FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of intravenous busulfan was studied in 124 evaluable patients following a 2-hour intravenous infusion for a total of 16 doses over four days.
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: CNS changes precede any of the more severe side effects.
Danish: Ændringer i centralnervesystemet går forud for alle sværere bivirkninger.
English: No patients were discontinued from treatment due to adverse reactions related to busulfan.
Danish: Ingen af patienterne afbrød behandlingen på grund af bivirkninger relateret til busulfan.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Danish: Din læge vil løbende kontrollere dine blodværdier og leverenzymer for at opdage og behandle disse bivirkninger.
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Danish: Den hæmatologiske status skal overvåges nøje, og intensiv understøttende behandling iværksættes efter medicinsk behov.
English: Ask your pharmacist how to throw away medicine you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Busulfan and DMA can impair fertility in man or woman.
Danish: Busulfan og DMA kan nedsætte fertiliteten hos mænd eller kvinder.
English: Paediatric population (0 to 17 years) The safety and efficacy of FB in pediatric population has not been established.
Danish: Pædiatrisk population (0 til 17 år) Fludarabins sikkerhed og virkning i den pædiatriske population er ikke klarlagt.
English: Data from a recently completed prospective multicentre phase 2 study including 80 patients, aged 18 to 65 years old, diagnosed with different hematologic malignancies who underwent allo-HCT with an FB (3 days of busulfan) reduced intensity conditioning regimen became available.
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 busulfan), er nu tilgængelige.
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 µmol/l.min efter 1 mg/kg.
English: IBW women (kg) = 45 + 0.91x (height in cm-152).
Danish: IBW kvinder (kg) =45+0,91x (højde i cm-152).
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 hæmatopoietiske progenitorceller, kan være i højrisikogruppen (se pkt.
English: OTHER SPECIAL WARNING IF NECESSARY Cytotoxic
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytostatikum
English: Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-S-transferase mediated).
Danish: Busulfan metaboliseres hovedsageligt gennem konjugation med glutathion (spontant og gennem glutathion-S-transferase).
English: It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with Busulfan Fresenius Kabi.
Danish: Det kan være, at det ikke længere er muligt for dig at blive gravid (ufrugtbarhed) efter behandling med Busulfan Fresenius Kabi.
English: Hypertension Hypotension Thrombosis Vasodilatation
Danish: Hypertension Hypotension Trombose Vasodilatation
English: The residual medicinal product must not be flushed in the administration tubing as rapid infusion of busulfan has not been tested and is not recommended.
Danish: Evt. lægemiddelrest i droppet må ikke skylles ind i venen, da hurtig infusion af busulfan ikke er afprøvet og derfor ikke anbefales.
English: 10 ml of concentrate for solution for infusion in clear colourless glass vials (type I) with teflon faced rubber stopper and sealed with aluminium flip-off seal.
Danish: 10 ml koncentrat til infusionsvæske, opløsning i klart farveløst hætteglas (type I) med teflonbelagt gummi prop og forseglet med aluminium flip-off kapsel.
English: The following information is intended for healthcare professionals only PREPARATION GUIDE
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: In the absence of haematopoietic progenitor cell transplantation, the recommended dose of busulfan would constitute an overdose of busulfan.
Danish: Uden sammenhæng med transplantation af hæmatopoietiske progenitorceller vil den anbefalede dosis af busulfan udgøre en overdosis af busulfan.
English: The use of paracetamol during the 72 hours prior to or with Busulfan Fresenius Kabi administration should be used with caution.
Danish: Brug af paracetamol i op til 72 timer før eller samtidig med indgivelse af Busulfan Fresenius Kabi skal ske med forsigtighed.
English: The safety profile of busulfan combined with fludarabine (FB) has been examined through a review of adverse reactions reported in published data from clinical trials in RIC regimen.
Danish: Sikkerhedsprofilen af busulfan i kombination med fludarabin (FB) er blevet undersøgt via en gennemgang af bivirkninger indrapporteret i publicerede data fra kliniske studier med RIC-regimet.
English: Adverse reactions information is derived from two clinical trials (n=103) of busulfan.
Danish: Informationerne om bivirkninger stammer fra to kliniske studier (n=103) med busulfan.
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 85,7-99,9 %).
English: The consequence of treatment with busulfan at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Danish: Behandlingen med busulfan i den anbefalede dosis og ifølge behandlingsplanen bevirker omfattende myelosuppression hos alle patienter.
English: As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to busulfan.
Danish: Som dokumenteret i kliniske studier, oplevede ingen af de behandlede patienter hjertetamponade eller særlig kardiotoksicitet med forbindelse til busulfan.
English: A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimen-related 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 most serious side effects of busulfan therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Danish: De alvorligste bivirkninger ved behandlingen med busulfan eller selve transplantationen kan være et fald i antallet af blodlegemer i blodcirkulationen (ønsket effekt af lægemidlet for at forberede dig til transplantationsinfusionen), betændelse, leversygdomme herunder blokering af en vene i leveren, graft-versus-host-disease (hvor donorcellerne angriber din krop) og lungekomplikationer.
English: Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Danish: Busulfan-behandling hos præpubertær pige forhindrede pubertetsstart på grund af ovariesvigt.
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 eller granisetron.
English: Busulfan dose (mg/kg)
Danish: Busulfan-dosis (mg/kg)
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 µmol/l.min pr. administration (svarende til en daglig eksponering mellem 3.600 og 6.000 mol/l.min ).
English: Renal and urinary disorders It has been suggested that conditioning regimens containing fludarabine were associated with higher incidence of opportunistic infections after transplantation because of the immunosuppressive effect of fludarabine.
Danish: Det er blevet antydet, at konditionerende regimer indeholdende fludarabin var forbundet med højere forekomst af opportunistiske infektioner efter transplantation på grund af fludarabins immunsupprimerende virkning.
English: - The other ingredients are dimethylacetamide and macrogol 400.
Danish: - Øvrige indholdsstoffer: dimethylacetamid og macrogol 400.
English: Busulfan must not be infused concomitantly with another intravenous solution.
Danish: Busulfan må ikke infunderes samtidig med en anden intravenøs opløsning.
English: All patients should be pre-medicated with anticonvulsant medicinal products to prevent seizures reported with the use of high dose busulfan.
Danish: Alle patienter bør præmedicineres med antikonvulsiva for at forhindre kramper, som er indberettet efter høje doser busulfan.
English: Respiratory: decrease in blood oxygen.
Danish: Åndedræt: nedsat mængde ilt i blodet.
English: Women must not be pregnant during treatment with Busulfan Fresenius Kabi and up to 6 months after treatment.
Danish: Kvinder skal undgå at blive gravide under behandling med Busulfan Fresenius Kabi og op til 6 måneder efter endt behandling.
English: Documentation on the safety and efficacy of busulfan in combination with fludarabine (FB) prior to allogeneic HPCT derives from the literature review of 7 published studies involving 731 patients with myeloid and lymphoid malignancies reporting the use of intravenous busulfan infused once daily instead of four doses per day.
Danish: Dokumentation for sikkerhed og virkning af busulfan 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: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan påvirke mere end 1 ud af 10 patienter):
English: Hepato-biliary disorders VOD was reported with a range between 3.9% and 15.4%.
Danish: Lever og galdeveje Venookklusiv sygdom blev indberettet hos mellem 3,9 % og 15,4 %.
English: Periodic monitoring of renal function should be considered during therapy with busulfan (see section
Danish: Regelmæssig overvågning af nyrefunktionen bør overvejes under behandling med busulfan (se pkt.
English: Clear, colourless viscous solution.
Danish: Klar, farveløs viskøs opløsning.
English: Busulfan is for single use only.
Danish: Busulfan er kun til engangsbrug.
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: Med baggrund i de undersøgte kliniske data blev en kontinuerlig variation inden for området 2,49 til 3,92 ml/min/kg fastlagt hos børn i alderen < 6 måneder og op til 17 år.
English: Preparation of the solution for infusion
Danish: Fremstilling af infusionsopløsningen
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2°C - 8°C)
English: Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Danish: Ernæring: appetitløshed, nedsat indhold af magnesium, calcium, kalium, fosfat og albumin i blodet samt stigning i blodsukker.
English: You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.
Danish: Du vil få denne medicin som forbehandling, før du skal have foretaget en transplantation med enten knoglemarv eller hæmatopoietiske progenitorceller.
English: Only a clear solution without any particles should be used.
Danish: Opløsningen skal være klar og uden partikler.
English: At 2 years, the cumulative incidence of NRM was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI, 31.1-55.7%).
Danish: Efter 2 år var den samlede forekomst af NRM 11,3 % (95 % CI 5,5-19,3 %), og den samlede forekomst af recidiv eller progression efter allo-HCT var 43,8 % (95 % CI 31,1-55,7 %).
English: Antiemetics should be administered prior to the first dose of busulfan and continued on a fixed schedule according to local practice through its administration.
Danish: Der bør gives antiemetika før første dosis af busulfan og fortsættes hermed efter et fast skema under behandlingen i overensstemmelse med almindelig praksis.
English: Nervous system: confusion, nervous system disorders.
Danish: Nervesystemet: forvirring (konfus), sygdomme i nervesystemet.
English: Busulfan is for intravenous use.
Danish: Busulfan er til intravenøs anvendelse.
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.
Danish: Der kan forekomme tilfælde af blodpropdannelse i de små blodkar efter hæmatopoietisk celletransplantation (HCT), hvis du får højdosis-behandling i kombination med andre lægemidler.
English: Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
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).
Danish: Under kliniske studier med intravenøst busulfan, administreret som 0,80 mg/kg fire gange dagligt, lå 90 % af patienternes AUC under den øvre AUC grænse (1.500 µmol/l.min), og mindst 80 % lå inden for det tilsigtede terapeutiske vindue (900 -1500 µmol/l.min).
English: Pack size 1 pack containing 8 vials (8 cartons of 1 vial).
Danish: Pakningsstørrelse 1 pakning indeholdende 8 hætteglas (8 æsker á 1 hætteglas).
English: Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Danish: Ifølge publicerede studier med deltagelse af voksne kan ketobemidon (analgetikum) muligvis sættes i forbindelse med høje plasmaniveauer af busulfan.
English: RECOMMENDATION FOR SAFE HANDLING Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Danish: ANBEFALET FREMGANGSMÅDE FOR SIKKER HÅNDTERING Der bør fastlægges procedurer for korrekt håndtering og bortskaffelse af cytotoksiske lægemidler.
English: Busulfan Fresenius Kabi can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Danish: Busulfan Fresenius Kabi kan også give symptomer på overgangsalder, og hos præteenagepiger kan det forhindre, at puberteten indtræder.
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with busulfan due to a possible decrease in the metabolism of busulfan (See section 4.5).
Danish: Der bør udvises forsigtighed ved anvendelse af paracetamol før (under 72 timer) eller samtidig med busulfan, da dette muligvis vil nedsætte metaboliseringen af busulfan (se pkt.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Danish: Kvinder i den fertile alder Fertile kvinder skal anvende sikker prævention under og op til 6 måneder efter behandlingen.
English: However cardiac function should be monitored regularly in patients receiving busulfan (see section 4.8).
Danish: Hjertefunktionen skal dog kontrolleres regelmæssigt hos patienter, der får busulfan (se pkt.
English: It is possible that use of Busulfan Fresenius Kabi may increase the risk of suffering another malignancy in the future.
Danish: Det er muligt, at anvendelse af busulfan øger risikoen for at få en anden ondartet sygdom i fremtiden.
English: Gastrointestinal disorders The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Danish: Mave-tarm-kanalen: Den højeste forekomst af kvalme og opkastning var 59,1 %, og den højeste forekomst af stomatitis var 11
English: There is no known antidote to busulfan other than haematopoietic progenitor cell transplantation.
Danish: Der kendes ingen antidot til busulfan bortset fra transplantation af hæmatopoietiske progenitorceller.
English: Busulfan administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Danish: Administration af busulfan skal superviseres af en læge med erfaring i konditionerende behandling før transplantation af hæmatopoietiske progenitorceller.
English: Busulfan in combination with cyclophosphamide or melphalan 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: Busulfan i kombination med cyclophosphamid eller melphalan Bivirkninger, der er indberettet hos både voksne og pædiatriske patienter i mere end et enkeltstående tilfælde, er angivet nedenfor efter systemorganklasse og hyppighed.
English: Therefore, men treated with busulfan are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with busulfan.
Danish: Det anbefales, at mænd behandlet med busulfan undgår at avle børn under og op til 6 måneder efter behandlingen, og at de rådgives om nedfrysning af sæd før behandlingen på grund af muligheden for irreversibel infertilitet på grund af behandling med busulfan.
English: Busulfan in combination with fludarabine (FB) In adults 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.
Danish: Busulfan i kombination med fludarabin (FB) Til voksne Den anbefalede dosis og behandlingsplan er: - fludarabin administreret som en enkelt daglig 1-times infusion på 30 mg/m2 i 5 på hinanden følgende dage eller 40 mg/m2 i 4 på hinanden følgende dage.
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.
Danish: For et behandlingsregime med BuCy2 til voksne er der indberettet, at tidsintervallet mellem sidste orale administration af busulfan og første administration af cyclophosphamid kan påvirke udviklingen af toksicitet.
English: Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Danish: Hjerte: øget hjertefrekvens, stigning eller fald af blodtrykket, vasodilatation (en tilstand, hvor blodkarrene udvides) og blodpropper.
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61) .
Danish: Data vedrørende forekomsten af akut graft-versus-host-disease (a-GVHD) blev indsamlet fra OMC-BUS4 studiet (under allogeneic) (n=61).
English: In new-born infants, children and adolescents, this medicine is used in combination with cyclophosphamide or melphalan.
Danish: Til spædbørn, børn og unge anvendes denne medicin i kombination med cyclophosphamid eller melphalan.
English: Busulfan Fresenius Kabi may interact with other medicines.
Danish: Busulfan Fresenius Kabi kan reagere med andre lægemidler.
English: Men treated with Busulfan Fresenius Kabi are advised not to father child during and up to 6 months after treatment.
Danish: Mænd, der behandles med Busulfan Fresenius Kabi, rådes til ikke at få børn under og i op til 6 måneder efter behandlingen.
English: It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity.
Danish: Det anbefales at monitorere serum-aminotransferase, alkalisk fosfatase og bilirubin regelmæssigt hos denne patientgruppe i 28 dage efter transplantationen med henblik på påvisning af eventuel hepatotoksicitet.
English: Read this guide prior to the preparation and administration of Busulfan Fresenius Kabi.
Danish: Læs denne vejledning før tilberedning og indgift af Busulfan Fresenius Kabi.
English: Busulfan should be administered by intravenous infusion via central venous catheter.
Danish: Busulfan skal gives som intravenøs infusion via centralt venekateter.
English: Busulfan can impair fertility.
Danish: Busulfan kan nedsætte fertiliteten.
English: The recommended dose of Busulfan Fresenius Kabi in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Danish: Den anbefalede dosis Busulfan Fresenius Kabi i kombination med cyclophosphamid eller melphalan afhænger af din legemsvægt og varierer fra mellem 0,8 og 1,2 mg/kg.
English: Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.
Danish: Da studier med busulfan hos mennesker og dyr har vist risiko for tumorgenicitet, skal amning ophøre under behandling med busulfan.
English: Do not freeze the diluted solution.
Danish: Den fortyndede opløsning må ikke fryses.
English: followed by: - 4 cycles of 50 mg/kg body weight (BW) cyclophosphamide (BuCy4) or - one administration of 140 mg/m² melphalan (BuMel) initiated for at least 24 hours following the 16th dose of busulfan (see section 4.5).
Danish: efterfulgt af: - 4 cykler a 50 mg/kg legemsvægt (BW) cyclophosphamid (BuCy4) eller - en enkelt administration af 140 mg/m² melphalan (BuMel) der først indledes mindst 24 timer efter den 16. dosis af busulfan (se pkt.
English: Busulfan Fresenius Kabi is supplied as a clear colourless viscous solution in 10 ml clear, colourless glass vials (type I).
Danish: Busulfan Fresenius Kabi leveres som klar farveløs viskøs opløsning i 10 ml klart farveløst hætteglas (type 1).
English: What Busulfan Fresenius Kabi contains - The active substance is busulfan.
Danish: Busulfan Fresenius Kabi indeholder: - Aktivt stof: busulfan.
English: Vials 2 years.
Danish: Hætteglas: 2 år
English: LIST OF EXCIPIENTS Excipients: Dimethylacetamide and Macrogol 400
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: Dimethylacetamid og Macrogol 400
English: - Busulfan will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days.
Danish: - busulfan administreres i en dosis på 3,2 mg/kg som en enkelt daglig 3-timers infusion umiddelbart efter fludarabin i 2 eller 3 på hinanden følgende dage.
English: Since busulfan is mainly metabolized through the liver, caution should be observed when busulfan is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Danish: Busulfan metaboliseres hovedsageligt via leveren, og der skal derfor udvises forsigtighed, når busulfan anvendes til patienter med nedsat leverfunktion, specielt patienter med svær nedsættelse.