FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: I betragtning af de fremlagte data i den gennemgåede PSUR vurderede PRAC, at det er påkrævet at indføre ændringer i produktinformationen for lægemidler, der indeholder busulfan.
English: Leukaemia patients treated with busulfan developed many different cytological abnormalities, and some developed carcinomas.
Danish: Leukæmipatienter, der fik busulfan, udviklede mange forskellige cytologiske anomalier, og nogle fik karcinomer.
English: Storage conditions
Danish: Opbevaringsforhold
English: Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
Danish: Der blev opnået busulfankoncentrationer i cerebrospinalvæske, som var sammenlignelige med koncentrationerne i plasma, om end disse koncentrationer formentlig er utilstrækkelige til at udvirke antineoplastisk aktivitet.
English: Various chromosome aberrations have been observed in cells from patients receiving oral busulfan.
Danish: Der er observeret forskellige kromosomafvigelser i celler fra patienter, der fik oralt busulfan.
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.
Danish: Der er indberettet enkelte tilfælde af medfødte anomalier med lavdosis oralt busulfan, men disse var ikke nødvendigvis relateret til den aktive substans, og eksponering i 3. trimester kan være forbundet med intrauterin væksthæmning.
English: IBW women (kg) = 45 + 0.91x (height in cm-152).
Danish: IBW kvinder (kg) =45+0,91x(højde i cm-152).
English: Malformations and anomalies included significant alterations in the musculoskeletal system, body weight gain, and size.
Danish: Misdannelser og anomalier omfattede signifikante ændringer i skeletmuskulaturen, vægtstigning og størrelse.
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.
Danish: En farmakokinetisk/farmakodynamisk forbindelse blev observeret mellem stomatitis og AUC'er hos autologe patienter og mellem en stigning i bilirubin og AUC'er i en kombineret analyse af autologe og allogene patienter.
English: Intravenous administration of busulfan to mice significantly increased the incidences of thymic and ovarian tumours.
Danish: Intravenøs administration af busulfan hos mus medførte signifikant øgning af incidensen af tumorer i thymus og ovarier.
English: The median time to neutropenia was 4 days for both autologous and allogeneic patients.
Danish: Middeltid frem til neutropeni var 4 dage for såvel autologe og allogene patienter.
English: The available data in animals support the carcinogenic potential of busulfan.
Danish: Data fra dyreforsøg bekræfter busulfans karcinogene potentiale.
English: Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Danish: Busilvex indeholder den aktive substans busulfan, som hører til en lægemiddelgruppe, der kaldes alkylerende midler.
English: On the basis of human data, busulfan has been classified by the IARC as a human carcinogen.
Danish: På grundlag af humane data er busulfan klassificeret af IARC som et humant karcinogen.
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.
Danish: Data fra et nyligt afsluttet prospektivt fase II-multicenterstudie med 80 patienter i alderen 18 til 65 år, der var diagnosticeret med forskellige hæmatologiske maligniteter, og som fik allo-HCT med et konditionerende FB-regime med reduceret intensitet (3 dage med Busilvex), er nu tilgængelige.
English: Adverse events information is derived from two clinical trials (n=103) of Busilvex.
Danish: Informationerne om bivirkninger stammer fra to kliniske studier (n=103) med Busilvex.
English: The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5).
Danish: Disse antikonvulsivas virkning på busulfans farmakokinetik blev undersøgt i et fase II-studie (se pkt.
English: Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Danish: Andre hyppige anomalier omfattede ganespalte, anasarca og anormal udvikling af skelettet i vertebrae og ribben.
English: Higher doses can produce hepatic necrosis and liver damage can be seen following single high exposures.
Danish: Højere doser kan give levernekroser, og leverskader kan forekomme efter enkelt højdosis eksponering.
English: Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Danish: Bivirkninger, der er indberettet hos både voksne og pædiatriske patienter i mere end et enkeltstående tilfælde, er angivet nedenfor efter systemorganklasse og hyppighed.
English: For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Danish: For adipøse patienter skal det overvejes, om doseringen bør baseres på en justeret idealvægt (AIBW).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 60 mg/10 ml
English: In pregnant rats, busulfan produced sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries.
Danish: Hos drægtige rotter har busulfan medført sterilitet hos afkom af begge køn på grund af manglende germinalceller i testikler og ovarier.
English: The safety and efficacy of FB in pediatric population has not been established.
Danish: Fludarabins sikkerhed og virkning i den pædiatriske population er ikke klarlagt.
English: The most frequent causes of reported TRM/NRMs were infection/sepsis, GVHD, pulmonary disorders and organ failure.
Danish: De hyppigste årsager til de indberettede TRM'er/NRM'er var infektion/sepsis, GVHD, lungesygdomme og organsvigt.
English: The pharmacokinetics of Busilvex has been investigated.
Danish: Busilvex' farmakokinetik er undersøgt.
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.
Danish: For de 40 % af børnene <9 kg, der ikke nåede målet, var AUC jævnt fordelt enten under eller over målgrænserne, dvs. 20 % henholdsvis < 900 og > 1.500 mikromol/l.min efter 1 mg/kg.
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.
Danish: - sprøjtens indhold skal overføres til en infusionspose (eller -sprøjte), som allerede indeholder den beregnede mængde af den valgte infusionsvæske.
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).
Danish: Det beskrives, at paracetamol nedsætter gluthation-niveauet i blod og væv og derfor måske nedsætter clearance af busulfan ved kombination dermed (se pkt.
English: A total of 11 patients (18%) experienced a-GVHD.
Danish: 11 patienter i alt (18 %) fik a-GVHD.
English: No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole.
Danish: Der er ikke udført specifikke kliniske studier med henblik på at vurdere lægemiddelinteraktion mellem intravenøs busulfan og itraconazol eller metronidazol.
English: In the absence of haematopoietic progenitor cell transplantation, the recommended dose of Busilvex would constitute an overdose of busulfan.
Danish: Uden sammenhæng med transplantation af hæmatopoietiske progenitorceller vil den anbefalede dosis af Busilvex udgøre en overdosis af busulfan.
English: Caution is recommended, particularly in those patients with severe hepatic impairment (see section
Danish: Det anbefales at udvise forsigtighed, specielt hos patienter med svær leverinsufficiens (se pkt.
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.
Danish: Der er rapporteret om tilfælde af trombotisk mikroangiopati efter hæmatopoietisk celletransplantation (HCT), inklusive dødelige tilfælde, ved højdosis-konditioneringsregimer, hvor busulfan blev administreret i kombination med en anden konditioneringsbehandling.
English: The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Danish: Forsøgenes primære effektparametre var myeloablation, optagelse af cellerne, recidiv og overlevelse.
English: The Fanconi anaemia cells have hypersensitivity to cross-linking agents.
Danish: Fanconis anæmiceller er overfølsomme over for krydsbindende midler.
English: The cumulative incidence of neutrophil recovery at day 28 was 98.8% (95%CI, 85.7-99.9%).
Danish: Den samlede forekomst af neutrofil restitution på dag 28 var 98,8 % (95 % CI 85,799,9 %).
English: Periodic monitoring of renal function should be considered during therapy with Busilvex (see section
Danish: Regelmæssig overvågning af nyrefunktionen bør overvejes under behandling med Busilvex (se pkt.
English: The glutathione conjugate is then further metabolised in the liver by oxidation.
Danish: Dernæst metaboliseres glutathion-konjugatet yderligere i leveren ved oxidation.
English: Respiratory: decrease in blood oxygen.
Danish: Åndedrættet: fald af ilt i blodet.
English: Ventricular extrasystoles Bradycardia
Danish: Ventrikulære ekstrasystoler Bradykardi
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.
Danish: Den anbefalede dosis Busilvex i kombination med cyclophosphamid eller melphalan afhænger af Deres legemsvægt og varierer fra mellem 0,8 og 1,2 mg/kg.
English: Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
Danish: Der skal monitoreres med hyppig måling af komplet blodstatus inklusive differentialtælling af leukocytter og trombocyttal under behandlingen og indtil helbredelse er indtrådt.
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).
Danish: Patienter, som tidligere har fået stråleterapi i et omfang, som var større end eller svarede til 3 behandlingsforløb med kemoterapi, eller som tidligere har fået transplantation af progenitorceller, kan være i højrisikogruppen (se pkt.
English: Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster and barley.
Danish: Busulfan var mutagent i Salmonella typhimurium, Drosophila melanogaster og byg.
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use (IV)
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse (i.v.)
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.
Danish: For behandlingsregimet med BuMel er det hos den pædiatriske patientpopulation blevet indberettet, at administration af melphalan mindre end 24 timer efter den sidste orale administration af busulfan kan påvirke udviklingen af toksicitet.
English: Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients.
Danish: Der er ikke udført studier omfattende patienter med nedsat nyrefunktion, men da busulfan udskilles i moderat omfang med urinen, anbefales dosisjustering ikke hos disse patienter.
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).
Danish: Litteraturen om busulfan peger på et terapeutisk AUC-vindue mellem 900 og 1.500 mol/l.min pr. administration (svarende til en daglig eksponering mellem 3.600 og 6.000 mol/l.min ).
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan påvirke flere end 1 ud af 10 personer):
English: Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Danish: Busulfan-behandling hos en præpubertær pige forhindrede pubertetsstart på grund af ovariesvigt.
English: The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Danish: Behandlingen med Busilvex i den anbefalede dosis og ifølge behandlingsplanen bevirker omfattende myelosuppression hos alle patienter.
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.
Danish: Dokumentation for sikkerhed og virkning af Busilvex i kombination med fludarabin (FB) før allogen HPTC stammer fra litteraturgennemgang af 7 publicerede studier med 731 patienter med myeloid og lymfoid malignitet, hvor der er rapporteret om intravenøs infusion af busulfan én gang daglig i stedet for fire doser om dagen.
English: - If Busilvex or diluted Busilvex solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Danish: - Hvis Busilvex eller den fortyndede Busilvex-opløsning kommer i kontakt med hud eller slimhinder, skal de berørte områder omgående skylles med rigeligt vand.
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.
Danish: 10 ml koncentrat til infusionsopløsning i klart hætteglas (type I-glas) med butylgummiprop, der er dækket af et rødt flip-off-låg af aluminium.
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Danish: Bivirkninger, der er indberettet i mere end et enkeltstående tilfælde, er angivet nedenfor efter systemorganklasse og hyppighed.
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-Stransferase mediated).
Danish: Busulfan metaboliseres hovedsageligt gennem konjugation med glutathion (spontant og gennem glutathion-S-transferase).
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.
Danish: I denne henseende kan monitorering af busulfans plasmakoncentration (terapeutisk lægemiddelmonitorering) med henblik på dosisjustering forbedre busulfans målrettede virkning hos børn < 9 kg, især hos meget små børn og nyfødte.
English: Busulfan and DMA can impair fertility in man or woman.
Danish: Busulfan og DMA kan nedsætte fertiliteten hos mænd og kvinder.
English: Nervous system: confusion, nervous system disorders.
Danish: Nervesystemet: konfusion, sygdomme i nervesystemet.
English: No age effect on busulfan clearance was evidenced from available intravenous busulfan data in patients over 60 years.
Danish: Alder påvirkede tilsyneladende ikke clearance af busulfan ifølge de tilgængelige oplysninger om intravenøst busulfan hos patienter over 60 år.
English: The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase whereas no interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan.
Danish: Samtidig systemisk administration af phenytoin til patienter, der får højdosis oral busulfan er blevet rapporteret at øge busulfan-clearance på grund af induktion af glutathion-S-transferase, mens der ikke er rapporteret interaktion, når benzodiazepiner såsom diazepam, clonazepam eller lorazepam har været anvendt krampeprofylaktisk med højdosis busulfan.
English: However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Danish: Hjertefunktionen skal dog kontrolleres regelmæssigt hos patienter, der får Busilvex (se pkt.
English: A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimenrelated toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Danish: Der er observeret nedsat forekomst af hepatisk veneoklussion (HVOD) og anden behandlingsrelateret toksicitet hos patienter, hvor tidsrummet mellem sidste dosis oral busulfan og første dosis cyclophosphamid er > 24 timer.
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).
Danish: Forekomsten af a-GVHD grad I-II var 46,4 % (13/28), mens forekomsten af grad III-IV var 3,6 % (1/28).
English: No patients were discontinued from treatment due to adverse reactions related to Busilvex.
Danish: Ingen af patienterne afbrød behandlingen på grund af bivirkninger relateret til Busilvex.
English: Ask your pharmacist how to throw away medicine you no longer use.
Danish: Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: Elimination in faeces is negligible.
Danish: Elimination med fæces er ubetydelig.
English: There is no common metabolism pathway between busulfan and fludarabine.
Danish: Der er ingen fælles metaboliseringsvej for busulfan og fludarabin.
English: From the assessment of these articles, the causality of busulfan in the development of tooth hypoplasia is confirmed.
Danish: På baggrund af vurderingen af disse artikler bekræftes det, at der er en årsagssammenhæng mellem busulfan og udvikling af hypoplasi af tænder.
English: Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen.
Danish: Myelosuppression og immunosuppression var den ønskede terapeutiske effekt af den konditionerende behandling.
English: Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen and consequently were not considered undesirable effects.
Danish: Myelosuppression og immunsuppression var de ønskede terapeutiske virkninger af den konditionerende behandling og blev derfor ikke betragtet som bivirkninger.
English: Delirium Nervousness Hallucination Agitation
Danish: Delirium Nervøsitet Hallucination Uro
English: Busulfan is mutagenic and clastogenic.
Danish: Busulfan er mutagent og klastogent.
English: The safety profile of Busilvex combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Danish: Sikkerhedsprofilen af Busilvex i kombination med fludarabin (FB) er blevet undersøgt via en gennemgang af bivirkninger indrapporteret i publicerede data fra kliniske studier med RIC-regimet.
English: Hyperventilation Respiratory failure Alveolar haemorrhages Asthma
Danish: Hyperventilation Respirationssvigt Alveolær hæmoragi Astma
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.
Danish: Analysen af data ved en populationsfarmakokinetisk metode viste ingen forskel på intravenøs busulfan-clearance mellem phenytoin- og clonazepambaseret behandling og derfor blev sammenlignelige busulfanplasmaeksponeringer opnået uanset typen af krampeprofylakse.
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).
Danish: Hos børn < 9 kg kan monitorering af det terapeutiske lægemiddel være berettiget, særligt hos meget små børn og nyfødte; bør vurderes fra sag til sag (se pkt.
English: Seizures have been reported with high dose busulfan treatment.
Danish: Der er indberettet krampeanfald ved behandling med høje doser busulfan.
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.
Danish: Misdannelserne omfattede alvorlige anomalier i hjerte og/eller større kar: en fælles truncus arteriosis og ingen ductus arteriosis, coarctatio af truncus pulmonalis og a. pulmonalis, intraventrikulære hjertedefekter.
English: A total of 14 patients (50%) experienced a-GVHD.
Danish: 14 patienter i alt (50 %) fik a-GVHD.
English: You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.
Danish: De vil få denne medicin som forbehandling, før De skal have foretaget en transplantation med enten knoglemarv eller hæmatopoietiske progenitorceller.
English: Platelet engraftment occurred at a median of 9 (range, 1-16) days after allo-HCT.
Danish: Dannelse af nye trombocytter indtrådte gennemsnitligt 9 (1-16) dage efter allo-HCT.
English: Preparation of Busilvex
Danish: Tilberedning af Busilvex
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2C - 8C)
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 °C - 8 °C)
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Danish: Lægen vil løbende kontrollere Deres blodstatus og leverenzymer for at opdage og behandle disse bivirkninger.
English: A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics.
Danish: Et klinisk fase II-studie blev udført for at vurdere indflydelsen af krampeprofylakse på farmakokinetikken af intravenøs busulfan.
English: The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Danish: Middelvarighed af neutropeni var 6 dage og 9 dage for henholdsvis autologe og allogene patienter.
English: The Kaplan-Meier estimate of DFS at 2 years was 49.9% (95%CI, 32.6-72.7).
Danish: Kaplan-Meier-estimat for sygdomsfri overlevelse (DFS) efter 2 år var 49,9 % (95 % CI 32,6-72,7).
English: No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.
Danish: Interaktion blev ikke observeret ved kombination af busulfan og 5-HT3-antiemetika såsom ondansetron og granisetron.
English: The 2-year OS rate was 61.9% (95%CI, 51.1-72.7%)].
Danish: Den samlede overlevelsesrate efter 2 år var 61,9 % (95 % CI 51,1-72,7 %).
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.
Danish: Der bør gives antiemetika før første Busilvex-dosis og fortsættes hermed efter et fast skema under behandlingen i overensstemmelse med almindelig praksis.
English: Premature menopause Ovarian failure**
Danish: Præmatur menopause Ovariesvigt**