natgillin/translations-raw huggingface dataset:
Drotrecogin alfa (activated) increases the risk of bleeding.
Drotrekogin alfa (aktiviran) poveča tveganje za krvavitev.
Xigris helps your body to get rid of the clots and also reduces the inflammation caused by the infection.
Zdravilo Xigris pomaga vašemu telesu, da se znebi strdkov in zmanjša vnetje, ki ga povzroči okužba.
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.
This medicine has been authorised under “Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
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).
There was no statistical difference in the rates of VTE between study arms.
Med obema krakoma študije ni bilo statistične razlike v stopnjah VTE.
B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK
Due to these biological and analytical variables, the APTT should not be used to assess the pharmacodynamic effect of drotrecogin alfa (activated).
Zaradi teh bioloških in analitičnih spremenljivk APTT ne moremo uporabljati za vrednotenje farmakodinamičnega učinka drotrekogina alfa (aktiviranega).
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).
Placebo rates in PROWESS 0.4% vs 1.2% respectively).
Placebo vrednosti v študiji PROWESS 0,4 % oziroma 1,2 %).
Xigris increases the risk of bleeding which can be serious or life-threatening.
Zdravilo Xigris povečuje nevarnost za krvavitev, ki je lahko resna ali smrtno nevarna.
Patients with single organ dysfunction and recent surgery Xigris is not approved for the treatment of patients with single organ dysfunction and should not be used in this particular subgroup of patients, especially if they had recent surgery (within 30 days).
Bolniki z okvarjenim delovanjem enega organa in nedavnim operacijskim posegom Zdravilo Xigris ni odobreno za zdravljenje bolnikov z okvarjenim delovanjem enega organa in ga pri tej podskupini bolnikov ne smemo uporabljati, zlasti, če so imeli nedavno operacijski poseg (v zadnjih 30 dneh).
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).
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).
Severe sepsis is defined as sepsis associated with acute organ dysfunction.
Huda sepsa je opredeljena kot sepsa, povezana z akutnimi okvarami delovanja organov.
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.
Like all medicines, Xigris can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Xigris neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18 April 2006 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici z dne, 18. aprila 2006, načrta za obvladovanje tveganja (RMP), predstavljenem v Modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP s katerimi soglaša CHMP.
WHAT XIGRIS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO XIGRIS IN ZA KAJ GA UPORABLJAMO
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.
The median duration of organ dysfunction prior to treatment was 18 hours.
Srednje trajanje motenega delovanja organov pred zdravljenjem je bilo 18 ur.
No death reduction was observed in the subgroup of patients with lower disease severity.
V podskupini bolnikov z manjšo resnostjo bolezni niso opažali zmanjšanja števila smrti.
Because drotrecogin alfa (activated) may increase the risk of bleeding, Xigris is contraindicated in the following situations:
Ker lahko drotrekogin alfa (aktiviran) poveča tveganje za krvavitev, je zdravilo Xigris kontraindicirano v naslednjih primerih:
Slowly add the Sterile Water for Injection to the vial and avoid inverting or shaking the vial.
Počasi dodajajte vodo za injekcije v vialo in pazite, da viale ne obračate ali stresate.
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.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE(UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Best standard care includes adequate antibiotics, source control and supportive treatment (fluids, inotropes, vasopressors and support of failing organs, as required).
Najboljše standardno zdravljenje vključuje ustrezne antibiotike, nadzor izvora okužbe in podporno zdravljenje (tekočine, inotropna sredstva, vazopresorje in podporo odpovedujočim organom, po potrebi).
A hospital pharmacist, nurse or doctor will have dissolved the Xigris powder in water for injection and sodium chloride solution.
Bolnišnični farmacevt, medicinska sestra ali zdravnik bo raztopil prašek zdravila Xigris v vodi za injekcije in raztopini soli.
The median duration of organ dysfunction prior to treatment was 25 hours.
Srednje trajanje motenega delovanja organov pred zdravljenjem je bilo 25 ur.
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 has similar properties to those of endogenous human Activated Protein C.
Zdravilo Xigris ima podobne lastnosti kot endogeni humani aktivirani protein C.
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 %).
Xigris increases the risk of bleeding.
Zdravilo Xigris poveča tveganje za krvavitev.
Hypersensitivity to the active substance, to any of the excipients or to bovine thrombin (a trace residue from the manufacturing process).
Preobčutljivost za zdravilno učinkovino, za katerokoli pomožno snov ali za goveji trombin (ostanek postopka izdelave v sledovih).
Excessive coagulation activation in the microcirculatory bed plays a significant part in the pathophysiology of severe sepsis.
Čezmerna aktivacija koagulacije v mikrocirkulaciji ima pomembno vlogo pri patofiziologiji hude sepse.
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 dosežena zadostna hemostaza.
STORING XIGRIS
SHRANJEVANJE ZDRAVILA XIGRIS
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).
In the following conditions, the risks of the administration of Xigris should be weighed against the anticipated benefits:
Pri naslednjih stanjih je potrebno oceniti tveganje dajanja zdravila Xigris glede na pričakovane koristi:
This leaflet was last approved on {date}
Navodilo je bilo odobreno {datum}
It is not known whether Xigris is excreted in human milk or if there is a potential effect on the breastfed infant.
Ni znano, ali se zdravilo Xigris izloča v materino mleko in ali obstaja možno tveganje za dojenega otroka.
The recommended dose of Xigris is 24 micrograms (μg) per kilogram (kg) of body weight each hour for 96 hours.
Priporočeni odmerek zdravila Xigris je 24 mikrogramov (μg) na kilogram (kg) telesne teže vsako uro 96 ur.
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.
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.
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
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.
Če zaporedni testi hemostaze pokažejo, da je koagulopatija nenadzorovana ali se slabša, kar pomembno povečuje tveganje za krvavitev, je potrebno oceniti koristi nadaljevanja infuzije glede na možno povečano tveganje za krvavitev pri tem bolniku.
If allergic or anaphylactic reactions occur, treatment should be discontinued immediately and appropriate therapy initiated.
Če se pojavijo alergijske ali anafilaktične reakcije, moramo zdravljenje nemudoma prekiniti in začeti z ustreznim zdravljenjem alergijske ali anafilaktične raekcije.
No incompatibilities have been observed between drotrecogin alfa (activated) and glass infusion bottles or infusion bags made of polyvinylchloride, polyethylene, polypropylene, or polyolefin.
Med drotrekoginom alfa (aktiviranim) in steklenimi steklenicami za infuzije ali vrečkami za infuzije, izdelanimi iz polivinilklorida, polietilena, polipropilena ali poliolefina, niso opazili nobenih inkompatibilnosti.
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 following information is intended for medical or healthcare professionals only: Instructions for use and handling
Naslednje informacije so namenjene samo zdravstvenemu osebju:
Xigris should not be used if you have a less severe form of sepsis (only one organ failure) and have recently had a surgical operation.
Zdravila Xigris ne smemo uporabljati, če imate lažjo obliko sepse (odpoved samo enega organa) in ste nedavno imeli kirurški poseg.
The incidence of serious bleeding events in the PROWESS and ENHANCE studies is provided below.
Incidenca resnih krvavitev v študijah PROWESS in ENHANCE je navedena spodaj.
In clinical trials and in post marketing experience there have been reports of accidental overdosing.
V kliničnih preskušanjih in iz izkušenj po uvedbi zdravila na trg so poročali o nezgodnih prevelikih odmerjanjih.
If sequential measures of coagulopathy (including platelet count) indicate severe or worsening coagulopathy, the risk of continuing the infusion should be weighed against the expected benefit.
Če zaporedne meritve koagulopatije (vključujoč število trombocitov) kažejo na hudo ali slabšajočo se koagulopatijo, je treba pretehtati tveganje nadaljevanja infuzije glede na pričakovano korist.
The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
Uporaba drugih vrst kompletov za infuzije bi lahko negativno vplivala na količino in jakost danega drotrekogina alfa (aktiviranega).
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).
Carcinogenicity studies and animal reproduction studies have not been conducted with Xigris.
Z zdravilom Xigris niso opravljali študij kancerogenosti in študij razmnoževanja pri živalih.
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.
Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Zdravilo Xigris naj uporabljajo izkušeni zdravniki v ustanovah z usposobljenim osebjem za zdravljenje bolnikov s hudo sepso.
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).
Gently invert the infusion bag to obtain a homogeneous solution.
Rahlo obrnite infuzijsko vrečko, da dobite homogeno raztopino.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke o zdravilu, ki bodo morda na voljo in posodobila SPC, če bo potrebno.
The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
O uporabi zdravila Xigris razmislimo zlasti v okoliščinah, ko lahko zdravljenje pričnemo v roku 24 ur od pojava odpovedovanja organov (za nadaljnje podatke glejte poglavje 5.1).
The trial was stopped for futility after an interim analysis.
Preskušanje so po vmesni analizi ustavili zaradi neuspešnosti.
• Chronic severe hepatic disease
• Hudo kronično obolenje jeter
Pharmacodynamic Effects
Farmakodinamični učinki
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.
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.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
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.
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.
These data confirmed that the benefit of Xigris is limited to the more severely affected sepsis patients such as patients with multiple organ failure and shock.
Ti podatki so potrdili, da je koristno delovanje zdravila Xigris omejeno na huje prizadete bolnike s sepso, kot so bolniki z odpovedjo več organov in bolniki s šokom.
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.
Poleg tega po približno 2 urah po zaključku infuzije zdravila praktično ni merljivega delovanja drotrekogina alfa (aktiviranega) v obtoku bolnika; po tem času zdravilo ne vpliva več na vzorce krvi, odvzete za določanje APTT.
Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line.
Drotrekogin alfa (aktiviran) je rekombinantna različica endogenega aktiviranega proteina C, ki jo izdelujejo s pomočjo genskega inženiringa iz posebne humane celične kulture.
Drotrecogin alfa (activated) present in plasma samples does not interfere with one-stage factor assays based on the PT (such as Factors II, V, VII and X assays).
Drotrekogin alfa (aktiviran) v vzorcih plazme ne vpliva na enostopenjske teste faktorjev, ki temeljijo na PT (kot so testi faktorjev II, V, VII in X).
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C - 8 °C).
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).
For a full list of excipients, see 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
In both treatment groups, the majority of bleeding events were ecchymosis or gastrointestinal tract bleeding.
V obeh skupinah zdravljenja je v večini krvavitev šlo za ekhimoze in krvavitve v prebavila.
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).
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).
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.
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.
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.
Slowly withdraw the appropriate amount of reconstituted drotrecogin alfa (activated) solution from the vial.
Počasi potegnite ustrezno količino pripravljene (rekonstituirane) raztopine drotrekogina alfa (aktiviranega) iz viale.
Xigris may be restarted immediately after uncomplicated less invasive procedures if adequate haemostasis has been achieved.
Zdravilo Xigris lahko po nezapletenih manj invazivnih posegih ponovno uvedemo takoj, če je dosežena zadostna hemostaza.
Xigris was added to best standard care.
Zdravilo Xigris je bilo dodano najboljšemu standardnemu zdravljenju.
The vial contains an excess of drotrecogin alfa (activated) to facilitate delivery of the label amount.
Viala vsebuje presežek drotrekogina alfa (aktiviranega) za doseganje dajanja označene količine.
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.
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.
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.
There was no evidence that the antibodies detected represented a specific immune response to drotrecogin alfa (activated) therapy.
Dokazov, da so zaznana protitelesa predstavljala specifičen imunski odgovor na zdravljenje z drotrekogin alfa (aktiviranim) ni bilo.
It is not known whether drotrecogin alfa (activated) appears in human milk and therefore you should not breast-feed whilst treated with Xigris.
Ni znano, ali se drotrekogin alfa (aktiviran) izloča v materino mleko, zato med zdravljenjem z zdravilom Xigris ne smete dojiti.
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.
Drotrekogin alfa (aktiviran) ima minimalen učinek na PT. 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.