natgillin/translations-raw huggingface dataset:
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.
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.
One vial of 5 ml solution contains 3,750 Units.
Ena viala s 5 ml raztopine vsebuje 3.750 enot.
General disorders and administration side conditions Pyrexia can occur after the injection, which usually subsides spontaneously.
Splošne težave in spremembe na mestu aplikacije Po injiciranju se lahko pojavi zvišana telesna temperatura, ki običajno izzveni spontano.
Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out an accelerated reduction of asparaginase activity.
Da se izključi pospešeno zmanjševanje aktivnosti asparaginaze, se lahko meri aktivnost asparaginaze v serumu ali plazmi.
Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenaemia can occur in patients receiving pegaspargase.
Pri bolnikih, ki prejemajo pegaspargazo, se lahko pojavijo podaljšan protrombinski čas (PČ), podaljšan parcialni tromboplastinski čas (PTČ) in hipofibrinogenemija.
One ml of solution contains 750 Units (U)** of pegaspargase*.
En ml raztopine vsebuje 750 enot (e.)** pegaspargaze*.
Mild hepatotoxicity was observed with the same dosages.
Pri enakih odmerkih so ugotovili blago hepatotoksičnost.
Fertility No studies investigating the effect of pegaspargase on fertility have been performed.
Študije učinka pegaspargaze na plodnost niso bile opravljene.
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
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
* 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
** 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.
A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5).
Ženske v rodni dobi morajo uporabiti drugo metodo kontracepcije, kot pa je peroralna (glejte poglavji 4.4 in 4.5).
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.
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.
Based on results from these two studies, a 2,500 U/m2 BSA dose of Oncaspar administered IM
Na podlagi rezultatov teh dveh študij odmerek zdravila Oncaspar 2.500 e./m2 BSA, ki se daje i.m.
One case of toxic epidermal necrolysis (Lyell‘s syndrome) has been described in association with L-asparaginase.
V povezavi z L-asparaginazo je bil opisan en primer toksične epidermalne nekrolize (Lyellov sindrom).
There have been isolated reports of formation of pseudocysts (up to four months after the last treatment).
(do štiri mesece po zadnjem zdravljenju).
Another method than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.6).
Ženske v rodni dobi morajo zato uporabiti drugo metodo kontracepcije, kot pa je peroralna (glejte poglavji 4.4 in 4.6).
Pegaspargase was well tolerated both in rats and dogs when administered intravenously in single dose up to 500 U/kg body weight.
Pegaspargazo so v enkratnem intravenskem odmerku do 500 e./kg telesne mase dobro prenašale tako podgane kot psi.
As impaired glucose tolerance may occur with concomitant use of Oncaspar with prednisone, blood glucose levels should be monitored.
Pri sočasni uporabi zdravila Oncaspar in prednizona moramo spremljati ravni glukoze v krvi, saj se lahko pojavi motnja tolerance za glukozo.
Very common: Decreased appetite, hyperglycaemia Common: Hyperlipidaemia, hypercholesterolaemia Not known: Diabetic ketoacidosis, hypoglycaemia
Zelo pogosti: zmanjšan apetit, hiperglikemija Pogosti: hiperlipidemija, hiperholesterolemija
Sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, water for injections.
SEZNAM POMOŽNIH SNOVI Natrijev dihidrogenfosfat monohidrat, natrijev fosfat heptahidrat, natrijev klorid, voda za injekcije.
Rare: Hepatic necrosis, jaundice, cholestasis, hepatic failure Immune system disorders Very common: Hypersensitivity, urticaria, anaphylactic reaction Not known: Toxic epidermal necrolysis*
Zelo pogosti: preobčutljivost, urtikarija, anafilaktična reakcija Neznana: toksična epidermalna nekroliza*
In Study CCG-1962, mean asparaginase activity reached peak value of 1 U/mL on Day 5 after the injection.
V študiji CCG-1962 je srednja vrednost aktivnosti asparaginaze dosegla najvišjo vrednost 1 e./ml
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),
zlasti če zdravilo Oncaspar uporabljamo skupaj z nevrotoksičnimi zdravili (kot sta vinkristin in metotreksat, glejte poglavje 4.5).
Do not use Oncaspar: - if you are allergic to pegaspargase or to any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na pegaspargazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste kdaj imeli pankreatitis,
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.
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.
Common: Seizure, peripheral motor neuropathy, syncope Rare: Posterior reversible leukoencephalopathy syndrome Not known: Somnolence, tremor*
Redki: sindrom posteriorne reverzibilne levkoencefalopatije Neznana: somnolenca, tremor*
5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.
Z injekcijsko brizgo in iglo kalibra 21 se injicira 5,2 ml vode za injekcije v vialo.
In case of contact, irrigate with plenty of water for at least 15 minutes.
Ob stiku z očmi, s kožo ali sluznicami, izpirajte z obilo vode vsaj 15 minut.
Table 3: Pharmacokinetic Parameters After a Single IV Dose of Oncaspar 2,500 U/m2 BSA During Induction (N=47; Study AALL07P4)
2.500 e./m2 BSA med indukcijo (n = 47; študija AALL07P4)
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.
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.
BSA during Induction, Consolidation, Delayed Intensification, and Interim Maintenance phases in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Münster therapy.
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.
Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment.
Jetrna okvara Pri bolnikih z jetrno okvaro ni potrebno prilagajanje odmerka.
During Induction (N=47; Study AALL07P4) PK Parameters
dajanju (AALL07P4).
The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, and water for injections (see section 2 “Oncaspar contains sodium”).
Pomožne snovi so: natrijev dihidrogenfosfat monohidrat, dinatrijev fosfat heptahidrat, natrijev klorid in voda za injekcije (glejte poglavje 2 Zdravilo Oncaspar vsebuje natrij).
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.
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.
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.
odmerku zdravila Oncaspar 2.500 e./m2 aktivnost asparaginaze ≥ 0,1 e./ml ohranjena do 18 dni po odmerku pri 95,3 % preiskovancev.
Pancreatitis, including haemorrhagic or necrotising pancreatitis with fatal outcomes, have been reported in patients receiving Oncaspar (see section 4.8).
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).
6925 Guion Road
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One vial of 5 ml solution contains 3750 units of pegaspargase.
Ena viala s 5 ml raztopine vsebuje 3.750 enot pegaspargaze.
Of these,
Eλλάδα
The use of disposable gloves and protective garments is recommended when handling Oncaspar.
Pri delu z zdravilom Oncaspar priporočamo uporabo rokavic in zaščitnih oblačil za enkratno uporabo.
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
*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
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).
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).
Disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, and sodium hydroxide and hydrochloric acid (for pH adjustment).
Natrijev fosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, natrijev klorid, saharoza ter natrijev hidroksid in klorovodikova kislina (za uravnavanje pH).
ALL patients with several relapses were treated either with Oncaspar or with native asparaginase from E. coli as part of an induction therapy.
Z zdravilom Oncaspar ali z nativno asparaginazo iz E. coli so v okviru indukcijske terapije zdravili bolnike z ALL z več recidivi.
Further detailed information can be found in the SmPC.
Podrobnejše informacije lahko najdete v povzetku glavnih značilnosti zdravila.
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.
≤ 21 let je 2.500 e. pegaspargaze (ustreza 3,3 ml zdravila Oncaspar)/m² telesne površine vsakih 14 dni.
A dose-independent rise in serum transaminases, and serum bilirubin is commonly observed.
Pogosta so zvišanja ravni transaminaz v serumu in zvišanja ravni bilirubina v serumu, ki so neodvisna od odmerka.
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.
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.
Each pack contains 1 glass vial with 3,750 U pegaspargase.
Eno pakiranje vsebuje 1 stekleno vialo s 3.750 e. pegaspargaze.
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).
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
Hypersensitivity reactions to pegaspargase, including life-threatening anaphylaxis, can occur during therapy, including in patients with known hypersensitivity to E. coli derived asparaginase formulations.
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.
PK Parameters
Farmakokinetični parametri
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).
Odstotek bolnikov v skupini z zdravilom Oncaspar z negativnim statusom ocenjene minimalne rezidualne bolezni (MRD - Minimal Residual Disease) (< 0,1 % levkemičnih celic v kostnem mozgu) na 29. dan indukcije je bil 80 % (40/50).
The 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”).
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).
The diluted solution can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose.
Razredčena raztopina se lahko daje skupaj z infuzijo, ki je že v uporabi, bodisi z natrijevim kloridom 9 mg/ml ali s 5-% glukozo.
What Oncaspar contains
Kaj vsebuje zdravilo Oncaspar
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.
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.
One ml of solution contains 750 units pegaspargase .
En ml raztopine vsebuje 750 enot pegaspargaze.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous or intramuscular use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko ali intramuskularno uporabo Pred uporabo preberite priloženo navodilo!
Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase.
Škodljivi učinki na sposobnost razmnoževanja Študije škodljivih učinkov pegaspargaze na sposobnost razmnoževanja niso bile opravljene.
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).
Varnost in učinkovitost zdravila Oncaspar so ocenili v odprti, multicentrični, randomizirani, aktivno kontrolirani študiji (študija CCG-1962).
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).
odmerku zdravila Oncaspar 2.500 e./m2 BSA med indukcijo in vsaka dva tedna po indukciji (glejte poglavje 5.1).
If pancreatitis is suspected, Oncaspar should be discontinued; if pancreatitis is confirmed, Oncaspar should not be restarted.
Če obstaja sum na pankreatitis, moramo uporabo zdravila Oncaspar prekiniti.
What Oncaspar looks like and contents of the pack Oncaspar is a white to off-white powder.
Zdravilo Oncaspar je bel do umazano bel prašek.
How to store Oncaspar
Shranjevanje zdravila Oncaspar
* N=47 evaluable subjects.
*n = 47 ocenljivih oseb † Mediana (10., 90. percentil)
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.
natančna vloga jeter ni znana, vendar se ne pričakuje, da zmanjšanje delovanja jeter predstavlja klinično pomembno težavo pri uporabi zdravila Oncaspar.
Inflammation of the pancreas, that in some cases caused death, can occur with Oncaspar treatment.
Pri zdravljenju z zdravilom Oncaspar se lahko pojavi vnetje trebušne slinavke, ki je v nekaterih primerih smrtno.
Talk to your doctor before you are given Oncaspar.
Preden boste prejeli zdravilo Oncaspar, se posvetujte z zdravnikom.
Oncaspar was given IM in a dose of 2,500 U/m² BSA on days 1 and 15 of induction.
v odmerku 2.500 e./m² BSA, intramuskularno na 1. in 15. dan indukcije.
Adverse reactions were loss of body weight, piloerection and reduced activity.
piloerekcija in zmanjšana aktivnost.
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.
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.
ALL patients hypersensitive to native E. coli L-asparaginase Six open-label studies evaluated Oncaspar in relapse/refractory haematological diseases.
Šest odprtih študij je vrednotilo zdravilo Oncaspar pri recidivnih/neodzivnih hematoloških boleznih.
Cases of accidental overdose have been reported with Oncaspar.
4.9 Preveliko odmerjanje Poročali so o primerih nenamernega prevelikega odmerjanja zdravila Oncaspar.
Ask the pharmacist how to dispose of unused medicines.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več,
Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Oncaspar 750 e./ml raztopina za injiciranje/infundiranje pegaspargaza
What you need to know before you are given Oncaspar
Kaj morate vedeti, preden boste uporabili zdravilo Oncaspar Ne uporabljajte zdravila Oncaspar:
Do not use if the reconstituted solution is cloudy or if a precipitate has formed.
Zdravila ne uporabljajte, če rekonstituirana raztopina postane motna ali če nastane oborina.
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.
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.
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
Klinična učinkovitost in varnost Varnost in učinkovitost zdravila Oncaspar so ocenjevali na podlagi treh kliničnih študij z zdravilom
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.
- 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,
The pharmacodynamic (PD) effect of Oncaspar was assessed after IM (Study CCG-1962) and IV administration (AALL07P4).
V oceni populacijske farmakokinetike zdravila Oncaspar na podlagi podatkov, pridobljenih iz študij AALL07P4 (i.v.
Effective non-oral method of contraception must be used during Oncaspar treatment and for at least 6 months after Oncaspar discontinuation.
Kontracepcija Med zdravljenjem z zdravilom Oncaspar in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar je treba uporabljati učinkovito neperoralno metodo kontracepcije.
Disodium phosphate heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat monohidrat dinatrijev fosfat heptahidrat natrijev klorid voda za injekcije
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.
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;
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
V študiji AALL07P4 so farmakodinamični učinek zdravila Oncaspar ocenili pri 47 ocenljivih osebah z
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.
Študija CCG-1962 ni bila zasnovana za ocenjevanje razlik v deležu EFS.
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.
Le zelo visoki odmerki pegaspargaze, dani mišim intraperitonealno v enkratnem odmerku (25.000
The following adverse reactions have been observed in association with asparaginase therapy.
Opis izbranih neželenih učinkov V povezavi z zdravljenjem z asparaginazo so opazili naslednje neželene učinke.
Oncaspar native E. coli L-asparaginase
Nativna L-asparaginaza iz E coli Oncaspar
Musculoskeletal and connective tissue disorders Common: Pain in extremities
Bolezni kože in podkožja Zelo pogosti: izpuščaj Žilne bolezni
Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase
Oncaspar 750 e./ml prašek za raztopino za injiciranje/infundiranje pegaspargaza