FrancophonIA/ELRC3.0 huggingface dataset:
English: It was considered as deaths that could be attributable to secondary side effects after HPCT and not related to the relapse/progression of the underlying haematological malignancies.
Slovenian: Upoštevali so smrti, ki so bile pripisljive sekundarnim neželenim učinkom po HPCT in niso bile povezane s ponovitvijo/napredovanjem obstoječega hematološkega malignega obolenja.
English: Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Slovenian: V vsaki pogostnosti skupini so neželeni učinki razvrščeni padajoče po resnosti.
English: Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Slovenian: Končni volumen porazdelitve Vz je bil med 0,62 in 0,85 l/kg.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pierre Fabre Médicament
English: The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5).
Slovenian: Učinek teh protikonvulzivnih učinkovin na farmakokinetiko busulfana so raziskovali v študiji 2. faze (glejte poglavje 4.5).
English: 47% of patients experienced chills which were mild/moderate in 46% and severe in 1%.
Slovenian: 47 % bolnikov je izkusilo mrzlico, ki je bila blaga/zmerna pri 46 % in resna pri 1 %.
English: In children < 9 kg, a therapeutic drug monitoring may be justified on a case by case basis, in particular in extremely young children and neonates (see section 5.2).
Slovenian: Pri otrocih s telesno maso < 9 kg je lahko od primera do primera upravičeno spremljanje zdravljenja, še posebej pri zelo majhnih otrocih in novorojenčkih (glejte poglavje 5.2).
English: Do not throw away any medicine via wastewater or household waste.
Slovenian: Zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: For any information about this medicine, please contact the Marketing Authorisation Holder
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom.
English: A total of 14 patients (50%) experienced a-GVHD.
Slovenian: Skupno 14 bolnikov (50 %) je imelo a-GVHD.
English: • Using a non polycarbonate syringe fitted with a needle:
Slovenian: • Z nepolikarbonatno brizgo, na kateri je nameščena igla:
English: 93% of allogeneic patients showed complete chimerism.
Slovenian: Pri 93 % alogenskih bolnikov je prišlo do popolnega himerizma.
English: In these studies, a total of 1574 patients received FB as a reduced intensity conditioning (RIC) regimen prior to haematopoietic progenitor cell transplantation.
Slovenian: V teh študijah je skupno 1574 bolnikov prejelo kombinacijo FB kot pripravljalno zdravljenje z zmanjšano intenzivnostjo (reduced intensity conditioning - RIC) pred transplantacijo hematopoetskih progenitorskih celic.
English: Late haemorrhagic cystitis occurring 2 weeks post-transplant are likely related to viral infection / reactivation.
Slovenian: Pozni hemoragični cistitis, ki se pojavi 2 tedna po transplantaciji, je najverjetneje posledica virusne okužbe / reaktivacije.
English: What Busilvex is and what it is used for
Slovenian: Kaj je zdravilo Busilvex in za kaj ga uporabljamo
English: Investigations: elevated liver enzymes and weight increased.
Slovenian: Preiskave: povečane vrednosti jetrnih encimov in povečana telesna teža.
English: Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Slovenian: Zdravilo Busilvex se pri odraslih, novorojencih, otrocih in mladostnikih uporablja kot terapija pred presaditvijo.
English: It is unknown whether busulfan and DMA are excreted in human milk.
Slovenian: Ni znano, ali se busulfan in DMA izločata v materino mleko.
English: The Fanconi anaemia cells have hypersensitivity to cross-linking agents.
Slovenian: Celice Fanconijeve anemije so preobčutljive na prečne povezovalce.
English: Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Slovenian: Neželeni učinki, ugotovljeni v obdobju trženja zdravila, so v preglednicah zabeleženi s pojavnostjo „neznana“.
English: Nevertheless the risk of liver toxicity may be increased in this population.
Slovenian: Vendar pri tej skupini bolnikov obstaja povečano tveganje toksičnosti za jetra.
English: In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin.
Slovenian: V tej študiji je 24 odraslih bolnikov prejelo klonazepam (0,025-0,03 mg/kg/dan z neprekinjenim intravenskim infundiranjem) kot antikonvulzivno terapijo, farmakokinetične podatke teh bolnikov so primerjali s predhodno zbranimi podatki bolnikov, ki so prejemali fenitoin.
English: Paracetamol is described to decrease glutathione levels in blood and tissues, and may therefore decrease busulfan clearance when used in combination (see section 4.4).
Slovenian: Za paracetamol je značilno, da znižuje koncentracijo glutationa v krvi in tkivih in lahko zmanjša očistek busulfana, če se uporabljata v kombinaciji (glejte poglavje 4.4).
English: Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.
Slovenian: Zaradi potencialne tumorogenosti busulfana, na katero kažejo študije pri ljudeh in živalih, je treba med zdravljenjem z busulfanom prekiniti dojenje.
English: The most frequent infectious adverse reactions were Cytomegalovirus (CMV) reactivation [range: 30.7% - 80.0%], Epstein-Barr Virus (EBV) reactivation [range: 2.3% - 61%], bacterial infections [range: 32.0% - 38.9%] and viral infections [range: 1.3% - 17.2%].
Slovenian: Najpogostejši infekcijski neželeni učinki so bili reaktivacija citomegalovirusa (CMV) [razpon: 30,7 %-80,0 %], virusa Epstein-Barr (EBV) [razpon: 2,3 %-61 %], bakterijske okužbe [razpon: 32,0 %-38,9 %] in virusne okužbe [razpon: 1,3 %-17,2 %].
English: The 2-year OS rate was 61.9% (95%CI, 51.1-72.7%)].
Slovenian: Stopnja celokupnega preživetja po 2 letih je bila 61,9 % (95-odstotni IZ 51,1-72,7 %)].
English: CNS changes precede any of the more severe side effects.
Slovenian: Spremembe v CŽS nastopijo pred katerimkoli hudim neželenim učinkom.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Slovenian: Če vas skrbi, da ne boste mogli imeti otrok, se pred začetkom zdravljenja posvetujte z zdravnikom.
English: It is of particular interest the study of this interaction in three groups of patients in which higher plasma levels of busulfan were observed in the group receiving metronidazol prophylaxis during busulfan treatment than in those without metronidazoles.
Slovenian: Posebej zanimiva je študija o takšnem medsebojnem delovanju v treh skupinah bolnikov, v kateri so zabeležili višje ravni busulfana pri skupini, ki je med zdravljenjem z busulfanom prejemala profilakso z metronidazolom, kot pri skupini, ki ni prejemala metronidazola.
English: It has been suggested that conditioning regimens containing fludarabine were associated with higher incidence of opportunistic infections after transplantation because of the immunosuppressive effect of fludarabine.
Slovenian: Domneva se, da so pripravljalne terapije s fludarabinom povezane z večjo pojavnostjo oportunističnih okužb po transplantaciji, kar je posledica imunosupresivnega učinka fludarabina.
English: The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Slovenian: Primarni parametri učinkovitosti v teh raziskavah so bili mieloablacija, prijetje presadka, ponovitev bolezni in preživetje.
English: Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Slovenian: Informacije o neželenih učinkih so pridobljene iz dveh kliničnih preskušanj (n = 103) zdravila Busilvex.
English: The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Slovenian: Kumulativna pojavnost obnove nevtrofilcev na 28. dan je bila 98,8 % (95-odstotni IZ 85,799,6 %).
English: In this regard, for children < 9 kg, a monitoring of the plasma concentrations of busulfan (therapeutic drug monitoring) for dose-adjustment may improve the busulfan targeting performance, especially in extremely young children and neonates.
Slovenian: V tem smislu lahko pri otrocih telesne mase < 9 kg spremljanje plazemskih koncentracij busulfana (terapevtsko spremljanje zdravila) s ciljem uravnavanja odmerka izboljša ciljno učinkovitost busulfana, kar še posebej velja pri izjemno majhnih otrocih in novorojenčkih.
English: The review of the literature allows a comparison of PK series performed either within the same study or between studies and demonstrated unchanged dose-independent PK parameters regardless the dosage or the schedule of administration.
Slovenian: Pregled literature omogoča primerjavo farmakokinetičnih nizov znotraj študije ali med študijami, ki pokaže nespremenjene, od odmerka neodvisne parametre farmakokinetike, ne glede na odmerjanje ali razpored dajanja.
English: Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Slovenian: Busulfan je povzročil kromosomske aberacije in vitro (v celicah glodavcev in v človeških celicah) ter in vivo (pri glodavcih in človeku).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 mg/10 ml
English: The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Slovenian: Najpogostejši vzroki objavljenih TRM/NRM so bili okužba/sepsa, GVHD, pljučne bolezni in odpoved organov.
English: For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Slovenian: Pri debelih bolnikih je treba razmisliti o odmerku, ki temelji na prilagojeni idealni telesni masi (adjusted ideal body weight - AIBW).
English: In pregnant rats, busulfan produced sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries.
Slovenian: Pri brejih podganah je uporaba busulfana povzročila neplodnost moških in ženskih mladičev zaradi odsotnosti germinalnih celic v testisih in jajčnikih.
English: - If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Slovenian: - Če zdravilo Busilvex ali razredčena raztopina zdravila Busilvex pride v stik s kožo ali sluznico, ju takoj temeljito sperite z vodo.
English: Patients who are concurrently treated with busulfan and itraconazole or metronidazole should be closely monitored for signs of busulfan toxicity.
Slovenian: Bolnike, ki so hkrati prejemali busulfan in itrakonazol ali metronidazol, je treba skrbno opazovati, če se pojavijo znaki toksičnosti busulfana.
English: 15% of SAEs involved liver toxicity.
Slovenian: 15 % resnih neželenih učinkov je vključevalo jetrno toksičnost.
English: Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
Slovenian: Hemoragični cistitis, vključno s hemoragičnim cistitisom zaradi virusne okužbe, so ugotovili pri 16 % do 18,1 % bolnikov.
English: Particular caution should be taken if you use itraconazole and metronidazole (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Slovenian: Bodite posebno pozorni, če jemljete itrakonazol in metronidazol (ki se uporablja za zdravljenje določenih vrst okužb) ali ketobemidon (ki se uporablja proti bolečinam).
English: OTHER SPECIAL WARNING IF NECESSARY Cytotoxic: handle with caution.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično zdravilo, ravnajte previdno.
English: The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.
Slovenian: Glavni toksični učinek je huda mieloablacija in pancitopenija, vendar so lahko prizadeti tudi centralni živčni sistem, jetra, pljuča in prebavni trakt.
English: Diseases included were acute leukaemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukaemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin's disease or non-Hodgkin's lymphoma, and myelodysplastic syndrome.
Slovenian: Vključene bolezni so bile akutna levkemija po prvi remisiji, v prvi ali naslednji ponovitvi, v prvi remisiji (veliko tveganje) ali napake v indukciji, kronična mieloidna levkemija v kronični ali napredovali fazi, primarna refraktarna ali rezistentna ponovljena Hodgkinsova bolezen ali ne-Hodgkinsov limfom ter mielodisplastični sindrom.
English: Busulfan and DMA can impair fertility in man or woman.
Slovenian: Busulfan in DMA lahko zmanjšata plodnost pri moških in ženskah.
English: For a microbiological point of view, the diluted solution should be used immediately.
Slovenian: Z mikrobiološkega vidika je priporočljivo razredčeno raztopino porabiti takoj.
English: In the absence of haematopoietic progenitor cell transplantation, the recommended dose of Busilvex would constitute an overdose of busulfan.
Slovenian: V odsotnosti transplantacije hematopoetskih progenitorskih celic bi priporočeni odmerek zdravila Busilvex povzročil prevelik odmerek busulfana.
English: From the assessment of these articles, the causality of busulfan in the development of tooth hypoplasia is confirmed.
Slovenian: Z oceno teh člankov so potrdili vzročno povezanost busulfana z razvojem zobne hipoplazije.
English: Busulfan is a teratogen in rats, mice and rabbits.
Slovenian: Busulfan je teratogen pri podganah, miših in kuncih.
English: A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and nonmalignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Slovenian: Populacijska farmakokinetična analiza je bila izvedena na kohorti 205 otrokglede na telesno maso (3,6 do 62,5 kg) ter biološke in bolezenske značilnosti (maligne in ne maligne bolezni) in je zato reprezantativna za visoko heterogenost otrok, podvrženih HPTC.
English: In one article it was studied the role of busulfan in juvenile rats resulting in abnormal root development; a review of two cases of immunodeficiency disorders treated with busulfan and cyclophosphamide in which dental orthodontic treatment was provided; additional 2 case report of hypoplasia of permanent tooth germ is presented; one review assessed the long term effects of cytotoxic therapy concluding that tooth agenesis was more prevalent in patients treated with busulfan and cyclophosphamide; a study of 81 patients concluded that busulfan is as toxic as total body irradiation in causing disturbances in dental development; finally, a study of risk factors of tooth formation anomalies in paediatric cancers concluded that the high risk group of tooth agenesis was the subject with high dose chemotherapy under 4 years old.
Slovenian: V enem od člankov so proučevali vpliv busulfana na nedorasle podgane, ki so se jim razvile korenine nenormalno; proučitev dveh primerov zdravljenja motenj imunske pomanjkljivosti z busulfanom in ciklofosfamidom, v katerih so bolnikom zagotovili dentalno ortodontsko zdravljenje; predstavitev dveh dodatnih poročil o primerih hipoplazije zasnove stalnih zob; v enem poročilu so proučevali dolgoročne učinke citotoksičnega zdravljenja in ugotovili, da je bila zobna ageneza bolj pogosta pri bolnikih, ki so jih zdravili z busulfanom in ciklofosfamidom; v raziskavi, v katero je bilo vključenih 81 bolnikov, so ugotovili, da je busulfan enako toksičen kot obsevanje celotnega telesa v smislu povzročanja motenj razvoja zob; ne nazadnje, v raziskavah dejavnikov tveganja nastanka motenj v razvoju zob pri pediatričnih rakavih bolnikih so ugotovili, da obstaja zelo visoko tveganje za zobno agenezo pri bolnikih, ki prejemajo zelo velike odmerke kemoterapije in so mlajši kot 4 leta.
English: Repeated doses of DMA produced signs of liver toxicity, the first being increases in serum clinical enzymes followed by histopatological changes in the hepatocytes.
Slovenian: Ponavljajoči odmerki DMA so povzročili znake jetrne toksičnosti; najprej je prišlo do povečanega izločanja serumskih encimov in nato do histopatoloških sprememb jetrnih celic.
English: In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Slovenian: Pri podganah je 9-dnevno odmerjanje DMA v višini 450 mg/kg/dan povzročilo neaktivno spermatogenezo.
English: - the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
Slovenian: - vsebino brizge morate prestaviti v vrečko ali brizgo za intravensko uporabo, v katero ste že dali izračunano količino izbranega redčila.
English: - If you have any further questions, ask your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients.
Slovenian: Raziskave niso bile izvajane pri bolnikih z okvaro ledvic, ker pa se busulfan zmerno izloča z urinom, pri teh bolnikih odmerka ni priporočljivo spreminjati.
English: Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Slovenian: Prehrana: izguba teka, zmanjšanje količine magnezija, kalcija, kalija, fosfata in albumina v krvi ter povečanje krvnega sladkorja.
English: What you need to know before you use Busilvex
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Busilvex
English: Also, there are published case reports of increased plasma levels of busulfan after administration of metronidazole.
Slovenian: Objavljena so tudi poročila o posameznih primerih povišanih plazemskih ravni busulfana po prejemu metronidazola.
English: As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to Busilvex.
Slovenian: Kot je dokumentirano v kliničnih raziskavah, se pri nobenem zdravljenem bolniku ni pojavila srčna tamponada ali katerakoli druga značilna srčna toksičnost, povezana z zdravilom Busilvex.
English: These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Slovenian: Te vključujejo infekcijo in reakcijo presadka proti gostitelju (graft-versus-host disease (GVHD)), ki sta glavna vzroka za obolevnost in smrtnost, zlasti v primeru alogenske HPCT, čeprav nista neposredno povezani.
English: Dose and administration: The dose of Busilvex will be calculated according to your body weight.
Slovenian: Odmerek in uporaba: Odmerek zdravila Busilvex vam bodo izračunali na osnovi telesne mase.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Slovenian: Zdravnik bo redno spremljal število krvnih celic in jetrne encime, da bi odkril te težave in primerno ukrepal.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW).
Slovenian: Izračun prilagojene idealne telesne mase (AIBW): AIBW = IBW + 0,25 x (dejanska telesna masa - IBW)
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2C - 8C)
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 C - 8 C).
English: Fever was reported in 87% of patients and graded as mild/moderate in 84% and severe in 3%.
Slovenian: Zvišana telesna temperatura se je pojavila pri 87 % bolnikov in je bila ocenjena za blago/zmerno pri 84 % in resno pri 3 %.
English: The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2hour intravenous infusion for a total of 16 doses over four days.
Slovenian: Farmakokinetiko intravensko uporabljenega busulfana so preučevali na 124 bolnikih, ki jih je bilo možno oceniti, po 2-urni intravenski infuziji do skupno 16 odmerkov v obdobju 4 dni.
English: Contribution of long-lasting metabolites is not excluded.
Slovenian: Prispevek dolgoobstojnih presnovkov ni izključen.
English: The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Slovenian: Med najresnejše neželene učinke zdravljenja z zdravilom Busilvex in postopka presaditve sodijo zmanjšanje števila krvnih celic v krvnem obtoku (nameravani učinek zdravila, ki vas pripravi na transplantacijsko infuzijo), okužba, motnje delovanja jeter, vključno z blokiranjem jetrne vene, reakcija presadka proti gostitelju (presadek napade vaše telo) in pljučni zapleti.
English: For storage conditions after dilution of the medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po redčenju zdravila glejte poglavje 6.3.
English: A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Slovenian: V večini objavljenih študij so ugotavljali popolni donorski himerizem 30. dan po transplantaciji pri 90-100 % bolnikov.
English: Only a clear solution without particles should be used.
Slovenian: Uporabiti smete samo bistro raztopino brez delcev.
English: Women must stop breast-feeding before starting their treatment with Busilvex.
Slovenian: Ženske morajo prekiniti dojenje pred začetkom zdravljenja z zdravilom Busilvex.
English: in combination with other medicine as a conditioning treatment previous HCT have been seen after reviewing the literature and the cases retrieved in the safety database of the company.
Slovenian: v kombinaciji z drugimi pripravljalnimi zdravili pred HCT so opazili po proučitvi literature in primerov iz imetnikove baze podatkov o varnosti zdravila.
English: Malformations and anomalies included significant alterations in the musculoskeletal system, body weight gain, and size.
Slovenian: Med malformacije in anomalije so sodile pomembne spremembe mišično-skeletnega sistema, pridobivanja telesne mase in velikosti.
English: Blood: decrease of blood circulating cells (red and white) and platelets.
Slovenian: Kri: zmanjšanje števila krvnih celic (rdečih in belih) in trombocitov v krvnem obtoku.
English: • Quantity of Busilvex:
Slovenian: • Količina zdravila Busilvex:
English: It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity.
Slovenian: Priporočamo, da med zdravljenjem teh bolnikov 28 dni po transplantaciji redno pregledujete serumske transaminaze, alkalne fosfataze in bilirubin za zgodnje odkrivanje hepatotoksičnosti.
English: From a microbiological point of view, the product should be used immediately after dilution.
Slovenian: Z mikrobiološkega stališča bi morali zdravilo uporabiti takoj po redčenju.
English: Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Slovenian: Zdravilo Busilvex je močno citotoksično zdravilo, ki zelo zmanjša število krvnih celic.
English: The incidence of a-GVHD grades I-II was 46.4% (13/28), while the incidence of grade III-IV was 3.6% (1/28).
Slovenian: Pogostost a-GVHD stopnje I-II je bila 46,4 % (13/28), medtem ko je bila pojavnost stopnje III-IV 3,6 % (1/28).
English: The information presented on biotransformation and elimination is based on oral busulfan.
Slovenian: Podatki o biotransformaciji in izločanju temeljijo na peroralni uporabi busulfana.