FrancophonIA/ELRC3.0 huggingface dataset:
English: The review of the literature allows a comparison of PK series performed either within the same study or between studies and demonstrated unchanged dose-independent PK parameters regardless the dosage or the schedule of administration.
Croatian: Pregled literature omogućuje usporedbu farmakokinetičkih serija provedenu bilo unutar istog ispitivanja bilo između ispitivanja i pokazao je da su farmokinetički parametri neovisni o dozi nepromijenjeni bez obzira na doziranje ili raspored primjene.
English: In pregnant rats, busulfan produced sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries.
Croatian: Busulfan je u trudnih štakora uzrokovao sterilnost u muškim i ženskim potomcima zbog odsutnosti zametnih stanica u testisima i jajnicima.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2C - 8C)
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2C - 8C).
English: The 2-year OS rate was 61.9% (95%CI, 51.1-72.7%)].
Croatian: Dvogodišnja stopa ukupnog preživljavanja (OS) iznosila je 61,9% (95%-tni CI, 51,1 - 72,7%).
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: Nervous system: confusion, nervous system disorders.
Croatian: Živčani sustav: smetenost, poremećaji živčanog sustava.
English: Brain abscess, Inflammation of the skin, generalised infection.
Croatian: Apsces mozga, upala kože, opća infekcija.
English: Brain abscess Cellulitis Sepsis
Croatian: Apsces mozga Celulitis Sepsa
English: No evidence of an induction effect of phenytoin has been seen on Busilvex data.
Croatian: Nisu zabilježeni dokazi indukcijskog učinka fenitoina iz podataka o Busilvexu.
English: The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Croatian: Posljedica liječenja Busilvexom u preporučenoj dozi i rasporedu je teška mijelosupresija koja se javlja u svih bolesnika.
English: Platelet engraftment occurred at a median of 9 (range, 1-16) days after allo-HCT.
Croatian: Primanje presatka trombocita dogodilo se u medijanu od 9 (raspon 1 - 16) dana nakon alogenog HCT-a.
English: The recommended dose and schedule of administration is: - fludarabine administered as a single daily one-hour infusion at 30 mg/m² for 5 consecutive days or 40 mg/m² for 4 consecutive days.
Croatian: Preporučena doza i raspored primjene je sljedeći: - fludarabin primijenjen kao jednosatna infuzija jednom dnevnom od 30 mg/m² 5 uzastopnih dana ili od 40 mg/m² 4 uzastopna dana.
English: Intravenous administration of busulfan to mice significantly increased the incidences of thymic and ovarian tumours.
Croatian: Intravenska primjena busulfana na miševima značajno je povećala učestalost tumora timusa i jajnika.
English: On the basis of the scientific conclusions for busulfan the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing busulfan is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za busulfan, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) busulfan nepromijenjen, uz predložene izmjene informacija o lijeku.
English: In view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing busulfan were warranted.
Croatian: U pogledu podataka prikazanih u pregledanom PSUR-u, PRAC smatra da su izmjene informacija o lijeku za lijekove koji sadrže busulfan opravdane.
English: The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Croatian: Količina Busilvexa i otapala koji se moraju primijeniti izračunavaju se na sljedeći način: za bolesnika s tjelesnom težinom Y kg:
English: Busulfan was shown to cause sterility in rodents.
Croatian: Pokazalo se da busulfan uzrokuje sterilnost u glodavaca.
English: This study demonstrated that bodyweight was the predominant covariate to explain the busulfan pharmacokinetic variability in children over body surface area or age.
Croatian: To je ispitivanje pokazalo prevladavajući utjecaj tjelesne težine na varijabilnost farmakokinetike busulfana u djece u odnosu na površinu tijela ili dob.
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.
Croatian: Slučajevi formiranja krvnih ugrušaka u malim krvnim žilama mogu se pojaviti nakon transplantacije hematopoetskih matičnih stanica (HCT), s visokim dozama terapije koja se kombinira s drugim lijekovima.
English: Creatinine elevated
Croatian: Povišeni kreatinin
English: In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT.
Croatian: U tom ispitivanju kod svih osim jednog bolesnika došlo je do primanja presatka u medijanu od 15 (raspon 10 - 23) dana nakon alogenog HCT-a.
English: You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.
Croatian: Ovaj pripremni lijek primit ćete prije presađivanja koštane srži ili hematopoetskih progenitorskih stanica.
English: The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis.
Croatian: Analiza podataka populacijskom farmakokinetičkom metodom pokazala je da ne postoje razlike u klirensu intravenskog busulfana između liječenja koje se temelji na fenitoinu i klonazepamu pa su stoga postignute slične izloženosti plazme busulfanu bez obzira na vrstu profilaktične terapije napadaja.
English: However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Croatian: No kardijalna se funkcija mora redovito nadzirati u bolesnika koji primaju Busilvex (vidjeti dio 4.8).
English: From a microbiological point of view, the product should be used immediately after dilution.
Croatian: S mikrobiološkog stajališta lijek treba primijeniti odmah nakon razrjeđivanja.
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: Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster and barley.
Croatian: Busulfan je bio mutagen u bakteriji Salmonella typhimurium, vinskoj mušici Drosophila melanogaster i ječmu.
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-Stransferase mediated).
Croatian: Busulfan se većinom metabolizira konjugacijom s glutationom (spontano i sudjelovanjem glutation-S-transferaze).
English: Thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Croatian: Trombocitopenija (< 25x109/l ili potreba za transfuzijom trombocita) se pojavila u medijanu od 5-6 dana u 98% bolesnika.
English: As a conclusion, busulfan could be one risk factor of development TMA and a warning is section 4.4 of the Busilvex SmPC is considered warranted.
Croatian: Stoga je zaključeno da bi busulfan mogao biti jedan od faktora rizika za razvoj trombotičke mikroangiopatije (TMA) pa se upozorenje u dijelu 4.4 Sažetka opisa svojstava lijeka za lijek Busilvex smatra opravdanim.
English: No age effect on busulfan clearance was evidenced from available intravenous busulfan data in patients over 60 years.
Croatian: Nije zabilježen učinak dobi na klirens busulfana na temelju dostupnih podataka o intravenskom busulfanu u bolesnika iznad 60 godina.
English: Muscle and bone: back, muscle and joint pain.
Croatian: Mišići i kosti: bol u leđima, mišićima i zglobovima.
English: On the basis of human data, busulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Croatian: Na temelju podataka dobivenih na ljudima, Međunarodna agencija za istraživanja raka (IARC) klasificirala je busulfan kao humani karcinogen.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza oznake „EXP“/ „Rok valjanosti“.
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Croatian: Podaci o pojavnosti akutne reakcije presatka protiv domaćina (a-GVHD) prikupljeni su od alogenih bolesnika (n=28).
English: The benefit risk profile of the product remains favourable in the approved indications.
Croatian: Profil omjera koristi i rizika lijeka pokazao se povoljnim pri primjeni kod odobrenih indikacija.
English: D: dose of Busilvex (see SPC section 4.2)
Croatian: D: doza Busilvexa (vidjeti Sažetak, dio 4.2)
English: 10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.
Croatian: 10 ml koncentrata za otopinu za infuziju u prozirnim staklenim bočicama (tip I) s gumenim butilnim čepom pokrivenim ljubičastim aluminijskim "flip-off" zaštitnim zatvaračem.
English: Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen and consequently were not considered undesirable effects.
Croatian: Mijelosupresija i imunosupresija bile su željeni terapijski učinak protokola kondicioniranja i posljedično nisu smatrane nuspojavama.
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 Busilvex) 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 lijeka Busilvex).
English: The malformations included serious heart and/or major vessels anomalies: a common truncus arteriosis and no ductus arteriosis, coarctation of the pulmonary trunk and the pulmonary arteries, intraventricular defects of the heart.
Croatian: Malformacije su uključivale teške anomalije srca i/ili glavnih krvnih žila: zajednički truncus arteriosus i odsutnost Botallijevog duktusa, koarktacija stabla plućne arterije i plućnih arterija, intraventrikularni defekti srca.
English: The median time to neutropenia was 4 days for both autologous and allogeneic patients.
Croatian: Medijan vremena do neutropenije bio je 4 dana za autologne i alogene bolesnike.
English: PK/PD relationship was observed between stomatitis and AUCs in autologous patients and between bilirubin increase and AUCs in a combined autologous and allogeneic patient analysis.
Croatian: Odnos farmakokinetike i farmakodinamike praćen je između stomatitisa i vrijednosti AUC u autolognih bolesnika i između povećanja bilirubina i vrijednosti AUC u kombiniranoj analizi autolognih i alogenih bolesnika.
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.
Croatian: Slučajevi trombotičke mikroangiopatije nakon transplantacije hematopoetskih matičnih stanica (HCT), uključujući i smrtne slučajeve, zabilježeni su u režimima kondicioniranja visokim dozama u kojima se busulfan daje u kombinaciji s drugom terapijom za kondicioniranje.
English: • Quantity of Busilvex:
Croatian: • Količina Busilvexa:
English: Polycarbonate syringes must not be used with Busilvex.
Croatian: Polikarbonatne štrcaljke se ne smiju upotrebljavati uz Busilvex.
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: It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
Croatian: Moguće je da nakon liječenja busulfanom više nećete moći ostvariti trudnoću (neplodnost).
English: The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2hour 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: Therefore, “tooth hypoplasia” should be added to the product information for both pharmaceutical forms.
Croatian: Stoga je u informacije o lijeku za oba farmaceutska oblika potrebno dodati „hipoplaziju zuba“.
English: Pain or inflammation at injection site Mucositis
Croatian: Bol ili upala na mjestu injiciranja Mukozitis
English: The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Croatian: Kaplan-Meierova procjena preživljenja bez progresije bolesti nakon 2 godine iznosila je 49,9% (95%-tni CI, 32,6 - 72,7).
English: • Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Croatian: • Busilvex mora pripremiti zdravstveni radnik koristeći se sterilnim tehnikama prijenosa.
English: Busilvex destroys the original bone marrow before the transplant.
Croatian: Busilvex uništava izvornu koštanu srž prije presađivanja.
English: Premature menopause Ovarian failure**
Croatian: Preuranjena menopauza Zatajenje jajnika **
English: In paediatric population, for the BuMel regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.
Croatian: U pedijatrijskoj je populaciji tijekom primjene protokola BuMel prijavljeno da primjena melfalana u razdoblju kraćem od 24 sata nakon posljednje peroralne primjene busulfana može utjecati na razvoj toksičnosti.
English: Similar targeting rate is achieved within the daily exposure of 3600 - 6000 µmol/L.minute following the administration of intravenous busulfan 3.2 mg/kg once daily.
Croatian: Slična ciljana stopa postiže se unutar dnevne izloženosti od 3600 - 6000 µmol/l.minutu koja slijedi nakon primjene intravenskog busulfana od 3,2 mg/kg jednom dnevno.
English: Medicines before you receive Busilvex: Before receiving Busilvex, you will be medicated with anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and antiemetic medicines to prevent vomiting.
Croatian: Prije primanja Busilvexa, dobit ćete lijekove - antikonvulzivne lijekove za sprječavanje napadaja (fenitoin ili benzodiazepine) i - antiemetike za sprječavanje povraćanja.
English: Ideal body weight (IBW) is calculated as follows: IBW men (kg) = 50 + 0.91x (height in cm-152);
Croatian: Idealna tjelesna težina (ITT) izračunava se na sljedeći način: ITT za muškarce (kg) = 50 + 0,91 x (visina u cm-152);
English: The signals concerning busulfan oral formulations and hepatic veno-oclusive disease risk in patients who have received prior radiation therapy /chemotherapy /HSCT, sterility, overdose treatment can be closed.
Croatian: Signali koji se odnose na formulacije busulfana za peroralnu primjenu i rizik od hepatičke veno-okluzivne bolesti u bolesnika koji su prethodno bili podvrgnuti zračenju /kemoterapiji / transplantaciji hematopoetskih matičnih stanica te od steriliteta i predoziranja mogu se zatvoriti.
English: The incidence of each adverse reactions presented in the following table has been defined according to the highest incidence observed in published clinical trials in RIC regimen for which the population treated with FB was clearly identified, whatever the schedules of busulfan administrations and endpoints.
Croatian: Incidencija svake nuspojave predstavljene u sljedećoj tablici definirana je prema najvećoj primijećenoj incidenciji u objavljenim kliničkim ispitivanjima protokola kondicioniranja smanjenog intenziteta za koje je populacija liječena FB-om jasno identificirana, neovisno o rasporedima primjene busulfana i ishodima.
English: Calculation of the quantity of Busilvex to be diluted and of the diluent
Croatian: Izračun količine Busilvexa koju je potrebno razrijediti i količine otapala
English: F-92654 Boulogne Billancourt cedex
Croatian: F-92654 Boulogne Billancourt Cedex Francuska
English: Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
Croatian: - Busilvex će se primjenjivati jednom dnevno tijekom 2 ili 3 uzastopna dana prije presađivanja.
English: Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Croatian: Ukupni klirens u plazmi bio je u rasponu od 2,25 - 2,74 ml/min/kg.
English: Documentation on the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy2 regimen prior to conventional allogeneic and/or autologous HPCT derives from two clinical trials (OMC-BUS-4 and OMC-BUS-3).
Croatian: Dokumentacija o sigurnosti i djelotvornosti Busilvexa u kombinaciji s ciklofosfamidom u protokolu BuCy2 prije konvencionalnog alogenog i/ili autolognog HPCT-a potječe iz dva klinička ispitivanja (OMC-BUS-4 i OMC-BUS-3).
English: In the absence of haematopoietic progenitor cell transplantation, the recommended dose of Busilvex would constitute an overdose of busulfan.
Croatian: U odsutnosti presađivanja hematopoetskih progenitorskih stanica preporučena doza Busilvexa uzrokovala bi predoziranje busulfanom.
English: It is of particular interest the study of this interaction in three groups of patients in which higher plasma levels of busulfan were observed in the group receiving metronidazol prophylaxis during busulfan treatment than in those without metronidazoles.
Croatian: Posebno je važno ispitivanje ove interakcije u tri skupine bolesnika kod kojih su, u skupini koja je primala metronidazol kao profilaksu tijekom liječenja busulfanom, opažene više vrijednosti busulfana u plazmi u odnosu na vrijednosti u skupini koja nije primala metronidazol.
English: Busulfan depleted oocytes of female rats, and induced sterility in male rats and hamster.
Croatian: Busulfan je smanjio broj jajnih stanica ženki štakora i inducirao sterilnost kod muških štakora i hrčaka.
English: Ventricular extrasystoles Bradycardia
Croatian: Ventrikularne ekstrasistole Bradikardija
English: The Fanconi anaemia cells have hypersensitivity to cross-linking agents.
Croatian: Stanice u Fanconijevoj anemiji su preosjetljive na sredstva koja stvaraju poprečne veze.
English: Dimethylacetamide Macrogol 400.
Croatian: 6.1 Popis pomoćnih tvari dimetilacetamid makrogol 400.
English: No patients were discontinued from treatment due to adverse reactions related to Busilvex.
Croatian: Niti jedan bolesnik nije prekinuo liječenje zbog nuspojava povezanih s Busilvexom.
English: Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Croatian: Ozbiljne toksičnosti koje su obuhvaćale hematološki, hepatički i respiratorni sustav smatrale su se očekivanim posljedicama protokola kondicioniranja i postupka presađivanja.
English: Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (embriofetalnu smrtnost i malformacije) (vidjeti dio 5.3).
English: The recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9 kg in achieving the therapeutic window (900-1500 µmol/L.minute).
Croatian: Preporučeno doziranje za djecu navedeno u dijelu 4.2 omogućilo je da više od 70% pa sve do 90% djece ≥ 9 kg postigne terapijski okvir (900-1500 µmol/l.minuta).
English: Rash Pruritis Alopecia
Croatian: Pruritis Alopecija
English: Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Croatian: Nuspojave iz ispitivanja nakon stavljanja lijeka u promet navedene su u tablicama pod „Nepoznato”.
English: LIST OF EXCIPIENTS Each vial contains Dimethylacetamide and Macrogol 400
Croatian: Svaka bočica sadrži dimetilacetamid i makrogol 400
English: Blood: decrease of blood circulating cells (red and white) and platelets.
Croatian: Krv: smanjenje krvnih stanica (crvenih i bijelih) i trombocita u krvotoku.
English: Nervous system: insomnia, anxiety, dizziness, and depression.
Croatian: Živčani sustav: nesanica, tjeskoba, omaglica i depresija.
English: Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Croatian: Žene ne smiju ostati trudne tijekom liječenja Busilvexom i do 6 mjeseci nakon liječenja.
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Croatian: Anemija (hemoglobin < 8,0 g/dl) se pojavila u 69% bolesnika.
English: Fast and complete engraftment rates in 80-100% of patients were reported in the majority of studies.
Croatian: U većini ispitivanja zabilježene su stope brzog i potpunog primanja presatka u 80 - 100% bolesnika.
English: In adults, for the BuCy2 regimen it has been reported that the time interval between the last oral busulfan administration and the first cyclophosphamide administration may influence the development of toxicities.
Croatian: U odraslih je tijekom primjene protokola BuCy2 prijavljeno da vremenski razmak između posljednje peroralne primjene busulfana i prve primjene ciklofosfamida može utjecati na razvoj toksičnosti.
English: However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
Croatian: No u djece < 9 kg postignuta je veća varijabilnost koja je dovela do toga da 60% djece postigne terapijski okvir (900-1500 µmol/l.minuta).
English: The warning for TMA after HCT only applies to one pharmaceutical form: the intravenous.
Croatian: Upozorenje za trombotičku mikroangiopaciju (TMA) nakon transplantacije hematopoetskih matičnih stanica (HCT) primjenjuje se samo na jedan farmaceutski oblik: intravenski.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW).
Croatian: Prilagođena idealna tjelesna težina (PITT) izračunava se na sljedeći način: PITT = ITT+0,25x (stvarna tjelesna težina - ITT).
English: 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.
Croatian: Slična prisutnost djelatnih tvari u krvi primijećena je u usporedbi koncentracija u plazmi odraslih bolesnika koji su busulfan primali peroralno i intravenski u dozi od 1 mg/kg, odnosno 0,8 mg/kg.
English: In children, thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
Croatian: U djece se trombocitopenija (< 25x109/l ili potreba za transfuzijom trombocita) pojavila u 100% bolesnika.