FrancophonIA/ELRC3.0 huggingface dataset:
English: - If the concentrate or diluted busulfan solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Danish: Hvis koncentratet eller den fortyndede busulfanopløsning kommer i kontakt med hud eller slimhinder, skal de berørte områder omgående skylles med rigeligt vand.
English: Infections.
Danish: Infektioner
English: Neutropenia Thrombocytopenia Febrile neutropenia Anaemia
Danish: Neutropeni Trombocytopeni Febril neutropeni Anæmi
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 µmol/l.minut).
English: Busulfan 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: Busulfan administreres som en 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: Y: body weight of the patient in kg D: dose of busulfan (see section 4.2)
Danish: Y: patientens legemsvægt i kg D: busulfandosis (se pkt.4.2)
English: Women must stop breast-feeding before starting their treatment with Busulfan Fresenius Kabi.
Danish: Kvinder skal stoppe med at amme, inden behandlingen med Busulfan Fresenius Kabi påbegyndes.
English: Special caution should be exercised when administering the recommended dose of busulfan to patients with a history of seizures.
Danish: Der skal udvises særlig forsigtighed, når den anbefalede busulfan-dosis gives til patienter, som tidligere har haft krampeanfald.
English: Busulfan in combination with cyclophosphamide
Danish: Busulfan i kombination med cyclophosphamid
English: Busulfan 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: Busulfan 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: Documentation on the safety and efficacy of busulfan 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 af sikkerhed og effekt af busulfan 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: Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Danish: Busulfan er et kraftigt virkende cytostatikum og et bifunktionelt alkylerende middel.
English: Busulfan Fresenius Kabi is a potent cytotoxic medicine that results in profound decrease of blood cells.
Danish: Busulfan Fresenius Kabi er en kraftig cellegift (et cytostatikum), som medfører et voldsomt fald i antallet af blodlegemer.
English: Each vial is sleeved with shrinkable plastic film.
Danish: Hvert hætteglas er forsynet med film af krympeplast.
English: Documentation of the safety and efficacy of busulfan 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 busulfan 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: Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Danish: Busulfan efterfulgt af cyclophosphamid (BuCy4) eller melphalan (BuMel) er indiceret som konditionerende behandling før konventionel transplantation af hæmatopoietiske progenitorceller til pædiatriske patienter.
English: Busulfan has not been studied in patients with hepatic impairment.
Danish: Busulfan er ikke undersøgt hos patienter med nedsat leverfunktion.
English: In adults Busulfan Fresenius Kabi is used in combination with cyclophosphamide or fludarabine.
Danish: Til voksne anvendes Busulfan Fresenius Kabi i kombination med cyclophosphamid eller fludarabin.
English: Elderly patients
Danish: Ældre patienter:
English: Busulfan 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: Busulfan 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: No evidence of an induction effect of phenytoin has been seen on busulfan data.
Danish: Der ikke fundet evidens for en induktiv effekt af phenytoin på busulfan.
English: Busulfan Fresenius Kabi must always be added to the diluent, not the diluent to the Busulfan Fresenius Kabi.
Danish: Busulfan Fresenius Kabi tilsættes altid til fortyndingsvæsken, ikke fortyndingsvæsken til Busulfan Fresenius Kabi.
English: Preparation of Busulfan Fresenius Kabi Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Danish: Tilberedning af Busulfan Fresenius Kabi Der bør fastlægges procedurer for korrekt håndtering og bortskaffelse af cytotoksiske lægemidler.
English: Gastro-intestinal haemorrhage Tooth hypoplasia*
Danish: Gastrointestinal blødning Tandhypoplasi**
English: Busulfan Fresenius Kabi in combination with fludarabine The recommended dose of busulfan is 3.2 mg/kg Each infusion will last 3 hours
Danish: Busulfan Fresenius Kabi i kombination med fludarabin Den anbefalede dosis af Busulfan Fresenius Kabi er 3,2 mg/kg Hver infusion varer 3 timer
English: Do not throw away any medicine via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller skraldespanden.
English: Dose and administration The dose of busulfan will be calculated according to your body weight.
Danish: Dosis og indgivelse Dosis af Busulfan Fresenius Kabi beregnes ud fra din legemsvægt.
English: As with other cytotoxic compounds, caution should be exercised in handling and preparing the busulfan solution: - The use of gloves and protective clothing is recommended.
Danish: Som for andre cytostatika skal der udvises forsigtighed ved håndtering og tilberedning af busulfanopløsningen:
English: Busulfan Fresenius Kabi must be prepared by a healthcare professional using sterile transfer techniques.
Danish: Busulfan Fresenius Kabi skal tilberedes af sundhedspersonale under anvendelse af steril overførselsmetode.
English: Before receiving Busulfan Fresenius Kabi, you will be medicated with - anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and - antiemetic medicines to prevent vomiting.
Danish: Medicin før du får Busulfan Fresenius Kabi: Før du får Busulfan Fresenius Kabi, vil du blive behandlet med krampestillende lægemidler for at forebygge krampeanfald (phenytoin eller benzodiazepiner) og lægemidler mod kvalme for at forebygge opkastning.
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 (range 8-19 days) in autologous patients (OMC-BUS 3).
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: Busulfan is administered prior to the haematopoietic progenitor cell transplantation (HPCT).
Danish: Busulfan administreres før transplantation af hæmatopoietiske progenitorceller (HPCT).
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 ekponering for busulfan og cancer.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 patienter):
English: Renal: increase in the amount of nitrogen components in the blood stream, moderate renal insufficiency, renal disorder.
Danish: Nyrer: øgning i mængden af kvælstofkomponenter i blodbanen, moderat nedsat nyrefunktion, nyresygdom.
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 á 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: The amount of Busulfan Fresenius Kabi and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight:
Danish: Mængden af Busulfan Fresenius Kabi og fortyndingsvæske, som skal administreres, vil blive beregnet på følgende vis for en patient, som vejer Y kg:
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
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 25°C ± 2°C or 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time).
Danish: Det er påvist, at den kemiske og fysiske i brug-stabilitet er 8 timer (inklusive infusionstid) efter fortynding med 5 % glucose injektionsvæske eller med 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, hvis opbevaring sker ved 25°C±2°C eller 12 timer efter fortynding, hvis opbevaring sker ved 2°C - 8°C efterfulgt af 3 timers opbevaring ved 25°C±2°C (inklusive infusionstid).
English: However, caution is recommended (see sections 4.8 and 5.2).
Danish: 4.8 og 5.2).
English: Busulfan Fresenius Kabi destroys the original bone marrow before the transplant.
Danish: Busulfan Fresenius Kabi ødelægger din egen knoglemarv før transplantationen.
English: Grade 3 elevated transaminases were reported in 24% of patients.
Danish: Lever og galdeveje: Forhøjede aminotransferaser grad 3 blev indberettet for 24 % af patienterne.
English: However, for the safe use of busulfan in patients older than 60 years only limited information is available.
Danish: Der er dog kun begrænset information om sikkerheden ved anvendelse af busulfan til patienter over 60 år.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/10 ml OTHER Cytotoxic
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 60 mg/10 ml
English: Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output and bloody urine.
Danish: Nyrer: øgning i kreatininudskillelsen, ubehag ved vandladning, nedsættelse af urinmængden og blod i urinen.
English: Hypoalbuminaemia Electrolyte disturbance Hyperglycaemia
Danish: Hypoalbuminæmi Elektrolytforstyrrelse Hyperglykæmi
English: Transaminases increased Bilirubine increased Alkaline phosphatases increased
Danish: Forhøjede aminotransferaser Forhøjet bilirubin Forhøjet GGT Forhøjet alkalisk fosfatase Vægtstigning
English: Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Danish: Hjerte: ændret og unormal hjerterytme, tilbageholdelse af væske eller betændelse omkring hjertet, nedsat hjertefunktion.
English: Adverse reactions 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: Busulfan in combination with cyclophosphamide or melphalan In adults
Danish: Busulfan i kombination med cyclophosphamid eller melphalan Hos voksne
English: In adults and children studies, data with busulfan were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Danish: Alle data fra busulfan-studier med voksne og børn blev indhentet under samtidig anvendelse af enten phenytoin eller benzodiazepiner som profylakse mod kramper.
English: Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in busulfan studies in one patient who died, although, no clear aetiology was identified.
Danish: I kliniske busulfan-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: Arrhythmia Atrial fibrillation Cardiomegaly Pericardial effusion
Danish: Kardiomegali Perikardie-effusion Perikardit
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:
Danish: Kemisk og fysisk i-brug stabilitet efter fortynding med 5 % glucose- eller 9 mg/ml (0,9 %) natriumchlorid injektionsvæske er påvist som følger:
English: Six of 103 patients (6%) experienced HVOD.
Danish: Seks af 103 patienter fik
English: - 12 hours after dilution when stored at 2°C-8°C followed by 3 hours stored at 25°C ± 2°C (including infusion time).
Danish: 12 timer efter fortynding, hvis opbevaring sker ved 2°C - 8°C efterfulgt af 3 timers opbevaring ved 25°C±2°C (inkl.
English: • Quantity of Busulfan Fresenius Kabi:
Danish: Mængde Busulfan Fresenius Kabi:
English: Busulfan Fresenius Kabi must be diluted prior to administration.
Danish: Busulfan Fresenius Kabi skal fortyndes før indgift.
English: Busulfan Fresenius Kabi is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Danish: Til voksne, spædbørn, børn og unge anvendes Busulfan Fresenius Kabi som behandling før transplantation.
English: Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent
Danish: Beregning af mængden af Busulfan Fresenius Kabi, der skal fortyndes, og af fortyndingsvæsken
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Danish: PROCEDURE FOR KORREKT BORTSKAFFELSE Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
English: Busulfan will be administered once daily during 2 or 3 consecutive days prior to transplant.
Danish: Busulfan Fresenius Kabi gives én gang dagligt 2 eller 3 dage i træk forud for transplantationen
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany 12.
Danish: Indehaver af markedsføringstilladelsen Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Tyskland
English: (A ml Busulfan Fresenius Kabi) x (10) = B ml of diluent
Danish: Mængde fortyndingsvæske: (A ml Busulfan Fresenius Kabi) x (10) = B ml fortyndingsvæske
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busulfan Fresenius Kabi 6 mg/ml sterile concentrate busulfan
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Busulfan Fresenius Kabi 6 mg/ml sterilt koncentrat busulfan i.v.
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 busulfan 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 busulfan iværksættes, og derefter skylles med 9 mg/ml (0,9 %) natriumchlorid injektionsvæske eller 5 % glucose injektionsvæske.
English: No interaction was observed when busulfan was combined with fluconazole (antifungal agent).
Danish: Der er ikke set nogen interaktion ved samtidig brug af busulfan og fluconazol (svampemiddel).
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: In adult and paediatric studies, patients received either phenytoin or benzodiazepines as seizure prophylaxis treatment (see sections 4.4 and 4.5).
Danish: I studierne fik voksne og pædiatriske patienter enten phenytoin eller benzodiazepiner profylaktisk mod kramper (se pkt.
English: Obese patients
Danish: Adipøse patienter
English: - 8 hours (including infusion time) after dilution when stored at 25°C ± 2°C
Danish: infusionstid) efter fortynding, hvis opbevaring sker ved 25°C±2°C.
English: Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Danish: Før og efter hver infusion gennemskylles det indlagte kateter og slange med ca. 5 ml 9 mg/ml (0,9 %) natriumchlorid injektionsvæske eller 5 % glucose injektionsvæske.
English: OUTER CARTON containing 8 vials
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske indeholdende 8 hætteglas
English: What you need to know before you use Busulfan Fresenius Kabi
Danish: Det skal du vide, før du begynder at bruge Busulfan Fresenius Kabi
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 interpatient (CV=21 %) og intrapatient (CV=12 %) variation for busulfan efter eksponering.
English: Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Danish: Nervesystemet: uklarhed, forvirring og desorientering, evt. hallucinationer og vrangforestillinger (delirium), nervøsitet, hallucinationer, rastløs uro, unormal hjernefunktion, hjerneblødning og kramper.
English: The terminal half life ranged from 2.26 to 2.52 h. Inter and intra patient variabilities in plasma exposure were lower than 20% and 10%, respectively.
Danish: De inter- og intra-individuelle variationer i plasmaeksponering var lavere end henholdsvis 20 % og 10
English: To prepare the final solution for infusion, add (A) ml of Busulfan Fresenius Kabi to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Danish: Til tilberedning af den endelige infusionsopløsning tilsættes (A) ml Busulfan Fresenius Kabi til (B) ml fortyndingsvæske (9 mg/ml (0,9 %) natriumchlorid injektionsvæske eller 5 % glucose injektionsvæske).
English: Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Danish: Åndedræt: hurtigere åndedræt, åndedrætssvigt, blødning i lungerne (alveolerne), astma, sammenfald af små dele i lungerne, væske omkring lungerne.
English: Haematuria Moderate renal insufficiency
Danish: Hæmaturi Moderat nyreinsufficiens
English: Other medicines and Busulfan Fresenius Kabi Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Busulfan Fresenius Kabi Fortæl det altid til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, alkyl sulfonates, ATC code: L01AB01.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, Alkylsulfonater.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use after dilution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: Respiratory: shortness of breath, nasal secretion (rhinitis), sore throat, cough, hiccup, nosebleeds, abnormal breath sounds.
Danish: Åndedræt: åndenød, snue (rhinitis), ondt i halsen, hoste, hikke, næseblod, unormale åndedrætslyde.
English: Cardiac: clotting of femoral artery, extra heart beats, decrease in heart rate, diffuse leak of fluid from the capillaries (small blood vessels).
Danish: Hjerte: blodpropper i femoralarterien (pulsåren, der fører blodet til benene og fødderne), ekstra hjerteslag, fald i hjertefrekvensen, diffus udsivning af væske fra kapillærerne (de små blodkar).
English: Using a non polycarbonate syringe fitted with a needle:
Danish: Der anvendes en sprøjte, der ikke er af polycarbonat, isat kanyle:
English: One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the busulfan studies.
Danish: I studierne med busulfan døde en patient på grund af shocklunge - acute respiratory distress syndromeefterfulgt af respirationssvigt forbundet med interstitiel lungefibrose.
English: After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Danish: Efter fortynding: En ml opløsning indeholder cirka 0,5 mg busulfan.
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 recommended posology for children as detailed in section 4.2 enabled over 70% up to 90% of children ≥ 9kg in achieving the therapeutic window (900 - 1500 µmol/L.minute).
Danish: 4.2, resulterede i, at over 70% og op til 90% af alle børn ≥ 9 kg nåede det terapeutiske vindue (fra 900 til 1.500 µmol/l.minut).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Danish: Én ml koncentrat indeholder 6 mg busulfan (60 mg i 10 ml).
English: Calculation of the quantity of Busulfan Fresenius Kabi to be diluted and of the diluent Busulfan Fresenius Kabi must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Danish: Beregning af mængden af Busulfan Fresenius Kabi, der skal fortyndes, og af fortyndingsvæsken Busulfan Fresenius Kabi skal fortyndes før brug med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske eller 5 % glucose injektionsvæske.
English: How to use Busulfan Fresenius Kabi
Danish: Sådan skal du bruge Busulfan Fresenius Kabi
English: BATCH NUMBER Lot 14.
Danish: Else-Kröner-Straße 1,
English: - the calculated volume of Busulfan Fresenius Kabi must be removed from the vial.
Danish: - den beregnede mængde Busulfan Fresenius Kabi tages ud af hætteglasset.
English: Gastro-intestinal: bleeding in the stomach and/or the gut.
Danish: Mave-tarm: mave- og/eller tarmblødning.
English: Femoral artery thrombosis Capillary leak
Danish: Trombose i a. femoralis Kapillært lækagesyndrom
English: When diluted Busulfan Fresenius Kabi is a clear colourless viscous solution.
Danish: Efter fortynding er Busulfan Fresenius Kabi en klar farveløs viskøs opløsning.
English: Pericarditis
Danish: Bradykardi
English: Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Danish: Mave-tarm: kvalme, betændelse af mundslimhinden, opkastning, mavesmerter, diarre, forstoppelse, halsbrand, ubehag ved endetarmsåbningen, væske i maven.