natgillin/translations-raw huggingface dataset:
- The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9
- Končno koncentracijo 5 mg/mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 10 mL) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL
Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: - Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Priprava raztopine Refludana v koncentraciji 2 mg/mL Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/mL: - Uporabite dve viali s po 50 mg lepirudina; vsako od njih rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous bolus injection a solution with a concentration of 5 mg/ml is needed: - Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Priprava raztopine Refludana v koncentraciji 5 mg/mL Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/mL: - Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
- The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9
- Končno koncentracijo 5 mg/mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 5 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL
Refludan 20 mg powder for solution for injection or infusion lepirudin
Refludan 20 mg prašek za raztopino za injiciranje ali infundiranje Lepirudin
Discard unused solution appropriately.
Neuporabljeno raztopino ustrezno zavrzite.
Refludan 50 mg powder for solution for injection or infusion Lepirudin
Refludan 50 mg prašek za raztopino za injiciranje ali infundiranje Lepirudin
single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution.
- Končno koncentracijo 2 mg/mL dobimo s prenosom obeh raztopin v eno sterilno perfuzijsko brizgo za enkratno uporabo (s prostornino 50 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL (0,9 %) ali z raztopino 5 % glukoze do skupnega volumna 20 ml. - Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika.
single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution.
- Končno koncentracijo 2 mg/mL dobimo s prenosom obeh raztopin v eno sterilno perfuzijsko brizgo za enkratno uporabo (s prostornino 50 mL) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL (0,9 %) ali z raztopino 5 % glukoze do skupnega volumna 50 mL. - Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika.
Skin and Subcutaneous Tissue Disorders
Bolezni koţe in podkoţja
Each vial contains 20 mg lepirudin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka viala vsebuje 20 mg lepirudina.
Each vial contains 50 mg lepirudin.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka viala vsebuje 50 mg lepirudina.
Main initiatives of this new framework:
Glavne pobude tega novega okvira:
Other 1% Netherlands
Drugo 1% Nizozemska
This success has been recognised by all of the Agency's stakeholders.
Ta uspeh priznavajo vse interesne skupine Agencije.
Special financial support from the EU budget
Posebna finančna podpora iz proračuna EU
The base system is in place.
Temeljni sistem je vzpostavljen.
Testing results showed that the majority of the products were of high quality.
Rezultati preizkušanja so pokazali, da je bila večina izdelkov visoke kakovosti.
6.3 Personnel
6.3 Osebje
Total Recalls Class 1 Class 2 Class 3
Skupaj Umiki Razred 1 Razred 2 Razred 3
These products potentially benefit some 1.6 million European patients suffering from 24 different rare conditions.
Od teh proizvodov ima potencialne koristi okoli 1,6 milijona evropskih bolnikov, ki bolehajo za 24 redkimi boleznimi.
A new system of revenue (invoicing) was introduced and implemented successfully.
Uveden in uspešno izveden je bil nov sistem prihodkov (fakturiranja).
2.8 Parallel distribution
2.8 Vzporedna distribucija
It is once again my pleasure to introduce to you our report on the activities and achievements of the European Medicines Agency in the past year.
Z veseljem vam ponovno predstavljam poročilo o dejavnostih in dosežkih Evropske agencije za zdravila v lanskem letu.
To pick out just a few notable achievements in core business areas:
Navedimo samo nekatere pomembne dosežke na ključnih področjih poslovanja:
Results requiring further investigation were found in 18 products.
Rezultati, ki so zahtevali nadaljnje preiskave, so bili ugotovljeni pri 18 izdelkih.
These included the first ‘opinions on any scientific matter', under Article 5(3) of Regulation (EC) No 726/2004.
Ta so vključevala prva „mnenja o katerikoli znanstveni zadevi“ na podlagi člena 5(3) Uredbe (ES) št. 726/2004.
Regulation (EC) No 1901/2006 on medicinal products for paediatric use.
Uredba (ES) št. 1901/2006 o zdravilih za pediatrično uporabo.
The European Commission adopts its decisions with the assistance of a standing committee composed of representatives of the Member States.
Evropska komisija sprejme odločitev s pomočjo stalnega odbora, ki ga sestavljajo predstavniki držav članic.
Other initiatives for improving the safety of veterinary medicines included:
Druge pobude za izboljšanje varnosti veterinarskih zdravil vključujejo:
In December 2006, the HMPC presented to the European Commission a comprehensive overview of its activities and achievements since its establishment in September 2004.
Decembra 2006 je HMPC Evropski komisiji predstavil celovit pregled svojih dejavnosti in dosežkov od njegove ustanovitve septembra 2004.
I would like to begin by congratulating the Executive Director, his staff, the scientific committees and all working parties for their outstanding performance in 2006.
Dovolite mi, da na začetku čestitam izvršnemu direktorju, njegovemu osebju, znanstvenim odborom in vsem delovnim skupinam za njihovo izjemno uspešnost v letu 2006.
An annual management review was conducted, aimed at ensuring that management tools are effective and suitable.
Opravil se je letni pregled upravljanja, katerega cilj je zagotoviti, da so orodja upravljanja učinkovita in primerna.
6.2 Integrated quality-management at the Agency
6.2 Integrirano upravljanje kakovosti v Agenciji
Implementation and further development of risk-management plans
Izvajanje in nadaljnji razvoj načrtov za obvladovanje tveganja
More procedures finalised, in shorter time
Več dokončanih postopkov v krajšem času
By the end of 2006, the Agency employed a total of 497 staff.
Konec leta 2006 je Agencija zaposlovala skupaj 497 članov osebja.
Both procedures are based upon the principle of recognition of national authorisations.
Oba postopka temeljita na načelu medsebojnega priznavanja nacionalnih dovoljenj za promet.
Before I come to the end, I would like to commemorate our dear friend and Management Board colleague, Professor Gianmartino Benzi, who passed away in November 2006.
Preden zaključim, želim počastiti spomin na našega dragega prijatelja in kolega iz upravnega odbora, profesorja Gianmartina Benzija, ki je umrl novembra 2006.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.: (44-20) 74 18 84 00 Faks: (44-20) 74 18 84 09 E-pošta: mail@emea.europa.eu http://www.emea.europa.eu
2006 was also the first full year in which the Management Board operated in its full composition.
Leto 2006 je bilo tudi prvo leto, v katerem je upravni odbor deloval v popolni sestavi.
The Board has been closely following the Agency's achievements in 2006.
Odbor je tesno spremljal dosežke Agencije v letu 2006.
Average assessment time quicker than in 2005
Povprečni čas ocenjevanja krajši kot v letu 2005
The network is in place, connecting regulatory authorities in the European Economic Area, including the two new EU Member States, Bulgaria and Romania.
Mreža je vzpostavljena in povezuje regulativne organe v evropskem gospodarskem prostoru, vključno z dvema novima državama članicama EU, Bolgarijo in Romunijo;
First year of the EMEA SME Office: supporting innovation among Europe's SMEs
Prvo leto Urada za mala in srednje velika podjetja EMEA: podpiranje inovativnosti med evropskimi malimi in srednje velikimi podjetji
Similar biological products
Biološko podobni izdelki
The decisions and actions arising from the management review are incorporated in planning directives, annual work programme and budget.
Sklepi in ukrepi, ki izhajajo iz pregleda upravljanja, so vključeni v načrtovalne direktive, letni program dela in proračun.
I am also grateful the European Commission and the European Parliament for their continuous support to the EMEA and its mission for public and animal health over the past year.
Zahvaljujem se tudi Evropski komisiji in Evropskemu parlamentu za njuno stalno podporo EMEA in njenemu poslanstvu za zdravje ljudi in živali v zadnjih letih.
A meeting with stakeholders held early in the year confirmed the successful removal of the legalisation step previously performed by the European Commission's UK representation.
Srečanje z zainteresiranimi stranmi, organizirano na začetku leta, je potrdilo uspešno odstranitev zakonodajnega koraka, ki ga je predhodno opravljalo predstavništvo Evropske komisije v Združenem kraljestvu.
The decentralised procedure and the mutual recognition procedure apply to the majority of conventional medicinal products.
Decentralizirani postopek in postopek medsebojnega priznavanja se uporabljata za večino konvencionalnih zdravil.
The Agency is responsible for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA.
Agencija je odgovorna za izvajanje telematske strategije EU, o kateri so se dogovorile Evropska komisija, države članice in EMEA.
Italy 10% Ireland
Latvija 0% Italija 10% Irska
All inspections were completed within the legal timeframes and to the standards required by the Agency's quality-management system.
Vsi inšpekcijski pregledi so bili zaključeni v zakonskih rokih in v skladu s standardi, ki jih zahteva sistem upravljanja kakovosti Agencije.
Coordinators and their assessors/experts are now systematically involved in the planning/presubmission phase of all scientific-advice procedures.
koordinatorji in njihovi ocenjevalci/strokovnjaki se sedaj sistematično vključujejo v fazo načrtovanja/fazo pred oddajo vlog vseh postopkov znanstvenega svetovanja.
The number of withdrawn applications (20) was the lowest in the past 6 years.
Število umaknjenih vlog (20) je bilo najnižje v zadnjih šestih letih.
The Committee for Orphan Medicinal Products (COMP) adopted 81 positive opinions.
Odbor za zdravila sirote (COMP) je sprejel 81 pozitivnih mnenj.
The Agency subsequently accepted a place in the coordination group set up to convert those parts of the agenda dealing with regulatory issues into an action plan.
Agencija je naknadno sprejela mesto v usklajevalni skupini, ustanovljeni za preoblikovanje tistih delov agende, ki zadevajo regulativna vprašanja, v akcijski načrt.
In addition, a project has also been running to prepare such summaries for products approved prior to 2006.
Poleg tega poteka projekt za pripravo takih povzetkov za proizvode, ki so bili odobreni pred letom 2006.
The successes we were able to achieve were due to the smooth operation of the European network as a whole, and in particular to the outstanding work of our scientific committees, working parties and secretariat personnel.
Uspehi, ki smo jih dosegli, so rezultat nemotenega delovanja evropske mreže kot celote in zlasti izjemnega dela naših znanstvenih odborov, delovnih skupin in osebja sekretariata.
In July 2006, the Agency implemented a new framework for the provision of scientific advice.
Julija 2006 je Agencija uvedla nov okvir za zagotavljanje znanstvenega svetovanja.
2.6 Arbitration, Community referrals and ‘opinions on any scientific matter' Substantial increase in arbitration and referral activity in 2006
2.6 Arbitraža, napotitve Skupnosti in „mnenja o katerikoli znanstveni zadevi“ Bistveno povečanje obsega dejavnosti arbitraže in napotitev leta 2006
At the end of 2006, new European legislation aimed at promoting the development of medicines for children was adopted.
Konec leta 2006 je bila sprejeta nova evropska zakonodaja, usmerjena k spodbujanju razvoja zdravil za otroke.
The members have therefore started to look at new ways to improve the Board's involvement in the work of the Agency and its strategic decisiontaking.
Člani so zato začeli iskati nove načine za izboljšanje vključenosti odbora v delo Agencije in njeno strateško odločanje.
This document provides a summary of the EMEA annual report for 2006.
Ta dokument je povzetek letnega poročila EMEA za leto 2006.
Pharmacovigilance in the veterinary sector in the EU is undergoing changes triggered by the new legislation.
Farmakovigilanca v veterinarskem sektorju v EU doživlja spremembe, ki jih je sprožila nova zakonodaja.
Contributing to the European Technology Platform for Global Animal Health
Prispevek k Evropski tehnološki platformi za globalno zdravje živali
Monitoring the new legal tools relating to risk-management, in particular risk-management plans.
Spremljanje novih zakonskih orodij, povezanih z obvladovanjem tveganja, zlasti načrtov za obvladovanje tveganja.
The scheme is part of the Agency's strategy to improve the availability of such medicines.
Program je del strategije Agencije za izboljšanje razpoložljivosti takih zdravil.
Of the 681 such opinions adopted, 60% related to safety and efficacy, and 40% related to quality changes.
Izmed sprejetih 681 tovrstnih mnenj se jih je 60 % nanašalo na varnost in učinkovitost, 40 % pa na spremembe kakovosti.
The changes brought about by the revised pharmaceutical legislation had a fundamental impact on the structure and organisation of the Management Board.
Spremembe, ki jih je povzročila revidirana farmacevtska zakonodaja, so bistveno vplivale na sestavo in organizacijo upravnega odbora.
The electronic exchange of pharmacovigilance information within the EU is improving, as are active surveillance, harmonisation and risk-management.
Elektronska izmenjava informacij farmakovigilance v EU se izboljšuje podobno kot aktiven nadzor, usklajevanje in obvladovanje tveganja.
The scientific advice procedure has been improved and is used increasingly by sponsors of medicinal products.
Postopek znanstvenega svetovanja je bil izboljšan, vse bolj pa ga uporabljajo tudi sponzorji zdravil.
The Board encourages the Agency to continue its good work and to remain alert in view of the threat levels.
Odbor spodbuja Agencijo, naj nadaljuje z dobrim delom in ostane v pripravljenosti zaradi stopnje nevarnosti.
2.4 Post-authorisation activities Number of variation applications up by almost one third
2.4 Dejavnosti po izdaji dovoljenja Število vlog za spremembe naraslo skoraj za tretjino
In addition, about 45 people worked at the Agency on a contractual basis, mainly on IT projects.
Poleg tega je okoli 45 ljudi delalo v Agenciji na podlagi pogodbe, predvsem pri projektih IT.
In 2006, information on 14 withdrawals and 7 refusals was published.
V letu 2006 so bile objavljene informacije o štirinajstih umikih in sedmih zavrnitvah.
This is a considerable increase - more than twice the number received in 2005 - and would appear to result from efforts to promote awareness of expedited reporting.
To je bistveno povečanje, več kot dvakratno število prejetih vlog leta 2005, za katero se zdi, da je posledica prizadevanj za spodbujanje ozaveščenosti o pospešenem poročanju.
Keen interest expressed by patients' and consumers' organisations
Velik interes organizacij bolnikov in potrošnikov
Generics, hybrid products, etc.
Generična zdravila, hibridna zdravila itd.
Further work is being done to better define minor uses and limited markets, in order to facilitate use of the guidelines and to allow for a harmonised implementation across the EU.
Opravlja se dodatno delo za boljšo opredelitev manjših uporab in omejenih trgov, da bi tako poenostavili uporabo smernic in zagotovili usklajeno izvajanje po vsej EU.
The scientific-advice procedure was streamlined to allow finalisation within 40 days (up to a maximum of 70 days), whereas the previous procedure could take up to 100 days.
postopek znanstvenega svetovanja je bil racionaliziran tako, da omogoča zaključek v 40 dneh (do največ 70 dni), medtem ko je prejšnji postopek lahko trajal do 100 dni;
Speeding up electronic reporting by all involved parties and discussing ways to improve the quality of the data submitted.
Pospeševanje elektronskega poročanja vseh vključenih strank in obravnavanje načinov za izboljšanje kakovosti predloženih podatkov.
4.2 Sampling and testing
4.2 Vzorčenje in preizkušanje
The EMEA continued its work on improving the availability of medicines.
EMEA je nadaljevala z delom za izboljšanje razpoložljivosti zdravil.
The Agency has continued its contribution to the promotion of research and development in Europe.
Agencija še naprej spodbuja raziskave in razvoj v Evropi.
There was a substantial increase (of €150,000) in the training budget, the range of professional-training opportunities was extended, and, for each staff member, a ‘training profile' was developed to serve as a competence-development guideline for the coming years.
Proračun za usposabljanje se je bistveno povečal (za 150.000 EUR), obseg možnosti za strokovno usposabljanje je bil razširjen in za vsakega člana osebja je bil razvit „profil usposabljanja“, ki bo služil kot smernica razvoja pristojnosti v prihodnjih letih.
The results presented in the annual report 2006 document that the Agency's preparatory work to implement the new legal provisions has fully paid off: the Agency has demonstrated that it adapted successfully to the new regulatory framework and was able to run new and existing procedures successfully and efficiently.
Rezultati, predstavljeni v letnem poročilu za leto 2006 dokazujejo, da je bilo pripravljalno delo Agencije za izvajanje novih zakonskih določb nadvse plodno: Agencija je dokazala, da se je uspešno prilagodila novemu regulativnemu okviru, prav tako je uspešno in učinkovito izvajala nove in obstoječe postopke.
of Directive 2001/83/EC
Direktive 2001/83/ES
His spirit, his enthusiasm and his contributions to the work of the European Medicines Agency are greatly missed.
Močno pogrešamo njegov duh, entuziazem in prispevek k delu Evropske agencije za zdravila.
By saying this I would also like to take this opportunity to thank all the Board members for their contributions to the work of the Board.
Ob tej priložnosti bi se rad zahvalil tudi članom upravnega odbora za njihove prispevke k delu odbora.
The number of such procedures finalised in 2006 was also greater, with a total of 32 opinions being adopted.
Število takih postopkov, ki so bili zaključeni leta 2006, je bilo prav tako višje, sprejetih pa je bilo skupaj 32 mnenj.
As always, I am grateful to the national competent authorities for the scientific resources they have made available to the EMEA.
Tudi tokrat se zahvaljujem nacionalnim pristojnim organom za znanstvene vire, ki so jih dali na razpolago EMEA.
This required no fee or formal application, provided the scientific criteria allowing such extrapolations were met.
Za to niso bile potrebne nobene pristojbine ali formalne vloge, če so bila izpolnjena znanstvena merila, ki omogočajo take ekstrapolacije.
The full EMEA annual report for 2006 was adopted by the Management Board on 8 March 2007, and is available on the EMEA website:
Celotno letno poročilo EMEA za leto 2006 je upravni odbor sprejel 8. marca 2007 in je na voljo na spletni strani EMEA:
Procedures for reporting into EudraVigilance Veterinary were considerably enhanced during the year.
Postopki za poročanje v EudraVigilance za veterinarstvo so se med letom bistveno okrepili.
I am convinced that the efforts made will help to secure and build up public confidence in the Agency's actions in relation to medicinal products.
Prepričan sem, da bodo ta prizadevanja pomagala ohraniti in okrepiti zaupanje javnosti v ukrepe Agencije v zvezi z zdravili.
Where the original national authorisation cannot be recognised, the points in dispute are submitted to the EMEA for arbitration.
Kadar se izvorno nacionalno dovoljenje za promet z zdravilom ne more priznati, se sporne točke predložijo EMEA v arbitražo.
Although these generic medicines are not innovative, they are considered to represent an important contribution to public health in the EU.
Čeprav ta generična zdravila niso inovativna, se jih obravnava kot zdravila, ki bistveno prispevajo k javnemu zdravju v EU.
The Committee reconfirmed its previous conclusion that no action was required regarding concerns of possible cardiovascular effects and skin reactions for this class of medicines.
Odbor je ponovno potrdil svoj predhodni sklep, da ni potrebno nobeno ukrepanje glede pomislekov o možnih kardiovaskularnih učinkih in kožnih reakcijah za ta razred zdravil.
There is a balanced geographical representation of EU Member State nationalities among the EMEA staff, with emphasis being made in recent years on recruiting from the new EU accession countries.
V osebju EMEA so uravnoteženo geografsko zastopana državljanstva držav članic EU, v zadnjih letih pa je poudarek na zaposlovanju osebja iz novih držav pristopnic EU.
1.5 Better medicines for children
1.5 Boljša zdravila za otroke
This was the first procedure conducted under the new pharmacovigilance provision of Article 78 of Directive 2001/82/EC, as amended.
To je bil prvi postopek, izveden v skladu z novo določbo farmakovigilance iz člena 78 Direktive 2001/82/ES, kakor je bila spremenjena.
The EMEA contributed towards the preparation of the new Paediatric Regulation2, which was published in December 2006.
EMEA je prispevala k pripravi nove pediatrične uredbe2, ki je bila objavljena decembra 2006.
Further progress was made in other areas too, notably our transparency, information and communication initiatives, preparations for the accession to the EU of Bulgaria and Romania, arrangements for the participation of Croatia and Turkey in EMEA activities, and international cooperation with our scientific and regulatory partners at the European and global levels.
Napredek je bil dosežen tudi na drugih področjih, predvsem pri naših pobudah za preglednost, zagotavljanje informacij in obveščanje, pripravah za pristop Bolgarije in Romunije k EU, ureditvi za sodelovanje Hrvaške in Turčije v dejavnostih EMEA in mednarodnem sodelovanju z našimi znanstvenimi in regulativnimi partnerji na evropski in svetovni ravni.
Facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry.
pospeševanjem inovacij in spodbujanjem raziskav, s čimer prispeva h konkurenčnosti farmacevtske industrije EU;
The average time required to finalise procedures for provision of scientific advice in 2006 was 55 days.
Povprečen čas, potreben za zaključek postopkov za zagotavljanje znanstvenega svetovanja, je leta 2006 znašal 55 dni.
Other revenue SME contribution Telematics strategy Orphan drug contribution Total fee revenue Basic EU contribution
Drugi prihodki Prispevek MSP Telematska strategija Prispevek zdravil sirot Skupni prihodki iz pristojbin Osnovni prispevek EU
As part of this, an ad hoc working group was created to re-define the Management Board's role and responsibilities.
V okviru tega je bila oblikovana priložnostna delovna skupina za ponovno opredelitev vloge in odgovornosti upravnega odbora.
Contra-indications, class labelling and warnings
Kontraindikacije, označevanje razreda in opozorila