FrancophonIA/ELRC3.0 huggingface dataset:
English: Sex (n, %)
Slovenian: Spol (n, %)
English: You should take this into consideration if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: Treatment with any therapeutic protein may induce an immune response.
Slovenian: Zdravljenje s katero koli terapevtsko beljakovino lahko sproži imunski odziv.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je potrebno uradne smernice za pravilno uporabo antibiotikov.
English: Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Please refer to section 4.4 for information on prevention and treatment of suspected meningococcal infection.
Slovenian: Glejte poglavje 4.4 za informacije o preprečevanju in zdravljenju domnevnih meningokoknih okužb.
English: The time to maximum observed concentration (tmax) is expected at the end of infusion (EOI) or soon after EOI.
Slovenian: Pričakovani čas največje ugotovljene koncentracije (tmax) je ob koncu infuzije (end of infusion - EOI) ali kratek čas po EOI.
English: The following requirements need to be fulfilled before the product is dispensed:
Slovenian: Pred izdajo zdravila morajo biti izpolnjene naslednje zahteve:
English: Each vial is intended for single use only.
Slovenian: Ena viala je namenjena samo za enkratno uporabo.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil morata biti jasno dokumentirana ime in številka serije prejetega zdravila.
English: All 3 recovered while continuing treatment with ravulizumab.
Slovenian: Vsi trije so okrevali med nadaljevanjem zdravljenja z ravulizumabom.
English: Adult patients with PNH
Slovenian: Odrasli bolniki s PNH
English: This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 133 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed.
Slovenian: Če opazite katerega izmed zgoraj opisanih simptomov, vzemite antibiotike, kot vam je bilo predpisano.
English: Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 UNITED STATES
Slovenian: Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 ZDRUŽENE DRŽAVE
English: This medicine has been prescribed for you only.
Slovenian: - Zdravilo je bilo predpisano vam osebno.
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.
Slovenian: V primeru infuzijske reakcije je potrebno infuzijo ravulizumaba prekiniti in uvesti ustrezne podporne ukrepe, če nastopijo znaki kardiovaskularne nestabilnosti ali kompromitiranega dihanja.
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of ravulizumab.
Slovenian: Študij na živalih za oceno genotoksičnega in kancerogenega potenciala ravulizumaba niso izvedli.
English: This anti-drug antibody was transient in nature with low titre and did not correlate with clinical response or adverse events.
Slovenian: To protitelo proti zdravilu je bilo po naravi prehodno z nizkim titrom in ni bilo v korelaciji s kliničnim odzivom ali neželenimi dogodki.
English: Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use.
Slovenian: Bolnike je treba cepiti ali ponovno cepiti v skladu z veljavnimi nacionalnimi smernicami za cepljenje.
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.
Slovenian: Ni dokazov, ki bi kazali, da so pri zdravljenju geriatrične populacije potrebni kakšni posebni previdnostni ukrepi - čeprav je izkušenj z ravulizumabom pri starejših bolnikih malo.
English: The following information is intended for healthcare professionals only: Instructions for Use for Healthcare Professionals Handling Ultomiris
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo za zdravstveno osebje Ravnanje z zdravilom Ultomiris
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: In pregnant women the use of ravulizumab may be considered following an assessment of the risks and benefits.
Slovenian: Pri nosečnicah se uporaba ravulizumaba ocenjuje na podlagi razmerja med tveganjem in koristjo.
English: This medicine contains sodium (see section 2 “Ultomiris contains sodium”).
Slovenian: To zdravilo vsebuje natrij (glejte poglavje 2 “Zdravilo Ultomiris vsebuje natrij”).
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).
Slovenian: Neželeni učinki so navedeni po organskem sistemu MedDRA (system organ class - SOC) in pogostnosti z uporabo naslednjega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor.
Slovenian: Če opazite simptome meningokokne okužbe (glejte poglavje 2 Simptomi meningokokne okužbe), nemudoma obvestite svojega zdravnika.
English: Vaccination may not be sufficient to prevent meningococcal infection.
Slovenian: Cepljenje mogoče ne bo zadostovalo za preprečitev meningokokne okužbe.
English: The prepared solution should be administered immediately following preparation unless it is stored at 2-8°C.
Slovenian: Pripravljeno raztopino je treba uporabiti takoj po pripravi, razen če je shranjena pri 2-8 °C.
English: Transfer the recommended dose to an infusion bag.
Slovenian: • Prenesite priporočeni odmerek v infuzijsko vrečko.
English: No case of overdose has been reported to date.
Slovenian: Doslej niso poročali o primerih prevelikega odmerjanja.
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.
Slovenian: Cilj izobraževalnega programa in sistema nadzorovane distribucije je izobraževanje in poučevanje zdravstvenih delavcev/bolnikov o odkrivanju, skrbnem spremljanju in/ali primernem obvladovanju določenih varnostnih tveganj, povezanih z zdravilom Ultomiris.
English: Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and their signs and symptoms.
Slovenian: Bolnike je treba seznaniti z informacijami iz navodila za uporabo zdravila, da bi povečali njihovo pozornost za možnost pojava resnih okužb ter njihovih znakov in simptomov.
English: Very common (may affect more than 1 in 10 people): Headache
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Physicians should advise patients about gonorrhoea prevention.
Slovenian: Zdravniki morajo bolnikom svetovati glede preprečevanja okužbe z gonorejo.
English: If you have any of these symptoms, contact your doctor.
Slovenian: Če imate katerega od teh simptomov, se posvetujte z zdravnikom.
English: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 UNITED STATES
Slovenian: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 ZDRUŽENE DRŽAVE
English: More than 80 % of patients in both treatment groups had a history of transfusion within 12 months of study entry.
Slovenian: Več kot 80 % bolnikov v obeh zdravljenih skupinah je imelo anamnezo transfuzije v zadnjih 12 mesecih od vključitve v študijo.
English: Mean (SD) Median Min, max
Slovenian: povprečje (SD) mediana min, maks
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.
Slovenian: Vendar pa so dokazali kemijsko in fizikalno stabilnost razredčenega zdravila za največ 24 ur pri 2 °C-8 °C in za največ 6 ur pri sobni temperaturi.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA43
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA43
English: Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Ultomiris ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: Infections Before starting Ultomiris, inform your doctor if you have any infections.
Slovenian: Okužbe Preden se začnete zdraviti z zdravilom Ultomiris, obvestite zdravnika, če imate katero koli okužbo.
English: Ravulizumab preserves the early components of complement activation that are essential for opsonisation of microorganisms and clearance of immune complexes.
Slovenian: Ravulizumab ohranja zgodnje komponente aktivacije komplementa, ki so bistvene za opsonizacijo mikroorganizmov in očistek imunskih kompleksov.
English: Your dose will be worked out by your doctor, based on your body weight, as shown in Table 1.
Slovenian: Vaš odmerek bo določil vaš zdravnik na podlagi vaše telesne mase, kot kaže preglednica 1.
English: After dilution, the medicinal product should be used immediately.
Slovenian: Po redčenju je treba zdravilo uporabiti takoj.
English: Any patient who discontinues ravulizumab should be monitored for at least 16 weeks to detect haemolysis and other reactions.
Slovenian: Vsakega bolnika, ki se preneha zdraviti z ravulizumabom, je treba spremljati najmanj 16 tednov, da odkrijemo hemolizo in druge reakcije.
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.
Slovenian: Shema odmerjanja sme občasno variirati za ± 7 dni od načrtovanega dne infuzije (razen pri prvem vzdrževalnem odmerku ravulizumaba), vendar je treba naslednji odmerek dati v skladu z originalno shemo.
English: You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Slovenian: Kljub temu je potrebno obiskati zdravnika, takoj ko je to mogoče, tudi v primeru boljšega počutja po jemanju antibiotikov.
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 %.
Slovenian: Povprečna skupna velikost klona RBC PNH je bila 60,05 %, povprečna skupna velikost klona granulocitov PNH je bila 83,30 %, povprečna skupna velikost klona monocitov PNH pa je bila 85,86 %.
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.
Slovenian: Če bolnik prehaja iz zdravljenja z ekulizumabom, morajo zdravniki preveriti, ali je meningokokno cepljenje glede na nacionalne smernice za uporabo cepiv veljavno.
English: Ultomiris should be prepared for administration by a qualified healthcare professional using aseptic technique.
Slovenian: Zdravilo Ultomiris mora pripraviti za uporabo usposobljen zdravstveni delavec z uporabo aseptične tehnike.
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.
Slovenian: Pred prihodom zdravila Ultomiris na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa in sistema nadzorovane distribucije, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
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.
Slovenian: Dva tedna po prejemu polnilnega odmerka boste prejeli vzdrževalni odmerek zdravila Ultomiris, nato boste tak odmerek prejemali enkrat na 8 tednov.
English: Vaccination reduces, but does not eliminate, the risk of meningococcal infections.
Slovenian: Cepljenje zmanjša, vendar pa ne odpravi tveganja za pojav meningokoknih okužb.
English: Note: LDH = lactate dehydrogenase; CI = Confidence Interval.
Slovenian: Opomba: LDH = laktat dehidrogenaza; IZ = interval zaupanja.
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.
Slovenian: Varnosti in učinkovitosti ravulizumaba pri bolnikih z okvaro jeter niso raziskovali; vendar farmakokinetični podatki kažejo, da pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno.
English: Age (years) at PNH diagnosis
Slovenian: Starost (leta) ob postavitvi diagnoze PNH
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).
Slovenian: 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).
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Slovenian: Bolnikom, ki prejmejo prevelik odmerek zdravila, je treba takoj prekiniti infuzijo in jih skrbno spremljati.
English: Due to its mechanism of action, the use of ravulizumab increases the patient's susceptibility to meningococcal infection/sepsis (Neisseria meningitidis).
Slovenian: Zaradi svojega mehanizma delovanja, uporaba ravulizumaba poveča bolnikovo dovzetnost za meningokokno okužbo/sepso (Neisseria meningitidis).
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.
Slovenian: 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.
English: Body weight at time of treatment.
Slovenian: Telesna masa v času zdravljenja.
English: Excipient(s) with known effect: Sodium (5 mmol per vial)
Slovenian: Pomožna(e) snov(i) z znanim učinkom: natrij (5 mmolov na vialo).
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.
Slovenian: 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.
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:
Slovenian: 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:
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.
Slovenian: 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.
English: Infusion must be administered through a 0.2 µm filter.
Slovenian: Infuzijo morate dajati skozi 0,2 µm filter.
English: Physicians should provide patients with a patient information brochure and a patient safety card.
Slovenian: Zdravniki morajo priskrbeti bolnikom brošuro z informacijami za bolnike in opozorilno kartico za bolnika.
English: As a result, patients with complement-mediated diseases, including PNH, may experience increased signs and symptoms of their underlying disease, such as haemolysis.
Slovenian: Zato se lahko pri bolnikih z boleznimi, ki jih povzroča komplement, vključno s PNH, pojavijo izrazitejši znaki in simptomi osnovne bolezni, na primer hemoliza.
English: These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis).
Slovenian: Okužbe z meningokoki so hude okužbe, ki prizadenejo možganske opne in se lahko širijo po krvi in telesu (sepsa).
English: Ultomiris is used to treat adult patients with a disease called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Slovenian: Zdravilo Ultomiris se uporablja za zdravljenje odraslih bolnikov z boleznijo, ki se imenuje paroksizmalna nočna hemoglobinurija (PNH).
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.
Slovenian: 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.
English: Other medicines and Ultomiris
Slovenian: Druga zdravila in zdravilo Ultomiris
English: Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: Ker je pot uporabe ravulizumaba intravenska infuzija in je oblika odmerjanja raztopina, menimo, da je biološko razpoložljivega 100 % danega odmerka.
English: Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.
Slovenian: Zato je treba bolnike po priporočenem cepljenju skrbno spremljati glede bolezenskih simptomov.
English: There are no clinical data from the use of ravulizumab in pregnant women.
Slovenian: Kliničnih podatkov o uporabi ravulizumaba pri nosečnicah ni.
English: “Other” category included neutropenia, renal dysfunction, and thrombopenia, as well as a number of other conditions.
Slovenian: “drugo” vključuje nevtropenijo, disfunkcijo ledvic in trombopenijo, pa tudi več drugih stanj.
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.
Slovenian: Če ste prej prejemali drugo zdravilo za PNH, ki se imenuje Soliris, morate prejeti polnilni odmerek 2 tedna po zadnji infuziji zdravila Soliris.
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.
Slovenian: Ravulizumab mora aplicirati zdravstveni delavec pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s hematološkimi motnjami.
English: It is unknown whether ravulizumab is excreted into human milk.
Slovenian: Ni znano, ali se ravulizumab izloča v materino mleko.
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.
Slovenian: 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.
English: If you stop using Ultomiris
Slovenian: Če prenehate uporabljati zdravilo Ultomiris
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.
Slovenian: To zdravilo se daje skozi 0,2 µm filter in se ga ne sme dajati kot intravensko hitro ali bolusno injekcijo.
English: The most serious adverse reactions in patients in clinical trials are meningococcal infection and meningococcal sepsis (see section 4.4).
Slovenian: Najresnejša neželena učinka pri bolnikih v kliničnih preskušanjih sta meningokokna okužba in meningokokna sepsa (glejte poglavje 4.4).
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'.
Slovenian: Ravulizumab so oblikovali tako, da se pripne na beljakovino komplementa C5, ki je del telesnega obrambnega sistema, ki se imenuje 'sistem komplementa'.
English: If you are not sure what the side effects below are, ask your doctor to explain them to you.
Slovenian: Če ste negotovi glede tega, kaj so neželeni učinki v nadaljevanju, prosite zdravnika, naj vam jih pojasni.
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.
Slovenian: Število vial, ki jih boste razredčili, je odvisno od telesne mase posameznega bolnika in predpisanega odmerka, glejte poglavje 4.2. 2.
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.
Slovenian: 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.