FrancophonIA/ELRC3.0 huggingface dataset:
English: It is plausible that the immunomodulatory effects of the drug are involved in immune-mediated adverse effects, such as autoimmune hepatitis, and could be related to the reported cases of encephalitis and/or meningoencephalitis.
Slovenian: Verjetno je, da imunomodulatorni učinki zdravila prispevajo k imunsko posredovanim neželenim učinkom, kot je avtoimunski hepatitis, in bi lahko bili povezani s prijavljenimi primeri encefalitisa in/ali meningoencefalitisa.
English: The PRAC discussed the possibility of the causal relationship of these adverse reactions, as well as the possible mechanism through which they could have been triggered.
Slovenian: Odbor PRAC je razpravljal o možnosti vzročne povezave med temi neželenimi učinki in o morebitnem mehanizmu, ki bi jih lahko sprožil.
English: Whilst the absolute numbers for each disorder is low, this raises concerns that these disorders could be induced by immune-mediated effects and could be causally associated with Zinbryta.
Slovenian: Medtem ko je absolutno število posameznih motenj majhno, to vzbuja skrb, da bi lahko te motnje nastale zaradi imunsko posredovanih učinkov in da bi lahko bile vzročno povezane z zdravilom Zinbryta.
English: It was initially indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Slovenian: Prvotno je bil namenjen za zdravljenje recidivnih oblik multiple skleroze (RMS) pri odraslih bolnikih.
English: The MAH plans to terminate the study as a result of the product suspension in the EU.
Slovenian: Imetnik dovoljenja za promet z zdravilom namerava to študijo prekiniti zaradi umika zdravila iz prometa v EU.
English: Three of these cases had a fatal outcome, 2 cases are still intubated, 1 has an Expanded Disability Status Scale (EDSS) score 9.5, 1 recovered with sequelae, 1 partially recovered, and the remaining cases had an unknown outcome.
Slovenian: Trije od teh primerov so se končali s smrtnim izidom, dva bolnika sta še vedno intubirana, eden ima oceno 9,5 po razširjeni lestvici stopnje prizadetosti (Expanded Disability Status Scale), eden je okreval, vendar ima posledice, eden je delno okreval, izidi ostalih primerov pa niso znani.
English: In the second PSUR (period from 27 November 2016 - 26 May 2017), the review of autoimmune encephalitis cases and other immune-related disorders cases showed that there was a wide variety of immune-mediated disorders reported (such as encompassed seronegative arthritis, blood dyscrasias, thyroid disorders, glomerulonephritis and skin and subcutaneous disorders).
Slovenian: V drugem rednem poročilu o varnosti zdravila (za obdobje od 27. novembra 2016 do 26. maja 2017) je pregled primerov avtoimunskega encefalitisa in drugih motenj, povezanih z imunskim sistemom, pokazal, da je bilo prijavljenih veliko različnih imunsko posredovanih motenj (kot so na primer seronegativni revmatoidni artritis, krvna diskrazija, motnje v delovanju ščitnice, glomerulonefritis ter bolezni kože in podkožja).
English: • The PRAC reviewed the totality of the available data, including data provided by the marketing authorisation holder in writing and in an oral explanation on the 12 cases of serious encephalitis and meningo-encephalitis (of which three fatal) reported since the initial marketing authorisation and safety data from clinical trials, in relation to the overall risk of immune-mediated disorders with CNS involvement during treatment with Zinbryta.
Slovenian: • Odbor PRAC je pregledal vse razpoložljive podatke, vključno s podatki, ki jih je imetnik dovoljenja za promet predložil v pisni obliki in v okviru ustne razlage v zvezi z 12 primeri hudega encefalitisa in meningoencefalitisa (vključno s tremi primeri s smrtnim izidom), prijavljenimi od izdaje prvega dovoljenja za promet, ter podatki o varnosti iz kliničnih preskušanj v zvezi s splošnim tveganjem za nastanek imunsko posredovanih motenj, ki prizadenejo osrednji živčni sistem, med zdravljenjem z zdravilom Zinbryta.
English: In view of the seriousness of the reactions reported and the biological plausibility, the risk of immunemediated encephalitis and its impact on the benefit-risk balance of the medicinal product should be investigated, as well as the adequacy of the risk minimization measures with regard to immunemediated CNS involvement (encephalitis) need to be assessed.
Slovenian: Glede na resnost reakcij, o katerih se je poročalo, in biološko verjetnost bi bilo treba raziskati tveganje za nastanek imunsko posredovanega encefalitisa in njegov vpliv na razmerje med tveganji in koristmi zdravila ter oceniti ustreznost ukrepov za zmanjšanje tveganja v zvezi z imunsko posredovano prizadetostjo osrednjega živčnega sistema (encefalitisom).
English: • In addition, PRAC also considered the known serious immune-mediated liver toxicity associated with Zinbryta as well as potential other immune-mediated disorders affecting other organs than the brain or the liver.
Slovenian: • Poleg tega je odbor PRAC upošteval resno imunsko posredovano toksičnost za jetra, za katero je znano, da je povezana z zdravilom Zinbryta, in morebitne druge imunsko posredovane motnje, ki vplivajo na druge organe, ki niso možgani ali jetra.
English: Activation and expansion of NK cells may lead to a higher cytotoxic response that may be involved in the pathogenesis of autoimmune hepatitis and other autoimmune diseases.
Slovenian: Aktivacija in ekspanzija naravnih celic ubijalk lahko povzroči večji citotoksični odziv, ki bi lahko bil vpleten v patogenezo avtoimunskega hepatitisa in drugih avtoimunskih bolezni.
English: Although the absolute number of the individual reports for each disorder was low, cumulatively there were a significant number of autoimmune events possibly related to daclizumab beta treatment.
Slovenian: Čeprav je bilo absolutno število posameznih poročil za vsako motnjo majhno, je bilo skupno število avtoimunskih dogodkov, ki bi lahko bili povezani z zdravljenjem z daklizumabom beta, veliko.
English: All cases were spontaneous reports, except for the Spanish case which came from an extension of a clinical trial.
Slovenian: Vsi primeri razen španskega so bili sporočeni na lastno pobudo (spontana poročila), španski primer pa je bil sporočen v okviru podaljšanega kliničnega preskušanja.
English: • Furthermore, PRAC recommended that a healthcare professional communication should be disseminated to inform healthcare professionals about the risks related to Zinbryta and provide instructions related to the cessation of the treatment and the follow-up of patients having received Zinbryta.
Slovenian: • Poleg tega je odbor PRAC priporočil, da se zdravstvenim delavcem pošlje obvestilo o tveganjih, povezanih z zdravilom Zinbryta, ter zagotovijo navodila v zvezi s prekinitvijo zdravljenja in spremljanjem bolnikov, ki so prejemali to zdravilo.
English: PRAC concluded that these adverse reactions could be causally associated with Zinbryta.
Slovenian: Zaključil je, da bi lahko bili ti neželeni učinki vzročno povezani z zdravilom Zinbryta.
English: Further, the PRAC took into consideration that interrupting treatment in patients whose disease is well-controlled with daclizumab beta may induce relapses, but considered that the serious risk of auto-immune or immune-mediated reactions outweighs the benefit that daclizumab beta may bring to relapsed patients eligible to the authorised indication.
Slovenian: Poleg tega je upošteval, da lahko prekinitev zdravljenja pri bolnikih, ki z daklizumabom beta dobro obvladujejo bolezen, povzroči ponovitev, vendar meni, da resno tveganje za nastanek avtoimunskih ali imunsko posredovanih reakcij prevlada nad koristjo, ki jo lahko daklizumab beta prinese bolnikom, pri katerih se je bolezen ponovila in ki ustrezajo odobreni indikaciji.
English: It was noted that there are ongoing clinical studies for which the MAH informed PRAC that the treatment with daclizumab beta is to be stopped.
Slovenian: Ugotovljeno je bilo, da potekajo klinične študije, v zvezi s katerimi je imetnik dovoljenja za promet z zdravilom odbor PRAC obvestil, da je treba zdravljenje z daklizumabom beta prekiniti.
English: PRAC has considered carefully the above described cases, the probable mechanism of action for these adverse events, along with the potential for auto-immune or immune-mediated reactions that appears associated with Zinbryta, the product mechanism of action, the biological plausibility, and that no risk minimisation measures (RMMs) can be foreseeable to prevent occurrence of these risks in patients on treatment with daclizumab beta at this stage.
Slovenian: Odbor PRAC je skrbno preučil zgoraj navedene primere, verjetni mehanizem delovanja pri teh neželenih dogodkih, možnost za avtoimunske ali imunsko posredovane reakcije, ki se zdi povezana z zdravilom Zinbryta, mehanizem delovanja zdravila, biološko verjetnost in dejstvo, da v tej fazi ni mogoče predvideti ukrepov za zmanjšanje tveganja, ki bi pri bolnikih, zdravljenih z daklizumabom beta, preprečili ta tveganja.
English: At least 5 of these patients had clinical symptoms compatible with ‘drug rash with eosinophilia and systemic symptoms' (DRESS) syndrome, one of which was confirmed with skin biopsy and one highly suspected.
Slovenian: Vsaj pet od teh bolnikov je imelo klinične simptome, združljive z „neželeno reakcijo z eozinofilijo in sistemskimi simptomi“ (sindrom DRESS); pri enem od njih je bil sindrom potrjen z biopsijo kože, pri drugem pa je obstajal utemeljen sum.
English: The use and the marketing authorisation for Zinbryta should be suspended and the product should be recalled from the market at the level of pharmacies and hospitals.
Slovenian: Dovoljenje za promet z zdravilom Zinbryta bi bilo treba začasno odvzeti, zdravilo pa umakniti iz uporabe in s trga na ravni lekarn in bolnišnic.
English: This effect is probably mediated through excess of IL-2 produced by activated T cells that cannot bind to high affinity IL-2 receptors, but is available to bind to intermediate IL-2 receptors.
Slovenian: Ta učinek se verjetno posreduje zaradi prekomernega izločanja interlevkina-2 iz aktiviranih celic T, ki se ne more vezati na receptorje IL-2 z visoko afiniteto, lahko pa se veže na receptorje IL-2 z zmerno afiniteto.
English: In summary, 12 cases of serious and potentially fatal immune-mediated events involving CNS, with symptoms initially compatible with relapse of MS and later on explained by unexpected findings in the neuropathology, with a predominantly inflammatory process and eosinophilic granulocytes, were reported.
Slovenian: Če povzamemo, prijavljenih je bilo 12 primerov resnih in potencialno usodnih imunsko posredovanih dogodkov, ki so prizadeli osrednji živčni sistem in pri katerih so bili simptomi na začetku združljivi s ponovitvijo multiple skleroze, pozneje pa so bili pojasnjeni z nepričakovanimi nevropatološkimi ugotovitvami, in sicer s prevladujočim vnetnim procesom in eozinofilnimi granulociti.
English: Some of these patients did not improve despite treatment with corticosteroids and/or plasmapheresis in these patients brain biopsies were obtained, which showed an unexpected finding of massive inflammation with eosinophilic granulocytes.
Slovenian: Pri nekaterih od teh bolnikov se stanje kljub zdravljenju s kortikosteroidi in/ali plazmaferezo ni izboljšalo; pri njih je bila opravljena biopsija možganov, ki je pokazala nepričakovano obsežno vnetje z eozinofilnimi granulociti.
English: In addition, no new patients should start treatment with Zinbryta.
Slovenian: Poleg tega se zdravljenje z zdravilom Zinbryta ne bi smelo predpisati nobenemu novemu bolniku.
English: Administration of acute corticosteroids and/or plasmapheresis did not improve the clinical situation, brain biopsies were obtained, which showed an unexpected finding of massive inflammation with eosinophilic granulocytes (unexpected in MS patients).
Slovenian: Zdravljenje z akutnimi kortikosteroidi in/ali s plazmaferezo ni izboljšalo kliničnega stanja, biopsije možganov pa so pokazale nepričakovano obsežno vnetje z eozinofilnimi granulociti (kar pri bolnikih z multiplo sklerozo ni pričakovano).
English: Daclizumab beta binds to the alpha-subunit (CD25) of the high-affinity interleukin-2 (IL-2) receptor.
Slovenian: Daklizumab beta se veže na alfa podenoto (CD25) receptorja za interlevkin-2 (IL-2) z visoko afiniteto.
English: Overall, 12 cases of encephalitis or encephalopathy in patients treated with daclizumab beta for multiple sclerosis have been identified.
Slovenian: Na splošno je bilo pri bolnikih z multiplo sklerozo, zdravljenih z daklizumabom beta, ugotovljenih 12 primerov encefalitisa ali encefalopatije.
English: Further to that on 22 February, PEI informed about 2 new cases of immunemediated disease with CNS involvement.
Slovenian: Poleg tega je Inštitut Paula Ehrlicha 22. februarja obvestil o dveh novih primerih imunsko posredovane bolezni, ki je prizadela osrednji živčni sistem.
English: Autoimmune haemolytic anemia is already known to be related to daclizumab beta treatment.
Slovenian: Povezava med avtoimunsko hemolitično anemijo in zdravljenjem z daklizumabom beta je že znana.
English: Immune-mediated or autoimmune conditions such as type I diabetes, colitis, autoimmune thyroiditis, pancreatitis, glomerulonephritis, among other, were reported in low numbers.
Slovenian: Prijavljenih je bilo le malo primerov imunsko posredovanih ali avtoimunskih bolezni, kot so diabetes tipa 1, kolitis, avtoimunski tiroiditis, pankreatitis in glomerulonefritis.
English: Daclizumab beta is a humanised IgG1 monoclonal antibody that modulates IL-2 signalling by blocking CD25-dependent, high affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Slovenian: Daklizumab beta je humanizirano monoklonsko protitelo IgG1, ki modulira sporočanje IL-2 z zaviranjem od CD25 odvisnega sporočanja receptorjev IL-2 z visoko afiniteto, kar povzroči višje ravni razpoložljivega IL-2 za sporočanje prek receptorja IL-2 z zmerno afiniteto.
English: • The PRAC recommended to suspend the use and the marketing authorisation for Zinbryta, and to recall all the batches of the medicinal product from the market up to the level of pharmacies and hospitals.
Slovenian: • Odbor PRAC je priporočil, da se dovoljenje za promet z zdravilom Zinbryta začasno odvzame, vse serije zdravila pa umaknejo iz uporabe in s trga na ravni lekarn in bolnišnic.
English: Daclizumab beta is hypothesized to exert its activity in MS through immunomodulatory mechanisms.
Slovenian: Domneva se, da daklizumab beta pri multipli sklerozi deluje prek imunomodulacijskih mehanizmov.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in multiple sclerosis (MS) include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Slovenian: Ključni učinki te modulacije poti IL-2, ki so morda povezani s terapevtskimi učinki daklizumaba beta pri multipli sklerozi, vključujejo selektivni antagonizem odzivov aktiviranih celic T in ekspanzijo imunoregulacijskih naravnih celic ubijalk CD56bright, za katere se je pokazalo, da selektivno zmanjšujejo aktivirane celice T. Ti imunomodulirajoči učinki daklizumaba beta naj bi skupaj zmanjševali patologijo osrednjega živčnega sistema pri multipli sklerozi ter s tem zmanjševali pojavnost ponovitve in upočasnili napredovanje bolezni.
English: Daclizumab beta blocks CD25 (alfa subunit of high affinity IL-2 receptor), decreasing the number and function of CD4+CD25+FoxP3+Treg and produces an activation and expansion of CD56 NK cells.
Slovenian: Tako blokira CD25 (alfa podenoto receptorja IL-2 z visoko afiniteto), s čimer zmanjša število regulatornih celic CD4+CD25+FoxP3+Treg in zavira njihovo delovanje ter povzroča aktivacijo in ekspanzijo naravnih celic ubijalk CD56.
English: More information concerning these immune-mediated events had been requested to the MAH to be submitted in the third PSUR.
Slovenian: Od imetnika dovoljenja za promet z zdravilom se je zahtevalo, naj v tretjem rednem poročilu o varnosti zdravila predloži več informacij o teh imunsko posredovanih dogodkih.
English: Furthermore, the analysis of PSUR data indicated that a range of immune-mediated disorders were reported in other organs than the brain and liver following the use of Zinbryta.
Slovenian: Poleg tega je analiza podatkov iz rednega poročila o varnosti zdravila pokazala, da so bile po začetku uporabe zdravila Zinbryta sporočene različne imunsko posredovane motnje v drugih organih, ki niso možgani ali jetra.
English: Four of the five patients experienced also fever, leukocytosis, exanthema/skin reactions, thus potentially meeting the criteria for DRESS.
Slovenian: Pri štirih od petih bolnikov so se pojavili tudi povišana telesna temperatura, levkocitoza in eksantemi/kožne reakcije, zato bi lahko bila izpolnjena merila za sindrom DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms - neželena reakcija z eozinofilijo in sistemskimi simptomi).
English: The doctor may decide to stop treatment if the condition does not improve after 28 weeks.
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja, če se stanje po 28 tednih ne izboljša.
English: Further information on Ilumetri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Ilumetri so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients do not experience many side effects.
Slovenian: Bolniki nimajo veliko neželenih učinkov.
English: What measures are being taken to ensure the safe and effective use of Ilumetri?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ilumetri?
English: After training, patients may inject Ilumetri themselves if the doctor considers it appropriate.
Slovenian: Bolniki si lahko po opravljenem usposabljanju zdravilo Ilumetri injicirajo sami, če zdravnik meni, da je to primerno.
English: The European Medicines Agency decided that Ilumetri's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Ilumetri večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The recommended dose is one 100 mg injection, followed by a further dose after 4 weeks and then an injection every 12 weeks.
Slovenian: Priporočeni odmerek je ena 100-miligramska injekcija, naslednji odmerek sledi čez štiri tedne, nato pa se injekcija daje na vsakih 12 tednov.
English: Information on the use of Ilumetri in the long term is limited and studies are ongoing.
Slovenian: Informacije o dolgoročni uporabi zdravila Ilumetri so omejene in potekajo študije o tem.
English: Ilumetri must not be used in patients who have a serious ongoing infection such as tuberculosis.
Slovenian: Zdravilo Ilumetri se ne sme uporabljati pri bolnikih, ki imajo resno potekajočo okužbo, kakršna je tuberkuloza.
English: Other information about Ilumetri
Slovenian: Druge informacije o zdravilu Ilumetri
English: The dose may be increased to 200 mg in certain patients, for example patients badly affected by the disease or with bodyweight over 90 kg.
Slovenian: Pri nekaterih bolnikih se lahko odmerek poveča na 200 mg, na primer pri bolnikih, ki jih bolezen močno prizadene ali s telesno maso nad 90 kg.
English: As for all medicines, data on the use of Ilumetri are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ilumetri stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilumetri have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ilumetri upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What is Ilumetri and what is it used for?
Slovenian: Kaj je zdravilo Ilumetri in za kaj se uporablja?
English: What benefits of Ilumetri have been shown in studies?
Slovenian: Kakšne koristi zdravila Ilumetri so se pokazale v študijah?
English: An overview of Ilumetri and why it is authorised in the EU
Slovenian: Pregled zdravila Ilumetri in zakaj je odobreno v EU
English: Why is Ilumetri authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ilumetri odobreno v EU?
English: Side effects reported with Ilumetri are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ilumetri, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Ilumetri, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ilumetri glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The second study involving 1,090 patients compared Ilumetri with placebo and with etanercept (another psoriasis medicine).
Slovenian: V drugi študiji, v katero je bilo vključenih 1 090 bolnikov, so zdravilo Ilumetri primerjali s placebom in etanerceptom (drugim zdravilom za zdravljenje psoriaze).
English: What are the risks associated with Ilumetri?
Slovenian: Kakšna tveganja so povezana z zdravilom Ilumetri?
English: Headache, gastroenteritis (diarrhoea and vomiting), nausea (feeling sick), diarrhoea, pain at the site of the injection and back pain may affect up to 1 in 10 people.
Slovenian: Glavobol, vnetje želodca in črevesja (driska in bruhanje), navzeja (slabost), driska, bolečina na mestu injiciranja in bolečina v hrbtu se lahko pojavijo pri največ 1 bolniku od 10.
English: The active substance in Ilumetri, tildrakizumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Slovenian: Učinkovina v zdravilu Ilumetri, tildrakizumab, je monoklonsko protitelo (vrsta beljakovine), ki je zasnovano tako, da se pritrdi na interlevkin 23 in zavira njegovo delovanje.
English: Ilumetri is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Slovenian: Ilumetri je zdravilo, ki deluje na imunski sistem in se uporablja za zdravljenje psoriaze s plaki, tj. bolezni, ki povzroča rdeče, luskaste zaplate na koži.
English: The first study involving 771 patients compared Ilumetri with placebo (a dummy treatment).
Slovenian: V prvi študiji, v katero je bilo vključenih 771 bolnikov, so zdravilo Ilumetri primerjali s placebom (zdravilom brez učinkovine).
English: Ilumetri can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Slovenian: Predpisovanje in izdaja zdravila Ilumetri je le na recept, zdravilo pa se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze s plaki.
English: Two main studies involving adults found Ilumetri effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
Slovenian: V treh glavnih študijah z odraslimi bolniki so ugotovili, da je zdravilo Ilumetri učinkovito pri zdravljenju zmerne do hude psoriaze s plaki pri bolnikih, pri katerih zdravila za nanos na kožo niso dovolj učinkovita.
English: Ilumetri is available as a solution in pre-filled syringes for injection under the skin.
Slovenian: Na voljo je v obliki raztopine v napolnjenih injekcijskih brizgah za injiciranje pod kožo.
English: How does Ilumetri work?
Slovenian: Kako zdravilo Ilumetri deluje?
English: For the full list of side effects and restrictions with Ilumetri, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ilumetri glejte navodilo za uporabo.