FrancophonIA/ELRC3.0 huggingface dataset:
English: Delay initiation of courses 2-6 until ALT is less than 10 times ULN.
Slovenian: Odložite začetek ciklov zdravljenja od 2 do 6, dokler ALT ni < 10 x ULN.
English: 14 days.
Slovenian: mesecev.
English: Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia.
Slovenian: Treba je izvajati podporne ukrepe in spremljati hidracijo, nenormalne vrednosti elektrolitov, hipertenzijo in anemijo.
English: Unituxin is a clear, colourless solution for infusion, provided in a clear glass vial.
Slovenian: Zdravilo Unituxin je prozorna, brezbarvna raztopina za infundiranje v prozorni stekleni viali.
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.
Slovenian: IL-2 se je dajal istočasno z dinutuksimabom kot stalna intravenska infuzija za štiri dni med 1. tednom ciklov 2 in 4 v odmerku 3.0 M i.e./m2/dan, med 2. tednom ciklov 2 in 4 pa v odmerku 4,5 M i.e./m2/dan.
English: Analgesics including intravenous opioids should be administered prior to each dose of Unituxin and continued until two hours following completion of Unituxin infusion.
Slovenian: Analgetike, vključno z intravenskimi opioidi, je potrebno dajati pred vsakim odmerkom zdravila Unituxin in se mora z njimi nadaljevati do dve uri po zaključku dajanja zdravila Unituxin.
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.
Slovenian: Interleukin-2 (IL-2): 3 M i.e./m2/dan, aplicirano prek neprekinjene intravenske infuzije v 96 urah od 1. do 4. dne in 4,5 M i.e./m2/dan od 8. do 11. dne.
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.
Slovenian: Priporoča se dajanje opioidov kot je morfinijev sulfat v obliki intravenske infuzije pred vsako infuzijo dinutuksimaba in nadaljevanje dajanja intravenske infuzije med terapijo ter do dve uri po zaključku terapije.
English: ANBL0032 was a randomised, controlled study that evaluated the effects of dinutuximab administered in combination with GM-CSF, IL-2, and isotretinoin compared with isotretinoin alone in high-risk neuroblastoma subjects.
Slovenian: ANBL0032 je bila randomizirana, kontrolirana študija za ocenjevanje učinkov dinutuksimaba, apliciranega v kombinaciji z GM-CSF, IL-2 in izotretinoinom, v primerjavi z zdravljenjem samo z izotretinoinom pri bolnikih z nevroblastomom z visokim tveganjem.
English: No cases of dinutuximab overdose have been reported.
Slovenian: Ni poročil o primerih prevelikega odmerjanja dinutuksimaba.
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.
Slovenian: vključno s perifernimi mononuklearnimi krvnimi celicami (PBMC- peripheral blood mononuclear cells) in granulociti iz zdravih človeških darovalcev, povzroča lizo številnih celičnih linij nevroblastoma, sorazmerno z odmerkom.
English: Dinutuximab is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa.
Slovenian: Dinutuksimab je himerno monoklonsko protitelo, sestavljeno iz mišje lahke in težke verige v variabilni domeni in humane težke verige IgG1 ter lahke verige kapa v konstantni domeni.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba
English: Capillary leak syndrome was a very common adverse reaction (45 % of patients) that occurred more frequently when Unituxin was co-administered with IL-2; it was severe (> Grade 3) in 14% of patients.
Slovenian: Sindrom kapilarnih razpok je zelo pogost neželen učinek (45 % bolnikov), ki se je pojavil pogosteje, ko se je zdravilo Unituxin apliciralo skupaj z IL-2.
English: Dinutuximab has been shown to bind to neuroblastoma cell lines known to express GD2 in vitro.
Slovenian: Dokazano je bilo, da se dinutuksimab veže na celične linije nevroblastoma, za katere je znano, da izražajo GD2 in vitro.
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.
Slovenian: Resne infuzijske reakcije, za katere je potrebno nujno ukrepanje, vključno s podporno terapijo za krvni tlak, terapijo z bronhodilatatorjem, kortikosteroidi, zmanjšanjem hitrosti infundiranja ali dokončno prekinitvijo zdravljenja z zdravilom Unituxin, so obsegale edem obraza in zgornjih dihal, dispnejo, bronhospazem, stridor, urtikarijo in hipotenzijo.
English: Your doctor will do blood tests and may do eye tests while you are taking this medicine.
Slovenian: Preiskave in preverjanja V obdobju uporabe tega zdravila bo vaš zdravnik izvajal preiskave krvi in morebitne preglede oči.
English: Augmentation of ADCC in the presence of GM-CSF and IL-2 provided the rationale for combining these cytokines with dinutuximab in clinical studies.
Slovenian: Zaradi povečanja ADCC v prisotnosti GM-CSF in IL-2 se v kliničnih študijah te citokine kombinira z dinutuksimabom.
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.
Slovenian: Odvzemite potrebni volumen dinutuksimaba in ga injicirajte v 100-mililitrsko vrečko natrijevega klorida 9 mg/ml (0,9 %) raztopine za injekcije.
English: What Unituxin is and what it is used for
Slovenian: Kaj je zdravilo Unituxin in za kaj ga uporabljamo
English: Findings of note included treatment related adverse reactions of the liver in rats (characterized by centrilobular congestion, abnormal cell division, hepatocellular necrosis and pericentral vein/interlobular fibrosis) which may be related to circulatory disturbances and changes indicative of increased haematopoiesis (high reticulocyte ratio and/or platelet count, increased cellularity of the haematopoietic cells in the femoral and sternal bone marrow, and/or extramedullary haematopoiesis in the liver and spleen).
Slovenian: Med pomembnimi odkritji so z zdravljenjem povezani neželeni učinki na jetrih podgan (ki se kažejo kot centrilobularna kongestija, anormalna delitev celic, hepatocelularna nekroza in fibroza pericentrične vene/interlobularna fibroza), kar je lahko povezano z motnjami cirkulacije in spremembami, ki kažejo na povečano hematopoezo (visoko število retikulocitov in/ali trombocitov, povečana celularnost hematopoetskih celic v stegneničnem in sternalnem kostnem mozgu in/ali ekstramedularna hematopoeza v jetrih in vranici).
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated Do not freeze.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prenašajte na hladnem.
English: Paracetamol should be administered orally 20 minutes prior to starting each dinutuximab infusion, and repeated every 4-6 hours as needed.
Slovenian: 20 minut pred začetkom posamezne infuzije dinutuksimaba je treba dati peroralno paracetamol in to po potrebi ponoviti vsakih 4-6 ur.
English: For severe pain, the Unituxin infusion rate should be decreased to 0.875 mg/m2/hour.
Slovenian: V primeru hudih bolečin je treba zmanjšati hitrost infundiranja zdravila Unituxin na 0,875 mg/m2/ura.
English: Electrolytes should be monitored daily during therapy with Unituxin.
Slovenian: Med zdravljenjem z zdravilom Unituxin je treba dnevno preverjati elektrolite.
English: • If you are breastfeeding, talk to your doctor or nurse before being given this medicine.
Slovenian: • Če dojite, se posvetujte s svojim zdravnikom ali medicinsko sestro, preden uporabite to zdravilo.
English: Breast-feeding should be discontinued during treatment with Unituxin.
Slovenian: Med zdravljenjem z zdravilom Unituxin je treba prenehati z dojenjem.
English: Talk to your doctor or nurse before you are given Unituxin if: - you have ever had fits (convulsions) - you have liver problems - you have a low number of white blood cells or platelets in your blood - shown in tests - you have breathing problems such as shortness of breath when resting - you have kidney problems - you have any infections.
Slovenian: - če ste kdaj imeli napad krčev (konvulzije) - če imate težave z jetri - če imate nizko število belih krvničk ali krvnih ploščic - to pokažejo preiskave krvi - če imate težave z dihanjem, kot npr. kratko sapo v mirovanju - če imate težave z ledvicami
English: Neurological disorders of the eye Dilated pupil with sluggish light reflex Onset of symptoms
Slovenian: Nevrološke očesne bolezni Razširjene zenice s počasnim svetlobnim refleksom
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.
Slovenian: Lidokain se lahko daje v obliki intravenske infuzije (2 mg/kg v 50 ml 0,9 % natrijevega klorida) 30 minut pred začetkom posamezne infuzije dinutuksimaba in se nadaljuje z dajanjem intravenske infuzije po
English: • Infections of the blood - tell your doctor if you notice fever, shaking chills, or feel faint or dizzy.
Slovenian: • Krvne okužbe - obvestite svojega zdravnika, če opazite zvišano telesno temperaturo, mrzlico,
English: Atypical Haemolytic Uraemic Syndrome
Slovenian: Atipični hemolitično uremični sindrom
English: Gabapentin may be administered at the time of starting morphine premedication, at an oral dose of 10 mg/kg/day.
Slovenian: Gabapentin se lahko daje v obliki peroralnega odmerka 10 mg/kg/dan, ko se začne s premedikacijo z morfinom.
English: You will be closely monitored for these signs while being given the medicine.
Slovenian: Ko boste jemali zdravilo, boste natančno spremljani glede teh simptomov.
English: For instructions on dilution of the medicinal product before administration see section 6.6 of the SmPC.
Slovenian: Za navodila glede priprave raztopine zdravila pred dajanjem glejte poglavje 6.6 SmPC.
English: Hypersensitivity (Grade 4) to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost (stopnja 4) na zdravilno učinkovino ali katero koli od pomožnih snovi, navedenih v poglavju
English: Table 2: Courses 2 and 4 dosing schedule for Unituxin and IL-2; Courses 2, 4, and 6 dosing schedule for isotretinoin
Slovenian: Preglednica 2: Cikla 2 in 4; časovni režim odmerjanja za zdravilo Unituxin in IL-2; Cikli 2, 4, in 6; režim odmerjanja za za izotretinoin
English: This is very common during treatment (affecting more than 1 in 10 people).
Slovenian: Te so zelo pogoste med zdravljenjem (pojavijo se lahko pri več kot 1 od 10 bolnikov).
English: Subgroup analyses of EFS and OS response indicated that patients with minimal residual disease, DNA hyperploidy, and those having received a purged bone marrow may not have benefited from dinutuximab immunotherapy.
Slovenian: Analiza podskupin glede na odgovor EFS in OS je pokazala, da imunoterapija z dinutuksimabom naj ne bi koristila bolnikom z minimalno rezidualno boleznijo, hiperploidijo DNA in bolnikom, ki so prejeli očiščeni kostni mozeg.
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.
Slovenian: Poznejši cikel zdravljenja • Če nenormalnosti ostajajo stabilne ali se izboljšajo pred naslednjim ciklom, aplicirajte 0,875 mg/m2/h dinutuksimaba in celotni odmerek GM-CSF ali IL-2.
English: The recommended interval time between treatment discontinuation and breastfeeding is 6 months.
Slovenian: Priroročeno je, da med prenehanjem zdravljenja in dojenjem mine vsaj 6 mesecev.
English: Granulocyte macrophage colony-stimulating factor (GM-CSF): 250 μg/m2/day, administered by either subcutaneous injection (strongly recommended) or intravenous infusion over 2 hours.
Slovenian: 1. granulocitno-makrofagne kolonije stimulirajoči faktor (GM-CSF): 250 μg/m2/dan, aplicirano s subkutano injekcijo (zelo priporočljivo) ali intravensko infuzijo v 2 2 urahi.
English: CSF or IL-2.
Slovenian: CSF, IL-2 in izotretinoinom.
English: Supplemental oxygen, respiratory support, and albumin replacement therapy should be used as necessary according to clinical response.
Slovenian: Po potrebi in glede na klinični odgovor je treba uporabljati dodatni kisik, umetno predihavanje in terapijo z nadomeščanjem albumina.
English: • Capillary Leak Syndrome due to leakage of blood components through small blood vessel wallsthis may cause rapid swelling to arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties
Slovenian: • »Sindrom kapilarnih razpok«, ki je posledica uhajanja krvnih elementov skozi stene kapilar - to lahko povzroča hitro otekanje rok, nog in drugih delov telesa, nenaden padec krvnega tlaka, omotičnost in težave z dihanjem.
English: Dinutuximab is a chimeric human/mouse monoclonal antibody produced in a murine myeloma cell line (Sp2/0) by recombinant DNA technology.
Slovenian: Dinutuksimab je himerno humano/mišje monoklonsko protitelo, izdelano v celični liniji mišjega plazmocitoma s tehnologijo rekombinantne DNA.
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.
Slovenian: Poznejši cikel zdravljenja • Če je bolnik prenesel 50 % odmerka GM-CSF ali IL-2, začnite s tem odmerkom in hitrostjo infuzije dinutuksimaba 0,875 mg/m2/h.
English: Table 1: Courses 1, 3, and 5 dosing schedule for Unituxin, GM-CSF and isotretinoin Day
Slovenian: Preglednica 1: Cikli 1, 3, in 5; režim odmerjanja za zdravilo Unituxin, GM-CSF in izotretinoin Dan
English: • If symptoms resolve the following day, resume dinutuximab at tolerated rate without GM-CSF or IL-2.
Slovenian: • Če simptomi izzvenijo naslednji dan, ponovno začnite z dajanjem dinutuksimaba s tolerirano hitrostjo brez GM-CSF ali IL-2.
English: The treatment regimen consists of dinutuximab, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.
Slovenian: Režim odmerjanja obsega dinutuksimab, GM-CSF, IL-2 in izotretinoin, ki se dajejo v šestih zaporednih ciklih.
English: Eye disorders may occur, especially with repeated courses (see section 4.8).
Slovenian: Očesne bolezni se pojavijo zlasti pri ponovnem zdravljenju (glejte poglavje 4.8).
English: • Do not resume GM-CSF or IL-2 until the following day.
Slovenian: • Do naslednjega dne ne aplicirajte ponovno GM-CSF ali IL-2.
English: Dinutuximab was administered at a dose equivalent to 17.5 mg/m2/day on four consecutive days (Days 4-7) of Courses 1-5.
Slovenian: Dinutuksimab se je dajal v odmerku 17,5 mg/m2/dan štiri zaporedne dni (od 4. do 7. dne) v ciklih od 1 do 5.
English: Unituxin recognises and attaches to a cell surface target called ‘GD2'.
Slovenian: Zdravilo Unituxin prepozna in se pritrdi na ciljno površino celice, imenovane »GD2«, ki se nahaja na površini nevroblastomskih celic.
English: What Unituxin contains - The active substance is dinutuximab.
Slovenian: Kaj vsebuje zdravilo Unituxin - Zdravilna učinkovina je dinutuksimab.
English: Hypokalaemia, hyponatraemia, hypocalcaemia, hypophosphataemia, hypoalbuminaemia, hyperglycaemia, decreased appetite
Slovenian: Presnovne in prehranske motnje hipokalemija, hiponatremija, hipokalciemija, hipofosfatemija, hipoalbuminemija, hiperglicemija, zmanjšan apetit hipomagneziemija, acidoza, hipoglikemija
English: It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with Unituxin.
Slovenian: Priporočeno je, da ženske v rodni dobi po prenehanju zdravljenja z zdravilom Unituxin 6
English: Regular dosing every 4-6 hours is recommended when IL-2 is coadministered.
Slovenian: Reden odmerek vsakih 4-6 ur je priporočen v primeru sočasnega dajanja
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose until the last dose of dinutuximab for that course.
Slovenian: • Ponovno začnite z aplikacijo 50 % odmerka GM-CSF ali IL-2 naslednji dan do zadnjega odmerka dinutuksimaba za ta cikel.
English: You might notice the following when you first receive Unituxin and during the course of treatment:
Slovenian: Ko prvič uporabite zdravilo Unituxin in med zdravljenjem, se bodo lahko pojavili naslednji simptomi:
English: Capillary leak syndrome is more likely when dinutuximab is co-administered with IL-2.
Slovenian: Sindrom kapilarnih razpok se pojavi bolj pogosto, ko se dinutuksimab daje skupaj z IL-2.
English: These are very common (may affect more than 1 in 10 people).
Slovenian: Tovrstne reakcije so zelo pogoste (pojavijo se lahko pri več kot 1 od 10 bolnikov).
English: If you notice any of these effects, tell your doctor or nurse straight away.
Slovenian: Če se vam pojavi kateri od teh simptomov, nemudoma obvestite svojega zdravnika ali medicinsko sestro.
English: Granulocytes were found to be more effective than PBMCs in mediating dinutuximab dependent cytotoxicity of neuroblastoma cells, with enhanced cell lysis observed with the addition of GM-CSF.
Slovenian: Granulociti so se izkazali za bolj učinkovite kot PBMC pri z dinutuksimab povzročeni citotoksičnosti za celice nevroblastoma.
English: Each 5 mL vial contains 17.2 mg sodium.
Slovenian: Ena viala po 5 ml vsebuje 17,2 mg natrija.
English: The primary intent-to-treat (ITT) analysis found an improvement in EFS associated with dinutuximab immunotherapy plus isotretinoin, as compared to isotretinoin alone.
Slovenian: Glavna analiza bolnikov z namenom zdravljenja (ITT-intent-to-treat) je pokazala izboljšanje EFS z imunoterapijo z dinutuksimabom skupaj z izotretinoinom v primerjavi s terapijo samo z izotretinoinom.
English: In addition, overall survival (OS) was evaluated with 3 years of follow-up after the EFS analysis as a secondary endpoint with a significant improvement observed among ITT subjects randomly allocated to receive dinutuximab immunotherapy plus isotretinoin as compared with isotretinoin alone.
Slovenian: Poleg tega je bilo splošno preživetje (OS - overall survival), kot sekundarni cilj študije, ocenjeno s troletnim sledenjem po analizi EFS, značilno boljše med ITT bolniki, ki so bili randomizirani v skupino imunoterapije z dinutuksimabom skupaj z izotretinoinom, v primerjavi s terapijo samo z izotretinoinom.
English: Table 5: Adverse reactions that have occurred during studies in high risk neuroblastoma patients receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin.
Slovenian: Preglednica 5: Neželeni učinki, ki so se pojavili med študijami pri bolnikih z nevroblastomom z visokim tveganjem, zdravljenih z dinutuksimabom v kombinaciji z GM-CSF, IL-2 in izotretinoinom.
English: Common side effects (may affect up to 1 in 10 people): - weight loss, weight gain - chills - headache - feeling tired, irritable - constipation, blood in stools - damage to the nerves around the body which may affect movement - blurred vision, being sensitive to light, the pupils of your eyes staying large (‘dilated') - not being able to urinate, blood or protein in your urine
Slovenian: - mrazenje - glavobol - občutek utrujenosti, razdražljivosti - zaprtje, kri v blatu - poškodbe na živcih po telesu, ki lahko vplivajo na gibanje - zamegljen vid, občutljivost na svetlobo, razširjene zenice - nezmožnost uriniranja, kri oziroma proteini v urinu
English: Dinutuximab: 17.5 mg/m2/day, administered by intravenous infusion over 10-20 hours.
Slovenian: 2. dinutuksimab: 17,5 mg/m2/dan, aplicirano z intravensko infuzijo v 10-20 urah.
English: Capillary leak syndrome
Slovenian: Sindrom kapilarnih razpok
English: Signs of an allergic reaction may include skin rash, hives, swelling in the face or throat, dizziness, a rapid heart beat or palpitations, being short of breath and difficulty breathing, fever, feeling sick, aches and pains in your joints.
Slovenian: Znaki alergijske reakcije lahko vključujejo: kožni izpuščaj, urtikarijo, otekline obraza ali grla, omotico, pospešen srčni utrip ali palpitacije, pomanjkanje sape ter težave z dihanjem, zvišano telesno temperaturo, slabost, zbadanje in bolečine v sklepih,.
English: - ‘intravenous immunoglobulin' - you should not have this type of medicine in the two weeks before
Slovenian: - »intravenske imunoglobuline« - tovrstnega zdravila ne smete jemati dva tedna pred zdravljenjem z zdravilom Unituxin in najmanj en teden po zaključku zdravljenja.
English: Pain typically occurred during the Unituxin infusion and was most commonly reported as abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal chest pain, and arthralgia; 41% of patients suffered severe pain.
Slovenian: Bolečine so se tipično pojavile med infuzijo zdravila Unituxin, običajno kot bolečine v trebuhu, splošne bolečine, bolečine v okončinah, bolečine v križu, nevralgija, mišično-kostne bolečine v prsnem košu in artralgija.
English: The pharmacokinetics of dinutuximab were evaluated in a clinical study of Unituxin in combination with GM-CSF, IL-2, and isotretinoin.
Slovenian: Farmakokinetika dinutuksimaba je bila ocenjena v klinični študiji o zdravilu Unituxin v kombinaciji z GM
English: Neurological disorders of the eye
Slovenian: Nevrološke očesne bolezni
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).
Slovenian: 3. izotretinoin: za telesno maso večjo kot 12 kg: 80 mg/m2, ki se daje peroralno dvakrat na dan v skupnem odmerku 160 mg/m2/dan; za telesno maso do 12 kg: 2,67 mg/kg, ki se daje peroralno dvakrat na dan vskupnem odmerku 5,33 mg/kg/dan (odmerek zaokrožite na 10 mg).
English: Severe allergic reactions are more likely when dinutuximab is co-administered with IL-2.
Slovenian: Hude alergijske reakcije so bolj pogoste v primeru sočasnega dajanja dinutuksimaba in IL-2.
English: How Unituxin works
Slovenian: Kako deluje zdravilo Unituxin
English: Peripheral oedema, chills, fatigue, irritability Injection site reaction
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edem, mrazenje, utrujenost, razdražljivost, reakcije na mestu injiciranja
English: Hepatic dysfunction Regular monitoring of liver function is recommended during dinutuximab immunotherapy.
Slovenian: Med imunoterapijo z dinutuksimabom se priporoča redno spremljanje delovanja jeter.
English: Anaphylaxis Grade 3 or 4
Slovenian: Anafilaksija Stopnja 3 ali 4
English: Increased gammaglutamyltransferase, increased blood creatinine, increased weight
Slovenian: zmanjšanje števila nevtrofilcev, zvišanje aspartataminotransferaze zvišanje alaninaminotransferaze zvišanje gama-glutamiltransferaze, zvišanje kreatinina v krvi, zvišanje telesne mase pozitivna hemokultura
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.
Slovenian: Neželeni učinki o katerih so poročali v štirih kliničnih študijah (ANBL0032, ANBL0931, CCG-0935A, in
English: Haemolytic uraemic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anaemia, and hypertension has been reported.
Slovenian: Obstajajo primeri, ko je zaradi nedokumentirane okužbe prišlo do hemolitično uremičnega sindroma, katerega posledice so ledvična insuficienca, nenormalne vrednosti elektrolitov, anemija in hipertenzija.
English: • Delay course initiation until platelet count is at least 20,000/μL.
Slovenian: • Odložite začetek cikla zdravljenja, dokler število trombocitov ni najmanj 20.000/µl.