natgillin/translations-raw huggingface dataset:
Infections Before starting Soliris, inform your doctor if you have any infections.
Pred začetkom jemanja zdravila Soliris obvestite zdravnika, če imate katerokoli okužbo.
Serious haemolysis was not observed.
Resna hemoliza ni bila opažena.
Severe TMA complications occurred in patients regardless of whether they had an identified genetic mutation, high risk polymorphism or auto-antibody.
Hudi zapleti TMA so se pojavili pri bolnikih ne glede na to, ali so imeli identificirano genetsko mutacijo, polimorfizem z velikim tveganjem ali avtoprotitelesa.
If you use this medicine to treat PNH
Če jemljete to zdravilo za zdravljenje PNH
Statistic Placebo
Statistika Placebo
Additional serious medical complications occurred in these patients including severe worsening of kidney function, disease-related hospitalization and progression to end stage renal disease requiring dialysis.
Pri teh bolnikih so se pojavili dodatni resni medicinski zapleti, ki so vključevali močno poslabšanje funkcije ledvic, hospitalizacijo zaradi bolezni in napredovanje v bolezen ledvic v končnem stadiju, zaradi katere je bila potrebna dializa.
In Paroxysmal Nocturnal Haemoglobinuria (PNH):
Pri paroksizmalni nočni hemoglobinuriji (PNH):
Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Študij razmnoževanja pri živalih z ekulizumabom niso opravili (glejte poglavje 5.3).
Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and the signs and symptoms of them.
Bolnike je treba seznaniti z informacijami, ki so v navodilih za uporabo, da bi tako povečali njihovo pozornost za potencialno hude okužbe ter njihove znake in simptome.
However, due to the limitations of the available data, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.
Ker pa je na voljo malo podatkov, je treba pretehtati razvojne in zdravstvene koristi dojenja in materino klinično potrebo po ekulizumabu ter vse možne neželene učinke na dojenega otroka zaradi ekulizumaba in zaradi materine osnovne bolezni.
Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Soliris, you will be provided a card to carry with you, listing specific trigger symptoms.
Zaradi pomembnosti hitre identifikacije in zdravljenja določenih vrst okužb pri bolnikih, ki prejemajo zdravilo Soliris, boste prejeli kartico, ki jo boste nosili s seboj in na kateri bodo navedeni specifični simptomi, ki jih zdravilo lahko sproži.
The median patient age was 6.5 years (range: 5 months to 17 years).
Mediana starost bolnikov je bila 6,5 let (razpon: od 5 mesecev do 17 let).
After dilution, the medicinal product should be used immediately.
Po redčenju je treba zdravilo takoj uporabiti.
Due to its mechanism of action, the use of Soliris increases the patient's susceptibility to meningococcal infection (Neisseria meningitidis).
Zaradi svojega načina delovanja zdravilo Soliris povečuje bolnikovo dovzetnost za meningokokno okužbo (Neisseria meningitidis).
Spontaneous penile erection,
• spontana erekcija penisa,
Soliris may be administered to patients aged 65 years and over.
Zdravilo Soliris se lahko daje bolnikom, ki so stari 65 let ali več.
Data on a limited number of pregnancies exposed to eculizumab (less than 300 pregnancy outcomes) indicate there is no increased risk of foetal malformation or foetal-neonatal toxicity.
Podatki o majhnem številu ekulizumabu izpostavljenih nosečnosti (manj kot 300 izidov nosečnosti) kažejo, da tveganje fetalnih malformacij ali toksičnosti za plod in novorojenčka ni zvečano.
Transfusion Avoidance during treatment (%)
Nepotrebnost transfuzije med zdravljenjem (%)
Meningococcal disease due to any serogroup may occur.
Meningokokna bolezen je možna zaradi katerekoli serološke skupine.
Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Poročali so o drugih primerih bakterij Neisseria species, vključno s sepso z bakterijo Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp nespecificirana.
Animal reproduction studies have not been conducted with eculizumab due to lack of pharmacologic activity in non-human species.
Študij razmnoževanja z ekulizumabom pri živalih niso opravili zaradi odsotnosti farmakološke aktivnosti pri živalih.
If the infusion is slowed, the total infusion time may not exceed two hours in adults and adolescents and four hours in children aged less than 12.
Če se infuzija upočasni, skupni čas infuzije ne sme presegati dveh ur pri odraslih in mladostnikih in štirih ur pri otrocih, mlajših od 12 let.
In normal kidneys, antibodies are not excreted and are excluded from filtration by their size.
V zdravih ledvicah se protitelesa ne izločajo in se zaradi svoje velikosti ne morejo filtrirati.
Monitoring may be insufficient to predict or prevent severe thrombotic microangiopathy complications in patients with aHUS after discontinuation of Soliris.
Spremljanje mogoče ne bo zadostovalo za napoved ali preprečitev težkih zapletov trombotične mikroangiopatije pri bolnikih z aHUS po ukinitvi zdravila Soliris.
At data cut off (20 April 2012)
1 Ob koncu zbiranja podatkov (20. aprila 2012).
• sudden and rapid development of extremely high blood pressure, low blood pressure, hot flush, vein disorder
• nenaden in hiter nastanek izjemno visokega krvnega tlaka, nizek krvni tlak, vročinski oblivi,
Instructions for Use for Healthcare Professionals Handling Soliris
Navodila za uporabo za zdravstveno osebje, ki ravna z zdravilom Soliris
FACIT-Fatigue score at last available assessment (median)
Utrujenost po lestvici FACIT ob zadnji razpoložljivi oceni (mediana)
Older people There are no special precautions needed for the treatment of patients aged from 65 years and over.
Za zdravljenje starejših bolnikov, starih 65 let in več, niso potrebni posebni previdnostni ukrepi.
Major baseline characteristics were balanced (see Table 2).
Glavne izhodiščne karakteristike so bile uravnotežene (glejte preglednico 2).
The most serious side effect was meningococcal sepsis.
Najbolj resen neželeni učinek je bila meningokokna sepsa.
The healthcare professionals should be advised to look for risk factors and signs and symptoms of Aspergillus infection.
Zdravstvenim delavcem je treba svetovati, naj bodo pozorni na dejavnike tveganja ter na znake in simptome okužbe z glivo vrste Aspergillus.
However, renal function was not changed due to prior irreversible kidney damage (Table 16).
Vendar pa zaradi predhodno nastale ireverzibilne okvare ledvic ni prišlo do sprememb ledvične funkcije (preglednica 16).
You should take into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”.
Če ste pozabili na termin za zdravljenje z zdravilom Soliris Če ste pozabili na termin, se takoj posvetujte z zdravnikom in si oglejte spodnje poglavje »Če ste prenehali uporabljati zdravilo Soliris«.
All physicians who intend to prescribe Soliris must ensure they are familiar with the physician's guide to prescribing.
Vsi zdravniki, ki nameravajo predpisovati zdravilo Soliris, morajo zagotoviti, da so seznanjeni z navodili za predpisovanje.
Refractory gMG
Refraktarna gMG
All patients enrolled in both prospective studies had an ADAMTS-13 level above 5%.
Vsi bolniki, ki so bili vključeni v obe prospektivni študiji, so imeli raven ADAMTS-13 nad 5 %.
The median patient age was 35 (range: 18 to 80 years).
Mediana starost bolnikov je bila 35 (razpon: od 18 do 80) let.
1- How is Soliris supplied?
1- Kako se zdravilo Soliris dobavlja?
• increase of liver enzymes, decrease of the proportion of blood volume that is occupied by red blood cells, decrease in the protein in red blood cells that carries oxygen
• zvišanje jetrnih encimov, zmanjšanje deleža krvnega volumna, ki ga zasedajo rdeče krvne celice, znižanje beljakovine v rdečih krvnih celicah, ki prenaša kisik,
Included Studies: Asthma (C07-002), aHUS(C08-002, C08-003, C10-003, C10-004), Dermatomyositis (C99-006), gMG (C08-001, ECU-MG-301, ECU-MG-302 data cut as of 31Dec2017), Neuromyelitis Optica Spectrum Disorder (ECU-NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05001, E07-001, M07-005, X03-001, X03-001A), Psoriasis (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
NMO-301), IMG (C99-004, E99-004), PNH (C02-001, C04-001, C04-002, C06-002, C07-001, E02-001, E05-001, E07-001, M07-005, X03-001, X03-001A), psoriaza (C99-007), RA (C01-004, C97-001, C99-001, E01-004, E99-001), STEC-HUS (C11-001), SLE (C97-002).
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Če ne poznate spodaj navedenih neželenih učinkov, prosite zdravnika za razlago.
What Soliris is and what it is used for What you need to know before you use Soliris How to use Soliris
Kaj je zdravilo Soliris in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Soliris Kako uporabljati zdravilo Soliris
In aHUS clinical studies, 61 patients (21 paediatric patients) discontinued Soliris treatment with a median follow-up period of 24 weeks.
V kliničnih študijah aHUS je 61 bolnikov (21 pediatričnih bolnikov) prekinilo zdravljenje z zdravilom Soliris z medianim obdobjem spremljanja 24 tednov.
Discontinued treatment PRBC in previous 12 months (median (Q1,Q3))
Koncentrirani eritrociti v preteklih 12 mesecih (mediana (Q1,Q3))
These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Ti učinki so bili opaženi pri bolnikih iz vseh treh plasti, opredeljenih glede na število transfuzij eritrocitov pred študijo (4-14 enot; 15-25 enot; > 25 enot).
If the infusion is slowed, the total infusion time may not exceed two hours in adults and adolescents (aged 12 years to under 18 years) and four hours in children aged less than 12 years.
Če se infuzija upočasni, skupni čas infuzije ne sme presegati dveh ur pri odraslih in mladostnikih (starih od 12 do manj kot 18 let) in štirih ur pri otrocih, mlajših od 12 let.
The patient's/carer's guides should be indication specific and contain the following key messages:
Smernice za bolnike/skrbnike morajo biti specifične za indikacije in morajo vsebovati naslednja ključna sporočila:
The Soliris antibody contains human constant regions and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions.
Protitelo zdravila Soliris vsebuje humane konstantne regije in murinske komplementarnost določajoče regije, presajene na humani okvir lahkih in težkih verig z variabilnimi regijami.
Human antibodies undergo endocytotic digestion in the cells of the reticuloendothelial system.
Biotransformacija Humana protitelesa so podvržena endocitotski presnovi v celicah retikuloendotelijskega sistema.
The haemoglobin set-point was less than or equal to 9 g/dL in patients with symptoms and was less than or equal to 7 g/dL in patients without symptoms.
Nastavitvena točka za hemoglobin je bila največ 9 g/dl pri bolnikih s simptomi oziroma največ 7 g/dl pri bolnikih brez simptomov.
Alexion Rhode Island Manufacturing Facility (ARIMF) 100 Technology Way
Velika Britanija Alexion Rhode Island Manufacturing Facility (ARIMF)
If severe thrombotic microangiopathy complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, supportive care with PE/PI, or appropriate organ-specific supportive measures including renal support with dialysis, respiratory support with mechanical ventilation or anticoagulation.
V primeru hudih zapletov trombotične mikroangiopatije po prekinitvi zdravljenja z zdravilom Soliris razmislite o ponovni uvedbi zdravljenja z zdravilom Soliris, podpornem zdravljenju s PE/PI ali za ustrezen organ specifičnih podpornih ukrepih, vključno s podporo ledvic z dializo, podporo dihal z mehansko ventilacijo ali antikoagulacijo.
All patients sustained a reduction in intravascular haemolysis over a total Soliris exposure time ranging from 10 to 54 months.
Pri vseh bolnikih je bilo ohranjeno zmanjšanje intravaskularne hemolize v celotnem obdobju izpostavljenosti zdravilu Soliris, trajajočem od 10 do 54 mesecev.
Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as eculizumab and thereby decrease serum eculizumab concentrations.
Kronično intravensko zdravljenje s humanim imunoglobulinom (IVIg) lahko ovira mehanizem recikliranja monoklonskih protiteles, kakršno je ekulizumab, preko endosomalnega neonatalnega receptorja Fc (FcRn) in tako zmanjša koncentracije serumskega ekulizumaba.
Note: Patients who did not experience an adjudicated On-trial Relapse were censored at the end of the Study Period.
Opomba: podatke bolnikov, ki niso imeli recidiva med preskušanjem po strokovni oceni, so na koncu obdobja študije prilagodili samo delno znanim podatkom.
30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene).
30 ml koncentrata v viali (steklo tipa I) z zamaškom (iz silikonizirane butilne gume) in obročkom (iz aluminija) s pokrovčkom tipa »flip-off« (iz polipropilena).
Primary efficacy endpoints were haemoglobin stabilization (patients who maintained a haemoglobin concentration above the haemoglobin set-point and avoid any RBC transfusion for the entire 26 week period) and blood transfusion requirement.
Končni stanji primarne učinkovitosti sta bili stabilizacija hemoglobina (bolniki, pri katerih se je koncentracija hemoglobina vzdrževala nad nastavitveno točko za hemoglobin ter pri katerih se transfuzija eritrocitov ni izvajala v celotnem 26-tedenskem obdobju) ter potreba po transfuziji krvi.
There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment.
Pri zdravljenju z zdravilom Soliris je prišlo do manjšega števila trombotičnih dogodkov kot v enako dolgem obdobju pred zdravljenjem.
2 to <12 years (n=10)
od 2 do < 12 let (n=10)
Hypersensitivity to eculizumab, murine proteins or to any of the excipients listed in section 6.1.
Preobčutljivost na ekulizumab, mišje beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
• irritation of eye
• razdraženost oči,
In the open-label extension trial (Study ECU-MG-302), physicians had the option to adjust background immunosuppressant therapies.
V odprtem podaljšanem preskušanju (študija ECU-MG-302) so imeli zdravniki možnost, da prilagodijo osnovna imunosupresivna zdravljenja.
Patients may have increased susceptibility to infections, especially with Neisseria and encapsulated bacteria.
Bolniki so lahko bolj dovzetni za okužbe, zlasti z bakterijo
Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days.
Viale zdravila Soliris v originalni ovojnini lahko vzamete iz hladilnika samo enkrat za največ 3 dni.
Adult Patients:
Odmerjanje Odrasli bolniki:
Antibodies to Soliris were detected in 2% of patients with PNH using an ELISA assay, 3% of patients with aHUS and 2% of patients with NMOSD using the ECL bridging format assay.
Protitelesa proti zdravilu Soliris so bila ugotovljena pri 2 % bolnikov s PNH s testom ELISA, 3 % bolnikov z aHUS in 2 % bolnikov z NMOSD z ECL premostitveno metodo.
< 2 months
< 2 meseca
Paediatric patients in PNH and aHUS:
Pediatrična populacija s PNH in aHUS:
This medicinal product contains 115 mg sodium per vial.
To zdravilo vsebuje 115 mg natrija na vialo.
Mean (SD) Median Min, Max
(SD) mediana min, maks
After dilution, the product should be used within 24 hours.
Po razredčenju je treba zdravilo uporabiti v roku 24 ur.
Your doctor will also want to monitor you closely.
Zdravnik bo želel tudi podrobneje spremljati vaše stanje.
Soliris is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Zdravilo Soliris je sestavljeno iz dveh težkih verig s 448 aminokislinami in dveh lahkih verig z 214 aminokislinami ter ima molekulsko maso približno 148 kDa.
Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Patients should be monitored for one hour following infusion.
Stanje bolnikov je treba spremljati eno uro po infuziji.
Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuroinflammatory disorders.
Zdravilo Soliris mora dajati zdravstveni delavec pod nadzorom zdravnika z izkušnjami z zdravljenjem bolnikov s hematološkimi, ledvičnimi, živčnomišičnimi ali nevro-inflamatornimi motnjami.
C5 expression in the human tissue panel examined in this study is consistent with published reports of C5 expression, as C5 has been reported in smooth muscle, striated muscle, and renal proximal tubular epithelium.
Izražanje C5 na panelu človeških tkiv, ki je bilo preučevano v tej študiji, je v skladu z objavljenimi poročili o izražanju C5, saj so o C5 poročali v gladkih mišicah, prečno progastih mišicah in ledvičnem proksimalnem tubulnem epiteliju.
All patients being treated with eculizumab receive a patient safety card.
2. bodo vsi bolniki, ki se zdravijo z ekulizumabom, prejeli opozorilno kartico za bolnika;
• 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