natgillin/translations-raw huggingface dataset:
Pack size 1 pack containing 8 vials (8 cartons of 1 vial). 
Veličina pakiranja Jedno pakiranje koje se sastoji od 8 bočica (8 pojedinačnih kutija sa po 1 bočicom).
The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5). 
Učinak tih antikonvulzivnih sredstava na farmakokinetiku busulfana ispitivan je u fazi II ispitivanja (vidjeti dio
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61) . 
Podaci o incidenciji akutne reakcije presatka na domaćina (a-GVHD) prikupljeni su u ispitivanju OMC-BUS-4 (alogeno) (n=61).
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 u 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.
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 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).
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).
In adults and children studies, data with busulfan were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis. 
U ispitivanjima na odraslima i djeci podaci za busulfan dobiveni su kada se za profilaksu napadaja istodobno primjenjivao ili fenitoin ili benzodiazepini.
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).
Busulfan will be administered once daily during 2 or 3 consecutive days prior to transplant. 
- Busulfan Fresenius Kabi će se primjenjivati jednom dnevno tijekom 2 ili 3 uzastopna dana prije presađivanja.
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 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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml OTHER Cytotoxic 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mg/10 ml
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. 
Vrijeme do apsolutnog broja neutrofila (ABN) većeg od 0,5x109 /l bilo je 21 dan (raspon od 12-47 dana) u alogenih bolesnika i 11 dana (raspon od 10-15 dana) u autolognih bolesnika.
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. 
Sigurnosni profil lijeka busulfan u kombinaciji s fludarabinom (FB) ispitan je putem pregleda nuspojava zabilježenih u objavljenim podacima iz kliničkih ispitivanja protokola kondicioniranja smanjenog intenziteta.
OTHER SPECIAL WARNING IF NECESSARY Cytotoxic 
DRUGO(A) POSEBNO(A) UPOZORENJE, AKO JE POTREBNO Citotoksično
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.
Busulfan administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation. 
Primjenu busulfana mora nadzirati liječnik iskusan u terapiji kondicioniranja koje prethodi presađivanju hematopoetskih progenitorskih stanica.
- Busulfan will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days. 
- Busulfan se primjenjuje u dozi od 3,2 mg/kg kao trosatna infuzija jednom dnevno odmah nakon fludarabina u 2 ili 3 uzastopna dana.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml. 
OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica od 10 ml.
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. 
Pretpostavlja se da su protokoli kondicioniranja koji sadrže fludarabin povezani s većim incidencijama oportunističkih infekcija nakon presađivanja zbog imunosupresivnog učinka fludarabina.
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). 
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 (raspon od 8-19 dana) u autolognih bolesnika (OMC-BUS 3).
Read this guide prior to the preparation and administration of Busulfan Fresenius Kabi. 
Pročitajte ove upute prije pripreme i primjene Busulfan Fresenius Kabia.
• Busulfan Fresenius Kabi must be prepared by a healthcare professional using sterile transfer techniques. 
• Busulfan Fresenius Kabi mora pripremiti zdravstveni djelatnik koristeći se sterilnim tehnikama prijenosa.
As with other cytotoxic compounds, caution should be exercised in handling and preparing the busulfan solution: - The use of gloves and protective clothing is recommended. 
U rukovanju otopinom lijeka Busulfan Fresenius Kabi i njenoj pripremi je potreban oprez, kao i s drugim citotoksičnim spojevima: - Preporučuje se uporaba rukavica i zaštitne odjeće.
Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients. 
Busulfan nakon kojeg slijedi ciklofosfamid (BuCy4) ili melfalan (BuMel) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica u pedijatrijskih bolesnika.
There is no known antidote to busulfan other than haematopoietic progenitor cell transplantation. 
Ne postoji poznati protulijek za busulfan osim presađivanja hematopoetskih progenitorskih stanica.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kartonskoj kutiji iza oznake „Rok valjanosti“.
Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output and bloody urine. 
Bubrezi: povećanje uklanjanja kreatinina, nelagoda pri mokrenju, smanjeno izlučivanje urina i krvavi urin.
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. 
Busulfan nakon kojeg slijedi ciklofosfamid (BuCy2) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica (HPCT, engl. haematopoietic progenitor cell transplantation) u odraslih bolesnika kada se ta kombinacija smatra najboljom raspoloživom mogućnošću.
Busulfan Fresenius Kabi is supplied as a clear colourless viscous solution in 10 ml clear, colourless glass vials (type I). 
Busulfan Fresenius Kabi se na tržištu nalazi kao bistra, bezbojna, viskozna otopina u prozirnim, bezbojnim, staklenim bočicama od 10 ml (staklo tip I).
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 8 vials of 10 ml 60 mg per vial 
OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 8 bočica od 10 ml
Clear, colourless viscous solution. 
Bistra, bezbojna viskozna otopina.
• Quantity of Busulfan Fresenius Kabi: 
• Količina Busulfan Fresenius Kabi:
Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 8 hours (including infusion time) after dilution when stored at 25°C ± 2°C or 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time). 
Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili otopini natrijeva klorida 9 mg/ml (0,9%) za injekciju dokazana je za 8 sati (uključujući vrijeme infuzije) nakon razrjeđivanja ako se čuva na temperaturi od 25°C ± 2°C ili 12 sati nakon razrjeđivanja ako se čuva na temperaturi od 2°C - 8°C nakon čega je uslijedilo 3 sata čuvanja na temperaturi od 25°C ± 2°C (uključujući vrijeme infuzije).
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. 
Nemojte primjenjivati Busulfan Fresenius Kabi: - ako ste alergični na busulfan ili neki drugi sastojak lijeka Busulfan Fresenius Kabi naveden u dijelu 6, - ako ste trudni ili mislite da ste možda trudni.
Busulfan in combination with cyclophosphamide 
Busulfan u kombinaciji s ciklofosfamidom
Blood: decrease of blood circulating cells (red and white) and platelets. 
Krv: smanjenje krvnih stanica (crvenih i bijelih) i trombocita u krvotoku.Invekcije.
Busulfan following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. 
Busulfan koji slijedi nakon fludarabina (FB) indiciran je kao terapija kondicioniranja prije presađivanja hematopoetskih progenitorskih stanica (HPCT) u odraslih bolesnika koji su kandidati za protokol kondicioniranja smanjenog intenziteta (RIC).
Busulfan Fresenius Kabi must be prepared by a healthcare professional using sterile transfer techniques. 
Busulfan Fresenius Kabi mora pripremiti zdravstveni djelatnik koristeći se sterilnim tehnikama prijenosa.
Other medicines and Busulfan Fresenius Kabi Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove dobivene bez recepta.
Adverse reactions information are derived from the clinical study in paediatrics (n=55). 
Informacije o nuspojavama dobivene su iz kliničkog ispitivanja pedijatrijske populacije (n=55).
What you need to know before you use Busulfan Fresenius Kabi 
Što morate znati prije nego počnete primjenjivati Busulfan Fresenius Kabi
Busulfan Fresenius Kabi must be diluted prior to administration. 
Busulfan Fresenius Kabi se prije primjene mora razrijediti.
Busulfan has not been studied in patients with hepatic impairment. 
Busulfan nije ispitivan na bolesnicima s oštećenjem funkcije jetre.
Busulfan in combination with fludarabine (FB) In adults The recommended dose and schedule of administration is: - fludarabine administered as a single daily one-hour infusion at 30 mg/m² for 5 consecutive days or 40 mg/m² for 4 consecutive days. 
U odraslih Preporučena doza i raspored primjene je sljedeći: - fludarabin primijenjen kao jednosatna infuzija jednom dnevnom od 30 mg/m² 5 uzastopnih dana ili od 40 mg/m² 4 uzastopna dana.
Uncommon (may affect up to 1 in 100 people): 
Manje često (mogu mogu se javiti u do 1 na 100 osoba):
The quantity of the diluent must be 10 times the volume of the Busulfan Fresenius Kabi ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml. 
Količina otapala mora biti 10 puta veća od volumena lijeka Busulfan Fresenius Kabi što će osigurati konačnu koncentraciju busulfana od približno 0,5 mg/ml.
Hypertension Hypotension Thrombosis Vasodilatation 
Hipertenzija Hipotenzija Tromboza Vazodilatacija
followed by: - 4 cycles of 50 mg/kg body weight (BW) cyclophosphamide (BuCy4) or - one administration of 140 mg/m² melphalan (BuMel) initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5). 
nakon čega slijedi: - 4 ciklusa sa 50 mg/kg tjelesne težine (TT) ciklofosfamida (BuCy4) ili - jedna primjena 140 mg/m² melfalana (BuMel)
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. 
Kada je to medicinski indicirano, potrebno je primijeniti potporna sredstva za porast broja trombocita i crvenih krvnih stanica i upotrijebiti faktore rasta kao što je sredstvo za stimulaciju rasta granulocitnih kolonija (G-CSF, engl. granulocyte colony stimulating factor).
Medicines before you receive Busulfan Fresenius Kabi: 
Lijekovi prije primanja lijeka Busulfan Fresenius Kabi:
Busulfan in combination with cyclophosphamide or melphalan In adults 
Busulfan u kombinaciji s ciklofosfamidom i melfalanom U odraslih
After dilution: one ml of solution contains approximately 0.5 mg of busulfan. 
Nakon razrjeđivanja: jedan ml otopine sadrži približno 0,5 mg busulfana.
Men treated with Busulfan Fresenius Kabi are advised not to father child during and up to 6 months after treatment. 
Muškarcima liječenima busulfanom ne preporučuje se da začinju dijete tijekom i do 6 mjeseci nakon liječenja.
- 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5). 
Preporučena doza i raspored primjene je sljedeći: - 0,8 mg/kg tjelesne težine (TT) busulfana u obliku dvosatne infuzije svakih 6 sati tijekom 4 uzastopna dana u ukupno 16 doza, - potom slijedi ciklofosfamid u dozi od 60 mg/kg/dan tijekom 2 dana s početkom najmanje 24 sata nakon 16. doze busulfana (vidjeti dio 4.5).
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. 
U ispitivanjima busulfana kod jednog bolesnika koji je preminuo prijavljena je pojava akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća, premda nije utvrđena jasna etiologija.
Precautions to be taken before handling or administering the medicinal product This medicinal product must be diluted prior to administration. 
Mjere koje treba poduzeti prije rukovanja ili primjene lijeka.
Periodic monitoring of renal function should be considered during therapy with busulfan (see section 
Periodični nadzor funkcije bubrega mora se razmotriti u bolesnika tijekom liječenja busulfanom (vidjeti dio 4.8).
For any information about this medicine, please contact the Marketing Authorisation Holder This leaflet was last revised in {MM/YYYY} Other sources of information 
Za bilo koje informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje lijeka u promet.
Increase of uric acid and urea in the blood. 
Povišenje mokraćne kiseline i ureje u krvi.
One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the busulfan studies. 
U ispitivanjima busulfana jedan je bolesnik doživio smrtonosni slučaj akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća.
- the calculated volume of Busulfan Fresenius Kabi must be removed from the vial. 
- izračunati volumen lijeka Busulfan Fresenius Kabi mora se ukloniti iz bočice.
Busulfan Fresenius Kabi in combination with fludarabine The recommended dose of busulfan is 3.2 mg/kg Each infusion will last 3 hours 
- Preporučena doza Busulfan Fresenius Kabi je 3,2 mg/kg - Svaka infuzija trajat će 3 sata.
Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent 
Izračun količine lijeka Busulfan Fresenius Kabi koju je potrebno razrijediti i količine otapala
Busulfan is administered prior to the haematopoietic progenitor cell transplantation (HPCT). 
Primjena busulfana prethodi presađivanju hematopoetskih progenitorskih stanica (HPCT).
Femoral artery thrombosis Capillary leak 
Tromboza femoralne arterije
Busulfan Fresenius Kabi must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%. 
Busulfan Fresenius Kabi se ne smije unositi u intravensku vrećicu koja ne sadrži otopinu natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tnu otopinu glukoze za injekciju.
In that case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual busulfan infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection. 
U tom je slučaju potrebno primjenjivati komplete za infuziju s minimalnim prostorom za ubrizgavanje (tj. 0,3-0,6 ml), u kojima je otopina lijeka infundirana prije početka stvarne infuzije busulfanom i potom isprana otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom glukoze (5%) za injekciju.
Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning) 
Poremećaji leće uključujući zamućenost leće oka (katarakta) i zamagljeni vid (stanjivanje rožnice) Simptomi menopauze i ženska neplodnost.
How to store Busulfan Fresenius Kabi 
Kako čuvati Busulfan Fresenius Kabi
Haematuria Moderate renal insufficiency 
Hematurija Umjerena bubrežna insuficijencija
The terminal half life ranged from 2.26 to 2.52 h. Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively. 
Inter- i intravarijabilnost bolesnika u plazmatskoj izloženosti bile su niže od 20%, odnosno 10%.
Busulfan Fresenius Kabi must always be added to the diluent, not the diluent to the Busulfan Fresenius Kabi. 
Busulfan Fresenius Kabi se uvijek mora dodati otapalu, a ne otapalo u koncentrat.
It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with Busulfan Fresenius Kabi. 
Moguće je da nakon liječenja busulfanom više nećete moći ostvariti trudnoću (neplodnost).
Skin desquamation Erythema Pigmentation disorder 
Poremećaj pigmentacije
- 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time). 
sata čuvanja na temperaturi od 25°C ± 2°C (uključujući vrijeme infuzije).
Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%. 
Izračun količine lijeka Busulfan Fresenius Kabi koju je potrebno razrijediti i količine otapala Prije upotrebe, lijek Busulfan Fresenius Kabi se mora razrijediti otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom 5%-tne glukoze za injekciju.
Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion Busulfan 
Busulfan Fresenius Kabi 6 mg/ml koncentrat za otopinu za infuziju busulfan
QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml). 
Busulfan Fresenius Kabi 6 mg/ml koncentrat za otopinu za infuziju 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 6 mg busulfana (60 mg u 10 ml).
How to use Busulfan Fresenius Kabi 
Kako primjenjivati Busulfan Fresenius Kabi
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use after dilution. 
Prije uporabe pročitajte Uputu o lijeku Primjena u venu nakon razrjeđivanja.
• Quantity of diluent: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent 
• Količina otapala: (A ml Busulfan Fresenius Kabi) x (10) = B ml otapala Za pripremu konačne otopine za infuziju, dodajte (A) ml busulfana u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tna otopina glukoze za injekciju) Priprema otopine za infuziju
Hepatic veno-occlusive disease is a major complication that can occur during treatment with busulfan. 
Glavna komplikacija koja se može pojaviti tijekom liječenja busulfanom je vensko-okluzivna bolest jetre.
Diluted Busulfan Fresenius Kabi is a clear colourless solution. 
Razrijeđeni Busulfan Fresenius Kabi je bistra, bezbojna otopina.
When diluted Busulfan Fresenius Kabi is a clear colourless viscous solution. 
Kada je razrijeđen, Busulfan Fresenius Kabi je bistra, bezbojna, viskozna otopina.
GENERAL CLASSIFICATION FOR SUPPLY 
Konačni volumen distribucije
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany 12. 
Nositelj odobrenja za stavljanje lijeka u promet Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution 
TVARI Jedan ml koncentrata sadrži 6 mg busulfana i nakon razrjeđivanja osigurava 0,5 mg/ml busulfana POPIS POMOĆNIH TVARI Pomoćne tvari: dimetilacetamid i makrogol 400
Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%. 
Prije upotrebe, Busulfan Fresenius Kabi je potrebno razrijediti s otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili otopinom 5%-tne glukoze za injekciju.
Busulfan Fresenius Kabi destroys the original bone marrow before the transplant. 
Busulfan uništava izvornu koštanu srž prije presađivanja.
NAME OF THE MEDICINAL PRODUCT Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion busulfan 
Uputa o lijeku: Informacija za korisnika Busulfan Fresenius Kabi 6 mg/ml koncentrat za otopinu za infuziju busulfan
Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for: 
Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju dokazana je za: - 8 sati (uključujući vrijeme infuzije) nakon razrjeđivanja ako se čuva na temperaturi od 25°C ±
Blood urea increased GGT increased 
Povišena mokraćna kiselina u krvi Povišena urea u krvi Povišeni GGT Povećanje tjelesne težine
To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) 
• Količina otapala: (A ml lijeka Busulfan Fresenius Kabi) x (10) = B ml otapala Za pripremu konačne otopine za infuziju, dodajte (A) ml lijeka Busulfan Fresenius Kabi u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tne otopine glukoze za injekciju) Priprema otopine za infuziju
Stomatitis Diarrhoea Abdominal pain Nausea 
Bol u abdomenu Mučnina Povraćanje Dispepsija Ascites