natgillin/translations-raw huggingface dataset:
Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Zato je menil, da koristi zdravila Rivastigmine Actavis, tako kot pri zdravilu Exelon, odtehtajo znana tveganja.
How has Rivastigmine Actavis been studied?
Kako je bilo zdravilo Rivastigmine Actavis raziskano?
How is Rivastigmine Actavis used?
Kako se zdravilo Rivastigmine Actavis uporablja?
What is Rivastigmine Actavis?
Kaj je zdravilo Rivastigmine Actavis?
How does Rivastigmine Actavis work?
Kako zdravilo Rivastigmine Activis deluje?
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo zagotoviti, da bodo uveljavljeni vsi spodaj opisani pogoji oziroma omejitve v zvezi z varno in učinkovito uporabo zdravila.
• Velcade 3.5mg can be administered both intravenously and subcutaneously while Velcade 1mg can be administered only intravenously
• Zdravilo VELCADE 3,5 mg se lahko daje intravensko in subkutano, zdravilo VELCADE 1 mg pa samo intravensko.
Prior to launch of Velcade 3.5mg new dual route of administration (subcutaneous and intravenous) package, in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se bo pred začetkom trženja novega, dvojnega načina uporabe zdravila VELCADE 3,5 mg (subkutana in intravenska uporaba), v vsaki državi članici s pristojnim nacionalnim organom države dogovoril za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce.
• potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
• Možna tveganja napak pri dajanju zdravila, vključno z informacijami o prevelikem odmerjanju,
• SmPC
ali subkutani (s.c.)
The MAH shall ensure that, at launch of Velcade 3.5mg new dual route package and thereafter, all healthcare professionals involved in the prescribing, dispensing, handling or administration of Velcade 3.5mg are provided with educational material.
Imetnik dovoljenja za promet z zdravilom bo ob začetku trženja novega, dvojnega načina uporabe zdravila VELCADE 3,5 mg in še naprej zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali ali uporabljali zdravilo prejeli izobraževalno gradivo.
• that Velcade 1mg is only for IV use
• Zdravilo VELCADE 1 mg se lahko uporablja samo intravensko.
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Velcade (both IV and SC use) required for different body surface areas.
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila VELCADE (za i.v.
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate VELCADE dose.
Navodila za odmerjanje zdravila morajo vsebovati naslednje ključne elemente: odel izračuna, s katerim bo lahko predpisovalec izračunal odmerek zdravila in telesno površino na podlagi bolnikove višine in telesne mase, in tako določil pravi odmerek zdravila VELCADE.
• that Velcade is to be given only by IV or SC injections; no other route of administration is allowed
ali s.c., nobena druga uporaba ni dovoljena.
It is a pleasure for me, at this point, to congratulate him and wish him every success in his further term of office.
V veliko zadovoljstvo mi je, da mu ob tej priložnosti čestitam in zaželim veliko uspeha v novem mandatu.
On behalf of the Management Board, I would like to emphasise a couple of events that took place last year.
V imenu upravnega odbora bi rad izpostavil nekaj dogodkov, ki so se zgodili v lanskem letu.
This close-knit network has been strengthened in recent years.
Ta tesno prepletena mreža se je v zadnjih letih okrepila.
1 IMPLEMENTATION OF THE REVISED LEGISLATION
1 IZVAJANJE REVIDIRANE ZAKONODAJE
7 SUPPORT TO SMALL AND MEDIUM-SIZED ENTERPRISES
7 PODPORA MALIM IN SREDNJE VELIKIM PODJETJEM
In addition to these notifications, the Agency received over 1,000 notifications of changes.
Agencija je poleg teh obvestil prejela tudi več kot 1000 obvestil o spremembah.
There were no negative opinions.
Negativnih mnenj ni bilo.
This number includes reports originating in the EU and in countries outside the EU, such as the United States.
Ta številka vključuje poročila, ki izvirajo iz EU in držav zunaj EU, kot na primer Združenih držav Amerike.
The evaluation period for the pandemic variation is then expected to be very short, typically less than one week.
Obdobje vrednotenja variacije pandemije naj bi bilo tako zelo kratko, navadno manj kot en teden.
This has been achieved by rationalisation of human resources and further process automation.
To je bilo doseženo z racionalizacijo človeških virov in nadaljnjo avtomatizacijo procesa.
An initial prototype was demonstrated to the responsible implementation group in December.
Začetni prototip je bil decembra predstavljen odgovorni izvedbeni skupini.
This initiative runs in parallel to a similar one initiated by Member States through the Mutual Recognition Facilitation Group.
Ta pobuda poteka vzporedno s podobno pobudo, ki so jo sprožile države članice prek skupine za poenostavitev medsebojnega priznavanja (Mutual Recognition Facilitation Group).
12 COORDINATION GROUPS FOR THE MUTUAL RECOGNITION PROCEDURE AND THE DECENTRALISED PROCEDURE
12 USKLAJEVALNI SKUPINI ZA POSTOPEK MEDSEBOJNEGA PRIZNAVANJA IN DECENTRALIZIRANI POSTOPEK
Ultimate responsibility for the Agency's operational work rests with the Executive Director.
Končno odgovornost za operativno delo Agencije ima izvršni direktor.
Working with national competent authorities
Sodelovanje z nacionalnimi pristojnimi organi
The full annual report 2005 in English can be found on the Agency's website: www.emea.eu.int
Celotno letno poročilo za leto 2005 v angleškem jeziku lahko najdete na spletni strani Agencije: www.emea.eu.int
OJ L 136, 30.04.2004, p. 1.
UL L 136, 30. 4. 2004, str. 1.
Competitiveness of the European pharmaceutical industry in the context of the ‘Lisbon Agenda' remains high on the political agenda.
Konkurenčnost evropske farmacevtske industrije v okviru "programa lizbonske strategije" ostaja še naprej ena od prednostnih nalog politične agende.
Despite the increasing number of requests, the average issuing time has remained within procedural limits.
Kljub naraščajočemu številu zahtevkov je povprečni čas izdaje ostal v postopkovnih mejah.
This document provides a summary of the Agency's annual report for 2005, adopted by the Management Board on 9 March 2006.
Ta dokument je povzetek letnega poročila Agencije za leto 2005, ki ga je upravni odbor sprejel 9. marca 2006.
The EMEA provided full secretariat and administrative support to the work of the two coordination groups.
EMEA je zagotovila polno podporo sekretariata in administrativno podporo za delo teh dveh usklajevalnih skupin.
10 CONTRIBUTION TO EU PUBLIC HEALTH STRATEGIES
10 PRISPEVEK K STRATEGIJAM JAVNEGA ZDRAVJA EU
The scheme will only become fully operational once the guidelines on adaptation of data requirements become available.
Program bo začel v celoti delovati, šele ko bodo na razpolago smernice o prilagoditvi podatkovnih zahtev.
Only 32 reports related to food-producing animals.
Samo 32 poročil se je nanašalo na živali, namenjene proizvodnji hrane.
Integrated quality management system
Integrirani sistem upravljanja kakovosti
I would also like to thank the secretariat of the Management Board for their constructive and outstanding collaboration throughout the year.
Rad bi se zahvalil tudi članom sekretariata upravnega odbora za njihovo konstruktivno in izjemno sodelovanje skozi vso leto.
I am confident that, as a result, the broadened outlook of the Management Board will have a favourable impact on our work.
Prepričan sem, da bodo tako povečane možnosti upravnega odbora pozitivno vplivale na naše delo.
On 20 November 2005, the Agency welcomed the full entry into force of Regulation (EC) No 726/20042, which heralds a more robust, modern and effective regulatory framework for pharmaceuticals in Europe.
20. novembra 2005 je Agencija pozdravila začetek veljavnosti Uredbe (ES) št. 726/20041, ki uvaja bolj robusten, sodoben in učinkovit regulativni okvir za farmacevtske izdelke v Evropi.
11 PREPARATION FOR NEW TYPES OF APPLICATIONS
11 PRIPRAVE ZA NOVE VRSTE VLOG
Achievements of particular note include:
Med še zlasti pomembnimi dosežki naj omenimo:
These stakeholders reported electronically a total of 144,786 individual case safety reports (ICSRs) originating from within and outside the EU.
Te zainteresirane strani so elektronsko sporočile skupno 144.786 varnostnih poročil o posameznih primerih (individual case safety reports - ICSR), ki so izvirali iz EU in zunaj nje.
Administrative and procedural assistance from the SME Office at the Agency
administrativno in postopkovno pomoč, ki jo zagotavlja Urad za MSP pri Agenciji;
Commission Regulation (EC) No 2049/2005, OJ L329, 16.12.2005, p. 4.
Uredba Komisije (ES) št. 2049/2005, UL L329, 16. 12. 2005, str. 4.
The Agency looked again at the safety of Micotil, following a request by the European Commission to take into account new information.
Agencija je spet preučila varnost Micotila, potem ko je Evropska komisija zahtevala, naj se upoštevajo nove informacije.
Fee exemptions for certain administrative services of the EMEA
oprostitve pristojbin za določene administrativne storitve EMEA;
It provided support to the European Commission with the technical requirements for such products, and will continue to do so as necessary during the Council and European Parliament consultation process.
Evropski komisiji je zagotovila podporo s tehničnimi zahtevami za takšne izdelke in bo po potrebi še naprej zagotavljala podporo med postopkom posvetovanja med Svetom in Evropskim parlamentom.
Thanks to the excellent planning and preparations put in place during the run-up to that date, the Agency was able to successfully implement all relevant provisions and guidelines stemming from the new legislation.
Zahvaljujoč izvrstnemu načrtovanju in pripravam v obdobju pred tem datumom, je Agenciji uspelo uspešno izvesti vse zadevne določbe in smernice, ki izhajajo iz nove zakonodaje.
A total of 1,213 applications were received, which represents a 10% increase compared to 2004.
Prejetih je bilo skupno 1213 vlog, kar pomeni 10-odstotno povečanje v primerjavi z letom 2004.
On behalf of the Management Board, therefore, I would like to thank the personnel of the EMEA for their important input in promoting European regulation in the field of pharmaceuticals.
V imenu upravnega odbora bi se zato rad zahvalil osebju EMEA za njihov pomemben prispevek k spodbujanju evropske regulacije na farmacevtskem področju.
Lastly, I extend my wholehearted thanks to all EMEA staff, whose tireless efforts throughout this challenging year resulted in such a positive outcome for the Agency.
Na koncu pa se iz vsega srca zahvaljujem tudi celotnemu osebju EMEA, katerega neutrudni napori skozi vse to leto, polno izzivov, so doprinesli k tako pozitivnim rezultatom Agencije.
The Committee concluded in November 2005 that, based on the available evidence, no action to protect consumer safety or animal safety was necessary.
Novembra 2005 je Odbor sklenil, da na podlagi razpoložljivih dokazov niso potrebni nobeni ukrepi za zaščito varnosti potrošnikov ali živali.
The recommendations were the outcome of an extensive external consultation exercise with the Agency's partners and stakeholders.
Priporočila so bila rezultat obsežnih zunanjih posvetovanj s partnerji Agencije in zainteresiranimi stranmi.
The SME Office has the sole remit of offering assistance to SMEs.
Urad za MSP je pristojen samo za zagotavljanje pomoči malim in srednje velikim podjetjem.
The Committee focused on work to establish the necessary procedures for conducting its business.
Odbor je namenil glavno pozornost pripravam za določitev potrebnih postopkov za opravljanje svoje dejavnosti.
3.2.3 Maximum residue limits
3.2.3 Najvišje mejne vrednosti ostankov
Those ten years of continuous growth and consolidation gave the Agency the experience and confidence it needed to meet the greatest challenge it has had to face so far: the full entry into force of the revised EU pharmaceutical legislation, in November 2005.
Teh deset let nenehne rasti in utrjevanja je dalo Agenciji izkušnje in zaupanje , ki ju potrebuje, da se bo lahko spopadla s svojim največjim izzivom doslej: novembra 2005 bo namreč v celoti stopila v veljavo revidirana farmacevtska zakonodaja EU.
9 INFORMATION AND COMMUNICATION
9 OBVEŠČANJE IN KOMUNICIRANJE
I know I can rely on your continuing commitment as we bring the EMEA forward into its second decade.
Vem, da se lahko na vašo nadaljnjo zavezanost zanesem tudi zdaj, ko EMEA stopa v svoje drugo desetletje.
A special group (ERMS facilitation group) was set up to oversee the delivery of these key objectives through the development of a rolling work plan for 2005-2007.
Ustanovljena je bila posebna skupina (skupina za poenostavitev ERMS) za nadzor izpolnjevanja teh ključnih ciljev s pomočjo razvoja tekočega načrta dela za obdobje 2005-2007.
The Year 2005 was a very promising beginning for the second decade of the EMEA.
Leto 2005 je bil zelo obetaven začetek drugega desetletja delovanja EMEA.
Altogether, 238 deaths in animals were reported.
Prijavljenih je bilo skupaj 238 smrtnih primerov pri živalih.
5.3 Sampling and testing
5.3 Vzorčenje in preizkušanje
Finally, in view of the next phase of EU enlargement, the EMEA completed preparations for pre-accession linguistic check activities for Bulgaria and Romania, to be launched in January 2006.
Končno, v luči nove faze širitve EU je EMEA zaključila priprave za predpristopne dejavnosti jezikovnega preverjanja za Bolgarijo in Romunijo, ki se bodo začele januarja 2006.
In years to come, the EMEA will need further top-quality expertise and will be increasingly reliant on the Member States and their authorities to offer this.
V prihodnjih letih bo EMEA potrebovala dodatno vrhunsko strokovno znanje in izkušnje ter se bo za zagotovitev tega vse bolj zanašala na države članice in njihove organe.
2 IMPLEMENTATION OF THE ROAD MAP
2 IZVAJANJE USMERITVENEGA NAČRTA ("ROAD MAP")
13 EU TELEMATICS STRATEGY AND INFORMATION TECHNOLOGY
13 TELEMATSKA STRATEGIJA EU IN INFORMACIJSKA TEHNOLOGIJA
The results presented in this Annual Report prove that the EMEA ably faced up to its many challenges in 2005.
Rezultati, predstavljeni v tem letnem poročilu, dokazujejo, da se je EMEA primerno spoprijela s številnimi izzivi v letu 2005.
The 11th year of operation of the European Medicines Agency (EMEA) was eventful.
Enajsto leto delovanja Evropske agencije za zdravila (EMEA) je bilo polno dogodkov.
A number of meetings were held with companies ahead of possible future applications.
Pred možnimi prihodnjimi uporabami so bili organizirani številni sestanki s podjetji.
Electronic reporting of adverse reactions is now mandatory.
Elektronsko poročanje o neželenih učinkih je sedaj obvezno.
The list was submitted to the Commission in May 2005 to serve as basis for a list of essential substances, which is provided for by the new legislation .
Seznam je bil predložen Komisiji maja 2005 in bo podlaga za seznam bistvenih snovi, ki ga določa nova zakonodaja.
The Agency contributed to the development of a proposed regulation on advanced therapies.
Agencija je prispevala k razvoju predlagane uredbe o naprednih zdravljenjih.
A further 15 applications were withdrawn prior to opinion.
Nadaljnjih 15 vlog je bilo umaknjenih, preden je bilo mnenje sprejeto.
The extrapolations are carried out without specific applications or payment of fees, provided the criteria detailed in the relevant CVMP guideline are met, thus ensuring consumer safety.
Ekstrapolacije se izvajajo brez posebnih vlog ali plačila pristojbin, če so izpolnjena merila iz ustreznih smernic CVMP in je tako zagotovljena varnost potrošnika.
Strengthening interaction with patients' and consumers' organisations
krepitvijo sodelovanja z organizacijami bolnikov in potrošnikov;
14 MANAGING THE AGENCY
14 UPRAVLJANJE AGENCIJE
It began with celebrations to mark an important milestone in the history of the EMEA: its tenth anniversary.
Začelo se je s praznovanjem v čast pomembnemu mejniku v zgodovini Agencije: njeni deseti obletnici.
While the majority of these concerned new pharmaceutical forms, 2 concerned new target species.
Medtem ko se jih je večina nanašala na nove farmacevtske oblike, sta 2 zadevali nove ciljne vrste.
This development will greatly enhance the ability of the EMEA to evaluate the safety of medicines.
Ta razvoj bo bistveno okrepil sposobnost EMEA za vrednotenje varnosti zdravil.
The year 2005 was the first full year of operation of the Committee on Herbal Medicinal Products (HMPC), following its inaugural meeting in September 2004.
Leto 2005 je bilo prvo polno leto delovanja Odbora za zdravila rastlinskega izvora (HMPC) po njegovem ustanovitvenem zasedanju septembra 2004.
In 2005, the Agency discussed implementation plans for electronic reporting with major partners in the veterinary pharmaceutical industry.
V letu 2005 je Agencija razpravljala o izvedbenih načrtih za elektronsko poročanje s pomembnejšimi partnerji v veterinarski farmacevtski industriji.
A total of 34,352 ICSRs relating to SUSARs were received.
Prejetih je bilo skupaj 34.352 ICSR-jev, ki so se nanašali na SUSAR-je.
The strategy includes earlier and more frequent involvement of experts particularly on rare diseases and new therapies.
Strategija vključuje zgodnejše in pogostejše vključevanje strokovnjakov, zlasti v zvezi z redkimi boleznimi in novimi zdravljenji.
Thomas Lönngren was unanimously appointed by the Management Board to serve in this demanding post for another five-year period, from 2006 to 2010.
Upravni odbor je soglasno imenoval Thomasa Lönngrena na to zahtevno delovno mesto za nadaljnje petletno obdobje, od leta 2006 do leta 2010.
5 INSPECTIONS
5 INŠPEKCIJSKI NADZOR
Strengthening the EU pharmacovigilance system to make the best use of the scientific resources and expertise available at EU level.
krepitvijo sistema farmakovigilance EU za čim boljšo uporabo znanstvenih virov in strokovnega znanja ter izkušenj, ki so na razpolago na ravni EU.
This policy put in place a framework for the checking of translations of product information by the national competent authorities, and set up a financial compensation scheme.
Ta politika je vzpostavila okvir za preverjanje prevodov informacij o izdelkih s strani pristojnih nacionalnih organov in oblikovala program finančnih nadomestil.
A reflection paper to highlight patients' benefits in this new area was issued.
Objavljen je bil preučitveni dokument za izpostavitev koristi za bolnike na tem novem področju.
New medicinal products (non-orphan) Orphan medicinal products Similar biological products
Nova zdravila (ki niso zdravila sirote) Zdravila sirote Biološko podobni izdelki
The Agency was given responsibility for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA.
Agenciji je bila zaupana odgovornost za izvajanje telematske strategije EU, o kateri so se dogovorile Evropska komisija, države članice in EMEA.
At the same time, it provides new tools for strengthened protection of public health.
Uredba hkrati zagotavlja nova orodja za okrepljeno varstvo javnega zdravja.
Electronic reporting into the EudraVigilance database became mandatory in November 2005.
Elektronsko poročanje v zbirko podatkov EudraVigilance je postalo obvezno novembra 2005.
The information updates published on the EMEA website relating to these issues have been acclaimed as extremely useful.
Posodobljene informacije o teh vprašanjih, ki se objavljajo na spletni strani EMEA, so bile ocenjene kot zelo uporabne.
In addition, I would like to thank the Member States' competent authorities, which, together with the EMEA, form the core regulatory network for medicinal products.
Poleg tega se želim zahvaliti pristojnim organom držav članic, ki skupaj z EMEA sestavljajo temeljni regulativni okvir za zdravila.
The EMEA will be involved in the issues of relative effectiveness and provision of information to patients.
EMEA bo sodelovala pri vprašanjih relativne učinkovitosti in zagotavljanja informacij bolnikom.
To further improve the management of translations, the Management Board adopted a revised EMEA translation policy in September 2005.
Za nadaljnje izboljšanje upravljanja prevodov je upravni odbor septembra 2005 sprejel revidirano prevajalsko politiko EMEA.
Pandemic influenza preparedness
Pripravljenost na pandemijo influence
Following the entry into force of new ‘Regulations and Rules applicable to officials and other servants of the European Communities', the EMEA prepared a series of implementing rules for adoption by the Management Board.
Po začetku veljavnosti novih "predpisov in pravil za uradnike in druge uslužbence Evropskih skupnosti" je EMEA pripravila vrsto izvedbenih pravil, ki jih sprejme upravni odbor.
This led to a doubling of parallel distribution notifications submitted to the EMEA in 2005.
To je pripeljalo do podvojitve števila obvestil o vzporedni distribuciji, predloženih EMEA v letu 2005.
The overall volume of pre- and post-authorisation applications received was high, but the Agency was able to handle its tasks successfully.
Skupno število prejetih vlog pred in po izdaji dovoljenja za promet je bilo visoko, vendar je Agencija zmogla uspešno opraviti svoje naloge.
The group will provide progress reports to the EMEA Management Board and to the group of heads of national medicines agencies.
Skupina bo poslala poročila o napredku upravnemu odboru EMEA in skupini vodij nacionalnih agencij za zdravila.
The Agency also developed guidelines and concept papers designed to improve the consistency of safety data assessments.
Agencija je razvila tudi smernice in konceptualne dokumente za izboljšanje skladnosti presoj podatkov o varnosti.
Together with this key document, a further 6 draft guidelines on specific types of products were released for consultation in the first half of the year.
Skupaj s tem ključnim dokumentom je bilo v prvi polovici leta za namene posvetovanja objavljenih 6 osnutkov smernic o posebnih vrstah izdelkov.
The Management Board has been closely following the progress of the European innovation and technology platform, especially in the area of veterinary medicines.
Upravni odbor budno spremlja napredek evropske platforme za inovacije in tehnologijo, zlasti na področju veterinarskih zdravil.
The number of issued certificates continued to increase, and certificate number 100,000 was issued (for an AIDS product) in August 2005.
Število izdanih potrdil še naprej narašča, avgusta 2005 pa je bilo izdano potrdilo številka 100.000 (za izdelek za AIDS).
In 2005 this included the annual management review, which aims to ensure that management tools are effective and suitable in relation to the Agency's needs, and a self-assessment carried out in the context of the EU benchmarking system in order to improve the EMEA management system.
V letu 2005 je to vključevalo letni pregled upravljanja, katerega cilj je zagotoviti, da so orodja upravljanja učinkovita in primerna za potrebe Agencije, ter samoocenjevanje, ki je bilo opravljeno v okviru sistema primerjalnih analiz EU za izboljšanje sistema upravljanja EMEA.
Strengthening the Agency's interaction with European industry associations representing the innovative, generic and self-medication industries
krepitvijo sodelovanja Agencije z evropskimi panožnimi združenji, ki zastopajo inovativno in generično industrijo in industrijo samozdravil;
5.2 Product defects and deviations
5.2 Pomanjkljivosti in odstopanja pri proizvodih
I am particularly grateful for the excellent participation of our partners from the new Member States, in what was the first full year of operation in a European Union of 25 nations.
Posebno zahvalo sem dolžan našim partnerjem iz novih držav članic za njihovo izjemno sodelovanje pri dejavnostih Agencije v prvem celem letu, ko Evropsko unijo sestavlja 25 narodov.