FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase 3 trial, the pharmacokinetics of drotrecogin alfa (activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24 μg/kg/hr.
Maltese: Fl-istudju tal-Fażi 3, il-farmakokinetiċi ta' drotrecogin alfa (attivat) kienu evalwati fi 342 pazjent b'sepsis gravi li ngħatatilhom infużjoni kontinwa għal 96 siegħa b'rata ta' 24 μg/kg/siegħa.
English: Xigris should be administered via a dedicated intravenous line or a dedicated lumen of a multilumen central venous catheter.
Maltese: Xigris għandu jingħata permezz ta' linja minn ġol-vina apposta jew lumen apposta ta' kateter ċentrali fil-vina multilumen.
English: In each of two randomised, placebo-controlled trials, PROWESS and ADDRESS (see section 5.1), 28day and in-hospital mortality were higher in patients treated with drotrecogin alfa (activated) compared to placebo for the sub-population of patients with single organ dysfunction and recent surgery (n=98 in PROWESS and n=636 in ADDRESS).
Maltese: F'kull wieħed minn żewġ studji kkontrollati bi plaċebo u magħmula b'mod arbitrarju, PROWESS u ADDRESS (ara sezzjoni 5.1), il-mortalità wara t-28 ġurnata u f'pazjenti flisptar kienu ogħla fil-pazjenti li ġew mogħtija d-drotrecogin alfa (attivat) meta kkomparat mal-plaċebo fis-sottopopolazzjoni ta' pazjenti b'disfunzjoni ta' organu wieħed u kirurġija reċenti (n=98 f'PROWESS u n=636 f'ADDRESS)
English: 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.
Maltese: F'pazjenti b'sepsis gravi, l-infużjoni ta' drotrecogin alfa (attivat) ta' bejn 12 μg/kg/siegħa u 30 μg/kg/siegħa pproduċiet bil-ħeffa konċentrazzjonijiet ta' drotrecogin alfa (attivat) fil-plażma fi stat stabbli li kienu proporzjonati għar-rati ta' infużjoni.
English: • Recent (within 3 months) ischaemic stroke
Maltese: • Puplesija iskemika reċenti (sa 3 xhur)
English: 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).
Maltese: Fl-istudju ADDRESS ikkontrollat mill-plaċebo, l-inċidenza ta' każijiet serji ta' fsada matul il-perijodu ta' studju ta' 28 ġurnata kienet ta' 51 (3.9%) u ta' 28 (2.2%) fil-pazjenti li ħadu drotrecogin alfa (attivat) u l-plaċebo, rispettivament (p=0.01).
English: Excipients: sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid and sodium hydroxide.
Maltese: Sustanzi mhux attivi : sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid u sodium hydroxide.
English: Eli Lilly farmacevtska družba, d.o.o.
Maltese: Slovenija Eli Lilly farmacevtska družba, d.o.o.Tel: +386
English: 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.
Maltese: L-inċidenza ta' fsada fis-CNS matul il-perijodu ta' studju ta' 28 ġurnata kienet ta' 6 (0.5%) u ta' 5 (0.4%) fil-pazjenti li ħadu drotrecogin alfa (attivat) u lplaċebo, rispettivament.
English: This medicine has been authorised under “Exceptional Circumstances”.
Maltese: Dan il-prodott mediċinali ġie awtorizzat taħt “Ċirkustanzi ta' Eċċezzjoni”.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA) http://www.emea.europa.eu/.
English: There was a higher rate of central nervous system (CNS) bleeding in the drotrecogin alfa (activated) versus the placebo group.
Maltese: Fil-grupp drotrecogin alfa (attivata) kien hemm rata ogħla ta' fsada fis-sistema nervuża ċentrali (CNS) milli fil-grupp plaċebo.
English: Clinical Efficacy
Maltese: Effikaċja klinika
English: Drotrecogin alfa (activated) increases the risk of bleeding.
Maltese: Drotrecogin alfa (attivat) iżid ir-riskju ta' fsada.
English: However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15ºC - 30ºC).
Maltese: Madanakollu, s-soluzzjoni rikostitwita fil-kunjett tista' tinżamm sa 3 sigħat f'temperatura ambjentali (15°C - 30ºC).
English: 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).
Maltese: F'XPRESS, studju kliniku magħmul b'mod arbitrarju ta' eparina mgħotija bħala profilassi kontra plaċebo f'pazjenti adulti b'sepsis gravi, kollha kkurati b'drotrecogin alfa (attivat), ir-rati ta' fsada serja matul il-perijodu ta' kura ta' 0-6 ġranet, kienu konsistenti ma' dawk ta' studji kliniċi preċedenti, u eparina mgħotija bħala profilassi ma żiedetx ir-riskju ta' fsada serja meta mqabbla ma' plaċebo (2.3% kontra 2.5%,rispettivament), inkluż il-fsada fis-CNS (0.3% fiż-żewġ fergħat).
English: 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).
Maltese: 5% fil-grupp ta' Xigris (168 minn 634) u ta' 33.9% fil-grupp talplaċebo (216 minn 637).
English: No incompatibilities have been observed between drotrecogin alfa (activated) and glass infusion bottles or infusion bags made of polyvinylchloride, polyethylene, polypropylene, or polyolefin.
Maltese: Ma ġewx innutati inkompatibilitajiet bejn drotrecogin alfa (attivat) u fliexken ta' l infużjoni tal-ħġieġ jew boroż ta' l-infużjoni magħmulin minn polyvinylchloride, polyethylene, polypropylene, jew polyolefin.
English: Samples available were subsequently tested and all were negative for anti-human Activated Protein C antibody.
Maltese: Sussegwentement ġew eżaminati xi kampjuni u kollha kienu negattivi għall-antikorp kontra l-Proteina Ċ Attivata umana.
English: 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.
Maltese: Drotrecogin alfa (attivat) ma kienx mutaġeniku fi studju mikronuklejku in vivo li sar fuq il-ġrieden jew studju in vitro ta' aberrazzjoni kromożomali fil-linfoċiti tad-demm periferali tal-bniedem b'attivazzjoni metabolika bil-fwied tal-firien jew mingħajrha.
English: 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.
Maltese: In-nuqqas fil-funżjoni ta' l-organi kien definit bħala xokk, pressjoni baxxa tad-demm jew il-ħtieġa għal għajnuna b'vażopressuri, minkejja resuxxitazzjoni adegwata bil-fluwidi, ipoksemija relattiva (proporzjon ta' pressjoni parzjali ta' l-ossiġenu fid-demm fl-arterji f'mmHg għall-perċentwal ta' l-ossiġenu fl-arja inspirata espress bħala deċimu (proporzjon ta' PaO2/FiO2) < 250), oligurja minkejja resuxxitazzjoni adegwata bilfluwidi, tnaqqis ġmielu fil-għadd tal-plejtlets, u/jew livelli għoljin ta' konċentrazzjonijiet ta' aċidu lattiku.
English: The ONLY other solutions that can be administered through the same line are 0.9% Sodium Chloride Injection, Lactated Ringer's Injection, Dextrose or Dextrose and Saline mixtures.
Maltese: Injezzjoni ta' 0.9% Sodium Chloride, Injezzjoni ta' Ringer Lactated, Dextrose jew taħlititiet ta'
English: In the subgroup of 885 patients who were already receiving prophylactic heparin at study entry, mortality was 26.9% in the group randomised to continue heparin versus 35.6% in the group whose randomisation (to placebo) led to the discontinuation of heparin.
Maltese: Fis-sottogrupp ta' 885 pazjent li meta beda l-istudju kliniku kienu diġa' qegħdin jirċievu eparina bħala profilassi, il-mortalità kienet ta' 26.9% fil-grupp li b'mod arbitrarju baqgħu jirċievu leparina kontra dik ta' 35.6% fil-grupp li minħabba l-arbitrarjetà (li jirċievu plaċebo) waslithom biex ma jibqgħux jirċievu l-eparina.
English: The trial was stopped for futility after an interim analysis.
Maltese: L-istudju twaqqaf minħabba l-inutilità wara analiżi ad interim..
English: Xigris 5 mg powder for solution for infusion Drotrecogin alfa (activated)
Maltese: Xigris 5 mg trab għal soluzzjoni għall-infużjoni drotrecogin alfa (attivat)
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Maltese: Tużahx wara d-data ta' skadenza li tidher fuq it-tikketta Aħżen fi friġġ (2°C - 8°C).
English: Exclusion criteria encompassed patients at high risk of bleeding (see sections 4.3 and 4.4), patients who were not expected to survive for 28 days due to a pre-existing, non-sepsis related medical condition, HIV positive patients whose most recent CD4 count was ≤ 50/mm3, patients on chronic dialysis, and patients who had undergone bone marrow, lung, liver, pancreas or small bowel transplantation, and patients with acute clinical pancreatitis without a proven source of infection.
Maltese: Il-kriterji ta' esklużjoni inkludew pazjenti b'riskju għoli ta' fsada (ara sezzjonijiet 4.3 u 4.4), pazjenti li ma kinux mistennija li jgħixu għal 28 jum minħabba kundizzjoni medika pri-eżistenti u mhix relatata mas-sepsis, pazjenti li kienu pożittivi għall-HIV li kellhom l-għadd ta' CD4 laktar reċenti tagħhom ta' ≤ 50/mm3, pazjenti b'dijaliżi kronika, u pazjenti li sarulhom trapjanti tal-mudullun, tal-pulmun, tal-fwied, tal-frixa jew tal-musrana ż-żgħira, kif ukoll pazjenti b'pankreatite klinika akuta mingħajr kawża ppruvata ta' infezzjoni.
English: The solution of reconstituted Xigris must be further diluted with sterile 0.9% Sodium Chloride Injection.
Maltese: Is-soluzzjoni ta' Xigris rikostitwit trid tkompli tiġi dilwita b'injezzjoni sterili ta' 0.9% sodium chloride.
English: Joint/Bone
Maltese: Ġog/Għadma
English: 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).
Maltese: Konċentrazzjonijiet fil-plażma ta' Proteina Ċ Attivata endoġena f'persuni u pazjenti b'saħħithom u dawk b'sepsis gravi ġeneralment ikunu taħt il-livelli li jistgħu jitkejlu (< 5 ng/ml) u ma jeffettwawx b'mod sinifikanti l-karatteristiċi farmakokinetiċi ta' drotrecogin alfa (attivat).
English: In adult patients in severe sepsis clinical studies, the frequency of anti-human Activated Protein C IgA/IgG/IgM antibodies or neutralizing antibodies is low and is similar between drotrecogin alfa (activated) and placebo-treated patients tested.
Maltese: F'studji kliniċi ta' pazjenti adulti b'sepsis gravi, il-frekwenza ta' antikorpi IgA/IgG/IgM kontra lProteina Ċ Attivata umana jew ta' antikorpi ta' newtralizzazzjoni hija baxxa u fil-pazjenti taħt studju, hija l-istess kemm għal dawk ikkurati b'drotrecogin alfa (attivat) u kemm għal dawk ikkurati bi plaċebo.
English: You should not be given : - if you are allergic (hypersensitive) to drotrecogin alfa (activated) or any of the other ingredients of Xigris, or bovine (cattle-derived) thrombin (protein) - if you are a child below the age of 18 - if you have internal bleeding - if you have a brain tumour, or pressure on the brain - if you are being given heparin at the same time (≥ 15 International Units/kg/hr) - if you have a bleeding tendency which is not related to sepsis - if you have a long-standing, severe problem with your liver - if your platelet (a type of cell in your blood) count is low, even if this has been increased by a transfusion - if you are at high risk of bleeding (for example): a) you have had surgery within the last twelve hours before you receive Xigris, or you are bleeding from a previous surgery, or you might have surgery while you receive Xigris b) you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine) c) you have been born with bleeding tendencies d) you have bled from your bowels within the last six weeks, unless treated adequately e) you have had a major accident and are at increased risk of bleeding
Maltese: • Pazjenti li jkollhom riskju akbar ta' fsada (per eżempju): a) kull kirurġija maġġura, definita bħala kirurġija li jeħtiġilha anestesija ġenerali jew fissinsla,li tkun saret sa 12-il siegħa qabel ma ssir l-infużjoni tal-mediċina, jew kull pazjent li tkun saritlu operazzjoni u li jkollu fsada attiva, jew kull pazjent li jkun se jagħmel operazzjoni pjanata jew antiċipata matul iż-żmien ta' l-infużjoni; b) passat mediku ta' xi trawma gravi fir-ras li tkun ħtieġet żmien fi sptar, kirurġija intrakranika jew intraspinali, jew attakk pupletku b'emorraġija sa 3 xhur qabel, jew kull storja ta' xi malformazzjoni arterjovenali intraċerebrali, anewriżma ċerebrali, jew xi leżjoni serja tas-sistema nervuża ċentrali; pazjenti b'kateter epidurali jew li jkun se jingħatalhom kateter epidurali matul l-infużjoni tal-mediċina; c) passat mediku ta' dijateżi konġenitali ta' fsada d) fsada gastrointestinali matul is-6 ġimgħat ta' qabel, li kienet teħtieġ intervent mediku,sakemm ma tkunx saret kirurġija definittiva e) pazjenti bi trawma li jkollhom riskju akbar ta' fsada
English: Use appropriate aseptic technique during the preparation of Xigris for intravenous administration.
Maltese: Uża teknika asettika adattata matul il-preparazzjoni biex Xigris jingħata fil-vina.
English: Each Xigris vial contains 20 mg of drotrecogin alfa (activated).
Maltese: Kull kunjett Xigris fih 20 mg drotrecogin alfa (attivat).
English: The incidence of serious bleeding events with Xigris was higher in patients with recent [within 30 days] surgery than in “medical” patients without surgery (see section 4.8).
Maltese: L-inċidenza ta' każijiet serji ta' fsada b'Xigris kienu ogħla f'pazjenti li kellhom kirurġija reċenti [fi żmien 30 ġurnata] milli f'pazjenti ‘tal-mediċina' li ma kellhom ebda kirurġija (ara sezzjoni 4.8).
English: Xigris 20 mg powder for solution for infusion Drotrecogin alfa (activated)
Maltese: Xigris 20 mg trab għal soluzzjoni għall-infużjoni drotrecogin alfa (attivat)
English: • Known bleeding diathesis except for acute coagulopathy related to sepsis
Maltese: • Dijateżi magħrufa tal-fsada, ħlief għal koagulopatija akuta relatata mas-sepsis
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur Id-Detentur ta' L-Awtorizzazzjoni Għat-Tqegħid fis-Suq:Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, L-Olanda
English: The mean steady-state plasma concentration of drotrecogin alfa (activated) in healthy subjects receiving 24 μg/kg/hr is 72 ng/ml.
Maltese: Il-medja tal-konċentrazzjoni ta' drotrecogin alfa (attivat) fil-plażma fi stat stabbli f'persuni b'saħħithom li jieħdu 24 μg/kg/siegħa hija ta' 72 ng/ml.
English: Each Xigris vial contains 5 mg of drotrecogin alfa (activated).
Maltese: Kull kunjett Xigris fih 5 mg drotrecogin alfa (attivat).
English: In the open-label ENHANCE study, the incidence of serious bleeding events during the 28-day study period was 6.5%, and the incidence of CNS bleeds during the 28-day study period was 1.5%.
Maltese: Fl-istudju bil-miftuħ ENHANCE, l-inċidenza ta' każijiet serji ta' fsada matul il-perijodu ta' studju ta' 28 ġurnata kienet ta' 6.5%, u l-inċidenza ta' fsada fis-CNS fl-istess perijodu ta' żmien kienet ta' 1.5%.
English: 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.
Maltese: Is-soluzzjoni ta' Xigris rikostitwit għandha tiġi dilwita f'borża ta' infużjoni li fiha injezzjoni sterili ta' 0.9% Sodium Chloride sakemm tintlaħaq konċentrazzjoni finali ta' bejn 100 μg/ml u 200 μg/ml.
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA
English: Furthermore, Activated Protein C is an important modulator of the systemic response to infection and has antithrombotic and profibrinolytic properties.
Maltese: Barra minn hekk, il-Proteina Ċ attivata hija modulatur importanti tarrispons sistemiku għall-infezzjoni u għandha karatteristiċi antitrombotiċi u profibrinolitiċi.
English: Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.
Maltese: Xigris huwa indikat għal kura ta' pazjenti adulti b'sepsis gravi b'indeboliment ta' organi multipli, meta jingħata ma' l-aħjar kura standardizzata.
English: 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.
Maltese: L-inċidenza ta' fsada fis-Sistema Nervuża Ċentrali waqt l-infużjoni kienet ta' 4 (0.3%) u ta' 3 (0.2%) għal dawk li ħadu drotrecogin alfa (attivat) u dawk li ħadu l-plaċebo, rispettivament.
English: 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.
Maltese: It-tnaqqis sinifikanti assolut fl-imwiet kien limitat għas-sottogrupp ta' pazjenti b'mard aktar gravi i.e., linja bażi ta' APACHE II >25 jew dawk b'mill-inqas żewġ organi li ma jiffunzjonawx b'mod akut fillinja bażi.
English: - The other ingredients are sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid
Maltese: - Is-sustanzi l-oħra huma sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid
English: There was no statistical difference in the rates of VTE between study arms.
Maltese: Statistikament, ma kien hemm ebda differenza fir-rati ta' VTE bejn iż-żewġ fergħat ta' studju.
English: 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).
Maltese: Il-kura għandha tibda fi żmien 48 siegħa, u preferibilment fi żmien 24 siegħa, mill-ewwel sinjali dokumentati ta' nuqqas ta' funzjoni ta' l-organi minħabba s-sepsis (ara sezzjoni 5.1).
English: A consistent treatment effect on mortality with Xigris administration was observed across patient subgroups defined by age, gender and infection type.
Maltese: Kien osservat effett konsistenti fuq il-mortalità bil-kura ta' Xigris f'sottogruppi ta' pazjenti magħżula bl-età, bis-sess u bit-tip ta' infezzjoni.
English: Nasopharyngeal
Maltese: Nażofarinġali
English: There was no evidence that the antibodies detected represented a specific immune response to drotrecogin alfa (activated) therapy.
Maltese: Ma kien hemm ebda evidenza li lantikorpi li nstabu jirrappreżentaw xi rispons immuni speċifiku għat-terapija b'drotrecogin alfa (attivat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg of Drotrecogin alfa (activated).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih 20 mg ta' Drotrecogin alfa (attivat).
English: In XPRESS serious bleeding rates were consistent with those observed in previous studies during the 28-day study period (days 0-28).
Maltese: F'XPRESS ir-rati ta' fsada serja matul il-perijodu ta' studju ta' 28 ġurnata (ġranet 0-28) kienu konsistenti ma' dawk osservati f'studji kliniċi preċedenti.
English: In the multiple organ dysfunction subgroup of ADDRESS the 28-day placebo mortality was 21.9%, similar to the single organ dysfunction subgroup of PROWESS (21.2%), confirming the lack of efficacy in patients with severe sepsis who are at low risk of death.
Maltese: Fis-sottogrupp ta' ħafna organi li mhux qed jiffunzjonaw tajjeb ta' ADDRESS, il-mortalità wara 28 ġurnata fil-grupp tal-plaċebo kienet ta' 21.9 % li hija simili għal dik tas-sottogrupp b'organu wieħed li mhux jiffunzjona ta' PROWESS (21.2 %), li tikkonferma n-nuqqas ta' effikaċja f'pazjenti b'sepsis gravi u li huma f'riskju baxx ta' mewt.
English: Xigris increases the risk of bleeding.
Maltese: Xigris iżid ir-riskju ta' fsada.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of Drotrecogin alfa (activated).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih 5 mg ta' Drotrecogin alfa (attivat).
English: 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).
Maltese: Kull kunjett fih 20 mg ta' Drotrecogin alfa (attivat) Wara r-rikostituzzjoni b'10 ml ta' Ilma għall-Injezzjonijiet kull ml fih 2 mg ta' Drotrecogin alfa.
English: Pack of 1 vial.
Maltese: KG Teichweg 3
English: Site unknown2
Maltese: Post mhux magħruf2
English: Xigris has similar properties to those of endogenous human Activated Protein C.
Maltese: Xigris għandu l-istess karatteristiċi tal-Proteina Ċ attivata umana endoġena.
English: Fatal CNS bleeding events, serious bleeding events (over the infusion period and over the 28-day study period), serious adverse events, and major amputations were similar in the drotrecogin alfa (activated) and placebo groups.
Maltese: L-għadd ta' każi ta' fsada fatali fis-CNS, każi ta' fsada gravi (waqt il-perjodu ta' infużjoni u waqt iż-żmien ta' studju ta' 28 ġurnata), każi gravi avversi, u każi ta' amputazzjonijiet maġġuri kien l-istess fil-grupp drotrecogin alfa (attivat) u fil-grupp plaċebo.
English: m.b.H.
Maltese: Eli Lilly Ges. m.b.H.
English: After preparation, the intravenous infusion solution can be used at room temperature (15ºC - 30ºC) for a period up to 14 hours.
Maltese: Wara l-preparazzjoni, s-soluzzjoni ta' infużjoni għal ġol-vina tista' tintuża f'temperatura ambjentali (15°C - 30ºC) għal terminu sa 14-il siegħa.
English: Excessive coagulation activation in the microcirculatory bed plays a significant part in the pathophysiology of severe sepsis.
Maltese: L-attivazzjoni eċċessiva tal-koagulazzjoni fil-livell mikroċirkolatorju għandha parti sinifikanti filpatofiżjoloġija ta' sepsis gravi.
English: • Recent administration (within 7 days) of aspirin or other platelet inhibitors
Maltese: • L-għoti reċenti (sa 7 ijiem) ta' aspirini jew inibituri oħrajn tal-plejtlets
English: NAME OF THE MEDICINAL PRODUCT Xigris 5 mg powder for solution for infusion
Maltese: Xigris 5 mg trab għal infużjoni
English: Prior to administration, 5 mg vials of Xigris must be reconstituted with 2.5 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin
Maltese: Qabel jingħataw, il-kunjetti ta' 5 mg ta' Xigris għandhom jiġu rikostitwiti ma' 2.5 ml Ilma Sterili għall-Injezzjoni, li jirriżulta f'soluzzjoni b' konċentrazzjoni ta' madwar 2 mg/ml drotrecogin alfa (attivat).
English: • Chronic severe hepatic disease
Maltese: • Mard gravi u kroniku tal-fwied
English: Because drotrecogin alfa (activated) may affect the APTT assays, drotrecogin alfa (activated) present in plasma samples may interfere with one-stage coagulation assays based on the APTT (such as factor VIII, IX, and XI assays).
Maltese: Minħabba li drotrecogin alfa (attivat) jista' jeffettwa l-analiżi ta' l-APTT, drotrecogin alfa (attivat) li jkun preżenti fil-kampjuni tal-plażma jista' jfixkel l-analiżi tal-koagulazzjoni magħmula f'daqqa, ibbażata fuq l-APTT (bħall-analiżi għall-fattur VIII, IX u XI).