FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people) - infections local wound infections reductions in numbers of certain white blood cells and platelets hypersensitivity (allergic) reactions nerve damage decreased consciouness headache heart problems which can cause shortness of breath or ankle swelling blood clot formation in the artery or vein of the affected arm or leg (thrombosis) - low blood pressure, shock - severe breathing problems - constipation, diarrhoea skin necrosis (death of skin cells) in the affected arm or leg swelling of the ankles, feet or fingers caused by fluid build up in the affected arm or leg “compartment syndrome”, a medical condition characterised by pain, swelling and neurological symptoms, as well as muscle damage in the affected arm or leg muscle pain - protein in urine night sweats tissue necrosis (death of tissue cells) in the affected arm or leg, which is severe enough to require amputation
Danish: - lavt blodtryk, shock - alvorlige åndedrætsproblemer - forstoppelse, diarré - hudnekrose (hudcellerne dør) i den berørte arm eller ben - hævede ankler, fødder eller fingre på grund af væskeophobning i den berørte arm eller ben kompartmentsymdrom, en lidelse, der er karakteriseret ved smerter, hævelse og nervesymptomer, såvel som muskelskade i den berørte arm eller ben - muskelsmerte - protein i urinen - nattesved - vævsnekrose (vævscellerne dør) i den berørte arm eller ben, hvilket i alvorlige situationer kan føre til amputation
English: Extremity necrosis, severe enough to warrant amputation
Danish: Nekrose i ekstremiteter alvorlig nok til, at amputation er nødvendig Beskrivelse af udvalgte bivirkninger
English: Please refer to the Summary of Product Characteristics for melphalan for information on overdose of melphalan.
Danish: Se produktresuméet for melfalan for yderligere oplysninger om overdosering af melfalan.
English: Combinations with cardiotoxic substances (e.g. anthracyclines) should be avoided because it is possible that tasonermin could enhance cardiotoxicity, as has been observed in preclinical 13-week toxicological investigations.
Danish: Man bør undgå kombinationsbehandling med kardiotoksiske stoffer (f.eks. antracykliner), idet det er muligt, at tasonermin kan øge kardiotoksisiteten.
English: 10 mg/l perfused lower limb volume
Danish: 10 mg/l perfunderet under ekstremitetsvolumen.
English: Beromun is a white to off-white powder for solution for infusion (powder for infusion) supplied in a glass vial with rubber stopper and sealed with aluminium flip-off cap.
Danish: Beromun er et hvidt til offwhite-farvet pulver, til brug i en infusionsopløsning (pulver til infusionsvæske).
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Human serum albumin.
Danish: Natriumdihydrogenphosphatdihydrat Dinatriumphosphatdodecahydrat Human serumalbumin
English: Wash-out should continue until a clear (pink, transparent) venous outflow is obtained.
Danish: Popliteal og brakial perfusion kræver sjældent mere end 1 l. Udvaskning skal fortsættes indtil klart (lyserødt, gennemsigtigt) venøst udløb er opnået.
English: In case the clinical diagnosis of compartment syndrome is made the following treatment should be considered: Fasciotomy of all muscle compartments of the limb affected, Forced diuresis and alkalinisation of the urine, if a muscle damage occurs with increased myoglobin levels in plasma and urine.
Danish: I tilfælde af klinisk diagnoseret kompartment syndrom skal følgende behandling overvejes: Faciotomi af alle muskelområder af den berørte legemsdel.
English: The Summary of Product Characteristics for melphalan should be consulted for information on the interactions of melphalan.
Danish: Produktresuméet for melfalan bør gennemlæses for yderligere information om melfalans interaktioner med andre medicinske produkter.
English: Diarrhoea, constipation
Danish: Diarré, forstoppelse.
English: Beromun and then melphalan are injected into this circuit, over a total of 90 minutes the affected limb will be exposed to Beromun.
Danish: Beromun og derefter melfalan bliver sprøjtet ind i dette kredsløb.
English: Powder for solution for infusion 4 vials of powder for solution for infusion
Danish: Pulver til infusionsvæske, opløsning 4 hætteglas pulver til infusionsvæske, opløsning
English: Uncommon (may affect up to 1 in 100 people) - blood poisoning (sepsis) - fluid in the lungs - stomach ache - inflammation of the gastric mucosa (gastritis) - temporary loss of finger or toe nails of the affected arm or leg - kidney failure - blood tests showing changes in the way the kidneys are working - narrowing or closing of limb vessels carrying blood from the heart
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) blodforgiftning (sepsis) væske i lungerne mavesmerter vævsirritation (inflammation) af maveslimhinden (gastrit) midlertidigt tab af finger- eller tånegle på den berørte arm eller ben nyresvigt blodtest kan vise ændringer i nyrefunktionen forsnævring eller lukning af arterier (blodårer, der transporterer blodet fra hjertet) i arme eller ben.
English: For instructions on administration, see section 4.2.
Danish: Den rekonstituerede opløsning skal administreres i henhold til afsnit 4.2.
English: Symptoms of muscle damage at the perfused limb include pain, swelling, as well as neurological symptoms (e. g. paraesthesia, paralysis), all of which should be reported immediately to the attending doctor.
Danish: Symptomerne på muskelskade i det behandlede ben eller arm er smerter, hævelse samt neurologiske symptomer (nervesymptomer, f.eks. føleforstyrrelser, lammelser).
English: Finally, your limb will be washed out to remove the rest of Beromun and melphalan.
Danish: Behandlingen afsluttes med, at arm eller ben skylles igennem for at fjerne rester af Beromun og melfalan i årerne.
English: as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP).
Danish: Beromun er indiceret til voksne som adjuvans til kirurgi med efterfølgende fjernelse af tumoren med henblik på at forhindre eller forsinke amputation, eller i palliative tilfælde, ved irresektabel bløddelssarkom i ekstremiteterne.
English: Skin necrosis, oedema peripheral
Danish: Hudnekrose, perifert ødem
English: Tabulated summary of adverse reactions
Danish: Resumé af bivirkninger på tabelform
English: - if you have significant heart problems - if you have severe lung disease - if you have or have recently had a stomach ulcer - if you have too low numbers of blood cells or bleeding problems - if you have moderate to severe liver or kidney disease - if you cannot use vasopressors (used to increase low blood pressure), anticoagulants (used to prevent blood clotting) or radioactive tracers - if you are also using medicines with heart toxicity - if you have raised levels of calcium in your blood - if you have certain infections which do not respond to antibiotics - if you have severe swelling of the affected arm or leg due to local fluid build-up, or severe fluid build-up in the abdomen - if you are pregnant or planning to become pregnant.
Danish: antikoagulanter (lægemidler, der bruges til at forhindre blodstørkning) eller radioaktive sporstoffer - hvis du samtidig behandles med lægemidler, som påvirker hjertet toksisk (f.eks. antracykliner) - hvis du har en forhøjet koncentration af kalcium i blodet - hvis du lider af infektioner, som ikke reagerer på behandling med antibiotika - hvis dures syge arm eller ben er hævet på grund af lokal væskeansamling, eller du har en svær væskeansamling i bughulen - hvis du er gravid eller planlægger at blive gravid - Du må ikke amme i mindst 7 dage efter Beromun-behandlingen
English: Arrhythmia
Danish: Hudreaktion
English: Please refer to the Summary of Product Characteristics for melphalan.
Danish: Se venligst produktresuméet for melfalan.
English: What Beromun is and what it is used for What you need to know before you use Beromun How to use Beromun
Danish: Det skal du vide, før du begynder at bruge Beromun Sådan skal du bruge Beromun Bivirkninger
English: Package leaflet: Information for the user Beromun 1 mg powder for solution for infusion
Danish: Indlægsseddel: Information til patienten Beromun 1 mg pulver til infusionsvæske, opløsning tasonermin
English: At the end of the perfusion, the perfusate should be collected into the reservoir while washout fluid is added simultaneously to the circuit and circulated at the same flow rate of 35 to 40 ml/litre limb volume/minute.
Danish: samtidigt tilsættes kredsløbet og cirkulerer med samme kredsløbshastighed på 35-40 ml/l ekstremitetsvolumen/min.
English: Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.5).
Danish: Samtidig behandling med stoffer, som kan forårsage signifikant hypotension, bør undgås (se pkt.
English: During the IPL and the seven to ten day period afterwards you will need to stay in hospital, your doctor will carefully monitor your blood pressure, circulation and any side effects.
Danish: I den periode vil lægerne nøje overvåge dit blodtryk og kredsløb og holde øje med alle bivirkninger.
English: Severe lymphoedema of the limb.
Danish: Alvorligt lymfeødem i ekstremiteten.
English: The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction.
Danish: Bivirkningerne kan være relaterede til Beromun, melfalan eller ILP og de dertil hørende foranstaltninger eller til en kombination af disse faktorer De hyppigste bivirkninger indberettet fra kliniske forsøg var feber, kvalme, opkastning, træthed, arytmi, kuldegysninger, smerte, sårinfektion og hudreaktioner.
English: Beromun 1 mg powder for solution for infusion
Danish: Beromun 1 mg, pulver til infusionsvæske, opløsning
English: Under conditions of less than 2% systemic leakage (observed in 38 of 51 patients), maximum systemic circulation concentrations of tasonermin were reached 5 min after the start of ILP and are approximately 200 times less than in the perfusion circuit.
Danish: systemiske koncentration af tasonermin opnået 5 min. efter påbegyndelse af ILP, og i så tilfælde var koncentrationen 200 gange mindre end i perfusionskredsløbet.
English: A tourniquet should be applied to the proximal limb.
Danish: En årepresse bør anlægges proksimalt på ekstremiteten.
English: Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common:
Danish: Onykomadesi (afstødning af negle) Knogler, led, muskler og bindevæv Almindelig:
English: Patients with contraindications to the use of vasopressor agents.
Danish: Patienter, hos hvilke brug af karkontraherende midler er kontraindiceret.
English: ), to a maximum dose of 150 mg. 13 mg/l perfused upper limb volume
Danish: 13 mg/l perfunderet over ekstremitetsvolumen.
English: Cardiac disorders Very common:
Danish: Mave-tarm-kanalen Meget almindelig:
English: Paediatric population
Danish: LISTE OVER HJÆLPESTOFFER
English: Please refer to the Summary of Product Characteristics of melphalan prior to commencing an ILP procedure.
Danish: Før påbegyndelse af ILP-procedure, se produktresuméet for melfalan.
English: Tasonermin
Danish: Levertoksicitet
English: Patients with contraindications to limb hyperthermia.
Danish: Patienter, hos hvilke brug af ekstremitetshypertermi er kontraindiceret.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevares i køleskab (2 °C - 8 °C) Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Hepatobiliary disorders Very common:
Danish: Infektioner og parasitære sygdomme Almindelig:
English: Removab 10 microgram Concentrate for solution for infusion
Danish: Removab 10 mikrogram Koncentrat til infusionsvæske, opløsning
English: Removab 50 microgram Concentrate for solution for
Danish: Removab 50 mikrogram Koncentrat til infusionsvæske,
English: 9 to < 16 16 to 23 > 23 to 34
Danish: 9 til <16 16 til 23 >23 til 34
English: Incomplete development of teeth
Danish: Ufuldstændig udvikling af tænder.
English: From a microbiological point of view, the product should be used immediately after dilution.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks efter fortynding.
English: Therefore special care is recommended when combining these two compounds.
Danish: Derfor anbefales det at udvise særlig omhu ved kombination af de to forbindelser.
English: - if you are pregnant, or think you may be pregnant.
Danish: - hvis du er gravid eller har mistanke om, at du kan være gravid.
English: Contact your doctor immediately if you get any of the following symptoms.
Danish: Kontakt din læge omgående, hvis du oplever nogle af ovenstående symptomer.
English: Therefore busulfan should be used with caution in this type of patients.
Danish: Busulfan skal derfor anvendes med forsigtighed til denne type patienter.
English: Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
Danish: To prospektive, single arm, åbne, ukontrollerede fase II-studier blev gennemført hos patienter med hæmatologisk sygdom, hvoraf de fleste havde sygdommen i fremskreden grad.
English: Patients older than 50 years of age (n=23) have been successfully treated with busulfan without dose-adjustment.
Danish: Patienter over 50 år (n=23) er blevet behandlet med succes med busulfan uden dosisjustering.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og æsken efter EXP.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2014
Danish: Dato for første markedsføringstilladelse: 22. september 2014
English: HPCT is contraindicated in pregnant women; therefore, busulfan is contraindicated during pregnancy.
Danish: HPCT er kontraindiceret hos gravide kvinder, hvorfor busulfan er kontraindiceret under graviditet.
English: *veno occlusive liver disease is more frequent in paediatric population.
Danish: *Hepatisk venookklusiv sygdom er hyppigere forekommende i den pædiatriske population.
English: ** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
Danish: **rapporteret post-marketing med iv-busulfan ***rapporteret post-marketing med oral busulfan
English: It must be considered that overdose of busulfan will also increase exposure to DMA.
Danish: Det skal tages i betragtning, at en overdosis af busulfan også øger eksponeringen for DMA.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation)
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: • The diluted solution must be mixed thoroughly by inverting several times.
Danish: Den fortyndede opløsning skal blandes grundigt ved at vende op og ned på posen flere gange.
English: Paediatric population (0 to 17 years) The recommended dose of busulfan is as follows:
Danish: Pædiatriske patienter (0 til 17 år) Den anbefalede dosis af busulfan er følgende:
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than the above-mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er brugeren ansvarlig for opbevaringstid og -betingelser før brug og vil almindeligvis ikke være længere end de ovenfor anførte betingelser, når fortyndingen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Precautions to be taken before handling or administering the medicinal product This medicinal product must be diluted prior to administration.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering eller administration af lægemidlet Lægemidlet skal fortyndes før indgift.
English: Particular caution should be taken if you use itraconazol and metronidazole (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Danish: Der skal udvises særlig forsigtighed, hvis du anvender itraconazol og metronidazol (anvendes til visse infektioner) eller ketobemidon (anvendes til at behandle smerter), fordi det kan forøge bivirkningerne.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Danish: Hvis du spekulerer på at få børn, skal du tale med din læge før behandlingen.
English: This medicine contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Danish: Denne medicin indeholder det aktive stof busulfan, som hører til en lægemiddelgruppe, der kaldes alkylerende midler.
English: Actual body weight (kg)
Danish: Faktisk legemsvægt (kg)
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction
Danish: Ukendt hyppighed (kan ikke estimeres ud fra forhåndenværende data) Nedsat funktion af kønskirtlerne.
English: Blood: decrease of blood circulating cells (red and white) and platelets.
Danish: Blodet: nedsat antal cirkulerende blodlegemer (røde og hvide) og blodplader.
English: Biotransformation
Danish: Biotranformation
English: Do not use Busulfan Fresenius Kabi: - if you are allergic to busulfan or any of the other ingredients of this medicine listed in section 6.
Danish: Brug ikke Busulfan Fresenius Kabi: hvis du er allergisk over for busulfan eller et af de øvrige indholdsstoffer i denne medicin (angivet i afsnit 6).
English: Busulfan should not be given by rapid intravenous, bolus or peripheral injection.
Danish: Busulfan må ikke gives som hurtig intravenøs injektion, bolus eller perifer injektion.
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/14/951/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/951/001
English: The effect of those anticonvulsant agents on busulfan pharmacokinetics was investigated in a phase II study (see section 4.5).
Danish: Disse antikonvulsivas virkning på busulfans farmakokinetik blev undersøgt i et fase II-studie (se afsnit 4.5).
English: In both studies, all patients received a 16/16 dose regimen of busulfan.
Danish: I begge studier fik alle patienter 16 ud af 16 doser busulfan.
English: A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and non-malignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Danish: En farmakokinetisk populationsanalyse er blevet udført i en kohorte af 205 børn fordelt på passende vis med hensyn til legemsvægt (3,5 til 62,5 kg) samt biologiske og sygdomsrelaterede (maligne og non-maligne) karakteristika, således at de var repræsentative for den høje grad af heterogenitet blandt børn, der gennemgår HPCT.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne angivet efter faldende alvorlighedsgrad.
English: These include infection and Graft-versus host disease (GVHD) which although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Danish: De omfattede infektion og graft-versushostdisease (GVHD), som, også selv om der ikke var en direkte årsagssammenhæng, var hovedårsagerne til morbiditet og mortalitet, især ved allogen HPCT.
English: Hypogonadism**
Danish: Hypogonadisme**
English: * reported in post-marketing experience ** include haemorrhagic cystitis induced by viral infection
Danish: * Indrapporteret efter markedsføringen ** Inkluderer hæmoragisk cystitis forårsaget af virusinfektion
English: 60 mg per vial
Danish: 60 mg pr. hætteglas.
English: It is recommended to administer anticonvulsants 12 h prior to busulfan to 24 h after the last dose of busulfan.
Danish: Det anbefales at administrere antikonvulsiva fra 12 timer før busulfan til 24 timer efter sidste busulfan-dosis.
English: Busulfan in combination with fludarabine (FB)
Danish: Busulfan i kombination med fludarabin (FB)
English: Overall mortality and non-relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Danish: Generel mortalitet og mortalitet uden recidiv mere end 100 dage efter transplantationen var henholdsvis (8/61) 13 % og (6/61) 10 % hos allotransplanterede patienter.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW + 0.25x (actual body weight-IBW).
Danish: Justeret idealvægt (AIBW) beregnes som følger: AIBW = IBW+0,25x (faktisk legemsvægt - IBW).
English: As a result, the control of intravenous busulfan AUC within the therapeutic windows is not modified and a similar targeting performance between the two schedules was illustrated.
Danish: Heraf følger, at kontrollen af AUC efter intravenøs busulfan inden for det terapeutiske vindue ikke ændres, og der blev påvist samme targetperformance med de to behandlingsplaner.
English: Polycarbonate syringes must not be used with busulfan.
Danish: Polycarbonat sprøjter må ikke anvendes med busulfan.
English: The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/ (m2) > 30 kg/m² until further data become available.
Danish: Lægemidlet bør ikke anvendes til adipøse børn og unge med en BMI-vægt (kg)/højde (m²) > 30 kg/m² før yderligere data foreligger.
English: Hepatic veno-occlusive disease is a major complication that can occur during treatment with busulfan.
Danish: Leversygdom med veneokklusion er en alvorlig komplikation, som kan forekomme under behandling med busulfan.
English: Each vial contains 10 ml of concentrate.
Danish: Hvert hætteglas indeholder 10 ml koncentrat.
English: The entire prescribed busulfan dose should be delivered over two or three hours depending on the conditioning regimen.
Danish: Hele den ordinerede busulfandosis skal indgives i løbet af 2 eller 3 timer, afhængigt af det konditionerende regime.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before you receive treatment with Busulfan Fresenius Kabi.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger Busulfan Fresenius Kabi.
English: There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi's anaemia.
Danish: Der er kun begrænset klinisk erfaring med anvendelse af busulfan som en del af et konditionerende regimen inden HSCT hos børn med Fanconis anæmi.
English: Studies in animals have shown reproductive toxicity (embryo-foetal lethality and malformations) (see section 5.3)
Danish: Dyreforsøg har vist reproduktionstoksicitet (embryoføtale dødsfald og misdannelser) (se pkt 5.3).
English: - the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
Danish: - sprøjtens indhold skal overføres til en infusionspose (eller -sprøjte), som allerede indeholder den beregnede mængde af den valgte fortyndingsvæske.
English: The pharmacokinetics of busulfan has been investigated.
Danish: Busulfans farmakokinetik er undersøgt.
English: On the basis of human data, busulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Danish: På grundlag af humane data er busulfan klassificeret af International Agency for Research on Cancer IARC som et humant karcinogen.