FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is defibrotide.
Danish: • Aktivt stof: defibrotid.
English: Forty-four children and 58 adult patients with severe VOD post-HSCT, were treated with Defitelio 25 mg/kg/day intravenous by infusion, and compared with 32 historical control patients.
Danish: 44 børn og 58 voksne med svær post-HSCT VOD blev behandlet med intravenøs infusion af Defitelio, 25 mg/kg/dag, og sammenlignet med 32 historiske kontrolpatienter.
English: It is recommended that the diluted Defitelio solution be administered to patients using an infusion set equipped with a 0.2 μm in-line filter.
Danish: Det anbefales, at den fortyndede opløsning af Defitelio administreres til patienterne ved hjælp af et infusionssæt med 0,2 μm in-line-filter.
English: There is limited efficacy and safety data on doses above this level and consequently it is not recommended to increase the dose above 25 mg/kg/day.
Danish: Over dette niveau foreligger der kun begrænsede oplysninger om virkning og sikkerhed, hvorfor doser over 25 mg/kg/dag frarådes.
English: Defitelio should not be used if the solution is cloudy or contains particles.
Danish: Defitelio må ikke anvendes, hvis opløsningen er uklar eller indeholder partikler.
English: Once diluted for use the infusion storage should not exceed 24 hours at 2°C -8°C unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Efter klargøring af lægemidlet til brug må infusionsvæsken højst opbevares i 24 timer ved 2 til 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Use of medicinal products that increase the risk of haemorrhage within 24 hours of Defitelio administration (within 12 hours in the case of unfractionated heparin) is not recommended.
Danish: Administration af lægemidler, der øger risikoen for blødning, frarådes inden for 24 timer efter administration af Defitelio (inden for 12 timer for ufraktioneret heparin).
English: A bolus administration of Defitelio may cause flushing or a sensation of “generalised heat”.
Danish: Administration af en bolus af Defitelio kan medføre hyperæmi (flushing) eller generaliseret varmefornemmelse.
English: Do not use Defitelio if you are pregnant unless your disease requires treatment with Defitelio.
Danish: Brug ikke Defitelio, hvis du er gravid, medmindre din sygdom gør behandling med Defitelio nødvendig.
English: This medicine can be used in adults, and in adolescents, children and infants over one month of age.
Danish: Dette lægemiddel kan anvendes til voksne og unge, børn og spædbørn over 1 måned.
English: Pulmonary haemorrhage Epistaxis
Danish: Pulmonal blødning Epistaxis
English: This leaflet was last revised in:
Danish: Denne indlægsseddel blev senest ændret :
English: In doses above the recommended dose of 25 mg/kg/day there was a higher proportion of patients with bleeding events in the high dose group but since many events occurred in the follow-up period, a clear relationship with defibrotide treatment could not be determined.
Danish: I doser højere end den anbefalede dosis på 25 mg/kg/dag var der en større andel af patienter med blødning i højdosisgruppen, men da der var mange hændelser i opfølgningsperioden, kunne der ikke fastslås en klar sammenhæng med behandlingen med defibrotid.
English: No special precautions are indicated.
Danish: Der kræves ingen særlige forsigtighedsregler.
English: Hypersensitivity Anaphylactic reaction
Danish: Overfølsomhed Anafylaktisk reaktion
English: The use of Defitelio rescue treatment for all patients who developed VOD meant that the study was not designed to assess any survival advantage and none was seen in this study.
Danish: Brugen af Defitelio som rescuebehandling til alle patienter, der fik VOD, indebar, at undersøgelsens design ikke gav mulighed for at vurdere en overlevelsesfordel, som undersøgelsen da heller ikke viste.
English: The tabulated list of adverse reactions incorporates the ADRs observed in study 2005-01 [ADR = any event reported as possibly related on at least two occasions] and TEAEs observed in T-IND 2006-05 study [TEAE = any AE that started or worsened in severity after the first dose of defibrotide].
Danish: Tabellen over bivirkninger omfatter de bivirkninger, der er observeret i studie 2005-01 [bivirkning = enhver hændelse, der er rapporteret som muligvis relateret ved mindst to lejligheder] samt TEAE'er observeret i T-IND 200605-studiet [TEAE = enhver bivirkning, der er startet eller forværret efter den første dosis defibrotid].
English: • if you are using other medicines to break down blood clots such as tissue plasminogen activator
Danish: • hvis du bruger anden medicin, der opløser blodpropper, såsom vævsplasminogenaktivator.
English: If you experience any of these side effects, you should contact your doctor immediately.
Danish: Hvis du kommer ud for nogen af disse bivirkninger, skal du straks kontakte lægen.
English: • localized blood collection out of the vessel (hematoma) in the brain
Danish: • lokaliseret blodansamling uden for blodkarrene (hæmatom) i hjernen
English: Depending on the type and amount of diluent the colour of the diluted solution may vary from colourless to light yellow.
Danish: Afhængigt af art og mængde af det anvendte fortyndingsmiddel kan den fortyndede opløsnings farve variere fra farveløs til bleggul.
English: Defibrotide does not inhibit or induce CYP450s.
Danish: Defibrotid hverken hæmmer eller inducerer CYP450-enzymer.
English: There are no studies using defibrotide in pregnant women.
Danish: Der foreligger ingen undersøgelser, hvor defibrotid er anvendt hos gravide kvinder.
English: Defitelio must be prescribed and administered to patients by specialised physicians experienced in the diagnosis and treatment of complications of HSCT.
Danish: Behandling med Defitelio skal ordineres og gives af læger med specialisterfaring i diagnosticering og behandling af komplikationer til HSCT.
English: No dose adjustment is therefore recommended but careful monitoring of patients should be undertaken (see section 5.2).
Danish: Dosisjustering anbefales derfor ikke, men omhyggelig monitorering af patienterne er nødvendig (se pkt.
English: The Day+100 all-cause mortality in patients with severe VOD who were not treated with defibrotide was 69%, and 61% in those patients who received defibrotide.
Danish: På dag +100 var mortaliteten af alle årsager 69 % hos patienter med svær VOD, der ikke blev behandlet med defibrotid, sammenholdt med 61 % hos dem, der blev behandlet med defibrotid.
English: The efficacy and safety of defibrotide in the treatment of severe VOD were studied in a pivotal Phase 3 historical-controlled study (2005-01).
Danish: Virkningen og sikkerheden af defibrotid til behandling af svær VOD blev undersøgt i et pivotalstudie (fase 3) (2005-01) med historiske kontroller.
English: In addition, Day+100 survival rate was improved in the Defitelio group with 38.2% (39/102) of the patients surviving versus 25.0% (8/32) in the historical control group (p=0.034).
Danish: Desuden var overlevelsen på dag +100 bedre i gruppen på Defitelio, idet 38,2 % (39/102) af patienterne overlevede mod 25,0 % (8/32) i den historiske kontrolgruppe (p=0,034).
English: The recommended dose for children aged 1 month to 18 years is the same mg/kg dose as for adults i.e. 6.25 mg/kg body weight every 6 hours.
Danish: Den anbefalede dosis til børn fra 1 måned til 18 år er den samme i mg/kg som til voksne, dvs. 6,25 mg/kg legemsvægt hver 6. time.
English: The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
Danish: Den anbefalede dosis er 6,25 mg/kg legemsvægt hver 6. time (25 mg/kg/dag).
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: It is indicated in adults and in adolescents, children and infants over 1 month of age.
Danish: Det er indiceret til voksne og unge, børn og spædbørn over 1 måned.
English: The required volume from the Defitelio vials should be withdrawn and combined.
Danish: Det nødvendige volumen af Defitelio trækkes op af hætteglassene og kombineres.
English: Accumulation of defibrotide over 4 doses was not found.
Danish: Der sås ikke akkumulation af defibrotid efter 4 doser.
English: It is used to treat a condition called hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots.
Danish: Det anvendes til behandling af hepatisk venookklusiv sygdom, hvor blodkarrene i leveren bliver beskadiget og tilstoppet af blodpropper.
English: From a microbiological point of view, after dilution, the reconstituted medicinal product should be used immediately.
Danish: Holdbarhed i brug efter første åbning og/eller fortynding Ud fra et mikrobiologisk synspunkt bør det rekonstituerede lægemiddel anvendes straks efter fortynding.
English: Based on the results of the QTc study, conducted in healthy subjects at therapeutic and supra-therapeutic doses, it can be concluded that Defitelio has no significant or clinically relevant QTc-prolonging potential at doses up to 4 times higher than therapeutically indicated.
Danish: På grundlag af QTc-studiet, der blev udført hos raske forsøgspersoner med terapeutiske og supraterapeutiske doser, kan det konkluderes, at Defitelio ikke har noget væsentligt eller klinisk relevant QTc-forlængende potentiale i doser op til fire gange den terapeutiske dosis.
English: As you will be given this medicine by a doctor or a nurse it is unlikely that a dose will be missed.
Danish: Hvis en dosis af Defitelio er blevet sprunget over Da du får dette lægemiddel af en læge eller sygeplejerske, er det usandsynligt, at der vil blive oversprunget en dosis.
English: It primarily acts through reducing excessive endothelial cell (EC) activation (endothelial dysfunction), modulating endothelial homeostasis as well as restoring thrombo-fibrinolytic balance.
Danish: Det virker primært ved at reducere kraftig endotelcelle (EC)-aktivering (endoteldysfunktion), modulere endotel homøostase samt genoprette den trombofibrinolytiske balance.
English: There are no studies investigating the effects of defibrotide on human fertility.
Danish: Der foreligger ingen undersøgelser om virkningerne af defibrotid på fertiliteten hos mennesker.
English: Do not use Defitelio after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke Defitelio efter den udløbsdato, der står på kartonen og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In order to collect comparative safety data, the MAH will provide the final CSR and a report of comparative safety data from the Phase 3, randomised, adaptive study (15-007) of Defibrotide vs best supportive care in the prevention of hepatic venoocclusive disease in adult and paediatric patients undergoing hematopoietic stem cell transplant (HSCT).
Danish: Med henblik på samling af de komparative sikkerhedsdata vil indehaveren af markedsføringstilladelsen udlevere den endelige kliniske forsøgsrapport og en rapport over de komparative sikkerhedsdata fra det randomiserede, adaptive fase 3-studie (15-007) med defibrotid vs. bedste supportive behandling i forebyggelsen af hepatisk venookklusiv sygdom hos voksne og pædiatriske patienter, der gennemgår hæmatopoietisk stamcelletransplantation (HSCT).
English: Defitelio has no or negligible influence on the ability to drive and operate machines.
Danish: Defitelio påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis og er således stort set natriumfrit.
English: In the Phase 3 pivotal treatment study (2005-01 Study), the overall incidence of adverse events was similar in the defibrotide treatment group and in the control group (historical).
Danish: I det pivotale studie (fase 3) (2005-01) var den totale forekomst af bivirkninger den samme i behandlingsgruppen med defibrotid og i kontrolgruppen (historisk).
English: After administration of the therapeutic dose (6.25 mg/kg) to healthy subjects, an average of 9.48% of the total dose administered is excreted in urine as unchanged defibrotide in 24 hours, with the majority excreted during the first collection interval of 0-4 hours (approximately 98%).
Danish: Efter administration af den terapeutiske dosis (6,25 mg/kg) hos raske forsøgspersoner blev gennemsnitligt 9,48 % af den samlede indgivne dosis udskilt i urinen som uomdannet defibrotid i løbet af 24 timer, hvoraf størstedelen blev udskilt i løbet af det første opsamlingsinterval på 0-4 timer (ca. 98 %).
English: A 40% reduction in the overall incidence of VOD in the Defitelio prophylaxis arm (from 19.9% in the control arm to 12.2% in the Defitelio arm), has been shown.
Danish: Der opnåedes en 40 % reduktion af den totale forekomst af VOD i den gruppe, der fik profylakse med Defitelio (fra 19,9 % i kontrolgruppen til 12,2 % i Defitelio-gruppen).
English: Defitelio 6.25 mg/kg was administered intravenously over 2 hours to subjects every 6 hours.
Danish: Defitelio 6,25 mg/kg blev administreret intravenøst til forsøgspersonerne over 2 timer hver 6. time.
English: In secondary analyses on the subset of patients undergoing allogeneic transplants, Defitelio prophylaxis was also associated with a lower incidence and less Grade 2 to 4 severity of acute graft versus host disease (aGvHD) by Day+100.
Danish: I sekundære analyser af den undergruppe af patienter, der fik foretaget allogen transplantation, var forebyggelse med Defitelio desuden forbundet med lavere forekomst af akut graft versus host disease (aGvHD) og færre tilfælde af grad 2 til 4 aGvHD på dag +100.
English: The efficacy data from this pivotal study are supported and confirmed with data from a dose-finding study (25 mg/kg arm) and the Open Label Treatment-IND study, as presented in Tables 1.
Danish: Resultater fra dette pivotalstudie vedrørende virkning understøttes og bekræftes af data fra en dosisfastsættelsesundersøgelse (behandlingsgruppen, der modtog 25 mg/kg) og det åbne INDbehandlingsstudie (“Investigational New Drug”) som vist i tabel 1.
English: Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
Danish: Defitelio er indiceret til behandling af svær hepatisk venookklusiv sygdom (VOD), også kaldet sinusoidalt obstruktionssyndrom (SOS), ved transplantationsbehandling med hæmatopoietiske stamceller (HSCT).
English: Juvenile toxicity
Danish: Toksicitet hos unge individer
English: Therefore, the use of defibrotide with antithrombotic/fibrinolytic medicinal products is not recommended.
Danish: Det frarådes derfor at anvende defibrotid sammen med antitrombotiske/fibrinolytiske lægemidler.
English: However, if used, in exceptional cases, caution should be exercised by closely monitoring the coagulation parameters (see section 4.4).
Danish: Hvis dette undtagelsesvis gøres, bør det ske med forsigtighed under tæt overvågning af koagulationsparametre (se pkt.
English: Defibrotide works by protecting the cells of the blood vessels and preventing or breaking down the blood clots.
Danish: Defibrotid virker ved at beskytte cellerne i blodkarrene og forhindre dannelsen af blodpropper eller nedbryde dem.
English: Contents of the pack and other information.
Danish: Pakningsstørrelser og yderligere oplysninger
English: In both species, the main findings were accumulation of vacuolated macrophages in liver of dogs and in liver, kidneys and lymph nodes of rats.
Danish: De vigtigste forandringer var ophobning af vakuoliserede makrofager i leveren hos hunde og i leveren, nyrerne og lymfeknuderne hos rotter.
English: Effective contraception is required for patients and partners of patients during exposure to Defitelio and for one week subsequent to discontinuation.
Danish: Patienterne og deres partner skal anvende effektiv antikonception under eksponeringen for Defitelio og en uge efter behandlingens ophør.
English: Defitelio contains sodium This medicine contains less than 23 mg of sodium, which means it is essentially “sodium-free”.
Danish: Defitelio indeholder natrium Dette lægemiddel indeholder mindre end 23 mg natrium og er således stort set natriumfrit.
English: One carton contains 10 glass vials with 2.5 mL of concentrate each.
Danish: En kartonæske med 10 hætteglas med hver 2,5 ml koncentrat.
English: • bleeding in general
Danish: • blødning generelt
English: Outcome data available from 611 patients treated with Defitelio on a compassionate use basis for non-severe and severe VOD post-transplant, are consistent with the controlled clinical trials, with complete response rate 24% (51/212) and survival 37% (78/212) in the subset of patients with severe VOD.
Danish: Data vedrørende udfald hos 611 patienter med ikke-svær og svær posttransplantations-VOD, der blev behandlet med Defitelio med særlig udleveringstilladelse (compassionate use), svarer til de kontrollerede kliniske forsøg: I undergruppen med svær VOD var raten af komplet respons 24 % (51/212) og overlevelsen 37 % (78/212).
English: − If you have any further questions, ask your doctor.
Danish: − Spørg lægen, hvis der er mere, du vil vide.
English: Defitelio is for intravenous use.
Danish: Defitelio er beregnet til intravenøs anvendelse.
English: In the Segment II reproductive studies in rats and rabbits, defibrotide has shown maternal toxicity by inducing a high rate of haemorrhagic abortion when infused intravenously over two hours at all dose levels tested including doses close to the human dose.
Danish: I Segment II-reproduktionsundersøgelser hos rotter og kaniner har defibrotid udvist maternel toksicitet ved at fremkalde en høj andel af hæmoragisk abort ved intravenøs infusion gennem 2 timer ved alle undersøgte dosisniveauer, herunder doser tæt på den humane dosis.
English: Gastrointestinal haemorrhage Vomiting
Danish: Gastrointestinal blødning Opkastning
English: Alive at Day +100 VOD resolved by Day +100
Danish: I live på dag +100 VOD svundet på dag +100
English: Defibrotide protects ECs from damage and promotes tissue homeostasis by decreasing fludarabine-mediated apoptosis of EC while maintaining its anti-leukemic effect and by inhibiting the expression of heparanase, shown in in vitro and in vivo studies respectively.
Danish: Defibrotid beskytter EC'er mod skade og fremmer vævshomøostase ved at nedsætte fludarabinmedieret apoptose af EC, mens den antileukæmiske virkning opretholdes, og ved at hæmme ekspressionen af heparanase, vist i hhv. in vitro- og in vivo-studier.
English: • The other ingredients are sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (both for pH-adjustment) and water for injections (see section 2 ‘Defitelio contains Sodium').
Danish: • Øvrige indholdsstoffer: natriumcitrat (dihydrat), saltsyre og natriumhydroxid (begge til pHjustering) og vand til injektionsvæsker (se afsnit 2 “Defitelio indeholder natrium”).
English: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italy
Danish: Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italien
English: Safety and efficacy in children aged less than 1 month have not yet been established.
Danish: Sikkerheden og virkningen hos børn under 1 måned er endnu ikke klarlagt.
English: Six patients with an estimated glomerular filtration rate <30 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease equation) and not currently on dialysis were compared to 6 healthy subjects with similar baseline demographics.
Danish: Seks patienter, der havde en estimeret glomerulær filtrationshastighed på < 30 ml/min/1,73 m (beregnet ud fra MDRD-formlen [Modification of Diet in Renal Disease]), og som ikke var i dialyse på det aktuelle tidspunkt, blev sammenlignet med 6 raske forsøgspersoner med samme demografiske karakteristika ved baseline.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate contains defibrotide* 80 mg corresponding to a quantity of 200 mg in 2.5 mL in a vial, and corresponding to a concentration in the range of 4 mg/mL to 20 mg/mL after dilution.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml koncentrat indeholder defibrotid* 80 mg svarende til en mængde på 200 mg i et 2,5 ml hætteglas og svarende til en koncentration mellem 4 mg/ml og 20 mg/ml efter fortynding.
English: Blood and lymphatic system disorders Common
Danish: Blod og lymfesystem
English: Before dilution, each vial should be inspected for particles.
Danish: Før fortynding inspiceres hvert hætteglas for partikler.
English: Pack size of 10 vials.
Danish: Pakningsstørrelse: 10 hætteglas.
English: • haemothorax (accumulation of blood in the area between the heart and the lung)
Danish: • hæmothorax (blodansamling i rummet mellem hjertet og lungerne)
English: The final concentration of Defitelio should be in the range of 4 mg/mL to 20 mg/mL.
Danish: Den endelige koncentration af Defitelio skal være mellem 4 mg/ml og 20 mg/ml.
English: Defitelio may be used during breastfeeding.
Danish: Defitelio kan anvendes under amning.
English: In the paediatric prevention study at 25 mg/kg/day there was an increased incidence of any bleeding events in the defibrotide group compared with the treatment group.
Danish: I den pædiatriske forebyggelsesundersøgelse med 25 mg/kg/dag var der højere forekomst af alle blødningsepisoder i gruppen på defibrotid end i behandlingsgruppen.
English: Difference in exposure is not considered clinically relevant and so dose adjustment is not advised for patients with renal impairment (see section 4.2).
Danish: Det vurderes, at forskelle i eksponering ikke er klinisk relevante, hvorfor dosisjustering ikke anbefales hos patienter med nedsat nyrefunktion (se pkt.
English: Prior to use the solution should be visually inspected for particulate matter.
Danish: Inden brug inspiceres opløsningen visuelt for partikler.
English: Pharmacokinetic modelling simulation analysis showed that Defitelio plasma concentrations do not accumulate upon multiple dose administration and with doses up to 4-fold the therapeutic dose.
Danish: Simulering med farmakokinetiske modeller viste, at Defitelio ikke akkumuleres i plasma ved administration af gentagne doser eller i doser op til fire gange den terapeutiske dosis.
English: Repeated intravenous administration of defibrotide, at doses below and close to the human therapeutic dose, to juvenile rats resulted in a delay in the mean age of preputial separation, suggesting a delay in the onset of male puberty in rats.
Danish: Gentagen intravenøs administration af defibrotid til unge rotter i doser under og tæt på den terapeutiske dosis hos mennesker medfører forsinket separation af præputium som tegn på forsinket indtræden af pubertet hos rotter.
English: No formal pharmacokinetic studies have been performed in patients with hepatic impairment; however, the medicinal product has been used in clinical trials of patients developing hepatic impairment without dose adjustment with no safety issues identified.
Danish: Der er ikke udført egentlige farmakokinetiske studier hos patienter med nedsat leverfunktion, men lægemidlet er uden dosisjustering blevet anvendt i kliniske studier hos patienter, der udviklede nedsat leverfunktion, uden at der er konstateret sikkerhedsproblemer.
English: Driving and using machines It is not expected that Defitelio will affect your ability to drive and operate machines.
Danish: Trafik- og arbejdssikkerhed Defitelio forventes ikke at påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: The solution for infusion should be mixed gently.
Danish: Infusionsopløsningen sammenblandes forsigtigt.
English: Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions.
Danish: Defibrotid er en oligonukleotidblanding med påviste antitrombotiske, fibrinolytiske, antiadhæsive og antiinflammatoriske virkninger.