FrancophonIA/ELRC3.0 huggingface dataset:
English: No hypersensitivity reactions were reported in these patients.
Danish: Der blev ikke rapporteret nogen overfølsomhedsreaktioner hos disse patienter.
English: • Patients with intracranial pathology; neoplasm or evidence of cerebral herniation
Danish: • Patienter med intrakraniel patologi; neoplasme eller tegn på cerebral brok
English: Additionally there was no increased risk of serious bleeding, including central nervous system (CNS) bleeding.
Danish: Yderligere var der ingen øget risiko for alvorlig blødning inklusive blødning i centralnervesystemet (CNS).
English: In the following conditions, the risks of the administration of Xigris should be weighed against the anticipated benefits:
Danish: Under følgende forhold bør risici ved administration af Xigris afvejes mod de forventede fordele:
English: (The APACHE II score is designed to assess the risk of mortality based on acute physiology and chronic health evaluation).
Danish: (APACHE II score anvendes til at vurdere risikoen for dødsfald baseret på en vurdering af den akutte fysiologi og den kroniske sundhedstilstand (acute physiology and chronic health evaluation)).
English: However, the possibility of allergic reactions to constituents of the preparation cannot be completely excluded in certain predisposed patients.
Danish: Muligheden for allergiske reaktioner overfor indholdsstoffer i præparatet kan dog ikke udelukkes for særligt disponerede patienter.
English: Like all medicines, Xigris can cause side effects, although not everybody gets them.
Danish: Xigris kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Activated Protein C is a crucial coagulation regulator.
Danish: Aktiveret protein C er en afgørende koagulationsregulator.
English: Survival status was assessed in a follow-up study of PROWESS survivors.
Danish: Overlevelsesstatus er blevet vurderet i en opfølgningsundersøgelse med overlevende fra PROWESSstudiet.
English: • Known bleeding diathesis except for acute coagulopathy related to sepsis
Danish: • Kendt blødningsdiatese undtagen akut koagulopati forbundet med sepsis
English: • Platelet count < 30,000 x 106/l, even if the platelet count is increased after transfusions
Danish: • Trombocyttal < 30.000 x 106/l, selvom trombocyttallet øges ved transfusioner
English: Drotrecogin alfa (activated) [ENHANCE] N=2378
Danish: Drotrecogin alfa (aktiveret) [ENHANCE] N=2378
English: In clinical trials and in post marketing experience there have been reports of accidental overdosing.
Danish: I kliniske forsøg og ved postmarketing erfaring er der rapporteret om utilsigtet overdosering.
English: Further Clinical Experience
Danish: Yderligere klinisk erfaring
English: “Further to uncertain conclusions of the XPRESS study investigating the possible interaction between Xigris and heparin, additional clarifications on the benefit/risk balance of Xigris are required.
Danish: ”Som følge af usikre konklusioner af XPRESS forsøget, der undersøgte en mulig interaktion mellem Xigris og heparin, er ekstra afklaring omkring risk/benefit forholdet påkrævet.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I henhold til ”CHMP Guideline on Risk Management Systems for medicinal products for human use” skal den opdaterede RMP indsendes på samme tidspunkt som den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: Gently swirl each vial until the powder is completely dissolved.
Danish: Hvert hætteglas svinges forsigtigt, indtil pulveret er fuldstændig opløst.
English: In case of overdose, immediately stop the infusion (see section 5.2).
Danish: I tilfælde af overdosering stoppes infusionen øjeblikkeligt (se pkt.
English: Avoid exposing drotrecogin alfa (activated) solutions to heat and/or direct sunlight.
Danish: Undgå at udsætte opløsninger af drotrecogin alfa (aktiveret) for varme og/eller direkte sollys.
English: Pharmacotherapeutic group: antithrombotic agents, enzymes, ATC code: B01AD10
Danish: Farmakoterapeutisk klassifikation: Antitrombotiske midler, enzymer, ATC-kode: B01A D10
English: This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel af videnskabelige årsager.
English: If allergic or anaphylactic reactions occur, treatment should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår allergiske eller anafylaktiske reaktioner, bør behandlingen straks seponeres, og relevant behandling iværksættes.
English: Patients treated with Xigris experienced improved 28-day survival compared to those treated with placebo.
Danish: Patienter, som blev behandlet med Xigris, oplevede en forbedret 28 dages overlevelse sammenlignet med dem, som fik placebo.
English: After reconstitution, immediate use is recommended.
Danish: Efter rekonstitution anbefales det at anvende opløsningen straks.
English: Due to these biological and analytical variables, the APTT should not be used to assess the pharmacodynamic effect of drotrecogin alfa (activated).
Danish: På grund af disse biologiske og analytiske variable bør APTT ikke anvendes til at vurdere den farmakodynamiske effekt af drotrecogin alfa (aktiveret).
English: • Chronic severe hepatic disease
Danish: • Kronisk svær leversygdom
English: Xigris should not be used during pregnancy unless clearly necessary.
Danish: Xigris bør ikke anvendes under graviditet, medmindre det er tvingende indiceret.
English: For procedures with an inherent bleeding risk, discontinue Xigris for 2 hours prior to the start of the procedure.
Danish: Ved procedurer, som indebærer en blødningsrisiko, skal Xigris afbrydes 2 timer før procedurens start.
English: The following information is intended for medical or healthcare professionals only: Instructions for use and handling
Danish: Følgende oplysninger er kun til læger og sundhedspersonale:
English: Severe sepsis is defined as sepsis associated with acute organ dysfunction.
Danish: Svær sepsis er defineret som sepsis forbundet med akut organdysfunktion.
English: The Marketing Authorisation Holder will continue to submit yearly PSURs.
Danish: Indehaveren af markedsføringstilladelsen skal fortsætte med at indsende årlige PSUR'er.
English: Excessive coagulation activation in the microcirculatory bed plays a significant part in the pathophysiology of severe sepsis.
Danish: Excessiv aktivering af koagulationen i det mikrocirkulatoriske karsystem spiller en væsentlig rolle i patofysiologien af svær sepsis.
English: Furthermore, Activated Protein C is an important modulator of the systemic response to infection and has antithrombotic and profibrinolytic properties.
Danish: Derudover er aktiveret protein C en vigtig modulator i det systemiske respons på infektion og har antitrombotiske og profibrinolytiske egenskaber.
English: There was no statistical difference in the rates of VTE between study arms.
Danish: Der var ingen statistisk forskel i hyppigheden af VT mellem forsøgsarmene.
English: This liquid is then passed from a bag through a tube into one of your veins for a period of 96 hours.
Danish: Denne væske løber fra en pose gennem en slange og ind i en af Deres blodårer i en periode på 96 timer.
English: Xigris increases the risk of bleeding which can be serious or life-threatening.
Danish: Xigris øger risikoen for blødninger, hvilket kan være alvorligt eller livstruende.
English: C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Danish: C. SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: No further study has confirmed the efficacy results of the single pivotal trial.
Danish: Intet yderligere forsøg har bekræftet resultaterne fra pivotalforsøget.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • Inden for 60 dage efter, at en vigtig milepæl er nået (i forbindelse med pharmacovigilance eller risikominimering)
English: It is not known whether drotrecogin alfa (activated) causes damage to an unborn child or affects your ability to have babies.
Danish: Det vides ikke, om drotrecogin alfa (aktiveret) kan skade et ufødt barn, eller om det kan påvirke Deres evne til at få børn.
English: In-hospital and 3 month survival status was reported for 98% and 94% of the 1690 PROWESS subjects respectively.
Danish: Overlevelsesstatus for hospitalsindlagte samt overlevelsesstatus efter 3 måneder var rapporteret for henholdsvis 98 % og 94 % af de 1690 PROWESS-patienter.
English: • Concurrent heparin therapy ≥ 15 International Units/kg/hr
Danish: • Samtidig heparin behandling ≥ 15 Internationale Enheder/kg/time
English: No incompatibilities have been observed between drotrecogin alfa (activated) and glass infusion bottles or infusion bags made of polyvinylchloride, polyethylene, polypropylene, or polyolefin.
Danish: Der er ikke observeret uforligelighed mellem drotrecogin alfa (aktiveret) og infusionsflasker af glas eller infusionsposer lavet af polyvinylchlorid, polyethylen, polypropylen eller polyolefin.
English: The difference in the incidence of serious bleeding events between the two treatment groups occurred primarily during study drug administration.
Danish: Forskellen i forekomsten af alvorlige tilfælde af blødning i de to behandlingsgrupper opstod primært under administration af forsøgsmedicinen.
English: Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Parenterale lægemidler bør inspiceres visuelt for partikler og misfarvning før administration.
English: Serious bleeding events during the infusion period
Danish: Alvorlige tilfælde af blødning i infusionsperioden.
English: No death reduction was observed in the subgroup of patients with lower disease severity.
Danish: Der blev ikke observeret en reduktion i dødeligheden i den subgruppe af patienter, der var mindre syge.
English: Using other medicines:
Danish: Brug af anden medicin
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEKST PÅ YDERKARTON
English: Pharmacodynamic Effects
Danish: Farmakodynamiske virkninger
English: Xigris caused a more rapid decline in thrombotic markers such as D-dimer, prothrombin F1.2, and thrombin-antithrombin levels and a more rapid increase in Protein C and antithrombin levels.
Danish: Xigris forårsagede et hurtigere fald i trombotiske markører, såsom D-dimer, protrombin F1.2 og trombin-antitrombinniveauer samt en hurtigere stigning i protein C og antitrombinniveauer.
English: The interpretation of sequential determinations of the PT and/or APTT should take these variables into consideration.
Danish: Disse variable bør tages i betragtning ved fortolkningen af gentagne bestemmelser af PT og/eller APTT.
English: Because drotrecogin alfa (activated) may increase the risk of bleeding, Xigris is contraindicated in the following situations:
Danish: Da drotrecogin alfa (aktiveret) kan øge risikoen for blødning, er Xigris kontraindiceret i følgende tilfælde:
English: Patients with single organ dysfunction and recent surgery Xigris is not approved for the treatment of patients with single organ dysfunction and should not be used in this particular subgroup of patients, especially if they had recent surgery (within 30 days).
Danish: Patienter med enkelt organ dysfunktion og nylig operativt indgreb Xigris er ikke godkendt til behandling af patienter med enkelt organ dysfunktion og bør ikke bruges til denne særlige undergruppe af patienter, især hvis de for nyligt har haft et operativt indgreb (indenfor 30 dage).
English: Xigris is supplied as a lyophilised, white to off-white powder.
Danish: Xigris leveres som et frysetørret, hvidt til offwhite pulver.
English: It is not known whether Xigris is excreted in human milk or if there is a potential effect on the breastfed infant.
Danish: Det vides ikke, hvorvidt Xigris udskilles i modermælken, eller om der er en potentiel effekt på børn, der ammes.
English: Xigris increases the risk of bleeding.
Danish: Xigris øger risikoen for blødning.
English: The mortality rate was lower for patients treated within 24 hours of organ dysfunction compared to those treated after 24 hours, even after adjustment for differences in disease severity.
Danish: Mortaliteten var lavere for patienter, som blev behandlet indenfor de første 24 timer efter organsvigt, sammenlignet med dem, som blev behandlet efter de efterfølgende 24 timer, selvom der var blevet korrigeret for sværhedsgraden af sygdommen.
English: Placebo rates in PROWESS 0.4% vs 1.2% respectively).
Danish: Hyppigheden ved placebo i PROWESS 0,4 % vs. 1,2 % henholdsvis).
English: The percentage of patients experiencing at least one bleeding event in the two treatment groups was 24.9% and 17.7%, respectively.
Danish: Procentdelen af patienter, der oplevede mindst et tilfælde af blødning i de to behandlingsarme var henholdsvis 24,9 % og 17,7 %.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Pack of 1 vial.
Danish: Pakninger af 1 hætteglas.
English: Xigris is used to treat adults with severe sepsis.
Danish: Xigris anvendes til at behandle voksne med svær sepsis.
English: These data confirmed that the benefit of Xigris is limited to the more severely affected sepsis patients such as patients with multiple organ failure and shock.
Danish: Disse data bekræftede, at fordelene ved Xigris er begrænset til de hårdest ramte sepsispatienter såsom patienter med multiorgandysfunktion eller shock.
English: No anti-activated Protein C antibody formation was detected in healthy subjects, even after repeat administration.
Danish: Der blev ikke set dannelse af anti-aktiveret protein C-antistoffer hos raske forsøgspersoner, selv efter gentagen administration.
English: Calculate the dose and the number of Xigris vials needed.
Danish: Beregn dosis og det nødvendige antal Xigris hætteglas.
English: Best standard care includes adequate antibiotics, source control and supportive treatment (fluids, inotropes, vasopressors and support of failing organs, as required).
Danish: Optimal standardpleje inkluderer adækvat antibiotika, kontrol af kilden til infektionen og understøttende behandling (væske, inotrope stoffer, vasopressorer og støtte til svigtende organer efter behov).
English: The recommended dose of Xigris is 24 micrograms (μg) per kilogram (kg) of body weight each hour for 96 hours.
Danish: Den anbefalede dosis af Xigris er 24 mikrogram (μg) pr. kilogram (kg) kropsvægt hver time i 96 timer.
English: STORING XIGRIS
Danish: SÅDAN OPBEVARES XIGRIS
English: This trial was stopped for futility after 477 patients had received the study drug (out of 600 patients intended).
Danish: Forsøget blev stoppet grundet manglende formål med at fortsætte, efter 477 patienter (ud af 600 tiltænkte patienter) havde fået forsøgsmedicinen.
English: This protein helps to control blood clotting and inflammation.
Danish: Dette protein hjælper med at kontrollere blodets størkning samt betændelsestilstande.
English: Xigris should not be used if you have a less severe form of sepsis (only one organ failure) and have recently had a surgical operation.
Danish: Xigris bør ikke anvendes, hvis De har en mildere form for sepsis (kun enkeltorgansvigt) og for nylig er blevet opereret.
English: Xigris helps your body to get rid of the clots and also reduces the inflammation caused by the infection.
Danish: Xigris hjælper Deres krop med at komme af med blodpropperne, og det formindsker også den betændelse, som er forbundet med infektionen.
English: This leaflet was last approved on {date}
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ}
English: Do not transport the infusion bag between locations using mechanical delivery systems.
Danish: Transporter ikke infusionsposen mellem afdelinger ved hjælp af mekaniske transportsystemer.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18 April 2006 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Disse er specificeret i den pharmacovigilanceplan, der er godkendt i den version af risk managementplanen (RMP), som er dateret 18. april 2006, og som findes i modul 1.8.2 i markedsføringstilladelsen, og enhver følgende opdatering af RMP'en, som CHMP har godkendt.
English: Patients were given a 96-hour constant rate infusion of Xigris at 24 μg/kg/hr (n=850) or placebo (n=840).
Danish: Patienterne fik en 96 timers Xigris infusion med en konstant hastighed på 24 μg/kg/time (n=850) eller placebo (n=840).
English: The incidence of serious bleeding events in the PROWESS and ENHANCE studies is provided below.
Danish: Forekomsten af alvorlige blødningstilfælde i PROWESS og ENHANCE forsøgene er vist nedenfor.
English: Survival through 3 months was also better in the Xigris group compared to placebo (log rank p=0.048).
Danish: Overlevelse efter 3 måneder var ligeledes bedre for Xigrisgruppen i forhold til placebo (Log-Rank p=0,048).
English: The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
Danish: Brugen af andre typer infusionssæt kan have en negativ effekt på mængden og styrken af det administrerede drotrecogin alfa (aktiveret).
English: Xigris has similar properties to those of endogenous human Activated Protein C.
Danish: Xigris har egenskaber, som ligner det endogene humane aktiverede protein C.
English: Xigris is very similar to a protein that occurs naturally in your blood.
Danish: Xigris er meget lig et af de naturligt forekommende proteiner i Deres blod.
English: Xigris may be restarted immediately after uncomplicated less invasive procedures if adequate haemostasis has been achieved.
Danish: Xigris kan genstartes umiddelbart efter procedurer, der er ukomplicerede og mindre invasive, såfremt adækvat hæmostase er opnået.
English: 1 CNS bleeding is defined as any bleed in the central nervous system including the following types of haemorrhage: Petechial, parenchymal, subarachnoid, subdural, and stroke with haemorrhagic transformation.
Danish: 1 CNS blødning er defineret som enhver blødning i centralnervesystemet inklusiv de følgende typer blødninger: Petecchiae, parenchyma, subaraknoidal, subdural og slagtilfælde med blødningstransformation.
English: Additionally, patients with severe sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response.
Danish: Derudover udviste patienter med svær sepsis, som blev behandlet med Xigris, et hurtigere fald i interleukin-6niveauerne, en global inflammationsmarkør, svarende til en reduktion i det inflammatoriske respons.
English: A consistent treatment effect on mortality with Xigris administration was observed across patient subgroups defined by age, gender and infection type.
Danish: Effekten af Xigris på mortaliteten var ensartet over patientsubgrupper defineret ud fra alder, køn og infektionens art.
English: Use appropriate aseptic technique during the preparation of Xigris for intravenous administration.
Danish: Brug passende aseptisk teknik under tilberedningen af Xigris til intravenøs administration.
English: A planned interim analysis (with 400 patients enrolled) showed a low likelihood of demonstrating a significant difference in the primary endpoint of “Composite Time to Complete Organ Failure Resolution” (CTCOFR score of 9.8 versus 9.7 mean days over 14 days).
Danish: En planlagt interimanalyse (med data fra 400 patienter) viste lav sandsynlighed for påvisning af en signifikant forskel på den primære måleparameter ”Sammensat tid til komplet organsvigthelbredelse” (”Composite Time to Complete Organ Failure Resolution” − CTCOFR score på 9,8 mod 9,7 dage i gennemsnit over 14 dage).
English: The short half-life of 13 minutes accounts for approximately 80% of the area under the plasma concentration curve and governs the initial rapid accrual of plasma drotrecogin alfa (activated) concentrations towards the steady-state.
Danish: Den korte halveringstid på 13 minutter udgør ca. 80 % af arealet under plasmakoncentrationskurven og styrer den initiale hurtige stigning i plasmakoncentrationen af drotrecogin alfa (aktiveret) mod steady state.
English: For intravenous infusion after reconstitution and dilution.
Danish: Til intravenøs infusion efter rekonstitution og fortynding.
English: The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
Danish: Brugen af Xigris bør overvejes hovedsagelig i situationer, hvor behandlingen kan påbegyndes indenfor 24 timer efter organsvigt er indtrådt (for yderligere information, se pkt.
English: Powder in Type I glass vial.
Danish: Pulver i type I-hætteglas.
English: The percentage of patients experiencing at least one bleeding event in the two treatment groups was 10.9% and 6.4%, respectively (p<0.001).
Danish: Procentdelen af patienter, der oplevede mindst et tilfælde af blødning i de to behandlingsarme var henholdsvis 10,9 % og 6,4 % (p<0,001).
English: Therefore, the patient should not breast feed whilst treated with Xigris.
Danish: Derfor bør patienten ikke amme under behandling med Xigris.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2002.
Danish: Dato for første markedsføringstilladelse: 22. august 2002 Dato for seneste fornyelse:
English: Significant absolute death reduction was limited to the subgroup of patients with greater disease severity i.e. baseline APACHE II score ≥25 or at least 2 acute organ dysfunctions at baseline.
Danish: En signifikant reduktion i den absolutte dødelighed blev kun set i den subgruppe af patienter, som var mest syge, dvs. APACHE II score ≥ 25 eller mindst 2 akutte organdysfunktioner ved baseline.
English: The pharmacokinetics of drotrecogin alfa (activated) were characterised by attainment of steady-state plasma concentration within 2 hours following the start of the infusion.
Danish: Farmakokinetikken af drotrecogin alfa (aktiveret) var karakteriseret ved opnåelse af steady state plasmakoncentrationer inden for 2 timer efter begyndelsen af infusionen.
English: Hypersensitivity to the active substance, to any of the excipients or to bovine thrombin (a trace residue from the manufacturing process).
Danish: Overfølsomhed over for det aktive stof, et eller flere af hjælpestofferne eller bovint trombin (en sporrest fra fremstillingsprocessen).
English: Patients requiring the administration of ≥ 3 units of packed red blood cells per day for 2 consecutive days without an identified site of bleeding
Danish: 2 Patienter som har brug for administration af ≥ 3 portioner af pakkede røde blodlegemer daglig i 2 på hinanden følgende dage uden at et blødningssted er blevet identificeret.
English: Keep the vial in the outer carton in order to protect it from light.
Danish: Opbevar hætteglasset i den ydre karton for at beskytte det mod lys.
English: Mechanism of Action
Danish: Virkningsmekanisme
English: Xigris also restored endogenous fibrinolytic potential, as evidenced by a more rapid trend toward normalisation in plasminogen levels and a more rapid decline in plasminogen activator inhibitor-1 levels.
Danish: Endvidere genetablerede Xigris det endogene fibrinolytiske potentiale, hvilket viste sig ved en hurtigere normalisering af plasminogenniveauet, og et hurtigere fald i plasminogenaktivator inhibitor-I niveauerne.