natgillin/translations-raw huggingface dataset:
Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter.
Za dajanje infuzije uporabite sterilen, apirogen, 0,2-mikrometrski linijski ali dodatni filter z zmanjšano vezavo beljakovin.
• Increased muscle enzyme in the blood
• zvišana vrednost mišičnega encima v krvi
• Belly pain, back pain, joint pain
• bolečine v trebuhu, bolečine v hrbtu, bolečine v sklepih
• Muscle pain
• suha usta
Immune-related nephritis did not lead to discontinuation of avelumab in any patient.
Pri nobenem bolniku imunsko pogojeni nefritis ni povzročil prekinitve uporabe avelumaba.
• An infusion bag of appropriate size (preferably 250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection should be used.
9 mg/ml (0,9 %) raztopino za injiciranje ali natrijev klorid 4,5 mg/ml (0,45 %) raztopino za injiciranje.
Acute kidney injury
Pogosti akutna okvara ledvic
Reduce infusion rate by
intravenska uporaba po redčenju
Pneumonitis*
Pogosti pnevmonitis*
Intravenous use after dilution Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo!
Avelumab should be withheld for Grade 3 or Grade 4 thyroid disorders (see section 4.2).
Pri motnjah delovanja žleze ščitnice 3. stopnje ali 4. stopnje je treba uporabo avelumaba odložiti (glejte poglavje 4.2).
• Nausea, loose stools, constipation, vomiting
• siljenje na bruhanje, mehko blato, zaprtost, bruhanje
The median time to onset of thyroid disorders was 2.8 months (range: 2 weeks to 13 months).
Mediana časa do nastopa imunsko pogojenih motenj delovanja ščitnice je bila 2,8 meseca (razpon: 2 tedna do 13 mesecev).
In patients treated with avelumab in combination with axitinib, 2.7% (13/489) of patients developed immune-related colitis.
Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je imunsko pogojeni kolitis razvil pri 2,7 % (13/489) bolnikov.
• Information that avelumab can cause serious side effects during or after treatment, that need to be treated right away and warning message on the importance of being aware of signs and symptoms while receiving avelumab treatment
• Priporočilo, da je treba prebrati navodilo za uporabo • Informacijo, da lahko avelumab med zdravljenjem ali po njem povzroči resne neželene učinke,
In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojeni kolitis razvil pri 1,5 % (26/1.738) bolnikov.
Immune-related pneumonitis occurred in patients treated with avelumab.
Pri bolnikih, zdravljenih z avelumabom, se je pojavil imunsko pogojeni pnevmonitis.
Nausea, diarrhoea, constipation, vomiting, abdominal pain
Zelo pogosti navzea, diareja, zaprtje, bruhanje, bolečine v trebuhu
Pancreatitis*
Redki pankreatitis*
Avelumab should be withheld for Grade 2 immune-related hepatitis until resolution and permanently discontinued for Grade 3 or Grade 4 immune-related hepatitis (see section 4.2).
Pri imunsko pogojenem hepatitisu 2. stopnje je treba uporabo avelumaba odložiti, dokler pojav ne izzveni, pri imunsko pogojenem hepatitisu 3. stopnje ali 4. stopnje pa je treba zdravljenje trajno ukiniti (glejte poglavje 4.2).
Immune-related adrenal insufficiency did not lead to discontinuation of avelumab in any patient.
Pri nobenem bolniku imunsko pogojena insuficienca nadledvične žleze ni povzročila prekinitve uporabe avelumaba.
In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis.
Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je imunsko pogojeni pnevmonitis razvil pri 0,6 % (3/489) bolnikov.
Adrenal insufficiency
Insuficienca nadledvične žleze
Avelumab should be withheld for Grade 3 or Grade 4 symptomatic adrenal insufficiency (see section 4.2).
Pri simptomatski insuficienci nadledvične žleze 3. stopnje ali 4. stopnje je treba uporabo avelumaba odložiti (glejte poglavje 4.2).
Infusion-related reactions Grade 1 infusion-related reaction
Neželeni učinki 1. stopnje, povezani z infundiranjem
Patients received a median of 7 doses of avelumab (range: 1 dose to 95 doses), and the median duration of treatment was 17 weeks (range: 2 weeks to 208 weeks).
Mediana trajanja zdravljenja je bila 17 tednov (razpon: 2 tedna do 208 tednov).
This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland.
To je zelo pogosto za ščitnico, pogosto za nadledvični žlezi in občasno za hipofizo.
Avelumab should be withheld for Grade 2 or Grade 3 immune-related colitis until resolution, and permanently discontinued for Grade 4 or recurrent Grade 3 immune-related colitis (see section 4.2).
Pri imunsko pogojenem kolitisu 2. stopnje ali 3. stopnje je treba uporabo avelumaba odložiti, dokler pojav ne izzveni, medtem ko je treba pri imunsko pogojenem kolitisu 4. stopnje ali ponavljajočem imunsko pogojenem kolitisu 3. stopnje zdravljenje trajno ukiniti (glejte poglavje 4.2).
Hyperglycaemia
Pogosti hiperglikemija
Myositis*
Občasni miozitis*
Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis.
Dajanje avelumaba so prekinili pri 0,5 % (9/1.738) bolnikov zaradi imunsko pogojenega kolitisa.
Grade 3 or Grade 4 endocrinopathies Withhold until adverse reactions recover to
Endokrinopatije 3. ali 4. stopnje
Avelumab was discontinued in 0.2% (1/489) of patients due to immune-related thyroid disorders.
Dajanje avelumaba so prekinili pri 0,2 % (1/489) bolnikov zaradi imunsko pogojenih motenj delovanja ščitnice.
Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related adrenal insufficiency.
Dajanje avelumaba so prekinili pri 0,1 % (2/1.738) bolnikov zaradi imunsko pogojene insuficience nadledvične žleze.
• Signs of inflammation of the heart (myocarditis) may include trouble breathing, dizziness or fainting, fever, chest pain and chest tightness or flu like symptoms.
• Znaki vnetja srca (miokarditis) lahko vključujejo oteženo dihanje, omotico ali omedlevico,
Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency.
Od teh sta imela 2 (0,4 %) bolnika imunsko pogojeno insuficienco nadledvične žleze 3. stopnje.
Human IgG1 immunoglobulins are known to cross the placental barrier.
Znano je, da humani imunoglobulini IgG1 prehajajo skozi placento, zato avelumab morda prehaja iz matere v plod.
Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
Neželeni učinki, povezani z infundiranjem Pri bolnikih, ki so dobivali avelumab, so poročali o neželenih učinkih, povezanih z infundiranjem, ki so lahko hudi (glejte poglavje 4.8).
In patients treated with avelumab in combination with axitinib, Grades 3 and Grade 4 increased ALT and increased AST were reported in 9% and 7% of patients, respectively.
3. stopnje in 4. stopnje pri 9 % bolnikov in zvišanju AST 3. stopnje in 4. stopnje pri 7 % bolnikov.
Back pain, arthralgia
Zelo pogosti bolečine v hrbtu, artralgija
Rash, pruritus
Zelo pogosti izpuščaj, pruritus
Immune-related hepatitis occurred in patients treated with avelumab.
Pri bolnikih, zdravljenih z avelumabom, se je pojavil imunsko pogojeni hepatitis.
In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojena insuficienca nadledvične žleze razvila pri 0,5 % (8/1.738) bolnikov.
Of these patients, there were 3 (0.2%) patients with Grade 3 immune-related thyroid disorders.
Od teh so imeli 3 (0,2 %) bolniki imunsko pogojene motnje delovanja ščitnice 3. stopnje.
Other immune-related adverse reactions
Drugi imunsko pogojeni neželeni učinki
Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related nephritis.
Od teh sta imela 2 (0,4 %) bolnika imunsko pogojeni nefritis 3. stopnje.
bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever,
mrzlica ali tresenje, dvignjen izpuščaj ali kožni mehurčki, rdečina, nizek krvni tlak
Corticosteroids should be administered for immune-related myocarditis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Pri bolnikih z imunsko pogojenim miokarditisom je treba uporabiti kortikosteroide (začetni odmerek 1 do 2 mg/kg/dan prednizona ali enakovrednega zdravila, ki mu sledi postopno zmanjševanje kortikosteroidov).
• Increased pancreatic enzymes in the blood
• zvišana vrednost encimov trebušne slinavke v krvi
Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized
Pogosti pruritični izpuščaj, makulopapularni izpuščaj, generalizirani pruritus, akneiformni dermatitis, eritem, makularni izpuščaj, papularni izpuščaj,
• Decrease in the number of platelets in the blood
• zmanjšano število trombocitov v krvi
Hepatotoxicity (in combination with axitinib)
Prilagoditev zdravljenja pri uporabi zdravila Bavencio v kombinaciji z aksitinibom
< 1/1,000); very rare (< 1/10,000).
zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je imunsko pogojena insuficienca nadledvične žleze razvila pri 1,8 % (9/489) bolnikov.
Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related thyroid disorders.
Dajanje avelumaba so prekinili pri 0,1 % (2/1.738) bolnikov zaradi imunsko pogojenih motenj delovanja ščitnice.
• Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
• Guillain-Barréjev sindrom (motnja imunskega sistema, ki povzroča vnetje živcev in lahko povzroči bolečine, odrevenelost, mišično oslabelost in težave pri hoji) Iz kliničnih preskušanj z avelumabom v kombinaciji z aksitinibom so poročali o naslednjih neželenih učinkih: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Hepatic impairment
Bolezni sečil
Do not freeze or shake the diluted solution.
Razredčene raztopine ne zamrzujte in ne stresajte.
Corticosteroids should be administered for Grade ≥ 2 events (initial dose 1 to 2 mg/kg/day prednisone or equivalent, followed by a corticosteroid taper).
Pri dogodkih stopnje ≥ 2 je treba uporabiti kortikosteroide (začetni odmerek 1 do 2 mg/kg/dan prednizona ali enakovrednega zdravila, kateremu sledi postopno zmanjševanje kortikosteroida).
Infusion related reaction
Zelo pogosti reakcije, povezane z infundiranjem
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
Arthralgia, back pain, myalgia
Zelo pogosti artralgija, bolečine v hrbtu, mialgija
Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Pri dogodkih stopnje ≥ 2 je treba uporabiti kortikosteroide (začetni odmerek 1 do 2 mg/kg/dan prednizona ali enakovrednega zdravila, ki mu sledi postopno zmanjševanje kortikosteroida).
• Swelling in the arms, feet or legs
• oteklina rok, stopal ali nog
• Swelling in the arms, feet or legs • Weight loss, feeling less hungry
• izguba telesne mase, zmanjšan občutek lakote
Clinical efficacy and safety
UČINKOVITO UPORABO ZDRAVILA
Grade 0-1
Hitrost infundiranja zmanjšajte za 50 %
For patients with Grade 2 infusion-related reactions, the infusion should be temporary discontinued until Grade 1 or resolved, then the infusion will restart with a 50% slower infusion rate (see section 4.2).
1. stopnjo ali izzvenijo, nato pa z infundiranjem nadaljevati s 50 % počasnejšo hitrostjo infundiranja (glejte poglavje 4.2).
Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2).
3. stopnje ali 4. stopnje je treba uporabo avelumaba odložiti, dokler pojavi ne izzvenijo (glejte poglavje 4.2).
• Skin rash, itching
• kožni izpuščaj, srbenje
Adverse reactions Respiratory, thoracic and mediastinal disorders
nekrotizirajoči pankreatitis Bolezni jeter, žolčnika in žolčevodov
Sodium content
SEZNAM POMOŽNIH SNOVI
Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related thyroid disorders.
Od teh sta imela 2 (0,4 %) bolnika imunsko pogojene motnje delovanja ščitnice 3. stopnje.
If you are breast-feeding, tell your doctor.
Povejte zdravniku, če dojite.
• Increased glucose in the blood
• zmanjšan krvni tlak • zvišana vrednost glukoze v krvi
Thyroid disorders
zvišanje transaminaz
Immune-related colitis
Imunsko pogojeni kolitis
Disposal
Odmerjanje
Pharmaceutical Form Route of administration Packaging
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
However the reasons for this difference are unknown and could be related to other factors.
Vendar so razlogi za to razliko neznani in so lahko povezani z drugimi dejavniki.
Some people will die from this illness.
Nekateri ljudje lahko zaradi te bolezni umrejo.
In the majority of cases, no reactions have been observed.
V večini primerov niso opažali nobenih reakcij.
Therefore, the potential risk for humans is unknown.
Zato možno tveganje za človeka ni znano.
• At the request of the EMEA
• na zahtevo EMEA-e
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.
3 years
3 leta.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2002.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. avgust 2002.
EXP {MM/YYYY}
EXP {MM/LLLL}
Risk Management Plan
Načrt za obvladovanje tveganja
• Active internal bleeding
• Aktivna notranja krvavitev
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
• ko so znane nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja
If you are pregnant your doctor will only give you Xigris if necessary.
Če ste noseči, vam bo vaš zdravnik dal zdravilo Xigris samo, če bo to nujno potrebno.
Drotrecogin alfa
Drotrekogin alfa
Please remember that you cannot take Xigris by yourself because both your illness and the use of this medicine need constant medical care.
Prosimo, zapomnite si, da zdravila Xigris ne morete jemati sami, ker tako vaša bolezen kot tudi uporaba tega zdravila zahtevata stalno zdravstveno oskrbo.
These can block the blood supply to important parts of your body such as the kidneys and lungs.
Ti lahko ovirajo oskrbo s krvjo pomembnih delov vašega telesa, kot so ledvice in pljuča.
New Hampshire 03801-2815 USA
New Hampshire 03801-2815 ZDA
The interpretation of sequential determinations of the PT and/or APTT should take these variables into consideration.
Pri interpretaciji zaporednih določanj PT in/ali APTT moramo upoštevati vse omenjene dejavnike.
- If you have any further questions, please ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
(The APACHE II score is designed to assess the risk of mortality based on acute physiology and chronic health evaluation).
(Število točk po APACHE II je zasnovano kot ocena tveganja za umrljivost na podlagi vrednotenja akutne fiziologije in kroničnega zdravja (acute physiology and chronic health evaluation)).
This means that for scientific reasons it has been impossible to get complete information on this medicine.
To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Additionally there was no increased risk of serious bleeding, including central nervous system (CNS) bleeding.
Poleg tega ni bilo povečanega tveganja za resno krvavitev, vključno s krvavitvijo v centralnem živčnem sistemu (CŽS).
This liquid is then passed from a bag through a tube into one of your veins for a period of 96 hours.
Ta tekočina nato po cevki prehaja iz vrečke v eno od vaših ven v obdobju 96 ur.
After reconstitution, immediate use is recommended.
Po raztapljanju priporočamo takojšnjo uporabo.
This causes an illness called severe sepsis which can make you very ill.
To povzroči bolezen, imenovano huda sepsa, zaradi katere lahko resno zbolite.
No further study has confirmed the efficacy results of the single pivotal trial.
Nobena nadaljnja študija ni potrdila učinkovitosti rezultatov posameznega ključnega preskušanja.
PROWESS Follow-up Study
PROWESS kontrolna študija
• Patients with intracranial pathology; neoplasm or evidence of cerebral herniation
• Bolniki z intrakranialnim obolenjem; novotvorbo ali znaki herniacije možganov
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 %.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
This protein helps to control blood clotting and inflammation.
Ta beljakovina pomaga nadzorovati strjevanje krvi in vnetje.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini, mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
Pharmacotherapeutic group: antithrombotic agents, enzymes, ATC code: B01AD10
Farmakoterapevtska skupina: Antitrombotiki, encimi, Oznaka ATC: B01AD10
Do not transport the infusion bag between locations using mechanical delivery systems.
Ne prenašajte infuzijske vrečke med lokacijami z mehanskimi sistemi za dostavo.
Further Clinical Experience
Nadaljnje klinične izkušnje
Xigris is very similar to a protein that occurs naturally in your blood.
Zdravilo Xigris je zelo podobno beljakovini, ki se naravno pojavlja v vaši krvi.
However, the possibility of allergic reactions to constituents of the preparation cannot be completely excluded in certain predisposed patients.
Vendar pa možnosti alergijskih reakcij na sestavine pripravka pri nekaterih bolnikih z nagnjenostjo ne moremo povsem izključiti.
The mortality rate was lower for patients treated within 24 hours of organ dysfunction compared to those treated after 24 hours, even after adjustment for differences in disease severity.
Stopnja umrljivosti je bila nižja pri bolnikih, zdravljenih v roku 24 ur od motenega delovanja organov v primerjavi s tistimi, ki so zdravilo prejeli po 24 urah, tudi po prilagoditvi glede razlik v resnosti bolezni.
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.
The Marketing Authorisation Holder will continue to submit yearly PSURs.
Imetnik dovoljenja za promet bo nadalje predajal letne PSUR-je.
Drotrecogin alfa (activated) [ENHANCE] N=2378
Drotrekogin alfa (aktiviran) [ENHANCE] N=2378
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja)
Xigris should not be used during pregnancy unless clearly necessary.
Zdravila Xigris med nosečnostjo ne smemo uporabljati, razen če to ni neobhodno potrebno.
In case of overdose, immediately stop the infusion (see section 5.2).
Ob prevelikem odmerjanju nemudoma ustavite infuzijo (glejte poglavje 5.2).
Activated Protein C is a crucial coagulation regulator.
Aktivirani protein C je ključni regulator koagulacije.
• Known bleeding diathesis except for acute coagulopathy related to sepsis
• Znana nagnjenost h krvavitvam z izjemo akutne koagulopatije, povezane s sepso
No hypersensitivity reactions were reported in these patients.
Pri teh bolnikih niso poročali o nobenih preobčutljivostnih reakcijah.
To be taken into consideration by patients on a controlled sodium diet.
To je potrebno upoštevati pri bolnikih z nadzorovano dieto natrija.
It is recommended that the bag be labelled accordingly.
Priporočamo ustrezno označevanje vrečke.
“Further to uncertain conclusions of the XPRESS study investigating the possible interaction between Xigris and heparin, additional clarifications on the benefit/risk balance of Xigris are required.
“Poleg nejasnih zaključkov študije XPRESS, ki raziskuje možne interakcije med zdravilom Xigris in heparinom, so potrebna dodatna pojasnila glede razmerja med koristmi in tveganji za zdravilo Xigris.
Using other medicines:
Uporaba drugih zdravil
• Concurrent heparin therapy ≥ 15 International Units/kg/hr
• Sočasno zdravljenje s heparinom ≥ 15 mednarodnih enot/kg/h
Calculate the dose and the number of Xigris vials needed.
Izračunajte odmerek in število potrebnih vial zdravila Xigris.
• Platelet count < 30,000 x 106/l, even if the platelet count is increased after transfusions
• Število trombocitov < 30.000 x 106/l, tudi če je število trombocitov povišano po transfuzijah
(activated) is a version of a natural protein in the blood called Activated Protein C and it is
(aktiviran) je različica naravne beljakovine v krvi, imenovane aktivirani protein C, ki jo
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja koristi/tveganj.
The difference in the incidence of serious bleeding events between the two treatment groups occurred primarily during study drug administration.
Razlika v incidenci resnih krvavitev med obema skupinama zdravljenja se je pojavila predvsem med dajanjem študijskega zdravila.
Furthermore, Activated Protein C is an important modulator of the systemic response to infection and has antithrombotic and profibrinolytic properties.
Nadalje je aktivirani protein C pomemben modulator sistemskega odziva na okužbo in ima antitrombotične in profibrinolitične lastnosti.
This trial was stopped for futility after 477 patients had received the study drug (out of 600 patients intended).
Preskušanje so zaradi neuspešnosti prekinili, potem, ko je študijsko zdravilo prejelo 477 bolnikov (od predvidenih 600 bolnikov).
When your body has a severe infection, clots can form in your blood.
Kadar ste zboleli za hudo okužbo, se lahko v krvi tvorijo strdki.
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 nujno potrebno (glejte poglavje 4.6).
It is not known whether drotrecogin alfa (activated) causes damage to an unborn child or affects your ability to have babies.
Ni znano, ali drotrekogin alfa (aktiviran) škodi nerojenemu otroku ali vpliva na vašo zmožnost imeti otroke.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Serious bleeding events during the infusion period
Resne krvavitve v času infundiranja
The entry criteria were similar to those employed in PROWESS.
Merila za vključitev so bila podobna kot v študiji PROWESS.
Mechanism of Action
Mehanizem delovanja