FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the above, Belgium national competent authorities triggered a referral under Article 31 of Directive 2001/83/EC on 9 March 2012, requesting the CHMP to review the benefit/risk of these vaccines in the above mentioned populations, i.e. pregnant women and subjects with immune deficiencies.
Slovenian: Na podlagi zgoraj navedenega so belgijski nacionalni pristojni organi 9. marca 2012 sprožili napotitveni postopek na podlagi člena 31 Direktive 2001/83/ES, v katerem CHMP naproša za ponovno presojo razmerja med tveganji in koristmi teh cepiv pri zgoraj omenjenih populacijah, tj. nosečnicah in osebah z imunskimi pomanjkljivostmi.
English: Immunocompromised subjects
Slovenian: Osebe z oslabljenim imunskim sistemom
English: Grounds for variation to the terms of the marketing authorisations
Slovenian: Razlogi za spremembo pogojev dovoljenj za promet z zdravilom
English: The CHMP acknowledged that MMRV vaccines should remain contraindicated in patients with severely impaired humoral and/or cellular immune systems such as severe combined immunodeficiency (SCID) and agammaglobulinemia.
Slovenian: CHMP je potrdil, da morajo cepiva MMRV ostati kontraindicirana pri bolnikih s hudo oslabljenim humoralnim in/ali celičnim imunskim sistemom, kot sta huda kombinirana imunska pomanjkljivost in agamaglobulinemija.
English: However, it was noted by the CHMP that the data from post-marketing surveillance and pregnancy registry were limited due to the current contraindication in the product information and were too poorly documented to draw any conclusion.
Slovenian: Vendar je CHMP ugotovil, da je podatkov iz postopka spremljanja v obdobju trženja in nosečniškega registra premalo zaradi trenutne kontraindikacije v informacijah o zdravilu in da so ti preslabo dokumentirani za postavitev kakršnega koli sklepa.
English: • that vaccination with MMRV vaccines may be considered in patients with selected immune deficiencies when the benefit outweighs the risk of vaccination.
Slovenian: • da je o cepljenju s cepivi MMRV možno razmisliti pri bolnikih z nekaterimi oblikami imunske pomanjkljivosti, kadar je korist teh cepiv večja od tveganja pri cepljenju.
English: Moreover, a warning should be added as vaccination may be considered in patients with selected immune deficiencies (e.g. IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases), if the benefit outweighs the risk of vaccination.
Slovenian: Poleg tega je treba dodati opozorilo, da je cepivo mogoče uporabiti pri bolnikih z nekaterimi oblikami imunske pomanjkljivosti (npr. pomanjkljivostmi podrazreda IgG, prirojeno nevtropenijo, kronično granulomatozno boleznijo in pomanjkljivostmi komplementa), če so koristi cepljenja večje od z njim povezanih tveganj.
English: Having considered all available data, the CHMP is of the opinion that MMRV vaccination should continue to be contraindicated in pregnant women.
Slovenian: Ob upoštevanju vseh razpoložljivih podatkov je CHMP bil mnenja, da mora ostati cepljenje proti MMVR še naprej kontraindicirano pri nosečnicah.
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom
English: Monovalent and multivalent measles, mumps, rubella and/or varicella containing vaccines (MMRV) are live attenuated vaccines which are indicated in vaccination of adults and children against these viruses.
Slovenian: Eno- in večvalentna cepiva, ki vsebujejo viruse ošpic, mumpsa, rdečk in/ali noric (MMRV), so živa oslabljena cepiva, indicirana za cepljenje odraslih in otrok proti tem virusom.
English: On the basis of the most recent published data on rubella containing vaccines, in particular for pregnant women Belgium national competent authorities considered it was justified to review whether monovalent and multivalent MMRV vaccines should remain contraindicated in pregnant women as vaccination in some individual cases may outweigh the risk.
Slovenian: Na podlagi najnovejših objavljenih podatkov o cepivih, ki vsebujejo virus rdečk, so belgijski nacionalni pristojni organi sklenili, da je zlasti pri nosečnicah upravičeno pregledati, ali naj eno- in večvalentna cepiva MMRV ostanejo kontraindicirana pri nosečnicah, saj so lahko koristi cepljenja v nekaterih posameznih primerih večje od z njim povezanih tveganj.
English: Taking into account that rubella and varicella vaccination induce a fast immune response that make post-exposure prophylaxis possible, based on available evidence and as reflected in WHO recommendation, the CHMP considered that there are sufficient data to reduce the period post-vaccination where pregnancy should be avoided.
Slovenian: Ker cepljenje proti rdečkam in noricam izzove hiter imunski odziv, ki omogoča zaščito po izpostavitvi, je CHMP na podlagi razpoložljivih dokazov in priporočil SZO menil, da podatki zadoščajo za skrajšanje obdobja po cepljenju, v katerem naj ženske ne zanosijo.
English: • that the data were sufficient to amend the product information to mention that pregnancy should be avoided for 1 month (instead of 3 months) following vaccination.
Slovenian: • da podatki zadoščajo, da se informacije o zdravilu spremenijo in se obdobje, v katerem naj ženske po cepljenju ne zanosijo, skrajša na 1 mesec (namesto 3 mesecev).
English: However, the CHMP concluded that the current contraindication for use of MMRV vaccines in immunocompromised subjects should be amended to clarify that, according to WHO guidelines and scientific data, for HIV-infected patients age specific %CD4+ is to be included.
Slovenian: Vendar pa je CHMP zaključil, da je treba trenutno kontraindikacijo za uporabo cepiv MMRV pri bolnikih z oslabljenim imunskim sistemom spremeniti tako, da se skladno s smernicami SZO in znanstvenimi podatki za bolnike, okužene z virusom HIV, vključi starostno specifični odstotek CD4+.
English: The CHMP considered that the contraindication should be harmonised and adjusted according to WHO guidance and scientific data and that although these vaccines are generally contraindicated in immunocompromised subjects, some individuals may benefit from vaccination.
Slovenian: CHMP je menil, da je treba kontraindikacijo uskladiti in prilagoditi v skladu s smernicami SZO in znanstvenimi podatki ter da lahko cepljenje koristi nekaterim posameznikom, čeprav so ta cepiva navadno kontraindicirana pri osebah z oslabljenim imunskim sistemom.
English: • the CHMP considered the referral under Article 31 of Directive 2001/83/EC for monovalent and multivalent measles, mumps, rubella and varicella containing vaccines.
Slovenian: • CHMP je obravnaval napotitveni postopek iz člena 31 Direktive 2001/83/ES za eno- in večvalentna cepiva, ki vsebujejo viruse ošpic, mumpsa, rdečk in noric;
English: • that the data provided were too limited and poorly documented to draw any conclusion and therefore without any sufficient data monovalent and multivalent MMRV vaccines should remain contraindicated during pregnancy.
Slovenian: • da je podatkov premalo in da so ti preslabo dokumentirani, da bi omogočali sklepe, zato morajo eno- in večvalentna cepiva proti MMRV zaradi odsotnosti zadostnih podatkov ostati kontraindicirana med nosečnostjo;
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zaradi celovitosti je CHMP priporočil tudi dopolnitev informacij o zdravilu z najnovejšimi objavljenimi podatki glede cepljenja nosečnic proti rdečkam.
English: Overall summary of the scientific evaluation of the measles, mumps, rubella and varicella containing vaccines (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja cepiv, ki vsebujejo viruse ošpic, mumpsa, rdečk in noric (glejte Prilogo I)
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Vaccination with these MMRV vaccines is contraindicated in pregnant women and in immunocompromised subjects.
Slovenian: Uporaba cepiv MMRV je kontraindicirana pri nosečnicah in osebah z oslabljenim imunskim sistemom.
English: The contraindication in this patient population was also further defined by inclusion of age specific %CD4+ for HIV-infected patients.
Slovenian: Z vključitvijo starostno specifičnega odstotka CD4+ za bolnike, okužene z virusom HIV, je bila podrobneje opredeljena tudi kontraindikacija pri tej populaciji bolnikov;
English: The product information is therefore amended accordingly to reflect that pregnancy should be avoided for 1 month following vaccination instead of 3 months.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: However, we want to take this a step forward.
Slovenian: Vendar pa želimo iti korak naprej.
English: The Agency will concentrate its efforts in three areas:
Slovenian: Agencija bo svoja prizadevanja osredotočila na tri področja:
English: The implementation of Article 5(3) and Article 107(2) procedures which are new legal provisions will be monitored carefully.
Slovenian: Izvajanje postopkov po členih 5(3) in 107(2), ki so nove pravne določbe, se bo skrbno spremljalo.
English: These systems are evolving in line with communicated requirements.
Slovenian: Ti sistemi se razvijajo skladno s sporočenimi zahtevami.
English: This will result from routine maintenance activities.
Slovenian: To bo rezultat rutinskih vzdrževalnih dejavnosti.
English: The implementation strategy concentrates on a number of projects with high European added value.
Slovenian: Izvajanje strategije je osredotočeno na nekaj projektov z visoko evropsko dodano vrednostjo.
English: Work on the next version will be postponed to 2009.
Slovenian: Delo na naslednji različici bo preloženo v leto 2009.
English: 1.6 Preparations for future enlargement
Slovenian: 1.6 Priprave na prihodnjo širitev
English: Additional priorities in 2007 will include:
Slovenian: Dodatne prednostne naloge v letu 2007 bodo vključevale:
English: The priorities and key objectives for 2007 can be summarised as follows:
Slovenian: Prednostne naloge in ključne cilje za leto 2007 je mogoče povzeti na naslednji način:
English: Protocol assistance will remain a priority area for these incentives.
Slovenian: Pomoč pri protokolu bo ostalo prednostno področje, kar zadeva te spodbude.
English: Generic, hybrid products, etc.
Slovenian: Generična, hibridna zdravila itd.
English: The volume of translations is expected to increase to 40,950 pages - 95% more than in 2006.
Slovenian: Pričakuje se, da se bo obseg prevodov povečal na 40.950 strani - 95 % več kot v letu 2006.
English: 302 Translation
Slovenian: 302 Prevajanje
English: This database is in the first stages of the design process.
Slovenian: Ta zbirka podatkov je v prvih fazah načrtovalskega procesa.
English: Except for specification, work on extending the system to mutual recognition and decentralised procedures has been postponed to 2008-2009.
Slovenian: Z izjemo specifikacije je bilo delo na področju širitve sistema medsebojnega priznavanja in decentraliziranih postopkov odloženo v obdobje 2008-2009.
English: 2.11 Coordination group
Slovenian: 2.11 Usklajevalna skupina
English: System or process 2007 milestones
Slovenian: Sistem ali proces Mejniki za leto 2007
English: The number of applications and related workload has increased over the last years.
Slovenian: Število vlog in povezana delovna obremenitev sta se v zadnjih letih povečala.
English: The SME office has been set up within the agency to address the particular needs of smaller companies.
Slovenian: Urad za mala in srednje velika podjetja je bil ustanovljen v okviru Agencije, da bi obravnaval posebne potrebe manjših družb.
English: The Agency will work to ensure timely and smooth transitions from the former Committees.
Slovenian: Agencija si bo prizadevala zagotoviti pravočasne in gladke prehode iz prejšnjih odborov.
English: With this in view, a number of guidance documents will be developed.
Slovenian: V ta namen bodo pripravljeni številni usmeritveni dokumenti.
English: Following discussion with stakeholders and interested parties, work will start on establishing a ‘Strategic plan for new technologies'.
Slovenian: Po razpravi z interesnimi skupinami in zainteresiranimi stranmi se bodo začela dela za oblikovanje „Strateškega načrta za nove tehnologije“.
English: 2.10 Scientific committees, working parties and scientific advisory groups
Slovenian: 2.10 Znanstveni odbori, delovne skupine in znanstvene svetovalne skupine
English: Some outcomes of these initiatives will contribute to the ongoing discussion on planning of activities at the level of the European medicines network.
Slovenian: Nekateri rezultati teh pobud bodo prispevali k trenutni razpravi o načrtovanju dejavnosti na ravni Evropske mreže zdravil.
English: The Agency plans to test 40 products in 2007.
Slovenian: Agencija načrtuje, da bo v letu 2007 preizkusila 40 proizvodov.
English: 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.
Slovenian: Povečanje upošteva tudi dejavnosti, preložene iz leta 2006, ter sodelovanje predstavnikov držav kandidatk na sestankih, tečajih usposabljanja in konferencah.
English: This document provides a summary of the Agency's work programme 2007.
Slovenian: Ta dokument je povzetek delovnega programa Agencije za leto 2007.
English: This new method has been used for the numbers as of 2006.
Slovenian: Ta nova metoda je bila uporabljena za podatke od leta 2006 naprej.
English: Scientific opinions for non-EU markets
Slovenian: Znanstvena mnenja za trge zunaj EU
English: 5 Support activities
Slovenian: 5 Podporne dejavnosti
English: 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.
Slovenian: 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.
English: As part of the implementation of the European pharmaceutical policy and legislation, the Agency was given responsibility to implement the EU telematics strategy.
Slovenian: V okviru izvajanja evropske farmacevtske politike in zakonodaje je bila Agencija zadolžena za izvajanje telematske strategije EU.
English: 305 Community programmes
Slovenian: 305 Programi Skupnosti
English: 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
Slovenian: 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
English: The majority of EU telematics systems will be in use at the beginning of 2007.
Slovenian: Večina telematskih sistemov EU se bo začela uporabljati na začetku leta 2007.
English: Availability or lack thereof will have a direct impact on the productivity of the HMPC in 2007 and beyond.
Slovenian: Njihova razpoložljivost ali pomanjkanje bo neposredno vplivalo na storilnost HMPC v letu 2007 in po njem.
English: Implementation of advanced network-management and performance services.
Slovenian: Uresničitev naprednega mrežnega upravljanja in izvajalskih storitev.
English: 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.
Slovenian: 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.
English: 1.7 International cooperation
Slovenian: 1.7 Mednarodno sodelovanje
English: Please note that figures for 2007 given in charts are estimates only.
Slovenian: Opozarjamo, da so številke za leto 2007, navedene v grafikonih, le ocene.
English: Provision of additional EudraNet back-up systems.
Slovenian: Zagotovitev dodatnih podpornih sistemov za EudraNet.
English: The Agency will ensure optimal coordination between concerned parties to minimise ‘unnecessary' referrals.
Slovenian: Agencija bo zagotovila optimalno koordinacijo med zadevnimi strankami, da bi čim bolj znižala število „nepotrebnih“ napotitev.
English: EU Telematics Controlled Terms (2nd Proof of Concept concluded)
Slovenian: EU Telematics Controlled Terms (zaključeno drugo preverjanje zasnove)
English: 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.
Slovenian: 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.
English: − Provide opinions on medicinal products intended for non-EU markets;
Slovenian: − dajanje mnenj o zdravilih, ki niso namenjena trgom EU;
English: 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).
Slovenian: V letu 2007 si bo Agencija prizadevala utrditi te dejavnosti na podlagi pregleda izkušenj, pridobljenih v prvem letu delovanja CMD(h) in CMD(v).