FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Croatian: Nema iskustva u bolesnika s oštećenjem jetrene funkcije (bilirubin u serumu > 1,5 x GGN, uz AST i ALT > 5 x GGN), a jetra je potencijalni ciljni organ za toksičnost.
English: Three patients died of adverse events considered by the study investigator to be related to treatment with clofarabine: one patient died from respiratory distress, hepatocellular damage, and capillary leak syndrome; one patient from VRE sepsis and multi-organ failure; and one patient from septic shock and multi-organ failure.
Croatian: Tri su bolesnika preminula od štetnih događaja koje je ispitivač smatrao povezanima s liječenjem klofarabinom: jedan je bolesnik preminuo od respiratornog distresa, hepatocelularnog oštećenja i sindroma povećane propusnosti kapilara; jedan bolesnik od sepse koju je prouzročio enterokok rezistentan na vankomicin (VRE) i višeorganskog zatajenja; a jedan bolesnik od septičkog šoka i višeorganskog zatajenja.
English: There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients.
Croatian: Trenutno nema dovoljno podataka za utvrđivanje sigurnosti i djelotvornosti klofarabina u odraslih bolesnika.
English: There are currently limited data on the safety and efficacy of clofarabine when administered for more than 3 treatment cycles.
Croatian: Trenutno postoje ograničeni podaci o sigurnosti i djelotvornosti klofarabina kada se primjenjuje u više od
English: If the product comes into contact with eyes, skin or mucous membranes, rinse immediately with copious amounts of water.
Croatian: Ako lijek dođe u dodir s očima, kožom ili sluznicom, zahvaćeno područje treba odmah temeljito isprati vodom.
English: The patients were enrolled into a single phase I (n = 12) or two phase II (n = 14 / n = 14) safety and efficacy studies, and received multiple doses of clofarabine by intravenous infusion (see section 5.1).
Croatian: (n = 12) ili dva ispitivanja sigurnosti i djelotvornosti faze II (n = 14 / n = 14) u kojima su intravenskom infuzijom primali višestruke doze klofarabina (vidjeti dio 5.1).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije često: kontuzija
English: Dose excreted in urine
Croatian: Doza izlučena mokraćom
English: There is no clinical study experience in paediatric patients with renal insufficiency (defined in clinical studies as serum creatinine ≥ 2 x ULN for age) and clofarabine is predominately excreted via the kidneys.
Croatian: Nema iskustva iz kliničkih ispitivanja s pedijatrijskim bolesnicima u kojih postoji zatajivanje bubrežne funkcije (u kliničkim ispitivanjima definirano vrijednošću kreatinina u serumu od ≥ 2 x GGN za dob), a klofarabin se uglavnom izlučuje putem bubrega.
English: During the post-marketing period, bacterial, fungal and viral infections have been reported and may be fatal.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi bakterijskih, gljivičnih i virusnih infekcija i one mogu imati smrtni ishod.
English: However, Cmax is inversely proportional to patient weight and, therefore, small children may have a higher Cmax at the end of infusion than a typical 40 kg child given the same dose of clofarabine per m2.
Croatian: Međutim, Cmax je obrnuto proporcionalan težini bolesnika i stoga mala djeca mogu imati viši Cmax na završetku infuzije od tipičnog djeteta od 40 kg koje je primilo istu dozu klofarabina po m2. U skladu s time treba razmotriti uvođenje duljeg trajanja infuzije u djece težine < 20 kg (vidjeti dio 4.2).
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, fainting spells, or decreased urine output.
Croatian: Bolesnicima treba reći da potraže savjet liječnika ako dožive simptome omaglice, nesvjestice ili ako smanjeno mokre.
English: No relationship between clofarabine or clofarabine triphosphate exposure and either efficacy or toxicity has been established in this population.
Croatian: U navedenoj populaciji nije utvrđena povezanost između izloženosti klofarabinu odnosno klofarabin trifosfatu i djelotvornosti ili toksičnosti.
English: It is supplied in 20 ml glass vials.
Croatian: Dolazi u staklenim bočicama od 20 ml.
English: A total of 83% of patients experienced at least 1 infection after clofarabine treatment, including fungal, viral and bacterial infections (see section 4.4).
Croatian: bolesnika nakon liječenja klofarabinom javila barem jedna infekcija, uključujući gljivične, virusne i bakterijske infekcije (vidjeti dio 4.4).
English: Ivozall must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Croatian: Ivozall se ne smije miješati niti primjenjivati istodobno s drugim lijekovima kroz istu intravensku liniju
English: Clofarabine clearance rates appear to be much higher than glomerular filtration rates suggesting filtration and tubular secretion as kidney elimination mechanisms.
Croatian: Brzina klirensa klofarabina doima se znatno višom od brzine glomerularne filtracije, što znači da su filtracija i tubularno izlučivanje mehanizmi eliminacije putem bubrega.
English: It is then recommended that clofarabine be administered at a further 25% dose reduction.
Croatian: U tom se slučaju preporučuje smanjenje doze klofarabina za dodatnih 25%.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 1 mg klofarabina.
English: It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) and then diluted in sodium chloride 9 mg/ml (0.9%) intravenous transparent PVC or polyolefine (polypropylene) infusion bags to produce a total volume according to the examples given in the table below.
Croatian: Lijek je potrebno filtrirati kroz štrcaljku sa sterilnim 0,2 mikrometarskim filtrom (preporučuje se primjena hidrofilnog PVDF filtera za štrcaljku) i potom razrijediti u 0,9 %-tnoj (9 mg/ml) otopini natrijeva klorida u prozirnim PVC ili poliolefinskim (polipropilenskim) vrećicama za intravensku infuziju kako bi se dobio ukupan volumen koji odgovara primjerima navedenima u tablici u nastavku.
English: One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Croatian: Jedan je bolesnik prekinuo liječenje zbog hiperbilirubinemije stupnja 4 za koju se smatralo da je povezana s primjenom klofarabina u dozi od 52 mg/m2 na dan.
English: Thirteen events of tumour lysis syndrome, capillary leak syndrome or SIRS have been reported; SIRS (2 events; both were considered to be serious), capillary leak syndrome (4 events; 3 of which were considered serious and related) and tumour lysis syndrome (7 events; 6 of which were considered related and 3 of which were serious).
Croatian: Prijavljeno je 13 događaja sindroma lize tumora, sindroma povećane propusnosti kapilara ili sindroma sistemskog upalnog odgovora; sindrom sistemskog upalnog odgovora (2 događaja, oba su se smatrala ozbiljnima), sindrom povećane propusnosti kapilara (4 događaja; 3 su se smatrala ozbiljnima i povezanima) i sindrom lize tumora (7 događaja; 6 ih se smatralo povezanima, od kojih 3 ozbiljnima).
English: Common: Weight decreased
Croatian: Pretrage često: smanjenje tjelesne težine
English: if you have suffered a severe reaction after previously using this medicine; if you have kidney disease, or used to have it; if you have liver disease, or used to have it; if you have heart disease, or used to have it.
Croatian: Ivozall možda neće biti prikladan za Vas: - ako ste doživjeli tešku reakciju nakon prethodnog uzimanja ovog lijeka; - ako imate ili ste imali bolest bubrega; - ako imate ili ste imali bolest jetre; - ako imate ili ste imali bolest srca.
English: (42.0 to -)
Croatian: (42,0 do -)
English: Patients taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.4 and 4.8).
Croatian: Bolesnike koji uzimaju lijekove za koje se zna da utječu na krvni tlak ili srčanu funkciju treba pažljivo nadzirati tijekom liječenja klofarabinom (vidjeti dijelove 4.4 i 4.8).
English: The concomitant use of medicinal products that have been associated with hepatic toxicity should be avoided wherever possible (see sections 4.5 and 4.8).
Croatian: Istodobnu primjenu lijekova povezanih s hepatotoksičnošću treba izbjegavati kad god je to moguće (vidjeti dijelove 4.5 i 4.8).
English: In vitro studies have demonstrated that clofarabine inhibits cell growth in and is cytotoxic to a variety of rapidly proliferating haematological and solid tumour cell lines.
Croatian: Ispitivanja in vitro pokazala su da klofarabin inhibira rast stanica te da je citotoksičan za različite brzoproliferativne stanične linije hematoloških i solidnih tumora.
English: Dose reduction for patients experiencing haematological toxicities
Croatian: Smanjenje doze u bolesnika u kojih je došlo do hematološke toksičnosti
English: (66.6 to -)
Croatian: (66,6 do -)
English: Patients should be monitored for renal toxicity and clofarabine should be discontinued as necessary.
Croatian: Bolesnike je potrebno nadzirati zbog bubrežne toksičnosti i ako je potrebno, prekinuti liječenje klofarabinom.
English: Ivozall 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Croatian: Ivozall 1 mg/ml koncentrat za otopinu za infuziju mora se razrijediti prije primjene.
English: Ivozall contains sodium
Croatian: Ivozall sadrži natrij
English: LIST OF EXCIPIENTS Excipients: Sodium chloride and water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev klorid i voda za injekcije.
English: Should a patient experience the same severe toxicity on a second occasion, treatment should be delayed until the toxicity resolves to baseline parameters or to the point where it is no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Croatian: Ako se u bolesnika ponovno pojavi ista teška toksičnost, liječenje treba odgoditi sve dok se parametri toksičnosti ne vrate na početne vrijednosti ili dok se njihova težina ne ublaži do te mjere da moguća korist nastavka liječenja klofarabinom nadilazi rizik.
English: Median overall survival (weeks) (95% CI)
Croatian: Medijan ukupnog preživljenja (tjedni) (95% CI)
English: Six events were considered to be related to clofarabine of which acute cholecystitis (1 event), cholelithiasis (1 event), hepatocellular damage (1 event; patient died (see above)) and hyperbilirubinaemia (1 event; the patient discontinued therapy (see above)) were considered to be serious.
Croatian: Šest se događaja smatralo povezanima s klofarabinom, a među njima su ozbiljni bili sljedeći: akutni kolecistitis (1 događaj), kolelitijaza (1 događaj), hepatocelularno oštećenje (1 događaj; bolesnik je preminuo (vidjeti gore)) i hiperbilirubinemija (1 događaj; bolesnik je prekinuo liječenje (vidjeti gore)).
English: Each 20 ml vial contains 70.77 mg of sodium .
Croatian: Jedna bočica od 20 ml sadrži 70,77 mg natrija.
English: Use in patients with severe renal insufficiency or severe hepatic impairment.
Croatian: Primjena u bolesnika s teškim zatajivanjem bubrega ili teškim oštećenjem jetrene funkcije.
English: If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 109/l.
Croatian: Ako nema znakova perzistentne leukemije, za sljedeći se ciklus nakon oporavka ABN na ≥ 0,75 × 109/l preporučuje smanjiti dozu za 25% u odnosu na prethodnu.
English: - little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and /or weakness (possible signs of acute kidney failure or kidney failure).
Croatian: - oštećenje jetre (zatajenje jetre). - mokrenje malo ili nimalo mokraće, omamljenost, mučnina, povraćanje, nedostatak zraka, gubitak apetita i/ili slabost (mogući znakovi akutnog zatajenja bubrega ili zatajenja bubrega).
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported (see section 4.8).
Croatian: Kožni i potkožni poremećaji Prijavljeni su Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN), uključujući i smrtne slučajeve (vidjeti dio 4.8).
English: Clofarabine has high affinity for one of the activating phosphorylating enzymes, deoxycytidine kinase, which exceeds that of the natural substrate, deoxycytidine.
Croatian: Klofarabin ima visok afinitet prema jednom od aktivirajućih fosforilirajućih enzima, deoksicitidin kinazi,
English: (9.7 to 47.9)
Croatian: (9,7 do 47,9)
English: (13.7 to 56.1)
Croatian: (13,7 do 56,1)
English: Therefore, for patients with a body surface area ≤ 0.38 m2, the partial contents of a single vial will be required to produce the recommended daily dosage of clofarabine.
Croatian: Stoga će u bolesnika s površinom tijela ≤ 0,38 m2 za postizanje preporučene dnevne doze klofarabina biti dovoljan dio sadržaja jedne bočice.
English: These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (≥ 7.5 mg/m2/day clofarabine).
Croatian: Među njih se ubrajaju bilateralna degeneracija epitela sjemenovoda (150 mg/m2/dan) i atrofija intersticijskih stanica u štakora kod izloženosti prekomjernim dozama (150 mg/m2 na dan) te stanična degeneracija epididimisa i degeneracija epitela sjemenovoda u pasa pri klinički značajnim razinama izloženosti (doza klofarabina od ≥ 7,5 mg/m2 na dan).
English: (3.4 to 5.1)
Croatian: (3,4 do 5,1)
English: The safety profile of clofarabine has not been established in patients with severe renal insufficiency or patients receiving renal replacement therapy (see section 4.3).
Croatian: Sigurnosni profil klofarabina nije utvrđen u bolesnika s teškom insuficijencijom bubrežne funkcije niti u bolesnika koji primaju bubrežno nadomjesno liječenje (vidjeti dio 4.3).
English: VOD cases reported during the post-marketing period in paediatric and adult patients have been associated with a fatal outcome (see section 4.4).
Croatian: Slučajevi venookluzivne bolesti (VOD), prijavljeni nakon stavljanja lijeka u promet u pedijatrijskih i odraslih bolesnika, povezani su sa smrtnim ishodom (vidjeti dio 4.4).
English: Clinical efficacy: To enable systematic evaluation of the responses seen in patients, an unblinded Independent Response Review Panel (IRRP) determined the following response rates based on definitions produced by the Children's Oncology Group:
Croatian: Independent Response Review Panel, IRRP) kojemu je otkriveno koju je terapiju primao pojedini bolesnik, odredilo je sljedeće stope odgovora na temelju definicija koje je sastavila Skupina za dječju onkologiju (eng.
English: (5.0 to -)
Croatian: (5,0 do -)
English: Any patient who experiences a severe non-hematologic toxicity (US NCI CTC Grade 3 toxicity) on a third occasion, a severe toxicity that does not recover within 14 days (excluding nausea/vomiting) or a life-threatening or disabling non-infectious non-hematologic toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.2).
Croatian: U svih bolesnika u kojih se teška nehematološka toksičnost pojavi po treći put (toksičnost NCI CTC stupnja 3), u kojih se teška toksičnost ne povuče u roku od 14 dana (izuzev mučnine/povraćanja) ili u kojih se pojavi po život opasna ili onesposobljavajuća neinfektivna nehematološka toksičnost (toksičnost NCI CTC stupnja 4) treba u potpunosti obustaviti liječenje klofarabinom (vidjeti dio 4.2).
English: Time to OR (weeks)
Croatian: Vrijeme do UR-a (tjedni)
English: The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML.
Croatian: Apsorpcija i distribucija Farmakokinetika klofarabina ispitana je u 40 bolesnika u dobi između 2 i 19 godina s relapsnom ili refraktornom ALL ili AML.
English: Chemical and physical in-use stability has been demonstrated for seven days at room temperature and under refrigeration (2°C - 8°C) at a concentration range of 0.15 mg/ml to 0.83 mg/ml after dilution with sodium chloride 9 mg/ml (0.9%).
Croatian: Nakon razrjeđivanja 0,9 %-tnom (9 mg/ml) otopinom natrijeva klorida koncentrat je kemijski i fizikalno stabilan tijekom sedam dana na sobnoj temperaturi te u hladnjaku (od 2 °C do 8 °C) pri koncentraciji od 0,15 mg/ml do 0,83 mg/ml.
English: CR
Croatian: KR
English: Very common: Headache Common: Somnolence, peripheral neuropathy, paraesthesia, dizziness, tremor
Croatian: Poremećaji živčanog sustava vrlo često: glavobolja često: somnolencija, periferna neuropatija, parestezija, omaglica, tremor
English: • An M2 bone marrow (≥ 5% and ≤ 25% blasts) and appearance of normal progenitor cells • An M1 marrow that did not qualify for CR or CRp
Croatian: • koštana srž M2 (≥ 5% i ≤ 25% blasta) i pojava normalnih progenitornih stanica
English: Median duration of remission (weeks) (95% CI)
Croatian: Medijan trajanja remisije (tjedni) (95% CI)
English: The no-observable effect level for maternal toxicity in rats was 18 mg/m2/day and in rabbits was more than 12 mg/m2/day.
Croatian: Razina izloženosti pri kojoj nisu uočeni štetni učinci za majku bila je 18 mg/m2 na dan u štakora te više od 12 mg/m2 na dan u kunića.
English: (18.1 to -)
Croatian: (18,1 do -)
English: (15.4 to 56.1)
Croatian: (15,4 do 56,1)
English: Nephrotoxic medicinal products, tumour lysis, and tumour lysis with hyperuricemia may contribute to renal toxicity (see sections 4.3 and 4.4).
Croatian: Nefrotoksičnosti mogu pridonijeti nefrotoksični lijekovi, liza tumora i liza tumora s hiperuricemijom (vidjeti dijelove 4.3 i 4.4).
English: Common: Anorexia, decreased appetite, dehydration Frequency not known: Hyponatremia
Croatian: Poremećaji metabolizma i prehrane često: anoreksija, smanjen tek, dehidracija nepoznata učestalost: hiponatrijemija
English: (7.6 to 47.9)
Croatian: (7,6 do 47,9)
English: No studies on the effects of clofarabine on the ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja utjecaja klofarabina na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients with cardiac disease and those taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.5 and
Croatian: Bolesnike sa srčanom bolešću i one koji uzimaju lijekove za koje se zna da utječu na krvni tlak ili srčanu funkciju treba pažljivo nadzirati tijekom liječenja klofarabinom (vidjeti dijelove 4.5 i 4.8).
English: Patients undergoing treatment with clofarabine should be evaluated and monitored for signs and symptoms of tumour lysis syndrome and cytokine release (e.g. tachypnoea, tachycardia, hypotension, pulmonary oedema) that could develop into Systemic Inflammatory Response Syndrome (SIRS), capillary leak syndrome and/or organ dysfunction (see section 4.8).
Croatian: U bolesnika koji se liječe klofarabinom treba procjenjivati i pratiti eventualnu pojavu znakova i simptoma sindroma lize tumora i otpuštanja citokina (npr. tahipneja, tahikardija, hipotenzija, plućni edem) koji bi se mogli razviti u sindrom sistemskog upalnog odgovora (eng.
English: It is then recommended that clofarabine be administered at a 25% dose reduction.
Croatian: U tom se slučaju preporučuje smanjiti dozu za 25%.
English: Clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system.
Croatian: Nije zabilježen primjetan metabolizam klofarabina posredstvom enzimskog sustava citokroma P450
English: Delayed ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at the only dose used of 225 mg/m2/day clofarabine.
Croatian: U ženki miševa primijećena je odgođena atrofija ili degeneracija jajnika i apoptoza sluznice maternice kod primjene jedine ispitivane doze klofarabina od 225 mg/m2 na dan.
English: Type I glass vial with grey chlorobutyl fluoropolymer coated rubber stopper, polypropylene flip-off cap and aluminium overseal.
Croatian: I sa sivim klorobutilnim fluoropolimerskim gumenim čepom, polipropilenskom
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place under controlled and validated aseptic conditions.
Croatian: Lijek pripremljen za primjenu ne bi se smio čuvati dulje od 24 sata na temperaturi od 2°C do 8°C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Common: Hyperbilirubinaemia, jaundice, veno-occlusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Croatian: Poremećaji jetre i žuči često: hiperbilirubinemija, žutica, venskookluzivna bolest, povišene vrijednosti alanin aminotransferaze (ALT)* i aspartat aminotransferaze (AST)*, zatajenje jetre manje često: hepatitis
English: Clofarabine is eliminated by a combination of renal and non-renal excretion.
Croatian: Biotransformacija i eliminacija Klofarabin se eliminira kombinacijom bubrežnog i nebubrežnog izlučivanja.
English: An infusion time of > 2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine (see section 5.2).
Croatian: Kako bi se ublažili simptomi anksioznosti i razdražljivosti te izbjegle neopravdano visoke maksimalne koncentracije klofarabina, treba razmotriti primjenu infuzije u trajanju duljem od 2 sata (vidjeti dio 5.2).
English: * = see below **All adverse reactions occurring at least twice (i.e., 2 or more reactions (1.7%)) are included in this table
Croatian: * = vidjeti u nastavku ** u tablici su navedene sve nuspojave koje su se pojavile barem dvaput (tj. 2 ili više nuspojava
English: within 10 days.
Croatian: 12 godina.
English: Renal failure or acute renal failure have been observed as a consequence of infections, sepsis and tumour lysis syndrome (see section 4.8).
Croatian: Zatajenje bubrega ili akutno zatajenje bubrega opaženo je kao posljedica infekcija, sepse i sindroma lize tumora (vidjeti dio 4.8).
English: Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse reaction.
Croatian: U 64 od 115 bolesnika (55,7%) javila se barem jedna nuspojava u obliku krvožilnog poremećaja.
English: Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse reaction.
Croatian: U 41 od 115 bolesnika (35,7%) javila se barem jedna nuspojava u obliku poremećaja bubrega i mokraćnog sustava.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ivozall 1 mg/ml sterile concentrate clofarabine
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ivozall 1 mg/ml sterilni koncentrat klofarabin
English: (13.7 to -)
Croatian: (13,7 do -)
English: Twenty-three patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Croatian: 115 bolesnika javili su se krvožilni poremećaji koji se smatraju povezanima s klofarabinom, a među njima su najčešće prijavljivani bili navale crvenila (13 događaja; nisu bili ozbiljni) i hipotenzija (5 događaja; svi su se smatrali ozbiljnima; vidjeti dio 4.4).
English: Each ml contains 1 mg of clofarabine.
Croatian: Jedan ml sadrži 1 mg klofarabina.