FrancophonIA/ELRC3.0 huggingface dataset:
English: Ear and labyrinth disorders
Slovenian: vključno z motnjami labirinta tinitus
English: How to take HETLIOZ
Slovenian: Kako jemati zdravilo HETLIOZ
English: In pregnant rabbits administered tasimelteon during the period of organogenesis, embryolethality and embryofoetal toxicity (reduced foetal body weight and delayed ossification) were observed at the highest dose tested (200 mg/kg/day).
Slovenian: so pri največjem preskušenem odmerku (200 mg/kg/dan) opazili smrt zarodkov in toksičnost za zarodek in plod (zmanjšano telesno maso ploda in zapoznelo osifikacijo).
English: Non-24 Scale of Clinical Response
Slovenian: Lestvica za oceno kliničnega odziva bolnikov z ne-24-urnim ciklusom
English: No dose adjustment is necessary for patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic odmerka zato ni treba prilagajati.
English: A composite scale of 4 measures of duration and timing of nighttime and daytime sleep and global functioning was used to evaluate clinical response in SET.
Slovenian: V študiji SET so za ocenjevanje kliničnega odziva uporabili lestvico, sestavljeno iz štirih meril, povezanih s trajanjem in časom spanja ponoči in podnevi ter splošnim delovanjem.
English: Caution should be used when administering tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions: the AUC0-inf and Cmax of tasimelteon increased by 7-fold and 2-fold, respectively, when co-administered with fluvoxamine 50 mg (after 6 days of fluvoxamine 50 mg per day).
Slovenian: Močni zaviralci CYP1A2 (npr. fluvoksamin, ciprofloksacin in enoksacin) Pri uporabi tasimelteona v kombinaciji s fluvoksaminom ali drugimi močnimi zaviralci CYP1A2, kot sta ciprofloksacin in enoksacin, je potrebna previdnost, saj obstaja možnost za veliko povečanje izpostavljenosti tasimelteonu in večje tveganje za neželene učinke: AUC0-∞ in Cmaks tasimelteona sta se pri sočasni uporabi
English: Phenolic glucuronidation is the major phase II metabolic route.
Slovenian: faze presnove je glukuronidacija fenolne skupine.
English: Tell your doctor if you have an allergy to Orange Yellow S (E110).
Slovenian: Če ste alergični na oranžno rumeno S (E110), se posvetujte z zdravnikom.
English: Renal and urinary disorders
Slovenian: Antagonisti adrenergičnih receptorjev beta
English: An example is fluvoxamine, which is used to treat depression and obsessive compulsive disorder (OCD).
Slovenian: To je na primer fluvoksamin, ki se uporablja za zdravljenje depresije in obsesivno-kompulzivne motnje (OKM); - zdravila, ki dokazano zmanjšujejo aktivnost encima, imenovanega „CYP3A4“.
English: Somnolence, dizziness
Slovenian: - omotičnost,
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol somnolenca, omotica disgevzija
English: How to store HETLIOZ
Slovenian: Shranjevanje zdravila HETLIOZ
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: posvetujte z zdravnikom ali farmacevtom.
English: How HETLIOZ works
Slovenian: Kako zdravilo HETLIOZ deluje
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Slovenian: Terapevtske indikacije
English: An example is rifampicin, which is used to treat tuberculosis (TB).
Slovenian: To je na primer rifampicin, ki se uporablja za zdravljenje tuberkuloze (TB); - zdravila, ki dokazano zmanjšujejo aktivnost encima, imenovanega „CYP2C19“.
English: Smokers (smoking is a moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section
Slovenian: Izpostavljenost tasimelteonu se je pri kadilcih zmanjšala za približno 40 % v primerjavi z nekadilci (glejte poglavje 4.5).
English: Tasimelteon This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo HETLIOZ 20 mg trde kapsule tasimelteon Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: EXPIRY DATE
Slovenian: urnem ciklusu
English: - medicines known to increase the activity of an enzyme called ‘CYP3A4'.
Slovenian: To je na primer ketokonazol, ki se uporablja za zdravljenje glivičnih okužb; - zdravila, ki dokazano povečujejo aktivnost encima, imenovanega „CYP3A4“.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Seznam pomožnih snovi
English: Nighttime sleep on 25% most symptomatic nights >45 minutes increase in average nighttime sleep duration
Slovenian: Spanje ponoči v 25 % noči z najbolj izraženimi simptomi
English: Route of Administration
Slovenian: Številka EU dovoljenja za promet
English: At present, the annual cost of support measures for these products is around €100,000.
Slovenian: Trenutno znašajo letni stroški podpornih ukrepov za ta zdravila približno 100 000 EUR.
English: They often contribute to the work of more than one scientific committee and various working parties.
Slovenian: Pogosto sodelujejo pri delu več kot enega znanstvenega odbora in različnih delovnih skupin.
English: The adopted preliminary draft budget (PDB) for 2010 totals €211.8 million.
Slovenian: Sprejeti predhodni osnutek proračuna (PDB) za leto 2010 znaša 211,8 milijona EUR.
English: This includes an estimated fee revenue of €158.3 million and a requested Community contribution of €46 million.
Slovenian: To zajema pričakovane prihodke iz pristojbin v višini 158,3 milijona EUR in zahtevani prispevek Skupnosti v višini 46 milijonov EUR.
English: A further report will be provided at the June meeting.
Slovenian: Naslednje poročilo bo predstavljeno na junijskem sestanku.
English: The Management Board welcomed the opinion of the Committee as it is of importance to many Member States.
Slovenian: Upravni odbor je pozdravil mnenje Odbora, saj je pomembno za veliko držav članic.
English: The Agency adopted a record number of positive opinions in the area of initial evaluations.
Slovenian: Agencija je sprejela rekordno število pozitivnih mnenj na področju začetnega vrednotenja.
English: The public consultation regarding the proposed policy is planned to start in mid June and finish at the end of September 2009.
Slovenian: Začetek javnega posvetovanja o predlagani politiki je načrtovan za sredino junija, konec pa za konec septembra 2009.
English: The Board discussed the topic and offered divergent views.
Slovenian: Odbor je razpravljal o temi in ponudil različne poglede.
English: The year 2010 is the final year covered by the current road map.
Slovenian: Leto 2010 je zadnje leto, ki ga pokriva sedanji časovni načrt.
English: The pilot will commence in April 2009 and will run for three months.
Slovenian: Pilotni projekt se bo začel aprila 2009 in bo trajal tri mesece.
English: The PDB includes an increase in the establishment plan of 37 posts, with a maximum number of 567 temporary agents.
Slovenian: PDB vključuje razširitev načrta delovnih mest za 37 delovnih mest, pri čemer je lahko začasnih uslužbencev največ 567.
English: The first centralised vaccine against bluetongue
Slovenian: Prvo centralizirano cepivo proti bolezni modrikastega jezika
English: Review of the remuneration system
Slovenian: Pregled sistema plačevanja nadomestil
English: Collaboration with the FDA
Slovenian: Sodelovanje z uradom FDA
English: Following the entry into force of the proposed additional measures, the cost may rise to an annual figure of €500,000 and, depending on the actual uptake, may even be significantly higher.
Slovenian: Po začetku veljavnosti predlaganih dodatnih ukrepov bi se stroški lahko povišali na 500 000 EUR letno in bi bili lahko glede na dejanski vnos celo bistveno višji.
English: The Agency delivered on all core business commitments and implemented its 2008 priorities.
Slovenian: Agencija je uspešno izpolnila vse ključne poslovne obveznosti in izvedla prednostne naloge za leto 2008.
English: Point 16 on Governance of EU agencies was deferred to the June meeting.
Slovenian: Točka 16 o upravljanju agencij EU je bila preložena na junijski sestanek.
English: The Board will discuss this proposal at a future meeting.
Slovenian: Odbor bo o tem predlogu razpravljal na enem od prihodnjih sestankov.
English: Options for adopting a new logo for the Agency are being explored.
Slovenian: Možnosti za sprejetje novega logotipa Agencije se še preverjajo.
English: Overall, the changes of the structure will ensure more accountability at various management levels, and will make the organisation better positioned to operate in the present conditions.
Slovenian: Splošno gledano, bodo spremembe strukture zagotovile večjo odgovornost na različnih ravneh upravljanja, zaradi česar bo organizacija v boljšem položaju za delovanje v sedanjih okoliščinah.
English: The Agency will also consider ways to promote use of its official name rather than the acronym ‘EMEA', which has limited recognition outside of the Agency's closest stakeholder groups.
Slovenian: Agencija bo tudi preučila načine za spodbujanje rabe svojega uradnega imena namesto kratice „EMEA“, ki je relativno neprepoznavna zunaj kroga najbližjih skupin zainteresiranih strani Agencije.
English: It was also stressed that the volume and complexity of procedures exert a lot of pressure on national scientific resources, with scientists having to spend increasingly more time at the Agency.
Slovenian: Poudarjeno je bilo tudi, da obseg in zapletenost postopkov zelo pritiskata na nacionalne znanstvene vire, saj morajo znanstveniki vedno več časa posvetiti delu v Agenciji.
English: The European Commission made a reservation regarding the level of the Community contribution in the 2010 budget, pending the completion of the budgetary process in the institutions.
Slovenian: Evropska komisija je izrazila pridržek v zvezi s stopnjo prispevka Skupnosti v proračun za leto 2010, ki velja do konca proračunskih postopkov v institucijah.
English: The EMEA's recommendation is an important step towards the availability of vaccines for use in vaccination campaigns across the EU and the protection of animal health in Europe.
Slovenian: Priporočilo agencije EMEA je pomemben korak k zagotavljanju razpoložljivosti cepiv za uporabo v programih cepljenja v EU in zaščiti zdravja živali v Evropi.
English: Work is ongoing at the two agencies on arrangements for the reciprocal assignment of staff.
Slovenian: V obeh agencijah poteka delo v skladu s sporazumi za obojestransko napotitev osebja.
English: This can be considered during the ongoing evaluation of the Agency.
Slovenian: To bi bilo mogoče med ocenjevanjem Agencije, ki poteka.
English: This would enable the Management Board to take decisions on establishment plans in the knowledge of the views of the European Commission (taking into account that the Commission opinion is transmitted to the budgetary authority).
Slovenian: To bi upravnemu odboru omogočilo sprejemanje sklepov o načrtih delovnih mest na podlagi znanih stališč Evropske komisije (upoštevajoč, da se mnenje Komisije posreduje proračunskemu organu).
English: Following the publication of relevant guidance, the work to extend the EudraCT database in line with the requirements of the legislation on paediatric medicinal products will continue.
Slovenian: Po objavi ustreznih smernic se bo delo pri razširitvi podatkovne zbirke EudraCT v skladu z zahtevami zakonodaje o pediatričnih zdravilih nadaljevalo.
English: The Agency has also implemented the legislation on advanced therapy medicinal products (ATMPs) and established the Committee for Advanced Therapies.
Slovenian: Agencija je tudi izvajala zakonodajo o zdravilih za napredno zdravljenje (ATMP) in ustanovila Odbor za napredno zdravljenje.
English: The annual report will now be submitted to the members for a three-week consultation period, after which time a written procedure for the adoption will be launched.
Slovenian: Letno poročilo bo zdaj predloženo članom v tritedensko obdobje posvetovanja, po katerem bo sprožen pisni postopek za sprejetje.
English: The year 2008 saw a further growth in the volume of core activities.
Slovenian: Leto 2008 je zaznamovala nadaljnja rast obsega ključnih dejavnosti.
English: Incentives for products for minor uses and minor species or for limited markets
Slovenian: Spodbude za zdravila, namenjena manjši uporabi in manj pomembnim vrstam ali omejenim trgom
English: The work programme and budget focus on the development of corporate information-technology systems, which aim to increase the efficiency with which procedures are monitored and tracked.
Slovenian: Delovni program in proračun se osredotočata na razvoj poslovnih informacijskih sistemov, namenjenih izboljšanju učinkovitosti spremljanja in sledenja postopkov.
English: Preparation for written procedures: changes to the rules for the implementation of Regulation (EC) No 297/95 on fees payable to the EMEA and other measures
Slovenian: Priprava za pisne postopke: spremembe izvedbenih pravil Uredbe (ES) št. 297/95 o pristojbinah, ki se plačujejo agenciji EMEA in drugih ukrepov
English: The request to develop similar interactions with representatives of healthcare professionals will be forwarded to the Healthcare Professionals Working Group, and will be discussed during the preparation of the framework for interaction with health care professional organisations.
Slovenian: Zahteva za razvoj podobnih odnosov s predstavniki zdravstvenih delavcev bo posredovana delovni skupini za zdravstvene delavce, o njej pa se bo razpravljalo med pripravo okvira za sodelovanje z organizacijami zdravstvenih delavcev.
English: The Management Board reiterated the need to find alternative ways of working, including greater use of communication technologies and, possibly, revision of the architecture of the system.
Slovenian: Upravni odbor je znova poudaril, da je treba najti druge načine dela, vključno z večjo uporabo komunikacijskih tehnologij in morda pregledom arhitekture sistema.
English: In case the Agency's budget is not sufficient to meet the demand, the Agency may introduce additional criteria to make sure that those products of highest benefit, in terms of animal health, continue to receive support.
Slovenian: Če proračun Agencije ne bo izpolnil povpraševanja, bo Agencija morda vpeljala dodatna merila za zagotovitev, da bodo zdravila z največjim učinkom v smislu zdravja živali še naprej prejemala podporo.
English: Proposal for involvement and participation of patients'/consumers' representatives in the meetings of the CHMP Pharmacovigilance Working Party
Slovenian: Predlog za vključitev in sodelovanje predstavnikov bolnikov/potrošnikov na sestankih delovne skupine odbora CHMP za farmakovigilanco.
English: EMEA annual report 2008
Slovenian: Letno poročilo agencije EMEA za leto 2008
English: The experience from this pilot will help to develop a general strategy to further involve patients and consumers at different levels of the Agency's work, as well as will help the Agency to acquire experience that will be useful in the context of the future pharmacovigilance legislation.
Slovenian: Izkušnje iz tega projekta bodo pomagale pri razvijanju splošne strategije nadaljnjega vključevanja bolnikov in potrošnikov na različne ravni dela Agencije, prav tako pa bodo pomagale Agenciji pridobiti izkušnje, ki bodo koristne v smislu prihodnje zakonodaje s področja farmakovigilance.
English: Governance of EU agencies The point was deferred to the next meeting.
Slovenian: Upravljanje agencij EU Točka je bila preložena na naslednjo sejo.
English: The wording in the rules of procedure will be clarified together with the European Commission, and the document will be submitted for adoption by written procedure.
Slovenian: Besedilo poslovnika bo prečiščeno ob sodelovanju Evropske komisije, dokument pa bo predložen za sprejetje s pisnim postopkom.
English: As part of the EU-FDA confidentiality arrangements, and of increased collaboration and cooperation between the EMEA and the US Food and Drug Administration (FDA), the two authorities have agreed to exchange staff on a defined-term basis.
Slovenian: Kot del sporazumov o zaupnosti med EU in uradom FDA ter povečanega obsega sodelovanja med agencijo EMEA in ameriškim Uradom za živila in zdravila (FDA) sta se organa dogovorila o izmenjavi osebja za določen čas.
English: Although the minutes are adopted by written procedure, they will continue to appear on the agenda to allow members to raise matters arising from a previous meeting.
Slovenian: Čeprav se zapisnik sprejema s pisnim postopkom, se bo še vedno uvrščal na dnevni red, da bodo člani lahko razpravljali o zadevah s prejšnje seje.
English: The Management Board was informed that the Court of Auditors will possibly visit the Agency later this year to review the progress of the revision of the remuneration system for the work of (co)rapporteurs.
Slovenian: Upravni odbor je bil obveščen, da bo Računsko sodišče pozneje letos verjetno obiskalo Agencijo, da bi pregledalo napredek pri reviziji sistema plačevanja nadomestil (so)poročevalcem.
English: The number of applications increased in the areas of scientific advice, initial evaluation, post-authorisation, paediatrics and other activities.
Slovenian: Povečalo se je število vlog na področju znanstvenega svetovanja, začetnega vrednotenja, dejavnosti po izdaji dovoljenja, pediatrije in drugih dejavnosti.
English: The task force was set up in response to the Management Board's legal role in the appointment process, with a view to further improving the consultation process.
Slovenian: Projektna skupina je bila ustanovljena kot odgovor na pravni položaj upravnega odbora v postopku imenovanja, da bi še izboljšala posvetovalni postopek.
English: Mandate for the Management Board task force on scientific qualification of committee members
Slovenian: Mandat projektne skupine upravnega odbora o znanstveni usposobljenosti članov odbora
English: In addition to adoption of the necessary procedures and changes to the fee-implementing rules, the Agency is currently preparing other measures that are necessary to put in place the proposed incentives, such as amendments to guidance, a communication strategy with stakeholders, and an official launch of the scheme, foreseen for later in 2009.
Slovenian: Agencija poleg sprejetja potrebnih postopkov in sprememb izvedbenih pravil o pristojbinah zdaj pripravlja druge ukrepe, ki so potrebni za izvajanje predlaganih spodbud, kot so spremembe smernic, strategija za komunikacijo z zainteresiranimi stranmi in uradni začetek programa spodbud, ki je predviden za nadaljevanje leta 2009.
English: Participants at the sixty-second meeting of the Management Board London, 4-5 March 2009 Chair: Pat O'Mahony
Slovenian: Udeleženci dvainšestdesete seje upravnega odbora London, 4. in 5. marca 2009 Predsednik Pat O'Mahony
English: The Board supported the amendments proposed by delegations to Articles 2(2) (Responsibilities of chair and vice-chair) and 5(4) (CAT (co)rapporteur and assessment team).
Slovenian: Odbor je podprl spremembe člena 2(2) (Odgovornosti predsednika in podpredsednika) in člena 5(4) (CAT (so)poročevalec in skupina za vrednotenje), ki so jih predlagale delegacije.
English: The meeting also noted the discussions to date, and encouraged the task force to take the time necessary to review the various options and liaise with the chairs and members of the scientific committees.
Slovenian: Na sestanku se je upravni odbor seznanil tudi s preteklimi razpravami in spodbudil projektno skupino, naj si vzame potreben čas, da pregleda različne možnosti ter stopi v stik s predsedniki in člani znanstvenih odborov.
English: It will be a year marked by further increases in the volume and complexity of activities.
Slovenian: Zaznamovala ga bo nadaljnja rast obsega in kompleksnosti dejavnosti.
English: The two-day meeting opened on Wednesday, 4 March 2009, with presentations and discussions on: future global challenges and directions for regulators; challenges linked to the globalisation of clinical trials; risk-based prioritisation of resources.
Slovenian: Dvodnevni sestanek se je začel v sredo, 4. marca 2009, s predstavitvami in razpravami o prihodnjih globalnih izzivih in usmeritvah za regulatorje; izzivih v zvezi z globalizacijo kliničnih preskušanj; prednostnem razvrščanju virov, ki temelji na tveganju.
English: The members welcomed the performance of the Agency and the achievement of substantial milestones in 2008.
Slovenian: Člani so pozdravili uspešno delovanje Agencije in pomembne mejnike, ki jih je dosegla v letu 2008.
English: Significant work was carried out in the fields of safety-monitoring of medicines (EudraVigilance, ENCePP projects), communication and transparency, support to innovation, and international activities.
Slovenian: Pomembno delo je bilo opravljeno na področjih spremljanja varnosti zdravil (EudraVigilance, projekti ENCePP), komunikacije in preglednosti, podpiranja inovativnosti in mednarodnih dejavnosti.
English: The Board agreed to the common understanding that the fee reductions or waivers will be borne by both the Agency and the national competent authorities that take up the (co)rapporteurships.
Slovenian: Odbor je sprejel skupni dogovor, da bodo stroške znižanja pristojbin oziroma oprostitve plačila nosili Agencija in pristojni nacionalni organi, ki pripravljajo (so)poročanje.
English: In February 2009, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion recommending a marketing authorisation under exceptional circumstances for BTVPUR Alsap 8, intended for the active immunisation of sheep and cattle, to prevent viraemia and to reduce clinical signs caused by the bluetongue virus serotype 8.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je februarja 2009 sprejel pozitivno mnenje, v katerem priporoča izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah za cepivo BTVPUR Alsap 8, ki je namenjeno aktivnemu cepljenju ovac in goveda za preprečevanje viremije in zmanjšanje kliničnih znakov, ki jih povzroča virus bolezni modrikastega jezika serotip 8.
English: The Board asked to revise the proposed wording of Article 8(7) to make it clear that the CHMP issues an opinion which is transmitted to the European Commission for adoption of a decision.
Slovenian: Odbor je zaprosil za spremembo predlaganega besedila člena 8(7), da bi bilo jasno, da odbor CHMP izda mnenje, ki se posreduje Evropski komisiji, ta pa nato sprejme sklep.
English: The European Commission representative requested the Board in the future, to allow that the draft establishment plan be submitted to the Directorate-General for Industry and Enterprise, the Directorate-General for Personnel and Administration and the Directorate-General for Budget ahead of the March Management Board meetings in order to allow the Commission to produce its consolidated opinion on the draft plan.
Slovenian: Predstavnik Evropske komisije je Odboru naložil, naj v prihodnje osnutek načrta delovnih mest predloži Generalnemu direktoratu za podjetništvo in industrijo, Generalnemu direktoratu za kadrovske zadeve in administracijo ter Generalnemu direktoratu za proračun pred sejami upravnega odbora v marcu, da bi Komisija lahko pripravila konsolidirano mnenje o osnutku načrta.
English: However, the funding of information-technology and telematics projects has a structural issue that will be further affected by future legislation in the field of pharmaceuticals (pharmacovigilance, counterfeit medicines and, possibly, information to patients).
Slovenian: Vendar pa se pri financiranju projektov informatizacije in telematike pojavlja strukturna težava, ki jo bo še povečala prihodnja zakonodaja s področja farmacevtskih izdelkov (farmakovigilanca, ponarejena zdravila in mogoče obveščanje bolnikov).
English: The Management Board was given a presentation about the Agency's transparency-policy project and associated action plan.
Slovenian: Upravnemu odboru sta bila predstavljena projekt Agencije za politiko preglednosti in s tem povezani akcijski načrt.
English: Following the completion of the discussion on the interaction between the CHMP and the CAT, the Management Board will consider whether any further revision of the rules of procedure are necessary.
Slovenian: Po koncu razprave o vzajemnem delovanju odborov CHMP in CAT bo upravni odbor preučil potrebo po nadaljnjih spremembah poslovnika.