FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Beromun Do not use Beromun
Danish: Det skal du vide, før du begynder at bruge Beromun Brug ikke Beromun:
English: Instructions for reconstitution
Danish: Vejledning for rekonstitution
English: Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.4).
Danish: Samtidig administration af midler, som kan forårsage signifikant hypotension, kan ikke anbefales (se pkt 4.4).
English: Significant hepatic dysfunction, e.g. > 2 x upper limits of normal levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase; or bilirubin levels > 1.25 x upper limits of normal.
Danish: Alvorlig hepatisk dysfunktion f.eks. >2 x øvre grænse af normal værdi af aspartataminotransferase, alaninaminotransferase eller alkalisk fosfatase; eller et bilirubinniveau på >1,25 x den øvre grænse for normalen.
English: For ILP, you will also receive other medicines to control pain, fever, blood pressure and blood clotting, as well as general anaesthesia.
Danish: Ved behandlingen med ILP vil du også få lægemidler, der virker på smerter, feber, blodtryk og blodets størkningsevne, og du vil komme i fuld bedøvelse.
English: No reproduction toxicity or carcinogenicity studies were performed due to testing being inappropriate as the intended clinical use of Beromun is in ILP for soft tissue sarcoma treatment.
Danish: Ingen reproduktionstoksicitets- eller karcinogenicitetsstudier har været udført, da dette har været vurderet upassende, eftersom den kliniske anvendelse af Beromun i ILP er bløddelssarkombehandling.
English: The haematological changes included anaemia, increased haematocrit and increased or decreased leukocytes and platelets depending upon species and treatment duration.
Danish: De hæmatologiske ændringer omfattede anæmi, øget hæmatokrit samt reduceret eller forøget antal af leukocytter og blodplader alt afhængig af art og behandlingsvarighed.
English: If more than 10% of your Beromun dose reaches the main part of your body, your doctor will take similar measures as in the case of overdose.
Danish: Hvis mere end 10 % af Beromun-dosis når ud i resten af kroppen (også kaldet systemisk lækage), tager lægen samme forholdsregler som ved overdosering.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Perfusion level should be chosen to adequately encompass affected tissue (external iliac, common femoral, femoro-popliteal, popliteal, axillary and brachial being accepted routes) and catheters introduced.
Danish: Perfusionsniveauet skal fastsættes på passende vis således, at det kan dække hele det berørte væv (vena iliaca externa, femoralis, femoro-poplitea, poplitea, axilaris og brachialis kan benyttes som indgangsveje) og til introduktion af katetere.
English: Each vial contains 20.12 mg (0.87 mmol) sodium.
Danish: Hvert hætteglas indeholder 20,12 mg (0,87 mmol) natrium.
English: Extremity necrosis and compartment syndrome might be severe enough to warrant amputation.
Danish: Nekrose i ekstremiteterne og kompartmentsyndrom kan være så alvorlig, at amputation er nødvendig.
English: Each pack contains 4 vials.
Danish: Hver pakning indeholder 4 hætteglas.
English: The reconstituted medicinal product contains up to 151.27 mg (6.58 mmol) sodium per recommended dose.
Danish: Det rekonstituerede lægemiddel indeholder op til 151,27 mg (6,58 mmol) natrium per anbefalet dosis.
English: Contraindications to melphalan:
Danish: Kontraindikationer for melfalan:
English: In the Rhesus monkey, pharmacokinetic studies following intravenous injection of tasonermin indicated a non-specific, non-saturable excretion via glomerular filtration in the kidney.
Danish: I Rhesus-aben viste de farmakokinetiske undersøgelser efter intravenøs injicering af tasonermin en uspecifik og umættet udskillelse via glomerulær filtrering gennem nyren.
English: Direct inhibition of tumour cell proliferation: Tasonermin is cytotoxic or cytostatic in vitro for a variety of tumour cell lines of different histogenesis.
Danish: Direkte hæmning af tumorcelleproliferation: Tasonermin virker cytotoksisk eller cytostatisk in vitro på en række tumorcellelinjer med forskellig histogenese.
English: Cases of compartment syndrome characterised by pain, swelling and neurological symptoms, as well as muscle damage affecting the perfused limb have been observed in isolated patients treated with Beromun.
Danish: Tilfælde af kompartment-syndrom karakteriseret ved smerte, hævelse og neurologiske symptomer samt muskelskade har været observeret hos enkelte patienter behandlet med Beromun.
English: Abdominal pain upper, gastritis erosive
Danish: Øvre abdominalsmerter, erosiv gastrit
English: Late onset of peripheral arterial occlusive disease (PAOD) of the lower limbs has been reported in patients several years after ILP, predominantly in patients presenting with established cardiovascular risk factors, or who had undergone additional irradiation therapy of the concerned limb.
Danish: Sen indtræden af arteriel insufficiens (PAOS) i underben eller -arme er rapporteret hos patienter flere år efter ILP, overvejende hos patienter med kardiovaskulære risikofaktorer og hos patienter, der har gennemgået yderligere strålebehandling af det pågældende ben eller arm.
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 (see section 4.4).
Danish: Kombinationer med kardiotoksiske midler (f.eks. antracykliner) bør undgås, idet det er muligt, at tasonermin kan øge risikoen for kardiotoksicitet, således som det er blevet observeret i 13-ugers prækliniske toksikologiske undersøgelser (se pkt.
English: Leukopenia, thrombocytopenia
Danish: Leukopeni, trombocytopeni.
English: No significant interactions have so far been noted, but caution should be exercised (see section 4.5).
Danish: Ingen signifikante interaktioner er hidtil observeret, men forsigtighed bør udvises (se pkt.
English: Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 107 IU (International Units).
Danish: Hvert hætteglas indeholder 1 mg tasonermin*, svarende til 3,0-6,0 x 107 IE (Internationale Enheder).
English: The maximum tolerated dose (MTD) of tasonermin for ILP is 4 mg, which is 10 times the systemic MTD.
Danish: tolererede dosis (MTD) af tasonermin til ILP er 4 mg, hvilket sv.t.
English: When necessary a second ILP can be considered 6-8 weeks after the first ILP (see section 4.4).
Danish: Om nødvendigt kan en yderligere ILP overvejes 6-8 uger efter den første ILP (se pkt.
English: The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection.
Danish: Indholdet af et hætteglas med Beromun-pulver skal rekonstitueres med 5,3 ml steril 0,9 % natriumchlorid injektionsvæske, opløsning.
English: Volume expanders and vasopressors are recommended.
Danish: Volumenudvidende og karkontraherende midler anbefales.
English: Significant renal dysfunction, e.g. nephrotic syndrome, serum creatinine > 150 µmol/l, or creatinine clearance of < 50 ml/min.
Danish: Alvorlig nyredysfunktion f.eks. nefrotisk syndrom, serumkreatinin >150 µmol/l eller kreatininclearance på <50 ml/min.
English: Significant haematological dysfunction, e.g. leucocytes < 2.5 x 109/l, haemoglobin < 9 g/dl, platelets < 60 x 109/l, haemorrhagic diathesis or active bleeding disorder.
Danish: Alvorlig hæmatologisk dysfunktion f.eks. leukocytter <2,5 x 109/l hæmoglobin <9 g/dl, blodplader <60 x 109/l hæmoragisk diatese eller aktive blødningsforstyrrelser.
English: Tasonermin has been shown to be active in the classic assay for tumour necrosis factor, producing haemorrhagic necrosis of tumour nodules in murine syngeneic and human xenogeneic tumour systems after local or systemic injection.
Danish: Tasonermin er vist at være aktiv i den klassiske tumornekrosefaktoranalyse ved at forårsage hæmoragisk nekrose af tumornoduli i murinsynogene og humanxenogene tumorsystemer efter lokal eller systemisk injektion.
English: Beromun is used, together with melphalan containing medicine, for the treatment of soft tissue sarcoma of the arms and legs.
Danish: Beromun bruges sammen med lægemidlet melfalan til at behandle bløddelssvulster i arme eller ben.
English: Fever, chills, pain, fatigue
Danish: Feber, kulderystelser, smerter, træthed
English: Severe pulmonary dysfunction.
Danish: Alvorlig lungedysfunktion
English: Infection, wound infection
Danish: Infektion, sårinfektion
English: Adjustment of flow rate and tourniquet may be required to ensure leakage is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10%.
Danish: Justering af flowhastigheden og kompressionen kan være nødvendig, for at sikre at lækagen er stabil (det systemiske radioaktive niveau har nået et stabilt leje) og ikke overskrider 10 %.
English: Blood, supplied with oxygen by a heart and lung machine, is pumped into your affected limb via a catheter in the main artery, while it is drained (pumped out) from the main vein.
Danish: Blodet forsynes med ilt ved hjælp af hjerte/lungemaskine og pumpes ind i den syge arm/det syge ben via et kateter i hovedåren (arterien), mens blodet ledes ud via et andet kateter i hovedvenen.
English: These include standard anaesthetic agents, analgesics, antipyretics, intravenous fluids, anticoagulants and vasopressor agents.
Danish: Disse omfatter standardanæstetika, -analgetika, -antipyretika, -infusionsvæsker, -antikoagulantia og karkontraherende midler.
English: Following the ILP, a standard wash-out procedure should always be employed, using dextran 70 intravenous infusion or similar fluid.
Danish: Efter ILP bør en standard udvaskningsprocedure altid anvendes, idet man skal anvende dextran 70 intravenøs infusionsvæske eller lignende væske.
English: A Swan-Ganz catheter may be considered for monitoring pulmonary artery pressure and wedge pressure during the ILP and in the post-operative period.
Danish: Et Swan-Ganz kateter bør overvejes til monitorering af pulmonalt arterietryk og ”wedge” tryk under ILP samt postoperativt.
English: The recommended dose of Beromun depends on the affected limb, usually 3 mg for the arm and 4 mg for the leg. Beromun powder has to be dissolved before use.
Danish: Den anbefalede Beromun-dosis afhænger af legemsdelen - den er sædvanligvis 3 mg, hvis det er armen, og 4 mg, hvis det er benet.
English: Renal failure acute General disorders and administration site conditions Very common:
Danish: Akut nyreinsufficiens Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: Other medicines and Beromun
Danish: Brug af anden medicin sammen med Beromun
English: Adjustment of flow rate and tourniquet may be required to ensure leakage from perfusion circuit to systemic circulation is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10 %.
Danish: Justering af flowhastigheden og årepresse kan være nødvendigt for at sikre at lækage fra perfusionskredsløbet til det systemiske kredsløb er stabil (det systemiske radioaktivitetsniveau er nået op på et stabilt leje) og ikke overstiger 10 %.
English: After connection of the limb to the isolated circuit, flow rate should be adjusted to 35 to 40 ml/litre limb volume/minute and leakage from limb to systemic circulation checked using a radioactive tracer technique (see section 4.4).
Danish: Efter at have forbundet ekstremiteten med det isolerede kredsløb, bør flowhastigheden justeres til 3540 ml/l ekstremitetsvolume/min., og lækage fra ekstremiteten ud i det systemiske kredsløb skal kontrolleres med en radioaktiv sporingsteknik (se pkt.
English: Each vial contains 1 mg tasonermin, corresponding to 3.0-6.0 x 107 IU.
Danish: Ét hætteglas indeholder 1 mg tasonermin, svarende til 3,0-6,0 x 107 IE.
English: Should accidental overdose occur, ILP should be terminated immediately and the limb washed out using at least 2 litres of dextran 70 intravenous infusion or similar fluid (see also section 4.4).
Danish: Skulle der forekomme en utilsigtet overdosering, bør ILP straks afsluttes, og ekstremiteten gennemskylles med mindst 2 l dextran 70 intravenøs infusionsvæske eller lignende væske (se også pkt.
English: In such cases, a standard wash-out procedure should follow, using at least 2 litres of dextran 70 intravenous infusion or similar fluid.
Danish: I sådanne tilfælde bør der efterfølgende foretages en standard udvaskningsprocedure med brug af mindst 2 l dextran 70 intravenøs infusionsvæske eller lignende væske.
English: Significant cardiovascular disease, e.g. congestive heart failure (New York Heart Association Class II, III or IV), severe angina pectoris, cardiac arrhythmias, myocardial infarction within a 3 months period prior to treatment, venous thrombosis, occlusive peripheral arterial disease, recent pulmonary embolism.
Danish: Udtalte kardiovaskulære sygdomme f.eks. hjerteinsuffiens (New York Heart Association Klassificering II, III eller IV), alvorlig angina pectoris, hjertearytmi, myokardieinfarkt inden for de seneste 3 mdr.
English: In addition, as the clinical situation dictates, a vasopressor agent, e.g. dopamine, can be considered for administration during the ILP procedure, as well as in the post-operative period.
Danish: Endvidere og såfremt det skønnes klinisk nødvendigt kan administration af karkontraherende midler som f.eks. dopamin overvejes under ILP-proceduren og postoperativt.
English: If you do, this will not be until at least six weeks after your first ILP.
Danish: Hvis du skal behandles mere end én gang, går der mindst 6 uger fra din første ILP-behandling.
English: External heat loss from the limb should be prevented by application of thermal blankets and limb temperature continuously monitored by thermistor probes inserted into subcutaneous tissue and muscle.
Danish: Eksternt varmetab fra ekstremiteten bør undgås ved at anvende varmetæpper og samtidig konstant overvåge ekstremitetstemperaturen via termiske sonder som indføres i det subkutane væv og muskler.
English: The container contains latex rubber
Danish: Beholderen indeholder latexgummi
English: If signs of systemic toxicity appear, for example fever, cardiac arrhythmias, shock/hypotension, adult respiratory distress syndrome (ARDS), general supportive measures should be employed and the patient immediately transferred to an Intensive Care Unit for monitoring.
Danish: Hvis tegn på systemisk toksicitet forekommer, f.eks. feber, hjertearytmier, shock/hypotension, adult respiratory distress syndrome (ARDS), bør generel understøttende foranstaltninger igangsættes og patienten omgående overflyttes til observation på en intensivafdeling.
English: You may have to stay in an intensive care unit (ICU) directly after the ILP for a short time.
Danish: Du skal muligvis tilbringe en kortere periode på intensivafdelingen, umiddelbart efter ILP.
English: Direct effects on tumour vasculature: Tasonermin affects the morphology and reduces proliferation of endothelial cells and modifies expression of specific cell surface and secretory proteins (including adhesion molecules and proteins modulating coagulation, interleukins and haematopoietic growth factors).
Danish: Direkte effekt på tumorvaskularisering: Tasonermin påvirker morfologien og reducerer proliferationen af endotelceller og modificerer udtrykket af specifik celleoverflade og sekretionsproteiner (inkl.
English: Contents of the pack and other information What Beromun contains
Danish: Pakningsstørrelser og yderligere oplysninger Beromun indeholder:
English: Haematological disorders, in particular leukopaenia, thrombocytopaenia and clotting dysfunction, might be expected.
Danish: Hæmatologiske forstyrrelser især leukopeni, trombocytopeni og koagulationsforstyrrelser kan forventes.
English: The synthesis capacity of the liver was lowered as indicated by increased liver enzymes.
Danish: Leverens syntesekapacitet blev formindsket, vist ved en forøgelse af leverenzymerne.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om Beromun på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The blood flow to and from your affected limb will be stopped using a tourniquet.
Danish: Blodforsyningen fra og til den syge arm/det sygeben vil blive standset ved hjælp af en årepresse.
English: In particular, you should tell your doctor if you are using medicines to lower blood pressure (to treat hypertension).
Danish: Det gælder især, hvis du tager medicin, der sænker blodtrykket.
English: Sepsis Blood and lymphatic system disorders Common:
Danish: Blod- og lymfesystem Almindelig:
English: Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun:
Danish: Kontraindikationerne i forbindelse med Beromun ILP angives herunder opdelt i henhold til procedurens faser:
English: Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common:
Danish: Arteriel insufficiens Luftveje, thorax og mediastinum Almindelig:
English: Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Danish: Beromun vil blive indgivet ved hjælp af isoleret ekstremitetsperfusion (ILP) sammen med kræftmidlet melfalan.
English: The resulting solution will be administered into an artery in your affected arm or leg by ILP for an initial period of 30 minutes.
Danish: Den færdige opløsning vil blive indgivet i en blodåre i den syge arm eller det syge ben ved hjælp af ILP-teknik over en periode på 30 minutter.
English: It belongs to a class of medicines known as immunostimulants, which help your body's immune system fight cancer cells.
Danish: Disse hjælper dit immunsystem med at bekæmpe kræftceller.
English: A recent history of, or active peptic ulcer.
Danish: Nyligt tilfælde af eller aktivt mavesår
English: Thus, the duration of the total perfusion should be 90 minutes.
Danish: tilførslen af melfalan bør være 60 min. Varigheden af den samlede perfusion bliver således 90 min.
English: Reconstituted solution Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C.
Danish: Kemisk og fysisk ”i-brug” stabilitet er blevet påvist i op til 48 timer ved 25 oC. Set ud fra et mikrobiologisk synspunkt skal produktet bruges straks.
English: If you use more Beromun than you should
Danish: Hvis du har brugt for meget Beromun
English: ILP should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities for continuous monitoring for medicinal product leakage into the systemic circulation.
Danish: ILP bør foretages på specialafdelinger af kirurgiske teams med erfaring i behandling af ekstremitetssarkomer og ILP-procedure, med en intensivafdeling til rådighed og med mulighed for kontinuerlig monitorering for lægemiddellækage til den systemiske cirkulation.
English: Data obtained from 51 ILP patients demonstrated maximum concentrations of tasonermin in the perfusion circuit are reached 30 min after the onset of ILP and range between 3000 and 4000 ng/ml.
Danish: koncentrationer af tasonermin i perfusionskredsløbet opnås inden for 30 min. efter påbegyndelse af ILP og rangerer mellem 3000 og 4000 nanogram/ml.
English: Very common (may affect more than 1 in 10 people) - disturbances in your heart beat (arrhythmia) - feeling sick, vomiting - liver damage blistering of the skin fever (usually mild to moderate), chills pain in the affected arm or leg tiredness (fatigue)
Danish: Meget almindelig (kan forekomme hos mere end 1 ud af 10 personer) - uregelmæssig hjerterytme (arytmi) - kvalme, opkastning - leverskade - blærer på huden - feber (normalt let til moderat), kulderystelser - smerte i den berørte arm eller ben - træthed
English: Cardiac failure
Danish: Hjerteforstyrrelser
English: Powder vial Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Danish: Pulverhættteglas Type-1 glas med chlorbutyl-gummiprop og forseglede med aluminium ”flip-off”-låg
English: How to use Beromun
Danish: Sådan skal du bruge Beromun
English: Patients with contraindications to radioactive tracer monitoring.
Danish: Patienter, hos hvilke brug af radioaktivt sporstofsmonitorering er kontraindiceret.
English: Patients with contraindications to the use of anticoagulants.
Danish: Patienter, hos hvilke brug af antikoagulantia er kontraindiceret.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, human serum albumin
Danish: Natriumdihydrogenphosphatdihydrat, dinatriumphosphatdodecahydrat, human serumalbumin.
English: The solution has a clear to light yellow colour.
Danish: Opløsningens farve er klar eller let lysegul farve.
English: This will occur whilst you are unconscious, under the influence of a general anaesthetic.
Danish: Dette vil foregå, mens du er under fuld bedøvelse (narkose).
English: Upper limb: 3 mg total dose by ILP Lower limb: 4 mg total dose by ILP
Danish: Nedre ekstremitet: 4 mg total dosis ved ILP.
English: This treatment should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities for continuous monitoring for medicinal product leakage into the systemic circulation.
Danish: Denne behandling bør foretages på specialafdelinger af kirurgiske teams med erfaring i behandling af ekstremitetssarkomer og ILP-procedure, med en intensivafdeling til rådighed og med mulighed for kontinuerlig monitorering af lægemiddellækage til det systemiske kredsløb.
English: Proliferation of activated B- and T-lymphocytes, development of cytotoxic T-cells and immunoglobulin-secreting cells is enhanced, monocytes/macrophages are activated for killing of tumour cells, granulocytes are activated to display enhanced phagocytic activity, respiratory burst and degranulation, and adherence to endothelium.
Danish: Monocytter/makrofager aktiveres til drab af tumorceller, granulocytter aktiveres til at udvise øget fagocytisk aktivitet, ”respiratorisk brist” og degranulering, og adhæsion til endotelium.
English: Beromun 1 mg powder for infusion Tasonermin
Danish: Beromun 1 mg pulver til infusionsvæske tasonermin
English: Please refer to the Summary of Product Characteristics for melphalan for details regarding incompatabilities with melphalan.
Danish: Se venligst produktresuméet for melfalan for yderligere oplysninger om uforligeligheder med melfalan.
English: You will usually not receive a second ILP with Beromun.
Danish: Sædvanligvis får man kun én behandling med ILP.
English: By reducing the size of the tumour, the treatment is intended to facilitate the removal of the tumor by surgery or to prevent severe damage to the surrounding healthy tissue and thus to delay or prevent the need for arm or leg amputation.
Danish: Den gives også for at forebygge alvorlige skader på det omgivende sunde væv, så amputation af armen eller benet kan udsættes eller helt undgås.