natgillin/translations-raw huggingface dataset:
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).
Zdravljenje začnemo v roku 48 ur, najbolje v 24 urah, po pojavu prve zabeležene motnje delovanja organov, ki jo povzroči sepsa (glejte poglavje 5. 1).
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.
Priporočeni odmerek zdravila Xigris je 24 µg/ kg/ h (na osnovi dejanske telesne mase), ki ga dajemo kot neprekinjeno intravensko infuzijo v skupnem trajanju 96 ur.
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.
Če je infuzija iz kakršnegakoli vzroka prekinjena, je treba zdravilo Xigris ponovno uvesti s hitrostjo infuzije 24 µg/ kg/ h in nadaljevati do dopolnitve priporočenih 96 ur dajanja odmerka.
Data from a placebo-controlled clinical trial which was stopped for futility after 477 patients 0 to 17 years-old had received the study treatment did not establish efficacy of Xigris in
Rezultati s placebom nadzorovanega kliničnega preskušanja, ki so ga zaradi neuspešnosti prekinili, potem, ko je študijsko zdravljenje prejelo 477 bolnikov, starih 0 do 17 let, niso pokazali učinkovitosti zdravila Xigris pri pediatričnih bolnikih in so pokazali višjo stopnjo krvavitve v osrednje živčevje v skupini bolnikov, ki so dobivali zdravilo Xigris, v primerjavi s skupino, ki je 2 dobivala placebo.
Therefore no dosage recommendation can be made and the use of Xigris is not recommended in children below the age of 18 (see section 4.4).
Zato odmerjanja ne moremo priporočiti in hkrati odsvetujemo uporabo zdravila Xigris pri otrocih mlajših od 18 let (glejte poglavje 4. 4).
• Active internal bleeding • Patients with intracranial pathology; neoplasm or evidence of cerebral herniation • Concurrent heparin therapy ≥ 15 International Units/ kg/ hr • Known bleeding diathesis except for acute coagulopathy related to sepsis • Chronic severe hepatic disease • Platelet count < 30,000 x 106/ l, even if the platelet count is increased after transfusions • Patients at increased risk for bleeding (for example):
• Aktivna notranja krvavitev • Bolniki z intrakranialnim obolenjem; novotvorbo ali znaki herniacije možganov • Sočasno zdravljenje s heparinom ≥ 15 mednarodnih enot/ kg/ h • Znana nagnjenost h krvavitvam z izjemo akutne koagulopatije, povezane s sepso • Hudo kronično obolenje jeter Število trombocitov < 30. 000 x 106/ l, tudi če je število trombocitov povišano po transfuzijah • • Bolniki s povečanim tveganjem za krvavitev (na primer):
any major surgery, defined as surgery that requires general or spinal anesthesia, performed within the 12-hour period immediately preceding drug infusion, or any postoperative patient who demonstrates evidence of active bleeding, or any patient with planned or anticipated surgery during the drug infusion period.
kakršenkoli večji operacijski poseg, opredeljen kot operacijski poseg, ki zahteva splošno ali spinalno anestezijo, opravljen v 12- urnem obdobju neposredno pred infuzijo zdravila, ali katerikoli bolnik po operaciji, ki kaže znake aktivne krvavitve, ali katerikoli bolnik z načrtovanim ali pričakovanim operacijskim posegom v obdobju infuzije zdravila
history of congenital bleeding diatheses gastrointestinal bleeding within the last 6 weeks that has required medical intervention unless definitive surgery has been performed
prirojena nagnjenost h krvavitvam v anamnezi krvavitev v prebavila v zadnjih 6 tednih, ki je zahtevala medicinsko posredovanje, z izjemo krvavitev, ki so bile dokončno ozdravljene s kirurškim posegom
trauma patients at increased risk of bleeding
bolniki po poškodbah s povečanim tveganjem za krvavitev
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).
V vsakem od dveh randomiziranih s placebom kontroliranih preskušanj, PROWESS in ADDRESS (glejte poglavje 5. 1), sta bili 28- dnevna umrljivost in umrljivost v času hospitalizacije višji pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), v primerjavi s placebom, pri podskupini bolnikov z okvarjenim delovanjem enega organa in nedavnim operacijskim posegom (n = 98 v preskušanju PROWESS in n = 636 v preskušanju ADDRESS).
Bleeding Drotrecogin alfa (activated) increases the risk of bleeding.
Krvavitev Drotrekogin alfa (aktiviran) poveča tveganje za krvavitev.
• 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
• Trombolitično zdravljenje v zadnjih 3 dnevih • Uporaba peroralnih antikoagulantov v zadnjih 7 dnevih • Uporaba aspirina ali drugih zaviralcev agregacije trombocitov v zadnjih 7 dnevih • Ishemični cerebrovaskularni insult v zadnjih 3 mesecih • Katerokoli drugo stanje, pri katerem zdravnik meni, da je verjetna močnejša krvavitev
Xigris may be restarted 12 hours after major invasive procedures or surgery if adequate haemostasis has been achieved.
Zdravilo Xigris lahko ponovno uvedemo 12 ur po večjih invazivnih posegih ali operacijah, če je
3 patients with recent [within 30 days] surgery than in “ medical” patients without surgery (see section 4.8).
Incidenca resnih primerov krvavitve z zdravilom Xigris je bila višja pri bolnikih, ki so bili nedavno (do vključno pred 30 dnevi) operarirani, kot pri bolnikih, ki niso bili operirani (glejte poglavje 4. 8).
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.
Med infuzijo zdravila Xigris morate rutinsko meriti parametre hemostaze (npr. aktivirani parcialni tromboplastinski čas (APTT), protrombinski čas (PT) in število trombocitov).
Laboratory tests Drotrecogin alfa (activated) has minimal effect on the PT.
Laboratorijski testi Drotrekogin alfa (aktiviran) ima minimalen učinek na 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.
Podaljšanje APTT pri bolnikih s hudo sepso, ki prejemajo zdravilo Xigris, je lahko posledica prej obstoječe koagulopatije, farmakodinamičnega učinka drotrekogina alfa (aktiviranega) in/ ali učinka drugih sočasno uporabljenih zdravil.
The interpretation of sequential determinations of the PT and/ or APTT should take these variables into consideration.
Pri interpretaciji zaporednih določanj PT in/ ali APTT moramo upoštevati vse omenjene dejavnike.
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.
Imunogenost V kliničnih študijah hude sepse pri odraslih bolnikih, je pogostnost protiteles IgA/ IgG/ IgM proti humanemu aktiviranemu proteinu C ali nevtralizirajočih protiteles nizka ter podobna kot med testiranimi bolniki, zdravljenimi z drotrekoginom alfa (aktiviranim) in s placebom.
Samples available were subsequently tested and all were negative for anti-human Activated Protein C antibody.
Vzorce, ki so bili na voljo, so naknadno testirali in vsi so bili negativni glede protiteles proti humanemu aktiviranemu proteinu C.
No anti-activated Protein C antibody formation was detected in healthy subjects, even after repeat administration.
Pri zdravih osebah tvorbe protiteles proti aktiviranemu proteinu C, tudi po večkratnem dajanju zdravila Xigris niso zaznali.
Paediatric patients Xigris is not recommended in children below the age of 18 and therefore it should not be used in children.
Pediatrični bolniki Uporabo zdravila Xigris pri otrocih mlajših od 18 let odsvetujemo in se naj torej ne uporablja pri otrocih.
4 cardiovascular organ dysfunction.
4 Rezultati s placebom nadzorovanega kliničnega preskušanja niso pokazali učinkovitosti zdravila Xigris pri pediatričnih bolnikih s hudo sepso, akutno infekcijo, sistemskim vnetjem in motenim delovanjem dihal in srčnožilnih organov.
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).
Načrtovana vmesna analiza (z 400 sodelujočimi) je pokazala majhno verjetnost za prikaz značilne razlike v primarni končni vrednosti “ časa do izboljšanja po popolni odpovedi organov ” (CTCOFR – Composite Time to Complete Organ Failure Resolution; 9, 8 proti 9, 7 povprečnih dni v obdobju14 dni).
There was also no difference in 28-day mortality (17.1% versus 17.3% in the Xigris and placebo groups, respectively).
Tudi ni bilo razlike v 28- dnevni umrljivosti (17, 1% pri bolnikih, ki so jemali zdravilo Xigris, v primerjavi s 17, 3% v skupini s placebom).
Investigators attributed 2 deaths in the Xigris group and 5 deaths in the placebo group to bleeding events.
Raziskovalci so pripisali krvavitvi 2 smrtna primera v skupini bolnikov, ki so jemali zdravilo Xigris, in 5 smrtnih primerov v skupini s placebom.
There was a higher rate of central nervous system (CNS) bleeding in the drotrecogin alfa (activated) versus the placebo group.
Stopnja krvavitve v osrednje živčevje je bila višja v skupini, ki je dobivala drotrekogin alfa (aktiviranega) v primerjavi s skupino, ki je dobivala placebo.
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.
Med infundiranjem (dnevi študije 0- 6) je bilo za celotno populacijo število bolnikov s krvavitvijo v osrednje živčevje 5 proti 1 (2, 1% proti 0, 4% za drotrekogin alfa (aktivirani) proti placebu), z pojavnostjo 4 od 5 dogodkov v skupini z drotrekoginom alfa (aktiviranim) pri bolnikih, starih ≤ 60 dni oz. s telesno maso ≤ 3, 5 kg.
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.
Podobna je bila pojavnost usodnih krvavitev v osrednje živčevje, hudih krvavitev (med infundiranjem in v 28- dnevnem obdobju trajanja študije), resnih neželenih učinkov in obsežnejših amputacij v skupini z drotrekoginom alfa (aktiviranim) in placebom.
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.
Previdnost je potrebna, kadar zdravilo Xigris uporabljamo skupaj z drugimi zdravili, ki vplivajo na hemostazo (glejte poglavji 4. 3 in 4. 4), vključno s proteinom C, trombolitiki (npr. streptokinazo, tPA, rPA in urokinazo), peroralnimi antikoagulanti (npr. varfarinom), hirudini, antitrombinom, aspirinom in drugimi zaviralci agregacije trombocitov, npr. nesteroidnimi protivnetnimi zdravili, tiklopidinom in klopidogrelom, antagonisti glikoproteina IIb/ IIIa (kot so abciksimab, eptifibatid, tirofiban) in prostaciklini, kot je iloprost.
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).
Sočasno dajanje heparina v nizkih odmerkih za profilakso venskih trombotičnih dogodkov (VTE – venous thrombotic events) Heparin v nizkih odmerkih za profilakso VTE lahko dajemo sočasno z drotrekoginom alfa (aktiviranim).
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)).
V randomizirani študiji heparina proti placebu (XPRESS) pri 1935 odraslih bolnikih s hudo sepso, zdravljenih z drotrekoginom alfa (aktiviranim), profilaktični heparin ni negativno vplival na smrtnost (heparin 28, 3% proti placebu 31, 9% v celotni ITT populaciji in heparin 30, 3% proti placebu 26, 9% pri bolnikih s slabim delovanjem več organov, ki so bili zdravljeni v 24 urah po pojavu s sepso inducirane disfunkcije organov (n=890)).
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.
V podskupini 885 bolnikov, ki so ob vključitvi v študijo že prejemali profilaktični heparin, je bila smrtnost v randomizirani skupini, ki je nadaljevala s heparinom 26, 9%, v primerjavi s 35, 6% v skupini, ki so jo randomizirali na placebo.
Prophylactic heparin increased the risk of non-serious bleeding (see section 4.8).
Profilaktični heparin je povečal tveganje za neresno krvavitev (glejte poglavje 4. 8).
Animal studies with respect to effects on pregnancy, embryonal/ foetal development, parturition and postnatal development have not been conducted with Xigris.
Študij vpliva zdravila Xigris na nosečnost, razvoj zarodka/ plodu, porod in postnatalni razvoj pri živalih niso opravili.
Not relevant.
5 Podatek ni potreben.
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.
V mednarodnemu multicentričnemu randomiziranemu dvojno slepemu s placebom kontroliranemu kliničnemu preskušanju faze 3 (PROWESS) je sodelovalo 850 bolnikov, ki so prejemali drotrekogin alfa (aktiviran) in 840 bolnikov, ki so prejemali placebo.
The percentage of patients experiencing at least one bleeding event in the two treatment groups was 24.9% and 17.7%, respectively.
Odstotek bolnikov v obeh skupinah zdravljenja, ki so doživeli vsaj eno krvavitev, je bil 24, 9% oziroma 17, 7%.
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).
Delež bolnikov, ki so doživeli vsaj eno krvavitev, je bil v dveh skupinah zdravljenja 10, 9% oziroma 6, 4% (p < 0, 001).
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).
Resne krvavitve v času infundiranja V naslednji preglednici so navedeni odstotki bolnikov v preskušanjih PROWESS in ENHANCE z resno krvavitvijo po mestih krvavitve v času infudiranja preiskovanega zdravila (kar je definirano kot trajanje infuzije skupaj z naslednjim polnim koledarskim dnevom po koncu infundiranja).
Site of haemorrhage Gastrointestinal Intra-abdominal Intra-thoracic Retroperitoneal Central Nervous
Mesto krvavitve
[PROWESS] N=850 5 (0.6%) 2 (0.2%) 4 (0.5%) 3 (0.4%)
[PROWESS] N=850 5 (0, 6%)
System (CNS)1
Prebavila
2 (0.2%)
4( 0, 5%)
15 (0.6%)
19 (0, 8%)
1
2 (2 1
Genitourinary Skin/ soft tissue Nasopharyngeal Joint/ Bone Site unknown2 Total
0, 2%) 0 (0, 2%) 0 (0, 1%) 0 0 0 0 0
2 (0.2%) 1 (0.1%) 0 0 1 (0.1%) 20 (2.4%)
15 (0, 6%) 0 16 (0, 7%) 4 (0, 2%) 1 (0, 04%)
0 16 (0.7%) 4 (0.2%) 1 (0.04%) 6 (0.3%) 853 (3.6%)
853 (3, 6%)
CNS bleeding is defined as any bleed in the central nervous system including the following types of haemorrhage:
6 1 Krvavitev v osrednje živčevje je definirana kot kakršnakoli krvavitev v osrednje živčevje, vključno z naslednjimi vrstami krvavitev: petehije, parenhimska, subarahnoidna in subduralna krvavitev ter cerebrovaskularni insult s hemoragično preobrazbo.
Petechial, parenchymal, subarachnoid, subdural, and stroke with haemorrhagic transformation.
2 Bolniki, ki so potrebovali dajanje ≥ 3 enot koncentriranih eritrocitov na dan 2 zaporedna dneva brez ugotovljenega mesta krvavitve.
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).
3 V študiji ENHANCE je šest bolnikov izkusilo več resnih krvavitev v času infundiranja preiskovanega zdravila (94 krvavitev pri 85 bolnikih).
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:
V času infuzije v študiji PROWESS in ENHANCE je bila incidenca resnih primerov krvavitve z zdravilom Xigris številčno višja pri bolnikih, ki so bili nedavno (do vključno pred 30 dnevi) operirani, kot pri bolnikih, ki niso bili operirani (PROWESS:
3.3% vs 2.0%; ENHANCE:
3, 3% oziroma 2, 0%; ENHANCE:
5.0% vs 3.1% respectively.
5, 0% oziroma 3, 1%.
Placebo rates in PROWESS 0.4% vs 1.2% respectively).
Placebo vrednosti v študiji PROWESS 0, 4% oziroma 1, 2%).
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).
Incidenca resnih krvavitev v času infundiranja (definirano kot obdobje od dneva študije 0 do dneva študije 6) je bila 31 (2, 4%) oziroma 15 (1, 2%), pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo, (p = 0, 02).
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.
Incidenca krvavitev v osrednje živčevje v času infundiranja je bila 4 (0, 3%) oziroma 3 (0, 2%), pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
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:
Nedavni operacijski poseg (v 30 dneh pred vstopom v študijo) je bil povezan s številčno višjim tveganjem za resno krvavitev v času infundiranja tako pri bolnikih, zdravljenih z zdravilom Xigris, kot tudi pri bolnikih, ki so prejemali placebo (zdravilo Xigris:
3.6% in patients with recent surgery versus 1.6% in patients without recent surgery; placebo:
3, 6% bolnikov z nedavnim operacijskim posegom v primerjavi z 1, 6% bolnikov brez nedavnega operacijskega posega; placebo:
1.6% versus 0.9% respectively).
1, 6% oziroma 0, 9%).
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).
V XPRESS, randomizirani študiji profilaktičnega heparina proti placebu pri odraslih bolnikih s hudo sepso, vsi zdravljeni z drotrekoginom alfa (aktiviranim), so bile stopnje resne krvavitve v skladu s tistimi, ki so jih opazili v predhodnih študijah v obdobju zdravljenja 0- 6 dni, pa tudi profilaktični heparin ni povečal tveganja za resno krvavitev v primerjavi s placebom (2, 3% oziroma 2, 5%), vključno s krvavitvijo v CŽS (0, 3% v obeh krakih).
However prophylactic heparin increased the risk of non-serious bleeding compared with placebo (8.7% vs 5.7%, respectively; p= 0.0116).
Vendar pa je profilaktični heparin povečal tveganje za neresno krvavitev v primerjavi s placebom (8, 7% oziroma 5, 7%; p=0, 0116).
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.
Resne krvavitve v 28- dnevnem obdobju študije V študiji PROWESS je bila incidenca resnih krvavitev v 28- dnevnem trajanju študije 3, 5% oziroma 2, 0% pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
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.
Incidenca krvavitev v osrednje živčevje v 28- dnevnem trajanju študije je bila 0, 2% oziroma 0, 1% pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
The risk of CNS bleeding may increase with severe coagulopathy and severe thrombocytopenia (see sections 4.3 and 4.4).
Tveganje za krvavitev v osrednje živčevje je lahko pri hudi koagulopatiji in hudi trombocitopeniji povečano (glejte poglavji 4. 3 in 4. 4).
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%.
V študiji z znanim zdravilom ENHANCE je bila incidenca resnih krvavitev v 28- dnevnem trajanju študije 6, 5%, incidenca krvavitev v osrednje živčevje v 28- dnevnem trajanju študije pa 1, 5%.
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).
V s placebom kontrolirani študiji ADDRESS je bila incidenca resnih krvavitev v 28- dnevnem trajanju študije 51 (3, 9%) oziroma 28 (2, 2%), pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo, (p = 0, 01).
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.
Incidenca krvavitev v osrednje živčevje v 28 - dnevnem trajanju študije je bila 6 (0, 5%) oziroma 5 (0, 4%), pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
In XPRESS serious bleeding rates were consistent with those observed in previous studies during the 28-day study period (days 0-28).
V XPRESS so bile stopnje resne krvavitve v skladu s tistimi, ki so jih opazili v predhodnih študijah v obdobju 28- dnevnega preučevanja (dnevi 0- 28).
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).
Profilaktični heparin ni povečal tveganja za resno krvavitev v primerjavi s placebom (3, 9% oziroma 5, 2%), vključno s krvavitvijo v CŽS (1, 0% oziroma 0, 7%).
In the phase 1 studies, adverse events with a frequency of ≥ 5% included headache (30.9%), ecchymosis (23.0%), and pain (5.8%).
V študijah faze 1 so neželeni dogodki s pogostnostjo ≥ 5% vključevali: glavobol (30, 9%), ekhimoze (23, 0%) in bolečine (5, 8%).