in speaking or slurred speech, confusion and disorientation, or loss of balance. 
• če se vam pojavijo napadi krčev, težave z govorjenjem ali nejasen govor, zmedenost in dezorientiranost ali izguba ravnotežja.
The type of adverse events observed in infants were similar to those observed in the overall paediatric population. 
Opaženi neželeni učinki pri dojenčkih so bili podobni tistim, ki so jih opazili na splošno pri pediatrični populaciji.
1/Complete remission with partial haematological recovery (CRh*) CR 
1/popolna remisija z delnim hematološkim okrevanjem (CRh*) CR