FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with any PNH conditions a prior to informed consent n (%)
Croatian: Bolesnici s bilo kojim stanjem zbog PNH-a a prije davanja informiranog pristanka n (%)
English: Vaccination reduces, but does not eliminate, the risk of meningococcal infections.
Croatian: Cijepljenje smanjuje, ali ne uklanja rizik od meningokokne infekcije.
English: Ravulizumab must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders.
Croatian: Ravulizumab mora primjenjivati zdravstveni radnik i to pod nadzorom liječnika s iskustvom u liječenju bolesnika s hematološkim poremećajima.
English: As a result, patients with complement-mediated diseases, including PNH, may experience increased signs and symptoms of their underlying disease, such as haemolysis.
Croatian: Posljedično tomu, u bolesnika s bolestima posredovanim komplementom, uključujući PNH, mogu se pojaviti pojačani znakovi i simptomi osnovne bolesti kao što je hemoliza.
English: Free C5 levels less than 0.5 µg/mL were correlated with maximal intravascular haemolysis control and complete terminal complement inhibition.
Croatian: Koncentracije slobodnog C5 niže od 0,5 µg/ml bile su u korelaciji s maksimalnom kontrolom intravaskularne hemolize i potpunom inhibicijom završne aktivacije sustava komplementa.
English: Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately.
Croatian: Bolesnike je potrebno upoznati s tim znakovima i simptomima kako bi poduzeli potrebne korake i odmah potražili liječničku pomoć.
English: Note: The black triangle indicates the non-inferiority margins, and grey dot indicates point estimates.
Croatian: Napomena: Crni trokut pokazuje granice neinferiornosti, a sive točke točkovne procjene.
English: What Ultomiris is and what it is used for
Croatian: Što je Ultomiris i za što se koristi
English: The active substance is ravulizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL).
Croatian: Djelatna tvar je ravulizumab (300 mg/30 ml u bočici što odgovara 10 mg/ml).
English: Due to its mechanism of action, the use of ravulizumab increases the patient's susceptibility to meningococcal infection/sepsis (Neisseria meningitidis).
Croatian: Zbog mehanizma djelovanja ravulizumaba, njegova primjena povećava bolesnikovu osjetljivost na meningokoknu infekciju/sepsu (Neisseria meningitidis).
English: The MAH shall ensure that in each Member State where Ultomiris is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use Ultomiris have access to/are provided with the following educational package to be disseminated through professional bodies:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da u svakoj državi članici u kojoj je lijek Ultomiris stavljen u promet, svi zdravstveni radnici za koje se očekuje da će propisivati, izdavati i primjenjivati lijek Ultomiris i bolesnici koji će ga primati, imaju pristup/dobiju sljedeći edukacijski paket putem stručnih tijela:
English: Administration of ravulizumab may result in infusion reactions.
Croatian: Primjena ravulizumaba može rezultirati reakcijama na infuziju.
English: All 3 recovered while continuing treatment with ravulizumab.
Croatian: Sva 3 bolesnika oporavila su se tijekom nastavljenog liječenja ravulizumabom.
English: The most serious side effect was meningococcal infection/sepsis.
Croatian: Najozbiljnija nuspojava bila je meningokokna infekcija/sepsa.
English: This medicinal product must be administered through a 0.2 µm filter and should not be administered as an intravenous push or bolus injection.
Croatian: Ovaj se lijek mora primjenjivati kroz filtar veličine pora od 0,2 µm i ne smije se primjenjivati kao intravenska brza ili bolus injekcija.
English: In clinical trials, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ravulizumab; all 3 had been vaccinated.
Croatian: U kliničkim su ispitivanjima 3 od 261 bolesnika s PNH-om razvila ozbiljnu meningokoknu infekciju/sepsu dok su primala terapiju ravulizumabom; sva 3 bolesnika bila su cijepljena.
English: Ravulizumab blocks terminal complement activation; therefore patients may have increased susceptibility to infections caused by Neisseria species and encapsulated bacteria.
Croatian: Ravulizumab blokira završnu aktivaciju sustava komplementa; stoga bolesnici mogu biti osjetljiviji na infekcije prouzročene bakterijom roda Neisseria i enkapsuliranim bakterijama.
English: Therapeutic steady-state drug concentrations are reached after the first dose.
Croatian: Terapijske koncentracije lijeka u stanju dinamičke ravnoteže postižu se nakon prve doze.
English: If you were previously receiving another medicine for PNH called Soliris, the loading dose should be given 2 weeks after the last Soliris infusion.
Croatian: Ako ste prije primali drugi lijek protiv paroksizmalne noćne hemoglobinurije pod nazivom Soliris, udarnu dozu trebate primiti 2 tjedna nakon posljednje infuzije lijeka Soliris.
English: The safety and efficacy of ravulizumab have not been studied in patients with hepatic impairment; however pharmacokinetic data suggest that no dose adjustment is required in patients with hepatic impairment.
Croatian: Sigurnost i djelotvornost ravulizumaba nisu ispitane u bolesnika s oštećenjem jetrene funkcije, ali farmakokinetički podaci ukazuju na to da u bolesnika s oštećenjem jetrene funkcije nije potrebna prilagodba doze.
English: If you stop using Ultomiris
Croatian: Ako prestanete primati Ultomiris
English: If the medicinal product is not used immediately after dilution, storage times must not exceed 24 hours at 2°C-8°C or 6 hours at room temperature taking into account the expected infusion time.
Croatian: Ako se lijek ne upotrijebi odmah nakon razrjeđivanja, vrijeme čuvanja ne smije biti dulje od 24 sata na temperaturi 2°C-8°C ili 6 sati na sobnoj temperaturi, uzimajući u obzir i očekivano trajanje infuzije.
English: The following requirements need to be fulfilled before the product is dispensed:
Croatian: Prije izdavanja lijeka potrebno je ispuniti sljedeći zahtjev:
English: 2- Before administration Dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Croatian: Razrjeđivanje treba provoditi prema pravilima dobre prakse, osobito u pogledu asepse.
English: When given the same dose, heavier patients with PNH had lower median serum ravulizumab concentrations compared with lighter patients.
Croatian: Kada su primili jednake doze, bolesnici s PNH-om veće tjelesne težine imali su niži medijan koncentracija ravulizumaba u serumu nego oni manje tjelesne težine.
English: One vial of 30 mL contains 300 mg of ravulizumab.
Croatian: Jedna bočica od 30 ml sadrži 300 mg ravulizumaba.
English: The 12-month transfusion history was similar between ravulizumab and eculizumab treatment groups and more than 87 % of patients in both treatment groups had not received a transfusion within 12 months of study entry.
Croatian: Primjena transfuzije u prethodnih 12 mjeseci bila je slična u skupini koja je primala ravulizumab i onoj koja je primala ekulizumab i više od 87% bolesnika u obje terapijske skupine nije primilo transfuziju unutar 12 mjeseci prije uključivanja u ispitivanje.
English: Treatment for meningococcal infection while travelling If you are travelling in a region where you are unable to contact your doctor or will be temporarily unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis to bring with you.
Croatian: Ako putujete u područja gdje nećete moći stupiti u kontakt sa svojim liječnikom ili Vam privremeno neće biti dostupna medicinska pomoć, liječnik Vam može propisati recept za antibiotik protiv bakterije
English: Ravulizumab preserves the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes.
Croatian: Ravulizumab ne inhibira komponente s početka aktivacije komplementa koje su neophodne za opsonizaciju mikroorganizama i uklanjanje imunokompleksa.
English: o Risk of serious haemolysis following ravulizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management.
Croatian: o Rizik od ozbiljne hemolize nakon prekida ravulizumaba i odgođene primjene, kriteriji za to, neophodan nadzor nakon liječenja i predloženo liječenje.
English: Over the studied dose and regimen range, ravulizumab exhibited dose proportional and time linear pharmacokinetics (PK).
Croatian: U ispitivanom rasponu doza i režima doziranja ravulizumab je pokazao farmakokinetiku proporcionalnu dozi i vremenski linearnu.
English: o Treatment with ravulizumab increases the risk of N. meningitidis infections.
Croatian: o Liječenje ravulizumabom povećava rizik od infekcija bakterijom N. meningitidis.
English: You should take this into consideration if you are on a controlled sodium diet.
Croatian: O tome trebate voditi računa ako ste na prehrani s ograničenim unosom natrija.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Alexion Europe SAS
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Alexion Europe SAS
English: Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as ravulizumab and thereby decrease serum ravulizumab concentrations.
Croatian: Kronično liječenje intravenskom primjenom ljudskih imunoglobulina može interferirati s mehanizmom recikliranja monoklonskih protutijela, kao što je ravulizumab, putem endosomskog neonatalnog receptora Fc (FcRn) i tako smanjiti koncentracije ravulizumaba u serumu.
English: In PNH patient studies (N = 261), only 1 (0.38 %) case with development of treatment-emergent anti-drug antibody has been reported with ravulizumab.
Croatian: U ispitivanjima s bolesnicima s PNH-om (N = 261), tijekom liječenja ravulizumabom zabilježen je samo 1 slučaj (0,38%) razvoja protutijela na lijek.
English: For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses are administered once every 8 weeks, starting 2 weeks after loading dose administration, as shown in Table 1.
Croatian: U bolesnika koji prelaze s ekulizumaba na ravulizumab, udarnu dozu ravulizumaba treba primijeniti 2 tjedna nakon posljednje infuzije ekulizumaba, a zatim se doze održavanja primjenjuju jednom svakih 8 tjedana s početkom primjene 2 tjedna nakon udarne doze, kako je prikazano u tablici 1.
English: Meningococcal infection/sepsis
Croatian: Meningokokna infekcija/sepsa
English: Non-clinical data reveal no special hazard for humans based on nonclinical studies using a murine surrogate molecule, BB5.1, in mice.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju nekliničkih ispitivanja primjenom mišje surogatne molekule BB5.1 u miševa.
English: “Other” category included neutropenia, renal dysfunction, and thrombopenia, as well as a number of other conditions.
Croatian: „Drugo“ uključuje neutropeniju, disfunkciju bubrega i trombocitopeniju, kao i brojna druga stanja.
English: Nonclinical reproductive toxicology studies were not conducted with ravulizumab (see section 5.3).
Croatian: Neklinička ispitivanja reproduktivne toksičnosti ravulizumaba nisu provedena (vidjeti dio 5.3).
English: If the patient is being switched from eculizumab treatment, physicians should verify that meningococcal vaccination is current according to national guidelines for vaccination use.
Croatian: Ako bolesnik prelazi s terapije ekulizumabom, liječnici moraju provjeriti traje li zaštita protiv meningokoka stečena cijepljenjem prema nacionalnim smjernicama za primjenu cjepiva.
English: Body weight range (kg)
Croatian: Raspon tjelesne težine (kg)
English: Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution.
Croatian: Ultomiris je bistra do prozirno bjelkasta otopina, zapravo bez prisutnih čestica.
English: The diluted solution should be allowed to warm to room temperature (18°C-25°C) prior to administration by exposure to ambient air during approximately 30 min.
Croatian: Prije primjene razrijeđenu je otopinu potrebno ostaviti da se zagrije na sobnu temperaturu (18°C-25°C) izlaganjem zraku okoline otprilike 30 minuta.
English: No formal trial of the effect of sex, race, age (geriatric), hepatic or renal impairment on the pharmacokinetics of ravulizumab was conducted.
Croatian: Nije provedeno službeno ispitivanje učinka spola, etničke pripadnosti, dobi (gerijatrija), oštećenja bubrežne ili jetrene funkcije na farmakokinetiku ravulizumaba.
English: The time to maximum observed concentration (tmax) is expected at the end of infusion (EOI) or soon after EOI.
Croatian: Maksimalna opažena koncentracija očekuje se na kraju infuzije ili ubrzo nakon toga.
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported in patients treated with other terminal complement inhibitors.
Croatian: Ozbiljne infekcije prouzročene bakterijama roda Neisseria (koje nisu bile Neisseria meningitidis), uključujući diseminirane gonokokne infekcije, zabilježene su u bolesnika liječenih drugim inhibitorima završne aktivacije sustava komplementa.
English: Ultomiris must be diluted to a final concentration of 5 mg/mL.
Croatian: Ultomiris se mora razrijediti do konačne koncentracije od 5 mg/ml.
English: Weight-based dosing is proposed in section 4.2, Table
Croatian: Doze na temelju tjelesne težine predložene su u dijelu 4.2, tablica 1.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, and water for injections.
Croatian: Natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80 i voda za injekcije.
English: Meningococcal disease due to any serogroup may occur.
Croatian: Može se razviti meningokokna bolest prouzročena meningokokom bilo koje serološke skupine.
English: What Ultomiris contains
Croatian: Što Ultomiris sadrži
English: Patients were vaccinated against meningococcal infection prior to or at the time of initiating treatment with ravulizumab or eculizumab, or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Croatian: Bolesnici su bili cijepljeni protiv meningokokne infekcije prije ili u vrijeme početka liječenja ravulizumabom ili ekulizumabom, ili su primali odgovarajuću antibiotsku profilaksu do 2 tjedna poslije cijepljenja.
English: The coprimary endpoints were transfusion avoidance, and haemolysis as directly measured by normalisation of LDH levels (LDH levels ≤ 1 × ULN; the ULN for LDH is 246 U/L).
Croatian: Mjere koprimarnog ishoda bile su izbjegavanje transfuzije i hemoliza na temelju izravnog mjerenja normalizacije razina LDH (razine LDH ≤ 1 × GGN, s tim da je GGN za LDH 246 U/l).
English: Meningococcal and other Neisseria infections symptoms Because the medicine blocks the complement system, which is part of the body's defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis.
Croatian: Simptomi meningokokne i drugih infekcija prouzročenih bakterijom Neisseria Budući da lijek blokira sustav komplementa, a on je dio tjelesnog obrambenog sustava protiv infekcija, primjena lijeka Ultomiris povećava rizik od meningokokne infekcije koju uzrokuje bakterija
English: What you need to know before you use Ultomiris 3.
Croatian: Što morate znati prije nego počnete primjenjivati Ultomiris
English: What is Ultomiris
Croatian: Što je Ultomiris
English: Volume of NaCl diluent b
Croatian: Volumen NaCl otapala b
English: Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation.
Croatian: Prije razrjeđivanja otopinu u bočicama treba vizualno pregledati; u otopini ne smije biti čestica ili taloga.
English: Do not administer Ultomiris as an intravenous push or bolus injection.
Croatian: Ultomiris nemojte primjenjivati kao brzu intravensku ili bolus injekciju.
English: Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 UNITED STATES
Croatian: Patheon Biologics LLC 4766 La Guardia Drive St.
English: Infections and infestations Upper respiratory tract infection, Nasopharyngitis
Croatian: Infekcije i infestacije infekcija gornjih dišnih puteva nazofaringitis meningokokna infekcija*
English: Ultomiris contains sodium
Croatian: Ultomiris sadrži natrij
English: The mean (standard deviation [SD]) volume of distribution at steady state for patients with PNH on the studied weight-based dose regimen was 5.34 (0.92) L.
Croatian: Srednja vrijednost (standardna devijacija [SD]) volumena distribucije u stanju dinamičke ravnoteže u bolesnika s PNH-om kojima je doza lijeka određena na temelju tjelesne težine iznosila je 5,34 (0,92) l.
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE
Croatian: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francuska
English: Body weight at time of treatment b
Croatian: Tjelesna težina u vrijeme liječenja b
English: After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the medicine should be used immediately, or within 24 hours if refrigerated or within 6 hours at room temperature.
Croatian: Nakon razrjeđivanja 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju, lijek treba primijeniti odmah ili u roku od 24 sata ako se čuva u hladnjaku, ili u roku od 6 sati ako se čuva na sobnoj temperaturi.
English: There are no clinical data from the use of ravulizumab in pregnant women.
Croatian: Nema kliničkih podataka o primjeni ravulizumaba u trudnica.
English: *Meningococcal infection includes preferred terms of meningococcal infection and meningococcal sepsis
Croatian: *Meningokokna infekcija uključuje preporučene pojmove „meningokokna infekcija“ i „meningokokna sepsa“.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip pruritus
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „Rok valjanosti“.
English: Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity.
Croatian: Privremeni prekid ili prestanak terapije lijekom Ultomiris može prouzročiti vraćanje simptoma paroksizmalne noćne hemoglobinurije u još težem obliku.
English: Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use.
Croatian: Bolesnike se mora cijepiti ili docjepljivati prema važećim nacionalnim smjernicama za primjenu cjepiva.
English: Serious meningococcal infection
Croatian: Ozbiljna meningokokna infekcija
English: Based on medical history.
Croatian: Na temelju anamneze.
English: “Other” as specified on case report form included thrombocytopenia, chronic kidney disease, and pancytopenia, as well as a number of other conditions.
Croatian: b „Drugo“ prema onome što je navedeno na obrascu za prikaz slučaja uključuje trombocitopeniju, kroničnu bubrežnu bolest i pancitopeniju, kao i više drugih stanja.
English: Ravulizumab was non-inferior compared to eculizumab for the primary endpoint, percent change in LDH from baseline to day 183, and for all 4 key secondary endpoints (Figure 2).
Croatian: Ravulizumab je bio neinferioran u usporedbi s ekulizumabom u mjeri primarnog ishoda, postotnoj promjeni vrijednosti LDH od početka do 183. dana, i u sve 4 ključne mjere sekundarnog ishoda (slika 2).
English: Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines.
Croatian: Ovaj lijek ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • The patient alert card shall contain the following key messages: o Signs and symptoms of meningococcal infection o Warning to seek immediate medical care if above are present o Statement that the patient is receiving ravulizumab o Contact details where a healthcare professional can receive further information
Croatian: • Kartica s upozorenjima za bolesnika sadržavat će sljedeće ključne poruke: o znakove i simptome meningokokne infekcije o upozorenje da se odmah potraži liječnička pomoć ako su prisutni znakovi i simptomi te infekcije o navod da bolesnik prima ravulizumab o podaci kome se zdravstveni radnik može obratiti za dodatne informacije.
English: Very common (may affect more than 1 in 10 people): Headache
Croatian: Vrlo često (mogu se pojaviti u više od 1 na 10 osoba): glavobolja infekcija gornjih dišnih puteva obična prehlada (nazofaringitis)
English: Gently agitate the infusion bag containing the diluted Ultomiris solution to ensure thorough mixing of the medicinal product and diluent.
Croatian: Lagano protresite infuzijsku vrećicu koja sadrži razrijeđenu otopinu lijeka Ultomiris kako bi se sadržaj lijeka temeljito pomiješao s otapalom.
English: No specific test-article related reproductive toxicities were identified in these studies.
Croatian: U ovim ispitivanjima nije utvrđena nikakva posebna reproduktivna toksičnost povezana s ispitivanim lijekom.
English: In patients with PNH, the complement system is overactive and attacks their red blood cells, which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing, erectile dysfunction and blood clots.
Croatian: U bolesnika s PNH-om sustav komplementa pretjerano je aktivan i napada crvene krvne stanice, što može dovesti do smanjenog broja tih stanica (anemija), umora, teškoća u funkcioniranju, bolova, bola u trbuhu, tamne boje mokraće, nedostatka zraka, otežanog gutanja, erektilne disfunkcije i nastanka krvnih ugrušaka.
English: Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1).
Croatian: Ultomiris je indiciran za liječenje odraslih bolesnika s paroksizmalnom noćnom hemoglobinurijom (PNH): u bolesnika s hemolizom s jednim ili više kliničkih simptoma koji ukazuju na visokoaktivnu bolest u bolesnika koji su klinički stabilni nakon liječenja ekulizumabom najmanje proteklih 6 mjeseci (vidjeti dio 5.1).
English: Do not use if there is evidence of particulate matter or precipitation.
Croatian: Nemojte upotrijebiti ako su vidljive čestice ili talog.
English: At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections if you have not previously had one or if your vaccination is outdated.
Croatian: Najmanje 2 tjedna prije nego što počnete primati Ultomiris liječnik će Vas cijepiti protiv meningokoknih infekcija ako prethodno niste bili cijepljeni, ili ako je od cijepljenja proteklo previše vremena.
English: 1- How is Ultomiris supplied?
Croatian: 1 - Kako se Ultomiris isporučuje?
English: Dilute Ultomiris to a final concentration of 5 mg/mL (initial concentration divided by 2) by adding the appropriate amount of sodium chloride 9 mg/mL (0.9%) solution for injection to the infusion as per the instructions provided in table below.
Croatian: Razrijedite Ultomiris do konačne koncentracije od 5 mg/ml (početna koncentracija podijeljena s 2) dodavanjem odgovarajuće količine 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju u infuzijsku vrećicu prema uputama navedenim u tablici u nastavku.