FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Common: Hypoxia
Croatian: Često: hipoksija
English: - if you suffer abdominal pain.
Croatian: - ako imate bolove u trbuhu.
English: Pegaspargase was not mutagenic in the Ames test using Salmonella typhimurium strains.
Croatian: Pegaspargaza nije pokazala mutagenost u Amesovom testu u kojem su korišteni sojevi Salmonella typhimurium.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja rekonstituiranog i razrijeđenog lijeka vidjeti dio 6.3.
English: Fatty liver can be observed very frequently.
Croatian: Vrlo često je zabilježena masna jetra.
English: This is important as Oncaspar may increase the side effects of other medicines through its effect on the liver which plays an important role in removing medicines from the body.
Croatian: To je važno jer Oncaspar može povećati nuspojave drugih lijekova svojim učinkom na jetru koja igra važnu ulogu u uklanjanju lijekova iz tijela.
English: Pegaspargase may cause myelosuppression, either directly or indirectly (by altering myelosuppressive effects of other agents such as methotrexate or 6-mercaptopurine).
Croatian: Pegaspargaza može uzrokovati mijelosupresiju, izravno ili posredno (promjenom imunosupresivnih učinaka lijekova kao što su metotreksat ili 6-merkaptopurin).
English: The PEGylation does not change the enzymatic properties of L-asparaginase, but it influences the pharmacokinetics and immunogenicity of the enzyme.
Croatian: PEGilacija ne mijenja enzimatska svojstva L-asparaginaze, no utječe na farmakokinetiku i imunogenost enzima.
English: To monitor the therapeutic effect, the peripheral blood count and the patient's bone marrow should be monitored closely.
Croatian: Kako bi se nadzirao terapijski učinak, potrebno je pomno pratiti perifernu krvnu sliku i koštanu srž bolesnika.
English: If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4).
Croatian: Ako vrijednosti aktivnosti asparaginaze ne dosegnu ciljanu razinu, može se razmotriti prebacivanje na drugi pripravak asparaginaze (vidjeti dio 4.4).
English: Oncaspar should be prescribed and administered by physicians and/or health care personnel experienced in the use of antineoplastic products.
Croatian: Oncaspar trebaju propisivati i primjenjivati liječnici i/ili zdravstveni radnici s iskustvom u primjeni antineoplastičnih lijekova.
English: An alteration in serum lipid levels was observed and changes in serum lipid values, in most cases without clinical symptoms, are very common.
Croatian: Primijećena je promjena serumske razine lipida i vrlo su česte promjene vrijednosti serumskih lipida, u većini slučajeva bez kliničkih simptoma.
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out an accelerated reduction of asparaginase activity.
Croatian: Može se provesti mjerenje razine aktivnosti asparaginaze u serumu ili plazmi kako bi se isključilo ubrzano smanjenje aktivnosti asparaginaze.
English: Long-term investigations of carcinogenicity or studies of the effect on fertility in animals were not conducted with pegaspargase.
Croatian: Dugoročna ispitivanja karcinogenosti ili ispitivanja učinka na plodnost kod životinja nisu provedena s pegaspargazom.
English: During the maintenance phase, 19 patients were evaluated, with 17 patients (89%) achieving complete remission, and 1 patient (5%) with therapeutic efficacy.
Croatian: Tijekom faze održavanja procjenjivano je 19 bolesnika, od kojih je 17 bolesnika (89%) postiglo potpunu remisiju, a 1 bolesnik (5%) terapijsku djelotvornost.
English: Since an indirect interaction between the oral contraceptives and pegaspargase cannot be ruled out, the use of oral contraception is not considered an acceptable method of contraception (see sections 4.5 and 4.6).
Croatian: Budući da se ne može isključiti neizravna interakcija između oralnih kontraceptiva i pegaspargaze, korištenje oralne kontracepcije ne smatra se prihvatljivom metodom kontracepcije (vidjeti dijelove 4.5 i 4.6).
English: CL (L/day)
Croatian: CL (l/dan)
English: In Study CCG-1962, the most common adverse reactions were infections, including two life-threatening infections (1 patient in each arm).
Croatian: Ispitivanju CCG-1962 najčešće nuspojave bile su infekcije, uključujući dvije infekcije opasne po život (1 bolesnik u svakoj skupini).
English: The active substance is pegaspargase.
Croatian: Djelatna tvar je pegaspargaza.
English: Oncaspar may cause central nervous system dysfunctions manifesting as convulsions, and less frequently confusional state and somnolence (mildly impaired consciousness).
Croatian: Oncaspar može uzrokovati disfunkcije središnjeg živčanog sustava koje se manifestiraju kao konvulzije i manje često kao konfuzno stanje i somnolencija (blago smanjena svijest).
English: If you get any side effects you think might be related to your chemotherapy , talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu za koju smatrate da je povezana s kemoterapijom, potrebno je obavijestiti liječnika.
English: It should be explained to patients that Oncaspar should not be used at the same time as other medicines associated with an increased risk of bleeding (see section 2 “Other medicines and Oncaspar”).
Croatian: Bolesnicima treba objasniti da se Oncaspar ne smije primjenjivati istodobno kada i ostali lijekovi povezani s povećanim rizikom od krvarenja (vidjeti dio 2 "Drugi lijekovi i Oncaspar").
English: Administration of Oncaspar before vincristine may increase the neurotoxicity of vincristine.
Croatian: Primjena lijeka Oncaspar prije vinkristina može povećati neurotoksičnost vinkristina.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika, a to uobičajeno nije dulje od 24 sata pri 2 °C-8 °C, osim ako je rekonstitucija/ razrjeđivanje provedeno kontroliranim i validiranim aseptičkim uvjetima.
English: Specific antibodies to pegaspargase have been detected; uncommonly they were associated with hypersensitivity reactions.
Croatian: Otkrivena su specifična protutijela na pegaspargazu; manje često su bila povezana s reakcijama preosjetljivosti.
English: Oncaspar lowers asparagine level in blood cancer cells and stops the cancer cells growing.
Croatian: Oncaspar smanjuje razinu asparagina u krvnim stanicama raka i zaustavlja rast stanica raka.
English: Methotrexate and cytarabine can interact differently with Oncaspar: their prior administration can increase the action of pegaspargase synergistically.
Croatian: Metotreksat i citarabin mogu ulaziti u interakciju s lijekom Oncaspar na različite načine: njihova prethodna primjena može sinergistički povećati djelovanje pegaspargaze.
English: Oncaspar is usually administered as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Croatian: Doziranje Oncaspar se obično primjenjuje kao dio protokola kombinirane kemoterapije s ostalim antineoplastičnim lijekovima (također vidjeti dio 4.5).
English: Simultaneous vaccination with live vaccines may increase the risk of severe infections attributable to the immunosuppressive activity of pegaspargase, the presence of the underlying disease and combination chemotherapy (see section 4.4).
Croatian: Istodobno cijepljenje živim cjepivima može povećati rizik od teških infekcija, što se može pripisati imunosupresivnoj aktivnosti pegaspargaze, prisutnosti podležeće bolesti i kombiniranoj kemoterapiji (vidjeti dio 4.4).
English: During Induction (N=47; Study AALL07P4) PK Parameters
Croatian: BSA tijekom indukcije (N=47; Ispitivanje AALL07P4) PK parametri
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: osim ako metoda rekonstitucije isključuje rizik kontaminacije mikroorganizmima, lijek treba odmah upotrijebiti.
English: Oncaspar should be discontinued in patients with serious thrombotic events.
Croatian: Oncaspar treba prekinuti u bolesnika s ozbiljnim trombotskim događajima.
English: Rare (may affect up to 1 in 1,000 people) - Liver failure.
Croatian: Rijetke (mogu se javiti u manje od 1 na 1000 osoba) - zatajenje jetre.
English: Patients who receive Oncaspar are at increased risk of bleeding and thrombotic disorders.
Croatian: Bolesnici koji primaju Oncaspar imaju povećani rizik od poremećaja zgrušavanja krvi i trombotičkih poremećaja.
English: The volume of distribution at steady-state and clearance were estimated at 1.86 L/m2 and 0.169 L/m2 per day, respectively.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže i klirens procijenjeni su na 1,86 l/m2, odnosno 0,169 l/m2 dnevno.
English: 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.
Croatian: Za razliku od toga, normalne stanice sposobne su sintetizirati L-asparagin i na njih slabije utječe njegovo brzo smanjenje tijekom liječenja enzimom L-asparaginazom.
English: Table 1: Adverse reactions reported with Oncaspar therapy MedDRA standard system organ class
Croatian: Tablica 1: Nuspojave prijavljene uz terapiju lijekom Oncaspar MedDRA standardna klasifikacija organskih sustava
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.
Croatian: Budući da su protelitički enzimi odgovori za metabolizam lijeka Oncaspar široko rasprostranjeni u tkivima, točna uloga jetre nije poznata: međutim, ne očekuje se da će ikakvo smanjenje jetrene funkcije predstavljati klinički relevantne probleme u primjeni lijeka Oncaspar.
English: Although they have not been specifically associated with the use of pegaspargase, they may occur with the use of Oncaspar:
Croatian: Iako nisu specifično povezane s primjenom pegaspargaze, mogu se javiti uz primjenu lijeka Oncaspar:
English: For intramuscular injection, the volume should not exceed 2 ml in children and adolescents and 3 ml in adults.
Croatian: Za intramuskularnu injekciju volumen ne smije prekoračiti 2 ml u djece i adolescenata te 3 ml u odraslih.
English: Serum asparagine concentrations during the induction phase are shown in Figure 1.
Croatian: Serumske koncentracije asparagina tijekom faze indukcije prikazane su na slici 1.
English: Since an indirect interaction between oral contraceptives and pegaspargase cannot be ruled out , oral contraceptives are not considered sufficiently safe in such clinical situation.
Croatian: Budući da se ne može isključiti neizravna interakcija između oralne kontracepcije i pegaspargaze, oralni kontraceptivi ne smatraju se dovoljno sigurnima u takvoj kliničkoj situaciji.
English: 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).
Croatian: Poluvijek eliminacije lijeka Oncaspar iz plazme statistički je značajno duži (5,7 dana) od poluvijekova eliminacije iz plazme nativnih asparaginaza iz E. coli (1,3 dana) i Erwinije (0,65 dana).
English: The Cmax and AUC of Oncaspar trended lower in males, subjects with larger BMI, and subjects >10 years.
Croatian: Cmax i AUC lijeka Oncaspar imali su niže vrijednosti u muškaraca, ispitanika s većim ITM-om i ispitanicima s >10 godina.
English: Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN).
Croatian: Teško oštećenje jetre (bilirubin > 3 puta veći od gornje granice normale [GGN]; transaminaze > 10 puta veće od GGN).
English: The below mentioned studies were performed on the solution for injection/infusion formulation.
Croatian: Ispitivanja navedena u nastavku provedena su za formulaciju otopine za injekciju/infuziju.
English: Oral contraception is not an effective method of contraception while on treatment with Oncaspar.
Croatian: Oralna kontracepcija nije učinkovita metoda kontracepcije tijekom liječenja lijekom Oncaspar.
English: Following overdose, increased liver enzymes, rash and hyperbilirubinaemia have been observed.
Croatian: Nakon predoziranja primijećeni su povišeni jetreni enzimi, osip i hiperbilirubinemija.
English: 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.
Croatian: Oncaspar je indiciran kao dio antineoplastične kombinirane terapije u akutnoj limfoblastičnoj leukemiji (ALL) u pedijatrijskih bolesnika od rođenja do 18 godina, i u odraslih bolesnika.
English: - if you suffer from a bleeding disorder or had serious blood clots.
Croatian: - ako bolujete od poremećaja zgrušavanja krvi ili ste imali ozbiljne ugruške krvi - ako dobijete vrućicu.
English: Men must also use effective contraception while they or their partners are treated with Oncaspar.
Croatian: Muškarci također trebaju koristiti učinkovitu kontracepciju dok se liječe lijekom Oncaspar ili dok se njihove partnerice liječe lijekom Oncaspar.
English: Depending on the severity of the symptoms, administration of antihistamines, corticosteroids and vasopressors may be indicated as counter-measure.
Croatian: Ovisno o težini simptoma, kao protumjera može biti indicirana primjena antihistaminika, kortikosteroida i vazopresora.
English: The patterns of serum asparagine depletion in the 2 delayed intensification phases are similar to the pattern of serum asparagine depletion in the induction phase.
Croatian: Uzorci pada razine serumskog asparagina u dvije faze kasne intenzifikacije slične su uzroku pada razine serumskog asparagina u fazi indukcije.
English: Cases of encephalopathy (including reversible posterior leukoencephalopathy syndrome) have been reported (see section 4.8).
Croatian: Prijavljeni su slučajevi encefalopatije (uključujući sindrom reverzibilne posteriorne leukoencefalopatije) (vidjeti dio 4.8).
English: Arithmetic Mean (SD)
Croatian: Aritmetička srednja vrijednost (SD)
English: Reproductive toxicity No studies of reproductive toxicity were conducted with pegaspargase.
Croatian: Reproduktivna toksičnost Nisu provedena ispitivanja reproduktivne toksičnosti s pegaspargazom.
English: When glucocorticoids (e.g., prednisone) and pegaspargase are given at the same time, alterations in coagulation parameters (e.g., fall in fibrinogen and antithrombin III deficiency, ATIII) can be more pronounced.
Croatian: Kada se istodobno daju glukokortikoidi (npr., prednizon) i pegaspargaza, moguće su izraženije promjene u parametrima koagulacije (npr., pad fibrinogena i nedostatak antitrombina III, ATIII).
English: The protocol-specified goal was achievement of asparagine depletion to a serum concentration of ≤1 µM.
Croatian: Cilj specifičan za ovaj plan ispitivanja bio je postizanje pada razine asparagina do serumske koncentracije ≤1 µM.
English: Vaccination with live vaccines should therefore be given no earlier than 3 months after termination of the entire antileukaemic treatment.
Croatian: Stoga se cijepljenje živim cjepivima ne smije primjenjivati prije nego prođu 3 mjeseca nakon prekida ukupnog antileukemijskog liječenja.
English: The immediate cell death of leukaemic cells in vivo, measured by rhodamine fluorescence, was the same for all three L-asparaginase preparations.
Croatian: Neposredna stanična smrt leukemijskih stanica in vivo, izmjerena fluorescencijom rodamina, bila je ista za sva tri pripravka koji sadrže L-asparaginazu.
English: 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.
Croatian: Četverotjedno ispitivanje u štakora liječenih dozom pegaspargaze od 400 U/kg/dan intraperitonealno rezultiralo je padom unosa hrane i tjelesne težine u usporedbi s kontrolnom skupinom.
English: Other medicines and Oncaspar Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako koristite, nedavno ste koristili ili biste mogli koristiti bilo koje druge lijekove.
English: 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.
Croatian: Ne može se isključiti neizravna interakcija između pegaspargaze i oralnih kontraceptiva zbog hepatotoksičnosti pegaspargaze koja može smanjiti hepatički klirens oralnih kontraceptiva.
English: 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.
Croatian: Randomizirano je ukupno 239 bolesnika, od toga je 237 liječeno ispitivanim lijekom (146 muškog i 91 ženskog spola), od toga, 119 bolesnika (115 s dijagnozom ALL-a) liječeno je lijekom Oncaspar 2500 U/m2.
English: 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.
Croatian: Kada se Oncaspar daje intramuskularnom injekcijom, volumen injiciran na jednom mjestu ne smije premašiti 2 ml kod djece i adolescenata, odnosno 3 ml kod odraslih osoba.
English: Instructions for handling
Croatian: Upute za rukovanje
English: MedDRA standard system organ class
Croatian: MedDRA standardna klasifikacija organskih sustava
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.
Croatian: Privremeno smanjenje povećanja tjelesne težine i privremeno smanjenje ukupnog broja leukocita primijećeno je u pasa koji su tretirani s pegaspargazom od 1200 U/kg tjedno tijekom 2 tjedna.
English: 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.
Croatian: Osim toga, inhibicijom sinteze proteina i diobe stanica, pegaspargaza može ometati mehanizam djelovanja drugih tvari kojima je potrebna dioba stanica da bi bile učinkovite, npr., metotreksat.
English: Oncaspar can cause mild to moderate myelosuppression, and all three blood cell lines can be affected.
Croatian: Oncaspar može uzrokovati blagu do umjerenu mijelosupresiju i može utjecati na sve tri linije krvnih stanica.
English: Haemorrhagic or necrotising pancreatitis occurs rarely.
Croatian: Hemoragijski i nekrotizirajući pankreatitis pojavljuje se rijetko.
English: 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.
Croatian: Tromjesečno ispitivanje pegaspargaze u dozama do 500 U/kg intraperitonealno ili intramuskularno u miševa rezultiralo je blažim hepatocelularnim promjenama samo pri najvećoj intraperitonealnoj dozi.
English: Ask the pharmacist how to dispose of unused medicines.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: Patients should be closely monitored and carefully observed for any adverse reactions throughout the administration period (see section 4.4).
Croatian: Bolesnike je potrebno pomno pratiti i pažljivo promatrati kako bi se uočila pojava bilo koje nuspojave tijekom razdoblja primjene (vidjeti dio 4.4).
English: Alterations in endocrine pancreatic function are observed commonly and are expressed mainly in the form of abnormal glucose metabolism.
Croatian: Promjene endokrine funkcije gušterače često se primjećuju i pokazuju se uglavnom u obliku abnormalnog metabolizma glukoze.
English: Oncaspar is to be administered intravenously or intramuscularly after reconstitution of the product.
Croatian: Oncaspar se primjenjuje intravenski ili intramuskularno nakon rekonstitucije lijeka.
English: 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).
Croatian: Bolesnicima treba savjetovati da ne upravljaju vozilima niti ne rade sa strojevima tijekom uzimanja lijeka Oncaspar ako osjećaju te ili druge nuspojave koje mogu smanjiti njihovu sposobnost upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.4).
English: A rise in serum urea occurs regularly, is dose-independent and nearly always a sign of pre-renal metabolic imbalance.
Croatian: Redovito dolazi do povećanja ureje u serumu, neovisno o dozi, što je gotovo uvijek pokazatelj prerenalne metaboličke neravnoteže.
English: Both diabetic ketoacidosis and hyperosmolar hyperglycaemia have been described, which generally respond to administration of insulin.
Croatian: Opisane su i dijabetička ketoacidoza i hiperosmolarna hiperglikemija, koje većinom reagiraju na primjenu inzulina.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3,750 U
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3750 U
English: 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.
Croatian: Pegaspargaza može ometati metabolizam i klirens ostalih lijekova, što se je utemeljeno na njenim učincima na sintezu proteina i funkciju jetre, kao i na istodobnoj primjeni s ostalim lijekovima za kemoterapiju za koje je poznato da ulaze u interakciju s CYP enzimima.
English: Pegaspargase was well tolerated both in rats and dogs when administered intravenously in single dose up to 500 U/kg body weight.
Croatian: Pegaspargaza se dobro podnosila u štakora i pasa kada je primjenjivana intravenski u jednoj dozi do 500 U/kg tjelesne težine.
English: Patients should be informed about possible hypersensitivity reactions to Oncaspar, including immediate anaphylaxis.
Croatian: Bolesnike treba informirati o mogućim reakcijama preosjetljivosti na Oncaspar, uključujući trenutnu anafilaksiju.
English: - cytarabine, a medicine which can be used in cancer treatment, and could interfere with the effects of Oncaspar.
Croatian: - citarabin, lijek koji se može primjenjivati u liječenju raka i može utjecati na učinke lijeka
English: The following adverse reactions have been reported in patients treated with Oncaspar along with other chemotherapy medicinal products: somnolence, confusion, dizziness, syncope, seizure.
Croatian: Sljedeće nuspojave prijavljene su u bolesnika liječenih lijekom Oncaspar uz ostale lijekove za kemoterapiju: somnolencija, konfuzija, omaglica, sinkopa, napadaj.
English: Figure 1: Mean (± standard error) serum asparagine during Study CCG-1962 induction phase
Croatian: Slika 1: Srednja vrijednost (± standardna pogreška) razine serumskog asparagina tijekom faze indukcije u Ispitivanju CCG-1962