FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase 1 studies, adverse events with a frequency of ≥ 5% included headache (30.9%), ecchymosis (23.0%), and pain (5.8%).
Danish: Hændelser med en hyppighed på ≥ 5 % i fase 1 forsøgene omfattede hovedpine (30,9 %), ekkymose (23,0 %) og smerter (5,8 %).
English: Patients meeting the clinical diagnosis of severe sepsis had a) known or suspected infection, b) clinical evidence of systemic response to infection including fever or hypothermia, leucopenia or leucocytosis, tachycardia and tachypnoea, and c) acute organ dysfunction.
Danish: De patienter, som levede op til diagnosen svær sepsis havde a) kendt eller mistænkt infektion, b) kliniske tegn på en systemisk reaktion på infektion inklusiv feber eller hypotermi, leukopeni eller leukocytose, takykardi og takypnø og c) akut organdysfunktion.
English: If sequential measures of coagulopathy (including platelet count) indicate severe or worsening coagulopathy, the risk of continuing the infusion should be weighed against the expected benefit.
Danish: Hvis gentagne målinger af koagulopati (inklusiv trombocyttal) indikerer svær eller forværret koagulopati, skal risikoen ved fortsat infusion afvejes mod den forventede fordel.
English: In healthy subjects, greater than 90% of the steady state condition is attained within 2 hours following the start of a constant-rate intravenous infusion of Xigris.
Danish: Hos raske forsøgspersoner er mere end 90 % af steady state koncentrationen opnået inden for 2 timer efter påbegyndelsen af en Xigrisinfusion med konstant hastighed.
English: Drotrecogin alfa (activated) increases the risk of bleeding.
Danish: Drotrecogin alfa (aktiveret) øger risikoen for blødning.
English: The median duration of organ dysfunction prior to treatment was 18 hours.
Danish: Medianen af tiden fra organdysfunktion til behandling var 18 timer.
English: Following the completion of an infusion, the decline in plasma drotrecogin alfa (activated) concentrations is biphasic and is comprised of a rapid initial phase (t1/2 α=13 minutes) and a slower second phase (t1/2 β=1.6 hours).
Danish: Efter afslutningen af infusionen falder plasmakoncentrationen af drotrecogin alfa (aktiveret) i to faser omfattende en hurtig første fase (t½ α = 13 minutter) og en langsommere anden fase (t½ β = 1,6 time).
English: WHAT XIGRIS IS AND WHAT IT IS USED FOR
Danish: XIGRIS' VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: In both treatment groups, the majority of bleeding events were ecchymosis or gastrointestinal tract bleeding.
Danish: I begge behandlingsgrupper stod ekkymoser eller gastrointestinale blødninger for de fleste blødningstilfælde.
English: However, with respect to the latter, the potential risk for humans being unknown, Xigris should not be used during pregnancy unless clearly necessary (see section 4.6).
Danish: Da den potentielle risiko for mennesker med hensyn til sidstnævnte er ukendt, bør Xigris ikke anvendes under graviditet, medmindre det er tvingende indiceret (se pkt.
English: It is recommended that Xigris be infused with an infusion pump to accurately control the infusion rate.
Danish: Det anbefales, at infusionen af Xigris foretages med en infusionspumpe for en præcis styring af infusionshastigheden.
English: The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende produktet, og produktresuméet vil om nødvendigt blive opdateret.
English: A hospital pharmacist, nurse or doctor will have dissolved the Xigris powder in water for injection and sodium chloride solution.
Danish: Hospitalets farmaceut, sygeplejerske eller læge opløser Xigrispulveret i vand til injektionsvæsker og dernæst i en saltvandsopløsning.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/225/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/02/225/001
English: If sequential tests of haemostasis indicate an uncontrolled or worsening coagulopathy that significantly increases the risk of bleeding, the benefits of continuing the infusion must be weighed against the potential increased risk of bleeding for that patient.
Danish: Hvis gentagne analyser af hæmostasen indikerer en koagulopati, som er ukontrolleret eller forværres, og som signifikant øger blødningsrisikoen, skal fordelene ved fortsat infusion afvejes mod den potentielt øgede blødningsrisiko for den pågældende patient.
English: The median duration of organ dysfunction prior to treatment was 25 hours.
Danish: Medianen af tiden fra organdysfunktion til behandling var 25 timer.
English: In placebo-controlled clinical trials in patients with severe sepsis, Xigris exerted an antithrombotic effect by limiting thrombin generation and improved sepsis-associated coagulopathy, as shown by a more rapid improvement in markers of coagulation and fibrinolysis.
Danish: I placebokontrollerede kliniske forsøg hos patienter med svær sepsis bevirkede Xigris en antitrombotisk effekt ved at begrænse dannelsen af trombin og forbedre den sepsisrelaterede koagulopati, som vist ved en hurtigere forbedring af markørerne for koagulation og fibrinolyse.
English: When administering drotrecogin alfa (activated) at low flow rates (less than approximately 5 ml/hr), the infusion set must be primed for approximately 15 minutes at a flow rate of
Danish: Hvis drotrecogin alfa (aktiveret) administreres ved lave flowhastigheder (mindre end ca. 5 ml/time) skal infusionssættet primes i ca. 15 minutter ved en flowhastighed på ca. 5 ml/time.
English: Organ dysfunction was defined as shock, hypotension or the need for vasopressor support despite adequate fluid resuscitation, relative hypoxemia (ratio of partial pressure of oxygen in arterial blood in mmHg to the percentage of oxygen in the inspired air expressed as a decimal (PaO2/FiO2 ratio) < 250), oliguria despite adequate fluid resuscitation, marked reduction in blood platelet counts, and/or elevated lactic acid concentrations.
Danish: Organdysfunktion blev defineret som shock, hypotension eller behov for vasopressorstøtte på trods af adækvat væsketilskud, relativ hypoxæmi (forholdet mellem det partielle oxygentryk i arterieblodet i mm Hg og det procentvise indhold af oxygen i indåndingsluften udtrykt som decimaltal (PaO2/FiO2 forholdet) < 250), oliguri på trods af adækvat væsketilskud, væsentligt nedsat trombocyttal og/eller forhøjede mælkesyrekoncentrationer.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2°C - 8°C ).
English: Lilly Pharma Fertigung und Distribution GmbH & Co. KG Teichweg 3
Danish: Lilly Pharma Fertigung und Distribution GmbH & Co.
English: No dose adjustments are required in adult patients with severe sepsis with regard to age, gender, hepatic function (as measured by transaminase levels), renal function, obesity or co-administration of prophylactic heparin.
Danish: Det er ikke nødvendigt at justere dosis til voksne patienter med svær sepsis på baggrund af alder, køn, leverfunktion (målt ved transaminaseniveauer), nyrefunktion, fedme eller samtidig administration af profylaktisk heparin.
English: Xigris was added to best standard care.
Danish: Xigris blev givet sammen med optimal standardpleje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/225/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/02/225/002
English: If the infusion is interrupted for any reason, Xigris should be restarted at the 24 μg/kg/hr infusion rate and continued to complete the full recommended 96 hours of dosing administration.
Danish: Hvis infusionen afbrydes, bør Xigris, uanset årsagen til afbrydelsen, genstartes med infusionshastigheden 24 μg/kg/time og fortsættes for at fuldende den anbefalede administrationstid på 96 timer.
English: There was also no difference in 28-day mortality (17.1% versus 17.3% in the Xigris and placebo groups, respectively).
Danish: Der var ingen forskel i 28-dages total mortalitet (17,1 % og 17,3 % for hhv. Xigris- og placebogrupperne).
English: It is recommended that the bag be labelled accordingly.
Danish: Det anbefales, at infusionsposen mærkes i overensstemmelse med dette.
English: Bleeding into the brain was uncommon, occurring in 0.2% (1 in 500) of patients treated with Xigris.
Danish: Blødning i hjernen var ikke almindeligt og forekom hos 0,2 % (1 ud af 500) af patienterne, der blev behandlet med Xigris.
English: The trial was stopped for futility after an interim analysis.
Danish: Forsøget blev standset grundet manglende formål med at fortsætte efter en interim analyse.
English: Drotrecogin alfa (activated) was not mutagenic in an in vivo micronucleus study in mice or in an in vitro chromosomal aberration study in human peripheral blood lymphocytes with or without rat liver metabolic activation.
Danish: Drotrecogin alfa (aktiveret) var hverken mutagent i en in vivo mikronukleustest med mus eller i en in vitro undersøgelse for kromosomafvigelser i lymfocytter fra perifert humant blod med eller uden metabolisk aktivering med rottelever.
English: Slowly withdraw the appropriate amount of reconstituted drotrecogin alfa (activated) solution from the vial.
Danish: Træk langsomt den ønskede mængde rekonstitueret drotrecogin alfa (aktiveret) opløsning ud af hætteglasset.
English: Xigris was studied in one Phase 3 international, multi-centre, randomised, double-blind, placebocontrolled trial (PROWESS) in 1690 patients with severe sepsis.
Danish: Xigris blev undersøgt i et internationalt, fase 3, multicenter, randomiseret, dobbeltblindt, placebokontrolleret forsøg (PROWESS), omfattende 1690 patienter med svær sepsis.
English: BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch {nummer}
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: Dose escalation or bolus doses of Xigris are not necessary to account for the interruption in the infusion.
Danish: Det er ikke nødvendigt at øge dosis eller at give bolusdoser af Xigris for at kompensere for afbrydelsen af infusionen.
English: In patients developing antibodies adverse events were not more frequent in drotrecogin alfa (activated) than in placebo patients.
Danish: Hos de patienter, som udviklede antistoffer, var bivirkninger ikke hyppigere hos patienter behandlet med drotrecogin alfa (aktiveret) end hos placebobehandlede patienter.
English: The plasma clearance of drotrecogin alfa (activated) is approximately 41.8 l/hr in sepsis patients as compared with 28.1 l/hr in healthy subjects.
Danish: Plasmaclearance af drotrecogin alfa (aktiveret) er ca. 41,8 l/time hos patienter med sepsis mod 28,1 l/time hos raske forsøgspersoner.
English: In patients with severe sepsis, infusion of drotrecogin alfa (activated) from 12 μg/kg/hr to 30 μg/kg/hr rapidly produced steady-state plasma concentrations that were proportional to infusion rates.
Danish: Hos patienter med svær sepsis medførte infusion af drotrecogin alfa (aktiveret) fra 12 μg/kg/time til 30 μg/kg/time hurtigt steady state plasmakoncentrationer, som var proportionale med infusionshastighederne.
English: Patients received drotrecogin alfa (activated) within 48 hours of onset of the first sepsisinduced organ dysfunction.
Danish: Patienterne fik drotrecogin alfa (aktiveret) indenfor 48 timer efter, at det første sepsisinducerede organsvigt var indtrådt.
English: In patients with severe sepsis, the plasma clearance of drotrecogin alfa (activated) was significantly decreased by renal impairment and hepatic dysfunction, but the magnitude of the differences in clearance (< 30 %) does not warrant any dosage adjustment.
Danish: Hos patienter med svær sepsis blev plasmaclearance af drotrecogin alfa (aktiveret) signifikant nedsat ved nyresvækkelse og lever dysfunktion, men forskellen i clearance (< 30 %) berettiger ikke til en justering af dosis.
English: Drotrecogin alfa (activated) present in plasma samples does not interfere with one-stage factor assays based on the PT (such as Factors II, V, VII and X assays).
Danish: Drotrecogin alfa (aktiveret) i plasmaprøver interfererer ikke med ettrins faktoranalyser baseret på PT (såsom faktor II, V, VII, og X analyser).
English: Prophylactic heparin increased the risk of non-serious bleeding (see section 4.8).
Danish: Profylaktisk heparinbehandling forøgede risikoen for ikke-alvorlig blødning (se pkt.
English: The entry criteria were similar to those employed in PROWESS.
Danish: Inklusionskriterierne var lig kriterierne i PROWESS.
English: At 28 days, the mortality rate in the Phase 3b study was 25.3%.
Danish: I fase 3b forsøget var mortaliteten 25,3 % efter 28 dage.
English: The recommended dose of Xigris is 24 μg/kg/hr (based on actual body weight) given as a continuous intravenous infusion for a total duration of 96 hours.
Danish: Den anbefalede dosis af Xigris er 24 μg/kg/time (baseret på aktuel kropsvægt), indgivet som en kontinuerlig intravenøs infusion over i alt 96 timer.
English: In the subgroup of patients with an APACHE II score ≥25 at baseline, the mortality was 31% in the Xigris group (128 out of 414) and 44% in the placebo group (176 out of 403).
Danish: I subgruppen af patienter med en APACHE II score ≥ 25 ved baseline var mortaliteten 31 % i Xigrisgruppen (128 ud af 414) og 44 % i placebogruppen (176 ud af 403).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL TEXT
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: No benefit of drotrecogin alfa (activated) was observed in the subgroup of 872 patients at low risk of death with multiple organ dysfunction, so ADDRESS did not confirm the efficacy results of the PROWESS study.
Danish: Der blev ikke observeret nogen fordel af drotrecogin alfa (aktiveret) hos undergruppen på 872 patienter med en lav dødelighedsrisiko og flere organ dysfunktioner, så ADDRESS-forsøget bekræftede ikke resultaterne fra PROWESS-forsøget.
English: In the PROWESS trial, treatment was initiated within 48 hours of onset of the first sepsis-induced organ dysfunction.
Danish: I PROWESS forsøget, blev behandling iværksat indenfor 48 timer efter det første sepsis-inducerede organsvigt.
English: The following table lists the percent of patients in PROWESS and ENHANCE experiencing serious bleeding events by site of haemorrhage during the study drug infusion period (defined as the duration of infusion plus the next full calendar day following the end of the infusion).
Danish: Den følgende tabel indeholder en procentvis fremstilling af de patienter i PROWESS og ENHANCE, som oplevede alvorlige tilfælde af blødning opdelt i grupper for blødningens opståen i infusionsperioden med forsøgsmedicin (defineret som under infusionen samt den efterfølgende fulde kalenderdag).
English: At 28 days, the overall mortality rates were 24.7% for the Xigris-treated group and 30.8% for the placebo-treated group (p=0.005).
Danish: Efter 28 dage var den totale dødelighed 24,7 % for gruppen, som blev behandlet med Xigris, og 30,8 % for placebogruppen (p=0,005).
English: Animal studies with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development have not been conducted with Xigris.
Danish: Der er ikke udført dyreforsøg med Xigris med henblik på virkningen på graviditet, embryonal/føtal udvikling, fødsel og postnatal udvikling.
English: Treatment should be started within 48 hours, and preferably within 24 hours, of onset of the first documented sepsis-induced organ dysfunction (see section 5.1).
Danish: Behandling skal startes indenfor 48 timer og helst indenfor de første 24 timer efter det første sepsisinducerede organsvigt er dokumenteret (se pkt.
English: Drotrecogin alfa (activated) and endogenous human Activated Protein C are inactivated in plasma by endogenous protease inhibitors but the mechanism by which they are cleared from plasma is unknown.
Danish: Drotrecogin alfa (aktiveret) og endogent humant aktiveret protein C bliver inaktiveret i plasma af endogene proteasehæmmere, men mekanismen for eliminationen fra plasma er ukendt.
English: Slowly add the Sterile Water for Injection to the vial and avoid inverting or shaking the vial.
Danish: Tilsætningen af sterilt vand til injektionsvæsker til hætteglasset skal foregå langsomt, og det bør undgås at vende hætteglasset på hovedet eller ryste det.
English: Plasma concentrations of endogenous Activated Protein C in healthy subjects and patients with severe sepsis are usually below detection limits (< 5 ng/ml) and do not significantly influence the pharmacokinetic properties of drotrecogin alfa (activated).
Danish: Plasmakoncentrationer af endogent aktiveret protein C hos raske forsøgspersoner og hos patienter med svær sepsis ligger normalt under detektionsgrænsen (< 5 ng/ml) og påvirker ikke signifikant de farmakokinetiske egenskaber af drotrecogin alfa (aktiveret).
English: There is no known antidote for drotrecogin alfa (activated).
Danish: Der er ingen kendt antidot til drotrecogin alfa (aktiveret).
English: When adding the reconstituted drotrecogin alfa (activated) into the infusion bag, direct the stream to the side of the bag to minimise the agitation of the solution.
Danish: Når det rekonstituerede drotrecogin alfa (aktiveret) tilsættes infusionsposen, skal strålen rettes mod siden af infusionsposen for at minimere uro i opløsningen.
English: Changes observed in monkeys at, or in small excess of, the maximum human exposure during repeated dose studies, were all related to the pharmacological effect of Xigris and include beside the expected prolongation of APTT, decreases in haemoglobin, erythrocytes and haematocrit, and increases in reticulocyte count and PT.
Danish: Under forsøg med gentagen dosering var alle forandringer, som blev observeret hos aber ved doser svarende til eller let overstigende den maksimale humane eksponering, relateret til den farmakologiske effekt af Xigris og inkluderede udover den forventede forlængelse af APTT, et fald i hæmoglobin, erytrocytter og hæmatokrit, samt en stigning i retikulocyttallet og PT.
English: Drotrecogin alfa (activated) that is present in a blood or plasma sample drawn from a patient who is being infused with the drug will be gradually neutralized by endogenous plasma protease inhibitors present in the sample.
Danish: Drotrecogin alfa (aktiveret), som forefindes i en blod- eller plasmaprøve udtaget fra en patient, som får lægemidlet, vil gradvist blive neutraliseret af endogene plasmaproteaseinhibitorer, som findes i prøven.
English: Therefore the MAH has committed to performing a placebo-controlled study in patients (who were either on low-dose prophylactic heparin or not receiving any thrombosis prophylaxis) with severe sepsis and documented organ failure (e.g. MOD or vasopressor dependent septic shock) when treated within a strictly defined time window, to assert the benefit/risk profile of Xigris.”
Danish: Indehaveren af markedsføringstilladelsen har derfor forpligtet sig til at udføre et placebokontrolleret forsøg hos patienter (der enten modtager lav-dosis profylaktisk heparinbehandling eller ikke modtager nogen tromboseprofylakse) med svær sepsis og dokumenteret organsvigt (fx MOD eller vasopressorafhængigt septisk chok), der behandles indenfor en nøje defineret tidshorisont, for at afklare Xigris' risk/benefit profil.
English: Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.
Danish: Xigris er indiceret til behandling af voksne patienter, som har svær sepsis med multiorgandysfunktion, og gives sammen med optimal standardpleje.
English: In the overall population, the in-hospital mortality was significantly lower in patients on Xigris than in patients on placebo (29.4% vs. 34.6%; p=0.023).
Danish: For den samlede population var mortaliteten for hospitalsindlagte signifikant lavere for patienter i behandling med Xigris end for placebo (29,4 % versus 34,6 %, p=0,023).
English: In these studies serious bleeding events included any intracranial haemorrhage, any life-threatening or fatal bleed, any bleeding event requiring the administration of ≥ 3 units of packed red blood cells per day for 2 consecutive days, or any bleeding event assessed as serious by the investigator.
Danish: I disse forsøg omfattede alvorlige tilfælde af blødning enhver intrakraniel blødning, enhver livstruende eller fatal blødning, ethvert tilfælde af blødning, som nødvendiggjorde administration af ≥ 3 portioner pakkede røde blodlegemer daglig i 2 på hinanden følgende dage eller ethvert tilfælde af blødning, som investigator vurderede som værende alvorligt.
English: Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line.
Danish: Drotrecogin alfa (aktiveret) er en rekombinant udgave af det endogene aktiverede protein C. Det fremstilles ved hjælp af genmanipulation i en etableret human cellelinje.
English: Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Danish: Xigris bør bruges af erfarne læger på hospitalsafsnit, der har megen erfaring i behandling af patienter med svær sepsis.
English: However prophylactic heparin increased the risk of non-serious bleeding compared with placebo (8.7% vs 5.7%, respectively; p= 0.0116).
Danish: Profylaktisk heparinbehandling forøgede dog risikoen for ikke-alvorlig blødning sammenlignet med placebo (8,7 % mod 5,7 %; p=0,0116).
English: The Phase 3 international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (PROWESS) involved 850 drotrecogin alfa (activated)-treated and 840 placebo-treated patients.
Danish: Det internationale fase 3, multicenter, randomiserede, dobbeltblinde, placebokontrollerede kliniske forsøg (PROWESS) omfattede 850 drotrecogin alfa (aktiveret)-behandlede og 840 placebobehandlede patienter.
English: Care should be taken to administer Xigris at the appropriate rate, calculated based on kg of bodyweight and infused for the correct duration.
Danish: Det er vigtigt at Xigris bliver indgivet med den rette hastighed, udregnet på baggrund af kropsvægt i kg, og infunderet over det rette tidsrum.
English: In the majority of patients, measurements of Activated Protein C beyond 2 hours after termination of the infusion were below the quantifiable limit, suggesting rapid elimination of drotrecogin alfa (activated) from the systemic circulation.
Danish: Senere end 2 timer efter afslutningen af infusionen lå målingerne af aktiveret protein C under kvantificeringsgrænsen hos størstedelen af patienterne, hvilket tyder på en hurtig elimination af drotrecogin alfa (aktiveret) fra det systemiske kredsløb.
English: In the subgroup of patients with at least 2 acute organ dysfunctions at baseline, the mortality was 26.5% in the Xigris group (168 out of 634) and 33.9% in the placebo group (216 out of 637).
Danish: I subgruppen af patienter med mindst 2 akutte organdysfunktioner ved baseline var mortaliteten 26,5 % i Xigrisgruppen (168 ud af 634) og 33,9 % i placebogruppen (216 ud af 637).
English: • Recent administration (within 7 days) of oral anticoagulants
Danish: • Nylig (indenfor 7 dage) administration af orale antikoagulantia
English: Caution should be employed when Xigris is used with other drugs that affect haemostasis (see sections 4.3 and 4.4) including Protein C, thrombolytics (e.g. streptokinase, tPA, rPA and urokinase), oral anticoagulants (e.g. warfarin), hirudins, antithrombin, aspirin and other anti platelets agents, e.g. nonsteroidal anti-inflammatory drugs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (such as abciximab, eptifibatide, tirofiban) and prostacyclins such as iloprost.
Danish: 4.3 og 4.4) inklusive protein C, trombolytika (f.eks. streptokinase, tPA, rPA og urokinase), orale antikoagulatia (f.eks. warfarin), hirudiner, antitrombin, acetylsalicylsyre og andre trombocytfunktionshæmmende midler, f.eks. nonsteroide antiinflammatoriske lægemidler, ticlopidin og clopidogrel, glykoprotein IIb/IIIa antagonister (såsom abciximab, eptifibatid, tirofiban) og prostacyclinanaloger såsom iloprost.