natgillin/translations-raw huggingface dataset:
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Time from current clinical TMA manifestation until first study dose (months), median ( min, max)
čas od trenutne klinične manifestacije TMA do prvega odmerka v okviru študije (meseci), mediana (min, maks)
No IST usage at baseline n (%)
Brez uporabe IST v izhodišču n (%)
Impetigo,
• modrice,
Study C08-002A/B was a prospective, controlled, open-label study which accrued patients in the early phase of aHUS with evidence of clinical thrombotic microangiopathy manifestations with platelet count ≤
Študija C08-002A/B je bila prospektivna, kontrolirana, odprta študija, ki je vključevala bolnike v zgodnji fazi aHUS z znaki klinično izražene trombotične mikroangiopatije s številom trombocitov ≤ 150 x 109/l kljub PE/PI in z vrednostmi LDH in serumskega kreatinina nad normalnimi vrednostmi.
Soliris change relative to placebo - LS Mean Difference (95%
Sprememba pri zdravilu Soliris v primerjavi s placebom - povprečna razlika z metodo najmanjših kvadratov (95-% IZ)
An observational non-interventional Registry in patients with PNH (M07-001) was also initiated to characterize the natural history of PNH in untreated patients and the clinical outcomes during Soliris treatment.
PNH (M07-001) za opredelitev naravnega poteka PNH pri nezdravljenih bolnikih in kliničnih izidov med zdravljenjem z zdravilom Soliris.
Table 7: Baseline Characteristics of Patients Enrolled in aHUS Study C10-004
Preglednica 7: Izhodiščne značilnosti bolnikov, vključenih v študijo aHUS C10-004
Fifty percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Petdeset odstotkov bolnikov je imelo identificirano mutacijo regulativnega faktorja komplementa ali avtoprotitelo.
Cases of serious or fatal meningococcal infections have been reported in Soliris-treated patients.
Pri bolnikih, ki so bili zdravljeni z zdravilom Soliris, so poročali o primerih meningokokne okužbe z resnim ali s smrtnim izidom.
FACIT-Fatigue is measured on a scale of 0-52, with higher values indicating less fatigue Atypical Haemolytic Uremic Syndrome
Utrujenost po FACIT je merjena na lestvici od 0 do 52, višje vrednosti pomenijo manjšo utrujenost.
• The importance of meningococcal vaccination prior to treatment with eculizumab and/or to receive antibiotic prophylaxis.
• pomen cepljenja proti meningokokom in/ali antibiotične zaščite pred zdravljenjem z ekulizumabom,
Forty seven percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Sedeminštirideset odstotkov bolnikov je imelo potrjeno mutacijo regulatornega faktorja komplementa ali avto-protitelo.
In order to qualify for enrolment, patients were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH, and serum creatinine above the upper limits of normal, without the need for chronic dialysis.
Da so bolniki izpolnili pogoje za vključitev, so morali imeti število trombocitov manjše od spodnje meje normalnega razpona (lower limit of normal range - LLN), znake hemolize, npr. zvišanje serumske LDH, in serumski kreatinin nad zgornjo mejo normalne vrednosti,
Time from aHUS diagnosis to first study dose (months), median ( min, max)
čas od diagnoze aHUS do prvega odmerka v okviru študije (meseci), mediana (min, maks)
No patient required new dialysis with Soliris.
Noben bolnik ob zdravljenju z zdravilom Soliris ni potreboval nove dialize.
• After the fifth week, your doctor will administer 1,200 mg of diluted Soliris every two weeks as a long-term treatment.
• Od petega tedna dalje vam bo zdravnik vsaka dva tedna dal 1.200 mg razredčenega zdravila
• The patient safety card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with eculizumab.
o smernice za bolnike/skrbnike in njihovo vsebino, o opozorilno kartico za bolnika morajo imeti vedno pri sebi in vse zdravstvene delavce, ki sodelujejo pri njihovem zdravljenju opozoriti, da se zdravijo z ekulizumabom,
Interrupting or stopping treatment with Soliris may cause your NMOSD to worsen and relapse to happen.
Prekinitev ali prenehanje zdravljenja z zdravilom Soliris lahko povzroči, da se vaš NMOSD poslabša in nastopi ponovitev bolezni.
Change from baseline at 12 weeks of LDH Value (U/L)
Sprememba vrednosti LDH od izhodišča ob 12. tednu (enot/l)
For 600 mg doses, use 60 ml of Soliris and add 60 ml of diluent.
Za 600 mg odmerke uporabite 60 ml zdravila Soliris in dodajte 60 ml vehikla za redčenje.
All aHUS patients treated with Soliris when administered as recommended demonstrated rapid and sustained reduction in terminal complement activity.
Pri vseh bolnikih z aHUS, ki so bili zdravljeni z zdravilom Soliris po priporočilih, je prišlo do hitrega in vztrajnega znižanja aktivnosti terminalnega komplementa.
Soliris is also used to treat adults and children patients with a certain type of disease affecting the blood system and kidney called atypical Haemolytic Uremic Syndrome (aHUS).
Zdravilo Soliris se uporablja tudi za zdravljenje odraslih in pediatričnih bolnikov z določeno vrsto bolezni, ki prizadene krvni sistem in ledvice, in jo imenujemo atipični hemolitični uremični sindrom (aHUS).
In all aHUS patients, eculizumab serum concentrations of approximately 50 - 100 microgram/mL are sufficient for essentially complete inhibition of terminal complement activity.
Pri vseh bolnikih z aHUS serumske koncentracije ekulizumaba približno 50-100 mikrogramov/ml zadoščajo za praktično popolno zavrtje aktivnosti terminalnega komplementa.
Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration.
Pred uporabo je treba vizualno pregledati ali raztopina zdravila Soliris vsebuje delce in ali je razbarvana.
Do not administer as an intravenous push or bolus injection.
Zdravila ni dovoljeno dajati v obliki hitre intravenske ali bolusne injekcije.
Table 9: Patient Demographic and Characteristics in Study ECU-MG-301
Preglednica 9: Demografske in druge značilnosti bolnikov v študiji ECU-MG-301 Soliris (n = 62)
In PNH patients, pharmacodynamic activity correlates directly with eculizumab serum concentrations and maintenance of trough levels above ≥ 35 microgram/mL results in essentially complete blockade of haemolytic activity in the majority of PNH patients.
Med farmakodinamično aktivnostjo in koncentracijami ekulizumaba v serumu pri bolnikih s PNH obstaja neposredna korelacija; vzdrževanje minimalne koncentracije nad ≥ 35 mikrogramov/ml pri večini bolnikov s PNH povzroči praktično popolno zaustavitev hemolize.
Fifty-one percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Enainpetdeset odstotkov bolnikov je imelo identificirano mutacijo regulativnega faktorja komplementa ali avtoprotitelo.
Patients who discontinue Soliris treatment should be carefully monitored for signs and symptoms of disease exacerbation.
Bolnike, ki prekinejo zdravljenje z zdravilom Soliris, je treba skrbno spremljati glede znakov in simptomov eksacerbacije bolezni.
Total number of patients reporting clinical deterioration n (%) Total number of patients requiring rescue therapy n (%)
Celotno število bolnikov, ki so potrebovali rešilno zdravljenje n (%)
• inability to sleep
• nespečnost,
Anaphylactic reaction, Hypersensitivity
Bolezni imunskega sistema anafilaktična reakcija, preobčutljivost
If you stop using Soliris for NMOSD
Če ste prenehali uporabljati zdravilo Soliris za NMOSD
The treatment will be given by your doctor or other health care provider by infusing a dilution of the Soliris vial from a drip bag through a tube directly into one of your veins.
Zdravilo vam bo dajal zdravnik ali drug zdravstveni delavec z infundiranjem razredčene vsebine viale zdravila Soliris iz infuzijske vrečke skozi cevko neposredno v eno od ven. Priporočljivo je, da traja začetek zdravljenja, imenovan začetna faza, 4 tedne, tej fazi pa sledi faza vzdrževanja.
In aHUS patients, uncontrolled terminal complement activation and the resulting complement-mediated thrombotic microangiopathy are blocked with Soliris treatment.
Pri bolnikih z aHUS sta zaradi zdravljenja z zdravilom Soliris zavrta nekontrolirana aktivacija terminalnega komplementa in posledična trombotična mikroangiopatija, ki je posredovana s komplementom.
Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Almac Pharma Services 22 Seagoe Industrial Estate
Twenty of the 24 patients who required dialysis at baseline were able to discontinue dialysis during Soliris treatment.
24 bolnikov, pri katerih je bila v izhodišču potrebna dializa, je lahko med zdravljenjem z zdravilom
Accelerated hypertension, Hypotension, Hot flush, Vein disorder
hipotenzija, vročinski oblivi, venske motnje hematom
In the eculizumab NMOSD clinical development program, the dose of Soliris in adult patients with NMOSD was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg at Week 5 ± 2 days, then 1200 mg every 14 ± 2 days for the study duration.
V kliničnem razvojnem programu ekulizumaba za NMOSD je bil odmerek zdravila Soliris pri odraslih bolnikih z NMOSD 900 mg vsakih 7 ± 2 dni 4 tedne, sledil mu je odmerek 1200 mg v 5. tednu ± 2 dni, nato 1200 mg vsakih 14 ± 2 dni do konca študije.
Soliris is also used to treat adult patients with a certain type of disease that predominantly affects the eye nerves and the spinal cord called Neuromyelitis Optica Spectrum Disorder (NMOSD).
Zdravilo Soliris se uporablja tudi za zdravljenje odraslih bolnikov z vrsto bolezni, ki prizadene pretežno očesne živce in hrbtenjačo in se imenuje specifična oblika nevromielitisa vidnega živca (NMOSD).
In aHUS Study C08-003A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
V študiji aHUS C08-003A/B so podobne učinke zdravljenja z zdravilom Soliris opažali pri bolnikih z identificiranimi mutacijami genov, ki kodirajo proteine regulatornih faktorjev komplementa, ali brez njih.
Withdraw the total amount of Soliris from the vial(s) using a sterile syringe.
S sterilno brizgo odvzemite celotno količino zdravila Soliris iz viale (vial).
Interrupting or stopping treatment with Soliris may cause your gMG symptoms to come back.
Prekinitev ali prenehanje zdravljenja z zdravilom Soliris lahko povzroči, da se simptomi gMG znova pojavijo.
In aHUS Study C08-002A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
V študiji aHUS C08-002A/B so podobne učinke zdravljenja z zdravilom Soliris opažali pri bolnikih z identificiranimi mutacijami genov, ki kodirajo proteine regulatornih faktorjev komplementa, ali brez njih.
• Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
• tveganje za resno trombotično mikroangiopatijo (pri bolnikih z aHUS) po prekinitvi/odlogu dajanja ekulizumaba, znake in simptome zapleta in priporočilo, naj se pred prekinitvijo/odlogom zdravljenja z ekulizumabom posvetujejo z zdravnikom, ki je zdravilo predpisal,
Soliris 300 mg concentrate for solution for infusion Eculizumab
Soliris 300 mg koncentrat za raztopino za infundiranje ekulizumab
Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon.
Prekinitev ali prenehanje zdravljenja z zdravilom Soliris lahko povzroči, da se simptomi PNH znova kmalu pojavijo v resnejši obliki.
Efficacy Endpoints: Total score change from baseline at Week 26
Preglednica 10: Sprememba izidov učinkovitosti od izhodišča do 26. tedna v študiji
Your doctor will discuss the possible side effects with you and explain the risks and benefits of Soliris with you prior to treatment.
Pred zdravljenjem vam bo zdravnik razložil morebitne neželene učinke ter tveganja in koristi zdravila
In PNH, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated haemolytic activity.
Pri PNH je kronična uporaba zdravila Soliris povzročila hitro in trajno zmanjšanje hemolize, pogojene s komplementom.
Data from 143 patients in one controlled study (Study ECU-NMO-301) and from 119 patients who continued in one open-label extension trial (Study ECU-NMO-302) were used to evaluate the efficacy and safety of Soliris in the treatment of patients with NMOSD.
Za ocenjevanje učinkovitosti in varnosti zdravila Soliris pri zdravljenju bolnikov z NMOSD so uporabili podatke 143 bolnikov v eni kontrolirani študiji (študija ECU-NMO-301) in 119 bolnikov, ki so nadaljevali v enem odprtem podaljšanem preskušanju (študija ECU-NMO-302).
PK parameters are consistent across PNH, aHUS, refractory gMG and NMOSD patient populations.
FK parametri se skladajo s tistimi v populacijah z bolniki s PNH, aHUS, refraktarno gMG in NMOSD.
2) Failed at least one immunosuppressant therapy and required chronic plasma exchange or IVIg to control symptoms, ie, patients require PE or IVIg on a regular basis for the management of muscle weakness at least every 3 months over previous 12 months.
2) vsaj ena imunosupresivna terapija je bila neuspešna, bolnik je potreboval kronično izmenjavo plazme ali i.v.
• Diluents are Sodium chloride 9 mg/ml (0.9%) solution for injection, Sodium chloride 4.5 mg/ml
• Vehikli za redčenje so 9 mg/ml (0,9-%) raztopina natrijevega klorida za injiciranje, 4,5 mg/ml (0,45-%) raztopina natrijeva klorida za injiciranje ali 5 % raztopina dekstroze v vodi.
For 1,200 mg doses, use 120 ml of Soliris and add
Za 1.200 mg odmerke uporabite 120 ml zdravila Soliris in dodajte 120 ml vehikla za redčenje.
• The need for children to be vaccinated against pneumococcus and Haemophilus influenzae before eculizumab treatment.
• pred zdravljenjem z ekulizumabom je treba otroke cepiti proti pnevmokokom in Haemophilus influenzae,
Table 13: Adjudicated On-trial Annualized Relapse Rate - Full Analysis Set Variable
Preglednica 13: Pogostnost recidivov, preračunana na eno leto, med preskušanjem po strokovni presoji - celotni nabor za analizo
Patients who discontinue Soliris treatment should be carefully monitored for signs and symptoms of potential NMOSD relapse.
Bolnike, ki prekinejo zdravljenje z zdravilom Soliris, je treba skrbno spremljati glede znakov in simptomov možnega recidiva NMOSD.
Table 17 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in aHUS Study C10-003.
V preglednici 17 so povzete ključne izhodiščne klinične in z boleznijo povezane značilnosti bolnikov, vključenih v študijo aHUS C10-003.
When Soliris treatment was continued for more than 26 weeks, one additional patient (68% of patients in total) achieved Complete TMA Response and two additional patients (91% of patients in total)
26 tednov, je en dodaten bolnik (vsega skupaj 68 % bolnikov) dosegel popoln odziv TMA, dva dodatna bolnika (vsega skupaj 91 % bolnikov) pa sta dosegla hematološko normalizacijo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology.
Ekulizumab je humanizirano monoklonsko protitelo IgG2/4κ, pridobljeno s tehnologijo rekombinantne
RMP.
PNH.
Discontinuation of the therapy should be considered in a patient who shows no evidence of therapeutic benefit by 12 weeks.
Če bolnik po 12 tednih ne kaže nobenih znakov koristi zdravljenja, je treba razmisliti o prekinitvi zdravljenja.
• inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen), constipation,
• vnetje peritoneja (tkiva, ki obdaja večino organov v trebuhu), zaprtje, nelagodje v želodcu po obrokih (dispepsija), napihnjenost trebuha,
Infrequent antibody responses have been detected in Soliris-treated patients across all clinical studies.
V vseh kliničnih študijah so se pri bolnikih, zdravljenih z zdravilom Soliris, odzivi s protitelesi pojavljali redko.
Renal function, as measured by eGFR, was improved during Soliris therapy.
Delovanje ledvic, merjeno z eGFR, se je med zdravljenjem z zdravilom Soliris izboljšalo.
• Inspect visually Soliris solution for particulate matter and discolouration.
• Vizualno preverite, ali raztopina zdravila Soliris vsebuje delce in ali je razbarvana.
Your doctor will discuss the possible side effects with you and explain the risks.
Zdravnik vam bo razložil morebitne neželene učinke in tveganja.
LDH AUC (U/L x Day)
Površina pod krivuljo LDH (enot/l x dan)
Clearance values of Soliris in paediatric aHUS patients were 10.4, 5.3, and 2.2 mL/hr with body weight of 70, 30, and 10 kg, respectively; and the corresponding volume of distribution values were 5.23, 2.76, and 1.21 L, respectively.
10,4; 5,3 oziroma 2,2 ml/h pri telesni masi 70, 30 oziroma 10 kg; ustrezne vrednosti porazdelitvenega prostora pa so bile 5,23; 2,76 oziroma 1,21 l. Ustrezna razpolovna doba izločanja je ostala skoraj nespremenjena v razponu 349 do 378 h (približno 14,5 do 15,8 dni).
In a refractory gMG placebo controlled study, none (0/62) of the Soliris treated patients showed antidrug antibody response during the 26 week active treatment.
V študiji refraktarne gMG, kontrolirani s placebom, ni noben (0/62) bolnik, zdravljen z zdravilom
≥15 mL/min/1.73 m2,
sprememba eGFR (≥15 ml/min/1,73•m2) po
Patients in aHUS study C08-003A/B received Soliris for a minimum of 26 weeks.
Bolniki v študiji aHUS C08-003A/B so prejemali zdravilo Soliris najmanj 26 tednov.
Table 8 summarizes the efficacy results for aHUS study C10-004.
V preglednici 8 so povzeti rezultati učinkovitosti za študijo aHUS C10-004.
• swelling (edema), chest discomfort, feeling of weakness (asthenia), chest pain, infusion site pain, chills
• otekanje (edem), nelagodje v prsnem košu, občutek šibkosti (astenija), bolečine v prsnem košu,
No clear treatment-related effects or adverse effects were observed in reproductive toxicology studies in mice with a surrogate terminal complement inhibitory antibody, which was utilized to assess the reproductive safety of C5 blockade.
V okviru reproduktivnih toksikoloških študij na miših z nadomestnim protitelesom z zaviralnim učinkom na terminalni komplement, ki so ga uporabili za oceno reproduktivne varnosti blokade C5, niso opazili učinkov, nedvoumno povezanih z zdravljenjem, ali neželenih učinkov.
eGFR improvement ≥15 mL/min/ 1.73•m2, n (%) Change in eGFR ( ≥15 mL/min/1.73•m2) at 26
Sprememba eGFR ml/min/1,73 m2: mediana (razpon) Izboljšanje eGFR ≥ 15 ml/min/1,73 m2, n (%) (95-% IZ) Sprememba hemoglobina > 20 g/l, n
Table 18 summarizes the efficacy results for aHUS C10-003.
V preglednici 18 so povzeti rezultati učinkovitosti za študijo aHUS C10-003.
Decreased appetite
občutek vročine
• Warning to seek immediate medical care if above are present.
• znake in simptome okužbe in sepse, • opozorilo, naj nemudoma poišče zdravniško pomoč, če se zgoraj našteto pojavi,
• Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only).
• tveganje za resno hemolizo po prekinitvi zdravljenja z ekulizumabom in odlogu dajanja zdravila, kriterije zanjo, potrebno spremljanje po prekinitvi zdravljenja z zdravilom Soliris in predlagani načini zdravljenja hemolize (samo za bolnike s PNH);
• infection, fungal infection, collection of pus (abscess), type of infection of the skin (cellulitis),
• okužba, glivična okužba, kopičenje gnoja (absces), vrsta okužbe kože (celulitis), gripa, sinusitis, okužba zoba (absces),
In all studies, the dose of Soliris in adult and adolescent aHUS patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1,200 mg 7 ± 2 days later, then 1,200 mg every 14 ± 2 days for the study duration.
vseh študijah je bil odmerek zdravila Soliris pri odraslih in mladoletnih bolnikih z aHUS 900 mg vsakih 7 ± 2 dni 4 tedne, čemur je sledil odmerek 1.200 mg 7 ± 2 dni in nato 1.200 mg vsakih
• infection of the lung (pneumonia), common cold (nasopharyngitis), infection of the urinary system
• okužba pljuč (pljučnica), navaden prehlad (nazofaringitis), okužba sečil,
PRBC transfused during treatment (median)
Raven LDH pred zdravljenjem (mediana,
• Initial phase: 600 mg of Soliris administered via a 25 - 45 minute intravenous infusion every week for the first 4 weeks.
• začetna faza: 600 mg zdravila Soliris se daje v obliki 25-45-minutne intravenske infuzije enkrat na teden prve 4 tedne,
Patients who initiate Soliris treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
Bolniki, ki se začnejo zdraviti z zdravilom Soliris prej kot 2 tedna po cepljenju proti meningokoku, morajo prejeti ustrezno profilaktično antibiotično zdravljenje, dokler od cepljenja ne mineta 2 tedna.
Table 7 summarizes the key baseline clinical and diseaserelated characteristics of patients enrolled in aHUS C10-004.
V preglednici 7 so povzete ključne izhodiščne klinične in z boleznijo povezane značilnosti bolnikov, vključenih v študijo aHUS C10-004.
The primary endpoint for Study ECU-MG-301 was the change from baseline in the MG Activities of Daily Living Profile (MG-ADL - a patient reported outcome measure validated in gMG) total score at Week 26.
profila aktivnosti vsakdanjega življenja (MG-ADL - merilo izida, o katerem poroča bolnik, validirano pri gMG) od izhodišča do 26. tedna.
Patients in aHUS Study C10-004 received Soliris for a minimum of 26 weeks.
Bolniki v študiji aHUS C10-004 so prejemali zdravilo Soliris najmanj 26 tednov.
Data from 139 patients in two prospective controlled studies (Studies C08-001 and ECU-MG-301), and one open-label extension trial (Study ECU-MG-302) were used to evaluate the efficacy of Soliris in the treatment of patients with refractory gMG.
ECU-MG-301) in enem odprtem podaljšanem preskušanju (študija ECU-MG-302), so uporabili za oceno učinkovitosti zdravila Soliris za zdravljenje bolnikov z refraktarno gMG.
Withdrawal of immunosuppressant and anticholinesterase therapies during Soliris treatment for refractory gMG was not assessed in the placebocontrolled studies.
Ukinitve imunosupresivnih in antiholinesteraznih zdravljenj med zdravljenjem refraktarne gMG z zdravilom Soliris v študijah,
Patients either received meningococcal vaccination at least 2 weeks prior to initiating treatment with Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Bolniki so prejeli bodisi cepljenje proti meningokokom vsaj 2 tedna pred začetkom zdravljenja z zdravilom Soliris bodisi profilaktično zdravljenje z ustreznimi antibiotiki do 2 tedna po cepljenju.
- If you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated .
organizmu, ki povzroča meningokokno okužbo, ali da bi jemali antibiotike za zmanjšanje tveganja okužbe, dokler ne mineta 2 tedna po cepljenju.
class V), n (%)
Ženske, n (%)
The proportion of clinical responders at Week 26 with no rescue therapy was 59.7% on Soliris compared with 39.7% on placebo (p=0.0229).
Delež bolnikov, ki se je v 26. tednu klinično odzval na zdravljenje brez rešilnega zdravljenja, je bil pri zdravilu Soliris 59,7 %,
- sodium phosphate dibasic - sodium chloride
− natrijev dihidrogenfosfat
Renal function, as measured by median eGFR, increased during Soliris therapy.
Delovanje ledvic, merjeno z mediano eGFR, se je med zdravljenjem z zdravilom Soliris izboljšalo.