FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 18 summarizes the efficacy results for aHUS C10-003.
Croatian: Tablica 18 prikazuje sažete rezultate djelotvornosti u ispitivanju aHUS-a C10-003.
English: ≥6 were randomized to either Soliris (n = 62) or placebo (n = 63).
Croatian: bili su randomizirani u omjeru 2:1 u skupinu koja je primala Soliris (n = 96) ili placebo (n = 47).
English: In patients with NMOSD, uncontrolled terminal complement activation caused by autoantibodies against AQP4 leads to the formation of the MAC and C5a-dependent inflammation which results in astrocyte necrosis and increased permeability of the blood brain barrier, as well as death of the surrounding oligodendrocytes and neurons.
Croatian: C5a, što ima za posljedicu nekrozu astrocita i povećanu propusnost krvno-moždane barijere, a također i smrt okolnih oligodendrocita i neurona.
English: Discontinuation of the therapy should be considered in a patient who shows no evidence of therapeutic benefit by 12 weeks.
Croatian: bolesnika koji ne pokazuje znakove terapijske koristi nakon 12 tjedana, potrebno je razmotriti prekid terapije.
English: Data from 143 patients in one controlled study (Study ECU-NMO-301) and from 119 patients who continued in one open-label extension trial (Study ECU-NMO-302) were used to evaluate the efficacy and safety of Soliris in the treatment of patients with NMOSD.
Croatian: Za procjenu djelotvornosti i sigurnosti primjene Solirisa u liječenju bolesnika s NMOSD-om upotrijebljeni su podaci 143 bolesnika iz jednog kontroliranog ispitivanja (ispitivanje ECU-NMO-301) i 119 bolesnika koji su nastavili sudjelovati u otvorenom produžetku ispitivanja (ispitivanje
English: For 1,200 mg doses, use 120 ml of Soliris and add
Croatian: Za doze od 1200 mg upotrijebite 120 ml lijeka Soliris i dodajte 120 ml otapala.
English: Forty seven percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Croatian: U 47% bolesnika utvrđena je mutacija gena koji kodiraju regulatorni čimbenika komplementa ili autoprotutijela.
English: Vaccines against serogroups A, C, Y, W 135 and B where available are recommended in preventing the commonly pathogenic meningococcal serogroups.
Croatian: Za sprječavanje najčešćih patogenih seroloških skupina meningokoka preporučuju se cjepiva protiv seroloških skupina A, C, Y, W 135 i B, ako su dostupna (vidjeti Meningokokna infekcija).
English: • Risk of serious haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Croatian: • Rizik od ozbiljne hemolize (kod PNH-a) nakon prekida/odgode primjene ekulizumaba, njezini znakovi i simptomi te preporuka da se potraži savjet nadležnog liječnika prije prekida/odgode primjene ekulizumaba.
English: RMP presented in Module 1.8.2 of the Marketing Authorisation, and any agreed subsequent updates of the
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Fifty percent of patients had an identified complement regulatory factor mutation or auto-antibody.
Croatian: U 50% bolesnika utvrđena je mutacija gena čimbenika regulatornog komplementa ili autoprotutijela.
English: • Initial phase: 600 mg of Soliris administered via a 25 - 45 minute intravenous infusion every week for the first 4 weeks.
Croatian: • Početna faza: 600 mg lijeka Soliris primjenjuje se intravenskom infuzijom u trajanju od 25 - 45 minuta jedanput na tjedan tijekom prva 4 tjedna.
English: Despite Soliris re-initiation following discontinuation, progression to end stage renal disease occurred in one patient.
Croatian: Progresija do završnog stadija bolesti bubrega dogodila se u jednog bolesnika unatoč tome što je liječenje Solirisom, nakon prekida, ponovno započeto.
English: Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Croatian: Almac Pharma Service 22 Seagoe Industrial Estate
English: Pneumonia, Upper respiratory tract infection, Bronchitis, Nasopharyngitis, Urinary tract infection, Oral Herpes
Croatian: Infekcije i infestacije pneumonija, infekcije gornjih dišnih puteva, bronhitis, nazofaringitis,
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Croatian: • Rizik od teških komplikacija trombotične mikroangiopatije (kod aHUS-a) nakon prekida/odgode primjene ekulizumaba, njihovi znakovi i simptomi te preporuke da se potraži savjet nadležnog liječnika prije prekida/odgode primjene ekulizumaba.
English: EU/1/07/393/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/393/001
English: Patients who discontinue Soliris treatment should be carefully monitored for signs and symptoms of disease exacerbation.
Croatian: Bolesnike u kojih se liječenje Solirisom prekine potrebno je pažljivo pratiti zbog moguće pojave znakova i simptoma egzacerbacije bolesti.
English: Table 9: Patient Demographic and Characteristics in Study ECU-MG-301
Croatian: Tablica 9: Demografski podaci i karakteristike bolesnika u ispitivanju ECU-MG-301 Soliris (n = 62)
English: No effects on the breastfed newborn / infant are anticipated as limited data available suggest that eculizumab is not excreted in human breast milk.
Croatian: Ograničeni podaci ne ukazuju da se ekulizumab izlučuje u majčino mlijeko te se ne očekuju učinci na dojenu novorođenčad/dojenčad.
English: Drug interaction studies have not been conducted with eculizumab in patients treated with IVIg.
Croatian: Nisu provedena ispitivanja interakcija s ekulizumabom u bolesnika liječenih imunoglobulinima za intravensku primjenu.
English: ECU-MG-301
Croatian: ECU-NMO-301).
English: (n=62) (SEM)
Croatian: Soliris (n = 62) (SEM)
English: In aHUS patients, uncontrolled terminal complement activation and the resulting complement-mediated thrombotic microangiopathy are blocked with Soliris treatment.
Croatian: U bolesnika s aHUS-om, liječenje lijekom Soliris blokira nekontroliranu aktivaciju terminalnih komponenti komplementa i posljedičnu trombotičnu mikroangiopatiju posredovanu komplementom.
English: TMA Event-free Status, n (%) 95% CI
Croatian: Status bez događaja TMA, n (%) 95% CI
English: In children and adolescent PNH patients (aged 11 years to less than 18 years) included in the paediatric
Croatian: U djece i adolescenata s PNH-om (u dobi od 11 godina do manje od 18 godina) uključenih u pedijatrijsko PNH ispitivanje M07-005, sigurnosni profil činio se sličnim onom u odraslih bolesnika s PNH-om.
English: 2 Study C08-002: 3 patients received ESA which was discontinued after eculizumab initiation Study C08-003: 8 patients received ESA which was discontinued in 3 of them during eculizumab therapy aHUS Study C10-004 enrolled 41 patients who displayed signs of thrombotic microangiopathy (TMA).
Croatian: 3Ispitivanje C08-003: 8 bolesnika primilo je sredstvo koje stimulira eritropoezu, čija je primjena obustavljena u njih 3 za vrijeme terapije ekulizumabom.
English: Prior to initiating Soliris therapy, it is recommended that PNH, aHUS, refractory gMG and NMOSD patients initiate immunizations according to current immunization guidelines.
Croatian: Prije početka terapije lijekom Soliris preporučuje se započeti imunizaciju u bolesnika s paroksizmalnom noćnom hemoglobinurijom, atipičnim hemolitičko-uremijskim sindromom, refraktornom generaliziranom miastenijom gravis i NMOSD-om prema važećim smjernicama za imunizaciju.
English: n (%)
Croatian: Žene, n (%)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Nositelj odobrenja za stavljanje lijeka u promet:
English: Table 8 summarizes the efficacy results for aHUS study C10-004.
Croatian: Tablica 8 prikazuje sažete rezultate djelotvornosti u ispitivanju aHUS-a C10-004.
English: Table 8: Efficacy Outcomes in Prospective aHUS Study C10-004
Croatian: Tablica 8: Ishodi u pogledu djelotvornosti u prospektivnom ispitivanju aHUS-a C10-004 Parametar djelotvornosti
English: Soliris has not been studied in patients with PNH who weigh less than 40kg.
Croatian: Soliris nije ispitivan u bolesnika s paroksizmalnom noćnom hemoglobinurijom tjelesne težine ispod 40 kg.
English: In aHUS Study C08-003A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Croatian: U ispitivanju aHUS-a C08-003A/B, terapijski odgovor na Soliris u bolesnika s utvrđenim mutacijama gena koji kodiraju regulatorne proteine komplementa bio je sličan odgovoru bolesnika bez tih mutacija.
English: Table 18: Efficacy Outcomes in Prospective aHUS Study C10-003
Croatian: Tablica 18: Ishodi djelotvornosti za prospektivno ispitivanje aHUS-a C10-003 Parametar djelotvornosti
English: Gently agitate the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent.
Croatian: Lagano protresite infuzijsku vrećicu koja sadrži razrijeđenu otopinu kako biste bili sigurni da se lijek dobro pomiješao s otapalom.
English: • Initial phase: 900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every week for the first 4 weeks.
Croatian: • Početna faza: 900 mg lijeka Soliris primjenjuje se intravenskom infuzijom u trajanju od 25 - 45 minuta jedanput na tjedan tijekom prva 4 tjedna.
English: The final volume of a 5 mg/ml diluted solution is 60 ml for 300 mg doses, 120 ml for 600 mg doses, 180 ml for 900 mg doses and 240 ml for 1,200 mg doses.
Croatian: Konačni volumen razrijeđene otopine od 5 mg/ml iznosi 60 ml za doze od 300 mg, 120 ml za doze od
English: Soliris therapy must not be initiated in patients (see section 4.4): - with unresolved Neisseria meningitidis infection - who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Croatian: Terapija lijekom Soliris ne smije se započeti u bolesnika (vidjeti dio 4.4): - s neizliječenom infekcijom bakterijom Neisseria meningitidis
English: Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant IST treatment.
Croatian: U bolesnika liječenih Solirisom poboljšanje vremena do pojave prvog recidiva u ispitivanju prema neovisnoj procjeni bilo je slično bez obzira na to jesu li istodobno primali terapiju imunosupresivima ili nisu.
English: CKD improvement by ≥1 stage, n (%)
Croatian: KBB poboljšanje za ≥1 stupnja, n (%) (95% CI)
English: Complete TMA response, n (%) Median duration of complete TMA response, weeks (range) 1
Croatian: Medijan trajanja potpune hematološke normalizacije, tjedni (raspon) Potpuni TMA odgovor, n (%) Medijan trajanja potpunog TMA odgovora, tjedni (raspon)1
English: • sleep disorder, abnormal dreams
Croatian: promjene raspoloženja abnormalni snovi,
English: In aHUS Study C08-002A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Croatian: U ispitivanju aHUS-a C08-002A/B, terapijski odgovor na Soliris u bolesnika s utvrđenim mutacijama gena koji kodiraju regulatorne proteine komplementa bio je sličan odgovoru bolesnika bez tih mutacija.
English: Patients in aHUS study C08-003A/B received Soliris for a minimum of 26 weeks.
Croatian: Bolesnici s aHUS-om u ispitivanju C08-003A/B primali su Soliris najmanje 26 tjedana.
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).
Croatian: 9/l za jedan tjedan; ovaj učinak održao se kroz 26 tjedana (prosječna vrijednost (±SD) broja trombocita u 26. tjednu: 252 ± 70 x10 9/l).
English: Reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris.
Croatian: Smanjenje aktivnosti terminalnih komponenti komplementa te povećanje broja trombocita u odnosu na početnu vrijednost, opaženo je nakon započete primjene lijeka Soliris.
English: Baseline LDH (U/L) median (min, max )
Croatian: (min, maks) LDH na početku (U/l), medijan (min, maks)
English: Table 7: Baseline Characteristics of Patients Enrolled in aHUS Study C10-004
Croatian: Tablica 7: Karakteristike bolesnika uključenih u ispitivanje aHUS-a C10-004 na početku ispitivanja
English: • dyspnoea (difficulty breathing), nose bleed, stuffy nose (nasal congestion), throat irritation, runny nose
Croatian: • otežano disanje (dispneja), krvarenje iz nosa, začepljen nos (kongestija nosa), nadraženost grla,
English: Time from aHUS diagnosis until first study dose (months) median (min, max )
Croatian: Vrijeme od postavljanja dijagnoze aHUS-a do prve doze ispitivanog lijeka (mjeseci), medijan (min, maks)
English: Headache Dizziness, Dysgeusia
Croatian: dizurija, hematurija
English: Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of <5 g/dL or a decrease of >4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Croatian: Na ozbiljnu hemolizu upućuju razine LDH u serumu veće od onih prije liječenja, uz bilo što od sljedećeg: apsolutno smanjenje broja PNH klonalnih stanica za više od 25% (kad nema razrjeđenja zbog transfuzije) u roku od jednog tjedna ili kraćem;
English: Table 17 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in aHUS Study C10-003.
Croatian: U tablici 17 sažeto su prikazane ključne početne kliničke karakteristike, i one s obzirom na bolest, u bolesnika uključenih u ispitivanje aHUS-a C10-003.
English: Patients in aHUS Study C08-002 A/B received Soliris for a minimum of 26 weeks.
Croatian: Bolesnici s aHUS-om u ispitivanju C08-002A/B primali su Soliris tijekom najmanje 26 tjedana.
English: (urinary tract infection),
Croatian: (infekcija mokraćnih puteva)
English: NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion Eculizumab
Croatian: Uputa o lijeku: Informacije za korisnika Soliris 300 mg koncentrat za otopinu za infuziju ekulizumab
English: • Risk of substantial disease exacerbation or relapse following eculizumab discontinuation (refractory gMG and NMOSD)
Croatian: • Rizik od znatne egzacerbacije bolesti ili relapsa nakon prekida primjene ekulizumaba
English: Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26
Croatian: Soliris je smanjio znakove aktivnosti TMA posredovane komplementom, što je vidljivo iz porasta prosječne vrijednosti (±SD)
English: LDH AUC (U/L x Day)
Croatian: (U/l x dan)
English: shortness of breath (dyspnoea), anaemia (haemoglobin <100 g/L), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Croatian: veliki štetni krvožilni događaj (uključujući trombozu), disfagija ili erektilna disfunkcija.
English: Patients in aHUS Study C10-004 received Soliris for a minimum of 26 weeks.
Croatian: Bolesnici u ispitivanju aHUS-a C10-004 primali su Soliris najmanje 26 tjedana.
English: Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing.
Croatian: Djeca i adolescenti s paroksizmalnom noćnom hemoglobinurijom ili atipičnim hemolitičko-uremijskim sindromom težine 40 kg i više, liječe se dozama kao i odrasli bolesnici.
English: Septic shock, Peritonitis, Lower respiratory tract infection, Fungal infection, Viral a, infection, Abscess Cellulitis, Influenza, Gastrointestinal infection, Cystitis, Infection, Sinusitis,
Croatian: a, celulitis, gripa, apsces gastrointestinalna infekcija, cistitis, infekcija, sinusitis infekcija plijesnima iz c, roda Aspergillus bakterijski artritisc, gonokokna infekcija urogenitalnog sustava, infekcija bakterijom Haemophilus influenzae, impetigo, gingivitis
English: Number of patients with prior exacerbations since diagnosis, n (%)
Croatian: Broj bolesnika s egzacerbacijama između dijagnoze i ispitivanja, n (%)
English: Monitoring may be insufficient to predict or prevent severe thrombotic microangiopathy complications in patients with aHUS after discontinuation of Soliris.
Croatian: Nakon prekida primjene Solirisa, praćenje može biti nedovoljno da bi se predvidjele ili spriječile teške komplikacije zbog trombotične mikroangiopatije.
English: ADRs identified in postmarketing reports
Croatian: Nuspojave zabilježene u prijavama nakon stavljanja lijeka u promet.
English: Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Croatian: Obratite se svom liječniku prije nego što primite Soliris kako biste bili sigurni da ćete biti cijepljeni protiv bakterije Neisseria meningitidis, mikroorganizma koji uzrokuje meningokoknu infekciju,
English: • Details of the PNH and aHUS registries and how to enter patients.
Croatian: • Podaci o registrima oboljelih od paroksizmalne noćne hemoglobinurije i atipičnog hemolitičko-uremijskog sindroma te kako upisati bolesnike.
English: Paediatric PNH and aHUS patients with body weight ≥ 40 kg are treated with the adult dosing recommendations, respectively.
Croatian: U pedijatrijskih bolesnika s paroksizmalnom noćnom hemoglobinurijom i atipičnim hemolitičko-uremijskim sindromom težine ≥40 kg, vrijede preporuke za doziranje kao u odraslih bolesnika.
English: No case of overdose has been reported.
Croatian: 4.9 Predoziranje Nije zabilježen niti jedan slučaj predoziranja.
English: Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.
Croatian: Stoga se nakon preporučenog cijepljenja bolesnike mora pomno pratiti zbog mogućih simptoma bolesti.
English: The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause: - A significant fall in your red blood cell counts (anaemia), - Confusion or change in how alert you are, - Chest pain, or angina, - An increase in your serum creatinine level (problems with your kidneys), or - Thrombosis (blood clotting).
Croatian: Rizici prekida primanja lijeka Soliris uključuju povećanu upalu krvnih pločica, što može prouzročiti: - značajno smanjenje broja krvnih pločica (trombocitopeniju) - značajno povećano razaranje crvenih krvnih stanica
English: Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately.
Croatian: Bolesnike treba upoznati s tipičnim simptomima i znacima meningokokne infekcije te ih treba savjetovati da u slučaju pojave takvih simptoma odmah potraže liječničku pomoć.
English: achieved hematologic normalization.
Croatian: Hematološka normalizacija, n
English: NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion
Croatian: Soliris 300 mg koncentrat za otopinu za infuziju
English: Vaccination reminders are sent to the prescribers.
Croatian: 4. da se liječnicima koji propisuju lijek šalju podsjetnici za cijepljenje.
English: Trismus
Croatian: EDSS
English: In aHUS Study C08-003A/B, the median duration of Soliris therapy was approximately 114 weeks
Croatian: U ispitivanju aHUS-a C08-003A/B, medijan trajanja terapije lijekom Soliris iznosio je približno 114 tjedana (raspon: 26 do 129 tjedana).
English: Patients who initiate Soliris treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
Croatian: Bolesnici koji započnu liječenje Solirisom prije nego što je proteklo 2 tjedna od meningokoknog cjepiva, moraju uz liječenje primati profilaktičku terapiju odgovarajućim antibioticima do 2 tjedna nakon cijepljenja.
English: Interrupting or stopping treatment with Soliris may cause your NMOSD to worsen and relapse to happen.
Croatian: Privremeni prekid ili trajan prestanak liječenja lijekom Soliris može prouzročiti pogoršanje i povratak simptoma optičkog neuromijelitisa.
English: Timing of
Croatian: ROK VALJANOSTI
English: Body Weight
Croatian: Tjelesna težina Početna faza
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta tinitus, vrtoglavica
English: • dizziness, taste disorders (dysgeusia), high blood pressure
Croatian: • omaglica, promjena osjeta okusa (disgeuzija)
English: • Treatment with eculizumab increases the risk of severe infection, especially Neisseria meningitidis and other Neisseria species, including disseminated gonorrhoeae.
Croatian: • Liječenje ekulizumabom povećava rizik od teške infekcije, osobito one koju uzrokuju
English: Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration.
Croatian: Prije primjene otopinu lijeka Soliris treba vizualno pregledati da ne sadrži čestice i da nije promijenila boju.
English: In all studies, the dose of Soliris in adult and adolescent aHUS patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1,200 mg 7 ± 2 days later, then 1,200 mg every 14 ± 2 days for the study duration.
Croatian: U svim se ispitivanjima u odraslih bolesnika i adolescenata s aHUS-om primjenjivala doza lijeka Soliris od 900 mg svakih 7 ± 2 dana tijekom 4 tjedna, nakon čega se 7 ± 2 dana kasnije dala doza od 1200 mg, a potom 1200 mg svakih
English: • muscle cramp, muscle aches, back and neck pain, bone pain, joint swelling, pain in the limbs (arms and legs)
Croatian: • koprivnjača, crvenilo kože, suha koža, crvene ili ljubičaste mrlje pod kožom, pojačano znojenje • grčevi u mišićima, bolovi u mišićima, bol u leđima i vratu, bol u kostima, oticanje zglobova, bol u udovima (ruke i noge)
English: PK parameters are consistent across PNH, aHUS, refractory gMG and NMOSD patient populations.
Croatian: Farmakokinetički parametri opaženi u populacijama bolesnika s PNH-om, aHUS-om, refraktornim gMG-om i NMOSD-om bili su međusobno slični.
English: In PNH patients, uncontrolled terminal complement activation and the resulting complement-mediated intravascular haemolysis are blocked with Soliris treatment.
Croatian: U bolesnika s PNH-om, liječenje lijekom Soliris blokira nekontroliranu aktivaciju terminalnih komponenti komplementa i posljedičnu intravaskularnu hemolizu posredovanu komplementom.
English: Cases of serious or fatal meningococcal infections have been reported in Soliris-treated patients.
Croatian: U bolesnika liječenih lijekom Soliris zabilježeni su slučajevi ozbiljne meningokokne infekcije ili meningokokne infekcije sa smrtnim ishodom.
English: If you stop using Soliris for refractory gMG
Croatian: Ako prestanete primati Soliris za liječenje poremećaja iz spektra optičkog neuromijelitisa
English: • severe infection (meningococcal infection), sepsis, septic shock, viral infection, , lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis
Croatian: Manje često: mogu se javiti u do 1 na 100 osoba: • teška infekcija (meningokokna infekcija), sepsa, septički šok, virusna infekcija, infekcija donjih dišnih puteva, želučana gripa (gastrointestinalna infekcija), upala mokraćnog mjehura (cistitis) • infekcija, gljivična infekcija, nakupljanje gnoja (apsces), infekcije kože (celulitis), gripa