FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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;
English: In addition, 4 cases of serious liver injury were reported from clinical trials, in the first periodic safety update report (PSUR).
Slovenian: Poleg tega so bili v redno posodobljenem poročilu o varnosti zdravila (PSUR) zabeleženi še štirje primeri resne poškodbe jeter v okviru kliničnih preskušanj.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Slovenian: Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Zinbryta (daklizumab).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Slovenian: Zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Zinbryta (daklizumab).
English: 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.
Slovenian: Če ni bil dosežen ustrezen odgovor ali če bolnik ne upošteva zahtev za načrtovane preiskave delovanja jeter, morajo zdravniki razmisliti o prekinitvi zdravljenja.
English: The Company submitted a total of seven studies, involving over 1,000 patients.
Slovenian: Podjetje je predložilo skupaj sedem raziskav, ki so vključevale preko 1000 bolnikov.
English: International Non-proprietary Name (INN): besilesomab
Slovenian: Mednarodno nelastniško ime (INN): besilesomab
English: London, 1 June 2006 Doc.Ref.
Slovenian: London, 1. junija 2006 Ref. dok.
English: The Company will continue to supply this product in the countries where the product is authorised nationally (Czech Republic, Hungary and Sweden).
Slovenian: Podjetje bo nadaljevalo z dobavo tega izdelka v državah, kjer je izdelek odobren na nacionalni ravni (Češka republika, Madžarska in Švedska).
English: 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.
Slovenian: 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.
English: The letter from the Company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Pismo podjetja, v katerem so EMEA obvestili o umiku vloge, je na voljo tukaj.
English: 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.
Slovenian: 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.
English: The CHMP had formulated a list of questions to be answered by the Company, and the Company had not responded to them.
Slovenian: CHMP je pripravil seznam vprašanj, na katera bi naj podjetje odgovorilo, vendar pa podjetje odgovorov na vprašanja ni posredovalo.
English: This medicine was to be restricted for administration by healthcare professionals experienced on handling radioactive medicines only.
Slovenian: Dajanje tega zdravila bi bilo omejeno izključno na zdravstvene delavce z izkušnjami z rokovanjem z radioaktivnimi zdravili.
English: 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.
Slovenian: 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.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with SCINTIMUN?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila SCINTIMUN?
English: See here for information on outcome of resubmission.
Slovenian: Za informacije o zaključku postopka za ponovno predloženo vlogo glejte tukaj.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Slovenian: Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje podjetju.
English: The Company has informed the CHMP that the ongoing clinical studies of SCINTIMUN will continue until completion.
Slovenian: Podjetje je CHMP obvestilo, da se bodo potekajoče klinične raziskave zdravila SCINTIMUN nadaljevale do zaključka.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF THE MARKETING APPLICATION for SCINTIMUN
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo SCINTIMUN
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih podeli dovoljenje.
English: The design of the main studies essentially focused on the safety and how well the medicine was tolerated by the patient.
Slovenian: Glavne raziskave so bile zasnovane tako, da so se osredotočale na varnost zdravila ter na to, kako ga bolnik prenaša.
English: 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).
Slovenian: 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).
English: What were the reasons given by the Company to withdraw the application?
Slovenian: Kakšni so bili razlogi podjetja za umik vloge?
English: The effects of SCINTIMUN were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila SCINTIMUN so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: What documentation has been presented by the Company to support the application to the CHMP?
Slovenian: Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi ?
English: SCINTIMUN is a white powder to be mixed with a radioactive substance (sodium pertechnetate (99mTc)), to make up a solution for intravenous injection.
Slovenian: Zdravilo SCINTIMUN je bel prašek, ki se zmeša z radioaktivno snovjo (natrijev pertehnetat (99mTc)), s čimer dobimo raztopino za intravensko injiciranje.
English: What is SCINTIMUN?
Slovenian: Kaj je zdravilo SCINTIMUN?
English: After combination with the radioactive substance and administration, it binds to the antigen present on the surface of a certain type of blood cells, called granulocytes, bringing the radioactivity to them.
Slovenian: Po kombiniranju z radioaktivno snovjo in aplikaciji se veže na antigen, ki se nahaja na površini določenega tipa krvnih celic, imenovanih granulociti, s čimer »prinese« do njih radioaktivno snov.
English: On 17 May 2006, CIS bio international has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for SCINTIMUN, for diagnostic imaging to determine the location of infectious or inflammatory lesions and to detect metastases (when cancer spreads) in bone marrow.
Slovenian: Podjetje CIS bio international je dne 17. maja 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za izdajo dovoljenja za promet z zdravilom SCINTIMUN, namenjenim za diagnostično slikanje z namenom določitve mesta infekcijskih ali vnetnih lezij ter za zaznavo metastaz (ko se rak širi) v kostnem mozgu.
English: The radioactive accumulation can therefore be detected in areas of infection or inflammation, using a special camera that reveals the areas of radioactivity, as can the lack of radioactivity in bone marrow occupied by metastases.
Slovenian: Posledično je na področjih z infekcijskimi in vnetnimi žarišči mogoče ob uporabi posebne kamere, ki prikazuje področja radioaktivnosti, zaznati kopičenje radioaktivnih snovi, kakor tudi odsotnost radioaktivnosti v kostnem mozgu, zasedenem z metastazami.
English: Those cells accumulate where infection and inflammation occur in the body and also in bone marrow.
Slovenian: Te celice se kopičijo na mestih z infekcijskimi in vnetnimi žarišči v telesu ter tudi v kostnem mozgu.
English: SCINTIMUN contains the active substance besilesomab.
Slovenian: Zdravilo SCINTIMUN vsebuje učinkovino besilesomab.
English: Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that SCINTIMUN could not be approved for diagnostic imaging to determine the location of infectious or inflammatory lesions and to detect metastases in bone marrow.
Slovenian: Na podlagi pregleda podatkov je imel CHMP v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo SCINTIMUN ni mogoče odobriti dovoljenja za diagnostično slikanje z namenom določitve mesta infekcijskih ali vnetnih lezij ter za zaznavo metastaz v kostnem mozgu.
English: What was SCINTIMUN expected to be used for?
Slovenian: Za kaj naj bi se zdravilo SCINTIMUN uporabljalo?
English: The application was at Day 120 when the Company withdrew it.
Slovenian: Ko je podjetje vlogo umaknilo, je bila le-ta v postopku 120. dan.
English: SCINTIMUN was to be used in adults to locate an infection or inflammatory lesion and also to detect whether any metastasis is present in bone marrow.
Slovenian: Zdravilo SCINTIMUN naj bi se uporabljalo pri odraslih za določitev mesta infekcijskih ali vnetnih lezij ter tudi za ugotavljanje, ali so v kostnem mozgu prisotne metastaze.
English: Information from scientific publications was presented to support the use of SCINTIMUN in detection of metastases in bone marrow.
Slovenian: V podporo uporabi zdravila SCINTIMUN pri zaznavanju metastaz v kostnem mozgu so bile uporabljane informacije iz znanstvenih publikacij.
English: How is SCINTIMUN expected to work?
Slovenian: Kako naj bi zdravilo SCINTIMUN delovalo?
English: Keep the bottle tightly closed.
Slovenian: Stekleničko shranjujte tesno zaprto.
English: • Avoid contact with the eyes.
Slovenian: • Preprečite stik z očmi.
English: The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response.
Slovenian: Zdravljenje je treba ponovno preveriti po 4 do 6 tednih, da bi ocenili začetni odziv.
English: Specific measures to be taken in case of the above reactions are described in section 4.5.
Slovenian: Posebni ukrepi, ki jih je treba izvesti v primeru zgoraj naštetih reakcij, so opisani v poglavju 4.5.
English: Do not increase or double the dose.
Slovenian: Ne povečujte ali podvajajte odmerka.
English: Tablets should always be administered in the same manner, with food.
Slovenian: Tablete je treba vedno dajati na enak način, s hrano.
English: It is a heterogeneous disease which can be relatively innocent or aggressively malignant.
Slovenian: Gre za heterogeno bolezen, ki je lahko sorazmerno nedolžna ali agresivno maligna.
English: Your veterinarian will tell you what amount is right for your dog.
Slovenian: Vaš veterinar vam bo povedal, kolikšna količina je ustrezna za vašega psa.
English: ATCvet code: QL01XE90.
Slovenian: oznaka ATC vet: QL01XE90.
English: There are some medicines that you should not give to your dog during treatment because together, they might cause serious adverse effects.
Slovenian: Obstajajo zdravila, ki jih med zdravljenjem ne smete dajati svojemu psu, saj bi skupaj lahko povzročila resne neželene učinke.
English: Please contact your veterinarian.
Slovenian: Prosimo, posvetujte se z veterinarjem.
English: Your veterinarian can best describe these for you.
Slovenian: Te vam lahko najbolje opiše vaš veterinar.
English: 63800 Cournon d'Auvergne France
Slovenian: 63800 Cournon d'Auvergne Francija
English: Masitinib is approximately 93 % bound to plasma proteins.
Slovenian: Masitinib je v približno 93 % vezan na plazemske beljakovine.
English: Long term treatment should be under regular (at least monthly) veterinary control.
Slovenian: Dolgotrajno zdravljenje mora potekati pod rednim (najmanj enkrat mesečno) veterinarskim nadzorom.
English: The elimination half-life (t½) is approximately 3-6 hours.
Slovenian: Razpolovni čas izločanja (t½) je približno 3 - 6 ur.
English: Special information for the veterinarian
Slovenian: Posebne informacije za veterinarja
English: Other, commonly observed adverse reactions were in most cases mild or moderate:
Slovenian: Drugi pogosto opaženi neželeni učinki so bili v večini primerov blagi ali zmerni:
English: Your dog should not be given Masivet if it:
Slovenian: Vaš pes (psica) ne sme prejeti zdravila Masivet, če:
English: Monitoring of renal function
Slovenian: Nadzor ledvične funkcije
English: Tel.: +33 (0)1 47 20 00 14 Fax: +33 (0)1 47 20 24 11 MASIVET@ab-science.com
Slovenian: Tel.:+33 (0)1 47 20 00 14 Faks:+33 (0)1 47 20 24 11 MASIVET@ab-science.com
English: Response to treatment with masitinib was expressed as stable disease; i.e. static, partial or complete response.
Slovenian: Odziv na zdravljenje z masitinibom je bil opredeljen kot stabilna bolezen, tj. statični, delni ali popolni odziv.
English: Summary of thresholds for laboratory evaluations resulting in contra-indication or treatment modification (interruption, dose reduction or discontinuation)
Slovenian: Povzetek mejnih vrednosti za laboratorijska vrednotenja, ki privedejo do kontraindikacije ali spremembe zdravljenja (prekinitve, zmanjšanja odmerka ali prenehanja zdravljenja)
English: • Take care not to touch the eyes before gloves have been removed and disposed of and the hands have been thoroughly washed.
Slovenian: • Pazite, da se ne dotikate oči, dokler ne snamete in odstranite rokavic ter si temeljito ne umijete rok.
English: During clinical studies, the daily dose was decreased due to adverse events in approximately 16 % of treated dogs and mainly due to an increase in transaminases.
Slovenian: Med kliničnimi študijami je bil dnevni odmerek zmanjšan zaradi neželenih učinkov pri približno 16 % zdravljenih psov in sicer predvsem zaradi zvišanja transaminaz.
English: Do not eat, drink, or smoke when treating the dog.
Slovenian: Pri zdravljenju psa ne jejte, ne pijte in ne kadite.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: The tablets must be administered as a whole and should not be divided, broken or ground.
Slovenian: Tablete je treba dajati cele in se jih ne sme deliti, lomiti ali zdrobiti.
English: Duration of treatment depends on the response to treatment.
Slovenian: Trajanje zdravljenja je odvisno od odziva na zdravljenje.
English: Very common effects:
Slovenian: Zelo pogosti učinki:
English: It also inhibits the Platelet Derived Growth Factor (PDGF) receptor and the Fibroblast Growth Factor Receptor (FGFR3).
Slovenian: Prav tako zavira receptor trombocitnega rastnega faktorja (PDGF - Platelet Derived Growth Factor) in receptor fibroblastnega rastnega faktorja (FGFR3 - Fibroblast Growth Factor Receptor).
English: In case of adverse reactions, your veterinarian may decide to reduce the dose or to discontinue treatment.
Slovenian: V primeru neželenih učinkov se bo vaš veterinar morda odločil za zmanjšanje odmerka ali prenehanje zdravljenja.
English: No information relating to potential cross-resistance with other cytostatic products is available.
Slovenian: Informacije o morebitni navzkrižni rezistenci z drugimi citostatiki niso na voljo.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals)
Slovenian: Pogostost neželenih reakcij je določena v skladu s konvencijo, kot sledi: - zelo pogosto (več kot 1na 10 živalih, pri katerih nastane neželena reakcija(-e) med potekom enega zdravljenja), - pogosto (več kot 1, vendar na manj kot 10 od 100 živali).
English: Duration of treatment will be dependent on the response observed.
Slovenian: Trajanje zdravljenja je odvisno od ugotovljenega odziva.