natgillin/translations-raw huggingface dataset:
The Product Information for Iclusig was revised to include the following:
Informacije o zdravilu Iclusig so bile spremenjene tako, da vključujejo:
A total of 81 (18%) patients on the phase 2 study (n=449) have experienced serious vascular occlusive events and overall, a total of 101 patients (23%) have experienced vascular occlusive events (serious and non-serious).
V študiji 2. faze (n = 449) je imelo skupno 81 (18 %) bolnikov resne dogodke žilne okluzije, skupno 101 bolnik (23 %) pa je imel dogodke žilne okluzije (resne in neresne).
However these data include a relatively small number of patients, most of which had been dose reduced due to adverse events, and follow-up time is limited.
Vendar ti podatki vključujejo sorazmerno malo bolnikov, pri večini katerih so odmerek zmanjšali zaradi neželenih dogodkov, čas sledenja pa je omejen.
• Updated recommendations to assess cardiovascular status and consider alternative treatments where appropriate.
• posodobljena priporočila za oceno kardiovaskularnega stanja in razmislek o nadomestnih oblikah zdravljenja, kadar je to primerno;
It is therefore unclear whether the maintenance of response observed in this particular group of patients can be generalised to the CP-CML population.
Zato torej ni jasno, ali je mogoče vzdrževanje odziva, ki so ga opazili v tej skupini bolnikov, posplošiti za celotno populacijo KML v kronični fazi.
Serious cardiac failure events have occurred in a total of 23 patients (5.1%).
Resni dogodki srčnega popuščanja so se pojavili pri skupno 23 bolnikih (5,1 %).
In October 2013, the EMA was informed that the rate of vascular occlusive events was higher than observed in the clinical trials that supported the initial marketing authorisation.
Oktobra 2013 so agencijo EMA obvestili, da je delež dogodkov žilne okluzije večji od deleža, opaženega v kliničnih preskušanjih, ki so podprla prvotno dovoljenje za promet z zdravilom.
This raises the question of whether similar outcomes in terms of efficacy could be achieved with lower (starting and/or maintenance) doses, which are expected to reduce the risk of vascular occlusive events.
Pri tem se pojavi vprašanje, ali bi bilo mogoče podobne izide glede učinkovitosti doseči z manjšimi (začetnimi in/ali vzdrževalnimi) odmerki, za katere je pričakovati, da bodo zmanjšali tveganje za dogodke žilne okluzije.
While these data can be useful for physicians considering dose reduction, it is currently considered insufficient to adopt a formal recommendation for dose reduction in patients who have not experienced an adverse event.
Medtem ko so lahko ti podatki koristni za zdravnike, ki razmišljajo o zmanjšanju odmerka, trenutno ne zadostujejo za sprejetje uradnega priporočila za zmanjšanje odmerka pri bolnikih brez neželenega dogodka.
A type II variation was submitted and additional risk minimisation measures such as updates to the product information were put in place.
Predložila se je vloga za spremembo tipa II in uvedli so se dodatni ukrepi za zmanjševanje tveganja, kot so posodobitve informacij o zdravilu.
Non-clinical issues
Neklinična vprašanja
Ponatinib is a tyrosine kinase inhibitor (TKI), designed with the purpose of inhibiting the kinase activity of native BCR-ABL, and all mutant variants, including ‘gatekeeper' T315I.
Ponatinib je zaviralec tirozin-kinaze, zasnovan za zaviranje kinazne dejavnosti nativnega produkta BCR-ABL in vseh mutiranih različic, vključno s T315I.
In view of the high risk for vascular occlusive events, the PRAC considered that it should be made clear in the product information that ponatinib should be discontinued in patients who do not respond to treatment (no haematologic response by 3 months).
Odbor PRAC je zaradi velikega tveganja za dogodke žilne okluzije menil, da je treba v informacijah o zdravilu jasno navesti, da je treba uporabo ponatiniba prekiniti pri bolnikih, ki se ne odzivajo na zdravljenje (brez hematološkega odziva po treh mesecih).
• The PRAC considered Iclusig (ponatinib) in the procedure under Article 20 of Regulation (EC) No
• odbor PRAC je proučil zdravilo Iclusig (ponatinib) v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004, ki ga je uvedla Evropska komisija;
The PRAC considered whether a recommendation for dose reduction (in the absence of an adverse event) in patients with chronic phase CML who have achieved major cytogenetic response was appropriate.
Odbor PRAC je pretehtal, ali je priporočilo za zmanjšanje odmerka (ob odsotnosti neželenega dogodka) pri bolnikih s KML v kronični fazi, ki so dosegli velik citogenetski odziv, ustrezno.
However, there were a number of outstanding issues which could not be resolved within the expedited variation procedure and which required a further review of the benefit-risk balance of Iclusig.
Vendar so bile prisotne številne izrazite težave, ki jih ni bilo mogoče odpraviti s hitrim postopkom za spremembo in so zahtevale dodatno presojo razmerja med tveganji in koristmi zdravila Iclusig.
• Additional warnings about hypertension, cardiac failure and risk of bleeding with anti-clotting agents.
• dodatna opozorila glede hipertenzije, srčnega popuščanja in tveganja za krvavitev v kombinaciji z učinkovinami proti strjevanju krvi;
A number of plausible molecular mechanism exists that may contribute to vascular occlusive events.
Obstajajo številni verjetni molekularni mehanizmi, ki bi lahko prispevali k dogodkom žilne okluzije.
As part of the assessment of potential causes that may lead to an increased occurrence of vascular occlusive events in ponatinib treated patients, molecular mechanisms based on on-target and offtarget effects were discussed.
V okviru ocene morebitnih vzrokov, ki lahko pripeljejo do povečane pojavnosti dogodkov žilne okluzije pri bolnikih, zdravljenih s ponatinibom, so razpravljali o molekularnih mehanizmih, ki temeljijo na predvidenih in nepredvidenih učinkih.
The possible role of anti-platelet, anti-coagulant or lipid lowering drugs in reducing the risk of vascular occlusive events remains uncertain.
Morebitna vloga antitrombotikov, antikoagulantov ali zdravil za zniževanje ravni lipidov pri zmanjševanju tveganja za dogodke žilne okluzije ostaja neznana.
There is also an association between vascular occlusive events and a risk of cardiac failure as a secondary event.
Obstaja tudi povezava med dogodki žilne okluzije in tveganjem za srčno popuščanje kot sekundarnim dogodkom.
The majority of cases of cardiac failure occurred in patients at known risk from underlying disease, cardiovascular risk factors and prior treatment with cardiotoxic medications including other TKIs.
Večina primerov srčnega popuščanja se je pojavila pri bolnikih z znanim tveganjem zaradi osnovne bolezni, kardiovaskularnih dejavnikov tveganja in predhodnega zdravljenja s kardiotoksičnimi zdravili, vključno z drugimi zaviralci tirozin-kinaze.
• The PRAC took note of the serious risk of vascular occlusive events associated with Iclusig, which is likely to be dose-related.
• odbor PRAC se je seznanil z resnim tveganjem za dogodke žilne okluzije, povezanim z zdravilom Iclusig, ki je verjetno odvisno od odmerka;
• The PRAC reviewed all data presented by the MAH on the safety and efficacy of Iclusig, as well as the views expressed by the oncology scientific advisory group.
• odbor PRAC je pregledal vse podatke o varnosti ter učinkovitosti zdravila Iclusig, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, in mnenja Znanstvene svetovalne skupine za onkologijo;
The risk of vascular occlusive events is likely to be dose related and therefore a dose reduction would be expected to reduce the risk of vascular occlusive events.
Tveganje za dogodke žilne okluzije je verjetno povezano z odmerkom, zato je pričakovati, da bo zmanjšanje odmerka zmanjšalo tveganje za dogodke žilne okluzije.
The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisation for Iclusig should be varied.
Po proučitvi priporočila odbora PRAC se je odbor CHMP strinjal s splošnimi znanstvenimi zaključki odbora PRAC in menil, da je treba dovoljenje za promet z zdravilom Iclusig spremeniti.
Therefore no formal recommendation can be issued regarding concomitant the use of these agents and the potential risks of haemorrhage with anti-platelet and anticoagulant agents in ponatinib treated patients need to be considered.
Posledično ni mogoče pripraviti nobenega uradnega priporočila glede sočasne uporabe teh učinkovin, prav tako pa je treba upoštevati morebitna tveganja za krvavitev pri uporabi antitrombotikov in antikoagulantov v kombinaciji s ponatinibom.
Further non-clinical studies will be conducted with the aim to further characterise the potential mechanisms for vascular occlusive events with ponatinib treatment.
Opravile se bodo dodatne predklinične študije, katerih cilj bo nadaljnja karakterizacija morebitnih mehanizmov za dogodke žilne okluzije pri zdravljenju s ponatinibom.
These included further consideration of the PK-PD profile of ponatinib to determine the optimal dosing in all patient populations and indications (including recommendations for initial dose and dose reductions), further assessment of the nature, severity and frequency of all treatment-emergent vascular occlusive adverse events (and possible sequelae), and heart failure, exploration of the potential mechanisms of action leading to vascular occlusive events and consideration of the possibilities for further risk minimisation measures.
To je vključevalo dodatno presojo FK/FD profila ponatiniba, s katero bi določili optimalno odmerjanje pri vseh skupinah bolnikov in indikacijah (vključno s priporočili za začetni odmerek in zmanjšanje odmerka), dodatno oceno značaja, resnosti ter pogostnosti vseh z zdravljenjem povezanih neželenih dogodkov žilne okluzije (in morebitnih posledic) in srčnega popuščanja, raziskavo morebitnih mehanizmov delovanja, ki povzročajo dogodke žilne okluzije, in presojo možnosti za dodatne ukrepe za zmanjševanje tveganja.
The MAH shall provide relevant healthcare professionals with educational material highlighting important medical risks for which monitoring and/or dose adjustment are recommended, instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal and available data on the relationship between dose and risk of vascular occlusive events.
Imetnik dovoljenja za promet z zdravilom bo zadevnim zdravstvenim delavcem posredoval izobraževalno gradivo, ki izpostavlja pomembna zdravstvena tveganja, pri katerih se priporoča spremljanje in/ali prilagajanje odmerka, navodila za obravnavo neželenih dogodkov na podlagi spremljanja ter spreminjanja odmerka ali prekinitve zdravljenja in razpoložljive podatke o razmerju med odmerkom ter tveganjem za dogodke žilne okluzije.
The overall safety profile for ponatinib is generally consistent with that considered at the time of marketing authorisation, with the notable addition of the risk of vascular occlusive events.
Splošni varnostni profil ponatiniba je na splošno skladen z varnostnim profilom, ki so ga obravnavali v času izdaje dovoljenja za promet z zdravilom, pri čemer pa je treba omeniti pomembno vključitev tveganja za dogodke žilne okluzije.
• Inclusion of safety and efficacy data following dose reduction in CP-CML patients who have achieved MCyR to inform physicians of the currently available data on dose reduction.
• vključitev podatkov o varnosti in učinkovitosti po zmanjšanju odmerka pri bolnikih s KML v kronični fazi, ki so dosegli velik citogenetski odziv (MCyR), da bi zdravnike obvestili o trenutno razpoložljivih podatkih o zmanjšanju odmerka;
This study is considered key to the benefit-risk of ponatinib and has been imposed as a condition to the marketing authorisation.
Ta študija je ključna za oceno razmerja med tveganji in koristmi ponatiniba in je pogoj za izdajo dovoljenja za promet z zdravilom.
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation and
• s kronično mieloično levkemijo (KML) v kronični, pospešeni ali blastni fazi, ki so odporni proti dasatinibu ali nilotinibu, ki ne prenašajo dasatiniba ali nilotiniba in pri katerih poznejše zdravljenje z imatinibom ni klinično primerno, oziroma ki imajo mutacijo T315I, in
Based on the totality of the data assessed during the procedure and on the advice from the Scientific Advisory Group for oncology, the PRAC concluded that the benefit-risk balance of Iclusig remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Na podlagi celotnih podatkov, ocenjenih med postopkom, in nasveta Znanstvene svetovalne skupine za onkologijo je odbor PRAC sklenil, da razmerje med tveganji in koristmi zdravila Iclusig ostaja pozitivno, če se upoštevajo spremembe informacij o zdravilu in ukrepi za zmanjševanje tveganja ter se izvajajo dodatne dogovorjene farmakovigilančne dejavnosti.
• The PRAC also considered the currently available data on dose-efficacy and dose-toxicity relationship, and concluded that it was too limited to allow for a formal recommendation for dose reduction as a risk minimisation measure in patients who have not experienced toxicity.
• odbor PRAC je prav tako pregledal trenutno razpoložljive podatke o razmerju med odmerkom in učinkovitostjo ter odmerkom in toksičnostjo ter sklenil, da so preveč omejeni za sprejetje uradnega priporočila glede ukrepa za zmanjšanje odmerka pri bolnikih brez toksičnosti.
Efficacy data in relation to dose reduction indicates that patients who have been dose reduced maintained response (MCyR and MMR) for the duration of the currently available follow-up.
Podatki o učinkovitosti, povezani z zmanjšanjem odmerka, kažejo, da se je pri bolnikih, pri katerih so zmanjšali odmerek, odziv (velik citogenetski odziv (MCyR) in velik molekulski odziv (MMR)) ohranil med celotnim trenutno razpoložljivim sledenjem.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
• z za kromosom Philadelphia pozitivno akutno limfoblastno levkemijo (Ph+ ALL), ki so odporni proti dasatinibu, ki ne prenašajo dasatiniba in pri katerih poznejše zdravljenje z imatinibom ni klinično primerno, oziroma ki imajo mutacijo T315I.
The PRAC has therefore recommended the variation to the terms of the marketing authorisation for Iclusig.
Posledično je odbor PRAC priporočil spremembo pogojev dovoljenja za promet z zdravilom Iclusig.
The PRAC also recommended that a dose-ranging study be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving major cytogenetic response.
Odbor je prav tako priporočil, da se pri bolnikih s KML v kronični fazi izvede študija z različnimi odmerki, v kateri bodo določili optimalni začetni odmerek zdravila Iclusig in opredelili varnost ter učinkovitost zdravila Iclusig po zmanjšanju odmerka, ko je bolnik dosegel velik citogenetski odziv.
A dose-ranging study will be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR.
Pri bolnikih s KML v kronični fazi bodo izvedli študijo z različnimi odmerki, v kateri bodo določili optimalni začetni odmerek zdravila Iclusig in opredelili varnost ter učinkovitost zdravila Iclusig po zmanjšanju odmerka, ko je bolnik dosegel velik citogenetski odziv (MCyR).
Grounds for the recommendation
Podlaga za priporočilo Ob upoštevanju naslednjega:
• The PRAC also noted that, although limited, the data in chronic phase CML is indicative of maintenance of response in patients who are dose reduced and therefore it was considered important to generate further data on the dose-efficacy relationship to potentially inform future risk minimisation measures.
• odbor PRAC je prav tako opazil, da podatki (čeprav omejeni) pri KML v kronični fazi kažejo na vzdrževanje odziva pri bolnikih, pri katerih so zmanjšali odmerek, zato je menil, da je pomembno pridobiti dodatne podatke o razmerju med odmerkom in učinkovitostjo, ki bi podprli morebitne ukrepe za zmanjševanje tveganja v prihodnosti, odbor PRAC meni, da razmerje med tveganji in koristmi zdravila Iclusig ostaja pozitivno, če se upoštevajo spremembe informacij o zdravilu in ukrepi za zmanjševanje tveganja ter se izvajajo dodatne dogovorjene farmakovigilančne dejavnosti.
Conducting further studies aimed at clarifying the dose-efficacy relationship of ponatinib is considered key to allow exploration of dose reduction in the context of risk minimisation, which could ultimately lead to improving the benefit-risk balance of the product.
Za preučevanje zmanjšanja odmerka za zmanjšanje tveganja, ki bi lahko pripeljalo do izboljšanja razmerja med tveganji in koristmi zdravila, so ključne dodatne študije, usmerjene na pojasnjevanje razmerja med učinkovitostjo ter odmerkom ponatiniba.
Outcome of a procedure under Article 6(13) of Regulation (EC) 1084/2003 as amended
Izid postopka po členu 6(13) Uredbe (ES) 1084/2003, kakor je bila spremenjena
In addition, evidence in support of the proposed dose was insufficient.
Poleg tega so bili dokazi v podporo predlaganega odmerka nezadostni.
The European Commission issued a decision on 26 August 2010.
Evropska komisija je odločbo izdala 26. avgusta 2010.
Seroquel XR is authorised in Austria, Belgium, Cyprus, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, and Sweden under a mutual recognition procedure on the basis of the initial authorisation granted by the ‘reference Member State', the Netherlands, in August 2007.
Zdravilo Seroquel XR je odobreno v Avstriji, Belgiji, na Cipru, v Nemčiji, na Danskem, v Grčiji, Španiji, na Finskem, Irskem, v Islandiji, Luksemburgu, na Malti, Nizozemskem, Norveškem, Poljskem, Portugalskem in Švedskem s postopkom medsebojnega priznavanja na osnovi prve odobritve „referenčne države članice“ Nizozemske avgusta leta 2007.
However, Astra Zeneca was not in agreement with the grounds for refusal and, on 22 May 2009, it referred the matter to the CHMP for arbitration.
Vendar se družba Astra Zeneca ni strinjala s podlago za zavrnitev in je 22. maja 2009 zadevo napotila na CHMP v arbitražo.
30 October 2009, 25 January 2010, 22 February 2010, 26 March 2010
30. oktobra 2009, 25. Januarja 2010, 22. februarja 2010, 26. marca 2010
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that a new indication for Seroquel XR can be granted.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je ta zaključil, da se nova indikacija za zdravilo Seroquel XR lahko odobri.
Not enough data had been submitted to support the restriction to patients not responsive to standard antidepressants.
Ni bilo predloženih dovolj podatkov v podporo omejevanja na bolnike, ki se niso odzvali na standardne antidepresive.
Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Podaljšano sproščanje pomeni, da se zdravilna učinkovina počasi sprošča iz tablete več ur.
The variation to the marketing authorisation was rejected because the Member States concluded that the benefit-risk balance of the medicine was unfavourable.
Sprememba dovoljenja za promet z zdravilom je bila zavrnjena, ker so države članice menile, da je razmerje med koristmi in tveganji, povezanimi z zdravilom, neugodno.
The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Natančen mehanizem delovanja ketiapina ni znan, vendar se pritrjuje na več receptorjev na površini živčnih celic v možganih, vključno z receptorji za živčna prenašalca dopamin in serotonin.
As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this disrupts signals transmitted between brain cells.
Ker so živčni prenašalci kemične snovi, ki omogočajo medsebojno komunikacijo med živčnimi celicami, to moti signale, ki se prenašajo med možganskimi celicami.
The European Medicines Agency has completed an arbitration procedure for Seroquel XR and associated names.
Evropska agencija za zdravila je končala postopek arbitraže za zdravilo Seroquel XR in povezana imena.
Seroquel XR is also marketed under other trade names: Seroquel Depot, Seroquel Prolong, and Seroquel SR.
Zdravilo Seroquel XR je v prometu tudi pod drugimi tržnimi imeni: Seroquel Depot, Seroquel Prolong in Seroquel SR.
On 15 May 2009, the Netherlands and all the other concerned Member States rejected a change (variation) to the marketing authorisation to add as a new indication the treatment of recurrent depressive episodes in patients with major depressive disorder (MDD).
Nizozemska in vse druge zadevne države članice so 15. maja 2009 zavrnile spremembo (variacijo) dovoljenja za promet z zdravilom za dodatek nove indikacije zdravljenja ponovitev depresivnih epizod pri bolnikih s poglavitno depresivno motnjo (MDD).
Since these neurotransmitters are involved in schizophrenia and bipolar disorder, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Ker živčni prenašalci sodelujejo pri shizofreniji in bipolarni motnji, ketiapin pomaga normalizirati aktivnost možganov, kar zmanjša simptome teh bolezni.
It is used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Uporablja se pri bolnikih s shizofrenijo, duševno boleznijo s številnimi simptomi, vključno z neorganiziranim mišljenjem in govorom, halucinacijami (prisluhi in prividi), sumničavostjo in blodnjami.
Why was Seroquel XR reviewed?
Zakaj je bilo zdravilo Seroquel XR pregledano?
Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine)
Vprašanja in odgovori v zvezi z zdravilom Seroquel XR in povezanimi imeni (50, 150, 200, 300 in 400 mg tablete s podaljšanim sproščanjem, ki vsebujejo ketiapin)
26 August 2010
26. avgust 2010
Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine) EMA/256694/2010
Vprašanja in odgovori v zvezi z zdravilom Seroquel XR in povezanimi imeni (50, 150, 200, 300 in 400 mg tablete s podaljšanim sproščanjem, ki vsebujejo ketiapin) EMA/256694/2010
The indication excluded the use of Seroquel XR as initial treatment, and restricted its use only to patients who cannot be appropriately managed on alternative antidepressant treatment.
V indikaciji je bila uporaba zdravila Seroquel XR kot prvega zdravljenja izključena ter omejena le na bolnike, ki jih ni možno ustrezno obravnavati z alternativnimi antidepresivnimi zdravljenji.
It is also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Uporablja se za preprečevanje in zdravljenje bipolarne motnje, duševne bolezni, pri kateri imajo bolniki manične epizode (obdobja nenormalne vznesenosti), ki se izmenjujejo z obdobji običajnega počutja ter epizodami depresije.
What is Seroquel XR?
Kaj je zdravilo Seroquel XR?
Seroquel XR is available as prolonged-release tablets.
Zdravilo Seroquel XR je na voljo v obliki tablet s podaljšanim sproščanjem.
Seroquel XR is an antipsychotic medicine that contains the active substance quetiapine.
Zdravilo Seroquel XR je antipsihotik, ki vsebuje zdravilno učinkovino ketiapin.