FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
Croatian: Prijavljene su ozbiljne infekcije bakterijama roda Neisseria (ne samo bakterijom Neisseria meningitidis), uključujući i diseminirane gonokokne infekcije.
English: Time from NMOSD initial clinical presentation to first dose of study drug (years)
Croatian: Vrijeme između prve kliničke prezentacije NMOSD-a i prve doze ispitivanog lijeka (godine)
English: Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections.
Croatian: Natrijev klorid, natrijev hidrogenfosfat, natrijev dihidrogenfosfat, polisorbat 80 i voda za injekcije.
English: Soliris should only be administered via intravenous infusion as described below.
Croatian: Soliris se smije primijeniti samo intravenskom infuzijom kako je opisano u daljnjem tekstu.
English: • The risk of infusion reactions including anaphylaxis and advice on post-infusion monitoring.
Croatian: • Rizik od reakcija na infuziju uključujući anafilaksiju i savjet o nadzoru bolesnika nakon infuzije.
English: Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description).
Croatian: Liječnici moraju razgovarati s bolesnicima o koristima i rizicima terapije Solirisom i dati im brošuru s informacijama za bolesnike te karticu za bolesnika sa sigurnosnim podacima (vidjeti Uputu o lijeku za opis).
English: 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 ≤
Croatian: Ispitivanje C08-002A/B bilo je prospektivno, kontrolirano ispitivanje otvorenog tipa koje je uključilo bolesnike u ranoj fazi aHUS-a s dokazanim kliničkim manifestacijama trombotične mikroangiopatije, brojem trombocita ≤150 x 10
English: Soliris is indicated in adults and children for the treatment of: - Paroxysmal nocturnal haemoglobinuria (PNH).
Croatian: Soliris je indiciran u odraslih i djece za liječenje: - paroksizmalne noćne hemoglobinurije (PNH).
English: After completion of the initial 26-week treatment period, most patients continued to receive Soliris by enrolling into an extension study.
Croatian: Nakon završetka početnog razdoblja liječenja od 26 tjedana, većina je bolesnika nastavila primati Soliris tako što su bili uključeni u produžetak ispitivanja.
English: Mean Age (SD)
Croatian: Prosječna dob (SD)
English: When immunosuppressant and anticholinesterase therapies are decreased or discontinued, patients should be monitored closely for signs of disease exacerbation.
Croatian: Kada se terapije imunosupresivima i antikolinesteraznim lijekovima smanje ili prekinu, bolesnike treba pomno pratiti zbog moguće pojave znakova egzacerbacije bolesti.
English: weeks, median (range)
Croatian: 26 tjedana, medijan (raspon)
English: 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.
Croatian: U nekih bolesnika komplikacije zbog trombotične mikroangiopatije (TMA) opažene su već nakon 4 tjedna pa sve do 127. tjedna nakon prestanka liječenja Solirisom.
English: aHUS Laboratory Monitoring aHUS patients receiving Soliris therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, 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 aHUS-om koji primaju terapiju lijekom Soliris treba pratiti zbog trombotične mikroangiopatije mjerenjem broja trombocita, serumskog LDH i serumskog kreatinina, a možda će biti potrebno prilagoditi dozu unutar preporučenog rasporeda doziranja od 14 ± 2 dana tijekom faze održavanja (najviše svakih 12 dana).
English: Free Haemoglobin at end of study (median, mg/dL)
Croatian: Slobodni hemoglobin na kraju ispitivanja (medijan, mg/dl)
English: Patients should be instructed that if they develop fever, headache accompanied with fever and/or stiff neck or sensitivity to light, they should immediately seek medical care as these signs may be indicative of meningococcal infection.
Croatian: Bolesnicima treba savjetovati da odmah potraže medicinsku pomoć ako razviju vrućicu, glavobolju praćenu vrućicom i/ili ukočenim vratom ili osjetljivošću na svjetlo, jer ti znakovi mogu ukazivati na meningokoknu infekciju.
English: A second population PK analysis with a standard 1 compartmental model was conducted on the multiple dose PK data from 37 aHUS patients receiving the recommended Soliris regimen in studies C08-002A/B
Croatian: Druga populacijska farmakokinetička analiza sa standardnim modelom jednog odjeljka provela se pomoću farmakokinetičkih podataka za višestruke doze prikupljenima u 37 bolesnika s aHUS-om koji su primali preporučeni režim lijeka Soliris u ispitivanjima C08-002A/B i C08-003A/B.
English: The efficacy of eculizumab treatment in paediatric PNH patients appears to be consistent with that observed in adult PNH patients enrolled in PNH pivotal Studies (C04-001 and C04-002) (Table 3 and
Croatian: Djelotvornost terapije ekulizumabom u pedijatrijskih bolesnika s PNH-om čini se sukladna onoj opaženoj u odraslih bolesnika s PNH-om uključenih u ključna ispitivanja PNH-a (C04-001 i C04-002) (tablice 3 i 14).
English: TMA-event free status was defined as the absence for at least 12 weeks of the following: decrease in platelet count of > 25% from baseline, PE/PI, and new dialysis.
Croatian: Stanje bez TMA incidenta definiralo se kao najmanje 12 tjedana bez smanjenja broja trombocita za >25% u odnosu na početnu vrijednost, bez PE/PI terapije i nove dijalize.
English: Pharmacokinetics and Drug Metabolism
Croatian: Farmakokinetika i metabolizam lijeka Biotransformacija
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.
Croatian: Kada je liječenje Solirisom nastavljeno više od 26 tjedana, tri dodatna bolesnika (63% od ukupnog broja bolesnika) postiglo je potpuni TMA odgovor a 4 dodatna bolesnika (98% od ukupnog broja bolesnika) postiglo je hematološku normalizaciju.
English: If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with Soliris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Croatian: Ako je Vaše dijete mlađe od dobi prikladne za cijepljenje ili ako Vi niste cijepljeni barem 2 tjedna prije početka liječenja lijekom Soliris, liječnik će Vam propisati antibiotike kako bi se smanjio rizik od infekcije, a uzimat ćete ih tijekom 2 tjedna od obavljenog cijepljenja.
English: Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s)
Croatian: Dokazana klinička korist pokazala se u bolesnika s hemolizom i kliničkim simptomom
English: • The risk of developing antibodies to eculizumab.
Croatian: • Rizik od razvoja protutijela na ekulizumab.
English: Dosing for paediatric patients <40 kg is based on paediatric patients with aHUS.
Croatian: Doziranje u pedijatrijskih bolesnika težine <40 kg temeljilo se na onom primjenjivanom u pedijatrijskih bolesnika s aHUS-om.
English: LDH AUC at end of study (median, U/L x Day)
Croatian: LDH AUC na kraju ispitivanja (medijan, U/l x dan)
English: • Signs and symptoms of infection and sepsis.
Croatian: • Znakovi i simptomi infekcije i sepse.
English: FACIT-Fatigue score at last available assessment (median)
Croatian: Rezultat FACIT-umor na zadnjem dostupnom pregledu (medijan)
English: Within 60 minutes after each plasmapheresis or plasma exchange
Croatian: Unutar 60 minuta nakon svake plazmafereze ili zamjene plazme
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.
Croatian: Razrijeđenu otopinu lijeka Soliris treba primijeniti intravenskom infuzijom u trajanju od 25 - 45 minuta u odraslih i 1 - 4 sata u pedijatrijskih bolesnika, običnom infuzijom, pumpom za štrcaljku ili infuzijskom pumpom.
English: Patients must receive vaccination according to current national vaccination guidelines for vaccination use.
Croatian: Bolesnike se mora cijepiti u skladu s važećim nacionalnim smjernicama za cijepljenje.
English: • inflammation of the skin, skin color disorder
Croatian: • upala kože, poremećaj boje kože,
English: An interim analysis of Study ECU-NMO-302 demonstrates a significant and clinically meaningful reduction in On-trial ARR (as determined by the Treating Physician) on eculizumab treatment, based on the median (min, max) change (-1.829 [-6.38, 1.63], p<0.0001) from historical ARR (24 months prior to screening in Study ECU-NMO-301).
Croatian: Međuanaliza provedena za ispitivanje ECU-NMO-302 pokazuje da je liječenje ekulizumabom dovelo do statistički značajnog i klinički važnog smanjenja godišnje stope recidiva u ispitivanju (kako je utvrdio nadležni liječnik) na temelju medijana (min, maks) promjene (-1,829 [-6,38; 1,63], p<0,0001),
English: In aHUS Study C08-002A/B, the median duration of Soliris therapy was approximately100 weeks (range: 2 weeks to 145 weeks).
Croatian: U ispitivanju aHUS-a C08-002A/B medijan trajanja terapije lijekom Soliris iznosio je približno 100 tjedana (raspon: 2 tjedna do 145 tjedana).
English: • infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), Haemophilus influenzae infection, gum infection, impetigo, bacterial sexual transmitted disease (gonorrhea)
Croatian: • gljivična infekcija (infekcija plijesnima iz roda Aspergillus), infekcija zglobova (bakterijski artritis), infekcija bakterijom Haemophilus influenzae, infekcija desni, impetigo, bakterijska spolno prenosiva bolest (gonoreja)
English: Dedicated studies have not been conducted to evaluate the pharmacokinetics of Soliris in special patient populations identified by gender, race, age (geriatric), or the presence of renal or hepatic impairment.
Croatian: Nisu provedena ispitivanja isključivo radi procjene farmakokinetike Solirisa u posebnih populacija bolesnika razgraničenih po spolu, rasi, dobi (gerijatrijski bolesnici) ili prisutnosti oštećenja funkcije bubrega ili jetre.
English: Weight was a significant covariate resulting in a lower eculizumab clearance 0.0105 L/h in the adolescent PNH patients.
Croatian: Težina je bila značajna kovarijata koja je u adolescentnih bolesnika s PNH-om rezultirala nižim klirensom ekulizumaba od 0,0105 l/h.
English: Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Croatian: Nisu provedena ispitivanja utjecaja ekulizumaba na reprodukciju u životinja (vidjeti dio 5.3).
English: Table 15: Efficacy Results in Paediatric Patients Enrolled in aHUS C09-001r
Croatian: Tablica 15: Rezultati ispitivanja djelotvornosti u pedijatrijskih bolesnika uključenih u ispitivanje aHUS-a C09-001r
English: All patients being treated with eculizumab receive a patient safety card.
Croatian: 2. da svi bolesnici koji se liječe ekulizumabom dobiju karticu za bolesnika sa sigurnosnim podacima
English: In a NMOSD placebo controlled study, 2/96 (2%) of the Soliris treated patients showed antidrug antibody response post-baseline.
Croatian: U placebom kontroliranom ispitivanju NMOSD-a, 2 od 96 (2%) bolesnika liječenih Solirisom odgovorila su stvaranjem protutijela protiv lijeka nakon početka ispitivanja.
English: 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.
Croatian: rezultat [nominalni p=0,0597] i mRS [nominalni p=0,0154]), funkcionalnu onesposobljenost (HAI [nominalni p=0,0002]) te kvalitetu života (EQ-5D VAS [nominalni p=0,0309] i indeks EQ-5D [nominalni p=0,0077]).
English: Treatment discontinuation for NMOSD:
Croatian: Prekid liječenja NMOSD-a
English: Lonza Biologics, plc.
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Lonza Biologics, plc.
English: • kidney disorder, difficulties or pain when urinating (dysuria), blood in urine
Croatian: • poremećaj bubrega, poteškoće ili bol pri mokrenju (dizurija), krv u mokraći
English: Hepatic impairment The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Croatian: Oštećenje funkcije jetre Sigurnost i djelotvornost lijeka Soliris nisu ispitane u bolesnika s oštećenjem funkcije jetre.
English: Overall, the efficacy results for these paediatric patients appeared consistent with what was observed in patients enrolled in aHUS pivotal Studies C08-002 and C08-003 (Table 6).
Croatian: Rezultati djelotvornosti u pedijatrijskih bolesnika općenito su bili sukladni onima primijećenima u bolesnika uključenih u ključna ispitivanja aHUS-a C08-002 i C08-003 (tablica 6).
English: If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician.
Croatian: Ako za vrijeme primjene lijeka Soliris nastupe nuspojave, infuziju treba usporiti ili prekinuti ovisno o procjeni liječnika.
English: 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).
Croatian: U 26. tjednu, udio bolesnika s kliničkim odgovorom bez simptomatske terapije bio je 59,7% u skupini koja je primala Soliris u usporedbi s 39,7% u skupini koja je primala placebo (p = 0,0229).
English: Patients who entered NMOSD clinical trials while receiving background immunosuppressant therapy continued treatment with immunosuppressant therapy while on Soliris treatment (See section 5.3).
Croatian: Bolesnici koji su bili uključeni u klinička ispitivanja NMOSD-a dok su primali osnovnu terapiju imunosupresivima nastavili su s tom terapijom i tijekom liječenja Solirisom (vidjeti dio 5.3).
English: Soliris can block the body's inflammatory response, and its ability to attack and destroy its own eye nerves and spinal cord, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living.
Croatian: Soliris može blokirati upalnu reakciju tijela i sposobnost tijela da napada i uništava vlastite očne živce i leđnu moždinu, te tako smanjuje simptome bolesti te utjecaj bolesti na svakodnevni život.
English: • Physician's guides to prescribing
Croatian: • upute liječnicima za propisivanje lijeka
English: Table 3: Efficacy Outcomes in C04-001 and C04-002 C04-001
Croatian: Tablica 3: Ishodi u pogledu djelotvornosti u ispitivanjima C04-001 i C04-002 C04-001
English: No patient required new dialysis with Soliris.
Croatian: Nijednom bolesniku nije bila potrebna nova dijaliza uz Soliris.
English: Stratified analyses are based on four randomization strata: (i) low EDSS at randomization (<=2.0), (ii) high EDSS (>=2.5 to <=7) and treatment naive at randomization, (iii) high EDSS (>=2.5 to <=7) and continuing on the same IST(s) since last relapse at randomization, (iv) high EDSS (>=2.5 to <=7) and changes in IST(s) since last relapse at randomization.
Croatian: (i) bolesnici s niskim EDSS rezultatom pri randomizaciji (<=2,0), (ii) bolesnici s visokim EDSS rezultatom (>=2,5 do <=7) pri randomizaciji koji prethodno nisu bili liječeni, (iii) bolesnici s visokim EDSS rezultatom (>=2,5 do <=7) pri randomizaciji koji su i dalje primjenjivali istu terapiju imunosupresivima kojom su se liječili nakon posljednjeg recidiva, (iv) bolesnici s visokim EDSS rezultatom (>=2,5 do <=7) pri randomizaciji kojima se terapija imunosupresivima kojom su se liječili nakon posljednjeg recidiva promijenila.
English: A total of 10 patients received PE/PI prior to eculizumab.
Croatian: Ukupno 10 bolesnika primilo je PE/PI prije ekulizumaba.
English: Fresh frozen plasma infusion
Croatian: Infuzija svježe zamrznute plazme
English: Fertility No specific study of eculizumab on fertility has been conducted.
Croatian: Nisu provedena posebna ispitivanja utjecaja ekulizumaba na plodnost.
English: Soliris was administered as an intravenous infusion over 35 minutes.
Croatian: Soliris se primjenjivao kao intravenska infuzija u trajanju od 35 minuta.
English: Meningococcal infection includes the following group of PTs: Meningococcal infection, Meningococcal sepsis, Meningitis meningococcal, Neisseria infection.
Croatian: Meningokokna infekcija uključuje sljedeću skupinu preporučenih pojmova: meningokokna infekcija, meningokokna sepsa, meningokokni meningitis, infekcija bakterijom Neisseria.
English: Chronic administration of Soliris results in immediate, complete, and sustained inhibition of terminal complement activity.
Croatian: Kronična primjena Solirisa dovodi do trenutne, potpune i dugotrajne inhibicije aktivnosti terminalnih komponenti komplementa.
English: In paediatric patients with shorter duration of current severe clinical thrombotic microangiopathy (TMA) manifestation prior to eculizumab, there was TMA control and improvement of renal function with eculizumab treatment (Table 15).
Croatian: U pedijatrijskih bolesnika s kraćim trajanjem postojeće klinički teške manifestne trombotične mikroangiopatije (TMA) prije ekulizumaba, uz liječenje ekulizumabom TMA je bila pod kontrolom i poboljšala se funkcija bubrega (tablica 15).
English: Table 5: Patient Demographics and Characteristics in C08-002A/B and C08-003A/B
Croatian: Tablica 5: Demografski podaci i značajke bolesnika u ispitivanjima C08-002A/B i C08-003A/B Parametar
English: − The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
Croatian: Djelatna tvar je ekulizumab (300 mg/30 ml u bočici što odgovara 10 mg/ml).
English: Cases of thrombotic microangiopathy complication have been reported in the setting of missed or delayed Soliris dose in aHUS clinical trials (see also Section 4.4).
Croatian: Slučajevi komplikacije zbog trombotične mikroangiopatije zabilježeni su u situacijama kad se propustilo ili zakasnilo s primjenom doze lijeka Soliris u kliničkim ispitivanjima aHUS-a (vidjeti također dio 4.4).
English: • destruction of red blood cells (haemolysis), clumping of cells, abnormal clotting factor, abnormal blood clotting,
Croatian: • raspadanje crvenih krvnih stanica (hemoliza), sljepljivanje stanica, abnormalnosti faktora zgrušavanja, abnormalno zgrušavanje krvi
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gammaglutamyltransferase increased, Haematocrit decreased,
Croatian: Pretrage povišena alanin aminotransferaza, povišena aspartat aminotransferaza, povišena gama-glutamil transferaza, snižen hematokrit, snižen hemoglobin pozitivan Coombsov testc
English: Adverse reactions reported in patients with disease other than PNH, aHUS, refractory gMG or NMOSD were similar to those reported in patients with PNH, aHUS, refractory gMG or NMOSD (see Table 1 above).
Croatian: Nuspojave zabilježene u bolesnika s bolestima koje nisu PNH, aHUS, refraktorni gMG ili NMOSD bile su slične onima zabilježenim u bolesnika s PNH-om, aHUS-om, refraktornim gMG-om ili NMOSD-om (vidjeti tablicu 1 iznad).
English: • abnormal leakage of the infused drug out of the vein, infusion site abnormal sensation, feeling hot
Croatian: • abnormalno istjecanje lijeka iz vene za vrijeme infuzije, neuobičajen osjećaj na mjestu infuzije,
English: • Gently agitate the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the medicinal product and diluent.
Croatian: • Lagano protresite infuzijsku vrećicu koja sadrži razrijeđenu otopinu lijeka Soliris kako bi se sadržaj lijeka temeljito pomiješao s otapalom.
English: 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.
Croatian: Registar bolesnika s PNH-om (M07-001) kako bi se opisao prirodni tijek PNH-a kod neliječenih bolesnika i klinički ishodi tijekom liječenja lijekom Soliris.
English: Haemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry.
Croatian: Hemoliza se uglavnom pratila pomoću mjerenja razine LDH u serumu, a udio PNH crvenih krvnih stanica pratio se protočnom citometrijom.
English: The final volume of a 5 mg/ml diluted Soliris solution is 60 ml for 300 mg doses,
Croatian: Konačni volumen od 5 mg/ml razrijeđene otopine lijeka Soliris iznosi 60 ml za dozu od 300 mg,
English: Soliris can block the body's inflammatory response, and its ability to attack and destroy its own muscles to improve muscle contraction, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living.
Croatian: Soliris može blokirati upalnu reakciju tijela i sposobnost tijela da napada i uništava vlastite mišiće, te tako poboljšava stezanje mišića, smanjuje simptome bolesti te utjecaj bolesti na svakodnevni život.
English: Soliris (eculizumab) has not been studied for the treatment of acute relapses in NMOSD patients.
Croatian: Soliris (ekulizumab) nije ispitivan za liječenje akutnih recidiva u bolesnika s NMOSD-om.
English: In Study ECU-NMO-301, patients with NMOSD with a positive serologic test for anti-AQP4 antibodies, a history of at least 2 relapses in last 12 months or 3 relapses in the last 24 months with at least 1 relapse in the 12 months prior to screening and an Expanded Disability Status Scale (EDSS) score ≤ 7, were randomized 2:1 to either Soliris (n = 96) or placebo (n = 47).
Croatian: U ispitivanju ECU-NMO-301, bolesnici s NMOSD-om i pozitivnim serološkim testom na protutijela protiv AQP4, povijesti bolesti od najmanje 2 recidiva u posljednjih 12 mjeseci ili 3 recidiva u posljednja 24 mjeseca te najmanje 1 recidivom u 12 mjeseci prije probira, i rezultatom od ≤7 bodova na proširenoj ocjenskoj ljestvici onesposobljenosti (engl.
English: The adjudicated on-trial annualized relapse rate (ARR) ratio (95% CI) for eculizumab compared with placebo was 0.045 (0.013, 0.151), representing a 95.5% relative reduction in adjudicated On-trial ARR for patients treated with eculizumab compared with placebo (p<0.0001) (Table 13).
Croatian: Prema neovisnoj procjeni, omjer (95% CI) godišnje stope recidiva u ispitivanju iznosio je za ekulizumab u odnosu na placebo 0,045 (0,013; 0,151), što je predstavljalo relativno smanjenje godišnje stope recidiva u ispitivanju prema neovisnoj procjeni od 95,5% za bolesnike liječene ekulizumabom u usporedbi s onima koji su primali placebo (p<0,0001) (tablica 13).
English: Most Recent Soliris Dose
Croatian: Zadnja doza lijeka Soliris
English: Each infusion will consist of a dose of 900 mg (3 vials of 30 ml) and will take 25 - 45 minutes.
Croatian: Svaka infuzija sadržavat će dozu od 900 mg (3 bočice od 30 ml) i trajat će 25 - 45 minuta.
English: Patients enrolled in aHUS C10-003 had an ADAMTS-13 level above 5%.
Croatian: Bolesnici uključeni u ispitivanje aHUS-a C10-003 imali su razinu ADAMTS-13 iznad 5%.
English: The diluted solution should be allowed to warm to room temperature prior to administration by exposure to ambient air.
Croatian: Razrijeđenu otopinu prije primjene treba pustiti da se ugrije na sobnu temperaturu izlaganjem zraku okoline.
English: Population PK analysis on data collected across studies in PNH, aHUS, gMG and NMOSD patients showed gender, race, age (geriatric), or the presence of renal or hepatic impairment.function do not influence the PK of eculizumab.
Croatian: Populacijska farmakokinetička analiza provedena na podacima prikupljenim u ispitivanjima bolesnika s PNH-om, aHUS-om, gMG-om i NMOSD-om pokazala je da spol, rasna pripadnost, dob (gerijatrijski bolesnici) ili prisutnost oštećenja funkcije bubrega ili jetre ne utječu na farmakokinetiku ekulizumaba.