natgillin/translations-raw huggingface dataset:
• In addition, the PRAC recommended strengthening the current warnings to take due account that liver functions, including bilirubin levels, of all patients should be monitored at least monthly, close to each administration of daclizumab, and for six months after end of treatment and stricter discontinuation criteria in case of elevated transaminase should now be applied.
• poleg tega je odbor PRAC priporočil okrepitev trenutnih opozoril, da je treba delovanje jeter, vključno z ravnmi bilirubina, pri vseh bolnikih spremljati vsaj mesečno, blizu časa dajanja daklizumaba, in še šest mesecev po koncu zdravljenja in da je treba zdaj uporabljati strožja merila za prekinitev zdravljenja v primeru zvišanih vrednosti transaminaz.
The description of hepatic injury in the product information should be brought up to date in line with current knowledge.
Opis poškodb jeter v informacijah o zdravilu je treba posodobiti glede na trenutno vedenje.
As the risk has been shown to persist for up to six months after the last dose of daclizumab, this monitoring should be continued for the same period after the end of treatment.
Ker so dokazali, da tveganje traja še do šest mesecev po zadnjem odmerku daklizumaba, je treba spremljanje nadaljevati še šest mesecev po koncu zdravljenja.
Cases of liver injury were identified both through signs and symptoms and through laboratory values, therefore patient serum transaminase and total bilirubin levels should be monitored at least monthly and as close as possible before each administration, and more frequently if clinically indicated during treatment.
Primere poškodb jeter so prepoznali s pomočjo znakov in simptomov ter z laboratorijskimi preiskavami, zato je treba ravni transaminaze in skupnega bilirubina v serumu pri bolnikih spremljati vsaj mesečno in čim bližje posameznemu odmerku ter pogosteje, če se med zdravljenjem izkaže, da je to klinično indicirano.
The PRAC concluded therefore that caution should be exercised when using such medicines concomitantly with daclizumab.
Odbor PRAC je zato zaključil, da je pri uporabi tovrstnih zdravil hkrati z daklizumabom potrebna previdnost.
The efficacy of daclizumab was demonstrated in two pivotal studies in subjects with relapsing remitting multiple sclerosis (RRMS) that led to the indication in relapsing multiple sclerosis.
Učinkovitost daklizumaba je bila dokazana v dveh ključnih študijah na subjektih z recidivnoremitentno multiplo sklerozo (RRMS), kar je vodilo v sprejetje indikacije za zdravljenje recidivne multiple skleroze.
• The PRAC concluded that daclizumab is associated, during the treatment and for several months after the end of treatment, with an unpredictable and potentially fatal risk of immune-mediated liver injury.
• Odbor PRAC je zaključil, da je daklizumab med zdravljenjem in še več mesecev po koncu zdravljenja povezan z nepredvidljivim in potencialno usodnim tveganjem za imunsko posredovane poškodbe jeter.
Taking into account the conclusions from the SAG that the use of the medicinal product should be restricted to patients who are unsuitable for treatment with other disease modifying therapies (DMTs), the PRAC considered that the identification of sub-groups within the target population (i.e. with highly active disease and with rapidly evolving severe disease) was not warranted and that the restriction of the use would apply to all patients with RMS who are unsuitable for treatment with other DMT.
Z upoštevanjem zaključkov znanstvenega svetovalnega odbora, da je treba uporabo zdravila omejiti na bolnike, ki so neprimerni za zdravljenje z drugimi zdravili, ki spreminjajo potek bolezni (DMT), je odbor PRAC presodil, da ugotavljanje podskupin v okviru ciljne populacije (tj. podskupin z visoko aktivno boleznijo in hitro napredujočo hudo boleznijo) ni upravičeno in da bo omejitev uporabe veljala za vse bolnike z RMS, ki so neprimerni za zdravljenje z drugimi zdravili DMT.
The PRAC noted that a fatal case had occurred despite the risk minimisation measures already implemented, including monthly liver monitoring.
Odbor PRAC je opozoril, da je do usodnega primera prišlo kljub že izvajanim ukrepom za zmanjšanje tveganja, vključno z mesečnim spremljanjem delovanja jeter.
Results from both studies demonstrated clinically meaningful and statistically significant reductions in relapse rate, the primary efficacy endpoint in each study.
Rezultati obeh študij so dokazali klinično pomembno in statistično značilno zmanjšanje števila recidivov, kar je bilo v obeh študijah primarni opazovani dogodek.
The PRAC thus considered that further measures to those implemented as part of the provisional measures were justified to minimise this risk and, in view of its unpredictable and potentially fatal nature, to limit the use of the medicinal product.
Odbor PRAC je zato presodil, da so za zmanjšanje tega tveganja poleg ukrepov, ki se že izvajajo v okviru začasnih ukrepov, utemeljeni še dodatni ukrepi, glede na nepredvidljivo in potencialno usodno naravo pa je utemeljena tudi omejitev uporabe tega zdravila.
Daclizumab treatment also resulted in clinically meaningful slowing of the accumulation of neurological disability as measured by both clinician-assessed and patient-reported outcome measures.
Zdravljenje z daklizumabom je povzročilo tudi klinično pomembno upočasnitev napredovanja nevrološke invalidnosti, merjene z izidi, kot jih je ocenil zdravnik in kot jih je navajal bolnik.
Transaminases elevations and serious hepatic injury are known risks associated to treatment with Zinbryta (daclizumab) and several risk minimisation measures (RMMs) were implemented in this regard at the time of the initial marketing authorisation, including monthly liver function monitoring.
Dvig ravni transaminaz in resne poškodbe jeter so znana tveganja pri zdravljenju z zdravilom Zinbryta (daklizumab), zaradi česar so bili v času izdaje prvotnega dovoljenja za promet z zdravilom uvedeni številni ukrepi za zmanjševanje teh tveganj (RMM), vključno z mesečnim spremljanjem delovanja jeter.
Based on the limited data available, any synergistic hepatotoxic effects in patients taking concomitant hepatotoxic medications on the liver injury caused by daclizumab could not be fully elucidated.
Ker so razpoložljivi podatki omejeni, sinergistični hepatotoksični učinki pri bolnikih, ki jemljejo tudi druga hepatotoksična zdravila, na poškodbe jeter, ki jih povzroča daklizumab, niso bili popolnoma pojasnjeni.
The PRAC concluded that daclizumab is associated with a potentially fatal risk of immune-mediated liver injury.
Odbor PRAC je zaključil, da je daklizumab povezan s potencialno usodnim tveganjem za imunsko posredovane poškodbe jeter.
The PRAC also considered that daclizumab should be contraindicated in patients with pre-existing hepatic disease or impairment.
Odbor PRAC prav tako meni, da mora biti daklizumab kontraindiciran pri bolnikih s predhodno obstoječo boleznijo ali okvaro jeter;
Zinbryta (daclizumab) is a centrally authorised medicinal product indicated at the start of this review in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Zinbryta (daklizumab) je zdravilo, ki je odobreno po centraliziranem postopku in na začetku tega pregleda namenjeno zdravljenju recidivnih oblik multiple skleroze pri odraslih bolnikih.
Administration of daclizumab with other medicinal products of known hepatotoxic potential should be done with caution.
Daklizumab je treba dajati previdno skupaj z drugimi zdravili z znanim hepatotoksičnim potencialom;
In view of the uncertainties around the exact mechanism of action of the immune-mediated liver injury and as the risk of hepatitis B reactivation with daclizumab has not been characterised, the PRAC recommended that patients should be screened for these viruses prior to treatment initiation.
Zaradi negotovosti glede točnega mehanizma delovanja imunsko posredovanih poškodb jeter in ker tveganje za reaktivacijo hepatitisa B zaradi daklizumaba ni bilo opredeljeno, je odbor PRAC priporočil, da je treba pred uvedbo zdravljenja bolnike presejati glede prisotnosti teh virusov.
The CHMP discussed the recommended wording of the indication, in particular that restricting daclizumab treatment to patients for whom another disease modifying therapy is contraindicated or otherwise unsuitable, and considered that for clarity it should be stated that this relates to any other disease modifying therapy.
Odbor CHMP je razpravljal o priporočenem besedilu za indikacijo, zlasti o omejitvi zdravljenja z daklizumabom na bolnike, pri katerih je drugo zdravilo, ki spreminja potek bolezni, kontraindicirano ali kako drugače neprimerno, in je menil, da je zaradi jasnosti treba navesti, da to velja za vsako zdravilo, ki spreminja potek bolezni.
If a patient develops such signs or symptoms suggestive of livery injury they should be promptly referred to a hepatologist.
Če se pri bolniku pojavijo znaki in simptomi, ki kažejo na poškodbo jeter, ga je treba nemudoma napotiti k hepatologu.
In addition, considering the lack of clinical data in patients with pre-existent significant hepatic diseases as these were excluded from clinical trials, the seriousness of the hepatic adverse reaction, and the increased susceptibility of patients with basal hepatic disease to experience worsening of the hepatic impairment, the PRAC considered that daclizumab should be contraindicated in all patients with pre-existing hepatic disease or hepatic impairment.
Poleg tega je glede na pomanjkanje kliničnih podatkov pri bolnikih z obstoječo pomembno jetrno boleznijo, saj so bili ti iz kliničnih preskušanj izključeni, glede na resnost neželenih učinkov na jetra in povečane dovzetnosti bolnikov z osnovno jetrno boleznijo za poslabšanje jetrne okvare odbor PRAC menil, da mora biti daklizumab kontraindiciran pri vseh bolnikih z obstoječo jetrno boleznijo ali jetrno okvaro.
To complement the laboratory follow-up, it was considered key by the SAG and the PRAC, that patients should be informed about the risk of hepatic injury, and warned about signs or symptoms suggestive of hepatic dysfunction.
Kot dopolnilo laboratorijskemu spremljanju sta znanstvena svetovalna skupina in odbor PRAC presodila, da je treba bolnike seznaniti s tveganjem za poškodbe jeter in jih opozoriti na znake in simptome, ki kažejo na motnje delovanja jeter.
Autoimmune hepatitis and fulminant hepatitis should be added as adverse drug reactions to the product information respectively with the frequencies uncommon and not known.
Avtoimunski hepatitis in fulminantni hepatitis je treba dodati med neželene učinke v informacije o zdravilu, in sicer z občasno oziroma neznano pogostnostjo pojavljanja.
The occurrence of a fatal case of fulminant liver failure despite adherence to the risk minimisation measures implemented before this procedure, including monthly liver monitoring, was particularly of concern.
Še zlasti zaskrbljujoč je bil pojav usodnega primera fulminantne odpovedi jeter kljub izvajanju ukrepov za zmanjšanje tveganja pred tem postopkom, vključno z mesečnim spremljanjem delovanja jeter.
• The PRAC reviewed the totality of the data provided by the marketing authorisation holder on cases of serious liver injury reported since the initial marketing authorisation and safety and efficacy data from clinical trials, in relation to the overall risk of liver injury with daclizumab.
• odbor PRAC je pregledal vse podatke, ki jih je posredoval imetnik dovoljenja za promet z zdravilom glede primerov resne poškodbe jeter, ki so bili zabeleženi po izdaji dovoljenja za promet, ter podatke o varnosti in učinkovitosti iz kliničnih preskušanj v zvezi s celokupnim tveganjem za poškodbo jeter z daklizumabom.
However, in view of the seriousness of the reactions reported, leading in one case to a fatal outcome despite adherence to the RMMs, the EC considered that the impact of the risk of liver injury on the benefit-risk balance of the medicinal product and the adequacy of the related RMMs should be reviewed.
Vendar glede na resnost zabeleženih neželenih učinkov, ki so se v enem primeru kljub izvajanju ukrepov za zmanjšanje tveganja končali s smrtnim izidom, Evropska komisija meni, da je treba ponovno pregledati vpliv tveganja za poškodbe jeter na razmerje med tveganji in koristmi zdravila ter primernost obstoječih ukrepov za zmanjšanje tveganja.
The PRAC considered all the data provided by the MAH on cases of liver injury that occurred since the marketing authorisation, including a recent fatal case of fulminant liver failure, as well as safety and efficacy data from clinical trials with daclizumab, in relation to the overall risk of liver injury with daclizumab.
Odbor PRAC je proučil vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, o primerih poškodb jeter, ki so se pojavili od izdaje dovoljenja za promet z zdravilom, vključno z nedavnim smrtnim primerom zaradi fulminantne odpovedi jeter, ter podatke o varnosti in učinkovitosti iz kliničnih preskušanj z daklizumabom v povezavi s celokupnim tveganjem za poškodbe jeter zaradi daklizumaba.
Furthermore, PRAC recommended that all patients are informed about signs or symptoms suggestive of liver dysfunction and promptly referred to a hepatologist in case of such signs or symptoms.
Odbor PRAC je priporočil tudi, da se vse bolnike seznani o znakih ali simptomih, ki kažejo na motnje delovanja jeter, v primeru pojava tovrstnih znakov ali simptomov pa jih je treba takoj napotiti k hepatologu;
In addition, 4 cases of serious liver injury were reported from clinical trials, in the first periodic safety update report (PSUR).
Poleg tega so bili v redno posodobljenem poročilu o varnosti zdravila (PSUR) zabeleženi še štirje primeri resne poškodbe jeter v okviru kliničnih preskušanj.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Zinbryta (daklizumab).
In view of the above, the Committee considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the agreed amendments to the product information and the additional risk minimisation measures.
Z upoštevanjem zgoraj navedenega je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Zinbryta (daklizumab) še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in dodatni ukrepi za zmanjševanje tveganja.
Considering that immune-mediated conditions and autoimmune conditions have been reported in clinical trials, that the effect of daclizumab on other autoimmune disorders and the role of such disorder on daclizumab-induced liver injury is unknown, as also highlighted by the SAG, the PRAC considered that daclizumab treatment should not be recommended in patients with history of concurrent autoimmune conditions other than multiple sclerosis.
Glede na to, da so v kliničnih preskušanjih poročali o imunsko posredovanih in avtoimunskih stanjih, ter da sta učinek daklizumaba na druge avtoimunske bolezni in vloga tovrstnih stanj na z daklizumabom povzročene poškodbe jeter neznana, kot je poudarila tudi znanstvena svetovalna skupina, je odbor PRAC presodil, da se zdravljenje z daklizumabom odsvetuje pri bolnikih, ki imajo poleg multiple skleroze še anamnezo sočasnih avtoimunskih stanj.
The CHMP, as a consequence, considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the amendments to the product information described above.
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravila Zinbryta (daklizumab) še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
Risk or predictive factors that may play a role on the occurrence of liver damage such as comorbidities, relation with dose, timing, genetic or biochemical markers could not be identified by the PRAC or the SAG.
Ne odbor PRAC ne znanstvena svetovalna skupina nista mogla prepoznati nobenih dejavnikov tveganja oziroma napovednih dejavnikov, ki morda igrajo vlogo pri razvoju poškodb jeter, kot so sočasne bolezni, odvisnost od odmerka, čas dajanja, genetski ali biokemijski označevalci.
The PRAC concluded that the benefit-risk balance remained positive, provided that Zinbryta is only used in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable and that changes are implemented in the product information to minimise the risk of serious liver injury.
Odbor PRAC je presodil, da razmerje med tveganji in koristmi ostaja pozitivno, pod pogojem, da se zdravilo Zinbryta uporablja samo pri zdravljenju odraslih bolnikov z recidivnimi oblikami multiple skleroze (RMS), ki so se nezadostno odzvali na vsaj dve predhodni zdravili, ki spreminjata potek bolezni (DMT), in pri katerih je zdravljenje še z enim zdravilom DMT kontraindicirano ali kako drugače neprimerno, in da se informacije o zdravilu spremenijo, da se zmanjša tveganje za resne poškodbe jeter.
Therefore PRAC recommended that the indication of daclizumab should be restricted to the treatment of adult patients with RMS who have had an inadequate response to at least two DMTs and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
Zato je odbor PRAC priporočil, da je treba indikacijo za daklizumab omejiti na zdravljenje odraslih bolnikov z RMS, ki so se nezadostno odzvali na vsaj dve zdravili DMT in pri katerih je zdravljenje še z enim zdravilom DMT kontraindicirano ali kako drugače neprimerno.
• As a consequence, the PRAC recommended restriction of the indication of daclizumab to the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with another DMT is contraindicated or otherwise unsuitable.
• posledično je odbor PRAC priporočil omejitev indikacije daklizumaba na zdravljenje odraslih bolnikov z recidivnimi oblikami multiple skleroze (RMS), ki so se nezadostno odzvali na vsaj dve zdravili, ki spreinjajo potek bolezni in pri katerih je zdravljenje še z enim zdravilom DMT kontraindicirano ali kako drugače neprimerno.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Zinbryta (daklizumab).
Physicians should consider discontinuing therapy if an adequate response has not been achieved or the patient fails to follow the requirement for scheduled liver test monitoring.
Če ni bil dosežen ustrezen odgovor ali če bolnik ne upošteva zahtev za načrtovane preiskave delovanja jeter, morajo zdravniki razmisliti o prekinitvi zdravljenja.
The Company submitted a total of seven studies, involving over 1,000 patients.
Podjetje je predložilo skupaj sedem raziskav, ki so vključevale preko 1000 bolnikov.
International Non-proprietary Name (INN): besilesomab
Mednarodno nelastniško ime (INN): besilesomab
London, 1 June 2006 Doc.Ref.
London, 1. junija 2006 Ref. dok.
The Company will continue to supply this product in the countries where the product is authorised nationally (Czech Republic, Hungary and Sweden).
Podjetje bo nadaljevalo z dobavo tega izdelka v državah, kjer je izdelek odobren na nacionalni ravni (Češka republika, Madžarska in Švedska).
In the European Union, this product has already been authorised in the Czech Republic, Hungary and Sweden, in 1993 and 1994, through national procedures, for similar indications.
V Evropski uniji je ta izdelek v letih 1993 in 1994 že bil odobren v Češki republiki, na Madžarskem in Švedskem na podlagi nacionalnega postopka, in sicer za podobne indikacije.
The letter from the Company notifying the EMEA of the withdrawal of the application is available here.
Pismo podjetja, v katerem so EMEA obvestili o umiku vloge, je na voljo tukaj.
They will also continue their compassionate use programme (where doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised) where those are available.
Ravno tako bodo nadaljevali s svojim programom sočutne uporabe (ta zdravnikom omogoča, da zaprosijo za zdravilo za določeno bolezen za katerega od svojih bolnikov, še preden je zdravilo v celoti odobreno), kjer je ta na voljo.
The CHMP had formulated a list of questions to be answered by the Company, and the Company had not responded to them.
CHMP je pripravil seznam vprašanj, na katera bi naj podjetje odgovorilo, vendar pa podjetje odgovorov na vprašanja ni posredovalo.
This medicine was to be restricted for administration by healthcare professionals experienced on handling radioactive medicines only.
Dajanje tega zdravila bi bilo omejeno izključno na zdravstvene delavce z izkušnjami z rokovanjem z radioaktivnimi zdravili.
If you are being treated, in a clinical trial or in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preizkušanje ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with SCINTIMUN?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila SCINTIMUN?
See here for information on outcome of resubmission.
Za informacije o zaključku postopka za ponovno predloženo vlogo glejte tukaj.
Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje podjetju.
The Company has informed the CHMP that the ongoing clinical studies of SCINTIMUN will continue until completion.
Podjetje je CHMP obvestilo, da se bodo potekajoče klinične raziskave zdravila SCINTIMUN nadaljevale do zaključka.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF THE MARKETING APPLICATION for SCINTIMUN
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo SCINTIMUN
The studies as they were designed could not generate sufficient evidence of the diagnostic value of SCINTIMUN, and the Company is carrying out further work to provide more information on this medicine.
Raziskave na način na katerega so bile zasnovane niso mogle ponuditi zadostnega dokaza o diagnostični vrednosti zdravila SCINTIMUN, podjetje pa nadaljuje s preučevanjem, da bi tako zagotovilo več informacij o tem zdravilu.
Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at day 180).
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence.
Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih podeli dovoljenje.
The design of the main studies essentially focused on the safety and how well the medicine was tolerated by the patient.
Glavne raziskave so bile zasnovane tako, da so se osredotočale na varnost zdravila ter na to, kako ga bolnik prenaša.
Besilesomab is a monoclonal antibody (a type of protein that has been designed to recognise and bind to a specific structure called an antigen, that may be found on certain cells in the body).
Besilesomab je monoklonsko protitelo (tip beljakovine, ki je bila oblikovano tako, da prepozna in se veže na specifično strukturo, imenovano antigen, ki se lahko nahaja na posameznih celicah v telesu).
What were the reasons given by the Company to withdraw the application?
Kakšni so bili razlogi podjetja za umik vloge?
The effects of SCINTIMUN were first tested in experimental models before being studied in humans.
Učinki zdravila SCINTIMUN so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.