natgillin/translations-raw huggingface dataset:
Combination therapy with Oncaspar and other hepatotoxic products can result in severe hepatic toxicity. 
Kombinirano zdravljenje z zdravilom Oncaspar in hepatotoksičnimi zdravili lahko privede do hude toksičnosti za jetra.
As a routine precautionary measure the patient should be monitored for an hour after administration; resuscitation equipment and other appropriate means for the treatment of anaphylaxis should be available (epinephrine, oxygen, intravenous steroids, etc.). 
Rutinski previdnostni ukrep je, da bolnika spremljamo 1 uro po dajanju z razpoložljivo opremo za oživljanje in drugimi primernimi sredstvi za zdravljenje anafilaksije (adrenalin, kisik, intravenski steroidi itd.).
Do not use this medicine if you notice the reconstituted solution is cloudy or has visible particles. 
Ne uporabljajte tega zdravila, če opazite, da je rekonstituirana raztopina motna ali če vsebuje vidne delce.
If used at the same time as Oncaspar, the effects on the clotting ability of your blood are increased. 
Če ga uporabite sočasno z zdravilom Oncaspar, se poveča sposobnost strjevanja vaše krvi;
Note: Oncaspar (2,500 Units/m2 BSA intramuscular) was administered on Day 3 of the 4-week induction phase. 
Opomba: Zdravilo Oncaspar (2.500 enot/m2 BSA, intramuskularno) je bilo uporabljeno 3. dan 4-tedenske indukcijske faze.
About half of patients develop mild to moderate gastrointestinal reactions such as loss of appetite, nausea, vomiting, abdominal cramps, diarrhoea and weight loss. 
Pri približno polovici bolnikov se pojavijo blage do zmerne reakcije v prebavilih, kot so izguba apetita, siljenje na bruhanje, bruhanje, trebušni krči, driska in izguba telesne mase.
Post-authorisation efficacy study (PAES): In order to further define the efficacy and safety of Oncaspar in adult patients with acute lymphoblastic leukaemia, the MAH should submit the results of a multicentre, open label single arm phase II trial evaluating the efficacy and toxicity of treatment regimens including Oncaspar in adults (aged 18-60) with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukaemia. 
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljnjo opredelitev učinkovitosti in varnosti zdravila Oncaspar pri odraslih bolnikih z akutno limfoblastno levkemijo mora imetnik dovoljenja za promet z zdravilom predložiti rezultate multicentričnega odprtega preskušanja faze II brez primerjalne skupine o oceni učinkovitosti in toksičnosti režimov zdravljenja, ki vključujejo zdravilo Oncaspar, pri odraslih (v starosti od 18 do 60 let) z na novo diagnosticirano akutno limfoblastno levkemijo z negativnim kromosomom Philadelphia.
CSF asparagine concentrations were reduced by the 4th day following the Induction dose, and remained largely undetectable by the 18th day after dosing. 
Znižanje ravni asparagina v likvorju je bilo ugotovljeno 4. dan po indukcijskem odmerku, raven pa je ostala v glavnem nezaznavna do 18. dne po odmerku.
If used at the same time as Oncaspar, there is a higher risk of bleeding disorders. 
Če se uporabijo sočasno z zdravilom Oncaspar, se poveča tveganje za motnje strjevanja krvi;
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C. 
Dokazali so, da kemijska in fizikalna stabilnost med uporabo pri temperaturi 2 °C-8 °C traja 48 ur.
Patients with newly diagnosed ALL received a single IM injection of Oncaspar (2,500 U/m² BSA) or native asparaginase from E. coli (25,000 U/m² BSA) or from Erwinia (25,000 U/m² BSA). 
injekcijo zdravila Oncaspar (2.500 e./m² BSA) ali nativne asparaginaze iz E. coli (25.000 e./m² BSA) ali iz bakterije Erwinia (25.000 e./m² BSA).
The use of Oncaspar can lead to fluctuation in coagulation factors. 
Uporaba zdravila Oncaspar lahko privede do spremenljivih ravni faktorjev strjevanja krvi.
Plasma L-asparagine concentrations were depleted to below the assay limit of quantification within 24 hours following the Induction and first Consolidation dose of Oncaspar and depletion was sustained for approximately two weeks. 
Ravni L-asparagina v plazmi so se znižale pod mejo določljivosti testa v 24 urah po indukcijskem in prvem konsolidacijskem odmerku zdravila Oncaspar.
During the post-Induction phase, a nadir (trough) asparaginase activity above 0.4 U/mL was sustained in 100% of subjects from Week 7 up until Week 25. 
Po indukciji je bila najnižja aktivnost asparaginaze nad 0,4 e./ml ohranjena pri 100 % oseb od 7. tedna do 25. tedna.
As pegaspargase is a protein with a high molecular weight, it is not excreted renally, and no dose adjustment is necessary in patients with renal impairment. 
Ker je pegaspargaza beljakovina z veliko molekulsko maso, se ne izloča skozi ledvice in pri bolnikih z ledvično okvaro ni potrebno prilagajanje odmerka.
Very common: Febrile neutropenia Common: Anaemia, coagulopathy Not known: Bone marrow failure 
Zelo pogosti: febrilna nevtropenija Pogosti: anemija, koagulopatija Neznana: odpoved kostnega mozga
White to off-white powder. 
Bel do umazano bel prašek.
As your doctor will administer the medicine, it is very unlikely you will be given more than you need. 
Če ste prejeli večji odmerek zdravila Oncaspar, kot bi smeli Ker vam bo zdravilo dajal zdravnik, ni verjetno, da boste prejeli večji odmerek, kot ga potrebujete.
- if you ever had severe bleeding following asparaginase therapy. 
- če ste kdaj imeli hude krvavitve po zdravljenju z asparaginazo, - če ste kdaj imeli krvne strdke po zdravljenju z asparaginazo.
These findings were similar to those observed in the native E. coli L-asparaginase treatment arm. 
Ti izsledki so bili podobni kot v skupini, ki je prejemala nativno L-asparaginazo iz E. coli.
Other hypersensitivity reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnoea, pruritus and rash (see sections 4.3 and 4.8). 
Druge preobčutljivostne reakcije lahko vključujejo angioedem, otekanje ustnic, otekanje oči, eritem, znižanje krvnega tlaka, bronhospazem, dispnejo, pruritus in izpuščaj (glejte poglavji 4.3 in 4.8).
One case of pancreatitis with simultaneous acute parotitis has been described with L-asparaginase treatment. 
Pri zdravljenju z L-asparaginazo je opisan en primer pankreatitisa s sočasnim akutnim parotitisom.
Each vial contains 3,750 Units (U)** of pegaspargase*. 
Ena viala raztopine vsebuje 3.750 enot (e.)** pegaspargaze*.
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 reconstitution/dilution has taken place in controlled and validated aseptic conditions. 
Čas shranjevanja naj praviloma ne presega 24 ur pri temperaturi 2 °C-8 °C, razen če sta rekonstitucija oz. redčenje potekala v nadzorovanih in validiranih aseptičnih pogojih.
5-Year EFS Rate, % (95% CI) 
3-letni delež EFS, % (95-odstotni IZ) 5-letni delež EFS, % (95-odstotni IZ) 7-letni delež EFS, % (95-odstotni IZ)
Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C. 
Rekonstituirana raztopina Dokazali so, da kemijska in fizikalna stabilnost med uporabo pri temperaturi do 25 °C traja 24 ur.
As a precautionary measure, breast-feeding should be discontinued during treatment with Oncaspar and should not be re-started until after treatment with Oncaspar has been discontinued. 
Kot previdnostni ukrep moramo dojenje med zdravljenjem z zdravilom Oncaspar prekiniti in ga smemo nadaljevati šele po prekinitvi uporabe zdravila Oncaspar.
Oncaspar was administered intramuscularly at a dose of 2,500 Units/m2 BSA on Day 3 of the 4-week Induction phase and on Day 3 of each of two 8-week 
Zdravilo Oncaspar so dajali intramuskularno v odmerku 2.500 enot/m2 BSA 3. dan 4-tedenske indukcijske faze in 3. dan obeh 8-tedenskih faz pozne intenzifikacije.
Oncaspar can cause mild to moderate myelosuppression, and all three blood cell lines can be affected. 
Bolezni krvi in limfatičnega sistema Zdravilo Oncaspar lahko povzroči blago do zmerno mielosupresijo in lahko vpliva na vse tri linije krvnih celic.
Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving pegaspargase (see section 4.8). 
Pri bolnikih, ki prejemajo pegaspargazo, se lahko pojavijo resni trombotični dogodki, vključno s trombozo sagitalnega sinusa (glejte poglavje 4.8).
After reconstitution, 1 ml of solution contains 750 U pegaspargase (750 U/ml). 
Po rekonstituciji 1 ml raztopine vsebuje 750 e. pegaspargaze (750 e./ml).
What Oncaspar is and what it is used for What you need to know before you are given Oncaspar How Oncaspar is given 
Kaj je zdravilo Oncaspar in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Oncaspar Kako uporabljati zdravilo Oncaspar
These results indicate that, when Oncaspar 2,500 U/m2 BSA is administered as single and repeated doses every two weeks, clinically relevant asparaginase activity is sustained over the entire dosing interval (i.e., two weeks). 
Oncaspar 2.500 e./m2 BSA, ki se daje enkratno in vsake dva tedna, ohranja klinično pomembna aktivnost asparaginaze ves čas intervala odmerjanja (tj. dva tedna).
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. 
Čas shranjevanja naj praviloma ne presega 24 ur pri temperaturi 2 °C-8 °C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
Women who are able to get pregnant must use reliable contraception during treatment, and for at least 6 months after Oncaspar treatment has been discontinued. 
Ženske, ki lahko zanosijo, morajo med zdravljenjem in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar uporabljati učinkovito kontracepcijo.
Combination therapy with Oncaspar can result in central nervous system toxicity. 
Kombinirano zdravljenje z zdravilom Oncaspar lahko privede do toksičnosti za osrednje živčevje.
The following adverse reactions have been reported in patients treated with Oncaspar along with other chemotherapy medicinal products: somnolence, confusion, dizziness, syncope, seizure. 
Pri bolnikih, ki so bili zdravljeni z zdravilom Oncaspar sočasno z drugimi kemoterapevtiki, so opazili naslednje neželene učinke: somnolenco, zmedenost, omotico, sinkopo, epileptični napad.
A reduction in serum asparagine concentration was evident by the 4th day after the first Induction dose and reached an apparent nadir by the 10th day after the dose. 
Znižanje ravni asparagina v serumu je bilo ugotovljeno 4. dan po prvem indukcijskem odmerku, medtem ko je bila raven najnižja 10. dan po odmerku.
The solution can be diluted with 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for injection before intravenous injection (see section 4.2). 
Raztopino lahko pred intravenskim injiciranjem razredčite s 5-% raztopino glukoze ali 9 mg/ml (0,9-%) raztopino natrijevega klorida za injiciranje (glejte poglavje 4.2).
One patient received Oncaspar doses of 250 and 500 Units/m2 BSA intravenously. 
En bolnik je prejel odmerka zdravila Oncaspar 250 in 500 enot/m2 BSA intravensko.
After the medicinal product has been diluted, the solution should be used immediately. 
Ko je zdravilo razredčeno, je treba raztopino takoj uporabiti.
The solution must therefore be handled and administered with particular caution. 
Z raztopino morate ravnati in jo dajati s posebno previdnostjo.
Name and address of the manufacturer of the biological active substance Exelead, Inc. 
Ime in naslov izdelovalca biološke učinkovine
No immunogenic response was detected in a 12-week study in mice in which pegaspargase was administered weekly at the dose of 10.5 U/mouse intramuscular or intraperitoneally. 
V 12-tedenski študiji na miših, katerim so tedensko dajali pegaspargazo v odmerku 10,5 e./miš intramuskularno ali intraperitonealno, niso ugotovili imunogenega odziva.
History of serious thrombosis with prior L-asparaginase therapy. 
Anamneza hude tromboze pri predhodnem zdravljenju z L-asparaginazo.
The Cmax and AUC of Oncaspar trended lower in males, subjects with larger BMI, and subjects >10 years. 
zdravila Oncaspar so bili nižji pri moških, pri osebah z večjo vrednostjo ITM in pri osebah >10 let.
The most common, severe adverse reactions with Oncaspar (graded 3 or 4) observed in studies DFCI 11-001 and AALL07P4 with a frequency of >5% included: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, febrile neutropenia, hyperglycaemia, lipase increased, and pancreatitis. 
Med najpogostejše hude neželene učinke zdravila Oncaspar (stopnje 3 ali 4), ugotovljene v študijah DFCI 11-001 in AALL07P4, s pogostnostjo > 5 %, so spadali: zvišana raven alanin-aminotransferaze, zvišana raven aspartat-aminotransferaze, zvišana raven bilirubina v krvi, febrilna nevtropenija, hiperglikemija, zvišana raven lipaze in pankreatitis.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 
MINIMALNI PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH
Oncaspar contains sodium 
Zdravilo Oncaspar vsebuje natrij
Depletion of L-asparagine in blood results in inhibition of protein-synthesis, DNA-synthesis and RNA-synthesis, especially in leukaemic blasts which are not able to synthesise L-asparagine, thus undergoing apoptosis. 
DNA in sinteze RNA, zlasti v levkemičnih mieloblastih, ki niso sposobni sintetizirati L-asparagina,
Oncaspar efficacy and safety were evaluated on the basis of three clinical studies using Oncaspar solution for injection/infusion in the first line treatment of ALL: Study CCG-1962 in standard risk ALL patients; Study AALL07P4 in high risk ALL patients; Study DFCI 11-001 enrolled both standard and high-risk ALL patients. 
Oncaspar raztopina za injiciranje/infundiranje kot zdravilom prve izbire pri ALL: študije CCG-1962 pri bolnikih z ALL z običajnim tveganjem, študije AALL07P4 pri bolnikih z ALL z visokim tveganjem in študije DFCI 11-001, v katero so bili vključeni bolniki z ALL z običajnim in visokim tveganjem.
One vial of 5 ml solution contains 3,750 Units. 
Ena viala s 5 ml raztopine vsebuje 3.750 enot.
General disorders and administration side conditions Pyrexia can occur after the injection, which usually subsides spontaneously. 
Splošne težave in spremembe na mestu aplikacije Po injiciranju se lahko pojavi zvišana telesna temperatura, ki običajno izzveni spontano.
Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out an accelerated reduction of asparaginase activity. 
Da se izključi pospešeno zmanjševanje aktivnosti asparaginaze, se lahko meri aktivnost asparaginaze v serumu ali plazmi.
Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenaemia can occur in patients receiving pegaspargase. 
Pri bolnikih, ki prejemajo pegaspargazo, se lahko pojavijo podaljšan protrombinski čas (PČ), podaljšan parcialni tromboplastinski čas (PTČ) in hipofibrinogenemija.
One ml of solution contains 750 Units (U)** of pegaspargase*. 
En ml raztopine vsebuje 750 enot (e.)** pegaspargaze*.
Mild hepatotoxicity was observed with the same dosages. 
Pri enakih odmerkih so ugotovili blago hepatotoksičnost.
Fertility No studies investigating the effect of pegaspargase on fertility have been performed. 
Študije učinka pegaspargaze na plodnost niso bile opravljene.
Very common: Weight decreased, hypoalbuminaemia, alanine aminotransferase increased, aspartate aminotransferase increased, hypertriglyceridaemia, blood fibrinogen decreased, lipase increased, amylase increased, activated partial thromboplastin time prolonged, blood bilirubin increased 
Zelo pogosti: zmanjšana telesna masa, hipoalbuminemija, zvišana raven alanin-aminotransferaze, zvišana raven aspartat-aminotransferaze, hipertrigliceridemija, znižana raven fibrinogena v krvi, zvišana raven lipaze, zvišana raven amilaze, podaljšan aktivirani parcialni tromboplastinski čas, zvišana raven bilirubina v krvi
* The active substance is a covalent conjugate of Escherichia coli-derived L-asparaginase with monomethoxypolyethylene glycol **One unit is defined as the quantity of enzyme required to liberate 1 µmol ammonia per minute at pH 7.3 and 37°C 
** Ena enota je opredeljena kot količina encima, ki je potrebna za sprostitev 1 µmol amoniaka na minuto pri pH 7,3 in 37 °C Jakosti tega zdravila ne smemo primerjati z jakostjo druge pegilirane ali nepegilirane beljakovine iz iste terapevtske skupine.
A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5). 
Ženske v rodni dobi morajo uporabiti drugo metodo kontracepcije, kot pa je peroralna (glejte poglavji 4.4 in 4.5).
As pegaspargase is a protein with a high molecular weight, it is not excreted renally, and no change of pharmacokinetic of Oncaspar in patients with renal impairment is foreseen. 
Ker je pegaspargaza beljakovina z veliko molekulsko maso, se ne izloča skozi ledvice in pri bolnikih z ledvično okvaro ni pričakovati spremembe farmakokinetike zdravila Oncaspar.
Based on results from these two studies, a 2,500 U/m2 BSA dose of Oncaspar administered IM 
Na podlagi rezultatov teh dveh študij odmerek zdravila Oncaspar 2.500 e./m2 BSA, ki se daje i.m.
One case of toxic epidermal necrolysis (Lyell‘s syndrome) has been described in association with L-asparaginase. 
V povezavi z L-asparaginazo je bil opisan en primer toksične epidermalne nekrolize (Lyellov sindrom).
There have been isolated reports of formation of pseudocysts (up to four months after the last treatment). 
(do štiri mesece po zadnjem zdravljenju).
Another method than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.6). 
Ženske v rodni dobi morajo zato uporabiti drugo metodo kontracepcije, kot pa je peroralna (glejte poglavji 4.4 in 4.6).
Pegaspargase was well tolerated both in rats and dogs when administered intravenously in single dose up to 500 U/kg body weight. 
Pegaspargazo so v enkratnem intravenskem odmerku do 500 e./kg telesne mase dobro prenašale tako podgane kot psi.
As impaired glucose tolerance may occur with concomitant use of Oncaspar with prednisone, blood glucose levels should be monitored. 
Pri sočasni uporabi zdravila Oncaspar in prednizona moramo spremljati ravni glukoze v krvi, saj se lahko pojavi motnja tolerance za glukozo.
Very common: Decreased appetite, hyperglycaemia Common: Hyperlipidaemia, hypercholesterolaemia Not known: Diabetic ketoacidosis, hypoglycaemia 
Zelo pogosti: zmanjšan apetit, hiperglikemija Pogosti: hiperlipidemija, hiperholesterolemija
Sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, water for injections. 
SEZNAM POMOŽNIH SNOVI Natrijev dihidrogenfosfat monohidrat, natrijev fosfat heptahidrat, natrijev klorid, voda za injekcije.
Rare: Hepatic necrosis, jaundice, cholestasis, hepatic failure Immune system disorders Very common: Hypersensitivity, urticaria, anaphylactic reaction Not known: Toxic epidermal necrolysis* 
Zelo pogosti: preobčutljivost, urtikarija, anafilaktična reakcija Neznana: toksična epidermalna nekroliza*
In Study CCG-1962, mean asparaginase activity reached peak value of 1 U/mL on Day 5 after the injection. 
V študiji CCG-1962 je srednja vrednost aktivnosti asparaginaze dosegla najvišjo vrednost 1 e./ml
Patients should be closely monitored for such symptoms, especially if Oncaspar is used in association with neurotoxic products (such as vincristine and methotrexate; see section 4.5), 
zlasti če zdravilo Oncaspar uporabljamo skupaj z nevrotoksičnimi zdravili (kot sta vinkristin in metotreksat, glejte poglavje 4.5).
Do not use Oncaspar: - if you are allergic to pegaspargase or to any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na pegaspargazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste kdaj imeli pankreatitis,
The most common adverse reactions with Oncaspar (observed in at least 2 studies with a frequency of >10%) included: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, activated partial thromboplastin time prolonged, hypertriglyceridaemia, hyperglycaemia, and febrile neutropenia. 
Med najpogostejše neželene učinke zdravila Oncaspar (ugotovljene v najmanj 2 študijah s pogostnostjo > 10 %) so spadali: zvišana raven alanin-aminotransferaze, zvišana raven aspartataminotransferaze, zvišana raven bilirubina v krvi, podaljšan aktivirani parcialni tromboplastinski čas, hipertrigliceridemija, hiperglikemija in febrilna nevtropenija.
Common: Seizure, peripheral motor neuropathy, syncope Rare: Posterior reversible leukoencephalopathy syndrome Not known: Somnolence, tremor* 
Redki: sindrom posteriorne reverzibilne levkoencefalopatije Neznana: somnolenca, tremor*
5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle. 
Z injekcijsko brizgo in iglo kalibra 21 se injicira 5,2 ml vode za injekcije v vialo.
In case of contact, irrigate with plenty of water for at least 15 minutes. 
Ob stiku z očmi, s kožo ali sluznicami, izpirajte z obilo vode vsaj 15 minut.
Table 3: Pharmacokinetic Parameters After a Single IV Dose of Oncaspar 2,500 U/m2 BSA During Induction (N=47; Study AALL07P4) 
2.500 e./m2 BSA med indukcijo (n = 47; študija AALL07P4)
There may be an increased risk of hepatotoxicity in Philadelphia chromosome positive patients, for whom treatment with tyrosine kinase inhibitors (e.g., imatinib) is combined with L-asparaginase therapy. 
Pri kombiniranju zdravljenja z L-asparaginazo z zaviralci tirozin-kinaze (npr. imatinibom) je možno povečanje tveganja za hepatotoksičnost pri bolnikih s pozitivnim kromosomom Philadelphia, kar je treba upoštevati, kadar se odločamo za uporabo zdravila Oncaspar pri teh bolnikih.
BSA during Induction, Consolidation, Delayed Intensification, and Interim Maintenance phases in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Münster therapy. 
Zdravilo Oncaspar so dajali intravensko v odmerku 2.500 enot/m2 BSA v fazah indukcije, konsolidacije, pozne intenzifikacije in vmesnega vzdrževanja pri bolnikih z ALL visokega tveganja, ki so prejemali razširjeno terapijo Berlin-Frankfurt-Münster.
Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment. 
Jetrna okvara Pri bolnikih z jetrno okvaro ni potrebno prilagajanje odmerka.
During Induction (N=47; Study AALL07P4) PK Parameters 
dajanju (AALL07P4).
The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, and water for injections (see section 2 “Oncaspar contains sodium”). 
Pomožne snovi so: natrijev dihidrogenfosfat monohidrat, dinatrijev fosfat heptahidrat, natrijev klorid in voda za injekcije (glejte poglavje 2 Zdravilo Oncaspar vsebuje natrij).
Intravenous infusion of Oncaspar is usually given over a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution. 
Intravensko infuzijo zdravila Oncaspar običajno dajemo v obdobju od 1 do 2 ur v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9-%) za injiciranje ali 5-% raztopino glukoze.
During Induction, following a single IV dose of Oncaspar 2,500 U/m2, asparaginase activity ≥0.1 U/mL was sustained for up to 18 days post-dose in 95.3% of subjects. 
odmerku zdravila Oncaspar 2.500 e./m2 aktivnost asparaginaze ≥ 0,1 e./ml ohranjena do 18 dni po odmerku pri 95,3 % preiskovancev.
Pancreatitis, including haemorrhagic or necrotising pancreatitis with fatal outcomes, have been reported in patients receiving Oncaspar (see section 4.8). 
Učinki na trebušno slinavko Pri bolnikih, ki so prejemali zdravilo Oncaspar, so poročali o pankreatitisu, vključno s hemoragičnim ali nekrotizirajočim pankreatitisom s smrtnim izidom (glejte poglavje 4.8).
6925 Guion Road 
6925 Guion Road Indianapolis Indiana 46268 ZDA
One vial of 5 ml solution contains 3750 units of pegaspargase. 
Ena viala s 5 ml raztopine vsebuje 3.750 enot pegaspargaze.
Of these, 
Eλλάδα
The use of disposable gloves and protective garments is recommended when handling Oncaspar. 
Pri delu z zdravilom Oncaspar priporočamo uporabo rokavic in zaščitnih oblačil za enkratno uporabo.