FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenaemia can occur in patients receiving pegaspargase.
Croatian: Produljeno protrombinsko vrijeme (PT), produljeno parcijalno tromboplastinsko vrijeme (PTT) i hipofibrinogenemija mogu se pojaviti u bolesnika koji primaju pegaspargazu.
English: Two patients in the Oncaspar arm had allergic reactions during Delayed Intensification (DI) DI #1 (Grade 1 allergic reaction and Grade 3 hives).
Croatian: Dva bolesnika u skupini na lijeku Oncaspar imala su alergijske reakcije tijekom faze kasne intenzifikacije (engl. delayed intensification, DI) DI br.1 (alergijska reakcija 1.
English: Patients were not allowed prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine.
Croatian: Bolesnici nisu smjeli prethodno primiti citotoksičnu kemoterapiju uz iznimku steroida i intratekalnog citarabina.
English: Oncaspar may cause central nervous system signs and symptoms manifesting as somnolence, confusion, convulsions.
Croatian: Oncaspar može uzrokovati znakove i simptome središnjeg živčanog sustava koji se manifestiraju kao somnolencija, konfuzija i konvulzije.
English: Treatment may be monitored based on the trough serum asparaginase activity measured before the next administration of pegaspargase.
Croatian: Liječenje se može pratiti na temelju najniže razine aktivnosti asparaginaze u serumu mjerene prije sljedeće primjene pegaspargaze.
English: It is strongly recommended that every time Oncaspar is administered to a patient, the name and lot number of the product are recorded in order to link the patient and the lot of the product.
Croatian: Strogo se preporučuje da se pri svakoj primjeni lijeka Oncaspar u bolesnika, zabilježi naziv i broj serije lijeka kako bi se povezalo bolesnika i seriju lijeka.
English: In addition, Oncaspar studies using the intramuscular route of administration (studies CCG-1962 and CCG-1991) were also considered to determine the safety profile (see section 5.1).
Croatian: Nadalje, ispitivanja lijeka Oncaspar u kojima je korištena primjena u mišić (ispitivanja CCG-1962 i CCG-1991) također su uzeta u obzir za određivanje sigurnosnog profila (vidjeti dio 5.1).
English: If used at the same time as Oncaspar, the effects on the clotting ability of your blood are increased.
Croatian: Ako se koristi istodobno kada i Oncaspar, pojačavaju se učinci na sposobnost zgrušavanja Vaše krvi.
English: Method of administration Oncaspar can be given by intramuscular (IM) injection or intravenous (IV) infusion.
Croatian: Oncaspar se može davati intramuskularnom (IM) injekcijom ili intravenskom (IV) infuzijom.
English: 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).
Croatian: Vrijednost asparagina u CSF-u od 2,3 µM prije liječenja pala je na 1,1 µM 7. dana i 0,6 µM 28. dana indukcije (vidjeti Kliničku djelotvornost i sigurnost).
English: If pancreatitis is suspected, Oncaspar should be discontinued; if pancreatitis is confirmed, Oncaspar should not be restarted.
Croatian: U slučaju sumnje na pankreatitis, treba prekinuti liječenje lijekom Oncaspar; ako se pankreatitis potvrdi, Oncaspar se ne smije ponovo primjenjivati.
English: About half of all serious haemorrhages and thromboses affect cerebral vessels and can lead to e.g., stroke, seizure, headache or loss of consciousness.
Croatian: Otprilike polovica svih ozbiljnih krvarenja i tromboza utječe na žile u mozgu i može dovesti npr., do moždanog udara, napadaja, glavobolje ili gubitka svijesti.
English: If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours (see section 6.3).
Croatian: Ako neposredna primjena nije moguća, razrijeđena otopina može se čuvati na temperaturi od 2 °C-8 °C do 48 sati (vidjeti dio 6.3).
English: Patients received Oncaspar as a single agent or in combination with multi-agent chemotherapy.
Croatian: Bolesnici su primali Oncaspar kao jedini lijek ili u kombinaciji s kemoterapijom s više lijekova.
English: For smaller volumes, the preferred route of administration is intramuscular.
Croatian: Za manje volumene preferira se intramuskularni način primjene.
English: Caution is required when Oncaspar is given in combination with hepatotoxic products, especially if there is pre-existing hepatic impairment.
Croatian: Potreban je oprez kada se Oncaspar daje u kombinaciji s hepatotoksičnim lijekovima, naročito ako već postoji oštećenje jetre.
English: Therefore, use of Oncaspar could increase the risk of infections.
Croatian: Stoga primjena lijeka Oncaspar može povećati opasnost od infekcija.
English: Type I flint glass vial with chlorobutyl elastomer stopper, capped with a 20 mm aluminium flip-off seal, containing 3,750 U pegaspargase.
Croatian: Bočica (kremeno staklo tipa I) s čepom od klorobutil elastomera, zatvorena aluminijskim prstenom od 20 mm, koja sadrži 3750 U pegaspargaze.
English: About half of patients develop mild to moderate gastrointestinal reactions such as loss of appetite, nausea, vomiting, abdominal cramps, diarrhoea and weight loss.
Croatian: Otprilike polovica bolesnika razvije blage do umjerene gastrointestinalne reakcije poput gubitka apetita, mučnine, povraćanja, abdominalnih grčeva, proljeva i gubitka težine.
English: Anti-asparaginase antibodies may be associated with low asparaginase activity levels due to potential neutralising activity of these antibodies.
Croatian: Protutijela na asparaginazu mogu biti povezana s niskom razinom aktivnosti asparaginaze zbog potencijalne neutralizirajuće aktivnosti tih protutijela.
English: In rabbits doses of 50 or 100 U/kg intravenous on days 8 and 9 of gestation induced viable fetuses with congenital malformations: no NOEL has been determined.
Croatian: ili 100 U/kg intravenski 8. i 9. dana gestacije inducirale su vijabilne fetuse s kongenitalnim malformacijama: NOEL nije utvrđen.
English: The mean plasma half-life of Oncaspar was 8 days in non-hypersensitive patients (AUC 10.35 U/ml/day), and 2.7 days in hypersensitive patients (AUC 3.52 U/ml/day).
Croatian: Srednji poluvijek lijeka Oncaspar u plazmi bio je 8 dana u bolesnika bez preosjetljivosti (AUC 10,35 U/ml/dan), odnosno 2,7 dana u preosjetljivih bolesnika (AUC 3,52 U/ml/dan).
English: What Oncaspar contains
Croatian: Što Oncaspar sadrži
English: Common: Hepatotoxicity, fatty liver
Croatian: Često: hepatotoksičnost, masna jetra
English: A pilot study was conducted for newly diagnosed patients from 1 to <31 years of age with high risk B-precursor ALL (Study AALL07P4).
Croatian: Provedeno je pilot ispitivanje za novodijagnosticirane bolesnike u dobi od 1 do <31 godine s ALL-om prekursora B-limfocita visokog rizika (Ispitivanje AALL07P4).
English: Alteration of liver parameters is common.
Croatian: Česta je promjena jetrenih parametara.
English: Embryotoxicity studies with L-asparaginase have given evidence of teratogenic potential in rats treated from day 6 to 15 of gestation with a No Observed Effect Level (NOEL) for teratogenic effects at 300 U/kg intravenous.
Croatian: Ispitivanja embriotoksičnosti s L-asparaginazom pružila su dokaze o teratogenom potencijalu u štakora tretiranih od 6. do 15. dana gestacije pri čemu je doza od 300 U/kg intravenski bila razina bez opaženih teratogenih učinaka (engl.
English: 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.
Croatian: Smanjenje razine L-asparagina u krvi rezultira inhibicijom sinteze proteina, sinteze DNK i sinteze RNK, naročito u leukemijskim blastima koji ne mogu sintetizirati
English: 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),
Croatian: Bolesnike je potrebno pomno pratiti kako bi se uočili ti simptomi, posebno ako se Oncaspar primjenjuje zajedno s neurotoksičnim lijekovima (primjerice s vinkristinom i metotreksatom; vidjeti dio 4.5),
English: Do not use this medicine if you notice the solution is cloudy or has visible particles.
Croatian: Nemojte upotrijebiti ovaj lijek ako primijetite da je otopina mutna ili ima vidljive čestice.
English: White blood cell (WBC) criteria were: a) Age 1-10 years: WBC ≥50,000/μL; b) Age 10-30 years: Any WBC; c) Prior steroid therapy: Any WBC.
Croatian: Kriteriji za leukocite bili su: b) Dob 1-10 godina: leukociti ≥ 50 000/μl; b) Dob 10-30 godina: bilo koji broj leukocita ;c)
English: The solution should be used within 24 hours after reconstitution, when stored below 25°C.
Croatian: Otopinu treba iskoristiti unutar 24 sata nakon rekonstitucije ako se čuva ispod 25 °C.
English: 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.
Croatian: Udisanje pare i doticaj s kožom i sluznicama, naročito očiju, mora se izbjegavati; ako lijek dođe u kontakt s očima, kožom ili sluznicom, odmah isperite s puno vode najmanje 15 minuta.
English: Immediately preceding or simultaneous treatment with vincristine can increase the toxicity of pegaspargase.
Croatian: Liječenje vinkristinom neposredno prije ili istodobno s pegaspargazom može pojačati toksičnost pegaspargaze.
English: It is not known whether pegaspargase is excreted into the breast milk.
Croatian: Nije poznato izlučuje li se pegaspargaza u majčino mlijeko.
English: Therefore, the concomitant use of Oncaspar with oral contraceptives is not recommended.
Croatian: Stoga se ne preporučuje istodobna primjena lijeka Oncaspar s oralnim kontraceptivima.
English: 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.).
Croatian: Rutinska mjera opreza je promatranje bolesnika tijekom sat vremena sa spremnom opremom za oživljavanje i ostalim što je potrebno za liječenje anafilaksije (adrenalin, kisik, intravenski steroidi itd.).
English: Cases of accidental overdose have been reported with Oncaspar.
Croatian: Slučajevi slučajnog predoziranja prijavljeni su vezano uz Oncaspar.
English: Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving pegaspargase (see section 4.8).
Croatian: Ozbiljni trombotski događaji, uključujući trombozu sagitalnog sinusa, mogu se pojaviti kod bolesnika koji primaju pegaspargazu (vidjeti dio 4.8).
English: In view of the unpredictability of adverse reactions, Oncaspar should be administered only by health care personnel experienced in the use of cancer chemotherapeutic medicinal products.
Croatian: S obzirom na nepredvidljivost nuspojava, Oncaspar smiju primjenjivati samo zdravstveni radnici s iskustvom u primjeni kemoterapijskih lijekova protiv raka.
English: There are limited data on the use of L-asparaginase and no data on the use of Oncaspar in pregnant women.
Croatian: Trudnoća Podaci o primjeni L-asparaginaze u trudnica su ograničeni, a podataka o primjeni lijeka Oncaspar u trudnica nema.
English: In this study, 118 paediatric patients aged 1 to 9 years with previously untreated standard-risk ALL were randomised 1:1 to Oncaspar or native E. coli L-asparaginase as part of combination therapy.
Croatian: U ovom ispitivanju 118 pedijatrijskih bolesnika u dobi od 1 do 9 godina, kojima prethodno nije bio liječen ALL standardnog rizika, randomizirano je 1:1 u skupinu koja je uzimala Oncaspar ili nativnu Lasparaginazu iz E. coli u sklopu kombinirane terapije.
English: Each pack contains 1 vial.
Croatian: Svako pakiranje sadrži
English: - if you ever had severe bleeding following asparaginase therapy.
Croatian: - ako ste ikada imali teško krvarenje nakon terapije asparaginazom - ako ste ikada imali ugruške krvi nakon terapije asparaginazom.
English: 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.
Croatian: Žene koje mogu zatrudnjeti za vrijeme trajanja liječenja moraju upotrebljavati pouzdanu kontracepciju, kao i najmanje 6 mjeseci nakon prekida liječenja lijekom Oncaspar.
English: The mechanism of action of L-asparaginase is the enzymatic cleavage of the amino acid L-asparagine into aspartic acid and ammonia.
Croatian: Mehanizam djelovanja L-asparaginaze je enzimsko cijepanje aminokiseline L-asparagina na aspartatnu kiselinu i amonijak.
English: Serum amylase and/or lipase levels should be monitored frequently to identify early signs of pancreatic inflammation.
Croatian: Razine serumske amilaze i/ili lipaze potrebno je redovito pratiti kako bi se otkrili rani znakovi upale gušterače.
English: Therefore and due to its pharmacological properties, Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase.
Croatian: Oncaspar se ne smije koristiti tijekom trudnoće osim ako kliničko stanje žene zahtijeva liječenje pegaspargazom.
English: 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
Croatian: Djelotvornost i sigurnost lijeka Oncaspar procijenjena je na temelju tri klinička ispitivanja koja su koristila Oncaspar otopinu za injekciju/infuziju u prvoj liniji liječenja ALL-a: Ispitivanje CCG-1962
English: Of these, 3 patients (27%) achieved complete remission, 1 patient (9%) had partial remission, 1 patient (9%) had haematologic improvement and 2 patients (18%) had therapeutic efficacy.
Croatian: Od tog broja, 3 su bolesnika (27%) postigla potpunu remisiju, 1 bolesnik (9%) djelomičnu remisiju, 1 bolesnik (9%) je imao hematološko poboljšanje, a 2 bolesnika (18%)
English: Infections and infestations Common: Infections, sepsis
Croatian: Često: infekcije, sepsa
English: 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.
Croatian: Moguć je povećan rizik od hepatotoksičnosti u bolesnika s pozitivnim Philadelphia kromosomom za koje se liječenje inhibitorima tirozin kinaze (npr. imatinib) kombinira s L-asparaginazom.
English: 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.
Croatian: Primarno određivanje djelotvornosti temeljeno je na dokazu sličnog pada razine asparagina (opsega i trajanja) u skupinama na lijeku Oncaspar i nativnoj L-asparaginazi iz E. coli.
English: The adverse reactions described in this section are derived from clinical trial data and post-marketing experience of Oncaspar in ALL patients.
Croatian: Nuspojave opisane u ovom dijelu dobivene su iz podataka kliničkih ispitivanja i iskustva s lijekom Oncaspar u bolesnika s ALL-om nakon stavljanja lijeka u promet.
English: The use of Oncaspar can lead to fluctuation in coagulation factors.
Croatian: Primjena lijeka Oncaspar može dovesti do fluktuacije faktora koagulacije.
English: Do not use this medicine if you notice the reconstituted solution is cloudy or has visible particles.
Croatian: Nemojte upotrijebiti ovaj lijek ako primijetite daje rekonstituirana otopina mutna ili ima vidljive čestice.
English: CSF asparagine concentrations were determined in 50 patients during the induction phase.
Croatian: Koncentracije asparagina u cerebrospinalnoj tekućini određene su u 50 bolesnika tijekom faze indukcije.
English: The symptoms of hyperammonaemia are often transient in nature and can include: nausea, vomiting, headache, dizziness and rash.
Croatian: Simptomi hiperamonijemije često su prolazne prirode, a mogu uključivati: mučninu, povraćanje, glavobolju, omaglicu i osip.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C.
Croatian: Kemijska i fizikalna stabilnost dokazana je tijekom 48 sati pri 2 °C-8 °C.
English: * 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
Croatian: ** Jedna jedinica definirana je kao količina enzima potrebna za oslobađanje 1 µmol amonijaka po minuti pri pH 7,3 i 37° C
English: One case of pancreatitis with simultaneous acute parotitis has been described with L-asparaginase treatment.
Croatian: Jedan slučaj pankreatitisa uz istodobni akutni parotitis opisan je tijekom liječenja L-asparaginazom.
English: In the other study, with 29 hypersensitive ALL patients exposed to Oncaspar, 11 patients were evaluated for response during induction.
Croatian: U drugom ispitivanju u kojem je sudjelovalo 29 preosjetljivih bolesnika oboljelih od ALL-a izloženih lijeku Oncaspar, procijenjen je odgovor 11 bolesnika u fazi indukcije.
English: 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).
Croatian: Postotak bolesnika u skupini liječenoj lijekom Oncaspar s ocjenjivim negativnim statusom (<0,1% stanica leukemije u koštanoj srži) minimalne ostatne bolesti (engl. minimal residual disease, MRD) 29. dana indukcije iznosio je 80% (40/50).
English: This medicine may make you more susceptible to infections.
Croatian: Ovaj lijek može povećati Vašu sklonost zarazama.
English: 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.
Croatian: Koncentracije L-asparagina u plazmi smanjile su se na vrijednosti ispod granice kvantifikacije za procjenu unutar 24 sata nakon doze indukcijske i prve doze konsolidacijske faze terapije lijekom Oncaspar i smanjenje se održalo približno dva tjedna.
English: Adults >21 years
Croatian: ˃ 21 godinu iznosi
English: During treatment with Oncaspar
Croatian: Za vrijeme liječenja lijekom Oncaspar
English: Pancreatitis, including haemorrhagic or necrotising pancreatitis with fatal outcomes, have been reported in patients receiving Oncaspar (see section 4.8).
Croatian: Prijavljen je pankreatitis, uključujući hemoragijski ili nekrotizirajući pankreatitis sa smrtnim ishodima, u bolesnika koji su primali Oncaspar (vidjeti dio 4.8).
English: 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).
Croatian: Otopina se može razrijediti 5%-tnom otopinom glukoze ili otopinom natrijevog klorida od 9 mg/ml (0,9%) za injekciju prije intravenske injekcije (vidjeti dio 4.2).
English: 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.
Croatian: Stoga je potreban oprez kada se istodobno primjenjuju antikoagulansi kao što su kumarin, heparin, dipiridamol, acetilsalicilatna kiselina ili nesteroidni protuupalni lijekovi ili kada se primjenjuje istodobni režim kemoterapije uključujući metotreksat, daunorubicin, kortikosteroide.
English: One case of toxic epidermal necrolysis (Lyell‘s syndrome) has been described in association with L-asparaginase.
Croatian: Jedan slučaj toksične epidermalne nekrolize (Lyellov sindrom) opisan je u vezi s L-asparaginazom.
English: This can be associated with a marked rise in the serum uric acid level.
Croatian: To se može povezati s izrazitim porastom razine uratne (mokraćne) kiseline u serumu.
English: When Oncaspar is used in combination with other cancer treatments, liver and central nervous system damage can occur.
Croatian: Oncaspar koristi u kombinaciji s drugim lijekovima protiv raka, može doći do oštećenja jetre i središnjeg živčanog sustava.
English: In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) may occur.
Croatian: U rijetkim se slučajevima može pojaviti sindrom reverzibilne posteriorne leukoencefalopatije.
English: The safety profile is based on randomised, controlled, prospective, open label multicentre studies using Oncaspar at a dose of 2500 U/m2 administered intravenously as a comparative treatment (studies DFCI 11-001 and AALL07P4).
Croatian: Sigurnosni profil temelji se na randomiziranim, kontroliranim, prospektivnim, otvorenim multicentričnim ispitivanjima primjene lijeka Oncaspar pri dozama od 2500 U/m2 primijenjenim intravenski kao usporedno liječenje (ispitivanja DFCI 11-001 i AALL07P4).
English: 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.
Croatian: Nativna L-asparaginaza iz E. coli primijenjena je intramuskularno pri dozi od 6000 U/m2 BSA tri puta tjedno u ukupno 9 doza tijekom indukcije i ukupno 6 doza tijekom svake od faza kasne intenzifikacije.
English: Intravenous administration of asparaginase may therefore cause serum levels of ammonia to rise sharply following administration.
Croatian: Intravenska primjena asparaginaze stoga može uzrokovati oštar porast razina amonijaka u serumu nakon primjene.
English: The impact of renal and hepatic impairment on the PK of Oncaspar has not been evaluated.
Croatian: Nije ocijenjen utjecaj oštećenja bubrega i jetre na PK lijeka Oncaspar.
English: CSF asparagine concentrations were reduced by the 4th day following the Induction dose, and remained largely undetectable by the 18th day after dosing.
Croatian: Koncentracije asparagina u CSF-u smanjene su do 4. dana nakon doze indukcije i uglavnom ih nije bilo moguće otkriti do 18. dana nakon doziranja.
English: The solution should be administered slowly.
Croatian: Otopinu treba primijeniti polako.
English: After reconstitution, 1 ml of solution contains 750 U pegaspargase (750 U/ml).
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži 750 U pegaspargaze (750 U/ml).
English: A population pharmacokinetic evaluation of Oncaspar based on data obtained from Studies AALL07P4 (IV), DFCI 11-001 (IV), and CCG-1962 (IM) identified that clearance (linear and saturable) increased approximately proportional to BSA and volume of distribution increased slightly more proportional to BSA.
Croatian: Ocjenjivanje populacijske farmakokinetike za lijek Oncaspar temeljeno na podacima dobivenim iz ispitivanja AALL07P4 (i.v.), DFCI 11-001 (i.v.) i CCG-1962 (i.m.) identificiralo je da se klirens (linearni i zasićeni) povećao približno proporcionalno s BSA, a da se volumen distribucije povećao nešto proporcionalnije s BSA.
English: The remaining patients were treated with 2,000 or 2,500 U/m2 BSA administered intramuscularly or intravenously.
Croatian: Ostali bolesnici liječeni su s 2000 ili 2500 U/m2 BSA primijenjeno intramuskularno ili intravenski.
English: Hypersensitivity reactions to pegaspargase, including life-threatening anaphylaxis, can occur during therapy, including in patients with known hypersensitivity to E. coli derived asparaginase formulations.
Croatian: Preosjetljivost Reakcije preosjetljivosti na pegaspargazu, uključujući anafilaksiju opasnu po život, mogu se pojaviti tijekom terapije, uključujući u bolesnika s poznatom preosjetljivošću na formulacije L-asparaginaze dobivene od E. coli.
English: Note: Oncaspar (2,500 Units/m2 BSA intramuscular) was administered on Day 3 of the 4-week induction phase.
Croatian: Napomena: Oncaspar (2500 jedinica/m2 BSA intramuskularno) primijenjen je 3. dana četverotjedne faze indukcije.
English: For intravenous or intramuscular use.
Croatian: Za intravensku ili intramuskularnu primjenu.