natgillin/translations-raw huggingface dataset:
Patients who are already on treatment will have their treatment reviewed by their doctor. 
Pri bolnikih, ki se že zdravijo, bo zdravnik njihovo zdravljenje pregledal.
To ensure that the medicine is used as safely as possible changes have been made to the way the medicine is used: 
Da bi zagotovili čim varnejšo uporabo zdravila, se je način njegove uporabe spremenil:
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States. 
Končna faza postopka pregleda je sprejetje pravno zavezujoče odločbe s strani Evropske komisije, ki stopi v veljavo v vseh državah članicah EU.
While the review is ongoing the PRAC has made a set of provisional recommendations to protect public health. 
Medtem ko pregled poteka, je odbor PRAC pripravil vrsto začasnih priporočil za zaščito javnega zdravja.
Measures include close monitoring and use of antibiotics to prevent pneumonia 
Ukrepi vključujejo skrbno spremljanje in uporabo antibiotikov za preprečevanje pljučnice
Healthcare professionals will be informed in writing about the precautionary measures to be taken. 
Zdravstveni delavci so bili pisno obveščeni o previdnostnih ukrepih, ki jih morajo izvajati.
Once the review is concluded, EMA will communicate further and provide guidance to patients and healthcare professionals. 
Po koncu pregleda bo EMA sporočila še več informacij ter bolnikom in zdravstvenim delavcem posredovala navodila.
If you are taking Zydelig and have any questions or concerns speak to your doctor or pharmacist. 
Če jemljete zdravilo Zydelig in imate kakršna koli vprašanja ali pomisleke, se pogovorite z zdravnikom ali farmacevtom.
Once the PRAC review is concluded any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion. 
Ko bo odbor PRAC zaključil pregled, bodo vsa nadaljnja priporočila posredovana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki bo sprejel končno mnenje.
These are provisional recommendations which the PRAC has issued, as a precaution, to protect patients while the medicine is being reviewed. 
To so začasna priporočila, ki jih je odbor PRAC izdal kot previdnostni ukrep za zaščito bolnikov v času pregleda zdravila.
Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended. 
Priporoča se tudi redno klinično in laboratorijsko spremljanje za okužbe s citomegalovirusom.
Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection. 
Bolnike je treba tudi spremljati zaradi okužbe in pri njih redno opravljati krvne preiskave za določitev števila belih krvnih celic, saj zmanjšano število lahko poveča tveganje za okužbo.
In case of neutropenia your doctor may stop your treatment with Zydelig. 
V primeru nevtropenije bo zdravnik morda vaše zdravljenje z zdravilom Zydelig prekinil.
• Patients should be informed about the risk of serious infections with Zydelig. 
• Bolnike je treba obvestiti, da pri zdravljenju z zdravilom Zydeliog obstaja tveganje za resne okužbe.
• You should not stop Zydelig before speaking to your doctor. 
• Zdravila Zydelig ne prenehajte jemati, dokler se ne posvetujete z zdravnikom.
More information on the approved uses of Zydelig can be found here. 
Več informacij o odobreni uporabi zdravila Zydelig je na voljo tukaj.
Other excess deaths related mainly to respiratory events. 
Drugi smrtni primeri, ki so presegali običajno umrljivost, so bili v glavnem povezani z dogodki na dihalih.
• Further information on the review of Zydelig will be provided as necessary and once the review is concluded. 
• Več informacij o pregledu zdravila Zydelig bo na voljo po potrebi in po zaključku pregleda.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. 
Pregled opravlja Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
Doctors should reevaluate each patient taking Zydelig first-line for CLL, and only continue treatment if the benefits outweigh the risks. 
Zdravniki morajo ponovno oceniti vsakega bolnika, ki prejema zdravilo Zydelig kot zdravilo prve izbira za KLL, zdravljenje pa se sme nadaljevati le, če so koristi večje od tveganj.
• a type of non-Hodgkin lymphoma called follicular lymphoma where it is used on its own. 
• vrste ne-Hodgkinovega limfoma, imenovane folikularni limfom, kjer se uporablja samostojno.
• Studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indication and investigated a combination of medicines not currently approved. 
• Študije pri ne-Hodgkinovem limfomu so vključevale bolnike z značilnostmi bolezni, ki so bile drugačne od značilnosti, zajetih v trenutno odobreno indikacijo, v študijah pa so preučevali kombinacijo zdravil, ki trenutno ni odobrena.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible. 
Odbor za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA je 17. marca 2016 izdal začasni nasvet za zdravnike in bolnike, ki uporabljajo zdravilo Zydelig (idelalizib) za zdravljenje raka, da bi še naprej zagotavljali njegovo čim varnejšo uporabo.
In case the patient has moderate or severe neutropenia treatment with Zydelig may have to be interrupted, in line with the updated summary of product characteristics (SmPC). 
Če ima bolnik zmerno ali hudo nevtropenijo, bo zdravljenje z zdravilom Zydelig skladno s posodobljenim povzetkom glavnih značilnosti zdravila morda treba prekiniti.
• If you are taking Zydelig, you will receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia) and be monitored for signs of infections. 
• Če jemljete zdravilo Zydelig, boste prejeli antibiotike za preprečevanje določene vrste pljučne okužbe (pljučnice, ki jo povzroča Pneumocystis jirovecii) in spremljali vas bodo zaradi znakov okužbe.
The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia). 
Odbor PRAC je priporočil, naj vsi bolniki, ki se zdravijo z zdravilom Zydelig, prejemajo antibiotike za preprečevanje določene vrste pljučne okužbe (pljučnice, ki jo povzroča Pneumocystis jirovecii).
• Further details on these provisional measures will be provided in writing to healthcare professionals and the product information will be updated accordingly. 
• Zdravstveni delavci so v pisni obliki prejeli več podrobnosti o začasnih ukrepih, v skladu s tem pa so bile posodobljene tudi informacije o zdravilu.
Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called nonHodgkin lymphoma). 
Zdravilo Zydelig je trenutno odobreno v EU za zdravljenje dveh vrst krvnega raka, imenovanih kronična limfocitna levkemija (KLL) in folikularni limfom (eden iz skupine rakov, imenovane ne-Hodgkinov limfom).
• Your doctor will order regular blood tests to minimise the risk of infections or neutropenia (low white blood cell count which may make you more likely to develop an infection). 
• Zdravnik vas bo poslal na redne krvne preiskave, da bi se tveganje za okužbe in nevtropenijo (nizko število belih krvnih celic, zaradi česar ste bolj dovzetni za razvoj okužbe) čim bolj zmanjšalo.
Most deaths related to infections such as Pneumocystis jirovecii pneumonia and cytomegalovirus infections. 
Večina smrtnih primerov je bila povezana z okužbami, kot je pljučnica, ki jo povzroča Pneumocystis jirovecii, in okužbami s citomegalovirusom.
• All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and should be monitored for respiratory signs and symptoms. 
• Vsi bolniki morajo med zdravljenjem z zdravilom Zydelig prejemati profilaktično zdravljenje za pljučnico, ki jo povzroča P. jirovecii, spremljati pa jih je treba zaradi pojava znakov in simptomov na dihalih.
• No new patients with chronic lymphocytic leukaemia (CLL) will be started on Zydelig if they have not received previous treatment for their cancer. 
• Novi bolniki s kronično limfocitno levkemijo (KLL) se ne bodo začeli zdraviti z zdravilom Zydelig, če zdravil za zdravljenje raka predhodno še niso prejemali.
The clinical trials, which have now been stopped, involved patients with CLL and indolent non-Hodgkin lymphoma. 
Klinična preskušanja, ki so jih že prekinili, so vključevala bolnike s KLL in indolentnim neHodgkinovim limfomom.
• Further information on Zydelig will be provided as necessary. 
• Več podatkov o zdravilu Zydelig bo na voljo po potrebi.
Zydelig should not be started in patients with a generalised infection. 
Zdravilo Zydelig se ne sme uvesti pri bolnikih z generalizirano okužbo.
• Zydelig can continue to be used in combination, only with rituximab, in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment. 
• Zdravilo Zydelig se lahko še naprej uporablja v kombinaciji, samo z rituksimabom, pri bolnikih s KLL, ki so prejemali vsaj eno predhodno zdravljenje, in kot monoterapija pri bolnikih s folikularnim limfomom, neodzivnim na dve obliki zdravljenja.
Zydelig must not be started in patients with any evidence of ongoing systemic infection. 
Zdravilo Zydelig se ne sme uvesti pri bolnikih s kakršnimi koli znaki potekajoče sistemske okužbe.
The review started after a higher rate of serious adverse events was seen in three clinical trials among patients receiving Zydelig compared with placebo (a dummy treatment).1 The adverse events included deaths related to infections such as pneumonia. 
Pregled se je začel, ko so v treh kliničnih preskušanjih pri bolnikih, ki so prejemali zdravilo Zydelig, opazili povečano pogostnost resnih neželenih učinkov v primerjavi s placebom (zdravilom brez zdravilne učinkovine).1 Neželeni učinki so vključevali smrtne primere, povezane z okužbami, kot je pljučnica.
It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation). 
Prav tako se ne sme uvesti pri predhodno nezdravljenih bolnikih s KLL, pri katerih rakave celice vsebujejo določeno gensko mutacijo (delecijo 17p ali mutacijo TP53).
These will now be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States. 
Priporočila so bila predložena Evropski komisiji, ki je 23. marca 2016 izdala začasno pravno zavezujočo odločbo, ki velja za vse države članice EU.
• As a precaution and while a thorough review is ongoing, Zydelig should not be started as first-line treatment in patients with CLL who have the 17p deletion or TP53 mutation. 
• Kot previdnostni ukrep in v času temeljitega pregleda se zdravilo Zydelig ne sme uvesti kot zdravilo prve izbire pri bolnikih s KLL, ki imajo delecijo 17p ali mutacijo TP53.
• chronic lymphocytic leukaemia in patients who have received previous treatment as well as in previously untreated patients who have certain genetic mutations (17p deletion or TP53 mutation) in their cancer cells. 
• kronične limfocitne levkemije pri bolnikih, ki so predhodno že prejemali zdravljenje, in pri predhodno nezdravljenih bolnikih z določenimi genskimi mutacijami (delecijo 17p ali mutacijo TP53) v rakavih celicah.
• Patients should also have regular checks of their blood counts to detect neutropenia. 
• Redno je treba preverjati krvno sliko za odkrivanje nevtropenije.
There have been reports of serious side effects in clinical studies with the cancer medicine Zydelig. 
Iz kliničnih študij z zdravilom Zydelig za zdravljenje raka so poročali o resnih neželenih učinkih.
You should contact your doctor straight away if you develop fever, cough or difficulty breathing. 
Če se pojavijo povišana telesna temperatura, kašelj ali težave z dihanjem, se takoj posvetujte z zdravnikom.
• Increased rates of serious adverse effects including deaths were seen in 3 clinical trials in the treatment arm evaluating the addition of Zydelig to standard therapy in first-line CLL and relapsed indolent non-Hodgkin lymphoma. 
• V treh kliničnih preskušanjih, v katerih so vrednotili dodatek zdravila Zydelig k standardnemu zdravljenju pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu, so v terapevtski veji opazili povečano pogostnost resnih neželenih učinkov, vključno s smrtnimi primeri.
The clinical trial in CLL involved patients who had not received previous treatment, some of whom had the 17p deletion or TP53 mutation; however, it also investigated a combination of medicines which is currently not approved. 
V klinično preskušanje pri KLL so bili vključeni bolniki, ki se predhodno niso zdravili, in med njimi so bili tudi bolniki z delecijo 17p ali mutacijo TP53.
No meeting in August 
V avgustu ni sestanka
3 Final accounts 2004. 
3 Zaključni račun 2004.
NATIONAL COMPETENT AUTHORITIES NATIONAL COMPETENT AUTHORITIES 3,500 EUROPEAN EXPERTS 3,500 EUROPEAN EXPERTS 
NACIONALNI PRISTOJNI ORGANI NATIONAL COMPETENT AUTHORITIES 3500 EVROPSKIH STROKOVNJAKOV 3,500 EUROPEAN EXPERTS
A need for this type of meeting may emerge, for example, in the event of a pandemic-influenza outbreak. 
Potreba po takem sestanku se na primer lahko pojavi pri izbruhu pandemije gripe.
The priorities and key objectives for 2006 can be summarised as follows: 
Prednostne naloge in ključne cilje za leto 2006 je mogoče povzeti na naslednji način:
18 Staff insurances 
18 Zavarovanje osebja
London E14 4HB UK 
London E14 4HB Združeno kraljestvo
• by writing to: 
• pisno na:
The Agency will be able to organise meetings within 24 hours, on any day of the week. 
Agencija bo sestanke lahko organizirala v 24 urah, vse dni v tednu.
301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes 
300 Sestanki 301 Ocenjevanje 302 Prevajanje 303 Študije in svetovalci 304 Objavljanje 305 Programi Skupnosti
Safety of medicines has been the Agency's priority for a number of years. 
Varnost zdravil je že vrsto let prednostna naloga Agencije.
Experience obtained so far will be reviewed and opportunities for improvement will be identified. 
Do sedaj pridobljene izkušnje bodo pregledane in določene bodo možnosti za izboljšave.
Small and medium-sized enterprises 
Mala in srednje velika podjetja
The European Commission has issued new regulations on transparency and will be reviewing European copyright laws. 
Evropska komisija je izdala nove predpise o preglednosti in bo pregledovala evropske zakone o avtorskih pravicah.
The EMEA is deeply committed to being a transparent, open and accessible organisation. 
EMEA je globoko zavezana, da bo pregledna, odprta in dostopna organizacija.
A twoyear rolling work plan on the detailed initiatives to be undertaken up to mid 2007 has been established. 
Oblikovan je bil dvoletni krožni delovni načrt o podrobnih pobudah, ki jih je treba sprejeti do sredine leta 2007.
A pilot project for the introduction of Internet telephony (voice over IP) will be started. 
Začel se bo izvajati pilotni projekt za uvedbo internetne telefonije (prenos glasu prek IP).
Meeting forecasts for 2006 again point to a significant increase in the number of meetings and delegate-days. 
Napovedi sestankov za leto 2006 spet kažejo na pomembno povečanje števila sestankov in delegatskih dni.
MANAGEMENT BOARD MANAGEMENT BOARD Chairman: Hannes Wahlroos Chairman: Hannes Wahlroos 
UPRAVNI ODBOR MANAGEMENT BOARD Predsednik: Hannes Wahlroos Chairman: Hannes Wahlroos
The Agency also expects good progress on external evaluations carried out by Canada by the end of the year. 
Agencija do konca leta pričakuje tudi dober napredek na področju zunanjih ocenjevanj, ki jih izvaja Kanada.
This should result in a more intensive drug-monitoring system. 
Tako bi morali vzpostaviti intenzivnejši sistem spremljanja zdravil.
The first production version of EudraGMP will be ready for use in the third quarter of 2006. 
Prva delovna različica EudraGMP bo pripravljena za uporabo v tretji četrtini leta 2006.
AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total grade AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total grade AST Total Staff 
AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Stopnja AD skupaj AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Stopnja AST skupaj Osebje skupaj
This will be done by identifying areas where expertise needs to be reinforced and developed. 
To bo dosegla tako, da bo opredelila področja, kjer je treba strokovno znanje in izkušnje okrepiti in razviti.
Implementation of the Management Board decision on access to the Agency's documents, ensuring the widest possible public access. 
izvajanje sklepa upravnega odbora o dostopu do dokumentov Agencije, kar zagotavlja največji možni dostop javnosti.
Efficient handling of the process is, therefore, essential. 
Zato je bistvenega pomena učinkovito vodenje postopkov.
EUROPEAN UNION INSTITUTIONS EUROPEAN UNION INSTITUTIONS 
INSTITUCIJE EVROPSKE UNIJE EUROPEAN UNION INSTITUTIONS
The Agency will implement procedures for the organisation of emergency meetings. 
Agencija bo izvedla postopke za organizacijo izrednih sestankov.
This is in line with the Agency's priorities in the area of safety of medicinal products. 
To je v skladu s prednostnimi nalogami Agencije na področju varnosti zdravil.
Shoulder-to-shoulder cooperation with the national competent authorities is vital to the success of these initiatives. 
Tesno sodelovanje z nacionalnimi pristojnimi organi je ključno za uspeh teh pobud.
Providing targeted, understandable and accessible information to patients and healthcare professionals is an important element of that commitment, and will continue to be a priority for the Agency in 2006. 
Zagotavljanje ciljno usmerjenih, razumljivih in dostopnih informacij bolnikom in zdravstvenim strokovnjakom je pomemben element te zavezanosti in bo še naprej prednostna naloga Agencije v letu 2006.
The Agency will implement the new legislation and guidelines concerning SMEs. 
Agencija bo izvajala novo zakonodajo in smernice, ki zadevajo mala in srednje velika podjetja.
The EU telematics programme is delivering improved communication and better access to data. 
Telematski program EU zagotavlja izboljšano sporočanje in boljši dostop do podatkov.
The EMEA plans to review its key processes in order to rationalise their functioning. 
EMEA načrtuje pregled svojih ključnih procesov, da bi racionalizirala njihovo delovanje.
In the increasingly global pharmaceuticals sector, the Agency's contribution to international scientific forums on harmonisation of the regulatory environment is significant. 
V vse bolj globaliziranem farmacevtskem sektorju je prispevek Agencije k mednarodnim znanstvenim forumom o usklajevanju regulativnega okolja bistven.
11 Staff in active employment 13 Mission expenses 
11 Aktivno zaposleno osebje 13 Stroški nalog
The corresponding suite for veterinary medicines will be rolled out in September 2006. 
Ustrezen nabor za veterinarska zdravila bo objavljen septembra 2006.
A pilot exercise for web meetings will run during the first half of 2006 to examine the potential benefits of this approach. 
Pilotna izvedba spletnih sestankov se bo začela v prvi polovici leta 2006, da bi preučili morebitne prednosti tega pristopa.
Information on nationally authorised products may be included for those Member States who have provided their product data and signed a memorandum of understanding on data exchange and maintenance. 
Informacije o nacionalno odobrenih izdelkih se lahko vključijo za tiste države članice, ki so zagotovile podatke o svojih izdelkih in podpisale memorandum o soglasju glede izmenjave podatkov in vzdrževanja.
The Agency's involvement in this cycle will continue in 2006. 
Sodelovanje Agencije v tem ciklusu se bo nadaljevalo tudi v letu 2006.
The Agency therefore needs to revisit its policy on access to documents and related copyright issues. 
Agencija mora tako pregledati svojo politiko dostopa do dokumentacije in s tem povezanih vprašanj avtorskih pravic.
In the coming year, the Agency will continue to build on the priorities set out in its long-term strategy, and will focus on the following areas: 
V prihajajočem letu bo Agencija še naprej gradila na prednostnih nalogah, določenih v njeni dolgoročni strategiji, in se osredotočila na naslednja področja:
The Agency will continue to work with its international partners to create a more comprehensible regulatory environment and to improve access to medicines. 
Agencija bo še naprej sodelovala s svojimi mednarodnimi partnerji za oblikovanje razumljivejšega regulativnega okolja in izboljšanje dostopa do zdravil.
Strengthening the European medicines network. 
krepitev Evropske mreže zdravil.
Community programmes 
Programi Skupnosti
Emphasis will be placed on full implementation of the new Community legislation and on the monitoring of this implementation. 
Posebna pozornost se bo posvetila polnemu izvajanju nove zakonodaje Skupnosti in njegovemu spremljanju.
As a result of measures implemented in 2005, the Agency now provides a wider range of information to the public about the medicinal products it evaluates. 
Agencija zaradi izvedenih ukrepov leta 2005 sedaj javnosti zagotavlja več vrst informacij o zdravilih, ki jih vrednoti.
Consolidating and fully operating the procedures introduced by the Agency in 2005, following the entry into force of the new EU pharmaceutical legislation. 
utrditev in polna uporaba postopkov, ki jih je Agencija uvedla leta 2005, ko je začela veljati nova farmacevtska zakonodaja EU.
Contribute to the EU programme to reduce animal testing and develop other modern approaches for safety assessment of substances. 
prispevek k programu EU za zmanjšanje poskusov na živalih in razvoj drugih modernih pristopov za oceno varnosti snovi.
In the field of transparency, the Agency will build on the achievements of previous years, and will concentrate its efforts in three areas: 
Na področju preglednosti bo Agencija gradila na dosežkih preteklih let in bo svoja prizadevanja usmerila na tri področja:
Patients and healthcare professionals need access to useful, targeted and easily understandable information about medicines. 
Bolniki in zdravstveni strokovnjaki potrebujejo dostop do uporabnih, ciljno naravnanih in enostavno razumljivih informacij o zdravilih.
At the international level, the Agency will continue to coordinate the EU's participation in the International Conferences on Harmonisation (ICH and VICH), with an increased contribution expected from the Agency and its scientific committees in 2006. 
Na mednarodni ravni bo Agencija še naprej usklajevala sodelovanje EU na Mednarodnih konferencah o usklajevanju (ICH in VICH), kjer se pričakuje večji prispevek Agencije in njenih znanstvenih odborov leta 2006.
The number of meetings is forecast to increase by 5% and the number of reimbursed delegates by 33%. 
Napovedano je, da se bo število sestankov povečalo za 5 %, število delegatov, ki jim je treba povrniti stroške, pa za 33 %.
This is a challenging legislative initiative, requiring new expertise on medicines and diseases not encountered in Europe. 
To je zahtevna zakonodajna pobuda, za katero je treba imeti dodatno strokovno znanje o zdravilih in boleznih, ki jih v Evropi ni.
The second goal is to effectively manage arbitrations and referrals. 
Drugi cilj je učinkovito upravljanje arbitraže in predložitev.
Number of videoconferences and reimbursed meetings 
Število videokonferenc in sestankov s povrnjenim stroški