natgillin/translations-raw huggingface dataset:
Pegaspargase may cause myelosuppression, either directly or indirectly (by altering myelosuppressive effects of other agents such as methotrexate or 6-mercaptopurine). 
Pegaspargaza lahko povzroči mielosupresijo neposredno ali posredno (s spreminjanjem mielosupresivnih učinkov drugih zdravil, kot sta metotreksat in 6-merkaptopurin).
CSF asparagine concentrations were determined in 50 patients during the induction phase. 
Ravni asparagina v likvorju so bile določene pri 50 bolnikih v fazi indukcije.
Figure 1: Mean (± standard error) serum asparagine during Study CCG-1962 induction phase 
Slika 1: Povprečna vrednost (± standardna napaka) serumske ravni asparagina v indukcijski fazi študije CCG-1962
ǂ N= 46 evaluable subjects. 
n = 46 ocenljivih oseb
No statistically significant differences in PK characteristics between male and female subjects were identified in this analysis. 
V tej analizi razlike v farmakokinetičnih značilnostih med moškimi in ženskami niso bile statistično pomembne.
Serum amylase and/or lipase levels should be monitored frequently to identify early signs of pancreatic inflammation. 
Pogosto moramo določati raven amilaze v serumu in/ali lipaze, da prepoznamo zgodnje znake vnetja trebušne slinavke.
Do not drive or use machines when using this medicine because it may make you feel drowsy, tired or confused. 
Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte vozil in strojev, ko uporabljate to zdravilo, saj lahko postanete zaspani, utrujeni ali zmedeni.
Not known: Renal failure acute* 
Neznana: akutna odpoved ledvic*
There are limited data on the use of L-asparaginase and no data on the use of Oncaspar in pregnant women. 
Podatki o uporabi L-asparaginaze pri nosečnicah so omejeni, podatkov o uporabi zdravila Oncaspar pri nosečnicah ni.
There is a dose-independent decrease in serum albumin in the majority of patients during the treatment. 
Pri večini bolnikov se med zdravljenjem pojavi od odmerka neodvisno znižanje ravni albumina v serumu.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1070/002 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1070/002
No reproduction studies in animals with pegaspargase were performed but studies in animals with L-asparaginase have shown teratogenicity (see section 5.3). 
Študije vpliva pegaspargaze na sposobnost razmnoževanja pri živalih niso bile opravljene, vendar so v študijah na živalih z L-asparaginazo ugotovili teratogenost (glejte poglavje 5.3).
Pegaspargase was not mutagenic in the Ames test using Salmonella typhimurium strains. 
Pegaspergaza ni bila mutagena v Amesovem testu s sevi bakterije Salmonella typhimurium.
What Oncaspar is and what it is used for 
Kaj je zdravilo Oncaspar in za kaj ga uporabljamo
Patients were not allowed prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine. 
Bolniki niso smeli imeti predhodne citotoksične kemoterapije z izjemo steroidov in intratekalnega citarabina.
Normal cells, in contrast, are capable of synthesising L-asparagine and are less affected by its rapid depletion during treatment with the enzyme L-asparaginase. 
V nasprotju z njimi so normalne celice sposobne sintetizirati L-asparagin in jih hiter upad ravni L-asparagina med zdravljenjem z encimom L-asparaginazo manj prizadene.
MedDRA standard system organ class 
Organski sistem po standardu MedDRA
An alteration in serum lipid levels was observed and changes in serum lipid values, in most cases without clinical symptoms, are very common. 
Opazili so spremembe ravni serumskih lipidov, ki so v večini primerov brez kliničnih simptomov in zelo pogoste.
Since an indirect interaction between oral contraceptives and pegaspargase cannot be ruled out , oral contraceptives are not considered sufficiently safe in such clinical situation. 
Ker posredne interakcije med peroralnimi kontraceptivi in pegaspargazo ni mogoče izključiti, peroralnih kontraceptivov ne štejemo za dovolj varne v takšni klinični situaciji.
It is strongly recommended that every time Oncaspar is administered to a patient, the name and lot number of the product are recorded in order to link the patient and the lot of the product. 
Zelo priporočljivo je, da vsakič ko bolniku damo zdravilo Oncaspar, zabeležimo ime in številko serije zdravila zaradi sledljivosti bolnika in serije zdravila.
Oncaspar can also cause changes in liver function which can affect the way other medicines work. 
Zdravilo Oncaspar lahko povzroči tudi spremembe v delovanju jeter, ki vplivajo na delovanje drugih zdravil.
Serum asparagine concentrations of approximately 1 µM persisted for approximately 3 weeks. 
Raven asparagina v serumu približno 1 μM je vztrajala približno 3 tedne.
Instructions on how to prepare, store and dispose of Oncaspar Instructions for handling 
Navodila za pripravo, shranjevanje in odstranjevanje zdravila Oncaspar Navodila za ravnanje
In addition, it is especially important to tell your doctor if you are also using any of the following medicines: - immunisation with live vaccines within three months of completing your leukaemia treatment. 
Še zlasti je pomembno, da zdravniku poveste, če uporabljate katero izmed naslednjih zdravil: - živa cepiva v 3 mesecih po zaključku zdravljenja levkemije, saj lahko povečajo tveganje za hudo okužbo;
Patients who receive Oncaspar are at increased risk of bleeding and thrombotic disorders. 
Bolniki, ki prejemajo zdravilo Oncaspar, imajo povečano tveganje za krvavitve in trombotične motnje.
White blood cell (WBC) criteria were: a) Age 1-10 years: WBC ≥50,000/μL; b) Age 10-30 years: Any WBC; c) Prior steroid therapy: Any WBC. 
Kriteriji za levkocite so bili: a) starost 1-10 let: levkociti ≥ 50.000/μl; b) starost 10-30 let: vse ravni levkocitov; c) predhodno zdravljenje s steroidi:
Oncaspar lowers asparagine level in blood cancer cells and stops the cancer cells growing. 
Zdravilo Oncaspar znižuje raven asparagina v rakavih krvnih celicah in ustavi rast raka.
Oral contraception is not an effective method of contraception while on treatment with Oncaspar. 
Peroralna kontracepcija ni učinkovita metoda kontracepcije v času zdravljenja z zdravilom Oncaspar.
During the maintenance phase, 19 patients were evaluated, with 17 patients (89%) achieving complete remission, and 1 patient (5%) with therapeutic efficacy. 
V vzdrževalni fazi so ovrednotili 19 bolnikov, pri čemer je 17 bolnikov (89 %) doseglo popolno remisijo, 1 bolnik (5 %) pa je dosegel terapevtsko učinkovitost.
Oncaspar should be discontinued in patients with serious thrombotic events. 
Zdravljenje z zdravilom Oncaspar moramo prekiniti pri bolnikih z resnimi trombotičnimi dogodki.
Therefore and due to its pharmacological properties, Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase. 
Zdravila Oncaspar zaradi navedenega in farmakoloških lastnosti ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje s pegaspargazo.
Oncaspar should be discontinued in patients with serious hypersensitivity reactions (see sections 4.3 and 4.8). 
Zdravljenje z zdravilom Oncaspar moramo prekiniti pri bolnikih z resnimi preobčutljivostnimi reakcijami (glejte poglavji 4.3 in 4.8).
A total of 239 patients were randomised, 237 of whom were treated with study drug (146 male and 91 female), of these, 119 patients (115 with a diagnosis of ALL) were treated with Oncaspar 2500 U/m2. 
Randomiziranih je bilo skupno 239 bolnikov, od katerih je bilo 237 bolnikov zdravljenih s preiskovanim zdravilom (146 moških in 91 žensk), od teh je bilo 119 bolnikov (115 z diagnozo ALL) zdravljenih z zdravilom Oncaspar 2.500 e./m2.
In addition, by inhibiting protein synthesis and cell division, pegaspargase can disturb the mechanism of action of other substances which require cell division for their effect, e.g., methotrexate. 
Poleg tega lahko pegaspargaza, z inhibicijo sinteze beljakovin in celične delitve, moti mehanizem delovanja drugih učinkovin, ki za svoj učinek potrebujejo celično delitev, kot je npr. metotreksat.
Patients should be advised not to drive or operate machines while receiving Oncaspar if they experience these or other adverse reactions which can impair their ability to drive or operate machines (see section 4.4). 
Bolnikom moramo svetovati, naj med prejemanjem zdravila Oncaspar ne vozijo ali upravljajo strojev, če se pri njih pojavijo zgoraj navedeni ali drugi neželeni učinki, ki lahko ovirajo sposobnost vožnje ali upravljanja strojev (glejte poglavje 4.4).
Patients should be informed of the signs and symptoms of pancreatitis which, if left untreated, could become fatal. 
Bolnike moramo poučiti o znakih in simptomih pankreatitisa, ki je lahko smrten, če ga ne zdravimo.
Embryotoxicity studies with L-asparaginase have given evidence of teratogenic potential in rats treated from day 6 to 15 of gestation with a No Observed Effect Level (NOEL) for teratogenic effects at 300 U/kg intravenous. 
V študijah embriotoksičnosti L-asparaginaze so dokazali teratogeni potencial pri podganah, ki so prejemale učinkovino od 6. do 15. dne gestacije, pri čemer je bila raven brez opaznega teratogenega učinka (NOEL - no observed effect level) 300 e./kg intravensko.
If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours (see section 6.3). 
Če razredčene raztopine ni mogoče uporabiti takoj, jo lahko do 48 ur hranite pri temperaturi 2 °C-8 °C (glejte poglavje 6.3).
Oncaspar is for single use only. 
Zdravilo Oncaspar je samo za enkratno uporabo.
MARKETING AUTHORISATION HOLDER Les Laboratoires Servier 50, rue Carnot 
Imetnik dovoljenja za promet z zdravilom Les Laboratoires Servier 50, rue Carnot
Fatty liver can be observed very frequently. 
Zelo pogosto lahko opazimo zamaščena jetra.
Haemorrhagic or necrotising pancreatitis occurs rarely. 
Hemoragični ali nekrotizirajoči pankreatitis se pojavi redko.
Oncaspar is used to treat acute lymphoblastic leukaemia (ALL) in children from birth to 18 years and adults. 
Zdravilo Oncaspar se uporablja za zdravljenje akutne limfoblastne levkemije (ALL) pri otrocih od rojstva do 18 let in odraslih.
Oncaspar efficacy in ALL in patients with relapse/refractory disease and a history of prior clinical allergic reaction to native E. coli L-asparaginase was based on a pool of 94 patients from six open-label studies [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 and ASP-001C/003C]. 
Učinkovitost zdravila Oncaspar pri ALL pri bolnikih z recidivno/neodzivno boleznijo in anamnezo predhodne klinične alergijske reakcije na nativno L-asparaginazo iz E. coli je temeljila na združeni skupini 94 bolnikov iz šestih odprtih študij [ASP-001, ASP-201A, ASP-302, ASP-304, ASP-400 in ASP-001C/003C].
In the other study, with 29 hypersensitive ALL patients exposed to Oncaspar, 11 patients were evaluated for response during induction. 
V preostali študiji z 29 bolniki z ALL s preobčutljivostjo, ki so bili izpostavljeni zdravilu Oncaspar, so 11 bolnikov ovrednotili glede na odziv med indukcijo.
An indirect interaction cannot be ruled out between pegaspargase and oral contraceptives due to pegaspargase hepatotoxicity that may impair the hepatic clearance of oral contraceptives. 
Ni mogoče izključiti možnosti posredne interakcije med pegaspargazo in peroralnimi kontraceptivi zaradi hepatotoksičnosti pegaspargaze, ki lahko privede do zmanjšanja jetrnega očistka peroralnih kontraceptivov.
If used at the same time as Oncaspar there is an increased risk of side effects or allergic reactions. 
Če se uporabi sočasno z zdravilom Oncaspar, se poveča tveganje za pojav neželenih učinkov ali alergijskih reakcij;
- cytarabine, a medicine which can be used in cancer treatment, and could interfere with the effects of Oncaspar. 
- citarabin, zdravilo, ki se lahko uporablja pri zdravljenju raka in lahko moti učinek zdravila
The below mentioned studies were performed on the solution for injection/infusion formulation. 
Spodaj navedene študije so izvedli z raztopino za injiciranje/infundiranje.
Serum asparagine concentrations during the induction phase are shown in Figure 1. 
Serumske ravni asparagina v fazi indukcije so prikazane na Sliki 1.
Cases of encephalopathy (including reversible posterior leukoencephalopathy syndrome) have been reported (see section 4.8). 
Poročali so o primerih encefalopatije (vključno s sindromom posteriorne reverzibilne levkoencefalopatije) (glejte poglavje 4.8).
For intravenous or intramuscular use. 
za intravensko ali intramuskularno uporabo
Methotrexate and cytarabine can interact differently with Oncaspar: their prior administration can increase the action of pegaspargase synergistically. 
Metotreksat in citarabin lahko povzročita različno medsebojno delovanje z zdravilom Oncaspar: predhodno dajanje lahko sinergistično poveča delovanje pegaspargaze.
Caution is required when Oncaspar is given in combination with hepatotoxic products, especially if there is pre-existing hepatic impairment. 
Previdnost je potrebna, če zdravilo Oncaspar dajemo v kombinaciji s hepatotoksičnimi zdravili, zlasti v primeru obstoječe okvare jeter.
Your doctor will decide what dose of the medicine is needed and how often, based on your age and body surface area which is calculated from your height and weight. 
Na osnovi vaše starosti in telesne površine, ki se izračuna na podlagi vaše telesne višine in mase, bo zdravnik presodil, kakšen odmerek potrebujete in kako pogosto ga morate prejemati.
The PEGylation does not change the enzymatic properties of L-asparaginase, but it influences the pharmacokinetics and immunogenicity of the enzyme. 
PEGilacija ne spremeni encimskih lastnosti L-asparaginaze, temveč vpliva na farmakokinetiko in imunogenost encima.
The symptoms of hyperammonaemia are often transient in nature and can include: nausea, vomiting, headache, dizziness and rash. 
Simptomi hiperamoniemije so pogosto prehodne narave in lahko vključujejo: navzeo, bruhanje, glavobol, omotico in izpuščaj.
- if you suffer abdominal pain. 
- če imate bolečine v trebuhu.
Overall, in the group receiving Oncaspar, the rate of all grade hypersensitivity was 5.8%, anaphylactic reactions was 19.2%, and pancreatitis 7.7%. 
Skupno je bilo v skupini, ki je prejemala zdravilo Oncaspar, stopnja preobčutljivosti vseh stopenj 5,8 %, anafilaktičnih reakcij 19,2 % in pankreatitisa 7,7 %.
Vaccination with live vaccines should therefore be given no earlier than 3 months after termination of the entire antileukaemic treatment. 
Bolnika lahko zato cepimo z živimi oslabljenimi virusnimi cepivi ne prej kot 3 mesece po zaključku celotnega zdravljenja levkemije.
- medicines which reduce the blood´s ability to clot such as anticoagulants (e.g., coumarin/warfarin and heparin), dipyridamol, acetylsalicylic acid or non-steroidal anti-inflammatory medicines (such as ibuprofen or naproxen). 
- zdravila, ki zmanjšujejo strjevanje kri, kot so antikoagulanti (npr. kumarin/varfarin in heparin), dipiridamol, acetilsalicilna kislina ali nesteroidna protivnetna zdravila (kot sta ibuprofen ali naproksen).
Infections and infestations Common: Infections, sepsis 
Pogosti: okužbe, sepsa
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. 
mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če metoda rekonstitucije izključuje tveganje kontaminacije z mikrobi.
A 3-month study in mice with pegaspargase at doses up to 500 U/kg intraperitoneal or intramuscular resulted in slight hepatocellular changes only at the highest intraperitoneal dose. 
V 3-mesečni študiji na miših s pegaspargazo v odmerkih do 500 e./kg intraperitonealno ali intramuskularno so ugotovili rahle hepatocelične spremembe samo pri največjem intraperitonealnem odmerku.
Depending on the severity of the symptoms, administration of antihistamines, corticosteroids and vasopressors may be indicated as counter-measure. 
Kot protiukrep lahko, odvisno od resnosti simptomov, uporabimo antihistaminike, kortikosteroide in vazopresorje.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other antineoplastic agents, ATC code: L01XX24 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX24
In all phases of treatment, serum asparagine concentrations decreased within 4 days of the first dose of asparaginase in the treatment phase and remained low for approximately 3 weeks for both Oncaspar and native E. coli L-asparaginase arms. 
V vseh fazah zdravljenja se je raven asparagina v serumu znižala v 4 dneh po prvem odmerku asparaginaze v fazi zdravljenja in ostala nizka približno 3 tedne, tako pri zdravilu Oncaspar kot nativni L-asparaginazi iz E. coli.
If you are the parent of a child being treated with Oncaspar, tell the doctor if any of the above conditions apply to your child. 
Če ste starši otroka, ki se zdravi z zdravilom Oncaspar, zdravniku povejte, če kar koli od zgoraj navedenega velja za vašega otroka.
Frequencies are defined by the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
(≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
The One-year EFS was 98.0 [95%CI 92.3, 99.5]; the One-year OS was 100 [95% CI 100, 100] in this study. 
V tej študiji sta bila delež EFS po enem letu 98,0 [95-odstotni IZ 92,3, 99,5] in vrednost OS po enem letu 100 [95-odstotni IZ 100, 100].
- if you get a fever. 
- če imate zvišano telesno temperaturo.
Oncaspar should be prescribed and administered by physicians and/or health care personnel experienced in the use of antineoplastic products. 
Zdravilo Oncaspar smejo predpisati in dajati samo zdravniki in/ali zdravstveni delavci, ki imajo izkušnje pri uporabi citostatičnih zdravil.
Consolidation phases. 
- jetrna odpoved.
Inhalation of the vapour and contact with the skin and mucous membranes, especially the eyes, must be avoided. 
Preprečite vdihavanje hlapov in stik s kožo in sluznico, zlasti z očmi.
The solution should be used within 24 hours after reconstitution, when stored below 25°C. 
Raztopino je treba uporabiti v 24 urah po rekonstituciji, če jo hranite pri temperaturi do 25 °C.
In rabbits doses of 50 or 100 U/kg intravenous on days 8 and 9 of gestation induced viable fetuses with congenital malformations: no NOEL has been determined. 
Pri kuncih so odmerki 50 ali 100 e./kg intravensko na 8. in 9. dan gestacije inducirali preživetja zmožne plodove s prirojenimi okvarami: vrednost NOEL ni bila določena.
Oncaspar is to be administered intravenously or intramuscularly after reconstitution of the product. 
Zdravilo Oncaspar je treba dajati intravensko ali intramuskularno po rekonstituciji zdravila.
A 4-week study in rats treated with a dose of pegaspargase of 400 U/kg/day intraperitoneal resulted in a fall in food intake and body weight compared to the control group. 
V 4-tedenski študiji na podganah, zdravljenih z odmerkom pegaspargaze 400 e./kg/dan intraperitonealno, so ugotovili upad količine zaužite hrane in telesne mase v primerjavi s kontrolno skupino.
The plasma elimination half-life of Oncaspar was statistically significantly longer (5.7 days) than the plasma elimination half-lives of the native asparaginases from E. coli (1.3 days) and Erwinia (0.65 days). 
Plazemska razpolovna doba je bila statistično značilno daljša pri zdravilu Oncaspar (5,7 dni) kot pri nativni asparaginazi iz E. coli (1,3 dni) in Erwinia (0,65 dni).
The mechanism of action of L-asparaginase is the enzymatic cleavage of the amino acid L-asparagine into aspartic acid and ammonia. 
Mehanizem delovanja L-asparaginaze je encimska cepitev aminokisline L-asparagina v asparaginsko kislino in amoniak.
Hyperammonaemia 
Hiperamoniemija
Impaired protein synthesis can lead to a decline in the serum proteins. 
Okvarjena sinteza beljakovin lahko privede do znižanja ravni beljakovin v serumu.
Alterations in endocrine pancreatic function are observed commonly and are expressed mainly in the form of abnormal glucose metabolism. 
Bolezni endokrinega sistema Pogoste so spremembe endokrine funkcije trebušne slinavke, ki se izražajo predvsem v obliki nenormalne presnove glukoze.
Parenteral medicinal products should be inspected for particulate matter prior to administration, only a clear, colourless solution free from visible foreign particles should be used. 
Parenteralna zdravila je treba pred dajanjem pregledati glede prisotnosti delcev; uporabite lahko samo bistro, brezbarvno raztopino, ki ne vsebuje vidnih tujih delcev.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium-free'. 
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni, da je „brez natrija“.
The mean plasma half-life of Oncaspar was 8 days in non-hypersensitive patients (AUC 10.35 U/ml/day), and 2.7 days in hypersensitive patients (AUC 3.52 U/ml/day). 
Povprečna plazemska razpolovna doba zdravila Oncaspar je bila 8 dni pri bolnikih brez preobčutljivosti (vrednost AUC 10,35 e./ml/dan) in 2,7 dni pri bolnikih s preobčutljivostjo (AUC 3,52 e./ml/dan).
The impact of renal and hepatic impairment on the PK of Oncaspar has not been evaluated. 
Vpliv ledvične in jetrne okvare na farmakokinetiko zdravila Oncaspar ni bil ocenjen.
In this study, 118 paediatric patients aged 1 to 9 years with previously untreated standard-risk ALL were randomised 1:1 to Oncaspar or native E. coli L-asparaginase as part of combination therapy. 
V tej študiji so 118 pediatričnih bolnikov, starih od 1 do 9 let, s predhodno nezdravljeno ALL s standardnim tveganjem, randomizirali v razmerju 1:1 na prejemanje zdravila Oncaspar ali nativne L-asparaginaze iz E. coli kot del kombinirane terapije.
After the medicinal product has been reconstituted and diluted, the solution should be used immediately. 
Ko je zdravilo rekonstituirano in razredčeno, je treba raztopino takoj uporabiti.
Acute pancreatitis can occur commonly. 
Akutni pankreatitis se lahko pojavi pogosto.
The safety profile is based on randomised, controlled, prospective, open label multicentre studies using Oncaspar at a dose of 2500 U/m2 administered intravenously as a comparative treatment (studies DFCI 11-001 and AALL07P4). 
Varnostni profil temelji na randomiziranih, nadzorovanih, prospektivnih in neslepih multicentričnih študijah zdravila Oncaspar v odmerku 2.500 e./m2, ki so ga dajali intravensko kot primerjalno zdravljenje (študiji DFCI 11-001 in AALL07P4).
Your treatment with Oncaspar has been prescribed by a doctor experienced in medicines used to treat cancer. 
Kako uporabljati zdravilo Oncaspar Zdravljenje z zdravilom Oncaspar je predpisal zdravnik, ki ima izkušnje z zdravili za zdravljenje raka.
Of these, 3 patients (27%) achieved complete remission, 1 patient (9%) had partial remission, 1 patient (9%) had haematologic improvement and 2 patients (18%) had therapeutic efficacy. 
Od teh so 3 bolniki (27 %) dosegli popolno remisijo, 1 bolnik (9 %) je dosegel delno remisijo, 1 bolnik (9 %) je dosegel hematološko izboljšanje in 2 bolnika (18 %) sta dosegla terapevtsko učinkovitost.
In addition, Oncaspar studies using the intramuscular route of administration (studies CCG-1962 and CCG-1991) were also considered to determine the safety profile (see section 5.1). 
Poleg tega sta bili za ugotavljanje varnostnega profila upoštevani študiji zdravila Oncaspar z intramuskularno uporabo (študiji CCG1962 in CCG-1991) (glejte poglavje 5.1).
Administration of Oncaspar before vincristine may increase the neurotoxicity of vincristine. 
Dajanje zdravila Oncaspar pred vinkristinom lahko poveča nevrotoksičnost vinkristina.
What Oncaspar looks like and contents of the pack Oncaspar is a clear, colourless solution for injection contained in a glass vial. 
Izgled zdravila Oncaspar in vsebina pakiranja Zdravilo Oncaspar je bistra, brezbarvna raztopina za injiciranje v stekleni viali.
Therefore, the concomitant use of Oncaspar with oral contraceptives is not recommended. 
Zato sočasna uporaba zdravila Oncaspar s peroralnimi kontraceptivi ni priporočljiva.