natgillin/translations-raw huggingface dataset:
Traumatiserede patienter med øget risiko for blødning
trauma patients at increased risk of bleeding
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).
In each of two randomised, placebo-controlled trials, PROWESS and ADDRESS (see section 5.1), 28- day 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).
Blødning Drotrecogin alfa (aktiveret) øger risikoen for blødning.
Bleeding Drotrecogin alfa (activated) increases the risk of bleeding.
• Nylig (indenfor 3 dage) administration af trombolytisk behandling • Nylig (indenfor 7 dage) administration af orale antikoagulantia • Nylig (indenfor 7 dage) administration af acetylsalicylsyre eller andre trombocytfunktionshæmmende midler • Nylig (indenfor 3 måneder) iskæmisk apopleksi • Enhver anden tilstand, hvor lægen mener, at en signifikant blødning er sandsynlig
• Recent administration (within 3 days) of thrombolytic therapy • Recent administration (within 7 days) of oral anticoagulants • Recent administration (within 7 days) of aspirin or other platelet inhibitors • Recent (within 3 months) ischaemic stroke • Any other condition in which the physician considers significant bleeding is likely
Hyppigheden af alvorlig blødningstilfælde med Xigris var højere hos patienter med
The incidence of serious bleeding events with Xigris was higher in
4. 8).
3 patients with recent [within 30 days] surgery than in “ medical” patients without surgery (see section 4.8).
Blødningsrisikoen bør tages i betragtning, når man vurderer risk- benefit for individuelle patienter.
Bleeding risk should be taken into account when considering the risk benefit for individual patients.
Som led i den rutinemæssige pleje under infusion af Xigris bør hæmostasen måles (fx. aktiveret partiel tromboplastintid (APTT), protrombintid (PT) og trombocyttal).
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.
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 blødnings - risiko for den pågældende patient.
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.
Laboratorieanalyser Drotrecogin alfa (aktiveret) har minimal effekt på PT.
Laboratory tests Drotrecogin alfa (activated) has minimal effect on the PT.
Forlængelse af APTT hos patienter med svær sepsis, som får Xigris, kan skyldes den tilgrundliggende koagulopati, de farmakodynamiske egen - skaber ved drotrecogin alfa (aktiveret) og/ eller samtidig indgift af andre lægemidler.
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.
Den farmako - dynamiske 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.
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.
Drotrecogin alfa (aktiveret), som forefindes i en blod - eller plasmaprøve udtaget fra en patient, som får lægemidlet, vil gradvist blive neutraliseret af endogene plasmaprotease - inhibitorer, som findes i prøven.
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.
Blodprøver, der udtages til APTT efter dette tidspunkt, påvirkes ikke længere af lægemidlet.
In addition, approximately 2 hours after terminating the infusion of the drug, there is virtually no measurable activity of drotrecogin alfa (activated) remaining in the circulation of the patient; blood samples drawn for APTT determination after this point are no longer affected by the drug.
Disse variable bør tages i betragtning ved fortolkningen af gentagne bestemmelser af PT og/ eller APTT.
The interpretation of sequential determinations of the PT and/ or APTT should take these variables into consideration.
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).
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).
Immunogenicitet I kliniske studier for svær sepsis er frekvensen af anti- human aktiveret protein C IgA/ IgG/ IgM - antistoffer eller neutraliserende antistoffer lav hos voksne patienter og er ens for de testede drotrecogin alfa (aktiveret) - og placebobehandlede patienter.
Immunogenicity 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.
Der var ingen tegn på, at de påviste antistoffer repræsenterede et specifikt immunrespons til drotrecogin alfa (aktiveret) - behandling.
There was no evidence that the antibodies detected represented a specific immune response to drotrecogin alfa (activated) therapy.
De var alle negative for anti- human aktiveret protein C- antistof.
Samples available were subsequently tested and all were negative for anti-human Activated Protein C antibody.
Der blev ikke set dannelse af anti- aktiveret protein C- antistoffer hos raske forsøgspersoner, selv efter gentagen administration.
No anti-activated Protein C antibody formation was detected in healthy subjects, even after repeat administration.
Børn Xigris anbefales ikke til børn under 18 år og bør derfor ikke bruges til behandling af børn.
Paediatric patients Xigris is not recommended in children below the age of 18 and therefore it should not be used in children.
4 Data fra et placebokontrolleret klinisk forsøg har ikke fastslået effekten af Xigris hos børn, som lider af svær sepsis, akut infektion, systemisk inflammation samt respiratorisk og kardiovaskulær organ dysfunktion.
4 cardiovascular organ dysfunction.
Forsøget blev stoppet grundet manglende formål med at fortsætte efter, at 477 patienter (ud af 600 tiltænkte patienter) havde modtaget forsøgsmedicinen.
This trial was stopped for futility after 477 patients had received the study drug (out of 600 patients intended).
En planlagt interim analyse (med data fra 400 patienter) viste lav sandsynlighed for påvisning af en signifikant forskel på den primære måleparameter ” Sammensat tid til komplet organsvigt helbredelse ” (” Composite Time to Complete Organ Failure Resolution ” CTCOFR score på 9, 8 mod 9, 7 dage i gennemsnit over 14 dage).
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).
Xigris og placebo grupperne).
There was also no difference in 28-day mortality (17.1% versus 17.3% in the Xigris and placebo groups, respectively).
Investigatorer bedømmer, at 2 dødsfald i drotrecogin alfa (aktiveret) gruppen og 5 dødsfald i placebo gruppen skyldes blødningshændelser.
Investigators attributed 2 deaths in the Xigris group and 5 deaths in the placebo group to bleeding events.
I infusionsperioden (forsøgsdag 0- 6) var der en højere forekomst af blødninger i centralnervesystemet (CNS) i drotrecogin alfa (aktiveret) gruppen i forhold til placebo gruppen.
There was a higher rate of central nervous system (CNS) bleeding in the drotrecogin alfa (activated) versus the placebo group.
4 ud af 5 hændelser i drotrecogin alfa (aktiveret) gruppen opstod hos patienter ≤ 60 dage gamle eller en kropsvægt ≤ 3, 5 kg.
Over the infusion period (study days 0-6) the number of patients experiencing CNS bleeding was 5 versus 1 (2.1% versus 0.4%) for the overall population (drotrecogin alfa (activated) versus placebo), with 4 of the 5 events in the drotrecogin alfa (activated) group occurring in patients ≤ 60 days old or ≤ 3.5 kg bodyweight.
Dødelige CNS blødningshændelser, alvorlige blødningshændelser (i infusionsperioden og i den 28 - dage lange forsøgsperiode), alvorlige utilsigtede hændelser og større amputationer var sammen - lignelige i drotrecogin alfa (aktiveret) og placebo grupperne.
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.
68 mg natrium pr. hætteglas.
This medicinal product contains approximately 68 mg sodium per vial.
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.
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. non- steroidal anti-inflammatory drugs, ticlopidine and clopidogrel, glycoprotein IIb/ IIIa antagonists (such as abciximab, eptifibatide, tirofiban) and prostacyclins such as iloprost.
Samtidig administration af lavdosis heparin for profylaktisk behandling af venøs trombose (VT) Lavdosis heparinbehandling for VT- profylakse kan gives samtidig med drotrecogin alfa (aktiveret).
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).
I forsøget påvirkede profylaktisk heparinbehandling ikke i nævneværdig grad dødeligheden (heparin 28, 3% mod placebo 31, 9% i den samlede ITT population, og heparin 30, 3% mod placebo 26, 9% hos de patienter med multipel organdysfunktion, som havde modtaget behandling inden for 24 timer efter deres første sepsis - inducerede organdysfunktion (n=890).
In a randomised study of heparin versus placebo (XPRESS) in 1935 adult severe sepsis patients, all treated with drotrecogin alfa (activated), prophylactic heparin did not adversely affect mortality (heparin 28.3% versus placebo 31.9% in the overall ITT population, and heparin 30.3% versus placebo 26.9% in patients with multiple organ dysfunction treated within 24 hours of their first sepsis-induced organ dysfunction (n=890)).
Heroverfor var dødeligheden 35, 6% i gruppen, hvis randomisering (til placebo) førte til afbrydelse af heparinbehandlingen.
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.
4. 8).
Prophylactic heparin increased the risk of non-serious bleeding (see section 4.8).
Der er ikke udført dyreforsøg med Xigris med henblik på virkningen på graviditet, embryonal/ føtal udvikling, fødsel og postnatal udvikling.
Animal studies with respect to effects on pregnancy, embryonal/ foetal development, parturition and postnatal development have not been conducted with Xigris.
5 Ikke relevant.
Not relevant.
Det internationale fase 3, multicenter, randomiserede, dobbeltblinde, placebokontrollerede kliniske forsøg (PROWESS) omfattede 850 drotrecogin alfa (aktiveret) - behandlede og 840 placebobehandlede patienter.
5 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.
Procentdelen af patienter, der oplevede mindst et tilfælde af blødning i de to behandlings - arme var henholdsvis 24, 9% og 17, 7%.
The percentage of patients experiencing at least one bleeding event in the two treatment groups was 24.9% and 17.7%, respectively.
I begge behandlingsgrupper stod ekkymoser eller gastro - intestinale blødninger for de fleste blødningstilfælde.
In both treatment groups, the majority of bleeding events were ecchymosis or gastrointestinal tract bleeding.
I et internationalt, enkelt arm, open- label fase 3b klinisk forsøg (ENHANCE) modtog i alt 2378 voksne patienter med svær sepsis drotrecogin alfa (aktiveret).
A total of 2378 adult patients with severe sepsis received drotrecogin alfa (activated) in a Phase 3b, international, single-arm, open-label clinical trial (ENHANCE).
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.
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.
Procentdelen af patienter, der oplevede mindst et tilfælde af blødning i de to behandlingsarme var henholdsvis 10, 9% og 6, 4% (p < 0, 001).
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).
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).
Serious bleeding events during the infusion period 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).
Blødningssted
Site of haemorrhage Gastrointestinal Intra-abdominal Intra-thoracic Retroperitoneal Central Nervous
[PROWESS] N=850
[PROWESS] N=850 5 (0.6%) 2 (0.2%) 4 (0.5%) 3 (0.4%)
[PROWESS] N=840
[PROWESS] N=840 4(0.5%) 3 (0.4%) 0 0
[ENHANCE] N=2378
[ENHANCE] N=2378 19 (0.8%) 18 (0.8%) 11 (0.5%) 4 (0.2%)
4( 0, 5%) 3 (0, 4%) 0 0
System (CNS)1
Genitourinary Hud/ blødt væv Nasopharyngeal Led/ knogler Ukendt sted2 Total
Genitourinary Skin/ soft tissue Nasopharyngeal Joint/ Bone Site unknown2 Total
0 16 (0, 7%) 4 (0, 2%) 1 (0. 04%) 6 (0, 3%) 853 (3, 6%)
0 16 (0.7%) 4 (0.2%) 1 (0.04%) 6 (0.3%) 853 (3.6%)
CNS blødning er defineret som enhver blødning i centralnervesystemet inklusiv de følgende typer blødninger:
CNS bleeding is defined as any bleed in the central nervous system including the following types of haemorrhage:
Petecchiae, parenchyma, subaraknoidal, subdural og slagtilfælde med blødningstransformation.
Petechial, parenchymal, subarachnoid, subdural, and stroke with haemorrhagic transformation.
3 Seks patienter oplevede flere alvorlige tilfælde af blødning i perioden med infusion af forsøgsmedicin i ENHANCE forsøget (94 tilfælde er observeret hos 85 patienter).
2 Patients requiring the administration of ≥ 3 units of packed red blood cells per day for 2 consecutive days without an identified site of bleeding 3 In ENHANCE six patients experienced multiple serious bleeding events during the study drug infusion period (94 events observed in 85 patients).
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:
6 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:
2, 0%; ENHANCE:
3.3% vs 2.0%; ENHANCE:
3, 1% henholdsvis.
5.0% vs 3.1% respectively.
1, 2% henholdsvis).
Placebo rates in PROWESS 0.4% vs 1.2% respectively).
Den procentvise andel af behandlede patienter, der oplevede alvorlige blødningstilfælde, fordelt på blødningsstedet, i ADDRESS- forsøget var sammenlignelig med PROWESS- forsøget.
In ADDRESS, the percent of treated patients experiencing a serious bleeding event by site of haemorrhage was similar to that observed in PROWESS.
Forekomsten af tilfælde af alvorlige blødning i løbet af infusionsperioden (defineret som forsøgsdag 0 til og med forsøgsdag 6) var henholdsvis 31 (2, 4%) og 15 (1, 2%) af de drotrecogin alfa (aktiveret) - behandlede og placebobehandlede patienter (p=0, 02).
The incidence of serious bleeding events during infusion (defined as study Day 0 through study Day 6) was 31 (2.4%) and 15 (1.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (p=0.02).
Hyppigheden af CNS- blødninger i løbet af infusions - perioden var henholdsvis 4 (0, 3%) og 3 (0, 2%) af de drotrecogin alfa (aktiveret) - behandlede og placebobehandlede patienter.
The incidence of CNS bleeds during infusion was 4 (0.3%) and 3 (0.2%) for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
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%).
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:
I XPRESS, et randomiseret forsøg med profylaktisk heparinbehandling versus placebo hos voksne patienter med alvorlig sepsis, blev alle behandlet med drotrecogin alfa (aktiveret).
3.6% in patients with recent surgery versus 1.6% in patients without recent surgery; placebo:
Hyppigheden af alvorlige blødninger stemte overens med den hyppighed, der var observeret i tidligere forsøg med en behandlingsperiode på 0- 6 dage.
1.6% versus 0.9% respectively).
Profylaktisk heparinbehandling forøgede ikke risikoen for alvorlig blødning sammenlignet med placebo (henholdsvis 2, 3% for heparinbehandling mod 2, 5% for placebo), dette inkluderer CNS- blødning (0, 3% for begge forsøgsarme).
In XPRESS, a randomised study of prophylactic heparin versus placebo in adult severe sepsis patients, all treated with drotrecogin alfa (activated), serious bleeding rates were consistent with those observed in previous studies over the treatment period of 0-6 days, and prophylactic heparin did not increase the risk of serious bleeding compared to placebo (2.3% vs 2.5%, respectively), including CNS bleeding (0.3% on both arms).
Profylaktisk heparinbehandling forøgede dog risikoen for ikke- alvorlig blødning sammenlignet med placebo (8, 7% mod 5, 7%; p=0, 0116).
However prophylactic heparin increased the risk of non-serious bleeding compared with placebo (8.7% vs 5.7%, respectively; p= 0.0116).
I PROWESS forsøget opstod der alvorlige tilfælde af blødning hos henholdsvis 3, 5% og 2, 0% af de drotrecogin alfa (aktiveret) - behandlede og placebobehandlede patienter i løbet af den 28- dages forsøgsperiode.
Serious bleeding events during the 28-day study period In PROWESS, the incidence of serious bleeding events during the 28-day study period was 3.5% and 2.0% in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
Hyppigheden af CNS- blødninger i løbet af den 28- dages forsøgsperiode var henholdsvis 0, 2% og 0, 1% af de drotrecogin alfa (aktiveret) - behandlede og placebobehandlede patienter.
The incidence of CNS bleeds during the 28-day study period was 0.2% and 0.1% for drotrecogin alfa (activated)- treated and placebo-treated patients, respectively.
4. 3, og 4. 4).
The risk of CNS bleeding may increase with severe coagulopathy and severe thrombocytopenia (see sections 4.3 and 4.4).
Samtidig var hyppigheden af CNS- blødninger 1, 5% i løbet af den 28 - dages forsøgsperiode.
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%.
I den 28- dages forsøgsperiode i det placebokontrollerede ADDRESS forsøg var hyppigheden af tilfælde af alvorlige blødning henholdsvis 51 (3, 9%) og 28 (2, 2%) af de drotrecogin alfa (aktiveret) - behandlede og placebobehandlede patienter (p=0, 01).
In the placebo-controlled ADDRESS study, the incidence of serious bleeding events during the 28-day study period was 51 (3.9%) and 28 (2.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (p=0.01).
Hyppigheden af CNS- blødninger i den 28- dages forsøgsperiode var henholdsvis 6 (0, 5%) og 5 (0, 4%) af de drotrecogin alfa (aktiveret) - behandlede og placebobehandlede patienter.
The incidence of CNS bleeds during the 28-day study period was 6 (0.5%) and 5 (0.4%) for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
I løbet at den 28 dages forsøgsperiode (dag 0- 28) i XPRESS- forsøget var hyppigheden af alvorlig blødning i overensstemmelse med, hvad der blev observeret i tidligere forsøg.
In XPRESS serious bleeding rates were consistent with those observed in previous studies during the 28-day study period (days 0-28).
Profylaktisk heparin - behandling forøgede ikke risikoen for alvorlig blødning sammenlignet med placebo (3, 9% mod 5, 2%), CNS blødning inkluderet (1, 0% mod 0, 7%).
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).
Hændelser med en hyppighed på ≥ 5% i fase 1 forsøgene omfattede hovedpine (30, 9%), ekkymose (23, 0%) og smerter (5, 8%).
In the phase 1 studies, adverse events with a frequency of ≥ 5% included headache (30.9%), ecchymosis (23.0%), and pain (5.8%).
4. 4) eller konsekvenser af den tilgrundliggende sepsis.
For the other reports, the observed events were consistent with known undesirable effects of the drug (see section 4.8), effects of the drug on laboratory tests (see section 4.4), or consequences of the underlying condition of sepsis.
5. 2).
In case of overdose, immediately stop the infusion (see section 5.2).
Antitrombotiske midler, enzymer, ATC- kode:
Pharmacotherapeutic group: antithrombotic agents, enzymes, ATC code:
B01A D10
B01AD10
Det afviger kun ved unikke oligosaccharider i kulhydratdelen af molekylet.
Mechanism of Action Xigris is a recombinant version of the natural plasma-derived activated Protein C, from which it differs only by unique oligosaccharides in the carbohydrate portion of the molecule.