FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 or Grade 4 endocrinopathies Withhold until adverse reactions recover to
Slovenian: Endokrinopatije 3. ali 4. stopnje
English: Avelumab was discontinued in 0.2% (1/489) of patients due to immune-related thyroid disorders.
Slovenian: Dajanje avelumaba so prekinili pri 0,2 % (1/489) bolnikov zaradi imunsko pogojenih motenj delovanja ščitnice.
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related adrenal insufficiency.
Slovenian: Dajanje avelumaba so prekinili pri 0,1 % (2/1.738) bolnikov zaradi imunsko pogojene insuficience nadledvične žleze.
English: • Signs of inflammation of the heart (myocarditis) may include trouble breathing, dizziness or fainting, fever, chest pain and chest tightness or flu like symptoms.
Slovenian: • Znaki vnetja srca (miokarditis) lahko vključujejo oteženo dihanje, omotico ali omedlevico,
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency.
Slovenian: Od teh sta imela 2 (0,4 %) bolnika imunsko pogojeno insuficienco nadledvične žleze 3. stopnje.
English: Human IgG1 immunoglobulins are known to cross the placental barrier.
Slovenian: Znano je, da humani imunoglobulini IgG1 prehajajo skozi placento, zato avelumab morda prehaja iz matere v plod.
English: Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
Slovenian: 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).
English: 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.
Slovenian: 3. stopnje in 4. stopnje pri 9 % bolnikov in zvišanju AST 3. stopnje in 4. stopnje pri 7 % bolnikov.
English: Back pain, arthralgia
Slovenian: Zelo pogosti bolečine v hrbtu, artralgija
English: Rash, pruritus
Slovenian: Zelo pogosti izpuščaj, pruritus
English: Immune-related hepatitis occurred in patients treated with avelumab.
Slovenian: Pri bolnikih, zdravljenih z avelumabom, se je pojavil imunsko pogojeni hepatitis.
English: In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
Slovenian: Pri bolnikih, zdravljenih z avelumabom v monoterapiji, se je imunsko pogojena insuficienca nadledvične žleze razvila pri 0,5 % (8/1.738) bolnikov.
English: Of these patients, there were 3 (0.2%) patients with Grade 3 immune-related thyroid disorders.
Slovenian: Od teh so imeli 3 (0,2 %) bolniki imunsko pogojene motnje delovanja ščitnice 3. stopnje.
English: Other immune-related adverse reactions
Slovenian: Drugi imunsko pogojeni neželeni učinki
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related nephritis.
Slovenian: Od teh sta imela 2 (0,4 %) bolnika imunsko pogojeni nefritis 3. stopnje.
English: bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever,
Slovenian: mrzlica ali tresenje, dvignjen izpuščaj ali kožni mehurčki, rdečina, nizek krvni tlak
English: 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).
Slovenian: 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).
English: • Increased pancreatic enzymes in the blood
Slovenian: • zvišana vrednost encimov trebušne slinavke v krvi
English: Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized
Slovenian: Pogosti pruritični izpuščaj, makulopapularni izpuščaj, generalizirani pruritus, akneiformni dermatitis, eritem, makularni izpuščaj, papularni izpuščaj,
English: • Decrease in the number of platelets in the blood
Slovenian: • zmanjšano število trombocitov v krvi
English: Hepatotoxicity (in combination with axitinib)
Slovenian: Prilagoditev zdravljenja pri uporabi zdravila Bavencio v kombinaciji z aksitinibom
English: < 1/1,000); very rare (< 1/10,000).
Slovenian: 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).
English: In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
Slovenian: Pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom, se je imunsko pogojena insuficienca nadledvične žleze razvila pri 1,8 % (9/489) bolnikov.
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related thyroid disorders.
Slovenian: Dajanje avelumaba so prekinili pri 0,1 % (2/1.738) bolnikov zaradi imunsko pogojenih motenj delovanja ščitnice.
English: • Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Slovenian: • 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)
English: Hepatic impairment
Slovenian: Bolezni sečil
English: Do not freeze or shake the diluted solution.
Slovenian: Razredčene raztopine ne zamrzujte in ne stresajte.
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose 1 to 2 mg/kg/day prednisone or equivalent, followed by a corticosteroid taper).
Slovenian: 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).
English: Infusion related reaction
Slovenian: Zelo pogosti reakcije, povezane z infundiranjem
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
English: Arthralgia, back pain, myalgia
Slovenian: Zelo pogosti artralgija, bolečine v hrbtu, mialgija
English: 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).
Slovenian: 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).
English: • Swelling in the arms, feet or legs
Slovenian: • oteklina rok, stopal ali nog
English: • Swelling in the arms, feet or legs • Weight loss, feeling less hungry
Slovenian: • izguba telesne mase, zmanjšan občutek lakote
English: Clinical efficacy and safety
Slovenian: UČINKOVITO UPORABO ZDRAVILA
English: Grade 0-1
Slovenian: Hitrost infundiranja zmanjšajte za 50 %
English: 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).
Slovenian: 1. stopnjo ali izzvenijo, nato pa z infundiranjem nadaljevati s 50 % počasnejšo hitrostjo infundiranja (glejte poglavje 4.2).
English: Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2).
Slovenian: 3. stopnje ali 4. stopnje je treba uporabo avelumaba odložiti, dokler pojavi ne izzvenijo (glejte poglavje 4.2).
English: • Skin rash, itching
Slovenian: • kožni izpuščaj, srbenje
English: Adverse reactions Respiratory, thoracic and mediastinal disorders
Slovenian: nekrotizirajoči pankreatitis Bolezni jeter, žolčnika in žolčevodov
English: Lymphopenia
Slovenian: Kolitis
English: Sodium content
Slovenian: SEZNAM POMOŽNIH SNOVI
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related thyroid disorders.
Slovenian: Od teh sta imela 2 (0,4 %) bolnika imunsko pogojene motnje delovanja ščitnice 3. stopnje.
English: If you are breast-feeding, tell your doctor.
Slovenian: Povejte zdravniku, če dojite.
English: • Increased glucose in the blood
Slovenian: • zmanjšan krvni tlak • zvišana vrednost glukoze v krvi
English: Thyroid disorders
Slovenian: zvišanje transaminaz
English: Immune-related colitis
Slovenian: Imunsko pogojeni kolitis
English: Disposal
Slovenian: Odmerjanje
English: Pharmaceutical Form Route of administration Packaging
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: However the reasons for this difference are unknown and could be related to other factors.
Slovenian: Vendar so razlogi za to razliko neznani in so lahko povezani z drugimi dejavniki.
English: Some people will die from this illness.
Slovenian: Nekateri ljudje lahko zaradi te bolezni umrejo.
English: In the majority of cases, no reactions have been observed.
Slovenian: V večini primerov niso opažali nobenih reakcij.
English: Therefore, the potential risk for humans is unknown.
Slovenian: Zato možno tveganje za človeka ni znano.
English: • At the request of the EMEA
Slovenian: • na zahtevo EMEA-e
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedeni v poglavju 6.6.
English: 3 years
Slovenian: 3 leta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2002.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. avgust 2002.
English: EXP {MM/YYYY}
Slovenian: EXP {MM/LLLL}
English: Risk Management Plan
Slovenian: Načrt za obvladovanje tveganja
English: • Active internal bleeding
Slovenian: • Aktivna notranja krvavitev
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • ko so znane nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja
English: If you are pregnant your doctor will only give you Xigris if necessary.
Slovenian: Če ste noseči, vam bo vaš zdravnik dal zdravilo Xigris samo, če bo to nujno potrebno.
English: Drotrecogin alfa
Slovenian: Drotrekogin alfa
English: Please remember that you cannot take Xigris by yourself because both your illness and the use of this medicine need constant medical care.
Slovenian: Prosimo, zapomnite si, da zdravila Xigris ne morete jemati sami, ker tako vaša bolezen kot tudi uporaba tega zdravila zahtevata stalno zdravstveno oskrbo.
English: These can block the blood supply to important parts of your body such as the kidneys and lungs.
Slovenian: Ti lahko ovirajo oskrbo s krvjo pomembnih delov vašega telesa, kot so ledvice in pljuča.
English: New Hampshire 03801-2815 USA
Slovenian: New Hampshire 03801-2815 ZDA
English: The interpretation of sequential determinations of the PT and/or APTT should take these variables into consideration.
Slovenian: Pri interpretaciji zaporednih določanj PT in/ali APTT moramo upoštevati vse omenjene dejavnike.
English: - If you have any further questions, please ask your doctor or your pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: (The APACHE II score is designed to assess the risk of mortality based on acute physiology and chronic health evaluation).
Slovenian: (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)).
English: This means that for scientific reasons it has been impossible to get complete information on this medicine.
Slovenian: To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: Additionally there was no increased risk of serious bleeding, including central nervous system (CNS) bleeding.
Slovenian: Poleg tega ni bilo povečanega tveganja za resno krvavitev, vključno s krvavitvijo v centralnem živčnem sistemu (CŽS).
English: This liquid is then passed from a bag through a tube into one of your veins for a period of 96 hours.
Slovenian: Ta tekočina nato po cevki prehaja iz vrečke v eno od vaših ven v obdobju 96 ur.
English: After reconstitution, immediate use is recommended.
Slovenian: Po raztapljanju priporočamo takojšnjo uporabo.
English: This causes an illness called severe sepsis which can make you very ill.
Slovenian: To povzroči bolezen, imenovano huda sepsa, zaradi katere lahko resno zbolite.
English: No further study has confirmed the efficacy results of the single pivotal trial.
Slovenian: Nobena nadaljnja študija ni potrdila učinkovitosti rezultatov posameznega ključnega preskušanja.
English: PROWESS Follow-up Study
Slovenian: PROWESS kontrolna študija
English: • Patients with intracranial pathology; neoplasm or evidence of cerebral herniation
Slovenian: • Bolniki z intrakranialnim obolenjem; novotvorbo ali znaki herniacije možganov
English: At 28 days, the mortality rate in the Phase 3b study was 25.3%.
Slovenian: Po 28 dnevih je bila stopnja umrljivosti v študiji faze 3b 25,3 %.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: This protein helps to control blood clotting and inflammation.
Slovenian: Ta beljakovina pomaga nadzorovati strjevanje krvi in vnetje.
English: 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).
Slovenian: 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).
English: Pharmacotherapeutic group: antithrombotic agents, enzymes, ATC code: B01AD10
Slovenian: Farmakoterapevtska skupina: Antitrombotiki, encimi, Oznaka ATC: B01AD10
English: Do not transport the infusion bag between locations using mechanical delivery systems.
Slovenian: Ne prenašajte infuzijske vrečke med lokacijami z mehanskimi sistemi za dostavo.
English: Further Clinical Experience
Slovenian: Nadaljnje klinične izkušnje
English: Xigris is very similar to a protein that occurs naturally in your blood.
Slovenian: Zdravilo Xigris je zelo podobno beljakovini, ki se naravno pojavlja v vaši krvi.
English: However, the possibility of allergic reactions to constituents of the preparation cannot be completely excluded in certain predisposed patients.
Slovenian: Vendar pa možnosti alergijskih reakcij na sestavine pripravka pri nekaterih bolnikih z nagnjenostjo ne moremo povsem izključiti.
English: 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.
Slovenian: 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.
English: Avoid exposing drotrecogin alfa (activated) solutions to heat and/or direct sunlight.
Slovenian: Izogibajte se izpostavljanju raztopin drotrekogina alfa (aktiviranega) vročini in/ali neposredni sončni svetlobi.
English: The Marketing Authorisation Holder will continue to submit yearly PSURs.
Slovenian: Imetnik dovoljenja za promet bo nadalje predajal letne PSUR-je.
English: Drotrecogin alfa (activated) [ENHANCE] N=2378
Slovenian: Drotrekogin alfa (aktiviran) [ENHANCE] N=2378
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja)
English: Xigris should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Xigris med nosečnostjo ne smemo uporabljati, razen če to ni neobhodno potrebno.
English: In case of overdose, immediately stop the infusion (see section 5.2).
Slovenian: Ob prevelikem odmerjanju nemudoma ustavite infuzijo (glejte poglavje 5.2).
English: Activated Protein C is a crucial coagulation regulator.
Slovenian: Aktivirani protein C je ključni regulator koagulacije.
English: • Known bleeding diathesis except for acute coagulopathy related to sepsis
Slovenian: • Znana nagnjenost h krvavitvam z izjemo akutne koagulopatije, povezane s sepso
English: No hypersensitivity reactions were reported in these patients.
Slovenian: Pri teh bolnikih niso poročali o nobenih preobčutljivostnih reakcijah.
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je potrebno upoštevati pri bolnikih z nadzorovano dieto natrija.
English: It is recommended that the bag be labelled accordingly.
Slovenian: Priporočamo ustrezno označevanje vrečke.
English: “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.
Slovenian: “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.
English: Using other medicines:
Slovenian: Uporaba drugih zdravil
English: • Concurrent heparin therapy ≥ 15 International Units/kg/hr
Slovenian: • Sočasno zdravljenje s heparinom ≥ 15 mednarodnih enot/kg/h
English: Calculate the dose and the number of Xigris vials needed.
Slovenian: Izračunajte odmerek in število potrebnih vial zdravila Xigris.
English: • Platelet count < 30,000 x 106/l, even if the platelet count is increased after transfusions
Slovenian: • Število trombocitov < 30.000 x 106/l, tudi če je število trombocitov povišano po transfuzijah
English: (activated) is a version of a natural protein in the blood called Activated Protein C and it is
Slovenian: (aktiviran) je različica naravne beljakovine v krvi, imenovane aktivirani protein C, ki jo
English: 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.
Slovenian: 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.
English: The difference in the incidence of serious bleeding events between the two treatment groups occurred primarily during study drug administration.
Slovenian: Razlika v incidenci resnih krvavitev med obema skupinama zdravljenja se je pojavila predvsem med dajanjem študijskega zdravila.
English: Furthermore, Activated Protein C is an important modulator of the systemic response to infection and has antithrombotic and profibrinolytic properties.
Slovenian: Nadalje je aktivirani protein C pomemben modulator sistemskega odziva na okužbo in ima antitrombotične in profibrinolitične lastnosti.
English: This trial was stopped for futility after 477 patients had received the study drug (out of 600 patients intended).
Slovenian: Preskušanje so zaradi neuspešnosti prekinili, potem, ko je študijsko zdravilo prejelo 477 bolnikov (od predvidenih 600 bolnikov).
English: When your body has a severe infection, clots can form in your blood.
Slovenian: Kadar ste zboleli za hudo okužbo, se lahko v krvi tvorijo strdki.
English: 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).
Slovenian: 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).
English: It is not known whether drotrecogin alfa (activated) causes damage to an unborn child or affects your ability to have babies.
Slovenian: Ni znano, ali drotrekogin alfa (aktiviran) škodi nerojenemu otroku ali vpliva na vašo zmožnost imeti otroke.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Serious bleeding events during the infusion period
Slovenian: Resne krvavitve v času infundiranja
English: The entry criteria were similar to those employed in PROWESS.
Slovenian: Merila za vključitev so bila podobna kot v študiji PROWESS.
English: Mechanism of Action
Slovenian: Mehanizem delovanja
English: Drotrecogin alfa (activated) increases the risk of bleeding.
Slovenian: Drotrekogin alfa (aktiviran) poveča tveganje za krvavitev.
English: Xigris helps your body to get rid of the clots and also reduces the inflammation caused by the infection.
Slovenian: Zdravilo Xigris pomaga vašemu telesu, da se znebi strdkov in zmanjša vnetje, ki ga povzroči okužba.
English: Bleeding risk should be taken into account when considering the risk benefit for individual patients.
Slovenian: Pri oceni tveganja in koristi za posameznega bolnika, je potrebno upoštevati tveganje za krvavitev.
English: This medicine has been authorised under “Exceptional Circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
English: In XPRESS serious bleeding rates were consistent with those observed in previous studies during the 28-day study period (days 0-28).
Slovenian: 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).
English: There was no statistical difference in the rates of VTE between study arms.
Slovenian: Med obema krakoma študije ni bilo statistične razlike v stopnjah VTE.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK
English: Due to these biological and analytical variables, the APTT should not be used to assess the pharmacodynamic effect of drotrecogin alfa (activated).
Slovenian: Zaradi teh bioloških in analitičnih spremenljivk APTT ne moremo uporabljati za vrednotenje farmakodinamičnega učinka drotrekogina alfa (aktiviranega).
English: Prophylactic heparin increased the risk of non-serious bleeding (see section 4.8).
Slovenian: Profilaktični heparin je povečal tveganje za neresno krvavitev (glejte poglavje 4.8).
English: Placebo rates in PROWESS 0.4% vs 1.2% respectively).
Slovenian: Placebo vrednosti v študiji PROWESS 0,4 % oziroma 1,2 %).
English: Xigris increases the risk of bleeding which can be serious or life-threatening.
Slovenian: Zdravilo Xigris povečuje nevarnost za krvavitev, ki je lahko resna ali smrtno nevarna.
English: 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).
Slovenian: 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).