FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment.
Croatian: Nije potrebno prilagođavanje doze u bolesnika s oštećenjem jetre.
English: After reconstitution, the solution should be clear, colourless and free from visible foreign particles.
Croatian: Nakon rekonstitucije, otopina treba biti bistra, bezbojna i bez vidljivih čestica.
English: The most common adverse reactions with Oncaspar (observed in at least 2 studies with a frequency of >10%) included: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, activated partial thromboplastin time prolonged, hypertriglyceridaemia, hyperglycaemia, and febrile neutropenia.
Croatian: Najčešće nuspojave s lijekom Oncaspar (uočene u barem 2 ispitivanja s učestalošću od >10%) uključivale su: povišenu alanin aminotransferazu, povišenu aspartat aminotransferazu, povišen bilirubin u krvi, produljeno aktivirano parcijalno tromboplastinsko vrijeme, hipertrigliceridemiju, hiperglikemiju i febrilnu neutropeniju.
English: Adverse reactions and their frequencies are reported in Table 1.
Croatian: Nuspojave i njihove učestalosti prikazane su u Tablici 1.
English: The powder must therefore be handled and administered with particular caution.
Croatian: Praškom se stoga mora naročito oprezno rukovati i primjenjivati ga.
English: As a precautionary measure, breast-feeding should be discontinued during treatment with Oncaspar and should not be re-started until after treatment with Oncaspar has been discontinued.
Croatian: Kao mjeru opreza, dojenje treba prekinuti tijekom liječenja lijekom Oncaspar i ne bi se smjelo ponovno započeti do prekida liječenja lijekom
English: History of serious haemorrhagic events with prior L-asparaginase therapy (see section 4.4).
Croatian: Anamneza ozbiljnih događaja krvarenja kod prethodne terapije L-asparaginazom (vidjeti dio 4.4).
English: Tél/Tel: +32 (0)2 529 43 11
Croatian: Tel: +32 (0)2 529 43 11
English: Oncaspar was given IM in a dose of 2,500 U/m² BSA on days 1 and 15 of induction.
Croatian: Oncaspar je primjenjivan u IM dozi od 2500 U/m² BSA 1. i 15. dana indukcije.
English: Common: Seizure, peripheral motor neuropathy, syncope Rare: Posterior reversible leukoencephalopathy syndrome Not known: Somnolence, tremor*
Croatian: Rijetko: sindrom reverzibilne posteriorne leukoencefalopatije Nepoznato: somnolencija, tremor*
English: ALL patients; Study AALL07P4 in high risk ALL patients; Study DFCI 11-001 enrolled both standard and high-risk ALL patients.
Croatian: na bolesnicima s ALL-om standardnog rizika, Ispitivanje AALL07P4 na bolesnicima s ALL-om visokog rizika; Ispitivanje DFCI 11-001 uključivalo je bolesnike s ALL-om standardnog i ALL-om visokog rizika.
English: Rare (may affect up to 1 in 1,000 people) - Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome characterised by headache, confusion, seizures and visual loss which resolves after some time.
Croatian: Rijetke (mogu se javiti u manje od 1 na 1000 osoba) - sindrom reverzibilne posteriorne leukoencefalopatije, sindrom koji karakteriziraju glavobolja,
English: PHARMACEUTICAL FORM Solution for injection/infusion.
Croatian: OBLIK Otopina za injekciju/infuziju.
English: Very common (may affect more than 1 in 10 people) - Inflammation or other disorders of the pancreas (pancreatitis) causing severe stomach pain which may spread to your back, vomiting, increase in blood sugar levels; - Serious allergic reactions with symptoms such as rash, itching, swelling, hives, shortness of breath, fast heart beat and drop in blood pressure; - Severe infection with very high fever; - Blood clots.
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) - upala ili ostali poremećaji gušterače (pankreatitis) koji uzrokuju jaku bol u trbuhu koja se može proširiti na leđa, povraćanje, povećane razine šećera u krvi; - ozbiljne alergijske reakcije sa simptomima kao što su osip, svrbež, oticanje, koprivnjača,
English: Do not use if the reconstituted solution is cloudy or if a precipitate has formed.
Croatian: Nemojte upotrijebiti ako je rekonstituirana otopina mutna ili ako se stvorio talog.
English: Combination therapy with Oncaspar and other hepatotoxic products can result in severe hepatic toxicity.
Croatian: Kombinirano liječenje uz Oncaspar i hepatotoksične lijekove može prouzročiti tešku toksičnost jetre.
English: For intravenous administration, the reconstituted solution should be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
Croatian: Za intravensku primjenu, rekonstituiranu otopinu treba razrijediti u 100 ml otopine natrijeva klorida od 9 mg/ml (0,9%) za injekciju ili 5%-tne otopine glukoze.
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Croatian: Tel: +39 (06) 669081
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1070/001
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1070/001
English: No immunogenic response was detected in a 12-week study in mice in which pegaspargase was administered weekly at the dose of 10.5 U/mouse intramuscular or intraperitoneally.
Croatian: U 12-tjednom ispitivanju na miševima u kojih je pegaspargaza primjenjivana jednom tjedno u dozi od 10,5 U po mišu intramuskularno ili intraperitonealno, nije otkriven imunogeni odgovor.
English: Powder for solution for injection/infusion.
Croatian: OBLIK Prašak za otopinu za injekciju/infuziju.
English: One vial of 5 ml solution contains 3,750 Units.
Croatian: Jedna bočica od 5 ml otopine sadrži 3750 jedinica.
English: 7-Year EFS Rate, % (95% CI)
Croatian: Stopa EFS-a u 7. godini, % (95% CI)
English: Sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, sodium chloride, water for injections.
Croatian: Natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, voda za injekcije.
English: BSA during Induction, Consolidation, Delayed Intensification, and Interim Maintenance phases in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Münster therapy.
Croatian: Oncaspar je primijenjen intravenski u dozi od 2500 jedinica/m2 BSA tijekom faza indukcije, konsolidacije, kasne intenzifikacije i međuodržavanja u bolesnika oboljelih od ALL-a visokog rizika koji su primali augumentiranu terapiju Berlin-Frankfurt-Munster.
English: History of serious thrombosis with prior L-asparaginase therapy.
Croatian: Anamneza ozbiljne tromboze kod prethodne terapije L-asparaginazom.
English: This medicine contains less than 1 mmol sodium per dose, i.e., it is essentially ´sodium-free´.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija po dozi, tj., zanemarive količine natrija.
English: As a routine precautionary measure the patient should be monitored for an hour after administration; resuscitation equipment and other appropriate means for the treatment of anaphylaxis should be available (epinephrine, oxygen, intravenous steroids, etc.).
Croatian: Bolesnika treba u sklopu rutinske mjere opreza nadzirati sat vremena nakon primjene uz dostupnu opremu za oživljavanje i ostala odgovarajuća sredstva za liječenje anafilaksije (adrenalin, kisik,
English: Further detailed information can be found in the SmPC.
Croatian: Dodatne detaljne informacije mogu se pronaći u Sažetku opisa svojstava lijeka.
English: Name and address of the manufacturer of the biological active substance Exelead, Inc.
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: Oncaspar was administered intramuscularly at a dose of 2,500 Units/m2 BSA on Day 3 of the 4-week Induction phase and on Day 3 of each of two 8-week
Croatian: Oncaspar je primijenjen intramuskularno pri dozi od 2500 U/m2 BSA 3. dana četverotjedne faze indukcije i 3. dan svake od dvije osmotjedne faze kasne intenzifikacije.
English: Very common: Weight decreased, hypoalbuminaemia, alanine aminotransferase increased, aspartate aminotransferase increased, hypertriglyceridaemia, blood fibrinogen decreased, lipase increased, amylase increased, activated partial thromboplastin time prolonged, blood bilirubin increased
Croatian: Vrlo često: smanjenje tjelesne težine, hipoalbuminemija, povišena alanin aminotransferaza, povišena aspartat aminotransferaza, hipertrigliceridemija, smanjen fibrinogen u krvi, povišena lipaza, povišena amilaza, produljeno aktivirano parcijalno tromboplastinsko vrijeme, povišen bilirubin u krvi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1070/002
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1070/002
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other antineoplastic agents, ATC code: L01XX24
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Antineoplastici i imunomodulirajući lijekovi, ostala antineoplastici, ATK
English: - medicines which require cell division for their effect, for example, methotrexate (a medicine used for cancer as well as arthritis treatment) may have a decrease in its effect.
Croatian: Ako se koriste istodobno kada i Oncaspar, postoji veći rizik od poremećaja zgrušavanja krvi. - lijekovi kojima je potrebna dioba stanica za njihov učinak, primjerice, metotreksat (lijek koji se primjenjuje za rak, ali i za liječenje artritisa) može imati smanjeni učinak. - prednizon, steroidni lijek.
English: The other ingredients are: disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) (see section 2 “Oncaspar contains sodium”).
Croatian: Drugi sastojci su: natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat hidrat, natrijev klorid, saharoza, natrijev hidroksid (za prilagodbu pH), kloridna kiselina (za prilagodbu pH) (vidjeti dio 2 "Oncaspar sadrži natrij").
English: Intravenous infusion of Oncaspar is usually given over a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
Croatian: Intravenska infuzija lijeka Oncaspar obično se daje tijekom razdoblja od 1 do 2 sata u 100 ml otopine za injekciju natrijeva klorida od 9 mg/ml (0,9%) ili u 5%-tnoj otopini glukoze.
English: Hepatic effects Combination therapy with Oncaspar and hepatotoxic products can result in severe hepatic toxicity.
Croatian: Učinci na jetru Kombinirano liječenje uz Oncaspar i druge hepatotoksične lijekove može prouzročiti tešku toksičnost jetre.
English: 5-Year EFS Rate, % (95% CI)
Croatian: Stopa EFS-a u 5. godini, % (95% CI)
English: 5.3 Preclinical safety data
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Akutna toksičnost
English: Very common: Embolism** Common: Thrombosis*** Not known: Cerebrovascular accident, haemorrhage, superior sagittal sinus thrombosis *Adverse reactions observed with other asparaginases in the class **Cases of pulmonary embolism, venous thrombosis, venous thrombosis limb, and thrombophlebitis superficial were observed in DFCI 11-001 ***Legend: CNS thrombosis
Croatian: Nepoznato: cerebrovaskularni inzult, krvarenje, tromboza gornjeg sagitalnog sinusa *Nuspojave opažene s drugim asparaginazama u skupini **Slučajevi plućne embolije, venske tromboze, venske tromboze u udovima i površinski tromboflebitis uočeni su u ispitivanju DFCI 11-001
English: A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5).
Croatian: Kod žena u reproduktivnoj dobi treba primjenjivati drugu metodu koja nije oralna kontracepcija (vidjeti dijelove 4.4 i 4.5).
English: Very common: Pancreatitis, diarrhoea, abdominal pain, nausea Common: Vomiting, stomatitis, ascites Rare: Pancreatitis necrotising, pancreatitis haemorrhagic Not known: Pancreatic pseudocyst, parotitis*
Croatian: Vrlo često: pankreatitis, proljev, bol u abdomenu, mučnina Često: povraćanje, stomatitis, ascites Rijetko: nekrotizirajući pankreatitis, hemoragijski pankreatitis
English: One patient received Oncaspar doses of 250 and 500 Units/m2 BSA intravenously.
Croatian: Jedan bolesnik primio je doze lijeka Oncaspar od 250 i 500 jedinica/m2 BSA
English: One ml of solution contains 750 Units (U)** of pegaspargase*.
Croatian: Jedan ml otopine sadrži 750 jedinica (U)** pegaspargaze*.
English: Hypersensitivity reactions to Oncaspar, including life-threatening anaphylaxis, angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnoea, pruritus and rash, can occur during therapy (see sections 4.3 and 4.4).
Croatian: Reakcije prosjetljivosti na Oncaspar, uključujući životno ugrožavajuću anafilaksu, angioedem, oticanje usana, oticinja očiju, eritem, sniženje krvnog tlaka, bronhospazam, dispneja, svrbež i osip, mogu se javiti tijekom liječenja (vidjeti dijelove 4.3 i 4.4).
English: Very common (may affect more than 1 in 10 people) - Changes in the function of the pancreas; - Weight loss; - Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism); - Loss of appetite, general weakness, vomiting, diarrhoea, nausea; - Increased blood sugar levels.
Croatian: - gubitak tjelesne težine; - bol u nogama (koji može biti simptom tromboze), bolovi u prsima ili nedostatak zraka (što može biti simptom krvnih ugrušaka u plućima, što se naziva plućna embolija); - gubitak apetita, opća slabost, povraćanje, proljev, mučnina; - povišena razina šećera u krvi.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Oncaspar Lijek čuvajte izvan pogleda i dohvata djece.
English: In Study AALL07P4, the PD effect of Oncaspar was assessed in 47 evaluable subjects with high risk B-precursor ALL who received IV doses of Oncaspar 2,500 U/m2 BSA during the Induction and
Croatian: Ispitivanju AALL07P4, PD učinak lijeka Oncaspar ocijenjen je u 47 ocjenjivih ispitanika s ALL-om prekursora B-limfocita visokog rizika koji su primili i.v. dozu lijeka Oncaspar od 2500 U/m2 BSA
English: Disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, and sodium hydroxide and hydrochloric acid (for pH adjustment).
Croatian: Natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat hidrat, natrijev klorid, saharoza i natrijev hidroksid i kloridna kiselina (za prilagodbu pH).
English: - if you get a fever.
Croatian: - teška infekcija s vrlo visokom vrućicom;
English: How Oncaspar is given
Croatian: Kako se primjenjuje Oncaspar
English: s r.o.
Croatian: C.A.
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 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
English: - 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).
Croatian: Ako se koristi istodobno kada i Oncaspar, postoji povećani rizik od nuspojava ili alergijskih reakcija. - lijekovi koji smanjuju sposobnost zgrušavanja krvi, primjerice antikoagulansi (npr., kumarin/varfarin i heparin), dipiridamol, acetilsalicilatna kiselina ili nesteroidni protuupalni lijekovi (kao što su ibuprofen ili naproksen).
English: After the medicinal product has been diluted, the solution should be used immediately.
Croatian: Nakon razrjeđivanja lijeka, otopinu treba odmah primijeniti.
English: international normalised ratio increased, hypokalaemia, blood cholesterol increased, hypofibrinogenaemia, gamma-glutamyl transferase increased Not known: Blood urea increased, anti-pegaspargase antibodies, neutrophil count decreased, platelet count decreased, hyperammonaemia
Croatian: Često: produljeno protrombinsko vrijeme, povišen međunarodni normalizirani omjer, hipokalijemija, povišen kolesterol u krvi, hipofibrinogenemija, povišena gama-glutamiltransferaza Nepoznato: povišena ureja u krvi, protutijela na pegaspargazu, smanjen broj neutrofila, smanjen broj trombocita, hiperamonemija
English: Each vial contains 3,750 Units (U)** of pegaspargase*.
Croatian: Jedna bočica sadrži 3750 jedinica (U)** pegaspargaze*.
English: Rare: Hepatic necrosis, jaundice, cholestasis, hepatic failure Immune system disorders Very common: Hypersensitivity, urticaria, anaphylactic reaction Not known: Toxic epidermal necrolysis*
Croatian: Vrlo često: preosjetljivost, urtikarija, anafilaktička reakcija Nepoznato: toksična epidermalna nekroliza*
English: The pharmacodynamic (PD) effect of Oncaspar was assessed after IM (Study CCG-1962) and IV administration (AALL07P4).
Croatian: Oncaspar ocijenjen je nakon i.m. (Ispitivanje CCG-1962) i i.v. primjene (AALL07P4).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Les Laboratoires Servier
English: One ml of solution contains 750 units pegaspargase .
Croatian: Jedan ml otopine sadrži 750 jedinica pegaspargaze.
English: Acute renal failure may develop in rare cases during treatment with L-asparaginase-containing regimens.
Croatian: Poremećaji bubrega i mokraćnog sustava Akutno zatajenje bubrega može se razviti u rijetkim slučajevima tijekom liječenja režimima koji sadrže L-asparaginazu.
English: 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.
Croatian: Muškarci i žene trebaju upotrebljavati učinkovitu kontracepciju tijekom liječenja kao i najmanje 6 mjeseci nakon prekida primjene lijeka Oncaspar.
English: The solution must therefore be handled and administered with particular caution.
Croatian: Otopinom se stoga mora naročito oprezno rukovati i primjenjivati je.
English: E. coli Native E. coli L-Asparaginase
Croatian: Nativna L-asparaginaza iz E. coli
English: Not known: Renal failure acute*
Croatian: Nepoznato: akutno zatajenje bubrega*
English: 3-Year EFS Rate, % (95% CI)
Croatian: Stopa EFS-a u 3. godini, % (95% CI)
English: One vial of 5 ml solution contains 3750 units of pegaspargase.
Croatian: Jedna bočica sa 5 ml otopine sadrži 3750 jedinica pegaspargaze.
English: 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.
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - teška kožna reakcija koja se zove toksična epidermalna nekroliza;
English: Indiana 46268
Croatian: 6925 Guion Road Indianapolis Indiana 46268 SAD
English: Very common: Febrile neutropenia Common: Anaemia, coagulopathy Not known: Bone marrow failure
Croatian: Vrlo često: febrilna neutropenija Često: anemija, koagulopatija
English: If used at the same time as Oncaspar, there is a higher risk of bleeding disorders.
Croatian: Ako se koristi istodobno kada i Oncaspar, pojačavaju se učinci sposobnost zgrušavanja Vaše krvi.
English: Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Croatian: Oncaspar 750 U/ml otopina za injekciju/infuziju pegaspargaza
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection/infusion 1 vial with 3,750 U pegaspargase.
Croatian: Prašak za otopinu za injekciju/infuziju 1 bočica s 3750 U pegaspargaze.
English: As impaired glucose tolerance may occur with concomitant use of Oncaspar with prednisone, blood glucose levels should be monitored.
Croatian: Budući da može doći do smanjenja tolerancije glukoze uz istodobnu primjenu lijeka
English: What Oncaspar looks like and contents of the pack Oncaspar is a white to off-white powder.
Croatian: Oncaspar je bijeli do bjelkasti prašak.
English: - prednisone, a steroid medicine.
Croatian: intravenski steroidi, itd.).
English: Another method than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.6).
Croatian: Žene u reproduktivnoj dobi moraju koristiti neku drugu metodu kontracepcije, koja nije oralna kontracepcija (vidjeti dio 4.4 i 4.6)
English: Median (10
Croatian: † Medijan (10., 90. percentil).
English: The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml (0.9%) solution or 5% glucose.
Croatian: Razrijeđena otopina može se davati tijekom 1 do 2 sata zajedno s infuzijom otopine natrijeva klorida od 9 mg/ml (0,9%) ili 5%-tne otopine glukoze koja je već u tijeku.
English: Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 222
Croatian: Tel.: +385 (0)1 3016 222
English: Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase
Croatian: Oncaspar 750 U/ml prašak za otopinu za injekciju/infuziju pegaspargaza
English: The recommended dose in patients with a body surface area (BSA) ≥0.6 m2 and who are ≤21 years of age is 2,500 U of pegaspargase (equivalent to 3.3 ml Oncaspar)/m2 body surface area every 14 days.
Croatian: 21 godinu iznosi 2500 U pegaspargaze (što odgovara 3,3 ml lijeka Oncaspar)/m² tjelesne površine svakih 14 dana.
English: Do not use if the solution is cloudy or a precipitate has formed.
Croatian: Nemojte upotrijebiti ako je otopina mutna ili se stvorio talog.
English: Servier Pharma d. o. o. Tel: + 386 (0)1 563 48 11
Croatian: Tel.: +386 (0)1 563 48 11
English: The use of disposable gloves and protective garments is recommended when handling Oncaspar.
Croatian: Pri rukovanju lijekom Oncaspar preporučuje se korištenje jednokratnih rukavica i zaštitne odjeće.
English: The diluted solution can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose.
Croatian: Razrijeđena otopina može se dati zajedno s infuzijom natrijeva klorida od 9 mg/ml ili 5%-tne otopine glukoze koja je već u tijeku.
English: Oncaspar native E. coli L-asparaginase
Croatian: Oncaspar i na nativnoj L-asparaginazi iz E. coli.
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate heptahydrate Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev klorid voda za injekcije
English: General disorders and administration site conditions
Croatian: Opći poremećaji i stanja na mjestu primjene
English: Hepatobiliary disorders
Croatian: Poremećaji metabolizma
English: flushing or swelling of the airways, because major allergic reactions to Oncaspar can occur.
Croatian: - ako ste imali ozbiljne alergijske reakcije na druge oblike asparaginaze, primjerice svrbež, navale crvenila ili oticanje dišnih puteva, jer se mogu pojaviti ozbiljne alergijske reakcije na Oncaspar
English: These findings were similar to those observed in the native E. coli L-asparaginase treatment arm.
Croatian: Ti su rezultati bili slični onima zabilježenima u skupini liječenoj nativnom
English: Asparaginase antibodies
Croatian: Ostale nuspojave
English: Inflammation of the pancreas, that in some cases caused death, can occur with Oncaspar treatment.
Croatian: Tijekom liječenja lijekom Oncaspar može se pojaviti upala gušterače, koja u nekim slučajevima može biti smrtonosna.
English: Pack size of 1.
Croatian: stupnja i koprivnjača 3. stupnja).
English: Uric acid nephropathy may develop.
Croatian: Jedan slučaj toksične epidermalne nekrolize
English: General disorders and administration side conditions Pyrexia can occur after the injection, which usually subsides spontaneously.
Croatian: Nakon injekcije može se pojaviti vrućica koja se obično spontano povlači.
English: Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 U of pegaspargase (equivalent to 2.67 ml Oncaspar)/m2 body surface area every 14 days.
Croatian: 2000 U/ pegaspargaze (što odgovara 2,67 ml lijeka Oncaspar)/m2 površine tijela svakih 14 dana.
English: Consolidation phases.
Croatian: (površine tijela) tijekom faza indukcije i konsolidacije.
English: Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110
Croatian: Tel: +353 (0)1 663 8110
English: Indianapolis
Croatian: intravenski.