natgillin/translations-raw huggingface dataset:
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.
Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Zdravilo Oncaspar se običajno daje kot del kombiniranih protokolov za kemoterapijo skupaj z drugimi citostatiki (glejte tudi poglavje 4.5).
OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if a precipitate has formed, or if the solution is cloudy.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravila ne uporabljajte, če je nastala oborina ali če raztopina postane motna.
This medicine contains less than 1 mmol sodium per dose, i.e., it is essentially ´sodium-free´.
Zdravilo vsebuje manj kot 1 mmol natrija na odmerek, kar v bistvu pomeni, da je „brez natrija“.
If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4).
Če aktivnost asparaginaze ne doseže ciljne vrednosti, se lahko razmisli o prehodu na drugo zdravilo z asparaginazo (glejte poglavje 4.4).
Other side effects Talk to your doctor if you get any of the following:
Drugi neželeni učinki Posvetujte se z zdravnikom, če se pri vas pojavi kaj od naslednjega:
5 ml solution in a vial (type I glass) with stopper (rubber) and a seal (aluminium) with flip-off cap.
5 ml raztopine v viali (steklo vrste I) z zamaškom (guma) in pokrovčkom (aluminij) z zaporko, ki se odtrga na poteg (flip-off).
A total of 166 patients were enrolled in this study; 54 patients were randomised to treatment with 2,500 U/m2 BSA Oncaspar and 111 patients were randomised to the investigational pegylated asparaginase product.
V to študijo je bilo vključenih skupno 166 bolnikov: 54 bolnikov je bilo randomiziranih na zdravljenje z 2.500 enot/m2 BSA zdravila Oncaspar in 111 bolnikov na prejemanje preiskovane pegilirane asparaginaze.
The volume of distribution at steady-state and clearance were estimated at 1.86 L/m2 and 0.169 L/m2 per day, respectively.
Volumen porazdelitve v stanju dinamičnega ravnovesja je bil ocenjen na 1,86 l/m2, očistek pa na 0,169 l/m2 na dan.
Not known (frequency cannot be estimated from the available data) - Severe skin reaction called toxic epidermal necrolysis; - Loss of kidney function (e.g., change in urine output, swelling of feet and ankles); - Stroke.
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): - huda kožna reakcija, imenovana toksična epidermalna nekroliza; - prenehanje delovanja ledvic (npr. spremenjeno izločanje urina, otekanje stopal in gležnjev);
Inhalation of the vapour and contact with the skin and mucous membranes, especially the eyes, must be avoided; if the medicinal product comes in contact with eyes, skin or mucous membranes, rinse immediately with plenty of water for at least 15 minutes.
Preprečite vdihavanje hlapov in stik s kožo in sluznico, zlasti z očmi; če zdravilo pride v stik z očmi, s kožo ali sluznicami, takoj izpirajte z obilo vode vsaj 15 minut.
This can be associated with a marked rise in the serum uric acid level.
To je lahko povezano z izrazitim zvišanjem ravni sečne kisline v serumu.
When Oncaspar is given by intramuscular injection the volume injected at one site should not exceed 2 ml in children and adolescents and 3 ml in adults.
Če zdravilo Oncaspar injiciramo intramuskularno, injicirani volumen na enem mestu ne sme preseči 2 ml pri otrocih in mladostnikih ter 3 ml pri odraslih bolnikih.
CSF asparagine of 2.3 µM pre-treatment fell to 1.1 µM on Day 7 and 0.6 µM on Day 28 of Induction (see Clinical efficacy and safety).
V likvorju je raven asparagina upadla z vrednosti 2,3 μM pred zdravljenjem na 1,1 μM 7. dan oz. na 0,6 μM 28. dan indukcije (glejte poglavje Klinična učinkovitost in varnost).
Pegaspargase can interfere with metabolism and clearance of other medicinal products, based on its effects on protein synthesis and hepatic function, as well as from its combined use with other chemotherapy products known to interact with CYP enzymes.
Pegaspargaza lahko moti presnovo in očistek drugih zdravil, zlasti v jetrih, zaradi njenih učinkov na sintezo beljakovin in delovanje jeter, pa tudi zaradi kombinirane uporabe z drugimi kemoterapevtiki z dokazano interakcijo z encimi CYP.
EXP After reconstitution, the solution should be used immediately.
EXP Po rekonstituciji je treba raztopino takoj uporabiti.
Multiple malformations and embryolethal effects were observed with doses in the therapeutic range.
Pri odmerkih v terapevtskem območju so ugotovili več okvar in embrioletalnih učinkov.
Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar (see section 4.2).
V času dajanja zdravila Oncaspar skozi isto intravensko linijo ne infundirajte drugih zdravil (glejte poglavje 4.2).
During treatment with Oncaspar
Med zdravljenjem z zdravilom Oncaspar
CSF asparagine decreased from a mean pre-treatment concentration of 3.1 µM to 1.7 µM on Day 4 ± 1 and 1.5 µM at 25 ± 1 days after administration of Oncaspar.
Ravni asparagina v likvorju so upadle s povprečne vrednosti pred zdravljenjem 3,1 µM na 1,7 µM po 4 ± 1 dneh in 1,5 µM po 25 ± 1 dneh uporabe zdravila Oncaspar.
Two patients in the Oncaspar arm had allergic reactions during Delayed Intensification (DI) DI #1 (Grade 1 allergic reaction and Grade 3 hives).
Dva bolnika v skupini, ki je prejemala zdravilo Oncaspar, sta imela alergijske reakcije med fazo pozne intenzifikacije (DI - delayed intensification) (alergijska reakcija 1. stopnje in koprivnica 3. stopnje).
Anti-asparaginase antibodies may be associated with low asparaginase activity levels due to potential neutralising activity of these antibodies.
Protitelesa proti asparaginazi so lahko povezana z nizko aktivnostjo asparaginaze zaradi potencialne nevtralizirajoče aktivnosti teh protiteles.
Pharmacokinetic/pharmacodynamic nonclinical comparability between the two pharmaceutical forms of Oncaspar, solution for injection/infusion, and powder for solution, was demonstrated in dogs after single and repeated doses (500 U/kg), by the intravenous route.
Neklinično primerljivost farmakokinetike/farmakodinamike med dvema farmacevtskima oblikama zdravila Oncaspar, in sicer raztopino za injiciranje/infundiranje in praškom za raztopino, so dokazali pri psih po enkratnem odmerku in ponovljenih odmerkih (500 e./kg), danih intravensko.
Blood and urine sugar levels, liver and pancreas function and other tests will be carried out regularly to monitor your health during and after treatment because this medicine can affect your blood and other organs.
Zaradi spremljanja vašega zdravstvenega stanja med zdravljenjem in po njem boste opravljali redne preiskave ravni sladkorja v krvi in urinu, delovanja jeter in trebušne slinavke ter druge preiskave, saj lahko zdravilo vpliva na kri in druge organe.
Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
Zdravilo Oncaspar je indicirano kot sestavina kombiniranega citostatičnega zdravljenja pri akutni limfoblastni levkemiji (ALL) pri pediatričnih bolnikih od rojstva do 18 let in pri odraslih bolnikih.
What Oncaspar contains The active substance is pegaspargase.
Kaj vsebuje zdravilo Oncaspar Učinkovina je pegaspargaza.
- if you ever had blood clots following asparaginase therapy.
- če ste kdaj imeli krvne strdke po zdravljenju z asparaginazo.
Patients received Oncaspar as a single agent or in combination with multi-agent chemotherapy.
Bolniki so prejeli zdravilo Oncaspar kot samostojno zdravilo ali v kombinaciji s polikemoterapijo.
Study DFCI 11-001, conducted by the Dana-Farber Cancer Institute (DFCI), is an ongoing, active-controlled, randomised multicentre study of an intravenous investigational pegylated asparaginase product versus Oncaspar, in children and adolescents aged 1 to <22 years with newly diagnosed ALL treated with a DFCI ALL consortium therapeutic backbone.
Študija DFCI 11-001, ki jo izvaja ustanova Dana-Farber Institute of Cancer (DFCI), je tekoča, aktivno nadzorovana, randomizirana multicentrična študija intravenskega dajanja preiskovanega pegiliranega zdravila z asparaginazo v primerjavi z zdravilom Oncaspar pri otrocih in mladostnikih, starih od 1 do < 22 let, z novo diagnozo ALL, ki se zdravijo v okviru konzorcija DFCI ALL.
Specific antibodies to pegaspargase have been detected; uncommonly they were associated with hypersensitivity reactions.
Zaznali so specifična protitelesa proti pegaspargazi, ki so bila občasno povezana s preobčutljivostnimi reakcijami.
Oncaspar may cause central nervous system signs and symptoms manifesting as somnolence, confusion, convulsions.
Zdravilo Oncaspar lahko povzroči znake in simptome v osrednjem živčnem sistemu, ki se pokažejo kot somnolenca, zmedenost, konvulzije.
- if you suffer from a bleeding disorder or had serious blood clots.
- če imate motnjo strjevanja krvi ali ste kdaj imeli resno stanje zaradi krvnih strdkov;
At 4-years, the EFS and overall survival (OS) for the Oncaspar treatment arm were 81.8% [95% CI 62.9-91.7%] and 90.4% [95% CI 78.5-95.9%], respectively.
Po 4 letih sta bila EFS in celokupno preživetje v skupini, ki je prejemala zdravilo Oncaspar, 81,8 % [95-odstotni IZ 62,9-91,7 %] in 90,4 % [95-odstotni IZ 78,5-95,9 %], v tem zaporedju.
About half of all serious haemorrhages and thromboses affect cerebral vessels and can lead to e.g., stroke, seizure, headache or loss of consciousness.
Približno polovica vseh resnih krvavitev in tromboz vpliva na možganske žile in lahko npr. privede do možganske kapi, epileptičnih napadov, glavobola in izgube zavesti.
Women of childbearing potential/Contraception in males and females Men and women should use effective contraception during treatment and for at least 6 months after Oncaspar discontinuation.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Moški in ženske morajo med zdravljenjem in še najmanj 6 mesecev po prekinitvi zdravljenja z zdravilom Oncaspar uporabljati učinkovito kontracepcijo.
This medicinal product can cause irritation on contact.
Zdravilo lahko povzroči draženje pri stiku.
Long-term investigations of carcinogenicity or studies of the effect on fertility in animals were not conducted with pegaspargase.
Dolgoročne študije karcinogenosti pegaspargaze ali študije njenih učinkov na plodnost pri živalih niso bile opravljene.
Additional monitoring tests
Dodatne preiskave za spremljanje vašega stanja
Type I flint glass vial with chlorobutyl elastomer stopper, capped with a 20 mm aluminium flip-off seal, containing 3,750 U pegaspargase.
Viala iz kremenovega stekla vrste I z zamaškom iz klorobutilnega elastomera, pokrita z 20-mm aluminijasto zaporko, ki se odtrga na poteg (flip-off), ki vsebuje 3.750 e. pegaspargaze.
Patients should be closely monitored and carefully observed for any adverse reactions throughout the administration period (see section 4.4).
Bolnike moramo med dajanjem zdravila skrbno spremljati in natančno opazovati za vse morebitne neželene učinke (glejte poglavje 4.4).
If you are the parent of a child who is being treated with Oncaspar, please tell the doctor if any of them apply to your child.
Če ste eden od staršev otroka, ki se zdravi z zdravilom Oncaspar, obvestite zdravnika, če kaj od navedenega velja zanj.
In Study CCG-1962, PD effect of Oncaspar was assessed through serial measurements of asparagine in serum (n=57) and CSF (n=50) of newly diagnosed paediatric patients with standard-risk ALL who received three intramuscular doses of Oncaspar (2,500 Units/m2 BSA), one each during induction and two during delayed intensification treatment phases.
V študiji CCG-1962 so ocenili farmakodinamični učinek zdravila Oncaspar na osnovi zaporednih meritev asparagina v serumu (n = 57) in likvorju (n = 50) pri pediatričnih bolnikih z novo diagnozo ALL s standardnim tveganjem, ki so prejeli tri intramuskularne odmerke zdravila Oncaspar (2.500 enot/m2 BSA), po eno injekcijo med indukcijo in dvema fazama pozne intenzifikacije zdravljenja.
(CCG-1962) and IV (AALL07P4) provides maintenance of L-asparagine depletion for approximately two weeks following dosing.
(AALL07P4), zagotavlja ohranjanje znižanih ravni L-asparagina približno dva tedna po odmerjanju.
Coagulation parameters should be monitored at baseline and periodically during and after treatment, particularly when other medicinal products with anticoagulant effects are used simultaneously, such as acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (see section 4.5), or when concomitant chemotherapy regimen including methotrexate, daunorubicin, corticosteroids is administered.
Na začetku zdravljenja, redno med zdravljenjem in po njem moramo spremljati koagulacijske parametre, zlasti pri sočasni uporabi drugih zdravil z antikoagulacijskimi učinki, kot so acetilsalicilna kislina in nesteroidna protivnetna zdravila (glejte poglavje 4.5), ali pri sočasni kemoterapevtski shemi, ki vključuje dajanje metotreksata,
PHARMACEUTICAL FORM AND CONTENTS Solution for injection/infusion 1 vial of 5 ml.
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje/infundiranje ena viala po 5 ml
Rare (may affect up to 1 in 1,000 people) - Liver failure.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
The remaining patients were treated with 2,000 or 2,500 U/m2 BSA administered intramuscularly or intravenously.
Druge bolnike so zdravili z 2.000 ali 2.500 enot/m2 BSA intramuskularno ali intravensko.
- prednisone, a steroid medicine.
- prednizon (steroidno zdravilo).
Children with a body surface area <0.6 m2 should receive 82.5 U of pegaspargase (equivalent to 0.1 ml Oncaspar)/kg body weight every 14 days.
Otroci s telesno površino < 0,6 m² morajo prejeti 82,5 e. pegaspargaze (kar ustreza 0,1 ml zdravila Oncaspar)/kg telesne mase vsakih 14 dni.