natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the EU for Busilvex to Pierre Fabre Médicament on 9 July 2003.
Evropska komisija je dovoljenje za promet z zdravilom Busilvex, veljavno po vsej Evropski uniji (EU), odobrila družbi Pierre Fabre Médicament dne 9. julija 2003.
The marketing authorisation was renewed on 9 July 2008.
Dovoljenje za promet je bilo obnovljeno dne 9. julija 2008.
The record of Busilvex’ s designation as an orphan medicine is available here.
Zapis o določitvi zdravila Busilvex kot zdravila sirote najdete tukaj.
The full EPAR for Busilvex can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Busilvex je na voljo tukaj.
Pharmaceutical Form Concentrate for solution for infusion
Koncentrat za pripravo raztopine za infundiranje
Route of Administration Intravenous use
Intravenska uporaba.
Package size 8 vials
8 vial
Busilvex 6 mg/ ml concentrate for solution for infusion
Busilvex 6 mg/ ml koncentrat za raztopino za infundiranje
1 ml of solution contains 0.5 mg of busulfan For a full list of excipients see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Postopek z Busilvexom in nato s ciklofosfamidom (BuCy2) se uporablja kot pripravljalna terapija pred transplantacijo progenskih hematopoetskih celic (HPCT) pri odraslih bolnikih, kadar ocenimo, da je ta kombinacija najboljša možnost.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Postopek z Busilvexom in nato s ciklofosfamidom (BuCy4) ali Melphalanom (BuMel) je indiciran za pripravljalno terapijo pred transplantacijo progenskih hematopoetskih celic pri pediatričnih bolnikih.
Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Uporabo Busilvexa mora nadzorovati zdravnik, izkušen v pripravljalnih terapijah pred transplantacijo progenskih hematopoetskih celic.
Busilvex is administered prior the conventional haematopoietic progenitor cell transplantation (HPCT).
Zdravilo Busilvex se daje pred običajno transplantacijo progenskih hematopoetskih celic (HPCT).
Dosage in adults The recommended dosage and schedule of administration is:
Priporočeno odmerjanje in razpored uporabe busulfana:
- 0.8 mg/ kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4
Tako
consecutive days for a total of 16 doses,
bolnik prejme skupno 16 odmerkov busulfana.
- followed by cyclophosphamide at 60 mg/ kg/ day over 2 days initiated for a least 24 hours
- Sledi ciklofosfamid 60 mg/ kg/ dan 2 dni vsaj 24 ur po 16. odmerku zdravila Busilvex (glejte
following the 16th dose of Busilvex (see section 4.5).
poglavje 4. 5).
Dosage in paediatric patients (0 to 17 years) The recommended dose of Busilvex is as follows:
Odmerjanje pri pediatričnih bolnikih (0- 17 let)
Actual
Priporočeni odmerki Busilvexa so:
body weight (kg) < 9 9 to < 16 16 to 23
Dejanska telesna masa (kg) < 9 9 do < 16 16 do 23 > 23 do 34 > 34
dose (mg/ kg) 1.0 1.2 1.1
Odmerek Busilvexa (mg/ kg) 1, 0 1, 2 1, 1 0, 95 0, 8
> 23 to 34 > 34
Temu sledijo:
- 4 cycles of 50 mg/ kg body weight (BW) cyclophosphamide (BuCy4) or
- 4 cikli po 50 mg/ kg telesne mase (TM) ciklofosfamida (BuCy4) ali
- one administration of 140 mg/ m² melphalan (BuMel)
en odmerek 140 mg/ m2 Melphalana (BuMel),
initiated for a least 24 hours following the 16th dose of Busilvex. (see section 4.5).
ki se začnejo vsaj 24 ur po 16. odmerku zdravila Busilvex (glejte poglavje 4. 5).
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 conventional haematopoietic progenitor cell transplantation (HPCT)
Busilvex se uporablja v obliki dveurne infuzije vsakih 6 ur 4 zaporedne dni, kar je skupaj 16 odmerkov pred uporabo ciklofosfamida ali Melphalana in običajno transplantacijo hematopoetskih progenskih celic (HPCT - Haematopoietic Progenitor Cell Transplantation).
Administration Busilvex must be diluted prior to administration (see section 6.6).
Uporaba Busilvex morate razredčiti pred uporabo (glejte poglavje 6. 6).
A final concentration of approximately 0.5 mg/ ml busulfan should be achieved.
Končna koncentracija busulfana mora biti približno 0, 5 mg/ ml.
Busilvex should be administered by intravenous infusion via central venous catheter.
Busilvex morate uporabiti kot intravensko infuzijo skozi osrednji venski kateter.
Busilvex should not be given by rapid intravenous, bolus or peripheral injection.
Busilvexa ne smete uporabiti v obliki hitre intravenske injekcije, bolusa ali periferne injekcije.
All patients should be pre-medicated with anticonvulsant medicinal products to prevent seizures reported with the use of high dose busulfan.
Vsi bolniki bi morali predhodno prejeti zdravila proti konvulzijam, ki preprečijo epileptične napade, o katerih so poročali pri uporabi visokih odmerkov busulfana.
It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex.
Antikonvulzive jim je priporočeno dati 12 ur pred Busilvexom do 24 ur po zadnjem odmerku Busilvexa.
In adults all studied patients received phenytoin.
Vsi odrasli bolniki v študijah so prejemali fenitoin.
There is no experience with other anticonvulsant agents such as benzodiazepines (see sections 4.4 and 4.5).
O uporabi drugih zdravil proti konvulzijam, kot so benzodiazepini, ni podatkov (glejte poglavji 4. 4 in 4. 5).
In children studied patients received either phenytoin or benzodiazepines.
Otroci v študijah so prejemali fenitoin ali benzodiazepine.
Antiemetics should be administered prior to the first dose of Busilvex and continued on a fixed schedule according to local practice through its administration.
Njihova uporaba bi morala trajati po določenem razporedu po standardnih predpisih ves čas uporabe Busilvexa.
In adults For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Odrasli Pri bolnikih s čezmerno telesno maso je treba pretehtati odmerek, ki je prilagojen idealni telesni masi (adjusted ideal body weight - AIBW).
Ideal body weight (IBW) is calculated as follows:
Izračun idealne telesne mase (IBW):
IBW men (kg)=50 + 0.91x (height in cm-152); IBW women (kg)= 45 + 0.91x (height in cm-152).
IBW pri moških (kg) = 50 + 0, 91 x (višina v cm - 152) IBW pri ženskah (kg) = 45 + 0, 91 x (višina v cm - 152)
Adjusted ideal body weight (AIBW) is calculated as follows:
Izračun prilagojene idealne telesne mase (AIBW):
AIBW= IBW+0.25x (actual body weight - IBW).
AIBW = IBW + 0, 25 x (dejanska telesna masa - IBW)
In paediatric patients The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/ (m)² > 30 kg/ m² until further data become available.
Pediatrični bolniki Dokler ne bodo na voljo dodatni podatki, uporaba zdravila pri debelih otrocih in mladostnikih z indeksom BMI (masa (kg) / višina (m) 2) nad 30 kg/ m2 ni priporočljiva.
Renally impaired patient:
Bolniki z okvaro ledvic:
However, caution is recommended (see sections 4.8 and 5.2).
Vendar bodite previdni (glejte poglavji 4. 8 in 5. 2).
Hepatically impaired patient:
Bolniki z okvaro jeter:
Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Raziskav Busilvexa in busulfana pri bolnikih z okvaro jeter niso izvajali.
Caution is recommended, particularly in those patients with severe hepatic impairment (see section 4.4).
Bodite previdni, zlasti pri bolnikih s hudo okvaro jeter (glejte poglavje 4. 4).
3 Elderly patient:
Starejši bolniki:
Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without dose- adjustment.
Bolniki, starejši od 50 let (n = 23), so bili uspešno zdravljeni z Busilvexom brez prilagoditve odmerka.
However, for the safe use of Busilvex in patients older than 60 years only limited information is available.
Vendar so za varno uporabo Busilvexa pri bolnikih, starejših od 60 let, na voljo le omejeni podatki.
Same dose (see section 5.2) for elderly as for adults (< 50 years old) should be used.
Priporočamo uporabo enakega odmerka (glejte poglavje 5. 2) za starejše in za odrasle (< 50 let).
Hypersensitivity to the active substance or to any of the excipients Pregnancy (see section 4.6)
Nosečnost (glejte poglavje 4. 6).
The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Posledica zdravljenja z Busilvexom s priporočenim odmerkom in razporedom je globoka mielosupresija, ki se pojavlja pri vseh bolnikih.
Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Za preprečevanje in upravljanje okužb v nevtropeničnem obdobju je treba pretehtati možnost preventivne ali empirične uporabe zdravil proti okužbam (bakterijskim, glivičnim in virusnim).
Platelet and red blood cell support, as well as the use of growth factors such as granulocyte colony stimulating agent (G-CSF), should be employed as medically indicated.
Kadar so prisotne zdravstvene indikacije, je treba nuditi trombocitno ali eritrocitno podporo in uporabiti rastne faktorje, kot je granulocitne kolonije stimulirajoči faktor (G- CSF).
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).
Pri odraslih se absolutno število nevtrofilcev < 0, 5 x 109/ l pri mediani 4 dni po transplantaciji pojavi pri 100% bolnikov in se popravi v povprečju 10 po avtologni oziroma 13 dni po alogenski transplantaciji (povprečno obdobje nevtropenije je od 6 do 9 dni).
Thrombocytopenia (< 25x109/ l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Trombocitopenija (< 25 x 109/ l ali zahtevana transfuzija trombocitov) se pojavi pri mediani 5- 6 dni pri 98% bolnikov.
Anaemia (haemoglobin < 8.0 g/ dl) occurred in 69% of patients.
Anemija (hemoglobin < 8, 0 g/ dl) se pojavi pri 69% bolnikov.
In paediatric patients, absolute neutrophil counts < 0.5x109/ l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Pri pediatričnih bolnikih se je absolutno število nevtrofilcev < 0, 5x109/ l pri mediani 3 dni po transplantaciji pojavilo pri 100% bolnikov in je trajalo 5 dni pri avtologni ter 18, 5 dneva pri alogenski transplantaciji.
In children, thrombocytopenia (< 25x109/ l or requiring platelet transfusion) occurred in 100% of patients.
Trombocitopenija (< 25 x 109/ l ali taka, da je bila potrebna transfuzija trombocitov) se je pojavila pri 100% bolnikov.
Anaemia (haemoglobin < 8.0 g/ dl) occurred in 100% of patients.
Anemija (hemoglobin < 8, 0 g/ dl) se je pojavila pri 100% bolnikov.
Therefore Busilvex should be used with caution in this type of patients.
Ni zadostnih kliničnih izkušenj z uporabo busulfana kot komponente pri pripravljalnem zdravljenju pred hematopoetskim presajanjem matičnih celic (HPCT - Haematopoietic Progenitor Cell Transplantation) pri otrocih s Fanconijevo anemijo, zato je treba Busilvex pri tej skupini bolnikov uporabljati previdno.
Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Raziskav Busilvexa in busulfana pri bolnikih z okvaro jeter niso opravljali.
Since busulfan is mainly metabolized through the liver, caution should be observed when Busilvex is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Ker se busulfan v glavnem presnavlja v jetrih, je priporočljiva posebna previdnost pri uporabi Busilvexa pri bolnikih z že okvarjeno jetrno funkcijo, zlasti pri tistih s hudo okvaro jeter.
Hepatic veno-occlusive disease is a major complication that can occur during treatment with Busilvex.
Poglavitni zaplet, ki se lahko pojavi med zdravljenjem z Busilvexom, je veno- okluzivna bolezen jeter.
Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).
Bolniki, ki so bili podvrženi predhodni radiacijski terapiji, večji kot ali enaki trem ciklom kemoterapije, ali predhodni transplantaciji progenskih celic, so izpostavljeni večjemu tveganju (glejte poglavje 4. 8).
Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with Busilvex due to a possible decrease in the metabolism of busulfan (See section 4.5).
Pri predhodni (manj kot 72 ur) ali sočasni uporabi paracetamola z Busilvexom morate biti previdni zaradi možne upočasnjene presnove busulfana (glejte poglavje 4. 5).
As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to Busilvex.
Kot je dokumentirano v kliničnih raziskavah, se pri nobenem zdravljenem bolniku ni pojavila srčna tamponada ali katerakoli druga značilna srčna toksičnost, povezana z Busilvexom.
However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Vendar je pri bolnikih, ki so prejemali Busilvex, potreben reden nadzor delovanja srca (glejte poglavje 4. 8).
4 Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified.
V raziskavah Busilvexa je bil pri enem bolniku, ki je umrl, zabeležen pojav sindroma akutne dihalne stiske, ki ji je sledila respiratorna odpoved, povezana z intersticijsko fibrozo pljuč, vendar jasne etiologije niso identificirali.
In addition, busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents.
Poleg tega lahko busulfan izzove pljučno toksičnost, ki utegne povečati učinke citotoksičnih učinkovin.
Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation (see section 4.8).
Zato morate biti pri bolnikih z anamnezo obsevanja pljuč ali medpljučnega prostora na ta pojav pozorni (glejte poglavje 4. 8).
Periodic monitoring of renal function should be considered during therapy with Busilvex (see section 4.8).
4 Med terapijo z Busilvexom je potreben občasen nadzor ledvičnih funkcij (glejte poglavje 4. 8).
Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Posebna previdnost pri uporabi priporočenega odmerka Busilvexa je potrebna pri bolnikih z anamnezo epileptičnih napadov.
Patients should receive adequate anti-convulsant prophylaxis.
Bolnikom je treba zagotoviti zadostno protikonvulzivno profilakso.
In adults, all data with Busilvex were obtained using phenytoin.
Vsi podatki Busilvexa pri odraslih so bili pridobljeni z uporabo fenitoina.
There are no data available on the use of other anticonvulsant agents such as benzodiazepines.
Na voljo ni nobenih podatkov o uporabi drugih protikonvulzivnih učinkovin, kot so benzodiazepini.
(see sections 4.2 and 4.5).
Zato učinek protikonvulzivnih učinkovin (razen fenitoina) na farmakokinetiko busulfana ni znan (glejte poglavji 4. 2 in 4. 5).
In paediatric patients, data with Busilvex were obtained using benzodiazepines or phenytoin.
Pri pediatričnih bolnikih so podatke o uporabi Busilvexa pridobili z uporabo benzodiazepinov ali fenitoina.
The World Health Association has concluded that there is a causal relationship between busulfan exposure and cancer.
Svetovna zdravstvena organizacija (World Health Association) je ugotovila, da obstaja vzročno razmerje med izpostavljanjem busulfenu in rakom.
Fertility: busulfan can impair fertility.
Plodnost: busulfan lahko zmanjša plodnost.
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.
Zato ni priporočljivo, da moški, zdravljeni z Busilvexom, spočnejo otroka med zdravljenjem in do 6 mesecev pozneje.
Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
Priporočamo, da se pred zdravljenjem z Busilvexom posvetujejo o shranjevanju sperme z zamrznitvijo, kajti zaradi zdravljenja obstaja možnost ireverzibilne neplodnosti.
Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Zdravljenje z busulfanom pri predadolescentnih dekletih zaradi okvare jajčnikov preprečuje začetek pubertete.
DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3)
DMA zmanjšuje plodnost pri moških in ženskih glodalcih (glejte poglavji 4. 6 in 5. 3).
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole.
Specifičnega kliničnega preskušanja za oceno o medsebojni interakciji med intravensko uporabljenim busulfanom in itrakonazolom niso bile izvedene.
From published studies, in adults administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
Glede na objavljene raziskave se uporaba itrakonazola pri odraslih bolnikih, ki jemljejo visoke odmerke busulfana, lahko kaže v zmanjšanem očistku busulfana.
Patients should be monitored for signs of busulfan toxicity when itraconazole is used as an antifungal prophylaxis with intravenous busulfan.
Ko se itrakonazol uporablja kot profilaksa proti glivicam z intravensko uporabljenim busulfanom, je pri bolnikih treba spremljati znake toksičnosti busulfana.
A reduced incidence of Hepatic Veino Occlusive Disease (HVOD) and other regimen- related toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Pri bolnikih, kjer je čas zakasnitve med zadnjim peroralnim odmerkom busulfana in prvim odmerkom ciklofosfamida > 24 ur, so opazili zmanjšano pojavnost veno- okluzivne bolezni jeter (Hepatic Veno - Occlusive Disease - HVOD) in drugih toksičnosti, povezanih z njihovo uporabo.
In paediatric patients, 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.
Pri pediatričnih bolnikih, ki se zdravijo z BuMel, so poročali, da uporaba Melphalana manj kot 24 ur po zadnjem peroralnem odmerku busulfana lahko vpliva na nastanek toksičnosti.
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).
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).
5 Phenytoin or benzodiazepines were administered for seizure prophylaxis in all patients in the clinical trials conducted with intravenous busulfan.
5 očistek busulfana zaradi indukcije glutation- S- transferaze.
The concomitant systemic administration of phenytoin to patients receiving high-dose busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase.
Vendar pa ni dokazov o teh učinkih v podatkih o intravenskem dajanju (glejte poglavje 4. 4).
However no evidence of this effect has been seen in intravenous data. (see section 4.4) No interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan (see sections 4.2 and 4.4).
Prav tako niso poročali o medsebojnem delovanju med benzodiazepini, kot so diazepam, klonazepam ali lorazepam, ki so jih uporabljali za preventivo epileptičnih napadov, z visokimi odmerki busulfana (glejte poglavji 4. 4 in 4. 4).
No interaction was observed when busulfan was combined with fluconazole (antifungal agent) or 5 HT3 antiemetics such as ondansetron or granisetron.
Niso opazili interakcij, ko so busulfan kombinirali z flukonazolom (protiglivična učinkovina) ali 5- HT3- antiemetiki, kot sta ondansetron ali granisetron.
Pregnancy HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy.
Nosečnost HPCT je kontraindiciran pri nosečnicah, zato je Busilvex kontraindiciran med nosečnostjo.
Busulfan has caused embryofoetal lethality and malformations in pre-clinical studies. (see section 5.3)
Busulfan je v predkliničnih raziskavah povzročil embriofetalno smrtnost in malformacije (glejte poglavje 5. 3).
There are no adequate data from the use of either busulfan or DMA in pregnant woman.
Pri nosečnicah ni podatkov o uporabi busulfana in DMA.
A few cases of congenital abnormalities have been reported with low-dose oral busulfan, not necessarily attributable to the active substance, and third trimester exposure may be associated with impaired intrauterine growth.
Izpostavljenost v tretjem trimesečju lahko povežemo s poslabšanim znotrajmaterničnim razvojem.
Lactation It is not known whether busulfan and DMA are excreted in human milk.
Dojenje Ni še znano, ali se busulfan in DMA izločata v materinem mleku.
Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued at the start of therapy.
Zaradi potencialne tumorigenosti, prikazane v človeških in živalskih raziskavah busulfana, ob začetku terapije prekinite dojenje.
Fertility Busulfan and DMA can impair fertility in man or woman.
Plodnost Busulfan in DMA lahko zmanjšata plodnost pri moških in ženskah.
Therefore it is advised not to father child during the treament 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 (see section 4.4).
Priporočamo, da se pred zdravljenjem posvetujejo o shranjevanju sperme z zamrznitvijo, kajti zaradi zdravljenja obstaja možnost ireverzibilne neplodnosti (glejte poglavje 4. 4).
Averse events in adults Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Neželeni učinki pri odraslih Informacije o neželenih učinkih so pridobljene iz dveh kliničnih preskušanj (n = 103) Busilvexa.
Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Resne toksičnosti, ki vključujejo hematološki, jetrni in respiratorni sistem, so upoštevali kot pričakovane posledice pripravljalne terapije in transplantacijskega procesa.
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.
Te vključujejo infekcijo in reakcijo presadka proti gostitelju (graft- versus- host disease (GVHD)), ki sta glavna vzroka za obolevnost in smrtnost, zlasti v primeru alogenskega HPCT, čeprav nista neposredno povezani.
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen.
Bolezni krvi in limfatičnega sistema Mielosupresija in imunosupresija sta zaželena terapevtska učinka pripravljalne terapije.
Therefore all patients experienced profound cytopenia: leukopenia 96%, thrombocytopenia 94%, and anemia 88%.
Zato se je pri vseh bolnikih pojavila huda citopenija: levkopenija pri 96%, trombocitopenija pri 94% in anemija pri 88%.
The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Pri avtolognih in alogenih bolnikih je bila mediana trajanja nevtropenije 6 in 9 dni.