FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatal CNS bleeding events, serious bleeding events (over the infusion period and over the 28-day study period), serious adverse events, and major amputations were similar in the drotrecogin alfa (activated) and placebo groups.
Danish: Dødelige CNS-blødningshændelser, alvorlige blødningshændelser (i infusionsperioden og i den 28dage lange forsøgsperiode), alvorlige utilsigtede hændelser og større amputationer var sammenlignelige i drotrecogin alfa (aktiveret)- og placebogrupperne.
English: During the infusion period in PROWESS and ENHANCE the incidence of serious bleeding events with Xigris was numerically higher in patients with recent [within 30 days] surgery than in patients without surgery (PROWESS: 3.3% vs 2.0%; ENHANCE: 5.0% vs 3.1% respectively.
Danish: Under infusionsperioden i PROWESS og ENHANCE var hyppigheden af alvorlig blødningstilfælde med Xigris numerisk højere hos patienter med nylig (indenfor 30 dage) operation, end hos patienter, der ikke var opereret (PROWESS: 3,3 % vs. 2,0 %; ENHANCE: 5,0 % vs. 3,1 % henholdsvis.
English: The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
Danish: Det europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende Xigris, og denne indlægsseddel vil om nødvendigt blive opdateret.
English: Samples available were subsequently tested and all were negative for anti-human Activated Protein C antibody.
Danish: De var alle negative for anti-human aktiveret protein C-antistof.
English: Drotrecogin alfa (activated) is contraindicated in children below the age of 18 years (see section 5.1).
Danish: Drotrecogin alfa (aktiveret) er kontraindiceret til børn under 18 år (se pkt.
English: Investigators attributed 2 deaths in the Xigris group and 5 deaths in the placebo group to bleeding events.
Danish: Investigatorer bedømmer, at 2 dødsfald i drotrecogin alfa (aktiveret)gruppen og 5 dødsfald i placebogruppen skyldes blødningshændelser.
English: The pharmacodynamic effect of drotrecogin alfa (activated) on the APTT assay is dependent on the reagent and instrument used to perform the assay and the time that elapses between sample acquisition and assay performance.
Danish: Den farmakodynamiske virkning af drotrecogin alfa (aktiveret) på APTT-analysen afhænger af det reagens og udstyr, som anvendes til at udføre analysen, samt den tid, der går mellem indsamling af prøven og udførelse af analysen.
English: The vial contains an excess of drotrecogin alfa (activated) to facilitate delivery of the label amount.
Danish: Hætteglasset indeholder et overskud af drotrecogin alfa (aktiveret) for at sikre, at den deklarerede mængde kan trækkes ud.
English: No significant death reduction was observed in the subgroup of patients with less than 2 acute organ dysfunctions at baseline.
Danish: Der blev ikke observeret nogen signifikant reduktion i dødeligheden hos subgruppen af patienter, der havde mindre end 2 akutte organdysfunktioner.
English: Because drotrecogin alfa (activated) may affect the APTT assays, drotrecogin alfa (activated) present in plasma samples may interfere with one-stage coagulation assays based on the APTT (such as factor VIII, IX, and XI assays).
Danish: Idet drotrecogin alfa (aktiveret) kan påvirke APTT-analyser, kan drotrecogin alfa (aktiveret) i en plasmaprøve interferere med ettrins koagulationsanalyser baseret på APTT (såsom faktor VIII, IX, og XI analyser).
English: Exclusion criteria encompassed patients at high risk of bleeding (see sections 4.3 and 4.4), patients who were not expected to survive for 28 days due to a pre-existing, non-sepsis related medical condition, HIV positive patients whose most recent CD4 count was ≤ 50/mm3, patients on chronic dialysis, and patients who had undergone bone marrow, lung, liver, pancreas or small bowel transplantation, and patients with acute clinical pancreatitis without a proven source of infection.
Danish: 4.3 og 4.4), patienter som ikke forventedes at overleve i 28 dage på grund af eksisterende, ikke-sepsis relaterede medicinske forhold, HIV-positive patienter, hvis seneste CD4 tal var ≤ 50/mm3, patienter i kronisk dialyse, patienter, som havde fået foretaget knoglemarvs-, lunge-, lever-, pankreas- eller tyndtarmstransplantation, og patienter med akut klinisk pankreatitis uden kendt infektionskilde.
English: The ONLY other solutions that can be administered through the same line are 0.9% Sodium Chloride Injection, Lactated Ringer's Injection, Dextrose or Dextrose and Saline mixtures.
Danish: De ENESTE andre opløsninger, som må administreres gennem den samme slange, er natriumchlorid injektionsvæske 0,9 %, Ringer-laktat infusionsvæske, glukose eller glukose-/saltblandinger.
English: The pharmacokinetics of drotrecogin alfa (activated) have not been studied in patients with severe sepsis and pre-existing end stage renal disease and chronic hepatic disease.
Danish: Drotrecogin alfa (aktiveret) er ikke blevet undersøgt farmakokinetisk hos patienter med svær sepsis og eksisterende terminal nyresygdom eller kronisk leversygdom.
English: In the Phase 3 trial, the pharmacokinetics of drotrecogin alfa (activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24 μg/kg/hr.
Danish: I det kliniske fase 3 forsøg blev farmakokinetikken af drotrecogin alfa (aktiveret) evalueret hos 342 patienter med svær sepsis, som fik administreret 24 μg/kg/time kontinuerligt infunderet over 96 timer.
English: There was no evidence that the antibodies detected represented a specific immune response to drotrecogin alfa (activated) therapy.
Danish: Der var ingen tegn på at de påviste antistoffer repræsenterede et specifikt immunrespons til drotrecogin alfa (aktiveret)-behandling.
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Danish: Resultaterne af undersøgelserne vil danne grundlaget for den årlige revurdering af risk/benefit-forholdet.
English: A Phase 3b international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (ADDRESS) of adult severe sepsis patients at low risk of death, involved 1317 drotrecogin alfa (activated)-treated and 1293 placebo-treated patients.
Danish: Et internationalt fase 3, multicenter, randomiseret, dobbeltblindt, placebokontrolleret klinisk forsøg (ADDRESS) med voksne patienter med svær sepsis og en lav dødelighedsrisiko omfattede 1317 drotrecogin alfa (aktiveret)-behandlede og 1293 placebobehandlede patienter.
English: The risk of CNS bleeding may increase with severe coagulopathy and severe thrombocytopenia (see sections 4.3 and 4.4).
Danish: Risikoen for CNS-blødninger kan øges ved svær koagulopati og svær trombocytopeni (se pkt.
English: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Danish: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, Holland
English: However, a small number of patients in severe sepsis controlled clinical trials received a prior course of drotrecogin alfa (activated).
Danish: Et lavt antal patienter i kliniske studier for svær sepsis har dog tidligere gennemgået et forløb med drotrecogin alfa (aktiveret).
English: You should not be given : - if you are allergic (hypersensitive) to drotrecogin alfa (activated) or any of the other ingredients of Xigris, or bovine (cattle-derived) thrombin (protein) - if you are a child below the age of 18 - if you have internal bleeding - if you have a brain tumour, or pressure on the brain - if you are being given heparin at the same time (≥ 15 International Units/kg/hr) - if you have a bleeding tendency which is not related to sepsis - if you have a long-standing, severe problem with your liver - if your platelet (a type of cell in your blood) count is low, even if this has been increased by a transfusion - if you are at high risk of bleeding (for example): a) you have had surgery within the last twelve hours before you receive Xigris, or you are bleeding from a previous surgery, or you might have surgery while you receive Xigris b) you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine) c) you have been born with bleeding tendencies d) you have bled from your bowels within the last six weeks, unless treated adequately e) you have had a major accident and are at increased risk of bleeding
Danish: De bør ikke få Xigris: - hvis De er allergisk (overfølsom) over for drotrecogin alfa (aktiveret) eller et af de øvrige indholdsstoffer i Xigris eller bovint (udvundet fra kvæg) trombin (et protein) - hvis De er et barn under 18 år - hvis De har indre blødninger - hvis De har en svulst eller forhøjet tryk i hjernen - hvis De samtidigt får heparin (≥15 internationale enheder/kg/time) - hvis De har en tendens til blødning, som ikke er relateret til sepsis - hvis De har haft længerevarende og alvorlige problemer med Deres lever - hvis Deres blodpladetal (mængden af en bestemt type celler i Deres blod) er lavt, selvom det øges efter en transfusion - hvis De har en høj risiko for blødninger (for eksempel hvis): a) De har gennemgået en operation indenfor de sidste 12 timer før De får Xigris, De bløder fra en tidligere operation eller De måske skal opereres, mens De får Xigris b) De har været indlagt med en alvorlig skade på hovedet, De er blevet opereret i hovedet eller rygsøjlen, De har haft en blødning i hjernen (slagtilfælde) indenfor de seneste tre måneder, De har abnorme blodårer i hjernen, en svulst i hovedet eller De har et epiduralkateter (en slange ind i ryggen) c) De er født med tendens til blødning d) De har blødt fra tarmene inden for de sidste seks uger, medmindre dette er tilstrækkeligt behandlet e) De har været ude for en større ulykke og har en forhøjet risiko for blødning
English: The mean steady-state plasma concentration of drotrecogin alfa (activated) in healthy subjects receiving 24 μg/kg/hr is 72 ng/ml.
Danish: Den gennemsnitlige steady state plasmakoncentration af drotrecogin alfa (aktiveret) hos raske forsøgspersoner, der får 24 μg/kg/time, er 72 ng/ml.
English: It limits thrombin formation by inactivating factors Va and VIIIa,
Danish: Det begrænser trombindannelsen ved at inaktivere faktor Va og VIIIa, hvorved det giver negativ feedback regulering af koagulationen.
English: These can block the blood supply to important parts of your body such as the kidneys and lungs.
Danish: Når De har en alvorlig infektion i kroppen, kan der dannes propper i Deres blod, og disse kan standse blodforsyningen til vigtige dele af Deres krop, såsom nyrerne og lungerne.
English: Co-administration of low-dose heparin for prophylaxis of venous thrombotic events (VTE) Low-dose heparin for VTE prophylaxis may be co-administered with drotrecogin alfa (activated).
Danish: Samtidig administration af lavdosis heparin for profylaktisk behandling af venøs trombose (VT) Lavdosis heparinbehandling for VT-profylakse kan gives samtidig med drotrecogin alfa (aktiveret).
English: In ADDRESS, the percent of treated patients experiencing a serious bleeding event by site of haemorrhage was similar to that observed in PROWESS.
Danish: Den procentvise andel af behandlede patienter, der oplevede alvorlige blødningstilfælde, fordelt på blødningsstedet, i ADDRESS-forsøget var sammenlignelig med PROWESS-forsøget.
English: Clinical Efficacy
Danish: Klinisk effekt
English: The incidence of serious bleeding events with Xigris was higher in patients with recent [within 30 days] surgery than in “medical” patients without surgery (see section 4.8).
Danish: Hyppigheden af alvorlig blødningstilfælde med Xigris var højere hos patienter med nylig (indenfor 30 dage) operation, end hos medicinske patienter, der ikke var opereret (se pkt.
English: Plasma drotrecogin alfa (activated) steady-state concentrations are proportional to the infusion rate over a range of infusion rates from 12 μg/kg/hr to 48 μg/kg/hr.
Danish: Steady state plasmakoncentrationerne af drotrecogin alfa (aktiveret) er proportionale med infusionshastigheden i intervallet 12 μg/kg/time til 48 μg/kg/time.
English: Carcinogenicity studies and animal reproduction studies have not been conducted with Xigris.
Danish: Xigris har hverken været undersøgt i karcinogenicitets - eller reproduktionsforsøg hos dyr.
English: Add the reconstituted drotrecogin alfa (activated) into a prepared infusion bag of sterile 0.9% Sodium Chloride Injection.
Danish: Tilsæt det rekonstituerede drotrecogin alfa (aktiveret) til en forberedt infusionspose med steril natriumchlorid injektionsvæske 0,9 %.
English: Recent surgery (within 30 days prior to study entry) was associated with a numerically higher risk of serious bleeding during infusion in both the Xigris-treated and the placebo-treated patients (Xigris: 3.6% in patients with recent surgery versus 1.6% in patients without recent surgery; placebo: 1.6% versus 0.9% respectively).
Danish: Nylig operativt indgreb (indenfor 30 dage inden indtræden i forsøget) var forbundet med en numerisk højere risiko for alvorlig blødning i infusionsperioden hos både Xigrisbehandlede og placebobehandlede patienter (for Xigris: henholdsvis 3,6 % hos patienter med nylig operativt indgreb og 1,6 % hos patienter uden nylig operativt indgreb; for placebo: henholdsvis 1,6 % og 0,9 %).
English: Important information about some of the ingredients of Xigris This medicinal product contains approximately 17 mg sodium per vial.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Xigris Dette produkt indeholder ca. 17 mg natrium pr. hætteglas.
English: Data from a placebo-controlled clinical trial (RESOLVE) did not establish efficacy of Xigris in paediatric patients suffering from severe sepsis, acute infection, systemic inflammation and respiratory and cardiovascular organ dysfunction.
Danish: Data fra et placebokontrolleret klinisk forsøg har ikke fastslået virkningen af Xigris hos børn, som lider af svær sepsis, akut infektion, systemisk inflammation samt respiratorisk og kardiovaskulær organdysfunktion.
English: Caution should be employed when Xigris is used with other medicines that affect how your blood clots (for example medicines that dissolve blood clots, thin the blood, or medicines that inhibit platelets such as aspirin, non-steroidal anti-inflammatory medicines, or clopidogrel).
Danish: Der bør udvises forsigtighed, når Xigris bruges sammen med anden medicin, der påvirker blodets evne til at størkne (f.eks. medicin, der opløser blodpropper, blodfortyndende medicin eller medicin, der hæmmer blodpladernes funktion, såsom acetylsalicylsyre, nonsteroid antiinflammatorisk medicin eller clopidogrel).
English: Excipients: sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid and sodium hydroxide.
Danish: Hjælpestoffer: Saccharose, natriumchlorid, natriumcitrat, citronsyre, saltsyre og natriumhydroxid.
English: Pregnancy and breast-feeding
Danish: Graviditet og amning:
English: In the subgroup of 885 patients who were already receiving prophylactic heparin at study entry, mortality was 26.9% in the group randomised to continue heparin versus 35.6% in the group whose randomisation (to placebo) led to the discontinuation of heparin.
Danish: I undergruppen med 885 patienter, der allerede blev behandlet med profylaktisk heparin ved indtræden i forsøget, var dødeligheden 26,9 % i den gruppe, der var randomiseret til fortsat heparinbehandling.
English: In the open-label ENHANCE study, the incidence of serious bleeding events during the 28-day study period was 6.5%, and the incidence of CNS bleeds during the 28-day study period was 1.5%.
Danish: I open-label forsøget ENHANCE var hyppigheden af alvorlige tilfælde af blødning 6,5 % i løbet af den 28-dages forsøgsperiode.
English: EXP {MM/YYYY}
Danish: Udløbsdato {MM/ÅÅÅÅ}
English: As a component of routine care, measures of haemostasis (e.g., activated partial thromboplastin time (APTT), prothrombin time (PT) and platelet count) should be obtained during the infusion of Xigris.
Danish: Som led i den rutinemæssige pleje under infusion af Xigris bør hæmostasen måles (fx. aktiveret partiel tromboplastintid (APTT), protrombintid (PT) og trombocyttal).
English: In adult patients in severe sepsis clinical studies, the frequency of anti-human Activated Protein C IgA/IgG/IgM antibodies or neutralizing antibodies is low and is similar between drotrecogin alfa (activated) and placebo-treated patients tested.
Danish: I kliniske studier for svær sepsis er frekvensen af anti-human aktiveret protein C IgA/IgG/IgMantistoffer eller neutraliserende antistoffer lav hos voksne patienter og er ens for de testede drotrecogin alfa (aktiveret)- og placebobehandlede patienter.
English: Important information about some of the ingredients of Xigris This medicinal product contains approximately 68 mg sodium per vial.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Xigris Dette produkt indeholder ca. 68 mg natrium pr. hætteglas.
English: In the ADDRESS trial, serious bleeding events included any fatal bleed, any life-threatening bleed, any CNS bleed, or any bleeding event assessed as serious by the investigator.
Danish: In ADDRESS forsøget omfattede alvorlige tilfælde af blødning enhver fatal blødning, enhver livstruende blødning, ethvert tilfælde af blødning i centralnervesystemet eller ethvert tilfælde af blødning, som investigator vurderede som værende alvorligt.
English: Serious bleeding during the infusion period occurred in 1% (1 in 100) of patient with severe sepsis and in 2.4% (roughly 1 in 40) of patients treated with Xigris, with most bleeding in both groups occurring in the stomach and bowel.
Danish: Alvorlig blødning under infusionsperioden forekom hos 1 % (1 ud af 100) af patienterne med svær sepsis og hos 2,4 % (ca. 1 ud af 40) af patienterne, der blev behandlet med Xigris.
English: • Recent (within 3 months) ischaemic stroke
Danish: • Nylig (inden for 3 måneder) iskæmisk apopleksi
English: Prophylactic heparin did not increase the risk of serious bleeding compared to placebo (3.9% vs 5.2%, respectively), including CNS bleeding (1.0% vs 0.7%, respectively).
Danish: Profylaktisk heparinbehandling forøgede ikke risikoen for alvorlig blødning sammenlignet med placebo (3,9 % mod 5,2 %), CNS blødning inkluderet (1,0 % mod 0,7 %).
English: In this leaflet: What Xigris is and what it is used for
Danish: Oversigt over indlægssedlen: Xigris' virkning og hvad De skal bruge det til
English: - If you have any further questions, please ask your doctor or your pharmacist.
Danish: - Spørg lægen eller apoteket, hvis der er mere, De vil vide.
English: Drotrecogin alfa (activated) has minimal effect on the PT. Prolongation of the APTT in patients with severe sepsis receiving Xigris may be due to the underlying coagulopathy, the pharmacodynamic effect of drotrecogin alfa (activated), and/or the effect of other concurrent medicinal products.
Danish: Forlængelse af APTT hos patienter med svær sepsis, som får Xigris, kan skyldes den tilgrundliggende koagulopati, de farmakodynamiske egenskaber ved drotrecogin alfa (aktiveret) og/eller samtidig indgift af andre lægemidler.
English: Gently invert the infusion bag to obtain a homogeneous solution.
Danish: Vend forsigtigt infusionsposen op og ned for at opnå en homogen opløsning.
English: In each of two randomised, placebo-controlled trials, PROWESS and ADDRESS (see section 5.1), 28day and in-hospital mortality were higher in patients treated with drotrecogin alfa (activated) compared to placebo for the sub-population of patients with single organ dysfunction and recent surgery (n=98 in PROWESS and n=636 in ADDRESS).
Danish: 5.1), i undergruppen af patienter med enkelt organ dysfunktion og nylig operation var 28-dages dødeligheden under indlæggelse højere for patienter behandlet med drotrecogin alfa (aktiveret) sammenlignet med placebobehandlede (n=98 i PROWESS og n=636 i ADDRESS).
English: What Xigris looks like and contents of the pack Xigris is presented as a powder for solution for infusion in a vial.
Danish: Xigris' udseende og pakningsstørrelse Xigris er et pulver, der skal opløses til en infusionsvæske.
English: This medicinal product contains approximately 68 mg sodium per vial.
Danish: Dette lægemiddel indeholder ca. 68 mg natrium pr. hætteglas.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, Holland
English: There have been no clinical trials in severe sepsis specifically studying drotrecogin alfa (activated) readministration.
Danish: Der er ikke blevet foretaget kliniske undersøgelser for svær sepsis, hvor gentagen administration af drotrecogin alfa (aktiveret) er specifikt undersøgt.
English: This medicinal product contains approximately 17 mg sodium per vial.
Danish: Dette lægemiddel indeholder ca. 17 mg natrium pr. hætteglas.
English: The solution of reconstituted Xigris must be further diluted with sterile 0.9% Sodium Chloride Injection.
Danish: Opløsningen af rekonstitueret Xigris skal yderligere fortyndes med steril natriumchlorid injektionsvæske 0,9 %.
English: Bleeding
Danish: Blødning
English: Special care should be taken with Xigris if you are at risk of bleeding, for example: - if you are taking other medicines which affect how your blood clots (for example medicines that dissolve blood clots, thin the blood, or medicines that inhibit platelets such as aspirin) - if within the last three months, you have had a stroke caused by a blood clot - if you have a known problem with bleeding
Danish: Xigris bør anvendes med særlig forsigtighed, hvis De har øget risiko for blødninger, for eksempel: - hvis De tager anden medicin, som påvirker Deres blods evne til at størkne (f.eks. medicin, der opløser blodpropper, blodfortyndende medicin eller medicin, der hæmmer blodpladernes funktion, såsom acetylsalicylsyre) - hvis De, indenfor de seneste tre måneder, har haft et slagtilfælde, som skyldtes en blodprop - hvis De ved, at De har problemer med blødninger
English: In placebo controlled clinical trials, the treatment effect was most evident at sites enrolling larger numbers of patients.
Danish: Behandlingseffekten var mest tydelig på sites, som indrullerede større mængder af patienter i de placebokontrollerede forsøg.
English: Sodium chloride Sodium citrate Citric acid Hydrochloric acid Sodium hydroxide
Danish: Saccharose Natriumchlorid Natriumcitrat Citronsyre Saltsyre
English: The solution of reconstituted Xigris must be further diluted with sterile 0.9% Sodium Chloride Injection to a final concentration of between 100 μg/ml and 200 μg/ml.
Danish: Opløsningen af rekonstitueret Xigris skal yderligere fortyndes med steril natriumchlorid injektionsvæske 0,9 % til en endelig koncentration mellem 100 μg/ml og 200 μg/ml.
English: (activated) is a version of a natural protein in the blood called Activated Protein C and it is
Danish: Drotrecogin alfa (aktiveret) er en udgave af et naturligt protein i blodet, som kaldes aktiveret protein C, og det er fremstillet
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Hvis patienten er på natriumfattig diæt, skal der tages hensyn til dette.
English: 1 vial, powder for solution for infusion.
Danish: 1 hætteglas, pulver til infusionsvæske, opløsning.
English: Xigris is contraindicated in children below the age of 18 years (see also sections 4.2 and 4.3).
Danish: Xigris er kontraindiceret hos børn under 18 år (se også pkt.