FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics.
Croatian: U svih je bolesnika potrebno pratiti moguću pojavu ranih znakova meningokokne infekcije i sepse, potvrditi što prije sumnju na infekciju i liječiti odgovarajućim antibioticima.
English: • The Guide for healthcare professionals shall contain the following key elements: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Croatian: • Vodič za zdravstvene radnike sadržavat će sljedeće ključne elemente: o Upozorenja na rizik od meningokokne infekcije, ozbiljne hemolize nakon prekida primjene lijeka u bolesnika s PNH-om, imunogeničnosti, ozbiljnih infekcija, maligniteta i hematoloških abnormalnosti, primjene u trudnica i dojilja.
English: Figure 2: Analysis of primary and secondary endpoints - full analysis set (eculizumabexperienced study)
Croatian: Slika 2: Analiza mjera primarnog i sekundarnog ishoda - potpuni skup podataka za analizu (ispitivanje primjene u bolesnika koji su prethodno primali ekulizumab)
English: Ravulizumab was non-inferior compared to eculizumab for both coprimary endpoints, avoidance of pRBC transfusion per protocol-specified guidelines and LDH normalisation from day 29 to day 183, and for all 4 key secondary endpoints (Figure 1).
Croatian: Ravulizumab je bio neinferioran u usporedbi s ekulizumabom u obje mjere koprimarnog ishoda, izbjegavanje transfuzije koncentrata eritrocita prema smjernicama određenima planom ispitivanja i normalizacija LDH od 29. do 183. dana, i u sve 4 ključne mjere sekundarnog ishoda (slika 1).
English: Ultomiris should only be administered via intravenous infusion.
Croatian: Ultomiris se smije primijeniti samo intravenskom infuzijom.
English: INFORMATION IN BRAILLE Justification for not including braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single use Type I glass vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica od stakla tipa
English: Ultomiris volume (mL)
Croatian: Volumen lijeka Ultomiris (ml)
English: Discard any unused portion left in a vial as the medicinal product contains no preservatives.
Croatian: Bacite sav neiskorišteni dio lijeka iz bočice jer lijek ne sadrži konzervanse.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Reproductive toxicology studies were conducted in mice using the murine surrogate molecule BB5.1, which assessed effect of C5 blockade on the reproductive system.
Croatian: Ispitivanja reproduktivne toksičnosti provedena su u miševa pomoću mišje surogatne molekule BB5.1, čime je ocijenjen učinak blokade C5 na reproduktivni sustav.
English: Pre-treatment LDH levels
Croatian: Normalizacija LDH
English: Body weight at time of treatment.
Croatian: Tjelesna težina u vrijeme liječenja.
English: However, based on population-PK assessment no impact of sex, age, race and hepatic or renal function on ravulizumab PK was identified in the studied healthy volunteers subjects and patients with PNH, and as a result, no dosing adjustment is considered necessary.
Croatian: Međutim, na temelju ocjene populacijske farmakokinetike u ispitivanih zdravih ispitanika i bolesnika s PNH-om nije ustanovljen utjecaj spola, dobi, etničke pripadnosti i bubrežne ili jetrene funkcije na farmakokinetiku ravulizumaba, pa se stoga prilagodba doze ne smatra potrebnom.
English: For intravenous use, after dilution.
Croatian: Za intravensku primjenu nakon razrjeđivanja.
English: If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Croatian: Ako se ne možete cijepiti 2 tjedna prije terapije, liječnik će Vam propisati antibiotike koji smanjuju rizik od infekcije, a uzimat ćete ih do 2 tjedna nakon što ste bili cijepljeni.
English: Human IgG are known to cross the human placental barrier, and thus ravulizumab may potentially cause terminal complement inhibition in the foetal circulation.
Croatian: Poznato je da ljudski IgG prolaze kroz ljudsku posteljicu pa stoga ravulizumab može potencijalno prouzročiti inhibiciju završne aktivacije sustava komplementa u fetalnoj cirkulaciji.
English: After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the final concentration of the solution is 5 mg/mL.
Croatian: Nakon razrjeđivanja 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju, konačna koncentracija otopine iznosi 5 mg/ml.
English: Physicians should provide patients with a patient information brochure and a patient safety card.
Croatian: Liječnici moraju bolesnicima dati vodič za bolesnika i karticu s upozorenjima za bolesnika.
English: Meningococcal infection symptoms Because of the importance of rapidly identifying and treating meningococcal infection in patients who receive Ultomiris, you will be provided a ‘patient safety card' to carry with you at all times, listing relevant signs and symptoms of meningococcal infection/sepsis.
Croatian: Budući da je važno da se u bolesnika koji primaju Ultomiris brzo ustanovi i počne liječiti meningokokna infekcija, dobit ćete „karticu s upozorenjima za bolesnika“ koju morate stalno nositi sa sobom, a na kojoj su navedeni svi važni znakovi i simptomi meningokokne infekcije/sepse.
English: Eligible patients to enter this trial had to demonstrate high disease activity, defined as LDH level ≥ 1.5 × upper limit of normal (ULN) at screening along with the presence of 1 or more of the following PNH-related signs or symptoms within 3 months of screening: fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), anaemia (haemoglobin < 10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cell (pRBC) transfusion due to PNH.
Croatian: Bolesnici prikladni za uključivanje u ovo ispitivanje morali su imati dokazanu visoku aktivnost bolesti, definiranu kao razina LDH ≥ 1,5 × gornja granica normale (GGN) na probiru te prisutan 1 ili više od sljedećih znakova ili simptoma povezanih s PNH-om unutar 3 mjeseca prije probira: umor, hemoglobinuriju, bol u abdomenu, nedostatak zraka (dispneja), anemiju (hemoglobin < 10 g/dl), veliki štetan vaskularni događaj u anamnezi (uključujući trombozu), disfagiju ili erektilnu disfunkciju; ili primjenu transfuzije koncentrata eritrocita zbog PNH-a.
English: If you are allergic to ravulizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primati Ultomiris: ako ste alergični na ravulizumab, proteine dobivene iz mišjih proizvoda, druga monoklonska protutijela ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako niste cijepljeni protiv meningokokne infekcije ako imate meningokoknu infekciju.
English: Ultomiris 300 mg concentrate for solution for infusion ravulizumab
Croatian: Ultomiris 300 mg koncentrat za otopinu za infuziju ravulizumab
English: Patients who initiate ravulizumab 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 terapiju ravulizumabom prije nego što je prošlo 2 tjedna otkako su primili meningokokno cjepivo, moraju primati odgovarajuću antibiotsku profilaksu tijekom 2 tjedna poslije cijepljenja.
English: The patient information pack should contain: o Package leaflet o A patient guide o A patient alert card
Croatian: Paket informacija za bolesnika mora sadržavati: o uputu o lijeku o vodič za bolesnika o karticu s upozorenjima za bolesnika
English: Secondary endpoints included the proportion of patients with breakthrough haemolysis, quality-of-life (FACITFatigue), transfusion avoidance (TA), and proportion of patients with stabilised haemoglobin.
Croatian: Mjere sekundarnog ishoda uključivale su udio bolesnika s probojnom hemolizom, kvalitetu života (FACIT-umor), izbjegavanje transfuzije i udio bolesnika sa stabiliziranim hemoglobinom.
English: Common (may affect up to 1 in 10 people): dizziness vomiting, nausea, diarrhoea, abdominal pain, dyspepsia rash, itchy skin (pruritus) back pain, joint pain (arthralgia), muscle pain (myalgia) and muscle spasms fever (pyrexia), influenza like illness, chills, feeling tired (fatigue, asthenia) meningococcal infection, meningococcal sepsis
Croatian: Često (mogu se pojaviti u manje od 1 na 10 osoba): omaglica povraćanje, mučnina, proljev, bol u trbuhu, dispepsija osip, svrbež kože (pruritus) bol u leđima, bol u zglobovima (artralgija), bol u mišićima (mialgija) i grčevi u mišićima vrućica (pireksija), bolest slična gripi, zimica, osjećaj umora (astenija) meningokokna infekcija, meningokokna sepsa
English: The MAH shall send annually to prescribers or pharmacists who prescribe/dispense ravulizumab, a reminder in order that prescriber/pharmacist checks if a (re)-vaccination against Neisseria meningitidis is needed for his/her patients on ravulizumab.
Croatian: Nositelj odobrenja poslat će svake godine liječnicima koji propisuju ravulizumab ili ljekarnicima koji ga izdaju podsjetnik da provjere postoji li potreba da se bolesnici koji primaju ravulizumab (ponovno) cijepe protiv bakterije
English: Key secondary endpoints included the percent change from baseline in LDH levels, change in quality of life (FACITFatigue), the proportion of patients with breakthrough haemolysis and proportion of patients with stabilized haemoglobin.
Croatian: Ključne mjere sekundarnog ishoda uključivale su postotnu promjenu razina LDH u odnosu na početne vrijednosti, promjene u kvaliteti života (FACIT-umor), udio bolesnika s probojnom hemolizom i udio bolesnika sa stabiliziranim hemoglobinom.
English: This medicinal product when diluted with sodium chloride 9 mg/mL (0.9 %) solution for injection contains 2.65 g sodium per 720 mL at the maximal dose, equivalent to 133 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Kada je razrijeđen 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju, ovaj lijek sadrži 2,65 g natrija po 720 ml u maksimalnoj dozi, što odgovara 133% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO-a za odraslu osobu.
English: The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Croatian: Edukacijski materijal za liječnike mora sadržavati: o sažetak opisa svojstava lijeka o vodič za zdravstvene radnike.
English: The 12-month transfusion history was similar between ravulizumab and eculizumab treatment groups within each of the Phase 3 studies.
Croatian: Primjena transfuzije u prethodnih 12 mjeseci u skupini liječenoj ravulizumabom i onoj liječenoj ekulizumabom bila je slična u oba ispitivanja faze III.
English: PNH is a chronic disease and treatment with ravulizumab is recommended to continue for the patient's lifetime, unless the discontinuation of ravulizumab is clinically indicated (see section 4.4).
Croatian: PNH je kronična bolest pa se preporučuje da bolesnik nastavi liječenje ravulizumabom tijekom cijeloga života, osim ako je prestanak primjene ravulizumaba klinički indiciran (vidjeti dio 4.4).
English: If stored at 2-8°C, allow the diluted solution to warm to room temperature prior to administration.
Croatian: Ako je bila čuvana na temperaturi 2°C-8°C, razrijeđenu otopinu pustite da prije primjene dosegne sobnu temperaturu.
English: If patients with PNH discontinue treatment with ravulizumab, they should be closely monitored for signs and symptoms of serious intravascular haemolysis, identified by elevated LDH (lactate dehydrogenase) levels along with sudden decrease in PNH clone size or haemoglobin, or reappearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Croatian: Ako se u bolesnika s PNH-om obustavi liječenje ravulizumabom, bolesnike je potrebno pomno pratiti zbog moguće pojave znakova i simptoma ozbiljne intravaskularne hemolize na koju ukazuju povišene vrijednosti LDH (laktat dehidrogenaza) zajedno s naglim smanjenjem broja PNH klonalnih stanica ili hemoglobina, ili ponovne pojave simptoma kao što su umor, hemoglobinurija, bol u abdomenu, nedostatak zraka (dispneja), veliki štetni vaskularni događaj (uključujući trombozu), disfagija ili erektilna disfunkcija.
English: • Patient information pack
Croatian: • paket informacija za bolesnike.
English: The eculizumab-experienced study was a 26-week, multicentre, open-label, randomised, active-controlled Phase 3 study conducted in 195 patients with PNH who were clinically stable (LDH ≤ 1.5 x ULN) after having been treated with eculizumab for at least the past 6 months.
Croatian: Ispitivanje primjene u bolesnika koji su prethodno primali ekulizumab bilo je 26-tjedno, multicentrično, otvoreno, randomizirano ispitivanje faze III s aktivnom kontrolom, a uključivalo je 195 bolesnika s PNH-om koji su bili klinički stabilni (LDH ≤ 1,5 × GGN) nakon liječenja ekulizumabom najmanje proteklih 6 mjeseci.
English: Pregnancy, breast-feeding, and fertility
Croatian: Trudnoća, dojenje i plodnost
English: It is unknown whether ravulizumab is excreted into human milk.
Croatian: Nije poznato izlučuje li se ravulizumab u majčino mlijeko.
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Croatian: Izračunati volumen lijeka izvuče se iz odgovarajućeg broja bočica i razrijedi u infuzijskoj vrećici pomoću 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju kao otapala.
English: The other ingredients are: - sodium dihydrogen phosphate dihydrate - disodium phosphate dihydrate - sodium chloride - polysorbate 80 Solvent: water for injections
Croatian: Drugi sastojci su: - natrijev dihidrogenfosfat dihidrat - natrijev hidrogenfosfat dihidrat - natrijev klorid - polisorbat 80
English: The safety and efficacy of ravulizumab in patients with PNH were assessed in two open-label, randomised, active-controlled Phase 3 trials: a complement-inhibitor naïve study in adult patients with PNH who were naïve to complement inhibitor treatment, an eculizumab -experienced study in patients with PNH who were clinically stable after having been treated with eculizumab for at least the previous 6 months.
Croatian: Sigurnost i djelotvornost ravulizumaba u bolesnika s PNH-om ocijenjene su u dva otvorena, randomizirana ispitivanja faze III s aktivnom kontrolom: u ispitivanju primjene u odraslih bolesnika s PNH-om koji prethodno nisu primali inhibitor sustava komplementa u ispitivanju primjene u bolesnika koji su prethodno primali ekulizumab, provedenom u bolesnika s PNH-om koji su bili klinički stabilni nakon liječenja ekulizumabom najmanje proteklih 6 mjeseci.
English: Following ravulizumab treatment in both complement-inhibitor naïve patients and eculizumab-experienced patients with PNH in Phase 3 studies, immediate and complete inhibition of serum free C5 (concentration of < 0.5 µg/mL) was observed by the end of the first infusion and sustained throughout the entire 26-week treatment period in all patients.
Croatian: U ispitivanjima faze III, nakon terapije ravulizumabom u bolesnika s PNH-om koji prethodno nisu primali inhibitor sustava komplementa i u onih koji su primali ekulizumab, neposredna i potpuna inhibicija slobodnog C5 u serumu (koncentracija < 0,5 µg/ml) opažena je do kraja prve infuzije i u svih se bolesnika održala tijekom cijelog 26-tjednog razdoblja liječenja.
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Croatian: U slučaju predoziranja, primjenu infuzije treba odmah prekinuti, a bolesnika pažljivo pratiti.
English: Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
Croatian: Za sprječavanje čestih patogenih seroloških skupina meningokoka preporučuju se, ako su dostupna, cjepiva protiv seroloških skupina A, C, Y, W135 i B.
English: No dose adjustment is required for patients with PNH aged 65 years and over.
Croatian: U bolesnika s PNH-om u dobi od 65 ili više godina nije potrebna prilagodba doze.
English: The majority of the complement-inhibitor naïve study population was highly haemolytic at baseline; 86.2 % of enrolled patients presented with elevated LDH ≥ 3 × ULN, which is a direct measurement of intravascular haemolysis, in the setting of PNH.
Croatian: Većina populacije u ispitivanju u kojem bolesnici prethodno nisu primali inhibitor sustava komplementa imala je na početku ispitivanja jaku hemolizu; 86,2% uključenih bolesnika imalo je povišene LDH vrijednosti ≥ 3 × GGN, što je u okolnostima PNH-a izravna mjera intravaskularne hemolize.
English: Eculizumab (N = 121)
Croatian: Ekulizumab (N = 121)
English: Each vial of Ultomiris contains 300 mg of active substance in 30 mL of product solution.
Croatian: Jedna bočica lijeka Ultomiris sadrži 300 mg djelatne tvari u 30 ml otopine lijeka.
English: Nonclinical reproductive toxicology studies conducted in mice with a murine surrogate molecule (BB5.1) identified no adverse effect on fertility of the treated females or males.
Croatian: Neklinička ispitivanja reproduktivne toksičnosti provedena u miševa pomoću mišje surogatne molekule (BB5.1) pokazala su da nema štetnog učinka na plodnost liječenih ženki ili mužjaka.
English: If you cannot be vaccinated at least 2 weeks before you start treatment with Ultomiris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Croatian: Ako se ne možete cijepiti najmanje 2 tjedna prije nego što počnete primati Ultomiris, liječnik će Vam propisati antibiotike koje ćete uzimati dok ne prođu 2 tjedna nakon što ste bili cijepljeni kako bi se smanjio rizik od infekcije.
English: 4- Special handling and storage
Croatian: 4 - Posebne mjere pri rukovanju i čuvanju
English: This medicine when diluted with sodium chloride 9 mg/mL (0.9%) solution for injection for IV administration contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose.
Croatian: Kada je razrijeđen 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju za intravensku primjenu, ovaj lijek sadrži 2,65 g natrija (glavni sastojak kuhinjske soli) u 720 ml pri najvišoj dozi.
English: Do not administer as an intravenous push or bolus injection.
Croatian: Nemojte primjenjivati kao intravensku brzu ili bolus injekciju.
English: Immunization
Croatian: Imunizacija
English: Breast-feeding should be discontinued during and up to eight months after treatment.
Croatian: Dojenje treba prekinuti tijekom liječenja i do osam mjeseci nakon toga.
English: The primary endpoint was haemolysis as measured by LDH percent change from baseline.
Croatian: Mjera primarnog ishoda bila je hemoliza mjerena kao postotna promjena vrijednosti LDH u odnosu na početnu.
English: ravulizumab
Croatian: Nuspojave
English: Figure 1: Analysis of coprimary and secondary endpoints - Full analysis set (complementinhibitor naïve study)
Croatian: Slika 1: Analiza mjera koprimarnih i sekundarnih ishoda - potpuni skup podataka za analizu (ispitivanje u kojem bolesnici prethodno nisu primali inhibitor sustava komplementa)
English: Eculizumab (N = 98)
Croatian: Ekulizumab (N = 98)
English: Animal reproductive toxicology studies have not been conducted with ravulizumab, but were conducted in mice with a murine surrogate complement inhibitory antibody, BB5.1.
Croatian: Ispitivanja reproduktivne toksičnosti nisu provedena s ravulizumabom na životinjama, ali su provedena u miševa s BB5.1, mišjim surogat protutijelom koje inhibira komplement.
English: The complement-inhibitor naïve study was a 26-week, multicentre, open-label, randomised, active-controlled, Phase 3 study conducted in 246 patients who were naïve to complement inhibitor treatment prior to study entry.
Croatian: Ispitivanje u bolesnika koji prethodno nisu primali inhibitor sustava komplementa bilo je 26-tjedno, multicentrično, otvoreno, randomizirano ispitivanje faze III s aktivnom kontrolom, provedeno u 246 bolesnika koji prije uključivanja u ispitivanje nisu primali terapiju inhibitorom sustava komplementa.
English: Number of patients with pRBC/whole blood transfusions within 12 months prior to first dose n (%)
Croatian: Broj bolesnika s transfuzijama koncentrata eritrocita / pune krvi primljenim u 12 mjeseci prije prve doze n (%)
English: It is not necessary to protect the diluted solution of Ultomiris from light during administration to the patient.
Croatian: Tijekom primjene bolesniku, razrijeđenu otopinu lijeka Ultomiris nije potrebno zaštititi od svjetlosti.
English: Myelodysplastic syndrome Pregnancy complication Other b a
Croatian: anemija hematurija ili hemoglobinurija aplastična anemija zatajenje bubrega mijelodisplastični sindrom komplikacije trudnoće drugo b a
English: Study in PNH patients previously treated with eculizumab
Croatian: Ispitivanje u bolesnika s PNH-om prethodno liječenih ekulizumabom
English: Renal impairment No dose adjustment is required for patients with renal impairment, see section 5.2.
Croatian: Oštećenje bubrežne funkcije U bolesnika s oštećenjem bubrežne funkcije nije potrebna prilagodba doze, vidjeti dio 5.2.
English: One vial of 30 mL contains 300 mg of ravulizumab, produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Croatian: Chinese hamster ovary, CHO) tehnologijom rekombinantne DNK.
English: After dilution, the final concentration of the solution to be infused is 5 mg/mL.
Croatian: Nakon razrjeđivanja konačna koncentracija otopine za primjenu infuzijom iznosi 5 mg/ml.
English: Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.
Croatian: Stoga je poslije preporučenog cijepljenja bolesnike potrebno pažljivo pratiti zbog moguće pojave simptoma bolesti.
English: Number of patients with packed red blood cell (pRBC) transfusions within 12 months prior to first dose n (%)
Croatian: Broj bolesnika s transfuzijama koncentrata eritrocita primljenim u 12 mjeseci prije prve doze n (%)
English: o No clinical data on exposed pregnancies is available.
Croatian: o Nema kliničkih podataka o izlaganju lijeku u trudnoći.
English: Table 2: Maintenance dose administration reference table
Croatian: Tablica 2: Tablica referentnih vrijednosti kod primjene doza održavanja
English: Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja te do 8 mjeseci nakon liječenja.
English: What you need to know before you use Ultomiris Do not use Ultomiris:
Croatian: Što je Ultomiris i za što se koristi Što morate znati prije nego počnete primjenjivati Ultomiris Kako primjenjivati Ultomiris
English: o The need for patients to be vaccinated against N. meningitidis two weeks prior to receiving ravulizumab and/or to receive antibiotic prophylaxis.
Croatian: Neisseria meningitidis dva tjedna prije primanja ravulizumaba i/ili primati antibiotsku profilaksu.
English: Please refer to section 4.4 for information on prevention and treatment of suspected meningococcal infection.
Croatian: Informacije o sprječavanju i liječenju meningokokne infekcije vidjeti u dijelu 4.4.
English: NAME OF THE MEDICINAL PRODUCT Ultomiris 300 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA Ultomiris 300 mg koncentrat za otopinu za infuziju