FrancophonIA/ELRC3.0 huggingface dataset:
English: The infusion is started at a dose rate of 0.875 mg/m2/h and continued at this rate for 30 minutes; the rate is then increased to 1.75 mg/m2/h and continued at this rate for the remainder of the infusion, if tolerated.
Croatian: Infuzija počinje brzinom doze od 0,875 mg/m2/sat i nastavlja se tom brzinom tijekom 30 minuta; zatim se brzina povećava na 1,75 mg/m2/sat te, ako se ponosi, nastavlja se tom brzinom za ostatak infuzije.
English: • Low blood pressure - this may make you feel dizzy or faint.
Croatian: • Nizak krvni tlak - može uzrokovati omaglicu ili nesvjesticu.
English: Non-clinical studies demonstrate that dinutuximab-induced neurotoxicity is likely due to the induction of mechanical allodynia that may be mediated by reactivity of dinutuximab with GD2 antigen located on the surface of peripheral nerve fibres and/or myelin.
Croatian: Neklinička ispitivanja pokazuju da dinutuksimabom uzrokovana neurotoksičnost vjerojatno nastaje zbog izazivanja mehaničke alodinije koju može posredovati reaktivnost dinutuksimaba s antigenom GD2 smještenim na površini perifernih živčanih vlakana i/ili mijelina.
English: See section 2 for further information about sodium.
Croatian: Pogledajte dio 2 za dodatne informacije o natriju.
English: Unituxin is a cancer medicine that contains the active substance dinutuximab.
Croatian: Unituxin je lijek za liječenje raka koji sadrži djelatnu tvar dinutuksimab.
English: The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay and for these reasons, comparison of the incidence of antibodies to dinutuximab with the incidence of antibodies to other products may be misleading.
Croatian: Incidencija stvaranja protutijela izrazito ovisi o osjetljivosti i specifičnosti testa, te slijedom toga, usporedba incidencije protutijela na dinutuksimab s incidencijom protutijela na druge lijekove može biti varljiva.
English: Eye disorders may occur, especially with repeated courses.
Croatian: Neurološki poremećaji oka Mogu se pojaviti poremećaji oka, osobito nakon ponovljenih ciklusa.
English: Non-interventional post authorisation safety study (PASS): In order to evaluate the long-term safety outcomes of dinutuximab in high-risk neuroblastoma patients (including central and peripheral nervous system, prevalence of organ dysfunction, long-term effects on growth and endocrine development, hearing loss, cardiac toxicity and survival data) the applicant should conduct and submit the results of a safety registry.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS): u svrhu procjene dugoročnih ishoda sigurnosti primjene dinutuksimaba u bolesnika s neuroblastomom visokog rizika (uključujući podatke o središnjem i perifernom živčanom sustavu, prevalenciji poremećaja funkcije organa, dugotrajnim učincima na rast i razvoj endokrinog sustava, gubitku sluha, kardiotoksičnosti i preživljenju) podnositelj treba provoditi registar sigurnosti primjene i podnijeti rezultate.
English: If hypotension occurs, this can be repeated, or intravenous albumin or packed red blood cells can be administered as clinically indicated.
Croatian: Ako se pojavi hipotenzija, ovo se može ponoviti, ili se može primijeniti intravenski albumin ili koncentrat eritrocita prema kliničkoj indikaciji.
English: The infusion duration may be extended up to 20 hours to help minimise reactions during infusion that do not respond adequately to other supportive measures.
Croatian: 20 sati da bi se pomoglo umanjiti reakcije tijekom infuzije koje ne reagiraju odgovarajuće na druge potporne mjere.
English: • If symptoms resolve that day, resume the next day with premedication in the intensive care setting.
Croatian: • Ako se simptomi povuku tog dana, nastaviti sljedećeg dana s premedikacijom na odjelu intenzivne njege.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated Do not freeze.
Croatian: POSEBNE MJERE ČUVANJA Čuvati i prevoziti na hladnom.
English: Originally reported terms have been coded to preferred terms (using the Medical Dictionary for Regulatory Activities [MedDRA]).
Croatian: (koristeći Medicinski rječnik za regulatorne poslove [MedDRA]).
English: During courses (months) 1, 3 and 5
Croatian: Za vrijeme 1., 3. i 5. ciklusa (mjeseca)
English: Capillary leak syndrome Grade 3 (severe) Onset of symptoms
Croatian: Sindrom kapilarnog curenja 3. stupnja (teški) Pojava simptoma
English: Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia.
Croatian: Treba primijeniti potporne mjere uključujući kontrolu stanja hidracije, odstupanja elektrolita, hipertenzije i anemije.
English: Pregnancy There are no data from the use of dinutuximab in pregnant women.
Croatian: Nema podataka o primjeni dinutuksimaba u trudnica.
English: During courses (months) 2 and 4
Croatian: Za vrijeme 2. i 4. ciklusa (mjeseca)
English: Then increase to full dose if tolerated for the remainder of
Croatian: Zatim, ako se podnosi, povećati na punu dozu za ostatak
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium flip-off seal containing 5 mL of concentrate for solution for infusion.
Croatian: I s čepom od bromobutilne gume i aluminijskim flip-off zatvaračem, koja sadrži 5 mL koncentrata za otopinu za infuziju.
English: Symptomatic and/or systolic BP less than 70 mmHg or a decrease that is more than 15% below baseline Onset of symptoms
Croatian: Simptomatska i/ili sistolički krvni tlak niži od 70 mmHg ili smanjenje za više od 15% ispod početne vrijednosti Pojava simptoma
English: There is insufficient information on the excretion of dinutuximab in human milk.
Croatian: Nema dovoljno podataka o izlučivanju dinutuksimaba u majčino mlijeko.
English: It is recommended to administer oral metolazone or intravenous furosemide every 6-12 hours as required.
Croatian: Preporučuje se primijeniti metolazon peroralno ili furosemid intravenski svakih 6 do 12 sati po potrebi.
English: It is recommended that antihistamine medicinal product be repeated every 4-6 hours as required during infusion of Unituxin.
Croatian: Preporučuje se ponavljanje antihistaminika svakih 4 do 6 sati po potrebi tijekom infuzije Unituxina.
English: • Any kind of pain: in the stomach, throat, chest, face, hands, feet, legs or arms (such as numbness, tingling or burning) back, neck, joint, bone, muscle, mouth, eye, genitals.
Croatian: • Bilo kakvu vrstu boli: u trbuhu, grlu, prsima, licu, šakama, stopalima, nogama ili rukama (poput utrnulosti, trnaca ili osjećaja žarenja), leđima, vratu, zglobovima, kostima, mišićima, ustima, očima,
English: Table 3: Clinical criteria that must be evaluated prior to the start of each treatment course of Unituxin
Croatian: Tablica 3: Klinički kriteriji koji se moraju procijeniti prije početka svakog ciklusa liječenja Unituxinom Toksičnost za središnji živčani sustav (SŽS)
English: Specifically, in the presence of human effector cells including peripheral blood mononuclear cells (PBMC) and granulocytes from normal human donors, dinutuximab was found to mediate the lysis of several neuroblastoma cell lines in a dose-dependent manner.
Croatian: Posebice, u prisutnosti ljudskih efektorskih stanica, uključujući mononuklearne stanice periferne krvi i granulocite normalnih ljudskih davatelja, otkriveno je da dinutuksimab posreduje u lizi nekoliko staničnih linija neuroblastoma, na način koji je ovisan o dozi.
English: Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m2.
Croatian: Unituxin se primjenjuje intravenskom infuzijom kroz pet ciklusa u dnevnoj dozi od 17,5 mg/m2.
English: Dinutuximab is a chimeric human/mouse monoclonal antibody produced in a murine myeloma cell line (Sp2/0) by recombinant DNA technology.
Croatian: Dinutuksimab je kimerično ljudsko/mišje monoklonsko protutijelo proizvedeno tehnologijom rekombinantne DNA u staničnoj liniji mišjeg mijeloma (Sp2/0).
English: Systemic infection or sepsis Grade 3 or 4
Croatian: Sistemska infekcija ili sepsa 3. ili 4. stupnja Pojava simptoma
English: An opioid, such as morphine sulphate, is recommended to be administered by intravenous infusion prior to each dinutuximab infusion and continued as an intravenous infusion during and until 2 hours after completion of the treatment.
Croatian: Opioid, poput morfinsulfata, preporučuje se primjenjivati intravenskom infuzijom prije svake infuzije dinutuksimaba te nastaviti u obliku intravenske infuzije tijekom i do 2 sata nakon završetka liječenja.
English: Respiratory dysfunction
Croatian: Poremećaj respiratorne funkcije
English: • Rapid swelling of the arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties (Capillary Leak Syndrome).
Croatian: • Brzo oticanje Vaših ruku, nogu i drugih dijelova tijela, brzi pad krvnog tlaka, ošamućenost i otežano disanje (sindrom kapilarnog curenja).
English: The clinical study report should be submitted by PASS: In order to better characterise the safety and immunogenicity of Unituxin and its impact on drug exposure, the applicant should conduct and submit the results of a safety study.
Croatian: PASS: u svrhu bolje karakterizacije sigurnosti i imunogenosti lijeka Unituxin i njezinog utjecaja na izloženost lijeku, podnositelj treba provesti i podnijeti rezultate ispitivanja sigurnosti primjene lijeka.
English: Antihistamine premedication (e.g. hydroxyzine or diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab infusion.
Croatian: Premedikaciju antihistaminikom (npr. hidroksizin ili difenhidramin) treba primijeniti intravenskom injekcijom otprilike 20 minuta prije početka svake infuzije dinutuksimaba.
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures (see sections 4.2 and 4.8).
Croatian: Liječenje Unituxinom treba prekinuti ako bol nije zadovoljavajuće kontrolirana unatoč smanjenju brzine infuzije i uvođenju najviših potpornih mjera (vidjeti dijelove 4.2. i 4.8.).
English: From a microbiological point of view, the diluted solution should be used immediately.
Croatian: S mikrobiološkog stajališta razrijeđena otopina se mora odmah primijeniti.
English: Serum sickness Grade 4 (life-threatening)
Croatian: Serumska bolest 4. stupnja (opasno po život)
English: The 2-year estimates of EFS were 66 % among subjects receiving dinutuximab immunotherapy plus isotretinoin as compared with 48 % in subjects receiving isotretinoin alone (log-rank test p = 0.033) although this difference did not reach formal statistical significance according to the pre-specified plan for interim analyses.
Croatian: Dvogodišnje procjene preživljenja bez događaja su iznosile 66% među ispitanicima koji su primali imunoterapiju dinutuksimabom uz izotretinoin, u usporedbi s 48% u ispitanika koji su primali samo izotretinoin (log-rang test p = 0,033), premda ova razlika formalno nije bila statistički značajna prema unaprijed utvrđenom planu interim analiza.
English: Unequal pupils
Croatian: midrijaza nejednake zjenice
English: Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvu prisutnost čestica ili promjenu boje prije primjene.
English: • GM-CSF is given as either an injection under the skin or as a drip into one of your veins each day for
Croatian: • GM-CSF se primjenjuje potkožnom injekcijom ili infuzijom kap po kap u jednu od Vaših vena svakodnevno tijekom 14 dana.
English: 6.6 Special precautions for disposal and other handling The exact volume of Unituxin concentrate for solution for infusion required for the patient dose (see section 4.2) must be injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Croatian: Posebne mjere za zbrinjavanje i druga rukovanja lijekom Točan volumen Unituxin koncentrata za otopinu za infuziju potreban za bolesnikovu dozu (vidjeti dio 4.2.) mora se injicirati u vrećicu od 100 mL otopine natrijevog klorida 9 mg/mL (0,9%) za injekciju.
English: Human IgG is known to be secreted in human milk.
Croatian: Poznato je da se ljudski IgG izlučuje u majčino mlijeko.
English: See section 4 for more information about pain side effects.
Croatian: Pogledajte dio 4 za više informacija o boli kao nuspojavi.
English: Following ASCT, 226 subjects were randomly assigned 1:1 to either a standard therapy arm (six courses of isotretinoin) or a dinutuximab immunotherapy arm (five courses of dinutuximab in combination with alternating GM-CSF and IL-2; combined with isotretinoin concurrently for six courses).
Croatian: Nakon ASCT-a, 226 ispitanika je nasumično raspodijeljeno u omjeru 1:1 ili u skupinu standardne terapije (šest ciklusa izotretinoina) ili u skupinu imunoterapije dinutuksimabom (pet ciklusa dinutuksimaba u kombinaciji s naizmjenično GM-CSF-om i IL-2; i istovremeno u kombinaciji s izotretinoinom kroz šest ciklusa).
English: • If patient tolerated 50 % dose of GM-CSF or IL-2, start at this dose and dinutuximab rate of 0.875 mg/m2/h.
Croatian: • Ako je bolesnik podnosio 50% doze GM-CSF-a ili IL-2, započeti s tom dozom i infuzijom dinutuksimaba brzinom od 0,875 mg/m2/sat.
English: • Delay course initiation until dyspnoea at rest has been resolved and/or peripheral oxygen saturation is at least 94 % on room air. Renal dysfunction
Croatian: • Odgoditi početak ciklusa dok se dispneja u mirovanju ne povuče i/ili dok periferna zasićenost kisikom ne bude najmanje 94% pri sobnom zraku.
English: • For IL-2 courses, administer IL-2 at 50 % of the dose starting the next day and continue for the remainder of the course.
Croatian: • Za cikluse s IL-2, primijeniti 50% doze IL-2 počevši od sljedećeg dana i nastaviti tijekom ostatka ciklusa.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Croatian: manje često (≥ 1/1000 i < 1/100).
English: The required volume of dinutuximab should be withdrawn and injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Croatian: Potrebni volumen dinutuksimaba treba izvući i injicirati u vrećicu od 100 mL otopine natrijevog klorida 9 mg/mL (0,9%) za injekciju.
English: The 5 year estimates of OS were 74 % for dinutuximab immunotherapy compared to 57 % for isotretinoin alone (log-rank test p = 0.030).
Croatian: Petogodišnje procjene ukupnog preživljenja su iznosile 74% za imunoterapiju dinutuksimabom u odnosu na 57% za liječenje samo izotretinoinom (log-rang test p = 0,030).
English: Interleukin-2 (IL-2): 3 MIU/m 2/day administered by continuous intravenous infusion over 96 hours on Days 1-4 and4.5 MIU/m2/day on Days 8-11.
Croatian: Interleukin-2 (IL-2): 3 MIU/m2/dan primijenjeno kontinuiranom intravenskom infuzijom tijekom 96 sati od 1. do 4. dana te 4,5 MIU/m2/dan od 8. do 11. dana.
English: Breast-feeding should be discontinued during treatment with Unituxin.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Unituxin.
English: • Delay initiation of first course until absolute phagocyte count (APC) is at least 1,000/μL.
Croatian: • Odgoditi početak prvog ciklusa dok apsolutni broj fagocita ne bude najmanje 1000/μL.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva makulopapularni osip
English: • If signs and symptoms resolve rapidly with the above measures, dinutuximab infusion may be resumed at a rate of 0.875 mg/m2/h.
Croatian: • Ako se znakovi i simptomi brzo povuku uz gore navedene mjere, može se nastaviti infuzija dinutuksimaba brzinom od 0,875 mg/m2/sat.
English: Characteristic symptoms and signs include hypotension, generalized oedema, ascites, dyspnoea, pulmonary oedema and acute renal failure associated with hypoalbuminaemia and haemoconcentration.
Croatian: Karakteristični simptomi i znakovi uključuju hipotenziju, generalizirani edem, ascites, dispneju, plućni edem i akutno zatajenje bubrega povezano s hipoalbuminemijom i hemokoncentracijom.
English: It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Croatian: Primjenjuje se u kombinaciji s faktorom stimulacije kolonija granulocita i makrofaga (GM-CSF), interleukinom-2 (IL-2) i izotretinoinom.
English: Hypersensitivity (Grade 4) to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost (4. stupnja) na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Adverse reactions reported in four clinical studies (ANBL0032, ANBL0931, CCG-0935A, and DIV-NB201) of dinutuximab in patients (N=984) with high-risk neuroblastoma are summarized in Table 5.
Croatian: Nuspojave dinutuksimaba u bolesnika (N=984) s neuroblastomom visokog rizika koje su prijavljene u četiri klinička ispitivanja (ANBL0032, ANBL0931, CCG-0935A i DIV-NB-201) su sažete u Tablici 5.
English: Long-term overall survival was evaluated with 5 years of follow up after the EFS analysis and continued to demonstrate a survival advantage for patients who received dinutuximab immunotherapy compared to those who received isotretinoin alone.
Croatian: Dugoročno ukupno preživljenje je procijenjeno uz petogodišnje praćenje nakon analize preživljenja bez događaja te je i dalje pokazivalo prednost u preživljenju za bolesnike koji su primali imunoterapiju dinutuksimabom u odnosu na one koji su primali samo izotretinoin.
English: Device-related infection, infection susceptibility increased, bacteraemia, enterocolitis
Croatian: Infekcije i infestacije infekcija vezana uz pomagalo, povećana podložnost infekciji, bakterijemija, enterokolitis
English: Unituxin will be given to you in five of the six courses.
Croatian: Koliko ćete lijeka primiti Primat ćete Unituxin u pet od šest ciklusa.
English: It is recommended that additional intravenous bolus doses of an opioid are administered as needed for treatment of pain up to once every 2 hours during the dinutuximab infusion.
Croatian: Preporučuje se primjena dodatnih intravenskih bolusnih doza opioida po potrebi radi liječenja boli do jednom svaka 2 sata tijekom infuzije dinutuksimaba.
English: Lidocaine may be administered as an intravenous infusion (2 mg/kg in 50 mL of 0.9 % sodium chloride) over 30 minutes prior to the start of each dinutuximab infusion and continued via intravenous infusion at 1 mg/kg/h up to 2 hours after completion of the treatment.
Croatian: Lidokain se može primijeniti u obliku intravenske infuzije (2 mg/kg u 50 ml 0,9%-tnog natrijevog klorida) tijekom 30 minuta prije početka svake infuzije dinutuksimaba te nastaviti intravenskom infuzijom brzinom od 1 mg/kg/sat do 2 sata nakon završetka liječenja.
English: Pre-medication should always be considered before starting each infusion.
Croatian: Prije početka svake infuzije uvijek treba uzeti u obzir premedikaciju.
English: • If abnormalities remain stable or improve before the next course administer dinutuximab at 0.875 mg/m2/h and full dose GM-CSF or IL-2.
Croatian: • Ako abnormalnosti ostanu stabilne ili se poboljšaju prije sljedećeg ciklusa, primijeniti infuziju dinutuksimaba brzinom od 0,875 mg/m2/sat i punu dozu GM-CSF-a ili IL-2.
English: Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway oedema, dyspnoea, bronchospasm, stridor, urticaria, and hypotension.
Croatian: Ozbiljne reakcije na infuziju koje zahtijevaju hitnu intervenciju uključujući potporu krvnog tlaka, terapiju bronhodilatatorom, kortikosteroide, smanjenje brzine infuzije, prekid infuzije ili trajni prekid liječenja Unituxinom su uključivale edem lica i gornjih dišnih puteva, dispneju, bronhospazam, stridor, urtikariju i hipotenziju.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before being given Unituxin.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili medicinskoj sestri prije nego primite Unituxin.
English: Hepatic dysfunction Regular monitoring of liver function is recommended during dinutuximab immunotherapy.
Croatian: Preporučuje se redovito praćenje funkcije jetre tijekom imunoterapije dinutuksimabom.
English: • If blood pressure (BP) remains stable for at least 2 hours, resume GM
Croatian: • Ako krvni tlak ostane stabilan tijekom najmanje 2 sata, nastaviti primjenu
English: Tachycardia (sinusal, atrial, ventricular)
Croatian: Srčani poremećaji tahikardija (sinusna, atrijska, ventrikulska)
English: IL-2 was administered concurrently with dinutuximab as a continuous intravenous infusion for four days during Week 1 of Courses 2 and 4 at a dose of 3.0 MIU/m2/day, and during Week 2 of Courses 2 and 4 at a dose of 4.5 MIU/m2/day.
Croatian: IL-2 je primijenjen istovremeno s dinutuksimabom kao kontinuirana intravenska infuzija kroz četiri dana u 1. tjednu 2. i 4. ciklusa u dozi od 3,0 MIU/m2/dan te u 2. tjednu 2. i 4. ciklusa u dozi od 4,5 MIU/m2/dan.
English: 160 mg/m2/day; for body weight up to 12 kg: 2.67 mg/kg administered orally twice daily for a total daily dose of 5.33 mg/kg/day (round dose up to nearest 10 mg).
Croatian: 160 mg/m2/dan; za tjelesnu težinu do 12 kg: 2,67 mg/kg primijenjeno peroralno dvaput dnevno u ukupnoj dozi od 5,33 mg/kg/dan (zaokružiti dozu na najbližih 10 mg).
English: This is very common during treatment (affecting more than 1 in 10 people).
Croatian: To je vrlo često tijekom liječenja (javlja se u više od 1 na 10 osoba).
English: GM-CSF was administered at a dose of 250 μg/m2/day during Courses 1, 3, and 5 and dosed daily for 14 days.
Croatian: GM-CSF je primijenjen u dozi od 250 μg/m2/dan tijekom 1., 3. i 5. ciklusa svakodnevno kroz 14 dana.
English: • Resume infusion at the original rate.
Croatian: • Nastaviti infuziju prvotnom brzinom.
English: • Delay course initiation until CNS toxicity is Grade 1 or resolved and/or seizure disorder is well controlled Hepatic dysfunction
Croatian: • Odgoditi početak ciklusa dok se toksičnost za SŽS ne smanji na 1. stupanj ili ne povuče i/ili dok poremećaj s napadajima ne bude pod kontrolom Poremećaj funkcije jetre
English: Adverse reactions are defined as those adverse events that occurred at a higher frequency in the dinutuximab, GMCSF, IL-2 and isotretinoin-treated group compared with the isotretinoin-treated control group during the ANBL0032 randomised, controlled, pivotal study, and that have a plausible mechanistic relationship to treatment with dinutuximab.
Croatian: Nuspojave su definirane kao štetni događaji koji su se pojavili češće u skupini liječenoj dinutuksimabom, GM-CSF-om, IL-2 i izotretinoinom u usporedbi s kontrolnom skupinom liječenom izotretinoinom tijekom randomiziranog, kontroliranog, pivotalnog ispitivanja ANBL0032, a koje imaju vjerojatnu vezu, s obzirom na mehanizam djelovanja, s liječenjem dinutuksimabom.
English: - If you have any further questions, ask your doctor or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili medicinskoj sestri.
English: If tolerated, increase GM-CSF or IL-2 to full dose the next day.
Croatian: Ako se podnosi, povećati dozu GM-CSF-a ili IL-2 na punu dozu sljedećeg dana.
English: Intravenous sodium chloride 9 mg/mL (0.9%) solution for injection (10 mL/kg) should be administered over one hour just prior to the dinutuximab infusion.
Croatian: Otopinu natrijevog klorida 9 mg/mL (0,9%) za injekciju (10 mL/kg) treba primijeniti intravenski tijekom jednog sata neposredno prije infuzije dinutuksimaba.