FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, the solution should be clear, colourless and free from visible foreign particles.
Slovenian: Po rekonstituciji mora biti raztopina bistra, brezbarvna in brez vidnih tujih delcev.
English: In single cases, haemorrhagic or necrotising pancreatitis with fatal outcome has been reported.
Slovenian: Poročali so o posameznih primerih hemoragičnega ali nekrotizirajočega pankreatitisa s smrtnim izidom.
English: The medicinal product should be administered intravenously or intramuscularly.
Slovenian: Zdravilo je treba dajati intravensko ali intramuskularno.
English: 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.
Slovenian: To je bila odprta, kontrolirana, randomizirana študija, ki je primerjala preiskovano pegilirano asparaginazo z zdravilom Oncaspar kot komponento polikemoterapije ALL prve izbire.
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).
Slovenian: 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).
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.
Slovenian: 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.
English: The active substance is pegaspargase.
Slovenian: Učinkovina je pegaspargaza.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3,750 U
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3.750 e.
English: Asparaginase antibodies
Slovenian: Protitelesa proti asparaginazi
English: 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.
Slovenian: 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.
English: Immediately preceding or simultaneous treatment with vincristine can increase the toxicity of pegaspargase.
Slovenian: Uporaba vinkristina neposredno pred ali sočasno s pegaspargazo lahko poveča toksičnost zdravila Oncaspar.
English: Other medicines and Oncaspar Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: The powder must therefore be handled and administered with particular caution.
Slovenian: S praškom morate ravnati in ga dajati s posebno previdnostjo.
English: After reconstitution, the solution is clear, colourless and free from visible foreign particles.
Slovenian: Po rekonstituciji je raztopina bistra, brezbarvna in ne vsebuje vidnih tujih delcev.
English: During Induction, plasma asparaginase activity ≥0.1 U/mL was sustained in 93.5% of subjects 18 days after administration.
Slovenian: Med indukcijo je bila aktivnost asparaginaze v plazmi ≥ 0,1 e./ml ohranjena pri 93,5 % preiskovancev 18 dni po dajanju.
English: Anti-leukaemic effect of L-asparaginase is related to a sustained L-asparagine depletion in blood and cerebrospinal fluid (CSF).
Slovenian: Antilevkemični učinek L-asparaginaze je povezan s trajnim upadom ravni L-asparagina v krvi in likvorju.
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.
Slovenian: 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,
English: Do not use this medicine if you notice the solution is cloudy or has visible particles.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali če vsebuje vidne delce.
English: Increased serum glutamic pyruvic transaminase activity also occurred in one out of four dogs.
Slovenian: Pri enem od štirih psov so ugotovili tudi povečano aktivnost serumske glutamat-piruvat-transaminaze.
English: Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar.
Slovenian: V času dajanja zdravila Oncaspar skozi isto intravensko linijo ne infundirajte drugih zdravil.
English: The adverse reactions described in this section are derived from clinical trial data and post-marketing experience of Oncaspar in ALL patients.
Slovenian: 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).
English: The solution should be administered slowly.
Slovenian: Raztopino je treba dajati počasi.
English: Native E. coli L-asparaginase (6,000 Units/m2 BSA intramuscular) was administered 3 times weekly for 9 doses during induction.
Slovenian: Nativna L-asparaginaza iz E. coli (6.000 enot/m2 BSA, intramuskularno) je bila uporabljena 3-krat tedensko v skupno 9 odmerkih med indukcijo.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection/infusion 1 vial with 3,750 U pegaspargase.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za injiciranje/infundiranje ena viala s 3.750 e. pegaspargaze
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.
Slovenian: 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.
English: Native E. coli L-Asparaginase Oncaspar®
Slovenian: Nativna L-asparaginaza iz E coli Oncaspar®
English: If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours.
Slovenian: Če razredčene raztopine ni mogoče uporabiti takoj, jo lahko do 48 ur hranite pri temperaturi 2 °C-8 °C.
English: Allergic reactions can manifest in the skin.
Slovenian: Bolezni kože in podkožja Na koži se lahko pojavijo alergijske reakcije.
English: PHARMACEUTICAL FORM Solution for injection/infusion.
Slovenian: FARMACEVTSKA OBLIKA Prašek za raztopino za injiciranje/infundiranje.
English: 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.
Slovenian: 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.
English: Τηλ: + 30 210 939 1000
Slovenian: ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000
English: Table 1: Adverse reactions reported with Oncaspar therapy
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali med zdravljenjem z zdravilom Oncaspar
English: Combination therapy with Oncaspar and other hepatotoxic products can result in severe hepatic toxicity.
Slovenian: Kombinirano zdravljenje z zdravilom Oncaspar in hepatotoksičnimi zdravili lahko privede do hude toksičnosti za jetra.
English: 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.).
Slovenian: 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.).
English: Do not use this medicine if you notice the reconstituted solution is cloudy or has visible particles.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je rekonstituirana raztopina motna ali če vsebuje vidne delce.
English: Les Laboratoires Servier Tél: + 33 (0)1 55 72 60 00
Slovenian: Les Laboratoires Servier Tel: +33 (0)1 55 72 60 00
English: If used at the same time as Oncaspar, the effects on the clotting ability of your blood are increased.
Slovenian: Če ga uporabite sočasno z zdravilom Oncaspar, se poveča sposobnost strjevanja vaše krvi;
English: Note: Oncaspar (2,500 Units/m2 BSA intramuscular) was administered on Day 3 of the 4-week induction phase.
Slovenian: Opomba: Zdravilo Oncaspar (2.500 enot/m2 BSA, intramuskularno) je bilo uporabljeno 3. dan 4-tedenske indukcijske faze.
English: About half of patients develop mild to moderate gastrointestinal reactions such as loss of appetite, nausea, vomiting, abdominal cramps, diarrhoea and weight loss.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: CSF asparagine concentrations were reduced by the 4th day following the Induction dose, and remained largely undetectable by the 18th day after dosing.
Slovenian: 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.
English: If used at the same time as Oncaspar, there is a higher risk of bleeding disorders.
Slovenian: Če se uporabijo sočasno z zdravilom Oncaspar, se poveča tveganje za motnje strjevanja krvi;
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C.
Slovenian: Dokazali so, da kemijska in fizikalna stabilnost med uporabo pri temperaturi 2 °C-8 °C traja 48 ur.
English: 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).
Slovenian: 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).
English: The use of Oncaspar can lead to fluctuation in coagulation factors.
Slovenian: Uporaba zdravila Oncaspar lahko privede do spremenljivih ravni faktorjev strjevanja krvi.
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.
Slovenian: Ravni L-asparagina v plazmi so se znižale pod mejo določljivosti testa v 24 urah po indukcijskem in prvem konsolidacijskem odmerku zdravila Oncaspar.
English: 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.
Slovenian: Po indukciji je bila najnižja aktivnost asparaginaze nad 0,4 e./ml ohranjena pri 100 % oseb od 7. tedna do 25. tedna.
English: 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.
Slovenian: Ker je pegaspargaza beljakovina z veliko molekulsko maso, se ne izloča skozi ledvice in pri bolnikih z ledvično okvaro ni potrebno prilagajanje odmerka.
English: Very common: Febrile neutropenia Common: Anaemia, coagulopathy Not known: Bone marrow failure
Slovenian: Zelo pogosti: febrilna nevtropenija Pogosti: anemija, koagulopatija Neznana: odpoved kostnega mozga
English: White to off-white powder.
Slovenian: Bel do umazano bel prašek.
English: As your doctor will administer the medicine, it is very unlikely you will be given more than you need.
Slovenian: 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.
English: - if you ever had severe bleeding following asparaginase therapy.
Slovenian: - če ste kdaj imeli hude krvavitve po zdravljenju z asparaginazo, - če ste kdaj imeli krvne strdke po zdravljenju z asparaginazo.
English: These findings were similar to those observed in the native E. coli L-asparaginase treatment arm.
Slovenian: Ti izsledki so bili podobni kot v skupini, ki je prejemala nativno L-asparaginazo iz E. coli.
English: 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).
Slovenian: 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).
English: One case of pancreatitis with simultaneous acute parotitis has been described with L-asparaginase treatment.
Slovenian: Pri zdravljenju z L-asparaginazo je opisan en primer pankreatitisa s sočasnim akutnim parotitisom.
English: Each vial contains 3,750 Units (U)** of pegaspargase*.
Slovenian: Ena viala raztopine vsebuje 3.750 enot (e.)** pegaspargaze*.
English: 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.
Slovenian: 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.
English: 5-Year EFS Rate, % (95% CI)
Slovenian: 3-letni delež EFS, % (95-odstotni IZ) 5-letni delež EFS, % (95-odstotni IZ) 7-letni delež EFS, % (95-odstotni IZ)
English: Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C.
Slovenian: Rekonstituirana raztopina Dokazali so, da kemijska in fizikalna stabilnost med uporabo pri temperaturi do 25 °C traja 24 ur.
English: 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.
Slovenian: Kot previdnostni ukrep moramo dojenje med zdravljenjem z zdravilom Oncaspar prekiniti in ga smemo nadaljevati šele po prekinitvi uporabe zdravila Oncaspar.
English: 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
Slovenian: 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.
English: Oncaspar can cause mild to moderate myelosuppression, and all three blood cell lines can be affected.
Slovenian: Bolezni krvi in limfatičnega sistema Zdravilo Oncaspar lahko povzroči blago do zmerno mielosupresijo in lahko vpliva na vse tri linije krvnih celic.
English: Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving pegaspargase (see section 4.8).
Slovenian: Pri bolnikih, ki prejemajo pegaspargazo, se lahko pojavijo resni trombotični dogodki, vključno s trombozo sagitalnega sinusa (glejte poglavje 4.8).
English: After reconstitution, 1 ml of solution contains 750 U pegaspargase (750 U/ml).
Slovenian: Po rekonstituciji 1 ml raztopine vsebuje 750 e. pegaspargaze (750 e./ml).
English: What Oncaspar is and what it is used for What you need to know before you are given Oncaspar How Oncaspar is given
Slovenian: Kaj je zdravilo Oncaspar in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Oncaspar Kako uporabljati zdravilo Oncaspar
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
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.
Slovenian: Ženske, ki lahko zanosijo, morajo med zdravljenjem in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar uporabljati učinkovito kontracepcijo.
English: Combination therapy with Oncaspar can result in central nervous system toxicity.
Slovenian: Kombinirano zdravljenje z zdravilom Oncaspar lahko privede do toksičnosti za osrednje živčevje.
English: The following adverse reactions have been reported in patients treated with Oncaspar along with other chemotherapy medicinal products: somnolence, confusion, dizziness, syncope, seizure.
Slovenian: Pri bolnikih, ki so bili zdravljeni z zdravilom Oncaspar sočasno z drugimi kemoterapevtiki, so opazili naslednje neželene učinke: somnolenco, zmedenost, omotico, sinkopo, epileptični napad.
English: 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.
Slovenian: Znižanje ravni asparagina v serumu je bilo ugotovljeno 4. dan po prvem indukcijskem odmerku, medtem ko je bila raven najnižja 10. dan po odmerku.
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).
Slovenian: 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).
English: One patient received Oncaspar doses of 250 and 500 Units/m2 BSA intravenously.
Slovenian: En bolnik je prejel odmerka zdravila Oncaspar 250 in 500 enot/m2 BSA intravensko.
English: After the medicinal product has been diluted, the solution should be used immediately.
Slovenian: Ko je zdravilo razredčeno, je treba raztopino takoj uporabiti.
English: The solution must therefore be handled and administered with particular caution.
Slovenian: Z raztopino morate ravnati in jo dajati s posebno previdnostjo.
English: Name and address of the manufacturer of the biological active substance Exelead, Inc.
Slovenian: Ime in naslov izdelovalca biološke učinkovine
English: 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.
Slovenian: V 12-tedenski študiji na miših, katerim so tedensko dajali pegaspargazo v odmerku 10,5 e./miš intramuskularno ali intraperitonealno, niso ugotovili imunogenega odziva.
English: History of serious thrombosis with prior L-asparaginase therapy.
Slovenian: Anamneza hude tromboze pri predhodnem zdravljenju z L-asparaginazo.
English: The Cmax and AUC of Oncaspar trended lower in males, subjects with larger BMI, and subjects >10 years.
Slovenian: zdravila Oncaspar so bili nižji pri moških, pri osebah z večjo vrednostjo ITM in pri osebah >10 let.
English: 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.
Slovenian: 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.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Slovenian: MINIMALNI PODATKI, KI MORAJO BITI NAVEDENI NA MANJŠIH STIČNIH
English: Oncaspar contains sodium
Slovenian: Zdravilo Oncaspar vsebuje natrij
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.
Slovenian: DNA in sinteze RNA, zlasti v levkemičnih mieloblastih, ki niso sposobni sintetizirati L-asparagina,
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 ALL patients; Study AALL07P4 in high risk ALL patients; Study DFCI 11-001 enrolled both standard and high-risk ALL patients.
Slovenian: 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.
English: One vial of 5 ml solution contains 3,750 Units.
Slovenian: Ena viala s 5 ml raztopine vsebuje 3.750 enot.
English: General disorders and administration side conditions Pyrexia can occur after the injection, which usually subsides spontaneously.
Slovenian: Splošne težave in spremembe na mestu aplikacije Po injiciranju se lahko pojavi zvišana telesna temperatura, ki običajno izzveni spontano.
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out an accelerated reduction of asparaginase activity.
Slovenian: Da se izključi pospešeno zmanjševanje aktivnosti asparaginaze, se lahko meri aktivnost asparaginaze v serumu ali plazmi.