FrancophonIA/ELRC3.0 huggingface dataset:
English: − The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
Slovenian: - Učinkovina je ekulizumab (300 mg/30 ml v viali, kar ustreza 10 mg/ml).
English: Number of PE/PI sessions for current clinical TMA manifestation, median (min, max)
Slovenian: Število terapij PE/PI za nedavno klinično izražene TMA, mediana (min, maks)
English: Infusion Reactions
Slovenian: Reakcije na infuzijo
English: Withdrawal of immunosuppressant therapy during Soliris treatment for NMOSD has not been assessed.
Slovenian: Ukinitve imunosupresivnega zdravljenja med zdravljenjem NMOSD z zdravilom Soliris niso ocenjevali.
English: Each infusion will consist of a dose of 900 mg (3 vials of 30 ml) and will take 25 - 45 minutes.
Slovenian: Vsaka infuzija bo vsebovala odmerek 900 mg (3 viale po 30 ml) in bo trajala 25-45 minut.
English: Paediatric PNH and aHUS patients with body weight ≥ 40 kg are treated with the adult dosing recommendations, respectively.
Slovenian: Pediatrične bolnike s PNH in z aHUS s telesno maso ≥ 40 kg zdravimo po priporočilih za odmerjanje za zdravljenje odraslih.
English: When immunosuppressant therapy is decreased or discontinued, patients should be monitored closely for signs and symptoms of potential NMOSD relapse.
Slovenian: Kadar se imunosupresivno zdravljenje zmanjša ali ukine, je treba bolnike skrbno spremljati glede znakov in simptomov možnega recidiva NMOSD.
English: In refractory gMG patients, uncontrolled terminal complement activation causes membrane attack complex (MAC) dependent lysis and C5a-dependent inflammation at the Neuromuscular Junction (NMJ) leading to failure of neuromuscular transmission.
Slovenian: Pri bolnikih z refraktarno gMG nekontrolirana aktivacija terminalnega komplementa povzroči lizo, odvisno od kompleksa membranskega napada (membrane attack complex - MAC), in od C5a odvisno vnetje v živčnomišičnem stiku (ŽMS), kar povzroči prekinitev živčnomišičnega prenosa.
English: Patients enrolled in aHUS C10-003 had an ADAMTS-13 level above 5%.
Slovenian: vključeni v študijo aHUS C10-003, so imeli raven ADAMTS-13 nad 5 %.
English: Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks.
Slovenian: Zdravilo Soliris je zmanjšalo znake aktivnosti TMA, posredovane s komplementom, kot kaže zvečanje povprečnega števila trombocitov od izhodišča do 26. tedna.
English: • Patient safety card
Slovenian: • opozorilno kartico za bolnika.
English: C08-002A/B C08-003A/B
Slovenian: C08-002A/B C08-003A/B Soliris
English: When Soliris treatment was continued for more than 26 weeks, three additional patients (63% of patients in total) achieved Complete TMA response and four additional patients (98% of patients in total) achieved hematologic normalization.
Slovenian: Ko se je zdravljenje z zdravilom Soliris nadaljevalo več kot 26 tednov, so trije dodatni bolniki (vsega skupaj 63 % bolnikov) dosegli popoln odziv TMA, štirje dodatni bolniki (vsega skupaj 98 %
English: What is Soliris used for
Slovenian: Za kaj se zdravilo Soliris uporablja
English: The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant.
Slovenian: Pri ženskah, ki lahko zanosijo, je treba razmisliti o uporabi učinkovite kontracepcije med zdravljenjem in do 5 mesecev po zdravljenju.
English: In aHUS, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated thrombotic microangiopathy.
Slovenian: Pri aHUS je kronična uporaba zdravila Soliris povzročila hitro in trajno zmanjšanje trombotične mikroangiopatije, posredovane s komplementom.
English: ≥15 mL/min/1.73 m2, n (%)
Slovenian: izboljšanje eGFR ≥ 15 ml/min/1,73•m2, n (%)
English: Table 1: Adverse Reactions reported in eculizumab clinical trials, including patients with PNH, aHUS, refractory gMG and NMOSD as well as from postmarketing experience MedDRA System Organ Class
Slovenian: Preglednica 1: Neželeni učinki ekulizumaba v kliničnih preskušanjih, o katerih so poročali pri bolnikih s PNH, aHUS, refraktarno gMG in NMOSD in pri izkušnjah iz obdobja trženja MedDRA glede na organske sisteme
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only).
Slovenian: • tveganje za resne zaplete trombotične mikroangiopatije po prekinitvi zdravljenja z ekulizumabom in odlogu dajanja zdravila, znake in simptome zapleta, spremljanje in zdravljenje (samo za bolnike z aHUS);
English: Soliris has not been studied in patients with PNH who weigh less than 40kg.
Slovenian: Zdravila Soliris niso preučevali pri bolnikih s PNH, ki tehtajo manj kot 40 kg. Odmerjanje zdravila
English: Soliris was administered as an intravenous infusion over 35 minutes.
Slovenian: Zdravilo Soliris so dobili v obliki 35-minutne intravenske infuzije.
English: Table 9 presents the baseline characteristics of the refractory gMG patients enrolled in Study ECU-MG
Slovenian: Preglednica 9 kaže izhodiščne značilnosti bolnikov z refraktarno gMG, vključenih v študijo
English: This medicinal product contains 5 mmol sodium per vial.
Slovenian: Pomožne snovi To zdravilo vsebuje 5 mmol natrija na vialo.
English: The diluted solution of Soliris should be administered by intravenous infusion over 25 - 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump.
Slovenian: Razredčena raztopina zdravila Soliris se daje v obliki 25-45-minutne intravenske infuzije pri odraslih oziroma 1-4-urne intravenske infuzije pri pediatričnih bolnikih s pomočjo kapalnega sistema, brizgalne črpalke ali infuzijske črpalke.
English: Complete TMA response, n (%)
Slovenian: popoln TMA odgovor, n (%)
English: If you stop using Soliris for refractory gMG
Slovenian: Če ste prenehali uporabljati zdravilo Soliris za refraktarno gMG
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gammaglutamyltransferase increased, Haematocrit decreased,
Slovenian: Preiskave zvišana alanin aminotransferaza, zvišana aspartat aminotransferaza, zvišana gamaglutamil transferaza, znižan hematokrit, znižan hemoglobin pozitiven Coombsov test c
English: In Study ECU-MG-301, a clinical responder in the MG-ADL total score was defined as having at least a 3-point improvement.
Slovenian: V študiji ECU-MG-301 je bil bolnik, ki se je klinično odzval na zdravljenje, kar zadeva celotni rezultat MG-ADL, opredeljen kot tisti, ki je imel izboljšanje za vsaj 3 točke.
English: Eculizumab can block the body's inflammatory response, and its ability to attack and destroy its own vulnerable blood and kidney cells.
Slovenian: Ekulizumab lahko blokira vnetni odziv telesa in njegovo zmožnost, da napada in uničuje svoje lastne občutljive krvne in ledvične celice.
English: In aHUS C10-004, mean (±SD) platelet count increased from 119 ± 66 x109/L at baseline to 200 ± 84 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 252 ± 70 x109/L).
Slovenian: V študiji aHUS C10-004 se je povprečno število trombocitov (± SD) zvečalo od 119 ± 66 ×109/l v izhodišču na 200 ± 84 ×109/l en teden po začetku zdravljenja; ta učinek je trajal vseh 26 tednov (povprečno število trombocitov (± SD) v 26. tednu: 252 ± 70 ×109/l).
English: and C08-003A/B.
Slovenian: C08-003A/B
English: • Gently agitate the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the medicinal product and diluent.
Slovenian: • Infuzijsko vrečko z razredčenim zdravilom Soliris rahlo pretresite, da zagotovite temeljito mešanje zdravila in vehikla za redčenje.
English: Haematologic normalization, n (%) (95% CI)
Slovenian: Hematološka normalizacija, n (%) (95-% IZ)
English: • Do not administer Soliris as an intravenous push or bolus injection.
Slovenian: • Zdravila Soliris ni dovoljeno dajati v obliki hitre intravenske ali bolusne injekcije.
English: In paediatric patients with longer duration of current severe clinical TMA manifestation prior to eculizumab, there was TMA control with eculizumab treatment.
Slovenian: Pri pediatričnih bolnikih z daljšim trajanjem nedavne resne manifestacije trombotične mikroangiopatije (TMA) pred ekulizumabom je prišlo ob zdravljenju z ekulizumabom do nadzora
English: Cases of haemolysis have been reported in the setting of missed or delayed Soliris dose in PNH clinical trials (see also Section 4.4).
Slovenian: Poročali so o primerih hemolize pri izpuščenem odmerku ali nepravočasnem dajanju odmerka v kliničnih preskušanjih PNH (glejte tudi poglavje 4.4).
English: Injury, poisoning and procedural complication
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih reakcija, povezana z infuzijo
English: Soliris is also used to treat adult patients with a certain type of disease affecting the muscles and called generalized Myasthenia Gravis (gMG).
Slovenian: Zdravilo Soliris se uporablja tudi za zdravljenje odraslih bolnikov z določeno vrsto bolezni, ki vpliva na mišice in se imenuje generalizirana miastenija gravis (gMG).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Soliris Vsebina pakiranja in dodatne informacije
English: Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections.
Slovenian: Zaradi načina delovanja zdravila je treba pri bolnikih z aktivnimi sistemskimi okužbami zdravljenje z zdravilom Soliris izvajati previdno.
English: • In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 1,200 mg (4 vials of 30 ml) over a 25 - 45 minute period.
Slovenian: • Peti teden vam bo zdravnik dal intravensko infuzijo razredčenega zdravila Soliris v odmerku 1.200 mg (4 viale po 30 ml), ki bo trajala 25-45 minut.
English: • There is an important risk of Aspergillus infection in patients treated with eculizumab.
Slovenian: • pri bolnikih, zdravljenih z ekulizumabom, obstaja pomembno tveganje okužbe z glivo vrste Aspergillus.
English: Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing.
Slovenian: Otroci in mladostniki s PNH in aHUS in tisti s telesno maso 40 kg ali več se zdravijo z odmerki za odrasle.
English: ≥1 stage,
Slovenian: Izboljšanje CKD za ≥ 1 stopnjo,
English: In TRIUMPH, study patients treated with Soliris had significantly reduced (p< 0.001) haemolysis resulting in improvements in anaemia as indicated by increased haemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see Table 3).
Slovenian: (p<0,001) hemolizo, kar je privedlo do izboljšanja slabokrvnosti, kakor to kaže večja stabilizacija hemoglobina in zmanjšanje potrebe po transfuziji eritrocitov v primerjavi z bolniki, zdravljenimi s placebom (glejte preglednico 3).
English: In most PNH patients, eculizumab serum concentrations of approximately 35 microgram/mL are sufficient for essentially complete inhibition of terminal complement-mediated intravascular haemolysis.
Slovenian: Pri večini bolnikov s PNH serumske koncentracije ekulizumaba približno 35 mikrogramov/ml zadoščajo za praktično popolno zavrtje intravaskularne hemolize, posredovane s terminalnim komplementom.
English: A total of 7 PNH paediatric patients, with a median weight of 57.2 kg (range of 48.6 to 69.8 kg) and aged from 11 to 17 years (median age : 15.6 years), received Soliris in study M07-005.
Slovenian: V študiji M07-005 je bilo z zdravilom Soliris skupaj zdravljenih 7 pediatričnih bolnikov s PNH, z mediano telesne mase 57,2 kg (razpon od 48,6 do 69,8 kg) in starih od 11 do 17 let (mediana starosti: 15,6 let).
English: Table 2: Patient Demographics and Characteristics in C04-001 and C04-002 C04-001
Slovenian: Preglednica 2: Demografske in druge značilnosti bolnikov v študijah C04-001 in C04-002
English: Time from NMOSD initial clinical presentation to first dose of study drug (years)
Slovenian: Čas od prvega kliničnega pojavljanja NMOSD do prvega odmerka zdravila v kliničnem preskušanju (leta)
English: The primary analysis of the MG-ADL was a Worst-Rank ANCOVA with a mean rank of 56.6
Slovenian: Primarna analiza MG-ADL je bila analiza najslabšega ranga (Worst-Rank) ANCOVA s srednjim rangom 56,6 za zdravilo Soliris in 68,3 za placebo na podlagi
English: Dermatitis, Skin depigmentation
Slovenian: suha koža dermatitis,
English: It is not necessary to protect the diluted solution of Soliris from light during administration to the patient.
Slovenian: Razredčene raztopine zdravila Soliris med dajanjem bolniku ni treba zaščititi pred svetlobo.
English: In paediatric PNH and aHUS patients with body weight below 40 kg, the Soliris dosing regimen consists of: Patient Body Weight
Slovenian: Pri pediatričnih bolnikih s PNH in z aHUS s telesno maso manj kot 40 kg je shema odmerjanja zdravila Soliris sestavljena iz:
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA25
Slovenian: Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC:
English: • Risk of substantial disease exacerbation or relapse (in refractory gMG and NMOSD) following discontinuation/postponement of eculizumab administrations and recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Slovenian: • tveganje za znatno eksacerbacijo bolezni ali recidiv (pri refraktarni gMG in NMOSD) po prekinitvi/odlogu dajanja ekulizumaba in priporočilo, naj se pred prekinitvijo/odlogom zdravljenja z ekulizumabom posvetujejo z zdravnikom, ki je zdravilo predpisal,
English: RMP presented in Module 1.8.2 of the Marketing Authorisation, and any agreed subsequent updates of the
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Table 8: Efficacy Outcomes in Prospective aHUS Study C10-004
Slovenian: Preglednica 8: Izidi učinkovitosti v prospektivni študiji aHUS C10-004
English: If you stop using Soliris for PNH
Slovenian: Če ste prenehali uporabljati zdravilo Soliris za PNH
English: Immunosuppressant and anticholinesterase therapies Patients in refractory gMG clinical trials continued treatment with immunosuppressant and anticholinesterase therapies while on Soliris treatment.
Slovenian: Bolniki v kliničnih preskušanjih refraktarne gMG so nadaljevali zdravljenje z imunosupresivnimi in antiholinesteraznimi zdravljenji, ko so se zdravili z zdravilom Soliris.
English: Meningococcal Infection
Slovenian: Meningokokna okužba
English: In Study ECU-MG-301, gMG patients with a positive serologic test for anti-AChR antibodies, MGFA (Myasthenia Gravis Foundation of America) clinical classification class II to IV and MG-ADL total score
Slovenian: V študiji ECU-MG-301 so bolnike z gMG, ki so imeli pozitiven serološki test za protitelesa proti AChR, klinično uvrstitev po MGFA (Myasthenia Gravis Foundation of America; Ameriška fundacija za miastenijo gravis) v skupino II do IV in celotni rezultat MG-ADL ≥ 6, randomizirali bodisi na zdravilo Soliris (n = 62) bodisi na placebo (n = 63).
English: As a result, patients with complement-mediated diseases, including PNH, aHUS, refractory gMG and NMOSD, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH), TMA (aHUS), MG exacerbation (refractory gMG) or relapse (NMOSD).
Slovenian: Zato se pri bolnikih z boleznimi, ki jih posreduje komplement, vključno s PNH, aHUS, refraktarno gMG in NMOSD, lahko pojavijo močnejši znaki in simptomi njihove osnovne bolezni, na primer hemoliza (PNH), TMA (aHUS), eksacerbacija MG
English: If aHUS patients discontinue treatment with Soliris, they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications.
Slovenian: Pri bolnikih z aHUS, ki prekinejo zdravljenje z zdravilom Soliris, je treba skrbno nadzirati znake in simptome hudih zapletov trombotične mikroangiopatije.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in eculizumab completed clinical trials, including PNH, aHUS, refractory gMG and NMOSD studies.
Slovenian: Seznam neželenih učinkov v preglednici Preglednica 1 navaja opazovane neželene učinke iz spontanega poročanja in iz zaključenih kliničnih preskušanj z ekulizumabom, vključno s študijami PNH, aHUS, refraktarne gMG in NMOSD.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 30 ml (10 mg/ml)
Slovenian: koncentrat za raztopino za infundiranje 1 viala s 30 ml (10 mg/ml)
English: 600 mg per each plasmapheresis or plasma exchange session
Slovenian: 600 mg na vsako plazmaferezo ali izmenjavo plazme
English: Common: may affect up to 1 in 10 people:
Slovenian: Pogosti: pojavijo se lahko pri največ 1 do 10 bolnikov:
English: Each vial of Soliris contains 300 mg of active ingredient in 30 ml of product solution.
Slovenian: Ena viala zdravila Soliris vsebuje 300 mg učinkovine v 30 ml raztopine.
English: LDH level at 6 months (median, U/L)
Slovenian: Raven LDH po 6 mesecih (mediana, enot/l)
English: What you need to know before you use Soliris
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Soliris Ne uporabljajte zdravila Soliris,
English: The use of adequate contraception to prevent pregnancy and for at least 5 months after the last dose of treatment with eculizumab should be considered for women of childbearing potential.
Slovenian: 4.6 Plodnost, nosečnost in dojenje Pri ženskah v rodni dobi je treba razmisliti o uporabi ustrezne kontracepcije za preprečevanje nosečnosti med zdravljenjem in še za vsaj 5 mesece po zadnjem odmerku zdravljenja z ekulizumabom.
English: Plasmapheresis or plasma exchange
Slovenian: Plazmafereza ali izmenjalna transfuzija s plazmo
English: Drug distribution will only be possible after written confirmation that the patient received or will receive meningococcal vaccination and/or antibiotic prophylaxis.
Slovenian: 3. bo distribucija zdravila možna samo po pisnem zagotovilu, da je bolnik bil ali bo cepljen proti meningokoku oziroma da je ali bo prejel ustrezno antibiotično profilakso; 4. bodo zdravniki, ki predpisujejo zdravilo, prejeli opomnik za cepljenje.
English: Most Recent Soliris Dose
Slovenian: Zadnji odmerek zdravila Soliris
English: • Soliris should only be administered via intravenous infusion.
Slovenian: • Zdravilo Soliris se daje samo kot intravenska infuzija.
English: • severe infection (meningococcal infection), sepsis, septic shock, viral infection, , lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis
Slovenian: • huda okužba (meningokokna okužba), sepsa, septični šok, virusna okužba, okužba spodnjih dihal, trebušna gripa (okužba prebavil), cistitis (vnetje sečnega mehurja),
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care.
Slovenian: • znaki in simptomi hude okužbe in potreba po nujni medicinski pomoči, • opozorilno kartico za bolnika mora imeti bolnik vedno pri sebi.
English: FACIT-Fatigue score at baseline (median)
Slovenian: Utrujenost po lestvici FACIT ob izhodišču (mediana)
English: Septic shock, Peritonitis, Lower respiratory tract infection, Fungal infection, Viral a, infection, Abscess Cellulitis, Influenza, Gastrointestinal infection, Cystitis, Infection, Sinusitis,
Slovenian: sepsa, septični šok, peritonitis, okužba spodnjih dihal, okužba z glivicami, virusna okužba, absces a, celulitis,
English: Gently agitate the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent.
Slovenian: Infuzijsko vrečko z razredčeno raztopino rahlo pretresite, da zagotovite temeljito mešanje zdravila in vehikla za redčenje.
English: Parameter aHUS Study C10-004 N = 41
Slovenian: Študija aHUS C10-004
English: p-value a Based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.
Slovenian: Učinek zdravljenjaa razmerje pogostnosti (ekulizumab/placebo) 95-% IZ vrednost p a Na podlagi Poissonove regresije, popravljene za plasti randomizacije in anamnestične ARR v 24 mesecih pred presejanjem.
English: n (%) (95% CI)
Slovenian: n (%) (95-% IZ)
English: Table 6 summarizes the efficacy results for aHUS Study C08-003A/B.
Slovenian: V preglednici 6 je povzetek rezultatov učinkovitosti za študijo aHUS C08-003A/B.
English: The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001).
Slovenian: 26-tedenske randomizirane dvojno slepe, s placebom kontrolirane študije (C04-001).
English: Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Slovenian: Zdravilo Soliris se uporablja za zdravljenje odraslih in pediatričnih bolnikov z določeno vrsto bolezni, ki prizadene krvni sistem, imenovano paroksizmalna nočna hemoglobinurija (PNH).
English: 300 mg per each plasmapheresis or plasma exchange session
Slovenian: 300 mg na vsako plazmaferezo ali izmenjavo plazme
English: The diluted solution should be allowed to warm to room temperature prior to administration by exposure to ambient air.
Slovenian: Pred uporabo razredčeno raztopino izpostavite temperaturi okolice in počakajte, da se ogreje na sobno temperaturo.
English: Daily TMA Intervention rate, median (range) Before eculizumab treatment, median On eculizumab treatment, median
Slovenian: (razpon) pred zdravljenjem z ekulizumabom, mediana ob zdravljenju z ekulizumabom, mediana
English: • Maintenance phase: 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).
Slovenian: • faza vzdrževanja: 900 mg zdravila Soliris se daje v obliki 25-45-minutne intravenske infuzije v petem tednu, čemur sledi 900 mg zdravila Soliris v obliki 25-45-minutne intravenske infuzije vsakih 14 ± 2 dni (glejte poglavje 5.1).
English: • Maintenance phase: 1,200 mg of Soliris administered via a 25 - 45 minute intravenous infusion for the fifth week, followed by 1,200 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).
Slovenian: • faza vzdrževanja: 1.200 mg zdravila Soliris se daje v obliki 25-45-minutne intravenske infuzije v petem tednu, čemur sledi 1.200 mg zdravila Soliris v obliki 25-45-minutne intravenske infuzije vsakih 14 ± 2 dni (glejte poglavje 5.1).
English: The mean (±SD) platelet count increased from 88 ± 42 x109/L at baseline to 281 ± 123 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 293 ± 106 x109/L).
Slovenian: V študiji aHUS C10-004 se je povprečno število trombocitov (± SD) zvečalo od 88 ± 42 ×109/l v izhodišču na 281 ± 123 ×109/l en teden po začetku zdravljenja; ta učinek je trajal vseh 26 tednov (povprečno število trombocitov (± SD) v 26. tednu: 293 ± 106 ×109/l).
English: Table 15: Efficacy Results in Paediatric Patients Enrolled in aHUS C09-001r
Slovenian: Preglednica 15: Izidi učinkovitosti za pediatrične bolnike, vključene v študijo aHUS C09-001r Parameter učinkovitosti
English: Complete TMA response, n (%) (95%
Slovenian: Popoln TMA odgovor, n (%) (95-% IZ)
English: Free Haemoglobin at end of study (median, mg/dL)
Slovenian: (mediana, enot/l x dan) Prosti hemoglobin ob koncu študije (mediana, mg/dl)
English: • Withdraw the required amount of Soliris from the vial(s) using a sterile syringe.
Slovenian: • S sterilno brizgo odvzemite zahtevano količino zdravila Soliris iz viale (vial).
English: Age at MG Diagnosis (years),
Slovenian: Trajanje MG (leta),
English: Baseline platelet count (x 109/L), median ( min, max)
Slovenian: izhodiščno število trombocitov (×109/l), mediana (min, maks)