FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast to normal cells, lymphoblastic tumour cells have a very limited capacity for synthesising asparagine because of a significantly reduced expression of asparagine synthetase.
Croatian: Nasuprot normalnim stanicama, stanice limfoblastičnog tumora imaju vrlo ograničeni kapacitet za sintetiziranje asparagina zbog značajno smanjene ekspresije asparagin sintetaze.
English: • Other anti-cancer medicines as they may contribute to the release of too much uric acid when tumour cells are destroyed by asparaginase.
Croatian: • Drugi lijekovi protiv raka mogu pridonijeti oslobađanju prevelike količine uratne kiseline kada su tumorske stanice uništene asparaginazom.
English: Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Croatian: Spectrila je indicirana kao komponenta antineoplastične kombinirane terapije za liječenje akutne limfoblastične leukemije (ALL) u pedijatrijskih bolesnika u dobi od rođenja do 18. godine te u odraslih.
English: Hyperammonaemia and sinus vein thrombosis may need to be excluded.
Croatian: Hiperamonijemija i tromboza venskog sinusa možda trebaju biti isključeni.
English: The mean ± SD terminal half-life (elimination half-life) of asparaginase activity in serum was 25.8 ± 9.9 h, with a range between 14.2 and 44.2 h.
Croatian: Srednja vrijednost ± SD terminalnog poluvijeka (poluvijek eliminacije) aktivnosti asparaginaze u serumu bila je 25,8 ± 9,9 h s rasponom između 14,2 i 44,2 h.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekovehttp://www.ema.europa.eu.
English: • Hypersensitivity to the active substance, any native (non-pegylated) E. coli-asparaginase preparation or to any of the excipients listed in section 6.1.
Croatian: • preosjetljivost na djelatnu tvar, bilo koji nativni (nepegilirani) pripravak asparaginaze dobiven iz E. coli ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: After induction treatment, patients continued treatment with chemotherapy regimens which included further treatment with asparaginases.
Croatian: Nakon indukcijskog liječenja bolesnici su nastavili s kemoterapijskim protokolima koji su uključivali daljnje liječenje asparaginazama.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing chemotherapy.
Croatian: Žene reproduktivne dobi / kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju primjenjivati učinkovitu kontracepciju i izbjeći trudnoću dok se liječe kemoterapijom koja sadrži asparaginazu.
English: To dissolve the powder, 3.7 ml of water for injection is carefully squirted against the inner wall of the vial with an injection syringe (do not squirt directly on or into the powder).
Croatian: Da bi se otopio prašak, 3,7 ml vode za injekciju treba pažljivo ištrcati na unutrašnju stijenku bočice štrcaljkom za injekcije (ne štrcajte izravno na prašak).
English: Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity of medicinal products metabolised by the liver or bound to plasma proteins and altered pharmacokinetics and pharmacodynamics of medicines bound to plasma proteins.
Croatian: Asparaginaza može povećati toksičnost drugih lijekova svojim učinkom na funkciju jetre, npr. povećanu hepatotoksičnost primjenom potencijalno hepatotoksičnih lijekova, povećanu toksičnost lijekova koji se metaboliziraju u jetri ili se vežu na proteine plazme te promijenjenu farmakokinetiku i farmakodinamiku lijekova vezanih na proteine u plazmi.
English: Rare Diabetic ketoacidosis
Croatian: Rijetko dijabetička ketoacidoza
English: Laboratory in vitro and in vivo data indicate that the efficacy of high-dose cytarabine is reduced by prior administration of asparaginase.
Croatian: Laboratorijski in vitro i in vivo podaci pokazuju da se djelotvornost visokih doza citarabina smanjuje s prethodnom primjenom asparaginaze.
English: Hypoglycaemia mostly without clinical symptoms has been commonly observed in patients treated with asparaginase.
Croatian: Hipoglikemija, većinom bez kliničkih simptoma, često je opažena u bolesnika liječenih asparaginazom.
English: Difference (95 % CIa)
Croatian: Nije procjenjivo Razlika (95% CI
English: There are no data on the use of asparaginase in pregnant women.
Croatian: Nema podataka o primjeni asparaginaze u trudnica.
English: Expert advice should first be sought.
Croatian: Prije toga treba zatražiti stručni savjet.
English: Asparaginase-associated hyperlipidaemia should be treated depending on its severity and on clinical symptoms.
Croatian: Hiperlipidemiju povezanu s primjenom asparaginaze treba liječiti ovisno o njenoj težini i kliničkim simptomima.
English: Treatment with asparaginase should be discontinued in patients developing acute pancreatitis.
Croatian: Liječenje asparaginazom treba prekinuti u bolesnika koji su razvili akutni pankreatitis.
English: The primary endpoint was the rate of patients with complete asparagine depletion in serum (defined as asparagine serum levels below the lower limit of quantification (< 0.5 µM) at all time points measured from day 12 up to day 33) during induction treatment.
Croatian: Primarni ishod bila je stopa bolesnika s potpunom deplecijom asparagina u serumu (definirano kao serumske razine asparagina ispod donje granice kvantifikacije (< 0,5 µM) u svim vremenskim točkama mjereno od 12. do 33. dana) tijekom indukcijskog liječenja.
English: Symptomatic thromboses related to the use of central venous catheters have been described, too.
Croatian: Opisane su također simptomatske tromboze povezane s upotrebom centralnih venskih katetera.
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 asparaginaze ne uspiju doseći ciljane razine, može se razmotriti prijelaz na neki drugi pripravak asparaginaze (vidjeti dio 4.4).
English: Because of the risk of severe anaphylactic reactions asparaginase should not be administered as a bolus intravenous injection.
Croatian: Zbog rizika od teških anafilaktičkih reakcija, asparaginazu se ne smije primjenjivati kao intravensku bolus injekciju.
English: Symptoms of RPLS essentially include elevated blood pressure, seizures, headaches, changes in mental state and acute visual impairment (primarily cortical blindness or homonymous hemianopsia).
Croatian: Simptomi RPLS-a u osnovi uključuju povišeni krvni tlak, napadaje, glavobolje, promjene mentalnog statusa i akutno oštećenje vida (prvenstveno kortikalna sljepoća ili homonimna hemianopsija).
English: Evidence from published data with asparaginase renders the mutagenic, clastogenic and carcinogenic potential of asparaginase negligible.
Croatian: Prema dokazima na temelju objavljenih podataka za asparaginazu, mutageni, klastogeni i kancerogeni potencijal asparaginaze je zanemariv.
English: The objective of the study was to demonstrate the non-inferiority of Spectrila to the reference E. coli-asparaginase with regard to the primary endpoint.
Croatian: Cilj ispitivanja bio je pokazati neinferiornost Spectrile u odnosu na referentnu asparaginazu dobivenu iz E. coli s obzirom na primarni ishod.
English: On the basis of the scientific conclusions for asparaginase (centrally authorised product) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing asparaginase (centrally authorised product) is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za asparaginazu (lijek odobren centraliziranim postupkom), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) asparaginazu (lijek odobren centraliziranim postupkom) nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4).
Croatian: Glukokortikoidi i/ili antikoagulansi Istovremena primjena glukokortikoida i/ili antikoagulansa s asparaginazom može povećati rizik od promjene u parametrima koagulacije (vidjeti dio 4.4).
English: Complete asparagine depletion in serum Yes
Croatian: Potpuna deplecija asparagina u serumu
English: Contraceptives
Croatian: Kontracepcija
English: Frequent evaluation of coagulation parameters is important before and during asparaginase treatment.
Croatian: Učestala procjena parametara koagulacije važna je prije i tijekom liječenja asparaginazom.
English: • Reversible posterior leukoencephalopathy syndrome (a condition characterised by headache,
Croatian: • sindrom reverzibilne posteriorne leukoencefalopatije (stanje koje obilježavaju glavobolja,
English: The following adverse reactions, listed in table 1, have been accumulated from clinical trials with Spectrila in 125 children with newly diagnosed acute lymphoblastic leukaemia as well as postmarketing experience with other E. coli-derived asparaginase preparations in children and adults.
Croatian: Sljedeće nuspojave, navedene u tablici 1, prikupljene su u kliničkim ispitivanjima Spectrile u 125 djece s novodijagnosticiranom akutnom limfoblastičnom leukemijom te iz iskustva u djece i odraslih s drugim pripravcima asparaginaze dobivene iz E. coli poslije njihova stavljanja na tržište.
English: The primary toxicity of asparaginase results from immunologic reactions caused by exposure to the bacterial protein.
Croatian: Primarna toksičnost asparaginaze rezultat je imunoloških reakcija prouzročenih izloženošću proteinu bakterije.
English: • History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy.
Croatian: • pankreatitis, ozbiljno krvarenje ili ozbiljna tromboza u anamnezi uz prijašnju terapiju asparaginazom.
English: Complete asparagine depletion in CSF Yesc
Croatian: Potpuna deplecija asparagina u CSF-u
English: • allergic reactions including wheezing (bronchospasm) or difficulty in breathing
Croatian: • alergijske reakcije uključujući piskanje pri disanju (bronhospazam) ili otežano disanje
English: Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products.
Croatian: Spectrilu smiju propisivati i primjenjivati samo liječnici i zdravstveno osoblje s iskustvom u primjeni antineoplastičnih lijekova.
English: Hepatic parameters should be monitored when potentially hepatotoxic medicinal products are given concomitantly with asparaginase (see sections 4.4 and 4.8).
Croatian: Parametre funkcije jetre treba pratiti kada se potencijalno hepatotoksični lijekovi primjenjuju istovremeno s asparaginazom (vidjeti dijelove 4.4 i 4.8).
English: After repeated administration of asparaginase at a dose of 5,000 U/m² every third day, trough asparaginase activity levels in serum ranged from 108 to 510 U/l.
Croatian: Nakon ponavljane primjene asparaginaze u dozi od 5000 U/m² svaki treći dan, najniže razine aktivnosti asparaginaze u serumu bile su u rasponu od 108 do 510 U/l.
English: In a clinical trial in children with newly diagnosed ALL (study MC-ASP.5/ALL), the following frequencies of allergic events were observed (table 2).
Croatian: U kliničkom ispitivanju u djece s novodijagnosticiranim ALL-om (ispitivanje MC-ASP.5/ALL), opažene su sljedeće učestalosti alergijskih događaja (tablica 2).
English: Because potential serious adverse reactions may occur in nursing infants, Spectrila should be discontinued during breast-feeding.
Croatian: Zbog mogućih ozbiljnih nuspojava koje se mogu pojaviti u dojenčadi, primjenu Spectrile treba prekinuti u razdoblju dojenja.
English: Simultaneous vaccination with live vaccines may increase the risk of a serious infection.
Croatian: Istovremeno cijepljenje živim cjepivima može povećati rizik od ozbiljne infekcije.
English: Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.
Croatian: Bočica od 20 ml izrađena od bezbojnog stakla (tipa I) zatvorena čepom od butilne gume, nepropusnim zatvaračem od aluminija i plastičnim poklopcem na podizanje (flip-off), koja sadrži 10 000 jedinica asparaginaze.
English: MRD status at end of induction treatment MRD negative
Croatian: MRD status na kraju indukcijskog liječenja
English: No case of asparaginase overdose with clinical symptoms has been reported.
Croatian: Nije zabilježen slučaj predoziranja asparaginazom s kliničkim simptomima.
English: It is unknown whether asparaginase is present in human breast milk.
Croatian: Nije poznato je li asparaginaza prisutna u majčinom mlijeku.
English: • if you have a blood clotting disorder (such as haemophilia),
Croatian: • ako imate poremećaj zgrušavanja krvi (kao što je hemofilija).
English: Pharmacokinetic parameters after administration of 5,000 U/m² of Spectrila were determined in 14 children/adolescents (age 2 - 14 years) with de novo ALL (study MC-ASP.4/ALL).
Croatian: Farmakokinetički parametri nakon primjene 5000 U/m² Spectrile utvrđeni su u 14 djece/adolescenata (u dobi od 2 do 14 godina) s de novo ALL-om (ispitivanje MC-ASP.4/ALL).
English: Median trough serum asparaginase activities were measured in 81 children/adolescents with de novo ALL three days after infusion of asparaginase (just before the next dose had to be given) during induction treatment and ranged from 168 to 184 U/l (study MC-ASP.5/ALL).
Croatian: Medijan najnižih aktivnosti asparaginaze u serumu izmjerene su u 81 djeteta/adolescenta s de novo ALL-om tijekom indukcijskog liječenja, tri dana poslije infuzije asparaginaze (neposredno prije nego što je trebala biti primijenjena sljedeća doza) i kretao se u rasponu od 168 do 184 U/l (ispitivanje MC-ASP.5/ALL).
English: • Medicines that reduce the ability of blood to clot, such as anticoagulants (e.g. warfarin and heparin), dipyridamole, acetylsalicylic acid or medicines to treat pain and inflammation, since using these medicines with asparaginase may increase the risk of bleeding.
Croatian: • Lijekovi koji smanjuju sposobnost zgrušavanja krvi, ko što su antikoagulansi (npr. varfarin i heparin), dipiridamol, acetilsalicilatna kiselina ili lijekovi za liječenje bola i upale, jer primjena tih lijekova s asparaginazom može povećati rizik od krvarenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 10,000 units of asparaginase*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 10 000 jedinica asparaginaze*.
English: Table 2: Frequency of patients with allergic reactions (MC-ASP.5/ALL; Safety analysis set) Treatment group
Croatian: Tablica 2: Učestalost bolesnika s alergijskim reakcijama (ispitivanje MC-ASP.5/ALL; skupina za sigurnosnu analizu)
English: Adverse reactions are ranked under headings of frequency, the most frequent first.
Croatian: Nuspojave su razvrstane po naslovima prema učestalosti, s tim da su najčešće nuspojave navedene prve.
English: Additionally, the urinary pH value and the relative weight of kidneys were increased at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Nadalje, u štakora su pH vrijednost mokraće i relativna težina bubrega bile povišene pri izloženostima koje su se smatrale dovoljno višim od najviše doze izloženosti za ljude, što ukazuje na malu važnost u kliničkoj primjeni.
English: Similarly to adults, the recommended dose in children and adolescents aged 1 - 18 years is 5,000 U per m² BSA given every third day.
Croatian: Slično kao u odraslih, preporučena doza u djece i adolescenata u dobi od 1 do 18 godina iznosi 5000 U po m² tjelesne površine davano svaki treći dan.
English: Hepatic steatosis
Croatian: Nepoznato hepatička steatoza
English: Therefore, Spectrila must not be used during breast-feeding.
Croatian: Iz tog razloga, Spectrila se ne smije primjenjivati u razdoblju dojenja.
English: Patients with severe hypertriglyceridaemia are at increased risk of developing acute pancreatitis.
Croatian: Bolesnici s teškom hipertrigliceridemijom pod povećanim su rizikom od razvoja akutnog pankreatitisa.
English: Median (range)
Croatian: Medijan (raspon)
English: Marketing Authorisation Holder and Manufacturer medac
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač medac
English: Concomitant vaccination with live vaccines increases the risk of serious infection.
Croatian: Istovremeno cijepljenje živim cjepivima povećava rizik od ozbiljne infekcije.
English: Clinical symptoms include abdominal pain, nausea, vomiting and anorexia.
Croatian: Klinički simptomi uključuju bol u abdomenu, mučninu, povraćanje i anoreksiju.
English: • Asparaginase may influence the efficacy of methotrexate or cytarabine (used to treat certain types of cancer): - if asparaginase is given after these agents their effect may be increased.
Croatian: • Asparaginaza može utjecati na djelotvornost metotreksata ili citarabina (koristi se za liječenje određenih vrsta raka): ako se asparaginaza daje poslije tih lijekova, njihov učinak može se povećati ako se asparaginaza daje prije tih lijekova, njihov učinak može biti oslabljen.
English: • Medicines which may have a negative effect on liver function since these negative effects may be worsened by concomitant treatment with asparaginase.
Croatian: • Lijekovi koji mogu imati negativni učinak na funkciju jetre jer se ti negativni učinci mogu pogoršati istovremenim liječenjem asparaginazom.
English: It is strongly recommended that every time Spectrila is administered to a patient, the tradename and batch number of the product should clearly be recorded in order to link the patient and the batch of the product.
Croatian: Strogo se preporučuje pri svakoj primjeni Spectrile u bolesnika jasno zabilježiti naziv i broj serije lijeka kako bi se očuvala poveznica između bolesnika i serije primijenjenog lijeka.
English: Treatment may be monitored based on the trough serum asparaginase activity measured three days after administration of Spectrila.
Croatian: Liječenje se može pratiti na temelju najniže aktivnosti asparaginaze u serumu izmjerene tri dana nakon primjene Spectrile.
English: Spectrila is for administration by intravenous infusion only.
Croatian: Spectrila je namijenjena za primjenu samo intravenskom infuzijom.
English: Expert advice should be sought.
Croatian: Potrebno je zatražiti stručni savjet.
English: In rare cases severe liver impairment has been described, including cholestasis, icterus, hepatic necrosis and hepatic failure with fatal outcome (see sections 4.8 and 4.5).
Croatian: U rijetkim slučajevima opisano je teško oštećenje funkcije jetre, uključujući kolestazu, ikterus, hepatičku nekrozu i zatajenje jetre sa smrtnim ishodom (vidjeti dijelove 4.8 i 4.5).
English: Median (range) serum trough asparaginase activities on days 18, 25, and 33 were 209 (42 - 330) U/l, 130 (6 - 424) U/l, and 32 (1 - 129) U/l, respectively.
Croatian: Medijan (raspon) najnižih aktivnosti asparaginaze u serumu iznosio je 18. dana 209 (42 - 330) U/l, 25. dana 130 (6 - 424) U/l i 33. dana 32 (1 - 129) U/l.
English: In a clinical trial in children with de novo ALL (study MC-ASP.4/ALL) it was shown that immediately after the end of infusion of asparaginase mean asparagine concentrations in serum dropped from the pre-dose concentrations of about 40 µM to below the lower limit of quantification of the bioanalytical method (< 0.5 µM).
Croatian: U kliničkom ispitivanju provedenom u djece s de novo ALL-om (ispitivanje MC-ASP.4/ALL), odmah po završetku infuzije asparaginaze pokazao se pad prosječnih koncentracija asparagina u serumu s koncentracije prije doze od 40 µM na vrijednost ispod donje granice kvantifikacije bioanalitičke metode (< 0,5 µM).
English: Reversible posterior leukoencephalopathy syndrome (characterised by headache, confusion, seizures and visual loss) may require blood-pressure lowering medicines and in case of seizure, anti-epileptic treatment.
Croatian: Sindrom reverzibilne posteriorne leukoencefalopatije (obilježava ga glavobolja, smetenost, napadaji i gubitak vida) može zahtijevati primjenu lijeka za snižavanje krvnog tlaka, a u slučaju napadaja, terapiju protiv epilepsije.
English: Vincristine
Croatian: Vinkristin
English: Chemical and physical in-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Croatian: Kemijska i fizikalna stabilnost lijeka u primjeni dokazana je u trajanju od 2 dana na temperaturi 2 °C - 8 °C.
English: G20210A-variation, methylenetetrahydrofolate reductase [MTHFR] T677T-genotype, increased lipoprotein A, hyperhomocysteinaemia).
Croatian: varijacija gena za protrombin G20210A, metilentetrahidrofolat reduktaza [MTHFR] genotip T677T, povećani lipoprotein A, hiperhomocisteinemija).
English: However, Spectrila should not be used in patients with severe hepatic impairment (see section 4.3).
Croatian: Međutim, Spectrila se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.3).
English: Additionally it may decrease insulin secretion from pancreatic β-cells and impair insulin receptor function.
Croatian: Osim toga, može smanjiti lučenje inzulina iz β-stanica gušterače i narušiti funkciju receptora za inzulin.
English: • hepatotoxicity,
Croatian: • hepatotoksičnost,
English: • Medicines which are metabolised in the liver, because the risk of side effects may increase.
Croatian: • Lijekovi koji se metaboliziraju putem jetre, jer se rizik od nuspojava može povećati.
English: Adverse central nervous system reactions observed in patients treated with asparaginase-containing therapy protocols include changes in EEG, seizures, dizziness, somnolence, coma and headache.
Croatian: Poremećaji živčanog sustava Nuspojave središnjeg živčanog sustava opažene u bolesnika liječenih terapijskim protokolima koji sadrže asparaginazu, uključuju promjene EEG-a, napadaje, omaglicu, somnolenciju, komu i glavobolju.
English: Thrombosis especially cavernous sinus thrombosis or deep vein thrombosis, haemorrhage
Croatian: Često tromboza, posebice tromboza kavernoznog sinusa ili duboka venska tromboza, hemoragija
English: Asparaginase hydrolyses asparagine to aspartic acid and ammonia.
Croatian: Asparaginaza hidrolizira asparagin na aspartatnu kiselinu i amonijak.
English: • blood clotting disorders (bleeding or formation of blood clots),
Croatian: • poremećaji zgrušavanja krvi (krvarenje ili stvaranje krvnih ugrušaka),
English: Nausea/vomiting are very commonly observed in patients treated with asparaginase-containing treatment regimens but are usually mild.
Croatian: Mučnina/povraćanje vrlo često su opažene nuspojave u bolesnika liječenih režimima koji uključuju asparaginazu, ali obično su blage.
English: • Vincristine (used to treat certain types of cancer) since the simultaneous use of vincristine and asparaginase may increase the risk of certain side effects.
Croatian: • Vinkristin (upotrebljava se za liječenje određenih vrsta raka) jer istovremena primjena vinkristina i asparaginaze može povećati rizik od određenih nuspojava.
English: Aggressive alkalinisation of the urine and use of allopurinol can prevent urate nephropathy.
Croatian: Agresivna alkalinizacija urina i primjena alopurinola mogu spriječiti uričnu nefropatiju.
English: Asparaginase must not be administered as a bolus dose.
Croatian: Asparaginaza se ne smije davati kao bolusna doza.
English: Caution is therefore needed when anticoagulants (e.g. coumarin, heparin, dipyridamole, acetylsalicylic acid or nonsteroidal anti-inflammatory medicinal products) or glucocorticoids are given at the same time.
Croatian: Stoga je potreban oprez kada se antikoagulansi (npr. kumarin, heparin, dipiridamol, acetilsalicilatna kiselina ili nesterodini protuupalni lijekovi) ili glukokortikoidi daju u isto vrijeme.