FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients received a conditioning regimen based on the administration of fludarabine immediately followed by single daily dose of 3.2 mg/kg busulfan over 2 or 3 consecutive days.
Danish: Patienterne fik et konditionerende regime baseret på administration af fludarabin, der øjeblikkeligt blev efterfulgt af en enkelt daglig dosis på 3,2 mg/kg busulfan i 2 eller 3 dage i træk.
English: The most serious side effects of Busilvex 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 Busilvex eller transplantationen kan omfatte et fald i antallet af blodlegemer i blodcirkulationen (ønsket effekt af lægemidlet for at forberede Dem til transplantationsinfusionen), betændelse, leversygdomme omfattende blokering af en vene i leveren, graft-versus-host-disease (hvor donorcellerne angriber organismen) og lungekomplikationer.
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 Busilvex i høje doser.
English: The incidence of a-GVHD grades I-II was 13% (8/61), while the incidence of grade III-IV was 5% (3/61).
Danish: Forekomsten af aGVHD grad I-II var 13 % (8/61), mens forekomsten af grad III-IV var 5 % (3/61).
English: The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Danish: Evt. lægemiddelrest i droppet må ikke skylles ind i venen, da hurtig infusion af Busilvex ikke er afprøvet og derfor ikke anbefales.
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: In one article it was studied the role of busulfan in juvenile rats resulting in abnormal root development; a review of two cases of immunodeficiency disorders treated with busulfan and cyclophosphamide in which dental orthodontic treatment was provided; additional 2 case report of hypoplasia of permanent tooth germ is presented; one review assessed the long term effects of cytotoxic therapy concluding that tooth agenesis was more prevalent in patients treated with busulfan and cyclophosphamide; a study of 81 patients concluded that busulfan is as toxic as total body irradiation in causing disturbances in dental development; finally, a study of risk factors of tooth formation anomalies in paediatric cancers concluded that the high risk group of tooth agenesis was the subject with high dose chemotherapy under 4 years old.
Danish: I en artikel er der rapporteret om abnorm tandudvikling hos unge rotter som følge af busulfan; I en gennemgang er der beskrevet to tilfælde, hvor der er gennemført tandregulering hos patienter med immundefektforstyrrelser, der blev behandlet med busulfan og cyclophosphamid; der er fremlagt 2 yderligere indberetninger om hypoplasi af permanent tandanlæg; i en gennemgang af de langsigtede virkninger af cytotoksisk behandling, konkluderes det, at tandagenesi er hyppigere hos patienter, der bliver behandlet med busulfan og cyclophosphamid; i et studie af 81 patienter konkluderes det, at busulfan er lige så toksisk som helkropsbestråling, hvad angår fremkaldelse af tandudviklingsforstyrrelser.
English: Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
Danish: Da busulfan metaboliseres gennem konjugation med glutathion, kan det overvejes at give glutathion.
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 aminotransferase, alkalisk fosfatase og bilirubin i serum regelmæssigt hos denne patientgruppe i 28 dage efter transplantationen med henblik på tidlig påvisning af eventuel hepatotoksicitet.
English: Polycarbonate syringes must not be used with Busilvex.
Danish: Injektionssprøjter af polycarbonat må ikke anvendes til Busilvex.
English: The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
Danish: Den anbefalede dosis af Busilvex er 3,2 mg/kg Hver infusion varer 3 timer
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.
Danish: Der opnås omtrent samme targetrate inden for den daglige eksponering på 3.600-6.000 µmol/l minut efter intravenøs administration af busulfan 3,2 mg/kg én gang dagligt.
English: In addition, busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents.
Danish: Endvidere kan busulfan muligvis inducere lungetoksicitet i tilgift til påvirkningen fra andre cytostatiske midler.
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 De får højdosis-behandling i kombination med andre lægemidler.
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: I 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 mol/l.min), og mindst 80 % lå inden for det tilsigtede terapeutiske vindue (900 - 1500 mol/l.min).
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Danish: Blodstatus skal overvåges nøje, og intensiv understøttende behandling iværksættes efter medicinsk behov.
English: Busilvex dose (mg/kg)
Danish: Busilvex-dosis (mg/kg)
English: Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with Busilvex 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 Busilvex, da dette muligvis vil nedsætte metaboliseringen af busulfan (se pkt.
English: Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Danish: Busilvex er en kraftig cellegift (et cytostatikum), som medfører et voldsomt fald i antallet af blodlegemer.
English: Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Danish: Ernæring: appetitløshed, tab af blodets indhold af magnesium, calcium, kalium, fosfat og albumin samt stigning i blodsukker.
English: Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Danish: Terminalt fordelingsvolumen Vz lå i intervallet 0,62-0,85 l/kg.
English: Rhinitis Pharyngitis
Danish: Rhinit Pharyngit
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 udvikling af toksicitet.
English: There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Danish: Der kendes ingen antidot til Busilvex bortset fra transplantation af hæmatopoietiske progenitorceller.
English: Any unused medicinal product or waste should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
English: The entire prescribed Busilvex dose should be delivered over two or three hours depending on the conditioning regimen.
Danish: Hele den ordinerede Busilvex-dosis skal indgives i løbet af 2 eller 3 timer, afhængigt af det konditionerende regime.
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 OMCBUS-4 studiet (under allogeneic) (n=61).
English: Pharmacokinetic/pharmacodynamic relationships:
Danish: Farmakokinetiske/farmakodynamiske forhold:
English: In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT.
Danish: I dette studie blev alle patienter undtagen én transplanteret med en mediantid efter allo-HCT på 15 dage (interval 10-23).
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Danish: Alle procedurer for overførsel kræver nøje overholdelse af aseptiske forhold, idet overførsel fortrinsvis skal udføres i en vertikal LAF-bænk.
English: What you need to know before you use Busilvex
Danish: Det skal De vide, før De begynder at bruge Busilvex
English: Thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Danish: Trombocytopeni (< 25x109/l eller behov for trombocyttransfusion) forekom ved median 5-6 dage hos 98 % af patienterne.
English: Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
Danish: Der er rapporteret om interaktion mellem busulfan og metronidazol i litteraturen og efter markedsføring.
English: A single s.c. dose of 2.2 g/kg administered on gestation day 4 terminated pregnancy in 100% of tested hamster.
Danish: En enkelt subkutan dosis på 2,2 g/kg administreret på 4. drægtighedsdag afsluttede drægtigheden hos 100 % af forsøgshamsterne.
English: Detailed information on this product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Danish: Yderligere information om Busilvex findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: - the calculated volume of Busilvex must be removed from the vial.
Danish: den beregnede mængde Busilvex skal tages ud af hætteglasset.
English: Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Danish: Busilvex leveres som klar, farveløs opløsning i 10 ml klart hætteglas af type I-glas.
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.
Danish: Den anbefalede dosis og behandlingsplan er: - fludarabin administreret som en enkelt daglig 1-times infusion af 30 mg/m2 fem dage i træk eller af 40 mg/m2 fire dage i træk.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {10ml type I glass vial}
Danish: MINDSTEKRAV TIL MÆRKNING, PÅ SMÅ INDRE EMBALLAGER {10 ml type I hætteglas}
English: The World Health Organisation has concluded that there is a causal relationship between busulfan exposure and cancer.
Danish: Verdenssundhedsorganisationen (WHO) har konkluderet, at der er en kausal sammenhæng mellem eksponering for busulfan og cancer.
English: Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Danish: Administration af Busilvex skal superviseres af en læge med erfaring i konditionerende behandling før transplantation af hæmatopoietiske progenitorceller.
English: Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Danish: Total plasmaclearance lå i intervallet 2,25-2,74 ml/min/kg.
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Danish: Data vedrørende forekomsten af akut graft-versus-host-disease (a-GVHD) blev indsamlet for allogene patienter (n=28).
English: The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/kg.
Danish: Der blev påvist stigende busulfaneksponering proportionelt med dosis efter intravenøs busulfan op til 1 mg/kg.
English: Do not freeze the diluted solution.
Danish: Den fortyndede opløsning må ikke nedfryses.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WITHOUT BLUE BOX { box containing 4 vials of 10ml}
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE PAKNING UDEN BLUE BOX {Æske indeholdende 4 hætteglas a 10 ml}
English: Gastrointestinal haemorrhage
Danish: Gastrointestinal hæmoragi
English: Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Danish: Til voksne, spædbørn, børn og unge anvendes Busilvex som behandling før transplantation.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WITH BLUE BOX {Box containing 8 vials of 10ml}
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MED BLÅ BOX {æske indeholdende 8 hætteglas a 10 ml}
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.
Danish: Der opnåedes samstemmende blodeksponering ved sammenligning af plasmakoncentrationer hos voksne patienter, der fik busulfan oralt og intravenøst i doser på hhv. 1 mg/kg og 0,8 mg/kg.
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 Busilvex.
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 24 timer efter den 16. dosis Busilvex (se pkt.
English: From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
Danish: Ifølge publicerede studier med voksne forsøgspersoner kan administration af itraconazol til patienter, der får højdosis busulfan nedsætte clearance af busulfan.
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent
Danish: • Mængde infusionsvæske: (A ml Busilvex)x(10) = B ml infusionsvæske
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: Hjertesymptomer: øgning af hjertefrekvens, stigning eller fald af blodtrykket, vasodilatation (en tilstand, hvor blodkarrene udvides) og blodpropper.
English: The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Danish: Mængden af Busilvex og infusionsvæske til administration beregnes som følger: Til en patient, der vejer Y kg:
English: Busilvex must not be infused concomitantly with another intravenous solution.
Danish: Busilvex må ikke infunderes samtidig med en anden intravenøs opløsning.
English: Platelet and red blood cell support, as well as the use of growth factors such as granulocyte colony stimulating agent (G-CSF), should be employed as medically indicated.
Danish: Der bør anvendes midler til understøttelse af trombocyt- og erytrocyttallet samt vækstfaktorer såsom granulocytkolonistimulerende middel (G-CSF) efter medicinsk behov.
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).
Danish: Dokumentation for sikkerhed og effekt af Busilvex i kombination med cyclophosphamid i et BuCy2behandlingsregime før konventionel allogen og/eller autolog HPCT stammer fra to kliniske studier (OMC-BUS-4 og OMC-BUS-3).
English: Busilvex should be administered by intravenous infusion via central venous catheter.
Danish: Busilvex skal gives som intravenøs infusion via centralt venekateter.
English: Busilvex is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and haematopoietic progenitor cell transplantation (HPCT).
Danish: Busilvex administreres som 2 timers infusion hver 6. time 4 dage i træk, så der opnås i alt 16 doser før cyclophosphamid eller melphalan og transplantation af hæmatopoietiske progenitorceller (HPCT).
English: Nutrition: low blood sodium.
Danish: Ernæring: lavt natriumindhold i blodet.
English: Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy4 or with melphalan in the BuMel regimen prior to conventional allogeneic and/or autologous HPCT derives from clinical trial F60002 IN 101 G0.
Danish: Dokumentation af sikkerhed og effekt af Busilvex i kombination med cyclophosphamid i et BuCy4behandlingsregimen eller med melphalan i BuMel-regimenet før konventionel allogen og/eller autolog HPCT stammer fra det kliniske studie F60002 IN 101 G0.
English: Agitation Confusional state Hallucination
Danish: Agitation Konfusion Hallucinationer
English: Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Danish: Der skal udvises særlig forsigtighed, når den anbefalede Busilvex-dosis gives til patienter, som tidligere har haft krampeanfald.
English: RECOMMENDATION FOR SAFE HANDLING
Danish: ANBEFALET FREMGANGSMÅDE FOR SIKKER HÅNDTERING
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busilvex 6 mg/ml sterile concentrate
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Busilvex 6 mg/ml sterilt koncentrat
English: Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Danish: Busulfan er et potent cytostatikum og et bifunktionelt alkylerende middel.
English: Rash Pruritis Alopecia
Danish: Udslæt Pruritus Alopeci
English: • Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Danish: • Busilvex skal tilberedes af sundhedspersonale under anvendelse af steril overførselsmetode.
English: - Busilvex 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: - Busilvex administreres i en dosis på 3,2 mg/kg som en enkelt daglig 3-timers infusion umiddelbart efter 2 eller 3 på hinanden følgende dage af fludarabin.
English: LIST OF EXCIPIENTS Each vial contains Dimethylacetamide and Macrogol 400
Danish: Hvert hætteglas indeholder Dimethylacetamid og Macrogol 400
English: - 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Danish: - 12 timer efter fortynding, hvis opbevaring sker ved 2 °C - 8 °C efterfulgt af 3 timers opbevaring ved 20 °C  5 °C (inklusive infusionstid).
English: Since busulfan is mainly metabolized through the liver, caution should be observed when Busilvex 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 Busilvex anvendes til patienter med nedsat leverfunktion, specielt patienter med svær nedsættelse.
English: Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Danish: Busilvex og busulfan er ikke undersøgt hos patienter med nedsat leverfunktion.
English: Creatinine elevated
Danish: Forhøjet kreatinin
English: Nervous system: insomnia, anxiety, dizziness, and depression.
Danish: Nervesystemet: søvnløshed, angst, svimmelhed og depression.
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 Busulfan-behandling.
English: WHO has concluded that there is a causal relationship between busulfan exposure and cancer.
Danish: WHO har konkluderet, at der er en kausal sammenhæng mellem eksponering for busulfan og cancer.
English: Respiratory failure
Danish: Respirationssvigt
English: Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.
Danish: Busilvex efterfølgende fludarabin (FB) er indiceret som konditionerende behandling før transplantation af hæmatopoietiske progenitorceller (HPTC) til voksne patienter, der er kandidater til et konditionerende regime med reduceret intensitet (RIC).
English: No evidence of an induction effect of phenytoin has been seen on Busilvex data.
Danish: Der ikke fundet evidens for en induktiv effekt af phenytoin på Busilvex.
English: PREPARATION GUIDE
Danish: VEJLEDNING I TILBEREDNING
English: Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Danish: Nervesystemet: delirium, nervøsitet, hallucinationer, agitation, abnorm hjernefunktion, hjerneblødning og krampeanfald.
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.
Danish: Det konkluderes derfor, at busulfan kan være en af risikofaktorerne for udvikling af TMA, og det vurderes, at en advarsel i pkt.
English: Busilvex destroys the original bone marrow before the transplant.
Danish: Busilvex ødelægger Deres egen knoglemarv før transplantationen.
English: Do not use Busilvex: if you are allergic to busulfan or any of the other ingredients of Busilvex listed in section 6, if you are pregnant, or think you may be pregnant.
Danish: Brug ikke Busilvex - hvis De er allergisk over for busulfan eller et af de øvrige indholdsstoffer i Busilvex (angivet i punkt 6).
English: = A ml of Busilvex to be diluted
Danish: = A ml Busilvex, der skal fortyndes
English: Calculation of the quantity of Busilvex to be diluted and of the diluent
Danish: Beregning af mængden af Busilvex, der skal fortyndes, og af infusionsvæsken
English: • Using a non polycarbonate syringe fitted with a needle:
Danish: • Der anvendes en sprøjte, der ikke er af polycarbonat, og med isat kanyle:
English: Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Danish: Busilvex efterfulgt af cyclophosphamid (BuCy4) eller melphalan (BuMel) er indiceret som konditionerende behandling før konventionel transplantation af hæmatopoietiske progenitorceller til pædiatriske patienter.
English: Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Danish: Kvinder skal undgå at blive gravide under behandling med Busilvex og op til 6 måneder efter endt behandling.
English: In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
Danish: Publicerede studier vedrørende FB-regimet hos voksne rapporterede ikke om indbyrdes interaktioner mellem intravenøs busulfan og fludarabin.
English: A final concentration of approximately 0.5 mg/ml busulfan should be achieved.
Danish: Slutkoncentrationen skal være ca. 0,5 mg busulfan/ml.