FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 30 mg of carfilzomib.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 30 mg karfilzomiba.
English: Musculoskeletal pain Musculoskeletal chest pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v hrbtu artralgija bolečine v okončini spazmi mišic mišično-skeletna bolečina mišično-skeletna prsna bolečina kostna bolečina mialgija šibkost mišic
English: • Sore throat
Slovenian: • vnetje žrela,
English: Stop Kyprolis for pulmonary hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2).
Slovenian: V primeru pljučne hipertenzije prekinite uporabo zdravila Kyprolis, dokler ne mine ali se ne vrne na izhodiščno raven, na podlagi ocene koristi in tveganja pa razmislite o ponovnem začetku uporabe zdravila Kyprolis (glejte poglavje 4.2).
English: Deep vein thrombosis Hypotension Flushing
Slovenian: Žilne bolezni hipertenzija globoka venska tromboza hipotenzija zardevanje hipertenzivna kriza krvavitev hipertenzivno nujno stanje
English: Intracranial haemorrhage Cerebrovascular accident
Slovenian: • možganska kap,
English: Death due to cardiac arrest has occurred within a day of Kyprolis administration and fatal outcomes have been reported with cardiac failure and myocardial infarction.
Slovenian: O smrti zaradi zastoja srca so poročali v dnevu po uporabi zdravila Kyprolis.
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion carfilzomib
Slovenian: Kyprolis 10 mg prašek za raztopino za infundiranje karfilzomib
English: • Multi-organ failure
Slovenian: • odpoved več organov,
English: sometimes spreading across to the neck and shoulders, sometimes with a fever
Slovenian: • otekanje ovojnice, ki obdaja srčno votlino (perikarditis), simptomi so bolečine za prsnico, ki se včasih širi po vratu in ramenih, včasih z zvišano telesno temperaturo,
English: Carfilzomib is primarily metabolised via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers.
Slovenian: Zato ni verjetno, da bi na njegove farmakokinetične značilnosti vplivala sočasna uporaba zaviralcev ali induktorjev citokroma P450.
English: For clinical management of hepatic toxicity during Kyprolis treatment, see section 4.4.
Slovenian: Za klinično obravnavo hepatotoksičnosti med zdravljenjem z zdravilom Kyprolis glejte poglavje 4.4.
English: For clinical management of hypertension during Kyprolis treatment, see section 4.4.
Slovenian: Za klinično obravnavo hipertenzije med zdravljenjem z zdravilom Kyprolis glejte poglavje 4.4.
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone; OS = overall survival; HR = hazard ratio; CI = confidence interval; mo = months a. Study PX-171-009
Slovenian: KRd = zdravilo Kyprolis, lenalidomid in deksametazon, Rd = lenalidomid in deksametazon, OS = celokupno preživetje, HR = razmerje ogroženosti, IZ = interval zaupanja.
English: • Blood clot in the lungs
Slovenian: • krvni strdek v pljučih,
English: For clinical management of cardiac disorders during Kyprolis treatment, see section 4.4.
Slovenian: Za klinično obravnavo srčnih bolezni med zdravljenjem z zdravilom Kyprolis glejte poglavje 4.4.
English: Discard unused portions in accordance with local requirements.
Slovenian: Neporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
English: • Indigestion
Slovenian: • bruhanje,
English: How to store Kyprolis
Slovenian: Shranjevanje zdravila Kyprolis
English: Myalgia
Slovenian: Shema
English: • Toothache
Slovenian: • omotica,
English: • A history of blood clots in your veins
Slovenian: • Krvni strdek v kateri od ven v preteklosti.
English: Death, n (%) Median OS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Slovenian: Mediana OS, meseci HR (Kd/Vd) (95 % IZ) p-vrednost (1-stranska)
English: • Stroke
Slovenian: • driska,
English: Death, n (%) Median OS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Slovenian: Mediana OS, meseci HR (KRd/Rd) (95 % IZ) p-vrednost (1-stranska)
English: Kyprolis should be discontinued if PRES is suspected.
Slovenian: V primeru suma na PRES je treba prenehati uporabljati zdravilo Kyprolis.
English: Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Slovenian: Po pomotoma uporabljenem odmerku 200 mg zdravila Kyprolis so poročali o akutnem pojavu mrzlice, hipotenzije, insuficience ledvic, trombocitopenije in limfopenije.
English: Oropharyngeal pain Dysphonia Wheezing
Slovenian: Očesne bolezni katarakta zamegljen vid
English: For clinical management of thrombocytopenia during Kyprolis treatment, see section 4.4.
Slovenian: Za klinično obravnavo trombocitopenije med zdravljenjem z zdravilom Kyprolis glejte poglavje 4.4.
English: Dyspnoea was commonly reported in patients treated with Kyprolis.
Slovenian: Med zdravljenjem z zdravilom Kyprolis so pogosto poročali o dispneji.
English: Pneumonia Respiratory tract infection
Slovenian: Bolezni imunskega sistema preobčutljivost na zdravilo
English: This has now been harmonised.
Slovenian: To je bilo zdaj usklajeno.
English: Generally the infant dose stays below 0.5% of the maternal dose, often even lower.
Slovenian: Na splošno odmerek za dojenčka ostaja pod 0,5 % materinega odmerka, pogosto celo nižje.
English: Quality of the product is considered satisfactory.
Slovenian: Kakovost zdravila velja za sprejemljivo.
English: Please see Annex III.
Slovenian: Glejte Prilogo III.
English: Discussions held were mainly around the amount of data currently available for the first trimester.
Slovenian: Razprava je bila večinoma osredotočena na količino podatkov, ki so trenutno na voljo za prvo trimesečje.
English: The content was therefore reworded and harmonised across all MSs.
Slovenian: Vsebina je bila zato preoblikovana in usklajena po vseh državah članicah.
English: No literature review to underpin that conclusion was provided.
Slovenian: Predložen ni bil noben pregled literature, ki bi podpiral ta sklep.
English: Common sources (Briggs et al., 2011; Reprotox Database) reviewed several case reports and some publications reporting on a limited series of pregnancies.
Slovenian: Splošni viri (Briggs et al., 2011; zbirka podatkov Reprotox) so pregledali več poročil primerov in nekaj publikacij, v katerih so poročali o omejenih primerih nosečnosti.
English: It is known that excretion in milk is low.
Slovenian: Znano je, da je izločanje v materino mleko majhno.
English: The CHMP considered all available data which concerned more than 300 cases of exposure during pregnancy.
Slovenian: CHMP je preučil vse razpoložljive podatke, ki vključujejo več kot 300 primerov izpostavljenosti med nosečnostjo.
English: The wording on “Constipation and intestinal obstruction” was already harmonised.
Slovenian: Besedilo o „zaprtosti in intestinalni obstrukciji“ je bilo že usklajeno.
English: The fact that quetiapine has not been studied on human fertility is now harmonised under this subheading.
Slovenian: Dejstvo, da kvetiapina še niso preučevali za plodnost pri človeku, je zdaj usklajeno pod tem podnaslovom.
English: However, part of the information in this section has been moved from the heading “Somnolence” as explained above.
Slovenian: Vendar je bil del informacij v tem poglavju umaknjen iz naslova „Utrujenost“, kot je obrazloženo zgoraj.
English: As a result of this harmonisation procedure, Module 3 was updated to harmonise the information between the Member States.
Slovenian: Kot rezultat tega postopka usklajevanja je bil posodobljen modul 3, s čimer so bile usklajene informacije med državami članicami.
English: The limited available data on treatment of mixed episodes was not designed to investigate the efficacy/safety of quetiapine in mixed episodes and showed only a positive non-significant trend in this subgroup.
Slovenian: Omejeni razpoložljivi podatki o zdravljenju mešanih epizod niso bili zasnovani za raziskavo učinkovitosti/varnosti kvetiapina pri mešanih epizodah in so pokazali samo pozitiven, nepomemben trend v tej podskupini.
English: • treatment of schizophrenia
Slovenian: • zdravljenje shizofrenije
English: Several clinical studies have been published during recent years (e.g. Haberman et al 2013) indicating that there is no major teratogenic risk due to the use of atypical antipsychotics.
Slovenian: V zadnjih letih je bilo objavljenih več kliničnih študij (npr. Haberman et al 2013), v katerih so zabeležili, da uporaba atipičnih antipsihotikov ne povzroča večjega teratogenega tveganja.
English: Nevertheless, it was considered that the information on the risk of agranulocytosis was unclear.
Slovenian: Ne glede na to so menili, da so informacije o tveganju za agranulocitozo nejasne.
English: Further amendments were introduced in this section consequently to the modifications made in section 4.6.
Slovenian: Uvedene so bile nadaljnje spremembe tega poglavja v skladu s spremembami poglavja 4.6.
English: The proposal presented by the MAH reflected the latest scientific information.
Slovenian: Predlog, ki ga je predstavil imetnik dovoljenja za promet z zdravilom, je odražal najnovejše znanstvene informacije.
English: Section 4.6 - Fertility, pregnancy and lactation
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in dojenje
English: In the heading referring to breastfeeding is stated that the degree of excretion in milk is not consistent.
Slovenian: V naslovu, ki se nanaša na dojenje, je navedeno, da stopnja izločanja v materino mleko ni konsistentna.
English: Only one MS had a warning regarding the hepatic effects.
Slovenian: Samo ena država članica je imela opozorilo o učinkih na jetra.
English: Constipation and intestinal obstruction
Slovenian: Zaprtost in intestinalna obstrukcija
English: The treatment of acute and chronic psychosis is a broader indication than schizophrenia and as such should be substantiated adequately.
Slovenian: Zdravljenje akutne in kronične psihoze je širša indikacija od shizofrenije in mora biti zato ustrezno utemeljena.
English: The CHMP agreed that no definitive conclusion on the risk during pregnancy can be drawn based on the data available.
Slovenian: CHMP se je strinjal, da na osnovi razpoložljivih podatkov ni mogoče dokončno sklepati o tveganju med nosečnostjo.
English: The final text was agreed within this harmonisation procedure and took into account the guidance provided in the guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005), which mentions the available data and lack of teratogenic effects up to now, but also states that no conclusions on risk can be drawn.
Slovenian: Končno besedilo je bilo sprejeto v okviru tega postopka usklajevanja in je vključevalo smernice, navedene v Smernicah o oceni tveganja zdravil za razmnoževanje in laktacijo pri človeku: od podatkov do označevanja (EMEA/CHMP/203927/2005), ki omenja razpoložljive podatke in odsotnost teratogenih učinkov do sedaj, vendar prav tako navaja, da ni mogoče sklepati o tveganju.
English: Severe neutropenia and agranulocytosis
Slovenian: Huda nevtropenija in agranulocitoza
English: Discontinuing antipsychotic medication in stabilised patients is of particular concern, as well as the development of jaundice.
Slovenian: Zlasti zaskrbljujoča je prekinitev zdravljenja z antipsihotiki pri stabiliziranih bolnikih ter tudi razvoj zlatenice.
English: The warning stated that “If jaundice develops, quetiapine should be discontinued”.
Slovenian: Opozorilo je navajalo, da „če se razvije zlatenica, je treba zdravljenje s kvetiapinom prekiniti“.
English: The limited available data does not indicate a risk for congenital abnormalities.
Slovenian: Omejeni razpoložljivi podatki ne kažejo na tveganje za prirojene anomalije.
English: However, the available data are very limited, and therefore it is recommended that a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Slovenian: Vendar so razpoložljivi podatki zelo omejeni, zato je priporočeno odločanje o tem, ali prekiniti dojenje ali zdravljenje z zdravilom Seroquel ob upoštevanju koristi dojenja za dojenčka in koristi zdravljenja za mater.
English: Seroquel XR or XL was first approved in the United States in May 2007 and it is available in 50 mg, 150 mg, 200 mg and 400 mg, and as prolonged released tablets in all European Union (EU) Member States (MS), with exception of Bulgaria and Poland.
Slovenian: Zdravilo Seroquel XR ali XL je bilo prvič odobreno v Združenih državah maja 2007 in je na voljo v jakostih 50 mg, 150 mg, 200 mg in 400 mg in v vseh državah članicah Evropske unije (EU), razen v Bolgariji in na Poljskem, v obliki tablet s podaljšanim sproščanjem.
English: Due to the divergent national decisions taken by MS concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised PIs and thus to harmonise its divergent PIs across the EU.
Slovenian: Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenih zdravil (in povezanih imen), je Evropska komisija obvestila Sekretariat CHMP/EMA o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom odprave razhajanj med nacionalno odobrenimi informacijami o zdravilu in uskladitve razhajajočih se informacij po vsej Evropski uniji.
English: However, divergent wording has been identified in seven MSs in which “major” was missing in the indication.
Slovenian: Vendar so v sedmih državah članicah ugotovili drugačno besedilo, v katerem je v indikaciji manjkala beseda „velikih“.
English: The final harmonised wording addresses all the identified discrepancies e.g. differences in frequency of reported adverse events like rhinitis.
Slovenian: Končno usklajeno besedilo vključuje vsa ugotovljena razhajanja, npr. razlike v pogostnosti poročanih neželenih učinkov, kot je na primer rinitis.
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Slovenian: Pri uskladitvi povzetkov glavnih značilnosti zdravila so bile upoštevane vse ustrezne terapevtske in regulatorne smernice v EU.
English: There were also discrepancies regarding recommendations for special population groups namely elderly and paediatric, administration with/without food.
Slovenian: Do razhajanj je prišlo tudi pri priporočilih za posebne populacije, zlasti starejše in pediatrične skupine, ter za jemanje s hrano ali brez.
English: In two MSs the heading read “Somnolence” instead of “Somnolence and dizziness”.
Slovenian: Dve državi članici sta uporabili naslov „Zaspanost“ namesto „Zaspanost in omotica“.
English: Lastly, an administrative change has been made to the section heading, and the frequency of severe neutropenia has been changed to maintain consistency with the information currently contained in Section 5.1 of the SmPC.
Slovenian: Nazadnje je bila izvedena administrativna sprememba naslova poglavja in spremenjena je bila pogostnost hude nevtropenije, da se ohrani skladnost z informacijami, trenutno navedenimi v poglavju 5.1 povzetka glavnih značilnosti zdravila.
English: The MAH proposal for harmonisation did not support this warning.
Slovenian: Predlog imetnika dovoljenja za promet z zdravilom za uskladitev ni podpiral tega opozorila.
English: Seroquel was first approved in the United Kingdom July 1997 and is available in 25 mg, 100 mg, 150 mg, 200 mg and 300 mg as immediate released tablets.
Slovenian: Zdravilo Seroquel je bilo prvič odobreno v Združenem kraljestvu julija 1997 in je na voljo v obliki tablet s takojšnjim sproščanjem pri jakostih 25 mg, 100 mg, 150 mg, 200 mg in 300 mg.
English: The manufacture and control of both the active substance and the finished product comply with CHMP/ICH guidelines.
Slovenian: Izdelava in nadzor nad obema zdravilnima učinkovina ter končnim izdelkom sta v skladu s smernicami CHMP/ICH.
English: However, the CHMP recommended moving this warning to a more prominent place in this section in order to increase awareness to the risk of developing metabolic syndrome associated with quetiapine treatment.
Slovenian: Vendar je CHMP priporočil, da se to opozorilo prestavi na pomembnejše mesto v tem poglavju, da se poveča ozaveščenost o tveganju za razvoj presnovnega sindroma, povezanega z zdravljenjem s kvetiapinom.
English: The warning on cardiomyopathy and myocarditis was included through a type II variation, which was finalised during the assessment of this referral procedure under Article 30 from Directive 2001/83/EC started.
Slovenian: Opozorilo za kardiomiopatijo in miokarditis je bilo vključeno po spremembi tipa II, ki je bila dokončana med začetkom ocene tega napotitvenega postopka v skladu s členom 30 Direktive 2001/83/ES.
English: Considering that the MAH had already committed to submit a cumulative review on hepatic effects within the PSUR in September 2014, the CHMP agreed that a harmonised wording in regard of hepatic effects should be assessed and agreed upon in the upcoming PSUR.
Slovenian: Ker se je imetnik dovoljenja za promet z zdravilom že obvezal, da bo predložil kumulativni pregled učinkov na jetra v okviru poročila PSUR septembra 2014, se je CHMP strinjal, da je treba oceniti usklajeno besedilo glede učinkov na jetra ter ga sprejeti v prihodnjem poročilu PSUR.
English: Section 4.4 - Special warnings and precautions for use Metabolic risk
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Presnovno tveganje
English: Quetiapine is an atypical antipsychotic agent, which together with its active metabolitenorquetiapine - interacts with a broad range of neurotransmitter receptors including serotonin 5hydroxytryptophan type 2 (5HT2A), dopamine type 1 and type 2 (D1, D2), histamine and adrenergic receptors (greatly α1).
Slovenian: Kvetiapin je atipični antipsihotik, ki skupaj s svojim aktivnim presnovkom norkvetiapinom medsebojno deluje na več nevrotransmiterskih receptorjev, kot so serotonin 5-hidroksitriptofan tipa 2 (5HT2A), dopamin tipa 1 in 2 (D1, D2), histamin in adrenergični receptorji (večinoma α1).
English: A simple extrapolation from schizophrenia trials to other psychosis is not encouraged by the Guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia (EMA/CHMP/40072/2010 Rev. 1).
Slovenian: Smernice za klinične preiskave zdravil, vključno z depotnimi pripravki pri zdravljenju shizofrenije, ne podpirajo preproste ekstrapolacije iz preskušanj shizofrenije na druge psihoze (EMA/CHMP/40072/2010 Rev. 1).
English: The exact mechanism of action of quetiapine, similarly with other antipsychotics, is still unknown, but the combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2 receptors may contribute to its psychotropic activity and mood stabilizing properties.
Slovenian: Natančen mehanizem delovanja kvetiapina je, podobno kot pri drugih antipsihotikih, še vedno neznan, vendar lahko kombinacija antagonističnega delovanja na receptorje in večje selektivnosti za receptorje 5HT2 v primerjavi z receptorji D2 prispeva k psihotropnemu delovanju in stabilizaciji razpoloženja.
English: Therefore, the following wording was added “Patients with intestinal obstruction / ileus should be managed with close monitoring and urgent care”.
Slovenian: Zato je bilo dodano besedilo „Bolnike z intestinalno obstrukcijo/ileusom je treba skrbno spremljati in jim zagotoviti nujno oskrbo“.
English: Although there were no major divergences in the wording, a more concise text concerning cardiovascular to prevent redundancy was agreed aiming specific product information for the prescriber instead of common knowledge on symptoms and consequences of orthostatic hypotension.
Slovenian: Čeprav ni bilo večjih razhajanj med besedili, so sprejeli bolj strnjeno besedilo glede srčnožilnih bolezni, da se prepreči redundanca in s tem zagotovi specifične informacije o zdravilu za zdravnika, ki predpisuje to zdravilo, namesto splošnega znanja o simptomih in posledicah ortostatske hipotenzije.
English: This section was updated in format of the adverse reactions listed according to the QRD template.
Slovenian: To poglavje je bilo posodobljeno v obliki neželenih učinkov, navedenih v skladu s predlogo QRD.
English: In four MSs the wording “moderate to severe” was missing in the therapeutic indication.
Slovenian: Pri štirih državah članicah je v terapevtskih indikacijah manjkalo besedilo „zmernih do hudih“.
English: The pivotal clinical studies for this indication were conducted in a patient population having moderate to severe manic episodes in bipolar disorder.
Slovenian: Ključne klinične študije za to indikacijo so bile izvedene pri populaciji bolnikov z zmernimi do hudimi maničnimi epizodami pri bipolarni motnji.
English: The CHMP agreed that this warning included redundant information regarding orthostatic hypotension and related dizziness, since it repeated information already included under subheading on Cardiovascular (now Orthostatic hypotension).
Slovenian: CHMP se je strinjal, da to opozorilo vključuje nepotrebne informacije o ortostatski hipotenziji in povezani omotici, saj so ponovljene informacije že vključene pod podnaslovom Srčnožilne bolezni (zdaj Ortostatska hipotenzija).
English: The CHMP commented on the wording namely on the affinity for serotonin 5HT1A and for norepinephrine transporter (NET) due to the current limited available data in this regard.
Slovenian: CHMP je podal svoj komentar na besedilo glede afinitete za serotonin 5HT1A in prenašalec norepinefrina zaradi trenutno omejenih razpoložljivih podatkov.
English: • The committee reviewed the data submitted by the MAH on the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the product information
Slovenian: • odbor je pregledal podatke iz obstoječih kliničnih študij, farmakovigilančne podatke in podatke iz objavljene literature, ki jih je predložil imetnik dovoljenja za promet z zdravilom in ki utemeljujejo predlagano uskladitev informacij o zdravilu;
English: The proposed wording was fully endorsed by the CHMP.
Slovenian: CHMP se je v celoti strinjal s predlaganim besedilom.
English: The wording approved by the variation as follows: “Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established.
Slovenian: Besedilo, odobreno s spremembo, je naslednje: „Kardiomiopatijo in miokarditis so zabeležili v kliničnih preskušanjih in v izkušnjah v obdobju trženja, vendar vzročne zveze s kvetiapinom niso ugotovili.
English: The indication “major depressive episodes” in the MRP SmPC was approved on November 2008 when the indication for bipolar depression was first approved.
Slovenian: Indikacija „velikih depresivnih epizod“ v povzetku glavnih značilnosti zdravila, odobrenem s postopkom z medsebojnim priznavanjem, je bila odobrena novembra 2008 ob prvi odobritvi indikacije za bipolarno depresijo.
English: The proposed wording was in line with the current guidance and a clear distinction could be made between the data relevant for the first trimester (potential for congenital abnormalities) and the third trimester (neonatal withdrawal effects).
Slovenian: Predlagano besedilo je bilo v skladu s trenutnimi smernicami in jasno so bili ločeni podatki, pomembni za prvo trimesečje (potencial za prirojene anomalije) in tretje trimesečje (odtegnitveni simptomi pri novorojenčkih).
English: It is approved via national, mutual recognition (MRP) or decentralised procedures (DCP).
Slovenian: Zdravilo je bilo odobreno z nacionalnimi postopki, postopki z medsebojnim priznavanjem ali decentraliziranimi postopki.