FrancophonIA/ELRC3.0 huggingface dataset:
English: A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Do pandemije gripe pride, ko se novi sev virusa gripe med ljudmi hitro širi, ker nanj niso imuni (zaščiteni).
English: How does Foclivia work?
Slovenian: Kako zdravilo Foclivia deluje?
English: Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease.
Slovenian: Cepivo Foclivia vsebuje nekaj delov virusa H5N1.
English: Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*: A/California/7/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
Slovenian: A/California/07/2009 (H1N1)v 7,5 mikrograma** na odmerek 0,5 ml * razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora) ** izraženo v mikrogramih hemaglutinina o č
English: Intramuscular use vial (glass) 0.5 ml
Slovenian: Intramuskularna uporaba viala (iz stekla)
English: Invented name Strength Pharmaceutical Form
Slovenian: Izmišljeno ime
English: The CHMP also looked at other small studies.
Slovenian: CHMP je obravnaval tudi druge manjše študije.
English: The 27-year post-marketing period offers a long period of safety profile surveillance.
Slovenian: Varnost 27-letno postmarketinško obdobje predstavlja dolgo obdobje spremljanja varnostnega profila.
English: It was first authorised in 1979 and is currently authorised in the EU in Belgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.
Slovenian: Prvič je bilo odobreno leta 1979 in je trenutno odobreno v EU v Belgiji, Franciji, Italiji, Luksemburgu in na Portugalskem pod imeni Agreal in Agradil.
English: Until June 2005, veralipride was authorised in Spain.
Slovenian: Do junija 2005 je bil veraliprid odobren v Španiji.
English: Few data are available beyond 3 months, mostly in non comparative studies.
Slovenian: Za obdobje, daljše od 3 mesecev, je na voljo malo podatkov, večinoma iz neprimerjalnih študij.
English: In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk;
Slovenian: Nadalje je Odbor menil, da predlagane aktivnosti za minimaliziranje tveganja ne morejo zmanjšati tveganja na sprejemljivo raven ali napovedati, katere ženske utegnejo biti ogrožene;
English: In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
Slovenian: V tem pregledu je CHMP ovrednotil vse razpoložljive informacije o varnosti in učinkovitosti veraliprida.
English: Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edifício 72º e 3º Porto Salvo
Slovenian: Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edificio 7 - 2° e 3° Porto Salvo
English: This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
Slovenian: Te so obsegale predvsem 11 študij, ki so vključevale približno 600 žensk in v katerih so veraliprid primerjali s placebom, ter dve študiji s približno 100 ženskami, v katerih so ga primerjali s konjugiranimi estrogeni.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing veralipride
Slovenian: • Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, z vsemi spremembami, za zdravila, ki vsebujejo veraliprid;
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO VERALIPRID (glejte Dodatek I)
English: In addition, some of these side effects can occur not only during treatment, but also after it is stopped and it is also impossible to predict which women may be at risk.
Slovenian: Nadalje lahko nekateri izmed teh učinkov nastopijo ne le med zdravljenjem, temveč tudi ko je le-to prekinjeno, poleg tega pa je nemogoče napovedati, katere ženske so ogrožene.
English: Most of them occurred beyond 3 months of treatment.
Slovenian: Večina med njimi je nastopila po 3 mesecih zdravljenja.
English: Spain therefore withdrew veralipride's marketing authorisation on 27 June 2005.
Slovenian: Španija je iz tega razloga dne 27. junija 2005 umaknila dovoljenje za promet za veraliprid.
English: It should be noted that in the evaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride is not always clear.
Slovenian: Omeniti je treba, da pri vrednotenju vzročnosti veraliprida v psihiatričnih dogodkih vloga veraliprida ni vedno jasna.
English: It has to be noted that tardive dyskinesias are not predictable and can develop even after the treatment has been discontinued.
Slovenian: Omeniti je treba, da tardivnih diskinezij ni mogoče napovedovati in se utegnejo razviti celo po prekinitvi zdravljenja.
English: The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
Slovenian: Odsotnost primerov sugestivnega podaljšanja QT v bazi podatkov ne zadošča za sklep, da ta učinek pri veralipridu ne nastopa.
English: In addition, the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Slovenian: Poleg tega je bilo trajanje študij prekratko, da bi dopuščalo ustrezno oceno vzdrževanja učinkovitosti.
English: No studies were performed to evaluate whether veralipride has an effect on QT.
Slovenian: Za ovrednotenje, ali veraliprid vpliva na QT, ni bila izvedena nobena študija.
English: In addition, hyperprolactinemia and the risk of QT prolongation are also concerns;
Slovenian: Nadalje predstavljata pomislek tudi hiperprolaktinemija in tveganje za podaljšanje QT;
English: Following reports of serious side effects affecting the nervous system, the Spanish National Competent Authority concluded that its benefits did not outweigh its potential risks.
Slovenian: Zaradi poročil o resnih neželenih učinkih, ki prizadenejo živčni sistem, je pristojni španski nacionalni organ sklenil, da njegove koristi ne odtehtajo potencialnih tveganj.
English: -Introduction of the contraindications in patients with Parkinson's disease, or in combination with other neuroleptics and dopaminergic agonists.
Slovenian: -Vključitev kontraindikacij za bolnike s Parkinsonovo boleznijo ali v kombinaciji z drugimi nevroleptiki in dopaminergičnimi agonisti.
English: However, cases of tardive dyskinesia have also been reported within the first 3 months of treatment.
Slovenian: Vendar pa so o primerih tardivne diskinezije poročali tudi v prvih 3 mesecih zdravljenja.
English: Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/risk assessment of veralipride.
Slovenian: Zaradi tega je Evropska komisija 7. septembra 2006 sprožila napotitveni postopek in zaprosila CHMP za mnenje, ali naj se dovoljenje za promet z izdelki, ki vsebujejo veraliprid, ohrani, spremeni, zacasno preklice ali umakne po vsej Evropski uniji v skladu z oceno z njimi povezanih tveganj in oceno razmerja med koristmi in tveganji zdravila veraliprid.
English: The proposal of close monitoring including neurological examination after each 20 day treatment cycle might reduce these risks, but is a measure of considerable burden to both patient and doctor.
Slovenian: Skrbno spremljanje, vključno z nevrološkim pregledom po vsakem 20-dnevnem ciklu zdravljenja, bi utegnilo zmanjšati ta tveganja, vendar pa predstavlja tak ukrep znatno obremenitev tako za bolnika kot zdravnika.
English: But the effect of hyperprolactinemia in women with history of breast cancer is not elucidated.
Slovenian: Vendar pa učinek hiperprolaktinemije pri ženskah z rakom dojke v anamnezi ni pojasnjen.
English: The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Slovenian: Njegovo korist je mogoče označiti kot omejeno, vendar pa obsega učinka zaradi metodoloških pomanjkljivosti razpoložljivih študij (v večini primerov npr. izhodiščne vrednosti niso bile navedene, kar onemogoča ustrezno oceno ugotovljenega izboljšanja; ne statističnega ne kliničnega pomena tega obsega učinka ni bilo mogoče točno ovrednotiti, saj statistični načrt ni bil jasen ali ni obstajal; predstavitev rezultatov je bila slaba) ni mogoče točno ovrednotiti.
English: Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c, B-1831 Diegem
Slovenian: Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c
English: Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride's product information was restricted with the aim to reduce the risk of patients developing side effects.
Slovenian: Zakonski ukrepi so bili sprejeti tudi v nekaterih drugih državah članicah EU, v katerih je izdelek odobren, tako da bile z namenom, da bi zmanjšali tveganje za pojav neželenih učinkov pri bolnikih, informacije o izdelku zaostrene.
English: However, tardive dyskinesia may still occur within the first 3 months of treatment.
Slovenian: Vendar pa lahko tardivna diskinezija še vedno nastopi v prvih 3 mesecih zdravljenja.
English: As for the other adverse events related with the blockage of the dopamine receptor, especially hyperprolactinemia is a concern.
Slovenian: Glede drugih neželenih učinkov, povezanih z blokado dopaminskega receptorja, je glavni pomislek zlasti hiperprolaktinemija.
English: -Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
Slovenian: -Omejitev trajanja zdravljenja na 3 mesece v kombinaciji z mesečnimi pregledi, da bi tako omejili psihiatrične in nevrološke neželene učinke.
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, POT UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: The CHMP therefore concluded on 19 July 2007 that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Slovenian: CHMP je zato 19. julija 2007 zaključil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo veraliprid, pri normalnih pogojih uporabe ni pozitivno.
English: In addition, the effect size cannot be accurately quantified due to methodological shortcomings and the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Slovenian: Obsega učinka tudi ni mogoče točno ovrednotiti zaradi metodoloških pomanjkljivosti, trajanje študij pa je bilo prekratko, da bi dopuščalo ustrezno oceno vzdrževanja učinkovitosti.
English: The CHMP took note of the MAH's proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
Slovenian: CHMP se je seznanil s predlogi imetnika dovoljenja za promet z zdravilom, med katerimi so bili nekateri v nekaterih državah že uvedeni, da bi tako zmanjšali ta tveganja.
English: Therefore, the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing veralipride throughout Europe.
Slovenian: Posledično je CHMP predlagal umik vseh dovoljenj za promet z zdravili, ki vsebujejo veraliprid, po celi Evropi.
English: Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
Slovenian: Podaljšanje QT je učinek, značilen za cel razred dopaminskih antagonistov.
English: The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
Slovenian: Predlagano intermitentno zdravljenje, trajajoče 20 dni, ki mu sledi 10 dnevno obdobje nezdravljenja, utegne zmanjšati ta vpliv na raven prolaktina, vendar pa ni znano, ali ima ta ukrep kakršenkoli vpliv na vzorec neželenih učinkov.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: -Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
Slovenian: -Priporočilo za zdravniške preglede dojk in intermitentno shemo (20 dni zdravljenja, ki mu sledi 10 dnevno obdobje nezdravljenja), da bi tako zmanjšali tveganje za hiperprolaktinemijo, vse z namenom izboljšanja varnosti za zdravje dojk (vendar pa ni znano, ali ima ta ukrep kakšen vpliv na opažen vzorec neželenih učinkov v zvezi z hiperprolaktinemijo kot so povečanje dojk, galaktoreja in tveganje za paciente s tumorji, odvisnimi od prolaktina, kot so prolaktinom hipofize ali rak dojke.
English: Overall, the restriction to limit the use of veralipride to 3 months in combination with monthly medical neurological examinations and breast monitoring is not considered adequate to limit the risk of all adverse effects reported with veralipride and adequately treat the vasomotor symptoms associated with the menopause.
Slovenian: Celostno gledano, omejitev uporabe veraliprida do največ 3 mesece v kombinaciji z mesečnimi zdravniškimi nevrološkimi pregledi in pregledi dojk ni bila ocenjena kot zadostna za omejitev tveganja za pojav vseh neželenih učinkov, o katerih so poročali pri uporabi veraliprida, in za ustrezno zdravljenje vazomotornih simptomov, povezanih z menopavzo.
English: The CHMP has recommended the withdrawal of the Marketing Authorisations for the medicinal products containing veralipride referred to in Annex I.
Slovenian: CHMP je predlagal umik dovoljenj za promet z zdravili, ki vsebujejo veraliprid, omenjenih v Dodatku I.
English: • The Committee, as a consequence, concluded that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Slovenian: • Odbor je posledično zaključil, da razmerje med tveganji in koristmi zdravil, vsebujočih veraliprid, pri normalnih pogojih uporabe ni pozitivno.
English: In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Slovenian: Z ozirom na razpoložljive klinične podatke je CHMP zaključil, da tveganja, povezana z uporabo veraliprida za zdravljenje navalov vročice, ki so povezani z menopavzo, zlasti nevrološke reakcije (diskinezija, ekstrapiramidalni zaplet, Parkinsonov sindrom) in psihiatrične reakcije (depresija, anksioznost, sindrom odtegnitve) presegajo omejene koristi.
English: In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAH proposed a maximally allowed duration of 3 months veralipride treatment.
Slovenian: Da bi preprečil psihiatrične neželene učinke, ekstrapiramidalne simptome in tardivno diskinezijo, je imetnik dovoljenja za promet predlagal najdaljše dopustno trajanje zdravljenja z veralipridom 3 mesece.
English: Sanofi-Synthelabo S.P.A. via Messina, 38
Slovenian: via Messina, 38
English: -Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
Slovenian: -Vključitev opozorila glede učinkov, značilnih za cel razred nevroleptikov (nevroleptični maligni sindrom, podaljšanje QT, tardivna diskinezija), in simptomov odtegnitve, kot so anksioznost in depresivni sindrom.
English: • The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause;
Slovenian: • Odbor je bil mnenja, da zdravila, ki vsebujejo veraliprid, izkazujejo le omejeno učinkovitost pri zdravljenju navalov vročice, povezanih z menopavzo;
English: • The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
Slovenian: • Z ozirom na razpoložljive klinične podatke je Odbor zaključil, da tveganja, povezana z uporabo veraliprida pri zdravljenju navalov vročice, ki so povezani z menopavzo, presegajo omejene koristi.
English: Veralipride treatment is contra-indicated in patients with prolactindependent tumours such as pituitary gland prolactinoma and breast cancer.
Slovenian: Zdravljenje z veralipridom je kontraindicirano pri bolnikih s tumorji, odvisnimi od prolaktina, kot so prolaktinom hipofize ali rak dojke.
English: Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
Slovenian: Veraliprid je benzamidno nevroleptično zdravilo, indicirano za zdravljenje vazomotoričnih simptomov, povezanih z menopavzo.
English: Neurological adverse events referred to extrapyramidal symptoms and particularly tardive dyskinesias have been reported with veralipride and represent a real concern due to their potential seriousness and irreversibility.
Slovenian: Pri uporabi veraliprida so poročali o nevroloških neželenih učinkih, nanašajočih se na ekstrapiramidalne simptome in zlasti tardivne diskinezije, ki predstavljajo realen pomislek zaradi njihove potencialne resnosti in nepovratnosti.
English: Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QTprolongation are considered a concern.
Slovenian: V povezavi z zdravljenjem z veralipridom so poročali o primerih nenapovedljive in potencialno nepovratne tardivne diskinezije, kakor tudi o zgodnjih ekstrapiramidalnih simptomih, depresiji, anksioznosti in sindromu odtegnitve; ta tveganja skupaj s tveganjem za hiperprolaktinemijo ter za podaljšanje QT, ki je značilno za celoten razred teh zdravil, so ocenjena kot zadržek.
English: • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
Slovenian: • Odbor je ugotovil, da so pri uporabi veraliprida poročali o nevroloških reakcijah (diskineziji, ekstrapiramidalnem zapletu, Parkinsonovem sindromu) in psihiatričnih reakcijah (depresiji, anksioznosti, sindromu odtegnitve), vključno s tardivno diskinezijo, ki je potencialno lahko nepovratna.
English: The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
Slovenian: CHMP je zaključil, da predloženi podatki izkazujejo zgolj omejen učinek veraliprida pri zdravljenju vazomotoričnih simptomov, povezanih z menopavzo.
English: Member State Marketing Authorisation Holder
Slovenian: PODLAGA ZA UMIK DOVOLJENJA ZA PROMET
English: Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
Slovenian: Na podlagi predloženih podatkov je videti, da ima veraliprid določen učinek pri zdravljenju vazomotoričnih simptomov, povezanih z menopavzo.
English: Psychiatric adverse events mainly referred to depressive and anxiety states have also been reported with veralipride.
Slovenian: Ravno tako so pri uporabi veraliprida poročali o psihiatričnih neželenih učinkih, nanašajočih se na depresivna in anksiozna stanja.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory
Slovenian: Zdravnike in bolnike je potrebno obvestiti, da je na razpolago za ta namen posvetovalna služba za posredovanje informacij o laboratorijskem testiranju plazemskih vrednosti leflunomida.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Slovenian: • O ugotovljenem tveganju za sinergistično hepatotoksičnost ali hematotoksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (DMARDdisease-modifying antirheumatic drug) (na primer metotreksat).
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide Teva with a physician educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo poskrbel, da bodo vsi zdravniki, ki bi lahko predpisovali zdravilo Leflunomid Teva dobili izobraževalno gradivo, ki vsebuje:
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of
Slovenian: Informacije v navodilu za zdravnika morajo vsebovati podatke o prilagajanju odmerka, prenehanju zdravljenja in postopkih izločanja učinkovine v primeru povišanih vrednosti ALT.
English: • The Summary of Product Characteristics • Physician Leaflet
Slovenian: • Povzetek glavnih značilnosti zdravila • Navodilo za zdravnika.
English: Treatment lasted between six months and a year.
Slovenian: Zdravljenje je trajalo od šest mesecev do enega leta.
English: The exact way that they work in treating viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Slovenian: Natančen način njihovega delovanja pri zdravljenju virusnih boleznih ni v celoti znan, vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema).
English: The company presented the results of two main studies involving a total of 2,255 adults with hepatitis C infection who had not previously been treated.
Slovenian: Družba je predstavila rezultate dveh glavnih študij, ki sta vključevali skupaj 2 255 odraslih, okuženih s hepatitisom C, ki pred tem še niso bili zdravljeni.
English: The effects of Joulferon were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Joulferon so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: It was to be available as an injection pen and as vials.
Slovenian: Na voljo naj bi bilo kot injekcijski peresnik in viale.