natgillin/translations-raw huggingface dataset:
There were 9 applications for extension of marketing authorisation.
Prejeli smo devet vlog za razširitev dovoljenja za promet z zdravilom.
Of these, 90% and 86% related to line-extension and extension-of-indication applications respectively.
Od teh se jih je 90 % nanašalo na vloge za razširitev linije, 86 % pa na vloge za razširitev terapevtskih indikacij.
Likewise, innovation and availability remained high priorities in the veterinary area, with input being given from the Agency to the Heads of Medicines Agencies (HMA) action plan to promote the availability of veterinary medicines and to the European Technology Platform for Global Animal Health, as well as to the further development of measures to assist companies seeking to authorise medicines for limited markets.
Tudi v veterinarski medicini sta inovativnost in razpoložljivost zdravil ostali pomembni prednostni nalogi, pri čemer je Agencija zagotavljala vhodne podatke za akcijski načrt vodij agencij za zdravila (HMA) za spodbujanje razpoložljivosti veterinarskih zdravil in evropsko tehnološko platformo za globalno zdravje živali (European Technology Platform for Global Animal Health) kot tudi za nadaljnji razvoj ukrepov, ki bodo pomagali podjetjem, ki poskušajo pridobiti dovoljenje za zdravila za omejene trge.
There was also a shortfall in the number of applications submitted for extension or modification of MRLs, with only 1 of the forecast 5 being submitted.
Primanjkljaj se kaže tudi pri številu predloženih vlog za razširitev ali spremembo najvišjih vrednosti ostankov, saj je bila od pričakovanih petih predložena samo ena taka vloga.
Development of EVV was delayed for a period of some 6 months during 2007, due to re-prioritisation of resources to further develop the EudraVigilance (human) data warehouse.
Razvoj zbirke podatkov sistema Eudravigilance za veterinarstvo je v letu 2007 zaostal za približno šest mesecev, ker smo sredstva preusmerili na drugo prednostno nalogo - nadaljnji razvoj podatkovnega skladišča sistema EudraVigilance (za humano medicino).
Almost half of orphan-designated medicines for treatment of children
Skoraj polovica zdravil z oznako zdravila sirote je namenjena za zdravljenje otrok
The CVMP adopted 3 positive opinions for the establishment of new MRLs.
CVMP je sprejel tri pozitivna mnenja za določitev novih mejnih vrednosti ostankov.
The EMEA received 381,990 adverse-drug-reaction (ADR) reports in 2007 - an increase of more than 25% compared to the previous year.
Agencija EMEA je v letu 2007 prejela 381 990 poročil o neželenih učinkih zdravil (ADR), kar pomeni več kot 25-odstotno povečanje v primerjavi s prejšnjim letom.
The Agency received a total of 15 initial marketing-authorisation applications for veterinary medicinal products, 8 of which were for pharmaceutical products and 7 for immunologicals.
Agencija je prejela skupaj 15 začetnih vlog za izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, od katerih jih je bilo osem za farmacevtske izdelke in sedem za imunološka zdravila.
It blocks the activity of renin, an enzyme which is involved in the production of angiotensin I that is subsequently converted into the hormone angiotensin II, a powerful vasoconstrictor (it narrows blood vessels and consequently raises the blood pressure).
Zavira delovanje renina, encima ki sodeluje pri nastajanju angiotenzina I, ki se naknadno spremeni v hormon angiotenzin II, močan vazokonstriktor (oži žile in posledično dvigne krvni tlak).
Innovation Task Force: supporting development of advanced-therapy medicines
Projektna skupina za inovacije: podpora razvoju zdravil za napredno zdravljenje
Following further investigation, 22% (132) of suspected signals required follow-up for intensively monitored medicines, including involving the rapporteur for 43 signals.
V nadaljevanju preiskave je bilo pri 22 % (132) sumih signalov pri intenzivno spremljanih zdravilih potrebno nadaljnje ukrepanje, pri tem je bilo pri 43 signalih treba vključiti poročevalca.
Forty-four orphan-designated medicines authorised for use in the EU
44 zdravil, določenih kot zdravila sirote, odobrenih za uporabo v EU
Similarly, new veterinary prevention and treatment options are now available for Europe's food-producing and companion animals.
Podobno so tudi v veterinarski medicini na voljo nove možnosti za preprečevanje in zdravljenje za evropske živali, namenjene za proizvodnjo hrane, in hišne živali.
1.4 Earlier and improved availability of medicines Special authorisation procedures in operation
1.4 Zgodnejša in izboljšana dostopnost zdravil Posebni postopki za izdajo dovoljenja za promet z zdravilom potekajo
Sixty-six quality defects were successfully coordinated, 22 of which resulted in recalls.
Uspešno usklajenih je bilo 66 pomanjkljivosti glede kakovosti, od katerih je bil pri 22 potreben umik izdelka.
2 vaccines for pigs, against porcine circovirus type 2.
• dve cepivi proti prašičjemu cirkovirusu tipa 2 za prašiče.
Two applications were made for medicines that had received free scientific advice under the programme for minor uses and minor species.
Dve vlogi sta bili podani za zdravili, za kateri je bilo zagotovljeno brezplačno znanstveno svetovanje po programu za manjšo uporabo in manj pomembne živalske vrste.
The EMEA actively participated in the preparatory steps of the Innovative Medicines Initiative - a public-private partnership between the pharmaceutical industry and the European Communities, which aims to address bottlenecks in the development of medicines.
Agencija EMEA je dejavno sodelovala pri pripravi pobude za inovativna zdravila - javno-zasebnega partnerstva med farmacevtsko industrijo in Evropskimi skupnostmi, katere cilj je spopadanje z ozkimi grli pri razvoju zdravil.
The Agency also progressed well with its development and maintenance of informationtechnology services, as well as with its programme to enhance the participation of patients and healthcare professionals in EMEA activities.
Agencija je dobro napredovala tudi pri razvoju in vzdrževanju storitev informacijske tehnologije ter programu za spodbujanje sodelovanja bolnikov in zdravstvenih strokovnjakov v dejavnostih Agencije.
A marked increase in the number of requests for protocol assistance was registered, with 17% more requests received than in 2006.
Opaženo je bilo izrazito povečanje števila zahtevkov za pomoč pri protokolu; prejeli smo 17 % več zahtevkov kot v letu 2006.
Review of medicines containing 30μg ethinyl estradiol + 2mg chlormadinone acetate, because of differences among Member States on whether the indication of these two medicines should be extended to include the treatment of women suffering from moderate acne.
• Presoja zdravil, ki vsebujejo 30 µg etinil estradiola + 2 mg klormadinon acetata, zaradi razhajanj med državami članicami glede tega, ali bi bilo treba indikacije teh zdravil razširiti, tako da bi vključevale zdravljenje žensk, ki trpijo zaradi zmernih aken.
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.