natgillin/translations-raw huggingface dataset:
This reflects the increasing number of authorised medicines requiring re-inspection, increasing numbers of variations, and some unanticipated PMF inspections. 
To odraža čedalje večje število zdravil z dovoljenjem za promet, za katera je potreben vnovični pregled, rastoče število sprememb in nekaj nepričakovanih inšpekcijskih pregledov glavnega dosjeja plazme.
Use of special authorisation procedures: facilitating availability of medicines 
Uporaba posebnih postopkov za izdajo dovoljenja za promet z zdravilom: zagotavljanje dostopnosti zdravil
Its benefit - when used in combination with other antiretroviral medicines - is its ability to reduce the amount of HIV in plasma (viral load) and increase the number of T cells (specifically CD4 cells) in treatmentexperienced patients with CCR5-tropic HIV-1. 
Njegova prednost, kadar se uporablja v kombinaciji z drugimi antiretrovirusnimi zdravili, je njegova sposobnost zmanjševanja števila virusov HIV v plazmi (virusna obremenitev) in povečevanja števila celic T (natančneje celic CD4) pri bolnikih, ki so vajeni zdravljenja in so okuženi s CCR5-tropnim virusom HIV-1;
Stocrin and Sustiva (efavirenz): deletion of the contra-indication for their co-administration with voriconazole. 
• Stocrin in Sustiva (efavirenz): brisanje kontraindikacij za njuno hkratno jemanje z vorikonazolom.
The first two dipeptidyl peptidase 4 (DPP-IV) inhibitors, both indicated for the treatment of type-II diabetes. 
• Prva dva zaviralca dipeptidil peptidaze (DPP-IV), terapevtska indikacija za oba zaviralca je zdravljenje diabetesa tipa 2.
Review of veralipride-containing medicines, following the withdrawal of veralipride form the Spanish market because of reports of serious side effects affecting the nervous system and a number of regulatory actions in other EU Member States where veralipride was authorised. 
• Presoja zdravil, ki vsebujejo veraliprid, po umiku veraliprida s španskega trga zaradi poročil o resnih stranskih učinkih, ki prizadenejo živčni sistem, in številnih regulativnih ukrepov v drugih državah članicah EU, v katerih je bilo izdano dovoljenje za promet z veralipridom.
2.2 Scientific advice and protocol assistance Interest in obtaining scientific advice and protocol assistance remained high 
2.2 Znanstveno svetovanje in pomoč pri protokolu Zanimanje za znanstveno svetovanje in pomoč pri protokolu je ostalo veliko
No such restrictions were recommended for the remaining indication, the treatment of community-acquired pneumonia; 
Za preostalo terapevtsko indikacijo, zdravljenje doma pridobljene pljučnice, niso bile priporočene take omejitve;
The EMEA, the European Directorate for the Quality of Medicines and HealthCare, and the national authorities in the sampling-and-testing programme continued their close collaboration in 2007, with a view to assuring effective and continued post-marketing surveillance of the quality of medicines. 
Agencija EMEA, Evropski direktorat za kakovost zdravil in zdravstvenega varstva ter nacionalni pristojni organi so v letu 2007 pri programu vzorčenja in preskušanja nadaljevali tesno sodelovanje, da zagotovijo učinkovit in neprekinjen nadzor kakovosti zdravil po pridobitvi dovoljenja za promet.
A total of 6 referral procedures relating to veterinary medicines were initiated, of which 1 related to safety concerns for existing medicines. 
Začetih je bilo skupno šest postopkov napotitve v zvezi z zdravili za uporabo v veterinarski medicini, od katerih se je eden nanašal na pomisleke o varnosti obstoječih zdravil.
The EMEA received a total of 92 requests for access to documents - an increase of more than 30% over 2006. 
Agencija EMEA je prejela skupno 92 zahtevkov za dostop do dokumentov - to pomeni, da se je število zahtevkov v primerjavi z letom 2006 povečalo za več kot 30 %.
Experts from academia and university hospitals on secondment to the EMEA contributed to the work of the European medicines network, ensuring the availability of complementary expertise. 
Strokovnjaki iz akademskih krogov in univerzitetnih bolnišnic, ki so bili začasno dodeljeni agenciji EMEA, so prispevali k delu Evropske mreže zdravil in tako zagotovili dosegljivost posebnega znanja.
One positive opinion related to the establishment of final MRLs further to previous provisional MRLs for a new substance. 
Eno pozitivno mnenje se je nanašalo na določitev končnih mejnih vrednosti ostankov po predhodni določitvi začasnih mejnih vrednosti ostankov za novo snov.
In 2007, the EMEA's Committee for Medicinal Products for Human Use (CHMP) adopted 58 positive opinions on initial-evaluation applications - the highest number ever. 
V letu 2007 je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA sprejel 58 pozitivnih mnenj o vlogah za začetno vrednotenje - to je največje število doslej.
The CHMP recommended the refusal of the new indication because the data submitted were considered insufficient to demonstrate efficacy in the applied indication (Article 6(12) procedure). 
CHMP je priporočil zavrnitev nove indikacije, ker je menil, da predloženi podatki ne zadostujejo za potrditev učinkovitost teh zdravil pri uporabljeni indikaciji (postopek iz člena 6(12)).
The Agency's total budget in 2007 was €163,113,000 - an increase of approximately 20% compared to 2006. 
Skupni proračun Agencije za leto 2007 je znašal 163 113 000 EUR - v primerjavi s proračunom za leto 2006 je to približno za 20 % višji znesek.
Safety review of Viracept 
Presoja varnosti zdravila Viracept
The public-health benefit behind these figures is that many new medicines to treat a range of diseases and conditions - from cancers to cardiovascular and neurological disorders - are now available for the treatment of Europe's patients. 
Ta številka za javno zdravje pomeni, da je zdaj za zdravljenje bolnikov v Evropi na voljo veliko novih zdravil za različne bolezni in stanja - od raka do bolezni srca in ožilja ter nevroloških motenj.
The CHMP concluded that the benefits of these medicines outweigh their risks, but only in those patients who are at high risk of their disease getting worse (Article 31 procedure). 
CHMP je sprejel odločitev, da koristi tega zdravila presegajo tveganja zaradi njegove uporabe, vendar le pri tistih bolnikih, pri katerih obstaja velika nevarnost, da se bo njihova bolezen poslabšala (postopek iz člena 31).
Review of medicines containing bicalutamide 150mg, triggered by safety concerns, in particular heart problems, when the medicine is used in the treatment of early prostate cancer. 
• Presoja zdravil, ki vsebujejo 150 mg bikalutamida, ki jo je spodbudila zaskrbljenost glede varnosti, še posebej zaradi težav s srcem, kadar se zdravilo uporablja za zdravljenje zgodnjega stadija raka prostate.
It is authorised for the treatment of multiple myeloma, where it works by blocking the development of tumour cells and by stimulating some of the specialised cells of the immune system to attack the cancerous cells. 
Odobreno je za zdravljenje multiplega mieloma, kjer deluje tako, da zavira razvoj celic tumorja in spodbuja nekatere specializirane celice imunskega sistema, naj napadejo rakaste celice;
Of the 8 pharmaceutical applications, 1 was a generic application. 
Od osmih farmacevtskih vlog je bila ena vloga generična.
Cooperation among EU Agencies was intensive too, with the EMEA engaging in activities with the European Centre for Disease Prevention and Control, in particular in relation to pandemic-influenza preparedness and advanced therapies; with the European Food Safety Authority; with the European Monitoring Centre for Drugs and Drug Addiction; and with the European Directorate for the Quality of Medicines and HealthCare. 
Tesno je bilo tudi sodelovanje med agencijami EU, saj je EMEA sodelovala pri dejavnostih z Evropskim centrom za preprečevanje in obvladovanje bolezni (zlasti v zvezi s pripravljenostjo na pandemijo gripe in naprednim zdravljenjem gripe), z Evropsko agencijo za varnost hrane, Evropskim centrom za spremljanje drog in zasvojenosti z drogami ter Evropskim direktoratom za kakovost zdravil in zdravstvenega varstva (European Directorate for the Quality of Medicines and HealthCare).
2.3 Initial evaluation New applications in 2007 
2.3 Začetno vrednotenje Nove vloge v letu 2007
Further support for increased availability of medicines was also generated through the Agency's high output in relation to medicines for rare diseases - with more positive opinions being adopted in favour of orphan designation than in any previous year - and through the continuing work of the Agency's Innovation Task Force and Think-tank on innovative drug development, as well as through its support for the European Commission's Pharmaceutical Forum and Innovative Medicines Initiative. 
Nadaljnja podpora za povečano dostopnost zdravil je bila prav tako ustvarjena na podlagi visoke storilnosti Agencije v zvezi z zdravili za redke bolezni - letos je bilo izdanih več pozitivnih mnenj za zdravila sirote kot katero koli leto prej - in na podlagi neprekinjenega dela delovne skupine Agencije za inovacije in možganskega trusta za razvoj inovativnih zdravil, pa tudi s podporo Agencije farmacevtskemu forumu Evropske komisije in pobudi za inovativna zdravila.
Six medicines had their use extended to include the treatment of children and adolescents suffering from diseases such as Crohn's disease, anaemia associated with chronic renal failure, or HIV, or to include immunisation against additional infections caused by streptococcus pneumoniae. 
• Pri šestih zdravilih je bila razširjena uporaba, tako da vključuje zdravljenje otrok in mladostnikov, ki so oboleli za boleznimi, kot so Crohnova bolezen, anemija, povezana s kronično odpovedjo ledvic, ali HIV, ali da vključuje imunizacijo pred dodatnimi okužbami, ki jih povzroča bakterija Streptococcus pneumoniae.
By the end of 2007, a total of 44 orphan medicines had been granted a marketing authorisation by the European Commission since the orphan policy entered into force in 2001. 
Od leta 2001, ko je začela veljati politika zdravil sirot, do konca leta 2007 je Evropska komisija podelila dovoljenja za promet za skupno 44 zdravil sirot.
In 3 cases, the CHMP recommended withdrawal and in 2 cases temporary suspension of the marketing authorisation. 
V treh primerih je CHMP priporočil ukinitev, v dveh pa začasni umik dovoljenja za promet z zdravilom.
EU Telematics Controlled Terms (In pilot production) 
Telematsko nadzorovani pogoji EU (v pilotni fazi izdelave)
The second vaccine for prophylaxis against high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papilloma virus (HPV) types 16 and 18. 
• Drugo cepivo za profilakso proti cervikalni intraepitelijski neoplaziji visoke stopnje (CIN 2. in 3. stopnje) in raku materničnega vratu, ki sta vzročno povezani s humanim papiloma virusom (HPV) tipov 16 in 18;
A designated orphan medicinal product intended to reduce haemolysis (destruction of red blood cells) in patients with paroxysmal nocturnal haemoglobinuria (PNH) - a rare blood disorder in which the red blood cells are destroyed more rapidly than normal, causing the urine to turn dark. 
• Zdravilo, določeno kot zdravilo sirota, ki je namenjeno za zmanjševanje hemolize (razpadanje rdečih krvničk) pri bolnikih s paroksizmalno nočno hemoglobinurijo (PNH) - redko krvno motnjo, pri kateri rdeče krvničke razpadajo hitreje kot običajno, kar povzroči, da urin potemni.
Eight of the 10 opinions adopted were for full waivers and 2 were for PIPs. 
Osem od desetih sprejetih mnenj se je nanašalo na popolne opustitve, dve mnenji pa na načrte pediatričnih raziskav.
By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall. 
Z zaviranjem nastajanja angiotenzina I se znižata ravni angiotenzina I in angiotenzina II.
Several extensions of indication were granted for the treatment of diabetes, providing more options for the combined use of oral antidiabetics and insulins. 
• Odobrenih je bilo več razširitev terapevtskih indikacij za zdravljenje sladkorne bolezni, kar ponuja več možnosti za hkratno uporabo oralnih antidiabetikov in inzulinov.
EudraCT Paediatrics Database (At inception) 
Pediatrična zbirka podatkov EudraCT (na začetku)
a new warning for recombinant factor VIII medicines regarding the possible recurrence of inhibitors after switching from one recombinant factor VIII medicine to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development (class labelling); 
• novim opozorilom za zdravila z rekombinantnim faktorjem VIII glede morebitnega vnovičnega pojava inhibitorjev po zamenjavi enega zdravila z rekombinantnim faktorjem VIII z drugim takim zdravilom pri predhodno zdravljenih bolnikih, ki so bili izpostavljeni več kot 100 dni in imajo zgodovino pojavljanja inhibitorjev (oznaka razreda);
Based on the available published data, the benefit/risk profile of mifepristone in combination with oral misoprostol for pregnancy from 50 to up to 63 days is unfavourable due to poor efficacy. 
Na podlagi dostopnih objavljenih podatkov je profil prednosti/tveganj za mifepriston v kombinaciji z misoprostolom za peroralno uporabo pri nosečnosti, ki traja od 50 do največ 63 dni, neugoden zaradi slabe učinkovitosti.
Procedures of high public-health interest finalised in 2007 
Postopki, ki so velikega pomena za zdravje ljudi, končani v letu 2007
3 MEDICINES FOR VETERINARY USE 
3 ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
They work by blocking the breakdown of incretin hormones in the body, thereby stimulating the pancreas to produce insulin when blood-glucose level is high, and also decreasing the levels of the hormone glucagon. 
Delujeta tako, da v telesu preprečujeta razpadanje hormonov inkretina in tako spodbujata trebušno slinavko k proizvajanju inzulina, kadar je raven glukoze v krvi visoka, ter tudi znižujeta raven hormona glukagon.
One of the class-1 recalls (Viracept) led to a substantial amount of follow-up activity, to prevent reoccurrence of similar issues (critical GMP failure leading to high-level contamination with genotoxic impurities) with any similar medicines (mesilate and related active substances) in the EU, whether centrally authorised or authorised through mutual-recognition, decentralised or national procedures. 
Eden od umikov 1. razreda (Viracept) je privedel do znatnega števila nadaljnjih ukrepov za preprečitev ponovitve podobnih težav (huda napaka pri dobri proizvodni praksi, ki je privedla do močnega onesnaženja z genotoksičnimi nečistočami) pri katerem koli podobnem zdravilu (mesilat in z njim povezane aktivne snovi) v EU, ne glede na to, ali je bilo dovoljenje za promet z zdravilom izdano po centraliziranem postopku, postopku medsebojnega priznavanja, decentraliziranem postopku ali pa je bilo izdano nacionalno.
About 10% (33) of signals were followed up for routinely monitored medicines, with involvement of the rapporteur in 21 cases. 
Pri rutinsko spremljanih zdravilih je bilo potrebno nadaljnje ukrepanje pri približno 10 % signalov (33), poročevalec pa je sodeloval pri 21 primerih.
a new warning with an urgent safety restriction (USR) concerning the rare but serious risk of drug rash with eosinophilia and systemic symptoms (a severe type of allergic reaction) with strontiumranelate-containing medicines (used to treat osteoporosis in women who have been through menopause). 
• novim opozorilom z nujnim varnostnim ukrepom (USR) glede redke, a resne nevarnosti izpuščajev zaradi zdravila z eozinofilijo in sistemskimi simptomi (huda oblika alergične reakcije) pri jemanju zdravil, ki vsebujejo stroncijev ranelat (uporabljajo se za zdravljenje osteoporoze pri ženskah v menopavzi).
The mission of the EMEA is to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public and animal health, and all that we do collectively is focused to that end. 
Poslanstvo agencije EMEA je spodbujanje znanstvene odličnosti pri ocenjevanju zdravil in nadzoru nad njimi v dobro zdravja ljudi in živali, in vse naše skupno delo se osredotoča na ta cilj.
Two marketing authorisations issued in 2007 for veterinary medicines benefited from having received scientific advice from the Committee for Medicinal Products for Veterinary Use (CVMP): 1 medicine for treatment of congestive heart failure in dogs, and 1 vaccine against porcine circovirus infection in pigs. 
Dve dovoljenji za promet z veterinarskim zdravilom, izdani v letu 2007, sta imeli korist od prejemanja znanstvenega svetovanja, ki ga je izvajal Odbor za zdravila za uporabo v veterinarski medicini (CVMP): eno zdravilo za zdravljenje kongestivne odpovedi srca pri psih in eno cepivo proti okužbi s prašičjim cirkovirusom (PCV) pri prašičih.
The CHMP restricted the indication for a number of medicines for efficacy or safety reasons, including: 
CHMP je zaradi učinkovitosti ali varnosti omejil terapevtske indikacije za več zdravil, med drugim za zdravila:
Development of the Eudra DataWarehouse was ongoing. 
Razvoj podatkovnega skladišča Eudra se je nadaljeval.
A new rolling two-year work programme for 2008-2009 was prepared by the EMEA and adopted by the Heads of Medicines Agencies, together with the ERMS status report. 
EMEA je pripravila nov tekoči dvoletni program za leti 2008 in 2009, vodje agencij za zdravila pa so ga sprejeli skupaj s poročilom o stanju evropske strategije obvladovanja tveganja.
3.3 Establishment of maximum residue limits Applications for maximum residue limits (MRLs) 
3.3 Določitev najvišjih mejnih vrednosti ostankov Vloge za najvišje mejne vrednosti ostankov (MRL)
The ongoing decrease in MRL applications is consistent with the comparatively greater interest currently seen for the development of new medicines for companion animals rather than for food-producing animals. 
Stalno upadanje števila vlog za najvišje mejne vrednosti ostankov se sklada z opaženim primerljivo povečanim zanimanjem za razvijanje novih zdravil za hišne živali namesto za živali, namenjene za proizvodnjo hrane.
Three opinions were adopted recommending granting of a conditional marketing authorisation (Isentress, Vectibix and Tyverb). 
Sprejeta so bila tri mnenja, ki priporočajo izdajo pogojnega dovoljenja za promet z zdravilom (Isentress, Vectibix in Tyverb).
Of these, 13 concerned pharmaceutical products and 34 concerned immunological products. 
Od teh se jih je 13 nanašalo na farmacevtske izdelke, 34 pa na imunološke izdelke.
a new warning for pioglitazone- and rosiglitazone-containing medicines regarding the increase of bone fractures in women; and for rosiglitazone-containing medicines only regarding a possible risk of ischaemic heart disease; 
• novim opozorilom za zdravila, ki vsebujejo pioglitazon in rosiglitazon, glede povečanega števila zlomov kosti pri ženskah ter opozorilom za zdravila, ki vsebujejo samo rosiglitazon, glede morebitne nevarnosti ishemične srčne bolezni;
Review of carisoprodol, following the plan to withdraw the marketing authorisation for this medicine in Norway due to risks of intoxication, psychomotor impairment, addiction and misuse due to offlabel prescribing. 
• Presoja carisoprodola po načrtu za ukinitev dovoljenja za promet s tem zdravilom na Norveškem zaradi tveganj zastrupitve, poslabšanja psihomotoričnih funkcij, zasvojenosti in zlorabe zaradi nedovoljenega predpisovanja.
In 2007, the EMEA received and validated 2 new applications for MRLs - 1 fewer than was forecast for the year. 
V letu 2007 je EMEA prejela in potrdila dve novi vlogi za najvišje mejne vrednosti ostankov - eno manj, kot je bilo predvideno.
Four opinions were adopted recommending granting of a marketing authorisation under exceptional circumstances (Focetria, Increlex, Atriance, Yondelis). 
Sprejeta so bila štiri mnenja, ki priporočajo izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah (Focetria, Increlex, Atriance in Yondelis).
Ten opinions on PIPs and waivers were adopted, covering 15 indications. 
Sprejetih je bilo deset mnenj o načrtih pediatričnih raziskav in opustitvah, kar obsega 15 indikacij.
Following its review of PSURs, the CVMP recommended in 6 cases that variations be submitted for the medicines concerned, mainly for the addition of new adverse-reaction information to the product information. 
Po pregledu z zadnjimi podatki dopolnjenih rednih poročil o varnosti je CVMP v šestih primerih priporočil predložitev sprememb za zadevna zdravila, predvsem za dodajanje novih podatkov o neželenih učinkih informacijam o izdelkih.
The CHMP first recommended the suspension of the marketing authorisation and the recall of Viracept from the market. 
CHMP je najprej priporočil začasno ukinitev dovoljenja za promet z zdravilom in odpoklic zdravila Viracept s trga.
3.5 Pharmacovigilance and maintenance activities 
3.5 Dejavnosti na področju farmakovigilance in ohranitve
A total of 2,045 applications were received in 2007 - an increase of almost 30% compared to the previous year. 
V letu 2007 je bilo prejetih skupno 2045 vlog, kar pomeni skoraj 30-odstotno povečanje v primerjavi s prejšnjim letom.
This was further to the decision by Germany to suspend all nationally authorised medicines containing aprotinin for intravenous use due to an increased risk of mortality in the aprotinin arm of the BART study (Article 107(2) procedure). 
Presoja se je izvedla po odločitvi Nemčije, da začasno ukine vsa nacionalno izdana dovoljenja za promet z zdravili, ki vsebujejo aprotinin, zaradi povečanega tveganja smrtnosti v delu študije BART, ki govori o aprotininu (postopek iz člena 107(2)).
epoetins, both centrally authorised (Aranesp, Nespo, Dynepo, Mircera, NeoRecormon, Binokrit, Epoetin Alfa Hexal, Abseamed) and nationally authorised (Eprex). 
• epoetini, za katere je bilo izdano dovoljenje po centraliziranem postopku (Aranesp, Nespo, Dynepo, Mircera, NeoRecormon, Binokrit, Epoetin Alfa Hexal, Abseamed) ali je bilo dovoljenje izdano nacionalno (Eprex).
The HMPC adopted 2 entries to the ‘list of herbal substances, preparations and combinations thereof for use in traditional herbal medicines' (bitter-fennel fruit and sweet-fennel fruit). 
HMPC je sprejel dva vpisa na „seznam rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora“ (plod grenkega navadnega komarčka in plod sladkega navadnega komarčka).
Restrictions of indication 
Omejitve terapevtskih indikacij
The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health. 
Poslanstvo Evropske agencije za zdravila je spodbujanje znanstvene odličnosti pri ocenjevanju zdravil in nadzorom nad njimi v dobro zdravja ljudi in živali.
3.4 Post-authorisation activities Number of applications for variations to marketing authorisations increases 
3.4 Dejavnosti po izdaji dovoljenja Število vlog za spremembe dovoljenj za promet z zdravilom se povečuje
Of the 1,424 reports received, 1,212 related to suspected adverse reactions in animals and 213 to reactions in humans following exposure to a veterinary medicinal product. 
Od prejetih 1424 poročil se jih je 1212 nanašalo na sume neželenih učinkov pri živalih, 213 pa na neželene učinke pri ljudeh po izpostavljenosti zdravilom za uporabo v veterinarski medicini.
New indications were also approved in the fields of cardiovascular, infectious, rheumatoid and inflammatory-bowel diseases and central-nervous-system disorders. 
• Nove terapevtske indikacije so bile odobrene na področjih bolezni srca in ožilja, infekcijskih, revmatskih in vnetnih črevesnih bolezni ter motenj centralnega živčnega sistema.
A total of 53 type-I variation applications were received, relating to 29 type-IA and 24 type-IB variations. 
Prejetih je bilo skupno 53 vlog za spremembo tipa I, od katerih se jih je 29 nanašalo na spremembo tipa IA, 24 pa na spremembo tipa IB. Bilo je tudi 47 vlog, ki so se nanašale na kompleksnejše spremembe tipa II.