natgillin/translations-raw huggingface dataset:
• unusual backflow of food from stomach, gum pain 
• neobičajno vračanje hrane iz želodca, boleče dlesni,
SEM= Standard Error of the Mean CI= Confidence Interval, MGC= Myasthenia Gravis Composite, MG-QoL15= Myasthenia Gravis Qualtiy of Life 15 
SEM = standardna napaka povprečja; IZ = interval zaupanja; MGC = kompozit miastenije gravis (Myasthenia Gravis Composite); MG-QoL-15 = kakovost življenja pri miasteniji gravis (Myasthenia Gravis Quality of Life
If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine. 
Če pri vas obstaja tveganje gonoreje, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction), 
• resna alergijska reakcija, ki lahko povzroči težko dihanje ali omotico (anafilaktična reakcija), preobčutljivost,
FACIT-Fatigue (effect size) * Results from study C04-002 refer to pre- versus post-treatment comparisons. 
Utrujenost po FACIT (velikost učinka) *Rezultati za študijo C04-002 se nanašajo na primerjavo stanja pred zdravljenjem s stanjem po zdravljenju.
Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the haemoglobin concentration (the "set-point") which would define each patient's haemoglobin stabilization and transfusion outcomes. 
Pred randomizacijo so bili vsi bolniki na uvodnem opazovanju, da bi tako lahko potrdili potrebo po transfuziji eritrocitov in ugotovili koncentracijo hemoglobina (»nastavitveno točko«), ki bi naj določila stabilizacijo hemoglobina pri posameznem bolniku ter izide transfuzij(e).
Soliris is not expected to affect the aplastic component of anaemia in patients with PNH. 
Ni pričakovati, da bi zdravilo Soliris vplivalo na aplastično komponento anemije pri bolnikih s PNH.
Thrombotic microangiopathy (TMA) complications have been observed as early as 4 weeks and up to 127 weeks following discontinuation of Soliris treatment in some patients. 
Zaplete trombotične mikroangiopatije (TMA) so pri nekaterih bolnikih opazili že 4 tedne in do 127 tednov po prekinitvi zdravljenja z zdravilom Soliris.
One hundred and eighteen (118) of the 125 (94%) patients completed the 26-week treatment period and 117 (94%) patients subsequently enrolled in Study ECU-MG-302, an open-label, multi-center long-term safety and efficacy extension study in which all patients received Soliris treatment. 
Sto osemnajst (118) od 125 (94 %) bolnikov je dokončalo 26-tedensko obdobje zdravljenja, 117 (94 %) bolnikov pa se je nato vključilo v študijo ECU-MG-302, odprto, multicentrično, dolgoročno podaljšano študijo varnosti in učinkovitosti, v kateri so vsi bolniki prejemali zdravljenje z zdravilom Soliris.
• kidney disorder, difficulties or pain when urinating (dysuria), blood in urine 
• bolezni ledvic, težave ali bolečine pri uriniranju (disurija), kri v urinu,
Vaccines against serogroups A, C, Y, W 135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. 
Cepiva proti seroskupinam A, C, Y, W 135 in B, kjer so na voljo, so priporočena pri preprečevanju pogosto patogenih meningokoknih seroskupin (glejte Meningokokna okužba).
• Diluted solution of Soliris may be stored at 2°C - 8°C for up to 24 hours prior to administration. 
• Razredčeno raztopino zdravila Soliris lahko hranite pri temperaturi 2 °C - 8 °C največ 24 ur pred uporabo.
• The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature. 
• Razredčene raztopine ne smete segrevati v mikrovalovni pečici ali z drugim virom toplote, ogreti se sme samo s toploto zraka pri temperaturi okolice.
The distribution of changes from Baseline to End of Study on other secondary endpoints favored eculizumab treatment over placebo across all neurologic disability (EDSS score [nominal p=0.0597] and mRS [nominal p=0.0154]), functional disability (HAI [nominal p=0.0002]) and quality of life (EQ-5D VAS [nominal p=0.0309] and EQ-5D Index [nominal p= 0.0077]) measures. 
Porazdelitev sprememb od izhodišča do konca študije v drugih sekundarnih opazovanih dogodkih je dajala prednost zdravljenju z ekulizumabom pred placebom v vseh merilih nevrološke invalidnosti (rezultat EDSS [nominalna p=0,0597] in mRS [nominalna p=0,0154]), funkcionalna invalidnost (HAI [nominalna p=0,0002]) in kakovost življenja (EQ-5D VAS [nominalna p=0,0309] in indeks EQ-5D [nominalna p= 0,0077]).
Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000) frequency with eculizumab, are listed by system organ class and preferred term. 
Neželeni učinki, o katerih so pri uporabi ekulizumaba poročali zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100) ali redko (≥ 1/10.000 do < 1/1.000), so navedeni glede na organski sistem in priporočeni izraz.
• ringing in the ears, vertigo 
• zvonjenje v ušesih, vrtoglavica,
The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase: 
Shema odmerjanja za PNH pri odraslih bolnikih (starih ≥18 let) je sestavljena iz 4-tedenske začetne faze, ki ji sledi faza vzdrževanja:
At the last evaluation, 25 of 41 patients (61%) achieved eGFR improvement of ≥ 15 mL/min/1.73 m2 from baseline. 
Pri zadnjem ocenjevanju je 25 od 41 bolnikov (61 %) doseglo izboljšanje eGFR za ≥ 15 ml/min/1,73 m2 od izhodišča.
Solvent: water for injections 
Topilo: voda za injekcije
When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the maximum recommended human Soliris dose, based on a body weight comparison); however, the exposure did not increase foetal loss or neonatal death. 
Pri izpostavitvi matere protitelesom v času organogeneze so opazili dva primera displazije retine in en primer umbilikalne hernije med 230 potomci, rojenimi materam, izpostavljenim večjim odmerkom protiteles (enakim približno štirikratniku največjega priporočenega odmerka zdravila Soliris za ljudi z ozirom na primerjavo telesne mase), vendar pa izpostavitev ni povečala izgube plodov ali neonatalne smrtnosti.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Nosečnost/dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
Patients were permitted to receive background immunosuppressant therapies at stable dose during the study, with the exclusion of rituximab and mitoxantrone. 
Bolnikom so dovolili, da so med študijo prejemali osnovne imunosupresivne terapije v stabilnih odmerkih, izključena sta bila rituksimab in mitoksantron.
Figure 2: Kaplan-Meier Survival Estimates for Time to First Adjudicated On-Trial Relapse - Full Analysis Set 
Slika 2: Ocene preživetja po Kaplan-Meierju za čas do prvega recidiva med preskušanjem po strokovni presoji - celotni nabor za analizo
Treatment with eculizumab at the proposed dosing regimen in the paediatric population was associated with a reduction of intravascular haemolysis as measured by serum LDH level. 
Zdravljenje z ekulizumabom ob predlaganem režimu odmerjanja pri pediatričnih bolnikih je bilo povezano z zmanjšanjem intravaskularne hemolize, kar je bilo izmerjeno z nivojem serumskega LDH.
Human IgG are known to cross the human placental barrier, and thus eculizumab may potentially cause terminal complement inhibition in the foetal circulation. 
Znano je, da človeški IgG prečkajo placentalno bariero pri človeku, zato bi ekulizumab morda lahko povzročil zaviranje terminalnega komplementa v krvnem obtoku ploda.
Because of the study sample size and duration, the effects of Soliris on thrombotic events could not be determined. 
Zaradi velikosti vzorca in trajanja študije ni bilo mogoče določiti vpliva zdravila Soliris na trombotične zaplete.
Prior to initiating Soliris therapy, it is recommended that PNH, aHUS, refractory gMG and NMOSD patients initiate immunizations according to current immunization guidelines. 
Pred začetkom zdravljenja z zdravilom Soliris je priporočljivo, da bolniki s PNH, aHUS, refraktarno gMG in NMOSD začnejo imunizacije v skladu z veljavnimi smernicami o imunizaciji.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALCI BIOLOŠKE E UČINKOVINE IN PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Treatment discontinuation for refractory gMG: 
Prekinitev zdravljenja pri bolnikih z refraktarno gMG:
• relatively few platelets in blood (thrombocytopenia), low level of lymphocytes a specific type of white blood cells (lymphopenia), feeling your heartbeat 
• relativno malo krvnih ploščic v krvi (trombocitopenija), nizko število limfocitov, posebne vrste belih krvnih celic (limfopenija), občutenje bitja srca,
It should be taken into consideration by patients on a controlled sodium diet. 
To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
60 minutes prior to each infusion of fresh frozen plasma 
60 minut pred vsako infuzijo sveže zmrznjene plazme
Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italy 
Patheon Italia S.p.A Viale G. B. Stucchi, 110
on Soliris compared with 19% on placebo (p=0.0018). 
pri placebu pa 19 % (p = 0,0018).
30 to <40 kg 600 mg weekly x 2 900 mg at week 3; then 900 mg every 2 weeks 20 to <30 kg 600 mg weekly x 2 600 mg at week 3; then 600 mg every 2 weeks 10 to <20 kg 600 mg weekly x 1 300 mg at week 2; then 300 mg every 2 weeks 5 to <10 kg 300 mg weekly x 1 300 mg at week 2; then 300 mg every 3 weeks 
30 do < 40 kg 600 mg tedensko x 2 900 mg 3. teden; nato 900 mg vsaka 2 tedna 20 do < 30 kg 600 mg tedensko x 2 600 mg 3. teden; nato 600 mg vsaka 2 tedna 10 do < 20 kg 600 mg tedensko x 1 300 mg 2. teden; nato 300 mg vsaka 2 tedna 5 do < 10 kg 300 mg tedensko x 1 300 mg 2. teden; nato 300 mg vsake 3 tedne
In this model, the clearance of Soliris for a typical aHUS patient weighing 70 kg was 0.0139 L/hr and the volume of distribution was 5.6 L. The elimination half-life was 297 h (approximately 12.4 days). 
V tem modelu je bil tipičen očistek zdravila Soliris pri tipičnem bolniku z aHUS, ki tehta 70 kg, 0,0139 l/h in volumen porazdelitve je bil 5,6 l. Razpolovni čas odstranjevanja je bil 297 h (približno 12,4 dni).
PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels. 
Pri bolnikih s PNH je treba spremljati znake in simptome intravaskularne hemolize, vključno z ravnmi serumske laktat dehidrogenaze (LDH).
There has been no observed correlation of antibody development to clinical response or adverse events. 
Korelacije med razvojem protiteles in kliničnim odzivom ali neželenimi učinki niso opazili.
Patients in both prospective studies were treated with Soliris for 26 weeks and most patients enrolled into a long-term, open-label extension study. 
Bolniki iz obeh prospektivnih študij so bili 26 tednov zdravljeni z zdravilom Soliris in vsi bolniki so bili vključeni v dolgotrajen, odprt podaljšek študije.
Discard any unused portion left in a vial, as the product contains no preservatives. 
Neuporabljene ostanke v viali zavrzite, saj izdelek ne vsebuje konzervansov.
Treatment for meningococcal infection while travelling If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. 
Če potujete na odročno območje, kjer se ne boste mogli posvetovati s svojim zdravnikom ali kjer začasno ne boste imeli možnosti zdravljenja, vam lahko zdravnik kot preventivni ukrep izda recept za antibiotik proti meningokoku Neisseria meningitidis, ki ga imejte ves čas pri sebi.
The dosing regimen in paediatric patients and adolescents weighing less than 40 kg was defined based on a pharmacokinetic (PK) simulation that identified the recommended dose and schedule based on body weight (see section 4.2). 
Shema odmerjanja pri pediatričnih bolnikih in mladostnikih s telesno maso manj kot 40 kg je temeljil na farmakokinetični (FK) simulaciji, ki je določila priporočeni odmerek in shemo na osnovi telesne mase (glejte poglavje 4.2).
The median time from current thrombotic microangiopathy manifestation to first dose of Soliris was 1 month (range <1 to 16 months). 
Mediana časa od nedavne manifestacije trombotične mikroangiopatije do prvega odmerka zdravila Soliris je bila 1 mesec (razpon < 1 mesec do 16 mesecev).
An interim analysis of Study ECU-NMO-302 demonstrates a significant and clinically meaningful reduction in On-trial ARR (as determined by the Treating Physician) on eculizumab treatment, based on the median (min, max) change (-1.829 [-6.38, 1.63], p<0.0001) from historical ARR (24 months prior to screening in Study ECU-NMO-301). 
Vmesna analiza študije ECU-NMO-302 nazorno prikazuje statistično značilno in klinično pomembno zmanjšanje ARR med preskušanjem (ki ga je ugotovil lečeči zdravnik) med zdravljenjem z ekulizumabom na podlagi mediane (min, maks) spremembe (-1,829 [-6,38, 1,63], p<0,0001) od anamnestične ARR (24 mesecev pred presejanjem v študiji ECU-NMO-301).
Eculizumab contains only naturally occurring amino acids and has no known active metabolites. 
Ekulizumab vsebuje samo naravne aminokisline in nima znanih aktivnih presnovkov.
Pharmacodynamic activity measured by free C5 concentrations of <0.5 ug/mL, is correlated with essentially complete blockade of terminal complement activity in PNH, aHUS, refractory gMG and NMOSD patients. 
Farmakodinamična aktivnost, izmerjena s koncentracijami prostega C5 < 0,5 µg/ml, je v korelaciji z v bistvu popolno blokado aktivnosti terminalnega komplementa pri bolnikih s PNH, aHUS, refraktarno gMG in NMOSD.
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections 
Bolniki, mlajši od 18 let, morajo biti cepljeni proti okužbam s Haemophilus influenzae in pnevmokokom.
Monitor any patient who discontinues Soliris for at least 8 weeks to detect serious haemolysis and other reactions. 
Vsakega bolnika, ki preneha uporabljati zdravilo Soliris, je treba spremljati najmanj 8 tednov, da bi tako zaznali morebitno resno hemolizo in druge reakcije.
Your doctor will administer a vaccine to your child aged less than 18 years against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group. 
Vaš zdravnik bo vašega otroka, starega manj kot 18 let, cepil proti Haemophilus influenzae in proti pnevmokoknim okužbam skladno z nacionalnimi priporočili glede cepljenja za vsako starostno skupino.
Refractory Generalized Myasthenia Gravis 
Refraktarna generalizirana miastenija gravis
Nine of the 11 patients who required dialysis at baseline no longer required dialysis after Study Day 15 of eculizumab treatment. 
Devet od 11 bolnikov, pri katerih je bila v izhodišču potrebna dializa, po 15. dnevu študije zdravljenja z ekulizumabom dialize ni več potrebovalo.
Study C08-003A/B was a prospective, controlled, open-label study which accrued patients with longer term aHUS without apparent evidence of clinical thrombotic microangiopathy manifestations and receiving chronic PE/PI (≥1 PE/PI treatment every two weeks and no more than 3 PE/PI treatments/week for at least 8 weeks before the first dose). 
Študija C08-003A/B je bila prospektivna, kontrolirana, odprta študija, ki je vključevala bolnike z dolgotrajnim aHUS brez očitnih znakov klinično izražene trombotične mikroangiopatije, ki so prejemali kronično PE/PI (≥ 1 PE/PI terapija vsake dva tedna in ne več kot 3 terapije PE/PI na teden vsaj 8 tednov pred prvim odmerkom).
Four of the five patients who required dialysis at study entry were able to discontinue dialysis for the duration of Soliris treatment, and one patient developed a new dialysis requirement. 
Štirje od petih bolnikov, ki so potrebovali dializo ob vstopu v študijo, so z dializo za čas zdravljenja z zdravilom Soliris prekinili in pri enem bolniku je bila potrebna nova dializa.
Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab. 
Na podlagi možnega zaviralnega učinka ekulizumaba na citotoksičnost rituksimaba, odvisno od komplementa, utegne ekulizumab zmanjšati pričakovane farmakodinamične učinke rituksimaba.
Soliris has no or negligible influence on the ability to drive and use machines. 
Zdravilo Soliris nima vpliva ali ima zanemarljiv vpliv na sposobnost upravljanja vozil in strojev.
• low white blood cell count (leukopenia), reduction in red blood cells which can make the skin pale and cause weakness or breathlessness 
• nizko število belih krvničk (levkopenija), znižanje števila rdečih krvničk, zaradi česar je lahko koža bleda in kar povzroči oslabelost ali zasoplost,
For adult aHUS, refractory gMG and NMOSD patients and paediatric aHUS patients supplemental dosing of Soliris is required in the setting of concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion): 
Za odrasle bolnike z aHUS, refraktarno gMG in NMOSD in pediatrične bolnike z aHUS je dodatno odmerjanje zdravila Soliris potrebno v primeru sočasne PE/PI (plazmafereza ali izmenjalna transfuzija s plazmo ali infuzija sveže zamrznjene plazme):
The median time from aHUS diagnosis to first dose of Soliris was 14 months (range <1, 110 months). 
Mediana časa od diagnoze aHUS do prvega odmerka zdravila Soliris je bila 14 mesecev (razpon < 1 mesec, 110 mesecev).
Figure 1 presents the change from baseline in both MG-ADL (A) and QMG (B) after 26 weeks of treatment in Study ECU-MG-301 and after 52 weeks of treatment in Study ECU-MG-302. 
Slika 1 kaže spremembo tako MG-ADL (A) kot QMG (B) od izhodišča po 26 tednih zdravljenja v študiji ECU-MG-301 in po 52 tednih zdravljenja v študiji ECU-MG-302.
Dosing for paediatric patients <40 kg is based on paediatric patients with aHUS. 
Odmerjanje za pediatrične bolnike < 40 kg temelji na odmerjanju za pediatrične bolnike z aHUS.
• infusion related reaction 
• reakcija v povezavi z infuzijo.
No overall differences in safety were reported between elderly (≥ 65 years) and younger refractory gMG 
Niso poročali o splošnih razlikah v varnosti med starejšimi (≥ 65 let) in mlajšimi (< 65 let) bolniki z refraktarno gMG (glejte poglavje 5.1).
Drug interaction studies have not been conducted with eculizumab in patients treated with IVIg. 
Študij medsebojnega delovanja med zdravili z ekulizumabom pri bolnikih, zdravljenih z IVIg, niso opravili.
Haemolytic activity during the course of the study was effectively blocked in both female and male mice. 
Hemoliza je bila med trajanjem študije učinkovito zaustavljena tako pri mišjih samicah kot samcih.
At 6 months, patients treated with Soliris with no history of RBC transfusion had significantly (p<0.001) reduced LDH levels (median LDH of 305 U/L; Table 4). 
Po šestih mesecih so imeli bolniki, zdravljeni z zdravilom Soliris, brez anamneze transfuzije eritrocitov pomembno (p<0,001) znižane ravni LDH (mediana LDH 305 enot/l; preglednica 4).
Of the 125 patients enrolled in ECU-MG-301, 117 patients subsequently were enrolled in a long-term extension study (Study ECU-MG-302), in which all receive Soliris. 
Od 125 bolnikov, vključenih v študijo ECU-MG-301, je bilo 117 bolnikov pozneje vključenih v dolgoročno podaljšano študijo (študija ECU-MG-302), v kateri so vsi prejemali zdravilo Soliris.
Soliris is produced in a murine myeloma (NS0 cell line) expression system and purified by affinity and ion exchange chromatography. 
Zdravilo Soliris se proizvaja v ekspresijskem sistemu iz mieloma miši (celične linije NS0) in je prečiščeno z afinitetno in ionsko izmenjevalno kromatografijo.
Stratified analyses are based on four randomization strata: (i) low EDSS at randomization (<=2.0), (ii) high EDSS (>=2.5 to <=7) and treatment naive at randomization, (iii) high EDSS (>=2.5 to <=7) and continuing on the same IST(s) since last relapse at randomization, (iv) high EDSS (>=2.5 to <=7) and changes in IST(s) since last relapse at randomization. 
Stratificirane analize temeljijo na štirih plasteh randomizacije: (i) nizka EDSS ob randomizaciji (< =2,0), (ii) visoka EDSS (> =2,5 do < =7) in brez zdravljenja kadarkoli pred randomizacijo, (iii) visoka EDSS (od > =2,5 do < =7) in nadaljevanje iste/istih IST od zadnjega recidiva ob randomizaciji, (iv) visoka EDSS (od > =2,5 do < =7) in spremembe (ene ali več) IST od zadnjega recidiva ob randomizaciji.
• Risk of substantial disease exacerbation or relapse following eculizumab discontinuation (refractory gMG and NMOSD) 
• tveganje za znatno eksacerbacijo bolezni ali recidiv po ukinitvi ekulizumaba (pri refraktarni gMG in NMOSD);
Body weight was a significant covariate resulting in a lower eculizumab clearance in pediatric patients requiring body weight based dosing in pediatric patients. 
Telesna masa je bila značilna sospremenljivka, ki je povzročila zmanjšan očistek ekulizumaba pri pediatričnih bolnikih, zaradi česar je pri pediatričnih bolnikih potrebno odmerjanje na podlagi telesne mase.
The proportion of clinical responders at Week 26 with no rescue therapy was 45.2% 
Delež bolnikov, ki se je v 26. tednu klinično odzval na zdravljenje brez rešilnega zdravljenja, je bil pri zdravilu Soliris 45,2 %,
When immunosuppressant and anticholinesterase therapies are decreased or discontinued, patients should be monitored closely for signs of disease exacerbation. 
Ko se imunosupresivna in antiholinesterazna zdravljenja zmanjša ali ukine, je treba bolnike skrbno spremljati glede znakov eksacerbacije bolezni.
Complete TMA response was defined as haematologic normalization and a ≥25% reduction in serum creatinine sustained in ≥ 2 consecutive measurements for ≥ 4 weeks. 
Popoln TMA odgovor je bil definiran kot hematološka normalizacija in ≥ 25 % znižanje ravni serumskega kreatinina, ki je bilo stabilno ob ≥ 2 zaporednih meritvah v ≥ 4 tednih.
There was an un-vaccinated patient diagnosed with idiopathic membranous glomerulonephropathy who experienced meningococcal meningitis. 
Pri enem necepljenem bolniku, pri katerem je bila diagnosticirana idiopatska membranska glomerulonefropatija, se je pojavil meningokokni meningitis.
Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body's systems from attacking and destroying vulnerable blood cells, kidneys, muscles or eye nerves and spinal cord. 
Ekulizumab se veže na specifično beljakovino v telesu, ki povzroča vnetje, in jo zavira ter tako prepreči, da bi vaše telo napadlo in uničilo občutljive krvne celice, ledvice, mišice ali očesne živce in hrbtenjačo.
Longer term treatment with Soliris (median 52 weeks ranging from 15 to 126 weeks) was associated with an increased rate of clinically meaningful improvements in adult patients with aHUS. 
Dolgotrajnejše zdravljenje z zdravilom Soliris (mediana 52 tednov, razpon od 15 do 126 tednov) je bilo povezano z zvečano pogostnostjo klinično pomembnih izboljšanj pri odraslih bolnikih z aHUS.
• abnormal leakage of the infused drug out of the vein, infusion site abnormal sensation, feeling hot 
• nenormalno uhajanje infundiranega zdravila iz vene, nenormalni občutki na mestu infuzije, občutek vročine.
Table 4: Efficacy Outcomes (LDH level and FACIT-Fatigue) in Patients with PNH with No History of Transfusion in M07-001 
Preglednica 4: Izidi učinkovitosti (raven LDH in utrujenost po FACIT) pri bolnikih s PNH brez anamneze transfuzije v M07-001
• Details of the PNH and aHUS registries and how to enter patients. 
o vključitev v register; • podrobnosti registrov bolnikov s PNH in aHUS in kako vanje vključiti bolnike.