FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Further non-clinical studies will be conducted with the aim to further characterise the potential mechanisms for vascular occlusive events with ponatinib treatment.
Slovenian: Opravile se bodo dodatne predklinične študije, katerih cilj bo nadaljnja karakterizacija morebitnih mehanizmov za dogodke žilne okluzije pri zdravljenju s ponatinibom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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;
English: This study is considered key to the benefit-risk of ponatinib and has been imposed as a condition to the marketing authorisation.
Slovenian: Ta študija je ključna za oceno razmerja med tveganji in koristmi ponatiniba in je pogoj za izdajo dovoljenja za promet z zdravilom.
English: • 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
Slovenian: • 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
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: The PRAC has therefore recommended the variation to the terms of the marketing authorisation for Iclusig.
Slovenian: Posledično je odbor PRAC priporočil spremembo pogojev dovoljenja za promet z zdravilom Iclusig.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: Grounds for the recommendation
Slovenian: Podlaga za priporočilo Ob upoštevanju naslednjega:
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: Outcome of a procedure under Article 6(13) of Regulation (EC) 1084/2003 as amended
Slovenian: Izid postopka po členu 6(13) Uredbe (ES) 1084/2003, kakor je bila spremenjena
English: In addition, evidence in support of the proposed dose was insufficient.
Slovenian: Poleg tega so bili dokazi v podporo predlaganega odmerka nezadostni.
English: The European Commission issued a decision on 26 August 2010.
Slovenian: Evropska komisija je odločbo izdala 26. avgusta 2010.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Vendar se družba Astra Zeneca ni strinjala s podlago za zavrnitev in je 22. maja 2009 zadevo napotila na CHMP v arbitražo.
English: 30 October 2009, 25 January 2010, 22 February 2010, 26 March 2010
Slovenian: 30. oktobra 2009, 25. Januarja 2010, 22. februarja 2010, 26. marca 2010
English: 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.
Slovenian: 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.
English: Not enough data had been submitted to support the restriction to patients not responsive to standard antidepressants.
Slovenian: Ni bilo predloženih dovolj podatkov v podporo omejevanja na bolnike, ki se niso odzvali na standardne antidepresive.
English: Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Slovenian: Podaljšano sproščanje pomeni, da se zdravilna učinkovina počasi sprošča iz tablete več ur.
English: The variation to the marketing authorisation was rejected because the Member States concluded that the benefit-risk balance of the medicine was unfavourable.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this disrupts signals transmitted between brain cells.
Slovenian: Ker so živčni prenašalci kemične snovi, ki omogočajo medsebojno komunikacijo med živčnimi celicami, to moti signale, ki se prenašajo med možganskimi celicami.
English: The European Medicines Agency has completed an arbitration procedure for Seroquel XR and associated names.
Slovenian: Evropska agencija za zdravila je končala postopek arbitraže za zdravilo Seroquel XR in povezana imena.
English: Seroquel XR is also marketed under other trade names: Seroquel Depot, Seroquel Prolong, and Seroquel SR.
Slovenian: Zdravilo Seroquel XR je v prometu tudi pod drugimi tržnimi imeni: Seroquel Depot, Seroquel Prolong in Seroquel SR.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Ker živčni prenašalci sodelujejo pri shizofreniji in bipolarni motnji, ketiapin pomaga normalizirati aktivnost možganov, kar zmanjša simptome teh bolezni.
English: 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).
Slovenian: Uporablja se pri bolnikih s shizofrenijo, duševno boleznijo s številnimi simptomi, vključno z neorganiziranim mišljenjem in govorom, halucinacijami (prisluhi in prividi), sumničavostjo in blodnjami.
English: Why was Seroquel XR reviewed?
Slovenian: Zakaj je bilo zdravilo Seroquel XR pregledano?
English: Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine)
Slovenian: 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)
English: 26 August 2010
Slovenian: 26. avgust 2010
English: Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine) EMA/256694/2010
Slovenian: 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
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: What is Seroquel XR?
Slovenian: Kaj je zdravilo Seroquel XR?
English: Seroquel XR is available as prolonged-release tablets.
Slovenian: Zdravilo Seroquel XR je na voljo v obliki tablet s podaljšanim sproščanjem.
English: Seroquel XR is an antipsychotic medicine that contains the active substance quetiapine.
Slovenian: Zdravilo Seroquel XR je antipsihotik, ki vsebuje zdravilno učinkovino ketiapin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that Seroquel XR can be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je zaključil, da se lahko zdravilo Seroquel XR uporablja kot dodatek obstoječemu zdravljenju poglavitnih depresivnih epizod pri bolnikih s poglavitno depresivno motnjo in podoptimalnim odzivom na zdravljenje z drugimi antidepresivi.
English: The Committee recommended that the medicine be used as add-on to ongoing treatment for major depressive episodes in MDD patients who have had sub-optimal response to monotherapy with another antidepressant.
Slovenian: Odbor je priporočil, da se zdravilo uporablja kot dodatek obstoječemu zdravljenju poglavitnih depresivnih epizod pri bolnikih s poglavitno depresivno motnjo in podoptimalnim odzivom na monoterapijo z drugim antidepresivom.
English: • is pregnant or might be pregnant.
Slovenian: • noseči ali bi lahko bili noseči.
English: The combination should be avoided.
Slovenian: Kombinaciji se je treba izogibati.
English: Clinical efficacy and safety in the paediatric population
Slovenian: Klinična učinkovitost in varnost pri pediatrični populaciji
English: Frequency not known (reported from use in adults)
Slovenian: Pogostost ni znana (se poroča iz uporabe pri odraslih)
English: No special treatment is required.
Slovenian: Posebno zdravljenje ni potrebno.
English: These medicines should be taken in the morning.
Slovenian: Ta zdravila je treba jemati zjutraj;
English: If this change in behaviour occurs, you must tell your doctor.
Slovenian: Če pride do te spremembe vedenja, morate to povedati zdravniku.
English: Do not give this medicine to children below the age of 2 years as it has not been tested and its effects are unknown.
Slovenian: Tega zdravila ne dajajte otrokom, mlajšim od 2 let, ker ni bilo preizkušeno in njegovi učinki niso znani.
English: What it is used for
Slovenian: Za kaj se uporablja
English: These medicines should be avoided, especially in the evening.
Slovenian: Tem zdravilom se je treba izogibati, zlasti zvečer;
English: Interaction studies have only been performed in adults.
Slovenian: Študije o medsebojnem delovanju so bile izvedene samo pri odraslih.
English: Terminal half life (t½) is 3.5-4 hours.
Slovenian: Končni razpolovni čas (t½) je od 3,5 do 4 ure.
English: Treatment difference (SE)
Slovenian: Razlika v zdravljenju (SE)
English: For children and adolescents aged 2-18
Slovenian: Za otroke in mladostnike od 2 do 18 let
English: The treatment effects on sleep variables were associated with improved parents' well-being.
Slovenian: Učinki zdravljenja na spremenljivke spanja so bili povezani z izboljšanim počutjem staršev.
English: Mood swings, Aggression, Irritability
Slovenian: Nihanje razpoloženja, agresivnost, razdražljivost
English: p-value*
Slovenian: vrednost p*
English: Common: may affect between 1 in 100 to 1 in 10 people
Slovenian: pogosti: lahko prizadenejo med 1 od 100 in 1 od 10 ljudi
English: Data are available for up to 2 years' treatment.
Slovenian: Na voljo so podatki za zdravljenje do dveh let.
English: This leaflet was last revised in { month/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano { mesec/LLLL}.
English: Bioavailability is in the order of 15%.
Slovenian: Biološka uporabnost znaša 15 %.
English: The tablets should be taken after the evening meal, i.e. on a full stomach.
Slovenian: Tablete je treba vzeti po večerji, tj. na poln želodec.
English: 4.7 Effects on ability to drive and use machines Melatonin has a moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Melatonin ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Melatonin is a hormone produced naturally by the body.
Slovenian: Melatonin je hormon, ki ga naravno proizvaja telo.
English: If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of 10 mg.
Slovenian: Če je bil ugotovljen neustrezen odziv, je treba odmerek povečati na 5 mg, pri čemer je največji odmerek 10 mg.
English: When
Slovenian: Kdaj
English: There is a significant first pass effect with an estimated first pass metabolism of 85%.
Slovenian: Pomemben je učinek prvega prehoda, pri čemer je ocenjeni metabolizem prvega prehoda 85 %.
English: A five-fold variability in Cmax between different members of the same sex has also been observed.
Slovenian: Opazili so tudi petkratno spremenljivost Cmax med različnimi predstavniki istega spola.
English: -3.64,3.89 ns
Slovenian: -3,64, 3,89 ni pomembno
English: DO NOT take Slenyto if you or your child: - is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: NE uporabljajte zdravila Slenyto, če ste vi ali vaš otrok: - alergični na melatonin ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: How long
Slovenian: Kako dolgo
English: The doctor may want you/your child to stop taking this medicine.
Slovenian: Zdravnik bo morda želel, da vi/vaš otrok prenehate jemati to zdravilo.
English: • Low levels of white blood cells (neutropenia)
Slovenian: • nizke ravni belih krvničk (nevtropenija)
English: Treatment was administered for up to two years.
Slovenian: Zdravljenje se je izvajalo do dve leti.
English: The medicine can help you or your child fall asleep and may help you or your child sleep for longer during the night.
Slovenian: Zdravilo lahko vam ali vašemu otroku pomaga zaspati in morda vam ali vašemu otroku pomaga ponoči spati dlje časa.
English: The maximum daily dose that you/your child will receive is 10 mg (two 5-mg tablets).
Slovenian: Največji dnevni odmerek, ki ga boste dobili vi/vaš otrok, je 10 mg (dve 5 mg tableti).
English: Somnolence, Headache, Sudden onset of sleep
Slovenian: Zaspanost, glavobol, nenaden spanec
English: Therefore the medicinal product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety (see section 4.7).
Slovenian: Zdravilo je zato treba uporabljati previdno, če so učinki zaspanosti lahko povezani s tveganjem za varnost (glej poglavje 4.7).
English: However, no pharmacodynamic differences between males and females were found despite differences in blood levels.
Slovenian: Vendar farmakodinamičnih razlik med moškimi in ženskami kljub različnim ravnem v krvi niso zaznali.
English: 5- or 8-methoxypsoralen
Slovenian: 5- ali 8-metoksipsoralen
English: It is important to continue taking this medicine to treat the condition.
Slovenian: Za zdravljenje bolezni je pomembno še naprej jemati to zdravilo.
English: Unexpected changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 100 to 1 in 10 people).
Slovenian: Pogosto se lahko pojavijo nepričakovane spremembe vedenja, kot je agresivnost (med 1 od 100 in 1 od 10 ljudi).
English: Concomitant use of the following medicinal products is not recommended (see section 4.4):
Slovenian: Sočasna uporaba naslednjih zdravil ni priporočljiva (glejte poglavje 4.4):