FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common adverse drug reactions are upper respiratory tract infection (very common), nasopharyngitis (very common) and headache (very common).
Slovenian: Najpogostejši neželeni učinki zdravila so okužba zgornjih dihal (zelo pogosti), nazofaringitis (zelo pogosti) in glavobol (zelo pogosti).
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.
Slovenian: Zdravilo Ultomiris je zdravilo, ki vsebuje učinkovino ravulizumab in pripada skupini zdravil, imenovanih monoklonska protitelesa, ki se vežejo na določeno tarčo v telesu.
English: 30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Slovenian: 30 ml sterilnega koncentrata v viali (steklo tipa I) z zamaškom in zaporko.
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).
Slovenian: V kliničnih preskušanjih so se pri nekaterih bolnikih s PNH pojavile reakcije na infuzijo, ki so bile blage in prehodne (npr. bolečina v križu in padec krvnega tlaka).
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.
Slovenian: Povprečni (SD) vrednosti končnega razpolovnega časa izločanja in očistka ravulizumaba pri bolnikih s PNH sta 49,7 (8,9) dneva oziroma 0,003 (0,001) l/h.
English: Ultomiris has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Ultomiris nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: What Ultomiris is and what it is used for 2.
Slovenian: Kaj je zdravilo Ultomiris in za kaj ga uporabljamo 2.
English: No formal trial of the effect of sex, race, age (geriatric), hepatic or renal impairment on the pharmacokinetics of ravulizumab was conducted.
Slovenian: Formalnih preskušanj vpliva spola, rase, starosti (starejši), okvare jeter ali ledvic na farmakokinetiko ravulizumaba niso izvedli.
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.
Slovenian: Simptomi meningokoknih okužb in drugih okužb z bakterijami Neisseria Ker zdravilo blokira sistem komplementa, ki je del telesne obrambe proti okužbam, lahko uporaba zdravila Ultomiris zveča tveganje okužbe z meningokoki, ki jo povzroči Neisseria meningitidis.
English: When given the same dose, heavier patients with PNH had lower median serum ravulizumab concentrations compared with lighter patients.
Slovenian: Težji bolniki s PNH so ob prejetju enakega odmerka imeli v serumu nižje mediane koncentracije ravulizumaba kot lažji bolniki.
English: See the leaflet for further information.
Slovenian: Za nadaljnje informacije glejte navodilo za uporabo.
English: Patients should be informed of the signs and symptoms of meningococcal septicaemia and advised to seek medical care immediately.
Slovenian: Bolnike je treba poučiti o znakih in simptomih meningokokne septikemije in jim svetovati, naj nemudoma poiščejo zdravniško pomoč.
English: Administration of ravulizumab may result in infusion reactions.
Slovenian: Aplikacija ravulizumaba lahko privede do reakcije na infuzijo.
English: What you need to know before you use Ultomiris 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ultomiris 3.
English: Free C5 levels less than 0.5 µg/mL were correlated with maximal intravascular haemolysis control and complete terminal complement inhibition.
Slovenian: Proste koncentracije C5, manjše od 0,5 µg/ml, se ujemajo z največjim obvladovanjem intravaskularne hemolize in popolno inhibicijo terminalnega komplementa.
English: One vial of 30 mL contains 300 mg of ravulizumab.
Slovenian: Ena viala s 30 ml vsebuje 300 mg ravulizumaba.
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.
Slovenian: • predložitev pisne potrditve, da je bil bolnik cepljen proti meningokoknim okužbam, in sicer proti vsem serotipom N. meningitidis, ki so na voljo, oziroma, da je prejel profilaktično antibiotično zdravljenje v skladu z nacionalnimi smernicami za cepljenje.
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”.
Slovenian: Če pozabite obiskati zdravnika in zato niste prejeli zdravila Ultomiris Če pozabite obiskati zdravnika, se takoj posvetujte z njim in glejte poglavje “Če prenehate prejemati zdravilo Ultomiris” v nadaljevanju.
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.
Slovenian: 12-mesečna anamneza transfuzij je bila v skupinah, zdravljenih z ravulizumabom in ekulizumabom, podobna in več kot 87 % bolnikov v obeh zdravljenih skupinah v 12 mesecih po vključitvi v študijo ni prejelo transfuzije.
English: If signs and symptoms of haemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ravulizumab.
Slovenian: Če se po prenehanju zdravljenja pojavijo znaki in simptomi hemolize, vključno z zvišano LDH, pride v poštev ponoven začetek zdravljenja z ravulizumabom.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli poleg oznake ‘EXP'.
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.
Slovenian: Vse bolnike je treba spremljati glede zgodnjih znakov meningokokne okužbe in sepse, jih nemudoma obravnavati, če domnevamo, da bi lahko šlo za sepso, in jih zdraviti z ustreznimi antibiotiki.
English: Ravulizumab blocks terminal complement activation; therefore patients may have increased susceptibility to infections caused by Neisseria species and encapsulated bacteria.
Slovenian: Ravulizumab zavira aktivacijo terminalnega komplementa, zato lahko bolniki postanejo dovzetnejši za okužbe, ki jih povzročajo vrsta Neisseria in inkapsulirane bakterije.
English: Total volume (mL)
Slovenian: Skupni volumen (ml)
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.
Slovenian: Če zdravila ne uporabite takoj po razredčenju, čas shranjevanja ne sme preseči 24 ur pri 2 °C8 °C ali 6 ur pri sobni temperaturi, pri čemer morate upoštevati pričakovano trajanje infuzije.
English: Meningococcal disease due to any serogroup may occur.
Slovenian: Meningokokno bolezen lahko povzroči katera koli seroskupina.
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.
Slovenian: V študijah bolnikov s PNH (N = 261) so pri ravulizumabu poročali samo o enem primeru (0,38 %) z razvojem protiteles proti zdravilu, ki se je pojavilo med zdravljenjem.
English: “Other” as specified on case report form included thrombocytopenia, chronic kidney disease, and pancytopenia, as well as a number of other conditions.
Slovenian: b “Drugo”, kot je bilo specificirano v poročilu o primeru, vključuje trombocitopenijo, kronično bolezen ledvic in pancitopenijo, pa tudi več drugih stanj.
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.
Slovenian: To zdravilo se veže na beljakovino C5 in jo blokira ter tako omeji bolezenske simptome, saj prepreči beljakovinam komplementa, da bi napadale rdeče krvničke.
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).
Slovenian: Opazovana dogodka sta bila odsotnost potrebe za transfuzijo in hemoliza, neposredno izmerjena z normalizacijo ravni LDH (ravni LDH ≤ 1 × ZMN; ZMN za LDH je 246 e./l).
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.
Slovenian: • Pustite, da se razredčena raztopina pred uporabo segreje na sobno temperaturo (18 °C-25 °C), tako da jo izpostavite temperaturi v okolici za približno 30 min.
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).
Slovenian: Izgled zdravila Ultomiris in vsebina pakiranja Zdravilo Ultomiris je na voljo v obliki koncentrata za raztopino za infundiranje (30 ml v vialivelikost pakiranja 1 viala).
English: Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution.
Slovenian: Zdravilo Ultomiris je bistra do prosojna, rahlo belkasta raztopina praktično brez delcev.
English: Volume of NaCl diluent b
Slovenian: Volumen vehikla za redčenje z NaCl b
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.
Slovenian: Priporočena shema odmerjanja za odrasle bolnike (≥ 18 let) s PNH se začne s polnilnim odmerkom, ki mu sledijo vzdrževalni odmerki intravenske infuzije.
English: *Meningococcal infection includes preferred terms of meningococcal infection and meningococcal sepsis
Slovenian: *Meningokokne okužbe vključujejo prednostna izraza meningokokne okužbe in meningokokna sepsa.
English: The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati: o povzetek glavnih značilnosti zdravila, o vodnik za zdravstvene delavce.
English: It should not be shaken.
Slovenian: Ne smete ga stresati.
English: Treatment discontinuation
Slovenian: Prenehanje zdravljenja
English: Therapeutic steady-state drug concentrations are reached after the first dose.
Slovenian: Terapevtske koncentracije zdravila v stanju dinamičnega ravnovesja so dosežene po prvem odmerku.
English: INFORMATION IN BRAILLE Justification for not including braille accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: The most serious side effect was meningococcal infection/sepsis.
Slovenian: Najresnejši neželeni učinek je meningokokna okužba/sepsa.
English: Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity.
Slovenian: Če boste prekinili ali opustili zdravljenje z zdravilom Ultomiris, se bodo mogoče simptomi PNH ponovili v hujši obliki.
English: If stored at 2-8°C, allow the diluted solution to warm to room temperature prior to administration.
Slovenian: Če je shranjena pri 2-8 °C, pustite, da se razredčena raztopina pred uporabo ogreje na sobno temperaturo.
English: Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately.
Slovenian: Bolnike je treba obveščati o teh znakih in simptomih ter zagotoviti, da v tem primeru poiščejo takojšnjo medicinsko pomoč.
English: Table 3 gives the adverse reactions observed from clinical trials.
Slovenian: V preglednici 3 so navedeni neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih.
English: The active substance is ravulizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL).
Slovenian: − Učinkovina je ravulizumab (300 mg/30 ml v viali, kar ustreza 10 mg/ml).
English: Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation.
Slovenian: Pred redčenjem je treba raztopino v vialah pregledati; raztopina mora biti brez vidnih delcev ali oborine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label
Slovenian: PODATKI NA ZUNANJI OVOJNINI Etiketa na kartonski škatli
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.
Slovenian: V kliničnih preskušanjih so se med zdravljenjem z ravulizumabom pri treh od 261 bolnikov s PNH razvile resne meningokokne okužbe/sepsa; vsi trije so bili cepljeni.
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.
Slovenian: Ko so bile med organogenezo breje samice izpostavljene protitelesu, so med 230 potomci, ki so jih povrgle samice, izpostavljene večjemu odmerku protitelesa (približno štirikrat večjemu od največjega priporočenega odmerka ravulizumaba za človeka na podlagi primerjave telesnih mas), ugotovili dva primera retinalne displazije in en primer popkovne kile; izpostavljenost pa ni zvečala izgube plodov ali smrtnosti novorojenčkov.
English: Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment.
Slovenian: Zdravnik se bo pred začetkom zdravljenja pogovoril z vami o možnih neželenih učinkih in vam razložil tveganja in koristi zdravila Ultomiris.
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).
Slovenian: Odmerki ravulizumaba so v skladu s priporočenim odmerjanjem, opisanim v poglavju 4.2 (4 infuzije ravulizumaba v obdobju 26 tednov), odmerki ekulizumaba pa so v skladu z odobreno shemo odmerjanja ekulizumaba: 600 mg vsak teden prve 4 tedne in 900 mg vsaka 2 tedna (15 infuzij v obdobju 26 tednov).
English: 5 mg/mL after dilution
Slovenian: 30 ml 5 mg/ml po razredčenju
English: The primary endpoint was haemolysis as measured by LDH percent change from baseline.
Slovenian: Primarni opazovani dogodek je bila hemoliza, izmerjena z odstotno spremembo LDH od izhodišča.
English: 2- Before administration Dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Slovenian: Redčenje morate izvesti v skladu s pravili dobre prakse, predvsem glede asepse.
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.
Slovenian: Večina populacije študije brez predhodnega inhibitorja komplementa je bila v izhodišču močno hemolitična; 86,2 % vključenih bolnikov je imelo zvišano LDH ≥ 3 × ZMN, ki je direktna mera intravaskularne hemolize, v okviru PNH.
English: Water for injections
Slovenian: Vehikel: voda za injekcije.
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.
Slovenian: Vendar na podlagi ocene populacijske FK pri raziskanih zdravih prostovoljcih in bolnikih s PNH niso ugotovili nikakršnega vpliva spola, starosti, rase in funkcije jeter ali ledvic, zato prilagajanje odmerjanja ni potrebno.
English: When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain.
Slovenian: Ko vam bodo dali zdravilo Ultomiris, se lahko pojavijo reakcije na infuzijo, na primer glavobol, bolečine v križu in bolečina, povezana z infuzijo.
English: Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
Slovenian: Za preprečevanje pogosto patogenih meningokoknih serotipov se priporočajo cepiva proti seroskupinam A, C, Y, W135 in B, kjer so ta na voljo.
English: Ravulizumab therapy should be administered with caution to patients with active systemic infections.
Slovenian: Ravulizumab je treba pri bolnikih z aktivnimi sistemskimi okužbami uporabljati previdno.
English: Maintenance doses should be administered at a once every 8-week interval, starting 2 weeks after loading dose administration.
Slovenian: Vzdrževalne odmerke je treba dajati v intervalu enkrat na 8 tednov, z začetkom v 2. tednu po polnilnem odmerku.
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.
Slovenian: Na miših so izvedli reproduktivne toksikološke študije z uporabo mišje nadomestne molekule BB5.1, s katero so ocenili učinek blokade C5 na reproduktivni sistem.
English: One vial of 30 mL contains 300 mg of ravulizumab, produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s 30 ml vsebuje 300 mg ravulizumaba, pridobljenega s tehnologijo rekombinantne DNA v celični kulturi ovarijskih celic kitajskega hrčka (Chinese hamster ovary - CHO).
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.
Slovenian: Zaradi pomembnosti hitre identifikacije in zdravljenja meningokokne okužbe pri bolnikih, ki se zdravijo z zdravilom Ultomiris, boste prejeli 'opozorilno kartico za bolnika', ki jo boste vedno nosili s seboj in na kateri bodo navedeni pomembni znaki in simptomi meningokokne okužbe/sepse.
English: Maintenance dose (mg)
Slovenian: Vzdrževalni odmerek (mg)
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.
Slovenian: Po redčenju z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje je treba zdravilo uporabiti takoj ali v 24 urah, če je shranjeno v hladilniku, ali v 6 urah, če je shranjeno pri sobni temperaturi.
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.
Slovenian: Vsaj 2 tedna pred začetkom zdravljenja z zdravilom Ultomiris vas bo zdravnik cepil proti meningokoknim okužbam, če niste bili cepljeni že prej ali če je vaše cepljenje zastaralo.
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol,
English: Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy.
Slovenian: Posvetujte se z zdravnikom, preden se začnete zdraviti z zdravilom Ultomiris, da bi tako najmanj dva tedna pred začetkom zdravljenja zanesljivo prejeli cepivo proti bakteriji Neisseria meningitidis.
English: No specific test-article related reproductive toxicities were identified in these studies.
Slovenian: V teh študijah niso ugotovili specifične reproduktivne toksičnosti.
English: Study in PNH patients previously treated with eculizumab
Slovenian: Študija pri bolnikih s PNH, ki so se predhodno zdravili z ekulizumabom
English: Ravulizumab contains only natural occurring amino acids and has no known active metabolites.
Slovenian: Ravulizumab vsebuje samo aminokisline, ki se pojavljajo v naravi in nima znanih aktivnih presnovkov.
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.
Slovenian: Ključni sekundarni opazovani dogodki so vključevali odstotno spremembo ravni LDH od izhodišča, spremembo v kvaliteti življenja (FACIT-utrujenost), delež bolnikov s prekinitveno hemolizo in delež bolnikov s stabiliziranim hemoglobinom.
English: Non-clinical data reveal no special hazard for humans based on nonclinical studies using a murine surrogate molecule, BB5.1, in mice.
Slovenian: Predklinični podatki ne kažejo posebnega tveganja za človeka na podlagi predkliničnih študij z mišjo nadomestno molekulo, BB5.1, na miših.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, and water for injections.
Slovenian: Natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid, polisorbat 80 in voda za injekcije.
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE
Slovenian: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francija
English: Discard any unused portion left in a vial as the medicinal product contains no preservatives.
Slovenian: • Zavrzite neuporabljeno zdravilo, ki ostane v viali, saj zdravilo ne vsebuje konzervansov.
English: Based on medical history.
Slovenian: Na podlagi anamneze.
English: Your doctor will discuss the possible side effects with you and explain the risks.
Slovenian: Vaš zdravnik vam bo razložil morebitne neželene učinke in tveganja.
English: The prepared solution should be administered immediately following preparation.
Slovenian: • Pripravljeno raztopino morate uporabiti takoj po pripravi.
English: Meningococcal infection/sepsis
Slovenian: Meningokokne okužbe/sepsa
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.
Slovenian: Bolniki so bili cepljeni proti meningokokni okužbi pred začetkom ali ob začetku zdravljenja z ravulizumabom ali ekulizumabom, ali pa so bili profilaktično zdravljeni z ustreznimi antibiotiki, dokler od cepljenja nista minila 2 tedna.
English: Infections and infestations Upper respiratory tract infection, Nasopharyngitis
Slovenian: Infekcijske in parazitske bolezni okužbe zgornjih dihal, nazofaringitis,
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.
Slovenian: Po zdravljenju z ravulizumabom so pri bolnikih s PNH v študijah 3. faze, ki še niso prejemali inhibitorjev komplementa, in pri bolnikih, ki so že prejemali ekulizumab, ugotovili takojšnjo in popolno inhibicijo prostega C5 v serumu (koncentracija < 0,5 µg/ml) ob koncu prve infuzije, ki je pri vseh bolnikih trajala celotno obdobje 26-tedenskega zdravljenja.