natgillin/translations-raw huggingface dataset:
• the CHMP reviewed all available data regarding use in pregnant women and in immunocompromised patients of rubella containing vaccines, including the most recent publications and data from post-marketing surveillance for monovalent and multivalent measles, mumps, rubella and varicella vaccines.
• CHMP je pregledal vse razpoložljive podatke o uporabi cepiv, ki vsebujejo virus rdečk, pri nosečnicah in bolnikih z oslabljenim imunskim sistemom, vključno z najnovejšimi publikacijami in podatki iz postopka spremljanja v obdobju trženja za eno- in večvalentna cepiva proti ošpicam, mumpsu, rdečkam in noricam;
When considering the data from studies in the literature and the data from post-marketing surveillance the CHMP concluded that although a theoretical risk cannot be excluded, no case of CRS has been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated against rubella.
Ko je CHMP obravnaval podatke iz študij v literaturi in podatke iz postopka spremljanja v obdobju trženja, je ugotovil, da kljub temu, da ni mogoče izključiti teoretičnega tveganja, pri več kot 3 500 dovzetnih ženskah, ki so bile cepljene proti rdečkam v zgodnji nosečnosti, ko za nosečnost še niso vedele, niso poročali o nobenem primeru sindroma prirojenih rdečk.
For completeness, the CHMP also recommended the update of the product information to reflect the most recent published data regarding vaccination against rubella in pregnant women.
Zaradi celovitosti je CHMP priporočil tudi dopolnitev informacij o zdravilu z najnovejšimi objavljenimi podatki glede cepljenja nosečnic proti rdečkam.
Overall summary of the scientific evaluation of the measles, mumps, rubella and varicella containing vaccines (see Annex I)
Splošni povzetek znanstvenega vrednotenja cepiv, ki vsebujejo viruse ošpic, mumpsa, rdečk in noric (glejte Prilogo I)
Regarding the contraindication on immunocompromised subjects, an assessment of the safety of MMRV vaccines (based on experience to date) in subjects with various types of immune deficiencies (e.g. T-cell defects, sub-class deficiencies etc.) was provided by the Marketing Authorisation Holders (MAHs).
Glede kontraindikacije pri osebah z oslabljenim imunskim sistemom so imetniki dovoljenj za promet z zdravilom predložili oceno varnosti cepiv MMRV (ki temelji na dosedanjih izkušnjah) pri osebah z različnimi vrstami imunske pomanjkljivosti (npr. okvarami limfocitov T, pomanjkljivostmi podrazreda).
Therefore, the CHMP recommended the variation to the terms of the marketing authorisations for which the relevant sections of the summaries of product characteristics and package leaflets are set out in Annex III for monovalent and multivalent measles, mumps, rubella and varicella containing vaccines (see Annex I).
CHMP je posledično priporočil spremembo pogojev dovoljenj za promet z zdravilom, za katera so zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo za eno- in večvalentna cepiva, ki vsebujejo viruse ošpic, mumpsa, rdečk ter noric (glejte Prilogo I), določena v Prilogi III.
The CHMP also considered that the most recent published data regarding vaccination against rubella in pregnant women should be reflected in the summary of product characteristics of the monovalent rubella vaccines and multivalent MMR vaccines.
CHMP je prav tako menil, da je treba najnovejše podatke o cepljenju proti rdečkam pri nosečnicah vključiti v povzetek glavnih značilnosti zdravila za enovalentna cepiva proti rdečkam in večvalentna cepiva MMR;
In addition, published data also indicated that some groups of individuals other than pregnant women could benefit from a MMRV vaccine and therefore the contraindication for immunocompromised subjects needed to be reviewed.
Objavljeni podatki kažejo tudi,da bi lahko cepivo MMRV razen nosečnicam koristilo tudi drugim skupinam posameznikov, zato je bilo treba ponovno presoditi o kontraindikaciji pri osebah z oslabljenim imunskim sistemom.
Based on the low theoretical teratogenic risk and the fact that no case of CRS has been reported, it should also be mentioned in the SmPC that inadvertent vaccination of unknowingly pregnant women with monovalent or multivalent mumps, measles and rubella containing vaccines should not be a reason for termination of pregnancy.
Glede na majhno teoretično teratogeno tveganje in odsotnost poročil o primerih sindroma prirojenih rdečk je treba v povzetku glavnih značilnosti zdravila navesti tudi, da nenamerno cepljenje žensk, ki ne vedo, da so noseče, z eno- ali večvalentnimi cepivi, ki vsebujejo viruse mumpsa, ošpic in rdečk, ni razlog za prekinitev nosečnosti.
Vaccination with these MMRV vaccines is contraindicated in pregnant women and in immunocompromised subjects.
Uporaba cepiv MMRV je kontraindicirana pri nosečnicah in osebah z oslabljenim imunskim sistemom.
The contraindication in this patient population was also further defined by inclusion of age specific %CD4+ for HIV-infected patients.
Z vključitvijo starostno specifičnega odstotka CD4+ za bolnike, okužene z virusom HIV, je bila podrobneje opredeljena tudi kontraindikacija pri tej populaciji bolnikov;
The product information is therefore amended accordingly to reflect that pregnancy should be avoided for 1 month following vaccination instead of 3 months.
Informacije o zdravilu so bile zato spremenjene tako, da se obdobje po cepljenju, v katerem naj ženske ne zanosijo, skrajša s 3 mesecev na 1 mesec.
Evidence from post marketing surveillance and published literature that focused on risk of spontaneous abortion, miscarriage, stillbirth, immaturity and low birth weight in women susceptible to measles, mumps, rubella and/or varicella, risk of malformation and congenital rubella syndrome (CRS) in offspring of such women, and risk of congenital varicella syndrome (CVS) were considered for the review of the contraindication on pregnancy.
Pri ponovni presoji kontraindikacije med nosečnostjo so bili uporabljeni dokazi iz postopka spremljanja v obdobju trženja in objavljene literature, ki zadevajo tveganja spontanega splava, abortusa, mrtvorojenega otroka, nedonošenosti ali nizke porodne teže pri ženskah, dovzetnih za ošpice, mumps, rdečke in/ali norice, tveganje okvar in sindrom prirojenih rdečk pri potomcih teh žensk ter sindrom prirojenih noric.
Data provided from post marketing surveillance and published literature did not show any safety concern with respect to spontaneous abortion or congenital malformations in pregnant women that were inadvertently vaccinated with MMRV vaccines and no case of CRS or CVS have been reported.
Podatki iz postopka spremljanja v obdobju trženja in objavljene literature niso pokazali nobenih varnostnih zadržkov, povezanih s spontanim splavom ali prirojenimi okvarami pri nosečnicah, ki so bile nenamerno cepljene s cepivi MMRV, poleg tega tudi niso poročali o primerih sindroma prirojenih rdečk ali sindroma prirojenih noric.
Because of this theoretical teratogenic risk, the World Health Organization (WHO) recommended in 2011 that vaccination against rubella should be avoided in principle in pregnant women and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination1.
Zaradi tega teoretičnega teratogenega tveganja je Svetovna zdravstvena organizacija (SZO) leta 2011 priporočila, da se je treba cepljenju nosečnic proti rdečkam načeloma izogibati, ženskam, ki načrtujejo zanositev, pa je treba svetovati, da še 1 mesec po cepljenju proti rdečkam ne zanosijo.1 Trenutni podatki kažejo, da so ravni IgM proti rdečkam najvišje približno 30 dni po cepljenju, prav tako pa je mogoče zaznati IgG.
However, we want to take this a step forward.
Vendar pa želimo iti korak naprej.
The Agency will concentrate its efforts in three areas:
Agencija bo svoja prizadevanja osredotočila na tri področja:
The implementation of Article 5(3) and Article 107(2) procedures which are new legal provisions will be monitored carefully.
Izvajanje postopkov po členih 5(3) in 107(2), ki so nove pravne določbe, se bo skrbno spremljalo.
These systems are evolving in line with communicated requirements.
Ti sistemi se razvijajo skladno s sporočenimi zahtevami.
This will result from routine maintenance activities.
To bo rezultat rutinskih vzdrževalnih dejavnosti.
The implementation strategy concentrates on a number of projects with high European added value.
Izvajanje strategije je osredotočeno na nekaj projektov z visoko evropsko dodano vrednostjo.
Work on the next version will be postponed to 2009.
Delo na naslednji različici bo preloženo v leto 2009.
1.6 Preparations for future enlargement
1.6 Priprave na prihodnjo širitev
Additional priorities in 2007 will include:
Dodatne prednostne naloge v letu 2007 bodo vključevale:
The priorities and key objectives for 2007 can be summarised as follows:
Prednostne naloge in ključne cilje za leto 2007 je mogoče povzeti na naslednji način:
Protocol assistance will remain a priority area for these incentives.
Pomoč pri protokolu bo ostalo prednostno področje, kar zadeva te spodbude.
Generic, hybrid products, etc.
Generična, hibridna zdravila itd.
The volume of translations is expected to increase to 40,950 pages - 95% more than in 2006.
Pričakuje se, da se bo obseg prevodov povečal na 40.950 strani - 95 % več kot v letu 2006.
302 Translation
302 Prevajanje
This database is in the first stages of the design process.
Ta zbirka podatkov je v prvih fazah načrtovalskega procesa.
Except for specification, work on extending the system to mutual recognition and decentralised procedures has been postponed to 2008-2009.
Z izjemo specifikacije je bilo delo na področju širitve sistema medsebojnega priznavanja in decentraliziranih postopkov odloženo v obdobje 2008-2009.
2.11 Coordination group
2.11 Usklajevalna skupina
System or process 2007 milestones
Sistem ali proces Mejniki za leto 2007
The number of applications and related workload has increased over the last years.
Število vlog in povezana delovna obremenitev sta se v zadnjih letih povečala.
The SME office has been set up within the agency to address the particular needs of smaller companies.
Urad za mala in srednje velika podjetja je bil ustanovljen v okviru Agencije, da bi obravnaval posebne potrebe manjših družb.
The Agency will work to ensure timely and smooth transitions from the former Committees.
Agencija si bo prizadevala zagotoviti pravočasne in gladke prehode iz prejšnjih odborov.
With this in view, a number of guidance documents will be developed.
V ta namen bodo pripravljeni številni usmeritveni dokumenti.
Following discussion with stakeholders and interested parties, work will start on establishing a ‘Strategic plan for new technologies'.
Po razpravi z interesnimi skupinami in zainteresiranimi stranmi se bodo začela dela za oblikovanje „Strateškega načrta za nove tehnologije“.
2.10 Scientific committees, working parties and scientific advisory groups
2.10 Znanstveni odbori, delovne skupine in znanstvene svetovalne skupine
Some outcomes of these initiatives will contribute to the ongoing discussion on planning of activities at the level of the European medicines network.
Nekateri rezultati teh pobud bodo prispevali k trenutni razpravi o načrtovanju dejavnosti na ravni Evropske mreže zdravil.
The Agency plans to test 40 products in 2007.
Agencija načrtuje, da bo v letu 2007 preizkusila 40 proizvodov.
The increase also takes into account activities postponed from 2006, as well as participation of representatives of candidate countries in meetings, training courses and conferences.
Povečanje upošteva tudi dejavnosti, preložene iz leta 2006, ter sodelovanje predstavnikov držav kandidatk na sestankih, tečajih usposabljanja in konferencah.
This document provides a summary of the Agency's work programme 2007.
Ta dokument je povzetek delovnega programa Agencije za leto 2007.
This new method has been used for the numbers as of 2006.
Ta nova metoda je bila uporabljena za podatke od leta 2006 naprej.
Scientific opinions for non-EU markets
Znanstvena mnenja za trge zunaj EU
5 Support activities
5 Podporne dejavnosti
Mutual recognition agreements (MRAs) with Australia, New Zealand, Switzerland, Canada and Japan are currently operational, but with slightly different provisions as to scope and applicability.
Trenutno veljajo sporazumi o medsebojnem priznavanju (MRA) z Avstralijo, Novo Zelandijo, Švico, Kanado in Japonsko, vendar pa se njihove določbe nekoliko razlikujejo glede obsega in uporabe.
As part of the implementation of the European pharmaceutical policy and legislation, the Agency was given responsibility to implement the EU telematics strategy.
V okviru izvajanja evropske farmacevtske politike in zakonodaje je bila Agencija zadolžena za izvajanje telematske strategije EU.
305 Community programmes
305 Programi Skupnosti
AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total Function Group AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total Function Group AST Total Staff
AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Funkcionalna skupina AD skupaj AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Funkcionalna skupina AST skupaj Osebje skupaj
The majority of EU telematics systems will be in use at the beginning of 2007.
Večina telematskih sistemov EU se bo začela uporabljati na začetku leta 2007.
Availability or lack thereof will have a direct impact on the productivity of the HMPC in 2007 and beyond.
Njihova razpoložljivost ali pomanjkanje bo neposredno vplivalo na storilnost HMPC v letu 2007 in po njem.
Implementation of advanced network-management and performance services.
Uresničitev naprednega mrežnega upravljanja in izvajalskih storitev.
I wish to point out that this new area of responsibility will affect the existing core activities of the Agencyfor example scientific advice, an area in which the Agency expects to receive 30% more requests than in 2006.
Rad bi poudaril, da bo to novo področje odgovornosti vplivalo na obstoječe glavne dejavnosti Agencije - na primer znanstveno svetovanje, kjer Agencija pričakuje, da bo prejela 30 % več zahtevkov kot v letu 2006.
1.7 International cooperation
1.7 Mednarodno sodelovanje
Please note that figures for 2007 given in charts are estimates only.
Opozarjamo, da so številke za leto 2007, navedene v grafikonih, le ocene.
Provision of additional EudraNet back-up systems.
Zagotovitev dodatnih podpornih sistemov za EudraNet.
The Agency will ensure optimal coordination between concerned parties to minimise ‘unnecessary' referrals.
Agencija bo zagotovila optimalno koordinacijo med zadevnimi strankami, da bi čim bolj znižala število „nepotrebnih“ napotitev.
EU Telematics Controlled Terms (2nd Proof of Concept concluded)
EU Telematics Controlled Terms (zaključeno drugo preverjanje zasnove)
This programme will allow the two countries to prepare themselves for participation in the activities of the EMEA and to develop the confidence of the existing Members States in the systems in place in the two candidate countries.
Program bo tema dvema državama omogočil, da se pripravita na sodelovanje pri dejavnostih EMEA in povečata zaupanje obstoječih držav članic v sisteme, ki veljajo v teh dveh državah kandidatkah.
− Provide opinions on medicinal products intended for non-EU markets;
− dajanje mnenj o zdravilih, ki niso namenjena trgom EU;
In 2007, the Agency will seek to consolidate these activities, based on a review of the experience gained from the first year of operation of the CMD(h) and CMD(v).
V letu 2007 si bo Agencija prizadevala utrditi te dejavnosti na podlagi pregleda izkušenj, pridobljenih v prvem letu delovanja CMD(h) in CMD(v).
We will work closely with Member States and their experts to ensure that the information we provide is of the highest quality in all languages.
Tesno bomo sodelovali z državami članicami in njihovimi strokovnjaki, da bi tako zagotovili najvišjo kakovost naših informacij v vseh jezikih.
A second key task will relate to the development of risk-management plans at the time when scientific advice is sought.
Druga ključna naloga bo povezana z razvojem načrtov za obvladovanje tveganj, kadar bo zaprošeno za znanstveno svetovanje.
Bringing inspections agencies into service over EudraNet where these are not part of the national competent authority.
Vključitev inšpekcijskih agencij v delovanje prek EudraNeta, kadar niso del nacionalnega pristojnega organa.
We look forward to fruitful cooperation with scientific experts from these countries to bring effective and safe medicines to all European citizens.
Veselimo se plodnega sodelovanja z znanstvenimi strokovnjaki iz teh držav, saj bomo tako lahko vsem evropskim državljanom zagotovili učinkovita in varna zdravila.
1.8 Integrated management at the Agency
1.8 Integrirano upravljanje Agencije
The aim of the Agency's activities will be to build contacts and relationships between Croatia and Turkey and the EMEA.
Dejavnosti Agencije bodo namenjene ustvarjanju stikov in odnosov med Hrvaško in Turčijo ter EMEA.
Following the tender procedure in 2006, it is anticipated that over the year, the system will be installed in agencies across the European Economic Area that require it.
Po razpisnem postopku v letu 2006 se pričakuje, da bo sistem preko leta nameščen v agencijah po celotnem Evropskem gospodarskem prostoru, ki ga zahtevajo.
The Agency will remain focused on the objectives of the Lisbon agenda.
Agencija bo ostala usmerjena k ciljem lizbonske strategije.
The list of these European experts is available for examination on request at the EMEA offices.
Seznam teh evropskih strokovnjakov je na zahtevo na voljo v uradih EMEA.
The year 2007 will be the thirteenth year of operation of the EMEA and of its contribution towards the promotion and protection of public and animal health.
Leto 2007 bo trinajsto leto delovanja Evropske agencije za zdravila (EMEA) ter njenega prispevanja k spodbujanju in varovanju zdravja ljudi in živali.
Although there has been a major increase in electronic reporting of ICSRs over the last two years, the EMEA will continue its initiatives to speed up the implementation of such reporting.
Čeprav se je v zadnjih dveh letih močno povečalo elektronsko sporočanje varnostnih poročil o posameznih primerih (ICSR), bo EMEA nadaljevala svoje pobude za pospešitev izvajanja takega poročanja.
The EMEA supports the objectives of the Lisbon agenda.
EMEA podpira cilje programa lizbonske strategije.
The Agency expects a significant increase in the number of arbitration and referral procedures in particular in the number of Article 29 arbitrations (relating to difference in opinions at the Member State level).
Agencija pričakuje precejšnje povečanje števila postopkov arbitraže in napotitve, zlasti pri številu arbitraž po členu 29 (glede na razliko v mnenjih na ravni držav članic).
The Agency estimates an increase in the number of reimbursed meetings by 30% and the number of reimbursed delegates by 25% in 2007.
Agencija ocenjuje, da se bo v letu 2007 število sestankov s povrnjenimi stroški povečalo za 30 %, število delegatov s povrnjenimi stroški pa za 25 %.
The Agency considers the availability of the same, high-quality information about medicines in all official EU languages to be essential for their optimal use in all Member States.
Agencija meni, da je razpoložljivost enakih visokokakovostnih informacij o zdravilih v vseh uradnih jezikih EU izredno pomembno za njihovo optimalno uporabo v vseh državah članicah.
3.3 Sampling and testing
3.3 Vzorčenje in preizkušanje
In addition, there is a set of horizontal services that are necessary to support the implementation of the systems mentioned.
Temu je treba dodati še sklop horizontalnih storitev, potrebnih za podporo izvajanju navedenih sistemov.
The large number of applications received in 2006 will have a significant impact on the workload in 2007 since procedures run over several months.
Veliko število vlog, prejetih v letu 2006, bo močno vplivalo na delovno obremenitev v letu 2007, saj postopki trajajo več mesecev.
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and EMEA.
Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet („farmakovigilanca“) je pomemben element dela pristojnih nacionalnih organov in EMEA.
The Agency's full work programme 2007, which was adopted by the Management Board on 19 December 2006, can be found on the Agency's website: www.emea.europa.eu
Celoten delovni program Agencije za leto 2007, ki ga je upravni odbor sprejel 19. decembra 2006, je na voljo na spletni strani Agencije www.emea.europa.eu.
The work will be carried out in the context of the European Risk Management Strategy (ERMS), and will include the development of additional activities and the implementation of agreed initiatives.
To delo bo opravljeno v okviru evropske strategije o obvladovanju tveganj (ERMS) ter bo vključevalo razvoj dodatnih dejavnosti in uresničevanje dogovorjenih pobud.
Promoting the safety of medicines has been an important area for the Agency over many years, and will remain a priority in 2007.
Spodbujanje varnosti zdravil je bilo dolga leta pomembno področje delovanja Agencije in bo tudi v letu 2007 ostalo prednostna naloga.
In some areas, growth during 2006 was substantial, with an increased workload expected again in 2007.
Na nekaterih področjih je bila rast v letu 2006 precejšnja in v letu 2007 se ponovno pričakuje povečana delovna obremenitev.
A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
EMEA objavlja širok razpon dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
Cooperation will continue with the partner EU agencies and the European Directorate for the Quality of Medicines.
Nadaljevalo se bo sodelovanje s partnerskimi agencijami EU in Evropskim direktoratom za kakovost zdravil.
To this end, the Agency has established a working group with healthcare professionals, which will prepare a framework for interaction with healthcare professionals' organisations.
V ta namen je Agencija ustanovila delovno skupino z zdravstvenimi strokovnjaki, ki bo pripravila okvir za medsebojno povezanost z organizacijami zdravstvenih strokovnjakov.
The Agency welcomes the national competent authorities of the two new Member States, Bulgaria and Romania, as valued partners in the European medicines network.
Agencija izraža dobrodošlico pristojnim nacionalnim organom dveh novih držav članic, Bolgarije in Romunije, kot cenjenim partnerjem v Evropski mreži zdravil.
Annex 3 Revenue and expenditure overview 2005-2007
Priloga 3 Pregled prihodkov in odhodkov za obdobje 2005-2007
We will also strive to improve our communications more generally, covering both our scientific and non-scientific activities.
Prizadevali si bomo tudi splošno izboljšati svoje komunikacije, vključno z znanstvenimi in neznanstvenimi dejavnostmi.
As in previous years, the Agency will carry out a number of self-assessment activities, internal audits and stakeholder surveys, and will introduce a system for 360-degree evaluation of management.
Agencija bo tako kot prejšnja leta izvajala številne dejavnosti samoocenjevanja, notranjih revizij in pregledov s strani interesnih skupin ter uvedla sistem za presojo upravljanja po načelu 360 stopinj.
1.5 European public health activities
1.5 Evropske dejavnosti na področju javnega zdravja
The EMEA will also begin the gradual establishment of a European network for paediatric research.
EMEA bo začela tudi postopno vzpostavljati evropsko mrežo za pediatrične raziskave.
17 Entertainment and representation expenses 18 Staff insurances
17 Stroški dodatkov za razvedrilo in reprezentanco 18 Zavarovanje osebja
The Agency will also develop measures to assist companies with authorisation of products for minor markets.
Agencija bo razvila tudi ukrepe za pomoč podjetjem pri pridobivanju dovoljenj za proizvode, namenjene majhnim trgom.
Integrated quality management - Internal audit
Celovito obvladovanje kakovosti - interna revizija
European public assessment report (EPAR).
Evropsko javno poročilo o oceni zdravila (EPAR).