natgillin/translations-raw huggingface dataset:
Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5). 
Zdravilo Oncaspar se običajno daje kot del kombiniranih protokolov za kemoterapijo skupaj z drugimi citostatiki (glejte tudi poglavje 4.5).
OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if a precipitate has formed, or if the solution is cloudy. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravila ne uporabljajte, če je nastala oborina ali če raztopina postane motna.
This medicine contains less than 1 mmol sodium per dose, i.e., it is essentially ´sodium-free´. 
Zdravilo vsebuje manj kot 1 mmol natrija na odmerek, kar v bistvu pomeni, da je „brez natrija“.
If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4). 
Če aktivnost asparaginaze ne doseže ciljne vrednosti, se lahko razmisli o prehodu na drugo zdravilo z asparaginazo (glejte poglavje 4.4).
Other side effects Talk to your doctor if you get any of the following: 
Drugi neželeni učinki Posvetujte se z zdravnikom, če se pri vas pojavi kaj od naslednjega:
5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap. 
5 ml raztopine v viali (steklo vrste I) z zamaškom (guma) in pokrovčkom (aluminij) z zaporko, ki se odtrga na poteg (flip-off).
A total of 166 patients were enrolled in this study; 54 patients were randomised to treatment with 2,500 U/m2 BSA Oncaspar and 111 patients were randomised to the investigational pegylated asparaginase product. 
V to študijo je bilo vključenih skupno 166 bolnikov: 54 bolnikov je bilo randomiziranih na zdravljenje z 2.500 enot/m2 BSA zdravila Oncaspar in 111 bolnikov na prejemanje preiskovane pegilirane asparaginaze.
The volume of distribution at steady-state and clearance were estimated at 1.86 L/m2 and 0.169 L/m2 per day, respectively. 
Volumen porazdelitve v stanju dinamičnega ravnovesja je bil ocenjen na 1,86 l/m2, očistek pa na 0,169 l/m2 na dan.
Not known (frequency cannot be estimated from the available data) - Severe skin reaction called toxic epidermal necrolysis; - Loss of kidney function (e.g., change in urine output, swelling of feet and ankles); - Stroke. 
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): - huda kožna reakcija, imenovana toksična epidermalna nekroliza; - prenehanje delovanja ledvic (npr. spremenjeno izločanje urina, otekanje stopal in gležnjev);
Inhalation of the vapour and contact with the skin and mucous membranes, especially the eyes, must be avoided; if the medicinal product comes in contact with eyes, skin or mucous membranes, rinse immediately with plenty of water for at least 15 minutes. 
Preprečite vdihavanje hlapov in stik s kožo in sluznico, zlasti z očmi; če zdravilo pride v stik z očmi, s kožo ali sluznicami, takoj izpirajte z obilo vode vsaj 15 minut.
This can be associated with a marked rise in the serum uric acid level. 
To je lahko povezano z izrazitim zvišanjem ravni sečne kisline v serumu.
When Oncaspar is given by intramuscular injection the volume injected at one site should not exceed 2 ml in children and adolescents and 3 ml in adults. 
Če zdravilo Oncaspar injiciramo intramuskularno, injicirani volumen na enem mestu ne sme preseči 2 ml pri otrocih in mladostnikih ter 3 ml pri odraslih bolnikih.
CSF asparagine of 2.3 µM pre-treatment fell to 1.1 µM on Day 7 and 0.6 µM on Day 28 of Induction (see Clinical efficacy and safety). 
V likvorju je raven asparagina upadla z vrednosti 2,3 μM pred zdravljenjem na 1,1 μM 7. dan oz. na 0,6 μM 28. dan indukcije (glejte poglavje Klinična učinkovitost in varnost).
Pegaspargase can interfere with metabolism and clearance of other medicinal products, based on its effects on protein synthesis and hepatic function, as well as from its combined use with other chemotherapy products known to interact with CYP enzymes. 
Pegaspargaza lahko moti presnovo in očistek drugih zdravil, zlasti v jetrih, zaradi njenih učinkov na sintezo beljakovin in delovanje jeter, pa tudi zaradi kombinirane uporabe z drugimi kemoterapevtiki z dokazano interakcijo z encimi CYP.
EXP After reconstitution, the solution should be used immediately. 
EXP Po rekonstituciji je treba raztopino takoj uporabiti.
Multiple malformations and embryolethal effects were observed with doses in the therapeutic range. 
Pri odmerkih v terapevtskem območju so ugotovili več okvar in embrioletalnih učinkov.
Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar (see section 4.2). 
V času dajanja zdravila Oncaspar skozi isto intravensko linijo ne infundirajte drugih zdravil (glejte poglavje 4.2).
During treatment with Oncaspar 
Med zdravljenjem z zdravilom Oncaspar
CSF asparagine decreased from a mean pre-treatment concentration of 3.1 µM to 1.7 µM on Day 4 ± 1 and 1.5 µM at 25 ± 1 days after administration of Oncaspar. 
Ravni asparagina v likvorju so upadle s povprečne vrednosti pred zdravljenjem 3,1 µM na 1,7 µM po 4 ± 1 dneh in 1,5 µM po 25 ± 1 dneh uporabe zdravila Oncaspar.
Two patients in the Oncaspar arm had allergic reactions during Delayed Intensification (DI) DI #1 (Grade 1 allergic reaction and Grade 3 hives). 
Dva bolnika v skupini, ki je prejemala zdravilo Oncaspar, sta imela alergijske reakcije med fazo pozne intenzifikacije (DI - delayed intensification) (alergijska reakcija 1. stopnje in koprivnica 3. stopnje).
Anti-asparaginase antibodies may be associated with low asparaginase activity levels due to potential neutralising activity of these antibodies. 
Protitelesa proti asparaginazi so lahko povezana z nizko aktivnostjo asparaginaze zaradi potencialne nevtralizirajoče aktivnosti teh protiteles.
Pharmacokinetic/pharmacodynamic nonclinical comparability between the two pharmaceutical forms of Oncaspar, solution for injection/infusion, and powder for solution, was demonstrated in dogs after single and repeated doses (500 U/kg), by the intravenous route. 
Neklinično primerljivost farmakokinetike/farmakodinamike med dvema farmacevtskima oblikama zdravila Oncaspar, in sicer raztopino za injiciranje/infundiranje in praškom za raztopino, so dokazali pri psih po enkratnem odmerku in ponovljenih odmerkih (500 e./kg), danih intravensko.
Blood and urine sugar levels, liver and pancreas function and other tests will be carried out regularly to monitor your health during and after treatment because this medicine can affect your blood and other organs. 
Zaradi spremljanja vašega zdravstvenega stanja med zdravljenjem in po njem boste opravljali redne preiskave ravni sladkorja v krvi in urinu, delovanja jeter in trebušne slinavke ter druge preiskave, saj lahko zdravilo vpliva na kri in druge organe.
Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients. 
Zdravilo Oncaspar je indicirano kot sestavina kombiniranega citostatičnega zdravljenja pri akutni limfoblastni levkemiji (ALL) pri pediatričnih bolnikih od rojstva do 18 let in pri odraslih bolnikih.
What Oncaspar contains The active substance is pegaspargase. 
Kaj vsebuje zdravilo Oncaspar Učinkovina je pegaspargaza.
- if you ever had blood clots following asparaginase therapy. 
- če ste kdaj imeli krvne strdke po zdravljenju z asparaginazo.
Patients received Oncaspar as a single agent or in combination with multi-agent chemotherapy. 
Bolniki so prejeli zdravilo Oncaspar kot samostojno zdravilo ali v kombinaciji s polikemoterapijo.
Study DFCI 11-001, conducted by the Dana-Farber Cancer Institute (DFCI), is an ongoing, active-controlled, randomised multicentre study of an intravenous investigational pegylated asparaginase product versus Oncaspar, in children and adolescents aged 1 to <22 years with newly diagnosed ALL treated with a DFCI ALL consortium therapeutic backbone. 
Študija DFCI 11-001, ki jo izvaja ustanova Dana-Farber Institute of Cancer (DFCI), je tekoča, aktivno nadzorovana, randomizirana multicentrična študija intravenskega dajanja preiskovanega pegiliranega zdravila z asparaginazo v primerjavi z zdravilom Oncaspar pri otrocih in mladostnikih, starih od 1 do < 22 let, z novo diagnozo ALL, ki se zdravijo v okviru konzorcija DFCI ALL.
Specific antibodies to pegaspargase have been detected; uncommonly they were associated with hypersensitivity reactions. 
Zaznali so specifična protitelesa proti pegaspargazi, ki so bila občasno povezana s preobčutljivostnimi reakcijami.
Oncaspar may cause central nervous system signs and symptoms manifesting as somnolence, confusion, convulsions. 
Zdravilo Oncaspar lahko povzroči znake in simptome v osrednjem živčnem sistemu, ki se pokažejo kot somnolenca, zmedenost, konvulzije.
- if you suffer from a bleeding disorder or had serious blood clots. 
- če imate motnjo strjevanja krvi ali ste kdaj imeli resno stanje zaradi krvnih strdkov;
At 4-years, the EFS and overall survival (OS) for the Oncaspar treatment arm were 81.8% [95% CI 62.9-91.7%] and 90.4% [95% CI 78.5-95.9%], respectively. 
Po 4 letih sta bila EFS in celokupno preživetje v skupini, ki je prejemala zdravilo Oncaspar, 81,8 % [95-odstotni IZ 62,9-91,7 %] in 90,4 % [95-odstotni IZ 78,5-95,9 %], v tem zaporedju.
About half of all serious haemorrhages and thromboses affect cerebral vessels and can lead to e.g., stroke, seizure, headache or loss of consciousness. 
Približno polovica vseh resnih krvavitev in tromboz vpliva na možganske žile in lahko npr. privede do možganske kapi, epileptičnih napadov, glavobola in izgube zavesti.
Women of childbearing potential/Contraception in males and females Men and women should use effective contraception during treatment and for at least 6 months after Oncaspar discontinuation. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Moški in ženske morajo med zdravljenjem in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar uporabljati učinkovito kontracepcijo.
This medicinal product can cause irritation on contact. 
Zdravilo lahko povzroči draženje pri stiku.
Long-term investigations of carcinogenicity or studies of the effect on fertility in animals were not conducted with pegaspargase. 
Dolgoročne študije karcinogenosti pegaspargaze ali študije njenih učinkov na plodnost pri živalih niso bile opravljene.
Additional monitoring tests 
Dodatne preiskave za spremljanje vašega stanja
Type I flint glass vial with chlorobutyl elastomer stopper, capped with a 20 mm aluminium flip-off seal, containing 3,750 U pegaspargase. 
Viala iz kremenovega stekla vrste I z zamaškom iz klorobutilnega elastomera, pokrita z 20-mm aluminijasto zaporko, ki se odtrga na poteg (flip-off), ki vsebuje 3.750 e. pegaspargaze.
Patients should be closely monitored and carefully observed for any adverse reactions throughout the administration period (see section 4.4). 
Bolnike moramo med dajanjem zdravila skrbno spremljati in natančno opazovati za vse morebitne neželene učinke (glejte poglavje 4.4).
If you are the parent of a child who is being treated with Oncaspar, please tell the doctor if any of them apply to your child. 
Če ste eden od staršev otroka, ki se zdravi z zdravilom Oncaspar, obvestite zdravnika, če kaj od navedenega velja zanj.
In Study CCG-1962, PD effect of Oncaspar was assessed through serial measurements of asparagine in serum (n=57) and CSF (n=50) of newly diagnosed paediatric patients with standard-risk ALL who received three intramuscular doses of Oncaspar (2,500 Units/m2 BSA), one each during induction and two during delayed intensification treatment phases. 
V študiji CCG-1962 so ocenili farmakodinamični učinek zdravila Oncaspar na osnovi zaporednih meritev asparagina v serumu (n = 57) in likvorju (n = 50) pri pediatričnih bolnikih z novo diagnozo ALL s standardnim tveganjem, ki so prejeli tri intramuskularne odmerke zdravila Oncaspar (2.500 enot/m2 BSA), po eno injekcijo med indukcijo in dvema fazama pozne intenzifikacije zdravljenja.
(CCG-1962) and IV (AALL07P4) provides maintenance of L-asparagine depletion for approximately two weeks following dosing. 
(AALL07P4), zagotavlja ohranjanje znižanih ravni L-asparagina približno dva tedna po odmerjanju.
Coagulation parameters should be monitored at baseline and periodically during and after treatment, particularly when other medicinal products with anticoagulant effects are used simultaneously, such as acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (see section 4.5), or when concomitant chemotherapy regimen including methotrexate, daunorubicin, corticosteroids is administered. 
Na začetku zdravljenja, redno med zdravljenjem in po njem moramo spremljati koagulacijske parametre, zlasti pri sočasni uporabi drugih zdravil z antikoagulacijskimi učinki, kot so acetilsalicilna kislina in nesteroidna protivnetna zdravila (glejte poglavje 4.5), ali pri sočasni kemoterapevtski shemi, ki vključuje dajanje metotreksata,
PHARMACEUTICAL FORM AND CONTENTS Solution for injection/infusion 1 vial of 5 ml. 
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje/infundiranje ena viala po 5 ml
Rare (may affect up to 1 in 1,000 people) - Liver failure. 
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
The remaining patients were treated with 2,000 or 2,500 U/m2 BSA administered intramuscularly or intravenously. 
Druge bolnike so zdravili z 2.000 ali 2.500 enot/m2 BSA intramuskularno ali intravensko.
- prednisone, a steroid medicine. 
- prednizon (steroidno zdravilo).
Children with a body surface area <0.6 m2 should receive 82.5 U of pegaspargase (equivalent to 0.1 ml Oncaspar)/kg body weight every 14 days. 
Otroci s telesno površino < 0,6 m² morajo prejeti 82,5 e. pegaspargaze (kar ustreza 0,1 ml zdravila Oncaspar)/kg telesne mase vsakih 14 dni.
Common: Hepatotoxicity, fatty liver 
Pogosti: hepatotoksičnost, zamaščena jetra
Rare (may affect up to 1 in 1,000 people) - Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome characterised by headache, confusion, seizures and visual loss which resolves after some time. 
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - sindrom reverzibilne posteriorne levkoencefalopatije (RPLS - reversible posterior leukoencephalopathy syndrome), za katerega so značilni glavobol, zmedenost, epileptični napadi in izguba vida, ki izzvenijo po določenem času.
To monitor the therapeutic effect, the peripheral blood count and the patient's bone marrow should be monitored closely. 
Za spremljanje terapevtskega učinka moramo skrbno spremljati krvno sliko in kostni mozeg.
Following overdose, increased liver enzymes, rash and hyperbilirubinaemia have been observed. 
Po prevelikem odmerjanju so opazili zvišane ravni jetrnih encimov, izpuščaj in hiperbilirubinemijo.
Intravenous administration of asparaginase may therefore cause serum levels of ammonia to rise sharply following administration. 
Intravensko dajanje asparaginaze lahko zato povzroči hitro naraščanje ravni amoniaka v serumu po dajanju zdravila.
A routine precaution is to observe the patients for an hour with resuscitation equipment and other items required for the treatment of anaphylaxis in readiness (epinephrine, oxygen, intravenous steroids etc.). 
Rutinski previdnostni ukrep naj bo, da bolnike spremljamo 1 uro ob pripravljenosti opreme za oživljanje in drugih sredstev, potrebnih za zdravljenje anafilaksije (adrenalin, kisik, intravenski steroidi itd).
History of serious haemorrhagic events with prior L-asparaginase therapy (see section 4.4). 
Anamneza resnih hemoragičnih dogodkov pri predhodnem zdravljenju z L-asparaginazo (glejte poglavje 4.4).
Oncaspar has major influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Oncaspar ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
Procedures for proper handling of antineoplastic agents should be observed. 
Treba je upoštevati postopke za pravilno ravnanje z zdravili z delovanjem na novotvorbe.
Patients should be informed about possible hypersensitivity reactions to Oncaspar, including immediate anaphylaxis. 
Bolnike moramo poučiti o možnih preobčutljivostnih reakcijah na zdravilo Oncaspar, vključno s takojšnjim pojavom anafilaksije.
This is important as Oncaspar may increase the side effects of other medicines through its effect on the liver which plays an important role in removing medicines from the body. 
To je pomembno, saj lahko zdravilo Oncaspar s svojim učinkom na jetra, ki imajo pomembno vlogo pri odstranjevanju zdravil iz telesa, poveča neželene učinke drugih zdravil.
After reconstitution, the solution should be clear, colourless and free from visible foreign particles. 
Po rekonstituciji mora biti raztopina bistra, brezbarvna in brez vidnih tujih delcev.
In single cases, haemorrhagic or necrotising pancreatitis with fatal outcome has been reported. 
Poročali so o posameznih primerih hemoragičnega ali nekrotizirajočega pankreatitisa s smrtnim izidom.
The medicinal product should be administered intravenously or intramuscularly. 
Zdravilo je treba dajati intravensko ali intramuskularno.
This was an open label, controlled, randomised study comparing an investigational pegylated asparaginase product to Oncaspar as a component of multi-agent chemotherapy in the first line treatment of ALL. 
To je bila odprta, kontrolirana, randomizirana študija, ki je primerjala preiskovano pegilirano asparaginazo z zdravilom Oncaspar kot komponento polikemoterapije ALL prve izbire.
The percentage of patients in the Oncaspar treatment arm with evaluable minimal residual disease (MRD) negative status (<0.1% leukaemia cells in bone marrow) at Day 29 of Induction was 80% (40/50). 
Odstotek bolnikov v skupini z zdravilom Oncaspar z negativnim statusom ocenjene minimalne rezidualne bolezni (MRD - Minimal Residual Disease) (<0,1 % levkemičnih celic v kostnem mozgu) na 29. dan indukcije je bil 80 % (40/50).
The primary determination of efficacy was based on demonstration of similar asparagine depletion (magnitude and duration) in the Oncaspar and native E. coli L-asparaginase arms. 
Primarna določitev učinkovitosti je temeljila na dokazu podobnega upada ravni asparagina (obseg in trajanje) v skupini, ki je prejemala zdravilo Oncaspar, in skupini, ki je prejemala nativno L-asparaginazo iz E. coli.
The active substance is pegaspargase. 
Učinkovina je pegaspargaza.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3,750 U 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3.750 e.
Asparaginase antibodies 
Protitelesa proti asparaginazi
In these studies a total of 94 patients with ALL diagnosis with a history of prior clinical allergic reaction to native E. coli L-asparaginase were exposed to Oncaspar. 
V teh študijah je bilo zdravilu Oncaspar izpostavljenih skupaj 94 bolnikov z diagnozo ALL in anamnezo predhodne klinične alergijske reakcije na nativno L-asparaginazo iz E. coli.
Immediately preceding or simultaneous treatment with vincristine can increase the toxicity of pegaspargase. 
Uporaba vinkristina neposredno pred ali sočasno s pegaspargazo lahko poveča toksičnost zdravila Oncaspar.
Other medicines and Oncaspar Tell your doctor if you are using, have recently used or might use any other medicines. 
Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
The powder must therefore be handled and administered with particular caution. 
S praškom morate ravnati in ga dajati s posebno previdnostjo.
After reconstitution, the solution is clear, colourless and free from visible foreign particles. 
Po rekonstituciji je raztopina bistra, brezbarvna in ne vsebuje vidnih tujih delcev.
During Induction, plasma asparaginase activity ≥0.1 U/mL was sustained in 93.5% of subjects 18 days after administration. 
Med indukcijo je bila aktivnost asparaginaze v plazmi ≥ 0,1 e./ml ohranjena pri 93,5 % preiskovancev 18 dni po dajanju.
Anti-leukaemic effect of L-asparaginase is related to a sustained L-asparagine depletion in blood and cerebrospinal fluid (CSF). 
Antilevkemični učinek L-asparaginaze je povezan s trajnim upadom ravni L-asparagina v krvi in likvorju.
Caution is therefore needed when anticoagulants such as coumarin, heparin, dipyridamole, acetylsalicylic acid or non-steroidal anti-inflammatory medicinal products are given concomitantly, or when concomitant chemotherapy regimen including methotrexate, daunorubicin, corticosteroids is administered. 
Zato je potrebna previdnost pri sočasnem dajanju antikoagulantov, kot so kumarin, heparin, dipiridamol, acetilsalicilna kislina ali nesteroidna protivnetna zdravila, ali pri sočasnem dajanju kemoterapevtske sheme, ki vključuje metotreksat,
Do not use this medicine if you notice the solution is cloudy or has visible particles. 
Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali če vsebuje vidne delce.
Increased serum glutamic pyruvic transaminase activity also occurred in one out of four dogs. 
Pri enem od štirih psov so ugotovili tudi povečano aktivnost serumske glutamat-piruvat-transaminaze.
Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar. 
V času dajanja zdravila Oncaspar skozi isto intravensko linijo ne infundirajte drugih zdravil.
The adverse reactions described in this section are derived from clinical trial data and post-marketing experience of Oncaspar in ALL patients. 
Neželeni učinki, opisani v tem poglavju, izvirajo iz podatkov kliničnih preskušanj in neželenih učinkov, ugotovljenih v obdobju trženja zdravila Oncaspar, pri bolnikih z akutno limfoblastno levkemijo (ALL).
The solution should be administered slowly. 
Raztopino je treba dajati počasi.
Native E. coli L-asparaginase (6,000 Units/m2 BSA intramuscular) was administered 3 times weekly for 9 doses during induction. 
Nativna L-asparaginaza iz E. coli (6.000 enot/m2 BSA, intramuskularno) je bila uporabljena 3-krat tedensko v skupno 9 odmerkih med indukcijo.
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection/infusion 1 vial with 3,750 U pegaspargase. 
FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje/infundiranje ena viala s 3.750 e. pegaspargaze
Native E. coli L-asparaginase was administered intramuscularly at a dose of 6,000 Units/m2 BSA three times weekly for a total of 9 doses during induction and for a total of 6 doses during each delayed intensification phase. 
Nativno L-asparaginazo iz E. coli so dajali intramuskularno v odmerku 6.000 enot/m2 BSA trikrat na teden v skupno 9 odmerkih med indukcijo in v skupno 6 odmerkih med obema fazama pozne intenzifikacije.
Native E. coli L-Asparaginase Oncaspar® 
Nativna L-asparaginaza iz E coli Oncaspar®
If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours. 
Če razredčene raztopine ni mogoče uporabiti takoj, jo lahko do 48 ur hranite pri temperaturi 2 °C-8 °C.
Allergic reactions can manifest in the skin. 
Bolezni kože in podkožja Na koži se lahko pojavijo alergijske reakcije.
PHARMACEUTICAL FORM Solution for injection/infusion. 
FARMACEVTSKA OBLIKA Prašek za raztopino za injiciranje/infundiranje.
Post-authorisation efficacy study (PAES): In order to further define the efficacy and safety of Oncaspar in patients with newly diagnosed acute lymphoblastic leukaemia, the MAH should submit the results of Study CAALL-F01, a prospective multicentre cohort study evaluating Oncaspar used in the first-line treatment of children and adolescents with ALL along with multi-agent chemotherapy. 
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljnjo opredelitev učinkovitosti in varnosti zdravila Oncaspar pri bolnikih z na novo diagnosticirano akutno limfoblastno levkemijo mora imetnik dovoljenja za promet z zdravilom predložiti rezultate študije CAALL-F01, multicentrično prospektivno kohortno študijo o oceni zdravila Oncaspar, uporabljenega v začetnem zdravljenju otrok in mladostnikov z akutno limfoblastno levkemijo skupaj s kemoterapijo z več zdravili.
Τηλ: + 30 210 939 1000 
ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000
Table 1: Adverse reactions reported with Oncaspar therapy 
Preglednica 1: Neželeni učinki, o katerih so poročali med zdravljenjem z zdravilom Oncaspar