natgillin/translations-raw huggingface dataset:
Da busulfan metaboliseres gennem konjugation med glutathion, kan det overvejes at give glutathion.
Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
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.
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.
Injektionssprøjter af polycarbonat må ikke anvendes til Busilvex.
Polycarbonate syringes must not be used with Busilvex.
Den anbefalede dosis af Busilvex er 3,2 mg/kg Hver infusion varer 3 timer
The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
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.
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.
Endvidere kan busulfan muligvis inducere lungetoksicitet i tilgift til påvirkningen fra andre cytostatiske midler.
In addition, busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents.
Der kan forekomme tilfælde af blodpropdannelse i de små blodkar efter hæmatopoietisk celletransplantation (HCT), hvis De får højdosis-behandling i kombination med andre lægemidler.
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.
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).
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).
Blodstatus skal overvåges nøje, og intensiv understøttende behandling iværksættes efter medicinsk behov.
The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Busilvex-dosis (mg/kg)
Busilvex dose (mg/kg)
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.
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).
Busilvex er en kraftig cellegift (et cytostatikum), som medfører et voldsomt fald i antallet af blodlegemer.
Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Ernæring: appetitløshed, tab af blodets indhold af magnesium, calcium, kalium, fosfat og albumin samt stigning i blodsukker.
Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate, albumine in blood, and increase in blood sugar.
Terminalt fordelingsvolumen Vz lå i intervallet 0,62-0,85 l/kg.
Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Rhinit Pharyngit
Rhinitis Pharyngitis
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.
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.
Der kendes ingen antidot til Busilvex bortset fra transplantation af hæmatopoietiske progenitorceller.
There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
Any unused medicinal product or waste should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Hele den ordinerede Busilvex-dosis skal indgives i løbet af 2 eller 3 timer, afhængigt af det konditionerende regime.
The entire prescribed Busilvex dose should be delivered over two or three hours depending on the conditioning regimen.
Data vedrørende forekomsten af akut graft-versus-host-disease (a-GVHD) blev indsamlet fra OMCBUS-4 studiet (under allogeneic) (n=61).
The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Farmakokinetiske/farmakodynamiske forhold:
Pharmacokinetic/pharmacodynamic relationships:
I dette studie blev alle patienter undtagen én transplanteret med en mediantid efter allo-HCT på 15 dage (interval 10-23).
In this study, all, but one, patients engrafted, at a median of 15 (range, 10-23) days after allo-HCT.
Alle procedurer for overførsel kræver nøje overholdelse af aseptiske forhold, idet overførsel fortrinsvis skal udføres i en vertikal LAF-bænk.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Det skal De vide, før De begynder at bruge Busilvex
What you need to know before you use Busilvex
Trombocytopeni (< 25x109/l eller behov for trombocyttransfusion) forekom ved median 5-6 dage hos 98 % af patienterne.
Thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Der er rapporteret om interaktion mellem busulfan og metronidazol i litteraturen og efter markedsføring.
Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
En enkelt subkutan dosis på 2,2 g/kg administreret på 4. drægtighedsdag afsluttede drægtigheden hos 100 % af forsøgshamsterne.
A single s.c. dose of 2.2 g/kg administered on gestation day 4 terminated pregnancy in 100% of tested hamster.
Yderligere information om Busilvex findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this product is available on the website of European Medicinal Agency http://www.ema.europa.eu
den beregnede mængde Busilvex skal tages ud af hætteglasset.
- the calculated volume of Busilvex must be removed from the vial.
Busilvex leveres som klar, farveløs opløsning i 10 ml klart hætteglas af type I-glas.
Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
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.
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.
MINDSTEKRAV TIL MÆRKNING, PÅ SMÅ INDRE EMBALLAGER {10 ml type I hætteglas}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {10ml type I glass vial}
Verdenssundhedsorganisationen (WHO) har konkluderet, at der er en kausal sammenhæng mellem eksponering for busulfan og cancer.
The World Health Organisation has concluded that there is a causal relationship between busulfan exposure and cancer.
Administration af Busilvex skal superviseres af en læge med erfaring i konditionerende behandling før transplantation af hæmatopoietiske progenitorceller.
Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Total plasmaclearance lå i intervallet 2,25-2,74 ml/min/kg.
Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Data vedrørende forekomsten af akut graft-versus-host-disease (a-GVHD) blev indsamlet for allogene patienter (n=28).
The incidence of acute graft versus host disease (a-GVHD) data was collected in allogeneic patients (n=28).
Der blev påvist stigende busulfaneksponering proportionelt med dosis efter intravenøs busulfan op til 1 mg/kg.
The dose proportional increase of busulfan exposure was demonstrated following intravenous busulfan up to 1 mg/kg.
Den fortyndede opløsning må ikke nedfryses.
Do not freeze the diluted solution.
MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE PAKNING UDEN BLUE BOX {Æske indeholdende 4 hætteglas a 10 ml}
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WITHOUT BLUE BOX { box containing 4 vials of 10ml}
Gastrointestinal hæmoragi
Gastrointestinal haemorrhage
Til voksne, spædbørn, børn og unge anvendes Busilvex som behandling før transplantation.
Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MED BLÅ BOX {æske indeholdende 8 hætteglas a 10 ml}
PARTICULARS TO APPEAR ON THE OUTER PACKAGING WITH BLUE BOX {Box containing 8 vials of 10ml}
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.
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.
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.
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.
Ifølge publicerede studier med voksne forsøgspersoner kan administration af itraconazol til patienter, der får højdosis busulfan nedsætte clearance af busulfan.
From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
• Mængde infusionsvæske: (A ml Busilvex)x(10) = B ml infusionsvæske
• Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent
Hjertesymptomer: øgning af hjertefrekvens, stigning eller fald af blodtrykket, vasodilatation (en tilstand, hvor blodkarrene udvides) og blodpropper.
Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Mængden af Busilvex og infusionsvæske til administration beregnes som følger: Til en patient, der vejer Y kg:
The amount of Busilvex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Busilvex må ikke infunderes samtidig med en anden intravenøs opløsning.
Busilvex must not be infused concomitantly with another intravenous solution.
Der bør anvendes midler til understøttelse af trombocyt- og erytrocyttallet samt vækstfaktorer såsom granulocytkolonistimulerende middel (G-CSF) efter medicinsk behov.
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.
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).
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).
Busilvex skal gives som intravenøs infusion via centralt venekateter.
Busilvex should be administered by intravenous infusion via central venous catheter.
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).
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).
Ernæring: lavt natriumindhold i blodet.
Nutrition: low blood sodium.
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.
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.
Agitation Konfusion Hallucinationer
Agitation Confusional state Hallucination
Der skal udvises særlig forsigtighed, når den anbefalede Busilvex-dosis gives til patienter, som tidligere har haft krampeanfald.
Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
ANBEFALET FREMGANGSMÅDE FOR SIKKER HÅNDTERING
RECOMMENDATION FOR SAFE HANDLING
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Busilvex 6 mg/ml sterilt koncentrat
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busilvex 6 mg/ml sterile concentrate
Busulfan er et potent cytostatikum og et bifunktionelt alkylerende middel.
Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Udslæt Pruritus Alopeci
Rash Pruritis Alopecia
• Busilvex skal tilberedes af sundhedspersonale under anvendelse af steril overførselsmetode.
• Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
- 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.
- 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.
Hvert hætteglas indeholder Dimethylacetamid og Macrogol 400
LIST OF EXCIPIENTS Each vial contains Dimethylacetamide and Macrogol 400
- 12 timer efter fortynding, hvis opbevaring sker ved 2 °C - 8 °C efterfulgt af 3 timers opbevaring ved 20 °C  5 °C (inklusive infusionstid).
- 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Busulfan metaboliseres hovedsageligt via leveren, og der skal derfor udvises forsigtighed, når Busilvex anvendes til patienter med nedsat leverfunktion, specielt patienter med svær nedsættelse.
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.
Busilvex og busulfan er ikke undersøgt hos patienter med nedsat leverfunktion.
Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Forhøjet kreatinin
Creatinine elevated
Nervesystemet: søvnløshed, angst, svimmelhed og depression.
Nervous system: insomnia, anxiety, dizziness, and depression.
Da studier med busulfan hos mennesker og dyr har vist risiko for tumorgenicitet, skal amning ophøre under Busulfan-behandling.
Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.
WHO har konkluderet, at der er en kausal sammenhæng mellem eksponering for busulfan og cancer.
WHO has concluded that there is a causal relationship between busulfan exposure and cancer.
Respirationssvigt
Respiratory failure
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).
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.
Der ikke fundet evidens for en induktiv effekt af phenytoin på Busilvex.
No evidence of an induction effect of phenytoin has been seen on Busilvex data.
VEJLEDNING I TILBEREDNING
PREPARATION GUIDE
Nervesystemet: delirium, nervøsitet, hallucinationer, agitation, abnorm hjernefunktion, hjerneblødning og krampeanfald.
Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Det konkluderes derfor, at busulfan kan være en af risikofaktorerne for udvikling af TMA, og det vurderes, at en advarsel i pkt.
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.
Busilvex ødelægger Deres egen knoglemarv før transplantationen.
Busilvex destroys the original bone marrow before the transplant.
Brug ikke Busilvex - hvis De er allergisk over for busulfan eller et af de øvrige indholdsstoffer i Busilvex (angivet i punkt 6).
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.
= A ml Busilvex, der skal fortyndes
= A ml of Busilvex to be diluted
Beregning af mængden af Busilvex, der skal fortyndes, og af infusionsvæsken
Calculation of the quantity of Busilvex to be diluted and of the diluent
• Der anvendes en sprøjte, der ikke er af polycarbonat, og med isat kanyle:
• Using a non polycarbonate syringe fitted with a needle:
Busilvex efterfulgt af cyclophosphamid (BuCy4) eller melphalan (BuMel) er indiceret som konditionerende behandling før konventionel transplantation af hæmatopoietiske progenitorceller til pædiatriske patienter.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Kvinder skal undgå at blive gravide under behandling med Busilvex og op til 6 måneder efter endt behandling.
Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
Publicerede studier vedrørende FB-regimet hos voksne rapporterede ikke om indbyrdes interaktioner mellem intravenøs busulfan og fludarabin.
In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
Slutkoncentrationen skal være ca. 0,5 mg busulfan/ml.
A final concentration of approximately 0.5 mg/ml busulfan should be achieved.
Busilvex efterfulgt af cyclophosphamid (BuCy2) er indiceret som konditionerende behandling før konventionel transplantation af hæmatopoietiske progenitorceller (HPCT) til voksne patienter, når kombinationen anses for at være det bedste behandlingsvalg.
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Byld i hjernen, betændelseslignende tilstand i huden, generaliseret infektion.
Brain abscess, Inflammation of the skin, generalised infection.
Imidlertid blev en højere variabilitet observeret hos børn under 9 kg førende til, at 60 % af børnene nåede det terapeutiske vindue (900 til 1.500 mikromol/l.minut).
However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
Gastrointestinal blødning Tandhypoplasi*
Gastro-intestinal haemorrhage Tooth hypoplasia*
Muskler og knogler: smerter i ryg, muskler og led.
Muscle and bone: back, muscle and joint pain.
Der anvendes en sprøjte, der ikke er af polycarbonat, isat kanyle: - den beregnede mængde Busilvex tages ud af hætteglasset.
Using a non polycarbonate syringe fitted with a needle: - the calculated volume of Busilvex must be removed from the vial.
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 %).
was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
Busilvex gives én gang dagligt 2 eller 3 dage i træk forud for transplantationen
Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i op til 6 måneder efter behandlingen.
Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Busilvex administreres før transplantation af hæmatopoietiske progenitorceller (HPCT).
Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Når ikke alt stoffet blev genfundet, kan det skyldes irreversibel proteinbinding.
Irreversible protein binding may explain the incomplete recovery.
Busilvex indeholder: - Aktivt stof: Busulfan.
The active substance is busulfan.
Kemisk og fysisk stabilitet efter fortynding i glucose 5 % eller natriumchlorid 9 mg / ml (0,9 %) injektionsvæske er påvist i 8 timer (inklusive infusionstid) efter fortynding, når det opbevares ved 20 °C  5 °C, og 12 timer efter fortynding, når det opbevares ved 2 °C-8 °C efterfulgt af 3 timer ved 20 °C  5 °C (inklusive infusionstid).
Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 8 hours (including infusion time) after dilution when stored at 20 °C  5 °C or 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Busulfan kan forårsage sterilitet hos gnavere.
Busulfan was shown to cause sterility in rodents.
Undersøgelser: forhøjede leverenzymer og vægtøgning.
Investigations: elevated liver enzymes and weight increased.
Tidsrummet frem til absolut neutrofiltal (ANC) > 0,5x109/l var 21 dage (interval 12-47 dage) hos allogene patienter og 11 dage (interval 10-15 dage) hos autologe patienter.
The time to Absolute Neutrophil Count (ANC) greater than 0.5x109/l was 21 days (range 12-47 days) in allogenic patients, and 11 days (range 10-15 days) in autologous patients.
Tandhypoplasi**
Tooth hypoplasia**
Anæmi (hæmoglobin < 8,0 g/dl) forekom hos 69 % af patienterne.
Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Absolut neutrofiltal < 0,5x109/l ved en median på 3 dage efter transplantationen optrådte hos 100 % af de pædiatriske patienter og varede 5 og 18,5 dage efter henholdsvis autolog og allogen transplantation.
In paediatric population, absolute neutrophil counts < 0.5x109/l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Informationerne om uønskede hændelser stammer fra det kliniske studie på børn (n=55).
Adverse events information are derived from the clinical study in paediatrics (n=55).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml koncentrat indeholder 6 mg busulfan, hvilket giver 0,5 mg/ml busulfan efter fortynding.
STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Vægtstigning Anormale vejrtrækningslyde Forhøjet kreatinin
Weight increased Abnormal breath sounds
Patienterne fik doser a 0,8 mg/kg busulfan som infusion hver 6. time - 16 doser i alt - efterfulgt af cyclophosphamid i doser på 60 mg/kg en gang daglig i 2 dage (BuCy2-regime).
Patients received doses of 0.8 mg/kg busulfan every 6 hours infusion for a total 16 doses followed by cyclophosphamide at 60 mg/kg once per day for two days (BuCy2 regimen).
Interstitiel lungesygdom**
Interstitial lung disease**