FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenaemia can occur in patients receiving pegaspargase.
Slovenian: Pri bolnikih, ki prejemajo pegaspargazo, se lahko pojavijo podaljšan protrombinski čas (PČ), podaljšan parcialni tromboplastinski čas (PTČ) in hipofibrinogenemija.
English: One ml of solution contains 750 Units (U)** of pegaspargase*.
Slovenian: En ml raztopine vsebuje 750 enot (e.)** pegaspargaze*.
English: Mild hepatotoxicity was observed with the same dosages.
Slovenian: Pri enakih odmerkih so ugotovili blago hepatotoksičnost.
English: Fertility No studies investigating the effect of pegaspargase on fertility have been performed.
Slovenian: Študije učinka pegaspargaze na plodnost niso bile opravljene.
English: Very common: Weight decreased, hypoalbuminaemia, alanine aminotransferase increased, aspartate aminotransferase increased, hypertriglyceridaemia, blood fibrinogen decreased, lipase increased, amylase increased, activated partial thromboplastin time prolonged, blood bilirubin increased
Slovenian: Zelo pogosti: zmanjšana telesna masa, hipoalbuminemija, zvišana raven alanin-aminotransferaze, zvišana raven aspartat-aminotransferaze, hipertrigliceridemija, znižana raven fibrinogena v krvi, zvišana raven lipaze, zvišana raven amilaze, podaljšan aktivirani parcialni tromboplastinski čas, zvišana raven bilirubina v krvi
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
Slovenian: ** Ena enota je opredeljena kot količina encima, ki je potrebna za sprostitev 1 µmol amoniaka na minuto pri pH 7,3 in 37 °C Jakosti tega zdravila ne smemo primerjati z jakostjo druge pegilirane ali nepegilirane beljakovine iz iste terapevtske skupine.
English: A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5).
Slovenian: Ženske v rodni dobi morajo uporabiti drugo metodo kontracepcije, kot pa je peroralna (glejte poglavji 4.4 in 4.5).
English: As pegaspargase is a protein with a high molecular weight, it is not excreted renally, and no change of pharmacokinetic of Oncaspar in patients with renal impairment is foreseen.
Slovenian: Ker je pegaspargaza beljakovina z veliko molekulsko maso, se ne izloča skozi ledvice in pri bolnikih z ledvično okvaro ni pričakovati spremembe farmakokinetike zdravila Oncaspar.
English: Based on results from these two studies, a 2,500 U/m2 BSA dose of Oncaspar administered IM
Slovenian: Na podlagi rezultatov teh dveh študij odmerek zdravila Oncaspar 2.500 e./m2 BSA, ki se daje i.m.
English: Tél/Tel: +32 (0)2 529 43 11
Slovenian: Tel: +32 (0)2 529 43 11
English: One case of toxic epidermal necrolysis (Lyell‘s syndrome) has been described in association with L-asparaginase.
Slovenian: V povezavi z L-asparaginazo je bil opisan en primer toksične epidermalne nekrolize (Lyellov sindrom).
English: There have been isolated reports of formation of pseudocysts (up to four months after the last treatment).
Slovenian: (do štiri mesece po zadnjem zdravljenju).
English: Another method than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.6).
Slovenian: Ženske v rodni dobi morajo zato uporabiti drugo metodo kontracepcije, kot pa je peroralna (glejte poglavji 4.4 in 4.6).
English: Pegaspargase was well tolerated both in rats and dogs when administered intravenously in single dose up to 500 U/kg body weight.
Slovenian: Pegaspargazo so v enkratnem intravenskem odmerku do 500 e./kg telesne mase dobro prenašale tako podgane kot psi.
English: As impaired glucose tolerance may occur with concomitant use of Oncaspar with prednisone, blood glucose levels should be monitored.
Slovenian: Pri sočasni uporabi zdravila Oncaspar in prednizona moramo spremljati ravni glukoze v krvi, saj se lahko pojavi motnja tolerance za glukozo.
English: Very common: Decreased appetite, hyperglycaemia Common: Hyperlipidaemia, hypercholesterolaemia Not known: Diabetic ketoacidosis, hypoglycaemia
Slovenian: Zelo pogosti: zmanjšan apetit, hiperglikemija Pogosti: hiperlipidemija, hiperholesterolemija
English: Sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Natrijev dihidrogenfosfat monohidrat, natrijev fosfat heptahidrat, natrijev klorid, voda za injekcije.
English: Rare: Hepatic necrosis, jaundice, cholestasis, hepatic failure Immune system disorders Very common: Hypersensitivity, urticaria, anaphylactic reaction Not known: Toxic epidermal necrolysis*
Slovenian: Zelo pogosti: preobčutljivost, urtikarija, anafilaktična reakcija Neznana: toksična epidermalna nekroliza*
English: In Study CCG-1962, mean asparaginase activity reached peak value of 1 U/mL on Day 5 after the injection.
Slovenian: V študiji CCG-1962 je srednja vrednost aktivnosti asparaginaze dosegla najvišjo vrednost 1 e./ml
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),
Slovenian: zlasti če zdravilo Oncaspar uporabljamo skupaj z nevrotoksičnimi zdravili (kot sta vinkristin in metotreksat, glejte poglavje 4.5).
English: Do not use Oncaspar: - if you are allergic to pegaspargase or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na pegaspargazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste kdaj imeli pankreatitis,
English: The most common adverse reactions with Oncaspar (observed in at least 2 studies with a frequency of >10%) included: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, activated partial thromboplastin time prolonged, hypertriglyceridaemia, hyperglycaemia, and febrile neutropenia.
Slovenian: Med najpogostejše neželene učinke zdravila Oncaspar (ugotovljene v najmanj 2 študijah s pogostnostjo > 10 %) so spadali: zvišana raven alanin-aminotransferaze, zvišana raven aspartataminotransferaze, zvišana raven bilirubina v krvi, podaljšan aktivirani parcialni tromboplastinski čas, hipertrigliceridemija, hiperglikemija in febrilna nevtropenija.
English: Common: Seizure, peripheral motor neuropathy, syncope Rare: Posterior reversible leukoencephalopathy syndrome Not known: Somnolence, tremor*
Slovenian: Redki: sindrom posteriorne reverzibilne levkoencefalopatije Neznana: somnolenca, tremor*
English: 5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.
Slovenian: Z injekcijsko brizgo in iglo kalibra 21 se injicira 5,2 ml vode za injekcije v vialo.
English: In case of contact, irrigate with plenty of water for at least 15 minutes.
Slovenian: Ob stiku z očmi, s kožo ali sluznicami, izpirajte z obilo vode vsaj 15 minut.
English: Table 3: Pharmacokinetic Parameters After a Single IV Dose of Oncaspar 2,500 U/m2 BSA During Induction (N=47; Study AALL07P4)
Slovenian: 2.500 e./m2 BSA med indukcijo (n = 47; študija AALL07P4)
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.
Slovenian: Pri kombiniranju zdravljenja z L-asparaginazo z zaviralci tirozin-kinaze (npr. imatinibom) je možno povečanje tveganja za hepatotoksičnost pri bolnikih s pozitivnim kromosomom Philadelphia, kar je treba upoštevati, kadar se odločamo za uporabo zdravila Oncaspar pri teh bolnikih.
English: BSA during Induction, Consolidation, Delayed Intensification, and Interim Maintenance phases in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Münster therapy.
Slovenian: Zdravilo Oncaspar so dajali intravensko v odmerku 2.500 enot/m2 BSA v fazah indukcije, konsolidacije, pozne intenzifikacije in vmesnega vzdrževanja pri bolnikih z ALL visokega tveganja, ki so prejemali razširjeno terapijo Berlin-Frankfurt-Münster.
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment.
Slovenian: Jetrna okvara Pri bolnikih z jetrno okvaro ni potrebno prilagajanje odmerka.
English: During Induction (N=47; Study AALL07P4) PK Parameters
Slovenian: dajanju (AALL07P4).
English: The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, and water for injections (see section 2 “Oncaspar contains sodium”).
Slovenian: Pomožne snovi so: natrijev dihidrogenfosfat monohidrat, dinatrijev fosfat heptahidrat, natrijev klorid in voda za injekcije (glejte poglavje 2 Zdravilo Oncaspar vsebuje natrij).
English: Intravenous infusion of Oncaspar is usually given over a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
Slovenian: Intravensko infuzijo zdravila Oncaspar običajno dajemo v obdobju od 1 do 2 ur v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9-%) za injiciranje ali 5-% raztopino glukoze.
English: During Induction, following a single IV dose of Oncaspar 2,500 U/m2, asparaginase activity ≥0.1 U/mL was sustained for up to 18 days post-dose in 95.3% of subjects.
Slovenian: odmerku zdravila Oncaspar 2.500 e./m2 aktivnost asparaginaze ≥ 0,1 e./ml ohranjena do 18 dni po odmerku pri 95,3 % preiskovancev.
English: Pancreatitis, including haemorrhagic or necrotising pancreatitis with fatal outcomes, have been reported in patients receiving Oncaspar (see section 4.8).
Slovenian: Učinki na trebušno slinavko Pri bolnikih, ki so prejemali zdravilo Oncaspar, so poročali o pankreatitisu, vključno s hemoragičnim ali nekrotizirajočim pankreatitisom s smrtnim izidom (glejte poglavje 4.8).
English: 6925 Guion Road
Slovenian: 6925 Guion Road Indianapolis Indiana 46268 ZDA
English: One vial of 5 ml solution contains 3750 units of pegaspargase.
Slovenian: Ena viala s 5 ml raztopine vsebuje 3.750 enot pegaspargaze.
English: Of these,
Slovenian: Eλλάδα
English: The use of disposable gloves and protective garments is recommended when handling Oncaspar.
Slovenian: Pri delu z zdravilom Oncaspar priporočamo uporabo rokavic in zaščitnih oblačil za enkratno uporabo.
English: Very common: Embolism** Common: Thrombosis*** Not known: Cerebrovascular accident, haemorrhage, superior sagittal sinus thrombosis *Adverse reactions observed with other asparaginases in the class **Cases of pulmonary embolism, venous thrombosis, venous thrombosis limb, and thrombophlebitis superficial were observed in DFCI 11-001 ***Legend: CNS thrombosis
Slovenian: *Neželeni učinki, ugotovljeni pri drugih asparaginazah v istem razredu **Primere pljučne embolije, venske tromboze, venske tromboze v okončini in površinskega tromboflebitisa so ugotovili v študiji DFCI 11-001 ***Legenda: tromboza CŽS
English: Hypersensitivity reactions to Oncaspar, including life-threatening anaphylaxis, angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnoea, pruritus and rash, can occur during therapy (see sections 4.3 and 4.4).
Slovenian: Med zdravljenjem se lahko pojavijo preobčutljivostne reakcije na zdravilo Oncaspar, vključno z življenjsko nevarno anafilaksijo, angioedemom, otekanjem ustnic, otekanjem oči, eritemom, znižanim krvnim tlakom, bronhospazmom, dispnejo, pruritusom in izpuščajem (glejte poglavji 4.3 in 4.4).
English: Disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, and sodium hydroxide and hydrochloric acid (for pH adjustment).
Slovenian: Natrijev fosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev klorid, saharoza ter natrijev hidroksid in klorovodikova kislina (za uravnavanje pH).
English: ALL patients with several relapses were treated either with Oncaspar or with native asparaginase from E. coli as part of an induction therapy.
Slovenian: Z zdravilom Oncaspar ali z nativno asparaginazo iz E. coli so v okviru indukcijske terapije zdravili bolnike z ALL z več recidivi.
English: Further detailed information can be found in the SmPC.
Slovenian: Podrobnejše informacije lahko najdete v povzetku glavnih značilnosti zdravila.
English: The recommended dose in patients with a body surface area (BSA) ≥0.6 m2 and who are ≤21 years of age is 2,500 U of pegaspargase (equivalent to 3.3 ml Oncaspar)/m2 body surface area every 14 days.
Slovenian: ≤ 21 let je 2.500 e. pegaspargaze (ustreza 3,3 ml zdravila Oncaspar)/m² telesne površine vsakih 14 dni.
English: A dose-independent rise in serum transaminases, and serum bilirubin is commonly observed.
Slovenian: Pogosta so zvišanja ravni transaminaz v serumu in zvišanja ravni bilirubina v serumu, ki so neodvisna od odmerka.
English: For intravenous administration, the reconstituted solution should be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
Slovenian: Pri intravenskem dajanju je treba rekonstituirano raztopino razredčiti v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9-%) za injiciranje ali 5% raztopini glukoze.
English: Each pack contains 1 glass vial with 3,750 U pegaspargase.
Slovenian: Eno pakiranje vsebuje 1 stekleno vialo s 3.750 e. pegaspargaze.
English: E. coli Native E. coli L-Asparaginase
Slovenian: Nativna L-asparaginaza iz E. coli
English: In Study AALL07P4, PK parameters after a single 2,500 U/m2 IV dose during Induction were calculated by noncompartmental PK analysis from sequential plasma samples and are depicted in Table 3 (see section 5.1).
Slovenian: V študiji AALL07P4 so bili v analizi farmakokinetike na osnovi zaporednih vzorcev plazme brez upoštevanja kompartmentov izračunani parametri farmakokinetike po enkratnem odmerku 2.500 e./m2
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.
Slovenian: Med zdravljenjem, vključno pri bolnikih z znano preobčutljivostjo za formulacije z asparaginazo iz E. coli, se lahko pojavijo preobčutljivostne reakcije na pegaspargazo, vključno z življenjsko nevarno anafilaksijo.
English: PK Parameters
Slovenian: Farmakokinetični parametri
English: The percentage of patients in the Oncaspar arm with evaluable Low End-Induction MRD (<0.001 detectable disease) at Day 32 was 87.9% (80/91).
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 other ingredients are: disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) (see section 2 “Oncaspar contains sodium”).
Slovenian: Pomožne snovi so: dinatrijev fosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev klorid in saharoza, natrijev hidroksid (za uravnavanje pH), klorovodikova kislina (za uravnavanje pH) (glejte poglavje 2 Zdravilo Oncaspar vsebuje natrij).
English: The diluted solution can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose.
Slovenian: Razredčena raztopina se lahko daje skupaj z infuzijo, ki je že v uporabi, bodisi z natrijevim kloridom 9 mg/ml ali s 5-% glukozo.
English: What Oncaspar contains
Slovenian: Kaj vsebuje zdravilo Oncaspar
English: A temporary suppression in body weight gains and a temporary reduction in total leukocyte counts were observed in dogs which were treated with pegaspargase 1200 U/kg weekly for 2 weeks.
Slovenian: Pri psih, ki so prejemali pegaspargazo 1.200 e./kg enkrat tedensko 2 tedna, so ugotovili začasno supresijo prirasta telesne mase in začasno znižanje skupnega števila levkocitov.
English: One ml of solution contains 750 units pegaspargase .
Slovenian: En ml raztopine vsebuje 750 enot pegaspargaze.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous or intramuscular use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko ali intramuskularno uporabo Pred uporabo preberite priloženo navodilo!
English: A.
Slovenian: C.A.
English: Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase.
Slovenian: Škodljivi učinki na sposobnost razmnoževanja Študije škodljivih učinkov pegaspargaze na sposobnost razmnoževanja niso bile opravljene.
English: First-Line (ALL patients non-hypersensitive to native E. coli L-asparaginase) The safety and efficacy of Oncaspar was evaluated in an open-label, multicentre, randomised, active-controlled study (StudyCCG-1962).
Slovenian: Varnost in učinkovitost zdravila Oncaspar so ocenili v odprti, multicentrični, randomizirani, aktivno kontrolirani študiji (študija CCG-1962).
English: In Study DFCI 11-001, assessments of asparaginase activity were performed following a single IV dose of Oncaspar 2,500 U/m2 BSA during Induction, and every two weeks during post-Induction (see section 5.1).
Slovenian: odmerku zdravila Oncaspar 2.500 e./m2 BSA med indukcijo in vsaka dva tedna po indukciji (glejte poglavje 5.1).
English: If pancreatitis is suspected, Oncaspar should be discontinued; if pancreatitis is confirmed, Oncaspar should not be restarted.
Slovenian: Če obstaja sum na pankreatitis, moramo uporabo zdravila Oncaspar prekiniti.
English: What Oncaspar looks like and contents of the pack Oncaspar is a white to off-white powder.
Slovenian: Zdravilo Oncaspar je bel do umazano bel prašek.
English: How to store Oncaspar
Slovenian: Shranjevanje zdravila Oncaspar
English: * N=47 evaluable subjects.
Slovenian: *n = 47 ocenljivih oseb † Mediana (10., 90. percentil)
English: Since the proteolytic enzymes responsible for Oncaspar metabolism are ubiquitously distributed in tissues the exact role of the liver is unknown: however any decrease in liver function is not expected to present clinical relevant problems in the use of Oncaspar.
Slovenian: natančna vloga jeter ni znana, vendar se ne pričakuje, da zmanjšanje delovanja jeter predstavlja klinično pomembno težavo pri uporabi zdravila Oncaspar.
English: Inflammation of the pancreas, that in some cases caused death, can occur with Oncaspar treatment.
Slovenian: Pri zdravljenju z zdravilom Oncaspar se lahko pojavi vnetje trebušne slinavke, ki je v nekaterih primerih smrtno.
English: Talk to your doctor before you are given Oncaspar.
Slovenian: Preden boste prejeli zdravilo Oncaspar, se posvetujte z zdravnikom.
English: Oncaspar was given IM in a dose of 2,500 U/m² BSA on days 1 and 15 of induction.
Slovenian: v odmerku 2.500 e./m² BSA, intramuskularno na 1. in 15. dan indukcije.
English: Adverse reactions were loss of body weight, piloerection and reduced activity.
Slovenian: piloerekcija in zmanjšana aktivnost.
English: The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose.
Slovenian: Razredčena raztopina se lahko daje v obdobju od 1 do 2 ur, skupaj z infuzijo, ki je že v uporabi, bodisi z natrijevim kloridom 9 mg/ml ali s 5-% glukozo.
English: ALL patients hypersensitive to native E. coli L-asparaginase Six open-label studies evaluated Oncaspar in relapse/refractory haematological diseases.
Slovenian: Šest odprtih študij je vrednotilo zdravilo Oncaspar pri recidivnih/neodzivnih hematoloških boleznih.
English: Cases of accidental overdose have been reported with Oncaspar.
Slovenian: 4.9 Preveliko odmerjanje Poročali so o primerih nenamernega prevelikega odmerjanja zdravila Oncaspar.
English: Ask the pharmacist how to dispose of unused medicines.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več,
English: Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Slovenian: Oncaspar 750 e./ml raztopina za injiciranje/infundiranje pegaspargaza
English: What you need to know before you are given Oncaspar
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Oncaspar Ne uporabljajte zdravila Oncaspar:
English: Do not use if the reconstituted solution is cloudy or if a precipitate has formed.
Slovenian: Zdravila ne uporabljajte, če rekonstituirana raztopina postane motna ali če nastane oborina.
English: The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml (0.9%) solution or 5% glucose.
Slovenian: Razredčena raztopina se lahko daje v obdobju 1 do 2 ur, skupaj z infuzijo, ki je že v uporabi, bodisi z raztopino natrijevega klorida 9 mg/ml (0,9-%) ali s 5-% glukozo.
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Slovenian: Tel: +39 06 669081
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
Slovenian: Klinična učinkovitost in varnost Varnost in učinkovitost zdravila Oncaspar so ocenjevali na podlagi treh kliničnih študij z zdravilom
English: Not known (frequency cannot be estimated from the available data) - Decreased number of white blood cells and platelets; - Palpitations; - Cysts in your pancreas, swelling of the salivary glands; - High levels of urea in your blood; antibodies against Oncaspar; high levels of ammonia in your blood; decreased blood sugar levels; - Sleepiness, confusion, mild twitching of the fingers.
Slovenian: - zmanjšano število belih krvnih celic in trombocitov, - palpitacije, - ciste v trebušni slinavki, otekanje žlez slinavk, - visoka raven sečnine v krvi, protitelesa proti zdravilu Oncaspar,visoka raven amoniaka v krvi,
English: The pharmacodynamic (PD) effect of Oncaspar was assessed after IM (Study CCG-1962) and IV administration (AALL07P4).
Slovenian: V oceni populacijske farmakokinetike zdravila Oncaspar na podlagi podatkov, pridobljenih iz študij AALL07P4 (i.v.
English: Effective non-oral method of contraception must be used during Oncaspar treatment and for at least 6 months after Oncaspar discontinuation.
Slovenian: Kontracepcija Med zdravljenjem z zdravilom Oncaspar in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar je treba uporabljati učinkovito neperoralno metodo kontracepcije.
English: Disodium phosphate heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat monohidrat dinatrijev fosfat heptahidrat natrijev klorid voda za injekcije
English: Very common (may affect more than 1 in 10 people) - Inflammation or other disorders of the pancreas (pancreatitis) causing severe stomach pain which may spread to your back, vomiting, increase in blood sugar levels; - Serious allergic reactions with symptoms such as rash, itching, swelling, hives, shortness of breath, fast heart beat and drop in blood pressure; - Severe infection with very high fever; - Blood clots.
Slovenian: Nemudoma se posvetujte z zdravnikom, če se pri vas pojavi kateri od naslednjih neželenih učinkov: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - vnetje ali druge motnje trebušne slinavke (pankreatitis), ki povzročijo hude trebušne bolečine, ki se lahko razširijo v hrbet, bruhanje, zvišanje ravni sladkorja v krvi;
English: In Study AALL07P4, the PD effect of Oncaspar was assessed in 47 evaluable subjects with high risk B-precursor ALL who received IV doses of Oncaspar 2,500 U/m2 BSA during the Induction and
Slovenian: V študiji AALL07P4 so farmakodinamični učinek zdravila Oncaspar ocenili pri 47 ocenljivih osebah z
English: Event-Free Survival (EFS) for the Oncaspar and native E. coli L-asparaginase arms are summarised in Table 2, Study CCG-1962 was not designed to evaluate differences in EFS rates.
Slovenian: Študija CCG-1962 ni bila zasnovana za ocenjevanje razlik v deležu EFS.
English: Only very high doses of pegaspargase given to mice intraperitoneally as a single dose (25,000100,000 U/kg body weight) caused the death of 14% of all treated mice.
Slovenian: Le zelo visoki odmerki pegaspargaze, dani mišim intraperitonealno v enkratnem odmerku (25.000