natgillin/translations-raw huggingface dataset:
This signal was open based on an isolated case from the literature and no additional cases have been reported.
Signal je bil odprt na osnovi izoliranega primera iz literature, ni poročil o dodatnih primerih.
The patients received the dosing mentioned in section 4.2.
Bolniki so prejeli odmerke, omenjene v poglavju 4.2.
The signal concerning interaction with deferasirox is refuted and it can be closed.
Signal v zvezi z medsebojnim delovanjem z defarasiroksom je zavrnjen in ga lahko zapremo.
PROCEDURE FOR PROPER DISPOSAL
POSTOPEK ZA USTREZNO ODSTRANJEVANJE
In new-born infants, children and adolescents (0 to 17 years):
Pri novorojencih, otrocih in mladostnikih (0 do 17 let):
Not known (frequency cannot be estimated from the available data) Sex glands dysfunction.
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Disfunkcija spolnih žlez.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve o oddaji redno posodobljenih poročil o varnosti zdravila so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh naknadnih spremembah, objavljene na evropskem spletnem portalu o zdravilih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Če raztopine ne uporabite takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika in ne bi smeli presegati zgoraj navedenih pogojev, če je redčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/254/002
Other sources of information
Drugi viri informacji
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja raziskav kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
* veno occlusive liver disease is more frequent in paediatric population.
* veno-okluzivna jetrna bolezen je pogostejša pri pediatrični populaciji.
None of the metabolites is thought to contribute significantly to either efficacy or toxicity.
Noben od presnovkov naj ne bi pomembno prispeval k učinkovitosti ali toksičnosti.
Six of 103 patients (6%) experienced HVOD.
Šest od 103 bolnikov (6 %) je izkusilo HVOD.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Pogostost pojavljanja je opredeljena na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
RECOMMENDATION FOR SAFE HANDLING
PRIPOROČILA ZA VARNO RAVNANJE
The warning for TMA after HCT only applies to one pharmaceutical form: the intravenous.
Opozorilo za TMA po HCT velja samo za eno farmacevtsko obliko: intravensko.
Seven literature reports have been published cumulatively concerning disturbance in dental development.
Kumulativno je bilo v literaturi objavljenih sedem poročil v zvezi z motnjami v razvoju zob.
39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
39 % bolnikov (40/103) je izkusilo eno ali več epizod infekcij, od katerih jih je bilo 83 % (33/40) ocenjenih za blage ali zmerne.
Two of the above four patients with serious serum hepatotoxicity were among patients with diagnosed HVOD.
Dva od zgoraj naštetih štirih bolnikov z resno serumsko hepatotoksičnostjo sta bila med bolniki z diagnosticirano HVOD.
Paediatric population (0 to 17 years)
Pediatrična populacija (od 0 do 17 let)
VOD observed were neither fatal nor severe and resolved in all cases.
V nobenem primeru VOD ni bila smrtna ali huda in v vseh primerih je izginila.
No pharmacokinetic explanation justifies this interaction.
Ni farmakokinetske razlage, ki bi utemeljila takšno vzajemno delovanje.
Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika, če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v prilogi V.S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
At the recommended dose, this is the desired effect.
Pri priporočenih odmerkih je to želen učinek.
Other infections were considered severe in 3% of patients.
Preostale infekcije so bile resne pri 3 % bolnikov.
Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
O kronični GVHD so poročali le, če je bila vzrok smrti: en bolnik je umrl 13 mesecev po transplantaciji.
Patients should receive adequate anticonvulsant prophylaxis.
Bolnikom je treba zagotoviti zadostno protikonvulzivno profilakso.
Infections.
Okužbe.
The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Uspešna presaditev pri vseh bolnikih v preskušanjih druge faze kaže na ustreznost ciljnih vrednosti AUC.
DMA is teratogenic in rats.
DMA je teratogen pri podganah.
Fast and complete engraftment rates in 80-100% of patients were reported in the majority of studies.
Stopnje hitrega in popolnega prijetja presadka so v večini študij ugotavljali pri 80-100 % bolnikov.
Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Približno 30 % uporabljenega odmerka se v 48 urah izloči z urinom, od tega 1 % kot nespremenjen busulfan.
It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Možno je, da bo uporaba zdravila Busilvex povečala tveganje za nastanek drugega malignega obolenja v prihodnosti.
Small volumes may be administered over 2 hours using electric syringes.
Majhne količine lahko damo v dveh urah z električnimi brizgami.
Detailed information on this product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Acute GVHD was rated as serious in 3 patients.
Akutna GVHD je bila ocenjena kot resna pri 3 bolnikih.
The available data in animals support the carcinogenic potential of busulfan.
Razpoložljivi podatki pri živalih potrjujejo rakotvorni potencial busulfana.
Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Reverzibilna vezava na plazemske beljakovine je bila približno 7-odstotna, medtem ko je bila ireverzibilna vezava, predvsem na albumin, približno 32-odstotna.
Elevated bilirubin (n=3) and elevated AST (n=1) were also observed.
Zaznali so tudi povišano vrednost bilirubina (n = 3) in povišano AST (n = 1).
Pharmacotherapeutic group: Alkyl sulfonates, ATC code: L01AB01.
Farmakoterapevtska skupina: Alkilsulfonati, Oznaka ATC: L01AB01
Infections (documented and non documented febrile neutropenia) were experienced in 89% of patients (49/55).
Infekcije (zabeleženo in nezabeleženo febrilno nevtropenijo) je imelo 89 % bolnikov (49/55).
VOD was reported with a range between 3.9% and 15.4%.
VOD so ugotovili pri 3,9 % do 15,4 % bolnikov.
Therefore special care is recommended when combining these two compounds.
Zato je pri kombinaciji teh dveh spojin priporočena posebna previdnost.
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 progenitorskih celic, so izpostavljeni večjemu tveganju (glejte poglavje 4.8).
DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
DMA zmanjšuje plodnost pri moških in ženskih glodavcih (glejte poglavji 4.6 in 5.3).
Headache Nervous system disorders [Not Elsewhere Classified]
Bolezni živčevja glavobol bolezni živčevja [niso opredeljene drugje]
Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without doseadjustment.
Bolniki, starejši od 50 let (n = 23), so bili uspešno zdravljeni z zdravilom Busilvex brez prilagoditve odmerka.
However, caution is recommended (see sections 4.8 and 5.2).
Vendar bodite previdni (glejte poglavji 4.8 in 5.2).
The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Največja pogostnost navzee in bruhanja je bila 59,1 %, največja pogostnost stomatitisa pa 11 %.
Therefore, this interaction should be included in the product information for both pharmaceutical forms.
Zato je treba to medsebojno delovanje dodati med informacije o zdravilu za obe farmacevtski obliki.
Grade 3 elevated transaminases were reported in 24% of patients.
O povečani ravni transaminaz tretje stopnje so poročali pri 24 % bolnikov.
Same dose (see section 5.2) for elderly patients as for adults (< 50 years old) should be used.
Za starejše priporočamo uporabo enakega odmerka (glejte poglavje 5.2) kot za odrasle (< 50 let).
Therefore, “tooth hypoplasia” should be added to the product information for both pharmaceutical forms.
Zato je treba dodati „zobno hipoplazijo” med informacije o zdravilu za obe farmacevtski obliki.
Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Morate upoštevati ustrezne postopke za ravnanje in odstranjevanje zdravil proti raku.
Therefore all patients experienced profound cytopenia: leucopenia 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 administration of FB regimen has not been specifically investigated in elderly patients.
Uporaba kombinacije FB ni bila posebej preučena pri starejših bolnikih.
Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
Koncentracije busulfana v cerebrospinalni tekočini lahko primerjamo s tistimi v plazmi, čeprav te koncentracije verjetno niso zadostne za protineoplastični učinek.
HVOD occurred in: 8.2% (5/61) allogeneic patients (fatal in 2 patients) and 2.5% (1/42) of autologous patients.
Ta se je pojavila pri: 8,2 % (5/61) alogenskih bolnikov (smrtna pri 2 bolnikih) in 2,5 % (1/42) avtolognih bolnikov.
A cumulative review of the literature and safety database has been performed.
Opravil je kumulativni pregled podatkov iz literature in baze podatkov o varnosti zdravila.
The benefit risk profile of the product remains favourable in the approved indications.
Razmerje med koristjo in tveganjem zdravila ostaja ugodno za odobrene indikacije.
In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Glavni toksični učinki pri človeku so hepatotoksičnost in učinki v centralnem živčnem sistemu (CŽS).
The terminal half life ranged from 2.26 to 2.52 h.
Končni razpolovni čas je bil od 2,26 do 2,52 h.
As a conclusion, busulfan could be one risk factor of development TMA and a warning is section 4.4 of the Busilvex SmPC is considered warranted.
Zaključimo, da je lahko busulfan eden od dejavnikov tveganja razvoja TMA in opozorilo v poglavju 4.4 SmPC zdravila Busilvex se šteje kot utemeljeno.
Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Skupni odmerek busulfana na bolnika je bil med 6,4 mg/kg in 9,6 mg/kg.
As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution: - The use of gloves and protective clothing is recommended.
Kot pri vseh citotoksičnih spojinah morate biti pri ravnanju z zdravilom Busilvex in njegovi pripravi previdni: - Priporočena je uporaba rokavic in zaščitnih oblačil.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 12.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM 12.
The terminal half-life ranged from 2.8 to 3.9 hours.
Končna razpolovna doba je bila med 2,8 in 3,9 ure.
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 je lahko aditivna učinkom drugih citotoksičnih učinkovin.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before you receive treatment with Busilvex.
Če ste noseči ali dojite menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden prejmete zdravilo Busilvex.
Pharmacokinetics in adults
Farmakokinetika pri odraslih
if you are currently taking other medicines.
- če ste kdaj imeli epileptične napade, - če trenutno jemljete druga zdravila.
The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Pojavnost nalezljivih bolezni ali reaktivacije oportunističnih povzročiteljev nalezljivih bolezni v glavnem odraža imunsko stanje bolnika, ki prejema pripravljalno terapijo.
As a result, the control of intravenous busulfan AUC within the therapeutic windows is not modified and a similar targeting performance between the two schedules was illustrated.
Posledično se obvladovanje AUC intravenskega busulfana znotraj terapevtskih oken ne spremeni, zato je dokazana podobna ciljna učinkovitost obeh razporedov.
Each infusion will last 2 hours
Vsaka infuzijo bo trajala 2 uri.
Pneumonia was fatal in 1% (1/103) and life-threatening in 3% of patients.
Pljučnica je bila smrtna pri 1 % (1/103) in smrtno nevarna pri 3 % bolnikov.
In both studies, all patients received a 16/16 dose regimen of Busilvex.
Pri obeh raziskavah so vsi bolniki prejeli terapevtski odmerek 16/16 zdravila Busilvex.
HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy.
HPCT je kontraindicirana pri nosečnicah, zato je zdravilo Busilvex med nosečnostjo kontraindicirano.
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
PRILOGA IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
Elimination in faeces is negligible.
Izločanje z blatom je zanemarljivo.
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.
Upoštevali so smrti, ki so bile pripisljive sekundarnim neželenim učinkom po HPCT in niso bile povezane s ponovitvijo/napredovanjem obstoječega hematološkega malignega obolenja.
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
V vsaki pogostnosti skupini so neželeni učinki razvrščeni padajoče po resnosti.
Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Končni volumen porazdelitve Vz je bil med 0,62 in 0,85 l/kg.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pierre Fabre Médicament
The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5).
Učinek teh protikonvulzivnih učinkovin na farmakokinetiko busulfana so raziskovali v študiji 2. faze (glejte poglavje 4.5).
47% of patients experienced chills which were mild/moderate in 46% and severe in 1%.
47 % bolnikov je izkusilo mrzlico, ki je bila blaga/zmerna pri 46 % in resna pri 1 %.
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).
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).
Do not throw away any medicine via wastewater or household waste.
Zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
For any information about this medicine, please contact the Marketing Authorisation Holder
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom.
A total of 14 patients (50%) experienced a-GVHD.
Skupno 14 bolnikov (50 %) je imelo a-GVHD.
• Using a non polycarbonate syringe fitted with a needle:
• Z nepolikarbonatno brizgo, na kateri je nameščena igla:
93% of allogeneic patients showed complete chimerism.
Pri 93 % alogenskih bolnikov je prišlo do popolnega himerizma.
In these studies, a total of 1574 patients received FB as a reduced intensity conditioning (RIC) regimen prior to haematopoietic progenitor cell transplantation.
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.
Late haemorrhagic cystitis occurring 2 weeks post-transplant are likely related to viral infection / reactivation.
Pozni hemoragični cistitis, ki se pojavi 2 tedna po transplantaciji, je najverjetneje posledica virusne okužbe / reaktivacije.
What Busilvex is and what it is used for
Kaj je zdravilo Busilvex in za kaj ga uporabljamo
Investigations: elevated liver enzymes and weight increased.
Preiskave: povečane vrednosti jetrnih encimov in povečana telesna teža.
Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Zdravilo Busilvex se pri odraslih, novorojencih, otrocih in mladostnikih uporablja kot terapija pred presaditvijo.
It is unknown whether busulfan and DMA are excreted in human milk.
Ni znano, ali se busulfan in DMA izločata v materino mleko.
The Fanconi anaemia cells have hypersensitivity to cross-linking agents.
Celice Fanconijeve anemije so preobčutljive na prečne povezovalce.
Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Neželeni učinki, ugotovljeni v obdobju trženja zdravila, so v preglednicah zabeleženi s pojavnostjo „neznana“.
Nevertheless the risk of liver toxicity may be increased in this population.
Vendar pri tej skupini bolnikov obstaja povečano tveganje toksičnosti za jetra.
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.
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.
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).
Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.
Zaradi potencialne tumorogenosti busulfana, na katero kažejo študije pri ljudeh in živalih, je treba med zdravljenjem z busulfanom prekiniti dojenje.
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%].
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 %].
The 2-year OS rate was 61.9% (95%CI, 51.1-72.7%)].
Stopnja celokupnega preživetja po 2 letih je bila 61,9 % (95-odstotni IZ 51,1-72,7 %)].
CNS changes precede any of the more severe side effects.
Spremembe v CŽS nastopijo pred katerimkoli hudim neželenim učinkom.
If you are concerned about having children, you should discuss this with your doctor before treatment.
Če vas skrbi, da ne boste mogli imeti otrok, se pred začetkom zdravljenja posvetujte z zdravnikom.
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.
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.
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.
Domneva se, da so pripravljalne terapije s fludarabinom povezane z večjo pojavnostjo oportunističnih okužb po transplantaciji, kar je posledica imunosupresivnega učinka fludarabina.
The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Primarni parametri učinkovitosti v teh raziskavah so bili mieloablacija, prijetje presadka, ponovitev bolezni in preživetje.
Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Informacije o neželenih učinkih so pridobljene iz dveh kliničnih preskušanj (n = 103) zdravila Busilvex.
The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Kumulativna pojavnost obnove nevtrofilcev na 28. dan je bila 98,8 % (95-odstotni IZ 85,799,6 %).
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.
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.
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.
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.
Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Busulfan je povzročil kromosomske aberacije in vitro (v celicah glodavcev in v človeških celicah) ter in vivo (pri glodavcih in človeku).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 mg/10 ml
The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Najpogostejši vzroki objavljenih TRM/NRM so bili okužba/sepsa, GVHD, pljučne bolezni in odpoved organov.