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posledično na ljudeh intravaskularne farmakokinetične študije niso bile izvedene.
as a consequence, intravascular pharmacokinetic studies were not performed in man.

zaradi tega intravaskularne farmakokinetične študije pri ljudeh niso bile opravljene.
as a consequence, intravascular pharmacokinetic studies were not performed in man.

poročali so o primerih diseminirane intravaskularne koagulacije, običajno v povezavi z nevtropenijo in/ali sepso.
cases of disseminated intravascular coagulation have been reported, typically in association with neutropenia and/or sepsis.

pri bolnikih, ki prekinejo zdravljenje z zdravilom soliris, je treba nadzirati znake in simptome resne intravaskularne hemolize.
patients who discontinue treatment with soliris should be monitored for signs and symptoms of serious intravascular haemolysis.

pri vseh bolnikih je bilo ohranjeno zmanjšanje intravaskularne hemolize v celotnem obdobju izpostavljenosti zdravilu soliris, trajajočem od 10 do 54 mesecev.
all patients sustained a reduction in intravascular haemolysis over a total soliris exposure time ranging from 10 to 54 months.

pojavili so se posamični primeri ledvične disfunkcije/ledvične odpovedi ali diseminirane intravaskularne koagulacije in smrti, povezani s hemolizo.
isolated cases of haemolysis-related renal dysfunction/renal failure or disseminated intravascular coagulation and death have occurred.

Čeprav zdravilo benefix vsebuje samo faktor ix, se moramo zavedati tveganja tromboze in diseminirane intravaskularne koagulacije (dic).
although benefix contains only factor ix, the risk of thrombosis and disseminated intravascular coagulation (dic) should be recognised.

pri bolnikih s pnh je treba spremljati znake in simptome intravaskularne hemolize, vključno z ravnmi serumske laktat dehidrogenaze (ldh).
pnh patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (ldh) levels.

koncentracije ekulizumaba v serumu približno 35 mikrogramov/ ml zadoščajo za dejansko popolno zavrtje intravaskularne hemolize, pogojene s terminalnim komplementom, pri večini bolnikov s pnh.
eculizumab serum concentrations of approximately 35 microgram/ml are sufficient for essentially complete inhibition of terminal complement-mediated intravascular haemolysis in most pnh patients.

doseženo je bilo trajno zmanjšanje intravaskularne hemolize, merjene z ravnjo ldh v serumu, v času zdravljenja, kar je privedlo do povečane nepotrebnosti transfuzije, zmanjšanja potrebe po transfuziji eritrocitov in zmanjšanja utrujenosti.
a reduction in intravascular haemolysis as measured by serum ldh levels was sustained for the treatment period and resulted in increased transfusion avoidance, a reduced need for rbc transfusion and less fatigue.

v patoloških stanjih, pri katerih je lahko tkivni faktor izražen znatneje kot normalno, obstaja med zdravljenjem z zdravilom novoseven možno tveganje za trombotične dogodke ali indukcije diseminirane intravaskularne koagulacije (dik).
in pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of disseminated intravascular coagulation (dic) in association with novoseven treatment.

bolnike s pnh, ki prejemajo zdravilo soliris, je treba podobno nadzirati glede intravaskularne hemolize z merjenjem ravni ldh ter po potrebi prilagoditi odmerek v okviru priporočene sheme odmerjanja 14+/-2 dni med fazo vzdrževanja (največ vsakih 12 dni).
pnh patients receiving soliris therapy should be similarly monitored for intravascular haemolysis by measuring ldh levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every