FrancophonIA/ELRC3.0 huggingface dataset:
English: The FB combination allowed sufficient myeloablation modulated by the intensity of conditioning regimen through the variation of number of days of busulfan infusion.
Danish: FB-kombinationen muliggjorde tilstrækkelig myeloablation moduleret via intensiteten af det konditionerende regime ved variation af antallet af dage med busulfaninfusion.
English: Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
Danish: Kronisk GVHD blev kun indberettet, hvis sygdommen førte til dødsfald: En patient døde 13 måneder efter transplantation.
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.
Danish: I vandige medier bevirker frigørelse af methansulphonatgrupperne produktion af carbonioner, som kan alkylere DNA, hvilket menes at være en vigtig biologisk mekanisme bag den cytotoksiske effekt.
English: Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively.
Danish: De inter- og intra-individuelle variationer i plasmaeksponering var lavere end henholdsvis 20 % og 10
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.
Danish: Der skal iagttages særlig forsigtighed, hvis De anvender itraconazol og metronidazol (anvendes til visse infektioner) eller ketobemidon (anvendes til at behandle smerter), fordi det kan forøge bivirkningerne.
English: Viral infection CMV reactivation EBV reactivation Bacterial infection
Danish: Virusinfektion CMV-reaktivering EBV-reaktivering Bakterieinfektion
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 12.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN 12.
English: The solvent dimethylacetamide (DMA) may also impair fertility.
Danish: Solvensen dimethylacetamid (DMA) kan også nedsætte fertiliteten.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret{MM/ÅÅÅÅ}
English: A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Danish: Størstedelen af publikationerne rapporterede om komplet donorkimærisme efter dag +30 hos 90-100 % af patienterne.
English: Same dose (see section 5.2) for elderly patients as for adults (< 50 years old) should be used.
Danish: 5.2) til ældre som til voksne (< 50 år).
English: The occurrence of TMA is multifactorial and busulfan IV by itself cannot be considered as a main factor in the development of this reaction.
Danish: Forekomsten af TMA er multifaktoriel, og intravenøs busulfan i sig selv vurderes ikke at være en primær faktor for udvikling af denne reaktion.
English: Acute GVHD was rated as serious in 3 patients.
Danish: Akut GVHD blev anset for alvorlig hos 3 patienter.
English: Doses of 400 mg/kg/day DMA administered during organogenesis caused significant developmental anomalies.
Danish: En dosis DMA på 400 mg/kg/dag administreret under organogenese gav signifikante udviklingsmæssige anomalier.
English: Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Danish: Omtrent 30 % af den indgivne dosis udskilles med urinen i løbet af 48 timer med 1 % som uomdannet busulfan.
English: The successful engraftment achieved in all patients during phase II trials suggests the appropriateness of the targeted AUCs.
Danish: Den vellykkede optagelse af cellerne hos alle patienter i fase II-studier indikerede, at mål-AUC'erne var korrekte.
English: There is no primary or secondary graft rejection.
Danish: Der var ingen primær eller sekundær transplantationsafstødning.
English: Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Danish: Den totale busulfandosis pr. patient var mellem 6,4 mg/kg og 9,6 mg/kg.
English: HVOD occurred in: 8.2% (5/61) allogeneic patients (fatal in 2 patients) and 2.5% (1/42) of autologous patients.
Danish: HVOD indtraf hos: 8,2 % (5/61) af de allogene patienter (fatal hos 2 patienter) og 2,5 % (1/42) af de autologe patienter.
English: 93% of allogeneic patients showed complete chimerism.
Danish: 93 % af de allogene patienter udviste fuldstændig kimærisme.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det det nationale rapporteringssystem anført i Appendiks V.
English: The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Danish: Forekomsten af infektiøse episoder eller reaktivering af opportunistiske patogener afspejler primært immunstatus hos den patient, der får konditionerende behandling.
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.
Danish: Gentagne doser af DMA medførte tegn på levertoksicitet, hvoraf det første var stigninger i enzymer i klinisk-kemiske serumprøver efterfulgt af histopatologiske forandringer i hepatocytterne.
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.
Danish: De omfattede infektion og graft-versushost-disease (GVHD), som, også selv om der ikke var en direkte årsagssammenhæng, var hovedårsagerne til morbiditet og mortalitet, især ved allogen HPCT.
English: Pain or inflammation at injection site Mucositis
Danish: Smerter eller betændelse ved injektionsstedet Mucosit
English: Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Danish: Veneokklusiv sygdom (VOD) blev indberettet for 15 % (4/27) og 7 % (2/28) efter henholdsvis autolog og allogen transplantation.
English: VOD was reported with a range between 3.9% and 15.4%.
Danish: Venookklusiv sygdom blev indberettet hos mellem 3,9 % og 15,4 %.
English: Busilvex may interact with other medicines.
Danish: Busilvex kan reagere med andre lægemidler.
English: Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
Danish: Ovariesuppression og amenoré med menopausale symptomer forekommer hyppigt hos præmenopausale patienter.
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.
Danish: En kontinuerlig variation i clearance inden for området 2,49 til 3,92 ml/min/kg er fastlagt hos børn i alderen < 6 måneder og op til 17 år.
English: Must be diluted before use
Danish: Skal fortyndes før brug
English: In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin.
Danish: I dette studie fik 24 voksne patienter clonazepam (0,025-0,03 mg/kg/dag som kontinuerlig intravenøs infusion) som antikonvulsiv behandling, og farmakokinetiske data for disse patienter blev sammenlignet med historiske data indsamlet hos patienter behandlet med phenytoin.
English: In both studies, all patients received a 16/16 dose regimen of Busilvex.
Danish: I begge studier fik alle patienter 16 ud af 16 doser Busilvex.
English: A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and nonmalignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Danish: En farmakokinetisk populationsanalyse er blevet udført i en kohorte af 205 børn fordelt på passende vis med hensyn til legemsvægt (3,5 til 62,5 kg) samt biologiske og sygdomsrelaterede (maligne og non-maligne) karakteristika, således at de var repræsentative for den høje grad af heterogenitet blandt børn, der gennemgår HPCT.
English: The principal toxic effect is profound myeloablation and pancytopenia but the central nervous system, liver, lungs, and gastrointestinal tract may also be affected.
Danish: Den væsentligste toksiske virkning er omfattende myeloablation og pancytopeni, men centralnervesystemet, lever, lunger og gastrointestinalkanalen kan også blive påvirket.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Danish: Hvis De spekulerer på at få børn, skal De tale med Deres læge før behandlingen.
English: This study demonstrated that bodyweight was the predominant covariate to explain the busulfan pharmacokinetic variability in children over body surface area or age.
Danish: Dette studie viste, at legemsvægt var den fremherskende covariat til at forklare busulfans farmakokinetiske variabilitet hos børn versus legemsoverflade eller alder.
English: Busulfan is thought to be leukemogenic.
Danish: Busulfan anses for at være leukæmogent.
English: In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Danish: Hos mennesker var de vigtigste toksiske virkninger hepatotoksicitet og virkninger på centralnervesystemet.
English: Also, there are published case reports of increased plasma levels of busulfan after administration of metronidazole.
Danish: Der er desuden rapporteret om tilfælde af øgede plasmaniveauer af busulfan efter administration af metronidazol.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for busulfan, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for busulfan er CHMP nået frem til følgende videnskabelige konklusioner:
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to restricted medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel med begrænset rekvirering.
English: Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation (see section 4.8).
Danish: Opmærksomheden bør derfor rettes mod dette pulmonale problem hos patienter, der tidligere har fået mediastinal eller pulmonal stråleterapi (se pkt.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW).
Danish: Justeret idealvægt (AIBW) beregnes som følger: AIBW = IBW+0,25x(faktisk legemsvægt - IBW).
English: In these studies, a total of 1574 patients received FB as a reduced intensity conditioning (RIC) regimen prior to haematopoietic progenitor cell transplantation.
Danish: I disse studier fik i alt 1.574 patienter FB som konditionering med reduceret intensitet (RIC) inden transplantation af hæmatopoietiske progenitorceller.
English: Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
Danish: Hæmoragisk cystitis, inklusive hæmoragisk cystitis forårsaget af virusinfektion, blev indberettet hos mellem 16 % og 18,1 %.
English: In rats, a DMA daily dose of 450 mg/kg given to rats for nine days caused inactive spermatogenesis.
Danish: Hos rotter medførte en døgndosis DMA på 450 mg/kg hos rotter i 9 dage inaktiv spermatogenese.
English: HVOD is a recognized potential complication of conditioning therapy post-transplant.
Danish: HVOD er en kendt potentiel komplikation til konditionerende behandling efter transplantation.
English: Undesirable effects coming from post-marketing survey have been implemented in the tables with the incidence “not known”.
Danish: Bivirkninger, der er indrapporteret i forbindelse med overvågningen efter markedsføring, er indført i tabellerne med hyppigheden ”ikke kendt”.
English: Busulfan is a teratogen in rats, mice and rabbits.
Danish: Busulfan er teratogent hos rotter, mus og kaniner.
English: Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
Danish: Impotens, sterilitet, azoospermi og testikulær atrofi er indberettet hos mandlige patienter.
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.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De bruger dette lægemiddel.
English: On the basis of human data, busulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Danish: På grundlag af humane data er busulfan klassificeret af International Agency for Research on Cancer (IARC) som et humant karcinogen.
English: Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne angivet efter faldende alvorlighedsgrad.
English: The other ingredients are dimethylacetamide and macrogol 400.
Danish: - Øvrige indholdsstoffer: Dimethylacetamid og macrogol 400.
English: Brain abscess Cellulitis Sepsis
Danish: Hjerneabsces Cellulitis Sepsis
English: Six of 103 patients (6%) experienced HVOD.
Danish: Seks af 103 patienter fik HVOD.
English: * reported in post marketing experience ** include haemorrhagic cystitis induced by viral infection
Danish: * Indrapporteret efter markedsføringen ** Inkluderer hæmoragisk cystitis forårsaget af virusinfektion
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%].
Danish: De hyppigste infektiøse bivirkninger var: Cytomegalovirus (CMV)-reaktivering [30,7 % - 80,0 %], Epstein-Barr-virus (EBV)-reaktivering [2,3 % - 61 %], bakterieinfektioner [32,0 % - 38,9 %] og virusinfektioner [1,3 % - 17,2 %].
English: For any information about this medicine, please contact the Marketing Authorisation Holder
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til indehaveren af markedsføringstilladelsen.
English: Hepatic veno-occlusive disease is a major complication that can occur during treatment with Busilvex.
Danish: Leversygdom med veneokklusion er en alvorlig komplikation, som kan forekomme under behandling med Busilvex.
English: Busilvex is available in multipacks comprising 2 packs, each containing 4 vials.
Danish: Busilvex fås i multipakninger med 2 pakninger, der hver indeholder 4 hætteglas.
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.
Danish: Gennemgang af litteraturen muliggør en sammenligning af farmakokinetiske serier udført enten inden for samme studie eller mellem studier og viste uændrede, dosisuafhængige farmakokinetiske parametre uanset dosering og behandlingsplan.
English: Dose and administration: The dose of Busilvex will be calculated according to your body weight.
Danish: Dosis og indgivelse: Dosen af Busilvex beregnes ud fra Deres legemsvægt.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Danish: Profylaktisk eller empirisk brug af midler mod infektionssygdomme (antibiotika, antimykotika, antivirale midler) bør overvejes til profylakse og behandling af infektioner i løbet af perioden med neutropeni.
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.
Danish: Lægemidlet bør ikke anvendes til adipøse børn og unge med en BMI (kg/m²) > 30 kg/m², før yderligere data foreligger.
English: Busilvex should not be given by rapid intravenous, bolus or peripheral injection.
Danish: Busilvex må ikke gives som hurtig intravenøs injektion, bolus eller perifer injektion.
English: Anxiety Depression Insomnia
Danish: Angst Depression Insomni
English: Fever was reported in 87% of patients and graded as mild/moderate in 84% and severe in 3%.
Danish: Feber blev indberettet for 87 % af patienterne og klassificeret som mild til moderat hos 84 % og alvorlig hos 3 %.
English: There have been two reports that busulfan is dialyzable, thus dialysis should be considered in the case of an overdose.
Danish: Ifølge to rapporter kan busulfan fjernes ved dialyse, og det bør derfor overvejes at sætte patienten i dialyse i tilfælde af en overdosis.
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.
Danish: Heraf følger, at kontrollen af AUC efter intravenøs busulfan inden for det terapeutiske vindue ikke ændres, og der blev påvist samme target-performance med de to behandlingsplaner.
English: Busulfan belongs to a class of substances which are potentially carcinogenic based on their mechanism of action.
Danish: Busulfan hører til en gruppe substanser, som er potentielt karcinogene på grund af deres virkemåde.
English: Women must stop breast-feeding before starting their treatment with Busilvex.
Danish: Kvinder skal stoppe med at amme, inden behandlingen med Busilvex påbegyndes.
English: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Danish: Der bør fastlægges procedurer for korrekt håndtering og bortskaffelse af cytotoksiske lægemidler.
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.
Danish: Generel mortalitet og mortalitet uden recidiv mere end 100 dage efter transplantationen var henholdsvis (8/61) 13 % og (6/61) 10 % hos allotransplanterede patienter.
English: There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi's anaemia.
Danish: Der er kun begrænset klinisk erfaring med anvendelse af busulfan som en del af et konditionerende regimen inden HPCT hos børn med Fanconis anæmi.
English: The terminal half-life ranged from 2.8 to 3.9 hours.
Danish: Terminalhalveringstiden lå i intervallet 2,8 til 3,9 timer.
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.
Danish: Sammenlignet med regimet med fire daglige administrationer er regimet med én daglig administration karakteriseret af en højere maksimal koncentration, ingen lægemiddelakkumulation og en udvaskningsperiode (uden cirkulerende busulfan) mellem administrationerne.
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.
Danish: Forekomsten af hver af de bivirkninger, der er angivet i nedenstående tabel, er defineret i henhold til den højeste forekomst, der er set i publicerede kliniske studier med RIC-regimet, i hvilke den population, der blev behandlet med FB, var tydeligt identificeret, uanset behandlingsplan for busulfan og endepunkter.
English: As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to Busilvex.
Danish: Som dokumenteret i kliniske studier oplevede ingen af de behandlede patienter hjertetamponade eller anden specifik kardiotoksicitet med forbindelse til Busilvex.
English: Pharmacokinetics in adults
Danish: Farmakokinetik hos voksne
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.
Danish: Det er af særlig interesse, at der i studiet af denne interaktion i tre patientgrupper blev set højere plasmaniveauer af busulfan i den gruppe, der fik metronidazolprofylakse under behandlingen med busulfan, end hos de patienter, der ikke fik metronidazol.
English: Diseases included were acute leukaemia past first remission, in first or subsequent relapse, in first remission (high risk), or induction failures; chronic melogenous leukaemia in chronic or advanced phase; primary refractory or resistant relapsed Hodgkin's disease or non-Hodgkin's lymphoma, and myelodysplastic syndrome.
Danish: De omfattede sygdomme var akut leukæmi efter første remission, under første eller senere recidiv, under første remission (højrisiko) eller ved induktionssvigt; kronisk myeloid leukæmi i den kroniske eller fremskredne fase; primær refraktær eller resistent recidiverende Hodgkins sygdom eller nonHodgkin lymfom samt myelodysplastisk syndrom.
English: It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex.
Danish: Det anbefales at administrere antikonvulsiva fra 12 timer før Busilvex til 24 timer efter sidste Busilvex-dosis.
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.
Danish: Farmakokinetikken for intravenøst busulfan blev undersøgt hos 124 evaluerbare patienter efter 2 timers intravenøs infusion af i alt 16 doser i løbet af 4 dage.
English: 47% of patients experienced chills which were mild/moderate in 46% and severe in 1%.
Danish: 47 % af patienterne fik kuldegysninger, som var milde til moderate hos 46 % og svære hos 1 %.
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.
Danish: Kronisk GVHD (c-GVHD) blev indberettet, hvis sygdommen var alvorlig eller førte til dødsfald, og blev angivet som dødsårsag hos 3 patienter.
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.
Danish: Signalerne vedrørende orale formuleringer af busulfan og risiko for hepatisk veno-okklusiv sygdom hos patienter, der har fået tidligere strålebehandling/kemoterapi/HSCT, sterilitet og overdoseringsbehandling kan lukkes.
English: Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Danish: Busilvex kan også give symptomer på overgangsalder, og hos præ-teenagepiger kan det forhindre, at puberteten indtræder.
English: Grade 3 elevated transaminases were reported in 24% of patients.
Danish: Forhøjede aminotransferaser grad 3 blev indberettet for 24 % af patienterne.
English: Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Danish: Busulfan inducerede kromosomafvigelser in vitro (gnaver- og humane celler) og in vivo (gnavere og mennesker).
English: Patients who are concurrently treated with busulfan and itraconazole or metronidazole should be closely monitored for signs of busulfan toxicity.
Danish: Patienter, der får samtidig behandling med busulfan og itraconazol eller metronidazol, bør monitoreres tæt for tegn på busulfantoksicitet.
English: The terminal half life ranged from 2.26 to 2.52 h.
Danish: Den terminale halveringstid var fra 2,26 til 2,52 timer.