natgillin/translations-raw huggingface dataset:
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.
V drugih poročilih so poročali o dogodkih v skladu z znanimi neželenimi učinki zdravila (glejte poglavje 4. 8), učinkih zdravila na laboratorijske teste (glejte poglavje 4. 4) ali posledicah sepse kot osnovne bolezni.
In case of overdose, immediately stop the infusion (see section 5.2).
Ob prevelikem odmerjanju nemudoma ustavite infuzijo (glejte poglavje 5. 2).
B01AD10
Antitrombotiki, encimi, Oznaka ATC:
This medicinal product has been authorised under “ Exceptional Circumstances”.
B01AD10 Zdravilo je pridobilo dovoljenje za promet v “ izjemnimih okoliščinah ”.
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.
Mehanizem delovanja Zdravilo Xigris je rekombinantna različica naravnega aktiviranega proteina C iz plazme, od katerega se razlikuje samo po posebnih oligosaharidih v delu molekule iz ogljikovih hidratov.
Pharmacodynamic Effects In placebo-controlled clinical trials in patients with severe sepsis, Xigris exerted an antithrombotic effect by limiting thrombin generation and improved sepsis-associated coagulopathy, as shown by a more rapid improvement in markers of coagulation and fibrinolysis.
Farmakodinamični učinki V s placebom kontroliranih kliničnih preskušanjih pri bolnikih s hudo sepso je zdravilo Xigris pokazalo antitrombotični učinek z omejevanjem tvorbe trombina in izboljšalo s sepso povezano koagulopatijo, kar se je pokazalo s hitrejšim izboljšanjem pokazateljev koagulacije in fibrinolize.
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.
Zdravilo Xigris je povzročilo hitrejši padec trombotičnih pokazateljev, kot so D- dimer, protrombin F1. 2 in ravni razmerja trombin- antitrombin, ter hitrejšo rast ravni proteina C in antitrombina.
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.
Zdravilo Xigris je obnovilo tudi endogeno fibrinolitično sposobnost, kot je bilo dokazano s hitrejšo normalizacijo ravni plazminogena in hitrejšim padcem ravni zaviralca- 1 aktivatorja plazminogena.
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.
Poleg tega so bolniki s hudo sepso, zdravljeni z zdravilom Xigris, kazali hitrejši padec ravni interlevkina- 6, splošnega pokazatelja vnetja, kar je v skladu z zmanjšanjem vnetnega odziva.
Clinical Efficacy Xigris was studied in one Phase 3 international, multi-centre, randomised, double-blind, placebo- controlled trial (PROWESS) in 1690 patients with severe sepsis.
Klinična učinkovitost Zdravilo Xigris so preučevali v mednarodnem multicentričnem randomiziranem dvojno slepem s placebom kontroliranim preskušanju faze 3 (PROWESS) pri 1690 bolnikih s hudo sepso.
Organ dysfunction was defined as shock, hypotension or the need for vasopressor support despite adequate fluid resuscitation, relative hypoxemia (ratio of partial pressure of oxygen in arterial blood in mmHg to the percentage of oxygen in the inspired air expressed as a decimal (PaO2/ FiO2 ratio) < 250), oliguria despite adequate fluid resuscitation, marked reduction in blood platelet counts, and/ or elevated lactic acid concentrations.
Akutna okvara delovanja organov je bila opredeljena kot šok, hipotenzija ali potreba po zdravljenju z vazopresorji kljub zadostnemu nadomeščanju tekočin, relativna hipoksemija (razmerje med parcialnim tlakom kisika v arterijski krvi v mm Hg in odstotkom kisika v vdihanem zraku, izraženo v decimalni obliki (razmerje PaO2/ FiO2) < 250), oligurija kljub zadostnemu nadomeščanju tekočin, pomembno znižanje števila trombocitov in/ ali povišanje koncentracije mlečne kisline.
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.
8 Merila za izključitev so obsegala bolnike z velikim tveganjem za krvavitev (glejte poglavji 4. 3 in 4. 4), bolnike, za katere niso pričakovali, da bodo preživeli 28 dni zaradi predhodnih zdravstvenih stanj, ki niso bila povezana s sepso, HIV pozitivne bolnike, katerih zadnja koncentracija CD4 je bila ≤ 50/ mm3, bolnike zdravljene s kronično dializo, bolnike, ki so imeli presajen kostni mozeg, pljuča, jetra, trebušno slinavko ali tanko črevo, in bolnike z akutnim klinično zaznavnim pankreatitisom brez dokazanega vira okužbe.
8 In the PROWESS trial, treatment was initiated within 48 hours of onset of the first sepsis-induced organ dysfunction.
V preskušanju PROWESS so z zdravljenjem začeli v 48 urah po pojavu prve motnje delovanja organov, povzročene s sepso.
Patients were given a 96-hour constant rate infusion of Xigris at 24 µg/ kg/ hr (n=850) or placebo (n=840).
Bolniki so prejeli 96- urno infuzijo zdravila Xigris s stalno hitrostjo v odmerku 24 µg/ kg/ h (n = 850) ali placebo (n = 840).
Patients treated with Xigris experienced improved 28-day survival compared to those treated with placebo.
28- dnevno preživetje bolnikov, zdravljenih z zdravilom Xigris, je bilo večje v primerjavi z bolniki, ki so prejemali placebo.
At 28 days, the overall mortality rates were 24.7% for the Xigris-treated group and 30.8% for the placebo-treated group (p=0.005).
Po 28 dneh je bila celokupna umrljivost bolnikov 24, 7% pri bolnikih, zdravljenih z zdravilom Xigris, in 30, 8% pri bolnikih, ki so prejemali placebo (p = 0, 005).
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.
Značilno absolutno znižanje števila smrti je bilo omejeno na podskupino bolnikov z večjo resnostjo bolezni, t. j. z izhodiščnim številom točk po APACHE II ≥ 25 ali z vsaj 2 akutnima okvarama delovanja organov ob izhodišču.
In the subgroup of patients with an APACHE II score ≥ 25 at baseline, the mortality was 31% in the Xigris group (128 out of 414) and 44% in the placebo group (176 out of 403).
V podskupini bolnikov s številom točk po APACHE II ≥ 25 ob izhodišču je bila umrljivost 31% v skupini zdravila Xigris (128 od 414) in 44% v skupini placeba (176 od 403).
In the subgroup of patients with at least 2 acute organ dysfunctions at baseline, the mortality was 26.5% in the Xigris group (168 out of 634) and 33.9% in the placebo group (216 out of 637).
V podskupini bolnikov z vsaj 2 akutnima okvarama delovanja organov ob izhodišču je bila umrljivost 26, 5% v skupini zdravila Xigris (168 od 634) in 33, 9% v skupini placeba (216 od 637).
PROWESS Follow-up Study Survival status was assessed in a follow-up study of PROWESS survivors.
PROWESS kontrolna študija V kontrolni študiji preživelih iz študije PROWESS so vrednotili stanje preživetja.
In-hospital and 3 month survival status was reported for 98% and 94% of the 1690 PROWESS subjects respectively.
O preživetju v bolnišnici in po 3 mesecih so poročali za 98% oziroma 94% od 1690 oseb, ki so sodelovale v študiji PROWESS.
In the overall population, the in-hospital mortality was significantly lower in patients on Xigris than in patients on placebo (29.4% vs.
V celotni populaciji je bila umrljivost v bolnišnici značilno nižja pri bolnikih, ki so prejemali zdravilo Xigris, kot pri bolnikih, ki so prejemali placebo (29, 4% v primerjavi s 34, 6%; p = 0, 023).
Survival through 3 months was also better in the Xigris group compared to placebo (log rank p=0.048).
Preživetje po 3 mesecih je bilo prav tako boljše v skupini zdravila Xigris v primerjavi s skupino placeba (log rang p = 0, 048).
Further Clinical Experience In a Phase 3b international, single-arm, open-label clinical trial (ENHANCE), 2378 adult patients with severe sepsis received drotrecogin alfa (activated).
Nadaljnje klinične izkušnje V mednarodnem kliničnem preskušanju (ENHANCE) faze 3b z enim krakom in znanim zdravilom je 2378 odraslih bolnikov s hudo sepso prejemalo drotrekogin alfa (aktiviran).
At 28 days, the mortality rate in the Phase 3b study was 25.3%.
Po 28 dnevih je bila stopnja umrljivosti v študiji faze 3b 25, 3%.
A total of 2640 adult patients with severe sepsis who were at low risk of death (e. g. patients with APACHE II < 25 or with only one sepsis-induced organ failure) were enrolled in a randomised, double- blind, placebo-controlled trial (ADDRESS).
V randomiziranemu dvojno slepemu s placebom kontroliranemu preskušanju (ADDRESS) je sodelovalo skupno 2640 odraslih bolnikov s hudo sepso z nizkim tveganjem za smrt (denimo, bolniki s številom točk po lestvici APACHE II < 25 ali s sepso povzročenim okvarjenim delovanjem samo
The trial was stopped after an interim analysis due to a low likelihood of demonstrating a significant difference in 28-day mortality by the end of the trial.
Preskušanje so po vmesni analizi ustavili zaradi majhne verjetnosti, da bi lahko do konca preskušanja dokazali značilno razliko 28- dnevne umrljivosti.
The ADDRESS trial did enrol 872 patients with multiple organ dysfunction.
V preskušanju ADDRESS je sodelovalo 872 bolnikov z okvarjenim delovanjem večih organov.
25) and were more likely to have two organ dysfunctions (76% vs.
V primerjavi z bolniki z okvarjenim delovanjem večih organov v preskušanju PROWESS je bilo delovanje organov pri bolnikih v preskušanju ADDRESS pred prejemanjem preiskovanega zdravila okvarjeno dlje časa (mediana 25 ur v primerjavi z 18 urami), bolniki v preskušanju ADDRESS so imeli nižje število točk po lestvici APACHE II (mediana 20 v primerjavi s 25), zanje je bilo tudi bolj verjetno, da imajo okvarjeno delovanje dveh organov (76% v primerjavi s 43%).
At 28 days, the mortality rates for multiple organ dysfunction patients in ADDRESS were 20.7% versus 21.9% for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
Po 28 dneh sta bili za bolnike z okvarjenim delovanjem večih organov v preskušanju ADDRESS stopnji umrljivosti 20, 7% oziroma 21, 9% pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
In-hospital mortality rates were 23.1% and 25.3% respectively.
Stopnji umrljivosti v času hospitalizacije sta bili 23, 1% oziroma 25, 3%.
In the subgroup with two organ dysfunctions, the results were similar to those seen in the PROWESS trial.
V podskupini bolnikov z okvarjenim delovanjem dveh organov so bili rezultati podobni kot v preskušanju PROWESS.
9 In placebo controlled clinical trials, the treatment effect was most evident at sites enrolling larger numbers of patients.
V s placebom kontroliranih kliničnih preskušanjih je bil učinek zdravljenja najbolj očiten na mestih, kjer je sodelovalo večje število bolnikov.
Plasma concentrations of endogenous Activated Protein C in healthy subjects and patients with severe sepsis are usually below detection limits (< 5 ng/ ml) and do not significantly influence the pharmacokinetic properties of drotrecogin alfa (activated).
Plazemske koncentracije endogenega aktiviranega proteina C pri zdravih osebah in bolnikih s hudo sepso so običajno pod pragom zaznave (< 5 ng/ ml) in na farmakokinetične lastnosti drotrekogina alfa (aktiviranega) ne vplivajo pomembno.
In healthy subjects, greater than 90% of the steady state condition is attained within 2 hours following the start of a constant-rate intravenous infusion of Xigris.
Pri zdravih osebah je več kot 90% ravnovesnega stanja doseženo v 2 urah po začetku intravenske infuzije zdravila Xigris s stalno hitrostjo.
Following the completion of an infusion, the decline in plasma drotrecogin alfa (activated) concentrations is biphasic and is comprised of a rapid initial phase (t1/ 2 α =13 minutes) and a slower second phase (t1/ 2 β =1.6 hours).
Po zaključku infuzije je padec plazemskih koncentracij drotrekogina alfa (aktiviranega) dvofazen in ga sestavljata hitra začetna faza (t1/ 2 α = 13 minut) in počasnejša druga faza (t1/ 2 β = 1, 6 ure).
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.
Kratek razpolovni čas 13 minut velja za približno 80% področja pod krivuljo plazemske koncentracije in vpliva na hitro začetno naraščanje plazemskih koncentracij drotrekogina alfa (aktiviranega) proti ravnovesnemu stanju.
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.
Plazemske koncentracije drotrekogina alfa (aktiviranega) v ravnovesnem stanju so sorazmerne hitrosti infuzije v razponu hitrosti infuzije od 12 µg/ kg/ h do 48 µg/ kg/ h.
The mean steady-state plasma concentration of drotrecogin alfa (activated) in healthy subjects receiving 24 µg/ kg/ hr is 72 ng/ ml.
Povprečna plazemska koncentracija drotrekogina alfa (aktiviranega) ravnovesnega stanja pri zdravih osebah, ki prejemajo 24 µg/ kg/ h, je 72 ng/ ml.
In patients with severe sepsis, infusion of drotrecogin alfa (activated) from 12 µg/ kg/ hr to 30 µg/ kg/ hr rapidly produced steady-state plasma concentrations that were proportional to infusion rates.
Pri bolnikih s hudo sepso je infuzija drotrekogina alfa (aktiviranega) od 12 µg/ kg/ h do 30 µg/ kg/ h hitro povzročila plazemske koncentracije ravnovesnega stanja, sorazmerne hitrostim infuzije.
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.
V preskušanju faze 3 so vrednotili farmakokinetiko drotrekogina alfa (aktiviranega) pri 342 bolnikih s hudo sepso, ki so prejeli 96- urno neprekinjeno infuzijo v odmerku 24 µg/ kg/ h.
The plasma clearance of drotrecogin alfa (activated) is approximately 41.8 l/ hr in sepsis patients as compared with 28.1 l/ hr in healthy subjects.
Plazemski očistek drotrekogina alfa (aktiviranega) je približno 41, 8 l/ h pri bolnikih s sepso v primerjavi z 28, 1 l/ h pri zdravih osebah.
In patients with severe sepsis, the plasma clearance of drotrecogin alfa (activated) was significantly decreased by renal impairment and hepatic dysfunction, but the magnitude of the differences in clearance (< 30%) does not warrant any dosage adjustment.
Pri bolnikih s hudo sepso je bil plazemski očistek drotrekogina alfa (aktiviranega) zaradi okvarjenega delovanja ledvic in jeter značilno znižan, vendar velikost razlik očistka (< 30%) ne upravičuje prilagoditve odmerka.
Drotrecogin alfa (activated) was not mutagenic in an in vivo micronucleus study in mice or in an in vitro chromosomal aberration study in human peripheral blood lymphocytes with or without rat liver metabolic activation.
10 Drotrekogin alfa (aktiviran) ni bil mutagen v in vivo študiji mikronukleusa pri miših ali v in vitro študiji kromosomskih aberacij v človeških limfocitih periferne krvi s presnovno aktivacijo s podganjimi jetri ali brez nje.
However, with respect to the latter, the potential risk for humans being unknown, Xigris should not be used during pregnancy unless clearly necessary (see section 4.6).
Ker pa glede na to možno tveganje za človeka ni znano, se zdravila Xigris med nosečnostjo ne sme uporabljati, razen če to ni neobhodno potrebno (glejte poglavje 4. 6).
Sucrose Sodium chloride Sodium citrate Citric acid Hydrochloric acid Sodium hydroxide
saharoza natrijev klorid natrijev citrat citronska kislina klorovodikova kislina natrijev hidroksid
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedeni v poglavju 6. 6.
Powder in Type I glass vial.
Prašek v viali stekla tipa I.
Prior to administration, 20 mg vials of Xigris must be reconstituted with 10 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ ml drotrecogin alfa (activated).
Pred dajanjem morate 20 mg vialo zdravila Xigris pripraviti (rekonstituirati) z 10 ml vode za injekcije, kar da raztopino s koncentracijo približno 2 mg/ ml drotrekogina alfa (aktiviranega).
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.
Raztopino rekonstituiranega zdravila Xigris morate nadalje razredčiti s sterilno 0, 9% raztopino natrijevega klorida do končne koncentracije, ki je med 100 µg/ ml in 200 µg/ ml.
Add the reconstituted drotrecogin alfa (activated) into a prepared infusion bag of sterile 0.9% Sodium Chloride Injection.
Raztopljeni drotrekogin alfa (aktiviran) dodajte v pripravljeno infuzijsko vrečko sterilne 0, 9% raztopine natrijevega klorida.
When adding the reconstituted drotrecogin alfa (activated) into the infusion 11 bag, direct the stream to the side of the bag to minimise the agitation of the solution.
Ko dodajate raztopljeni drotrekogin alfa (aktiviran) v infuzijsko vrečko, usmerite curek v steno vrečke, da čimbolj zmanjšate vrtinčenje raztopine.
The solution of reconstituted Xigris should be diluted into an infusion bag containing sterile 0.9% Sodium Chloride Injection to a final concentration of between 100 µg/ ml and 200 µg/ ml.
Raztopino pripravljenega (rekonstituiranega) zdravila Xigris moramo razredčiti s sterilno 0, 9% raztopino natrijevega klorida v infuzijski vrečki do končne koncentracije med 100 µg/ ml in 200 µg/ ml.
When administering drotrecogin alfa (activated) at low flow rates (less than approximately 5 ml/ hr), the infusion set must be primed for approximately 15 minutes at a flow rate of approximately 5 ml/ hr.
Pri dajanju drotrekogina alfa (aktiviranega) pri nizkih hitrostih pretoka (manj kot približno 5 ml/ h) morate infuzijski sistem pripravljati približno 15 minut s hitrostjo pretoka približno 5 ml/ h.
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.
EDINE raztopine, ki jih lahko dajate po istemkatetru, so 0, 9% raztopina natrijevega klorida, raztopina Ringerjevega laktata, raztopina dekstroze ali raztopina dekstroze in fiziološke raztopine.
Avoid exposing drotrecogin alfa (activated) solutions to heat and/ or direct sunlight.
Izogibajte se izpostavljanju raztopin drotrekogina alfa (aktiviranega) vročini in/ ali neposredni sončni svetlobi.
Eli Lilly Nederland B. V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA, Houten, Nizozemska
22 August 2002.
22. avgust 2002.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/ 12 1.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
After reconstitution with 2.5 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Po pripravi (rekonstituciji) z 2, 5 ml vode za injekcije vsak ml vsebuje 2 mg drotrekogina alfa (aktiviranega).
Each vial contains approximately 17 mg sodium.
Vsaka viala vsebuje približno 17 mg natrija.
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 paediatric patients and showed a higher rate of central nervous system bleeding in the Xigris versus
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 14 dobivala placebo.
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).
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).
14 Bleeding risk should be taken into account when considering the risk benefit for individual patients.
Pri oceni tveganja in koristi za posameznega bolnika, je potrebno upoštevati tveganje za krvavitev.
15 Data from a placebo-controlled clinical trial did not establish efficacy of Xigris in paediatric patients suffering from severe sepsis, acute infection, systemic inflammation and respiratory and cardiovascular organ dysfunction.
Rezultati s placebom nadzorovanega kliničnega preskušanja niso pokazali učinkovitosti zdravila Xigris pri pediatričnih bolnikih s hudo sepso, akutno infekcijo, sistemskim vnetjem in motenim
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 obdobju 14 dni).
16 4.8 Undesirable effects
17 4. 8 Neželeni učinki
CNS bleeding is defined as any bleed in the central nervous system including the following types of haemorrhage:
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.
18 2 Bolniki, ki so potrebovali dajanje ≥ 3 enot koncentriranih eritrocitov na dan 2 zaporedna dneva brez ugotovljenega mesta krvavitve.
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:
18 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 clinical trials and in post marketing experience there have been reports of accidental overdosing.
19 V kliničnih preskušanjih in iz izkušenj po uvedbi zdravila na trg so poročali o nezgodnih prevelikih odmerjanjih.
Additionally, patients with severe
Zdravilo Xigris je obnovilo tudi endogeno fibrinolitično sposobnost, kot je bilo dokazano s hitrejšo normalizacijo ravni plazminogena in hitrejšim padcem ravni zaviralca- 1 aktivatorja plazminogena.