FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal: increase in the amount of nitrogen components in the blood stream, moderate renal insufficiency, renal disorder.
Slovenian: Ledvica: povečanje količine dušikovih spojin v krvnem obtoku, zmerno zmanjšano delovanje ledvic, ledvična bolezen.
English: Preparation of Busilvex
Slovenian: Priprava zdravila Busilvex
English: One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
Slovenian: En mililiter koncentrata vsebuje 6 mg busulfana (60 mg v eni viali).
English: The increased risk of a second malignancy should be explained to the patient.
Slovenian: Bolnika je treba opozoriti na povečano tveganje ponovne malignosti.
English: Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
Slovenian: Ker pa se busulfan presnavlja s konjugacijo z glutationom, pride v poštev tudi uporaba glutationa.
English: Polycarbonate syringes must not be used with Busilvex.
Slovenian: Pri uporabi zdravila Busilvex ne smete uporabljati polikarbonatnih brizg.
English: Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Slovenian: Živčni sistem: delirij, živčnost, prividi, nemirnost, nenormalno delovanje možganov, možganske krvavitve in epileptični napadi.
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).
Slovenian: Priporočamo, da se pred zdravljenjem posvetujejo o shranjevanju sperme z zamrznitvijo, kajti zaradi zdravljenja obstaja možnost ireverzibilne neplodnosti (glejte poglavje 4.4).
English: Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Slovenian: Srce: povečanje hitrosti srčnega utripa, povišanje ali znižanje krvnega tlaka, vazodilatacija (širjenje krvnih žil) in krvni strdki.
English: Busilvex in combination with fludarabine (FB)
Slovenian: Zdravilo Busilvex v kombinaciji s fludarabinom (FB)
English: Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Slovenian: Zdravilo Busilvex se daje pred transplantacijo hematopoetskih progenitorskih celic (HPCT).
English: The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Slovenian: Pri avtolognih in alogenskih bolnikih je bila mediana trajanja nevtropenije 6 in 9 dni.
English: Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Slovenian: Postopek z zdravilom Busilvex 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.
English: The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/kg.
Slovenian: Po intravenski uporabi busulfana v odmerkih do 1 mg/kg se opazili povečanje izpostavljenosti busulfanu, sorazmerno odmerku.
English: Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning).
Slovenian: Bolezni očesne leče, vključno s sivo mreno (katarakto) in motnjami vida (tanjšanjem roženice).
English: Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
Slovenian: Moškim, ki prejemajo zdravilo Busilvex, svetujemo, naj ne spočnejo otroka med zdravljenjem in še vsaj 6 mesecev po zdravljenju.
English: Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
Slovenian: Pri moških bolnikih so poročali o impotenci, sterilnosti, azoospermiji in testikularni atrofiji.
English: Busulfan depleted oocytes of female rats, and induced sterility in male rats and hamster.
Slovenian: Busulfan je pri samicah podgan uničil oocite; pri samcih podgan in hrčkov je povzročil sterilnost.
English: In adults and children studies, data with Busilvex were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Slovenian: Vsi podatki o zdravilu Busilvex v študijah pri odraslih in otrocih so bili pridobljeni pri sočasni uporabi fenitoina ali benzodiazepinov za profilakso epileptičnih napadov.
English: Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Slovenian: Busulfan je učinkovita citotoksična in bifunkcionalna alkilirajoča učinkovina.
English: The MAH of Busilvex has responded to the question of “Thrombotic microangiopathy” (TMA) after hematopoietic cell transplantation (HCT) requested as supplementary information.
Slovenian: Imetnik dovoljenja za promet z zdravilom Busilvex se je odzval na zahtevo, naj zagotovi dodatne podatke glede „trombotične mikroangiopatije” (TMA) po presaditvi hematopoetskih celic (HCT).
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Slovenian: Podatki o pogostosti akutne reakcije presadka proti gostitelju (acute graft-versus-host disease - a-GVHD) so bili zbrani pri alogenskih bolnikih.
English: Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Slovenian: Zdravljenje z busulfanom pri je pri dekletu pred adolescenco zaradi okvare jajčnikov preprečilo začetek pubertete.
English: No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.
Slovenian: Ko so busulfan kombinirali s 5-HT3-antiemetiki, kot sta ondansetron ali granisetron, niso opazili interakcij.
English: HVOD is a recognized potential complication of conditioning therapy post-transplant.
Slovenian: Znan možni zaplet pripravljalne terapije po transplantaciji je HVOD.
English: However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Slovenian: Vendar je pri bolnikih, ki so prejemali Busilvex, potreben reden nadzor delovanja srca (glejte poglavje 4.8).
English: Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Slovenian: Postopek z zdravilom Busilvex in nato s ciklofosfamidom (BuCy4) ali melfalanom (BuMel) je indiciran za pripravljalno terapijo pred transplantacijo hematopoetskih progenitorskih celic pri pediatričnih bolnikih.
English: A continuous variation of clearance ranging from 2.49 to 3.92 ml/minute/kg has been established in children from < 6 months up to 17 years old.
Slovenian: Pri otrocih, starih od < 6 mesecev do 17 let, so ugotovili stalno nihanje očistka v intervalu od 2,49 do 3,92 ml/minuto/kg.
English: Nutrition: low blood sodium.
Slovenian: Prehrana: nizka koncentracija natrija v krvi.
English: Caution is recommended, particularly in those patients with severe hepatic impairment (see section
Slovenian: Bodite previdni, zlasti pri bolnikih s hudo okvaro jeter (glejte poglavje 4.4).
English: Gastro-intestinal haemorrhage Tooth hypoplasia*
Slovenian: Bolezni prebavil navzea bruhanje diareja stomatitis gastrointestinalna hemoragija zobna hipoplazija*
English: Premature menopause Ovarian failure**
Slovenian: Motnje reprodukcije in dojk predčasna menopavza odpoved jajčnikov**
English: busulfan.
Slovenian: dajanju busulfana.
English: Busulfan was shown to cause sterility in rodents.
Slovenian: Raziskave so pokazale, da busulfan povzroča neplodnost pri glodavcih.
English: Increase of uric acid and urea in the blood.
Slovenian: Povečane vrednosti sečne kisline in sečnine v krvi.
English: Hepatic: enlarged liver, jaundice, blocking of a liver vein.
Slovenian: Jetra: povečana jetra, zlatenica, zaprtje jetrne vene.
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.
Slovenian: Kadar so prisotne zdravstvene indikacije, je treba nuditi trombocitno ali eritrocitno podporo in uporabiti rastne faktorje, kot je granulocitne kolonije stimulirajoči faktor (G-CSF).
English: Read this guide prior to the preparation and administration of Busilvex.
Slovenian: Pred pripravo in uporabo zdravila Busilvex preberite to navodilo.
English: Antiemetics should be administered prior to the first dose of Busilvex and continued on a fixed schedule according to local practice through its administration.
Slovenian: Pred prvim odmerkom zdravila Busilvex morajo bolniki prejeti antiemetike in nadaljevati z njihovo uporabo po vnaprej določeni shemi odmerjanja, skladni z lokalno prakso, ves čas uporabe zdravila Busulfan.
English: General: fever, headache, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Slovenian: Splošno: povišana telesna temperatura, glavobol, oslabelost, mrzlica, bolečine, alergijske reakcije, edem, bolečina ali vnetje na mestu vboda, bolečine v prsih, vnetje sluznice.
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-Stransferase mediated).
Slovenian: Busulfan se presnavlja predvsem s konjugacijo z glutationom (ki je lahko spontana ali pa pri njej sodeluje glutation-S-transferaza).
English: 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.
Slovenian: S pregledom objavljenih podatkov kliničnih preskušanj so preiskali tudi z zdravljenjem povezano smrtnost in smrtnost, ki ni povezana s ponovitvijo bolezni (treatment-related mortality/non-relapse mortality [TRM/NRM]) do 100. dneva po transplantaciji.
English: * reported in post marketing experience ** include haemorrhagic cystitis induced by viral infection
Slovenian: ** vključno s hemoragičnim cistitisom zaradi virusne okužbe
English: Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Slovenian: Med farmakokinetično analizo, izvedeno na 102 bolnikih, so znotraj populacije ugotovili nizko inter- (CV = 21 %) in intravariabilnost (CV = 12 %) bolnikov pri izpostavljenosti busulfanu.
English: No evidence of an induction effect of phenytoin has been seen on Busilvex data.
Slovenian: V podatkih o zdravilu Busilvex ni bilo dokazov za indukcijski učinek fenitoina.
English: Encephalopathy Cerebral haemorrhage
Slovenian: cerebralna hemoragija encefalopatija
English: 8 MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Slovenian: Ženske, ki prejemajo zdravilo Busilvex, ne smejo biti noseče med zdravljenjem in ne smejo zanositi še do 6 mesecev po zdravljenju.
English: Diluted Busilvex is a clear colourless solution.
Slovenian: Razredčeno zdravilo Busilvex je prozorna, brezbarvna raztopina.
English: Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Slovenian: Presnovne in prehranske motnje anoreksija hiperglikemija hipokalciemija hipokaliemija hipomagneziemija hipofosfatemija hiponatriemija
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.
Slovenian: Pri bolnikih, ki so sodelovali v kliničnih preskušanjih z intravensko uporabo busulfana so za preprečevanje epileptičnih napadov uporabili fenitoin ali benzodiazepine (glejte poglavji 4.2 in 4.4) Poročali so, da sočasna sistemska uporaba fenitoina pri bolnikih, ki prejemajo visoke peroralne odmerke busulfana, poveča očistek busulfana zaradi indukcije glutation-S-transferaze, medtem ko pri uporabi benzodiazepinov, kot so diazepam, klonazepam ali lorazepam za preprečevanje epileptičnih napadov pri visokih odmerkih busulfana, niso poročali o nikakršnih interakcijah.
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.
Slovenian: Pri raziskavah zdravila Busilvex je bil izid akutnega sindroma dihalne stiske s posledično respiratorno odpovedjo, povezano z intersticijsko fibrozo pljuč, pri enem bolniku smrten.
English: Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Slovenian: Dihala: težave pri dihanju, izcedek iz nosu (rinitis), vneto grlo, kašelj, kolcanje, krvavenje iz nosu, neobičajni zvoki pri dihanju.
English: Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified.
Slovenian: V raziskavah zdravila Busilvex je bil pri enem bolniku, ki je umrl, zabeležen pojav sindroma akutne dihalne stiske, ki ji je sledila respiratorna odpoved, povezana z intersticijsko fibrozo pljuč, vendar jasne etiologije niso identificirali.
English: Busilvex in combination with fludarabine
Slovenian: Zdravilo Busilvex v kombinaciji s fludarabinom
English: Vascular disorders Hypertension Hypotension
Slovenian: Žilne bolezni hipertenzija
English: Busilvex in combination with fludarabine (FB) In adults
Slovenian: Zdravilo Busilvex v kombinaciji s fludarabinom (FB) Odrasli
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
Slovenian: Čas za doseg 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).
English: On the basis of human data, busulfan has been classified by the IARC as a human carcinogen.
Slovenian: IARC je na osnovi podatkov pri človeku uvrstila busulfan med rakotvorne snovi.
English: D: dose of Busilvex (see SPC section 4.2)
Slovenian: D: odmerek zdravila Busilvex (glejte Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Slovenian: Spodaj so po organskih sistemih in pogostnosti navedeni neželeni učinki, ugotovljeni pri odraslih in otrocih pri več kot enem osamljenem primeru.
English: In children, thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
Slovenian: Trombocitopenija (< 25 x 109/l ali taka, da je bila potrebna transfuzija trombocitov) se je pojavila pri 100 % bolnikov.
English: There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Slovenian: Razen transplantacije hematopoetskih progenitorskih celic ni znanega antidota za Busilvex.
English: Haemorrhagic cystitis**
Slovenian: Bolezni sečil hemoragični cistitis**
English: How to use Busilvex
Slovenian: Kako jemati zdravilo Busilvex
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial
Slovenian: Skupno pakiranje z 8 vialami (2 škatli po 4) volumna 10 ml 60 mg v vsaki viali
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.
English: Busilvex 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%.
Slovenian: Zdravila Busilvex ne smete dati v intravensko vrečko, v kateri ni 0,9 % raztopine natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopina glukoze za injiciranje.
English: Cases of formation of blood clots in the small blood vessels may appear after hematopoietic cell transplantation (HCT) with high-dose of your treatment in combination with other medicines.
Slovenian: Po presaditvi krvotvornih celic (HCT - hematopoietic cell transplantation) in zdravljenju z velikimi odmerki v kombinaciji z drugimi zdravili se lahko oblikujejo krvni strdki v majhnih krvnih žilah.
English: Haematuria Moderate renal Insufficiency
Slovenian: Bolezni sečil disurija oligurija hematurija zmerna ledvična insuficienca
English: PREPARATION GUIDE
Slovenian: NAVODILA ZA PRIPRAVO
English: Similar blood exposure was observed when comparing plasma concentrations in adult patients receiving oral and intravenous busulfan at 1 mg/kg and 0.8 mg/kg respectively.
Slovenian: Med primerjavo plazemskih koncentracij odraslih bolnikov s peroralno in intravensko uporabo busulfana (odmerki 1 mg/kg in 0,8 mg/kg) so opazili podobno prisotnost učinkovine v krvi.
English: A final concentration of approximately 0.5 mg/ml busulfan should be achieved.
Slovenian: Tako bo končna koncentracija busulfana približno 0,5 mg/ml.
English: It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
Slovenian: Po zdravljenju z busulfanom se lahko zgodi, da ne boste mogli več zanositi (da boste neplodni).
English: There is no primary or secondary graft rejection.
Slovenian: Pri vseh bolnikih je presaditev uspela brez primarne ali sekundarne zavrnitve presadka.
English: Skin: rash, itching, loss of hairs.
Slovenian: Koža: izpuščaji, srbenje, izpadanje las.
English: ** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
Slovenian: *** objavljeno po začetku trženja, pri peroralnem jemanju busulfana.
English: Busilvex must be diluted prior to administration.
Slovenian: Zdravilo Busilvex morate pred uporabo razredčiti.
English: • Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Slovenian: • Zdravilo Busilvex mora pripraviti usposobljen zdravstveni delavec ali delavka v sterilnih pogojih.
English: Skin desquamation Erythema Pigmentation disorder
Slovenian: Bolezni kože in podkožja izpuščaj pruritis alopecija deskvamacija kože eritem motnje pigmentacije
English: Femoral artery thrombosis Capillary leak syndrome
Slovenian: Žilne bolezni hipertenzija hipotenzija tromboza vazodilacija femoralna arterijska tromboza sindrom kapilarnega prepuščanja
English: Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Slovenian: Srčne bolezni tahikardija aritmija atrijska fibrilacija kardiomegalija perikardialni izliv perikarditis ventrikularna ekstrasistola bradikardija
English: A few cases of congenital abnormalities have been reported with low-dose oral busulfan, not necessarily attributable to the active substance, and third trimester exposure may be associated with impaired intrauterine growth.
Slovenian: Poročali so o nekaj primerih prirojenih nepravilnosti pri nizkih peroralnih odmerkih busulfana, ki pa niso bili nujno povezani z zdravilno učinkovino.
English: STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml koncentrata vsebuje 6 mg busulfana in po redčenju je koncentracija busulfana 0,5 mg/ml.
English: 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.
Slovenian: Pred in po vsaki infuziji izperite katetrsko cev s približno 5 mililitri 0,9 % raztopine natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopine glukoze za injiciranje.
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Slovenian: Spodaj so po organskih sistemih in pogostnosti navedeni neželeni učinki, ugotovljeni pri več kot enem osamljenem primeru.
English: Various chromosome aberrations have been observed in cells from patients receiving oral busulfan.
Slovenian: V celicah bolnikov, ki so peroralno prejemali busulfan, so opazili različne kromosomske aberacije.
English: What Busilvex is and what it is used for What you need to know before you use Busilvex How to use Busilvex
Slovenian: Kaj vsebuje navodilo Kaj je zdravilo Busilvex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Busilvex Kako uporabljati zdravilo Busilvex Možni neželeni učinki 5 Shranjevanje zdravila Busilvex 6 Vsebina pakiranja in dodatne informacije
English: After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Slovenian: Po redčenju: en mililiter raztopine vsebuje približno 0,5 mg busulfana.
English: 5 How to store Busilvex Contents of the pack and other information
Slovenian: Izgled zdravila Busilvex in vsebina pakiranja
English: Periodic monitoring of renal function should be considered during therapy with Busilvex (see section
Slovenian: Med terapijo z zdravilom Busilvex je potreben občasen nadzor ledvične funkcije (glejte poglavje 4.8).
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI 11.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: koncentrat za raztopino za infundiranje (sterilen koncentrat) bistra, brezbarvna raztopina
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: intravenska uporaba (i.v.)
English: Seizures have been reported with high dose busulfan treatment.
Slovenian: Pri zdravljenju z visokimi odmerki busulfana so poročali o epileptičnih napadih.
English: Must be diluted before use
Slovenian: Pred uporabo obvezno razredčite.
English: There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi's anaemia.
Slovenian: Ni zadostnih kliničnih izkušenj z uporabo busulfana kot komponente pri pripravljalnem zdravljenju pred presajanjem hematopoetskih matičnih celic (HSCT - Haematopoietic Stem Cell Transplantation) pri otrocih s Fanconijevo anemijo, zato je treba Busilvex pri tej skupini bolnikov uporabljati previdno.
English: After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Slovenian: Po redčenju 1 ml raztopine za infuzijo vsebuje 0,5 mg busulfana.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WITHOUT BLUE BOX { box containing 4 vials of 10ml}
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA VMESNI OVOJNINI BREZ »BLUE BOX«
English: Cases of thrombotic microangiopathy after hematopoietic cell transplantation (HCT), including fatal cases, have been reported in high-dose conditioning regimens in which busulfan was administered in combination with another conditioning treatment.
Slovenian: V režimih pripravljalnega zdravljenja z velikimi odmerki, v katerih so bolniki prejemali busulfan v kombinaciji z drugimi pripravljalnimi zdravili, so poročali o primerih trombotične mikroangiopatije po presaditvi hematopoetskih celic (HCT), tudi s smrtnim izidom.
English: 6.5 Nature and contents of container
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo
English: To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Slovenian: Za pripravo končne raztopine za infuzijo dodajte (A) ml zdravila Busilvex v (B) ml redčila (0,9 % raztopine natrijevega klorida (9 mg/ml) za injiciranje ali 5 % raztopine glukoze za injiciranje).