FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, either before or after an haematopoietic stem cell transplant (HSCT), and patients with moderate or severe hepatic impairment are at increased risk for developing VOD (see section 4.8).
Croatian: Na temelju analize potencijalnih čimbenika rizika odrasli bolesnici koji su primali lijek MYLOTARG kao monoterapiju, bilo prije ili poslije transplantacije hematopoetskih matičnih stanica (engl. haematopoietic stem cell transplant, HSCT), i bolesnici s umjerenim ili teškim oštećenjem jetre pod povećanim su rizikom za razvoj VOD-a (vidjeti dio 4.8).
English: Discontinuation of treatment should be strongly considered for patients who develop signs or symptoms of anaphylaxis, including severe respiratory symptoms or clinically significant hypotension (see section 4.2).
Croatian: Trajan prekid liječenja treba ozbiljno uzeti u obzir u slučaju bolesnika koji razviju znakove ili simptome anafilaktičke reakcije, uključujući teške respiratorne simptome ili klinički značajnu hipotenziju (vidjeti dio 4.2).
English: In subgroup analyses in ALFA-0701, the addition of MYLOTARG to standard combination chemotherapy did not improve EFS in the subgroup of patients having adverse-risk cytogenetics (HR 1.11; 95% CI: 0.63, 1.95).
Croatian: U analizama podskupina u ispitivanju ALFA-0701 dodavanje lijeka MYLOTARG standardnoj kombiniranoj kemoterapiji nije poboljšalo preživljenje bez događaja u podskupini bolesnika s nepovoljnom citogenetikom (HR 1,11; 95 % CI: 0,63; 1,95).
English: In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), haemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%).
Croatian: U ispitivanju kombiniranog liječenja ALFA-0701 zabilježene su sljedeće klinički relevantne ozbiljne nuspojave: hepatotoksičnost, uključujući VOD/SOS (3,8 %), hemoragija (9,9 %), teška infekcija (41,2 %) i sindrom lize tumora (1,5 %).
English: • Reduced number of red blood cells (anaemia) which may result in fatigue and shortness of breath
Croatian: • smanjen broj crvenih krvnih stanica (anemija), što može rezultirati umorom i nedostatkom zraka
English: Increased embryolethality and foetal morphological anomalies included digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae.
Croatian: Povećana embrionalna smrtnost i fetalne morfološke anomalije uključivale su malformacije prstiju, odsutnost luka aorte, anomalije u dugim kostima prednjih udova, deformiranu lopaticu, odsutnost centruma kralješka i spojene sternebre.
English: MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy.
Croatian: MYLOTARG se smije primjenjivati samo u bolesnika podobnih za primanje intenzivne indukcijske kemoterapije.
English: daunorubicin + cytarabine (N=137)
Croatian: daunorubicin + citarabin (N=137)
English: Your doctor may do blood tests and find abnormalities in liver blood tests, which might be signs of a potentially life-threatening condition called venoocclusive liver disease.
Croatian: Liječnik Vas može poslati na krvne pretrage i pronaći odstupanja u rezultatima jetrenih testova koja mogu biti znak stanja poznatog kao venookluzivna bolest jetre, a ono može biti opasno po život.
English: Discontinue MYLOTARG (see section 4.4).
Croatian: Prekinite liječenje lijekom MYLOTARG (vidjeti dio 4.4).
English: Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Croatian: Nakon rekonstitucije i razrjeđivanja otopinu treba zaštititi od svjetla te je treba primijeniti odmah.
English: Medicines of this type (monoclonal antibodies) can cause infusion reactions such as a rash, shortness of breath, difficulty breathing, a tight chest, chills or fever, back pain.
Croatian: Lijekovi ove vrste (monoklonska antitijela) mogu prouzročiti reakcije na infuziju kao što su osip, nedostatak zraka, otežano disanje, stezanje u prsnom košu, zimica ili vrućica, bolovi u leđima.
English: MYLOTARG does not undergo renal clearance, the pharmacokinetics in patients with severe renal impairment is unknown (see section 5.2).
Croatian: MYLOTARG ne prolazi bubrežni klirens, farmakokinetika u bolesnika s teškim oštećenjem bubrega nije poznata (vidjeti dio 5.2).
English: Complications associated with neutropenia and thrombocytopenia may include infections and bleeding/haemorrhagic reactions respectively.
Croatian: Komplikacije povezane s neutropenijom i trombocitopenijom mogu uključivati infekcije, odnosno reakcije krvarenja/hemoragije.
English: Based on a population PK analysis, age, race, and gender did not significantly affect gemtuzumab ozogamicin disposition.
Croatian: Na osnovi populacijske farmakokinetičke analize dob, rasa i spol nisu značajno utjecali na raspoređivanje gemtuzumab ozogamicina.
English: A systematic literature review of studies was conducted to evaluate MYLOTARG in paediatric patients with relapsed or refractory AML, which included 454 patients receiving MYLOTARG either as a monotherapy (single or fractionated dosing) or combination therapy from 16 published papers plus the US Expanded Access Study (see section 4.8).
Croatian: Proveden je sistematski pregled literature ispitivanja radi procjene lijeka MYLOTARG u pedijatrijskih bolesnika s recidivnim ili refraktornim AML-om te je uključio 454 bolesnika koji su primali lijek MYLOTARG kao monoterapiju (pojedinačno ili frakcionirano doziranje) ili kao kombinirano liječenje iz 16 objavljenih radova i američkog ispitivanja s proširenim pristupom (vidjeti dio 4.8).
English: Patients should be advised they may experience fatigue, dizziness and headache during treatment with MYLOTARG (see section 4.8).
Croatian: Bolesnike treba upozoriti da mogu osjetiti umor, omaglicu i glavobolju tijekom liječenja lijekom MYLOTARG (vidjeti dio 4.8).
English: The safety and efficacy of MYLOTARG in children and adolescents with previously untreated AML below the age of 15 years has not been established (see section 4.2).
Croatian: Sigurnost i djelotvornost lijeka MYLOTARG u djece i adolescenata mlađih od 15 godina s prethodno neliječenim AML-om nisu ustanovljene (vidjeti dio 4.2).
English: The reconstituted solution may contain small white to off-white, opaque to translucent, and amorphous to fibre-like particles.
Croatian: Rekonstituirana otopina može sadržavati male čestice koje su bijele do gotovo bijele, neprozirne do prozirne te amorfne do vlaknaste.
English: With MYLOTARG monotherapy, the response rate (CR/CRp/CRi; weighted average across studies) was 33.3% with fractionated dosing (1 study) and 24.3% with non-fractionated dosing (9 studies).
Croatian: S lijekom MYLOTARG kao monoterapijom stopa odgovora (CR/CRp/CRi; ponderirani prosjek u svim ispitivanjima) iznosila je 33,3 % s frakcioniranim doziranjem (1 ispitivanje) i 24,3 % s nefrakcioniranim doziranjem (9 ispitivanja).
English: When gemtuzumab ozogamicin is administered at 3 mg/m2 on Days 1, 4, and 7, the Cmax of hP67.6, which would occur at the end of infusion, is predicted to be 0.38 mg/L following the first dose and increased to 0.63 mg/L after the third dose.
Croatian: Kada se gemtuzumab ozogamicin primjenjuje u dozi od 3 mg/m2 1., 4. i 7. dana, predviđa se da bi Cmax za hP67.6, koji bi se pojavio na kraju infuzije, iznosio 0,38 mg/l nakon prve doze te se povećao na 0,63 mg/l nakon treće doze.
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=venoocclusive disease.
Croatian: Kratice: ALT=alanin aminotransferaza; AST=aspartat aminotransferaza; SOS=sindrom sinusoidalne opstrukcije; GGN=gornja granica normalne vrijednosti; VOD (engl. venoocclusive disease)
English: w. Pyrexia includes the following reported PTs: Pyrexia, Body temperature increased, and Hyperthermia.
Croatian: Pireksija uključuje sljedeće zabilježene preporučene pojmove: pireksija, povišena tjelesna temperatura i hipertermija.
English: In total, 271 patients were randomised in this study with 135 to induction treatment of 3+7 DA plus fractionated 3 mg/m2 × 3 doses of MYLOTARG and 136 to 3+7 DA alone (see section 4.2).
Croatian: Ukupno je 271 bolesnik bio randomiziran u ovom ispitivanju, a od njih je kao uvodno liječenje 135 bolesnika primalo 3+7 DA plus podijeljene doze lijeka MYLOTARG od 3 mg/m2 × 3, a 136 bolesnika samo 3+7 DA (vidjeti dio 4.2).
English: The relevance of the irreversible animal findings to humans is uncertain.
Croatian: Značaj ovih ireverzibilnih nalaza za ljude nije poznat.
English: Abbreviations: AML=acute myeloid leukaemia; AraC=cytarabine; BMA=bone marrow aspirate, DNR=daunorubicin.
Croatian: Kratice: AML=akutna mijeloična leukemija; AraC=citarabin; BMA=aspirat koštane srži, DNR=daunorubicin.
English: • bleeding: have unusual bleeding, bleeding from your gums, bruising easily or getting nose bleeds on a regular basis.
Croatian: • imate krvarenje: imate neobično krvarenje, ako Vam krvare desni, lako Vam nastaju modrice ili imate redovno krvarenje iz nosa
English: Efficacy results from study ALFA-0701 (mITT population)
Croatian: Rezultati djelotvornosti dobiveni tijekom ispitivanja ALFA-0701 (mITT populacija)
English: How to store MYLOTARG
Croatian: Kako čuvati MYLOTARG
English: a. See Table 3 and Table 4 for additional dose modification information.
Croatian: Vidjeti tablicu 3 i tablicu 4 za dodatne informacije o promjeni doze.
English: Abbreviations: C=cytarabine; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.
Croatian: Kratice: C=citarabin; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modificirana populacija planirana za liječenje.
English: • Redness of the skin
Croatian: • svrbež kože
English: N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy) butanoic acid) linker.
Croatian: N-acetil-gama-kalikeamicin je kovalentno vezan na antitijelo preko poveznice AcBut (4-(4-acetilfenoksi) butanoatna kiselina).
English: In the combination therapy study (N=131), all grades and Grade 3/4 bleeding/haemorrhagic reactions were reported in 118 (90.1%) and 27 (20.6%) patients, respectively.
Croatian: U ispitivanju kombiniranog liječenja (N=131) reakcije krvarenja/hemoragije svih stupnjeva i stupnja 3/4 zabilježene su u 118 (90,1 %) odnosno 27 (20,6 %) bolesnika.
English: No clinical drug interaction studies have been conducted with MYLOTARG.
Croatian: Nije provedeno nijedno kliničko ispitivanje interakcije lijekova s lijekom MYLOTARG.
English: Overall, 59.0% and 65.3% of patients had documented favourable/intermediate-risk disease by the National Comprehensive Cancer Network (NCCN) and European LeukaemiaNet (ELN) 2010 risk classifications, respectively.
Croatian: Sveukupno, u 59,0 %, odnosno 65,3 % bolesnika dokumentirana je bolest povoljnog/srednjeg rizika prema klasifikaciji rizika Nacionalne sveobuhvatne mreže za rak (engl.
English: Patients in either arm who did not receive the second course of induction therapy and did not achieve a CR after induction could receive a salvage course comprised of idarubicin, AraC, and granulocyte colonystimulating factor (G-CSF).
Croatian: Bolesnici iz bilo koje skupine koji nisu primili drugi ciklus uvodne terapije i nisu postigli potpunu remisiju nakon uvodnog liječenja, mogli su primiti ciklus terapije spasa (engl. salvage course) bolesnika koji se sastojao od idarubicina, AraC-a i čimbenika stimulacije kolonija granulocita.
English: a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer-Crowley method with log-log transformation.
Croatian: Medijan je procijenjen Kaplan-Meierovom metodom; CI je temeljen na Brookmeyer-Crowleyjevoj metodi s log-log transformacijom.
English: The incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, circulating gemtuzumab ozogamicin concentrations, sample handling, timing of sample collection, concomitant treatments and underlying disease.
Croatian: Na incidenciju pozitivnosti na antitijela u testu može utjecati nekoliko čimbenika, uključujući metodologiju testa, koncentracije cirkulirajućeg gemtuzumab ozogamicina, rukovanje uzorkom, izbor vremena kada će se uzorak prikupiti, terapije koje se istodobno primjenjuju i podležeću bolest.
English: Information about adverse drug reactions from monotherapy studies and post-marketing experience is presented Table 6 in order to provide full characterisation of adverse reactions.
Croatian: Podaci o nuspojavama lijeka iz ispitivanja monoterapije i razdoblja nakon stavljanja lijeka u promet prikazani su u tablici 6 kako bi se pružila cjelovita karakterizacija nuspojava.
English: This substance is delivered to cancer cells by the monoclonal antibody.
Croatian: Ova tvar se doprema do stanica raka pomoću monoklonskog antitijela.
English: • anaemia: have headaches, feel tired, experience dizziness, or look pale .
Croatian: • imate anemiju: imate glavobolje, umorni ste, imate omaglicu ili ste blijedi
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with gemtuzumab ozogamicin (see section 5.3).
Croatian: Na temelju nekliničkih nalaza liječenje gemtuzumab ozogamicinom može ugroziti plodnost muškarca i žene (vidjeti dio 5.3).
English: MYLOTARG contains the active substance gemtuzumab ozogamicin, an anticancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells.
Croatian: MYLOTARG sadrži djelatnu tvar gemtuzumab ozogamicin, koja je lijek protiv raka te koja se sastoji od monoklonskog antitijela vezanog na tvar namijenjenu ubijanju stanica raka.
English: Reconstitute each 5 mg vial with 5 mL of water for injections to obtain a single-use solution of 1 mg/mL of gemtuzumab ozogamicin.
Croatian: Rekonstituirajte svaku bočicu od 5 mg s 5 ml vode za injekcije kako biste dobili otopinu s 1 mg/ml gemtuzumab ozogamicina za jednokratnu upotrebu.
English: Therefore, coadministration of gemtuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl gamma calicheamicin dimethyl hydrazide.
Croatian: Stoga nije vjerojatno da će istodobna primjena gemtuzumab ozogamicina s inhibitorima ili induktorima citokroma P450 (CYP) ili uridin-difosfat-glukuroniltransferazom (UGT), enzimima koji metaboliziraju lijek, izmijeniti izloženost N-acetil-gama-kalikeamicindimetilhidrazidu.
English: The antibody portion binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of myeloid leukaemic blasts and immature normal cells of myelomonocytic lineage, but not on normal haematopoietic stem cells.
Croatian: Antitijelo iz konjugata veže se specifično na antigen CD33, o sijalinskoj kiselini ovisan adhezijski protein koji se nalazi na površini blasta mijeloične leukemije i nezrelih normalnih stanica mijelomonocitne loze, ali ne na normalnim hematopoetskim matičnim stanicama.
English: • have or ever had liver problems: MYLOTARG may cause, during or after treatment, a potentially life-threatening condition called hepatic venoocclusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots which may include fluid retention, rapid weight gain, increased liver size (which may be painful), and ascites (excessive accumulation of fluid in the abdominal cavity).
Croatian: • imate ili ste ikad imali problema s jetrom: MYLOTARG može tijekom ili nakon liječenja prouzrokovati stanje koje može biti opasno po život, poznato pod nazivom venookluzivna bolest jetre, u kojem dolazi do oštećenja krvnih žila u jetri i njihovog začepljenja krvnim ugruškom, te koje može uključivati zadržavanje tekućine, brzo dobivanje na težini, povećanje veličine jetre (što može biti bolno) i ascites (pretjerano nakupljanje tekućine u trbušnoj šupljini).
English: Interrupt the infusion and institute appropriate medical management based on the severity of symptoms.
Croatian: Reakcije povezane s infuzijom Privremeno prekinite infuziju i započnite s odgovarajućim liječenjem ovisno o težini simptoma.
English: Patients who experienced remission were also eligible for allogeneic transplantation.
Croatian: Bolesnici koji su postigli remisiju bili su isto tako podobni za alogenu transplantaciju.
English: Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)
Croatian: Tablica 5. Odabrane nuspojave u bolesnika koji su primali lijek MYLOTARG u ispitivanju kombiniranog liječenja (ALFA-0701)
English: t. Hepatic function abnormal includes the following reported PTs: Liver function test abnormal and Hepatic function abnormal.
Croatian: Abnormalna funkcija jetre uključuje sljedeće zabilježene preporučene pojmove: abnormalna vrijednost testa jetrene funkcije i abnormalna funkcija jetre.
English: The main toxicities occurred in the liver, bone marrow and lymphoid organs, haematology parameters (decreased RBC mass and WBC counts, mainly lymphocytes), kidney, eye and male and female reproductive organs.
Croatian: Glavne toksičnosti pojavile su se u jetri, koštanoj srži i limfoidnim organima, hematološkim parametrima (smanjena masa crvenih krvnih stanica i broj leukocita u krvi, uglavnom limfocita), bubrezima, oku i muškim i ženskim reproduktivnim organima.
English: There are no or limited amount of data from the use of gemtuzumab ozogamicin in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni gemtuzumab ozogamicina u trudnica ograničeni.
English: Several single agent studies measured target (CD33) saturation post-MYLOTARG dose in patients with relapsed and refractory AML.
Croatian: Nekoliko ispitivanja jednog lijeka mjerila su ciljanu (CD33) saturaciju nakon doze lijeka MYLOTARG u bolesnika s recidivnim ili refraktornim AML-om.
English: In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
Croatian: U ispitivanjima monoterapije klinički relevantne ozbiljne nuspojave uključivale su i reakcije povezane s infuzijom (2,5 %), trombocitopeniju (21,7 %) i neutropeniju (34,3
English: In clinical studies infusion related reactions, including anaphylaxis were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima prijavljene su reakcije povezane s infuzijom, uključujući anafilaktičku reakciju (vidjeti dio 4.8).
English: Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Croatian: Aktiviranje N-acetil-gama-kalikeamicindimetilhidrazida uzrokuje lomove dvolančane DNK te potom inducira zastoj staničnog ciklusa i apoptotsku smrt stanice.
English: • Doses administered by syringe must utilize small bore infusion lines (microbore) with an in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter.
Croatian: • Za doze primijenjene štrcaljkom moraju se koristiti cjevčice za infuziju malog promjera (microbore) s ugrađenim 0,2 mikronskim filtrom od polietersulfona (PES) kojeg karakterizira nisko vezanje proteina.
English: • Abnormalities in liver blood tests (which can be indicators of liver injury)
Croatian: • odstupanja u rezultatima krvnih pretraga funkcije jetre (koji mogu biti pokazatelji oštećenja jetre)
English: The results of the population modelling showed that the PK behaviour of gemtuzumab ozogamicin (hP67.6 antibody and unconjugated calicheamicin) is similar between adult and paediatric AML patients following the 9 mg/m2 dosing regimen.
Croatian: Rezultati populacijskog modeliranja pokazali su slično farmakokinetičko ponašanje gemtuzumab ozogamicina (hP67.6 antitijelo i nekonjugirani kalikeamicin) u odraslih i pedijatrijskih bolesnika s AML-om nakon režima doziranja od 9 mg/m
English: Supraventricular tachycardia#.
Croatian: # i supraventrikularna tahikardija k.
English: Premedication with a corticosteroid, antihistamine, and acetaminophen (or paracetamol) is recommended 1 hour prior to dosing to help ameliorate infusion-related symptoms (see section 4.4).
Croatian: Premedikacija kortikosteroidom, antihistaminikom i acetaminofenom (ili paracetamolom) preporučuje se 1 sat prije doziranja kako bi se ublažili simptomi povezani s infuzijom (vidjeti dio 4.4).
English: a. See Table 3 and Table 4 for dose modification information.
Croatian: Vidjeti tablicu 3 i tablicu 4 za informacije o promjeni doze.
English: Baseline characteristics were balanced between treatment arms with the exception of gender as a higher percentage of males were enrolled in the MYLOTARG arm (54.8%) than in the DA alone arm (44.1%).
Croatian: Početne karakteristike između liječenih skupina bile su uravnotežene, s iznimkom spola budući da je u skupinu koja je primala lijek MYLOTARG bio uključen veći postotak muškaraca (54,8 %) nego u skupinu koja je primala samo DA (44,1 %).
English: No dose adjustment is required in patients with mild to moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
English: In clinical studies, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening or fatal, were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima prijavljena su sljedeća stanja: neutropenija, trombocitopenija, anemija, leukopenija, febrilna neutropenija, limfopenija i pancitopenija, od kojih su neka bila opasna po život ili sa smrtnim ishodom (vidjeti dio 4.8).
English: • Infuse the diluted solution for 2 hours.
Croatian: • Primijenite razrijeđenu otopinu infuzijom u trajanju od 2 sata.
English: o Doses greater than or equal to 3.9 mg are to be diluted in a syringe or an IV bag in an appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure a final concentration between 0.075 mg/mL to 0.234 mg/mL.
Croatian: o Doze veće od ili jednake 3,9 mg treba razrijediti u štrcaljki ili infuzijskoj vrećici u odgovarajućem volumenu 0,9 %-tne (9 mg/ml) otopine natrijevog klorida za injekciju kako bi se postigla konačna koncentracija između 0,075 mg/ml i 0,234 mg/ml.
English: Overall response % [95% CI]e CR
Croatian: Ukupan odgovor % [95 % CI] CR
English: Men must use 2 methods of effective contraception during treatment and for at least 4 months after the last dose of treatment.
Croatian: Muškarci moraju koristiti 2 metode učinkovite kontracepcije tijekom terapije te najmanje 4 mjeseca nakon zadnje doze terapije.
English: If not used immediately, store at room temperature (below 25°C) for up to 6 hours, which includes the 2-hour infusion time and 1 hour, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature (below 25°C).
Croatian: Ako se lijek ne upotrijebi odmah, može se čuvati na sobnoj temperaturi (ispod 25 °C) do 6 sati, što uključuje vrijeme infuzije od 2 sata i, ako je potrebno, 1 sat da se razrijeđena otopina izvađena iz hladnjaka izjednači sa sobnom temperaturom (ispod 25 °C).
English: • Complication known as tumour lysis syndrome Tell your doctor right away if you experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Croatian: • Komplikacija poznata kao sindrom lize tumora Odmah obavijestite svog liječnika ako Vam se pojave omaglica, smanjeno mokrenje, smetenost, povraćanje, mučnina, oticanje, nedostatak zraka ili poremećaji srčanog ritma.
English: In monotherapy studies the most common adverse reactions (> 30%) included pyrexia, nausea, infection, chills, haemorrhage, vomiting, thrombocytopenia, fatigue, headache, stomatitis, diarrhoea, abdominal pain, and neutropenia.
Croatian: U ispitivanjima monoterapije najčešće nuspojave (> 30%) uključivale su pireksiju, mučninu, infekciju, zimicu, hemoragiju, povraćanje, trombocitopeniju, umor, glavobolju, stomatitis, proljev, bol u abdomenu i neutropeniju.
English: • Reduced number of blood platelets (cells that help blood to clot)
Croatian: • smanjen broj trombocita u krvi (stanica koje pomažu pri zgrušavanju krvi)