FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u modulu 1.8.2. odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Qarziba contains dinutuximab beta, which belongs to a group of medicines called ‘monoclonal antibodies'.
Croatian: Qarziba sadrži dinutuksimab beta koji pripada skupini lijekova pod nazivom „monoklonska protutijela”.
English: CLS is characterised by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space.
Croatian: Sindrom kapilarnog curenja karakterizira gubitak vaskularnog tonusa i ekstravazacija proteina i tekućine plazme u ekstravaskularni prostor.
English: 1 year
Croatian: 1 godina
English: • increased weight
Croatian: • povećanje tjelesne težine
English: In the presence of human effector cells, including peripheral blood nuclear cells and granulocytes from normal human donors, dinutuximab beta was found to mediate the lysis of human neuroblastoma and melanoma cell lines in a dose-dependent manner.
Croatian: U prisutnosti ljudskih efektorskih stanica, uključujući nuklearne stanice periferne krvi i granulocite zdravih ljudskih davatelja, otkriveno je da dinutuksimab beta posreduje u lizi ljudskih staničnih linija neuroblastoma i melanoma na način ovisan o dozi.
English: After reaching steady state, no difference in exposure is predicted, with and without ADA formation.
Croatian: Nakon postizanja dinamičke ravnoteže ne predviđa se razlika u izloženosti, sa stvaranjem protutijela na lijek i bez njihova stvaranja.
English: The exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion) is predicted to be similar in subjects with ages less than or equal to 12 years and decreases slightly for older, heavier subjects.
Croatian: Predviđa se da je izloženost (Cmax i AUC24h na 1. i 10. dan tijekom 10-dnevne infuzije) slična u ispitanika u dobi manjoj ili jednakoj 12 godina, a neznatno se smanjuje u starijih ispitanika, koji imaju veću tjelesnu težinu.
English: Mean plasma Cmax levels (around 12 micrograms/mL) were reached on the last day of infusion.
Croatian: Srednje vrijednosti razine Cmax u plazmi (otprilike 12 mikrograma/ml) dosegnute su posljednjeg dana primjene infuzije.
English: Most had an initial diagnosis of INSS stage 4 disease without MYCN amplification (16% of the subjects had MYCN amplified tumours and in 14% this information was missing).
Croatian: Većina ispitanika imala je početnu dijagnozu 4. stadija bolesti prema Međunarodnom sustavu određivanja stadija neuroblastoma (engl.International Neuroblastoma Staging System, INSS) bez MYCN amplifikacije (16 % ispitanika imalo je tumore s amplifikacijom MYCN onkogena, a u 14 % ispitanika ta informacija nije bila dostupna).
English: • pain in the stomach, throat, chest, face, hands, feet, legs, arms, back, neck, joint, or muscles
Croatian: • bol u trbuhu, grlu, prsnom košu, licu, šakama, stopalima, rukama, nogama, leđima, vratu, zglobovima ili mišićima
English: Mean plasma Cmax levels, observed during 8-hour infusions (20 mg/m2/day on five consecutive days), were determined in another study (n=15).
Croatian: Srednje vrijednosti razine Cmax u plazmi, zabilježene tijekom 8satnih infuzija (20 mg/m2/dan, pet uzastopnih dana) određene su u drugom ispitivanju (n = 15).
English: After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand.
Croatian: Nakon postupnog ukidanja intravenskog morfina, u slučaju teške neuropatske boli prema potrebi je moguće primijeniti peroralni morfinsulfat (0,2 do 0,4 mg/kg svaka 4 do 6 sati).
English: Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.
Croatian: Prije liječenja recidiva neuroblastoma svaku bolest koja aktivno napreduje potrebno je stabilizirati primjenom drugih odgovarajućih mjera.
English: The bone marrow changes were slight to severe and recovered after cessation of dosing.
Croatian: Promjene koštane srži bile su u rasponu od neznatnih do teških nakon prestanka davanja doze.
English: If IL-2 is combined with dinutuximab beta, it should be given as subcutaneous injections for 5 consecutive days twice during each course.
Croatian: Ako se IL-2 kombinira s dinutuksimabom beta, potrebno ga je primjenjivati u obliku supkutanih injekcija 5 uzastopnih dana dvaput tijekom svakog ciklusa.
English: Most commonly, patients reported abdominal pain, pain in the extremities, back pain, chest pain, or arthralgia.
Croatian: Bolesnici su najčešće prijavili bol u abdomenu, bol u ekstremitetima, bol u leđima, bol u prsnom košu ili artralgiju.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake EXP odnosno Rok valjanosti.
English: Efficacy without IL-2 N=73
Croatian: Djelotvornost bez IL2 N = 73
English: The pharmacokinetics of dinutuximab beta, based on 10-day continuous intravenous infusion of 10 mg/m2/day (equal to a total dose of 100 mg/m2/course) were evaluated in studies 1 and 2.
Croatian: Farmakokinetička svojstva dinutuksimaba beta, na temelju 10-dnevne kontinuirane intravenske infuzije od 10 mg/m2/dan (što odgovara ukupnoj dozi od 100 mg/m2/ciklus) ocijenjena su u 1. i 2. ispitivanju.
English: Due to their immunosuppressive activity, concomitant treatment with corticosteroids is not recommended within 2 weeks prior to the first treatment course until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
Croatian: Zbog imunosupresivnog djelovanja, istodobno liječenje kortikosteroidima ne preporučuje se od 2 tjedna prije prvog ciklusa liječenja do isteka 1 tjedna nakon zadnjeg ciklusa liječenja dinutuksimabom beta, osim u slučaju bolesti opasnih po život.
English: Laboratory abnormalities Regulatory monitoring of liver function and electrolytes is recommended.
Croatian: Odstupanja laboratorijskih parametara Preporučuje se redovito praćenje funkcije jetre i elektrolita.
English: Qarziba is a clear, colourless liquid, provided in a clear glass vial with a rubber stopper and aluminium seal.
Croatian: Qarziba je bistra, bezbojna tekućina isporučena u prozirnoj staklenoj bočici s gumenim čepom i aluminijskim zatvaračem.
English: The amount of solution to be infused per day (within a treatment course of 10 consecutive days) should be 48 mL; with 240 mL for a 5-day dose.
Croatian: Količina otopine koju je svakoga dana potrebno primijeniti u infuziji (unutar ciklusa liječenja od 10 uzastopnih dana) treba iznositi 48 ml, a 5-dnevna doza iznosi 240 ml.
English: Millmount Healthcare Ltd Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60
Croatian: Millmount Healthcare Ltd Block 7, City North Business Campus Stamullen, Co.
English: Findings of note included changes (decrease) in thymus weight as well as bone marrow changes (atrophy affecting myeloid and erythroid precursor cell lines).
Croatian: Značajni nalazi uključivali su promjene (smanjenje) težine timusa i promjene koštane srži (atrofija koja je zahvatila stanične linije mijeloidnih i eritroidnih prekursora).
English: Treatment with opioids is standard with dinutuximab beta.
Croatian: Liječenje opioidima standardno je uz primjenu dinutuksimaba beta.
English: Based on the physician's evaluation of the severity of adverse drug reactions to dinutuximab beta, patients may undergo a dose reduction of 50% or a temporary interruption of the infusion.
Croatian: Na temelju liječničke procjene težine nuspojava dinutuksimaba beta bolesnicima je moguće smanjiti dozu za 50 % ili privremeno prekinuti davanje infuzije.
English: For moderate neuropathic pain, oral tramodol may be administered.
Croatian: Za ublažavanje umjerene neuropatske boli može se primijeniti peroralni tramadol.
English: Occurrence of a severe infusion related reaction (including CRS) requires immediate discontinuation of dinutuximab beta therapy and may necessitate emergency treatment.
Croatian: Pojava teških reakcija povezanih s infuzijom (uključujući sindrom otpuštanja citokina) zahtijeva trenutačan prekid davanja terapije dinutuksimabom beta i možda će zahtijevati hitno liječenje.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid.
Croatian: OBLIK Koncentrat za otopinu za infuziju Bistra bezbojna tekućina.
English: Diluted solution (solution for infusion)
Croatian: Razrijeđena otopina (otopina za infuziju)
English: • rapid swelling of arms, legs and other body parts, rapid drop in blood pressure, light-headedness and breathing difficulties (capillary leak syndrome)
Croatian: • brzo oticanje ruku, nogu i ostalih dijelova tijela, brzi pad krvnog tlaka, ošamućenost i otežano disanje (sindrom kapilarnog curenja)
English: For 8-hour daily infusions, the solution is administered at a rate of approximately 13 mL per hour.
Croatian: Pri davanju 8-satnih dnevnih infuzija otopina se primjenjuje brzinom od otprilike 13 ml po satu.
English: Efficacy without IL-2 N=104
Croatian: Djelotvornost bez IL2 N = 104
English: • a brain disorder characterised by headache, confusion, seizures and loss of vision (posterior reversible encephalopathy syndrome)
Croatian: • poremećaj mozga koji karakteriziraju glavobolja, smetenost, napadaji i gubitak vida (sindrom posteriorne reverzibilne encefalopatije)
English: Vaccinations should be avoided during administration of dinutuximab beta until 10 weeks after the last treatment course, due to immune stimulation through dinutuximab beta and possible risk for rare neurological toxicities.
Croatian: Cijepljenja je potrebno izbjegavati tijekom primjene dinutuksimaba beta te 10 tjedana nakon završetka zadnjeg ciklusa liječenja zbog imunostimulacije dinutuksimabom beta i mogućeg rizika od pojave rijetkih neuroloških toksičnosti.
English: How to use Qarziba
Croatian: Kako čuvati Qarziba
English: Dinutuximab beta has major influence on the ability to drive and use machines.
Croatian: Dinutuksimab beta značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • a condition in which some of the small veins in the liver are obstructed (veno-occlusive disease)
Croatian: • stanje u kojem dolazi do začepljenja pojedinih malih vena u jetri (venookluzivna bolest)
English: Clear Type I glass vial (6 mL) with a halobutyl rubber stopper and aluminium flip-off cap, containing a minimum extractable volume of 4.5 mL concentrate for solution for infusion.
Croatian: Prozirna staklena (tipa I) bočica (6 ml) s čepom od halobutilne gume i aluminijskim zatvaračem, koja sadrži minimalni volumen koji je moguće izvući od 4,5 ml koncentrata za otopinu za infuziju.
English: Haematologic toxicities
Croatian: Hematološke toksičnosti
English: Neuropathic pain usually occurs at the beginning of the treatment and premedication with analgesics, including intravenous opioids, prior to each infusion of dinutuximab beta is required.
Croatian: Neuropatska bol obično se javlja na početku liječenja, a potrebna je premedikacija analgeticima, uključujući intravenske opioide prije svake infuzije dinutuksimaba beta.
English: The development of anti-drug antibodies is a class effect of monoclonal chimeric antibodies.
Croatian: Razvoj protutijela na lijek učinak je razreda monoklonskih kimeričnih protutijela.
English: • adequate bone marrow function: absolute neutrophil count ≥ 500/µL, platelet count
Croatian: • odgovarajuća funkcija koštane srži: apsolutni broj neutrofila ≥ 500/µl, broj trombocita
English: Grade ≥ 3
Croatian: Bilo koja stupanj ≥ 3
English: For continuous infusions, the solution is administered at a rate of 2 mL per hour (48 mL per day) using an infusion pump.
Croatian: Pri davanju kontinuiranih infuzija otopina se primjenjuje brzinom od 2 ml po satu (48 ml na dan) pomoću infuzijske pumpe.
English: • grade 3 or 4 anaphylaxis
Croatian: • anafilaksija 3. ili 4. stupnja
English: In order to evaluate the long-term survival effect of dinutuximab, the MAH will submit at least 5-year survival data for patients included in studies APN311-202 and APN311-302.
Croatian: Kako bi se ocijenio dugoročni učinak dinutuksimaba na preživljenje, nositelj odobrenja za stavljanje lijeka u promet predat će barem 5-godišnje podatke o preživljenju bolesnika uključenih u ispitivanja APN311-202 i APN311-302.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: • The other ingredients are histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid (for pH adjustment).
Croatian: • Drugi sastojci su histidin, saharoza, polisorbat 20, voda za injekcije, kloridna kiselina (za prilagodbu pH vrijednosti).
English: These included impaired visual accommodation that is correctable with eye glasses, as well as mydriasis (13%), blurred vision (3%) or photophobia (3%), which were usually reversible after treatment discontinuation.
Croatian: Problemi s očima obuhvaćali su smanjenu akomodaciju oka koju je moguće ispraviti naočalama, midrijazu (13 %), zamućen vid (3 %) ili fotofobiju (3 %), a svi navedeni problemi obično su nestali nakon prestanka liječenja.
English: In the case of overdose, patients should be carefully observed for signs or symptoms of adverse reactions and supportive care administered, as appropriate.
Croatian: U slučaju predoziranja bolesnike je potrebno pomno pratiti kako bi se pratila pojava znakova ili simptoma nuspojava te prema potrebi treba primijeniti suportivnu skrb.
English: • recurrent or grade 4 capillary leak syndrome (requires ventilator support)
Croatian: • sindrom kapilarnog curenja koji se opetovano pojavljuje ili je 4. stupnja (potrebna je podrška primjenom respiratora)
English: Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease.
Croatian: Qarziba indiciran je za liječenje bolesnika s neuroblastomom visokog rizika u dobi od 12 mjeseci i starijih, koji su prethodno primali indukcijsku kemoterapiju i postigli barem djelomični odgovor, nakon čega su slijedile mijeloablacijska terapija i transplantacija matičnih stanica te bolesnika koji imaju povijest recidiva neuroblastoma ili refraktornog neuroblastoma, sa ili bez rezidualne bolesti.
English: In order to better define the posology in children over the entire age range and the impact of HACAs on PD, efficacy and safety, the MAH will submit the results of an evaluation of plasma samples collected from patients in studies APN311-202v1-2-3 and APN311-304 according to an agreed protocol.
Croatian: Kako bi se bolje definiralo doziranje u djece u svim dobnim skupinama te utjecaj humanog antikimeričnog protutijela (HACA) na farmakodinamiku (PD), djelotvornost i sigurnost primjene, nositelj odobrenja za stavljanje lijeka u promet predat će rezultate ocjene uzoraka plazme prikupljenih od bolesnika u ispitivanjima APN311-202v1-2-3 i APN311-304 u skladu s dogovorenim protokolom.
English: 1 year 2 years
Croatian: 1 godina 2 godine
English: In the repeat-dose toxicity studies in Guinea pigs and cynomolgus monkeys, no adverse effects of dinutuximab beta were observed on reproductive organs at exposure levels above clinical levels.
Croatian: U ispitivanjima toksičnosti ponovljenih doza u zamoraca i makaki majmuna nisu zabilježeni štetni učinci dinutuksimaba beta na reproduktivnim organima pri razinama izloženosti koje su više od kliničkih razina.
English: Pain typically occurs during the first infusion of dinutuximab beta and decreases over the treatment courses.
Croatian: Bol se obično javlja tijekom prve infuzije dinutuksimaba beta, a smanjuje se tijekom ciklusa liječenja.
English: Severe infusion-related reactions, including cytokine release syndrome (CRS), anaphylactic and hypersensitivity reactions, may occur despite the use of premedication.
Croatian: Teške reakcije povezane s infuzijom, uključujući sindrom otpuštanja citokina, anafilaktičke reakcije i reakcije preosjetljivosti, mogu se pojaviti unatoč primjeni premedikacije.
English: Intravenous antihistamine, epinephrine (adrenaline) and prednisolone for intravenous administration should be immediately available at the bedside during administration of dinutuximab beta to manage life-threatening allergic reactions.
Croatian: Intravenski antihistaminik, epinefrin (adrenalin) i prednizolon za intravensku primjenu trebaju biti trenutačno dostupni uz krevet bolesnika tijekom primjene dinutuksimaba beta radi zbrinjavanja alergijskih reakcija opasnih po život.
English: First-line patients who received autologous stem cell transplantation In study 3, patients with high-risk neuroblastoma were enrolled after they had received induction chemotherapy and achieved at least a partial response, then myeloablative therapy and stem cell transplantation.
Croatian: Bolesnici koji su prošli prvu liniju liječenja i primili transplantaciju autolognih matičnih stanica U 3. ispitivanju bolesnici s neuroblastomom visokog rizika bili su uključeni nakon što su primili indukcijsku kemoterapiju i postigli barem djelomični odgovor, nakon čega su slijedile mijeloablacijska terapija i transplantacija matičnih stanica.
English: Infections and infestations infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis), device related infection sepsis
Croatian: Infekcije i infestacije infekcija (uključujući upalu pluća, kožne infekcije, infekciju virusom herpesa, mijelitis, encefalomijelitis), infekcija vezana uz kateter sepsa
English: Other frequent adverse reactions were hypersensitivity (63%), vomiting (57%), diarrhoea (51%), capillary leak syndrome (40%) and hypotension (39%).
Croatian: Ostale česte nuspojave bile su preosjetljivost (63 %), povraćanje (57 %), proljev (51 %), sindrom kapilarnog curenja (40 %) i hipotenzija (39 %).
English: Anaphylactic reactions may occur as early as within a few minutes of the first infusion with dinutuximab beta and are commonly associated with bronchospasm and urticaria.
Croatian: Anafilaktičke reakcije mogu se javiti već nekoliko minuta nakon prve infuzije lijeka dinutuksimaba beta, a često su povezane s bronhospazmom i urtikarijom.
English: Severe eye disorders were also reported including ophthalmoplegia (2%) and optic atrophy.
Croatian: Prijavljeni su i teški poremećaji oka, uključujući oftalmoplegiju (2 %) i atrofiju vidnog živca.
English: Overall, 10% of CLS were severe (grade 3-4) and their frequency decreased over the treatment courses.
Croatian: Sveukupno je 10 % slučajeva sindroma kapilarnog curenja bilo teško (3. - 4. stupanj), a njegova se učestalost smanjila tijekom ciklusa liječenja.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Croatian: Time se omogućuje stalno praćenje omjera koristi i rizika lijeka.
English: • low blood pressure, increased heartbeat
Croatian: • nizak krvni tlak, ubrzani puls
English: • Before initiation of a continuous intravenous morphine infusion, a bolus infusion of 0.02 to 0.05 mg/kg/hour morphine should be started 2 hours before dinutuximab beta infusion.
Croatian: • Prije početka davanja kontinuirane intravenske infuzije morfina potrebno je primijeniti bolusnu infuziju od 0,02 do 0,05 mg/kg/sat morfina 2 sata prije infuzije dinutuksimaba beta.
English: • nerve disorder in the arms and/or legs (with abnormal sensations or weakness), light headedness, trembling, muscle spasms
Croatian: • živčani poremećaj u rukama i/ili nogama (s abnormalnim osjetima ili slabosti), ošamućenost,
English: Other intravenously co-administered agents should be delivered via a separate infusion line.
Croatian: Ostala sredstva koja se istodobno primjenjuju intravenski potrebno je dati putem zasebne infuzijske linije.
English: Discontinue infusion, Resume next day if ADR resolves
Croatian: Opetovano pojavljivanje nuspojava Prekinuti davanje infuzije Ponovno primijeniti sljedeći dan ako nuspojave nestanu
English: IL-2 is administered as 6×106 IU/m2/day, resulting in an overall dose of 60×106 IU/m2/course.
Croatian: Ako se IL-2 primjenjuje kao 6 x 106 IU/M2/dan, dobiva se ukupna doza od 60 x 106IU/m2/ciklus.
English: It is recommended that a 0.22 micrometre in-line filter is used during infusion.
Croatian: Tijekom infuzije preporučuje se primjena linijskog filtra veličine pora od 0,22 mikrometra.
English: Other medicines and Qarziba
Croatian: Drugi lijekovi i Qarziba
English: For continuous infusions, any medical device suitable for infusion at a rate of 2 mL per hour can be applied, e.g. syringe infusion pumps/infusors, electronic ambulatory infusion pumps.
Croatian: Pri davanju kontinuiranih infuzija moguće je koristiti bilo koje medicinsko pomagalo prikladno za davanje infuzije brzine 2 ml na sat, na primjer infuzijske pumpe / infuzore sa štrcaljkom, elektroničke pokretne infuzijske pumpe.
English: Treatment with Qarziba consists of 5 consecutive courses, each course comprising 35 days.
Croatian: Liječenje lijekom Qarziba sastoji se od 5 uzastopnih ciklusa, od kojih svaki traje 35 dana.
English: • For continuous infusions, the solution for infusion can be prepared freshly on a daily basis, or sufficient for up to 5 days of continuous infusion.
Croatian: • Pri davanju kontinuiranih infuzija moguće je pripremiti svježu otopinu za infuziju svakoga dana ili dovoljne količine za do 5 dana primjene kontinuirane infuzije.
English: Dinutuximab beta has been administered to male and female juvenile Guinea pigs, as well as male and female young cynomolgus monkeys, as repeat-dose regimens that exceeded the recommended clinical dose.
Croatian: Dinutuksimab beta primijenjen je u mužjaka i ženki mladunaca zamoraca te mužjaka i ženki mladih makaki majmuna u režimima ponovljene doze koje su bile veće od doze koja se klinički primjenjuje.
English: • respiratory failure, fluid in the lungs
Croatian: • zatajenje disanja, nakupljanje tekućine u plućima
English: Antihistamine premedication (e.g. diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab beta infusion.
Croatian: Premedikaciju antihistaminikom (npr. difenhidramin) potrebno je primijeniti intravenskom injekcijom otprilike 20 minuta prije početka svake infuzije dinutuksimaba beta.
English: Renal and hepatic impairment There are no data in patients with renal and hepatic impairment (see section 5.2).
Croatian: Nisu dostupni podaci u bolesnika s oštećenjem funkcije bubrega i jetre (vidjeti dio 5.2).
English: Neurotoxicity associated to dinutuximab beta is likely due to the induction of mechanical allodynia that may be mediated by the reactivity of dinutuximab beta with the GD2 antigen located on the surface of peripheral nerve fibres and myelin.
Croatian: Postoji vjerojatnost pojave neurotoksičnosti povezane s dinutuksimabom beta zbog izazivanja mehaničke alodinije koja može biti posredovana reaktivnošću dinutuksimaba beta s antigenom GD2 smještenim na površini perifernih živčanih vlakana i mijelina.
English: No dose modification is necessary in the case of an impaired visual accommodation that is correctable with eye glasses, as long as this is judged to be tolerable.
Croatian: U slučaju smanjene akomodacije oka koju je moguće ispraviti naočalama nije potrebna prilagodba doze, dokle god bolesnik smatra da je podnosi.
English: No cases of dinutuximab beta overdose have been reported.
Croatian: Nije zabilježen nijedan slučaj predoziranja dinutuksimabom beta.