FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Ultomiris
Croatian: Drugi lijekovi i Ultomiris
English: If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed.
Croatian: Osjetite li bilo koji od prethodno navedenih simptoma, morate uzeti kuru antibiotika kako Vam je propisano.
English: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 UNITED STATES
Croatian: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 SJEDINJENE DRŽAVE
English: Vaccination may further activate complement.
Croatian: Cijepljenje može dodatno aktivirati komplement.
English: If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor.
Croatian: Ako Vam se pojavi bilo koji simptom meningokokne infekcije (pogledajte dio 2, Simptomi meningokokne infekcije), morate o tome odmah obavijestiti liječnika.
English: If you suspect that you have been accidentally given a higher dose of Ultomiris than prescribed, please contact your doctor for advice.
Croatian: Ako sumnjate da Vam je slučajno dana veća doza lijeka Ultomiris nego što je propisano, obratite se liječniku za savjet.
English: Age (years) at first infusion in study
Croatian: Dob (godine) u vrijeme prve infuzije u ispitivanju
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA43
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA43 Mehanizam djelovanja
English: Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ultomiris se ne preporučuje tijekom trudnoće ili u žena reproduktivne dobi koje ne primjenjuju kontracepciju.
English: Statistics
Croatian: Statistički podaci
English: Male Female
Croatian: Muškarci Žene
English: In pregnant women the use of ravulizumab may be considered following an assessment of the risks and benefits.
Croatian: Primjena ravulizumaba u trudnica može se uzeti u obzir nakon procjene rizika i koristi.
English: Instructions for proper use Ultomiris is given by infusion (drip) into a vein.
Croatian: Upute za pravilnu primjenu Ultomiris se daje putem infuzije (drip) u venu.
English: Your doctor will discuss the possible side effects with you and explain the risks.
Croatian: Liječnik će Vas upoznati s mogućim nuspojavama i objasniti rizike.
English: Each vial is intended for single use only.
Croatian: Jedna bočica namijenjena je samo za jednokratnu uporabu.
English: Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data).
Croatian: Nuspojave su navedene prema MedDRA-inoj klasifikaciji organskih sustava i učestalosti na temelju sljedećeg dogovora: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Infections Before starting Ultomiris, inform your doctor if you have any infections.
Croatian: Infekcije Prije nego što počnete primati Ultomiris obavijestite liječnika ako imate bilo kakvu infekciju.
English: In case of infusion reaction, infusion of ravulizumab should be interrupted and appropriate supportive measures should be instituted if signs of cardiovascular instability or respiratory compromise occur.
Croatian: U slučaju reakcije na infuziju, infuziju ravulizumaba treba prekinuti i uvesti odgovarajuće potporne mjere ako se pojave znakovi kardiovaskularne nestabilnosti ili kompromitiranog disanja.
English: o All patients must be monitored for signs of meningitidis.
Croatian: o Svi bolesnici moraju biti pod nadzorom zbog moguće pojave znakova meningitisa.
English: The educational and controlled distribution programme is aimed at education and instruction of healthcare professionals/patients about the detection, careful monitoring, and/or proper management of selected safety concerns associated with Ultomiris.
Croatian: Programom edukacije i kontrolirane distribucije namjerava se educirati i dati upute zdravstvenim radnicima/bolesnicima o tome kako otkriti, pažljivo pratiti i/ili pravilno postupati u pogledu odabranih sigurnosnih pitanja povezanih s lijekom Ultomiris.
English: Vaccination may not be sufficient to prevent meningococcal infection.
Croatian: Cijepljenje možda neće biti dovoljno da bi se spriječila meningokokna infekcija.
English: Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ravulizumab) but the subsequent dose should be administered according to the original schedule.
Croatian: Raspored doziranja katkad smije odstupati od predviđenog dana infuzije za ± 7 dana (osim za prvu dozu održavanja ravulizumaba), ali sljedeću se dozu mora primijeniti prema prvobitnom rasporedu.
English: Two weeks after receiving your loading dose, you will be given a maintenance dose of Ultomiris, and this will then be repeated once every 8 weeks.
Croatian: Dva tjedna nakon primljene udarne doze počet ćete primati doze održavanja lijeka Ultomiris i to će se potom ponavljati svakih 8 tjedana.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1371/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1371/001
English: Prior to launch of Ultomiris in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Ultomiris u promet u svakoj državi članici, nositelj odobrenja mora se s nadležnim nacionalnim tijelom usuglasiti oko sadržaja i oblika programa edukacije i kontrolirane distribucije, uključujući oblike priopćavanja, načine distribucije i sve druge aspekte programa.
English: There is no evidence indicating any special precautions are required for treating a geriatric population - although experience with ravulizumab in elderly patients is limited.
Croatian: Nema dokaza da su u liječenju gerijatrijske populacije potrebne neke posebne mjere opreza - iako je u bolesnika starije dobi iskustvo s primjenom ravulizumaba ograničeno.
English: By attaching to and blocking the C5 protein, this medicine can stop complement proteins from attacking red blood cells and so control symptoms of the disease.
Croatian: Time što se veže na protein C5 i blokira ga, ovaj lijek može spriječiti proteine sustava komplementa da napadaju crvene krvne stanice i time staviti pod kontrolu simptome bolesti.
English: Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the body's defence system called the ‘complement system'.
Croatian: Ravulizumab je namijenjen da se veže na komponentu komplementa C5, protein koji je sastavni dio tjelesnog obrambenog sustava pod nazivom „sustav komplementa“.
English: For intravenous infusion only.
Croatian: Samo za intravensku infuziju.
English: If you receive more Ultomiris than you should
Croatian: Ako primite više lijeka Ultomiris nego što ste trebali
English: Any patient who discontinues ravulizumab should be monitored for at least 16 weeks to detect haemolysis and other reactions.
Croatian: Svakog bolesnika u kojega se prekine terapija ravulizumabom treba pratiti najmanje 16 tjedana kako bi se otkrila hemoliza i druge reakcije.
English: Your dose will be worked out by your doctor, based on your body weight, as shown in Table 1.
Croatian: Dozu će Vam odrediti liječnik na temelju tjelesne težine, kako je prikazano u tablici 1.
English: Mean (SD) Median
Croatian: Srednja vrijednost (SD) Medijan
English: However, chemical and physical stability of the diluted product have been demonstrated for up to 24 hours at 2°C-8°C and up to 6 hours at room temperature.
Croatian: Međutim, kemijska i fizikalna stabilnost razrijeđenog lijeka dokazana je u trajanju do 24 sata pri temperaturi 2°C-8°C te do 6 sati na sobnoj temperaturi.
English: The following information is intended for healthcare professionals only: Instructions for Use for Healthcare Professionals Handling Ultomiris
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za primjenu za zdravstvene radnike koji rukuju lijekom Ultomiris
English: o The risk of developing antibodies to ravulizumab.
Croatian: o Rizik od razvoja protutijela na ravulizumab.
English: Ravulizumab was dosed in accordance with the recommended dosing described in section 4.2 (4 infusions of ravulizumab over 26 weeks) while eculizumab was administered according to the approved dosing regimen of eculizumab of 600 mg every week for the first 4 weeks and 900 mg every 2 weeks (15 infusions over 26 weeks).
Croatian: Ravulizumab je bio doziran u skladu s preporučenim doziranjem opisanim u dijelu 4.2 (4 infuzije ravulizumaba tijekom 26 tjedana), dok se ekulizumab primjenjivao prema režimu doziranja odobrenom za ekulizumab od 600 mg svaki tjedan u prva 4 tjedna i 900 mg svaka 2 tjedna (15 infuzija tijekom 26 tjedana).
English: This anti-drug antibody was transient in nature with low titre and did not correlate with clinical response or adverse events.
Croatian: To je protutijelo bilo prolazne prirode i prisutno u niskom titru te nije bilo povezano s kliničkim odgovorom ili štetnim događajima.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ultomiris in one or more subsets of the paediatric population in paroxysmal nocturnal haemoglobinuria (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Ultomiris u jednoj ili više podskupina pedijatrijske populacije u paroksizmalnoj noćnoj hemoglobinuriji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The mean total PNH RBC clone size was 60.05 %, mean total PNH granulocyte clone size was 83.30 %, and the mean total PNH monocyte clone size was 85.86 %.
Croatian: Srednja vrijednost ukupnog broja klonalnih eritrocita PNH-a bila je 60,05%, srednja vrijednost ukupnog broja klonalnih granulocita PNH-a 83,30%, a srednja vrijednost ukupnog broja klonalnih monocita PNH-a bila je 85,86%.
English: o The risk of immunogenicity and advice on post-infusion monitoring.
Croatian: o Rizik od imunogeničnosti i savjet o nadzoru bolesnika nakon infuzije.
English: The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
Croatian: Razrijeđenu se otopinu ne smije zagrijavati u mikrovalnoj pećnici ili pomoću nekog drugog izvora topline, osim ostavljanjem na sobnoj temperaturi.
English: Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment.
Croatian: Liječnik će Vas upoznati s mogućim nuspojavama i objasniti rizike i koristi lijeka Ultomiris prije liječenja.
English: Table 3 gives the adverse reactions observed from clinical trials.
Croatian: Tablica 3 prikazuje nuspojave opažene u kliničkim ispitivanjima.
English: 5 mg/mL after dilution
Croatian: 30 ml 5 mg/ml nakon razrjeđivanja
English: Total volume (mL)
Croatian: Ukupni volumen (ml)
English: Ravulizumab contains only natural occurring amino acids and has no known active metabolites.
Croatian: Ravulizumab sadrži samo prirodne aminokiseline i nema poznatih djelatnih metabolita.
English: Patients should be informed of the signs and symptoms of meningococcal septicaemia and advised to seek medical care immediately.
Croatian: Bolesnike se mora upoznati sa znakovima i simptomima meningokokne septikemije i savjetovati da odmah potraže liječničku pomoć.
English: The product should be mixed gently.
Croatian: Lijek se mora pažljivo izmiješati.
English: Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in nursing infants, breast-feeding should be discontinued during treatment with ravulizumab and up to 8 months after treatment.
Croatian: Budući da se mnogi lijekovi i imunoglobulini izlučuju u majčino mlijeko te zbog mogućeg razvoja ozbiljnih nuspojava u dojenčadi, dojenje je potrebno prekinuti tijekom liječenja ravulizumabom i do 8 mjeseci nakon toga.
English: Ravulizumab therapy should be administered with caution to patients with active systemic infections.
Croatian: Terapiju ravulizumabom treba primjenjivati s oprezom u bolesnika s aktivnim sistemskim infekcijama.
English: Ultomiris is used to treat adult patients with a disease called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Croatian: Ultomiris se koristi za liječenje odraslih bolesnika s bolesti pod nazivom paroksizmalna noćna hemoglobinurija (PNH).
English: To reduce this risk of infection, all patients must be vaccinated against meningococcal infections at least two weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection.
Croatian: Kako bi se smanjio rizik od infekcije, svi se bolesnici moraju cijepiti protiv meningokoknih infekcija najmanje dva tjedna prije započinjanja liječenja ravulizumabom, osim ako odgoda terapije ravulizumabom predstavlja veći rizik nego što je rizik od razvoja meningokokne infekcije.
English: Ultomiris has no or negligible influence on the ability to drive and use machines.
Croatian: Ultomiris ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Ultomiris must be diluted prior to administration by intravenous infusion over a minimal period of 1.7 to 2.4 hours depending of body weight, see Table 2 below.
Croatian: Ultomiris se najprije mora razrijediti, a zatim se primjenjuje intravenskom infuzijom u trajanju od najmanje 1,7 do 2,4 sata ovisno o tjelesnoj težini; vidjeti tablicu 2 u nastavku.
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Croatian: Ako niste sigurni na što se odnose nuspojave navedene u nastavku, zamolite liječnika da Vam ih objasni.
English: What Ultomiris looks like and contents of the pack Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial - pack size of 1).
Croatian: Kako Ultomiris izgleda i sadržaj pakiranja Ultomiris je koncentrat za otopinu za infuziju (30 ml u bočici - veličina pakiranja: 1).
English: Ravulizumab has not been studied in patients with PNH who weigh less than 40 kg.
Croatian: Ravulizumab nije ispitan u bolesnika s PNH-om koji teže manje od 40 kg.
English: If you forget an appointment to receive Ultomiris If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Ultomiris”.
Croatian: Ako ste u zakazano vrijeme zaboravili otići primiti lijek, odmah se obratite liječniku za savjet i pogledajte sljedeći odlomak pod naslovom „Ako prestanete primati Ultomiris“.
English: When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain.
Croatian: Tijekom primjene lijeka Ultomiris možete osjetiti reakcije na infuziju (drip) kao što su glavobolja, bol u donjem dijelu leđa i bol povezan s infuzijom.
English: Ravulizumab is a monoclonal antibody IgG2/4K that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the C5b-9.
Croatian: Ravulizumab je monoklonsko protutijelo IgG2/4K koje se specifično veže za protein C5 u sustavu komplementa, čime inhibira njegovo cijepanje na C5a (proupalni anafilatoksin) i C5b (podjedinica s kojom počinje stvaranje završnog kompleksa aktivacije komplementa [C5b-9]) i sprječava stvaranje
English: The recommended dosing regimen for adult patients (≥ 18 years of age) with PNH consists of a loading dose followed by maintenance dosing, administered by intravenous infusion.
Croatian: Preporučeni režim doziranja u odraslih bolesnika (≥ 18 godina) s PNH-om sastoji se od udarne doze nakon koje slijede doze održavanja, primijenjene intravenskom infuzijom.
English: Maintenance dose (mg)
Croatian: Doza održavanja (mg)
English: The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose, see section 4.2.
Croatian: Broj bočica potrebnih za razrjeđivanje određuje se na temelju tjelesne težine pojedinog bolesnika i propisane doze, vidjeti dio 4.2.
English: If an adverse event occurs during the administration of Ultomiris, the infusion may be slowed or stopped at the discretion of the physician.
Croatian: U slučaju da tijekom primjene lijeka Ultomiris nastupi štetni događaj, infuzija se može usporiti ili prekinuti prema odluci liječnika.
English: If signs and symptoms of haemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ravulizumab.
Croatian: Ako se nakon prestanka terapije pojave znakovi i simptomi hemolize, uključujući povišen LDH, razmotrite ponovno uvođenje terapije ravulizumabom.
English: Because the route of ravulizumab administration is an intravenous infusion and the dosage form is a solution, 100 % of the administered dose is considered bioavailable.
Croatian: Budući da je put primjene ravulizumaba intravenska infuzija, a farmaceutski oblik je otopina, bioraspoloživom se smatra 100% primijenjene doze.
English: The most serious adverse reactions in patients in clinical trials are meningococcal infection and meningococcal sepsis (see section 4.4).
Croatian: Najozbiljnije nuspojave u bolesnika u kliničkim ispitivanjima jesu meningokokna infekcija i meningokokna sepsa (vidjeti dio 4.4).
English: The prepared solution should be administered immediately following preparation.
Croatian: Pripremljenu otopinu treba primijeniti odmah nakon pripreme.
English: Clear to translucent, slight whitish colour, pH 7.0 solution.
Croatian: Bistra do prozirno bjelkasta otopina, pH 7,0.
English: • Submission of written confirmation of the patient`s vaccination against all available meningococcal infection serotypes N. meningitidis and/or prophylactic antibiotic treatment according to national vaccination guideline.
Croatian: • Dostava pismene potvrde o cijepljenju bolesnika protiv meningokoknih infekcija svim dostupnim serotipovima bakterije N. meningitidis i/ili primanju antibiotske profilakse u skladu s nacionalnim smjernicama za cijepljenje.
English: The MAH shall ensure that in each Member State where Ultomiris is marketed, a system aimed to control distribution of Ultomiris beyond the level of routine risk minimisation measures is in place.
Croatian: Nositelj odobrenja provjerit će je li u svakoj državi članici u kojoj je lijek Ultomiris stavljen u promet uveden sustav kojim se distribucija lijeka Ultomiris kontrolira iznad razine rutinskih mjera minimizacije rizika.
English: Physicians should advise patients about gonorrhoea prevention.
Croatian: Osim toga, liječnici moraju bolesnicima savjetovati kako spriječiti gonoreju.
English: In clinical trials, some patients with PNH experienced infusion reactions which were mild in severity and transient (e.g., lower back pain and drop in blood pressure).
Croatian: U kliničkim ispitivanjima neki bolesnici s PNH-om imali su reakcije na infuziju koje su bile blage i prolazne (npr. bol u donjem dijelu leđa i pad krvnog tlaka).
English: If you experience any of the following symptoms, you should immediately inform your doctor: headache with nausea or vomiting headache and fever headache with a stiff neck or stiff back fever fever and rash confusion muscle aches with flu-like symptoms eyes sensitive to light
Croatian: Ako Vam se pojavi bilo koji od sljedećih simptoma, odmah o tome obavijestite liječnika: glavobolja s mučninom ili povraćanjem glavobolja i vrućica glavobolja s ukočenim vratom ili ukočenim leđima vrućica vrućica i osip smetenost bol u mišićima sa simptomima sličnim gripi osjetljivost na svjetlo.
English: Ultomiris should be prepared for administration by a qualified healthcare professional using aseptic technique.
Croatian: Ultomiris treba za primjenu pripremiti osposobljeni zdravstveni radnik služeći se aseptičkom tehnikom.
English: The diluted solution of Ultomiris should be administered by intravenous infusion over approximately 2 hours using a syringe-type pump or an infusion pump.
Croatian: Razrijeđenu otopinu lijeka Ultomiris treba primijeniti intravenskom infuzijom tijekom približno 2 sata pomoću pumpe sa štrcaljkom ili infuzijske pumpe.
English: The mean (SD) values for terminal elimination half-life and clearance of ravulizumab in patients with PNH are 49.7 (8.9) days and 0.003 (0.001) L/h, respectively.
Croatian: Srednje vrijednosti (SD) terminalnog poluvijeka eliminacije i klirensa ravulizumaba u bolesnika s PNH-om iznose 49,7 (8,9) dana odnosno 0,003 (0,001) l/h.
English: Age (years) at PNH diagnosis
Croatian: Dob (godine) u vrijeme dijagnoze PNH-a
English: No specific non-clinical study on fertility has been conducted with ravulizumab.
Croatian: Nisu provedena specifična neklinička ispitivanja plodnosti s ravulizumabom.
English: Ultomiris is a medicine that contains the active substance ravulizumab and it belongs to a class of medicines called monoclonal antibodies, that attach to a specific target in the body.
Croatian: Ultomiris je lijek koji sadrži djelatnu tvar ravulizumab i pripada skupini lijekova pod nazivom monoklonska protutijela, koja se vežu za specifično ciljno mjesto u tijelu.
English: Excipient(s) with known effect: Sodium (5 mmol per vial)
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: natrij (5 mmol po bočici)
English: The most common adverse drug reactions are upper respiratory tract infection (very common), nasopharyngitis (very common) and headache (very common).
Croatian: Najčešće su nuspojave lijeka infekcija gornjih dišnih puteva (vrlo često), nazofaringitis (vrlo često) i glavobolja (vrlo često).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija
English: Infusion must be administered through a 0.2 µm filter.
Croatian: Infuzija se mora primjenjivati kroz filtar veličine pora od 0,2 µm.
English: When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the maximum recommended human ravulizumab dose, based on a body weight comparison); however, the exposure did not increase foetal loss or neonatal death.
Croatian: Pri maternalnoj izloženosti protutijelu tijekom organogeneze, opažena su dva slučaja retinalne displazije i jedan umbilikalne hernije u 230 mladunčadi ženki izloženih višim dozama protutijela (približno 4 puta većim od maksimalne preporučene doze ravulizumaba u ljudi, određeno na temelju usporedbe tjelesne težine); međutim, izloženost nije povećala gubitak fetusa ili neonatalnu smrtnost.
English: As an immunoglobulin gamma (IgG) monoclonal antibody, ravulizumab is expected to be metabolized in the same manner as any endogenous IgG (degraded into small peptides and amino acids via catabolic pathways), and is subject to similar elimination.
Croatian: Kao imunoglobulinsko gama (IgG) monoklonsko protutijelo, očekuje se da će se ravulizumab metabolizirati na jednaki način kao bilo koji drugi endogeni IgG (razgraditi na male peptide i aminokiseline kataboličkim putevima) te da je podložan sličnoj eliminaciji.
English: More than 80 % of patients in both treatment groups had a history of transfusion within 12 months of study entry.
Croatian: Više od 80% bolesnika u obje terapijske skupine primilo je transfuziju unutar 12 mjeseci prije uključivanja u ispitivanje.