FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematologic normalization was defined as normalization of platelet counts and LDH levels sustained for ≥2 consecutive measurements for ≥4 weeks.
Croatian: Hematološka normalizacija definirala se kao normalizacija broja trombocita i razine LDH koja se održala u ≥2 uzastopna mjerenja tijekom ≥4 tjedna.
English: Soliris change relative to placebo - LS Mean Difference (95%
Croatian: Promjena uz Soliris u odnosu na placebo - razlika srednjih vrijednosti dobivenih metodom najmanjih kvadrata (95% CI)
English: What you need to know before you use Soliris
Croatian: Što morate znati prije nego počnete primjenjivati Soliris Kako primjenjivati Soliris
English: Withdraw the total amount of Soliris from the vial(s) using a sterile syringe.
Croatian: Izvucite ukupnu količinu lijeka Soliris iz bočice (bočica) pomoću sterilne igle.
English: 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.
Croatian: Da bi bili prikladni za uključivanje, bolesnici su morali imati broj trombocita manji od donje granice normalnog raspona (LLN), dokazanu hemolizu kao što je povišenje LDH u serumu te kreatinin u serumu iznad gornje granice normale, bez potrebe za kroničnom dijalizom.
English: Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks.
Croatian: Soliris je smanjio znakove aktivnosti TMA posredovane komplementom, što je vidljivo iz porasta prosječne vrijednosti broja trombocita od početne do 26. tjedna.
English: How to store Soliris
Croatian: Kako čuvati Soliris
English: No paediatric patient required new dialysis during treatment with Soliris.
Croatian: Niti jedan pedijatrijski bolesnik nije trebao novo liječenje dijalizom tijekom liječenja lijekom Soliris.
English: Treatment discontinuation for refractory gMG:
Croatian: Prekid liječenja refraktornog gMG-a
English: Immunosuppressant and anticholinesterase therapies Patients in refractory gMG clinical trials continued treatment with immunosuppressant and anticholinesterase therapies while on Soliris treatment.
Croatian: Terapije imunosupresivima i antikolinesteraznim lijekovima Bolesnici u kliničkim ispitivanjima refraktornog gMG-a nastavili su s terapijama imunosupresivima i antikolinesteraznim lijekovima uz liječenje Solirisom.
English: <2 years (n=5)
Croatian: <2 godine (n = 5)
English: 002A/B C08-003A/B, C10-004) one in paediatric and adolescent patients (C10-003 ) and 30 patients in one retrospective study (C09-001r) were used to evaluate the efficacy of Soliris in the treatment of aHUS.
Croatian: (C08-002A/B, C08-003A/B, C10-004), a jedno u pedijatrijskih i adolescentnih bolesnika (C10-003) te podaci o 30 bolesnika iz jednog retrospektivnog ispitivanja (C09-001r).
English: Table 14: Efficacy Outcomes in Paediatric PNH Study M07-005
Croatian: Tablica 14: Ishodi djelotvornosti u pedijatrijskom ispitivanju PNH-a M07-005 P-vrijednost
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).
Croatian: Sigurnost i djelotvornost primjene lijeka Soliris u bolesnika s PNH-om procijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 26 tjedana
English: Meningococcal Infection
Croatian: Meningokokna infekcija
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.
Croatian: Ako je Vaše dijete mlađe od 18 godina, liječnik će ga cijepiti protiv bakterije Haemophilus influenzae i pneumokoknih infekcija sukladno nacionalnim smjernicama o cijepljenju pojedine dobne skupine.
English: Use of Soliris in NMOSD treatment has been studied only in the setting of chronic administration and the effect of Soliris discontinuation has not been characterized.
Croatian: Primjena Solirisa za liječenje NMOSD-a ispitivana je samo u okolnostima kronične primjene i učinak prekida primjene Solirisa nije opisan.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „Rok valjanosti“.
English: Complete TMA response, n (%)
Croatian: Potpuni TMA odgovor, n (%)
English: Table 12: Patient Disease history and Baseline Characteristics in Study ECU-NMO-301 Variable
Croatian: Tablica 12: Povijest bolesti i početne značajke bolesnika u ispitivanju ECU-NMO-301 Varijabla
English: In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots.
Croatian: Crvene krvne stanice bolesnika s paroksizmalnom noćnom hemoglobinurijom mogu biti uništene, što može dovesti do sniženog broja crvenih krvnih stanica (anemije), umora, otežanog funkcioniranja, bolova, tamne boje mokraće, nedostatka zraka i stvaranja krvnih ugrušaka.
English: MG-ADL
Croatian: MG-ADL QMG
English: eGFR improvement ≥15 mL/min/ 1.73•m2, n (%) Change in eGFR ( ≥15 mL/min/1.73•m2) at 26
Croatian: Poboljšanje eGFR ≥15 ml/min/1,73•m2, n Promjena eGFR (≥15 ml/min/1,73•m2) u
English: Withdrawal of immunosuppressant therapy during Soliris treatment for NMOSD has not been assessed.
Croatian: Prestanak terapije imunosupresivima tijekom liječenja NMOSD-a Solirisom nije procijenjen.
English: Primary endpoints included platelet count change from baseline in study C08-002A/B and thrombotic microangiopathy (TMA) event-free status in study C08-003A/B.
Croatian: Primarni ishodi uključivali su promjenu broja trombocita u odnosu na početnu u ispitivanju C08-002A/B i stanje bez trombotične mikroangiopatije (TMA) u ispitivanju C08-003A/B.
English: Infusion Reactions
Croatian: Reakcije na infuziju
English: In Study C10-003, patients who enrolled in the study were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH above the upper limits of normal and serum creatinine level ≥97 percentile for age without the need for chronic dialysis.
Croatian: Bolesnici uključeni u ispitivanje C10-003 morali su imati broj trombocita manji od donje granice normalnog raspona (LLN), dokazanu hemolizu kao što je povišenje LDH u serumu iznad gornje granice normale te kreatinin u serumu ≥97 percentila za dob, bez potrebe za kroničnom dijalizom.
English: PRBC transfused during treatment (median)
Croatian: Transfuzija eritrocita tijekom liječenja (medijan)
English: Table 11: Clinical deterioration and rescue therapy in ECU-MG-301 Variable
Croatian: Tablica 11: Kliničko pogoršanje i simptomatska terapija u ispitivanju ECU-MG-301 Varijabla
English: (rhinorrhoea)
Croatian: (bolesnici)
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:
Croatian: Dodatne mjere minimizacije rizika Nositelj odobrenja detaljno će dogovoriti kontrolirani sustav distribucije lijeka i edukacijske materijale, uključujući i karticu za bolesnika sa sigurnosnim podacima, sa svim nacionalnim nadležnim tijelima i taj će program morati provesti na nacionalnoj razini kako bi osigurao sljedeće: 1. da svi zdravstveni radnici koji bi mogli propisivati ekulizumab dobiju odgovarajući edukacijski materijal
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).
Croatian: Slučajevi hemolize zabilježeni su u situacijama kad se propustilo ili zakasnilo s primjenom doze lijeka Soliris u kliničkim ispitivanjima PNH-a (vidjeti također dio 4.4).
English: In paediatric patients with longer duration of current severe clinical TMA manifestation prior to eculizumab, there was TMA control with eculizumab treatment.
Croatian: U pedijatrijskih bolesnika s duljim trajanjem postojeće klinički teške manifestne TMA prije ekulizumaba, TMA je bila pod kontrolom uz liječenje ekulizumabom.
English: • Discard any unused portion left in a vial as the medicinal product contains no preservatives.
Croatian: • Bacite neiskorišteni dio lijeka u bočici, jer ne sadrži konzervanse.
English: • After the fifth week, your doctor will administer 1,200 mg of diluted Soliris every two weeks as a long-term treatment.
Croatian: • Nakon petog tjedna, liječnik će Vam davati 1200 mg razrijeđenog lijeka Soliris svaka dva tjedna kao dugoročno liječenje.
English: Eculizumab
Croatian: Ekulizumab
English: Discard any unused portion left in a vial, as the product contains no preservatives.
Croatian: Sav neiskorišteni lijek preostao u bočici bacite, jer ne sadrži konzervanse.
English: Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.1).
Croatian: Nije potrebno prilagođivati dozu u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.1).
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).
Croatian: Bolesnici s PNH-om uključeni u istraživanje liječeni su u jednom kraku istraživanja lijekom Soliris u trajanju od 52 tjedna (C04-002) te u dugotrajnom produžetku ispitivanja (E05-001).
English: Each vial of Soliris contains 300 mg of active ingredient in 30 ml of product solution.
Croatian: Jedna bočica lijeka Soliris sadrži 300 mg djelatne tvari u 30 ml otopine lijeka.
English: • After the fifth week, your doctor will administer 900 mg of diluted Soliris every two weeks as a long-term treatment.
Croatian: • Nakon petog tjedna, liječnik će Vam davati 900 mg razrijeđenog lijeka Soliris svaka dva tjedna kao dugoročno liječenje.
English: Soliris 300 mg concentrate for solution for infusion Eculizumab
Croatian: Soliris 300 mg koncentrat za otopinu za infuziju ekulizumab
English: • fever (pyrexia), feeling tired (fatigue), influenza like illness
Croatian: • vrućica (pireksija), zimica, osjećaj umora (umor), bolest nalik gripi.
English: METHOD OF ADMINISTRATION To be diluted before use.
Croatian: NAČIN PRIMJENE LIJEKA Razrijediti prije primjene.
English: Table 6: Efficacy Outcomes in Prospective aHUS Studies C08-002A/B and C08-003A/B C08-002A/B
Croatian: Tablica 6: Ishodi u pogledu djelotvornosti u prospektivnim ispitivanjima aHUS-a C08-002A/B i C08-003A/B
English: Use of Soliris in refractory gMG treatment has been studied only in the setting of chronic administration.
Croatian: Primjena Solirisa za liječenje refraktornog gMG-a ispitivana je samo u okolnostima kronične primjene.
English: A reduction in intravascular haemolysis as measured by serum LDH levels was sustained for the treatment period and resulted in increased transfusion avoidance, a reduced need for RBC transfusion and less fatigue.
Croatian: Smanjenje intravaskularne hemolize mjereno razinom LDH u serumu održalo se tijekom cijelog razdoblja liječenja i rezultiralo smanjenom potrebom za transfuzijom crvenih krvnih stanica i manjim umorom.
English: When immunosuppressant therapy is decreased or discontinued, patients should be monitored closely for signs and symptoms of potential NMOSD relapse.
Croatian: Kada se terapija imunosupresivima smanji ili prekine, bolesnike je potrebno pomno pratiti zbog moguće pojave znakova i simptoma potencijalnog recidiva NMOSD-a.
English: Abscess includes the following group of PTs: Abscess limb, Colonic abscess, Renal abscess, Subcutaneous abscess, Tooth abscess, Hepatosplenic abscess, Perirectal abscess, Rectal abscess.
Croatian: Apsces uključuje sljedeću skupinu preporučenih pojmova: apsces udova, apsces debelog crijeva, apsces bubrega, potkožni apsces, apsces zuba, hepatosplenični apsces, perirektalni apsces, rektalni apsces.
English: Spain
Croatian: Francuska
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.
Croatian: U ispitivanju PNH-a M07-005 Soliris je primalo ukupno 7 pedijatrijskih bolesnika s medijanom težine 57,2 kg (raspon od 48,6 do 69,8 kg), dobi od 11 do 17 godina (medijan dobi 15,6 godina).
English: In aHUS C10-003, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins or auto-antibodies to factor H.
Croatian: U ispitivanju aHUS-a C10-003, odgovori na Soliris bili su slični i u bolesnika kojima su utvrđene i u onih kojima nisu utvrđene mutacije gena koji kodiraju regulatorne proteine komplementa ili autoprotutijela na faktor H.
English: Change from baseline at 12 weeks of LDH Value (U/L)
Croatian: Promjena vrijednosti LDH-a (U/l) do 12. tjedna od početne vrijednosti LDH AUC
English: Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take 25 - 45 minutes.
Croatian: Jedna infuzija sadržavat će dozu od 600 mg (2 bočice od 30 ml) i trajat će 25 - 45 minuta.
English: p-value a Based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.
Croatian: Poissonove regresije prilagođene za randomizacijski sloj i godišnju stopu recidiva tijekom24 mjeseca prije probira.
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
Croatian: U ispitivanju ECU-MG-301, bolesnici s gMG-om s pozitivnim serološkim testom na protutijela protiv acetilkolinskih receptora, klasom II do IV prema kliničkoj klasifikaciji Američke zaklade za miasteniju gravis (engl.
English: 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.
Croatian: (≥1/1000 i <1/100) ili rijetke (≥1/10 000 i <1/1000) navedene su prema klasifikaciji organskih sustava i preporučenim pojmovima.
English: All patients enrolled in aHUS Study C10-004 had an ADAMTS-13 level above 5%.
Croatian: Svi bolesnici uključeni u ispitivanje aHUS-a C10-004 imali su razinu ADAMTS-13 iznad 5%.
English: In patients with gMG, their muscles can be attacked and damaged by the immune system which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk for aspiration, and markedly impaired activities of daily living.
Croatian: U bolesnika s tom bolešću, imunosni sustav može napasti i oštetiti mišiće, što dovodi do teške mišićne slabosti, narušene pokretljivosti, nedostatka zraka, izrazitog umora, rizika od aspiracije te izrazito narušene sposobnosti za svakodnevni život.
English: PE/PI Event-Free Status, n (%) New Dialysis Event-Free Status, n (%)
Croatian: KBB poboljšanje za ≥1 stupnja, n (%) Status bez PE/PI događaja, n (%) Status bez nove dijalize, n (%)
English: C08-002A/B C08-003A/B
Croatian: C08-002A/B
English: (N = 143)
Croatian: Ukupno (N = 143)
English: Supportive safety data were obtained from 30 completed and one ongoing clinical studies that included 1,503 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG and NMOSD.
Croatian: Podaci koji govore u prilog sigurnosti primjene dobiveni su iz 30 završenih i jednog kliničkog ispitivanja koje još traje, a uključila su 1503 bolesnika izložena ekulizumabu u populacijama bolesnika s komplementom posredovanom bolešću, uključujući PNH, aHUS, refraktorni gMG i NMOSD.
English: 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)
Croatian: Kada je liječenje Solirisom nastavljeno više od 26 tjedana, jedan dodatni bolesnik (68% od ukupnog broja bolesnika) postigao je potpuni TMA odgovor, a 2 dodatna bolesnika (91% od ukupnog broja bolesnika) postigla su hematološku normalizaciju.
English: Eculizumab Placebo
Croatian: (ekulizumab/placebo)
English: Accelerated hypertension, Hypotension, Hot flush, Vein disorder
Croatian: Krvožilni poremećaji hipertenzija ubrzana hipertenzija, hipotenzija, naleti vrućine, venski poremećaj hematomi
English: To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection.
Croatian: Da bi se smanjio rizik od infekcije, svi bolesnici moraju biti cijepljeni protiv meningokokne infekcije najmanje 2 tjedna prije nego što prime Soliris, osim ako odgoda terapije
English: Number of patients with prior MG crisis since diagnosis, n (%)
Croatian: Broj bolesnika s MG krizom između dijagnoze i ispitivanja, n (%)
English: <12 years (n=15)
Croatian: <12 godina (n = 15
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only).
Croatian: • Rizik od teških komplikacija trombotične mikroangiopatije nakon prekida ekulizumaba i odgađanja primjene, znakovi, simptomi, nadzor i liječenje (samo atipični hemolitičko-uremijski sindrom).
English: In aHUS, chronic administration of Soliris resulted in a rapid and sustained reduction in complementmediated thrombotic microangiopathy.
Croatian: Kod aHUS-a, kronična primjena lijeka Soliris rezultirala je brzim i trajnim smanjenjem trombotične mikroangiopatije posredovane komplementom.
English: The primary analysis of the QMG was a Worst-Rank ANCOVA with a mean rank of 54.7 for Soliris and 70.7 for placebo, based on 125 study patients (p=0.0129).
Croatian: Na temelju podataka za 125 bolesnika u ispitivanju, primarna analiza QMG-a bila je ANCOVA najgoreg ranga sa srednjom vrijednošću ranga od 54,7 u skupini koja je primala Soliris i 70,7 u skupini koja je primala placebo (p = 0,0129).
English: CKD improvement by
Croatian: eGFR poboljšanje
English: Table 13: Adjudicated On-trial Annualized Relapse Rate - Full Analysis Set Variable
Croatian: Tablica 13: Godišnje stope recidiva u ispitivanju prema neovisnoj procjeni - potpuni skup za analizu
English: Supportive safety data were obtained in 12 completed clinical studies that included 934 patients exposed to eculizumab in other disease populations other than PNH, aHUS, refractory gMG or NMOSD.
Croatian: Podaci koji govore u prilog sigurnosti primjene dobiveni su iz 12 završenih kliničkih ispitivanja u kojima su sudjelovala 934 bolesnika izložena ekulizumabu iz drugih populacija bolesnika koji nisu imali PNH, aHUS, refraktorni gMG ili NMOSD.
English: PNH patients receiving Soliris therapy should be similarly monitored for intravascular haemolysis by measuring LDH levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Croatian: Bolesnike s PNH koji primaju terapiju lijekom Soliris treba pratiti na sličan način zbog intravaskularne hemolize mjerenjem razina LDH, a možda će biti potrebna prilagodba doze unutar preporučenog rasporeda doziranja od 14 ± 2 dana tijekom faze održavanja
English: for Soliris and 68.3 for placebo, based on 125 study patients (p=0.0698).
Croatian: 68,3 u skupini koja je primala placebo (p = 0,0698).
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.
Croatian: U žena koje mogu zatrudnjeti potrebno je razmotriti upotrebu učinkovite kontracepcije tijekom liječenja i do 5 mjeseci nakon liječenja.
English: • Patient's/carer's information brochures
Croatian: • brošure s informacijama za bolesnika/njegovatelja • karticu za bolesnika sa sigurnosnim podacima.
English: Plasmapheresis or plasma exchange
Croatian: Plazmafereza ili zamjena plazme
English: In paediatric PNH and aHUS patients with body weight below 40 kg, the Soliris dosing regimen consists of: Patient Body Weight
Croatian: U pedijatrijskih bolesnika s paroksizmalnom noćnom hemoglobinurijom i atipičnim hemolitičko-uremijskim sindromom težine manje od 40 kg, režim doziranja lijeka Soliris je sljedeći: Tjelesna težina bolesnika
English: Eculizumab can block the body's inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.
Croatian: Ekulizumab može blokirati upalni odgovor organizma i njegovu sposobnost da napada i uništava vlastite osjetljive PNH krvne stanice.
English: 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.
Croatian: U bolesnika s PNH-om farmakodinamička aktivnost izravno korelira s koncentracijama ekulizumaba u serumu i održavanje najnižih razina iznad ≥35 mikrograma/ml rezultira u biti potpunom blokadom hemolitičke aktivnosti u većine bolesnika s PNH-om.
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.
Croatian: MG-ADL-a (A) i QMG-a (B) nakon 26 tjedana liječenja u ispitivanju ECU-MG-301 te nakon
English: These patients had high disease activity as defined by elevated haemolysis (LDH
Croatian: Ovi su bolesnici imali visokoaktivnu bolest, tako definiranu prema pojačanoj hemolizi (LDH ≥1,5x GGN), i pridruženim kliničkim simptomima:
English: What is Soliris used for
Croatian: Za što se Soliris koristi
English: Reduction in terminal complement activity was observed in all patients after commencement of Soliris.
Croatian: Smanjenje aktivnosti terminalnih komponenti komplementa bilo je opaženo u svih bolesnika nakon početka liječenja lijekom Soliris.
English: Soliris is not expected to affect the aplastic component of anaemia in patients with PNH.
Croatian: Ne očekuje se da će Soliris utjecati na aplastičnu komponentu anemije u bolesnika s paroksizmalnom noćnom hemoglobinurijom.
English: Major baseline characteristics were balanced (see Table 2).
Croatian: Glavne značajke ispitanika na početku ispitivanja bile su uravnoteženo raspodijeljene između skupina (vidjeti tablicu 2).
English: Atypical Haemolytic Uremic Syndrome
Croatian: Atipični hemolitičko-uremijski sindrom
English: Gender - Female (%) History of Aplastic Anaemia or MDS (%) Concomitant Anticoagulants (%) Concomitant Steroids/Immunosuppressant Treatments (%)
Croatian: Istovremeno uzimanje steroida/imunosupresivne terapije (%) Prekid liječenja
English: and C08-003A/B.
Croatian: C08-003A/B
English: (≥1/10,000 to <1/1,000)
Croatian: Rijetko (≥1/10 000 i <1/1000)
English: Baseline eGFR (mL/min/1.73 m2 ), median (min,
Croatian: eGFR na početku (ml/min/1,73 m2), medijan
English: In all studies, the dose of eculizumab was 600 mg every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
Croatian: U svim se ispitivanjima davala doza ekulizumaba od 600 mg svakih 7 ± 2 dana tijekom 4 tjedna, zatim 900 mg 7 ± 2 dana te zatim 900 mg svakih 14 ± 2 dana tijekom cijelog trajanja ispitivanja.
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).
Croatian: Soliris se koristi za liječenje djece i odraslih bolesnika s određenom vrstom bolesti koja zahvaća krv i zove se paroksizmalna noćna hemoglobinurija (PNH).
English: PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels.
Croatian: Laboratorijsko praćenje paroksizmalne noćne hemoglobinurije Bolesnike s PNH treba pratiti zbog znakova i simptoma intravaskularne hemolize, uključujući razinu laktat dehidrogenaze (LDH) u serumu.