natgillin/translations-raw huggingface dataset:
Ulunar Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older). 
Starejši bolniki (stari 75 let ali več) lahko uporabljajo zdravilo Ulunar Breezhaler v priporočenem odmerku.
Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Ulunar Breezhaler administered in four dose steps each separated by one hour and compared to the effects of placebo, indacaterol, glycopyrronium and salmeterol. 
Učinek na srčno frekvenco so raziskovali pri zdravih prostovoljcih po odmerjanju posameznih odmerkov, ki so bili štirikrat višji od priporočenega odmerka zdravila Ulunar Breezhaler, preiskovancem pa so jih odmerjali v štirih odmernih korakih s presledkom po eno uro.
Ulunar Breezhaler: 
Zdravilo Ulunar Breezhaler:
Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ulunar Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. 
Glede na podatke o kliničnih farmakokinetičnih lastnostih posameznih učinkovin v monoterapiji je zdravilo Ulunar Breezhaler pri bolnikih z blago do zmerno okvaro ledvic mogoče uporabljati v priporočenem odmerku.
How to use Ulunar Breezhaler 
Kako uporabljati zdravilo Ulunar Breezhaler
The components of Ulunar Breezhaler are not known to have a QT-prolongation potential at clinical dose levels. 
V okviru kliničnega odmerjanja učinkovini zdravila Ulunar Breezhaler ne sodita med učinkovini z znanim potencialom za podaljšanje intervala QT.
• One Ulunar Breezhaler inhaler 
• en inhalator Ulunar Breezhaler,
Therefore Ulunar Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use. 
Antagonisti beta adrenergičnih receptorjev lahko oslabijo ali zavrejo učinke agonistov beta-2 adrenergičnih receptorjev, zato se zdravila Ulunar Breezhaler ne sme uporabljati skupaj z antagonisti beta adrenergičnih receptorjev (kar pomeni tudi s kapljicami za oči), razen če za sočasno uporabo obstajajo nujni razlogi.
Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ulunar Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment. 
Glede na podatke o kliničnih farmakokinetičnih lastnostih posameznih učinkovin v monoterapiji je zdravilo Ulunar Breezhaler pri bolnikih z blago in zmerno okvaro jeter mogoče uporabljati v priporočenem odmerku.
Ulunar Breezhaler contains lactose 
Zdravilo Ulunar Breezhaler vsebuje laktozo
Other medicines and Ulunar Breezhaler 
Shranjevanje zdravila Ulunar Breezhaler
Indacaterol administered to dogs alone or in Ulunar Breezhaler was associated with a similar incidence and severity of myocardial lesions. 
Pogostnost in izraženost poškodb miokarda pri psih sta bili pri odmerjanju indakaterola posamezno podobni kot pri njegovem odmerjanju v zdravilu Ulunar Breezhaler.
What Ulunar Breezhaler is 
Kaj je zdravilo Ulunar Breezhaler
Ulunar Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. 
Bolniki z blago do zmerno okvaro ledvic lahko uporabljajo zdravilo Ulunar Breezhaler v priporočenem odmerku.
The year in brief 
Leto na kratko
Of these: 
Od tega:
Revenue increased by 10.7% 
Prihodki so se povečali za 10,7 %
received 85 requests for administrative assistance. 
prejel 85 zahtevkov za administrativno pomoč.
Implementing the European Risk Management Strategy 
Uvedba evropske strategije obvladovanja tveganja
9 Regulation (EC) No 1394/2007 on advanced therapy medicinal products. 
9 Uredba (ES) št. 1394/2007 o zdravilih za napredno zdravljenje.
2009 (forecast) 
2009 (napoved)
The European medicines network is a partnership of more than 40 national regulatory authorities across the European Economic Area. 
Evropska mreža zdravil je partnerstvo več kot 40 nacionalnih regulativnih organov v Evropskem gospodarskem prostoru.
appointment of an International Liaison Officer to oversee the further development of the Agency's activities with its international partners. 
imenovanje mednarodnega uradnika za zvezo za nadziranje dodatnega razvoja dejavnosti Agencije s svojimi mednarodnimi partnerji.
Scientific opinions for non-EU markets 
Znanstvena mnenja za trge izven EU
Improving the opportunities for interaction 
Izboljšanje priložnosti za interakcijo
Strengthening cooperation with international partners 
Okrepitev sodelovanja z mednarodnimi partnerji
the COMP adopted 86 positive opinions and 1 negative opinion; 
COMP sprejel 86 pozitivnih mnenj in 1 negativno mnenje;
6 The European Economic Area includes the 27 Member States of the European Union, plus Iceland, Liechtenstein and Norway. 
Evropski gospodarski prostor vključuje 27 držav članic Evropske unije ter Islandijo, Lihtenštajn in Norveško.
Interacting with patients, consumers and healthcare professionals 
Interakcija z bolniki, potrošniki in zdravstvenimi delavci
Improving the Agency's web communications 
Izboljšanje spletnih komunikacij Agencije
discussion within the Agency's Management Board about publication of its documents. 
razprava znotraj upravnega odbora Agencije o objavah svojih dokumentov.
Key activities in 2008 
Ključne dejavnosti v letu 2008
This system allows the Agency and its partners to take a more proactive and coherent approach to communicating on safety concerns within the network. 
Ta sistem Agenciji in njenim partnerjem omogoča bolj proaktiven in koherenten pristop k prenosu informacij o varnostnih vprašanjih znotraj mreže.
Strengthening cooperation with European and international partners Strengthening the European medicines network 
Okrepitev sodelovanja z evropskimi in mednarodnimi partnerji Okrepitev Evropske mreže zdravil
Generics, hybrid products, etc. 
Generična zdravila, hibridna zdravila itn.
Fostering transparency, communication and provision of information Providing greater access to the Agency's information 
Pospeševanje preglednosti, obveščanja in zagotavljanja informacij Omogočanje večje dostopnosti informacij Agencije
Preparing for the establishment of the Committee on Advanced Therapies 
Priprave za ustanovitev Odbora za napredno zdravljenje
In terms of the core assessment work of the Agency, 2008 was a highly productive year. 
Glede na ocenjevanje ključnega dela Agencije je bilo leto 2008 zelo produktivno.
The Agency contributes towards accelerating the availability of medicines through its provision of scientific advice to companies. 
Agencija prispeva k pospeševanju razpoložljivosti zdravil z zagotavljanjem znanstvenega svetovanja podjetjem.
In doing so, they also face very similar challenges, and by pooling their experiences, sharing information, exchanging expertise and harmonising their regulatory practices, they stand a better chance of overcoming those challenges. 
Pri tem se soočajo z zelo podobnimi izzivi in imajo z združevanjem svojih izkušenj, izmenjavo podatkov, izmenjavo strokovnih znanj ter usklajevanjem regulativnih praks večje možnosti premagati te izzive.
In 2008, key cooperation activities with international partners included: 
V letu 2008 so bile ključne dejavnosti sodelovanja z mednarodnimi partnerji:
This process is intended to greatly improve the presentation and functionality of the website, as well as improve the quality of the content accessible through the site. 
Postopek je namenjen bistvenemu izboljšanju predstavitve in funkcionalnosti spletne strani ter izboljšanju kakovosti vsebine, ki je dostopna na spletni strani.
further contributions to a series of activities with partners of the tri-partite (EU-USA-Japan) International Conference on Harmonisation (ICH) and its veterinary equivalent (VICH); 
dodatni prispevki k nizu dejavnosti s partnerji tristranske (EU-ZDA-Japonska) Mednarodne konference o harmonizaciji (ICH) ter veterinarskega ustreznika (VICH);
Explanation of post-authorisation categories: 
Obrazložitev kategorij dejavnosti po izdaji dovoljenja:
It can be used during a patient's first remission (a period without symptoms of the disease after the first course of treatment). 
Lahko se uporablja med prvo bolnikovo remisijo (obdobjem brez simptomov bolezni po prvem ciklu zdravljenja).
As in previous years, the majority (55%) relate to marketing-authorisation holders notifying the Agency about minor changes to their authorised medicines. 
Kot v prejšnjih letih se je večina (55 %) nanašala na obveščanje Agencije s strani imetnikov dovoljenj za promet o manjših spremembah odobrenih zdravil.
reviewed and approved 84 applications from SMEs for the reduction or deferment of fees; 
pregledal in odobril 84 vlog malih in srednje velikih podjetij za zmanjšanje ali odložitev pristojbin;
It was agreed that, from March 2009 onwards, non-confidential Board documents, including agendas and minutes, would be published on the Agency's website10 following each Board meeting; 
Soglasno so se odločili, da bodo od marca 2009 dokumenti odbora, ki nimajo statusa zaupno, vključno z dnevnimi redi in zapisniki, objavljeni na spletni strani10 Agencije po vsaki seji odbora;
One further positive opinion was adopted in favour of granting a conditional marketing authorisation (a one-year authorisation, renewable annually, on condition that certain specific obligations are met), while negative opinions were adopted for 7 applications. 
Sprejeto je bilo še eno pozitivno mnenje za odobritev pogojnega dovoljenja za promet (enoletna odobritev, ki se vsako leto obnavlja pod pogojem, da so izpolnjenje določene specifične obveznosti), in negativna mnenja za 7 vlog.
In 2008, the Agency intensified its cooperation with international partners to ensure its contribution to global efforts for safer and better medicines around the world. 
V letu 2008 je Agencija okrepila svoje sodelovanje z mednarodnimi partnerji, da bi zagotovila svoj prispevek k globalnim naporom za varnejša in boljša zdravila po celem svetu.
General EU contribution Special EU contribution for orphan medicines Contribution from EEA Community programmes Other 
Splošni prispevek EU Posebni prispevek EU za zdravila sirote Prispevek iz EGP
Small and medium-sized enterprises (SMEs) operating in the human and veterinary pharmaceutical sectors are often innovators of new technologies and emerging therapies. 
Mala in srednje velika podjetja, ki delujejo v humanem in veterinarskem farmacevtskem sektorju so pogosto izumitelji novih tehnologij in porajajočih se terapij.
In 2008, the Agency, through its relevant scientific committees and working parties: 
V letu 2008 je Agencija preko zadevnih znanstvenih odborov in delovnih skupin:
continued its work on identifying specific guidance needs relating to advanced therapies; 
nadaljeval opredeljevanje specifičnih potreb po smernicah v zvezi z naprednim zdravljenjem;
In 2008, the Paediatric Committee: 
V letu 2008 je Odbor za pediatrijo:
‘Regulatory and procedural guidance': http://www.emea.europa.eu/htms/human/raguidelines/intro.htm 13 ‘Medicines for the elderly': http://www.emea.europa.eu/htms/human/elderly/introduction.htm 
Dokumenti upravnega odbora: http://www.emea.europa.eu/htms/general/manage/MB/MB_documents.html Spletna stran ENCePP: http://www.encepp.eu „Regulativne in postopkovne smernice“: http://www.emea.europa.eu/htms/human/raguidelines/intro.htm 13 „Zdravila za starostnike“: http://www.emea.europa.eu/htms/human/elderly/introduction.htm
Staffing increased by 14% 
Povečanje deleža zaposlenih za 14 %
The role of the Agency is to prepare, through its Committee on Herbal Medicinal Products (HMPC), scientific opinions on the quality, safety and efficacy of such medicines, so that regulatory information relating to them can be harmonised across the EU. 
Vloga Agencije je, da prek Odbora za zdravila rastlinskega izvora (HMPC) pripravlja znanstvena mnenja o kakovosti, varnosti in učinkovitosti teh zdravil, tako da se regulativne informacije v zvezi z njimi v EU lahko uskladijo.
In 2008: 
V letu 2008 je:
Supporting innovation and the availability of medicines Supporting SMEs 
Podpora inovacijam in dostopnost zdravil Podpora malim in srednje velikim podjetjem
A ‘public-facing online information project' was launched in 2008 to begin a comprehensive overhaul of the Agency's public website. 
Leta 2008 je bil uveden „projekt spletnih informacij, namenjenih javnosti“, s katerim se je začela obsežna prenova javne spletne strani Agencije.
The authorisation of herbal medicines (i.e. medicinal plants or parts thereof, or medicinal preparations containing these) in the European Union usually takes place in accordance with the national procedures of individual countries. 
Odobritev zdravil rastlinskega izvora (tj. zdravilnih rastlin ali njihovih delov ali njih vsebujočih zdravilnih pripravkov) v Evropski uniji ponavadi poteka skladno z nacionalnimi postopki v posameznih državah.
two new mock-up vaccines that can be adapted for use in an influenza pandemic. 
Dve novi modelni cepivi, ki se lahko prilagodijo proti pandemiji gripe.
Collectively, these partner organisations provide the best-available scientific expertise to ensure a sound regulatory system for medicines in Europe. 
Te partnerske organizacije skupaj zagotavljajo najboljšo možno znanstveno strokovno znanje za zagotavljanje dobrega regulativnega sistema za zdravila v Evropi.
It is from within this network that the Agency sources most of the experts that serve as members of its scientific committees, working parties and related groups. 
Znotraj te mreže Agencija pridobi večino svojih strokovnjakov, ki sodelujejo v njenih znanstvenih odborih, delovnih skupinah in povezanih skupinah.
received 5 requests for scientific advice relating to veterinary medicines. 
prejela 5 zahtevkov za znanstveno svetovanje v zvezi z zdravili za uporabo v veterinarski medicini.
The main initiative undertaken in 2008 within the framework of this strategy was the introduction of an early notification system for improved communication between European regulatory authorities, as well as with the US Food and Drug Administration, on envisaged regulatory action to be taken in response to (emerging) safety issues. 
Glavna pobuda, opravljena v letu 2008 v okviru te strategije, je bila uvedba zgodnjega sistema prijavljanja za izboljšanje komunikacije med evropskimi regulativnimi organi ter tudi Uradom za živila in zdravila iz ZDA glede predvidenih regulativnih ukrepov, ki naj bi se izvedli kot odziv na (porajajoča se) varnostna vprašanja.
Medicines regulators around the world share the same objective of establishing adequate procedures for the development, testing, authorisation and monitoring of medicines, in the interest of protecting the populations they represent. 
Regulativni organi za zdravila po vsem svetu imajo isti cilj vzpostavljanje ustreznih postopkov za razvoj, preskušanje, odobritev in spremljanje zdravil z namenom zaščite ljudi, ki jih zastopajo.
Roughly half of these applications related to type-I variations (minor changes) and half to type-II variations (major changes). 
Približno polovica teh vlog se je nanašala na spremembe tipa I (manjše spremembe), druga polovica pa na spremembe tipa II (večje spremembe).
a series of exchanges of information with the medicines authorities of the USA, Canada and Japan, within the framework of confidentiality arrangements signed between the EU and these countries; 
niz izmenjav informacij z organi, pristojnimi za zdravila, v ZDA, Kanadi in na Japonskem, v okviru dogovorov o zaupnosti, ki so podpisani med EU in omenjenimi državami;
The CHMP will process these applications within 210 days, as stipulated in EU legislation, and adopt opinions in each case as to whether or not it recommends that a marketing authorisation should be granted. 
CHMP bo obdelal te vloge v 210 dneh, kakor določa zakonodaja EU, in v vsakem primeru sprejel mnenje o priporočilu odobritve dovoljenja ali zavrnitvi le-tega.
The EU offers pharmaceutical companies incentives to develop such medicines, so that patients suffering from rare diseases may benefit from a similar quality of medical treatment as other patients. 
EU nudi farmacevtskim družbam spodbude za razvoj takšnih zdravil, tako da so lahko bolniki, ki imajo redke bolezni, deležni zdravljenja podobne kakovosti kot drugi bolniki.
8 Maximum residue limit: the maximum acceptable concentration of the residue of a medicine in a food product obtained from a treated animal. 
Najvišje mejne vrednosti ostankov: najvišja sprejemljiva koncentracija ostankov zdravila v živilu, ki se pridobi iz zdravljene živali.
Supervising the development of medicines for children 
Nadzor razvoja zdravil za otroke
A CHMP opinion is a recommendation to the European Commission on whether or not it should grant a Community marketing authorisation (or licence) that allows the medicine concerned to be placed on the market in all 30 European Economic Area countries (the 27 European Union Member States, plus Iceland, Liechtenstein and Norway). 
Mnenje CHMP je priporočilo Evropski komisiji, da odobri ali zavrne dovoljenje (ali licenco) Skupnosti za promet z zdravilom, ki omogoča dajanje zdravila v promet v vseh 30 državah Evropskega gospodarskega prostora (27 držav članic Evropske unije ter Islandija, Lihtenštajn in Norveška).
The European Risk Management Strategy is a strategy developed by the Agency and its partners in the European regulatory network for medicines. 
Evropsko strategijo obvladovanja tveganja je Agencija pripravila s svojimi partnerji v evropski regulativni mreži za zdravila.
Minor changes require only that a notification be sent to the Agency for validation. 
Manjše spremembe zahtevajo le obveščanje Agencije, da jih potrdi.
Of the 66 medicines to receive a positive opinion from the CHMP in 2008, those that are of particular note include: 
Od 66 zdravil, ki so prejela pozitivno mnenje CHMP v letu 2008, je treba posebej izpostaviti naslednje:
improving resource-planning, notably by providing regular estimates of resources required for forthcoming applications for regulatory procedures; 
izboljšanje načrtovanja virov, zlasti s pripravo rednih ocen virov, ki so potrebni za prihodnje vloge za regulativne postopke;
In 2008, the Agency reviewed 391 such reports relating to medicines for human use and 91 relating to veterinary medicines. 
V letu 2008 je Agencija pregledala 391 takih poročil v zvezi z zdravili za uporabo v humani medicini in 91 poročil v zvezi z veterinarskimi zdravili.
The EudraVigilance reporting system, which is managed by the European Medicines Agency, allows the safety of authorised medicines to be monitored continuously, so that appropriate regulatory action, such as the suspension of a marketing authorisation, can be taken rapidly whenever there is a risk to public health. 
Sistem poročanja EudraVigilance, ki ga upravlja Evropska agencija za zdravila, omogoča stalno spremljanje varnosti odobrenih zdravil, tako da se lahko hitro sprejmejo ustrezni regulativni ukrepi, kot je zadržanje dovoljenja za promet, vedno ko obstaja tveganje za javno zdravje.
Revenue and staffing figures 
Prihodki in zaposleni
improving competence-development, notably by providing a series of training sessions for experts and assessors on a range of specialised topics. 
izboljšanje razvijanja usposobljenosti, zlasti s pripravo niza usposabljanj za strokovnjake in presojevalce o številnih specializiranih temah.
adopted 5 entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'5. 
sprejel 5 vnosov v „Seznam rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora“5.
preparing for the future provision of access to certain data contained in EudraCT - the EU's database of clinical-trial information - and preparing an implementation plan for adapting information-technology systems to allow for such access. 
priprave za prihodnje zagotavljanje dostopa do določenih podatkov v sistemu EudraCT, zbirke podatkov EU o kliničnih preskušanjih, in priprava načrta uresničevanja prilagoditve sistemov informacijske tehnologije, ki bodo omogočili ta dostop.
improving the organisation of meetings at the Agency, notably by improving the availability of video- and teleconferencing facilities, thus reducing the need for experts to travel to the Agency's premises; 
izboljšanje organizacije sej v Agenciji, zlasti izboljšanje razpoložljivosti video- in telekonferenčne opreme, kar zmanjša potrebo po potovanjih strokovnjakov na različne lokacije Agencije;
adopted 129 positive and 4 negative opinions on PIP applications, and 8 positive opinions on modification of agreed PIPs; 
sprejel 129 pozitivnih in 4 negativna mnenja o vlogah za PIP ter 8 pozitivnih mnenj o spremembah dogovorjenih načrtov pediatričnih raziskav;
almost two thirds of orphan designations were for medicines to treat conditions affecting children. 
bilo skoraj dve tretjini določitev zdravil sirot za zdravila, ki se uporabljajo za zdravljenje bolezni otrok.
participation in a series of projects being run by the World Health Organization, notably the ‘Make medicines child size' programme aimed at addressing the need for improved availability of safe medicines for children; 
sodelovanje v nizu projektov, ki jih vodi Svetovna zdravstvena organizacija, zlasti v programu „Zdravila po meri otrok“, katerega cilj je usmeriti pozornost na potrebo po izboljšanju razpoložljivosti varnih zdravil za otroke:
It is intended for use in patients who do not respond well to, or cannot tolerate, conventional arthritis treatments. 
Namenjeno je uporabi pri bolnikih, ki se ne odzivajo dobro na običajna zdravljenja artritisa ali jih ne prenašajo.
Providing scientific advice to support the development of medicines 
Zagotavljanje znanstvenega svetovanje v podporo razvoja zdravil
For major changes, the marketing-authorisation holder is usually obliged to submit new data for evaluation by the CHMP and adoption of an opinion on the acceptability of the proposed change. 
Pri večjih spremembah mora imetnik dovoljenja za promet z zdravili ponavadi predložiti nove podatke za oceno s strani CHMP ter sprejem mnenja o sprejemljivosti predlagane spremembe.
‘Orphan' medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10,000 persons in the European Union. 
Zdravila „sirote“ so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo do pet na 10.000 oseb v Evropski uniji.
In 2008, the SME Office: 
V letu 2008 je urad za mala in srednje velika podjetja:
However, set against a background of continuing globalisation of the pharmaceutical sector, further rapid advances in medical science and the unrelenting pace of regulatory activity in the medicines network of the European Union (EU), it was by no means a ‘dull' year for the Agency. 
Vendar zaradi nadaljevanja globalizacije farmacevtskega sektorja, dodatnega hitrega napredka v medicini in neizprosno hitrega poteka regulativnih dejavnosti v mreži zdravil v Evropski uniji (EU) to leto za Agencijo gotovo ni bilo „dolgočasno“.
Public-health benefits of medicines recommended for authorisation in 2008 
Koristi zdravil, priporočenih za odobritev v letu 2008, za javno zdravje
The CHMP adopts opinions after a rigorous evaluation of the scientific data submitted by pharmaceutical companies in support of their applications for approval of their medicinal products. 
CHMP sprejema mnenja po strogem ocenjevanju znanstvenih podatkov, ki so jih predložile farmacevtske družbe v podporo svojim vlogam za odobritev zdravil.
119 orphan-designation applications were submitted to the Agency; 
bilo Agenciji predloženih 119 vlog za določitev zdravila sirote;
The medicine concerned was an anti-obesity medicine. 
Zadevno zdravilo je bilo zdravilo proti debelosti.
processed 337 applications for qualification or renewal of SME status; 
obdelal 337 vlog za izpolnjevanje statusa malih in srednje velikih podjetij ali obnovitev tega statusa;