FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Busilvex: if you are allergic to busulfan or any of the other ingredients of Busilvex listed in section 6, if you are pregnant, or think you may be pregnant.
Croatian: Nemojte primjenjivati Busilvex: - ako ste alergični na busulfan ili neki drugi sastojak Busilvexa naveden u dijelu 6, - ako ste trudni ili mislite da ste možda trudni.
English: DMA is teratogenic in rats.
Croatian: DMA je teratogen u štakora.
English: Elimination in faeces is negligible.
Croatian: Eliminacija u fecesu zanemariva je.
English: 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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama, objavljenima na europskom internetskom portalu za lijekove.
English: Other infections were considered severe in 3% of patients.
Croatian: Ostale infekcije smatrale su se teškima u 3% bolesnika.
English: Pharmacotherapeutic group: Alkyl sulfonates, ATC code: L01AB01.
Croatian: Farmakoterapijska skupina: alkilsulfonati, ATK oznaka: L01AB01.
English: Therefore, this interaction should be included in the product information for both pharmaceutical forms.
Croatian: Stoga je ovu interakciju potrebno dodati u informacije o lijeku za oba farmaceutska oblika.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Croatian: Ako ste zabrinuti hoćete li moći imati djecu, razgovarajte sa svojim liječnikom prije liječenja.
English: In adults:
Croatian: U odraslih:
English: Read this guide prior to the preparation and administration of Busilvex.
Croatian: Pročitajte ovaj vodič prije pripreme i primjene Busilvexa.
English: 15% of SAEs involved liver toxicity.
Croatian: 15% teških nuspojava uključivalo je toksičnost jetre.
English: The signal concerning interaction with deferasirox is refuted and it can be closed.
Croatian: Signal koji se odnosi na interakciju s deferasiroksom odbačen je kao netočan i može se zatvoriti.
English: Therefore all patients experienced profound cytopenia: leucopenia 96%, thrombocytopenia 94%, and anemia 88%.
Croatian: Stoga su svi bolesnici doživjeli značajnu citopeniju: leukopeniju 96%, trombocitopeniju 94% i anemiju 88%.
English: The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Croatian: Parametri primarne djelotvornosti u tim ispitivanjima bili su mijeloablacija, primanje presatka, relaps i preživljavanje.
English: • Using a non polycarbonate syringe fitted with a needle:
Croatian: • Upotreba ne-polikarbonatnih štrcaljki opremljenih iglom:
English: For any information about this medicine, please contact the Marketing Authorisation Holder
Croatian: Za bilo koje informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje lijeka u promet.
English: Viral infection CMV reactivation EBV reactivation Bacterial infection
Croatian: Virusna infekcija Reaktivacija virusa CMV Reaktivacija virusa EBV Bakterijska infekcija
English: HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy.
Croatian: HPCT je kontraindiciran u trudnica, stoga je Busilvex kontraindiciran tijekom trudnoće.
English: It was considered as deaths that could be attributable to secondary side effects after HPCT and not related to the relapse/progression of the underlying haematological malignancies.
Croatian: Smatralo ih se smrtima koje se mogu pripisati sekundarnim nuspojavama nakon HPCT-a, a ne povezanim s relapsom/progresijom postojećih hematoloških malignih bolesti.
English: The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/(m²) > 30 kg/m² until further data become available.
Croatian: Primjena lijeka ne preporučuje se u pretile djece i adolescenata s indeksom tjelesne mase težina (kg)/ (m²) > 30 kg/m² sve dok ne budu dostupni dodatni podaci.
English: Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
Croatian: Kronični GVHD prijavljen je samo ako je bio uzrok smrti: jedan bolesnik preminuo je 13 mjeseci nakon presađivanja.
English: DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
Croatian: DMA smanjuje plodnost u muških i ženskih glodavaca (vidjeti dijelove 4.6 i 5.3).
English: What Busilvex is and what it is used for
Croatian: Što je Busilvex i za što se koristi
English: However, for the safe use of Busilvex in patients older than 60 years only limited information is available.
Croatian: No, o sigurnoj primjeni Busilvexa u bolesnika starijih od 60 godina dostupni su samo ograničeni podaci.
English: Particular caution should be taken if you use itraconazole and metronidazole (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Croatian: Osobito je potreban oprez ako upotrebljavate itrakonazol i metronidazol (upotrebljava se za određene tipove infekcija) ili ketobemidon (upotrebljava se za liječenje boli) jer to može povećati nuspojave.
English: The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Croatian: Najveća učestalost mučnine i povraćanja iznosila je 59,1%, a najveća učestalost stomatitisa iznosila je
English: Acute GVHD was rated as serious in 3 patients.
Croatian: Akutni GVHD ocijenjen je ozbiljnim u 3 bolesnika.
English: There was no regimen-related death through the first 100-day post-transplant and up to one year post-transplant.
Croatian: Nije bilo smrti povezanih s protokolom tijekom prvih 100 dana nakon presađivanja i do godinu dana nakon presađivanja.
English: Busulfan is a teratogen in rats, mice and rabbits.
Croatian: Busulfan je teratogen u štakora, miševa i zečeva.
English: Investigations: elevated liver enzymes and weight increased.
Croatian: Pretrage: povišeni jetreni enzimi i povećanje težine.
English: The use of paracetamol during the 72 hours prior to or with Busilvex administration should be used with caution.
Croatian: Upotreba paracetamola tijekom 72 sata prije ili zajedno s primjenom Busilvexa mora se primijeniti s oprezom.
English: HVOD occurred in: 8.2% (5/61) allogeneic patients (fatal in 2 patients) and 2.5% (1/42) of autologous patients.
Croatian: HVOD se pojavio u: 8,2% (5/61) alogenih bolesnika (smrtonosno kod 2 bolesnika) i 2,5% (1/42) autolognih bolesnika.
English: Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Croatian: Otprilike 30% primijenjene doze izlučuje se u urin tijekom 48 sati, pri čemu je 1% nepromijenjenog busulfana.
English: Adequate contraceptive precautions should be used when either partner is receiving Busilvex.
Croatian: Moraju se primijeniti odgovarajuće mjere kontracepcije kada bilo koji od partnera prima Busilvex.
English: A total of 14 patients (50%) experienced a-GVHD.
Croatian: Ukupno je 14 bolesnika (50%) doživjelo a-GVHD.
English: The terminal half-life ranged from 2.8 to 3.9 hours.
Croatian: Konačni poluvijek bio je u rasponu od 2,8 do 3,9 sati.
English: A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Croatian: Većina publikacija zabilježila je potpuni donorski kimerizam na dan + 30 za 90 - 100% bolesnika.
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Croatian: Hematološki status mora se pomno pratiti i moraju se primijeniti snažne potporne mjere u skladu s medicinskom indikacijom.
English: Doses of 400 mg/kg/day DMA administered during organogenesis caused significant developmental anomalies.
Croatian: Doze DMA 400 mg/kg/dan primijenjene tijekom organogeneze uzrokovale su značajne razvojne anomalije.
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 Busilvex.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku prije nego primite liječenje Busilvexom.
English: Other medicines and Busilvex
Croatian: Drugi lijekovi i Busilvex
English: Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
Croatian: Koncentracije busulfana u cerebrospinalnoj tekućini usporedive su s onima u plazmi, iako su te koncentracije vjerojatno nedovoljne za antineoplastično djelovanje.
English: Grade 3 elevated transaminases were reported in 24% of patients.
Croatian: Povišene transaminaze 3. stupnja prijavljene su u 24% bolesnika.
English: Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Croatian: Busilvex se primjenjuje u odraslih, novorođenčadi, djece i adolescenata kao liječenje prije presađivanja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mg/10 ml
English: Busulfan is thought to be leukemogenic.
Croatian: Busulfan se smatra leukemogenim.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom i do 6 mjeseci nakon liječenja.
English: Two of the above four patients with serious serum hepatotoxicity were among patients with diagnosed HVOD.
Croatian: Dva od gore navedena četiri bolesnika s teškom serumskom hepatotoksičnošću bili su među bolesnicima s dijagnosticiranim HVOD-om.
English: No pharmacokinetic explanation justifies this interaction.
Croatian: Ova interakcija ne može se opravdati nikakvim farmakokinetičkim objašnjenjem.
English: Busilvex is available in multipacks comprising 2 packs, each containing 4 vials.
Croatian: Busilvex je dostupan u višestrukim pakiranjima koja sadrže 2 pakiranja, svako s 4 bočice.
English: Pharmacokinetics in adults
Croatian: Farmakokinetika u odraslih
English: It must be considered that overdose of Busilvex will also increase exposure to DMA.
Croatian: Potrebno je uzeti u obzir da će predoziranje Busilvexom ujedno povećati izloženost DMA.
English: Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Croatian: Busilvex može također uzrokovati simptome menopauze i u preadolescentnih djevojaka može spriječiti početak puberteta.
English: 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%.
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.
Croatian: Stalna varijacija klirensa u rasponu od 2,49 do 3,92 ml/minuta/kg utvrđena je u djece u dobi od < 6 mjeseci do 17 godina.
English: Busulfan belongs to a class of substances which are potentially carcinogenic based on their mechanism of action.
Croatian: Busulfan pripada klasi tvari koje su potencijalno karcinogene na temelju svojih mehanizama djelovanja.
English: Do not freeze the diluted solution.
Croatian: Ne zamrzavati razrijeđenu otopinu.
English: Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Croatian: Ukupna doza busulfana po bolesniku iznosila je između 6,4 mg/kg i 9,6 mg/kg.
English: In children < 9 kg, a therapeutic drug monitoring may be justified on a case by case basis, in particular in extremely young children and neonates (see section 5.2).
Croatian: U djece < 9 kg praćenje terapijskog lijeka može biti opravdano ovisno o slučaju, naročito kada se radi o izrazito mladoj djeci i novorođenčadi (vidjeti dio 5.2).
English: As a result, the control of intravenous busulfan AUC within the therapeutic windows is not modified and a similar targeting performance between the two schedules was illustrated.
Croatian: Posljedicom toga, kontrola AUC-a intravenskog busulfana unutar terapijskih okvira nije promijenjena i prikazano je slično ciljano djelovanje između dva rasporeda.
English: The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Croatian: Kumulativna incidencija oporavka neutrofila u 28. danu iznosila je 98,8% (95%-tni CI, 85,7 - 99,9%).
English: Busilvex may interact with other medicines.
Croatian: Busilvex može međusobno djelovati s drugim lijekovima.
English: In both studies, all patients received a 16/16 dose regimen of Busilvex.
Croatian: U oba su ispitivanja svi bolesnici primili protokol sa 16/16 doza Busilvexa.
English: Dose and administration: The dose of Busilvex will be calculated according to your body weight.
Croatian: Doza i primjena: Doza lijeka Busilvex izračunat će se u skladu s Vašom tjelesnom težinom.
English: The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Croatian: Uspješno presađivanje ostvareno je kod svih bolesnika tijekom faze II ispitivanja, što upućuje da su ciljani AUC bili odgovarajući.
English: Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
Croatian: Hemoragični cistitis uključujući hemoragični cistitis induciran virusnom infekcijom prijavljen je u rasponu između 16% i 18,1%.
English: Repeated doses of DMA produced signs of liver toxicity, the first being increases in serum clinical enzymes followed by histopatological changes in the hepatocytes.
Croatian: Ponovljene doze DMA uzrokovale su znakove toksičnosti jetre, koje su se prvo pokazale kao povećanje kliničkih enzima u serumu nakon čega su uslijedile histopatološke promjene hepatocita.
English: A cumulative review of the literature and safety database has been performed.
Croatian: Sastavljeno je kumulativno izvješće na temelju literature i sigurnosne baze podataka.
English: CNS changes precede any of the more severe side effects.
Croatian: Promjene SŽS-a prethode svakoj od težih nuspojava.
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 (SŽS).
English: Busulfan and DMA can impair fertility in man or woman.
Croatian: Busulfan i DMA mogu narušiti plodnost u muškaraca ili žena.
English: Therefore Busilvex should be used with caution in this type of patients.
Croatian: Stoga Busilvex treba upotrebljavati s oprezom kod ovih bolesnika.
English: The information presented on biotransformation and elimination is based on oral busulfan.
Croatian: Informacije o biotransformaciji i eliminaciji temelje se na peroralnom busulfanu.
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 koja nije povezana s relapsom prijavljena do dana + 100 nakon presađivanja također je ispitana putem pregleda objavljenih podataka iz kliničkih ispitivanja.
English: In this regard, for children < 9 kg, a monitoring of the plasma concentrations of busulfan (therapeutic drug monitoring) for dose-adjustment may improve the busulfan targeting performance, especially in extremely young children and neonates.
Croatian: S obzirom na to, za djecu težine < 9 kg kontrola plazmatskih koncentracija busulfana (terapijsko praćenje lijeka) za prilagođavanje doze može poboljšati ciljano djelovanje busulfana, naročito u izrazito mlade djece i nedonoščadi.
English: Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without doseadjustment.
Croatian: Bolesnici stariji od 50 godina (n=23) uspješno su liječeni Busilvexom bez prilagođavanja doze.
English: It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Croatian: Moguće je da upotreba Busilvexa može povećati opasnost od obolijevanja od druge maligne bolesti u budućnosti.
English: HVOD is a recognized potential complication of conditioning therapy post-transplant.
Croatian: HVOD je prepoznat kao potencijalna komplikacija terapije kondicioniranja nakon presađivanja.
English: In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.
Croatian: Otpuštanje metansulfonatnih skupina u vodenom mediju stvara ugljikove ione koji mogu alkilirati DNK, što se smatra važnim biološkim mehanizmom za njegov citotoksičan učinak.
English: In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Croatian: U štakora je dnevna doza DMA 450 mg/kg koja je davana štakorima devet dana uzrokovala inaktivnu spermatogenezu.
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 internetskoj stranici Europske agencije za lijekove http://www.ema/europa.eu
English: The other ingredients are dimethylacetamide and macrogol 400.
Croatian: - Drugi sastojci su dimetilacetamid i makrogol 400.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/254/002
English: What Busilvex is and what it is used for What you need to know before you use Busilvex How to use Busilvex
Croatian: Što je Busilvex i za što se koristi Što morate znati prije nego počnete primjenjivati Busilvex Kako primjenjivati Busilvex
English: Oliguria
Croatian: Oligurija
English: Malformations and anomalies included significant alterations in the musculoskeletal system, body weight gain, and size.
Croatian: Malformacije i anomalije obuhvaćale su značajne promjene mišićno-koštanog sustava, povećanje tjelesne težine i veličine.
English: Detailed information on this product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: VOD observed were neither fatal nor severe and resolved in all cases.
Croatian: Zabilježena venska-okluzivna bolest nije bila niti smrtonosna niti teška i u svim slučajevima je izliječena.
English: 39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
Croatian: Jednu ili više epizoda infekcije doživjelo je 39% bolesnika (40/103), od čega je 83% (33/40) ocijenjeno blagima ili umjerenima.
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.
Croatian: Antiemetike treba primijeniti prije prve doze Busilvexa i nastaviti s njihovom primjenom prema dogovorenom rasporedu u skladu s lokalnom praksom.
English: The increased risk of a second malignancy should be explained to the patient.
Croatian: Bolesniku se mora objasniti povećani rizik od drugog malignog oboljenja.
English: Not relevant
Croatian: Nije značajno.
English: Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
Croatian: Faza II dvaju prospektivnih, nekontroliranih, otvorenih ispitivanja jedne skupine bolesnika provedena su na bolesnicima oboljelim od hematoloških bolesti, od kojih je većina imala uznapredovalu bolest.
English: The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Croatian: Pojava infekcija ili reaktivacija oportunističkih infektivnih uzročnika uglavnom pokazuje imunološko stanje bolesnika koji prima protokol kondicioniranja.
English: Busilvex should not be given by rapid intravenous, bolus or peripheral injection.
Croatian: Busilvex se ne smije primjenjivati brzom intravenskom, bolusnom ili perifernom injekcijom.
English: Chronic GVHD (c-GVHD) was reported if serious or the cause of death, and was reported as the cause of death in 3 patients.
Croatian: Kroničan GVHD (c-GVHD) prijavljen je ako je bio težak ili uzrok smrti, a kao uzrok smrti prijavljen je kod 3 bolesnika.
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: 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: No specific antidote for DMA overdose is known.
Croatian: Nije poznat specifični protulijek za predoziranje s DMA.
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 ≥ 50 godina s protokolima kondicioniranja FB-om imalo ishod djelotvornosti sličan mlađim bolesnicima.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for busulfan, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za busulfan, znanstveni zaključci CHMP-a su sljedeći:
English: Pneumonia was fatal in 1% (1/103) and life-threatening in 3% of patients.
Croatian: Upala pluća bila je smrtonosna u 1% (1/103), a po život opasna u 3% bolesnika.
English: * veno occlusive liver disease is more frequent in paediatric population.
Croatian: * vensko-okluzivna bolest jetre češća je u pedijatrijskoj populaciji.
English: For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Croatian: Za pretile bolesnike mora se razmotriti doziranje na temelju prilagođene idealne tjelesne težine (PITT).
English: Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Croatian: Informacije o nuspojavama dobivene su iz dva klinička ispitivanja (n=103) lijeka Busilvex.
English: Compared to the four times a day regimen, the once-daily regimen is characterized by a higher peak concentration, no drug accumulation and a wash out period (without circulating busulfan concentration) between consecutive administrations.
Croatian: U usporedbi s režimom četiri puta dnevno, režim jednom dnevno obilježava viša vršna koncentracija, neakumulacija lijeka i razdoblje ispiranja (bez koncentracije busulfana u cirkulaciji) između dviju uzastopnih primjena.