FrancophonIA/ELRC3.0 huggingface dataset:
English: Adsorption and distribution
Slovenian: Absorbcija in porazdelitev
English: If you use more Evoltra than you should If you think you may have been given too much medicine, tell your doctor straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Evoltra, kot bi smeli Če menite, da so vam dali preveč zdravila, takoj povejte zdravniku.
English: Date of first authorisation: 29 May 2006.
Slovenian: Datum pridobitve dovoljenja za promet: 29. maj 2006 Datum zadnjega podaljšanja dovoljenja za promet: 14. januar 2016
English: Evoltra contains salt
Slovenian: Zdravilo Evoltra vsebuje sol
English: Before Evoltra is given to you, it will be diluted in a sodium chloride solution (salt and water).
Slovenian: Preden vam bodo dali zdravilo Evoltra, ga bodo razredčili v raztopini natrijevega klorida (sol in voda).
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.
Slovenian: Prozorna, skoraj brezbarvna raztopina s pH 4,5 do 7,5 in osmolarnostjo 270 do 310 mOsm/l.
English: • Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
Slovenian: • Respiratorni status, krvni tlak, ravnotežje tekočin in telesno maso ves čas 5-dnevnega obdobja dajanja klofarabina in takoj po njem.
English: • Renal and hepatic function prior to, during active treatment and following therapy.
Slovenian: • Delovanje ledvic in jeter pred zdravljenjem, med aktivnim zdravljenjem in po njem.
English: Evoltra may harm both male and female reproductive organs.
Slovenian: Zdravilo Evoltra lahko škodljivo vpliva na moške in ženske spolne organe.
English: No interaction studies have been performed.
Slovenian: Študij interakcij do sedaj še niso opravili.
English: CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse
Slovenian: PR * Trajanje remisije preverjeno ob času presaditve ** Pri bolniku je bila izvedena presaditev po alternativnem zdravljenju *** Pri bolniku je bila izvedena presaditev po relapsu
English: This is usually reversible and appears to be dosedependent.
Slovenian: Ta je navadno reverzibilna in kaže, da je odvisna od odmerka.
English: • Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 10
Slovenian: • Bolniki, ki izpolnjujejo vsa merila za PR, razen obnovitve števila trombocitov na > 100 x 109/l
English: What you need to know before you use Evoltra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Evoltra
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).
Slovenian: Potrebno je razmisliti o času infundiranja > 2 uri, da bi zmanjšali simptome tesnobe in razdražljivosti ter preprečili pretirano visoke maksimalne koncentracije klofarabina (glejte poglavje 5.2).
English: Therefore, it is unlikely to interact with active substances which inhibit or induce cytochrome P450 enzymes.
Slovenian: Zato ni verjetno, da bi medsebojno deloval z zdravilnimi učinkovinami, ki zavirajo ali sprožajo delovanje encimov citokroma P450.
English: PR = Partial Remission
Slovenian: DR = Delna remisija
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 combination.
Slovenian: Ugotovljeno je bilo, da se pogostnost in resnost neželenih učinkov, zlasti okužbe, mielosupresija (nevtropenija) in hepatotoksičnost, poveča, če se klofarabin uporablja v kombinaciji.
English: Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Slovenian: Občasni neželeni učinki (pojavijo se lahko prinajveč 1 od 100 oseb): - vnetje jeter (hepatitis).
English: Tell your doctor if you are on a controlled sodium diet as it could affect how you will be given your medicine.
Slovenian: Povejte zdravniku, če imate dieto za nadzor natrija, ker to lahko vpliva na način dajanja zdravila.
English: These infections may lead to septic shock, respiratory failure, renal failure, and/or multiorgan failure.
Slovenian: Te okužbe lahko povzročijo septični šok, odpoved dihal, odpoved ledvic in/ali odpoved več organov.
English: Once prepared and diluted, Evoltra should be used straight away or within 24 hours if stored in a refrigerator (at 2
Slovenian: Ko je zdravilo Evoltra pripravljeno in razredčeno, ga je treba porabiti takoj ali v 24 urah, če je shranjeno v hladilniku (pri 2°C do 8°C).
English: Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias.
Slovenian: Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi levkemijami.
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.
Slovenian: Vendar je vrednost Cmax obratno sorazmerna s telesno maso bolnika, zato je pri majhnih otrocih vrednost Cmax na koncu infundiranja lahko večja kot pri tipičnem 40 kg otroku, ki prejme enak odmerek klofarabina na m2.
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:
Slovenian: Klinična učinkovitost: Da bi omogočili sistematično oceno odzivov pri bolnikih, so v neodvisni panelni raziskavi odzivov (Independent Response Review Panel - IRRP) določili naslednje stopnje odziva, glede na opredelitve Skupine za otroško onkologijo (Children's Oncology Group): PR = Popolna remisija
English: It works best against cells which are multiplying quickly - such as cancer cells.
Slovenian: Najučinkovitejše je proti celicam, ki se hitro delijo, kot so rakaste celice.
English: In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Slovenian: Poleg tega je treba zdravljenje s klofarabinom prekiniti, če se pri bolniku med 5-dnevnim odmerjanjem razvije hipotenzija zaradi kateregakoli vzroka.
English: Do not use Evoltra: - if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below); - if you have severe kidney or liver problems.
Slovenian: Ne uporabljajte zdravila Evoltra: - če ste alergični na klofarabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če dojite (prosimo, preberite poglavje Nosečnost in dojenje spodaj); - če imate hude težave z ledvicami ali jetri.
English: • Disruption of mitochondrial membrane integrity with the release of cytochrome C and other proapoptotic factors leading to programmed cell death even in non-dividing lymphocytes.
Slovenian: • Motnje integritete mitohondrijske membrane s sproščanjem citokroma C in drugih proapoptotičnih faktorjev, kar povzroči programirano celično smrt, tudi pri limfocitih, ki se ne delijo.
English: If you are breast-feeding, you must stop breast-feeding before starting the treatment, and must not breast-feed during your treatment and within 3 months after completion of your treatment.
Slovenian: Če dojite, morate z dojenjem prekiniti pred začetkom zdravljenja in ne smete dojiti niti med zdravljenjem in3 mesece po končanem zdravljenju.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstanjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: In addition, clofarabine is unlikely to inhibit any of the major 5 human CYP isoforms (1A2, 2C9, 2C19, 2D6 and 3A4) or to induce 2 of these isoforms (1A2 and 3A4) at the plasma concentrations achieved following intravenous infusion of 52 mg/m2/day.
Slovenian: Poleg tega ni verjetno, da bi klofarabin zaviral katerokoli od 5 glavnih izoform CYP pri človeku (1A2, 2C9, 2C19, 2D6 in 3A4) ali da bi sprožil delovanje 2 od teh izoform (1A2 in 3A4) pri doseženih koncentracijah v plazmi po intravenski infuziji 52 mg/m2/dan.
English: Evoltra is for single use only.
Slovenian: Zdravilo Evoltra je samo za enkratno uporabo.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, ATC code: L01BB06.
Slovenian: Farmakoterapevtska skupina: Pripravki za zdravljenje novotvorb, zaviralci celične presnove (antimetaboliti), oznaka ATC: L01BB06.
English: • Ribonucleotide reductase inhibition with reduction of cellular deoxynucleotide triphosphate (dNTP) pools.
Slovenian: • Inhibicija ribonukleotid reduktaze z zmanjšanjem zalog celičnih deoksinukleotid trifosfatov
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.
Slovenian: Klofarabin mora najprej difundirati ali se transportirati v ciljne celice, kjer ga znotrajcelične kinaze zaporedno fosforilirajo v mono- in difosfate, in na koncu v aktivni konjugat, klofarabin 5'-trifosfat.
English: Total diluted volume 100 ml
Slovenian: Skupni volumen po razredčitvi 100 ml
English: - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Slovenian: • (število bolnikov s PR + število bolnikov s PRt) ÷ število primernih bolnikov, ki so prejemali klofarabin
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).
Slovenian: Čeprav stopnja transplantacije ni bila končna točka študije, je po zdravljenju s klofarabinom 10/61 bolnikov (16 %) prejelo HSCT (3 po PR, 2 po PRt, 3 po DR, zdravljenje 1 bolnika je bilo ocenjeno kot neuspelo po IRRP, zdravljenje enega po so pri IRRP označili kot zdravljenje, ki ga ni mogoče oceniti).
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).
Slovenian: Pri 83 % bolnikov je prišlo do najmanj 1 pojava okužbe po zdravljenju s klofarabinom, vključno z glivičnimi, virusnimi in bakterijskimi okužbami (glejte poglavje 4.4).
English: Tell your doctor if you are using or have recently used: - medicines for heart disease; - any medicine that changes your blood pressure; - medicines that affect your liver or kidneys; - any other medicines including those obtained without a prescription.
Slovenian: Druga zdravila in zdravilo Evoltra Obvestite zdravnika, če jemljete ali ste pred kratkim jemali: - zdravila za srčne bolezni; - kakršnakoli zdravila, ki vplivajo na krvni tlak; - zdravila, ki vplivajo na jetra ali ledvice; - katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade  3.
Slovenian: Najpogostejše hematološke laboratorijske nenormalnosti, ki so jih opazili pri bolnikih, ki so se zdravili s klofarabinom, so bile anemija (83,3 %; 95/114), levkopenija (87,7 %; 100/114), limfopenija (82,3 %; 93/113), nevtropenija (63,7 %; 72/113) in trombocitopenija (80,7 %; 92/114).
English: • Periodic Safety Updated Reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: What Evoltra is and what it is used for What you need to know before you use Evoltra How to use Evoltra
Slovenian: Kaj je zdravilo Evoltra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Evoltra Kako uporabljati zdravilo Evoltra Možni neželeni učinki
English: Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
Slovenian: Zdravljenje z zdravilom Evoltra vam je predpisal zdravnik, ki ima izkušnje z zdravljenjem levkemije.
English: Evoltra is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Slovenian: Zdravilo Evoltra se uporablja za zdravljenje otrok, najstnikov in mladih odraslih do starosti 21 let z akutno limfoblastno levkemijo (ALL), pri katerih predhodna zdravljenja niso delovala ali so prenehala delovati.
English: Where follow-up data are available, the majority of bilirubin elevations returned to  grade 2 within 10 days.
Slovenian: Podatki iz nadaljnjega spremljanja, kjer so na voljo, kažejo, da se je večina povišanih vrednosti bilirubina znižala na  2. stopnjo v 10 dneh.
English: Very common: Febrile neutropaenia Common: Neutropaenia
Slovenian: Zelo pogosti: febrilna nevtropenija Pogosti: nevtropenija
English: Clofarabine AUC 0-24 hours (ng*h/ml)
Slovenian: AUC 0-24 ur klorafabina (ng*h/ml)
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium and should be taken into consideration for patients on a controlled sodium diet.
Slovenian: To ustreza 3,08 mmol (ali 70,77 mg) natrija, kar je treba upoštevati pri bolnikih, ki imajo dieto z malo natrija.
English: Multivariate analysis showed that the pharmacokinetics of clofarabine are weight dependent and although white blood cell (WBC) count was identified as having an impact on clofarabine pharmacokinetics, this did not appear sufficient to individualise a patient's dosage regimen based on their WBC count.
Slovenian: Multivariantna analiza je pokazala, da je farmakokinetika klofarabina odvisna od telesne mase in čeprav so ugotovili, da število belih krvnih celic vpliva na farmakokinetiko klofarabina, ta učinek ni bil zadosten, da bi odmerjanje za posameznega bolnika določili na podlagi števila belih krvnih celic.
English: Fifty percent of patients experienced at least one cardiac disorders adverse event.
Slovenian: Pri petdesetih odstotkih bolnikov je prišlo do vsaj enega neželenega dogodka v povezavi s srčnimi boleznimi.
English: Adult population (including elderly)
Slovenian: Odrasli (vključno s starejšimi bolniki)
English: However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Evoltra (see section 4.3).
Slovenian: Vendar je zaradi možnosti resnih neželenih učinkov pri dojenčkih treba dojenje prekiniti pred zdravljenjem z zdravilom Evoltra, med njim ali po njem (glejte poglavje 4.3).
English: Frequency not known: C. difficile colitis
Slovenian: Pogostnost neznana: kolitis zaradi C. difficile
English: If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of them apply to your child.
Slovenian: Če ste starši otroka, ki ga zdravijo z zdravilom Evoltra, obvestite zdravnika, če katerikoli od njih velja za vašega otroka.
English: Evoltra may not be suitable for you: - 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;
Slovenian: Zdravilo Evoltra morda ni primerno za vas: - če ste po uporabi tega zdravila v preteklosti imeli hude reakcije; - če imate ali ste imeli bolezen ledvic; - če imate ali ste imeli bolezen jeter; - če imate ali ste imeli srčno bolezen.
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.
Slovenian: Poročali so o hudih hepatotoksičnih dogodkih v fazi 1/2 združene klinične študije s klofarabinom pri pediatričnih bolnikih s ponovljeno ali neodzivno akutno levkemijo.
English: To date, there are limited data on the pharmacokinetics of clofarabine in paediatric patients with decreased creatinine clearance.
Slovenian: Do sedaj še ni dovolj podatkov o farmakokinetiki klofarabina pri pediatričnih bolnikih z zmanjšanim kreatininskim očistkom.
English: Tell your doctor if any of these conditions apply to you.
Slovenian: Obvestite zdravnika, če katerikoli od teh stanj velja za vas.
English: It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Slovenian: Filtrirati ga je treba skozi 0,2-mikrometrski filter v brizgi in nato razredčiti z 0,9 % raztopino natrijevega klorida (9 mg/ml) za intravensko infundiranje do prostornine, navedene v primerih v tabeli spodaj.
English: 1105 BP AmsterdamThe Netherlands
Slovenian: 1105 BP Amsterdam Nizozemska
English: Concentrate for solution for infusion 20 mg/20 ml
Slovenian: koncentrat za raztopino za infundiranje 20 mg/20 ml
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  and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Slovenian: Poleg tega je klofarabin odpornejši na razgradnjo z adenozin deaminazo v celici in je manj dovzeten za fosforolitično cepljenje kot druge zdravilne učinkovine v tej skupini zdravil, medtem ko je afiniteta klofarabin trifosfata za DNA-polimerazo  in ribonukleotid-reduktazo podobna ali večja kot pri deoksiadenozin trifosfatu.
English: The threshold for developmental toxicity was considered to be 6 mg/m 2/day in rats and 1.2 mg/m 2/day in rabbits.
Slovenian: Odmerek, pri katerem je prišlo do razvojne toksičnosti, je bil 6 mg/m2/dan pri podganah in 1,2 mg/m2/dan pri kuncih.
English: The safety and efficacy of clofarabine were evaluated in a phase I, open-label, non-comparative, dose-escalation study in 25 paediatric patients with relapsed or refractory leukaemia (17 ALL; 8 AML) who had failed standard therapy or for whom no other therapy existed.
Slovenian: Varnost in učinkovitost klofarabina so ocenili v odprti, neprimerjalni študiji s povečevanjem odmerka 1. faze, pri 25 pediatričnih bolnikih s ponovljeno ali neodzivno levkemijo (17 ALL; 8 AML), pri katerih standardno zdravljenje ni bilo uspešno ali pri katerih ni bilo drugega zdravljenja.
English: Tell your doctor if any of these apply to you.
Slovenian: Obvestite zdravnika, če karkoli od tega velja za vas.
English: • Complete blood and platelet counts should be obtained at regular intervals, more frequently in patients who develop cytopaenias.
Slovenian: • V rednih intervalih je treba opraviti pregled celotne krvne slike in štetje trombocitov, pogosteje pri bolnikih, pri katerih se pojavi citopenija.
English: Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients.
Slovenian: O perikardnem izlivu in perikarditisu so poročali pri 9 % (10/115) bolnikov.
English: Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Slovenian: Zdravilo Evoltra je močan antineoplastik z morebitno pomembnimi hematološkimi in nehematološkimi neželenimi učinki (glejte poglavje 4.8).
English: This medicine has been authorised under “Exceptional Circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v »izjemnih okoliščinah«.
English: There are currently limited data on the safety and efficacy of clofarabine when administered for more than 3 treatment cycles.
Slovenian: Podatkov o varnosti in učinkovitosti klofarabina, kadar se odmerja več kot 3 cikle zdravljenja, so trenutno omejeni.
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/m daily x 5.
Slovenian: Informacije o neželenih učinkih temeljijo na podatkih iz kliničnih preskušanj, pri katerih je 115 bolnikov (starih > 1 in ≤ 21 let) z ALL ali akutno mieloidno levkemijo (AML) prejelo vsaj en odmerek klofarabina v priporočenem odmerku 52 mg/m2 dnevno x 5.
English: There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section 5.2).
Slovenian: Trenutno ni na voljo dovolj podatkov, da bi ocenili varnost in učinkovitost klofarabina pri odraslih bolnikih (glejte poglavje 5.2).
English: If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of the above conditions apply to your child.
Slovenian: Če ste starši otroka, ki ga zdravijo z zdravilom Evoltra, obvestite zdravnika, če katerikoli od teh stanj velja za vašega otroka.
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.
Slovenian: Poleg tega je klofarabin upočasnil rast tumorjev ter v nekaterih primerih povzročil regresijo tumorjev pri različnih človeških in glodavskih heterolognih transplantatih, presajenih na miši.
English: The majority of elevations in ALT and AST occurred within 10 days of clofarabine administration and returned to  grade 2 within 15 days.
Slovenian: Do večine pojavov povišanih vrednosti ALT in AST je prišlo v 10 dneh po odmerjanju klofarabina ter so se znižale na  2. stopnjo v 15 dneh.
English: (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%).
Slovenian: Najpogosteje so poročali o navzei (61 % bolnikov), bruhanju (59 %), febrilni nevtropeniji (35 %), glavobolu (24 %), osipu (21 %), diareji (20 %), srbenju (20 %), pireksiji (19 %), sindromu palmarno-plantarne eritrodisestezije (15 %), utrujenosti (14 %), tesnobi (12 %), vnetju sluznice (11 %) in oblivanju (11 %).
English: Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Slovenian: Pogosti: septični šok*, sepsa, bakteremija, pljučnica, herpes zoster, herpes simpleks, oralna kandidoza
English: They were reported at exposure levels (Cmax) approximately 7 to 13 fold (after 3 or more dosing cycles) or 16 to 35 fold (after one or more dosing cycles) higher than clinical exposures.
Slovenian: O toksičnih učinkih so poročali pri izpostavljenosti (Cmax), ki je bila približno 7- do 13-krat (po 3 ali več ciklih odmerjanja) ali 16- do 35-krat (po enem ali več ciklih
English: - little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and /or weakness (possible signs of acute kidney failure or kidney failure).
Slovenian: - malo ali nič urina, zaspanost, slabost, bruhanje, zasoplost, izguba apetita in/ali oslabelost (možni znaki akutne odpovedi ledvic ali odpovedi ledvic).
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).
Slovenian: Med njimi je bila bilatelarna degeneracija seminifernega epitela z zadržanjem spermatid in atrofija intersticialnih celic pri podganah pri pretirani izpostavljenosti (150 mg/m2/dan) ter celična degeneracija epididimisa in degeneracija seminifernega epitela pri psih pri klinično ustrezni izpostavljenosti (> 7,5 mg klofarabina/m2/dan).