natgillin/translations-raw huggingface dataset:
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 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).
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: 3.6% in patients with recent surgery versus 1.6% in patients without recent surgery; placebo: 1.6% versus 0.9% respectively).
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 % bolnikov z nedavnim operacijskim posegom v primerjavi z 1,6 % bolnikov brez nedavnega operacijskega posega; placebo: 1,6 % oziroma 0,9 %).
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.
Bleeding events included serious bleeding events, bleeding events assessed as possibly study-drug related by the investigator, bleeding events associated with the need for a red blood cell transfusion, and bleeding events that led to permanent discontinuation of the study drug.
Krvavitve so vključevale resne krvavitve, krvavitve, ki jih je kot možno povezane s preiskovanim zdravilom ocenil preiskovalec, krvavitve, ki so zahtevale dajanje transfuzije eritrocitov, in krvavitve, zaradi katerih je bilo preiskovano zdravilo trajno ukinjeno.
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).
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 prejemala placebo.
Powder for solution for infusion.
Prašek za raztopino za infundiranje.
Important information about some of the ingredients of Xigris This medicinal product contains approximately 17 mg sodium per vial.
Pomembne informacije o nekaterih sestavinah zdravila Xigris To zdravilo vsebuje približno 17 mg natrija na vialo.
Data from a placebo-controlled clinical trial (RESOLVE) 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 preskušanj (RESOLVE) niso pokazali učinkovitosti zdravila Xigris pri pediatričnih bolnikih s hudo sepso, akutno okužbo, sistemskim vnetjem in motenim delovanjem dihal in srčno-žilnih organov.
In ADDRESS, the percent of treated patients experiencing a serious bleeding event by site of haemorrhage was similar to that observed in PROWESS.
V preskušanju ADDRESS je bil delež zdravljenih bolnikov, ki so doživeli resno krvavitev, po mestu krvavitve podoben opažanju v preskušanju PROWESS.
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.
A Phase 3b international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (ADDRESS) of adult severe sepsis patients at low risk of death, involved 1317 drotrecogin alfa (activated)-treated and 1293 placebo-treated patients.
V mednarodnemu multicentričnemu randomiziranemu dvojno slepemu s placebom kontroliranemu kliničnemu preskušanju faze 3b (ADDRESS) odraslih bolnikov s hudo sepso z nizkim tveganjem za smrt je sodelovalo 1317 bolnikov, ki so prejemali drotrekogin alfa (aktiviran), in 1293 bolnikov, ki so prejemali placebo.
Excipients: sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid and sodium hydroxide.
Pomožne snovi: saharoza, natrijev klorid, natrijev citrat, citronska kislina, klorovodikova kislina in natrijev hidroksid.
1 CNS bleeding is defined as any bleed in the central nervous system including the following types of haemorrhage: Petechial, parenchymal, subarachnoid, subdural, and stroke with haemorrhagic transformation.
1Krvavitev 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.
If Xigris is readministered to patients, caution should be employed.
Če se odločimo za ponovno uporabo zdravila Xigris, moramo to storiti previdno.
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.
Important information about some of the ingredients of Xigris This medicinal product contains approximately 68 mg sodium per vial.
Pomembne informacije o nekaterih sestavinah zdravila Xigris To zdravilo vsebuje približno 68 mg natrija na vialo.
• Recent administration (within 7 days) of aspirin or other platelet inhibitors
• Uporaba aspirina ali drugih zaviralcev agregacije trombocitov v zadnjih 7 dnevih
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.
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.
Xigris is contraindicated in children below the age of 18 (see section 4.3 and 5.1).
Uporaba zdravila Xigris je pri otrocih, mlajših od 18 let, kontraindicirana (glejte poglavji 4.3 in 5.1).
Nasopharyngeal
Imunogenost
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).
Therefore the MAH has committed to performing a placebo-controlled study in patients (who were either on low-dose prophylactic heparin or not receiving any thrombosis prophylaxis) with severe sepsis and documented organ failure (e.g. MOD or vasopressor dependent septic shock) when treated within a strictly defined time window, to assert the benefit/risk profile of Xigris.”
Za zagotovitev profila koristi/tveganja za zdravilo Xigris, se je imetnik dovoljenja za promet zavezal k izvedbi s placebom kontrolirane študije pri bolnikih (ki so bodisi prejemali nizke odmerke profilaktičnega heparina ali niso prejemali nobene trombozne profilakse) s hudo sepso in dokazano odpovedjo organov (npr. MOD ali vazopresorsko odvisen septični šok) pri zdravljenju v strogo določenem časovnem obdobju.”
This medicinal product contains approximately 17 mg sodium per vial.
To zdravilo vsebuje približno 17 mg natrija na vialo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL TEXT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Excipient: Each vial contains approximately 17 mg sodium.
Pomožna snov: Vsaka viala vsebuje približno 17 mg natrija.
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: 3.3% vs 2.0%; ENHANCE: 5.0% vs 3.1% respectively.
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 % oziroma 2,0 %; ENHANCE: 5,0 % oziroma 3,1 %.
This medicinal product contains approximately 68 mg sodium per vial.
To zdravilo vsebuje približno 68 mg natrija na vialo.
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
Zdravila Xigris ne smete prejeti: - če ste alergični na (preobčutljivi za) drotrekogin alfa (aktiviran) ali katerokoli sestavino zdravila Xigris ali goveji trombin (beljakovino) - če ste mlajši od 18 let - če imate notranjo krvavitev - če imate možganski tumor ali tvorbo, ki pritiska na možgane - če sočasno prejemate heparin (≥ 15 Mednarodnih enot/kg/h) - če kažete nagnjenost h krvavitvam, ki niso povezane s sepso - če imate dolgotrajne hude težave z jetri - če je vaše število trombocitov (vrste celic v vaši krvi) nizko, tudi če je bilo povišano s transfuzijo - če je pri vas povečano tveganje za krvavitev (na primer): a) če so vam v zadnjih dvanajstih urah pred prejemanjem zdravila Xigris opravili operacijski poseg, če krvavite od predhodnega operacijskega posega ali bi lahko med prejemanjem zdravila Xigris potrebovali operacijo b) če ste bili v zadnjih treh mesecih v bolnišnici zaradi hude poškodbe glave, so vam operirali možgane ali hrbtenico, ste v zadnjih treh mesecih doživeli krvavitev v možgane
Excipient: Each vial contains approximately 68 mg sodium.
Pomožna snov: Vsaka viala vsebuje približno 68 mg natrija.
Skin/soft tissue
Genitourinarno Koža/mehka tkiva Nosnožrelno Sklep/kost Neznano mesto2
In the ADDRESS trial, serious bleeding events included any fatal bleed, any life-threatening bleed, any CNS bleed, or any bleeding event assessed as serious by the investigator.
V preskušanju ADDRESS so resne krvavitve vključevale kakršnokoli usodno krvavitev, kakršnokoli smrtno nevarno krvavitev, kakršnokoli krvavitev v osrednje živčevje ali kakršnokoli krvavitev, ki jo je kot resno ocenil preiskovalec.
Therefore, the patient should not breast feed whilst treated with Xigris.
Zato bolnice med zdravljenjem z zdravilom Xigris ne smejo dojiti.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ZUNANJI ŠKATLI
No significant death reduction was observed in the subgroup of patients with less than 2 acute organ dysfunctions at baseline.
V podskupini bolnikov z manj kot 2 akutnima okvarama delovanja organov ob izhodišču niso opažali značilnega zmanjšanja števila smrti.
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 se jih sme dajati po istem katetru, so 0,9 % raztopina natrijevega klorida, raztopina Ringerjevega laktata, raztopina dekstroze ali raztopina dekstroze in fiziološke raztopine.
A consistent treatment effect on mortality with Xigris administration was observed across patient subgroups defined by age, gender and infection type.
Učinek zdravila Xigris na umrljivost je bil enak, ne glede na starost bolnikov, spol ali vrsto okužbe.
In a Phase 3b international, single-arm, open-label clinical trial (ENHANCE), 2378 adult patients with severe sepsis received drotrecogin alfa (activated).
V mednarodnem kliničnem preskušanju (ENHANCE) faze 3b z enim krakom in znanim zdravilom je 2378 odraslih bolnikov s hudo sepso prejemalo drotrekogin alfa (aktiviran).
- The other ingredients are sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid
- Pomožne snovi so saharoza, natrijev klorid, natrijev citrat, citronska kislina, klorovodikova
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. Pri zdravih osebah tvorbe protiteles proti aktiviranemu proteinu C, tudi po večkratnem dajanju zdravila Xigris niso zaznali.
The solution of reconstituted Xigris must be further diluted with sterile 0.9% Sodium Chloride Injection.
Raztopino pripravljenega zdravila Xigris je treba nadalje razredčiti s sterilno 0,9 % raztopino natrijevega klorida.
After preparation, the intravenous infusion solution can be used at room temperature (15ºC - 30ºC) for a period up to 14 hours.
Po končni pripravi lahko raztopino za intravensko infuzijo pri sobni temperaturi (15 ºC - 30 ºC) uporabimo v obdobju do 14 ur.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, Nizozemska
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).
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, Nizozemska
After preparation, the intravenous infusion solution can be used at room temperature (15 to
Po končni pripravi lahko raztopino za intravensko infuzijo uporabite pri sobni temperaturi (med
Pack of 1 vial.
Prašek v viali stekla tipa I. Pakiranje po 1 vialo.
There is no known antidote for drotrecogin alfa (activated).
Za drotrekogin alfa (aktiviran) ni znanega antidota.
• Recent administration (within 3 days) of thrombolytic therapy
• Trombolitično zdravljenje v zadnjih 3 dnevih
Site of haemorrhage
Mesto krvavitve
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.
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 pharmacokinetics of drotrecogin alfa (activated) have not been studied in patients with severe sepsis and pre-existing end stage renal disease and chronic hepatic disease.
Farmakokinetike drotrekogina alfa (aktiviranega) pri bolnikih s hudo sepso in končno odpovedjo ledvic ali s kroničnim obolenjem jeter niso preučevali.
It limits thrombin formation by inactivating factors Va and VIIIa,
Z inaktiviranjem faktorjev Va in VIIIa omeji tvorbo trombina in tako omogoči uravnavanje koagulacije z negativno povratno zvezo.
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, doubleblind, 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 enega organa).
Keep the vial in the outer carton in order to protect from light.
Za zagotovitev zaščite pred svetlobo shranjujte vialo v zunanji škatli.
• Any other condition in which the physician considers significant bleeding is likely
• Ishemični cerebrovaskularni insult v zadnjih 3 mesecih • Katerokoli drugo stanje, pri katerem zdravnik meni, da je verjetna močnejša krvavitev
NAME OF THE MEDICINAL PRODUCT Xigris 20 mg powder for solution for infusion
IME ZDRAVILA Xigris 20 mg prašek za raztopino za infundiranje
Keep the vial in the carton in order to protect it from light.
Za zagotovitev zaščite pred svetlobo shranjujte vialo v škatli.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/225/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/225/001
MARKETING AUTHORISATION NUMBER(S) EU/1/02/225/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/225/002
Parenteral drug products should be inspected visually for particulate matter and discolouration
Pred dajanjem parenteralnih izdelkov jih je treba vizualno preveriti, da ne vsebujejo trdnih
Manufacturer: Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D- 35396 Giessen, Germany.
KG, Teichweg 3, D-35396 Giessen, Nemčija
NAME OF THE MEDICINAL PRODUCT Xigris 5 mg powder for solution for infusion
IME ZDRAVILA Xigris 5 mg prašek za raztopino za infundiranje
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.
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).
Heparin v nizkih odmerkih za profilakso VTE lahko dajemo sočasno z drotrekoginom alfa (aktiviranim).
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.
There have been no clinical trials in severe sepsis specifically studying drotrecogin alfa (activated) readministration.
Kliničnih preskušanj hude sepse, ki bi podrobno preučevala ponovno dajanje drotrekogin alfa (aktiviranega) ni bilo.
What Xigris contains - The active substance is 5 mg of drotrecogin alfa (activated) in each vial.
Kaj vsebuje zdravilo Xigris - Zdravilna učinkovina je 5 mg drotrekogina alfa (aktiviranega) v vsaki viali.
What Xigris contains - The active substance is 20 mg of drotrecogin alfa (activated) in each vial.
Kaj vsebuje zdravilo Xigris - Zdravilna učinkovina je 20 mg drotrekogina alfa (aktiviranega) v vsaki viali.
It is recommended that Xigris be infused with an infusion pump to accurately control the infusion rate.
Za natančen nadzor hitrosti infundiranja za infuzijo zdravila Xigris priporočamo uporabo infuzijske črpalke.
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 28dnevnem trajanju študije je bila 6 (0,5 %) oziroma 5 (0,4 %), pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), oziroma bolnikih, ki so prejemali placebo.
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 Xigris vial contains 20 mg of drotrecogin alfa (activated).
Vsaka viala zdravila Xigris vsebuje 20 mg drotrekogina alfa (aktiviranega).
A vial contains 5 mg of drotrecogin alfa (activated).
Viala vsebuje 5 mg drotrekogina alfa (aktiviranega).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 5 mg of Drotrecogin alfa (activated).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 5 mg drotrekogina alfa (aktiviranega).