natgillin/translations-raw huggingface dataset:
The review of HPV vaccines was initiated on 9 July 2015 by the European Commission at the request of Denmark, under Article 20 of Regulation (EC) No 726/2004.
Pregled cepiv proti virusu HPV je Evropska komisija pričela 9. julija 2015 na zahtevo Danske v skladu z 20. členom Uredbe (ES) št. 726/2004.
In some patients they can severely affect the quality of life.
Pri nekaterih bolnikih lahko resno vplivata na kakovost življenja.
The assessment report containing the evidence supporting the Agency's review is available on EMA's website.
Poročilo o oceni z dokazi, ki podpirajo pregled agencije, je na voljo na spletni strani agencije EMA.
• Patients or families who have any concerns should consult their healthcare professional.
• Bolniki ali družine, ki jih kar koli skrbi, naj se posvetujejo z zdravnikom.
Following their approval, the vaccines have been introduced in national immunisation programs in many countries.
Po odobritvi so cepiva uvedli v državne programe cepljenja v številnih državah.
The syndromes are recognised to occur in the general population, including adolescents, regardless of vaccination.
Znano je, da se sindroma pojavljata med splošnim prebivalstvom, vključno z mladostniki, ne glede na cepljenje.
Gardasil 9 (approved in June 2015) is used similarly but contains antigens for 9 types of the virus (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).
Gardasil 9 (odobreno junija 2015) se uporablja podobno, vendar vsebuje antigene za 9 tipov virusa (tipi 6, 11, 16, 18, 31, 33, 45, 52 in 58).
• CRPS and POTS are difficult to diagnose.
• Sindroma CRPS in POTS je težko diagnosticirati.
The CHMP's position was passed to the European Commission which endorsed it and issued a legally binding decision.
Priporočilo odbora CHMP je bilo poslano Evropski komisiji, ki ga je podprla in izdala končno pravno zavezujočo odločbo.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom skupino vodilnih strokovnjakov s tega področja in upošteval podrobne informacije, ki jih je prejel od številnih skupin bolnikov, ki so prav tako opozarjali na vpliv, ki jih imata lahko omenjena sindroma na bolnike in njihove družine.
The Agency also consulted a group of experts in these syndromes and in neurology, cardiology and pharmacoepidemiology.
Agencija se je prav tako posvetovala s skupino strokovnjakov za ta sindroma ter za nevrologijo, kardiologijo in farmakoepidemiologijo.
The safety of these vaccines, as with all medicines, will continue to be carefully monitored and will take into account any future new evidence of side effects that becomes available.
Varnost teh cepiv bo, kot pri vseh ostalih zdravilih, še naprej skrbno spremljana in upoštevani bodo vsi novi razpoložljivi dokazi o neželenih učinkih.
It is recognised that in some affected girls these syndromes can be long lasting and severely impact quality of life.
Znano je, da so lahko pri nekaterih obolelih dekletih ti sindromi dolgotrajni in močno vplivajo na kakovost življenja.
1 Donegan K, et al. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
Donegan K., et al. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK. Vaccine
It contains antigens for types 16 and 18 of the virus.
Vsebuje antigene za tipa virusa 16 in 18.
HPV vaccines are available in the European Union under the names Gardasil/Silgard, Gardasil 9, and Cervarix.
Cepiva proti virusu HPV so v Evropski uniji na voljo pod imeni Gardasil/Silgard, Gardasil 9 in Cervarix.
It contains antigens (proteins that help product antibodies) against 4 types of HPV (types 6, 11, 16 and 18).
Vsebuje antigene (beljakovine, ki pomagajo proizvajati protitelesa) proti 4 tipom virusa HPV (tip 6, 11, 16 in 18).
They have been reported in the general population since before HPV vaccines became available.
Med splošnim prebivalstvom so o njima poročali že pred uvedbo cepiv proti virusu HPV.
It is estimated that more than 63 million girls and women worldwide have been vaccinated with Gardasil/Silgard and more than 19 million with Cervarix.
Ocenjuje se, da je bilo s cepivom Gardasil/Silgard cepljenih več kot 63 milijonov, s cepivom Cervarix pa več kot 19 milijonov deklet in žensk po vsem svetu.
Reports after HPV vaccination consistent with what would be expected in this age group
Poročila o cepljenju proti virusu HPV v skladu s pričakovanji v tej starostni skupini
Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals.
Simptomi sindromov CRPS in POTS se lahko prekrivajo z drugimi bolezenskimi stanji, zato je diagnostika tako med splošnim prebivalstvom kot tudi pri cepljenih posameznicah težavna.
The above recommendations are based on analyses of clinical trial and post-marketing data and included review of published literature, spontaneous reports of suspected adverse effects, reports submitted by Member States as well as information from other countries, and information submitted voluntarily by the public.
Zgornja priporočila so osnovana na analizah kliničnih preskušanj in podatkov dejavnosti v obdobju trženja ter vključujejo pregled objavljene literature, spontana poročila o domnevnih neželenih učinkih, poročila, ki so jih predložile države članice, kot tudi podatke drugih držav in informacije, ki jih je prostovoljno posredovala javnost.
The review noted that some symptoms of CRPS and POTS may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
Pregled je pokazal, da se nekateri simptomi sindromov CRPS in POTS lahko prekrivajo s sindromom kronične utrujenosti (CFS, znanim tudi kot mialgični encefalomielitis oziroma ME).
The benefits of HPV vaccines continue to outweigh their risks.
Koristi cepiv proti virusu HPV so še vedno večje od njihovih tveganj.
HPV vaccines are expected to prevent many cases of such conditions.
Pričakuje se, da bodo cepiva proti virusu HPV preprečila številne primere tovrstnih obolenj.
In line with its initial recommendations, EMA confirmed that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil 9) and development of CRPS or POTS.
V skladu s prvotnimi priporočili je agencija EMA potrdila, da ni dokazov o vzročni povezavi med cepivi (Cervarix, Gardasil/Silgard in Gardasil 9) in razvojem sindroma CRPS ali POTS.
The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) was responsible for the initial review.
Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji EMA je bil odgovoren za prvotni pregled.
• Patients with POTS (postural orthostatic tachycardia syndrome) typically show abnormal increases in heart rate on standing, without orthostatic hypotension.
• Pri bolnikih s sindromom POTS (sindrom posturalne ortostatske tahikardije) običajno prihaja do nenormalnega dviga srčnega utripa pri vstajanju, brez ortostatske hipotenzije.
The findings of the PRAC were passed to the Agency's Committee for Medicinal Products for Human Use (CHMP), along with further representations from patient groups.
Izsledki odbora PRAC so bili posredovani Odboru za zdravila za uporabo v humani medicini (CHMP) pri agenciji skupaj z naknadnimi navedbami skupin bolnikov.
• A careful review looking at the available evidence has concluded that the occurrence of CRPS and POTS in vaccinated girls is no higher than would be expected in girls in the general population (around 150 cases of CRPS and at least 150 of POTS per million each year), and that there is no evidence that the vaccines can trigger these syndromes.
• Skrben pregled razpoložljivih dokazov je privedel do zaključka, da pojavnost sindromov CRPS in POTS pri cepljenih dekletih ni višja od pričakovane pojavnosti pri dekletih med splošnim prebivalstvom (približno 150 primerov sindroma CRPS in vsaj 150 primerov sindroma POTS na milijon vsako leto) ter da ni dokazov, da so lahko cepiva povod za nastanek teh sindromov.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
The review took into account cases not reported as CRPS and POTS but with signs and symptoms suggestive of these conditions.
Pregled je upošteval primere, o katerih ne poročajo kot o sindromih CRPS in POTS, vendar imajo znake in simptome, ki kažejo na to.
The Agency's review included published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States.
Pregled agencije je vključeval objavljene raziskave, podatke iz kliničnih preskušanj in poročila o domnevnih neželenih učinkih, o katerih so poročali bolniki in zdravstveni delavci, kot tudi podatke, ki so jih priskrbele države članice.
Symptoms often overlap with other conditions such as chronic fatigue syndrome.
Simptomi se pogosto prekrivajo s simptomi drugih bolezni, kot je na primer sindrom kronične utrujenosti.
• The review found no evidence that the overall occurrence of these syndromes in vaccinated girls was different from that expected in these age groups, even taking into account a variety of possible scenarios for underreporting and reports that did not fully meet diagnostic criteria for these syndromes.
• S pregledom niso dokazali, da se splošna pojavnost teh sindromov pri cepljenih dekletih razlikuje od pričakovane pojavnosti v tej starostni skupini, tudi z upoštevanjem možnih scenarijev pomanjkljivega poročanja in poročil, ki niso v celoti izpolnjevali diagnostičnih kriterijev za ta sindroma.
• HPV (human papillomavirus) is a major cause of cancer of the cervix (neck of the womb) and some other cancers, as well as other conditions such as genital warts.
• Virus HPV (humani papiloma virus) je eden od glavnih povzročiteljev raka materničnega vratu in nekaterih drugih oblik raka kot tudi drugih obolenj, kot so na primer genitalne bradavice.
• CRPS (chronic regional pain syndrome) is defined as continuing pain that is disproportionate to the inciting event (typically an episode of trauma or limb immobilisation), and is associated with sensory, sudomotor, motor and dystrophic changes.
• Sindrom CRPS (kompleksni regionalni bolečinski sindrom) je opredeljen kot stalna bolečina, nesorazmerna z dogodkom, ki jo je izzval (navadno epizoda travme ali imobilizacija okončine) ter je povezan s senzoričnimi, sudomotoričnimi, motoričnimi in distrofnimi spremembami.
• Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of HPV vaccines and two syndromes, CRPS and POTS.
• Redno spremljanje poročil o domnevnih neželenih učinkih je sprožilo vprašanja o možni povezavi med uporabo cepiv proti virusu HPV in sindromoma CRPS in POTS.
Results of a large published study that showed no link between HPV vaccine and CFS were therefore particularly relevant.
Zatorej so bili še posebej pomembni rezultati velike objavljene študije, ki niso pokazali povezave med cepivom proti virusu HPV in sindromom CFS.
The benefits of HPV vaccines therefore continue to outweigh the known side effects.
Koristi cepiv proti virusu HPV so zatorej še vedno večje od znanih neželenih učinkov.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in podal več priporočil.
These are accompanied by symptoms (e.g. light-headedness, syncope, weakness, headaches, chronic aches and pains, gastrointestinal symptoms and fatigue) which differ between patients.
Spremljajo ga simptomi (npr. vrtoglavica, sinkopa, oslabelost, glavoboli, kronične bolečine, gastrointestinalni simptomi in utrujenost), ki se razlikujejo od bolnika do bolnika.
The review found no evidence that the overall occurrence of these syndromes in vaccinated girls were different from expected occurrence in these age groups, even taking into account possible underreporting.
S pregledom niso dokazali, da se pojavnost sindromov pri cepljenih dekletih razlikuje od pričakovane pojavnosti v tej starostni skupini, tudi z upoštevanjem morebitnega pomanjkljivega poročanja.
Given that many reports have features of chronic fatigue syndrome, evidence including a large published study1 that showed no link between chronic fatigue syndrome and HPV vaccines was also considered relevant.
Glede na to, da številna poročila vključujejo značilnosti sindroma kronične utrujenosti, so bili prav tako kot pomembni upoštevani dokazi, vključno z veliko objavljeno študijo,1 pri katerih ni bilo povezave med sindromom kronične utrujenosti in cepivi proti virusu HPV.
• Symptoms, in particular of POTS, may overlap with other conditions such as chronic fatigue syndrome, and patients may have a diagnosis of both chronic fatigue syndrome and POTS.
• Simptomi, še posebej pri sindromu POTS, se lahko prekrivajo s simptomi drugih bolezni, kot je na primer sindrom kronične utrujenosti, in bolniki imajo lahko diagnozo tako sindroma kronične utrujenosti kot sindroma POTS.
Many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS.
Številna poročila, zajeta v pregledu, vključujejo značilnosti sindroma CFS, nekateri bolniki pa imajo diagnozo tako sindroma POTS kot tudi sindroma CFS.
Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.
Pričakuje se, da bo uporaba teh cepiv preprečila številne primere raka materničnega vratu (rak, ki v Evropi vsako leto povzroči 20 000 smrti) in drugih vrst raka ter bolezni, ki jih povzroča virus HPV.
HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
Cepiva proti virusu HPV: EMA potrjuje, da ni dokazov, da povzročajo sindrom CRPS ali POTS
Cervarix has been approved since September 2007 for use in women and girls to protect against precancerous growths and cancer in the cervix and genital area.
Cepivo Cervarix je odobreno od septembra 2007 za uporabo pri ženskah in dekletih za zaščito pred predrakavimi izrastki ter rakom materničnega vratu in genitalij.
• There are therefore no recommendations to amend the product information or to change the way HPV vaccines are used.
• Zatorej ni priporočil za spremembo informacij o zdravilu ali za spremembo načina uporabe cepiv proti virusu HPV.
On 19 November EMA completed its review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines.
19. novembra je agencija EMA zaključila svoj pregled dokazov v zvezi s poročili, da cepiva proti humanemu papiloma virusu (HPV) pri mladih ženskah povzročajo kompleksni regionalni bolečinski sindrom (CRPS) in sindrom posturalne ortostatske tahikardije (POTS).
• There are therefore no recommendations to change the way in which the vaccines are used and no changes have been made to the prescribing information for these vaccines.
• Zatorej ni priporočil za spremembo načina uporabe cepiv, prav tako pa se niso spremenile informacije za predpisovanje teh cepiv.
The CHMP concurred that the available evidence does not support that CRPS and POTS are caused by HPV vaccines.
Odbor CHMP se je strinjal, da razpoložljivi dokazi ne podpirajo trditve, da cepiva proti virusu HPV povzročajo sindroma CRPS in POTS.
It therefore did not recommend any changes to the terms of licensing or the product information for these medicines.
Zatorej za ta zdravila ni priporočil nobenih sprememb pogojev izdaje dovoljenja za promet z zdravilom ali informacij o zdravilu.
Therefore there is no reason to change the way the vaccines are used or amend the current product information.
Zato ni razloga za spreminjanje načina uporabe cepiv ali obstoječih informacij o zdravilu.
CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue.
Sindrom CRPS je sindrom kronične bolečine, ki prizadene okončino, medtem ko je sindrom POTS bolezensko stanje, pri katerem se srčni utrip nenormalno dvigne pri usedanju ali vstajanju, bolezen pa spremljajo še drugi simptomi, kot so omotica, omedlevica in oslabelost, kot tudi glavobol, bolečine, slabost in utrujenost.
However, available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
Vendar pa razpoložljive ocene kažejo, da se sindrom CRPS med splošnim prebivalstvom na leto pojavi pri približno 150 dekletih in mladih ženskah, starih od 10 do 19 let, na milijon, sindrom POTS pa se na leto pojavi pri vsaj 150 dekletih in mladih ženskah na milijon.
CRPS produces long-lasting pain affecting a limb, and POTS is associated with an increase in heart rate on standing up, together with various symptoms including dizziness, weakness, pain, feeling sick, and fatigue.
Sindrom CRPS povzroča dolgotrajno bolečino v okončinah, sindrom POTS pa je povezan s povečanim srčnim utripom pri vstajanju, ki ga spremljajo različni drugi simptomi, vključno z omotico, oslabelostjo, bolečino, občutkom slabosti in utrujenostjo.
Use of these vaccines is expected to prevent many cases of cervical cancer as well as various other cancers and conditions caused by HPV.
Pričakuje se, da se z uporabo teh cepiv preprečijo številni primeri raka materničnega vratu kot tudi drugih vrst raka ter bolezni, ki jih povzroča virus HPV.
• Available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year and at least 150 girls and young women per million may develop POTS each year.
• Razpoložljive ocene kažejo, da se sindrom CRPS med splošnim prebivalstvom na leto pojavi pri približno 150 dekletih in mladih ženskah, starih od 10 do 19 let, na milijon, sindrom POTS pa se na leto pojavi pri vsaj 150 dekletih in mladih ženskah na milijon.
Gardasil has been authorised since September 2006, and is approved for use in males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts.
Cepivo Gardasil je od septembra 2006 odobreno za uporabo pri moških in ženskah za preprečevanje predrakavih izrastkov, raka materničnega vratu in zadnjika ter genitalnih bradavic.
These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions.
Cepljenje s temi cepivi se opravi za zaščito pred rakom materničnega vratu, drugimi oblikami raka, povezanimi z virusom HPV, in predrakavimi obolenji.
The review recognised that more than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination.
Pregled je pokazal, da je bilo do zdaj s temi cepivi cepljenih več kot 80 milijonov deklet in žensk po vsem svetu.
• There have been reports of two syndromes, CRPS and POTS, in girls who have been given HPV vaccines.
• Pri dekletih, ki so bila cepljena s cepivi proti virusu HPV, so poročali o pojavljanju sindromov CRPS in POTS.
In reaching its recommendations, it also consulted a group of leading experts in the field, and took into
Ta se je pri oblikovanju svojih priporočil posvetoval s
Date of first authorisation: 11 May 2006 Date of latest renewal: 11 May 2011
Datum prve odobritve: 11. maj 2006 Datum zadnjega podaljšanja: 11. maj 2011
Exposure was estimated at 171,000 infants per year.
Izpostavljenost je bila ocenjena na 171.000 dojenčkov na leto.
Not known (Frequency cannot be estimated from the available data)*
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)*
These data were reported based on more than 400 million doses distributed worldwide.
Podatki se nanašajo na več kot 400 milijonov odmerkov, ki so bili razdeljeni po vsem svetu.
In 297 reports a clear time to onset could be determined.
V 297 poročilih je bilo mogoče določiti jasen čas do nastopa.
The antibodies help protect against infections caused by these viruses.
Protitelesa pomagajo ščititi pred okužbami, ki jih povzročajo ti virusi.
Interference with laboratory tests: see section 4.5.
Interferenca z laboratorijskimi testi: glejte poglavje 4.5.
Symptoms may persist for a matter of months or on rare occasions for years.
Simptomi lahko vztrajajo več mesecev, v redkih primerih nekaj let.
Active untreated tuberculosis.
Aktivna nezdravljena tuberkuloza.
The interval between 2 doses should be at least 4 weeks.
Med 2 odmerkoma mora miniti vsaj 4 tedne.
Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Tudi starejše ženske (stare 35 do 45 let) te neželene učinke večinoma dobro prenašajo in le redko jih motijo pri običajnih dejavnostih.
The vaccine may contain traces of recombinant human albumin (rHA).
Cepivo lahko v sledeh vsebuje rekombinantni humani albumin (rHA).
Such infants should be revaccinated at 12 to 15 months of age.
Te dojenčke je treba ponovno cepiti v starosti od 12 do 15 mesecev.
Seroprotection rates [95% CI]
Stopnje serozaščite [95-odstotni IZ]
71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours.
71 % poročil (212 od 297) se je nanašalo na začetek joka več kot 24 urah po cepljenju.
The majority of the crying occurred 6 to 10 days after vaccination.
Večina primerov joka se je pojavila 6 do 10 dni po cepljenju.
The conclusion of the MAH is not endorsed by the PRAC.
Sklep MAH ni bil podprt s strani odbora PRAC.
The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Profil varnosti po 1. in 2. odmerku je bil v splošnem primerljiv za vse starostne skupine.
Aseptic meningitis
Aseptični meningitis
Current immunosuppressive therapy (including high doses of corticosteroids).
Trenutno imunosupresivno zdravljenje (vključno z velikimi odmerki kortikosteroidov).
Therefore, based on the aforementioned information the PRAC recommends a variation in section 4.8 to add “Crying” with the frequency “uncommon”.
Na podlagi zgoraj navedenih informacij odbor PRAC priporoča spremembo v poglavju 4.8 z dodatkom izraza "jok" s pogostnostjo "občasni".
After reconstitution, one dose (0.5 ml) contains:
Po pripravi cepiva en odmerek (0,5 ml) vsebuje:
Non-pregnant adolescent and adult females
Mladostnice in odrasle ženske, ki niso noseče
If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
Če je posameznik cepljen nekaj dni pred izpostavitvijo, je možna precejšnja zaščita.
This latency period appears to correspond with the time to onset of general malaise that often occurs after the MMR vaccination.
To latentno obdobje ustreza času do nastopa splošnega slabega počutja, ki se pogosto pojavi po cepljenju s cepivom MMR.
Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)]
Neželeni učinki so razvrščeni po pogostnosti v skladu z naslednjim dogovorom: [Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do ≤ 1/100), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)]