FrancophonIA/ELRC3.0 huggingface dataset:
English: Absorption Asparaginase is not absorbed by the gastrointestinal tract, thus Spectrila must be given intravenously.
Slovenian: Absorpcija Asparaginaza se v prebavilih ne absorbira, zato moramo zdravilo Spectrila dajati intravensko.
English: After repeated administration of asparaginase at a dose of 5,000 U/m² every third day, trough asparaginase activity levels in serum ranged from 108 to 510 U/l.
Slovenian: Po ponovnem dajanju asparaginaze v odmerku 5.000 E/m² vsak tretji dan je bila najnižja raven aktivnosti asparaginaze v serumu v razponu od 108 to 510 E/l.
English: In a clinical trial in children with de novo ALL (study MC-ASP.4/ALL) it was shown that immediately after the end of infusion of asparaginase mean asparagine concentrations in serum dropped from the pre-dose concentrations of about 40 µM to below the lower limit of quantification of the bioanalytical method (< 0.5 µM).
Slovenian: V kliničnem preskušanju pri otrocih z de novo ALL (študija MC-ASP.4/ALL) so pokazali, da so se takoj po koncu infuzije asparaginaze srednje serumske koncentracije asparagina znižale s koncentracij pred odmerkom, ki so bile okrog 40 µM, na vrednosti pod spodnjo mejo kvantitativnega določanja bioanalitične metode (<0,5 µM).
English: • nervousness (agitation) or somnolence (sleepiness)
Slovenian: • živčnost (agitiranost) ali somnolenca (zaspanost),
English: Vincristine
Slovenian: Vinkristin
English: Additionally it may decrease insulin secretion from pancreatic β-cells and impair insulin receptor function.
Slovenian: Poleg tega lahko zmanjša izločanje insulina iz pankreatičnih celic β in okvari delovanje insulinskih receptorjev.
English: No case of asparaginase overdose with clinical symptoms has been reported.
Slovenian: Poročali niso o nobenem primeru prevelikega odmerjanja asparaginaze s kliničnimi simptomi.
English: For intravenous use only.
Slovenian: SAMO za intravensko uporabo.
English: Even those few patients with trough asparaginase serum activity levels of 10 - 100 U/l usually experienced complete asparagine depletion in serum and CSF.
Slovenian: Celo pri tistih nekaj bolnikih, ki so imeli najnižjo raven serumske aktivnosti asparaginaze 10-100 E/l, je navadno bilo prisotno popolno izčrpanje asparagina v serumu in CSF.
English: Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.
Slovenian: Brezbarvna 20-mililitrska steklena viala (steklo tipa 1), zaprta z zamaškom iz butilne gume, aluminijasto zaporko in plastičnim dvižnim pokrovčkom, ki vsebuje 10.000 enot asparaginaze.
English: Reversible posterior leukoencephalopathy syndrome (characterised by headache, confusion, seizures and visual loss) may require blood-pressure lowering medicines and in case of seizure, anti-epileptic treatment.
Slovenian: Pri sindromu reverzibilne posteriorne levkoencefalopatije (za katerega so značilni glavobol, zmedenost, epileptični napadi in okvara vida) bodo morda potrebna zdravila za znižanje krvnega tlaka in, v primeru epileptičnih napadov, antiepileptično zdravljenje.
English: • acute pancreatitis,
Slovenian: • akutni pankreatitis,
English: Frequent evaluation of coagulation parameters is important before and during asparaginase treatment.
Slovenian: Pogosto določanje koagulacijskih parametrov je pomembno pred zdravljenjem z asparaginazo in med njim.
English: Spectrila has moderate influence on the ability to drive and use machines, especially through its potential effects on the nervous and gastrointestinal systems (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Spectrila ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji, posebno prek svojih potencialnih učinkov na živčevje in prebavila (glejte poglavje 4.8).
English: How to use Spectrila
Slovenian: Kako uporabljati zdravilo Spectrila
English: Asparaginase-associated hyperlipidaemia should be treated depending on its severity and on clinical symptoms.
Slovenian: Hiperlipidemijo, povezano z asparaginazo, moramo zdraviti odvisno od njene izraženosti in od kliničnih simptomov.
English: This antagonism is observed if asparaginase is administered prior to or concurrently with methotrexate.
Slovenian: Ta antagonizem je viden, če damo asparaginazo prej kot metotreksat ali sočasno z njim.
English: Expert advice should be sought in cases where AT III is decreased.
Slovenian: V primerih, ko je znižan AT III, je treba poiskati nasvet specialista.
English: Marketing Authorisation Holder and Manufacturer medac
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec medac
English: 17.33 (12.54 - 22.91) h
Slovenian: 17,33 (12,54-22,91) h skupni očistek
English: One vial contains 10,000 units of asparaginase.
Slovenian: Ena viala vsebuje 10.000 enot asparaginaze.
English: • blood clotting disorders (bleeding or formation of blood clots),
Slovenian: • motnje strjevanja krvi (krvavitev ali nastanek krvnih strdkov),
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 10,000 units of asparaginase*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 10.000 enot asparaginaze*.
English: 6,700 U/m² BSA,
Slovenian: 6.700 E/m² telesne površine,
English: • hepatotoxicity,
Slovenian: • hepatotoksičnost,
English: There have been reports of transitory secondary hypothyroidism probably caused by a decrease in the serum thyroxin-binding globulin due to asparaginase-induced protein synthesis inhibition.
Slovenian: Poročali so o prehodnem sekundarnem hipotiroidizmu, ki ga verjetno povzroča zmanjšanje serumskega globulina, ki veže tiroksin, zaradi inhibicije sinteze beljakovin, ki jo povzroča asparaginaza.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing chemotherapy.
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo in ne smejo zanositi, ko se zdravijo s kemoterapijo, katere del je asparaginaza.
English: Difference (95 % CIa)
Slovenian: da c ne ni mogoče oceniti razlika (95 % CI
English: It is unknown whether asparaginase is excreted into human breast milk.
Slovenian: Ni znano, ali se asparaginaza pri človeku izloča v materino mleko.
English: Pharmacokinetic parameters after administration of 5,000 U/m² of Spectrila were determined in 14 children/adolescents (age 2 - 14 years) with de novo ALL (study MC-ASP.4/ALL).
Slovenian: Pediatrična populacija Farmakokinetične parametre po dajanju 5.000 E/m zdravila Spectrila so določili pri 14 otrocih/mladostnikih (starih 2-14 let) z de novo ALL (študija MC-ASP.4/ALL).
English: Liver parameters should be monitored closely before and during treatment with asparaginase.
Slovenian: Jetrne parametre je treba skrbno spremljati pred zdravljenjem z asparaginazo in med njim.
English: As a result of asparaginase-induced asparagine depletion in serum, protein synthesis in lymphoblastic tumour cells is disturbed while sparing most normal cells.
Slovenian: Kot rezultat izčrpanja asparagina v serumu, ki ga povzroči asparaginaza, je sinteza beljakovin v limfoblastnih tumorskih celicah motena, kar pa ne vpliva na večino normalnih celic.
English: Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products.
Slovenian: Zdravilo Spectrila smejo predpisovati in dajati le zdravniki in zdravstveno osebje, ki imajo izkušnje z uporabo zdravil z delovanjem na novotvorbe.
English: • allergic reactions including wheezing (bronchospasm) or difficulty in breathing
Slovenian: • alergijske reakcije, vključno s sopenjem (bronhospazem) ali z oteženim dihanjem,
English: Very rare
Slovenian: Zelo redki tremor
English: Coagulation disorders
Slovenian: Motnje koagulacije
English: Clinical symptoms include abdominal pain, nausea, vomiting and anorexia.
Slovenian: Klinični simptomi vključujejo bolečine v trebuhu, navzeo, bruhanje in anoreksijo.
English: In an uncontrolled clinical trial (study MC-ASP.6/INF), 12 infants (median age [range] at time of first infusion: 6 months [0.5 - 12.2 months]) with de novo ALL were treated with Spectrila within the
Slovenian: V nekontroliranem kliničnem preskušanju (študija MC-ASP.6/INF) so zdravili 12 dojenčkov (mediana starost [razpon] v času prve infuzije: 6 mesecev [0,5-12,2 meseca]) z de novo ALL z zdravilom Spectrila po protokolu INTERFANT-06.
English: Your doctor decides on the dose you receive.
Slovenian: Odmerek, ki ga boste prejeli, bo določil vaš zdravnik.
English: Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij medac Gesellschaft für klinische Spezialpräparate mbH
English: Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: Gesellschaft für klinische Spezialpräparate mbH
English: The powder is white and it is supplied in a clear glass vial with a rubber stopper and an aluminium seal and a plastic flip-off cap.
Slovenian: Prašek je bel in je na voljo v viali iz prozornega stekla z gumijastim zamaškom, aluminijasto zaporko in plastičnim dvižnim pokrovčkom.
English: Neurological signs and symptoms including agitation, dizziness and somnolence
Slovenian: Pogosti nevrološki znaki in simptomi, vključno z agitiranostjo, omotičnostjo in zaspanostjo
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase (see section 4.8).
Slovenian: Sindrom reverzibilne posteriorne levkoencefalopatije Sindrom reverzibilne posteriorne levkoencefalopatije (RPLS) se lahko redko pojavi med zdravljenjem s katero koli asparaginazo (glejte poglavje 4.8).
English: MRD status at end of induction treatment MRD negative
Slovenian: Status MRD na koncu indukcijskega zdravljenja
English: The following life-threatening situations may arise during asparaginase treatment in patients of all age groups:
Slovenian: Med zdravljenjem z asparaginazo se lahko pri bolnikih vseh starostnih skupin pojavijo naslednja smrtno nevarna stanja:
English: Caution is therefore needed when anticoagulants (e.g. coumarin, heparin, dipyridamole, acetylsalicylic acid or nonsteroidal anti-inflammatory medicinal products) or glucocorticoids are given at the same time.
Slovenian: Zato je ob sočasnem dajanju antikoagulantov (npr. kumarin, heparin, dipiridamol, acetilsalicilno kislino ali nesteroidna protivnetna zdravila) ali glukokortikoidov, potrebna previdnost.
English: • Glucocorticoids (anti-inflammation medicines that dampen down your immune system) since the simultaneous use of glucocorticoids and asparaginase may increase the formation of blood clots (thrombosis).
Slovenian: • Glukokortikoidi (protivnetna zdravila, ki omilijo odziv vašega imunskega sistema), ker lahko sočasna uporaba glukokortikoidov in asparaginaze zveča nastajanje krvnih strdkov (tromboza).
English: • If you have any further questions, ask your doctor or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
English: • liver problems,
Slovenian: • težave z jetri,
English: Hyperammonaemia and sinus vein thrombosis may need to be excluded.
Slovenian: Mogoče bo treba izključiti hiperamonemijo in trombozo venskih sinusov.
English: In rare cases severe liver impairment has been described, including cholestasis, icterus, hepatic necrosis and hepatic failure with fatal outcome (see sections 4.8 and 4.5).
Slovenian: Hepatotoksičnost V redkih primerih so opisali hudo okvaro jeter, vključno s holestazo, zlatenico, nekrozo jeter in odpovedjo jeter s smrtnim izidom (glejte poglavji 4.8 in 4.5).
English: The reconstituted solution is stable for 2 days when stored at 2 °C - 8 °C.
Slovenian: Rekonstituirana raztopina je stabilna 2 dni, če jo hranimo pri 2 °C-8 °C.
English: 0.053 (0.043 - 0.178) l/h
Slovenian: 0,053 (0,043-0,178) l/h porazdelitveni volumen
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 January 2016
Slovenian: 14. januar 2016
English: Table 3: Efficacy results (MC-ASP.5/ALL; Full analysis set)
Slovenian: Preglednica 3: Rezultati učinkovitosti (MC-ASP.5/ALL; analiza vseh podatkov) Skupina glede na zdravilo
English: • Other anti-cancer medicines as they may contribute to the release of too much uric acid when tumour cells are destroyed by asparaginase.
Slovenian: • Druga zdravila z delovanjem na novotvorbe, ker lahko prispevajo k sproščanju prevelikih količin sečne kisline, ko asparaginaza uniči rakaste celice.
English: Immunisation with live vaccines should therefore take place at the earliest 3 months after completion of the course of antileukaemic treatment.
Slovenian: Zato ne smemo imunizirati bolnika z živimi vakcinami prej kot 3 mesece po dokončanju sheme antilevkemičnega zdravljenja.
English: In case of hyperammonaemia with severe clinical symptoms, therapeutic and pharmacological measures that rapidly reduce plasma ammonia levels (e.g. protein restriction and haemodialysis), reverse catabolic states and increase removal of nitrogen wastes should be initiated and expert advice sought.
Slovenian: V primeru hiperamonemije s hudimi kliničnimi simptomi je treba uvesti terapevtske in farmakološke ukrepe, ki hitro zmanjšajo koncentracijo amoniaka v plazmi (npr. omejitev beljakovin in hemodializa), odpravijo katabolična stanja in zvečajo odstranjevanje dušikovih odpadnih snovi, ter poiskati nasvet specialista.
English: Asparaginase hydrolyses asparagine to aspartic acid and ammonia.
Slovenian: Mehanizem delovanja Asparaginaza hidrolizira asparagin v asparaginsko kislino in amoniak.
English: In clinical trials with asparaginase, trough asparaginase serum activity levels greater than 100 U/l were achieved in the majority of patients which nearly always correlated with a complete depletion of asparagine in serum and cerebrospinal fluid (CSF).
Slovenian: V kliničnih preskušanjih z asparaginazo je večina bolnikov dosegla najnižjo raven serumske aktivnosti asparaginaze več kot 100 E/l, kar je skoraj vedno sovpadalo s popolnim izčrpanjem asparagina v serumu in cerebrospinalni tekočini (CSF).
English: • if you have a blood clotting disorder (such as haemophilia),
Slovenian: • če imate bolezen strjevanja krvi (na primer hemofilijo).
English: • infections
Slovenian: • okužbe,
English: Common Pain (back pain, joint pain)
Slovenian: Pogosti bolečina (bolečina v hrbtu, bolečina v sklepih)
English: Hypothyroidism
Slovenian: Hipotiroidizem
English: The diluted solution of asparaginase may be infused over 0.5 to 2 hours.
Slovenian: Razredčeno raztopino asparaginaze lahko infundirate 0,5 ure do 2 uri.
English: Nausea/vomiting are very commonly observed in patients treated with asparaginase-containing treatment regimens but are usually mild.
Slovenian: Navzeo in bruhanje zelo pogosto opažajo pri bolnikih, zdravljenih s terapevtskimi shemami, ki vsebujejo asparaginazo, a sta navadno blaga.
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated reduction of asparaginase activity.
Slovenian: Merjenje aktivnosti asparaginaze v serumu ali plazmi lahko opravimo, da izključimo možnost pospešenega zmanjšanja aktivnosti asparaginaze.
English: Acquired or genetically decreased physiologic coagulation inhibitors (protein C, protein S, antithrombin) are also described in relation to vascular complications.
Slovenian: V zvezi z žilnimi zapleti opisujejo tudi pridobljene ali genetsko zmanjšane fiziološke inhibitorje koagulacije (protein C, protein S, antitrombin).
English: If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4).
Slovenian: Če vrednosti aktivnosti asparaginaze ne dosežejo ciljnih ravni, bi lahko prišla v poštev zamenjava z drugim zdravilom z asparaginazo (glejte poglavje 4.4).
English: Study in children/adolescents aged 1 - 18 years with de novo ALL Efficacy and safety of Spectrila was compared to a native E. coli-asparaginase (reference medicinal product) in a randomised double-blinded clinical trial (study MC-ASP.5/ALL; based on ALL treatment protocol DCOG ALL10) in 199 children/adolescents aged 1 - 18 years with de novo ALL.
Slovenian: Učinkovitost in varnost zdravila Spectrila so primerjali z nativno asparaginazo E. coli (referenčno zdravilo) v randomiziranem dvojno slepem kliničnem preskušanju (študija MC-ASP.5/ALL; na podlagi protokola zdravljenja ALL DCOG ALL10) pri 199 otrocih/mladostnikih, starih 1-18 let z de novo ALL.
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation (see section 4.6).
Slovenian: Ker ni mogoče izključiti posredne interakcije med učinkovinami v peroralnih kontraceptivih in asparaginazo, peroralni kontraceptivi v taki klinični situaciji niso dovolj varni (glejte poglavje 4.6).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001 (1 vial)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1072/001 (1 viala)
English: The recommended dose in infants aged 0 - 12 months is as follows: - age less than 6 months:
Slovenian: Priporočeni odmerki za dojenčke, stare 0-12 mesecev, so:
English: As a result of impaired protein synthesis, the serum protein level (especially albumin) decreases very commonly in patients treated with asparaginase.
Slovenian: Zaradi motene sinteze beljakovin se raven serumskih beljakovin (posebno albumina) pri bolnikih, zdravljenih z asparaginazo, zelo pogosto zmanjša.
English: Pancreatitis with fatal outcome, pancreatic pseudocyst
Slovenian: Zelo redki pankreatitis s smrtnim izidom, pankreatična psevdocista
English: Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Spectrila je indicirano kot sestavni del kombinirane terapije z delovanjem na novotvorbe za zdravljenje akutne limfoblastne levkemije (ALL) pri pediatričnih bolnikih od rojstva do starosti 18 let in odraslih.
English: Inhibition of protein synthesis secondary to the asparaginase-induced depletion of asparagine has been shown to attenuate the cytotoxic effect of MTX which requires cell replication for its antineoplastic activity.
Slovenian: Metotreksat (MTX) Ugotovili so, da inhibicija sinteze beljakovin zaradi izpraznitve zalog asparagina, ki jo povzroči asparaginaza, zmanjša citotoksični učinek MTX, ki za svojo aktivnost proti novotvorbam potrebuje replikacijo celic.
English: Trough serum activity levels were measured in 12 infants (age from birth to 1 year) with de novo ALL (study MC-ASP.6/INF).
Slovenian: Najnižjo raven serumske aktivnosti so merili pri 12 dojenčkih (starost od rojstva do 1 leta) z de novo ALL (študija MC-ASP.6/INF).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for asparaginase (centrally authorised product), the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za asparaginazo (zdravilo, ki je pridobilo dovoljenje za promet po centraliziranem postopku), je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated elimination of asparaginase activity.
Slovenian: Merjenje aktivnosti asparaginaze v serumu ali plazmi lahko opravimo, da izključimo možnost pospešene eliminacije aktivnosti asparaginaze.
English: Asparaginase caused an increase in the incidence of malformations (including those of the central nervous system, heart and skeletal system) and foetal death at doses that are similar to or in excess of those proposed clinically (on a U/m² basis) in a number of species including the mouse, rat and/or rabbit.
Slovenian: Asparaginaza je pri več živalskih vrstah, med drugim pri miših, podganah in/ali kuncih, povzročila zvečano incidenco malformacij (vključno z malformacijami centralnega živčevja, srca in skeleta) in fetalnih smrti v odmerkih, ki so podobni tistim ali večji od tistih, ki so predlagani za klinično uporabo
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
English: Hyperammonaemia
Slovenian: Hiperamonemija
English: In rare cases, diabetic ketoacidosis has been reported.
Slovenian: V redkih primerih so poročali o diabetični ketoacidozi.
English: It is strongly recommended that every time Spectrila is administered to a patient, the tradename and batch number of the product should clearly be recorded in order to link the patient and the batch of the product.
Slovenian: Vsakokrat, ko damo bolniku zdravilo Spectrila, moramo zabeležiti ime in serijo zdravila, da tako ohranimo sledljivost med bolnikom in serijo zdravila.
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase.
Slovenian: Sindrom reverzibilne posteriorne levkoencefalopatije Sindrom reverzibilne posteriorne levkoencefalopatije (RPLS) se lahko redko pojavi med zdravljenjem s katero koli asparaginazo.
English: Adverse central nervous system reactions observed in patients treated with asparaginase-containing therapy protocols include changes in EEG, seizures, dizziness, somnolence, coma and headache.
Slovenian: Neželeni učinki na centralno živčevje, ki so jih opazili pri bolnikih, zdravljenih s terapevtskimi protokoli, ki vsebujejo asparaginazo, vključujejo spremembe EEG, epileptične napade, omedlevico,
English: • Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases
Slovenian: • huda okvara jeter (bilirubin > 3-krat zgornja meja normalnih vrednosti [ULN-upper limit of normal]; transaminaze > 10-krat višje od ULN).
English: Hyperammonaemia has been reported uncommonly in patients treated with asparaginase-containing therapy protocols, especially if patients suffer additionally from hepatic impairment.
Slovenian: O hiperamonemiji so občasno poročali pri bolnikih, zdravljenih s terapevtskimi protokoli, ki vsebujejo asparaginazo, še posebno pri bolnikih z okvaro jeter.
English: Hepatic parameters should be monitored when potentially hepatotoxic medicinal products are given concomitantly with asparaginase (see sections 4.4 and 4.8).
Slovenian: Kadar bolnik sočasno z asparaginazo prejema potencialno hepatotoksična zdravila, je treba spremljati jetrne parametre (glejte poglavji 4.4 in 4.8).
English: Most frequently (very common) observed side effects of Spectrila include hypersensitivity reactions, hyperglycaemia, hypoalbuminaemia, nausea, vomiting, diarrhoea, abdominal pain, oedema, fatigue, and change in laboratory parameters (e.g. transaminases, bilirubin, blood lipids, coagulation parameters).
Slovenian: Med najpogosteje (zelo pogosti) opaženimi neželenimi učinki zdravila Spectrila so preobčutljivostne reakcije, hiperglikemija, hipoalbuminemija, navzea, bruhanje, driska, bolečine v trebuhu, edemi, utrujenost in spremembe laboratorijskih parametrov (npr. transaminaze, bilirubin, lipidi v krvi, koagulacijski parametri).
English: 7,500 U/m² BSA.
Slovenian: 7.500 E/m² telesne površine.
English: • Asparaginase may influence the efficacy of methotrexate or cytarabine (used to treat certain types of cancer): - if asparaginase is given after these agents their effect may be increased.
Slovenian: • Asparaginaza lahko vpliva na učinkovitost metotreksata ali citarabina (ki se uporabljata za zdravljenje nekaterih vrst raka): če damo najprej ti zdravili in potem asparaginazo, se lahko njuni učinki zvečajo, če damo najprej asparaginazo in potem ti zdravili, se lahko njuni učinki zmanjšajo.