FrancophonIA/ELRC3.0 huggingface dataset:
English: You should also be aware that vaccination may not prevent this type of infection.
Slovenian: Vendar pa se morate zavedati dejstva, da cepljenje morda ne bo preprečilo tovrstne okužbe.
English: TMA interventions were defined as PE/PI or new dialysis.
Slovenian: Intervencije TMA so bile definirane kot PE/PI ali nova dializa.
English: - sensitivity to light
Slovenian: - občutljivost za svetlobo.
English: Soliris No transfusion
Slovenian: Soliris Brez transfuzije
English: Practical advice should be included to mitigate the risk.
Slovenian: Vključeni naj bodo praktični nasveti za zmanjšanje tveganja,
English: Vaccination may not be sufficient to prevent meningococcal infection.
Slovenian: Cepljenje morda ne bo zadostovalo za preprečevanje meningokokne okužbe.
English: However, this finding was shown in non-controlled clinical trials.
Slovenian: Vendar pa se je ta ugotovitev pokazala pri nekontroliranih kliničnih preskušanjih.
English: Type of Plasma Intervention
Slovenian: Vrsta intervencije s plazmo
English: Physicians should advise patients about gonorrhoea prevention.
Slovenian: Zdravniki morajo svetovati bolnikom glede preprečevanja gonoreje.
English: Other Systemic Infections
Slovenian: Druge sistemske okužbe
English: There is no evidence to suggest that any special precautions are needed when older people are treated - although experience with Soliris in this patient population is still limited.
Slovenian: Ni dokazov, da bi bili pri zdravljenju starejših ljudi potrebni posebni previdnostni ukrepi - čeprav so izkušnje z zdravilom Soliris pri tej populaciji bolnikov še vedno omejene.
English: Percentage of patients with stabilized Haemoglobin levels at end of study
Slovenian: Odstotek bolnikov s stabilizirano ravnijo hemoglobina ob koncu študije
English: Should such a treatment be considered necessary during pregnancy, a close maternal and foetal monitoring according to local guidelines is recommended.
Slovenian: Če se oceni, da je takšno zdravljenje med nosečnostjo potrebno, je priporočljivo skrbno spremljanje matere in ploda v skladu z lokalnimi smernicami.
English: Your doctor's instructions should be carefully observed.
Slovenian: Navodila zdravnika pozorno upoštevajte.
English: Total number of patient-years in study period n
Slovenian: Skupno število bolnikovih let v času študije n
English: This leaflet was last revised in.
Slovenian: Navodilo je bilo nazadnje revidirano.
English: The patient safety card should contain:
Slovenian: Opozorilna kartica za bolnika mora vsebovati:
English: Patients must receive vaccination according to current national vaccination guidelines for vaccination use.
Slovenian: Bolniki morajo biti cepljeni v skladu z veljavnimi nacionalnimi smernicami za cepljenje.
English: 4 Based on a stratified Cox proportional hazards model.
Slovenian: 4 Na podlagi stratificiranega Coxovega modela proporcionalnih tveganj.
English: Positive ADA samples were low titer and transient.
Slovenian: Pozitivni vzorci ADA so imeli nizek titer in so bili prehodni.
English: • All patients must be monitored for signs of meningococcal infection.
Slovenian: • vse bolnike je treba spremljati za znake meningokoknih okužb,
English: Smithfield, Rhode Island 02917
Slovenian: Smithfield, Rhode Island 02917 ZDA
English: 2 Based on the complementary log-log transformation.
Slovenian: 2 Na podlagi komplementarne transformacije log-log.
English: If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed.
Slovenian: Če se pri vas pojavi kateri od zgoraj navedenih simptomov, vzemite antibiotike, kot vam je bilo predpisano.
English: • Maintenance Phase:
Slovenian: • Faza vzdrževanja:
English: You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Slovenian: Vendar pojdite čim prej k zdravniku, tudi če se po zaužitju antibiotikov počutite bolje.
English: • Contact details where a health care practitioner can receive further information.
Slovenian: • kontaktne podatke, kamor se lahko zdravstveni delavec obrne za dodatne informacije.
English: • Statement that the patient is receiving eculizumab.
Slovenian: • izjavo, da bolnik prejema ekulizumab,
English: There are no well-controlled studies in pregnant women treated with eculizumab.
Slovenian: Ni dobro kontroliranih študij pri nosečnicah, zdravljenih z ekulizumabom.
English: - polysorbate 80 (vegetable origin)
Slovenian: − polisorbat 80 (rastlinskega izvora)
English: >2 months
Slovenian: > 2 meseca
English: 1 month to <12 years
Slovenian: Parameter od 1 mesec do < 12 let
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: glavobol.
English: • yellowing of the skin and/or eyes (jaundice)
Slovenian: • porumenelost kože in/ali oči (zlatenica),
English: Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Slovenian: Zdravilo Soliris vsebuje beljakovino, beljakovine pa lahko pri nekaterih ljudeh povzročijo alergijske reakcije.
English: Efficacy outcomes for the pre-specified repeated measures analyses of the primary and secondary endpoints are provided in Table 10.
Slovenian: Izidi učinkovitosti za analize vnaprej opredeljenih ponovljenih meritev primarnih in sekundarnih opazovanih dogodkov so v preglednici 10.
English: 3 Based on a stratified log-rank test.
Slovenian: 3 Na podlagi stratificiranega testa log-rank.
English: Table 11 presents an overview of the patients reporting clinical deterioration and patients requiring rescue therapy over the 26 weeks.
Slovenian: Preglednica 11 kaže pregled bolnikov, ki so poročali o kliničnem poslabšanju, in bolnikov, ki so potrebovali rešilno zdravljenje v teh 26 tednih.
English: Your doctor will want to monitor you closely for at least 8 weeks.
Slovenian: Zdravnik bo želel vsaj 8 tednov podrobneje spremljati vaše stanje.
English: 4- Special Handling and Storage
Slovenian: 4- Posebno ravnanje in shranjevanje
English: Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients.
Slovenian: Sočasno uporabljana zdravila so vključevala antitrombotike pri 63 % bolnikov in sistemske kortikosteroide pri 40 % bolnikov.
English: Discontinuation of treatment should only be considered if medically justified.
Slovenian: Prekinitev zdravljenja pride v poštev le, če je medicinsko upravičena.
English: The bulk drug substance manufacturing process also includes specific viral inactivation and removal steps.
Slovenian: Proces proizvodnje osnovne učinkovine vključuje tudi specifične postopke inaktivacije in odstranitve virusov.
English: The clearance and half-life of eculizumab were also evaluated during plasma exchange interventions.
Slovenian: Očistek in razpolovni čas ekulizumaba sta bila ocenjena tudi med intervencijami z izmenjavo plazme.
English: Supplemental Soliris Dose With Each PE/PI Intervention
Slovenian: Dodaten odmerek zdravila Soliris ob vsaki intervenciji s PE/PI
English: All patients included in the trial were refractory gMG patients and met the following predefined criteria:
Slovenian: Vsi bolniki, vključeni v preskušanje, so bili bolniki z refraktarno gMG in so izpolnjevali naslednja vnaprej opredeljena merila:
English: No unexpected tissue cross-reactivity was observed.
Slovenian: Ugotovljena ni bila nobena nepričakovana navzkrižna reaktivnost s tkivom.
English: 1/100 (1%) aHUS patients had low positive values for neutralizing antibodies.
Slovenian: 1/100 (1 %) bolnikov z aHUS je imel nizke pozitivne vrednosti nevtralizirajočih protiteles.
English: In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event).
Slovenian: Pri študiji SHEPHERD je 96 od 97 vključenih bolnikov dokončalo študijo (en bolnik je umrl zaradi trombotičnega zapleta).
English: Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Slovenian: Rekonstitucijo in redčenje je treba izvajati v skladu s pravili dobre prakse, še zlasti v zvezi z asepso.
English: These studies included assessment of fertility and early embryonic development, developmental toxicity, and pre and post-natal development.
Slovenian: Te študije so vključevale oceno plodnosti in zgodnjega razvoja zarodka, toksičnosti za razvoj in prenatalnega in postnatalnega razvoja.
English: Both patients were negative for neutralizing antibodies.
Slovenian: Oba bolnika sta bila negativna za nevtralizirajoča protitelesa.
English: Plasma exchange resulted in an approximately 50% decline in eculizumab concentrations following a 1 hour intervention and the elimination half-life of eculizumab was reduced to 1.3 hours.
Slovenian: Izmenjava plazme je imela za posledico približno 50 % padec koncentracije ekulizumaba po enourni intervenciji in razpolovni čas odstranjevanja se je zmanjšal na 1,3 ure.
English: Available data suggest that clinical response is usually achieved by 12 weeks of Soliris treatment.
Slovenian: Podatki, ki so na voljo, kažejo, da se klinični odziv navadno doseže v 12 tednih zdravljenja z zdravilom Soliris.
English: Maintenance Phase
Slovenian: Faza vzdrževanja
English: Therefore, Soliris should be given to a pregnant woman only if clearly needed.
Slovenian: Zato se sme zdravilo Soliris nosečnici dajati samo, če je to nedvomno potrebno.
English: After 3 weeks of Soliris treatment, patients reported less fatigue and improved health-related quality of life.
Slovenian: Po 3 tednih zdravljenja z zdravilom Soliris so bolniki poročali o manjši utrujenosti in izboljšanju z zdravjem povezane kakovosti življenja.
English: Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately.
Slovenian: Bolnike je treba obvestiti o teh znakih in simptomih ter ustreznih ukrepih, da bi lahko nemudoma poiskali medicinsko pomoč.
English: Berkshire SL1 4DX United Kingdom
Slovenian: Berkshire SL1 4DX
English: See Table 3.
Slovenian: Glejte preglednico 3.
English: Clear, colorless, pH 7.0 solution.
Slovenian: Bistra, brezbarvna raztopina s pH 7,0.
English: The median age at first dose of study drug was 45 years.
Slovenian: Mediana starost v času prvega odmerka zdravila v kliničnem preskušanju je bila 45 let.
English: Basedow's disease
Slovenian: Basedowova bolezen
English: All Patients (N = 22)
Slovenian: vsi bolniki (N = 22)
English: Aspergillus infectionc, Arthritis bacterial c,
Slovenian: Aspergillus c, bakterijski artritis c,
English: Date of latest renewal : 18 June 2012
Slovenian: Datum prve odobritve: 20. junij 2007 Datum zadnjega podaljšanja: 18. junij 2012
English: For children and adolescents with PNH and aHUS aged less than 18 years:
Slovenian: Za otroke in mladostnike s PNH in aHUS, mlajše od 18 let:
English: The most common adverse reaction reported in paediatric patients was headache.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali pri pediatričnih bolnikih, je bil glavobol.
English: Therefore, an individual risk benefit analysis is recommended before starting and during treatment with eculizumab in pregnant women.
Slovenian: Zato je priporočljiva analiza tveganja in koristi pri posamezni bolnici pred začetkom zdravljenja in med zdravljenjem nosečnic z ekulizumabom.
English: All rates of efficacy endpoints improved or were maintained through 2 years of treatment.
Slovenian: Vse stopnje ciljev študije učinkovitosti so se izboljšale ali ostale nespremenjene ves čas dveletnega zdravljenja.
English: The most common reason for change in immunosuppressant therapy was improvement in MG symptoms while on eculizumab treatment.
Slovenian: Najpogostejši razlog za spremembo imunosupresivnega zdravljenja je bilo izboljšanje simptomov MG med zdravljenjem z ekulizumabom.
English: The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues.
Slovenian: Navzkrižna reaktivnost med ekulizumabom in tkivom je bila ocenjena z vrednotenjem vezave na panel 38 človeških tkiv.
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab.
Slovenian: Študije na živalih, na podlagi katerih bi bilo mogoče oceniti genotoksični in karcinogeni potencial ekulizumaba, niso bile opravljene.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Slovenian: Datum: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Patients should be instructed that if they develop fever, headache accompanied with fever and/or stiff neck or sensitivity to light, they should immediately seek medical care as these signs may be indicative of meningococcal infection.
Slovenian: Bolnikom je treba naročiti, da morajo v primeru, če se pojavi vročina, glavobol, ki ga spremlja vročina, in/ali otrdel vrat ali občutljivost na svetlobo, nemudoma poiskati zdravniško pomoč, saj so lahko ti znaki pokazatelji meningokokne okužbe.
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 ovojnini poleg oznake »EXP«.
English: 1) Failed treatment for at least one year with 2 or more immunosuppressant therapies (either in combination or as monotherapy), ie, patients continued to have impairment in activities of daily living despite immunosuppressant therapies
Slovenian: 1) Neuspešno zdravljenje, ki je trajalo vsaj eno leto, z 2 ali več imunosupresivnimi zdravili (bodisi v kombinaciji bodisi kot monoterapija), t.j., bolniki so imeli še naprej težave pri aktivnostih vsakdanjega življenja kljub imunosupresivnim zdravilom ALI
English: If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor.
Slovenian: Če opazite kakšne simptome meningokokne okužbe (glejte poglavje 2 Opozorilo v zvezi z meningokoknimi okužbami in drugimi okužbami z bakterijami Neisseria), morate nemudoma obvestiti zdravnika.
English: 2- Before Administration
Slovenian: 2- Pred uporabo
English: Soliris is specifically indicated for patients who remain symptomatic despite treatment with other existing MG therapies.
Slovenian: Zdravilo Soliris je posebej indicirano za bolnike, pri katerih simptomi bolezni vztrajajo kljub zdravljenju z drugimi obstoječimi zdravili za MG.
English: Patients receiving anticoagulants and systemic corticosteroids at baseline continued these medications.
Slovenian: Bolniki, ki so predhodno prejemali antikoagulante in sistemske kortikosteroide, so nadaljevali z jemanjem teh zdravil.
English: No effects on the breastfed newborn / infant are anticipated as limited data available suggest that eculizumab is not excreted in human breast milk.
Slovenian: Ne pričakujemo učinkov na dojenega novorojenčka/dojenčka, ker omejeni podatki, ki so na voljo, kažejo, da se ekulizumab pri človeku ne izloča v materino mleko.
English: It also resulted in a marked decrease or elimination of blood transfusions, and a trend towards an overall improvement in general function.
Slovenian: Posledica zdravljenja je bilo tudi občutno zmanjšanje ali odsotnost potrebe po transfuziji krvi in trend proti celokupnemu izboljšanju splošnega stanja.
English: Data from 100 patients in four prospective controlled studies, three in adult and adolescent patients (C08
Slovenian: 100 bolnikih v štirih prospektivnih kontroliranih študijah, treh pri odraslih in mladostniških bolnikih
English: Additional endpoints included TMA intervention rate, haematologic normalization, complete TMA response, changes in LDH, renal function and quality of life.
Slovenian: Dodatni končni cilji so vključevali delež intervencij TMA, hematološko normalizacijo, popoln TMA odgovor, spremembe LDH, ledvično funkcijo in kakovost življenja.
English: All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary.
Slovenian: Vse bolnike je treba nadzorovati glede zgodnjih znakov meningokokne okužbe, jih v primeru suma na okužbo nemudoma ovrednotiti ter jih po potrebi zdraviti z ustreznimi antibiotiki.
English: Pharmacokinetic Parameters
Slovenian: Farmakokinetični parametri
English: The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis.
Slovenian: Najpogostejši neželeni učinek je bil glavobol (ki se je pojavil večinoma v začetni fazi odmerjanja), najresnejši neželeni učinek pa je bila meningokokna sepsa.
English: Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
Slovenian: Ekulizumab ohrani prvotne komponente aktivacije komplementa, ki so bistvene za opsonizacijo mikroorganizmov in očistek imunskih kompleksov.
English: In this setting, a decrease of the daily dose of at least 1 immunosuppressant was observed in 47% of patients.
Slovenian: V teh razmerah so pri 47 % bolnikov opazili zmanjšanje dnevnega odmerka vsaj enega imunosupresivnega zdravila.
English: Subjects who undergo plasma exchange may receive additional doses of Soliris.
Slovenian: Osebe, ki prejmejo izmenjalno transfuzijo plazme, bodo morda potrebovali dodatne odmerke zdravila Soliris.
English: achieved hematologic normalization.
Slovenian: bolnikov) pa so dosegli hematološko normalizacijo.
English: No specific adverse reactions have emerged from these clinical studies.
Slovenian: V teh kliničnih študijah se niso pojavili specifični neželeni učinki.
English: Anticoagulant therapy Treatment with Soliris should not alter anticoagulant management.
Slovenian: Zdravljenje z zdravilom Soliris ne sme spremeniti antikoagulantne terapije.
English: At 26 weeks At 2 years1 At 26 weeks At 2 years1
Slovenian: pri 26 tednih pri 2 letih1
English: In PNH placebo controlled studies low antibody responses have been reported with a frequency (3.4%) similar to that of placebo (4.8%).
Slovenian: V študijah PNH, kontroliranih s placebom, so o odzivu z nizkim titrom protiteles poročali s pogostnostjo (3,4 %), podobno kot pri placebu (4,8 %).
English: Infections Before starting Soliris, inform your doctor if you have any infections.
Slovenian: Pred začetkom jemanja zdravila Soliris obvestite zdravnika, če imate katerokoli okužbo.
English: Serious haemolysis was not observed.
Slovenian: Resna hemoliza ni bila opažena.
English: Severe TMA complications occurred in patients regardless of whether they had an identified genetic mutation, high risk polymorphism or auto-antibody.
Slovenian: Hudi zapleti TMA so se pojavili pri bolnikih ne glede na to, ali so imeli identificirano genetsko mutacijo, polimorfizem z velikim tveganjem ali avtoprotitelesa.
English: If you use this medicine to treat PNH
Slovenian: Če jemljete to zdravilo za zdravljenje PNH
English: Statistic Placebo
Slovenian: Statistika Placebo
English: Additional serious medical complications occurred in these patients including severe worsening of kidney function, disease-related hospitalization and progression to end stage renal disease requiring dialysis.
Slovenian: Pri teh bolnikih so se pojavili dodatni resni medicinski zapleti, ki so vključevali močno poslabšanje funkcije ledvic, hospitalizacijo zaradi bolezni in napredovanje v bolezen ledvic v končnem stadiju, zaradi katere je bila potrebna dializa.
English: In Paroxysmal Nocturnal Haemoglobinuria (PNH):
Slovenian: Pri paroksizmalni nočni hemoglobinuriji (PNH):
English: Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Slovenian: Študij razmnoževanja pri živalih z ekulizumabom niso opravili (glejte poglavje 5.3).
English: Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and the signs and symptoms of them.
Slovenian: Bolnike je treba seznaniti z informacijami, ki so v navodilih za uporabo, da bi tako povečali njihovo pozornost za potencialno hude okužbe ter njihove znake in simptome.
English: However, due to the limitations of the available data, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.
Slovenian: Ker pa je na voljo malo podatkov, je treba pretehtati razvojne in zdravstvene koristi dojenja in materino klinično potrebo po ekulizumabu ter vse možne neželene učinke na dojenega otroka zaradi ekulizumaba in zaradi materine osnovne bolezni.
English: Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Soliris, you will be provided a card to carry with you, listing specific trigger symptoms.
Slovenian: Zaradi pomembnosti hitre identifikacije in zdravljenja določenih vrst okužb pri bolnikih, ki prejemajo zdravilo Soliris, boste prejeli kartico, ki jo boste nosili s seboj in na kateri bodo navedeni specifični simptomi, ki jih zdravilo lahko sproži.
English: The median patient age was 6.5 years (range: 5 months to 17 years).
Slovenian: Mediana starost bolnikov je bila 6,5 let (razpon: od 5 mesecev do 17 let).
English: After dilution, the medicinal product should be used immediately.
Slovenian: Po redčenju je treba zdravilo takoj uporabiti.
English: Due to its mechanism of action, the use of Soliris increases the patient's susceptibility to meningococcal infection (Neisseria meningitidis).
Slovenian: Zaradi svojega načina delovanja zdravilo Soliris povečuje bolnikovo dovzetnost za meningokokno okužbo (Neisseria meningitidis).
English: Spontaneous penile erection,
Slovenian: • spontana erekcija penisa,
English: Soliris may be administered to patients aged 65 years and over.
Slovenian: Zdravilo Soliris se lahko daje bolnikom, ki so stari 65 let ali več.
English: Data on a limited number of pregnancies exposed to eculizumab (less than 300 pregnancy outcomes) indicate there is no increased risk of foetal malformation or foetal-neonatal toxicity.
Slovenian: Podatki o majhnem številu ekulizumabu izpostavljenih nosečnosti (manj kot 300 izidov nosečnosti) kažejo, da tveganje fetalnih malformacij ali toksičnosti za plod in novorojenčka ni zvečano.
English: Transfusion Avoidance during treatment (%)
Slovenian: Nepotrebnost transfuzije med zdravljenjem (%)
English: Meningococcal disease due to any serogroup may occur.
Slovenian: Meningokokna bolezen je možna zaradi katerekoli serološke skupine.
English: Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Slovenian: Poročali so o drugih primerih bakterij Neisseria species, vključno s sepso z bakterijo Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp nespecificirana.
English: Animal reproduction studies have not been conducted with eculizumab due to lack of pharmacologic activity in non-human species.
Slovenian: Študij razmnoževanja z ekulizumabom pri živalih niso opravili zaradi odsotnosti farmakološke aktivnosti pri živalih.
English: If the infusion is slowed, the total infusion time may not exceed two hours in adults and adolescents and four hours in children aged less than 12.
Slovenian: Če se infuzija upočasni, skupni čas infuzije ne sme presegati dveh ur pri odraslih in mladostnikih in štirih ur pri otrocih, mlajših od 12 let.
English: In normal kidneys, antibodies are not excreted and are excluded from filtration by their size.
Slovenian: V zdravih ledvicah se protitelesa ne izločajo in se zaradi svoje velikosti ne morejo filtrirati.
English: Monitoring may be insufficient to predict or prevent severe thrombotic microangiopathy complications in patients with aHUS after discontinuation of Soliris.
Slovenian: Spremljanje mogoče ne bo zadostovalo za napoved ali preprečitev težkih zapletov trombotične mikroangiopatije pri bolnikih z aHUS po ukinitvi zdravila Soliris.