natgillin/translations-raw huggingface dataset:
On the basis of the scientific conclusions for asparaginase (centrally authorised product) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing asparaginase (centrally authorised product) is unchanged subject to the proposed changes to the product information. 
Na podlagi znanstvenih zaključkov za asparaginazo (zdravilo, ki je pridobilo dovoljenje za promet po centraliziranem postopku) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) asparaginazo (zdravilo, ki je pridobilo dovoljenje za promet po centraliziranem postopku) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Data on efficacy and safety of Spectrila in the post-induction treatment phases are very limited. 
Podatkov o učinkovitosti in varnosti zdravila Spectrila v postindukcijskih fazah zdravljenja je zelo malo.
Therefore, Spectrila must not be used during breast-feeding. 
Zato se zdravilo Spectrila med dojenjem ne sme uporabljati.
EU/1/15/1072/002 (5 vials) 
EU/1/15/1072/002 (5 vial)
Complete asparagine depletion in CSF Yesc 
Popolno izčrpanje asparagina v CSF
In the study in children/adolescents aged 1 - 18 years with de novo ALL (study MC-ASP.5/ALL), by day 33 of induction treatment 10 patients in the Spectrila group (10.3 %) and 9 in the reference group (8.9 %) were measured positive for anti-asparaginase antibodies at least at one time point. 
V študiji pri otrocih in mladostnikih, starih 1-18 let, z de novo ALL (študija MC-ASP.5/ALL) je bilo do 33. dne indukcijskega zdravljenja 10 bolnikov v skupini z zdravilom Spectrila (10,3 %) in 9 v referenčni skupini (8,9 %) pozitivnih za antiasparaginazna protitelesa vsaj v eni časovni točki.
During treatment with asparaginase-containing regimens, myelosuppression, potentially affecting all three cell lines, and infections can occur. 
Med zdravljenjem s terapevtskimi shemami, ki vsebujejo asparaginazo, se lahko pojavijo mielosupresija, ki lahko prizadene vse tri celične linije, in okužbe.
Patients with severe hypertriglyceridaemia are at increased risk of developing acute pancreatitis. 
Pri bolnikih s hudo hipertrigliceridemijo je večje tveganje nastanka akutnega pankreatitisa.
If allergic symptoms occur, intravenous infusion of Spectrila must be discontinued immediately. 
Če se pojavijo alergijski simptomi, je treba nemudoma prekiniti intravensko infuzijo zdravila Spectrila.
Conversely, the antitumour effects of methotrexate are enhanced when asparaginase is administered 24 hours following methotrexate treatment. 
Nasprotno se protitumorsko delovanje metotreksata zveča, če damo asparaginazo 24 ur po zdravljenju z metotreksatom.
There is no known case of an overdose with asparaginase where patients showed any signs of an overdose. 
Ne poznamo nobenega primera prevelikega odmerjanja asparaginaze, kjer bi bolniki kazali kakršne koli znake prevelikega odmerjanja.
To avoid this, vincristine is usually given 3 - 24 hours before asparaginase. 
Temu se navadno izognemo tako, da vinkristin damo 3-24 ur pred asparaginazo.
Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of Spectrila. 
Spremljanje zdravljenja lahko temelji na najmanjši aktivnosti serumske asparaginaze, izmerjene tri dni po dajanju zdravila Spectrila.
Patients received 5,000 U/m² asparaginase (Spectrila versus a reference E.coli- asparaginase) at days 12, 15, 18, 21, 24, 27, 30, and 33 of induction treatment. 
Bolniki so prejeli po 5.000 E/m² asparaginaze (zdravila Spectrila oziroma referenčne asparaginaze E. coli) na 12., 15., 18., 21., 24., 27., 30. in 33. dan indukcijskega zdravljenja.
Median trough serum asparaginase activities were measured in 81 children/adolescents with de novo ALL three days after infusion of asparaginase (just before the next dose had to be given) during induction treatment and ranged from 168 to 184 U/l (study MC-ASP.5/ALL). 
Mediano najnižjo aktivnost asparaginaze v serumu so izmerili pri 81 otrocih/mladostnikih z de novo ALL tri dni po infuziji asparaginaze (tik preden je bilo treba dati naslednji odmerek) med indukcijskim zdravljenjem in je bila v mejah med 168 in 184 E/l (študija MC-ASP.5/ALL).
Symptomatic thromboses related to the use of central venous catheters have been described, too. 
Opisali so tudi simptomatske tromboze, povezane z uporabo centralnih venskih katetrov.
However, when asparaginase was given after cytarabine a synergistic effect was observed. 
Če pa damo asparaginazo po citarabinu, so ugotovili sinergističen učinek.
The toxicity of vincristine may be additive with that of asparaginase if both agents are administered concomitantly. 
Toksičnost vinkristina se lahko sešteva s toksičnostjo asparaginaze, če damo bolniku obe zdravili sočasno.
Expert advice should be sought. 
Treba je poiskati nasvet specialista.
Unconditional exact test of non-inferiority for binomial differences based on restricted maximum likelihood estimates c Patients were considered as responders if asparagine values in CSF on protocol day 33 were below the lower limit of quantification. 
Brezpogojni natančni interval zaupanja po Chanu in Zhangu b Brezpogojni natančni preskus neinferiornosti za binomialne razlike na podlagi omejenih ocen največje verjetnosti c Veljalo je, da so se bolniki odzvali na zdravljenje, če so bile vrednosti asparagina v CSF na 33. dan po protokolu pod spodnjo mejo kvantitativnega določanja.
Effective contraception must be used during treatment and for at least 3 months after asparaginase discontinuation. 
Med zdravljenjem in še vsaj 3 mesece po ukinitvi asparaginaze je treba uporabljati učinkovito kontracepcijo.
In a clinical trial in children with newly diagnosed ALL (study MC-ASP.5/ALL), the following frequencies of allergic events were observed (table 2). 
V kliničnem preskušanju pri otrocih z na novo diagnosticirano ALL (študija MC-ASP.5/ALL) so ugotovili naslednje pogostnosti alergijskih dogodkov (preglednica 2).
Evidence from published data with asparaginase renders the mutagenic, clastogenic and carcinogenic potential of asparaginase negligible. 
Sodeč po objavljenih podatkih za asparaginazo je mutageni, klastogeni in kancerogeni potencial asparaginaze zanemarljiv.
The metabolism of asparaginase is not known but thought to occur via degradation within the reticulohistiocytic system and by serum proteases. 
Presnova asparaginaze ni znana, mislijo pa, da poteka preko degradacije v retikulo-histiocitnem sistemu in s posredovanjem serumskih proteaz.
What Spectrila is and what it is used for What you need to know before you are given Spectrila How to use Spectrila 
Kaj je zdravilo Spectrila in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Spectrila Kako uporabljati zdravilo Spectrila Možni neželeni učinki
In case of occurrence of allergic symptoms, administration of Spectrila should be discontinued immediately (see section 4.4). 
Če se pojavijo alergijski simptomi, je treba takoj prekiniti dajanje zdravila Spectrila (glejte poglavje 4.4).
Simultaneous vaccination with live vaccines may increase the risk of a serious infection. 
Sočasno cepljenje z živimi cepivi lahko zveča tveganje za resne okužbe.
• severe liver function abnormalities (determined by laboratory tests), 
• hude nenormalnosti v delovanju jeter (ugotavljajo se z laboratorijskim testiranjem),
Spectrila contains asparaginase, which is an enzyme that interferes with natural substances necessary for cancer cell growth. 
Zdravilo Spectrila vsebuje asparaginazo, ki je encim, ki deluje na naravne snovi, potrebne za rast rakastih celic.
Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity of medicinal products metabolised by the liver or bound to plasma proteins and altered pharmacokinetics and pharmacodynamics of medicines bound to plasma proteins. 
Asparaginaza lahko zveča toksičnost drugih zdravil s svojim vplivom na funkcijo jeter, na primer zvečana hepatotoksičnost potencialno hepatotoksičnih zdravil, zvečana toksičnost zdravil, ki se presnavljajo v jetrih ali vežejo na plazemske beljakovine, in spremenjena farmakokinetika in farmakodinamika zdravil, vezanih na plazemske beljakovine.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Because of the risk of severe anaphylactic reactions asparaginase should not be administered as a bolus intravenous injection. 
Zaradi tveganja hudih anafilaktičnih reakcij asparaginaze ne smemo dajati v obliki bolusne intravenske injekcije.
However, Spectrila should not be used in patients with severe hepatic impairment (see section 4.3). 
Zdravilo Spectrila pa se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
Hypersensitivity including bronchospasm Rare 
Pogosti preobčutljivost, vključno z bronhospazmom
• if you have severe liver function problems, 
• če imate velike težave z delovanjem jeter,
Laboratory in vitro and in vivo data indicate that the efficacy of high-dose cytarabine is reduced by prior administration of asparaginase. 
Laboratorijski podatki in vitro in in vivo kažejo, da se učinkovitost velikih odmerkov citarabina zmanjša, če damo pred njim asparaginazo.
Clinical trials with asparaginase have shown that glutamine levels are only moderately affected with a very high interindividual variability. 
Klinična preskušanja z asparaginazo so pokazala, da ta le zmerno vpliva na koncentracijo glutamina z zelo veliko interindividualno variabilnostjo.
Data on efficacy and safety of Spectrila in adults are limited. 
Podatkov o učinkovitosti in varnosti zdravila Spectrila pri odraslih je malo.
The reconstituted solution may exhibit a slight opalescence. 
Rekonstituirana raztopina je lahko rahlo opalescenčna.
The primary endpoint was the rate of patients with complete asparagine depletion in serum (defined as asparagine serum levels below the lower limit of quantification (< 0.5 µM) at all time points measured from day 12 up to day 33) during induction treatment. 
Primarni končni opazovani dogodek je bil delež bolnikov s popolnim izčrpanjem asparagina v serumu (ki je bilo definirano kot koncentracija asparagina v serumu, nižja od spodnje meje kvantitativnega določanja (<0,5 µM) v vseh časovnih točkah, merjenih od 12. do 33. dne) med indukcijskim zdravljenjem.
Treatment group 
Skupina zdravljenja
Spectrila is available in packs containing 1 or 5 vials. 
Zdravilo Spectrila je na voljo v pakiranjih po 1 ali 5 vial.
• Medicines that reduce the ability of blood to clot, such as anticoagulants (e.g. warfarin and heparin), dipyridamole, acetylsalicylic acid or medicines to treat pain and inflammation, since using these medicines with asparaginase may increase the risk of bleeding. 
• Zdravila, ki zmanjšujejo zmožnost krvi za strjevanje, na primer antikoagulanti (npr. varfarin in heparin), dipiridamol, acetilsalicilna kislina ali zdravila za zdravljenje bolečine in vnetja, ker uporaba teh zdravil skupaj z asparaginazo lahko zveča tveganje krvavitve.
Study in infants with de novo ALL 
Študija pri dojenčkih z de novo ALL
Chemical and physical in-use stability has been demonstrated for 2 days at 2 °C - 8 °C. 
Rekonstituirana in razredčena raztopina Kemijsko in fizikalno stabilnost med uporabo so dokazali za 2 dni pri 2 °C - 8 °C.
During induction treatment, asparaginase-typical adverse drug reactions like elevated liver enzymes/bilirubin (≥ CTCAE Grade III: 44.3 % vs. 39.6 %), haemorrhage or thromboembolism (≥ CTCAE Grade II: 2.1 % vs. 4.0 %), and neurotoxicity (≥ CTCAE Grade III: 4.1 % vs. 5.9 %) were observed in comparable frequencies in both groups (Spectrila versus reference). 
Med indukcijskim zdravljenjem so ugotavljali za asparaginazo značilne neželene učinke, kot so zvišani jetrni encimi/bilirubin (≥CTCAE stopnje III: 44,3 % v primerjavi z 39,6 %), krvavitev ali trombembolija (≥ CTCAE stopnje II: 2,1 % v primerjavi s 4,0 %) in nevrotoksičnost (≥ CTCAE stopnje III: 4,1 % v primerjavi s 5,9 %), s primerljivimi pogostnostmi v obeh skupinah (zdravilo
Warnings and precautions Talk to your doctor or nurse before you are given Spectrila. 
Opozorila in previdnostni ukrepi Preden vam dajo zdravilo Spectrila, se posvetujte z zdravnikom ali medicinsko sestro.
• Vincristine (used to treat certain types of cancer) since the simultaneous use of vincristine and asparaginase may increase the risk of certain side effects. 
• Vinkristin (uporablja se za zdravljenje določenih vrst raka), ker lahko sočasna uporaba vinkristina in asparaginaze zveča tveganje za nekatere neželene učinke.
If severe liver problems occur, treatment with Spectrila must be interrupted immediately. 
Če bodo nastopile hude težave z jetri, je treba nemudoma prekiniti zdravljenje z zdravilom Spectrila.
Spectrila is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5). 
Zdravilo Spectrila se navadno uporablja kot del kombiniranih kemoterapevtskih protokolov z drugimi zdravili z delovanjem na novotvorbe (glejte tudi poglavje 4.5).
Efficacy and safety of Spectrila have not been established in Philadelphia chromosome-positive patients. 
Varnosti in učinkovitosti zdravila Spectrila pri bolnikih, pozitivnih na kromosom Philadelphia, niso dokazali.
Symptoms of RPLS essentially include elevated blood pressure, seizures, headaches, changes in mental state and acute visual impairment (primarily cortical blindness or homonymous hemianopsia). 
Simptomi RPLS v glavnem vključujejo zvišan krvni tlak, epileptične napade, glavobole, spremembe duševnega stanja in akutno okvaro vida (predvsem kortikalno slepoto ali homonimno hemianopsijo).
*Including all allergic reactions within 12 hours after asparaginase infusion and all adverse events with CTCAE terms syncope (fainting), hypotension, rash, flushing, pruritus, dyspnoea, injection site reaction or airway obstruction within 24 hours after asparaginase infusion 
*Vključno z vsemi alergijskimi reakcijami v 12 urah po infuziji asparaginaze in vsemi neželenimi učinki, označenimi z izrazi CTCAE sinkopa (omedlevica), hipotenzija, izpuščaj, vročinski oblivi, pruritus, dispnea, reakcija na mestu injiciranja ali zapora dihalnih poti v 24 urah po infuziji asparaginaze.
Allergic reactions within 12 hours after asparaginase infusion during induction treatment Any allergic event* within 24 hours after asparaginase infusion during induction treatment 
Zdravilo Spectrila Referenčna asparaginaza število bolnikov alergijske reakcije v 12 urah po infuziji asparaginaze med indukcijskim zdravljenjem kateri koli alergijski dogodek* v 24 urah po infuziji asparaginaze med indukcijskim zdravljenjem
Ischaemic strokes are rare. 
Ishemične možganske kapi so redke.
It is unknown whether asparaginase is present in human breast milk. 
Ni znano, ali je asparaginaza prisotna v materinem mleku.
Because potential serious adverse reactions may occur in nursing infants, Spectrila should be discontinued during breast-feeding. 
Ker se lahko pri dojenih otrocih pojavijo potencialno resni neželeni učinki, je treba med dojenjem zdravljenje z zdravilom Spectrila prekiniti.
Absorption Asparaginase is not absorbed by the gastrointestinal tract, thus Spectrila must be given intravenously. 
Absorpcija Asparaginaza se v prebavilih ne absorbira, zato moramo zdravilo Spectrila dajati intravensko.
After repeated administration of asparaginase at a dose of 5,000 U/m² every third day, trough asparaginase activity levels in serum ranged from 108 to 510 U/l. 
Po ponovnem dajanju asparaginaze v odmerku 5.000 E/m² vsak tretji dan je bila najnižja raven aktivnosti asparaginaze v serumu v razponu od 108 to 510 E/l.
In a clinical trial in children with de novo ALL (study MC-ASP.4/ALL) it was shown that immediately after the end of infusion of asparaginase mean asparagine concentrations in serum dropped from the pre-dose concentrations of about 40 µM to below the lower limit of quantification of the bioanalytical method (< 0.5 µM). 
V kliničnem preskušanju pri otrocih z de novo ALL (študija MC-ASP.4/ALL) so pokazali, da so se takoj po koncu infuzije asparaginaze srednje serumske koncentracije asparagina znižale s koncentracij pred odmerkom, ki so bile okrog 40 µM, na vrednosti pod spodnjo mejo kvantitativnega določanja bioanalitične metode (<0,5 µM).
• nervousness (agitation) or somnolence (sleepiness) 
• živčnost (agitiranost) ali somnolenca (zaspanost),
Additionally it may decrease insulin secretion from pancreatic β-cells and impair insulin receptor function. 
Poleg tega lahko zmanjša izločanje insulina iz pankreatičnih celic β in okvari delovanje insulinskih receptorjev.
No case of asparaginase overdose with clinical symptoms has been reported. 
Poročali niso o nobenem primeru prevelikega odmerjanja asparaginaze s kliničnimi simptomi.
For intravenous use only. 
SAMO za intravensko uporabo.
Even those few patients with trough asparaginase serum activity levels of 10 - 100 U/l usually experienced complete asparagine depletion in serum and CSF. 
Celo pri tistih nekaj bolnikih, ki so imeli najnižjo raven serumske aktivnosti asparaginaze 10-100 E/l, je navadno bilo prisotno popolno izčrpanje asparagina v serumu in CSF.
Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase. 
Brezbarvna 20-mililitrska steklena viala (steklo tipa 1), zaprta z zamaškom iz butilne gume, aluminijasto zaporko in plastičnim dvižnim pokrovčkom, ki vsebuje 10.000 enot asparaginaze.
Reversible posterior leukoencephalopathy syndrome (characterised by headache, confusion, seizures and visual loss) may require blood-pressure lowering medicines and in case of seizure, anti-epileptic treatment. 
Pri sindromu reverzibilne posteriorne levkoencefalopatije (za katerega so značilni glavobol, zmedenost, epileptični napadi in okvara vida) bodo morda potrebna zdravila za znižanje krvnega tlaka in, v primeru epileptičnih napadov, antiepileptično zdravljenje.
• acute pancreatitis, 
• akutni pankreatitis,
Frequent evaluation of coagulation parameters is important before and during asparaginase treatment. 
Pogosto določanje koagulacijskih parametrov je pomembno pred zdravljenjem z asparaginazo in med njim.
Spectrila has moderate influence on the ability to drive and use machines, especially through its potential effects on the nervous and gastrointestinal systems (see section 4.8). 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Spectrila ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji, posebno prek svojih potencialnih učinkov na živčevje in prebavila (glejte poglavje 4.8).
How to use Spectrila 
Kako uporabljati zdravilo Spectrila
Asparaginase-associated hyperlipidaemia should be treated depending on its severity and on clinical symptoms. 
Hiperlipidemijo, povezano z asparaginazo, moramo zdraviti odvisno od njene izraženosti in od kliničnih simptomov.
This antagonism is observed if asparaginase is administered prior to or concurrently with methotrexate. 
Ta antagonizem je viden, če damo asparaginazo prej kot metotreksat ali sočasno z njim.
Expert advice should be sought in cases where AT III is decreased. 
V primerih, ko je znižan AT III, je treba poiskati nasvet specialista.
Marketing Authorisation Holder and Manufacturer medac 
Imetnik dovoljenja za promet z zdravilom in izdelovalec medac
17.33 (12.54 - 22.91) h 
17,33 (12,54-22,91) h skupni očistek
One vial contains 10,000 units of asparaginase. 
Ena viala vsebuje 10.000 enot asparaginaze.
• blood clotting disorders (bleeding or formation of blood clots), 
• motnje strjevanja krvi (krvavitev ali nastanek krvnih strdkov),
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 10,000 units of asparaginase*. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 10.000 enot asparaginaze*.
6,700 U/m² BSA, 
6.700 E/m² telesne površine,
There have been reports of transitory secondary hypothyroidism probably caused by a decrease in the serum thyroxin-binding globulin due to asparaginase-induced protein synthesis inhibition. 
Poročali so o prehodnem sekundarnem hipotiroidizmu, ki ga verjetno povzroča zmanjšanje serumskega globulina, ki veže tiroksin, zaradi inhibicije sinteze beljakovin, ki jo povzroča asparaginaza.
Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing chemotherapy. 
Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo in ne smejo zanositi, ko se zdravijo s kemoterapijo, katere del je asparaginaza.
Difference (95 % CIa) 
da c ne ni mogoče oceniti razlika (95 % CI
It is unknown whether asparaginase is excreted into human breast milk. 
Ni znano, ali se asparaginaza pri človeku izloča v materino mleko.
Pharmacokinetic parameters after administration of 5,000 U/m² of Spectrila were determined in 14 children/adolescents (age 2 - 14 years) with de novo ALL (study MC-ASP.4/ALL). 
Pediatrična populacija Farmakokinetične parametre po dajanju 5.000 E/m zdravila Spectrila so določili pri 14 otrocih/mladostnikih (starih 2-14 let) z de novo ALL (študija MC-ASP.4/ALL).
Liver parameters should be monitored closely before and during treatment with asparaginase. 
Jetrne parametre je treba skrbno spremljati pred zdravljenjem z asparaginazo in med njim.
As a result of asparaginase-induced asparagine depletion in serum, protein synthesis in lymphoblastic tumour cells is disturbed while sparing most normal cells. 
Kot rezultat izčrpanja asparagina v serumu, ki ga povzroči asparaginaza, je sinteza beljakovin v limfoblastnih tumorskih celicah motena, kar pa ne vpliva na večino normalnih celic.
Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products. 
Zdravilo Spectrila smejo predpisovati in dajati le zdravniki in zdravstveno osebje, ki imajo izkušnje z uporabo zdravil z delovanjem na novotvorbe.
• allergic reactions including wheezing (bronchospasm) or difficulty in breathing 
• alergijske reakcije, vključno s sopenjem (bronhospazem) ali z oteženim dihanjem,
Very rare 
Zelo redki tremor
Coagulation disorders 
Motnje koagulacije
Clinical symptoms include abdominal pain, nausea, vomiting and anorexia. 
Klinični simptomi vključujejo bolečine v trebuhu, navzeo, bruhanje in anoreksijo.
In an uncontrolled clinical trial (study MC-ASP.6/INF), 12 infants (median age [range] at time of first infusion: 6 months [0.5 - 12.2 months]) with de novo ALL were treated with Spectrila within the 
V nekontroliranem kliničnem preskušanju (študija MC-ASP.6/INF) so zdravili 12 dojenčkov (mediana starost [razpon] v času prve infuzije: 6 mesecev [0,5-12,2 meseca]) z de novo ALL z zdravilom Spectrila po protokolu INTERFANT-06.
Your doctor decides on the dose you receive. 
Odmerek, ki ga boste prejeli, bo določil vaš zdravnik.
Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 
Ime in naslov izdelovalca, odgovornega za sproščanje serij medac Gesellschaft für klinische Spezialpräparate mbH
The powder is white and it is supplied in a clear glass vial with a rubber stopper and an aluminium seal and a plastic flip-off cap. 
Prašek je bel in je na voljo v viali iz prozornega stekla z gumijastim zamaškom, aluminijasto zaporko in plastičnim dvižnim pokrovčkom.
Neurological signs and symptoms including agitation, dizziness and somnolence 
Pogosti nevrološki znaki in simptomi, vključno z agitiranostjo, omotičnostjo in zaspanostjo
Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase (see section 4.8). 
Sindrom reverzibilne posteriorne levkoencefalopatije Sindrom reverzibilne posteriorne levkoencefalopatije (RPLS) se lahko redko pojavi med zdravljenjem s katero koli asparaginazo (glejte poglavje 4.8).
MRD status at end of induction treatment MRD negative 
Status MRD na koncu indukcijskega zdravljenja