natgillin/translations-raw huggingface dataset:
The fast-track review of pandemic vaccines - and the close monitoring of these vaccines once they were being used to vaccinate millions of European citizens - demonstrated to Europe and to the world that the European medicines network can deliver high-quality scientific assessments even under enormous pressure.
S hitrim pregledovanjem pandemskih cepiv ter skrbnim spremljanjem teh cepiv med cepljenjem milijonov Evropejcev smo Evropi in svetu dokazali, da lahko Evropska mreža zdravil zagotovi kakovostno znanstveno presojo tudi pod velikanskim pritiskom.
Contributing to improved availability of medicines
Prispevki k boljši dostopnosti zdravil
The outbreak of the 2009 H1N1 influenza pandemic put significant pressure on the European Medicines Agency and the European medicines network.
Izbruh pandemske gripe H1N1 v letu 2009 je povzročil velik pritisk na Evropsko agencijo za zdravila in Evropsko mrežo zdravil.
The European Medicines Agency appointed a staff member as a liaison officer to the FDA in July 2009.
Evropska agencija za zdravila je svojega člana osebja kot uradnika za zvezo pri FDA imenovala julija leta 2009.
A reflection paper on the concept of risk-management plans for veterinary medicines was published for consultation.
Za posvetovanje je bil objavljen razpravni dokument o konceptu načrtov za obvladovanje tveganja zdravil za uporabo v veterinarski medicini.
An action plan on paediatric pharmacovigilance, based on EudraVigilance data, was adopted in May 2009 to further strengthen the intensive monitoring of paediatric use of medicines.
Maja leta 2009 je bil sprejet akcijski načrt za pediatrično farmakovigilanco, ki je temelji na podatkih EudraVigilance, da bi se dodatno okrepilo intenzivno spremljanje pediatrične rabe zdravil.
The influenza pandemic was by definition a global challenge, so much credit for the achievements in Europe is also owed to the international partners with which the EU enjoys a mutually beneficial working relationship, notably the World Health Organization and the medicines authorities of the United States, Japan, Canada and Australia, among others.
Pandemija gripe je bila že po definiciji svetovni izziv, zato so za dosežke v Evropi predvsem zaslužni tudi mednarodni partnerji, s katerimi ima EU medsebojno koristne delovne povezave, zlasti Svetovna zdravstvena organizacija in organi, pristojni za zdravila v Združenih državah Amerike, na Japonskem, v Kanadi in Avstraliji ter drugje.
While many resources were devoted to dealing with the influenza pandemic, the European medicines network also made progress on a number of other initiatives during the year: work on the European Risk Management Strategy (ERMS) continued in accordance with the rolling two-year work programme; the Agency worked jointly with the Heads of Medicines Agencies (HMA) on developing a training strategy for the regulatory network; further progress was made on simplifying the contractual arrangements with the Member States for services provided to the Agency through the development of a Cooperation Agreement.
Čeprav je bilo veliko virov usmerjenih v obvladovanje pandemije gripe, je Evropska mreža zdravil med letom napredovala tudi na številnih drugih področjih: delo v zvezi z evropsko strategijo za obvladovanje tveganja (ERMS) se je nadaljevalo v skladu s tekočim dveletnim delovnim programom; agencija se je skupaj z vodjami agencij za zdravila (HMA) ukvarjala z razvojem strategije usposabljanja za regulativno mrežo; razvoj pogodbe o sodelovanju pa je pomenil napredek tudi glede poenostavitve pogodb z državami članicami za storitve, ki jih zagotavljajo agenciji.
The network demonstrated its strength during the 2009 H1N1 influenza pandemic.
Mreža je svojo čvrstost dokazala med pandemijo gripe H1N1 v letu 2009.
While awaiting the availability of vaccines, the Agency worked to facilitate the use of existing antiviral medicines that had shown effectiveness in treating people infected with the virus.
Agencija je v obdobju čakanja na razpoložljivost cepiv poskušala olajšati uporabo obstoječih protivirusnih zdravil, ki so pokazali učinkovitost pri zdravljenju ljudi, okuženih z virusom.
The Committee deals with ATMPs for human use that are based on gene therapy, somatic cell therapy or tissue engineering.
Odbor obravnava zdravila za napredno zdravljenje za uporabo v humani medicini, ki temeljijo na genski terapiji, terapiji s somatskimi celicami ali tkivnem inženirstvu.
Once a pandemic had been officially declared by the World Health Organization and the strain of the virus had been identified, in June, pharmaceutical companies were in a position to begin submitting data on H1N1 vaccines to the Agency.
Ko je junija Svetovna zdravstvena organizacija uradno razglasila pandemijo in je bil identificiran sev virusa, so lahko farmacevtske družbe agenciji začele pošiljati podatke o cepivih proti virusu H1N1.
While the rate of submission of applications for veterinary medicines was reasonably steady, there was a considerable increase in the number of requests relating to veterinary scientific advice and pharmacovigilance activities.
Čeprav je bila pogostost predložitev vlog za zdravila za uporabo v veterinarski medicini precej enakomerna, je bilo bistveno več zahtevkov v zvezi z veterinarskim znanstvenim svetovanjem in farmakovigilančnimi dejavnostmi.
This was done to fast-track the assessment process so that the urgent publichealth need for vaccines could be met before the autumn, when an intensification of the spread of the virus was expected in Europe.
Namen tega postopka je bil pospešiti postopek ocene, da bi lahko odgovorili na nujno javnozdravstveno potrebo po cepivih pred jesenjo, ko se je pričakovalo pospešeno širjenje virusa v Evropi.
Public consultation on draft EudraVigilance access policies in relation to human and veterinary medicines was completed in the spring of 2009, and work on revising the draft policies began.
Javna razprava o osnutku politike dostopa do zbirke EudraVigilance za zdravila za uporabo v humani in veterinarski medicini je bila končana spomladi leta 2009, začelo pa se je tudi popravljanje osnutka politike.
Initiatives were taken to facilitate the monitoring of adverse drug reactions in children using centrally authorised medicines.
Sprejeli smo pobude, s katerimi smo želeli olajšati spremljanje neželenih učinkov zdravil pri otrocih s pomočjo centralno odobrenih zdravil.
In June 2009, an FDA official took up a posting at the Agency, followed by an official from the Japanese authorities in November 2009.
Uradnik FDA je nastopil položaj v agenciji junija leta 2009, novembra 2009 pa mu je sledil uradnik iz japonskega pristojnega organa.
These innovative medicines offer groundbreaking new treatment opportunities for diseases and injuries of the human body.
Ta inovativna zdravila ponujajo revolucionarne možnosti zdravljenja za bolezni in poškodbe človeškega telesa.
The implementation and development of EudraVigilance Veterinary (EVVet) continued in 2009.
V letu 2009 se je nadaljevala uvedba in razvoj sistema EudraVigilance Veterinary.
In cooperation with King's College London, the Agency initiated a study on its benefit-risk communication activities, aimed at describing the Agency's approach to benefit-risk communication and identifying proposals for future implementation.
Agencija je v sodelovanju z univerzo King's College iz Londona začela študijo o svojem obveščanju o koristih in tveganjih, katere cilj je bil opisati pristop agencije k obveščanju o koristih in tveganjih ter oblikovati predloge za prihodnje ukrepe.
The third medicine, another gene-therapy product, was withdrawn by the applicant prior to the adoption of a final opinion by the CHMP.
Vlogo za tretje zdravilo, še eno zdravilo na podlagi genske terapije, je predlagatelj umaknil, preden je CHMP sprejel končno mnenje.
Bilateral relations with the US Food and Drug Administration (FDA) and the Japanese authorities were greatly enhanced when the notion of liaison placements was agreed.
Dvostranski odnosi med ameriško upravo za živila in zdravila (FDA) ter japonskim pristojnim organom je bistveno pospešil dogovor o imenovanju uradnika za zvezo.
A large part of their work in 2009 was dedicated to implementing and further developing the regulatory framework for ATMPs by drafting procedural and scientific guidelines for public consultation, and to helping applicants prepare their applications for procedures introduced by the new legislation.
Velik del njihovega dela je bil v letu 2009 namenjen uvedbi in dodatnem razvoju regulativnega okvira za zdravila za napredno zdravljenje s pripravo postopkovnih in znanstvenih smernic za javno razpravo ter pomoči predlagateljem pri pripravi vlog za postopke, ki jih uvaja nova zakonodaja.
In August 2009, the Agency signed its latest confidentiality arrangement with the Australian Therapeutic Goods Administration (TGA), bringing the number of confidentiality arrangements in place to four.
Avgusta leta 2009 je agencija podpisala svojo zadnjo pogodbo o zaupnosti z avstralsko upravo za terapevtske proizvode (TGA), ki je četrta veljavna pogodba o zaupnosti.
Involvement in the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) continued in 2009, with efforts focusing on establishing the database of ENCePP research centres (made publicly available in December 2009, to be populated in 2010), establishing the ENCePP Steering Group, and drafting an ENCePP code of conduct and a checklist of methodological research standards (both of which were released for public consultation in November 2009).
V letu 2009 se je nadaljevalo sodelovanje v Evropski mreži centrov za farmakoepidemiologijo in farmakovigilanco (ENCePP), pri čemer smo se trudili vzpostaviti zbirko podatkov raziskovalnih središč ENCePP (ki je bila javno objavljena decembra 2009 in se bo dopolnila v letu 2010), ustanoviti upravni odbor ENCePP in pripraviti osnutek kodeksa ravnanja in kontrolni seznam standardov metodološkega raziskovanja za ENCePP (oboje je bilo novembra leta 2009 dano na voljo za javno posvetovanje).
Looking to the future of medicines development, the Agency invites discussion on innovative therapeutic approaches and new development methods for human medicines.
V pričakovanju razvoja zdravil agencija spodbuja razpravo o inovativnih terapevtskih pristopih ter novih metodah razvoja zdravil za uporabo v humani medicini.
Responding to increasing stakeholder expectations, the Agency launched a public-consultation process on a new transparency policy, bringing together in one comprehensive document the Agency's vision on its level of openness towards its stakeholders.
Agencija je v odzivu na čedalje večja pričakovanja zainteresiranih strani sprožila postopek javne razprave o novi politiki preglednosti, tako da je v enem izčrpnem dokumentu združila vizijo agencije o odprtosti do zainteresiranih strani.
For one of these medicines, a tissue-engineered product containing chondrocytes, the CAT proposed a positive opinion to the Agency's Committee for Medicinal Products for Human Use (CHMP).
Za eno od zdravil, zdravilo s hondrociti, pridobljeno s tkivnim inženirstvom, je CAT Odboru za zdravila za uporabo v humani medicini (CHMP) pri agenciji predlagal pozitivno mnenje.
Substantial increases were seen across many of the core areas relating to human medicines, including scientific advice, orphan designations, variations and safety-related activities.
Bistveno več dela smo opazili na številnih glavnih področjih dejavnosti v zvezi z zdravili za uporabo v humani medicini, vključno z znanstvenim svetovanjem, dodelitvami statusov zdravil sirot, spremembami in dejavnostmi v zvezi z varnostjo.
Topics covered in 2009 included biomarkers and other novel development methods, nanotechnologies in life sciences and reinforced coordination between pharmaceuticals and devices authorities for the evaluation of targeted and combined medicinal products.
V letu 2009 smo obravnavali biološke označevalce in druge nove metode razvoja, nanotehnologije v bioloških vedah ter okrepljeno usklajevanje med pristojnimi organi za farmacevtske izdelke in pripomočke pri presoji ciljnih in kombiniranih zdravil.
By the end of 2009, the Agency had received marketing-authorisation applications for three ATMPs.
Do konca leta 2009 je agencija prejela vloge za pridobitev dovoljenja za promet s tremi zdravili za napredno zdravljenje.
The mobilisation of scientific experts from all over the EU made it possible to fast-track the scientific review of vaccines, so that by October 2009 three centrally authorised pandemic H1N1 vaccines were available for use by public-health authorities in the EU Member States.
Aktiviranje strokovnjakov iz celotne EU je omogočila pospešitev strokovne presoje cepiv, tako da so bila oktobra leta 2009 za javnozdravstvene organe v državah članicah EU na voljo tri centralno odobrena cepiva proti pandemski gripi H1N1.
The Agency was immediately engaged in monitoring the situation following the initial outbreak, in April, and subsequently stepped up its activities as the WHO raised the pandemic level.
Agencija je po prvotnem izbruhu aprila nemudoma začela spremljati razmere ter nato okrepila svoje dejavnosti, ko je SZO razglasila pandemijo.
EudraVigilance, the EU database and data-processing network for adverse drug reactions, was further developed in line with the project plan agreed by the EudraVigilance Steering Committee.
Zbirko in mrežo za obdelavo podatkov o neželenih učinkih zdravil v EU EudraVigilance smo dodatno razvili v skladu z načrtom projekta, ki ga je pripravil upravni odbor EudraVigilance.
Updated product information in all EU languages, weekly pharmacovigilance reports and much other scientific and regulatory information was published in a dedicated section of the Agency's website.
V posebnem razdelku na spletišču agencije so bile objavljene posodobljene informacije o cepivih v vseh jezikih EU, tedenska farmakovigilančna poročila ter veliko drugih znanstvenih in regulativnih podatkov.
For a genetherapy product, the CAT adopted a draft negative opinion.
Za zdravilo na podlagi genske terapije je CAT sprejel osnutek negativnega mnenja.
The Agency developed a European strategy for benefit/risk monitoring of A/H1N1 influenza vaccines, in close collaboration with the European Centre for Disease Prevention and Control (ECDC) and the HMA.
Agencija je v tesnem sodelovanju z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) ter HMA razvila evropsko strategijo spremljanja koristi in tveganj cepiv proti virusu gripe A/H1N1.
Core activities relating to medicines for human and veterinary use were conducted to a high level of quality, and regulatory timelines were consistently met.
Osnovne dejavnosti, ki veljajo za zdravila za uporabo v humani in veterinarski medicini, so bile izvedene na zelo visoki kakovostni ravni, v zakonodaji določeni roki pa niso bili nikoli prekoračeni.
Promoting the availability of veterinary medicines, the Agency continued its contribution to the implementation of the action plan arising from the HMA Taskforce on Availability.
Agencija je pri pospeševanju razpoložljivosti zdravil za uporabo v veterinarski medicini še naprej prispevala k izvajanju akcijskega načrta, ki ga je pripravila skupina za razpoložljivost pri HMA.
Pharmacovigilance of antivirals and vaccines used during the influenza pandemic was a major activity in 2009.
V letu 2009 je bila poglavitna dejavnost farmakovigilanca protivirusnih zdravil in cepiv, ki so se uporabljala med pandemijo gripe.
The results achieved under intense pressure were due to the sustained commitment and cooperation of the national authorities of the Member States, the European Commission, the European Directorate for the Quality of Medicines and
Rezultati, doseženi pod ogromnim pritiskom, so bili posledica vztrajne zaveze in sodelovanja nacionalnih organov držav članic, Evropske komisije, Evropskega direktorata za kakovost zdravil in zdravstvenega varstva, Evropskega centra za preprečevanje in obvladovanje bolezni, Evropske agencije za varnost hrane, Evropske agencije za zdravila ter seveda farmacevtske industrije.
Scientific-advice activities for human and veterinary medicines were significantly up, as were activities relating to the provision of support to small and medium-sized enterprises.
Bistveno več je bilo strokovnega svetovanja za zdravila za uporabo v humani in veterinarski medicini, ravno tako je bilo več podpore malim in srednje velikim podjetjem.
For their outstanding dedication and hard work throughout what was one of the most active and challenging years in the history of the Agency, I am very grateful to all members of the Agency's scientific committees, working parties, staff and Management Board, whose efforts contributed greatly once again not only to the success of our organisation, but to the protection of public and animal health in Europe.
Za izjemno predanost in trdo delo v letu, ki je bilo eno najdejavnejših in najtežjih v zgodovini Agencije, sem zelo hvaležen vsem članom znanstvenih odborov agencije in delovnih skupin ter osebju in upravnemu odboru.
The new identity was developed primarily to ensure that the communications materials of the Agency are created with a consistent look and feel, and to communicate to the public a clearer message about its role and activities.
Agencija je 8. decembra 2009 predstavila svojo novo vizualno podobo, ki je bila razvita predvsem, da bi zagotovili dosleden videz in občutek v celotnem komunikacijskem gradivu agencije ter da bi javnosti posredovali jasnejše sporočilo o svoji vlogi in dejavnostih.
The CHMP took the unprecedented measure of reviewing these data on a rolling-review basis as and when they were received, rather than waiting for exhaustive data to become available.
CHMP je prvič izvedel tekoče pregledovanje prihajajočih podatkov in ni čakal na predložitev obširnejših podatkov.
The Agency-led PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium) project was accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU).
Organizacija Innovative Medicines Initiative Joint Undertaking (IMI JU) je sklenila, da bo financirala projekt PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium - farmakoepidemiološko raziskavo izidov terapevtike, ki jo izvaja evropski konzorcij), ki ga vodi agencija.
Development of a new public website for the Agency - designed with the needs of the public in mind, offering improved navigation and search functionality, and better access to information on publichealth issues - was also a significant undertaking during the course of 2009.
Pomembna naloga v letu 2009 je bil tudi razvoj novega javnega spletišča agencije, ki je bilo zasnovano glede na potrebe javnosti, sedaj pa ponuja boljšo navigacijo in iskanje ter boljši dostop do informacij o javnozdravstvenih vprašanjih.
The Agency had regular exchanges with regulators from Australia, Canada, Japan, the United States and experts from the World Health Organization (WHO).
Zaradi pandemije gripe H1N1 se je raven dvo- in večstranskega mednarodnega sodelovanja povečala, ki še nikoli doslej..Agencija je večkrat gostila izmenjave med regulativnimi organi iz Avstralije, Kanade, Japonske in ZDA ter strokovnjake iz Svetovne zdravstvene organizacije (SZO).
Long-term effect
Dolgoročni učinek
The reconstitution procedure usually takes a few minutes, but may take up to 15 minutes in some cases.
Postopek rekonstitucije običajno traja nekaj minut, v nekaterih primerih pa tudi do 15 minut.
Key elements to be included in the educational material
Ključni elementi, ki morajo biti vključeni v izobraževalnem gradivu
Results of the confirmatory Phase III study
Rezultati potrditvene študije faze III
The muscle problems can be serious,
Težave z mišicami so lahko resne,
This medicine is usually injected by a nurse or a doctor.
To zdravilo navadno injicira medicinska sestra ali zdravnik.
Repeat the reconstitution procedure for the second dose.
Ponovite postopek rekonstitucije za drugi odmerek.
The distribution volume in healthy elderly men is approximately 1 l/kg.
Porazdelitveni prostor pri zdravih starejših moških je približno 1 l/kg.
This difference was statistically significant (p<0.001).
Ta razlika je bila statistično signifikantna (p<0,001).
A very serious allergic reaction to this medicine is rare.
Resna alergična reakcija na to zdravilo je redka.
These could be symptoms of a severe allergic reaction.
To so lahko znaki hude alergijske reakcije.
Of the 610 patients treated
Od 610 zdravljenih bolnikov jih je imelo
• Information on the identified and potential risks
• informacije o znanih in možnih tveganjih.
This is due to the pharmacological effect; and the effect was reversible.
To je posledica farmakološkega učinka; ta učinek je bil reverzibilen.
The first maintenance dose should be given one month after the starting dose.
Prvi vzdrževalni odmerek moramo dati en mesec po začetnem odmerku.
Changes in laboratory parameters
Spremembe laboratorijskih parametrov
<1/1,000) and very rare (<1/10,000).
< 1/1.000) in zelo redki (< 1/10.000).
Hence, the procedure described below need to be repeated a second time.
Zato je treba spodaj opisani postopek še enkrat ponoviti.
Therefore, all cardiovascular risk factors should be taken into account.
Zato je potrebno upoštevati vse srčnožilne dejavnike tveganja.
Response Rate (confidence intervals)* * Kaplan Meier estimates within group
Odzivnost (intervali zaupanja)* * Kaplan-Meierjeve ocene znotraj skupine
Plasma protein binding is estimated to be approximately 90%.
Ocenjujejo, da je vezava na plazemske beljakovine približno 90-odstotna.
In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if considered necessary.
V primeru prevelikega odmerka je treba bolnika spremljati in mu po potrebi nuditi ustrezno podporno zdravljenje.
This medicine is stable for 2 hours at 25ºC.
To zdravilo je stabilno 2 uri pri 25 ºC.
− Osteoporosis or any condition that affects the strenght of your bones.
− osteoporozo ali katero drugo stanje, ki vpliva na trdnost vaših kosti.
Due to the risk of microbial contamination, this medicine should be used immediately.
Zaradi tveganja mikrobiološke kontaminacije morate to zdravilo uporabiti takoj.
A ring of small air bubbles on the surface of the liquid is acceptable.
Obroček majhnih zračnih mehurčkov na površini tekočine je sprejemljiv.
If blood appears in the syringe, the medicinal product can no longer be used.
Če se v brizgi pojavi kri, zdravila ne smete več uporabiti.
In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study.
Vsega skupaj 620 bolnikov so randomizirali v eno od treh zdravljenih skupin, od katerih je 504 (81 %) bolnikov dokončalo študijo.
Worsening or onset of diabetes may occur.
Lahko pride do poslabšanja ali nastopa diabetesa.
The median age was 74 years (range 47 to 98 years).
Mediana starost bolnikov je bila 74 let (meje med 47 in 98 leti).
Tabulated list of adverse reactions The frequency of undesirable effects listed below is defined using the following convention:
Tabelarični seznam neželenih učinkov Pogostnost spodaj navedenih neželenih učinkov je opredeljena v skladu z naslednjim dogovorom:
These side effects may be due to the treatment or effects resulting from the underlying disease.
Ta neželena učinka sta lahko posledica zdravljenja ali posledica osnovne bolezni.
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Imetnik dovoljenja za promet z zdravilom (MAH) se mora z nacionalnimi pristojnimi organi dogovoriti o podrobnostih izobraževalnega programa in mora ta program uvesti nacionalno, s čimer bo zagotovil, da bodo pred začetkom predpisovanja vsi zdravniki prejeli paket z zdravstvenimi strokovnimi informacijami, ki bo vseboval: