natgillin/translations-raw huggingface dataset:
Busulfan should be administered by intravenous infusion via central venous catheter.
Busulfan je potrebno dajati intravensko, skozi osrednji venski kateter.
The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Ocena 2-letnega preživetja brez bolezni (DFS) po Kaplan-Meierju je bila 49,9 % (95 % IZ: od 32,6 do 72,7 %).
However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900 - 1500 µmol/L.minute).
Pri otrocih s telesno maso < 9 kg je bila opažena večja variabilnost, ki je povzročila, da je 60 % otrok doseglo terapevtsko okno (900-1500 µmol/l·min).
Busulfan Fresenius Kabi can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Zdravilo Busulfan Fresenius Kabi lahko izzove tudi znake menopavze in lahko prepreči začetek pubertete pri deklicah.
Patients received doses of 0.8 mg/kg busulfan every 6 hours infusion for a total 16 doses followed by cyclophosphamide at 60 mg/kg once per day for two days (BuCy2 regimen).
Bolniki so prejemali odmerke po 0,8 mg/kg busulfana, na vsakih 6 ur z infuzijo, do skupno 16 odmerkov, ki so jim sledili odmerki 60 mg/kg ciklofosfamida enkrat dnevno, 2 dni (terapija BuCy2).
- 8 hours (including infusion time) after dilution when stored at 25°C ± 2°C
- do 8 ur (vključno s časom infuzije) po redčenju, če je bila raztopina shranjena pri temperaturi
Do not use Busulfan Fresenius Kabi: - if you are allergic to busulfan or any of the other ingredients of this medicine listed in section 6.
Ne uporabljajte zdravila Busulfan Fresenius Kabi: - če ste alergični na busulfan ali katero koli drugo sestavino tega zdravila, navedeno v poglavju 6, - če ste noseči ali menite, da bi lahko bili noseči.
The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9kg in achieving the therapeutic window (900 - 1500 µmol/L.minute).
Priporočeno odmerjanje zdravila pri otrocih je podrobno navedeno v poglavju 4.2 in omogoča, da od 70 % do 90 % otrok s telesno maso ≥9 kg doseže terapevtsko okno (900-1500 µmol/l·min).
Adverse reactions information are derived from the clinical study in paediatrics (n=55).
Informacije o neželenih učinkih so pridobljene iz pediatrične klinične študije (n = 55).
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61) .
Podatki o pojavljanju akutne reakcije presadka proti gostitelju (acute graft-versus-host diseaseaGVHD) so bili zbrani v raziskavi OMC-BUS-4 (alogenska) (n = 61).
Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Srce: spremembe in nepravilnosti srčnega utripa, zadrževanje tekočine ali vnetje okrog srca, zmanjšan srčni iztis.
Before receiving Busulfan Fresenius Kabi, you will be medicated with - anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and - antiemetic medicines to prevent vomiting.
Zdravila, ki jih boste prejeli pred uporabo zdravila Busulfan Fresenius Kabi: Preden boste prejeli zdravilo Busulfan Fresenius Kabi, boste prejeli še: - antikonvulzivna zdravila, za preprečitev epileptičnih napadov (fenitoin ali benzodiazepine) in - antiemetična zdravila, za preprečitev bruhanja.
Busulfan Fresenius Kabi destroys the original bone marrow before the transplant.
Zdravilo Busulfan Fresenius Kabi uniči izvorni kostni mozeg bolnika pred presaditvijo.
In paediatric population, 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 pediatrični populaciji se je absolutno število nevtrofilcev < 0,5x109/l mediano 3 dni po transplantaciji pojavilo pri 100 % bolnikov in je trajalo 5 dni pri avtologni ter 18,5 dneva pri alogenski transplantaciji.
Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output and bloody urine.
Ledvice: povečanje kreatininskega očistka, bolečine pri uriniranju, zmanjšana količina urina in kri v urinu.
Busulfan 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).
Busulfan se uporablja v obliki 2-urne infuzije na 6 ur, 4 zaporedne dni, kar je skupaj 16 odmerkov pred uporabo ciklofosfamida ali melfalana in pred transplantacijo hematopoetskih progenitorskih celic.
Documentation of the safety and efficacy of busulfan 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 varnosti in učinkovitosti busulfana v kombinaciji s ciklofosfamidom v terapiji BuCy4 ali melfalanom v terapiji BuMel pred konvencionalnim alogensko in/ali avtologno HPCT izhaja iz kliničnega preskušanja F60002 IN 101 G0.
Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Srce: zamašitev femoralne arterije, dodatni utripi srca, zmanjšan srčni utrip, difuzno prepuščanje tekočine iz kapilar (majhne krvne žile).
Busulfan Fresenius Kabi may interact with other medicines.
Zdravilo Busulfan Fresenius Kabi lahko medsebojno učinkuje z drugimi zdravili.
The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Podatki o pojavnosti akutne reakcije presadka proti gostitelju (acute graft-versus-host diseaseaGVHD) so bili zbrani pri alogenskih bolnikih (n = 28).
Busulfan is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Busulfan se daje pred transplantacijo hematopoetskih progenitorskih celic (HPCT).
The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/ (m2) > 30 kg/m² until further data become available.
Dokler ne bodo na voljo dodatni podatki, uporaba tega zdravila pri debelih otrocih in mladostnikih z indeksom BMI (masa (kg)/višina (m2)) > 30 kg/m2 ni priporočljiva.
The amount of Busulfan Fresenius Kabi and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Količino zdravila Busulfan Fresenius Kabi in redčila za uporabo lahko izračunamo na naslednji način:za bolnika, ki tehta Y kg:
In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT.
V tej študiji je do vsaditve (engraftment) prišlo pri vseh bolnikih, razen pri enem, in sicer po mediano 15 dneh (razpon: od 10 do 23) po homologni transplantaciji hematopoetskih celic.
The pharmacokinetics of busulfan has been investigated.
Raziskovali so farmakokinetiko busulfana.
• The diluted solution must be mixed thoroughly by inverting several times.
• Vrečko z razredčeno raztopino morate temeljito premešati z nekajkratnim obračanjem.
Women must stop breast-feeding before starting their treatment with Busulfan Fresenius Kabi.
Ženske morajo prekiniti z dojenjem pred začetkom zdravljenja z zdravilom BusulfanFreseniua Kabi.
One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
En ml koncentrata vsebuje 6 mg busulfana (60 mg v eni viali).
The safety profile of busulfan combined with fludarabine (FB) has been examined through a review of adverse reactions reported in published data from clinical trials in RIC regimen.
Varnostne značilnosti busulfana v kombinaciji s fludarabinom (FB) so raziskali s pregledom neželenih učinkov, opisanih v objavljenih podatkih kliničnih preskušanj, v katerih so uporabljali pripravljalno shemo zmanjšane intenzivnosti (RIC).
Renal and urinary disorders 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.
Domnevno naj bi bile pripravljalne sheme s fludarabinom po transplantacijah povezane z višjo incidenco oportunističnih okužb, ker fludarabin deluje imunosupresivno.
Busulfan will be administered once daily during 2 or 3 consecutive days prior to transplant.
- Zdravilo Busulfan Fresenius Kabi boste prejemali enkrat dnevno, 2 ali 3 dni zaporedoma pred presaditvijo.
Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen and consequently were not considered undesirable effects.
Želena terapevtska učinka pripravljalne sheme sta bila mielosupresija in imunosupresija, ki zato nista bila obravnavana kot neželena učinka.
The treatment-related mortality/non-relapse mortality (TRM/NRM) reported until day+100 posttransplant has also been examined through a review of published data from clinical trials.
Prav tako so s pregledom objavljenih podatkov kliničnih preskušanj proučili z zdravljenjem povezano umrljivost/umrljivost, nepovezano s ponovitvijo bolezni (ZPU/UNP), zabeleženo do dneva + 100 po transplantaciji.
Hepato-biliary disorders VOD was reported with a range between 3.9% and 15.4%.
Bolezni jeter, žolčnika in žolčevodov: O veno-okluzivni bolezni so poročali v razponu med 3,9 in 15,4 %.
This study demonstrated that bodyweight was the predominant covariate to explain the busulfan pharmacokinetic variability in children over body surface area or age.
Ta študija je pokazala prevladujoč vpliv telesne mase v primerjavi s vplivom telesne površine ali starosti, na farmakokinetično variabilnost busulfana pri otrocih.
The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
Čas za dosego absolutnega števila nevtrofilcev, večjega od 0,5 x 109/l, je bil pri alogenskih bolnikih 21 dni (v razponu 12-47 dni), pri avtolognih bolnikih pa 11 dni (v razponu 10-15 dni).
Special caution should be exercised when administering the recommended dose of busulfan to patients with a history of seizures.
Posebna previdnost pri uporabi priporočenega odmerka busulfana je potrebna pri bolnikih z anamnezo epileptičnih napadov.
The recommended dose of Busulfan Fresenius Kabi in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Priporočeni odmerek zdravila Busulfan Fresenius Kabi v kombinaciji s ciklofosfamidom ali melfalanom je odvisen od telesne mase in je v razponu med 0,8 in 1,2 mg/kg.
Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Skupni plazemski očistek je bil med 2,25 in 2,74 ml/min/kg.
• Quantity of diluent:
• Količina redčila:
Overall mortality and non-relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Pri alogenskih bolnikih je bila celokupna smrtnost pri več kot 100 dnevih po transplantaciji 13-odstotna (8/61), smrtnost, ki ni bila povezana s ponovitvijo bolezni, pa 10-odstotna (6/61).
Renal: increase in the amount of nitrogen components in the blood stream, moderate renal insufficiency, renal disorder.
Ledvice: povečana količina dušikovih spojin v krvnem obtoku, zmerno zmanjšano delovanje ledvic, ledvična motnja.
Antiemetics should be administered prior to the first dose of busulfan and continued on a fixed schedule according to local practice through its administration.
Pred prvim odmerkom busulfana morajo bolniki prejeti antiemetike in nadaljevati z njihovo uporabo po vnaprej določeni shemi odmerjanja, skladni z lokalno prakso, ves čas uporabe busulfana.
Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Busulfan je močna citotoksična in bifunkcionalno alkilirajoča učinkovina.
Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
Med zdravljenjem ter do končne ozdravitve je potrebno pogosto nadzorovati celotno krvno sliko, vključno z diferencialno sliko belih krvnih celic in trombocitov.
Busulfan in combination with cyclophosphamide or melphalan In adults
Busulfan v kombinaciji s ciklofosfamidom ali melfalanom Odrasli
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 nadzorovanje okužb tekom nevtropeničnega obdobja, je priporočljiva preventivna ali empirična uporaba zdravil proti okužbam (bakterijskim, glivičnim in virusnim).
Busulfan will be administered every 6 hours during 4 consecutive days prior to transplant.
- Zdravilo Busulfan Fresenius Kabi boste prejemali na vsakih 6 ur, 4 dni zaporedoma pred presaditvijo.
The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Najpogostejši vzroki zabeleženih ZPU/UNP so bili okužba/sepsa, bolezen presadka proti gostitelju, pljučne bolezni in odpovedi organov.
Busulfan Fresenius Kabi is supplied as a clear colourless viscous solution in 10 ml clear, colourless glass vials (type I).
Zdravilo Busulfan Fresenius Kabi je na voljo kot bistra, brezbarvna, viskozna raztopina v prozornih, brezbarvnih, steklenih vialah (steklo tipa I) s prostornino 10 ml.
Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Med preostale pogoste anomalije sodi volčje žrelo, ansarka in anomalije vretenc ter reber.
Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
Ker pa se busulfan presnavlja s konjugacijo z glutationom, je smiselno uporabiti tudi glutation.
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 (range 8-19 days) in autologous patients (OMC-BUS 3).
Čas za dosego absolutnega števila nevtrofilcev, večjega od 0,5 x 109/l , je bil pri alogenskih bolnikih (OMC-BUS-4) 13 dni (v razponu 9-29 dni), pri avtolognih bolnikih (OMC-BUS-3) pa 10 dni (v razponu 8-19 dni).
Busulfan 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 busulfanom in nato s ciklofosfamidom (BuCy2) se uporablja kot pripravljalna terapija pred transplantacijo hematopoetskih progenitorskih celic (HPCT - Haematopoietic Progenitor Cell Transplantation) pri odraslih bolnikih, kadar ocenimo, da je ta kombinacija najboljša možnost.
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 je absolutno število nevtrofilcev < 0,5 x 109/l mediano 4 dni po transplantaciji pojavilo pri 100 % bolnikov in se je popravilo mediano 10 dni po avtologni oziroma 13 dni po alogenski transplantaciji (mediano trajanje nevtropenije je znašalo 6 oziroma 9 dni).
In new-born infants, children and adolescents, this medicine is used in combination with cyclophosphamide or melphalan.
Pri novorojenčkih, otrocih in mladostnikih se zdravilo Busulfan Fresenius Kabi uporablja v kombinaciji s ciklofosfamidom ali z melfalanom.
Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
V drugi klinični fazi sta bili na bolnikih s hematološkimi obolenji, pri večini katerih je bolezen že napredovala, opravljeni dve eno-kraki, odprti, nekontrolirani raziskavi možnosti zdravljenja.
Therefore it is advised not to father child during the treatment 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 shranitvi semena z zamrznitvijo, ker zaradi zdravljenja obstaja možnost trajne neplodnosti (glejte poglavje 4.4).
Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Zdravljenje z busulfanom je pri dekletu pred adolescenco zaradi okvare jajčnikov preprečilo začetek pubertete.
- the calculated volume of Busulfan Fresenius Kabi must be removed from the vial.
- izračunan volumen zdravila Busulfan Fresenius Kabi morate odstraniti iz viale,
In adults and children studies, data with busulfan were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Vsi podatki o busulfanu v študijah pri odraslih in otrocih so bili pridobljeni pri sočasni uporabi fenitoina ali benzodiazepinov, kot profilakso pred epileptičnimi napadi.
What Busulfan Fresenius Kabi contains - The active substance is busulfan.
Kaj vsebuje zdravilo Busulfan Fresenius Kabi - Zdravilna učinkovina je busulfan.
Uncommon (may affect up to 1 in 100 people):
Občasni (pojavijo se lahko pri največ 1 od 100):
Men treated with Busulfan Fresenius Kabi are advised not to father child during and up to 6 months after treatment.
Moškim, ki prejemajo zdravilo Busulfan Fresenius Kabi, svetujemo, naj ne zaplodijo otroka med zdravljenjem in še vsaj 6 mesecev po zdravljenju.
What Busulfan Fresenius Kabi looks like and contents of the pack Busulfan Fresenius Kabi consists of a concentrate for solution for infusion.
Izgled zdravila Busulfan Fresenius Kabi in vsebina pakiranja Zdravilo Busulfan Fresenius Kabi je koncentrat za raztopino za infundiranje.
Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Objavljene raziskave, opravljene na odraslih bolnikih, opisujejo možnost povezave med ketobemidonom, (analgetik) in visokimi plazemskimi koncentracijami busulfana.
Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Postopek z busulfanom in nato s ciklofosfamidom (BuCy4) ali melfalanom (BuMel) se uporablja kot pripravljalna terapija pred transplantacijo hematopoetskih progenitorskih celic pri pediatričnih bolnikih.
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 II.
Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Pred in po vsaki infuziji izperite katetrsko cev s približno 5 ml 0,9 % raztopine natrijevega klorida za injiciranje (9 mg/ml) ali 5 % raztopine glukoze za injiciranje.
Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Živčni sistem: delirij, nervoza, prividi, nemirnost, nenormalno delovanje možganov, možganske krvavitve in epileptični napadi.
Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Dihala: povečana frekvenca dihanja, dihalna odpoved, alveolarne krvavitve, astma, ohlapnost manjših delov pljuč, nabiranje tekočine okrog pljuč.
What Busulfan Fresenius Kabi is and what it is used for
Kaj je zdravilo Busulfan Fresenius Kabi in za kaj ga uporabljamo 2.
Increase of uric acid and urea in the blood.
Povišanje sečne kisline in sečnine v krvi.
Busulfan Fresenius Kabi in combination with cyclophosphamide: - The recommended dose of Busulfan Fresenius Kabi is 0.8 mg/kg
Zdravilo Busulfan Fresenius Kabi v kombinaciji s ciklofosfamidom - Priporočeni odmerek zdravila Busulfan Fresenius Kabi je 0,8 mg/kg.
Women must not be pregnant during treatment with Busulfan Fresenius Kabi and up to 6 months after treatment.
Ženske, ki prejemajo zdravilo Busulfan Fresenius Kabi, ne smejo biti noseče med zdravljenjem in ne smejo zanositi še do 6 mesecev po zdravljenju.
However cardiac function should be monitored regularly in patients receiving busulfan (see section 4.8).
Vendar je pri bolnikih, ki so prejemali busulfan, potreben reden nadzor delovanja srca (glejte poglavje 4.8).
Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Srce: povišan srčni utrip, dvig ali padec krvnega tlaka, vazodilatacija (razširjenje krvnih žil) in krvni strdki.
Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning)
Bolezni očesne leče, vključno s sivo mreno (katarakta) in motnjami vida (tanjšanje roženice).
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 II.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml OTHER Cytotoxic
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 mg/10 ml
Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Presnovne in prehranske motnje anoreksija hiperglikemija hipokalcemija hipokaliemija hipomagneziemija hipofosfatemija hiponatriemija
CARTON containing 1 vial
PODATKI NA PRIMARNI OVOJNINI KARTON, ki vsebuje 1 vialo
LIST OF EXCIPIENTS Excipients: Dimethylacetamide and Macrogol 400
SEZNAM POMOŽNIH SNOVI Pomožne snovi: dimetilacetamid in makrogol 400.
** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
** objavljeno v obdobju, ko je zdravilo že na trgu, pri intravenskem dajanju busulfana *** objavljeno v obdobju, ko je zdravilo že na trgu, pri peroralnem jemanju busulfana
What you need to know before you use Busulfan Fresenius Kabi
Kaj morate vedeti, preden boste uporabili zdravilo Busulfan Fresenius Kabi
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.
V primeru zdravstvenih indikacij je potrebno nuditi trombocitno ali eritrocitno podporo in uporabiti rastne faktorje, kot je granulocitne kolonije stimulirajoči faktor (G-CSF).
One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the busulfan studies.
Pri raziskavah busulfana je bil pojav akutnega sindroma dihalne stiske s posledično respiratorno odpovedjo, povezano z intersticijsko fibrozo pljuč, pri enem bolniku smrten.
The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/kg.
Po intravenski uporabi busulfana v odmerkih do 1 mg/kg so dokazali, da je izpostavljenost busulfanu naraščala sorazmerno z odmerkom.
• Busulfan Fresenius Kabi must be prepared by a healthcare professional using sterile transfer techniques.
• Zdravilo Busulfan Fresenius Kabi mora pripraviti usposobljen zdravstveni delavec/delavka v sterilnih pogojih.
Busulfan Fresenius Kabi must always be added to the diluent, not the diluent to the Busulfan Fresenius Kabi.
Zdravilo Busulfan Fresenius Kabi morate vedno dodajati v redčilo in ne redčila v zdravilo Busulfan Fresenius Kabi.
Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in busulfan studies in one patient who died, although, no clear aetiology was identified.
V raziskavah busulfana je bil pri enem bolniku, ki je umrl, zabeležen pojav sindroma akutne dihalne stiske, ki ji je sledila respiratorna odpoved, povezana z intersticijsko pljučno fibrozo, vendar jasne etiologije niso identificirali.
The effects of renal dysfunction on intravenous busulfan disposition have not been assessed.
Učinki okvare ledvic na delovanje intravensko uporabljenega busulfana še niso bili ocenjeni.
Clear, colourless viscous solution.
Bistra, brezbarvna, viskozna raztopina.