natgillin/translations-raw huggingface dataset:
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). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Ultomiris za eno ali več podskupin pediatrične populacije s paroksizmalno nočno hemoglobinurijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients who experience overdose should have immediate interruption of their infusion and be closely monitored. 
Bolnikom, ki prejmejo prevelik odmerek zdravila, je treba takoj prekiniti infuzijo in jih skrbno spremljati.
Due to its mechanism of action, the use of ravulizumab increases the patient's susceptibility to meningococcal infection/sepsis (Neisseria meningitidis). 
Zaradi svojega mehanizma delovanja, uporaba ravulizumaba poveča bolnikovo dovzetnost za meningokokno okužbo/sepso (Neisseria meningitidis).
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. 
Ravulizumab je monoklonsko protitelo IgG2/4K, ki se specifično veže na beljakovino komplementa C5 in s tem zavira njegovo cepitev v C5a (anafilatoksin, ki pospešuje vnetje) in C5b (sprožilno podenoto terminalnega kompleksa komplementa [C5b-9]) in preprečuje nastajanje C5b-9.
Body weight at time of treatment. 
Telesna masa v času zdravljenja.
Excipient(s) with known effect: Sodium (5 mmol per vial) 
Pomožna(e) snov(i) z znanim učinkom: natrij (5 mmolov na vialo).
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. 
Zdravljenje meningokokne okužbe med potovanjem Če potujete po območju, kjer se ne morete obrniti na svojega zdravnika ali kjer se začasno ne boste mogli zdraviti, vam lahko zdravnik predpiše antibiotik proti bakteriji Neisseria meningitidis, ki ga boste imeli pri sebi.
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: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Ultomiris trži, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo Ultomiris, imeli dostop ali prejeli naslednji paket izobraževalnih gradiv, ki ga bodo razdeljevali strokovni organi:
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. 
Ker se mnogo zdravil in imunoglobulinov izloča v materino mleko in zaradi možnosti resnih neželenih učinkov pri dojenčkih, je treba prenehati z dojenjem med zdravljenjem z ravulizumabom in do 8 mesecev po njem.
Infusion must be administered through a 0.2 µm filter. 
Infuzijo morate dajati skozi 0,2 µm filter.
Physicians should provide patients with a patient information brochure and a patient safety card. 
Zdravniki morajo priskrbeti bolnikom brošuro z informacijami za bolnike in opozorilno kartico za bolnika.
As a result, patients with complement-mediated diseases, including PNH, may experience increased signs and symptoms of their underlying disease, such as haemolysis. 
Zato se lahko pri bolnikih z boleznimi, ki jih povzroča komplement, vključno s PNH, pojavijo izrazitejši znaki in simptomi osnovne bolezni, na primer hemoliza.
These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis). 
Okužbe z meningokoki so hude okužbe, ki prizadenejo možganske opne in se lahko širijo po krvi in telesu (sepsa).
Ultomiris is used to treat adult patients with a disease called Paroxysmal Nocturnal Haemoglobinuria (PNH). 
Zdravilo Ultomiris se uporablja za zdravljenje odraslih bolnikov z boleznijo, ki se imenuje paroksizmalna nočna hemoglobinurija (PNH).
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. 
Kronično intravensko zdravljenje s človeškim imunoglobulinom (IVIg) lahko ovira endosomski mehanizem recikliranja neonatalnih receptorjev Fc (FcRn) monoklonskih protiteles, na primer ravulizumaba, in s tem zniža serumske koncentracije ravulizumaba.
Other medicines and Ultomiris 
Druga zdravila in zdravilo Ultomiris
Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev To zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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. 
Ker je pot uporabe ravulizumaba intravenska infuzija in je oblika odmerjanja raztopina, menimo, da je biološko razpoložljivega 100 % danega odmerka.
Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. 
Zato je treba bolnike po priporočenem cepljenju skrbno spremljati glede bolezenskih simptomov.
There are no clinical data from the use of ravulizumab in pregnant women. 
Kliničnih podatkov o uporabi ravulizumaba pri nosečnicah ni.
“Other” category included neutropenia, renal dysfunction, and thrombopenia, as well as a number of other conditions. 
“drugo” vključuje nevtropenijo, disfunkcijo ledvic in trombopenijo, pa tudi več drugih stanj.
If you were previously receiving another medicine for PNH called Soliris, the loading dose should be given 2 weeks after the last Soliris infusion. 
Če ste prej prejemali drugo zdravilo za PNH, ki se imenuje Soliris, morate prejeti polnilni odmerek 2 tedna po zadnji infuziji zdravila Soliris.
Ravulizumab must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders. 
Ravulizumab mora aplicirati zdravstveni delavec pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s hematološkimi motnjami.
It is unknown whether ravulizumab is excreted into human milk. 
Ni znano, ali se ravulizumab izloča v materino mleko.
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. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vseh državah članicah, kjer se zdravilo Ultomiris trži, vzpostavljen sistem, katerega cilj bo nadzor distribucije zdravila Ultomiris, ki presega raven rednih ukrepov za zmanjševanje tveganj.
If you stop using Ultomiris 
Če prenehate uporabljati zdravilo Ultomiris
This medicinal product must be administered through a 0.2 µm filter and should not be administered as an intravenous push or bolus injection. 
To zdravilo se daje skozi 0,2 µm filter in se ga ne sme dajati kot intravensko hitro ali bolusno injekcijo.
The most serious adverse reactions in patients in clinical trials are meningococcal infection and meningococcal sepsis (see section 4.4). 
Najresnejša neželena učinka pri bolnikih v kliničnih preskušanjih sta meningokokna okužba in meningokokna sepsa (glejte poglavje 4.4).
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'. 
Ravulizumab so oblikovali tako, da se pripne na beljakovino komplementa C5, ki je del telesnega obrambnega sistema, ki se imenuje 'sistem komplementa'.
If you are not sure what the side effects below are, ask your doctor to explain them to you. 
Če ste negotovi glede tega, kaj so neželeni učinki v nadaljevanju, prosite zdravnika, naj vam jih pojasni.
The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose, see section 4.2. 
Število vial, ki jih boste razredčili, je odvisno od telesne mase posameznega bolnika in predpisanega odmerka, glejte poglavje 4.2. 2.
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. 
Za zmanjšanje tveganja okužbe je potrebno vse bolnike cepiti proti meningokoknim okužbam vsaj 2 tedna pred uvedbo ravulizumaba, razen če tveganje odložitve zdravljenja z ravulizumabom odtehta tveganja razvoja meningokokne okužbe.
The most common adverse drug reactions are upper respiratory tract infection (very common), nasopharyngitis (very common) and headache (very common). 
Najpogostejši neželeni učinki zdravila so okužba zgornjih dihal (zelo pogosti), nazofaringitis (zelo pogosti) in glavobol (zelo pogosti).
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. 
Zdravilo Ultomiris je zdravilo, ki vsebuje učinkovino ravulizumab in pripada skupini zdravil, imenovanih monoklonska protitelesa, ki se vežejo na določeno tarčo v telesu.
30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal. 
30 ml sterilnega koncentrata v viali (steklo tipa I) z zamaškom in zaporko.
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). 
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).
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. 
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.
Ultomiris has no or negligible influence on the ability to drive and use machines. 
Zdravilo Ultomiris nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
What Ultomiris is and what it is used for 2. 
Kaj je zdravilo Ultomiris in za kaj ga uporabljamo 2.
No formal trial of the effect of sex, race, age (geriatric), hepatic or renal impairment on the pharmacokinetics of ravulizumab was conducted. 
Formalnih preskušanj vpliva spola, rase, starosti (starejši), okvare jeter ali ledvic na farmakokinetiko ravulizumaba niso izvedli.
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. 
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.
When given the same dose, heavier patients with PNH had lower median serum ravulizumab concentrations compared with lighter patients. 
Težji bolniki s PNH so ob prejetju enakega odmerka imeli v serumu nižje mediane koncentracije ravulizumaba kot lažji bolniki.
See the leaflet for further information. 
Za nadaljnje informacije glejte navodilo za uporabo.
Patients should be informed of the signs and symptoms of meningococcal septicaemia and advised to seek medical care immediately. 
Bolnike je treba poučiti o znakih in simptomih meningokokne septikemije in jim svetovati, naj nemudoma poiščejo zdravniško pomoč.
Administration of ravulizumab may result in infusion reactions. 
Aplikacija ravulizumaba lahko privede do reakcije na infuzijo.
What you need to know before you use Ultomiris 3. 
Kaj morate vedeti, preden boste uporabili zdravilo Ultomiris 3.
Free C5 levels less than 0.5 µg/mL were correlated with maximal intravascular haemolysis control and complete terminal complement inhibition. 
Proste koncentracije C5, manjše od 0,5 µg/ml, se ujemajo z največjim obvladovanjem intravaskularne hemolize in popolno inhibicijo terminalnega komplementa.
One vial of 30 mL contains 300 mg of ravulizumab. 
Ena viala s 30 ml vsebuje 300 mg ravulizumaba.
• 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. 
• 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.
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”. 
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.
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. 
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.
If signs and symptoms of haemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ravulizumab. 
Če se po prenehanju zdravljenja pojavijo znaki in simptomi hemolize, vključno z zvišano LDH, pride v poštev ponoven začetek zdravljenja z ravulizumabom.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli poleg oznake ‘EXP'.
All patients should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics. 
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.
Ravulizumab blocks terminal complement activation; therefore patients may have increased susceptibility to infections caused by Neisseria species and encapsulated bacteria. 
Ravulizumab zavira aktivacijo terminalnega komplementa, zato lahko bolniki postanejo dovzetnejši za okužbe, ki jih povzročajo vrsta Neisseria in inkapsulirane bakterije.
Total volume (mL) 
Skupni volumen (ml)
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. 
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.
Meningococcal disease due to any serogroup may occur. 
Meningokokno bolezen lahko povzroči katera koli seroskupina.
In PNH patient studies (N = 261), only 1 (0.38 %) case with development of treatment-emergent anti-drug antibody has been reported with ravulizumab. 
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.
“Other” as specified on case report form included thrombocytopenia, chronic kidney disease, and pancytopenia, as well as a number of other conditions. 
b “Drugo”, kot je bilo specificirano v poročilu o primeru, vključuje trombocitopenijo, kronično bolezen ledvic in pancitopenijo, pa tudi več drugih stanj.
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. 
To zdravilo se veže na beljakovino C5 in jo blokira ter tako omeji bolezenske simptome, saj prepreči beljakovinam komplementa, da bi napadale rdeče krvničke.
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). 
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).
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. 
• 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.
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). 
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).
Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution. 
Zdravilo Ultomiris je bistra do prosojna, rahlo belkasta raztopina praktično brez delcev.
Volume of NaCl diluent b 
Volumen vehikla za redčenje z NaCl b
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. 
Priporočena shema odmerjanja za odrasle bolnike (≥ 18 let) s PNH se začne s polnilnim odmerkom, ki mu sledijo vzdrževalni odmerki intravenske infuzije.
*Meningococcal infection includes preferred terms of meningococcal infection and meningococcal sepsis 
*Meningokokne okužbe vključujejo prednostna izraza meningokokne okužbe in meningokokna sepsa.
The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals 
Izobraževalno gradivo za zdravnike mora vsebovati: o povzetek glavnih značilnosti zdravila, o vodnik za zdravstvene delavce.
It should not be shaken. 
Ne smete ga stresati.
Treatment discontinuation 
Prenehanje zdravljenja
Therapeutic steady-state drug concentrations are reached after the first dose. 
Terapevtske koncentracije zdravila v stanju dinamičnega ravnovesja so dosežene po prvem odmerku.
INFORMATION IN BRAILLE Justification for not including braille accepted. 
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
The most serious side effect was meningococcal infection/sepsis. 
Najresnejši neželeni učinek je meningokokna okužba/sepsa.
Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity. 
Če boste prekinili ali opustili zdravljenje z zdravilom Ultomiris, se bodo mogoče simptomi PNH ponovili v hujši obliki.
If stored at 2-8°C, allow the diluted solution to warm to room temperature prior to administration. 
Če je shranjena pri 2-8 °C, pustite, da se razredčena raztopina pred uporabo ogreje na sobno temperaturo.
Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately. 
Bolnike je treba obveščati o teh znakih in simptomih ter zagotoviti, da v tem primeru poiščejo takojšnjo medicinsko pomoč.
Table 3 gives the adverse reactions observed from clinical trials. 
V preglednici 3 so navedeni neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih.
The active substance is ravulizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL). 
− Učinkovina je ravulizumab (300 mg/30 ml v viali, kar ustreza 10 mg/ml).
Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation. 
Pred redčenjem je treba raztopino v vialah pregledati; raztopina mora biti brez vidnih delcev ali oborine.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label 
PODATKI NA ZUNANJI OVOJNINI Etiketa na kartonski škatli
In clinical trials, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ravulizumab; all 3 had been vaccinated. 
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.
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. 
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.
Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment. 
Zdravnik se bo pred začetkom zdravljenja pogovoril z vami o možnih neželenih učinkih in vam razložil tveganja in koristi zdravila Ultomiris.
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). 
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).
5 mg/mL after dilution 
30 ml 5 mg/ml po razredčenju
The primary endpoint was haemolysis as measured by LDH percent change from baseline. 
Primarni opazovani dogodek je bila hemoliza, izmerjena z odstotno spremembo LDH od izhodišča.
2- Before administration Dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis. 
Redčenje morate izvesti v skladu s pravili dobre prakse, predvsem glede asepse.
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. 
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.
Water for injections 
Vehikel: voda za injekcije.