FrancophonIA/ELRC3.0 huggingface dataset:
English: on Soliris compared with 19% on placebo (p=0.0018).
Slovenian: pri placebu pa 19 % (p = 0,0018).
English: 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
Slovenian: 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
English: 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).
Slovenian: 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).
English: PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels.
Slovenian: Pri bolnikih s PNH je treba spremljati znake in simptome intravaskularne hemolize, vključno z ravnmi serumske laktat dehidrogenaze (LDH).
English: There has been no observed correlation of antibody development to clinical response or adverse events.
Slovenian: Korelacije med razvojem protiteles in kliničnim odzivom ali neželenimi učinki niso opazili.
English: Patients in both prospective studies were treated with Soliris for 26 weeks and most patients enrolled into a long-term, open-label extension study.
Slovenian: Bolniki iz obeh prospektivnih študij so bili 26 tednov zdravljeni z zdravilom Soliris in vsi bolniki so bili vključeni v dolgotrajen, odprt podaljšek študije.
English: Discard any unused portion left in a vial, as the product contains no preservatives.
Slovenian: Neuporabljene ostanke v viali zavrzite, saj izdelek ne vsebuje konzervansov.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: The median time from current thrombotic microangiopathy manifestation to first dose of Soliris was 1 month (range <1 to 16 months).
Slovenian: Mediana časa od nedavne manifestacije trombotične mikroangiopatije do prvega odmerka zdravila Soliris je bila 1 mesec (razpon < 1 mesec do 16 mesecev).
English: 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).
Slovenian: 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).
English: Eculizumab contains only naturally occurring amino acids and has no known active metabolites.
Slovenian: Ekulizumab vsebuje samo naravne aminokisline in nima znanih aktivnih presnovkov.
English: 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.
Slovenian: 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.
English: Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections
Slovenian: Bolniki, mlajši od 18 let, morajo biti cepljeni proti okužbam s Haemophilus influenzae in pnevmokokom.
English: Monitor any patient who discontinues Soliris for at least 8 weeks to detect serious haemolysis and other reactions.
Slovenian: Vsakega bolnika, ki preneha uporabljati zdravilo Soliris, je treba spremljati najmanj 8 tednov, da bi tako zaznali morebitno resno hemolizo in druge reakcije.
English: 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.
Slovenian: 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.
English: Refractory Generalized Myasthenia Gravis
Slovenian: Refraktarna generalizirana miastenija gravis
English: Nine of the 11 patients who required dialysis at baseline no longer required dialysis after Study Day 15 of eculizumab treatment.
Slovenian: Devet od 11 bolnikov, pri katerih je bila v izhodišču potrebna dializa, po 15. dnevu študije zdravljenja z ekulizumabom dialize ni več potrebovalo.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.
Slovenian: Na podlagi možnega zaviralnega učinka ekulizumaba na citotoksičnost rituksimaba, odvisno od komplementa, utegne ekulizumab zmanjšati pričakovane farmakodinamične učinke rituksimaba.
English: Soliris has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Soliris nima vpliva ali ima zanemarljiv vpliv na sposobnost upravljanja vozil in strojev.
English: • low white blood cell count (leukopenia), reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
Slovenian: • nizko število belih krvničk (levkopenija), znižanje števila rdečih krvničk, zaradi česar je lahko koža bleda in kar povzroči oslabelost ali zasoplost,
English: 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):
Slovenian: 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):
English: The median time from aHUS diagnosis to first dose of Soliris was 14 months (range <1, 110 months).
Slovenian: Mediana časa od diagnoze aHUS do prvega odmerka zdravila Soliris je bila 14 mesecev (razpon < 1 mesec, 110 mesecev).
English: 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.
Slovenian: 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.
English: Dosing for paediatric patients <40 kg is based on paediatric patients with aHUS.
Slovenian: Odmerjanje za pediatrične bolnike < 40 kg temelji na odmerjanju za pediatrične bolnike z aHUS.
English: • infusion related reaction
Slovenian: • reakcija v povezavi z infuzijo.
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger refractory gMG
Slovenian: Niso poročali o splošnih razlikah v varnosti med starejšimi (≥ 65 let) in mlajšimi (< 65 let) bolniki z refraktarno gMG (glejte poglavje 5.1).
English: Drug interaction studies have not been conducted with eculizumab in patients treated with IVIg.
Slovenian: Študij medsebojnega delovanja med zdravili z ekulizumabom pri bolnikih, zdravljenih z IVIg, niso opravili.
English: Haemolytic activity during the course of the study was effectively blocked in both female and male mice.
Slovenian: Hemoliza je bila med trajanjem študije učinkovito zaustavljena tako pri mišjih samicah kot samcih.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Soliris is produced in a murine myeloma (NS0 cell line) expression system and purified by affinity and ion exchange chromatography.
Slovenian: Zdravilo Soliris se proizvaja v ekspresijskem sistemu iz mieloma miši (celične linije NS0) in je prečiščeno z afinitetno in ionsko izmenjevalno kromatografijo.
English: 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.
Slovenian: 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.
English: • Risk of substantial disease exacerbation or relapse following eculizumab discontinuation (refractory gMG and NMOSD)
Slovenian: • tveganje za znatno eksacerbacijo bolezni ali recidiv po ukinitvi ekulizumaba (pri refraktarni gMG in NMOSD);
English: Body weight was a significant covariate resulting in a lower eculizumab clearance in pediatric patients requiring body weight based dosing in pediatric patients.
Slovenian: 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.
English: The proportion of clinical responders at Week 26 with no rescue therapy was 45.2%
Slovenian: Delež bolnikov, ki se je v 26. tednu klinično odzval na zdravljenje brez rešilnega zdravljenja, je bil pri zdravilu Soliris 45,2 %,
English: When immunosuppressant and anticholinesterase therapies are decreased or discontinued, patients should be monitored closely for signs of disease exacerbation.
Slovenian: Ko se imunosupresivna in antiholinesterazna zdravljenja zmanjša ali ukine, je treba bolnike skrbno spremljati glede znakov eksacerbacije bolezni.
English: Complete TMA response was defined as haematologic normalization and a ≥25% reduction in serum creatinine sustained in ≥ 2 consecutive measurements for ≥ 4 weeks.
Slovenian: 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.
English: There was an un-vaccinated patient diagnosed with idiopathic membranous glomerulonephropathy who experienced meningococcal meningitis.
Slovenian: Pri enem necepljenem bolniku, pri katerem je bila diagnosticirana idiopatska membranska glomerulonefropatija, se je pojavil meningokokni meningitis.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • abnormal leakage of the infused drug out of the vein, infusion site abnormal sensation, feeling hot
Slovenian: • nenormalno uhajanje infundiranega zdravila iz vene, nenormalni občutki na mestu infuzije, občutek vročine.
English: Table 4: Efficacy Outcomes (LDH level and FACIT-Fatigue) in Patients with PNH with No History of Transfusion in M07-001
Slovenian: Preglednica 4: Izidi učinkovitosti (raven LDH in utrujenost po FACIT) pri bolnikih s PNH brez anamneze transfuzije v M07-001
English: • Details of the PNH and aHUS registries and how to enter patients.
Slovenian: o vključitev v register; • podrobnosti registrov bolnikov s PNH in aHUS in kako vanje vključiti bolnike.
English: • Discard any unused portion left in a vial as the medicinal product contains no preservatives.
Slovenian: • Neuporabljene ostanke v viali zavrzite, saj zdravilo ne vsebuje konzervansov.
English: Supplemental dosing is recommended when Soliris is administered to aHUS patients receiving plasma infusion or exchange (see section 4.2).
Slovenian: Priporočeni so dodatni odmerki, kadar zdravilo Soliris dajemo bolnikom z aHUS, ki prejemajo infuzijo plazme ali imajo izmenjavo plazme (glejte poglavje 4.2).
English: Ensure that your current meningococcal vaccination is up to date.
Slovenian: Prepričajte se, da je vaše cepljenje proti meningokokni okužbi še učinkovito.
English: One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).
Slovenian: Ena 30 ml viala vsebuje 300 mg ekulizumaba (10 mg/ml).
English: 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:
Slovenian: 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:
English: Driving and using machines Soliris has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Soliris nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Soliris should only be administered via intravenous infusion as described below.
Slovenian: Zdravilo Soliris se sme dajati izključno v obliki intravenske infuzije, kot je opisano v nadaljevanju.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Ko so zdravljenje nadaljevali po 26. tednu, je še šest dodatnih bolnikov doseglo in vzdrževalo popoln TMA odgovor zaradi znižanja serumskega kreatinina.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: In 40 patients with PNH, a 1-compartmental model was used to estimate pharmacokinetic parameters after multiple doses.
Slovenian: Pri 40 bolnikih s PNH je bil za oceno farmakokinetičnih parametrov po več odmerkih uporabljen enorazdelčni model.
English: 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).
Slovenian: 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).
English: Table 14: Efficacy Outcomes in Paediatric PNH Study M07-005
Slovenian: Preglednica 14: Izidi učinkovitosti v pediatrični študiji PNH M07-005
English: 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.
Slovenian: 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.
English: Soliris should be prepared for administration by a qualified healthcare professional using aseptic technique.
Slovenian: Zdravilo Soliris mora z aseptično tehniko za uporabo pripraviti strokovno usposobljen zdravstveni delavec.
English: <12 years (n=15)
Slovenian: < 12 let (n = 15)
English: Soliris contains sodium
Slovenian: Zdravilo Soliris vsebuje natrij
English: Abbreviations: CI = confidence interval; EDSS = Expanded Disability Status Scale; IST = immunosuppressive therapy
Slovenian: Okrajšave: IZ = interval zaupanja; EDSS = razširjena lestvica stanja invalidnosti (Expanded Disability Status
English: Abbreviations: ARR = annualized relapse rate; CI = confidence interval.
Slovenian: Okrajšave: ARR = pogostnost recidiva, preračunana na eno leto (annualized relapse rate); IZ = interval zaupanja.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Mean Hgb level (g/dL) at setpoint (SD)
Slovenian: Povprečna raven Hb (g/dl) v nastavitveni točki
English: 5.3 Preclinical safety data The specificity of eculizumab for C5 in human serum was evaluated in two in vitro studies.
Slovenian: Specifičnost ekulizumaba za C5 v humanem serumu so preučevali v okviru dveh študij in vitro.
English: Reduction in terminal complement activity was observed in all patients after commencement of Soliris.
Slovenian: Znižanje aktivnosti terminalnega komplementa so opazili pri vseh bolnikih po začetku zdravljenja z zdravilom Soliris.