FrancophonIA/ELRC3.0 huggingface dataset:
English: It must be considered that overdose of busulfan will also increase exposure to DMA.
Croatian: Potrebno je uzeti u obzir da će predoziranje busulfanom ujedno povećati izloženost DMA.
English: You should tell your doctor: - if you have a liver, kidney, heart or lung problem, - if you have a history of seizures, - if you are currently taking other medicines.
Croatian: Obavijestite liječnika: - ako imate jetrene, bubrežne, srčane ili plućne tegobe, - ako ste u prošlosti doživjeli napadaje, - ako trenutno uzimate druge lijekove.
English: In both studies, all patients received a 16/16 dose regimen of busulfan.
Croatian: U oba su ispitivanja svi bolesnici primili protokol sa 16/16 doza busulfana.
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.
Croatian: Smrtnost povezana s liječenjem/smrtnost (TRM/NRM) koja nije povezana s relapsom prijavljena do dana + 100 nakon presađivanja također je ispitana putem pregleda objavljenih podataka iz kliničkih ispitivanja.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before you receive treatment with Busulfan Fresenius Kabi.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite terapiju lijekom Busulfan Fresenius Kabi.
English: In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Croatian: Glavni toksični učinci kod ljudi bili su hepatotoksičnost i učinci na središnji živčani sustav (CNS).
English: This medicine contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Croatian: Ovaj lijek sadrži djelatnu tvar busulfan koja pripada skupini lijekova nazvanih alkilirajuće tvari.
English: Dose and administration The dose of busulfan will be calculated according to your body weight.
Croatian: Doziranje i primjena: Doza lijeka Busulfan izračunat će se u skladu s Vašom tjelesnom težinom.
English: Antiemetics should be administered prior to the first dose of busulfan and continued on a fixed schedule according to local practice through its administration.
Croatian: Antiemetike treba primijeniti prije prve doze busulfana i nastaviti s njihovom primjenom prema dogovorenom rasporedu u skladu s lokalnom praksom.
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, alkyl sulfonates, ATC code: L01AB01.
Croatian: Farmakoterapijska skupina: antineoplastici, alkilirajući pripravci, alkilsulfonati ATK oznaka: L01AB01.
English: Polycarbonate syringes must not be used with busulfan.
Croatian: Polikarbonatne štrcaljke ne smiju biti korištene s busulfanom.
English: However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Croatian: Međutim, u publikacijama je zabilježeno da je više od 500 bolesnika u dobi od ≥ 55 godina s protokolima kondicioniranja FB-om imalo ishod djelotvornosti sličan mlađim bolesnicima.
English: Busulfan Fresenius Kabi can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Croatian: Busulfan Fresenius Kabi može također uzrokovati simptome menopauze i u preadolescentnih djevojaka može spriječiti početak puberteta.
English: Busulfan should not be given by rapid intravenous, bolus or peripheral injection.
Croatian: Busulfan se ne smije primjenjivati brzom intravenskom, bolusnom ili perifernom injekcijom.
English: The information presented on biotransformation and elimination is based on oral busulfan.
Croatian: Informacije o biotranformaciji i eliminaciji temelje se na peroralnom busulfanu.
English: Studies in animals have shown reproductive toxicity (embryo-foetal lethality and malformations) (see section 5.3)
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (embriofetalnu smrtnost i malformacije) (vidjeti dio 5.3).
English: Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema/europa.eu
English: Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Croatian: Vensko-okluzivna bolest (VOD) prijavljena je u 15% (4/27) autolognih i 7% (2/28) alogenih presađivanja.
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with busulfan 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 busulfanom zbog mogućeg skraćenja metabolizma busulfana (vidjeti dio 4.5).
English: A total of 11 patients (18%) experienced a-GVHD.
Croatian: Ukupno je 11 bolesnika (18%) doživjelo a-GVHD.
English: Hepato-biliary disorders VOD was reported with a range between 3.9% and 15.4%.
Croatian: Poremećaji jetre i žuči VOD je prijavljen u rasponu između 3,9% i 15,4%.
English: *veno occlusive liver disease is more frequent in paediatric population.
Croatian: * vensko-okluzivna bolest jetre češća je u pedijatrijskoj populaciji.
English: The use of paracetamol during the 72 hours prior to or with Busulfan Fresenius Kabi administration should be used with caution.
Croatian: Upotreba paracetamola tijekom 72 sata prije ili zajedno s primjenom lijeka Busulfan Fresenius Kabi mora se primijeniti s oprezom.
English: As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to busulfan.
Croatian: Kao što je dokumentirano u kliničkim ispitivanjima, nije bilo liječenih bolesnika koji su doživjeli kardijalnu tamponadu ili ostale specifične kardijalne toksičnosti povezane s busulfanom.
English: Overall mortality and non-relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Croatian: Ukupna smrtnost i smrtnost bez relapsa na više od 100 dana nakon presađivanja bila je (8/61) 13%, odnosno (6/61) 10% u alotransplantiranih bolesnika.
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 non-malignant) 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: 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: Investigations: elevated liver enzymes and weight increased.
Croatian: Pretrage: povišeni jetreni enzimi, povećanje težine.
English: The most frequent infectious adverse reactions were Cytomegalovirus (CMV) reactivation [range: 30.7% - 80.0%], Epstein-Barr Virus (EBV) reactivation [range: 2.3% - 61%], bacterial infections [range: 32.0% - 38.9%] and viral infections [range: 1.3% - 17.2%].
Croatian: Najčešće infekcijske nuspojave bile su reaktivacija citomegalovirusa (CMV) [raspon: 30,7% - 80,0%], reaktivacija Epstein-Barrovog virusa (EBV) [raspon: 2,3% - 61%], bakterijske infekcije [raspon: 32,0%38,9%] i virusne infekcije [raspon: 1,3% - 17,2%].
English: Busulfan should be administered by intravenous infusion via central venous catheter.
Croatian: Busulfan treba primijeniti intravenskom infuzijom putem centralnog venskog katetera.
English: RECOMMENDATION FOR SAFE HANDLING Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Croatian: Treba razmotriti postupke za pravilno rukovanje i zbrinjavanje lijekova protiv raka.
English: It is recommended to administer anticonvulsants 12 h prior to busulfan to 24 h after the last dose of busulfan.
Croatian: Preporučuje se primjena antikonvulzivnih lijekova 12 sati prije davanja busulfana do 24 sata nakon zadnje doze busulfana.
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: Women must not be pregnant during treatment with Busulfan Fresenius Kabi and up to 6 months after treatment.
Croatian: Žene ne smiju ostati trudne tijekom liječenja lijekom Busulfan Fresenius Kabi i do 6 mjeseci nakon liječenja.
English: Each vial is sleeved with shrinkable plastic film.
Croatian: Svaka bočica je omotana toploskupljajućom plastičnom folijom.
English: - If the concentrate or diluted busulfan solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Croatian: - Ako koncentrat ili razrijeđeni busulfan dođe u doticaj s kožom ili sluznicom, odmah ih temeljito operite vodom.
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: Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Croatian: U objavljenim ispitivanjima na odraslima opisano je da ketobemidon (analgetik) može biti povezan s visokim razinama busulfana u plazmi.
English: Like all medicines, Busulfan Fresenius Kabi can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Busulfan Fresenius Kabi može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Adverse reactions information is derived from two clinical trials (n=103) of busulfan.
Croatian: Informacije o nuspojavama dobivene su iz dva klinička ispitivanja (n=103) busulfana.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above-mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene su odgovornost korisnika i ne bi trebali biti dulji od gore navedenih uvjeta, kada je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: In new-born infants, children and adolescents, this medicine is used in combination with cyclophosphamide or melphalan.
Croatian: Kod novorođenčadi, djece i adolescenata ovaj lijek se primjenjuje u kombinaciji s ciklofosfamidom ili melfalanom.
English: Gastrointestinal disorders The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Croatian: Poremećaji probavnog sustava Najveća učestalost mučnine i povraćanja iznosila je 59,1%, a najveća učestalost stomatitisa iznosila je
English: Since busulfan is mainly metabolized through the liver, caution should be observed when busulfan 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 busulfan primjenjuje u bolesnika koji već imaju oštećenje funkcije jetre, naročito u onih s teškim oštećenjem funkcije jetre.
English: The consequence of treatment with busulfan at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Croatian: Posljedica liječenja busulfanom u preporučenoj dozi i rasporedu je teška mijelosupresija koja se javlja u svih bolesnika.
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-S-transferase mediated).
Croatian: Busulfan se većinom metabolizira konjugacijom s glutationom (spontano i sudjelovanjem glutation-S-transferaze).
English: Before receiving Busulfan Fresenius Kabi, you will be medicated with - anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and - antiemetic medicines to prevent vomiting.
Croatian: Prije primanja lijeka Busulfan Fresenius Kabi, dobit ćete lijekove - antikonvulzivne lijekove za sprječavanje napadaja (fenitoin ili benzodiazepine) i - antiemetike za sprječavanje povraćanja.
English: Adequate contraceptive precautions should be used when either partner is receiving Busulfan Fresenius Kabi.
Croatian: Moraju se primijeniti odgovarajuće mjere kontracepcije kada bilo koji od partnera prima Busulfan Fresenius Kabi.
English: It is possible that use of Busulfan Fresenius Kabi may increase the risk of suffering another malignancy in the future.
Croatian: Moguće je da upotreba lijeka Busulfan Fresenius Kabi može povećati opasnost od obolijevanja od druge maligne bolesti u budućnosti.
English: However cardiac function should be monitored regularly in patients receiving busulfan (see section 4.8).
Croatian: No kardijalna se funkcija mora redovito nadzirati u bolesnika koji primaju busulfan (vidjeti dio 4.8).
English: Busulfan dose (mg/kg)
Croatian: Doza busulfana (mg /kg)
English: From a microbiological point of view, the product should be used immediately after dilution.
Croatian: S mikrobiološkog stajališta, lijek treba primijeniti odmah nakon razrijeđivanja.
English: - the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
Croatian: - sadržaj štrcaljke mora se ubrizgati u intravensku vrećicu (ili štrcaljku) koja već sadrži izračunatu količinu odabranog otapala.
English: The residual medicinal product must not be flushed in the administration tubing as rapid infusion of busulfan has not been tested and is not recommended.
Croatian: Preostali lijek ne smije se ispirati u cijevima za primjenu jer brza infuzija busulfana nije testirana i ne preporučuje se.
English: the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
Croatian: sadržaj štrcaljke mora se ubrizgati u intravensku vrećicu (ili štrcaljku) koja već sadrži izračunatu količinu odabranog otapala.
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 intravenoznog busulfana do 1 mg/kg.
English: D: dose of busulfan (see SPC section 4.2)
Croatian: D: doza busulfana (vidjeti dio 4.2)
English: The most serious side effects of busulfan 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 terapije lijekom Busulfan Fresenius Kabi 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 na domaćina (presadak napada Vaše tijelo) i plućne komplikacije.
English: * reported in post-marketing experience ** include haemorrhagic cystitis induced by viral infection
Croatian: * prijavljeno nakon stavljanja lijeka u promet ** uključuje hemoragični cistitis induciran virusnom infekcijom
English: Nervous system: confusion, nervous system disorders.
Croatian: Živčani sustav: smetenost, poremećaji živčang sustava.
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 Desease), koji su, iako nisu bili izravno povezani, bili glavni uzroci pobolijevanja i smrtnosti, naročito kod alogeničnog HPCT.
English: The pharmacokinetics of busulfan has been investigated.
Croatian: Ispitivana je farmakokinetika busulfana.
English: Documentation on the safety and efficacy of busulfan 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: Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Croatian: Anoreksija Hiperglikemija Hipokalcijemija Hipokalijemija Hipomagnezijemija Hipofosfatemija
English: During clinical trials with intravenous busulfan administered as 0.80 mg/kg four-times daily, 90% of patients AUCs were below the upper AUC limit (1500 µmol/L.minute) and at least 80% were within the targeted therapeutic window (900 - 1500 µmol/L.minute).
Croatian: Tijekom kliničkih ispitivanja s intravenskim busulfanom primijenjenim u dozi od 0,80 mg/kg četiri puta dnevno, 90% vrijednosti AUC svih bolesnika bilo je ispod gornje granice AUC (1500 μmol/l.minuta) i najmanje 80% bilo je unutar ciljanog terapijskog okvira (900-1500 μmol/l.minuta).
English: In adults Busulfan Fresenius Kabi is used in combination with cyclophosphamide or fludarabine.
Croatian: U odraslih se Busulfan Fresenius Kabi primjenjuje u kombinaciji s ciklofosfamidom ili fludarabinom.
English: The recommended dose of Busulfan Fresenius Kabi in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Croatian: Preporučena doza lijeka Busulfan Fresenius Kabi u kombinaciji s ciklofosfamidom ili melfalanom temelji se na Vašoj tjelesnoj težini i varira između 0,8 i 1,2 mg/kg.
English: Busulfan must not be infused concomitantly with another intravenous solution.
Croatian: Busulfan se ne smije infundirati istodobno s drugom intravenskom otopinom.
English: At 2 years, the cumulative incidence of NRM was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI, 31.1-55.7%).
Croatian: Nakon 2 godine, ukupna incidencija smrtnosti koja nije povezana s relapsom iznosila je 11,3% (95%tni CI, 5,5 - 19,3%), a ona od relapsa ili progresije od alogenog HCT-a iznosila 43,8% (95%-tni CI, 31,1 - 55,7%).
English: Data from a recently completed prospective multicentre phase 2 study including 80 patients, aged 18 to 65 years old, diagnosed with different hematologic malignancies who underwent allo-HCT with an FB (3 days of busulfan) reduced intensity conditioning regimen became available.
Croatian: Postali su dostupni podaci iz nedavno završenog, prospektivnog, multicentričnog ispitivanja faze 2 koje je uključivalo 80 bolesnika, u dobi od 18 do 65 godina, s dijagnozom različitih hematoloških malignih bolesti, koji su se podvrgnuli alogenom HCT-u s protokolom kondicioniranja smanjenog intenziteta s FB-om (3 dana busulfana).
English: No evidence of an induction effect of phenytoin has been seen on busulfan data.
Croatian: Nisu zabilježeni dokazi indukcijskog učinka fenitoina iz podataka o busulfanu.
English: Busulfan in combination with fludarabine (FB)
Croatian: Busulfan u kombinaciji s fludarabinom (FB)
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/14/951/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/951/001
English: No patients were discontinued from treatment due to adverse reactions related to busulfan.
Croatian: Niti jedan bolesnik nije prekinuo liječenje zbog nuspojava povezanih s busulfanom.
English: The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2-hour intravenous infusion for a total of 16 doses over four days.
Croatian: Farmakokinetika intravenskog busulfana ispitivana je na 124 bolesnika koje je bilo moguće ocijeniti nakon dvosatne intravenske infuzije ukupno 16 doza tijekom četiri dana.
English: The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Croatian: Medijan trajanja neutropenije bio je 6 dana i 9 dana za autologne i alogene bolesnike.
English: In the absence of haematopoietic progenitor cell transplantation, the recommended dose of busulfan would constitute an overdose of busulfan.
Croatian: U odsutnosti presađivanja hematopoetskih progenitorskih stanica preporučena doza busulfana uzrokovala bi predoziranje busulfanom.
English: Using a non polycarbonate syringe fitted with a needle:
Croatian: Upotrebom nepolikarbonatnih štrcaljki opremljenih iglom:
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent).
Croatian: Nisu zabilježene interakcije kada je busulfan kombiniran s flukonazolom (sredstvom protiv gljivica).
English: The literature on busulfan suggests a therapeutic AUC window between 900 and 1500 µmol/L.minute per administration (equivalent to a daily exposure between 3600 and 6000 µmol/L.minute).
Croatian: U literaturi o busulfanu preporučen je terapijski AUC okvir između 900 i 1500 μmol/l.minutu po primjeni (ekvivalentno dnevnoj izloženosti između 3600 i 6000 µmol/l.minutu.
English: Special caution should be exercised when administering the recommended dose of busulfan to patients with a history of seizures.
Croatian: Posebna pozornost potrebna je kada se preporučena doza busulfana daje bolesnicima s anamnezom napadaja.
English: For storage conditions after dilution of the medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka, vidjeti u dijelu 6.3.
English: Therefore, men treated with busulfan are advised not to father a child during 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 due to therapy with busulfan.
Croatian: Stoga se muškarcima liječenim busulfanom preporuča 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 uslijed liječenja busulfanom.
English: Busulfan is for intravenous use.
Croatian: Busulfan je za intravensku primjenu.
English: 10 ml of concentrate for solution for infusion in clear colourless glass vials (type I) with teflon faced rubber stopper and sealed with aluminium flip-off seal.
Croatian: 10 ml koncentrata za otopinu za infuziju u prozirnim staklenim bočicama (tip I) s gumenim zatvaračem presvučenim teflonom i aluminijskim "flip-off" zaštitnim zatvaračem.
English: Busulfan Fresenius Kabi is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
Croatian: Busulfan Fresenius Kabi se isporučuje u bezbojnim staklenim bočicama, svaka bočica sadrži 60 mg busulfana.
English: Busulfan Fresenius Kabi may interact with other medicines.
Croatian: Busulfan Fresenius Kabi može međusobno djelovati s drugim lijekovima.
English: Ventricular Extrasystoles Bradycardia
Croatian: Ventrikularne ekstrasistole Bradikardija