natgillin/translations-raw huggingface dataset:
Elevations in ALT >3 × upper limit of normal (ULN) or ALP>2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg). 
Pri bolnikih, ki so se zdravili s telotristatom, so poročali o zvišanju vrednosti ALT > 3 × zgornja meja normalne vrednosti (ZMN) ali vrednosti alkalne fosfataze > 2 ZMN.
You may feel sick or be sick, have diarrhoea or stomach ache. 
Če ste vzeli večji odmerek zdravila Xermelo, kot bi smeli Lahko se pojavi občutek siljenja na bruhanje ali bruhanje, driska ali bolečina v trebuhu.
Tablet core 
Drugi CYP
Acid Reducers 
• zvišana telesna temperatura
pain in the upper right belly. 
rumeno obarvanje kože ali očesnih beločnic, bolečina v zgornjem desnem predelu trebuha.
Number of patients Change averaged over 12 weeks: mean (SD) 
Povprečna sprememba v 12 tednih:
A. 
(SD)
This is approximately 14 times the human exposure (AUC total) at the maximum recommended human dose (MRHD) of 750 mg/day for the active metabolite LP-778902. 
To je približno 14-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
This is approximately 0.4 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902. 
To je približno 0,4-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
This is approximately 21 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902. 
To je približno 21-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
This is approximately 20 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902. 
To je približno 20-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
However, 100% compliance has still not been achieved. 
Kljub temu 100-odstotna skladnost še vedno ni bila dosežena.
London, 17 June 2008 
London, 17. junija 2008
Early dialogue with sponsors 
Zgodnji dialog s sponzorji
A decision was taken to extend the pilot phase into 2008. 
Sprejeta je bila odločitev za podaljšanje pilotne faze v leto 2008.
I look forward to continued progress and success in 2008. 
Že vnaprej se veselim nadaljnjega napredka in uspehov v letu 2008.
Bulgaria and Romania joined the EU on 1 January 2007. 
Bolgarija in Romunija sta se pridružili EU 1. januarja 2007.
The levels of activity in these areas increased again in 2007 (see chapter 2). 
Stopnja dejavnosti na teh področjih se je leta 2007 znova zvišala (glej poglavje 2).
Vaccination is seen as an important method of control. 
Cepljenje se šteje za pomembno nadzorno metodo.
System or process (Status in 2006) 
Sistem ali postopek (stanje v letu 2006)
Workshops, conferences, training 
Delavnice, konference, usposabljanje
Following this meeting, it was concluded that joint meetings would be held at least once a year, and that representatives from each group would attend meetings of the other group. 
Po tem sestanku je bila sprejeta odločitev, da bo skupni sestanek vsaj enkrat na leto in da se bodo predstavniki iz vsake skupine udeleževali sestankov druge skupine.
These systems are evolving in line with communicated requirements. 
Ti sistemi se razvijajo v skladu s sporočenimi zahtevami.
2.5 Parallel distribution 
2.5 Vzporedna distribucija
Communication on safety issues between all stakeholders is also considered a high priority. 
Visoko prednost ima tudi obveščanje o varnostnih vprašanjih med vsemi zainteresiranimi stranmi.
In summary, 2007 was a very productive year with intense activity in many areas, as you will note when you read the detail of this annual report. 
Če povzamemo, je bilo leto 2007 zelo plodno leto z intenzivnim delovanjem na številnih področjih, kar boste spoznali, ko boste podrobneje prebrali to letno poročilo.
• We assure continual improvement of our processes and procedures, in accordance with recognised quality standards. 
• Zagotavljamo nenehne izboljšave naših procesov in postopkov v skladu s priznanimi standardi kakovosti.
Resource planning in the network 
Načrtovanje sredstev v mreži
Information about medicines in all EU languages 
Informacije o zdravilih v vseh jezikih EU
As in previous years, the Agency and the Scientific Advice Working Party (SAWP) once again shortened the average time required for the delivery of scientific advice. 
Kot v preteklih letih sta Agencija in delovna skupina za znanstveno svetovanje (SAWP) znova skrajšali povprečen čas, ki je potreben za zagotovitev znanstvenega svetovanja.
A series of conclusions were reached that will assist decisionmakers in the relevant organisations. 
Sprejetih je bilo vrsto sklepov, ki bodo pomagali nosilcem odločanja v ustreznih organizacijah.
I succeeded Professor Hannes Wahlroos, who had so successfully chaired the Management Board for the previous three years. 
Nasledil sem profesorja Hannesa Wahlroosa, ki je zadnja tri leta tako uspešno predsedoval upravnemu odboru.
The majority of EU telematics systems were in use at the beginning of 2007. 
Večina telematskih sistemov EU se je uporabljala na začetku leta 2007.
Safety of medicines included in 7th Framework Programme 
Varnost zdravil, vključenih v 7. okvirni program
Thirty-six procedures were finalised. 
Končanih je bilo 36 postopkov.
Efforts to provide product-related information in all EU languages continued throughout 2007. 
Prizadevanja za zagotovitev informacij, povezanih z izdelki, v vseh jezikih EU so se nadaljevala skozi vse leto 2007.
Paediatric Committee fully operational 
Odbor za pediatrijo v celoti deluje
This was the first medicine for which an accelerated-assessment procedure was concluded successfully. 
To je bilo prvo zdravilo, za katero je bil uspešno dokončan postopek za pospešeno vrednotenje.
It was also the first medicine submitted by a company benefiting from incentives for SMEs. 
To je bilo tudi prvo zdravilo, ki ga je predložilo podjetje, ki uporablja spodbude za MSP;
Action plan for European Surveillance Strategy 
Akcijski načrt za evropsko strategijo nadzorovanja
The number of withdrawn applications - 19 - was the lowest in the past seven years. 
Število umaknjenih vlog - 19 - je bilo najnižje v zadnjih sedmih letih.
These proposals require contributions from both the Agency and national competent authorities. 
Ti predlogi zahtevajo prispevek Agencije in nacionalnih pristojnih organov.
• We are strongly committed to public and animal health. 
• Močno smo zavezani zdravju ljudi in živali.
Good progress on implementing rules on access to documents 
Dober napredek pri izvajanju pravil o dostopu do dokumentov
Work on this has barely started, as guidelines fundamental to the determination of the scope and functionality of the proposed system are not yet available in final form. 
Delo pri tem sistemu se je komaj začelo, saj smernice, ki so temelj določanja obsega in funkcionalnosti predlaganega sistema, še niso na voljo v končni obliki.
The Agency also contributed to the availability of a number of new medicines on the market, including new chemical entities and similar biological and generic medicines. 
Agencija je prispevala tudi k dostopnosti številnih novih zdravil na trgu, vključno z novimi kemijskimi entitetami ter podobnimi biološkimi in generičnimi zdravili.
Further development of interaction with healthcare professionals, patients and consumers 
Nadaljnji razvoj sodelovanja z zdravstvenim osebjem, bolniki in potrošniki
It is a great honour to be appointed to this post and I look forward to working with the members and all partners to advance the important work we undertake on behalf of citizens. 
V veliko čast mi je, da sem bil imenovan na to mesto, in zelo se veselim, da bomo s člani in vsemi partnerji nadaljevali pomembno delo, ki ga opravljamo v imenu državljanov.
In addition, feedback from the Member States indicated good quality overall of the translations provided by the pharmaceutical industry. 
Poleg tega so povratne informacije držav članice kazale na splošno dobro kakovost prevodov, ki jih je zagotovila farmacevtska industrija.
In collaboration with IFAH-Global, the EMEA hosted a Global Animal Health Conference on 15-16 November 2007. 
V sodelovanju z organizacijo IFAH-Global je agencija EMEA gostila konferenco o globalnem zdravju živali, ki je bila 15. in 16. novembra 2007.
1.5 Transparency, communication and provision of information 
1.5 Preglednost, obveščanje in zagotavljanje informacij
The first joint meeting with patients and healthcare professionals was held on 1 June 2007. 
Prvi skupni sestanek z bolniki in zdravstvenim osebjem je bil 1. junija 2007.
• We value the contribution of our partners and stakeholders to our work. 
• Spoštujemo prispevek naših partnerjev in zainteresiranih strani pri našem delu.
Twenty-nine internal and external recruitment procedures were carried out. 
Izvedenih je bilo 29 notranjih in zunanjih postopkov za zaposlovanje.
In addition, the EMEA systematically updated EPAR summaries relating to major variations. 
Poleg tega je agencija EMEA sistematično posodabljala povzetke EPAR, ki se nanašajo na večje spremembe.
The EMEA had adopted a decision on 4 of the 10 opinions by the end of 2007. 
EMEA je do konca leta 2007 sprejela sklepe o štirih od desetih mnenj.
They were transmitted to the European Commission for approval. 
Vpisa sta bila poslana v odobritev Evropski komisiji.
Sixty-seven percent of the Agency's revenue came from fee income. 
67 % prihodkov Agencije so pomenili prihodki od pristojbin.
At this stage, there is no suggestion that there is a general trend for decreasing activity in this area, but the level of activity will continue to be monitored. 
Za zdaj nič ne kaže na splošne smernice zmanjševanja dejavnosti na tem področju, vendar pa bomo stopnjo dejavnosti spremljali še naprej.
1 PRIORITIES IN 2007 
1 PREDNOSTNE NALOGE V LETU 2007
Three of the referrals were made under Article 33 and 3 were made under Article 35 of Directive 2001/82/EC. 
Tri napotitve so bile izvedene v skladu s členom 33, tri pa v skladu s členom 35 Direktive 2001/82/ES.
Improving the safety of medicines for human and veterinary use was once again one of the Agency's top priorities. 
Izboljšanje varnosti zdravil za uporabo v humani in veterinarski medicini je bila znova ena od najpomembnejših nalog Agencije.
In 2007, the Agency's activities in relation to transparency and communication concentrated on consolidating existing activities. 
V letu 2007 so se dejavnosti Agencije v zvezi s preglednostjo in obveščanjem osredotočale na krepitev sedanjih dejavnosti.
Seven meetings were held in total. 
Skupno je imel sedem sestankov.
The Agency strengthened its internal handling of requests for access to documents. 
Agencija je okrepila notranjo obravnavo zahtev za dostop do dokumentov.
The EMEA provided guidance and training for SMEs. 
Agencija EMEA je zagotavljala smernice in usposabljanje za MSP.
EudraVigilance Veterinary became the main reporting tool used by national competent authorities. 
EudraVigilance za veterinarstvo je postal glavno orodje za poročanje, ki ga uporabljajo nacionalni pristojni organi.
1.3 Stimulation of innovation 
1.3 Spodbujanje inovacij
Time required for centralised procedure remains low 
Čas, ki je potreben za centralizirani postopek, ostaja kratek
A new referral procedure - the procedure following Article 107(2) of Directive 2001/83/EC as amended - was used for the first time in 2007. 
Novi postopek napotitve - postopek v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena - je bil prvič uporabljen v letu 2007.
Contra-indications, warnings and precautions for use 
Kontraindikacije, opozorila in previdnostni ukrepi za uporabo
SME Office: supporting innovation among Europe's SMEs 
Urad za MSP: podpora inovacijam pri evropskih MSP
In addition to preliminary specification work for the next major upgrade, technical upgrades were implemented on the system. 
Poleg predhodnega načrtovanja za naslednjo večjo nadgradnjo so bile v sistemu izvedene tehnične nadgradnje.
Concept of risk-management plans firmly established 
Zasnova načrta za obvladovanje tveganja je trdno določena
3.1 Scientific advice Level of activity in relation to scientific advice lower than expected 
3.1 Znanstveno svetovanje Stopnja dejavnosti v zvezi z znanstvenim svetovanjem nižja od pričakovane
I would like to thank the members of all the scientific committees and working parties for their hard work, and also to thank the staff of the European Commission for their ongoing support. 
Zahvalil bi se še vsem članom znanstvenih odborov in delovnih skupin za njihovo trdo delo ter tudi osebju Evropske komisije za njegovo nenehno podporo.
The EMEA experienced yet another year of increases in all of its areas of activity. 
Za agencijo EMEA je bilo to še eno leto porasta na vseh področjih njene dejavnosti.
Two good laboratory practice (GLP) (non-clinical) inspections were carried out. 
Izvedena sta bila dva inšpekcijska pregleda dobre laboratorijske prakse (neklinična).
4.3 Sampling and testing 
4.3 Vzorčenje in preskušanje
2007 was the fifth year of implementation of the EU telematics projects by the Agency. 
Leto 2007 je bilo peto leto, odkar Agencija izvaja telematske projekte EU.
5 EU TELEMATICS STRATEGY 
5 TELEMATSKA STRATEGIJA EU
• involves representatives of patients, healthcare professionals and other stakeholders in its work, to facilitate dialogue on issues of common interest; 
• v svoje delo vključuje predstavnike bolnikov, zdravstvenih strokovnjakov in drugih zainteresiranih strani, da olajša dialog o temah, ki so v skupnem interesu;
• We promote the well-being, motivation and ongoing professional development of every member of the Agency. 
• Spodbujamo dobrobit, motivacijo in nenehno strokovno izpopolnjevanje vsakega člana Agencije.
The EMEA reviewed 92% of the risk-management plans submitted as part of new applications. 
EMEA je pregledala 92 % načrtov za obvladovanje tveganja, ki so bili predloženi kot del nove vloge.
EU enlargement 
Širitev EU
The Agency received entirely new responsibilities with the entry into force of Regulation (EC) No 1901/2006 on medicinal products for paediatric use (the Paediatric Regulation) on 26 January 2007. 
Agencija je dobila popolnoma nove odgovornosti, ko je začela veljati Uredba (ES) št. 1901/2006 o zdravilih za pediatrično uporabo (Uredba o pediatriji) 26. januarja 2007.
This increase from 183 days in 2006 arose due to fewer accelerated procedures being completed in 2007. 
To povečanje glede na 183 dni v letu 2006 je nastalo zaradi manjšega števila končanih postopkov pospešenega vrednotenja v letu 2007.
This plan now gives the required predictability to future development of EVV that is necessary for national competent authorities to commit the necessary resources to ensure its full and timely implementation. 
Ta načrt zdaj daje potrebno predvidljivost prihodnjemu razvoju EVV, ki je potrebna, da lahko nacionalni pristojni organi dodelijo potrebna sredstva za zagotovitev njegovega popolnega in pravočasnega izvajanja.
Inspections agencies that are not part of the national medicines agencies were added into the EudraNet. 
Agencije za inšpekcijske preglede, ki niso del nacionalnih agencij za zdravila, so bile dodane v omrežje EudraNet.
The EMEA also supported the Commission in its work to develop the new Regulation on Advanced Therapies, which was published in December 2007 and which will usher in further new responsibilities for the Agency in 2008. 
EMEA je tudi podpirala Komisijo pri njenem delu za razvoj nove Uredbe o naprednih terapijah, ki je bila objavljena decembra 2007 in ki uvaja nove odgovornosti za Agencijo v letu 2008.
EudraPharm was updated in 2007. 
Sistem EudraPharm je bil posodobljen v letu 2007.
Sponsors may request advice on whether their product can be classed as a medicinal product, thus being eligible for EMEA procedures. 
Sponzorji lahko zaprosijo za nasvet, ali je njihove izdelke mogoče opredeliti kot medicinske izdelke, da tako postanejo upravičenci za postopke agencije EMEA.
Six of these were class-1 recalls, compared with 2 during all of 2006. 
Šest od teh umikov je bilo 1. razreda v primerjavi z dvema v vsem letu 2006.
In 2007, the Agency received 7 requests for scientific advice (16 were forecast). 
V letu 2007 je Agencija prejela sedem zahtevkov za znanstveno svetovanje (pričakovanih jih je bilo 16).
As of December 2007, however, no referrals regarding herbal medicines had been received. 
Vendar pa od decembra 2007 ni bila prejeta nobena napotitev v zvezi z zdravili rastlinskega izvora.
INTRODUCTION BY THE EXECUTIVE DIRECTOR 
UVOD IZVRŠNEGA DIREKTORJA
It is believed this results from, among other factors, the Agency's efforts to promote awareness of expedited reporting. 
Menimo, da je to med drugim posledica prizadevanj Agencije, da spodbuja zavest o pospešenem poročanju.
The guideline on summary of product characteristics was revised in order to introduce new requirements in accordance with the new Paediatric Regulation. 
Smernica o povzetku značilnosti izdelka je bila spremenjena, tako da so v njej uvedene nove zahteve v skladu z novo Uredbo o pediatriji.
An important indicator of the EMEA's activity during any year is the number of applications it receives and processes for the initial marketing authorisation of medicines. 
Pomemben kazalnik dejavnosti agencije EMEA med katerim koli letom je število vlog, ki jih prejme, in postopkov za začetna dovoljenja za promet z zdravili.
Strengthening EudraVigilance to support proactive pharmacovigilance in the EU 
Krepitev sistema EudraVigilance za podpiranje proaktivne farmakovigilance v EU
Definition and implementation of EU Telematics controlled terms continued. 
Določanje in uveljavljanje sistema telematsko nadzorovanih pogojev EU se je nadaljevalo.
The HMPC status report on the progress made in relation to the implementation of the Directive since its entry into force, which had been forwarded to the European Commission for the preparation of its draft communication, was published on the EMEA website. 
Poročilo HMPC o doseženem napredku v zvezi z izvajanjem Direktive od začetka njene veljavnosti, ki je bilo posredovano Evropski komisiji za pripravo osnutka sporočila, je bilo objavljeno na spletni strani agencije EMEA.
However, work on the interim DataWarehouse solution for EudraVigilance Human had severe impact on work in this area. 
Vendar pa je delo pri začasni rešitvi podatkovnega skladišča za sistem EudraVigilance Human resno vplivalo na delo na tem področju.
Thirty-seven of the 92 requests were refused. 
Od 92 zahtevkov jih je bilo 37 zavrnjenih.
The number of reports received was almost double the number of reports received in 2006. 
Število prejetih poročil je bilo skoraj dvakrat tolikšno kot število prejetih poročil v letu 2006.
Activities in the area of supporting innovation and improving access to medicines yielded some very positive results in 2007. 
Dejavnosti na področju podpore inovacijam in izboljševanja dostopnosti zdravil so v letu 2007 prinesle nekaj zelo spodbudnih rezultatov.
The summaries of activities presented here reflect the excellent performance of all EMEA staff and national competent authority experts. 
Povzetki dejavnosti, predstavljeni tukaj, odražajo izvrstno delo celotnega osebja agencije EMEA in strokovnjakov nacionalnih pristojnih organov.
• We support research and innovation to stimulate the development of better medicines. 
• Podpiramo raziskave in inovativnost za spodbujanje razvoja boljših zdravil.
However, it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions (Article 31 procedure). 
Kljub temu ne sme biti prva izbira pri zdravljenju teh bolezni z nesteroidnimi protivnetnimi zdravili (NSAID) (postopek iz člena 31).
In this context, the CVMP adopted a positive opinion for an H7 avian-influenza vaccine. 
Zato je CVMP sprejel pozitivno mnenje za cepivo proti aviarni influenci H7.
With the legal and regulatory framework for similar biological medicines now firmly established, 10 applications for these were received in 2007. 
Pravni in regulativni okvir za podobna biološka zdravila je zdaj trdno določen, in tako smo v letu 2007 prejeli 10 vlog za taka zdravila.
Experts participate in the work of the EMEA as members of the scientific committees, working parties, scientific advisory groups or related groups. 
Strokovnjaki sodelujejo pri delu agencije EMEA kot člani znanstvenih odborov, delovnih skupin, znanstvenih svetovalnih skupin ali povezanih skupin.
Ninety-five percent of requests for access to documents were processed within the established timelines. 
95 odstotkov zahtevkov za dostop do dokumentov je bilo obravnavanih v določenem časovnem okviru.
Implementation of new procedures to facilitate early dialogue with sponsors resulted in an increased number of requests for regulatory eligibility and briefing meetings. 
Izvajanje novih postopkov za spodbujanje zgodnjega dialoga s sponzorji je prineslo povečano število zahtevkov za regulativno upravičenost in informativne sestanke.
• publishes impartial and comprehensible information about medicines and their use; 
• objavlja nepristranske in razumljive podatke o zdravilih in njihovi uporabi;
The meeting considered the major challenges facing the development of new medicines and the continuing availability of existing ones. 
Na srečanju so razpravljali o glavnih izzivih pri razvoju novih zdravil in stalni razpoložljivosti obstoječih zdravil.
6 EMEA BUDGET AND STAFF 
6 PRORAČUN IN OSEBJE AGENCIJE EMEA
Discussions with the European Commission resulted in the inclusion of the topic ‘Relative safety of NSAIDs' in the 2007 work programme for the health theme of the 7th Framework Programme. 
Rezultat razprav z Evropsko komisijo je bila vključitev teme „Relativna varnost nesteroidnih protivnetnih zdravil (NSAID)“ v delovni program za leto 2007 kot zdravstvena tema 7. okvirnega programa.
2.7 Arbitration and Community referrals Number of referrals submitted to the EMEA continued to rise 
2.7 Arbitraža in napotitve Skupnosti Število napotitev, predloženih agenciji EMEA, se je še naprej povečevalo
The average time required for the assessment, post-opinion and decision phases of the centralised procedure remained approximately at the 2006 level. 
Povprečni čas, ki je potreben za vrednotenje, stopnjo po izdaji mnenja in stopnjo odločitve pri centraliziranem postopku, je ostal približno enak kot v letu 2006.
On an organisational level, the EMEA conducted elections of chairs and vice-chairs for four of its scientific committees, including the new Paediatric Committee, and of a new chair for its Management Board. 
Na organizacijski ravni je EMEA izvedla volitve predsednikov in podpredsednikov za štiri od svojih znanstvenih odborov, vključno z novim Odborom za pediatrijo, in volitve novega predsednika upravnega odbora.
1.1 Implementation of the legislation on medicines for children 
1.1 Izvajanje zakonodaje o zdravilih za otroke
A total of €4.89 million from the EU special contribution was used to grant fee reductions for orphan medicines in 2007. 
Skupno 4,89 milijona EUR od posebnega prispevka EU je bilo v letu 2007 uporabljenih za odobritev znižanja pristojbin za zdravila sirote.
• develops best practice for medicines evaluation and supervision in Europe, and contributes alongside the Member States and the European Commission to the harmonisation of regulatory standards at the international level. 
• razvija najboljšo prakso za vrednotenje zdravil in nadzor nad njimi v Evropi ter skupaj z državami članicami in Evropsko komisijo prispeva k usklajevanju regulativnih standardov na mednarodni ravni.
Medicines to treat cancer still dominate 
Zdravila za zdravljenje raka še vedno prevladujejo
The electronic exchange of pharmacovigilance information within the EU is improving, as are active surveillance, harmonisation and risk management. 
Elektronska izmenjava podatkov o farmakovigilanci v EU se izboljšuje, enako pa velja tudi za aktivni nadzor, usklajevanje in obvladovanje tveganja.
More procedures finalised, in shorter time 
Večje število postopkov je bilo dokončno obdelanih v krajšem času