FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common (may affect more than 1 in 10 people) - decrease in the number of red blood cells - reduced thyroid gland activity - feeling less hungry - headache - shortness of breath; cough - diarrhoea; stomach pain; nausea; vomiting; constipation - itching; skin rash - pain in muscle and bones; joint pain - feeling tired; unusual tiredness or weakness; swelling; fever
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) - smanjen broj crvenih krvnih stanica - smanjena aktivnost štitnjače - smanjen osjećaj gladi - glavobolja - nedostatak zraka; kašalj - proljev; bol u trbuhu; mučnina; povraćanje; zatvor - svrbež; osip kože - bol u mišićima i kostima; bol u zglobovima - osjećaj umora; neuobičajen umor ili slabost; oticanje; vrućica
English: KEYNOTE-006: Controlled trial in melanoma patients naïve to treatment with ipilimumab The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, controlled, Phase III study for the treatment of advanced melanoma in patients who were naïve to ipilimumab.
Croatian: Sigurnost i djelotvornost pembrolizumaba ispitivane su u ispitivanju KEYNOTE-006, multicentričnom, kontroliranom ispitivanju faze III u liječenju uznapredovalog melanoma u bolesnika koji prethodno nisu liječeni ipilimumabom.
English: Common (may affect up to 1 in 10 people) - lung infection - decrease in the number of platelets (bruising or bleeding more easily); decrease in the number of white blood cell (lymphocytes) - reactions related to the infusion of the medicine - overactive thyroid gland activity; hot flush - decreased sodium, potassium, or calcium in the blood - trouble sleeping - dizziness; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; lack of energy; change in your sense of taste - dry eye - abnormal heart rhythm - high blood pressure - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash sometimes with blisters; patches of skin which have lost colour; dry, itchy skin;
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) - infekcija pluća - smanjen broj krvnih pločica (povećana sklonost nastanku modrica ili krvarenju); smanjen broj bijelih krvnih stanica (limfocita) - reakcije povezane s infuzijom ovog lijeka - prekomjerna aktivnost štitnjače; navala vrućine - smanjene vrijednosti natrija, kalija ili kalcija u krvi - poteškoće sa spavanjem - omaglica; upala živaca koja uzrokuje utrnulost, slabost, trnce ili žareću bol u rukama i nogama;
English: * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model
Croatian: * Omjer hazarda (pembrolizumab u usporedbi s kemoterapijom) na temelju stratificiranog Coxovog modela proporcionalnog hazarda
English: Animal fertility studies have not been conducted with pembrolizumab.
Croatian: Nisu provedena ispitivanja učinaka pembrolizumaba na plodnost u životinja.
English: Common (may affect up to 1 in 10 people) - lung infection - decreased number of white blood cells (neutrophils) with a fever - reaction related to the infusion of the medicine - thyroid gland problems - decreased sodium or calcium in the blood - trouble sleeping - dry eye - abnormal heart rhythm - high blood pressure - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash, sometimes with blisters - muscle pain, aches or tenderness; joint pain with swelling; pain in arms or legs - inflammation of the kidneys; sudden kidney damage - chills; influenza like illness - increased calcium in the blood; increased liver enzyme levels in the blood
Croatian: manjak energije; promjena osjeta okusa - suho oko - poremećaj srčanog ritma - visok krvni tlak - upala pluća - upala crijeva; suha usta - izdignut crveni osip, ponekad praćen mjehurićima; gubitak boje na nekim dijelovima kože; suha koža koja svrbi; gubitak kose; kožne promjene nalik aknama - bolovi i osjetljivost mišića; bol u rukama ili nogama; bol u zglobovima praćena oticanjem - zimica; bolest nalik gripi - povišene vrijednosti jetrenih enzima u krvi; povišene vrijednosti kalcija u krvi; odstupanja u nalazima testova funkcije bubrega
English: Colitis has been reported in patients receiving pembrolizumab (see section 4.8).
Croatian: U bolesnika liječenih pembrolizumabom prijavljen je kolitis (vidjeti dio 4.8).
English: KEYNOTE-001: Open label study in melanoma patients naïve and previously treated with ipilimumab The safety and efficacy of pembrolizumab for patients with advanced melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001.
Croatian: Sigurnost i djelotvornost pembrolizumaba u bolesnika s uznapredovalim melanomom ispitivane su u nekontroliranom, otvorenom ispitivanju KEYNOTE-001.
English: KEYTRUDA in combination with axitinib in RCC
Croatian: International Metastatic RCC Database Consortium, IMDC).
English: Ipilimumab Pembrolizumab 10 mg/kg every 2 or 3 weeks (pooled)
Croatian: Ipilimumab Pembrolizumab 10 mg/kg svaka 2 ili 3 tjedna (objedinjeni podaci)
English: Based on the stratified Cox proportional hazard model Based on stratified log-rank test Assessed by BICR using RECIST 1.1 Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region Based on Kaplan-Meier estimation NA = not available
Croatian: Ocjena zaslijepljenog neovisnog središnjeg povjerenstva na temelju verzije 1.1 kriterija RECIST Na temelju bolesnika s najboljim ukupnim odgovorom kao potvrđenim potpunim ili djelomičnim odgovorom
English: The primary efficacy outcome measure was PFS as assessed by BICR using RECIST 1.1.
Croatian: Primarna mjera ishoda za djelotvornost bio je PFS prema ocjeni zaslijepljenog neovisnog središnjeg povjerenstva na temelju verzije 1.1 kriterija RECIST.
English: Pembrolizumab + Chemo Standard
Croatian: Pembrolizumab + aksitinib 60%
English: The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively.
Croatian: Početne značajke ove populacije uključivale su: medijan dobi od 63 godine (42% u dobi od 65 ili više godina); 61% muškaraca; 72% bijelaca i 21% azijata te 34% bolesnika s funkcionalnim ECOG statusom 0 i 66% njih s funkcionalnim ECOG statusom 1. Značajke bolesti uključivale su skvamozne (21%) i neskvamozne (70%) stanice; stadij M1 (91%); stabilne metastaze u mozgu (15%) te incidenciju mutacija gena EGFR (8%) ili ALK (1%).
English: Median in months (95% CI) Overall response rate ORR % (95% CI) Complete response % Partial response % Response duration Median in months (range)
Croatian: Medijan u mjesecima (95% CI) Stopa ukupnog odgovora ORR % (95% CI)
English: Treatment arm OS rate at 12 months OS rate at 24 months HR (95% CI) p-value Pembrolizumab
Croatian: Liječena skupina Stopa OS-a u 12. mj. Stopa OS-a u 24. mj. HR (95% CI) p-vrijednost Pembrolizumab
English: Treatment arm PFS rate at 12 months PFS rate at 18 months HR (95% CI) p-value Pembrolizumab + Axitinib 60%
Croatian: Liječena skupina Stopa OS-a u 12. mj. Stopa OS-a u 24. mj. HR (95% CI) p-vrijednost Pembrolizumab + KT
English: Pembrolizumab 2 mg/kg every 3 weeks:
Croatian: Pembrolizumab 2 mg/kgsvaka 3 tjedna:
English: Number of responders Median in months (range)
Croatian: Medijan u mjesecima (raspon)
English: Hazard ratio * (95% CI)
Croatian: Omjer hazarda za RFS* (95% CI)
English: Randomisation to the chemotherapy and the chemotherapy-pembrolizumab arms remains open.
Croatian: I dalje traje randomizacija u skupinu koja prima kemoterapiju odnosno skupinu koja prima kemoterapiju s pembrolizumabom.
English: • Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks.
Croatian: 100 mg/m2 primijenjenim 1., 8. i 15. dana svakog 21-dnevnog ciklusa tijekom 4 ciklusa, nakon čega se primjenjivao pembrolizumab 200 mg svaka 3 tjedna.
English: Hazard ratio (pembrolizumab compared to standard treatment) based on the stratified Cox proportional hazard model One-sided p-Value based on log-rank test
Croatian: Omjer hazarda (pembrolizumab u usporedbi sa standardnim liječenjem) na temelju stratificiranog Coxovog modela proporcionalnih hazarda
English: Do not perform these activities if your ability to concentrate and react is affected.
Croatian: Nemojte obavljati te aktivnosti ako je narušena vaša sposobnost koncentracije i reakcije.
English: 31 December 2020
Croatian: 31. prosinca 2020.
English: This means that for ethical reasons it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da zbog etičkih razloga nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: There are also links to other websites about rare diseases and treatments.
Croatian: Dostupne su i poveznice na druge internetske stranice o rijetkim bolestima i njihovom liječenju.
English: Date of first authorisation: 08 May 2017
Croatian: Datum prvog odobrenja: 8. svibnja 2017.
English: Two modes of administration are possible:
Croatian: Moguća su dva načina primjene:
English: It will be given to you by a doctor or nurse while you are in hospital.
Croatian: Lijek će vam davati liječnik ili medicinska sestra tijekom vašeg boravka u bolnici.
English: The solution must not be exposed to direct sunlight or heat.
Croatian: Otopina se ne smije izlagati izravnoj sunčevoj svjetlosti ili toplini.
English: This dosing schedule should be maintained for as long as required by the patient.
Croatian: Taj raspored doziranja potrebno je održati dokle god je to potrebno bolesniku.
English: Tell your doctor immediately if you notice any of these problems.
Croatian: Odmah obavijestite liječnika ako primijetite bilo koji od ovih problema.
English: The doctor will calculate your body surface area from your height and weight.
Croatian: Liječnik će izračunati vašu tjelesnu površinu na temelju vaše visine i težine.
English: What Qarziba is and what it is used for
Croatian: Što je Qarziba i za što se koristi
English: 31 December 2021
Croatian: 31. prosinca 2021.
English: This medicine should not be given to children under 12 months because there is insufficient experience in this age group.
Croatian: Lijek se ne smije davati djeci mlađoj od 12 mjeseci jer ne postoji dovoljno iskustva za tu dobnu skupinu.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: Your doctor will do blood tests and may do eye tests while you are taking this medicine.
Croatian: Vaš liječnik napravit će krvne pretrage, a možda i testove vida dok uzimate ovaj lijek.
English: A total of 370 patients were randomised and received treatment.
Croatian: Randomizirano je ukupno 370 bolesnika koji su primili terapiju.
English: Patients with progressive disease were excluded.
Croatian: Bolesnici s progresivnom bolešću bili su isključeni.
English: Annual reports to be submitted
Croatian: Godišnja izvješća koja je potrebno predati
English: Serious anaphylactic reactions occurred in 3.5% of the patients.
Croatian: Ozbiljne anafilaktičke reakcije pojavile su se u 3,5 % bolesnika.
English: Systemic infections
Croatian: Sistemske infekcije
English: Classical biotransformation studies have not been performed.
Croatian: Nisu provedena klasična ispitivanja biotransformacije.
English: It is used for patients aged 12 months and above.
Croatian: Koristi se za liječenje bolesnika u dobi od 12 mjeseci i starijih
English: Grade 1 - 2
Croatian: Bilo koja stupanj 1 - 2
English: Note that elastomeric pumps are not considered suitable in combination with in-line filters.
Croatian: Valja napomenuti da se elastomerne pumpe ne smatraju prikladnima u kombinaciji s linijskim filtrima.
English: The same treatment regimen was used in a Phase II study (study 2), which enrolled 44 patients.
Croatian: Isti režim liječenja upotrijebljen je u ispitivanju faze II. (2. ispitivanje) u kojem su sudjelovala 44 bolesnika.
English: The individual dose may vary widely.
Croatian: Individualna doza može se znatno razlikovati.
English: These were 61 boys and 37 girls, aged 1 to 26 years (median 5 years).
Croatian: U ispitivanju je sudjelovao 61 dječak i 37 djevojčica u dobi između 1 i 26 godina (medijan dobi bio je 5 godina).
English: Both motor and sensory peripheral neuropathies have been reported, overall in 9% of the patients.
Croatian: Zabilježene su i motorna i senzorna periferna neuropatija, sveukupno u 9 % bolesnika.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Croatian: Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100).
English: • adequate liver function: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST)
Croatian: • odgovarajuća funkcija jetre: alanin aminotransferaza (ALT) / aspartat aminotranferaza (AST)
English: A doctor experienced in the use of medicines to treat cancer will supervise your treatment.
Croatian: Liječnik s iskustvom u korištenju lijekova za liječenje raka pratit će vaše liječenje.
English: Qarziba is for intravenous infusion.
Croatian: Qarziba namijenjen je za intravensku infuziju.
English: Prior to starting each treatment course, the following clinical parameters should be evaluated and treatment should be delayed until these values are reached:
Croatian: Prije početka svakog ciklusa liječenja potrebno je ocijeniti sljedeće kliničke parametre, a liječenje je potrebno odgoditi dok se ne postignu sljedeće vrijednosti:
English: The daily dose is 10 mg/m2.
Croatian: Dnevna doza iznosi 10 mg/m2.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako primjenjujete ili ste nedavno primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Overall, measurable ADA titres were detected in 65 (62%) of the 105 patients examined.
Croatian: Općenito, mjerljivi titri protutijela na lijek otkriveni su u 65 (62 %) od 105 pregledanih bolesnika.
English: Careful monitoring of circulatory and respiratory function is required.
Croatian: Potrebno je pozorno praćenje cirkulatorne i respiratorne funkcije.
English: Your doctor will further decide whether the co-administration of a second medicine, interleukin-2, is necessary for the treatment of your cancer.
Croatian: Vaš liječnik dodatno će odlučiti je li istodobna primjena drugog lijeka, interleukina-2, potrebna za liječenje vašeg raka.
English: The safety and efficacy of Qarziba in children aged less than 12 months have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Qarziba u djece mlađe od 12 mjeseci nisu još ustanovljene.
English: These are proteins, which specifically recognise and bind to other unique proteins in the body.
Croatian: To su proteini koji specifično prepoznaju druge jedinstvene proteine u tijelu i vežu se za njih.
English: • eye problems You may notice changes to your vision.
Croatian: Možda ćete primijetiti promjene koje se odnose na vaš vid.
English: It usually occurs at the beginning of infusion.
Croatian: Uobičajeno se javlja na početku davanja infuzije.
English: The maximum single dose of gabapentin is 300 mg.
Croatian: Najviša pojedinačna doza gabapentina iznosi 300 mg.
English: The first infusion day and course usually requires a higher dose than subsequent days and courses.
Croatian: Prvi dan infuzije i ciklusa obično zahtijeva veću dozu u odnosu na sljedeće dane i cikluse.
English: The solution for infusion must be prepared under aseptic conditions.
Croatian: Otopina za infuziju mora se pripremiti u aseptičkim uvjetima.
English: < 5 times upper limit of normal (ULN)
Croatian: < 5-erostruke vrijednosti gornje granice normale (GGN)
English: • grade 4 hyponatremia (< 120 mEq/L) despite appropriate fluid management
Croatian: • hiponatrijemija 4. stupnja (< 120 mEq/l) unatoč odgovarajućoj kontroli tekućina
English: ≥ 20,000/µL, haemoglobin > 8.0 g/dL
Croatian: ≥ 20 000/µl, hemoglobin > 8,0 g/dl
English: Safety profile with and without IL-2
Croatian: Sigurnosni profil s IL-2 i bez IL-2
English: Elimination The half-life observed in studies 1 and 2 was in the range of 190 hours, i.e. 8 days.
Croatian: Eliminacija Poluvijek zabilježen u 1. i 2. ispitivanju bio je u rasponu od 190 sati, odnosno 8 dana.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i uobičajeno ne bi smjeli iznositi više od 24 sata pri temperaturi od 2 °C do 8 °C, osim ako se razrjeđivanje odvija u kontroliranim i validiranim aseptičkim uvjetima.
English: • pulse oximetry > 94% on room air
Croatian: • pulsna oksimetrija > 94 % pri sobnom zraku
English: Cytokine release syndrome was also reported in 32% of the patients.
Croatian: Sindrom otpuštanja citokina također je zabilježen u 32 % bolesnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1191/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1191/001
English: Most patients with relapsed disease were enrolled after their first relapse and the median time from diagnosis to first relapse was about 14 months.
Croatian: Većina bolesnika s recidivom bolesti uključila se nakon prvog recidiva, a medijan vremena između postavljanja dijagnoze do prvog recidiva iznosio je otprilike 14 mjeseci.
English: Once opened, Qarziba is intended for immediate use.
Croatian: Nakon otvaranja, Qarziba namijenjen je za trenutačnu primjenu.
English: • are allergic to dinutuximab beta or any of the other ingredients of this medicine (listed in section 6)
Croatian: • alergični na dinutuksimab beta ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6),
English: • infection, in particular infection associated with the catheter that delivers the medicine
Croatian: • infekcija, osobito infekcija povezana s kateterom putem kojeg se primjenjuje lijek
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u popisu referentnih datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: It is also used to treat neuroblastoma that has come back (relapsed) or could not be completely treated with previous therapies.
Croatian: Također se koristi za liječenje neuroblastoma koji se vratio (recidiv) ili koji nije bilo moguće u potpunosti izliječiti prethodnim terapijama.
English: For patients without evidence of disease at baseline, addition of IL-2 did not improve EFS and OS.
Croatian: U pogledu bolesnika bez dokaza o bolesti na početku, dodavanje IL-2 nije poboljšalo EFS ni OS.
English: As they typically have a central venous catheter in situ, they are at risk of developing systemic infection.
Croatian: Budući da bolesnici uobičajeno imaju postavljen centralni venski kateter in situ, postoji rizik od razvoja sistemske infekcije.
English: It was combined with 13-cis retinoic in most patients and with IL-2 in 307 patients.
Croatian: Kombiniran je s 13-cis retinoičnom kiselinom u većine bolesnika te s IL-2 u 307 bolesnika.
English: It is one of the most common cancers in infancy.
Croatian: Riječ je o jednoj od najčešćih vrsta raka u dojenčadi.
English: Qarziba should not be used during pregnancy.
Croatian: Qarziba ne smije se primjenjivati u trudnica.
English: This has to be taken into consideration when interpreting PK parameters (Cmax, exposure, half-life) listed below.
Croatian: To valja uzeti u obzir pri tumačenju farmakokinetičkih parametara (Cmax, izloženost, poluvijek) navedenih u nastavku.
English: There are no data on pregnant women.
Croatian: Nema podataka o primjeni u trudnica.
English: Treatment must be interrupted in patients who experience Grade 3 vision toxicity (i.e. subtotal vision loss per toxicity scale).
Croatian: Liječenje se mora prekinuti u bolesnika u kojih se javlja toksičnost za vid 3. stupnja (tj. nepotpun gubitak vida prema ljestvici toksičnosti).
English: Qarziba will be given to you in five treatment courses of 35 days and the infusion will last 5 or 10 days in the beginning of each course.
Croatian: Qarziba dobivat ćete u pet ciklusa liječenja u trajanju od 35 dana, a infuzija će trajati 5 ili 10 dana na početku svakog ciklusa.
English: Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body, in particular in the glands above the kidneys.
Croatian: Neuroblastom je vrsta raka koji raste iz abnormalnih živčanih stanica u tijelu, osobito u nadbubrežnim žlijezdama.
English: Given the limitation of the bioanalytical methods, data are currently insufficient to properly evaluate the impact of the formation of anti-drug antibodies on pharmacokinetic and pharmacodynamic parameters, as well as on the efficacy and safety of dinutuximab beta.
Croatian: S obzirom na ograničenje bioanalitičkih metoda, postojeći podaci nisu dovoljni kako bi se odgovarajuće ocijenio utjecaj stvaranja protutijela na lijek na farmakokinetičke i farmakodinamičke parametre kao i na djelotvornost i sigurnost dinutuksimaba beta.
English: • decreased weight, loss of fluids (dehydration)
Croatian: • smanjena tjelesna težina, gubitak tekućine (dehidracija)
English: Effects of gender and age were not found to influence the pharmacokinetics of dinutuximab beta but data in children less than 2 years of age are very limited and insufficient to support dosing.
Croatian: Nije utvrđeno da spol i dob utječu na farmakokinetiku dinutuksimaba beta, ali podaci u djece mlađe od 2 godine vrlo su ograničeni i nisu dovoljni da bi se doziranje potkrijepilo.
English: Qarziba is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies.
Croatian: Qarziba ograničen je samo na bolničku primjenu i mora se primjenjivati pod nadzorom liječnika s iskustvom u primjeni onkoloških terapija.
English: Examples of medicines that suppress the immune system are corticosteroids used to reduce inflammation or prevent organ transplant rejection.
Croatian: Primjeri lijekova koji potiskuju imunosni sustav jesu kortikosteroidi, koji se koriste za smanjenje upala ili sprečavanje odbacivanja presađenih organa.
English: • shock due to decreased body fluid volume
Croatian: • šok uzrokovan smanjenjem količine tjelesne tekućine
English: Treatment with dinutuximab beta should be permanently discontinued if the following toxicities occur:
Croatian: Liječenje dinutuksimabom beta potrebno je trajno prekinuti ako se pojave sljedeće toksičnosti:
English: A population pharmacokinetic modelling approach was used to investigate the influence of covariates.
Croatian: Pristup populacijskog farmakokinetičkog modeliranja upotrijebljen je za istraživanje utjecaja kovarijabli.
English: Pre-medication should always be considered before starting each infusion (see section 4.4).
Croatian: Prije početka svake infuzije uvijek treba uzeti u obzir premedikaciju (vidjeti dio 4.4).
English: No non-clinical studies to evaluate the potential of dinutuximab beta to cause carcinogenicity, genotoxicity or developmental and reproductive toxicity have been conducted.
Croatian: Nisu provedena neklinička ispitivanja za procjenu potencijala dinutuksimaba beta za izazivanje kancerogenosti, genotoksičnosti ili razvojne i reproduktivne toksičnosti.