FrancophonIA/ELRC3.0 huggingface dataset:
English: For continuous infusions, the solution is administered at a rate of 2 mL per hour (48 mL per day) using an infusion pump.
Slovenian: Za neprekinjene infuzije se raztopina daje s hitrostjo 2 ml na uro (48 ml na dan) z infuzijsko črpalko.
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.
Slovenian: • Pred uvedbo neprekinjene intravenske infuzije morfina je treba začeti z bolusno infuzijo morfina 0,02 do 0,05 mg/kg/h dve uri pred infundiranjem dinutuksimaba beta.
English: Concomitant use of intravenous immunoglobulins is not recommended as they may interfere with dinutuximab beta-dependent cellular cytotoxicity.
Slovenian: Sočasna uporaba intravenskih imunoglobulinov ni priporočljiva, saj lahko vplivajo na od dinutuksimaba beta odvisno celično citotoksičnost.
English: • grade 3 or 4 anaphylaxis
Slovenian: • anafilaksija stopnje 3 ali 4,
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.
Slovenian: Zdravilo Qarziba je indicirano za zdravljenje nevroblastoma z visokim tveganjem pri bolnikih, starih 12 mesecev in več, ki so že prejeli indukcijsko kemoterapijo in dosegli vsaj delni odziv, po katerem so prejeli še mieloablacijsko terapijo in presaditev matičnih celic, in pri bolnikih z recidivnim ali neodzivnim nevroblastomom v anamnezi, z rezidualno boleznijo ali brez nje.
English: • Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with dinutuximab beta infusion.
Slovenian: • Nato je priporočljiva hitrost odmerjanja 0,03 mg/kg/h, sočasno z infuzijo dinutuksimaba beta.
English: Oral gabapentin should be tapered off after weaning off intravenous morphine infusion, at the latest after dinutuximab beta infusion therapy has stopped.
Slovenian: Peroralni odmerek gabapentina je treba po prekinitvi intravenske infuzije morfina postopoma ukiniti, najkasneje po zaključku zdravljenja z infuzijo dinutuksimaba beta.
English: Most commonly, patients reported abdominal pain, pain in the extremities, back pain, chest pain, or arthralgia.
Slovenian: Bolniki so najpogosteje poročali o bolečini v trebuhu, bolečini v okončinah, bolečini v hrbtu, bolečini v prsnem košu in artralgiji.
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.
Slovenian: • Ob dnevnih infuzijah dinutuksimaba beta je treba infundiranje morfina nadaljevati z zmanjšano hitrostjo (npr. 0,01 mg/kg/h) še štiri ure po zaključku infuzije dinutuksimaba beta.
English: For patients without evidence of disease at baseline, addition of IL-2 did not improve EFS and OS.
Slovenian: Pri bolnikih brez dokazov o bolezni v izhodišču dodajanje IL-2 ni izboljšalo preživetja brez dogodka in skupnega preživetja.
English: • paralysis of eye muscles, blurred vision, light sensitivity, swelling in the retina
Slovenian: • paraliza očesnih mišic, zamegljen vid, občutljivost na svetlobo, otekanje v mrežnici
English: The patient should be primed with 10 mg/kg/day, starting 3 days prior to dinutuximab beta infusion.
Slovenian: Bolnike je treba pripraviti z odmerkom 10 mg/kg/dan, ki ga začnemo dajati tri dni pred infuzijo dinutuksimaba beta.
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.
Slovenian: Dnevni odmerek gabapentina se naslednji dan poveča na 2 × 10 mg/kg/dan peroralno, dan pred prvo infuzijo dinutuksimaba beta in naslednje dni pa na 3 × 10 mg/kg/dan peroralno.
English: Efficacy without IL-2 N=104
Slovenian: Učinkovitost brez IL-2 N = 104
English: • adequate bone marrow function: absolute neutrophil count ≥ 500/µL, platelet count
Slovenian: • ustrezna funkcija kostnega mozga: absolutno število nevtrofilcev ≥ 500/µl, število trombocitov
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.
Slovenian: Dinutuksimab beta so dajali v odmerku 20 mg/m2/dan pet zaporednih dni, z osemurno intravensko infuzijo v pettedenskem ciklu zdravljenja, in so ga kombinirali s 13-cis-RA in z dodatnim subkutanim IL-2 ali brez njega v enakih odmerjanjih kot v prejšnjih študijah.
English: Do not perform these activities if your ability to concentrate and react is affected.
Slovenian: Če se pri vas pojavijo učinki na vašo sposobnost koncentracije in reagiranja, ne upravljajte vozil in strojev.
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.
Slovenian: • Za neprekinjene infuzije je mogoče svežo raztopino za infundiranje pripraviti vsakodnevno ali pa v količini, ki zadošča za največ pet dni neprekinjenega infundiranja.
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.
Slovenian: Namenskih študij o plodnosti pri živalih niso izvedli, vendar pa v študijah toksičnosti pri morskih prašičkih in javanskih makakih niso bili opaženi neželeni učinki na reproduktivne organe.
English: Treatment of hypersensitivity reactions
Slovenian: Zdravljenje preobčutljivostnih reakcij
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
Slovenian: V programu sočutne uporabe (študija 1) je 54 bolnikov prejemalo odmerek 10 mg/m2/dan dinutuksimaba beta v obliki neprekinjene 10-dnevne intravenske infuzije v pettedenskem ciklu zdravljenja, sočasno s subkutanim IL-2 (6 x 106 i. e./m²/dan, ki so ga prejemali od 1. do 5. dneva in od
English: These adverse reactions are presented by MedDRA system organ class and frequency.
Slovenian: Predstavljeni so v skladu z organskimi sistemi in pogostnostjo po sistemu MedDRA.
English: • rapid swelling of arms, legs and other body parts, rapid drop in blood pressure, light-headedness and breathing difficulties (capillary leak syndrome)
Slovenian: • hitro otekanje rok, nog in drugih delov telesa, nenaden padec krvnega tlaka, omotičnost in težave z dihanjem (sindrom povečane prepustnosti kapilar)
English: PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid.
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje Prozorna, brezbarvna tekočina.
English: Other medicines and Qarziba
Slovenian: Druga zdravila in zdravilo Qarziba
English: with IL-2 N=76
Slovenian: z IL-2 N = 76
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.
Slovenian: Učinkovitost dinutuksimaba beta so ocenjevali v randomiziranem nadzorovanem preskušanju, v katerem so primerjali dajanje dinutuksimaba beta z IL-2 in brez IL-2 v zdravljenju prve linije pri bolnikih z nevroblastomom z visokim tveganjem in v dveh študijah s po eno skupino bolnikov z recidivno/neodzivno boleznijo.
English: • nerve disorder in the arms and/or legs (with abnormal sensations or weakness), light headedness, trembling, muscle spasms
Slovenian: • motnja živcev v rokah in/ali nogah (z nenormalnimi občutki ali šibkostjo), vrtoglavica, tresenje,
English: • increased weight
Slovenian: • povečana telesna masa
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Kategorije pogostnosti so opredeljene: zelo pogosti (≥ 1/10); pogosti
English: Occurrence of haematologic toxicities has been reported with Qarziba, such as erythropenia, thrombocytopenia or neutropenia.
Slovenian: Pri zdravljenju z zdravilom Qarziba so poročali o pojavu hematoloških toksičnosti, kot so eritropenija, trombocitopenija ali nevtropenija.
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.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za obdobje do 48 ur pri temperaturi 25 °C (50-mililitrska brizga) in za obdobje do sedem dni pri temperaturi 37 ºC (250-mililitrska infuzijska vrečka), po skupno 72-urnem shranjevanju v hladilniku (2 °C-8 °C).
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).
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za obdobje do 48 ur pri temperaturi 25 °C (50-mililitrska brizga) in za obdobje do 7 dni pri temperaturi 37 ºC (250-mililitrska infuzijska vrečka), po skupno 72-urnem shranjevanju v hladilniku (2 °C-8 °C) (glejte poglavje 6.6).
English: Treatment with dinutuximab beta consists of 5 consecutive courses, each course comprising 35 days.
Slovenian: Zdravljenje z dinutuksimabom beta je sestavljeno iz pet zaporednih ciklov, vsak cikel pa traja 35 dni.
English: Efficacy without IL-2 N=73
Slovenian: Učinkovitost brez IL-2 N = 73
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.
Slovenian: Dokazali so, da dinutuksimab beta ob prisotnosti humanih efektorskih celic, vključno z jedrnimi celicami periferne krvi in granulociti zdravih človeških darovalcev, povzroča lizo celičnih linij humanega nevroblastoma in melanoma, sorazmerno z odmerkom.
English: Infections and infestations infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis), device related infection sepsis
Slovenian: Infekcijske in parazitske bolezni okužba (vključno s pljučnico, okužbo kože, okužbo z virusom herpesa, mielitisom, encefalomielitisom), okužba, povezana z medicinskimi pripomočki sepsa
English: The container should be inspected visually for particulates prior to administration.
Slovenian: Vsebnik je treba pred uporabo vizualno pregledati, da ne vsebuje trdnih delcev.
English: Treatment with opioids is standard with dinutuximab beta.
Slovenian: Zdravljenje z opioidi je standardni ukrep pri zdravljenju z dinutuksimabom beta.
English: Study 1 N=29
Slovenian: Študija 1 N = 29
English: CLS is characterised by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space.
Slovenian: Sindrom povečane prepustnosti kapilar (capillary leak syndrome - CLS) Za CLS je značilna izguba žilnega tonusa in ekstravazacija plazemskih beljakovin in tekočine v zunajžilni prostor.
English: A triple therapy, including nonopioid analgesics (according to WHO guidelines), gabapentin and opioids, is recommended for pain treatment.
Slovenian: Za lajšanje bolečin je priporočljiva trojna terapija, ki vključuje neopioidne analgetike (skladno s smernicami Svetovne zdravstvene organizacije), gabapentin in opioide.
English: reaction to light
Slovenian: prekomerno potenje, reakcija na svetlobo
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).
Slovenian: Prvi petdnevni cikel se mora začeti sedem dni pred prvo infuzijo dinutuksimaba beta, drugi petdnevni cikel pa se mora začeti sočasno z infuzijo dinutuksimaba beta (1. do 5. dan vsakega cikla z dinutuksimabom beta).
English: Table 1: Event-free survival (EFS) and overall survival (OS) rates in relapsed and refractory patients
Slovenian: Preglednica 1: Preživetje brez dogodka (event-free survival - EFS) in skupno preživetje (overall survival - OS) pri bolnikih z recidivno in neodzivno boleznijo
English: System organ class Very common
Slovenian: Razvrstitev po organskih sistemih zelo pogosti pogosti občasni
English: Second 5-day treatment with IL-2 should start concurrently with dinutuximab beta infusion (days 1 to 5 of each course).
Slovenian: Drugo petdnevno zdravljenje z IL-2 se mora začeti sočasno z infuzijo dinutuksimaba beta (1. do 5. dan vsakega cikla).
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.
Slovenian: Za neprekinjene infuzije je mogoče svežo raztopino za infundiranje pripraviti vsakodnevno ali pa v količini, ki zadošča za največ pet dni neprekinjenega infundiranja.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za boljšo določitev odmerjanja pri otrocih v celotnem starostnem razponu in vplivu humanih antihimernih protiteles (HACA) na farmakodinamiko predložiti rezultate ocene plazemskih vzorcev, zbranih pri bolnikih v študijah APN311-202v1-2-3 in APN311-304 v skladu z dogovorjenim protokolom.
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).
Slovenian: S preskušanji in vitro so dokazali, da se dinutuksimab beta veže na celične linije nevroblastoma, za katere je znano, da izražajo GD2, in da povzroča od komplementa odvisno citotoksičnost (complement dependent cytoxicity - CDC) in od protiteles odvisno celično posredovano citotoksičnost (antibody dependent cell-mediated cytoxicity - ADCC).
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.
Slovenian: V času dajanja dinutuksimaba beta in deset tednov po zadnjem ciklu zdravljenja se je priporočljivo izogibati cepljenjem, saj dinutuksimab beta stimulira imunski odziv in povzroči tveganje za redke nevrološke toksičnosti.
English: Nervous system disorders headache peripheral neuropathy, seizure, paraesthesia, dizziness, tremor intracranial pressure increased, posterior reversible encephalopathy syndrome
Slovenian: Bolezni živčevja glavobol periferna nevropatija, epileptični napad, parestezija, omotica, tremor povišan intrakranialni tlak, sindrom posteriorne reverzibilne encefalopatije
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.
Slovenian: V primeru motenj akomodacije vida, ki jih je mogoče korigirati z očali, prilagajanje odmerka ni potrebno, če se presodi, da bolnik te motnje dobro prenaša.
English: Relapsed and refractory patients
Slovenian: Bolniki z recidivno in neodzivno boleznijo
English: What Qarziba looks like and contents of the pack
Slovenian: Izgled zdravila Qarziba in vsebina pakiranja
English: It is recommended to use contraception for 6 months after discontinuation of treatment with Qarziba.
Slovenian: Priporočljivo je, da šest mesecev po prenehanju zdravljenja z zdravilom Qarziba uporabljate kontracepcijo.
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.
Slovenian: Dinutuksimab beta se veže na molekulo, imenovano disialogangliozid 2 (GD2), ki je prisotna na rakavih celicah, in aktivira imunski sistem, da začne napadati rakave celice.
English: Study 2 N=19
Slovenian: Študija 2 N = 19
English: Preparation of the infusion
Slovenian: Priprava infuzije
English: • injection-site reactions, skin problems such as reddening, dry skin, eczema, excessive sweating,
Slovenian: • reakcije na mestu injiciranja, težave s kožo, kot se npr. pordelost, suha koža, ekcem,
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)
Slovenian: Preglednica 2: Stopnje preživetja brez dogodka (EFS) in skupnega preživetja (OS) [95-odstotni interval zaupanja] pri bolnikih brez dokazov o bolezni v izhodišču (popoln odziv na začetno zdravljenje)
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
Slovenian: Preiskave povečana telesna masa, povečana vrednost transaminaz, povečana vrednost gama-glutamiltransferaze, povečana vrednost bilirubina v krvi, povečana vrednost kreatinina v krvi zmanjšana telesna masa, zmanjšana stopnja glomerulne filtracije, hipertrigliceridemija, podaljšan aktivirani parcialni tromboplastinski čas, podaljšan protrombinski čas, podaljšan trombinski čas *vključuje bolečine v trebuhu, bolečine v okončinah, mišično-skeletne bolečine, bolečine v prsnem košu, artralgijo
English: • respiratory failure, fluid in the lungs
Slovenian: • odpoved dihal, tekočina v pljučih
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.
Slovenian: Med dajanjem dinutuksimaba beta morajo biti intravenski antihistaminiki, adrenalin in prednizolon za intravensko dajanje takoj na razpolago ob bolniški postelji za obvladovanje življenjsko nevarnih alergijskih reakcij.
English: LIST OF EXCIPIENTS Histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid.
Slovenian: SEZNAM POMOŽNIH SNOVI histidin, saharoza, polisorbat 20, voda za injekcije, klorovodikova kislina.
English: • recurrent or grade 4 capillary leak syndrome (requires ventilator support)
Slovenian: • sindrom povečane prepustnosti kapilar, ki se ponavlja oziroma doseže stopnjo 4 (zahteva dihalno podporo z respiratorjem).
English: Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Slovenian: Dinutuksimab beta je himerno mišje-človeško monoklonsko protitelo IgG1, pridobljeno v celični liniji sesalskih celic (CHO) s tehnologijo rekombinantne DNK.
English: 13-cis-RA treatment (160 mg/m2/day for 14 days per course).
Slovenian: 8. do 12. dneva vsakega cikla), infuziji pa je sledilo zdravljenje s peroralno 13-cis-RA (160 mg/m2/dan 14 dni v vsakem ciklu).
English: Dose modification of dinutuximab beta
Slovenian: Prilagajanje odmerka 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.
Slovenian: Dinutuksimab beta je himerno monoklonsko protitelo IgG1, ki je specifično usmerjeno proti ogljikovodikovemu delu disialogangliozida 2 (GD2), ki je močno izražen na površini celic nevroblastoma.
English: • cardiac failure, fluid around the heart
Slovenian: • srčno popuščanje, tekočina okrog srca
English: Vascular disorders hypotension, capillary leak syndrome hypertension hypovolaemic shock, veno-occlusive disease
Slovenian: Žilne bolezni hipotenzija, sindrom povečane prepustnosti kapilar hipertenzija hipovolemični šok, venska okluzivna bolezen
English: Musculoskeletal and connective tissue disorders muscle spasms
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični krči
English: No cases of dinutuximab beta overdose have been reported.
Slovenian: Ni poročil o primerih prevelikega odmerjanja dinutuksimaba beta.
English: • a type of allergy (serum sickness) with fever, rash, joint inflammation
Slovenian: • vrsta alergije (serumska bolezen) s povišano telesno temperaturo, izpuščaj, vnetje sklepov
English: Capillary leak syndrome
Slovenian: Sindrom kapilarnega prepuščanja
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.
Slovenian: Kadar se IL-2 daje v kombinaciji z zdravilom Qarziba, ga je treba dati v obliki subkutanih injekcij 6 × 106 i. e./m2/dan, v dveh obdobjih po 5 zaporednih dni, tako da bolnik prejme skupni odmerek 60 × 106 i. e./m2 na cikel zdravljenja.
English: First 5-day treatment should start 7 days prior to first dinutuximab beta infusion.
Slovenian: Prvi petdnevni cikel se mora začeti sedem dni pred prvo infuzijo dinutuksimaba beta.
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.
Slovenian: Cilj delovanja dinutuksimaba beta (GD2) se nahaja na površini nevronskih tkiv, zlasti v obdobju razvoja zarodka/plodu, in lahko prehaja prek posteljice, zato lahko zdravilo Qarziba ob dajanju nosečnicam škoduje plodu.
English: Skin and subcutaneous tissue disorders pruritus , rash, urticaria dermatitis (including exfoliative) , erythema, dry skin, hyperhidrosis, petechiae, photosensitivity reaction
Slovenian: Bolezni kože in podkožja pruritus, izpuščaj, urtikarija dermatitis (vključno z eksfoliativnim dermatitisom), eritem, suha koža, hiperhidroza, petehije, reakcije preobčutljivosti na svetlobo
English: • pain Pain is one of the most common side effects of Qarziba.
Slovenian: Bolečina je eden od najpogostejših neželenih učinkov zdravila Qarziba.
English: What Qarziba is and what it is used for What you need to know before you use Qarziba How to use Qarziba
Slovenian: Kaj je zdravilo Qarziba in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Qarziba Kako uporabljati zdravilo Qarziba Možni neželeni učinki
English: Treatment with Qarziba consists of 5 consecutive courses, each course comprising 35 days.
Slovenian: Zdravljenje z zdravilom Qarziba je sestavljeno iz petih zaporednih ciklov, vsak cikel pa traja 35 dni.
English: Do not use medicines that suppress the immune system from 2 weeks before the first dose of Qarziba until 1 week after the last treatment course, unless prescribed by your doctor.
Slovenian: V dveh tednih pred prvim odmerkom zdravila Qarziba do en teden po zadnjem ciklu zdravljenja ne uporabljajte zdravil, ki zavirajo delovanje imunskega sistema, razen če vam jih predpiše zdravnik.
English: • grade 3 peripheral neuropathy
Slovenian: • periferna nevropatija stopnje 3,
English: Patients should not use or drive machines during treatment with dinutuximab beta.
Slovenian: Bolniki med zdravljenjem z dinutuksimabom beta ne smejo voziti in upravljati strojev.