FrancophonIA/ELRC3.0 huggingface dataset:
English: A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and nonmalignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Croatian: U skupini od 205 djece provedena je populacijska farmakokinetička analiza koja je bila raspoređena na odgovarajući način u skladu s tjelesnom težinom (3,5 do 62,5 kg), biološkim svojstvima i svojstvima oboljenja (maligna i nemaligna) te prema tome reprezentativna za visoku heterogenost djece koja su podvrgnuta HPCT-u.
English: The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Croatian: Preostali lijek ne smije se ispirati u cjevima za primjenu jer brza infuzija Busilvexa nije testirana i ne preporučuje se.
English: Infections and infestations:
Croatian: Infekcije i infestacije:
English: Precautions to be taken before handling or administering the medicinal product
Croatian: Mjere koje treba poduzeti prije rukovanja ili primjene lijeka.
English: Late haemorrhagic cystitis occurring 2 weeks post-transplant are likely related to viral infection / reactivation.
Croatian: Hemoragični cistitis u kasnoj fazi koji se pojavljuje 2 tjedna nakon presađivanja vjerojatno je povezan s virusnom infekcijom / reaktivacijom.
English: Paracetamol is described to decrease glutathione levels in blood and tissues, and may therefore decrease busulfan clearance when used in combination (see section 4.4).
Croatian: Za paracetamol je opisano da smanjuje razinu glutationa u krvi i tkivima pa stoga može smanjiti klirens busulfana kada se upotrebljava u kombinaciji (vidjeti dio 4.4).
English: All patients should be pre-medicated with anticonvulsant medicinal products to prevent seizures reported with the use of high dose busulfan.
Croatian: Svi bolesnici moraju primiti premedikaciju antikonvulzivnim lijekovima kako bi se spriječili napadaji koji su prijavljeni uz primjenu visoke doze busulfana.
English: For the 40% of children < 9 kg outside the target, the AUC was evenly distributed either below or above the targeted limits; i.e. 20% each < 900 and > 1500 µmol/L.min following 1 mg/kg.
Croatian: Za 40% djece s težinom < 9 kg izvan cilja, AUC se ravnomjerno rasporedio ili ispod ili iznad ciljnih ograničenja; tj. po 20% < 900 i > 1500 µmol/l.min nakon 1 mg/kg.
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).
Croatian: Bolesnici koji su prethodno primili terapiju zračenjem, u dozi većoj ili jednakoj trima ciklusima kemoterapije, ili su im već prije presađene progenitorske stanice mogu biti pod povećanim rizikom (vidjeti dio 4.8).
English: Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation (see section 4.8).
Croatian: Stoga je potrebno obratiti pozornost na plućne probleme u bolesnika s prethodnom anamnezom zračenja sredoprsja ili pluća (vidjeti dio 4.8).
English: DMA decreases fertility in male and female rodents.
Croatian: DMA smanjuje plodnost u muških i ženskih glodavaca.
English: These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Croatian: Graft-versus host disease), koji su, iako nisu bili izravno povezani, bili glavni uzroci pobolijevanja i smrtnosti, naročito kod alogenog HPCT.
English: Mild/moderate fever was reported in 76% of patients.
Croatian: Blaga/umjerena vrućica prijavljena je u 76% bolesnika.
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with Busilvex due to a possible decrease in the metabolism of busulfan (See section 4.5).
Croatian: Potreban je oprez pri primjeni paracetamola prije (manje od 72 sata) ili istodobno s Busilvexom zbog mogućeg skraćenja metabolizma busulfana (vidjeti dio 4.5).
English: What you need to know before you use Busilvex
Croatian: Što morate znati prije nego počnete primjenjivati Busilvex
English: Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.
Croatian: Zbog svojeg potencijala tumorogenosti koji je busulfan pokazao u ispitivanjima na ljudima i životinjama, tijekom liječenja busulfanom treba prekinuti dojenje.
English: Leukaemia patients treated with busulfan developed many different cytological abnormalities, and some developed carcinomas.
Croatian: Bolesnici oboljeli od leukemije liječeni busulfanom razvili su mnoge različite citološke abnormalnosti, a kod nekih su se razvili karcinomi.
English: The FB combination allowed sufficient myeloablation modulated by the intensity of conditioning regimen through the variation of number of days of busulfan infusion.
Croatian: Kombinacija s FB-om omogućila je dovoljnu mijeloablaciju moduliranu intenzitetom protokola kondicioniranja putem varijacije broja dana infuzije busulfana.
English: Diseases included were acute leukaemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukaemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin's disease or non-Hodgkin's lymphoma, and myelodysplastic syndrome.
Croatian: Obuhvaćene bolesti bile su akutna leukemija nakon prve remisije, u prvom ili naknadnom relapsu, u prvoj remisiji (visoki rizik) ili neuspješnim indukcijama; kronična mijeloična leukemija u kroničnoj ili uznapredovaloj fazi; primarna refraktorna ili rezistento-relapsna Hodginkova bolest ili non-Hodgkingov limfom i mijelodisplastični sindrom.
English: Respiratory: decrease in blood oxygen.
Croatian: Disanje: smanjenje kisika u krvi.
English: From the assessment of these articles, the causality of busulfan in the development of tooth hypoplasia is confirmed.
Croatian: Na temelju ocjene tih članaka, potvrđena je uzročna povezanost busulfana za razvoj hipoplazije zuba.
English: No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.
Croatian: Nisu zabilježene interakcije kada je busulfan kombiniran s antiemeticima 5 HT3 poput ondansetrona ili granisetrona.
English: It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity.
Croatian: Preporučuje se da se prilikom liječenja tih bolesnika redovito prate serumske transaminaze, alkalna fosfataza i bilirubin 28 dana nakon presađivanja kako bi se rano otkrila hepatotoksičnost.
English: The glutathione conjugate is then further metabolised in the liver by oxidation.
Croatian: Konjugat glutationa potom se oksidacijom dalje metabolizira u jetri.
English: IBW women (kg) = 45 + 0.91x (height in cm-152).
Croatian: ITT za žene (kg) = 45 + 0,91 x (visina u cm-152).
English: All patients experienced a profound myelosuppression.
Croatian: Svi su bolesnici doživjeli tešku mijelosupresiju.
English: Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Croatian: Prehrana: gubitak apetita, smanjenje magnezija, kalcija, kalija, fosfata, albumina u krvi i povećanje šećera u krvi.
English: Fever was reported in 87% of patients and graded as mild/moderate in 84% and severe in 3%.
Croatian: Vrućica je prijavljena u 87% bolesnika i ocijenjena blagom/umjerenom u 84% i teškom u 3%.
English: In addition, busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents.
Croatian: Osim toga, busulfan može inducirati plućnu toksičnost koja može povećati učinke ostalih citotoksičnih sredstava.
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent
Croatian: • Količina otapala: (A ml Busilvex) x (10) = B ml otapala
English: As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to Busilvex.
Croatian: Kao što je dokumentirano u kliničkim ispitivanjima, nije bilo liječenih bolesnika koji su doživjeli kardijalnu tamponadu ili ostale specifične kardijalne toksičnosti povezane s Busilvexom.
English: Busilvex should be administered by intravenous infusion via central venous catheter.
Croatian: Busilvex treba primijeniti intravenskom infuzijom putem centralnog venskog katetera.
English: In one article it was studied the role of busulfan in juvenile rats resulting in abnormal root development; a review of two cases of immunodeficiency disorders treated with busulfan and cyclophosphamide in which dental orthodontic treatment was provided; additional 2 case report of hypoplasia of permanent tooth germ is presented; one review assessed the long term effects of cytotoxic therapy concluding that tooth agenesis was more prevalent in patients treated with busulfan and cyclophosphamide; a study of 81 patients concluded that busulfan is as toxic as total body irradiation in causing disturbances in dental development; finally, a study of risk factors of tooth formation anomalies in paediatric cancers concluded that the high risk group of tooth agenesis was the subject with high dose chemotherapy under 4 years old.
Croatian: U jednom članku proučavana je uloga busulfana u mladih štakora koja je kod njih izazvala abnormalan razvoj korijena zubi; pregled dvaju slučajeva poremećaja imunodeficijencije liječenih busulfanom i ciklofosfamidom kod kojih je provedeno ortodontsko liječenje; podnesena su i dodatna izvješća o 2 slučaja koji govore o hipoplaziji zametka trajnog zuba; jednim pregledom ocjenjivali su se dugotrajni učinci terapije citotoksičnim lijekovima gdje je zaključeno da je ageneza zuba prisutnija u bolesnika liječenih busulfanom i ciklofosfamidom; studijom provedenom na 81 bolesniku zaključeno je da je, što se tiče poremećaja dentalnog razvoja, busulfan jednako toksičan kao i zračenje cijelog tijela; i na kraju, studijom faktora rizika od anomalija u formiranju zubi u slučaju raka kod pedijatrijskih bolesnika zaključeno je da visokorizičnu skupinu ageneze zubi predstavlja ispitanik koji je primao visoku dozu kemoterapije u dobi mlađoj od 4 godine.
English: It seems that the recommended intravenous busulfan dose administered either as an individual infusion (3.2 mg/kg) or into 4 divided infusions (0.8 mg/kg) provided equivalent daily plasma exposure with similar both inter-and intrapatient variability.
Croatian: Čini se da je preporučena doza intravenskog busulfana primijenjena ili kao pojedinačna infuzija (3,2 mg/kg) ili kao 4 podijeljene infuzije (0,8 mg/kg) pružila ekvivalentnu dnevnu plazmatsku izloženost sa sličnom varijabilnošću i kod istog i između više bolesnika.
English: - If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Croatian: - Ako Busilvex ili razrijeđeni Busilvex dođe u doticaj s kožom ili sluznicom, odmah ih temeljito operite vodom.
English: The recommended dose of Busilvex in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Croatian: Preporučena doza Busilvexa u kombinaciji s ciklofosfamidom ili melfalanom temelji se na Vašoj tjelesnoj težini i varira između 0,8 i 1,2 mg/kg.
English: The solvent dimethylacetamide (DMA) may also impair fertility.
Croatian: Otapalo dimetilacetamid (DMA) također može smanjiti plodnost.
English: The terminal half life ranged from 2.26 to 2.52 h.
Croatian: Konačni poluvijek bio je u rasponu od 2,26 do 2,52 sati.
English: A single s.c. dose of 2.2 g/kg administered on gestation day 4 terminated pregnancy in 100% of tested hamster.
Croatian: Jedna doza 2,2 g/kg s.c. (supkutano) primijenjena 4. dana gestacije uzrokovala je prekid trudnoće u 100% testiranih hrčaka.
English: 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: Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Croatian: Busulfan je inducirao kromosomske aberacije in vitro (stanica glodavaca i ljudi) i in vivo (glodavci i ljudi).
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.
Croatian: Prijavljeno je nekoliko slučaja prirođenih abnormalnosti uz primjenu niskih peroralnih doza busulfana, što nije nužno povezano s djelatnom tvari, a izloženost u trećem tromjesečju može biti povezana s oštećenjem intrauterinog rasta.
English: No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole.
Croatian: Nisu provedena specifična klinička ispitivanja za procjenu lijek-lijek interakcije između intravenskog busulfana i itrakonazola ili metronidazola
English: A final concentration of approximately 0.5 mg/ml busulfan should be achieved.
Croatian: Mora se postići konačna koncentracija od otprilike 0,5 mg/ml busulfana.
English: In these studies, a total of 1574 patients received FB as a reduced intensity conditioning (RIC) regimen prior to haematopoietic progenitor cell transplantation.
Croatian: U tim ispitivanjima ukupno je 1574 bolesnika primilo FB kao protokol kondicioniranja smanjenog intenziteta prije presađivanja hematopoetskih progenitorskih stanica.
English: Higher doses can produce hepatic necrosis and liver damage can be seen following single high exposures.
Croatian: Veće doze mogu uzrokovati nekrozu jetre, a oštećenje jetre može biti vidljivo nakon jedne izloženosti visokim dozama.
English: It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex.
Croatian: Preporučuje se primjena antikonvulzivnih lijekova 12 sati prije davanja Busilvexa do 24 sata nakon zadnje doze Busilvexa.
English: For a microbiological point of view, the diluted solution should be used immediately.
Croatian: S mikrobiološkog stajališta, razrijeđenu otopinu treba primijeniti odmah.
English: Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Croatian: Busilvex je snažan, citotoksičan lijek koji dovodi do izrazitog smanjenja broja krvnih stanica.
English: The occurrence of TMA is multifactorial and busulfan IV by itself cannot be considered as a main factor in the development of this reaction.
Croatian: Na pojavu TMA utječe više faktora i intravenski (i.v.) busulfan sam po sebi ne može se smatrati glavnim faktorom razvoja ove reakcije.
English: Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Croatian: VOD) prijavljena je u 15% (4/27) autolognih i 7% (2/28) alogenih presađivanja.
English: Gastro-intestinal: bleeding in the stomach and/or the gut.
Croatian: Probavni sustav: krvarenje u želucu i/ili crijevu.
English: The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.
Croatian: Količina otapala mora biti 10 puta veća od volumena Busilvexa što će osigurati konačnu koncentraciju busulfana od približno 0,5 mg/ml.
English: A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics.
Croatian: Faza II kliničkog ispitivanja provedena je radi procjene utjecaja profilaktičke terapije napadaja na farmakokinetiku intravenskog busulfana.
English: Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Croatian: Busilvex sadrži djelatnu tvar busulfan koji pripada skupini lijekova nazvanih alkilirajuće tvari.
English: The incidence of a-GVHD grades I-II was 46.4% (13/28), while the incidence of grade III-IV was 3.6% (1/28).
Croatian: Pojavnost a-GVHD I-II stupnja bila je 46,4% (13/28), dok je incidencija III-IV stupnja bila 3,6% (1/28).
English: The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.
Croatian: Glavni toksični učinak je teška mijeloablacija i pancitopenija, no mogu biti pogođeni i središnji živčani sustav, jetra, pluća i probavni sustav.
English: As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution: - The use of gloves and protective clothing is recommended.
Croatian: U rukovanju otopinom Busilvexa i njenoj pripremi je potreban oprez kao i s drugim citotoksičnim spojevima: - Preporučuje se uporaba rukavica i zaštitne odjeće.
English: Do not use polycarbonate syringes with Busilvex.
Croatian: Ne upotrebljavajte polikarbonatne štrcaljke uz Busilvex.
English: Caution is recommended, particularly in those patients with severe hepatic impairment (see section
Croatian: Preporučuje se oprez, osobito u onih bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.4).
English: Also, there are published case reports of increased plasma levels of busulfan after administration of metronidazole.
Croatian: Objavljene su i prijave slučajeva povišenih razina busulfana u plazmi nakon primjene metronidazola.
English: Since busulfan is mainly metabolized through the liver, caution should be observed when Busilvex is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Croatian: Budući da se busulfan većinom metabolizira putem jetre, potreban je oprez kada se Busilvex primjenjuje kod bolesnika koji već imaju oštećenje funkcije jetre, naročito u onih s teškim oštećenjem funkcije jetre.
English: 47% of patients experienced chills which were mild/moderate in 46% and severe in 1%.
Croatian: 47% bolesnika doživjelo je zimicu koja je bila ocijenjena blagom/umjerenom u 46% i teškom u 1% slučajeva.
English: The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Croatian: Najozbiljnije nuspojave liječenja Busilvexom ili postupka presađivanja mogu uključivati smanjenje cirkulirajućeg broja krvnih stanica (namjerni učinak lijeka radi pripreme za transplantacijsku infuziju), infekciju, poremećaje jetre uključujući začepljenje jetrene vene, reakciju presatka protiv domaćina (presadak napada Vaše tijelo) i plućne komplikacije.
English: Patients who are concurrently treated with busulfan and itraconazole or metronidazole should be closely monitored for signs of busulfan toxicity.
Croatian: Bolesnike kojima se istovremeno daje busulfan i itrakonazol ili metronidazol treba pobliže pratiti zbog moguće pojave znakova toksičnosti busulfanom.
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 4.5).
English: The recommended dose of Busilvex is as follows: Actual body weight (kg)
Croatian: Preporučena doza lijeka Busilvex je sljedeća: Stvarna tjelesna težina (kg)
English: The incidence of a-GVHD grades I-II was 13% (8/61), while the incidence of grade III-IV was 5% (3/61).
Croatian: Pojavnost I-II stupnja a-GVHD-a bila je 13% (8/61), dok je incidencija III-IV stupnja bila 5% (3/61).
English: - 8 hours (including infusion time) after dilution when stored at 20 °C  5 °C
Croatian: - 8 sati (uključujući vrijeme infuzije) nakon razrjeđivanja ako se čuva na temperaturi od 20 °C 
English: There have been two reports that busulfan is dialyzable, thus dialysis should be considered in the case of an overdose.
Croatian: U dva je izvješća navedeno da je busulfan dijalizibilan pa u slučaju predoziranja treba razmotriti dijalizu.
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.
Croatian: Postoji ograničeno kliničko iskustvo u primjeni busulfana kao komponente protokola kondicioniranja prije HSCT-a u djece s Fanconijevom anemijom.
English: For storage conditions after dilution of the medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka, vidjeti dio 6.3.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WITHOUT BLUE BOX { box containing 4 vials of 10ml}
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BEZ PLAVOG OKVIRA {kutija koja sadrži 4 bočice od 10 ml}
English: The World Health Organisation has concluded that there is a causal relationship between busulfan exposure and cancer.
Croatian: Svjetska zdravstvena organizacija (WHO) zaključila je da postoji uzročno-posljedična veza između izloženosti busulfanu i raka.
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 preporučuje da tijekom liječenja i do 6 mjeseci nakon liječenja ne začinju dijete i da zatraže savjet o kriokonzervaciji sperme prije liječenja zbog mogućnosti ireverzibilne neplodnosti (vidjeti dio 4.4).
English: The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/kg.
Croatian: Dokazano je povećanje izloženosti busulfanu proporcionalno dozi nakon intravenskog busulfana do 1 mg/kg.
English: Multipack containing 8 (2 packs of 4) vials.
Croatian: Višestruko pakiranje sadrži 8 (2 pakiranja od 4) bočice.
English: The pharmacokinetics of Busilvex has been investigated.
Croatian: Farmakokinetika Busilvexa je ispitivana.
English: Pharmacokinetic/pharmacodynamic relationships:
Croatian: Farmakokinetički/farmakodinamički odnosi:
English: It is unknown whether busulfan and DMA are excreted in human milk.
Croatian: Nije poznato izlučuje li se busulfan i DMA u majčino mlijeko u ljudi.
English: Documentation on the safety and efficacy of Busilvex in combination with fludarabine (FB) prior to allogeneic HPCT derives from the literature review of 7 published studies involving 731 patients with myeloid and lymphoid malignancies reporting the use of intravenous busulfan infused once daily instead of four doses per day.
Croatian: Dokumentacija o sigurnosti i djelotvornosti Busilvexa u kombinaciji s fludarabinom (FB) prije alogenog HPCT-a potječe iz pregleda literature 7 objavljenih ispitivanja koja uključuju 731 bolesnika s mijeloidnim ili limfoidnim malignim bolestima koja bilježe primjenu intravenskog busulfana infundiranog jednom dnevno umjesto četiri doza dnevno.
English: Busilvex must not be infused concomitantly with another intravenous solution.
Croatian: Busilvex se ne smije infundirati istodobno s drugom intravenskom otopinom.
English: In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin.
Croatian: U tom su ispitivanju 24 odrasla bolesnika primila antikonvulzivnu terapiju klonazepamom (0,025-0,03 mg/kg/dan u obliku kontinuirane intravenske (i.v.) infuzije) i farmakokinetički podaci tih bolesnika uspoređeni su s povijesnim podacima prikupljenim od bolesnika liječenih fenitoinom.