FrancophonIA/ELRC3.0 huggingface dataset:
English: Zynteglo can only be obtained with a prescription and must be given in an approved centre by a doctor experienced in stem cell transplantation and in the treatment of beta thalassaemia.
Croatian: Zynteglo se izdaje samo na liječnički recept i mora ga primjenjivati liječnik s iskustvom u transplantaciji matičnih stanica i liječenju beta-talasemije, i to u kvalificiranom centru za liječenje.
English: What information is still awaited for Zynteglo?
Croatian: Koje se još informacije očekuju o lijeku Zynteglo?
English: Before Zynteglo is given, the patient will receive conditioning chemotherapy treatment to clear their bone marrow of cells.
Croatian: Prije nego što primi lijek Zynteglo, bolesnik će biti podvrgnut kondicionirajućoj kemoterapiji kako bi se uklonile stanice iz njegove koštane srži.
English: To make Zynteglo, the stem cells taken from the patient's blood are modified by a virus that carries working copies of the beta-globin gene into the cells.
Croatian: Da bi se proizveo lijek Zynteglo, matične stanice uzete iz bolesnikove krvi modificiraju se virusom koji prenosi funkcionalne kopije gena za beta-globin u stanice.
English: Zynteglo contains as its active substance stem cells taken from the patients that have been genetically modified to contain a working gene for beta-globin.
Croatian: Zynteglo sadržava djelatnu tvar u obliku matičnih stanica samih bolesnika koje su genetski modificirane kako bi sadržavale funkcionalni gen za beta-globin.
English: What benefits of Zynteglo have been shown in studies?
Croatian: Koje su koristi od lijeka Zynteglo utvrđene u ispitivanjima?
English: How is Zynteglo used?
Croatian: Kako se Zynteglo primjenjuje?
English: Zynteglo has been shown to be effective at reducing the need for blood transfusion in 2 main studies in patients with beta thalassaemia who required regular blood transfusions.
Croatian: U dvama glavnim ispitivanjima provedenima među bolesnicima s beta-talasemijom kojima je bila potrebna redovita transfuzija krvi, pokazalo se da se lijekom Zynteglo učinkovito smanjuje potreba za transfuzijama.
English: Ask your doctor how to throw away medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: Therefore only validated tests with demonstrated high sensitivity should be used.
Croatian: Stoga treba koristiti samo validirane testove dokazano visoke osjetljivosti.
English: Some of these side effects may be serious.
Croatian: Neke od ovih nuspojava mogu biti ozbiljne.
English: < 7 days (within a cycle)
Croatian: < 7 dana (unutar ciklusa)
English: 5 years
Croatian: 5 godine
English: Date of first authorisation: 29 June 2017
Croatian: Datum prvog odobrenja: 29. lipanj 2017.
English: The safety and efficacy of BESPONSA in children aged 0 to <18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka BESPONSA u djece u dobi od 0 do < 18 godina nije ustanovljena.
English: B-1930, Zaventem Belgium
Croatian: B-1930, Zaventem Belgija
English: The reconstituted solution must be used immediately.
Croatian: Rekonstituirana otopina se mora odmah iskoristiti.
English: What BESPONSA is and what it is used for 2.
Croatian: Što je BESPONSA i za što se koristi 2.
English: Subsequent cycles are 4 weeks in duration.
Croatian: Sljedeći ciklusi traju 4 tjedna.
English: The infusion must be administered over 1 hour.
Croatian: Infuzija se mora primijeniti tijekom 1 sata.
English: This procedure may take place if your disease responds completely to treatment.
Croatian: Ovaj se postupak može provesti ako Vaša bolest u potpunosti odgovara na liječenje.
English: a Infection also includes other types of infection (11%).
Croatian: Infekcija uključuje i druge vrste infekcija (11%).
English: The final concentration should be between 0.01 and 0.1 mg/mL.
Croatian: Konačna koncentracija mora biti između 0,01 i 0,1 mg/ml.
English: This belongs to a group of medicines that target cancer cells.
Croatian: On pripada skupini lijekova koji ciljaju stanice raka.
English: • Reduction in the number of various types of blood cells
Croatian: • Smanjenje broja raznih vrsta krvnih stanica
English: Omit the next dose within the cycle.
Croatian: Izostaviti sljedeću dozu unutar ciklusa.
English: Tell your doctor immediately if you have signs and symptoms of any of the following serious side effects:
Croatian: Odmah obavijestite svog liječnika ako imate znakove i simptome bilo koje od sljedećih ozbiljnih nuspojava:
English: In the clinical study, the sensitivity of some local tests was lower than the central laboratory test.
Croatian: U kliničkom ispitivanju je osjetljivost nekih lokalnih testova bila niža od laboratorijskih testova provedenih u središnjici.
English: • Your doctor will decide on the correct dose.
Croatian: • Vaš liječnik će odrediti točnu dozu.
English: BESPONSA should be administered in 3- to 4-week cycles.
Croatian: BESPONSA se treba primjenjivati u ciklusima od 3 do 4 tjedna.
English: Most effects were reversible to partially reversible except for effects in the liver and nervous system.
Croatian: Većina učinaka je bila reverzibilna do djelomično reverzibilna, osim učinaka na jetru i živčani sustav.
English: Note: patients may have had > 1 type of infection.
Croatian: Napomena: bolesnici su možda imali > 1 vrste infekcije.
English: All events were Grade ≤ 2 in severity.
Croatian: Svi slučajevi su bili stupnja ≤ 2 prema težini.
English: • Each dose is given weekly and each treatment cycle is 3 doses.
Croatian: • Svaka doza se daje jednom tjedno, a svaki ciklus liječenja čine 3 doze.
English: a, b, c, d, e, f For definition, see Table 6 (with the exception that CR/CRi was not per EAC for Study 2)
Croatian: a,b,c,d,e,f za definicije vidjeti Tablicu 6 (uz iznimku da u Ispitivanju 2 CR/CRi nije bio prema EAC)
English: What BESPONSA is and what it is used for
Croatian: Što je BESPONSA i za što se koristi
English: • If you do not respond to the medicine within 3 cycles, your treatment will be stopped.
Croatian: • Ako niste postigli odgovor na lijek unutar 3 ciklusa, Vaše liječenje će biti zaustavljeno.
English: Each pack of BESPONSA contains:
Croatian: Svako pakiranje lijeka BESPONSA sadrži:
English: Do not use filters made of nylon or mixed cellulose ester (MCE).
Croatian: Ne koristite filtere napravljene od najlona ili miješanog celuloznog estera (MCE).
English: [2.6 to 4.7]
Croatian: [2,6 do 4,7]
English: The relevance of these animal findings to humans is uncertain.
Croatian: Značaj ovih životinjskih nalaza za ljude nije siguran.
English: Use appropriate aseptic technique for the reconstitution and dilution procedures.
Croatian: Koristite odgovarajuću aseptičku tehniku za postupke rekonstitucije i razrjeđivanja.
English: BESPONSA should not to be used in children and adolescents under 18 years of age because no data are available in this population.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati lijek BESPONSA jer nisu dostupni podaci u ovoj populaciji.
English: Wyeth Pharmaceutical Division of Wyeth Holdings LLC, 401 North Middletown Road, Pearl River, New York (NY) 10965
Croatian: Wyeth Pharmaceutical Division, Wyeth Holding LLC 401 North Middletown Road, Pearl River, New York (NY) 10965 Sjedinjene Američke Države (SAD)
English: If the dose is reduced due to BESPONSA-related toxicity, the dose should not be re-escalated.
Croatian: Ako se doza smanji zbog toksičnosti povezane s lijekom BESPONSA, doza se ne smije ponovno povećati.
English: • Calculate the dose (mg) and number of vials of BESPONSA required.
Croatian: • Izračunajte dozu (mg) i broj potrebnih bočica lijeka BESPONSA.
English: These medicines are called antineoplastic agents.
Croatian: Ti se lijekovi zovu antineoplastični lijekovi.
English: Table 1 (see section 4.2) shows the dosing regimen used to treat patients.
Croatian: Tablica 1 (vidjeti dio 4.2) prikazuje režim doziranja koji se primjenjuje za liječenje bolesnika.
English: Tell your doctor if you have symptoms, such as dizziness, lightheadedness or fainting.
Croatian: Obavijestite svog liječnika ako imate simptome poput omaglice, ošamućenosti ili nesvjestice.
English: > 28 days
Croatian: > 28 dana
English: Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells.
Croatian: Akutna limfoblastična leukemija je rak krvi pri kojem se pojavljuje previše bijelih krvnih stanica.
English: Decreased appetite (12%)
Croatian: Smanjeni apetit (12%)
English: During treatment, especially in the first few days after starting treatment, you may have raised liver enzymes.
Croatian: Tijekom liječenja, osobito u prvih nekoliko dana nakon što ste započeli s liječenjem, možete imati povišene jetrene enzime.
English: • Changes in heart rhythm (may show on electrocardiogram)
Croatian: • Promjene u srčanom ritmu (mogu se pokazati na elektrokardiogramu)
English: you may receive 2 cycles or a maximum of 3 cycles of treatment.
Croatian: možete primiti 2 ciklusa ili maksimalno 3 ciklusa liječenja.
English: • Your doctor may lower your dose based on your response to treatment.
Croatian: • Vaš liječnik može smanjiti Vašu dozu ovisno o Vašem odgovoru na liječenje.
English: There are no data on the presence of inotuzumab ozogamicin or its metabolites in human milk, the effects on the breast-fed child, or the effects on milk production.
Croatian: Nema podataka o prisutnosti inotuzumab ozogamicina ili njegovih metabolita u majčinom mlijeku, učincima na dojenče ili učincima na proizvodnju mlijeka.
English: A stem cell transplant is a procedure to transplant another person's stem cells (cells which develop into new blood cells) into your bloodstream.
Croatian: Transplantacija matičnih stanica je postupak kojim se matične stanice druge osobe (stanice koje se razviju u nove krvne stanice) presađuju u Vaš krvotok.
English: Note: patients may have had > 1 type of haemorrhage.
Croatian: Napomena: bolesnici su možda imali > 1 vrste hemoragije.
English: The infusion line does not need to be protected from light.
Croatian: Cjevčicu za infuziju nije potrebno zaštititi od svjetlosti.
English: There is no information on fertility in patients.
Croatian: Ne postoje informacije o plodnosti bolesnika.
English: You should not use BESPONSA during pregnancy, unless your doctor thinks that it is the best medicine for you.
Croatian: BESPONSA se ne smije primjenjivati tijekom trudnoće, osim u slučaju da Vaš liječnik smatra da je to najbolji lijek za Vas.
English: BESPONSA must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus.
Croatian: BESPONSA se ne smije primjenjivati tijekom trudnoće osim u slučaju kada potencijalna korist za majku premašuje mogući rizik za fetus.
English: BESPONSA must be reconstituted and diluted before administration.
Croatian: BESPONSA se mora rekonstituirati i razrijediti prije primjene.
English: The table below shows the recommended dosing regimens.
Croatian: Tablica ispod prikazuje preporučene režime doziranja.
English: For patients who proceed to HSCT, liver tests should be monitored closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice.
Croatian: U bolesnika koji nastavljaju s HSCT-om treba pažljivo pratiti jetrene probe tijekom prvog mjeseca nakon HSCT-a, a nakon toga manje često, prema standardnoj medicinskoj praksi.
English: Once adequate recovery is achieved, decrease the total dose by 25% for the subsequent cycle.
Croatian: Kad se postigne odgovarajući oporavak, smanjiti ukupnu dozu za 25% za sljedeći ciklus.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS.
Croatian: Praćenje samo ukupne razine bilirubina ne mora nužno identificirati sve bolesnike u riziku od VOD/SOS-a.
English: Always use this medicine exactly as your doctor, pharmacist, or nurse has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
English: Dosing regimen for Cycle 1 All patients:
Croatian: Režim doziranja za 1. ciklus Svi bolesnici:
English: Five of the 18 VOD/SOS events that occurred post-HSCT were fatal (see section 5.1).
Croatian: Pet od 18 VOD/SOS slučajeva koji su se pojavili nakon HSCT-a su imali smrtni ishod (vidjeti dio 5.1).
English: Of the 326 patients (ITT population), 253 patients had samples that were evaluable for CD22 testing by both local and central laboratory.
Croatian: Od 326 bolesnika (ITT populacija), 253 bolesnika imalo je uzorke valjane za CD22 testiranje u lokalnom i središnjem laboratoriju.
English: White to off-white, lyophilised cake or powder.
Croatian: Bijeli do gotovo bijeli, liofilizirani kolačić ili prašak.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Dasatinib was the most commonly received TKI (42 patients) followed by imatinib (24 patients).
Croatian: Najčešće primijenjen TKI je bio dasatinib (42 bolesnika), nakon čega slijedi imatinib (24 bolesnika).
English: The 2 treatment groups were generally balanced with respect to the baseline demographics and disease characteristics.
Croatian: Dvije terapijske skupine općenito su bile ujednačene obzirom na početne demografske podatke i karakteristike bolesti.
English: If you feel unusually tired (this is a very common side effect of BESPONSA), you should not drive or use machines.
Croatian: Ako osjećate neuobičajen umor (to je vrlo česta nuspojava lijeka BESPONSA), ne biste smjeli upravljati vozilima ili raditi sa strojevima.
English: The effects of BESPONSA in pregnant women are not known, but based on its mechanism of action BESPONSA may harm your unborn baby.
Croatian: Nisu poznati učinci lijeka BESPONSA u trudnica, ali na temelju svog mehanizma djelovanja lijek BESPONSA može naškoditi Vašoj nerođenoj bebi.
English: Table 1 shows the recommended dosing regimens.
Croatian: Tablica 1 prikazuje preporučeni režim doziranja.
English: Analysis was based on the ITT population with patients without remission being given a duration of zero and considered an event.
Croatian: Analiza je bila temeljena na populaciji planiranoj za liječenje na način da se bolesnicima bez remisije dodijelilo trajanje nula i smatralo ih se događajem.
English: • Filtration of the diluted solution is not required.
Croatian: • Nije potrebno filtrirati razrijeđenu otopinu.
English: • are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na inotuzumab ozogamicin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Cycle length
Croatian: Trajanje ciklusa
English: This risk was most marked in patients who underwent subsequent HSCT.
Croatian: Rizik je bio najizraženiji u bolesnika koji su kasnije bili podvrgnuti HSCT-u.
English: BESPONSA has moderate influence on the ability to drive and use machines.
Croatian: BESPONSA može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Ascites (4%) Abdominal distension (6%)
Croatian: Ascites (4%) Distenzija abdomena (6%)
English: The relevance of the irreversible animal findings to humans is uncertain.
Croatian: Važnost ireverzibilnih životinjskih nalaza za ljude nije sigurna.
English: During treatment, especially in the first few days after starting treatment, your white blood cell count may be severely lowered (neutropenia), which may be accompanied by fever (febrile neutropenia).
Croatian: Tijekom liječenja, osobito u prvih nekoliko dana nakon što ste započeli s liječenjem, broj bijelih krvnih stanica može Vam se jako smanjiti (neutropenija), što može biti popraćeno vrućicom (febrilna neutropenija).
English: No formal clinical drug interaction studies have been performed (see section 5.2).
Croatian: Nisu provedena formalna klinička ispitivanja interakcija lijekova (vidjeti dio 5.2).
English: e 7-day treatment-free interval starting on Day 21.
Croatian: e sedmodnevno razdoblje bez liječenja koje počinje 21. dan.
English: Pregnant women, or patients becoming pregnant while receiving inotuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the fetus.
Croatian: Trudnice ili bolesnice koje zatrudne dok primaju inotuzumab ozogamicin, odnosno liječene muške bolesnike kao partnere trudnica, mora se informirati o mogućoj opasnosti za fetus.
English: BESPONSA improved OS versus Investigator's choice of chemotherapy for all stratification factors including duration of first remission ≥12 months, Salvage 1 status, and age at randomisation <55 years.
Croatian: BESPONSA je poboljšala ukupno preživljenje u odnosu na kemoterapiju po izboru ispitivača za sve čimbenike stratifikacije, uključujući trajanje prve remisije ≥ 12 mjeseci, status 1 spašavanja života i dob u vrijeme randomizacije < 55 godina.
English: Other medicines and BESPONSA
Croatian: Drugi lijekovi i BESPONSA
English: What BESPONSA looks like and contents of the pack
Croatian: Kako BESPONSA izgleda i sadržaj pakiranja
English: Table 7 shows the efficacy results from this study.
Croatian: Tablica 7 prikazuje rezultate djelotvornosti iz ovog ispitivanja.
English: In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.
Croatian: U ljudi je ukupan volumen distribucije inotuzumab ozogamicina iznosio približno 12 l.
English: • 1 glass vial containing a white to off-white lyophilised cake or powder.
Croatian: • 1 staklenu bočicu koja sadrži bijeli do gotovo bijeli liofilizirani kolačić ili prašak.
English: Contact your doctor immediately if you or your partner becomes pregnant during the period of treatment with this medicine.
Croatian: Odmah obavijestite svog liječnika ako Vi zatrudnite ili Vaša partnerica zatrudni tijekom razdoblja liječenja ovim lijekom.
English: No adjustment to the starting dose is required based on age (see section 5.2).
Croatian: Nije potrebna prilagodba početne doze obzirom na dob (vidjeti dio 5.2).
English: • Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL.
Croatian: • Dodajte rekonstituiranu otopinu u spremnik za infuziju s otopinom natrijevog klorida 9 mg/ml (0,9%) za injekciju do ukupnog nominalnog volumena od 50 ml.
English: In patients with an inadequate bone marrow aspirate sample, a peripheral blood sample was tested.
Croatian: U bolesnika s neodgovarajućim uzorkom aspirata koštane srži ispitivao se uzorak iz periferne krvi.
English: Patients should be monitored for increases in amylase and lipase.
Croatian: Bolesnike je potrebno pratiti radi povećanja razina amilaze i lipaze.
English: The use of HSCT conditioning regimens containing 2 alkylating agents should be avoided.
Croatian: Potrebno je izbjegavati primjenu režima kondicioniranja za HSCT koji uključuju 2 alkilirajuća agensa.
English: Table 6 shows the efficacy results from this study.
Croatian: Tablica 6 prikazuje rezultate djelotvornosti iz ovog ispitivanja.
English: These may include corticosteroids (e.g., dexamethasone), antipyretics (medicines to reduce fever), and antihistamines (medicines to reduce allergic reactions).
Croatian: Oni mogu uključivati kortikosteroide (npr. deksametazon), antipiretike (lijekove za snižavanje povišene tjelesne temperature) i antihistaminike (lijekove za smanjenje alergijskih reakcija).
English: The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su prikazane prema klasifikaciji organskih sustava i kategorijama učestalosti, definiranima prema sljedećoj konvenciji: vrlo često ( 1/10), često ( 1/100 i < 1/10), manje često ( 1/1000 i < 1/100), rijetko ( 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The median time from HSCT to onset of VOD/SOS was 15 days (range: 3-57 days).
Croatian: Medijan vremena od HSCT-a do pojave VOD/SOS-a je bio 15 dana (raspon: 3-57 dana).
English: Tell your doctor, pharmacist or nurse immediately if you became pregnant during the period of treatment with BESPONSA and for up to 8 months after finishing treatment.
Croatian: Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako zatrudnite tijekom razdoblja liječenja lijekom BESPONSA i do 8 mjeseci nakon završetka liječenja.
English: The number of patients was too small to assess the impact of anti-inotuzumab ozogamicin antibodies on efficacy and safety.
Croatian: Broj bolesnika je bio premalen kako bi se ocijenio utjecaj protutijela protiv inotuzumab ozogamicina na djelotvornost i sigurnost.
English: Your doctor will take an electrocardiogram (ECG) and blood tests to measure electrolytes (e.g., calcium, magnesium, potassium) before the first dose of BESPONSA and repeat these tests during treatment.
Croatian: Liječnik će Vam napraviti elektrokardiogram (EKG) i krvne pretrage za određivanje elektrolita (npr. kalcija, magnezija, kalija) prije prve doze lijeka BESPONSA te ponavljati ove pretrage tijekom liječenja.
English: Dose modifications for haematological toxicities at the start of a treatment cycle (Day 1)
Croatian: Tablica 2. Prilagodbe doze za hematološke toksičnosti na početku ciklusa liječenja (1. dan)
English: BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Croatian: BESPONSA se mora primjenjivati pod nadzorom liječnika s iskustvom u primjeni lijekova za liječenje raka te u okruženju gdje je odmah dostupna puna oprema za reanimaciju.
English: BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed.
Croatian: BESPONSA je namijenjena liječenju akutne limfoblastične leukemije u odraslih bolesnika koji su već pokušali sa drugim terapijama i kojima te terapije nisu uspjele.
English: Total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN
Croatian: Ukupni bilirubin > 1,5 × GGN i AST/ALT > 2,5 × GGN
English: Interrupt the next dose (maintain a minimum of 6 days between doses).
Croatian: Prekinuti sljedeću dozu (potreban je razmak od minimalno 6 dana između doza).
English: Although there was a higher frequency of early deaths post-HSCT (at Day 100) in the BESPONSA arm, there was evidence of a late survival benefit for BESPONSA.
Croatian: Premda je bila veća učestalost rane smrti nakon HSCT-a (na 100. dan) u skupini koja je primala lijek BESPONSA, bilo je dokaza o koristi od lijeka BESPONSA za kasno preživljenje.
English: b For patients who achieve a CR/CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e. 7-day treatment-free interval starting on Day 21).
Croatian: U bolesnika u kojih je postignut CR/CRi i/ili u svrhu omogućavanja oporavka od toksičnosti, trajanje ciklusa se može produljiti do 28 dana (odnosno uz sedmodnevno razdoblje bez liječenja počevši od 21. dana).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with BESPONSA in 1 or more subsets of the paediatric population for the treatment of relapsed or refractory ALL (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka BESPONSA u jednoj ili više podskupina pedijatrijske populacije liječene zbog recidivirajućeg ili refraktornog ALL-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).