FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Croatian: Podaci o pojavnosti akutne reakcije presatka na domaćina (a-GVHD) prikupljeni su od alogenih bolesnika (n=28).
English: 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:
Croatian: Količina lijeka Busulfan Fresenius Kabi i otapala koji se moraju primijeniti izračunavaju se na sljedeći način: za bolesnika s tjelesnom težinom Y kg:
English: Busulfan Fresenius Kabi is a potent cytotoxic medicine that results in profound decrease of blood cells.
Croatian: Busulfan Fresenius Kabi je snažan, citotoksičan lijek koji dovodi do izrazitog smanjenja broja krvnih stanica.
English: Busulfan Fresenius Kabi is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Croatian: Busulfan se primjenjuje u odraslih, novorođenčadi, djece i adolescenata kao liječenje prije presađivanja.
English: What Busulfan Fresenius Kabi contains - The active substance is busulfan.
Croatian: Što Busulfan Fresenius Kabi sadrži - Djelatna tvar je busulfan.
English: The entire prescribed busulfan dose should be delivered over two or three hours depending on the conditioning regimen.
Croatian: Ukupna propisana doza busulfana mora se primijeniti tijekom dva ili tri sata, ovisno o protokolu kondicioniranja.
English: What Busulfan Fresenius Kabi is and what it is used for
Croatian: Što je Busulfan Fresenius Kabi i za što se koristi
English: In adult and paediatric studies, patients received either phenytoin or benzodiazepines as seizure prophylaxis treatment (see sections 4.4 and 4.5).
Croatian: U ispitivanjima na odraslima i djeci bolesnici su primali fenitoin ili benzodiazepine kao profilaktičnu terapiju napadaja (vidjeti dijelove 4.4 i 4.5).
English: A reduced incidence of Hepatic Veno 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.
Croatian: Hepatic Veno Occlusive Disease, HVOD) i toksičnosti povezane s ostalim protokolima zabilježena je u bolesnika kada je vrijeme latencije između posljednje peroralne doze busulfana i prve doze ciklofosfamida > 24 sata.
English: 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).
Croatian: Preporučeno doziranje za djecu navedeno u dijelu 4.2 omogućilo je da više od 70% pa sve do 90% djece ≥ 9 kg postigne terapijski okvir (900-1500 μmol/l.minuta).
English: What Busulfan Fresenius Kabi looks like and contents of the pack Busulfan Fresenius Kabi consists of a concentrate for solution for infusion.
Croatian: Kako Busulfan Fresenius Kabi izgleda i sadržaj pakiranja Busulfan Fresenius Kabi se sastoji od koncentrata za otopinu za infuziju.
English: Documentation on the safety and efficacy of busulfan in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/or autologous HPCT derives from two clinical trials (OMC-BUS-4 and OMC-BUS-3).
Croatian: Dokumentacija o sigurnosti primjene i djelotvornosti busulfana u kombinaciji s ciklofosfamidom u protokolu BuCy2 prije konvencionalnog alogenog i/ili autolognog HPCT-a potječe iz dva klinička ispitivanja (OMC-BUS-4 i OMC-BUS-3).
English: 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).
Croatian: Stoga se bolesnicima preporučuje da tijekom liječenja i do 6 mjeseci nakon liječenja ne začinju dijete te da, zbog mogućnosti ireverzibilne neplodnosti, prije liječenja zatraže savjet o kriokonzervaciji sperme (vidjeti dio 4.4).
English: Pack size 1 pack containing 8 vials (8 cartons of 1 vial).
Croatian: Veličina pakiranja Jedno pakiranje koje se sastoji od 8 bočica (8 pojedinačnih kutija sa po 1 bočicom).
English: The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5).
Croatian: Učinak tih antikonvulzivnih sredstava na farmakokinetiku busulfana ispitivan je u fazi II ispitivanja (vidjeti dio
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61) .
Croatian: Podaci o incidenciji akutne reakcije presatka na domaćina (a-GVHD) prikupljeni su u ispitivanju OMC-BUS-4 (alogeno) (n=61).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900 - 1500 µmol/L.minute).
Croatian: 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).
English: In adults and children studies, data with busulfan were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Croatian: U ispitivanjima na odraslima i djeci podaci za busulfan dobiveni su kada se za profilaksu napadaja istodobno primjenjivao ili fenitoin ili benzodiazepini.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW + 0.25x (actual body weight-IBW).
Croatian: Prilagođena idealna tjelesna težina (PITT) izračunava se na sljedeći način: PITT = ITT + 0,25x (stvarna tjelesna težina - ITT).
English: Busulfan will be administered once daily during 2 or 3 consecutive days prior to transplant.
Croatian: - Busulfan Fresenius Kabi će se primjenjivati jednom dnevno tijekom 2 ili 3 uzastopna dana prije presađivanja.
English: 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.
Croatian: 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.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml OTHER Cytotoxic
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mg/10 ml
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: OTHER SPECIAL WARNING IF NECESSARY Cytotoxic
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE, AKO JE POTREBNO Citotoksično
English: From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
Croatian: U objavljenim ispitivanjima na odraslima pokazalo se da primjena itrakonazola na bolesnicima koji primaju visoke doze busulfana može rezultirati smanjenim klirensom busulfana.
English: Busulfan administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Croatian: Primjenu busulfana mora nadzirati liječnik iskusan u terapiji kondicioniranja koje prethodi presađivanju hematopoetskih progenitorskih stanica.
English: - 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.
Croatian: - Busulfan se primjenjuje u dozi od 3,2 mg/kg kao trosatna infuzija jednom dnevno odmah nakon fludarabina u 2 ili 3 uzastopna dana.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml.
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica od 10 ml.
English: 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.
Croatian: Pretpostavlja se da su protokoli kondicioniranja koji sadrže fludarabin povezani s većim incidencijama oportunističkih infekcija nakon presađivanja zbog imunosupresivnog učinka fludarabina.
English: 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).
Croatian: 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).
English: Read this guide prior to the preparation and administration of Busulfan Fresenius Kabi.
Croatian: Pročitajte ove upute prije pripreme i primjene Busulfan Fresenius Kabia.
English: • Busulfan Fresenius Kabi must be prepared by a healthcare professional using sterile transfer techniques.
Croatian: • Busulfan Fresenius Kabi mora pripremiti zdravstveni djelatnik koristeći se sterilnim tehnikama prijenosa.
English: 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.
Croatian: 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.
English: Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Croatian: Busulfan nakon kojeg slijedi ciklofosfamid (BuCy4) ili melfalan (BuMel) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica u pedijatrijskih bolesnika.
English: There is no known antidote to busulfan other than haematopoietic progenitor cell transplantation.
Croatian: Ne postoji poznati protulijek za busulfan osim presađivanja hematopoetskih progenitorskih stanica.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kartonskoj kutiji iza oznake „Rok valjanosti“.
English: Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output and bloody urine.
Croatian: Bubrezi: povećanje uklanjanja kreatinina, nelagoda pri mokrenju, smanjeno izlučivanje urina i krvavi urin.
English: 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.
Croatian: 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.
English: Busulfan Fresenius Kabi is supplied as a clear colourless viscous solution in 10 ml clear, colourless glass vials (type I).
Croatian: Busulfan Fresenius Kabi se na tržištu nalazi kao bistra, bezbojna, viskozna otopina u prozirnim, bezbojnim, staklenim bočicama od 10 ml (staklo tip I).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 8 vials of 10 ml 60 mg per vial
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 8 bočica od 10 ml
English: Clear, colourless viscous solution.
Croatian: Bistra, bezbojna viskozna otopina.
English: • Quantity of Busulfan Fresenius Kabi:
Croatian: • Količina Busulfan Fresenius Kabi:
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Busulfan in combination with cyclophosphamide
Croatian: Busulfan u kombinaciji s ciklofosfamidom
English: Blood: decrease of blood circulating cells (red and white) and platelets.
Croatian: Krv: smanjenje krvnih stanica (crvenih i bijelih) i trombocita u krvotoku.Invekcije.
English: 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.
Croatian: 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).
English: Busulfan Fresenius Kabi must be prepared by a healthcare professional using sterile transfer techniques.
Croatian: Busulfan Fresenius Kabi mora pripremiti zdravstveni djelatnik koristeći se sterilnim tehnikama prijenosa.
English: 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.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove dobivene bez recepta.
English: Adverse reactions information are derived from the clinical study in paediatrics (n=55).
Croatian: Informacije o nuspojavama dobivene su iz kliničkog ispitivanja pedijatrijske populacije (n=55).
English: What you need to know before you use Busulfan Fresenius Kabi
Croatian: Što morate znati prije nego počnete primjenjivati Busulfan Fresenius Kabi
English: Busulfan Fresenius Kabi must be diluted prior to administration.
Croatian: Busulfan Fresenius Kabi se prije primjene mora razrijediti.
English: Busulfan has not been studied in patients with hepatic impairment.
Croatian: Busulfan nije ispitivan na bolesnicima s oštećenjem funkcije jetre.
English: 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.
Croatian: 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.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (mogu mogu se javiti u do 1 na 100 osoba):
English: 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.
Croatian: 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.
English: Hypertension Hypotension Thrombosis Vasodilatation
Croatian: Hipertenzija Hipotenzija Tromboza Vazodilatacija
English: 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).
Croatian: nakon čega slijedi: - 4 ciklusa sa 50 mg/kg tjelesne težine (TT) ciklofosfamida (BuCy4) ili - jedna primjena 140 mg/m² melfalana (BuMel)
English: 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.
Croatian: 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).
English: Medicines before you receive Busulfan Fresenius Kabi:
Croatian: Lijekovi prije primanja lijeka Busulfan Fresenius Kabi:
English: Busulfan in combination with cyclophosphamide or melphalan In adults
Croatian: Busulfan u kombinaciji s ciklofosfamidom i melfalanom U odraslih
English: After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Croatian: Nakon razrjeđivanja: jedan ml otopine sadrži približno 0,5 mg busulfana.
English: Men treated with Busulfan Fresenius Kabi are advised not to father child during and up to 6 months after treatment.
Croatian: Muškarcima liječenima busulfanom ne preporučuje se da začinju dijete tijekom i do 6 mjeseci nakon liječenja.
English: - 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Precautions to be taken before handling or administering the medicinal product This medicinal product must be diluted prior to administration.
Croatian: Mjere koje treba poduzeti prije rukovanja ili primjene lijeka.
English: Periodic monitoring of renal function should be considered during therapy with busulfan (see section
Croatian: Periodični nadzor funkcije bubrega mora se razmotriti u bolesnika tijekom liječenja busulfanom (vidjeti dio 4.8).
English: For any information about this medicine, please contact the Marketing Authorisation Holder This leaflet was last revised in {MM/YYYY} Other sources of information
Croatian: Za bilo koje informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje lijeka u promet.
English: Increase of uric acid and urea in the blood.
Croatian: Povišenje mokraćne kiseline i ureje u krvi.
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the busulfan studies.
Croatian: U ispitivanjima busulfana jedan je bolesnik doživio smrtonosni slučaj akutnog respiratornog distres sindroma s posljedičnim zatajenjem pluća povezanog s intersticijskom fibrozom pluća.
English: - the calculated volume of Busulfan Fresenius Kabi must be removed from the vial.
Croatian: - izračunati volumen lijeka Busulfan Fresenius Kabi mora se ukloniti iz bočice.
English: Busulfan Fresenius Kabi in combination with fludarabine The recommended dose of busulfan is 3.2 mg/kg Each infusion will last 3 hours
Croatian: - Preporučena doza Busulfan Fresenius Kabi je 3,2 mg/kg - Svaka infuzija trajat će 3 sata.
English: Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent
Croatian: Izračun količine lijeka Busulfan Fresenius Kabi koju je potrebno razrijediti i količine otapala
English: Busulfan is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Croatian: Primjena busulfana prethodi presađivanju hematopoetskih progenitorskih stanica (HPCT).
English: Femoral artery thrombosis Capillary leak
Croatian: Tromboza femoralne arterije
English: 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%.
Croatian: 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.
English: 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.
Croatian: 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.
English: Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning)
Croatian: Poremećaji leće uključujući zamućenost leće oka (katarakta) i zamagljeni vid (stanjivanje rožnice) Simptomi menopauze i ženska neplodnost.
English: How to store Busulfan Fresenius Kabi
Croatian: Kako čuvati Busulfan Fresenius Kabi
English: Haematuria Moderate renal insufficiency
Croatian: Hematurija Umjerena bubrežna insuficijencija
English: 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.
Croatian: Inter- i intravarijabilnost bolesnika u plazmatskoj izloženosti bile su niže od 20%, odnosno 10%.