FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Brain abscess, Inflammation of the skin, generalised infection.
Danish: Byld i hjernen, betændelseslignende tilstand i huden, generaliseret infektion.
English: However a higher variability was observed in children < 9 kg leading to 60% of children achieving the therapeutic window (900-1500 µmol/L.minute).
Danish: 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).
English: Gastro-intestinal haemorrhage Tooth hypoplasia*
Danish: Gastrointestinal blødning Tandhypoplasi*
English: Muscle and bone: back, muscle and joint pain.
Danish: Muskler og knogler: smerter i ryg, muskler og led.
English: Using a non polycarbonate syringe fitted with a needle: - the calculated volume of Busilvex must be removed from the vial.
Danish: Der anvendes en sprøjte, der ikke er af polycarbonat, isat kanyle: - den beregnede mængde Busilvex tages ud af hætteglasset.
English: was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
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: Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
Danish: Busilvex gives én gang dagligt 2 eller 3 dage i træk forud for transplantationen
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i op til 6 måneder efter behandlingen.
English: Busilvex is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Danish: Busilvex administreres før transplantation af hæmatopoietiske progenitorceller (HPCT).
English: Irreversible protein binding may explain the incomplete recovery.
Danish: Når ikke alt stoffet blev genfundet, kan det skyldes irreversibel proteinbinding.
English: The active substance is busulfan.
Danish: Busilvex indeholder: - Aktivt stof: Busulfan.
English: 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).
Danish: 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).
English: Busulfan was shown to cause sterility in rodents.
Danish: Busulfan kan forårsage sterilitet hos gnavere.
English: Investigations: elevated liver enzymes and weight increased.
Danish: Undersøgelser: forhøjede leverenzymer og vægtøgning.
English: 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.
Danish: 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.
English: Tooth hypoplasia**
Danish: Tandhypoplasi**
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 69% of patients.
Danish: Anæmi (hæmoglobin < 8,0 g/dl) forekom hos 69 % af patienterne.
English: 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.
Danish: 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.
English: Adverse events information are derived from the clinical study in paediatrics (n=55).
Danish: Informationerne om uønskede hændelser stammer fra det kliniske studie på børn (n=55).
English: STATEMENT OF ACTIVE SUBSTANCE One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml koncentrat indeholder 6 mg busulfan, hvilket giver 0,5 mg/ml busulfan efter fortynding.
English: Weight increased Abnormal breath sounds
Danish: Vægtstigning Anormale vejrtrækningslyde Forhøjet kreatinin
English: 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).
Danish: 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).
English: Interstitial lung disease**
Danish: Interstitiel lungesygdom**
English: Medicines before you receive Busilvex: Before receiving Busilvex, you will be medicated with anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and antiemetic medicines to prevent vomiting.
Danish: Før De får Busilvex, vil De blive behandlet med - krampestillende lægemidler for at forebygge krampeanfald (phenytoin eller benzodiazepiner)
English: On the basis of the scientific conclusions for busulfan the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing busulfan is unchanged subject to the proposed changes to the product information
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne På baggrund af de videnskabelige konklusioner for busulfan er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder busulfan, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop.
Danish: Patienten kan udvikle svær granulocytopeni, trombocytopeni, anæmi eller en kombination deraf.
English: Busilvex must always be added to the diluent, not the diluent to Busilvex.
Danish: Busilvex skal altid tilsættes til infusionsvæsken, ikke infusionsvæsken til Busilvex.
English: Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Danish: Hjertesymptomer: ændringer og abnormaliteter i hjerterytmen, tilbageholdelse af væske eller betændelse omkring hjertet, fald i hjertets arbejde.
English: doses in combination with other drugs in conditioning treatment previous HCT could be an important role in the development of TMA.
Danish: Primært studier fra litteraturen har vist, at høje intravenøse busulfandoser i kombination med andre lægemidler ved konditioneringsbehandling inden HCT kan spille en vigtig rolle for udviklingen af TMA.
English: 15% of SAEs involved liver toxicity.
Danish: 15 % af de alvorlige uønskede hændelser (SAEs) omfattede levertoksicitet.
English: However, for the safe use of Busilvex in patients older than 60 years only limited information is available.
Danish: Der er dog kun begrænset information om sikkerheden ved anvendelse af Busilvex til patienter over 60 år.
English: Infections and infestations:
Danish: Infektioner og parasitære sygdomme:
English: Renal: increase in creatinine elimination, discomfort in urination, decrease in urine output and bloody urine.
Danish: Nyrer: øgning i kreatininudskillelsen, ubehag ved vandladning, nedsættelse af urinmængden og blod i urinen.
English: Busilvex must be diluted prior to administration.
Danish: Busilvex skal fortyndes før indgift.
English: Serious toxicities involving the hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Danish: Alvorlig toksicitet, der omfatter lever og åndedrætsorganer, blev anset for forventelige konsekvenser af konditioneringen og selve transplantationen.
English: Either phenytoin or benzodiazepines were administered for seizure prophylaxis in patients participating to the clinical trials conducted with intravenous busulfan (see section 4.2 and 4.4).
Danish: Der blev givet enten phenytoin eller benzodiazepiner som profylakse mod krampeanfald hos patienter, der deltog i de kliniske studier med intravenøs busulfan (se pkt.
English: Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
Danish: Mænd, der bliver behandlet med Busilvex, rådes til ikke at få børn under og i op til 6 måneder efter behandlingen.
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 100% of patients.
Danish: Anæmi (hæmoglobin < 8,0 g/dl) forekom hos 100 % af patienterne.
English: Transaminases increased Bilirubine increased Alkaline phosphatases increased
Danish: Forhøjede aminotransferaser Forhøjet bilirubin Forhøjet GGT Forhøjet alkalisk fosfatase
English: Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified.
Danish: I Busilvex-studier er der forekommet shocklunge - acute respiratory distress syndrome med efterfølgende respirationssvigt forbundet med interstitiel lungefibrose hos en patient, som afgik ved døden, om end det ikke var muligt at påvise en klar ætiologi.
English: Infections (documented and non documented febrile neutropenia) were experienced in 89% of patients (49/55).
Danish: 89 % af patienterne (49/55) oplevede infektioner (dokumenteret og udokumenteret febril neutropeni).
English: Busilvex in combination with cyclophosphamide:
Danish: Busilvex i kombination med cyclophosphamid:
English: Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Danish: Anoreksi Hyperglykæmi Hypokalcæmi Hypokaliæmi Hypomagnesiæmi Hypofosfatæmi
English: Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Danish: Busilvex skal tilberedes af sundhedspersonale under anvendelse af steril overførelsesmetode.
English: Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Danish: Alvorlig toksicitet, der omfatter hæmatologi, lever og åndedrætsorganer, blev anset for forventelige konsekvenser af konditioneringen og selve transplantationen.
English: In adults, absolute neutrophil counts < 0.5x109/l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
Danish: Absolut neutrofiltal < 0,5x109/l ved en median på 4 dage efter transplantationen optrådte hos 100 % af de voksne patienter og var normaliseret ved en median på 10 og 13 dage efter henholdsvis autolog og allogen transplantation (median for neutropeniperiode henholdsvis 6 og 9 dage).
English: One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
Danish: En ml koncentrat indeholder 6 mg busulfan (60 mg i et hætteglas).
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG ANTAL
English: Only a clear solution without particles should be used.
Danish: Opløsningen skal være klar og uden partikelindhold.
English: The use of paracetamol during the 72 hours prior to or with Busilvex administration should be used with caution.
Danish: Anvendelse af paracetamol skal undgås i 72 timer før administration af Busilvex.
English: Increase of uric acid and urea in the blood.
Danish: Forhøjet urinsyre og urinstof i blodet.
English: Obese patients In adults
Danish: Adipøse patienter Voksne
English: In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Danish: Til spædbørn, børn og unge anvendes Busilvex i kombination med cyclophosphamid eller melphalan.
English: The increased risk of a second malignancy should be explained to the patient.
Danish: Patienten bør oplyses om, at der foreligger en øget risiko for yderligere malignitet.
English: Renal: increase in the amount of nitrogen components in the blood stream, moderate renal insufficiency, renal disorder.
Danish: Nyrer: øgning af kvælstofskomponenter i blodet, moderat nyreinsufficiens, nyresygdom.
English: in combination with other medicine as a conditioning treatment previous HCT have been seen after reviewing the literature and the cases retrieved in the safety database of the company.
Danish: Der er set tilfælde af TMA efter høje intravenøse doser af busulfan i kombination med anden medicin som konditioneringsbehandling inden HCT efter gennemgang af litteraturen og tilfældene fra virksomhedens sikkerhedsdatabase.
English: D: dose of Busilvex (see SPC section 4.2)
Danish: D: Busilvex-dosis (se pkt.4.2)
English: Marketing Authorisation Holder Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne-Billancourt cedex France
Danish: Indehaver af markedsføringstilladelsen Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne Billancourt cedex Frankrig
English: Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).
Danish: Dyreforsøg har vist reproduktionstoksicitet (embryoføtale dødsfald og misdannelser) (se pkt 5.3).
English: When diluted Busilvex is a clear colourless solution.
Danish: Efter fortynding udgør Busilvex en klar, farveløs opløsning.
English: (see sections 4.4 and 4.5).
Danish: 4.4 og 4.5).
English: Intravenous use (IV) Must be diluted before use Read the package leaflet before use
Danish: Skal fortyndes før brug Læs indlægssedlen inden brug
English: In adult and paediatric studies, patients received either phenytoin or benzodiazepines as seizure prophylaxis treatment.
Danish: I studierne fik voksne og pædiatriske patienter enten phenytoin eller benzodiazepiner profylaktisk mod kramper (se pkt.
English: All evaluable patients engrafted.
Danish: Alle patienter, der kunne evalueres, fik transplantation.
English: In adults Busilvex is used in combination with cyclophosphamide or fludarabine.
Danish: Til voksne anvendes Busilvex i kombination med cyclophosphamid eller fludarabin.
English: The recommended dose and schedule of administration is: - 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses, - followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of Busilvex (see section 4.5).
Danish: Den anbefalede dosis og behandlingsplan er: - 0,8 mg/kg legemsvægt (BW) busulfan som 2 timers infusion hver 6. time 4 dage i træk, dvs. i alt 16 doser - efterfulgt af cyclophosphamid 60 mg/kg/dag i to dage, som først indledes, når der er forløbet mindst 24 timer efter den 16. dosis Busilvex (se pkt.
English: • Quantity of Busilvex:
Danish: • Mængde Busilvex
English: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
Danish: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex Frankrig
English: The effects of renal dysfunction on intravenous busulfan disposition have not been assessed.
Danish: Virkningen af leverdysfunktion på fordelingen af intravenøst busulfan er ikke vurderet.
English: Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Danish: Åndedrættet: hurtigere åndedræt, åndedrætssvigt, alveolære blødninger, astma, sammenfald af små dele af lungerne, væske omkring lungerne.
English: DMA decreases fertility in male and female rodents.
Danish: DMA nedsætter fertiliteten hos han- og hungnavere.
English: CNS changes precede any of the more severe side effects.
Danish: Symptomer fra centralnervesystemet forudgår alle sværere bivirkninger.
English: Busulfan depleted oocytes of female rats, and induced sterility in male rats and hamster.
Danish: Busulfan depleterede oocytter hos hunrotter og inducerede sterilitet hos hanrotter og -hamstere.
English: Hepatic: enlarged liver, jaundice, blocking of a liver vein.
Danish: Lever: forstørret lever, gulsot, blokering af vene i leveren.
English: Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
Danish: Busilvex gives hver 6. time 4 dage i træk forud for transplantationen.
English: The MAH of Busilvex has responded to the question of “Thrombotic microangiopathy” (TMA) after hematopoietic cell transplantation (HCT) requested as supplementary information.
Danish: “trombotisk mikroangiopati” (TMA) efter hæmatopoietisk celletransplantation (HCT) efter anmodning om supplerende information.
English: Busilvex in combination with fludarabine
Danish: Busilvex i kombination med fludarabin
English: Pharmacotherapeutic group: Alkyl sulfonates, ATC code: L01AB01.
Danish: ATC-kode: L01AB01
English: In adults and children studies, data with Busilvex were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Danish: Data fra Busilvex-studier med voksne og børn blev indhentet under samtidig anvendelse af enten phenytoin eller benzodiazepiner som profylakse mod kramper.
English: Haematemesis Ileus
Danish: Hæmatemese Ileus
English: Increase of lactate dehydrogenase in the blood.
Danish: Forhøjet laktatdehydrogenase i blodet.
English: General: fever, headache, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Danish: Generelt: feber, hovedpine, slaphed, kulderystelser, smerter, allergiske reaktioner, væskeansamlinger, generelle smerter eller betændelse ved injektionsstedet, brystsmerter, infektion i slimhinder.
English: Invasive fungal infection
Danish: Invasiv svampeinfektion Lungeinfektion
English: How to use Busilvex
Danish: Sådan skal De bruge Busilvex
English: Busilvex in combination with fludarabine (FB) In adults
Danish: Busilvex i kombination med fludarabin (FB) Hos voksne
English: In children, thrombocytopenia (< 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
Danish: Trombocytopeni (< 25x109/l eller behov for trombocyttransfusion) forekom hos 100 % af de pædiatriske patienter.
English: Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Danish: Atrieflimren Kardiomegali Perikardie-effusion Perikardit
English: It seems that the recommended intravenous busulfan dose administered either as an individual infusion (3.2 mg/kg) or into 4 divided infusions (0.8 mg/kg) provided equivalent daily plasma exposure with similar both inter-and intrapatient variability.
Danish: Den anbefalede intravenøse busulfandosis synes at give samme daglige plasmaeksponering med samme inter- og intraindividuelle variation, uanset om den administreres som en enkelt infusion (3,2 mg/kg) eller fordelt på 4 infusioner (0,8 mg/kg).
English: Lens disorders including clouding of the lens of the eye (cataract), and blurred vision (corneal thinning).
Danish: Sygdomme i øjets linse, herunder uklarhed af øjets linse (grå stær) og sløret syn (hornhinden bliver tyndere).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer 11.
English: Pulmonary infection
Danish: Pulmonal blødning
English: Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Danish: En populationsfarmakokinetisk analyse omfattende 102 patienter påviste lav interpersonlig (CV=21 %) og intrapersonlig (CV=12 %) variabilitet i busulfan efter lægemiddeleksponering
English: In that case infusion sets with minimal priming space should be used (i.e. 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Danish: I det tilfælde skal der anvendes infusionssæt med minimal volumen (dvs. 0,3-0,6 ml), som primes med lægemiddelopløsningen, inden den egentlige infusion med Busilvex iværksættes, og derefter skylles med 9 mg/ml (0,9 %) isotonisk natriumchloridinjektionsvæske eller 5 % isotonisk glucoseinjektionsvæske.
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109 /l was 13 days (range 9-29 days) in allogenic patients (OMC-BUS 4), and 10 days
Danish: Tidsrummet frem til absolut neutrofiltal (ANC) > 0,5x109/l var 13 dage (interval 9-29 dage) hos allogene patienter (OMC-BUS 4) og 10 dage (interval 8-19 dage) hos autologe patienter (OMC-BUS 3).
English: One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én ml koncentrat indeholder 6 mg busulfan (60 mg i 10 ml).
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.
Danish: I Busilvex-studierne døde en patient på grund af shocklunge - acute respiratory distress syndromeefterfulgt af respirationssvigt forbundet med interstitiel lungefibrose.
English: After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Danish: Efter fortynding: 1 ml infusionsopløsning indeholder 0,5 mg busulfan.
English: Busilvex in combination with fludarabine (FB)
Danish: Busilvex i kombination med fludarabin (FB)
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial
Danish: Multipakning indeholder 8 hætteglas (2 pakninger a 4) a 10 ml 60 mg pr. hætteglas
English: Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Danish: Åndedrætssymptomer: kortåndethed, snue (rhinitis), ondt i halsen, hoste, hikke, næseblod, unormale åndedrætslyde.
English: Haematuria Moderate renal Insufficiency
Danish: Hæmaturi Moderat nyreinsufficiens
English: After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Danish: Efter fortynding: Én ml opløsning indeholder cirka 0,5 mg busulfan.
English: Busilvex in combination with cyclophosphamide In adults
Danish: Busilvex i kombination med cyclophosphamid Hos voksne
English: Nausea Vomiting Diarrhoea Stomatitis
Danish: Mave-tarm-kanalen Stomatit Diarré
English: Veno occlusive liver disease *
Danish: Hepatisk venookklusiv sygdom*
English: Skin: rash, itching, loss of hairs.
Danish: Hud: udslæt, kløe, hårtab.
English: Ideal body weight (IBW) is calculated as follows: IBW men (kg) = 50 + 0.91x (height in cm-152);
Danish: IBW mænd (kg) =50+0,91x(højde i cm-152).
English: The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.
Danish: For at sikre, at den endelige koncentration af busulfan er ca. 0,5 mg/ml, skal mængden af infusionsvæske være 10 gange volumenet af Busilvex.