FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, clofarabine delayed tumour growth and, in some cases, caused tumour regression in an assortment of human and murine tumour xenografts implanted in mice.
Croatian: Osim toga, klofarabin je odgodio rast tumora i, u nekim slučajevima, prouzročio regresiju tumora u nizu ljudskih i mišjih tumorskih ksenotransplantata usađenih u miševa.
English: Patients with ALL must not have been eligible for therapy of higher curative potential and must have been in second or subsequent relapse and/or refractory i.e. failed to achieve remission after at least two prior regimens.
Croatian: Bolesnici s ALL-om nisu smjeli biti podobni za liječenje većeg kurativnog potencijala i morali su biti u drugom ili narednom relapsu i/ili refraktorni, tj. nisu postigli remisiju nakon barem dvaju prethodnih linija liječenja.
English: However, possible symptoms of overdose are expected to include nausea, vomiting, diarrhoea and severe bone marrow suppression.
Croatian: Ipak, očekuje se da bi mogući simptomi predoziranja mogli uključivati mučninu, povraćanje, proljev i tešku supresiju koštane srži.
English: If a patient becomes pregnant during treatment with clofarabine, she should be informed of the possible hazard to the foetus.
Croatian: Ako bolesnica zatrudni tijekom liječenja klofarabinom, treba je upozoriti na moguću opasnost za plod.
English: Neoplasms benign and malignant (including cysts and polyps)
Croatian: Dobroćudne i zloćudne novotvorine (uključujući ciste i polipe)
English: Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Croatian: Nuspojave za koje se smatra da su povezane s klofarabinom prijavljene s učestalošću od ≥ 1/1000 (tj. u > 1/115 bolesnika) u kliničkim ispitivanjima i nakon stavljanja lijeka u promet
English: The most prevalent renal toxicity in paediatric patients was elevated creatinine.
Croatian: Najčešći oblik nefrotoksičnosti u pedijatrijskih bolesnika bio je povišeni kreatinin.
English: Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non-activated chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells and in the in vivo rat micronucleus assay.
Croatian: Ispitivanja genotoksičnosti pokazala su da klofarabin nije bio mutagen u testu reverzne mutacije bakterija, ali je izazvao klastogene učinke u testu neaktivirane kromosomske aberacije na stanicama jajnika kineskog hrčka te u mikronukleusnom testu u štakora in vivo.
English: Clofarabine must first diffuse or be transported into target cells where it is sequentially phosphorylated to the mono- and bi-phosphate by intracellular kinases, and then finally to the active conjugate, clofarabine 5'-triphosphate.
Croatian: Klofarabin prvo mora difundirati ili biti prenesen u ciljne stanice gdje se djelovanjem unutarstaničnih kinaza sekvencijalno fosforilira u mono- i difosfat, a potom i u aktivni konjugat, klofarabin 5'-trifosfat.
English: These likely represent the superimposition of degenerative and regenerative changes as a result of treatment cycles, and were not associated with changes in serum chemistry.
Croatian: Ti su učinci vjerojatno posljedica degenerativnih i regenerativnih promjena koje nastaju kao rezultat liječenja, ali nisu povezani s promjenama biokemijskih parametara seruma.
English: Fifty percent of patients experienced at least one cardiac disorders adverse reaction.
Croatian: U 50% bolesnika zabilježena je barem jedna nuspojava u obliku srčanog poremećaja.
English: CRp = Complete remission in the Absence of Total Platelet Recovery
Croatian: KRt = kompletna remisija bez potpunog oporavka trombocita
English: Patients with moderate renal impairment (creatinine clearance 30 - < 60 ml/min) require a 50% dose reduction (see section 5.2).
Croatian: U bolesnika s umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - < 60 ml/min) potrebno je smanjiti dozu za 50% (vidjeti dio 5.2).
English: In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase α and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Croatian: Osim toga, klofarabin ima veću otpornost na staničnu razgranju djelovanjem adenozin deaminaze i manju osjetljivost na fosforilitičko cijepanje od drugih djelatnih tvari u svojoj skupini, dok je afinitet klofarabin trifosfata prema DNK polimerazi α i ribonukleotid reduktazi podjednak ili viši od afiniteta deoksiadenozin trifosfata.
English: There are currently insufficient data to establish the safety and efficacy of clofarabine in patients 65 years of age or older.
Croatian: Trenutno nema dovoljno podataka za utvrđivanje sigurnosti i djelotvornosti klofarabina u bolesnika u dobi od 65 godina ili starijih.
English: Those most frequently reported were nausea (61% of patients), vomiting (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Croatian: Najčešće prijavljeni bili su mučnina (61% bolesnika), povraćanje (59%), neutropenijska vrućica (35%), glavobolja (24%), osip (21%), proljev (20%), pruritus (20%), pireksija (19%), sindrom palmarno-plantarne eritrodizestezije (15%), umor (14%), anksioznost (12%), upala sluznice (11%) i navale crvenila (11%).
English: Glomerulonephropathy was reported in rats at exposure levels 3 to 5 fold higher than the clinical AUC after 6 dosing cycles of clofarabine.
Croatian: U štakora je prijavljena glomerulonefropatija kod razina izloženosti 3 do 5 puta većih od kliničkog AUCa nakon 6 ciklusa klofarabina.
English: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Croatian: Liječenje akutne limfoblastične leukemije (ALL) u pedijatrijskih bolesnika u kojih je došlo do relapsa ili je bolest refraktorna nakon najmanje dvije prethodne linije liječenja i kada ne postoji druga mogućnost liječenja koja bi dovela do trajnijeg odgovora.
English: The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m2 daily x 5.
Croatian: Navedene informacije temelje se na podacima iz kliničkih ispitivanja u kojima je 115 bolesnika (u dobi > 1 i ≤ 21 godine) s akutnom limfoblastičnom leukemijom (ALL) ili akutnom mijeloičnom leukemijom (AML) primilo barem jednu dozu klofarabina u preporučenoj dozi od 52 mg/m2 na dan x 5.
English: (7.9 to 18.1)
Croatian: (7,9 do 18,1)
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 20 mg/20 ml
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 20 mg/20 ml
English: Ivozall is for intravenous use.
Croatian: Ivozall je namijenjen za intravensku primjenu.
English: Dose related toxicities on male reproductive organs have been observed in mice, rats and dogs, and toxicities on female reproductive organs have been observed in mice (see section 5.3).
Croatian: Toksičnosti ovisne o dozi koje utječu na muške reproduktivne organe primijećene su u miševa, štakora i pasa, a toksičnosti za ženske reproduktivne organe primijećene su u miševa (vidjeti dio 5.3).
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for Ivozall, such as this leaflet.
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o referentnom lijeku te će se informacije o lijeku Ivozall, kao što je ova uputa, ažurirati u skladu s referentnim lijekom.
English: In this regard, patients should be closely monitored when clofarabine is used in combined regimens.
Croatian: Stoga, bolesnike treba pozorno pratiti kada se klofarabin koristi u kombiniranoj terapiji.
English: Young men and women must use effective contraception during and after treatment.
Croatian: Mladi muškarci i žene moraju primjenjivati učinkovitu kontracepciju tijekom liječenja i po njegovu završetku.
English: Pericardial effusion and pericarditis were reported as an adverse reaction in 9% (10/115) of patients.
Croatian: Perikardni izljev i perikarditis prijavljeni su kao nuspojave u 9% (10/115) bolesnika.
English: To date, the highest daily dose administered to human beings is 70 mg/m2 for 5 consecutive days (2 paediatric ALL patients).
Croatian: Najviša dosad primijenjena doza u ljudi je 70 mg/m2 na dan tijekom 5 uzastopnih dana (2 pedijatrijska bolesnika s ALL-om).
English: Histological evidence of hepatic effects was seen in dogs following acute administration of high doses, but was also not accompanied by changes in serum chemistry.
Croatian: Histološki dokazi učinaka na jetru primijećeni su u pasa nakon akutne primjene visokih doza, no ni oni nisu praćeni promjenama biokemijskih parametara seruma.
English: In addition, 50/113 patients receiving clofarabine had at least severely (at least US NCI CTC Grade 3) elevated ALT, 36/100 elevated AST and 15/114 elevated bilirubin levels.
Croatian: Uz to, 50/113 bolesnika koji su primali klofarabin imali su barem jače (najmanje NCI CTC stupanj 3) povišene vrijednosti ALT-a, 36/100 povišene vrijednosti AST-a, a 15/114 povišene razine bilirubina.
English: The vials contain 20 ml concentrate for solution for infusion and are packaged in a box.
Croatian: Bočice sadrže 20 ml koncentrata za otopinu za infuziju, a zapakirane su u kutiju.
English: • Prophylactic administration of allopurinol should be considered if hyperuricemia (tumour lysis)
Croatian: • Treba razmotriti profilaktičku primjenu alopurinola ako se očekuje pojava hiperuricemije (lize tumora).
English: Bleeding events have been observed in the setting of thrombocytopaenia.
Croatian: Primijećeni su događaji krvarenja pri trombocitopeniji.
English: Nine of 17 ALL patients were treated with clofarabine 52 mg/m2/day.
Croatian: Devet od 17 bolesnika s ALL-om liječeno je klofarabinom u dozi od 52 mg/m2 na dan.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/20 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 20 mg/20 ml
English: No specific antidotal therapy exists.
Croatian: Ne postoji poseban protulijek.
English: It was characterised by minor thickening of the glomerular basement membrane with only slight tubular damage and was not associated with changes in serum chemistry.
Croatian: Karakteriziraju je manja zadebljanja glomerularne bazalne membrane i sasvim mala tubularna oštećenja, ali nije povezana s promjenama biokemijskih parametara seruma.
English: The toxicities observed in these patients included vomiting, hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash.
Croatian: Toksični učinci primijećeni u tih bolesnika uključivali su povraćanje, hiperbilirubinemiju, povišene razine transaminaza i makulopapularni osip.
English: The vials contain 20 mg of clofarabine and are packaged in a box.
Croatian: Bočice sadrže 20 mg klofarabina, a zapakirane su u kutiju.
English: If you are the parent of a child who is being treated with Ivozall, tell the doctor if any of them apply to your child.
Croatian: Ako ste roditelj djeteta koje se liječi lijekom Ivozall, obavijestite liječnika ako se bilo što od navedenog odnosi na Vaše dijete.
English: Should patients experience an ANC < 0.5 × 109/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%.
Croatian: Ako u bolesnika ABN iznosi < 0,5 × 109/l dulje od 4 tjedna nakon početka posljednjeg ciklusa liječenja, u sljedećem se ciklusu preporučuje smanjiti dozu za 25%.
English: Three of these events were subsequently assessed as being related to clofarabine: pericardial effusion (2 events; 1 of which was serious) and pericarditis (1 event; not serious).
Croatian: Tri od tih događaja naknadno su procijenjeni kao povezani s klofarabinom: perikardni izljev (2 događaja; 1 od njih bio je ozbiljan) i perikarditis (1 događaj; nije bio ozbiljan).
English: Duration of Remission (weeks)
Croatian: Trajanje remisije (tjedni)
English: If a patient develops a clinically significant infection, clofarabine treatment may be withheld until the infection is clinically controlled.
Croatian: Ako se u bolesnika razvije klinički značajna infekcija, liječenje klofarabinom treba prekinuti dok infekcija ne bude pod kliničkom kontrolom.
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse reaction (see sections 4.3 and 4.4).
Croatian: Jetra je potencijalni ciljni organ toksičnog učinka klofarabina pa se u 25,2% bolesnika javila barem jedna nuspojava u obliku poremećaja jetre i žuči (vidjeti dijelove 4.3 i 4.4).
English: Sixty-eight patients (59%) experienced at least one serious clofarabine-related adverse event.
Croatian: U 68 bolesnika (59%) javio se barem jedan ozbiljni štetni događaj povezan s klofarabinom.
English: However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.
Croatian: Međutim, u bolesnika s površinom tijela > 0,38 m2 za postizanje preporučene dnevne doze klofarabina bit će potreban sadržaj od 1 do 7 bočica.
English: CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse The reference medicinal product containing clofarabine has been authorised under ‘exceptional circumstances'.
Croatian: KR * Trajanje remisije cenzurirano u trenutku transplantacije ** Bolesnik je transplantiran nakon zamjenskog liječenja *** Bolesnik je transplantiran nakon relapsa
English: In the event of a second clinically significant infection, clofarabine treatment should be withheld until the infection is clinically controlled and may be reinitiated at a 25% dose reduction.
Croatian: U slučaju pojave druge klinički značajne infekcije, liječenje klofarabinom treba prekinuti dok infekcija ne bude pod kliničkom kontrolom, nakon čega se može nastaviti uz smanjenje doze za 25%.
English: (6.7 to 12.6)
Croatian: (6,7 do 12,6)
English: It was observed that the frequency and severity of adverse reactions, in particular infection, myelosuppression (neutropenia) and hepatotoxicity, are increased when clofarabine is used in in combination.
Croatian: Primjećena je povećana učestalost i težina nuspojava, posebno infekcije, mijelosupresije (neutropenija) i hepatotoksičnosti, kada se klofarabin koristi u kombinaciji.
English: Not evaluable
Croatian: Ne može se procijeniti nije primjenjivo
English: No fertility studies have been conducted.
Croatian: Nisu provedena ispitivanja plodnosti.
English: Ivozall should not be handled by pregnant women.
Croatian: Trudnice ne smiju rukovati lijekom Ivozall.
English: However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m2 clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m2 clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Croatian: Međutim, farmakokinetika klofarabina u odraslih s relapsnom ili refraktornom AML nakon primjene jednokratne doze klofarabina od 40 mg/m2 intravenskom infuzijom tijekom 1 sata bila je usporediva s prethodno opisanom farmakokinetikom u bolesnika u dobi od 2 do 19 godina s relapsnom ili refraktornom ALL ili AML nakon primjene doze klofarabina od 52 mg/m2 intravenskom infuzijom tijekom 2 sata kroz 5 uzastopnih dana.
English: Although transplantation rate was not a study endpoint, 10/61 patients (16%) went on to receive a HSCT after treatment with clofarabine (3 after achieving a CR, 2 after a CRp, 3 after a PR, 1 patient that was considered a treatment failure by the IRRP and 1 that was considered not evaluable by the IRRP).
Croatian: Iako stopa transplantacije nije bila mjera ishoda ispitivanja, u 10/61 bolesnika (16%) provedena je TKMS nakon liječenja klofarabinom (3 bolesnika koja su postigla KR, 2 bolesnika koja su postigla KRt, 3 bolesnika koja su postigla PR, 1 bolesnik u kojega je IRRP
English: Intravenous infusion of 52 mg/m2 clofarabine produced equivalent exposure across a wide range of weights.
Croatian: Intravenska infuzija doze klofarabina od 52 mg/m2 rezultirala je jednakom izloženošću kod različitih tjelesnih težina.
English: (4.0 to 6.1)
Croatian: (4,0 do 6,1)
English: Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - upala jetre (hepatitis).
English: Very common: Anxiety Common: Agitation, restlessness, mental status change
Croatian: Psihijatrijski poremećaji vrlo često: anksioznost često: agitacija, nemir, promjena mentalnog stanja
English: Clofarabine is a purine nucleoside anti-metabolite.
Croatian: Klofarabin je antimetabolit purinskih nukleozida.
English: Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2).
Croatian: U bolesnika kod kojih je prethodno učinjena transplantacija krvotvornih matičnih stanica (TKMS) može postojati povećan rizik od hepatotoksičnosti, koja upućuje na venskookluzivnu bolest (VOB), nakon liječenja klofarabinom (40 mg/m2) kada se primjenjuje u kombinaciji s etopozidom (100 mg/m2) i ciklofosfamidom (440 mg/m2).
English: Do not use this medicine after the expiry date which is stated on the vial label and box after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i na kutiji iza oznake „Rok valjanosti“.
English: Severe hepatotoxic events have been reported in a Phase 1/2 combination study of clofarabine in paediatric patients with relapsed or refractory acute leukaemia.
Croatian: Prijavljeni su teški hepatotoksični događaji u kombiniranom ispitivanju faze I/II u kojem se ispituje primjena klofarabina u pedijatrijskih bolesnika s relapsom ili refraktornim oblikom akutne leukemije.
English: The recommended dosage should be administered by intravenous infusion although it has been administered via a central venous catheter in ongoing clinical trials.
Croatian: Preporučena doza primjenjuje se intravenskom infuzijom iako se u kliničkim ispitivanjima koja su u tijeku lijek primjenjuje putem centralnog venskog katetera.
English: amphotericin B); - any other medicines including those obtained without a prescription.
Croatian: - bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100; rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti (vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko
English: This is usually reversible and appears to be dose-dependent.
Croatian: Supresija koštane srži je očekivana no uglavnom reverzibilna, a čini se da ovisi o dozi.
English: You need to allow for this if you are on a controlled sodium diet.
Croatian: To morate uzeti u obzir ako ste na režimu prehrane s ograničenim unosom natrija.
English: Two paediatric reports (1.7%) of veno-occlusive disease (VOD) were considered related to study drug.
Croatian: Dva slučaja venskookluzivne bolesti u pedijatrijskih bolesnika (1,7%) smatrana su povezanima s ispitivanim lijekom.
English: In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
Croatian: U razdoblju nakon stavljanja lijeka u promet, poslije liječenja klofarabinom zabilježene su ozbiljne hepatotoksične nuspojave venookluzivne bolesti (VOD) u pedijatrijskih i odraslih bolesnika koje su povezane sa smrtnim ishodom.
English: Population pharmacokinetic data from adult and paediatric patients suggest that patients with stable moderate renal impairment (creatinine clearance 30 - < 60 ml/min) receiving a 50% dose reduction achieve similar clofarabine exposure to those with normal renal function receiving a standard dose.
Croatian: Populacijski farmakokinetički podaci prikupljeni u odraslih i pedijatrijskih bolesnika ukazuju na to da se primjenom 50% niže doze u bolesnika sa stabilnim umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - < 60 ml/min) postiže izloženost klofarabinu slična onoj u bolesnika s normalnom bubrežnom funkcijom kod primjene standardne doze.
English: In the majority of patients (8/10), the pericardial effusion and pericarditis were deemed to be asymptomatic and of little or no clinical significance on echocardiographic assessment.
Croatian: U većine su bolesnika (8/10) perikardni izljev i perikarditis pri ehokardiografskoj procjeni ocijenjeni asimptomatskima te od zanemarivog ili nikakvog kliničkog značaja.
English: Each box contains 1 vial.
Croatian: Jedna kutija sadrži 1 bočicu.
English: (58.6 to -)
Croatian: (58,6 do -)
English: Pharmacokinetic data indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see section 5.2).
Croatian: Farmakokinetički podaci ukazuju na mogućnost akumulacije klofarabina u bolesnika sa smanjenim klirensom kreatinina (vidjeti dio 5.2).
English: Of the 17 ALL patients, 2 achieved a complete remission (12%; CR) and 2 a partial remission (12%; PR) at varying doses.
Croatian: Od 17 bolesnika s ALL-om, 2 su postigla kompletnu remisiju (12%; KR), a
English: The recommended dose in monotherapy is 52 mg/m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Croatian: Preporučena doza u monoterapiji je 52 mg/m2 tjelesne površine primijenjena intravenskom infuzijom tijekom 2 sata na dan kroz 5 uzastopnih dana.
English: ALT and AST occurred within 10 days of clofarabine administration and returned to ≤ grade 2 within 15 days.
Croatian: Do povišenja vrijednosti ALT-a i AST-a većinom je došlo unutar 10 dana od primjene klofarabina, a vratile su se na stupanj ≤ 2 u roku od 15 dana.
English: Efficacy results from the pivotal study in patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL after at least two prior regimens
Croatian: Rezultati djelotvornosti pivotalnog ispitivanja u bolesnika (u dobi od ≤ 21 godine kod početne dijagnoze) s relapsnom ili refraktornom ALL nakon barem dvaju prethodnih linija liječenja Kategorija odgovora
English: It is a clear colourless solution that is prepared and diluted before it is used.
Croatian: Lijek je bistra i bezbojna otopina koja se prije primjene mora pripremiti za primjenu i razrijediti.
English: Dose-limiting toxicities in this study were hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash experienced at 70 mg/m2/day (2 ALL patients; see section 4.9).
Croatian: Toksičnosti koje su ograničavale dozu u ovom su ispitivanju bile hiperbilirubinemija, povišene vrijednosti transaminaza i makulopapularni osip, a pojavile su se kod doze od 70 mg/m2 na dan (2 bolesnika s ALL-om; vidjeti dio 4.9).