natgillin/translations-raw huggingface dataset:
The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Podaci o pojavnosti akutne reakcije presatka protiv domaćina (a-GVHD) prikupljeni su od alogenih bolesnika (n=28).
The benefit risk profile of the product remains favourable in the approved indications.
Profil omjera koristi i rizika lijeka pokazao se povoljnim pri primjeni kod odobrenih indikacija.
D: dose of Busilvex (see SPC section 4.2)
D: doza Busilvexa (vidjeti Sažetak, dio 4.2)
10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.
10 ml koncentrata za otopinu za infuziju u prozirnim staklenim bočicama (tip I) s gumenim butilnim čepom pokrivenim ljubičastim aluminijskim "flip-off" zaštitnim zatvaračem.
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen and consequently were not considered undesirable effects.
Mijelosupresija i imunosupresija bile su željeni terapijski učinak protokola kondicioniranja i posljedično nisu smatrane nuspojavama.
Data from a recently completed prospective multicentre phase 2 study including 80 patients, aged 18 to 65 years old, diagnosed with different hematologic malignancies who underwent allo-HCT with an FB (3 days of Busilvex) reduced intensity conditioning regimen became available.
Postali su dostupni podaci iz nedavno završenog, prospektivnog, multicentričnog ispitivanja faze 2 koje je uključivalo 80 bolesnika, u dobi od 18 do 65 godina, s dijagnozom različitih hematoloških malignih bolesti, koji su se podvrgnuli alogenom HCT-u s protokolom kondicioniranja smanjenog intenziteta s FB-om (3 dana lijeka Busilvex).
The malformations included serious heart and/or major vessels anomalies: a common truncus arteriosis and no ductus arteriosis, coarctation of the pulmonary trunk and the pulmonary arteries, intraventricular defects of the heart.
Malformacije su uključivale teške anomalije srca i/ili glavnih krvnih žila: zajednički truncus arteriosus i odsutnost Botallijevog duktusa, koarktacija stabla plućne arterije i plućnih arterija, intraventrikularni defekti srca.
The median time to neutropenia was 4 days for both autologous and allogeneic patients.
Medijan vremena do neutropenije bio je 4 dana za autologne i alogene bolesnike.
PK/PD relationship was observed between stomatitis and AUCs in autologous patients and between bilirubin increase and AUCs in a combined autologous and allogeneic patient analysis.
Odnos farmakokinetike i farmakodinamike praćen je između stomatitisa i vrijednosti AUC u autolognih bolesnika i između povećanja bilirubina i vrijednosti AUC u kombiniranoj analizi autolognih i alogenih bolesnika.
Cases of thrombotic microangiopathy after hematopoietic cell transplantation (HCT), including fatal cases, have been reported in high-dose conditioning regimens in which busulfan was administered in combination with another conditioning treatment.
Slučajevi trombotičke mikroangiopatije nakon transplantacije hematopoetskih matičnih stanica (HCT), uključujući i smrtne slučajeve, zabilježeni su u režimima kondicioniranja visokim dozama u kojima se busulfan daje u kombinaciji s drugom terapijom za kondicioniranje.
• Quantity of Busilvex:
• Količina Busilvexa:
Polycarbonate syringes must not be used with Busilvex.
Polikarbonatne štrcaljke se ne smiju upotrebljavati uz Busilvex.
The literature on busulfan suggests a therapeutic AUC window between 900 and 1500 µmol/L.minute per administration (equivalent to a daily exposure between 3600 and 6000 µmol/L.minute).
U literaturi o busulfanu preporučen je terapijski AUC okvir između 900 i 1500 µmol/l.minutu po primjeni (ekvivalentno dnevnoj izloženosti između 3600 i 6000 µmol/l.minutu.
It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
Moguće je da nakon liječenja busulfanom više nećete moći ostvariti trudnoću (neplodnost).
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.
Farmakokinetika intravenskog busulfana ispitivana je na 124 bolesnika koje je bilo moguće ocijeniti nakon dvosatne intravenske infuzije ukupno 16 doza tijekom četiri dana.
Therefore, “tooth hypoplasia” should be added to the product information for both pharmaceutical forms.
Stoga je u informacije o lijeku za oba farmaceutska oblika potrebno dodati „hipoplaziju zuba“.
Pain or inflammation at injection site Mucositis
Bol ili upala na mjestu injiciranja Mukozitis
The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Kaplan-Meierova procjena preživljenja bez progresije bolesti nakon 2 godine iznosila je 49,9% (95%-tni CI, 32,6 - 72,7).
• Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
• Busilvex mora pripremiti zdravstveni radnik koristeći se sterilnim tehnikama prijenosa.
Busilvex destroys the original bone marrow before the transplant.
Busilvex uništava izvornu koštanu srž prije presađivanja.
Premature menopause Ovarian failure**
Preuranjena menopauza Zatajenje jajnika **
In paediatric population, for the BuMel regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.
U pedijatrijskoj je populaciji tijekom primjene protokola BuMel prijavljeno da primjena melfalana u razdoblju kraćem od 24 sata nakon posljednje peroralne primjene busulfana može utjecati na razvoj toksičnosti.
Similar targeting rate is achieved within the daily exposure of 3600 - 6000 µmol/L.minute following the administration of intravenous busulfan 3.2 mg/kg once daily.
Slična ciljana stopa postiže se unutar dnevne izloženosti od 3600 - 6000 µmol/l.minutu koja slijedi nakon primjene intravenskog busulfana od 3,2 mg/kg jednom dnevno.
Medicines before you receive Busilvex: Before receiving Busilvex, you will be medicated with anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and antiemetic medicines to prevent vomiting.
Prije primanja Busilvexa, dobit ćete lijekove - antikonvulzivne lijekove za sprječavanje napadaja (fenitoin ili benzodiazepine) i - antiemetike za sprječavanje povraćanja.
Ideal body weight (IBW) is calculated as follows: IBW men (kg) = 50 + 0.91x (height in cm-152);
Idealna tjelesna težina (ITT) izračunava se na sljedeći način: ITT za muškarce (kg) = 50 + 0,91 x (visina u cm-152);
The signals concerning busulfan oral formulations and hepatic veno-oclusive disease risk in patients who have received prior radiation therapy /chemotherapy /HSCT, sterility, overdose treatment can be closed.
Signali koji se odnose na formulacije busulfana za peroralnu primjenu i rizik od hepatičke veno-okluzivne bolesti u bolesnika koji su prethodno bili podvrgnuti zračenju /kemoterapiji / transplantaciji hematopoetskih matičnih stanica te od steriliteta i predoziranja mogu se zatvoriti.
The incidence of each adverse reactions presented in the following table has been defined according to the highest incidence observed in published clinical trials in RIC regimen for which the population treated with FB was clearly identified, whatever the schedules of busulfan administrations and endpoints.
Incidencija svake nuspojave predstavljene u sljedećoj tablici definirana je prema najvećoj primijećenoj incidenciji u objavljenim kliničkim ispitivanjima protokola kondicioniranja smanjenog intenziteta za koje je populacija liječena FB-om jasno identificirana, neovisno o rasporedima primjene busulfana i ishodima.
Calculation of the quantity of Busilvex to be diluted and of the diluent
Izračun količine Busilvexa koju je potrebno razrijediti i količine otapala
F-92654 Boulogne Billancourt cedex
F-92654 Boulogne Billancourt Cedex Francuska
Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
- Busilvex će se primjenjivati jednom dnevno tijekom 2 ili 3 uzastopna dana prije presađivanja.
Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Ukupni klirens u plazmi bio je u rasponu od 2,25 - 2,74 ml/min/kg.
Documentation on the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/or autologous HPCT derives from two clinical trials (OMC-BUS-4 and OMC-BUS-3).
Dokumentacija o sigurnosti i djelotvornosti Busilvexa u kombinaciji s ciklofosfamidom u protokolu BuCy2 prije konvencionalnog alogenog i/ili autolognog HPCT-a potječe iz dva klinička ispitivanja (OMC-BUS-4 i OMC-BUS-3).
In the absence of haematopoietic progenitor cell transplantation, the recommended dose of Busilvex would constitute an overdose of busulfan.
U odsutnosti presađivanja hematopoetskih progenitorskih stanica preporučena doza Busilvexa uzrokovala bi predoziranje busulfanom.
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.
Posebno je važno ispitivanje ove interakcije u tri skupine bolesnika kod kojih su, u skupini koja je primala metronidazol kao profilaksu tijekom liječenja busulfanom, opažene više vrijednosti busulfana u plazmi u odnosu na vrijednosti u skupini koja nije primala metronidazol.
Busulfan depleted oocytes of female rats, and induced sterility in male rats and hamster.
Busulfan je smanjio broj jajnih stanica ženki štakora i inducirao sterilnost kod muških štakora i hrčaka.
Ventricular extrasystoles Bradycardia
Ventrikularne ekstrasistole Bradikardija
The Fanconi anaemia cells have hypersensitivity to cross-linking agents.
Stanice u Fanconijevoj anemiji su preosjetljive na sredstva koja stvaraju poprečne veze.
Dimethylacetamide Macrogol 400.
6.1 Popis pomoćnih tvari dimetilacetamid makrogol 400.
No patients were discontinued from treatment due to adverse reactions related to Busilvex.
Niti jedan bolesnik nije prekinuo liječenje zbog nuspojava povezanih s Busilvexom.
Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Ozbiljne toksičnosti koje su obuhvaćale hematološki, hepatički i respiratorni sustav smatrale su se očekivanim posljedicama protokola kondicioniranja i postupka presađivanja.
Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (embriofetalnu smrtnost i malformacije) (vidjeti dio 5.3).
The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9 kg in achieving the therapeutic window (900-1500 µmol/L.minute).
Preporučeno doziranje za djecu navedeno u dijelu 4.2 omogućilo je da više od 70% pa sve do 90% djece ≥ 9 kg postigne terapijski okvir (900-1500 µmol/l.minuta).
Rash Pruritis Alopecia
Pruritis Alopecija
Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Nuspojave iz ispitivanja nakon stavljanja lijeka u promet navedene su u tablicama pod „Nepoznato”.
LIST OF EXCIPIENTS Each vial contains Dimethylacetamide and Macrogol 400
Svaka bočica sadrži dimetilacetamid i makrogol 400
Blood: decrease of blood circulating cells (red and white) and platelets.
Krv: smanjenje krvnih stanica (crvenih i bijelih) i trombocita u krvotoku.
Nervous system: insomnia, anxiety, dizziness, and depression.
Živčani sustav: nesanica, tjeskoba, omaglica i depresija.
Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Žene ne smiju ostati trudne tijekom liječenja Busilvexom i do 6 mjeseci nakon liječenja.
Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Anemija (hemoglobin < 8,0 g/dl) se pojavila u 69% bolesnika.
Fast and complete engraftment rates in 80-100% of patients were reported in the majority of studies.
U većini ispitivanja zabilježene su stope brzog i potpunog primanja presatka u 80 - 100% bolesnika.
In adults, for the BuCy2 regimen it has been reported that the time interval between the last oral busulfan administration and the first cyclophosphamide administration may influence the development of toxicities.
U odraslih je tijekom primjene protokola BuCy2 prijavljeno da vremenski razmak između posljednje peroralne primjene busulfana i prve primjene ciklofosfamida može utjecati na razvoj toksičnosti.
However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
No u djece < 9 kg postignuta je veća varijabilnost koja je dovela do toga da 60% djece postigne terapijski okvir (900-1500 µmol/l.minuta).
The warning for TMA after HCT only applies to one pharmaceutical form: the intravenous.
Upozorenje za trombotičku mikroangiopaciju (TMA) nakon transplantacije hematopoetskih matičnih stanica (HCT) primjenjuje se samo na jedan farmaceutski oblik: intravenski.
Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW).
Prilagođena idealna tjelesna težina (PITT) izračunava se na sljedeći način: PITT = ITT+0,25x (stvarna tjelesna težina - ITT).
Similar blood exposure was observed when comparing plasma concentrations in adult patients receiving oral and intravenous busulfan at 1 mg/kg and 0.8 mg/kg respectively.
Slična prisutnost djelatnih tvari u krvi primijećena je u usporedbi koncentracija u plazmi odraslih bolesnika koji su busulfan primali peroralno i intravenski u dozi od 1 mg/kg, odnosno 0,8 mg/kg.
In children, thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
U djece se trombocitopenija (< 25x109/l ili potreba za transfuzijom trombocita) pojavila u 100% bolesnika.
Therefore, men treated with Busilvex are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Busilvex.
Stoga se muškarcima liječenim Busilvexom preporuča da tijekom liječenja i do 6 mjeseci nakon liječenja ne začinju dijete i da zatraže savjet o kriokonzervaciji sperme prije liječenja zbog mogućnosti ireverzibilne neplodnosti uslijed liječenja Busilvexom.
Serious toxicities involving the hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Ozbiljne toksičnosti koje su obuhvaćale hepatički i respiratorni sustav smatrale su se očekivanim posljedicama protokola kondicioniranja i postupka presađivanja.
Only a clear solution without any particles should be used.
Smije se primjenjivati samo bistra otopina bez ikakvih čestica.
Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
Muškarcima liječenima Busilvexom ne preporučuje se da začinju dijete tijekom i do 6 mjeseci nakon liječenja.
Only a clear solution without particles should be used.
Smije se primjenjivati samo bistra otopina bez čestica.
Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
Budući da se busulfan metabolizira konjugacijom s glutationom, može se razmotriti primjena glutationa.
Busilvex is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and haematopoietic progenitor cell transplantation (HPCT).
Busilvex se primjenjuje kao dvosatna infuzija svakih 6 sati tijekom 4 uzastopna dana odnosno ukupno 16 doza prije ciklofosfamida ili melfalana i presađivanja hematopoetskih progenitorskih stanica (HPCT).
Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Posebna pozornost potrebna je kada se preporučena doza Busilvexa daje bolesnicima s anamnezom napadaja.
Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
- Busilvex će se primjenjivati svakih 6 sati tijekom 4 uzastopna dana prije presađivanja.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Ostale česte anomalije obuhvaćale su rascjep nepca, anasarku i koštane anomalije kralježnice i rebara.
The time to Absolute Neutrophil Count (ANC) greater than 0.5x109 /l was 13 days (range 9-29 days) in allogenic patients (OMC-BUS 4), and 10 days
Vrijeme do apsolutnog broja neutrofila (ABN) većeg od 0,5x109 /l bilo je 13 dana (raspon od 9-29 dana) u alogenih bolesnika (OMC-BUS 4) i 10 dana
What Busilvex looks like and contents of the pack Busilvex consists of a concentrate for solution for infusion and is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
Busilvex se sastoji od koncentrata za otopinu za infuziju i isporučuje se u bezbojnim staklenim bočicama, svaka bočica sadrži 60 mg busulfana.
Various chromosome aberrations have been observed in cells from patients receiving oral busulfan.
Razne aberacije kromosoma primijećene su u stanicama bolesnika koji primaju peroralni busulfan.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial
Koncentrat za otopinu za infuziju Višestruko pakiranje: 8 (2 pakiranja od 4) bočice od 10 ml 60 mg po bočici
Busilvex dose (mg/kg)
Doza Busilvexa (mg/kg)
Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy4 or with melphalan in the BuMel regimen prior to conventional allogeneic and/or autologous HPCT derives from clinical trial F60002 IN 101 G0.
Dokumentacija o sigurnosti i djelotvornosti Busilvexa u kombinaciji s ciklofosfamidom u protokolu BuCy4 ili s melfalanom u protokolu BuMel prije konvencionalnog alogenog i/ili autolognog HPCT-a potječe iz kliničkog ispitivanja F60002 IN 101 G0.
Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Vz bio je u rasponu između 0,62 i 0,85 l/kg.
The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase whereas no interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan.
Prijavljeno je da istodobna sistemska primjena fenitoina kod bolesnika koji primaju visoke peroralne doze busulfana povećava klirens busulfana zbog indukcije glutation-S-transferaze, dok za primjenu benzodiazepina kao što su diazepam, klonazepam ili lorazepam koji se primjenjuju za sprječavanje napadaja uz visoke doze busulfana nije prijavljena interakcija.
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.
Ispitivanja na bolesnicima s oštećenjem funkcije bubrega nisu provedena, no kako se busulfan umjereno izlučuje u urin, u tih se bolesnika ne preporučuje prilagodba doze.
Rhinitis Pharyngitis
Rinitis Faringitis
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen.
Mijelosupresija i imunosupresija bile su željeni terapijski učinak protokola kondicioniranja.
The entire prescribed Busilvex dose should be delivered over two or three hours depending on the conditioning regimen.
Ukupna propisana doza Busilvexa mora se primijeniti tijekom dva ili tri sata, ovisno o protokolu kondicioniranja.
One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Jedan ml koncentrata sadrži 6 mg busulfana (60 mg u 10 ml).
Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Nuspojave prijavljene u odraslih i pedijatrijskih bolesnika veće brojnosti nego samo u izoliranim slučajevima navedene su u nastavku, prema klasifikaciji organskih sustava i po učestalosti.
Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop.
Moguć je razvoj teške granulocitopenije, trombocitopenije, anemije ili bilo koje kombinacije navedenih stanja.
Busilvex in combination with fludarabine (FB)
Busilvex u kombinaciji s fludarabinom (FB)
Anaemia (haemoglobin< 8.0 g/dl) occurred in 100% of patients.
Anemija (hemoglobin < 8,0 g/dl) se pojavila u 100% bolesnika.
From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
. U objavljenim ispitivanjima na odraslima pokazalo se da primjena itrakonazola na bolesnicima koji primaju visoke doze busulfana može rezultirati smanjenim klirensom busulfana.
- Busilvex will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days.
- Busilvex se primjenjuje u dozi od 3,2 mg/kg kao trosatna infuzija jednom dnevno odmah nakon fludarabina u 2 ili 3 uzastopna dana.
Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
Interakcija između busulfana i metronidazola navedena je u preglednim člancima i kod slučajeva nakon stavljanja lijeka u promet.
Intravenous use (IV) Must be diluted before use Read the package leaflet before use
Primjena u venu (i.v.) Prije uporabe mora se razrijediti Prije uporabe pročitajte uputu o lijeku
All children engrafted.
Kod sve je djece provedeno presađivanje.
The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
- Preporučena doza Busilvexa je 3,2 mg/kg - Svaka infuzija trajat će 3 sata.
Busulfan can impair fertility.
Busulfan može smanjiti plodnost.
** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
** prijavljeno nakon stavljanja lijeka u promet s intravenskim (i.v.) busulfanom *** prijavljeno nakon stavljanja lijeka u promet s peroralnim busulfanom
Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
Tijekom liječenja i do postizanja oporavka moraju se često kontrolirati kompletna krvna slika, uključujući diferencijalnu sliku bijelih krvnih zrnaca i broj trombocita.
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti nuspojave su navedene od težih do manje teških.
In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
Za protokol FB-a, u objavljenim ispitivanjima u odraslih nisu zabilježene nikakve međusobne interakcije između intravenskog busulfana i fludarabina.
In adults, absolute neutrophil counts < 0.5x109/l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
U odraslih se apsolutan broj neutrofila < 0,5x109/l pri medijanu od 4 dana nakon presađivanja pojavio u 100% bolesnika i oporavio u medijanu od 10 dana nakon autolognog i 13 dana nakon alogenog presađivanja (medijan neutropenijskog razdoblja od 6, odnosno 9 dana).
Skin: rash, itching, loss of hairs.
Koža: osip, svrbež, gubitak kose.