natgillin/translations-raw huggingface dataset:
• Discard any unused portion left in a vial as the medicinal product contains no preservatives. 
• Neuporabljene ostanke v viali zavrzite, saj zdravilo ne vsebuje konzervansov.
Supplemental dosing is recommended when Soliris is administered to aHUS patients receiving plasma infusion or exchange (see section 4.2). 
Priporočeni so dodatni odmerki, kadar zdravilo Soliris dajemo bolnikom z aHUS, ki prejemajo infuzijo plazme ali imajo izmenjavo plazme (glejte poglavje 4.2).
Ensure that your current meningococcal vaccination is up to date. 
Prepričajte se, da je vaše cepljenje proti meningokokni okužbi še učinkovito.
One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml). 
Ena 30 ml viala vsebuje 300 mg ekulizumaba (10 mg/ml).
The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National Competent Authority and must implement such programmes nationally to ensure that: 
Imetnik dovoljenja za promet z zdravilom mora s pristojnimi nacionalnimi organi uskladiti podrobnosti nadzorovanega sistema distribucije zdravila in izobraževalnega gradiva, vključno z opozorilnimi karticami za bolnika, ter na nacionalni ravni izvesti programe, ki bodo zagotovili, da:
Driving and using machines Soliris has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Soliris nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The MAH shall send annually to prescribers or pharmacists who prescribe/dispense eculizumab, a reminder in order that prescriber/pharmacist checks if a (re)-vaccination against Neisseria meningitidis is needed for his/her patients on eculizumab. 
Imetnik dovoljenja za promet z zdravilom mora zdravnikom, ki predpisujejo zdravilo, ali farmacevtom, ki izdajajo ekulizumab, pošiljati letne opomnike z namenom, da bo zdravnik, ki zdravilo predpisuje/farmacevt preveril, ali obstaja potreba po cepljenju/ponovnem cepljenju proti bakteriji Neisseria meningitidis svojih bolnikov, ki se zdravijo z ekulizumabom.
A significant effect on the time to first adjudicated On-trial Relapse was observed for eculizumab compared with placebo (relative risk reduction 94%; hazard ratio 0.058; p<0.0001) (Figure 2). 
Značilen vpliv na čas do prvega recidiva med preskušanjem po presoji strokovnega odbora so opazili za ekulizumab v primerjavi s placebom (relativno zmanjšanje tveganja 94 %; razmerje tveganja 0,058; p<0,0001) (slika 2).
Soliris should only be administered via intravenous infusion as described below. 
Zdravilo Soliris se sme dajati izključno v obliki intravenske infuzije, kot je opisano v nadaljevanju.
In Study ECU-NMO-301, patients with NMOSD with a positive serologic test for anti-AQP4 antibodies, a history of at least 2 relapses in last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to screening and an Expanded Disability Status Scale (EDSS) score ≤ 7, were randomized 2:1 to either Soliris (n = 96) or placebo (n = 47). 
V študiji ECU-NMO-301 so bolnike z NMOSD s pozitivnim serološkim testom za protitelesa proti AQP4, anamnezo vsaj 2 recidivov v zadnjih 12 mesecih ali 3 recidivov v zadnjih 24 mesecih z vsaj enim recidivom v 12 mesecih pred presejanjem in rezultatom razširjene lestvice stanja invalidnosti (Expanded Disability Status Scale - EDSS) ≤ 7, randomizirali v razmerju 2:1, bodisi na zdravilo Soliris (n = 96) ali placebo (n = 47).
When treatment was continued for more than 26 weeks, six additional patients achieved and maintained Complete TMA response due to a decrease in serum creatinine. 
Ko so zdravljenje nadaljevali po 26. tednu, je še šest dodatnih bolnikov doseglo in vzdrževalo popoln TMA odgovor zaradi znižanja serumskega kreatinina.
When treatment was continued for more than 26 weeks, two additional patients achieved and maintained Complete TMA response due to normalization of LDH (1 patient) and a decrease in serum creatinine (2 patients). 
Ko so zdravljenje nadaljevali po 26. tednu, sta še dva dodatna bolnika dosegla in vzdrževala popoln TMA odgovor zaradi normalizacije LDH (1 bolnik) in znižanja serumskega kreatinina (2 bolnika).
In patients with NMOSD, uncontrolled terminal complement activation caused by autoantibodies against AQP4 leads to the formation of the MAC and C5a-dependent inflammation which results in astrocyte necrosis and increased permeability of the blood brain barrier, as well as death of the surrounding oligodendrocytes and neurons. 
Pri bolnikih z NMOSD neobvladovana aktivacija terminalnega komplementa, ki jo povzročijo avtoprotitelesa proti AQP4, povzroči nastajanje MAC in od C5a odvisnega vnetja, ki povzroči nekrozo astrocitov in zvečano permeabilnost krvno-možganske pregrade, pa tudi smrt okolnih oligodendrocitov in nevronov.
In 40 patients with PNH, a 1-compartmental model was used to estimate pharmacokinetic parameters after multiple doses. 
Pri 40 bolnikih s PNH je bil za oceno farmakokinetičnih parametrov po več odmerkih uporabljen enorazdelčni model.
PNH patients were also treated with Soliris in a single arm 52 week study (C04-002), and in a long term extension study (E05-001). 
so bili z zdravilom Soliris zdravljeni tudi v okviru 52-tedenske študije z enim krakom (C04-002) ter v okviru dolgoročne podaljšane študije (E05-001).
Table 14: Efficacy Outcomes in Paediatric PNH Study M07-005 
Preglednica 14: Izidi učinkovitosti v pediatrični študiji PNH M07-005
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections, and strictly need to adhere to the national vaccination recommendations for each age group. 
Bolniki, mlajši od 18 let, morajo biti cepljeni proti Haemophilus influenzae in proti pnevmokoknim okužbam in dosledno upoštevati nacionalna priporočila glede cepljenja za vsako starostno skupino.
Soliris should be prepared for administration by a qualified healthcare professional using aseptic technique. 
Zdravilo Soliris mora z aseptično tehniko za uporabo pripraviti strokovno usposobljen zdravstveni delavec.
<12 years (n=15) 
< 12 let (n = 15)
Soliris contains sodium 
Zdravilo Soliris vsebuje natrij
Abbreviations: CI = confidence interval; EDSS = Expanded Disability Status Scale; IST = immunosuppressive therapy 
Okrajšave: IZ = interval zaupanja; EDSS = razširjena lestvica stanja invalidnosti (Expanded Disability Status
Abbreviations: ARR = annualized relapse rate; CI = confidence interval. 
Okrajšave: ARR = pogostnost recidiva, preračunana na eno leto (annualized relapse rate); IZ = interval zaupanja.
Study ECU-MG-301 (REGAIN) was a 26-week double-blind, randomized, placebo-controlled, multicenter Phase 3 study of Soliris in patients who had failed previous therapies and remain symptomatic. 
Študija ECU-MG-301 (REGAIN) je bila 26-tedenska dvojno slepa, randomizirana, s placebom kontrolirana multicentrična študija zdravila Soliris 3. faze pri bolnikih, pri katerih so bile prejšnje terapije neuspešne in so ostali simptomatski.
Fifteen severe thrombotic microangiopathy (TMA) complications in 12 patients were observed following treatment discontinuation, and 2 severe TMA complications occurred in an additional 2 patients that received a reduced dosing regimen of Soliris outside of the approved dosing regimen (See Section 4.2). 
Po prekinitvi zdravljenja so opazili petnajst hudih zapletov trombotične mikroangiopatije (TMA) pri 12 bolnikih, 2 huda zapleta TMA pa sta se pojavila pri še dveh bolnikih, ki sta prejela shemo zmanjšanega odmerjanja zdravila Soliris zunaj odobrene sheme odmerjanja (glejte poglavje 4.2).
Mean Hgb level (g/dL) at setpoint (SD) 
Povprečna raven Hb (g/dl) v nastavitveni točki
5.3 Preclinical safety data The specificity of eculizumab for C5 in human serum was evaluated in two in vitro studies. 
Specifičnost ekulizumaba za C5 v humanem serumu so preučevali v okviru dveh študij in vitro.
Reduction in terminal complement activity was observed in all patients after commencement of Soliris. 
Znižanje aktivnosti terminalnega komplementa so opazili pri vseh bolnikih po začetku zdravljenja z zdravilom Soliris.
• hives, redness of the skin, dry skin, red or purple spots under the skin, increased sweating 
• koprivnica, rdečina kože, suha koža, rdeči ali vijolični podkožni madeži, povečano potenje,
Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description). 
Zdravniki se morajo z bolniki pogovoriti o koristih in tveganjih zdravljenja z zdravilom Soliris in jim predložiti brošuro z informacijami za bolnike in opozorilno kartico za bolnika (opis najdete v navodilih za uporabo).
• Transfer the recommended dose to an infusion bag. 
• Priporočeni odmerek prenesite v infuzijsko vrečko.
<2 years (n=5) 
< 2 leti (n = 5)
ECU-MG-302 
in ECU-MG-302
Eculizumab, the active ingredient in Soliris, is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. 
Ekulizumab, učinkovina zdravila Soliris, je zaviralec terminalnega komplementa, ki se specifično veže na beljakovino komplementa C5 z visoko afiniteto in s tem zavira njeno cepitev na C5a in C5b ter preprečuje nastanek terminalnega kompleksa komplementa C5b-9.
Your doctor will want to monitor you closely. 
Zdravnik bo želel podrobneje spremljati vaše stanje.
Study ECU-NMO-301 was a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study of Soliris in patients with NMOSD. 
Študija ECU-NMO-301 je bila dvojno slepa, randomizirana, multicentrična, s placebo kontrolirana študija 3. faze zdravila Soliris pri bolnikih z NMOSD.
Longer term treatment with Soliris (median 55 weeks ranging from 1day to 107 weeks) was associated with an increased rate of clinically meaningful improvements in paediatric and adolescent patients with aHUS. 
Dolgotrajnejše zdravljenje z zdravilom Soliris (mediana 55 tednov, razpon od 1 dne do 107 tednov) je bilo povezano z zvečano pogostnostjo klinično pomembnih izboljšanj pri pediatričnih in mladostniških bolnikih z aHUS.
Other medicines and Soliris Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with Soliris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. 
Če je vaš otrok premlad za cepljenje oziroma če niste cepljeni vsaj 2 tedna pred začetkom zdravljenja z zdravilom Soliris, vam bo vaš zdravnik predpisal antibiotike za zmanjševanje tveganja okužbe, dokler ne mineta 2 tedna po cepljenju.
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. 
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.
In PNH clinical studies, 16 patients discontinued the Soliris treatment regimen. 
V kliničnih študijah PNH je 16 bolnikov prekinilo shemo zdravljenja z zdravilom Soliris.
Meningococcal and other Neisseria infections alert Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhea. 
Opozorilo v zvezi z meningokoknimi okužbami in drugimi okužbami z bakterijami Neisseria Zdravljenje z zdravilom Soliris lahko zmanjša vašo naravno odpornost proti okužbam, še posebno proti določenim organizmom, ki povzročajo meningokokno okužbo (huda okužba možganskih ovojnic in sepsa) in druge okužbe z bakterijami Neisseria, vključno z diseminirano gonorejo.
The pharmacokinetics of eculizumab was evaluated in Study M07-005 in PNH paediatric patients (aged from 11 to less than 18 years) and in Studies C08-002, C08-003, C09-001r and C10-003 in aHUS pediatric patients (aged 2 months to less than 18 years) with body-weight based dose regimen. 
Farmakokinetika ekulizumaba je bila ocenjena v študiji M07-005 pri pediatričnih bolnikih s PNH (starih od 11 do manj kot 18 let) in v študijah C08-002, C08-003, C09-001r in C10-003 pri pediatričnih bolnikih z aHUS (starih od 2 meseca do manj kot 18 let) s shemo odmerjanja na podlagi telesne mase.
Soliris treatment is recommended to continue for the patient's lifetime, unless the discontinuation of Soliris is clinically indicated (see section 4.4). 
Priporočeno je, da se bolnik z zdravilom Soliris zdravi celo življenje, razen če je prekinitev zdravljenja z zdravilom Soliris klinično indicirana (glejte poglavje 4.4).
Soliris (eculizumab) has not been studied for the treatment of acute relapses in NMOSD patients. 
Zdravila Soliris (ekulizumaba) niso raziskovali za zdravljenje akutnih recidivov pri bolnikih z NMOSD.
Soliris contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies. 
Zdravilo Soliris vsebuje učinkovino ekulizumab in spada v skupino zdravil, imenovano monoklonska protitelesa.
In the PNH Registry, patients treated with Soliris were observed to have a reduction in haemolysis and associated symptoms. 
V registru PNH so pri bolnikih, zdravljenih z zdravilom Soliris, opazili zmanjšano hemolizo in manj povezanih simptomov.
NMOSD History Age at NMOSD Initial Clinical Presentation (years) 
Anamneza NMOSD Starost pri prvem kliničnem pojavljanju NMOSD (leta)
The efficacy of eculizumab treatment in paediatric PNH patients appears to be consistent with that observed in adult PNH patients enrolled in PNH pivotal Studies (C04-001 and C04-002) (Table 3 and 
Učinkovitost zdravljenja z ekulizumabom pri pediatričnih bolnikih s PNH se zdi skladna s tisto, ki so jo opazovali pri odraslih bolnikih s PNH, ki so bili vključeni v ključne študije PNH (C04-001 in C04-002) (preglednici 3 in 14).
Baseline characteristics are shown in Table 5. 
Izhodiščne značilnosti so prikazane v preglednici 5.
The key secondary endpoint was the change from baseline in the Quantitative MG Scoring System (QMG - a physician reported outcome measure validated in gMG) total score at Week 26. 
Ključni sekundarni opazovani dogodek je bila sprememba celotnega rezultata kvantitativnega sistema za ocenjevanje MG (Quantitative MG Scoring System ali QMG - merilo izida, o katerem poroča zdravnik, validirano pri gMG) od izhodišča do 26. tedna.
The steady state is achieved by 4 weeks using the PNH adult dosing regimen. 
Stanje dinamičnega ravnovesja se z uporabo sheme odmerjanja za odrasle s PNH doseže po 4 tednih.
Treatment discontinuation for NMOSD: 
Prekinitev zdravljenja pri bolnikih z NMOSD:
Figure 1: Mean changes from baseline in MG-ADL (1A) and QMG (1B) over Studies ECU-MG-301 and ECU-MG-302 
Slika 1: Povprečne spremembe MG-ADL (1A) in QMG (1B) od izhodišča v študijah ECU-MG-301
Furthermore, 74% of the patients without a history of transfusion and treated with Soliris experienced clinically meaningful improvements in FACIT-Fatigue score (i.e., increase by 4 points or more) and 84% in EORTC fatigue score (i.e., decrease by 10 points or more). 
Soliris opazilo klinično pomembno izboljšanje utrujenosti po lestvici FACIT (t.j., zvišanje za 4 točke ali več) in 84 % po lestvici EORTC (t.j., znižanje za 10 točk ali več).
Despite Soliris re-initiation following discontinuation, progression to end stage renal disease occurred in one patient. 
Kljub temu, da je bilo po prekinitvi zdravljenja z zdravilom Soliris zdravilo spet uvedeno, je pri enem bolniku bolezen napredovala v bolezen ledvic v končnem stadiju.
No paediatric patient required new dialysis during treatment with Soliris. 
Noben pediatrični bolnik ni potreboval nove dialize med zdravljenjem z zdravilom Soliris.
Administration of Soliris may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis), though immune system disorders within 48 hours of Soliris administration did not differ from placebo treatment in PNH, aHUS, refractory gMG, NMOSD and other studies conducted with Soliris. 
Aplikacija zdravila Soliris lahko privede do reakcije na infuzijo ali imunogenosti, ki lahko povzroči alergijske ali preobčutljivostne reakcije (vključno z anafilaksijo), čeprav se motnje imunskega sistema v 48 urah po uporabi zdravila Soliris pri študijah z bolniki s PNH, aHUS, refraktarno gMG, NMOSD
Table 16: Efficacy Outcomes in Paediatric Patients in Study C09-001r according to duration of current severe clinical thrombotic microangiopathy (TMA) manifestation Duration of current severe clinical TMA manifestation 
Preglednica 16: Rezultati učinkovitosti pri pediatričnih bolnikih v študiji C09-001r glede na trajanje nedavne resne manifestacije klinične trombotične mikroangiopatije (TMA)
The PNH registry (M07-001) was used to evaluate the efficacy of Soliris in PNH patients with no history of RBC transfusion. 
Register PNH (M07-001) so uporabili za oceno učinkovitosti zdravila Soliris pri bolnikih s PNH brez anamneze transfuzije eritrocitov.
From the 195 patients that originated in C04-001, C04-002 and other initial studies, Soliris-treated PNH patients were enrolled in a long term extension study (E05-001). 
Od 195 bolnikov iz študij C04-001 in C04-002 ter drugih izhodiščnih študij so bili tisti bolniki s PNH, ki so bili zdravljeni z zdravilom Soliris, vključeni v dolgoročno podaljšano študijo (E05-001).
Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections. 
Natrijev klorid, natrijev hidrogenfosfat, natrijev dihidrogenfosfat, polisorbat 80 in voda za injekcije.
Abnormal dreams, Sleep disorder 
nihanje razpoloženja nenormalne sanje, motnje spanja
Overall, the efficacy results for these paediatric patients appeared consistent with what was observed in patients enrolled in aHUS pivotal Studies C08-002 and C08-003 (Table 6). 
V celoti so bili rezultati učinkovitosti za te otroke konsistentni s tistimi, ki so jih opazovali pri bolnikih, ki so bili vključeni v ključne študije za aHUS, C08-002 in C08-003 (preglednica 6).
Compared to placebo-treated patients, Soliris-treated patients had reduced annualized rates of hospitalizations (0.04 for Soliris versus 0.31 for placebo), of intravenous corticosteroid administrations to treat acute relapses (0.07 for Soliris versus 0.42 for placebo), and of plasma exchange treatments (0.02 for Soliris versus 0.19 for placebo). 
V primerjavi z bolniki, zdravljenimi s placebom, so imeli bolniki, zdravljeni z ekulizumabom, zmanjšano pogostnost, preračunano na eno leto, hospitalizacij (0,04 za ekulizumab proti 0,31 za placebo), intravenskih aplikacij kortikosteroidov za zdravljenje akutnih recidivov (0,07 za ekulizumab proti 0,42 za placebo) in zdravljenj z izmenjavo plazme (0,02 za ekulizumab proti 0,19 za placebo).
Within 60 minutes after each plasmapheresis or plasma exchange 
Znotraj 60 minut po vsaki plazmaferezi ali izmenjavi plazme
Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids. 
Humana protitelesa se pretežno razgrajujejo v majhne peptide in aminokisline s pomočjo lizosomskih encimov.
After completion of the initial 26-week treatment period, most patients elected to continue on chronic dosing. 
Po dokončanju začetnega 26-tedenskega obdobja zdravljenja je večina bolnikov izbrala nadaljevanje zdravljenja s kroničnim odmerjanjem.
How to use Soliris 
Kako uporabljati zdravilo Soliris
The median duration of Soliris therapy was 16 weeks (range 4 to 70 weeks) for children < 2 years of age (n=5) and 31 weeks (range 19 to 63 weeks) for children 2 to <12 years of age (n=10). 
16 tednov (razpon od 4 do 70 tednov) v skupini otrok, starih manj kot 2 leti (n = 5), in 31 tednov (razpon od 19 do 63 tednov) v skupini otrok, starih od 2 do največ 12 let (n = 10).
Treatment Discontinuation for aHUS 
Prekinitev zdravljenja pri bolnikih z aHUS
If you use this medicine to treat aHUS, refractory gMG or NMOSD For adults: 
Če jemljete to zdravilo za zdravljenje aHUS, refraktarne gMG ali NMOSD
Atypical Haemolytic Uremic Syndrome 
Atipični hemolitično uremični sindrom
Population PK analysis on data collected across studies in PNH, aHUS, gMG and NMOSD patients showed gender, race, age (geriatric), or the presence of renal or hepatic impairment.function do not influence the PK of eculizumab. 
Populacijska FK analiza podatkov, zbranih v študijah bolnikov s PNH, aHUS, gMG in NMOSD, je pokazala, da spol, rasa, starost (geriatrična) ali prisotnost okvare funkcije ledvic ali jeter ne vplivajo na FK ekulizumaba.
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 12 days). 
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).
The posology of Soliris for PNH patients less than 40kg weight is based on the posology used for patients with aHUS and who weigh less than 40kg. 
Soliris za bolnike s PNH s telesno maso manj kot 40 kg temelji na odmerjanju, ki ga uporabljamo za bolnike z aHUS, ki tehtajo manj kot 40 kg.
Dedicated studies have not been conducted to evaluate the pharmacokinetics of Soliris in special patient populations identified by gender, race, age (geriatric), or the presence of renal or hepatic impairment. 
Posebne skupine bolnikov Namenskih študij za oceno farmakokinetike zdravila Soliris pri posebnih skupinah bolnikov na podlagi spola, rase, starosti (geriatrične) ali prisotnosti okvare ledvic ali jeter niso izvedli.
Transfer the recommended dose to an infusion bag. 
Priporočeni odmerek prenesite v infuzijsko vrečko.
College Business and Technology Park Blanchardstown 
College Business and Technology Park
The European Medicines Agency has deferred the obligation to submit the results of studies with Soliris in one or more subsets of the paediatric population in the treatment of refractory gMG (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Soliris za eno ali več podskupin pediatrične populacije pri zdravljenju refraktarne gMG (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In refractory gMG placebo-controlled studies, no antidrug antibodies were observed. 
V študijah refraktarne gMG, kontroliranih s placebom, niso ugotovili protiteles proti zdravilu.
The clearance and volume of distribution of Soliris are weight dependent, which forms the basis for a weight categorical based dose regimen in paediatric patients (see section 4.2). 
Očistek in porazdelitveni prostor zdravila Soliris sta odvisna od telesne mase, ki pri pediatričnih bolnikih predstavlja podlago za shemo odmerjanja na temelju kategorij telesne mase (glejte poglavje 4.2).
Haemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry. 
Hemolizo so nadzirali predvsem z merjenjem ravni LDH v serumu, delež eritrocitov PNH pa s pretočno citometrijo.
300 mg per infusion of fresh frozen plasma 
300 mg na infuzijo sveže zmrznjene plazme
Primary endpoints included platelet count change from baseline in study C08-002A/B and thrombotic microangiopathy (TMA) event-free status in study C08-003A/B. 
Primarna končna cilja sta vključevala spremembo števila trombocitov od izhodišča v študiji C08-002A/B in stanje brez dogodkov trombotične mikroangiopatije v študiji C08-003A/B.