FrancophonIA/ELRC3.0 huggingface dataset:
English: Findings of note included treatment related adverse reactions of the liver in rats (characterized by centrilobular congestion, abnormal cell division, hepatocellular necrosis and pericentral vein/interlobular fibrosis) which may be related to circulatory disturbances and changes indicative of increased haematopoiesis (high reticulocyte ratio and/or platelet count, increased cellularity of the haematopoietic cells in the femoral and sternal bone marrow, and/or extramedullary haematopoiesis in the liver and spleen).
Croatian: Značajni nalazi su obuhvaćali nuspojave povezane s liječenjem na jetri štakora (karakterizirane centrilobularnom kongestijom, abnormalnim dijeljenjem stanica, hepatocelularnom nekrozom, fibrozom oko centralne vene i interobularnom fibrozom) koje mogu biti povezane s poremećajima cirkulacije i promjenama koje ukazuju na povećanu hematopoezu (povišen omjer retikulocita i/ili broj trombocita, povećana celularnost hematopoetskih stanica u femoralnoj te sternalnoj koštanoj srži i/ili ekstramedularna hematopoeza u jetri i slezeni).
English: Severe allergic reactions are more likely when dinutuximab is co-administered with IL-2.
Croatian: Teške alergijske reakcije su vjerojatnije kad se dinutuksimab primjenjuje zajedno s IL-2.
English: Granulocyte macrophage colony-stimulating factor (GM-CSF): 250 μg/m2/day, administered by either subcutaneous injection (strongly recommended) or intravenous infusion over 2 hours.
Croatian: Faktor stimulacije kolonija granulocita i makrofaga (GM-CSF): 250 μg/m2/dan, primijenjeno bilo supkutanom injekcijom (izrazito preporučeno) ili intravenskom infuzijom tijekom 2 sata.
English: Electrolyte abnormalities have been reported in patients who received Unituxin.
Croatian: Prijavljena su odstupanja vrijednosti elektrolita u bolesnika koji su primili Unituxin.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „Rok valjanosti“.
English: - atypical haemolytic uraemic syndrome (aHUS) - an illness that affects the blood system and kidney symptoms may include flu-like symptoms that do not go away, confusion, lethargy, loss of appetite, or dark coloured urine.
Croatian: - atipični hemolitički uremički sindrom (aHUS) - bolest koja zahvaća krv i bubrege - simptomi mogu uključivati simptome slične gripi koji ne nestaju, smetenost, letargiju, gubitak teka ili mokraću tamne boje.
English: The treatment regimen consists of dinutuximab, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.
Croatian: Režim liječenja se sastoji od dinutuksimaba, GM-CSF-a, IL-2 i izotretinoina koji se primjenjuju kroz šest uzastopnih ciklusa.
English: The solution should be mixed by gentle inversion.
Croatian: Otopinu treba promiješati nježnim okretanjem.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Unituxin Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: No cases of dinutuximab overdose have been reported.
Croatian: Nisu prijavljeni slučajevi predoziranja dinutuksimabom.
English: • Capillary Leak Syndrome due to leakage of blood components through small blood vessel wallsthis may cause rapid swelling to arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties
Croatian: • Sindrom kapilarnog curenja uslijed curenja sastavnica krvi kroz stijenke malih krvnih žila - može uzrokovati brzo oticanje Vaših ruku, nogu i drugih dijelova tijela, brzi pad krvnog tlaka, ošamućenost i otežano disanje.
English: These studies support the current dinutuximab dosing regimen of 17.5 mg/m2/day administered for four consecutive days during five monthly courses.
Croatian: Ova ispitivanja podupiru tekući režim doziranja dinutuksimaba od 17,5 mg/m2/dan primijenjenog kroz četiri uzastopna dana tijekom pet mjesečnih ciklusa.
English: ANBL0032 was a randomised, controlled study that evaluated the effects of dinutuximab administered in combination with GM-CSF, IL-2, and isotretinoin compared with isotretinoin alone in high-risk neuroblastoma subjects.
Croatian: ANBL0032 je randomizirano, kontrolirano ispitivanje u kojemu su procijenjeni učinci dinutuksimaba primijenjenog u kombinaciji s GM-CSF-om, IL-2 i izotretinoinom u usporedbi s primjenom samo izotretinoina u ispitanika s neuroblastomom visokog rizika.
English: Dinutuximab has been shown to bind to neuroblastoma cell lines known to express GD2 in vitro.
Croatian: Pokazalo se da se dinutuksimab veže na stanične linije neuroblastoma poznatih po ekspresiji GD2 in vitro.
English: Onset of symptoms
Croatian: Pojava simptoma
English: What Unituxin is
Croatian: Što je Unituxin
English: If you notice any of these effects, tell your doctor or nurse straight away.
Croatian: Ako primijetite bilo koju od ovih nuspojava, odmah obavijestite svog liječnika ili medicinsku sestru.
English: Capillary leak syndrome is more likely when dinutuximab is co-administered with IL-2.
Croatian: Sindrom kapilarnog curenja je vjerojatniji kad se dinutuksimab primjenjuje zajedno s IL-2.
English: • If patient has CNS metastases, delay course initiation and give platelet transfusion to maintain platelet count at least 50,000/μL.
Croatian: • Ako bolesnik ima metastaze u središnjem živčanom sustavu, odgoditi početak ciklusa i primijeniti transfuziju trombocita kako bi se broj trombocita održao na najmanje 50 000/μL.
English: • If tolerated without worsening symptoms, administer dinutuximab at 1.75 mg/m2/h for subsequent courses.
Croatian: • Ako se podnosi bez pogoršanja simptoma, primijeniti infuziju dinutuksimaba brzinom od 1,75 mg/m2/sat u sljedećim ciklusima.
English: Laboratory test abnormalities
Croatian: Odstupanja laboratorijskih nalaza
English: • Do not resume GM-CSF or IL-2 until the following day.
Croatian: • Ne nastavljati primjenu GM-CSF-a ili IL-2 do sljedećeg dana.
English: How to store Unituxin
Croatian: Kako čuvati Unituxin
English: Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Croatian: Prije početka svakog ciklusa liječenja, nužno je procijeniti kriterije navedene u popisu iz Tablice
English: Atypical haemolytic uraemic syndrome
Croatian: Atipični hemolitički uremički sindrom
English: Haemolytic uraemic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anaemia, and hypertension has been reported.
Croatian: Atipični hemolitički uremički sindrom Prijavljen je hemolitički uremički sindrom u odsutnosti dokumentirane infekcije koji je rezultirao bubrežnom insuficijencijom, odstupanjima elektrolita, anemijom i hipertenzijom.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili medicinskoj sestri.
English: Delay initiation of courses 2-6 until ALT is less than 10 times ULN.
Croatian: Odgoditi početak 2. do 6. ciklusa dok vrijednost ALT-a ne bude manja od deseterostruke vrijednosti GGN.
English: Dinutuximab was administered at a dose equivalent to 17.5 mg/m2/day on four consecutive days (Days 4-7) of Courses 1-5.
Croatian: Dinutuksimab je primijenjen u dozi ekvivalentnoj 17,5 mg/m2/dan kroz četiri uzastopna dana (od 4. do 7. dana) od 1. do 5. ciklusa.
English: • For GM-CSF courses, administer GM-CSF at 50 % of the dose starting the next day, and if tolerated, GM-CSF may be given at full dose after completing dinutuximab dosing for that course.
Croatian: • Za cikluse s GM-CSF-om, primijeniti 50% doze GM-CSF-a počevši od sljedećeg dana, a ako se podnosi, može se primijeniti puna doza GMCSF-a nakon završetka doziranja dinutuksimaba za taj ciklus.
English: • Any kind of allergic reaction or other reaction at the injection site - symptoms may include a skin rash, hives, swelling in the face or throat, dizziness, a rapid heart beat or palpitations, being short of breath and difficulty breathing, fever, feeling sick, aches and pains in your joints .
Croatian: • Bilo kakvu vrstu alergijske reakcije ili druge reakcije na mjestu injiciranja - simptomi mogu uključivati kožni osip, koprivnjaču, oticanje lica ili grla, omaglicu, ubrzane otkucaje srca ili osjećaj lupanja srca, nedostatak zraka i otežano disanje, vrućicu, mučninu, bolove u zglobovima.
English: • If you are breastfeeding, talk to your doctor or nurse before being given this medicine.
Croatian: • Ako dojite, obratite se svom liječniku ili medicinskoj sestri prije nego primite ovaj lijek.
English: The pharmacokinetics of dinutuximab were evaluated in a clinical study of Unituxin in combination with GM-CSF, IL-2, and isotretinoin.
Croatian: Farmakokinetika dinutuksimaba je procijenjena u kliničkom ispitivanju Unituxina u kombinaciji s GM-CSF-om, IL-2 i izotretinoinom.
English: Leukopaenia
Croatian: Leukopenija
English: Dinutuximab: 17.5 mg/m 2/day, administered by intravenous infusion over 10-20 hours.
Croatian: 2. dinutuksimab: 17,5 mg/m2/dan, primijenjeno intravenskom infuzijom tijekom 10 do 20 sati.
English: Grade 3 or 4 Onset of symptoms
Croatian: 3. ili 4. stupnja Pojava simptoma
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: For severe pain, the Unituxin infusion rate should be decreased to 0.875 mg/m2/hour.
Croatian: Kod jake boli, treba smanjiti brzinu infuzije Unituxina na 0,875 mg/m2/sat.
English: Anaphylaxis Grade 3 or 4
Croatian: Anafilaksija 3. ili 4. stupnja
English: Table 2: Courses 2 and 4 dosing schedule for Unituxin and IL-2; Courses 2, 4, and 6 dosing schedule for isotretinoin
Croatian: Tablica 2: Raspored doziranja Unituxina i IL-2 za 2. i 4. ciklus; raspored doziranja izotretinoina za 2., 4. i 6. ciklus
English: Augmentation of ADCC in the presence of GM-CSF and IL-2 provided the rationale for combining these cytokines with dinutuximab in clinical studies.
Croatian: Povećanje stanične citotoksičnosti ovisne o protutijelima u prisutnosti GM-CSF-a i IL-2 dalo je osnovu za kombiniranje ovih citokina s dinutuksimabom u kliničkim ispitivanjima.
English: Urticaria, pruritus
Croatian: - proljev, mučnina
English: How Unituxin will be given 4.
Croatian: Kako će se primjenjivati Unituxin 4. Moguće nuspojave
English: Granulocytes were found to be more effective than PBMCs in mediating dinutuximab dependent cytotoxicity of neuroblastoma cells, with enhanced cell lysis observed with the addition of GM-CSF.
Croatian: Pronađeno je da su granulociti učinkovitiji od mononuklearnih stanica periferne krvi u posredovanju o dinutuksimabu ovisne citotoksičnosti za stanice neuroblastoma, s pojačanom lizom stanica opaženom uz dodatak GM-CSF-a.
English: Increased gammaglutamyltransferase, increased blood creatinine, increased weight
Croatian: Pretrage povišena alanin aminotransferaza povišena gamaglutamiltransferaza, povišen kreatinin u krvi, povećana tjelesna težina pozitivna hemokultura
English: Hypokalaemia, hyponatraemia, hypocalcaemia, hypophosphataemia, hypoalbuminaemia, hyperglycaemia, decreased appetite
Croatian: Manje često i prehrane hiponatrijemija, hipokalcijemija, hipofosfatemija, hipoalbuminemija, hiperglikemija, smanjen apetit acidoza, hipoglikemija
English: Peripheral sensory neuropathy was reported in 3% of patients and peripheral motor neuropathy in 2% of patients; less than 1% of patients experienced serious peripheral neuropathy.
Croatian: Treba primijeniti analgetike uključujući intravenske opioide prije svake doze Unituxina te nastaviti s primjenom do 2 sata nakon završetka infuzije Unituxina.Periferna senzorna neuropatija prijavljena je u 3% bolesnika, a periferna motorna neuropatija u 2% bolesnika; manje od 1% bolesnika imalo je ozbiljnu perifernu neuropatiju.
English: • Administer supportive measures.
Croatian: • Primijeniti potporne mjere
English: If not tolerated, reduce rate to 0.875 mg/m2/h.
Croatian: Ako se ne podnosi, smanjiti brzinu na 0,875 mg/m2/sat.
English: • If symptoms recur with the addition of GM-CSF or IL-2 discontinue GMCSF or IL-2 and dinutuximab.
Croatian: • Ako se simptomi ponovno pojave prilikom dodavanja GM-CSF-a ili IL-2, prekinuti primjenu GM-CSF-a ili IL-2 i dinutuksimaba.
English: • Delay course initiation until platelet count is at least 20,000/μL.
Croatian: • Odgoditi početak ciklusa dok broj trombocita ne bude najmanje 20 000/μL.
English: Capillary leak syndrome, hypotension,
Croatian: Krvožilni poremećaji sindrom kapilarnog curenja, hipotenzija, hipertenzija
English: Neurological disorders of the eye Dilated pupil with sluggish light reflex Onset of symptoms
Croatian: Proširena zjenica s tromim svjetlosnim refleksom Pojava simptoma
English: • If symptoms resolve the following day, resume dinutuximab at tolerated rate without GM-CSF or IL-2.
Croatian: • Ako se simptomi povuku sljedećeg dana, nastaviti primjenu dinutuksimaba pri podnošljivoj brzini bez GM-CFS-a ili IL-2.
English: Unituxin should not be administered as an intravenous push or bolus.
Croatian: Unituxin se ne smije primijeniti brzom ili bolusnom intravenskom injekcijom.
English: Pain typically occurred during the Unituxin infusion and was most commonly reported as abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal chest pain, and arthralgia; 41% of patients suffered severe pain.
Croatian: generalizirana bol, bol u ekstremitetima, bol u leđima, neuralgija, mišićno-koštana bol u prsima i artralgija; jaku bol imalo je 41% bolesnika.
English: How Unituxin works
Croatian: Kako djeluje Unituxin
English: In addition, overall survival (OS) was evaluated with 3 years of follow-up after the EFS analysis as a secondary endpoint with a significant improvement observed among ITT subjects randomly allocated to receive dinutuximab immunotherapy plus isotretinoin as compared with isotretinoin alone.
Croatian: Overall Survival) je procijenjeno uz trogodišnje praćenje nakon analize EFS-a kao sekundarna mjera ishoda, sa značajnim poboljšanjem opaženim među ispitanicima predviđenim za liječenje koji su nasumično raspodijeljeni u skupinu koja je primala imunoterapiju dinutuksimabom uz izotretinoin, u usporedbi s liječenjem samo izotretinoinom.
English: Additional adverse reactions characteristic of an allergic response were also reported - including anaphylactic reaction (18 %) and bronchospasm (4 %).
Croatian: Također su prijavljene i dodatne nuspojave karakteristične za alergijski odgovor - uključujući anafilaktičku reakciju
English: Signs of an allergic reaction may include skin rash, hives, swelling in the face or throat, dizziness, a rapid heart beat or palpitations, being short of breath and difficulty breathing, fever, feeling sick, aches and pains in your joints.
Croatian: Znakovi alergijske reakcije mogu uključivati kožni osip, koprivnjaču, oticanje lica ili grla, omaglicu, ubrzane otkucaje srca ili osjećaj lupanja srca, nedostatak zraka i otežano disanje, vrućicu, mučninu, bolove u zglobovima.
English: You might notice the following when you first receive Unituxin and during the course of treatment:
Croatian: Tijekom liječenja ili kod prve primjene Unituxina možda ćete primijetiti sljedeće:
English: The 3-year estimates of OS were 80 % compared with 67 % among subjects receiving dinutuximab immunotherapy plus isotretinoin and isotretinoin alone, respectively (log-rank test p = 0.0165).
Croatian: Trogodišnje procjene ukupnog preživljenja iznosile su 80% u ispitanika koji su primali imunoterapiju dinutuksimabom uz izotretinoin, u usporedbi sa 67% u ispitanika koji su primali samo izotretinoin (log-rang test p = 0,0165).
English: Data from 409 subjects participating in several neuroblastoma studies and having samples available for the determination of human anti-chimeric antibodies (HACA) demonstrated that 71 (17%) developed binding antibodies and 15 (4%) developed a neutralising antibody response.
Croatian: Human Anti-Chimeric Antibody) su pokazali da je njih 71 (17%) razvilo vezujuća protutijela te njih 15 (4%) neutralizirajuća protutijela.
English: Capillary leak syndrome
Croatian: Sindrom kapilarnog curenja
English: Isotretinoin: for body weight greater than 12 kg: 80 mg/m2 administered orally twice daily for a total dose of
Croatian: 3. izotretinoin: za tjelesnu težinu veću od 12 kg: 80 mg/m2 primijenjeno peroralno dvaput dnevno u ukupnoj dozi od
English: • If IL-2 is not tolerated at 50 % of the dose, substitute with GM-CSF for
Croatian: • Ako se IL-2 ne podnosi pri 50% doze, zamijeniti ga GM-CSF-om za
English: • If capillary leak syndrome occurred during GM-CSF course, administer dinutuximab alone for subsequent GM-CSF courses.
Croatian: • Ako se sindrom kapilarnog curenja pojavio tijekom ciklusa s GM-CSFom, primijeniti samo dinutuksimab za sljedeće cikluse s GM-CSF-om.
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose until the last dose of dinutuximab for that course.
Croatian: • Nastaviti primjenu 50% doze GM-CSF-a ili IL-2 sljedećeg dana sve do posljednje doze dinutuksimaba za taj ciklus.
English: This is because it is not known if the medicine can pass into breast-milk.
Croatian: • Ne smijete dojiti za vrijeme liječenja ovim lijekom, zbog toga što nije poznato može li lijek prelaziti u majčino mlijeko.
English: • Problems with your nerves - you may notice numbness, tingling or burning in your hands, feet, legs or arms, reduced sensation or weakness with movement (peripheral neuropathy).
Croatian: nogama ili rukama, smanjen osjet ili slabost prilikom pokreta (periferna neuropatija).
English: • If capillary leak syndrome occurred during IL-2 course, substitute GM-CSF for remainder of IL-2 courses.
Croatian: • Ako se sindrom kapilarnog curenja pojavio tijekom ciklusa s IL-2, zamijeniti ga s GM-CSF-om za preostale cikluse s IL-2.
English: These are very common (affecting more than 1 in 10 people).
Croatian: One su vrlo česte (javljaju se u više od 1 na 10 osoba).
English: Unituxin 3.5 mg/mL concentrate for solution for infusion dinutuximab
Croatian: Unituxin 3,5 mg/mL koncentrat za otopinu za infuziju dinutuksimab
English: Unituxin 3.5 mg/mL concentrate for solution for infusion.
Croatian: Unituxin 3,5 mg/mL koncentrat za otopinu za infuziju.
English: • If BP remains stable for at least 2 hours after resuming GM-CSF or IL-2,
Croatian: • Ako krvni tlak ostane stabilan tijekom najmanje 2 sata, nastaviti primjenu GM-CSF-a ili IL-2.
English: • Administer dinutuximab at 0.875 mg/m2/h and resume GM-CSF or IL-2.
Croatian: • Primijeniti infuziju dinutuksimaba brzinom od 0,875 mg/m2/sat i nastaviti primjenu GM-CSF-a ili IL-2.
English: What Unituxin is used for
Croatian: Za što se koristi Unituxin
English: Dose modification
Croatian: Prilagodba doze
English: Neuralgia, peripheral neuropathy, headache
Croatian: Poremećaji živčanog sustava neuralgija, periferna neuropatija, glavobolja sindrom posteriorne reverzibilne encefalopatije
English: No non-clinical studies to evaluate the potential of dinutuximab to cause carcinogenicity, genotoxicity, or developmental and reproductive toxicity have been conducted.
Croatian: Nisu provedena neklinička ispitivanja za procjenu potencijala dinutuksimaba za izazivanje kancerogenosti,
English: For shelf life after dilution, see section 6.3.
Croatian: Za rok valjanosti nakon razrjeđivanja vidjeti dio 6.3.
English: Each 5 mL vial contains 17.2 mg sodium.
Croatian: Jedna bočica od 5 mL sadrži 17,2 mg natrija.
English: • Start GM-CSF or IL-2 at 50 % of the dose when administered with dinutuximab.
Croatian: • Započeti primjenu 50% doze GM-CSF-a ili IL-2 kada se primjenjuje uz dinutuksimab.
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the GM-CSF courses.
Croatian: • Ako se GM-CSF ne podnosi pri 50% doze, primijeniti samo dinutuksimab za preostale cikluse s GM-CSF-om.
English: 14 days.
Croatian: 12 mjeseci do 17 godina.
English: Urinary retention, proteinuria, haematuria
Croatian: Poremećaji bubrega i mokraćnog sustava retencija urina, proteinurija, hematurija zatajenje bubrega
English: GM-CSF for remainder of IL-2 courses.
Croatian: GM-CSF-a i IL-2 za preostale cikluse.
English: Table 4 provides dose modification guidance for dinutuximab, GM-CSF and IL-2.
Croatian: Tablica 4 sadrži smjernice za prilagodbu doze dinutuksimaba, GM-CSF-a i IL-2.
English: Table 1: Courses 1, 3, and 5 dosing schedule for Unituxin, GM-CSF and isotretinoin Day
Croatian: Tablica 1: Raspored doziranja Unituxina, GM-CSF-a i izotretinoina za 1., 3. i 5. ciklus Dan
English: • Start GM-CSF or IL-2 at 50 % of the dose, increase to full dose if tolerated the next day.
Croatian: • Započeti primjenu 50% doze GM-CSF-a ili IL-2, ako se podnosi, povećati sljedećeg dana na punu dozu.
English: The primary intent-to-treat (ITT) analysis found an improvement in EFS associated with dinutuximab immunotherapy plus isotretinoin, as compared to isotretinoin alone.
Croatian: Intent-To-Treat) otkrila je poboljšanje preživljenja bez događaja povezano s imunoterapijom dinutuksimabom uz izotretinoin u usporedbi s primjenom samo izotretinoina.
English: These are very common (may affect more than 1 in 10 people).
Croatian: Ove su nuspojave vrlo česte (mogu se javiti u više od 1 na 10 osoba).
English: • If capillary leak syndrome occurred during IL-2 course, substitute
Croatian: • Ako se sindrom kapilarnog curenja pojavio tijekom ciklusa s IL-2,
English: In particular, tell your doctor or nurse if you have recently received: - medicines called ‘corticosteroids' - these can affect the activity of your immune system which is important for Unituxin to work.
Croatian: - lijekove koji se nazivaju „kortikosteroidi“ - oni mogu utjecati na aktivnost Vašeg imunološkog sustava koji je važan za uspješno djelovanje Unituxina.
English: • If IL-2 is not tolerated at 50 % of the dose, substitute with GM-CSF for the remainder of the IL-2 courses.
Croatian: • Ako se IL-2 ne podnosi pri 50% doze, zamijeniti ga GM-CSF-om za preostale cikluse s IL-2.
English: Very common side effects (may affect more than 1 in 10 people): - cough - itching - loss of appetite - diarrhoea, being sick - low blood pressure that may make you feel dizzy or faint or high blood pressure - abnormal blood tests such as low platelets, low red or white blood cells, low level of albumin (this can cause swelling and make you feel weak and tired), abnormal liver function, low level of potassium,
Croatian: - nizak krvni tlak zbog čega možete osjetiti omaglicu ili nesvjesticu, ili visoki krvni tlak - odstupanja u krvnim nalazima poput niske razine krvnih pločica, niske razine crvenih ili bijelih krvnih stanica, niska razina albumina (ovo može uzrokovati oticanje te osjećaj slabosti i umora), poremećena jetrena funkcija, niska razina kalija, natrija, kalcija, fosfata, ili visoka razina glukoze.
English: Table 5: Adverse reactions that have occurred during studies in high risk neuroblastoma patients receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin.
Croatian: Tablica 5: Nuspojave koje su se pojavile tijekom ispitivanja u bolesnika s neuroblastomom visokog rizika koji su primali dinutuksimab u kombinaciji s GM-CSF-om, IL-2 i izotretinoinom.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports
Croatian: C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Reporting of suspected adverse reactions that occur after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
English: • Reduce rate of infusion to 0.875 mg/m2/h.
Croatian: • Smanjiti brzinu infuzije na 0,875 mg/m2/sat.
English: In addition, it has been shown to induce both antibody dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity in vitro.
Croatian: Osim toga, pokazalo se da in vitro inducira i staničnu citotoksičnost ovisnu o protutijelima i citotoksičnost ovisnu o komplementu.
English: • If IL-2 is not tolerated at 50 % of the dose, administer dinutuximab alone
Croatian: • Ako se IL-2 ne podnosi pri 50% doze, primijeniti samo dinutuksimab
English: How Unituxin will be given
Croatian: Kako će se primjenjivati Unituxin