FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP recommends the suspension of the marketing authorisations for nicotinic acid/laropiprant (see Annex A).
Slovenian: V skladu z določbami iz člena 20 Uredbe (ES) št. 726/2004 je CHMP priporočil začasni umik dovoljenja za promet z nikotinsko kislino/laropiprantom (glejte Prilogo A).
English: Although the population studied in HPS2-THRIVE was not selected based on high LDL cholesterol levels, the safety results observed in the 25,673 patients were considered to be of relevance to the current approved indication as there is no evidence to suggest that patients currently indicated for treatment with nicotinic acid/laropiprant would be protected from the adverse events observed in
Slovenian: Čeprav populacija bolnikov, vključena v študijo HPS2-THRIVE, ni bila izbrana na podlagi visokih ravni holesterola LDL, so bili rezultati o varnosti, opaženi pri 25 673 bolnikih, pomembni za trenutno odobreno indikacijo, saj ni dokazov, ki bi potrdili, da bolniki, za zdravljenje katerih je trenutno indicirana nikotinska kislina/laropiprant, ne bi bili izpostavljeni neželenim dogodkom, ki so jih opazili v študiji HPS2-THRIVE.
English: Important missing information, such as the effects of long-term exposure, bleeding and thrombotic cardiovascular events was expected to be clarified through routine pharmacovigilance and through monitoring of patients in clinical trials, in particular the HPS2-THRIVE study.
Slovenian: Pričakovano je bilo, da bodo pomembne manjkajoče informacije, na primer glede učinkov pri dolgotrajni izpostavljenosti, krvavitev in trombotičnih kardiovaskularnih dogodkov, pridobili z rednimi farmakovigilančnimi dejavnostmi in opazovanjem bolnikov v kliničnih preskušanjih, zlasti v študiji HPS2-THRIVE.
English: • The CHMP considered the totality of the data available for laropiprant/nicotinic acid, including the emerging preliminary data from the HPS2-THRIVE study, which was not available at the time of the original marketing authorisation, the MAH responses, the PRAC assessment and the discussions within the CHMP,
Slovenian: • da je CHMP upošteval vse podatke, ki so na voljo za laropiprant/nikotinsko kislino, vključno z novimi predhodnimi podatki iz študije HPS2-THRIVE, ki niso bili na voljo v času prvotne odobritve dovoljenja za promet, odgovore imetnika dovoljenja za promet z zdravilom, oceno odbora PRAC in razprave v odboru CHMP;
English: The PRAC concluded that data from the HPS2-THRIVE study has confirmed the previously known safety profile of nicotinic acid/laropiprant and additionally revealed new safety concerns.
Slovenian: PRAC je zaključil, da so podatki iz študije HPS2-THRIVE potrdili že znan varnostni profil nikotinske kisline/laropipranta in dodatno razkrili nove pomisleke glede varnosti.
English: This increase was driven by differences observed in the system organ class blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin, which all favoured placebo.
Slovenian: Na povečanje so močno vplivale razlike, opažene v organskih sistemih kri in limfatični sistem, prebavila, infekcijske bolezni, presnovne motnje, mišično-skeletni sistem, dihala in koža, ki so bile vse v korist placeba.
English: Identified risks were reflected in the product information and the risk management plan and included myopathy, glucose intolerance and abnormal liver function.
Slovenian: Ugotovljena tveganja so bila vključena v informacije o zdravilu in načrt za obvladovanje tveganja in so vključevala miopatijo, intoleranco za glukozo in motnje v delovanju jeter.
English: Having noted all of the above, the CHMP considers that the benefit-risk balance for nicotinic acid/laropiprant is not favourable in the approved indication and recommends the suspension of the marketing authorisation of the products containing laropiprant/nicotinic acid.
Slovenian: Ob upoštevanju vsega navedenega je CHMP menil, da razmerje med tveganji in koristmi za nikotinsko kislino/laropiprant ni ugodno za odobreno indikacijo, in je priporočil začasni umik dovoljenja za promet z zdravili, ki vsebujejo laropiprant/nikotinsko kislino.
English: In addition, the failure of the HPS2-THRIVE study to meet the primary efficacy endpoints raised serious concerns regarding the efficacy of nicotinic acid/laropiprant in the indicated patient population, as overlap between this and the study populations is expected.
Slovenian: Poleg tega so se zaradi dejstva, da študija HPS2-THRIVE ni dosegla primarnega cilja učinkovitosti, pojavili resni pomisleki glede učinkovitosti nikotinske kisline/laropipranta pri indicirani populaciji bolnikov, saj naj bi omenjena populacija sovpadala s populacijo v študiji.
English: The studies were not designed to evaluate cardiac effects but it was noted that serious cardiac disorders occurred more often in the nicotinic acid/laropiprant group compared to placebo.
Slovenian: Študije niso bile zasnovane za oceno učinkov na srce, vendar pa so opazili, da so se v skupini, ki je prejemala nikotinsko kislino/laropiprant, pogosteje pojavila resna srčna obolenja v primerjavi s skupino, ki je prejemala placebo.
English: Based on the known safety profile of the product, some adverse events were expected, such as elevations in transaminases, myopathy, some skin and gastrointestinal events and impaired glucose tolerance.
Slovenian: Na podlagi znanega varnostnega profila zdravila so bili pričakovani nekateri neželeni dogodki, na primer porast transaminaz, miopatija, nekateri neželeni dogodki, povezani s kožo in prebavili, ter motena toleranca za glukozo.
English: Considering the lack of clinically relevant efficacy and the negative safety profile (including the newly identified serious safety concerns) associated with the use of nicotinic acid/laropiprant, the PRAC considered that the benefit-risk balance has shifted towards a negative balance.
Slovenian: PRAC je upošteval pomanjkanje klinično pomembne učinkovitosti in negativen varnostni profil (vključno z novimi resnimi pomisleki glede varnosti), povezan z uporabo nikotinske kisline/laropipranta, in je menil, da je razmerje med tveganji in koristmi postalo negativno.
English: As part of the pharmacovigilance activities included in the adopted risk management plan, the marketing authorization holder (MAH) agreed to report on a randomised clinical study (HPS2-THRIVE1) designed to assess the incremental benefit of nicotinic acid/laropiprant versus placebo as add-on to simvastatin 40mg, with or without ezetimibe.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal, da bo v sklopu farmakovigilančnih dejavnosti, vključenih v načrt za obvladovanje tveganja, poročal o rezultatih randomizirane klinične študije (HPS2THRIVE1), namenjene oceni dodatnih koristi nikotinske kisline/laropipranta, ki se dodajata simvastatinu 40 mg, z ezetimibom ali brez njega, v primerjavi s placebom.
English: • The CHMP considered that the failure of the HPS2-THRIVE study to meet the primary efficacy endpoints raises serious concerns regarding the efficacy of laropiprant/nicotinic acid,
Slovenian: • da je CHMP menil, da zaradi dejstva, da študija HPS2-THRIVE ni dosegla primarnega cilja učinkovitosti, obstajajo resni pomisleki glede učinkovitosti laropipranta/nikotinske kisline;
English: • The CHMP therefore considered that a patient population in which nicotinic acid/laropiprant has a clear favourable benefit-risk cannot be identified based on the current data.
Slovenian: • je CHMP menil, da na podlagi trenutno razpoložljivih podatkov ni mogoče opredeliti populacije bolnikov, pri kateri ima nikotinska kislina/laropiprant jasno ugodno razmerje med tveganji in koristmi.
English: The risk of blood and lymphatic disorders was greater in the study drug group compared to the placebo group.
Slovenian: Tveganje za pojav bolezni krvi in limfatičnega sistema je bilo večje v skupini, ki je prejemala preskušano zdravilo, kot v skupini, ki je prejemala placebo.
English: • The CHMP concluded that the statistically significant increase in the incidence of serious adverse events observed in the nicotinic acid/laropiprant group compared to the placebo group of the HPS2-THRIVE study raises serious concerns,
Slovenian: • da je CHMP zaključil, da obstajajo resni zadržki zaradi statistično pomembnega povečanja pojava resnih neželenih dogodkov, ki so ga v študiji HPS2-THRIVE opazili v skupini, ki je prejemala nikotinsko kislino/laropiprant, v primerjavi s skupino, ki je prejemala placebo;
English: However, the new unexpected higher incidence of bleeding and infections in the study drug group compared to the placebo group was of concern.
Slovenian: Vendar pa je bil nov in nepričakovan pogostejši pojav krvavitev in okužb v skupini, ki je prejemala preskušano zdravilo, v primerjavi s
English: The CHMP therefore concluded that the benefit-risk balance of nicotinic acid/laropiprant is affected adversely by the results from the HPS2-THRIVE study and is considered no longer favourable.
Slovenian: Zato je CHMP zaključil, da so rezultati študije HPS2-THRIVE negativno vplivali na razmerje med tveganji in koristmi nikotinske kisline/laropipranta in da je razmerje postalo neugodno.
English: There was a statistically significant increase in the incidence of non-fatal serious adverse events in the nicotinic acid/laropiprant (study drug) group compared to the placebo group.
Slovenian: V skupini, ki je prejemala nikotinsko kislino/laropiprant (preiskovano zdravilo), se je statistično pomembno povečala pojavnost resnih neželenih dogodkov brez smrtnega izida v primerjavi s skupino, ki je prejemala placebo.
English: For the suspension to be lifted, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study.
Slovenian: Za preklic začasnega umika mora imetnik dovoljenja za promet z zdravilom predložiti prepričljive podatke za opredelitev populacije bolnikov, pri kateri se lahko dokaže učinkovitost nikotinske kisline/laropipranta in pri kateri koristi jasno odtehtajo tveganja, vključno z novimi tveganji, ki jih je razkrila študija HPS2-THRIVE.
English: To lift the suspension, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study (see Annex II).
Slovenian: Za preklic začasnega umika dovoljenja mora imetnik dovoljenja za promet z zdravilom predložiti prepričljive podatke za opredelitev populacije bolnikov, pri kateri se lahko dokaže učinkovitost nikotinske kisline/laropipranta in pri kateri koristi jasno odtehtajo tveganja, vključno z novimi tveganji, ki jih je razkrila študija HPS2-THRIVE (glejte Prilogo II).
English: Over the 3.9 years median follow-up, treatment with nicotinic acid/laropiprant compared to placebo did not achieve its primary endpoint.
Slovenian: V medianem času spremljanja 3,9 let zdravljenje z nikotinsko kislino/laropiprantom, ki je bilo primerjano s placebom, ni doseglo primarnega cilja.Zato je PRAC menil, da rezultati niso pokazali dodatne učinkovitosti nikotinske kisline/laropipranta kot dodatnega zdravljenja k statinom v smislu kardiovaskularnega izida.
English: Paroxetine
Slovenian: paroksetin
English: The final opinion was converted into a Decision by the European Commission on 29 March 2005.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 29. marca 2005.
English: BACKGROUND INFORMATION*
Slovenian: OSNOVNE INFORMACIJE*
English: International Non-Proprietary Name (INN): paroxetine
Slovenian: Mednarodno nelastniško ime (INN): paroksetin
English: The referral procedure started on 26 June 2003.
Slovenian: Napotitveni postopek se je začel 26. junija 2003.
English: Written explanations were provided by the Marketing Authorisation Holder by 1 September 2003, 13 February 2004, 2 April 2004 and 16 April 2004.
Slovenian: Pisne obrazložitve je imetnik dovoljenja za promet predložil do 1. septembra 2003, 13. februarja 2004, 2.aprila 2004 in 16. aprila 2004.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 31 REFERRAL
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 31
English: Paroxetine was first approved in 1990 as an antidepressant in the U.K.
Slovenian: Paroksetin so prvič odobrili leta 1990 v Združenem kraljestvu kot antidepresiv.
English: Oral explanations were given on 20 April
Slovenian: Ustna obrazložitev je bila podana dne 20. aprila 2004.
English: Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 8 December 2004.
Slovenian: * Opombe: Informacije, podane v tem dokumentu in Dodatkih, odražajo samo mnenje CHMP datirano z 8. decembrom 2004.
English: On 13 June 2003, UK referred the matter to the EMEA under Article Article 31 of Directive 2001/83/EC, as amended, for paroxetine containing medicinal products.
Slovenian: Dne 13. junija 2003 je Združeno kraljestvo napotilo zadevo na EMEA po 31. členu Direktive 2001/83/ES, kot je bila dopolnjena, za zdravila, vsebujoča paroksetin.
English: Paroxetine containing medicinal products are approved for the treatment of:
Slovenian: Zdravila, vsebujoča paroksetin, so odobrena za zdravljenje:
English: Paroxetine is a phenylpiperidine derivative and is a selective inhibitor of the presynaptic 5hydroxytryptamine (5-HT) reuptake.
Slovenian: Paroksetin je fenilpiperidinski derivat ter selektivni zaviralec presinaptičnega ponovnega privzema 5hidroksitriptamina (5-HT).
English: 29 March 2005 CHMP/187488/2004
Slovenian: 29. marec 2005 CHMP/187488/2004
English: For more information please refer to: http://www.emea.eu.int/pdfs/human/referral/SSRIs/29783705en.pdf http://www.emea.eu.int/pdfs/human/referral/SSRIs/EMEA-H-A-31-651-SSRIs-en.pdf
Slovenian: Za dodatne informacije glejte: http://www.emea.eu.int/pdfs/human/referral/SSRIs/29783705en.pdf http://www.emea.eu.int/pdfs/human/referral/SSRIs/EMEA-H-A-31-651-SSRIs-en.pdf
English: - Panic disorder with and without agoraphobia
Slovenian: - panične motnje z agorafobijo ali brez nje
English: The reasons for referral concerned the risk of emotional lability, including hostility and suicidal behaviour in children and adolescents and withdrawal reactions with paroxetine.
Slovenian: Razlog za napotilo je bilo tveganje za čustveno labilnost, vključujoč sovražno in samomorilno vedenje pri otrocih in mladostnikih ter odtegnitvene reakcije, povezane s paroksetinom.
English: An updated warning in relation to children and adolescents was recommended to be included in the Product Information.
Slovenian: Priporočeno je bilo, da se v informacije o zdravilu vključi posodobljeno opozorilo v zvezi z otroki in mladostniki.
English: - Social anxiety disorders / social phobia
Slovenian: - motenj socialne anksioznosti/socialne fobije
English: Subsequently national Marketing Authorisations have been granted in all EU Member States for the treatment of various psychiatric disorders.
Slovenian: Kasneje je bil odobren za zdravljenje različnih duševnih motenj v vseh državah članicah EU.
English: The Rapporteur and Co-Rapporteur appointed were: Dr. F. Lekkerkerker and Dr. P. Arlett, respectively.
Slovenian: Poročevalec (Rapporteur) in so-poročevalec (Corapporteur) sta bila dr. F. Lekkerkerker in dr. P. Arlett.
English: Following the adoption of the CHMP Opinion for paroxetine, the CHMP further reviewed the risk of suicidal behaviour in children and adolescents treated with this type of medicines.
Slovenian: Po sprejetju mnenja CHMP o paroksetinu je CHMP še nadalje obravnaval tveganje za samomorilno vedenje pri otrocih in mladostnikih, zdravljenih s to vrsto zdravil.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III ter pogoji dovoljenja za promet z zdravilom v Dodatku IV.
English: - Post-traumatic stress disorder
Slovenian: - posttravmatske stresne motnje
English: Paroxetine inhibits the neuronal uptake of serotonin and thereby facilitates serotonergic transmission.
Slovenian: Paroksetin zavira privzem serotonina v nevrone in tako pospešuje serotonergično prevajanje.
English: During the referral procedure Dr. B. van Zwieten Boot took over the Rapporteurship from Dr. F. Lekkerkerker and Dr. F. Rotblat took over from Dr. P. Arlett.
Slovenian: Med samim postopkom je dr. B. van Zwieten Boot prevzela poročevalsko nalogo od dr. F. Lekkerkerkerja, dr. F. Rotblat pa je nadomestila dr. P. Arletta.
English: Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of paroxetine containing medicinal products remains favourable.
Slovenian: Na podlagi ovrednotenja razpoložljivih podatkov in na podlagi poročil o oceni zdravila (Rapporteurs' assesment reports), je CHMP menil, da razmerje med tveganji in koristmi za zdravila, vsebujoča paroksetin, ostaja ugodno.
English: - Obsessive compulsive disorder
Slovenian: - obsesivno kompulzivne motnje
English: - Major depressive episode
Slovenian: - velike depresivne epizode
English: The final CHMP opinion was adopted on 8 December 2004 recommending the variation of the Marketing Authorisations in accordance with the Summary of Product Characteristics for paroxetine containing medicinal products.
Slovenian: CHMP je mnenje sprejel dne 22. aprila 2004. 8. decembra 2004 pa je bilo sprejeto končno mnenje CHMP, ki priporoča spremembo dovoljenja za promet z zdravilom v skladu s Povzetkom glavnih značilnosti zdravila za zdravila, vsebujoča paroksetin.
English: - Generalised anxiety disorder
Slovenian: - motnje generalizirane anksioznosti
English: This summary was last updated in 09/2013.
Slovenian: Povzetek je bil nazadnje posodobljen 09/2013.
English: The main measure of effectiveness was the change in symptoms.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje simptomov.
English: The company will also carry out studies to confirm the long-term safety of the medicine.
Slovenian: Prav tako bo družba izvedla študije za potrditev dolgoročne varnosti zdravila.
English: The dose is 5 mg per kilogram for the other diseases.
Slovenian: Odmerek pri ostalih boleznih je 5 mg na kilogram.
English: Inflectra infliximab
Slovenian: Inflectra infliksimab
English: Some side effects, including infections, may be more common in children than in adults.
Slovenian: Nekateri neželeni učinki, vključno z okužbami, so lahko pogostejši pri otrocih kot pri odraslih.
English: The full EPAR for Inflectra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Inflectra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Inflectra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inflectra?
English: How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Slovenian: Kako pogosto je treba zdravljenje ponavljati, je odvisno od vrste zdravljene bolezni in bolnikovega odziva na zdravilo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inflectra on 10 September 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Inflectra, veljavno po vsej Evropski uniji, odobrila dne 10. septembra 2013.
English: This means that Inflectra is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Inflectra and the reference medicine contain the same active substance.
Slovenian: To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU), in vsebuje isto zdravilno učinkovino kot referenčno zdravilo.
English: It is not intended to provide practical advice on how to use Inflectra.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Slovenian: Za več informacij o biološko podobnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
English: This is a summary of the European public assessment report (EPAR) for Inflectra.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Inflectra.
English: Inflectra was compared with Remicade in one main study involving 606 adult patients with rheumatoid arthritis.
Slovenian: Zdravilo Inflectra so primerjali z zdravilom Remicade v eni glavni študiji, v katero je bilo vključenih 606 odraslih bolnikov z revmatoidnim artritisom.
English: Inflectra is also used in patients aged between six and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Slovenian: Zdravilo Inflectra se uporablja tudi pri bolnikih, starih od 6 do 17 let, s hudo aktivno Crohnovo boleznijo ali močno aktivnim ulceroznim kolitisom, ki se niso odzvali na druga zdravila ali zdravljenja ali pa jih ne smejo prejemati.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Inflectra or the infusion time may be slowed down.
Slovenian: Za zmanjšanje tveganja za pojav reakcij, povezanih z infundiranjem, lahko bolniki pred ali med zdravljenjem z zdravilom Inflectra prejmejo druga zdravila ali pa se upočasni hitrost infundiranja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Inflectra podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Remicade.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna določeno strukturo (imenovano antigen) v telesu in se veže nanjo.
English: The Committee recommended that Inflectra be approved for use in the EU.
Slovenian: Odbor je priporočil, da se zdravilo Inflectra odobri za uporabo v EU.
English: Inflectra is given as an infusion lasting one or two hours.
Slovenian: Zdravilo Inflectra se daje v obliki infuzije, ki traja eno ali dve uri.
English: The most common side effects with Inflectra (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Slovenian: Najpogostejši neželeni učinki zdravila Inflectra (ki lahko prizadenejo več kot 1 osebo od 10) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (prehladi), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu (bolečine v želodcu), reakcije, povezane z infundiranjem, in bolečine.