FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthcare professionals are asked to report any suspected adverse reactions.
Croatian: Od zdravstvenih se radnika traži da prijave svaku sumnju na nuspojavu za ovaj lijek.
English: • paralysis of eye muscles, blurred vision, light sensitivity, swelling in the retina
Croatian: • paraliza očnih mišića, zamućen vid, osjetljivost na svjetlost, oticanje mrežnice
English: A triple therapy, including nonopioid analgesics (according to WHO guidelines), gabapentin and opioids, is recommended for pain treatment.
Croatian: Za liječenje boli preporučuje se trostruka terapija, uključujući neopioidne analgetike (prema smjernicama SZO-a), gabapentin i opioide.
English: Dinutuximab beta binds to the molecule known as disialoganglioside 2 (GD2), which is present on cancer cells, and this activates the body's immune system, causing it to attack the cancer cells.
Croatian: Dinutuksimab beta veže se za molekulu naziva disialogangliozid 2 (GD2), koji je prisutan na stanicama raka, čime se aktivira imunosni sustav tijela što dovodi do napada na stanice raka.
English: Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 °C (50 mL syringe) and for up to 7 days at 37 ºC (250 mL infusion bag), after cumulative storage in a refrigerator (2 °C - 8 °C) for 72 hours (see section 6.6).
Croatian: Dokazane su kemijska i fizikalna stabilnost u primjeni do 48 sati pri temperaturi od 25 °C (štrcaljka od 50 ml) te do 7 dana pri temperaturi od 37 ºC (vrećica za infuziju od 250 ml), nakon sveukupnog čuvanja u hladnjaku (2 °C - 8 °C) 72 sata (vidjeti dio 6.6).
English: • a type of allergy (serum sickness) with fever, rash, joint inflammation
Croatian: • vrsta alergije (serumska bolest) popraćena vrućicom, osipom, upalom zglobova
English: Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 °C (50 mL syringe) and for up to 7 days at 37 ºC (250 mL infusion bag), after cumulative storage in a refrigerator (2 °C - 8 °C) for 72 hours.
Croatian: Dokazane su kemijska i fizikalna stabilnost u primjeni do 48 sati pri temperaturi od 25 °C (štrcaljka od 50 ml) te do 7 dana pri temperaturi od 37 ºC (vrećica za infuziju od 250 ml), nakon sveukupnog čuvanja u hladnjaku (2 °C - 8 °C) 72 sata.
English: The patient-specific daily dose of Qarziba is calculated based on body surface area.
Croatian: Dnevna doza lijeka Qarziba za pojedinog bolesnika izračunava se na temelju tjelesne površine.
English: Dinutuximab beta target (GD2) is expressed on neuronal tissues, especially during embryofetal development, and may cross the placenta; therefore, Qarziba may cause fetal harm when administered to pregnant women.
Croatian: Ciljno mjesto dinutuksimaba beta (GD2) izraženo je na neuronima, posebno tijekom embriofetalnog razvoja, a on može prijeći posteljicu, stoga Qarziba može oštetiti plod kada se primjenjuje u trudnica.
English: • The active substance is dinutuximab beta.
Croatian: • Djelatna tvar je dinutuksimab beta.
English: Occurrence of haematologic toxicities has been reported with Qarziba, such as erythropenia, thrombocytopenia or neutropenia.
Croatian: Prijavljena je pojava hematoloških toksičnosti tijekom liječenja lijekom Qarziba, kao što su eritropenija, trombocitopenija ili neutropenija.
English: The individual dose is determined based on the body surface area and should be a total of 100 mg/m2 per course.
Croatian: Pojedinačna doza određuje se na temelju tjelesne površine, a trebala bi iznositi ukupno 100 mg/m2 po pojedinom ciklusu.
English: Treatment of hypersensitivity reactions
Croatian: Liječenje reakcija preosjetljivosti
English: In order to evaluate the add-on effect of IL-2 in patients with relapsed refractory neuroblastoma, the MAH will submit the results of study APN311202v3.
Croatian: Za ocjenu dodatnog učinka koji ima IL-2 u bolesnika s recidivom refraktornog neuroblastoma, nositelj odobrenja za stavljanje lijeka u promet podnijet će rezultate ispitivanja APN311-202v3.
English: Nervous system disorders headache peripheral neuropathy, seizure, paraesthesia, dizziness, tremor intracranial pressure increased, posterior reversible encephalopathy syndrome
Croatian: Poremećaji živčanog sustava glavobolja periferna neuropatija, napadaj, parestezija, omaglica, tremor povišen intrakranijalni tlak, sindrom posteriorne reverzibilne encefalopatije
English: ophthalmoplegia, papilloedema, accommodation disorder, blurred vision, photophobia
Croatian: oftalmoplegija, papiloedem, poremećaj akomodacije, zamućen vid, fotofobija
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Croatian: Ovaj lijek odobren je po shemi takozvanog „uvjetnog odobrenja”.
English: The solution for infusion should be administered via a peripheral or central intravenous line.
Croatian: Otopinu za infuziju potrebno je primjenjivati putem perifernog ili centralnog venskog katetera.
English: Dinutuximab beta was administered at a dose of 20 mg/m2/day on 5 consecutive days, given by 8-hour intravenous infusion in a 5-week treatment course, and was combined with 13-cis-RA and with or without additional subcutaneous IL-2 at the same posologies as in the previous studies.
Croatian: Dinutuksimab beta primijenjen je u dozi od 20 mg/m2/dan 5 uzastopnih dana u obliku 8-satne intravenske infuzije u 5-tjednom ciklusu liječenja, a kombiniran je s 13-cis-retinoičnom kiselinom s ili bez dodatnog IL-2 koji se primjenjivao supkutano u istom doziranju kao u prijašnjim ispitivanjima.
English: Eye disorders mydriasis, pupillotonia, eye oedema (eyelid, periorbital)
Croatian: Poremećaji oka midrijaza, pupilotonija, edem oka (kapak, periorbitalni)
English: The daily dose of gabapentin is increased to 2×10 mg/kg/day orally, the next day and to 3×10 mg/kg/day orally, the day before the onset of dinutuximab beta infusion and thereafter.
Croatian: Dnevna doza gabapentina povećava se sljedeći dan na 2 × 10 mg/kg/dan peroralno, a dan prije početka primjene infuzije dinutuksimaba beta i nakon toga na 3 x 10 mg/kg/dan.
English: The efficacy of dinutuximab beta has been evaluated in a randomised controlled trial comparing the administration of dinutuximab beta with or without IL-2 in the first-line treatment of patients with high-risk neuroblastoma and in two single-arm studies in the relapsed/refractory setting.
Croatian: Djelotvornost dinutuksimaba beta ocijenjena je u randomiziranom kontroliranom ispitivanju u kojem se uspoređivala primjena dinutuksimaba beta s ili bez IL-2 u prvoj liniji liječenja bolesnika s neuroblastomom visokog rizika te u dvama ispitivanjima s jednom skupinom s bolesnicima koji imaju recidiv neuroblastoma / refraktorni neuroblastom.
English: Vascular disorders hypotension, capillary leak syndrome hypertension hypovolaemic shock, veno-occlusive disease
Croatian: Krvožilni poremećaji hipotenzija, sindrom kapilarnog curenja hipertenzija hipovolemijski šok, venookluzivna bolest
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: The container should be inspected visually for particulates prior to administration.
Croatian: Spremnik je potrebno pregledati prije primjene kako bi se provjerilo da nema vidljivih čestica.
English: Eye disorders may occur as dinutuximab beta binds to optic nerve cells.
Croatian: Poremećaji oka mogu se pojaviti jer se dinutuksimab beta veže za stanice optičkog živca.
English: Oral gabapentin should be tapered off after weaning off intravenous morphine infusion, at the latest after dinutuximab beta infusion therapy has stopped.
Croatian: Gabapentin koji se primjenjuje peroralno potrebno je postupno prestati davati nakon postupnog ukidanja intravenske infuzije morfina, najkasnije nakon što se prekine infuzija dinutuksimaba beta.
English: Tell your doctor if you are breast-feeding.
Croatian: Recite svom liječniku ako dojite.
English: The primary efficacy endpoint was 3-year EFS and secondary endpoint was OS. EFS and OS rates are presented in Tables 2 and 3 according to the evidence of disease at baseline.
Croatian: Stope EFS-a i OS-a navedene su u tablicama 2. i 3. u skladu s dokazima o bolesti na početku.
English: The patient should be primed with 10 mg/kg/day, starting 3 days prior to dinutuximab beta infusion.
Croatian: Bolesnika je potrebno pripremiti davanjem doze od 10 mg/kg/dan, počevši 3 dana prije početka davanja infuzije dinutuksimaba beta.
English: Dinutuximab beta is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.
Croatian: Dinutuksimab beta je kimerično monoklonsko IgG1 protutijelo koje je specifično usmjereno na ugljikohidratni dio disialogangliozida 2 (GD2), koji je pretjerano izražen na stanicama neuroblastoma.
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (može se javiti u više od 1 na 10 osoba):
English: In animals, dedicated fertility studies have not been conducted, but no adverse effects on reproductive organs were observed in toxicity studies performed in Guinea pig and cynomolgous monkey.
Croatian: Nisu provedena posebna ispitivanja plodnosti na životinjama, no u ispitivanjima toksičnosti u zamoraca i makaki majmuna nisu primijećeni štetni učinci na reproduktivne organe.
English: Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Croatian: Dinutuksimab beta je kimerično ljudsko/mišje IgG1 monoklonsko protutijelo proizvedeno tehnologijom rekombinantne DNK u staničnoj liniji sisavaca (CHO).
English: In a compassionate use programme (study 1), 54 patients received 10 mg/m2/day dinutuximab beta given by continuous 10-day intravenous infusion in a 5-week treatment course, concurrently with subcutaneous IL-2 (6×106 IU/m²/day given on days 1-5 and 8-12 of each course) and followed by oral
Croatian: U programu milosrdne primjene (1. ispitivanje) 54 bolesnika primila su 10 mg/m2/dan dinutuksimaba beta u kontinuiranoj desetodnevnoj intravenskoj infuziji u petotjednom ciklusu liječenja, istodobno sa supkutanom primjenom IL-2 (6 x 106 IU/m²/dan na dane 1. - 5. i 8. - 12. svakog ciklusa), nakon čega je uslijedilo peroralno liječenje s 13-cis-retinoičnom kiselinom (160 mg/m2/dan 14 dana po ciklusu).
English: Metabolism and nutrition disorders fluid retention decreased appetite, hypoalbuminaemia, hyponatraemia, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, dehydration
Croatian: Poremećaji metabolizma i prehrane zadržavanje tekućine smanjen apetit, hipoalbuminemija, hiponatrijemija, hipokalijemija, hipofosfatemija, hipomagnezijemija, hipokalcijemija, dehidracija
English: LIST OF EXCIPIENTS Histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid.
Croatian: POPIS POMOĆNIH TVARI Histidin, saharoza, polisorbat 20, voda za injekcije, kloridna kiselina.
English: Dose modification of dinutuximab beta
Croatian: Prilagodba doze dinutuksimaba beta
English: • With daily infusions of dinutuximab beta, morphine infusion should be continued at a decreased rate (e.g. 0.01 mg/kg/h) for 4 hours after the end of dinutuximab beta infusion.
Croatian: • Uz dnevne infuzije dinutuksimaba beta potrebno je nastaviti primjenjivati infuziju morfina pri smanjenoj brzini (npr. 0,01 mg/kg/sat) tijekom 4 sata nakon prestanka davanja infuzije dinutuksimaba beta.
English: Nonopioid analgesics Nonopioid analgesics should be used permanently during the treatment, e.g. paracetamol or ibuprofen.
Croatian: Neopioidne analgetike, na primjer paracetamol ili ibuprofen, potrebno je trajno primjenjivati tijekom liječenja.
English: Table 2: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients without evidence of disease at baseline (complete response to initial treatment)
Croatian: Tablica 2.: Stope preživljenja bez događaja (EFS) i ukupnog preživljenja (OS) [95-postotni interval pouzdanosti] u bolesnika bez dokaza o bolesti na početku (potpun odgovor na početno liječenje)
English: First 5-day treatment should start 7 days prior to first dinutuximab beta infusion.
Croatian: Prvo petodnevno liječenje trebalo bi započeti 7 dana prije prve infuzije dinutuksimaba beta.
English: • cardiac failure, fluid around the heart
Croatian: • zatajenje srca, nakupljanje tekućine oko srca
English: • Periodic safety update reports (PSURs)
Croatian: • Periodičko izvješće o neškodljivosti lijeka (PSUR-evi)
English: Study 1 N=15
Croatian: 1. ispitivanje N = 15
English: • injection-site reactions, skin problems such as reddening, dry skin, eczema, excessive sweating,
Croatian: • reakcije na mjestu injekcije, problemi s kožom kao što su crvenilo, suha koža, ekcem,
English: reaction to light
Croatian: prekomjerno znojenje, reakcija na svjetlost
English: When IL-2 is combined with Qarziba, it should be administered as subcutaneous injections of 6×106 IU/m2/day, for 2 periods of 5 consecutive days, resulting in an overall dose of 60×106 IU/m2 per course.
Croatian: Kada se IL-2 kombinira s lijekom Qarziba, potrebno ga je primjenjivati u obliku supkutanih injekcija od 6 x 106 IU/m2 dnevno, tijekom 2 razdoblja od 5 uzastopnih dana, što u konačnici daje cjelokupnu dozu od 60 x 106 IU/m2 po pojedinom ciklusu.
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.
Croatian: Možda ćete primijetiti utrnulost, trnce ili osjećaj žarenja u šakama, stopalima, nogama ili rukama, smanjen osjet ili slabost pri pokretima.
English: Concomitant use of intravenous immunoglobulins is not recommended as they may interfere with dinutuximab beta-dependent cellular cytotoxicity.
Croatian: Ne preporučuje se istodobna primjena intravenskih imunoglobulina jer oni mogu utjecati na staničnu citotoksičnost ovisnu o dinutuksimabu beta.
English: What you need to know before you use Qarziba
Croatian: Što morate znati prije nego što počnete primjenjivati Qarziba Nemojte koristiti Qarziba ako ste
English: Table 3: Event-free survival (EFS) and overall survival (OS) rates [95% confidence interval] in patients with evidence of disease at baseline (no complete response to initial treatment)
Croatian: Tablica 3.: Stope preživljenja bez događaja (EFS) i ukupnog preživljenja (OS) [95-postotni interval pouzdanosti] u bolesnika s dokazom o bolesti na početku (bez potpunog odgovora na početno liječenje)
English: The first 5-day course should start 7 days prior to the first infusion of dinutuximab beta and the second 5-day course should start concurrently with dinutuximab beta infusion (days 1 to 5 of each dinutuximab beta course).
Croatian: Prvo petodnevno razdoblje trebalo bi započeti 7 dana prije primjene prve infuzije dinutuksimaba beta, a drugo petodnevno razdoblje trebalo bi započeti istodobno s primjenom infuzije dinutuksimaba beta (dani 1. - 5. svakog ciklusa liječenja dinutuksimabom beta).
English: It is unknown whether dinutuximab beta is excreted in human milk.
Croatian: Nije poznato izlučuje li se dinutuksimab beta u majčino mlijeko.
English: Preparation of the infusion
Croatian: Priprema infuzije
English: Decrease infusion rate to 50%, After resolution, resume infusion at original rate
Croatian: Smanjiti brzinu infuzije na 50 % Nakon nestanka nuspojava ponovno primijeniti izvornu brzinu infuzije
English: • decreased appetite, nausea, abdominal distension, accumulation of fluid in the abdominal cavity
Croatian: • smanjen apetit, mučnina, nadimanje trbuha, nakupljanje tekućine u trbušnoj šupljini
English: Investigations increased weight , increased transaminases, increased gamma glutamyltransferase, increased blood bilirubin increased blood creatinine decreased weight, decreased glomerular filtration rate, hypertriglyceridaemia, prolonged activated partial thromboplastin time, prolonged prothrombin time, prolonged thrombin time
Croatian: Pretrage povećana tjelesna težina, povišene transaminaze, povišena gamaglutamiltransferaza, povišen bilirubin u krvi, povišen kreatinin u krvi smanjena tjelesna težina, smanjena brzina glomerularne filtracije, hipertrigliceridemija, produljeno aktivirano parcijalno tromboplastinsko vrijeme, produljeno protrombinsko vrijeme, produljeno trombinsko vrijeme * uključuje bol u abdomenu, bol u ekstremitetima, mišićno-koštanu bol, bol u prsnom košu, artralgiju
English: Study 1 N=29
Croatian: 1. ispitivanje N = 29
English: The solution should be administered via a peripheral or central intravenous line.
Croatian: Otopinu je potrebno primjenjivati putem perifernog ili centralnog venskog katetera.
English: Acute grade 3 or 4, or extensive chronic graft-versus-host disease (GvHD)
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. Akutni GvHD 3. ili 4. stupnja, ili opsežni kronični GvHD (engl. graft-versus-host disease, reakcija presatka protiv primatelja)
English: Table 1: Event-free survival (EFS) and overall survival (OS) rates in relapsed and refractory patients
Croatian: Tablica 1.: Stope preživljenja bez događaja (engl. event-free survival, EFS) i ukupnog preživljenja (engl. overall survival, OS) u bolesnika s refraktornom bolešću i s recidivom bolesti
English: Qarziba should be diluted aseptically to the patient-specific concentration/dose with sodium chloride 9 mg/mL (0.9%) solution for infusion, containing 1% human albumin (e.g. 5 mL of human albumin 20% per 100 mL sodium chloride solution).
Croatian: Qarziba potrebno je aseptički razrijediti na koncentraciju/dozu prilagođenu pojedinom bolesniku pomoću otopine za infuziju natrijeva klorida od 9 mg/ml (0,9 %), koja sadrži 1 %-tni ljudski albumin (npr. 5 ml 20 %-tnog ljudskog albumina na 100 ml otopine natrijeva klorida).
English: • For repeated daily infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Croatian: • Pri davanju ponovljenih dnevnih infuzija dnevna doza iznosi 20 mg/m2, a izračunatu dozu potrebno je razrijediti u 100 ml natrijeva klorida koncentracije 9 mg/ml (0,9 %), koji sadrži 1%-tni ljudski albumin.
English: Second 5-day treatment with IL-2 should start concurrently with dinutuximab beta infusion (days 1 to 5 of each course).
Croatian: Drugo petodnevno liječenje s IL-2 trebalo bi započeti istodobno s primjenom infuzije dinutuksimaba beta (dani 1. - 5. svakog ciklusa).
English: Most events were of grade 1-2 and resolved.
Croatian: Većina poremećaja bila je 1. - 2. stupnja te je nestala.
English: For repeated daily 8-hour infusions, the daily dose is 20 mg/m2 and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.
Croatian: Pri davanju ponovljenih 8-satnih dnevnih infuzija dnevna doza iznosi 20 mg/m2, a izračunatu dozu potrebno je razrijediti u 100 ml natrijeva klorida koncentracije 9 mg/ml (0,9 %) koji sadrži 1 %-tni ljudski albumin.
English: Talk to your doctor before you receive Qarziba if you are of childbearing age.
Croatian: Prije primanja lijeka Qarziba recite liječniku jeste li u reproduktivnoj dobi.
English: Immune system disorders hypersensitivity , cytokine release syndrome anaphylactic reaction serum sickness
Croatian: Poremećaji imunosnog sustava preosjetljivost, sindrom otpuštanja citokina anafilaktička reakcija serumska bolest
English: Blood and lymphatic system disorders anaemia,leukopenia, neutropenia, thrombocytopenia lymphopenia disseminated intravascular coagulation, eosinophilia
Croatian: Poremećaji krvi i limfnog sustava anemija, leukopenija, neutropenija, trombocitopenija limfopenija diseminirana intravaskularna koagulacija, eozinofilija
English: Dinutuximab beta has been shown in vitro to bind to neuroblastoma cell lines known to express GD2 and to induce both complement dependent cytoxicity (CDC) and antibody dependent cell-mediated cytoxicity (ADCC).
Croatian: Pokazalo se da se dinutuksimab beta in vitro veže za stanične linije neuroblastoma za koje je poznato da eksprimiraju GD2 te da inducira citotoksičnost ovisnu o komplementu (CDC) i staničnu citotoksičnost ovisnu o protutijelima (ADCC).
English: You might notice the following when you first receive Qarziba and during the course of treatment:
Croatian: Nakon prve primjene lijeka Qarziba i tijekom liječenja mogli biste primijetiti sljedeće:
English: • grade 3 vision eye toxicity
Croatian: • toksičnost za vid 3. stupnja
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 4.5 mg dinutuximab beta.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 ml koncentrata sadrži 4,5 mg dinutuksimaba beta.
English: Avoid vaccinations during treatment with Qarziba and for 10 weeks afterwards.
Croatian: Izbjegavajte cijepljenja tijekom liječenja lijekom Qarziba i 10 tjedana nakon dovršetka liječenja.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: • pain Pain is one of the most common side effects of Qarziba.
Croatian: Bol je jedna od najčešćih nuspojava lijeka Qarziba.
English: • vomiting, diarrhoea, constipation
Croatian: • povraćanje, proljev, zatvor
English: Study 2 N=25
Croatian: 2. ispitivanje N = 25
English: NAME OF THE MEDICINAL PRODUCT Qarziba 4.5 mg/mL concentrate for solution for infusion
Croatian: NAZIV LIJEKA Qarziba 4,5 mg/ml koncentrat za otopinu za infuziju
English: Respiratory, thoracic and mediastinal disorders hypoxia, cough bronchospasm , dyspnoea, respiratory failure, lung infiltration, pulmonary oedema, pleural effusion, tachypnoea, laryngospasm
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja hipoksija, kašalj bronhospazam, dispneja, zatajenje disanja, plućna infiltracija, edem pluća, pleuralni izljev, tahipneja, laringospazam
English: The combination of Qarziba with IL-2 increases the risk of adverse drug reactions compared to Qarziba without IL-2, especially for pyrexia (92% vs. 79%), CLS (50% vs. 25%), pain related to dinutuximab beta (75% vs. 63%), hypotension (43% vs. 26%), and peripheral neuropathy (14% vs. 7%), respectively.
Croatian: Kombinacija lijeka Qarziba s IL-2 povećava rizik od nuspojava u usporedbi s primjenom lijeka Qarziba bez IL-2, posebno od pojave pireksije (92 % u odnosu na 79 %), sindroma kapilarnog curenja
English: Occasional occurrences of peripheral neuropathy have been reported with Qarziba.
Croatian: U liječenju lijekom Qarziba zabilježene su povremene pojave periferne neuropatije.
English: Study 2 N=19
Croatian: 2. ispitivanje N = 19
English: Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Croatian: Svaka bočica sadrži 20 mg dinutuksimaba beta u 4,5 ml.
English: • grade 3 peripheral neuropathy
Croatian: • pefirerna neuropatija 3. stupnja
English: Musculoskeletal and connective tissue disorders muscle spasms
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva grčevi u mišićima
English: per course.
Croatian: Vrlo često
English: 1 mL concentrate contains 4.5 mg dinutuximab beta.
Croatian: 1 ml koncentrata sadrži 4,5 mg dinutuksimaba beta.
English: Adverse reactions are summarised in the table below.
Croatian: Nuspojave su sažete u tablici u nastavku.
English: • inflammation of the intestine, injury to the liver
Croatian: • upala crijeva, oštećenje jetre
English: Gastrointestinal disorders vomiting , diarrhoea, constipation, stomatitis nausea, lip oedema, ascites, abdominal distension, ileus, dry lips enterocolitis
Croatian: Poremećaji probavnog sustava povraćanje, proljev, konstipacija, stomatitis mučnina, edem usne, ascites, abdominalna distenzija, ileus, suhe usne enterokolitis