natgillin/translations-raw huggingface dataset:
EMA and its scientific committees examine all available data and assess their benefits and risks before they are approved and while they are marketed in the EU.
Agencija EMA in njeni znanstveni odbori preučijo vse razpoložljive podatke ter ocenijo koristi in tveganja cepiv pred odobritvijo in v času njihovega trženja v EU.
This website was developed by the European Centre for Disease Prevention and Control (ECDC), in partnership with the European Commission, specifically, its Department on Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA).
To spletno mesto je razvil Evropski center za preprečevanje in obvladovanje bolezni (ECDC) v sodelovanju z Evropsko komisijo, zlasti z Generalnim direktoratom a zdravje in varnost hrane (DG SANTE) ter Evropsko agencijo za zdravila (EMA).
One of the departments is DG for Health and Food Safety , responsible for EU policy on food safety and health and for monitoring the implementation of related laws.
Ena od teh služb je GD za zdravje in varnost hrane , ki je odgovoren za politiko EU na področju varnosti hrane in zdravja ter za spremljanje izvajanja s tem povezanih predpisov.
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Evropska agencija za zdravila (EMA) je decentralizirana agencija Evropske unije (EU), ki je odgovorna za znanstveno vrednotenje, nadzor in spremljanje varnosti zdravil v EU.
The core functions cover a wide spectrum of activities: surveillance, epidemic intelligence, response, scientific advice, microbiology, preparedness, public health training, international relations, health communication, and the scientific journal Eurosurveillance.
Osrednje naloge zajemajo številne dejavnosti: spremljanje, epidemiološki podatki, odzivanje, znanstveni nasveti, mikrobiologija, pripravljenost, usposabljanje osebja v javnem zdravstvenem varstvu, mednarodni odnosi, komuniciranje v zvezi z zdravjem in znanstvena revija Eurosurveillance.
The main purpose of this website is to provide accurate, objective, up-to-date evidence on vaccines and vaccination in general.
Glavni namen tega spletnega mesta je zagotavljanje natančnih, objektivnih in posodobljenih dokazov o cepivih in cepljenju.
Read more: https://ec.europa.eu/health/vaccination/overview_en and https://ec.europa.eu/info/departments/health-and-food-safety_en
Več o tem: https://ec.europa.eu/health/vaccination/overview_en in https://ec.europa.eu/info/departments/health-and-food-safety_en
In the area of vaccine-preventable diseases, ECDC provides regular surveillance data, e.g. the number of confirmed cases, and scientific advice on vaccines, monitors disease outbreaks and develops materials to support communication on immunisation.
Na področju bolezni, ki jih je mogoče preprečiti s cepljenjem, center ECDC zagotavlja redne podatke o spremljanju, npr. število potrjenih primerov, in znanstvene nasvete o cepivih, spremlja izbruhe bolezni in pripravlja gradiva za podporo komuniciranju v zvezi z imunizacijo.
ECDC is an EU scientific agency aimed at strengthening Europe's defences against infectious diseases.
Evropski center za preprečevanje in obvladovanje bolezni je znanstvena agencija EU, ki je odgovorna za krepitev evropske obrambe pred nalezljivimi boleznimi.
The initiative aims to tackle vaccine hesitancy, improve coordination on vaccine procurement, support research and innovation, and strengthen EU cooperation on vaccine-preventable diseases.
Namen pobude je odpraviti nezaupanje v cepljenje, izboljšati usklajevanje pri nabavi cepiv, podpreti raziskave in inovacije ter okrepiti sodelovanje v EU v boju proti boleznim, ki jih je mogoče preprečiti s cepljenjem.
Representatives from EU and EEA countries' public health organisations were consulted for finalising the website's contents and its language versions.
Pri dokončnem oblikovanju vsebine spletnega mesta in njegovih jezikovnih različic so se posvetovali s predstavniki javnih zdravstvenih organizacij držav EU in EGP.
For more information visit: https://www.ema.europa.eu /
Dodatne informacije so na voljo na naslovu: https://www.ema.europa.eu /
It is an initiative of the European Union and was developed following the Council Recommendation on Strengthened Cooperation against Vaccine Preventable Diseases adopted in December 2018.
Spletno mesto je nastalo na pobudo Evropske unije in na podlagi Priporočila Sveta o okrepljenem sodelovanju v boju proti boleznim, ki jih je mogoče preprečiti s cepljenjem , sprejetega decembra 2018.
For more information visit: https://www.ecdc.europa.eu/
Dodatne informacije so na voljo na naslovu: https://www.ecdc.europa.eu/
To improve vaccination uptake, the Council adopted a Recommendation to strengthen the EU cooperation on vaccine-preventable diseases in December 2018.
Za izboljšanje precepljenosti je Svet decembra 2018 sprejel Priporočilo o okrepljenem sodelovanju v EU v boju proti boleznim, ki jih je mogoče preprečiti s cepljenjem .
They just take into account different circumstances and health systems.
Upoštevajo samo različne okoliščine in zdravstvene sisteme.
The differences between vaccination schedules do not mean that some are better than others.
Razlike med posameznimi koledarji cepljenj ne pomenijo, da so nekateri boljši od drugih.
Vaccines in the national schedules are given in the appropriate timeframes to ensure adequate protection.
Cepljenja se glede na nacionalni koledar izvedejo v ustreznih časovnih presledkih, da se zagotovi ustrezna zaščita.
Factors driving such differences may include the disease's burden, prevalence of the disease and trends in different countries, the resources and structures of healthcare systems, political and cultural factors, as well as the resilience of the vaccination programme.
Dejavniki, ki vplivajo na te razlike, so lahko breme bolezni, razširjenost bolezni ter trendi v različnih državah, viri in strukture sistemov zdravstvenega varstva, politični in kulturni dejavniki ter prožnost programa cepljenja.
These may include the age and population to be vaccinated (for example, all children of a certain age or only those in a risk group), the exact type of vaccine (e.g. some ingredients may differ), the number and timing of doses, and whether a vaccine is given alone or in combination with others.
Do razlik prihaja pri starosti in populaciji, ki jo je treba cepiti (na primer vsi otroci določene starosti ali samo tisti v ogroženi skupini), natančni vrsti cepiva (npr. določene sestavine se lahko razlikujejo), številu in časovnem razporedu odmerkov ter pri tem, ali se cepivo daje samostojno ali v kombinaciji z drugimi.
Each EU/EEA country is responsible for its own national public health policy, including its national immunisation programme and vaccination schedule.
Vsaka država EU/EGP je odgovorna za svojo nacionalno politiko na področju javnega zdravja, vključno s svojim nacionalnim programom imunizacije in koledarjem cepljenja.
The same level of protection is ensured in each EU/EEA country.
V vsaki državi EU/EGP je zagotovljena enaka raven varstva.
Vaccination schedules in the EU/EEA
Koledarji cepljenja v državah EU/EGP
There are some differences in the way countries organise their vaccination schedules, which are similar but not identical in different EU/EEA countries.
Obstajajo namreč določene razlike, kako države organizirajo svoj koledar cepljenja, zato so cepljenja v posameznih državah EU/EGP sicer podobna, vendar ne čisto enaka.
The childhood vaccination schedules in all EU/EEA countries include the vaccination against:
Koledarji cepljenja za otroke v vseh državah EU/EGP vključujejo cepljenje proti naslednjim boleznim:
Information on the national vaccination schedules in EU/EEA countries can be found in the ECDC Vaccine Scheduler .
Informacije o nacionalnih koledarjih cepljenja v državah EU/EGP so na voljo v koledarju cepljenj Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC) .
It can spread quickly.
Bolezen se zelo hitro širi.
Measles had almost been eliminated in many European countries.
Ošpice so bile v številnih evropskih državah skoraj izkoreninjene.
Vaccines are used in hundreds of millions of people worldwide each year to protect from serious diseases.
Vsako leto cepimo več sto milijonov ljudi po celem svetu za zaščito pred hudimi boleznimi.
For example, during 2018 about 86% of infants worldwide received three doses of the vaccine that protects them against diphtheria, tetanus and pertussis (DTP), and 85% of infants around the world received three doses of polio vaccine (1).
V letu 2018 je na primer 86 % dojenčkov po vsem svetu prejelo tri odmerke cepiva za zaščito proti davici, tetanusu in oslovskemu kašlju (DTP), 85 % dojenčkov po vsem svetu pa tri odmerke cepiva proti otroški paralizi (1).
It can cause severe spasms of cough and usually lasts three to six weeks.
Bolezen lahko povzroči zelo krčevito kašljanje in običajno traja od treh do šest tednov.
If people stopped being vaccinated, many of these diseases and related outbreaks could return.
Če bi prenehali s cepljenjem, bi se mnoge od teh bolezni in njihovi izbruhi lahko ponovno pojavili.
Vaccination against pertussis is part of national immunisation programmes in the EU.
Cepljenje proti oslovskemu kašlju je vključno v nacionalne programe imunizacije v EU.
The only protection against measles is vaccination.
Edina zaščita pred okužbo z ošpicami je cepljenje.
Less than 5% will have fever.
Pri manj kot 5 % otrok se lahko pojavi povišana telesna temperatura.
Many infectious diseases are very rare today thanks to vaccination, so the negative consequences of these diseases are sometimes forgotten.
Mnoge nalezljive bolezni so danes zelo redke prav po zaslugi cepljenja, zato včasih pozabimo na njihove negativne posledice.
Vaccines prevent diseases that could otherwise cause serious health problems, permanent disability or even death.
Cepljenje preprečuje bolezni, ki bi sicer lahko povzročile resne zdravstvene težave, trajno invalidnost ali celo smrt.
It will often lead to hospitalisation in infants, and the risk of complications and hospitalisation increases for infants younger than three months.
Oboleli dojenčki v veliko primerih potrebujejo bolnišnično oskrbo, tveganje za zaplete in hospitalizacijo pa je večje pri dojenčkih, mlajših od treh mesecev.
The MMR vaccine is safe and effective.
Je varno in učinkovito.
About 20% of infants will have redness and pain at the injection site.
Pri približno 20 % dojenčkov se lahko pojavi rdečina in bolečina na mestu injiciranja.
However, since October 2016 a resurgence of measles has been observed in the EU/EEA, with outbreaks in several countries (2), due to a decline in vaccination rates.
Toda od oktobra 2016 so se zaradi zmanjšane precepljenosti znova začele pojavljati v številnih državah članicah EU/EGP (2).
Complications can include pneumonia, encephalopathy (a disease of the brain), seizures and even death.
Med zapleti so lahko pljučnica, encefalopatija (obolenje možganov), epileptični napadi in celo smrt.
Measles can be serious or even life-threatening.
Ošpice so lahko zelo resna ali celo življenjsko nevarna bolezen.
The MMR vaccine protects against measles, mumps and rubella (German measles).
Cepivo OMR ščiti proti ošpicam, mumpsu in rdečkam.
Benefits of vaccinating
Primer: ošpice
Unlike a treatment given to cure an illness, vaccines are usually given to healthy people to prevent them from getting ill.
Za razliko od zdravil, ki se dajejo bolnim ljudem, se cepiva običajno dajejo zdravim ljudem, da bi preprečili bolezni, zato dolgoročne koristi cepljenja niso vedno vidne na prvi pogled.
Pertussis (whooping cough) is a disease affecting the airways.
Oslovski kašelj je bolezen, ki prizadene dihala.
This protects children from whooping cough, while it only causes minor side effects.
Z njim zaščitimo otroke pred to boleznijo, njegovi neželeni učinki pa so blagi.
For more information, see measles factsheet .
Več informacij je na voljo v informativnem listu o oslovskemu kašlju .
For more information, see pertussis factsheet .
Več informacij je na voljo v informativnem listu o ošpicah .
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Primer: oslovski kašelj
Decisions on vaccines in use in different European countries
Odločanje o cepivih, ki se uporabljajo v različnih evropskih državah
Combined use of vaccines is well established and based on scientific studies on its benefits and safety.
Takšna kombinirana uporaba cepiv je že uveljavljena in temelji na znanstvenih študijah o njihovih koristih in varnosti.
Individual European countries decide which vaccines should be part of their national vaccination programmes and funded by their national health systems.
Vsaka evropska država sama odloča, katera cepiva bodo vključena v njen nacionalni program cepljenja in financirana iz nacionalnega zdravstvenega sistema.
Most national vaccination programmes in the EU/EEA include vaccines for up to twenty diseases which are given to people at specific ages.
Večina nacionalnih programov cepljenja v državah EU/EGP vključuje cepiva proti največ dvajsetim boleznim, ki se dajejo v določeni starosti.
This is based on local conditions, such as how common the disease is, as well as economic factors.
Takšne odločitve temeljijo na lokalnih razmerah v posamezni državi, kot je na primer pojavnost določene bolezni, pa tudi na gospodarskih dejavnikih.
For more information about national vaccination programmes, see the ECDC vaccine scheduler and visit the official websites on immunisation of the EU/EEA countries here .
Več informacij o nacionalnih programih cepljenja je na voljo v koledarju cepljenja centra ECDC in na uradnih spletiščih o imunizaciji držav članic EU/EGP tukaj .
In addition, vaccines to protect against specific diseases are sometimes recommended for ‘high-risk' groups, such as people with long-term health conditions or people planning to travel to other parts of the world.
Določena cepiva se včasih priporočajo tudi bolj ogroženim skupinam prebivalstva, kot so na primer osebe s kroničnimi obolenji ali ljudje, ki se odpravljajo na potovanje v druge dele sveta.
Some vaccines protect against only one disease, but others protect against more than one.
Nekatera cepiva zagotavljajo zaščito samo proti eni, druga pa proti več boleznim.
Sometimes, more than one vaccine may be given at once to protect against several infectious diseases.
Včasih je treba opraviti več cepljenj istočasno, da se vzpostavi zaščita proti več nalezljivim boleznim.
Thousands of volunteers
Na tisoče prostovoljcev
This programme has to follow the procedures and protocols set by the regulators:
Ta program mora slediti postopkom in protokolom, ki so jih določili regulativni organi:
Is the vaccine safe?
Ali je cepivo varno?
its ingredients, including its inactive ingredients or ‘excipients';
njegove sestavine, vključno z neaktivnimi sestavinami ali pomožnimi snovmi;
What is the optimal dose?
Kakšen je optimalni odmerek?
These include the European Medicines Agency and other regulators in the EU/EEA countries.
V to so vključeni Evropska agencija za zdravila in drugi regulatorji v državah članicah EU in EGP.
How are the immune systems of the participants responding to the vaccine?
Kako se imunski sistemi udeležencev odzivajo na cepivo?
Testing includes checking the vaccine's quality:
Preskušanje zajema preverjanje kakovosti cepiva:
This is followed by a clinical testing programme in humans, which can take around ten years from initial concept to authorisation and must adhere to strict standards.
Temu sledi program kliničnega preskušanja pri ljudeh, ki lahko od začetnega koncepta do odobritve traja približno deset let in mora upoštevati stroge standarde.
This involves tests in the laboratory and in animals.
To zajema preskuse v laboratorijih in testiranje na živalih.
The vaccine developer tests the vaccine in three phases of clinical trials, with larger numbers of people in each phase.
Razvijalec cepiva preskuša cepivo v treh fazah kliničnih preskušanj, v vsaki fazi z večjim številom ljudi.
Are there serious side effects?
Ali obstajajo resni neželeni učinki?
Medicines regulatory authorities can carry out inspections to make sure that the information the vaccine developer provides is trustworthy.
Regulativni organi za zdravila lahko izvajajo inšpekcijske preglede, s katerimi zagotovijo, da so informacije, ki jih zagotavlja razvijalec cepiva, zanesljive.
At the end of the testing programme, the vaccine developer submits the results to the medicines regulatory authorities in Europe as part of a ‘marketing authorisation' application.
Ob koncu programa preskušanja razvijalec cepiva predloži rezultate regulativnim organom za zdravila v Evropi kot del vloge za pridobitev dovoljenja za promet.
They can also run tests to make sure that the batches of vaccines released onto the market are of the expected quality and have been manufactured correctly.
Izvajajo lahko tudi preskuse, s katerimi zagotovijo, da so serije cepiv, ki se sprostijo na trg, pričakovane kakovosti in da so bile ustrezno proizvedene.
The regulators can only approve the vaccine if its scientific evaluation of the tests results show that the vaccine's benefits are greater than its risks .
Regulativni organi lahko cepivo odobrijo le, če je iz znanstvene ocene rezultatov preskusov razvidno, da so njegove koristi večje od z njim povezanih tveganj .
What are the most common short-term side effects?
Kateri so najpogostejši kratkotrajni neželeni učinki?
Before a vaccine can be approved in the EU, it has to undergo rigorous testing by its developer and then scientific evaluation by regulatory authorities.
Preden se cepivo lahko odobri v EU, mora najprej prestati zelo zahtevna preskušanja razvijalca cepiva in nato še znanstveno vrednotenje regulativnih organov.
Then the vaccine developer tests the vaccine's effects.
Razvijalec cepiva nato preskusi njegove učinke.
What are the most common side effects?
Kateri so najpogostejši neželeni učinki?
The companies are required to conduct stringent testing, for which the acceptance criteria are pre-defined by the authorities, on each batch of vaccine released onto the EU market.
Podjetja morajo na vsaki seriji cepiva, ki se sprosti na trg EU, izvesti zelo zahtevne preskuse, za katere so organi vnaprej določili merila sprejemljivosti.
National governments take account of factors such as their health systems, legal systems and cultural norms.
Nacionalne vlade pri tem upoštevajo različne dejavnike, kot so denimo njihovi zdravstveni sistemi, pravni sistemi in kulturne norme.
Mandatory or recommended vaccination
Obvezno ali priporočeno cepljenje
Each EU/EEA country is responsible for its own national public health policy, including...
Vsaka država EU/EGP je odgovorna za svojo nacionalno politiko na področju javnega zdravja, vključno s...
Information on which countries have mandatory vaccination can be found in the Vaccine Scheduler .
Informacije o državah, ki imajo predpisana obvezna cepljenja, so na voljo v koledarju cepljenja .
Each EU/EEA country implements its own immunisation programme.
Vsaka država EU/EGP izvaja svoj program cepljenja.
In 12 EU/EEA countries, vaccinating children against some diseases is mandatory, although different vaccines are required as mandatory in those countries.
V 12 državah članicah EU/EGP je cepljenje otrok proti nekaterim boleznim obvezno, pri čemer lahko vsaka država članica predpiše vrsto cepiva za obvezno cepljenje.
EU/EEA countries have achieved high vaccination coverage rates through mandatory and non-mandatory vaccination.
Vse države članice EU/EGP so dosegle visoko stopnjo precepljenosti tako z neobveznim kot obveznim cepljenjem.
Each EU/EEA country decides if vaccination is mandatory or voluntary in its territory.
Vsaka država sama odloča o tem, katera cepljenja so obvezna ali neobvezna na njenem ozemlju.
Most EU/EEA countries offer vaccination on a recommended basis.
V večini držav članic EU/EGP je cepljenje neobvezno in se izvaja na osnovi uradnih priporočil.
Situation of measles in the EU
Stanje na področju ošpic v EU
Below are the most recent data on measles outbreaks in EU Member States.
V nadaljevanju so navedeni najnovejši podatki o izbruhih ošpic v državah članicah EU.
It provides options for the user to filter information by criteria such as disease and time-period.
Uporabniku omogoča filtriranje informacij na podlagi meril, kot sta bolezen in časovno obdobje.
The data is based on information submitted and verified by Member States through ECDC's disease surveillance system.
Podatki temeljijo na informacijah, ki so jih države članice predložile in preverile v okviru sistema za spremljanje bolezni pri Evropskem centru za preprečevanje in obvladovanje bolezni (ECDC).
The ECDC Surveillance Atlas of Infectious Diseases also provides data on other vaccine-preventable diseases, such as diphtheria, pertussis and rubella.
Atlas za spremljanje nalezljivih bolezni, ki ga ponuja ECDC,zagotavlja tudi podatke o drugih boleznih, ki jih je mogoče preprečiti s cepljenjem, kot so davica, oslovski kašelj in rdečke.
Vaccination also reduces the risk of spreading the diseases among family members, school mates or colleagues, friends and neighbours, as well as to other people in the community.
S cepljenjem se prav tako zmanjša tveganje širjenja bolezni med družinskimi člani, sošolci ali sodelavci, prijatelji, sosedi in drugimi pripadniki družbene skupnosti.
Thanks to vaccination, people can be protected against diseases that could have serious consequences for their health.
Zahvaljujoč cepljenju lahko zaščitimo posameznike pred boleznimi, ki bi lahko imele resne posledice za njihovo zdravje.
More factsheets will be included at a later stage.
Pozneje bodo dodani novi informativni listi.
Disease factsheets
Informativni listi o boleznih
Each factsheet provides key facts about a disease, with an overview of the symptoms, complications, how the disease spreads, who is at risk, how the disease can be prevented and how it can be treated.
Na vsakem listu so navedena ključna dejstva o bolezni, skupaj s pregledom simptomov, zapletov, načinov prenosa bolezni, ogroženih skupinah ljudi, načinov za preprečevanje bolezni in načinov zdravljenja
To learn more about the diseases that can be prevented by vaccination, consult the factsheets available below.
Če želite izvedeti več o boleznih, ki jih je mogoče preprečiti s cepljenjem, si oglejte spodaj priložene informativne liste.
Nowadays, several diseases can be prevented by vaccination.
Dandanes lahko s cepljenjem preprečimo številne bolezni.
Research is ongoing to develop vaccines against more diseases.
Raziskave in razvoj novih cepiv proti mnogim drugim boleznim pa še potekajo.
Factsheets of five vaccine- preventable diseases are currently available.
Trenutno je na voljo gradivo o petih boleznih, ki jih je mogoče preprečiti s cepljenjem.
These include:
Mednje sodijo:
These substances are consistently controlled to ensure they are present at levels that have been shown to be safe.
Te snovi so pod stalnim nadzorom za zagotovitev, da so prisotne v količinah, za katere je bilo dokazano, da so varne.
Regulators check that their benefits are weighed against the risk of any reactions to them.
Regulativni organi preverjajo, ali koristi teh sestavin odtehtajo tveganja morebitnih reakcij nanje.
There may also be trace amounts of other substances used in the manufacturing process, such as ovalbumin (a protein found in eggs) or neomycin (an antibiotic).
V cepivih se lahko v sledovih nahajajo tudi druge snovi, ki se uporabljajo v proizvodnem procesu, kot sta na primer ovalbumin (beljakovina v jajčnem beljaku) ali neomicin (antibiotik).
In addition to one or more antigens, there are other components in a vaccine.
Cepiva poleg enega ali več antigenov cepiva vsebujejo tudi druge sestavine.
Whenever these substances are present at a level that might trigger a reaction in a sensitive or allergic individual, their presence is declared in the information provided to healthcare workers and patients on the vaccine.
Kadar koli so te snovi prisotne v količini, ki bi lahko sprožila reakcijo pri občutljivih ali alergičnih osebah, se vsebnost tovrstnih snovi navede v informacijah o cepivu, ki jih prejmejo zdravstveni delavci in bolniki.