FrancophonIA/ELRC3.0 huggingface dataset:
English: The advice of the Scientific advisory group (SAG) on vaccines was sought; the expertise of this group was supplemented with additional European experts on these syndromes and on neurology, cardiology and pharmacoepidemiology.
Croatian: Zatražen je savjet od znanstvene savjetodavne skupine; stručnost te skupine nadopunjena je dodatnim europskim stručnjacima za te sindrome i neurologiju, kardiologiju i farmakoepidemiologiju.
English: These syndromes have been subject to previous repeated review by PRAC.
Croatian: Ovi su sindromi bili predmet prethodnih opetovanih pregleda PRAC-a.
English: Human papillomavirus (HPV) vaccines have been authorised in the European Union since 2006 for the prevention of cervical and various other cancers caused by HPV infection.
Croatian: Cjepiva protiv humanih papiloma virusa (HPV) odobrena su u Europskoj uniji od 2006. u svrhu sprječavanja nastanka raka grlića maternice i drugih karcinoma uzrokovanih infekcijom HPV-om.
English: The CHMP noted the recommendations to the MAHs that had been made by the PRAC in terms of future monitoring.
Croatian: CHMP je istaknuo preporuke koje je PRAC dao nositeljima odobrenja u pogledu budućeg nadzora.
English: The onset of symptoms of CRPS is difficult to define because the syndrome is usually only diagnosed from the point when normal recovery from the initiating trauma should have occurred, and is usually only recognised sometime later among those with continuing pain afterwards.
Croatian: Početak javljanja simptoma KRBS-a teško se može definirati jer se sindrom najčešće dijagnosticira tek u trenutku kada je već trebalo doći do uobičajenog oporavka od prvotne traume te se najčešće prepoznaje nakon nekog vremena, među osobama koje pate od stalne boli.
English: This is in accordance with the Scientific advisory group conclusions that most of the reviewed reports of POTS could better correspond to the definition of CFS or at least include some features of CFS.
Croatian: Navedeno je u skladu sa zaključcima znanstvene savjetodavne skupine da većina pregledanih prijava SPOT-a bolje odgovara definiciji SKU-a ili u najmanju ruku obuhvaća neka svojstva SKU-a.
English: POTS patients typically show persistent tachycardia for more than 10 minutes upon standing, as well as an increase in heart rate to above 120 bpm or by ≥ 30bpm, and in children and juveniles below 19 years of age by ≥ 40bpm, without arterial hypotension.
Croatian: Bolesnici koji boluju od SPOT-a najčešće proživljavaju neprestanu tahikardiju više od 10 minuta nakon ustajanja, kao i ubrzanje rada srca na više od 120 otkucaja po minuti ili za ≥ 30 otkucaja po minuti, dok kod djece i osoba mlađih od 19 godina to iznosi ≥ 40 bpm, bez arterijske hipotenzije.
English: Use of these vaccines is expected to prevent many cases of cervical cancer and various other cancers and conditions caused by HPV.
Croatian: Očekuje se da će se primjenom tih cjepiva spriječiti brojni slučajevi raka grlića maternica te drugih karcinoma i stanja koja uzrokuje HPV.
English: A diagnosis of POTS cannot solely rely on these criteria; other symptoms (e.g. syncope, fatigue, headaches, lightheadedness, diaphoresis, tremor, palpitations, exercise intolerance, near syncope upon standing upright) vary across patients and are otherwise non-specific.
Croatian: Dijagnoza SPOT-a ne može se temeljiti isključivo na tim kriterijima; ostali simptomi (npr. gubitak svijesti, umor, glavobolje, ošamućenost, dijaforeza, nevoljno drhtanje, palpitacije, nemogućnost vježbanja, osjećaj gubitka svijesti prilikom ustajanja) razlikuju se među pacijentima i nisu specifični.
English: CRPS
Croatian: KRBS
English: POTS is a systemic syndrome which has been known for a long time under different names and is still poorly understood.
Croatian: SPOT je sustavni sindrom koji je odavno poznat pod različitim nazivima te i dalje nije u dovoljnoj mjeri razjašnjen.
English: This centre has recently published more information on these reports, suggesting that some of these individuals were likely to have had chronic fatigue syndrome (CFS).
Croatian: Taj je centar nedavno objavio dodatne informacije o spomenutim prijavama koje upućuju na to da su neki od tih pojedinaca vjerojatno imali sindrom kroničnog umora (SKU).
English: The PRAC noted that some symptoms of these syndromes may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
Croatian: PRAC je uočio da se neki simptomi tih sindroma mogu preklapati s kroničnim sindromom umora (SKU, također poznat kao mijalgični encefalomijelitis, ME).
English: A study by Donegan and colleagues (2013)2, using self-controlled case series design (and therefore avoiding the issue of differential diagnostic practice in vaccinated and unvaccinated), evaluated diagnoses of CFS, as well as referrals from general practice for as yet undiagnosed symptoms of chronic fatigue and exhaustion, as well as diagnoses for fibromyalgia, post viral syndrome and neurasthenia.
Croatian: U studiji koju su proveli Donegan i suradnici (2013.)2, a u kojoj je korišten model niza samokontrolirajućih slučajeva (čime je izbjegnut problem diferencijalne dijagnoze kod cijepljenih i necijepljenih osoba), ocjenjivale su se dijagnoze SKU-a i upućivanja liječnika opće prakse za dotad nedijagnosticirane simptome kroničnog umora i iscrpljenosti, kao i dijagnoze fibromialgije, postviralnog sindroma i neurastenije.
English: As many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS, these results were considered relevant for the current evaluation.
Croatian: Budući da brojne prijave uzete u obzir u pregledu imaju značajke SKU-a, a brojni su pacijenti imali dijagnoze SPOT-a i SKU-a, ti su se rezultati smatrali relevantnima za trenutnu ocjenu.
English: The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting.
Croatian: Pregledom nisu utvrđeni dokazi o tome da se ukupne stope pojave tih sindroma u cijepljenih djevojaka razlikuju od očekivanih stopa u tim dobnim skupinama, čak ako se u obzir uzme i neprijavljivanje.
English: Analyses of observed versus expected number of spontaneous reports were undertaken, covering a wide range of scenarios regarding underreporting (from 1 - 100 % reporting) and including reports that did not fully meet the diagnostic criteria for the syndrome.
Croatian: Provedene su analize uočenog broja spontanih prijava u odnosu na njihov očekivani broj, pri čemu je obuhvaćen široki raspon scenarija u pogledu neprijavljivanja (od 1 - 100 % prijava) te su uključene prijave koje nisu u potpunosti ispunile dijagnostičke kriterije za sindrom.
English: Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus; Vaccine, 2015; 33(22):2602-5.
Croatian: Brinth L.S., Pors K., Theibel A.C., Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus (Sindrom ortostatske intolerancije i posturalne tahikardije kao moguća nuspojava cjepiva protiv humanog papiloma virusa);Vaccine, 2015.;
English: • The PRAC took note of the fact that CRPS and POTS occur in the general unvaccinated population and have been described in the medical literature before HPV vaccines were introduced.
Croatian: • PRAC je uzeo u obzir činjenicu da se sindromi KRBS i SPOT pojavljuju u općeg necijepljenog stanovništva te da su opisani u medicinskoj literaturi još prije uvođenja cjepiva protiv HPV-a.
English: In the review of clinical trial data a total of 60,594 subjects were included for Gardasil/Silgard and Gardasil 9 and 42,047 subjects for Cervarix.
Croatian: U pregledu podataka iz kliničkih ispitivanja ukupno 60 594 ispitanika uključeno je za Gardasil/Silgard i Gardasil 9 te 42 047 za Cervarix.
English: Overall, in these analyses the rates of these syndromes in vaccinated girls were consistent with expected rates in these age groups.
Croatian: Ukupno gledajući, u tim su analizama stope pojave tih sindroma u cijepljenih djevojaka bile sukladne očekivanim stopama u tim dobnim skupinama.
English: Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of the vaccines and two syndromes in particular, which are known as Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
Croatian: Rutinski nadzor prijava sumnji na nuspojave doveo je do pitanja o mogućoj povezanosti između korištenja cjepiva i posebice dvaju sindroma poznatih pod nazivima kompleksni regionalni bolni sindrom (KRBS) i sindrom posturalne ortostatske tahikardije (SPOT).
English: No cases were identified in the Cervarix and comparator cohorts.
Croatian: Nije utvrđen nijedan slučaj u skupini koja je primila Cervarix i skupinama koje su primile usporednik.
English: POTS
Croatian: SPOT
English: The PRAC requested data and analyses from the MAHs regarding CRPS and POTS from clinical trials and post-marketing safety data, and took into account literature review, data from Eudravigilance, reports submitted by member states, including Denmark, as well as information from Japan and information submitted voluntarily by the public.
Croatian: PRAC je od nositelja odobrenja zatražio podatke i analize u vezi s KRBS-om i SPOT-om iz kliničkih ispitivanja i podatke o sigurnosti nakon izdavanja odobrenja za stavljanje lijeka u promet te je uzeo u obzir pregled literature, podatke iz baze podataka Eudravigilance, izvješća država članica, uključujući Dansku, te informacije od Japana i informacije koje je su dobrovoljno dostavili članovi javnosti.
English: CRPS is defined as continuing pain that is disproportionate to the inciting event and may be associated with dysautonomic signs and symptoms and is usually confined to a single limb.
Croatian: KRBS se definira kao stalna bol koja nije razmjerna uzročnom događaju, koja se može povezati sa znakovima i simptomima disautonomije te se najčešće pojavljuje samo u jednom udu.
English: Taking into account the totality of the available information the PRAC concluded that the evidence does not support that HPV vaccines (Cervarix, Gardasil, Gardasil 9, Silgard) cause CRPS or POTS.
Croatian: Uzimajući u obzir ukupnost dostupnih podataka, PRAC je zaključio da nema dokaza da cjepiva protiv HPV-a (Cervarix, Gardasil, Gardasil 9, Silgard) uzrokuju KRBS ili SPOT.
English: CRPS typically follows an episode of trauma including fracture of the wrist or carpal tunnel syndrome surgery, or immobilisation of the limb.
Croatian: KRBS se najčešće javlja nakon traume, uključujući prijelom zapešća, operaciju zbog sindroma karpalnog tunela ili imobilizaciju uda.
English: 2 Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
Croatian: Donegan K., Beau-Lejdstrom R., King B., Seabroke S., Thomson A., Bryan P.
English: The study found no association between HPV vaccine and any of the conditions studied.
Croatian: Studijom nije utvrđena veza između cjepiva protiv HPV-a i bilo kojeg proučavanog stanja.
English: The PRAC therefore considered the results of a large published study which showed no link between HPV vaccine and CFS, as relevant for the current review.
Croatian: Stoga je PRAC zaključio da su rezultati velike objavljene studije koji nisu pokazali povezanost između cjepiva protiv HPV-a i SKU-a relevantni za trenutni pregled.
English: The SAG also concluded that most of the reports of CRPS under review did not appear to fulfil the established diagnostic criteria for CRPS.
Croatian: Stručna savjetodavna skupina također je zaključila kako se čini da većina pregledanih prijava KRBS-a nije ispunila utvrđene kriterije za KRBS.
English: • The PRAC considered that the observed versus expected analyses took into account a wide range of scenarios regarding underreporting and included reports that did not fully meet the diagnostic criteria for the syndromes.
Croatian: • PRAC je smatrao da je analizama uočenog i očekivanog uzet u obzir širok raspon scenarija u pogledu neprijavljivanja te da su te analize uključivale prijave koje nisu u potpunosti ispunjavale dijagnostičke kriterije za te sindrome.
English: 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.
Croatian: Iz dostupnih procjena može se zaključiti da u općem stanovništvu otprilike 150 djevojčica i mladih žena na milijun u dobi između 10 i 19 godina svake godine može početi patiti od KRBS-a.
English: Annex
Croatian: Dodatak
English: Overall, comparisons of observed versus expected number of spontaneous reports, with the same scenarios as described above for CRPS, do not suggest an increased occurrence of POTS in relation to the HPV vaccines.
Croatian: Ukupno gledajući, usporedbe između uočenog i očekivanog broja spontanih prijava s istim scenarijima prethodno opisanima za KRBS ne ukazuju na povećanu pojavu SPOT-a u odnosu na cjepiva protiv HPVa.
English: • The PRAC also noted that many of the reviewed reports of POTS had features in common with chronic fatigue syndrome (CFS).
Croatian: • Nadalje, PRAC je uočio da su brojne pregledane prijave SPOT-a imale značajke sindroma kroničnog umora (SKU).
English: The Committee, having considered all the information available, concluded that the evidence does not support a causal association between HPV vaccination and CRPS and/or POTS.
Croatian: Nakon što je razmotrio sve dostupne podatke, Odbor je zaključio da dokazi ne idu u prilog uzročnoj povezanosti između cjepiva protiv HPV-a i KRBS-a i/ili SPOT-a.
English: This should include follow-up of CRPS or POTS reports to determine relevant clinical characteristics, to identify possible cases of POTS and CRPS based on broad search strategies including outcome details and to compare reporting rates against available information on the known epidemiology of POTS and CRPS.
Croatian: To treba obuhvaćati praćenje prijava KRBS-a i SPOT-a kako bi se utvrdile relevantne kliničke značajke, prepoznali mogući slučajevi SPOT-a i KRBS-a na temelju strategija opsežnog pretraživanja, uključujući pojedinosti o ishodima, te kako bi se usporedile stope prijavljivanja s dostupnim informacijama o poznatoj epidemiologiji SPOT-a i KRBS-a.
English: It was agreed that employing broad search strategies to identify possible cases of CRPS and POTS and ongoing comparison of reporting rates against available information on the known epidemiology of CRPS and POTS is important.
Croatian: Složio se da je važno primjenjivati strategije opsežnog pretraživanja kako bi se utvrdili mogući slučajevi KRBS-a i SPOT-a te provoditi stalnu usporedbu stopa prijavljivanja s dostupnim informacijama o poznatoj epidemiologiji KRBS-a i SPOT-a.
English: The results of a large published study2 showed no link between HPV vaccine and CFS.
Croatian: Rezultati velike objavljene studije2 nisu pokazali vezu između cjepiva protiv HPV-a i SKU-a.
English: Overall, the comparisons of observed versus expected number of spontaneous reports do not suggest an increased occurrence of CRPS in relation to the HPV vaccines.
Croatian: Ukupno gledajući, usporedbe uočenog i očekivanog broja spontanih prijava ne ukazuju na povećanu pojavu KRBS-a u odnosu na cjepiva protiv HPV-a.
English: The incidence of CRPS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard and Gardasil 9 and corresponding placebo cohorts.
Croatian: Pojava SPOT-a u kliničkim ispitivanjima cjepiva Gardasil/Silgard i Gardasil 9 prisutna je u manje od 1 slučaja na 10 000 osoba godišnje i usporediva sa skupinama Gardasil/Silgard/Gardasil 9 i odgovarajućim skupinama koje su primile placebo.
English: The CHMP, as a consequence, considers that the benefit-risk balance of HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and therefore recommends the maintenance of the marketing authorisations.
Croatian: CHMP smatra da omjer koristi i rizika cjepiva protiv HPV-a (Cervarix, Gardasil, Gardasil 9 i Silgard) ostaje povoljan i preporučuje zadržavanje odobrenja za stavljanje cjepiva u promet.
English: The PRAC confirmed that the benefit-risk balance of the HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and recommends the maintenance of the marketing authorisations.
Croatian: PRAC je potvrdio da omjer koristi i rizika cjepiva protiv HPV-a (Cervarix, Gardasil, Gardasil 9 i Silgard) ostaje povoljan te preporučuje zadržavanje odobrenja za stavljanje cjepiva na tržište.
English: 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.
Croatian: Međutim, dostupne procjene ukazuju na to da se svake godine među općim stanovništvom u oko 150 djevojčica i mladih žena u dobi od 10 do 19 godina na njih milijun može razviti KRBS, te da se svake godine u najmanje 150 djevojčica i mladih žena na milijun može razviti SPOT.
English: Available estimates suggest that at least 150 girls and young women per million may develop POTS each year.
Croatian: Dostupne procjene ukazuju na to da se SPOT može razviti u najmanje 150 djevojčica i mladih žena na milijun svake godine.
English: Furthermore, the detailed review of the reports of CRPS did not show a consistent pattern regarding time-to-onset (TTO) following vaccination or clinical characteristics.
Croatian: Nadalje, detaljnim pregledom prijava KRBS-a nije uočen dosljedan uzorak u pogledu vremena nastupa simptoma nakon cijepljenja ili kliničkih svojstava.
English: Furthermore, the detailed review of the reports did not show a consistent pattern regarding time-toonset (TTO) following vaccination or clinical characteristics.
Croatian: Nadalje, detaljnim pregledom prijava nije uočen dosljedan uzorak u pogledu vremena do nastupa simptoma nakon cijepljenja ili kliničkih svojstava.
English: Overall, available data do not provide support for a causal association between HPV vaccines and CRPS.
Croatian: Općenito gledajući, dostupni podaci ne podržavaju uzročnu vezu između cjepiva protiv HPV-a i KRBS-a.
English: This included the responses submitted by the marketing authorisation holders, published literature, Eudravigilance data, and the outcome of the Scientific advisory group (SAG) on vaccines as well as data submitted by member states and information submitted by the public.
Croatian: • je PRAC pregledao sve podatke dostavljene u pogledu moguće povezanosti između cjepiva protiv HPV-a i pojave kompleksnog regionalnog bolnog sindroma (KRBS) i sindroma postularne ortostatske tahikardije (SPOT); su ti podaci obuhvaćali odgovore koje su dostavili nositelji odobrenja za stavljanje lijeka u promet, objavljenu literaturu, podatke iz baze podataka Eudravigilance, zaključak znanstvene savjetodavne skupine o cjepivima, kao i podatke koje su dostavile države članice i informacije koje je dostavila javnost;
English: Overall, available data do not provide support for a causal relation between HPV vaccines and POTS.
Croatian: Ukupno gledajući, dostupni podaci ne podržavaju u dovoljnoj mjeri uzročnu vezu između cjepiva protiv HPV-a i SPOT-a.
English: Further information on Lenvima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Lenvima nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine is available as capsules (4 mg and 10 mg).
Croatian: Lijek je dostupan u obliku kapsula (4 mg i 10 mg).
English: What is Lenvima and what is it used for?
Croatian: Što je Lenvima i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Lenvima?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lenvima?
English: The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo.
Croatian: Glavno mjerilo djelotvornosti bilo je razdoblje koje su bolesnici preživjeli bez pogoršanja bolesti: u bolesnika koji su uzimali lijek Lenvima ovo je razdoblje iznosilo prosječno 18,3 mjeseca, u usporedbi s 3,6 mjeseci u bolesnika koji su uzimali placebo.
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Croatian: To znači da onemogućuje djelovanje enzima poznatih pod nazivom tirozin kinaze.
English: For treatment of hepatocellular carcinoma, the recommended daily dose is either 8 or 12 mg depending on bodyweight.
Croatian: Za liječenje hepatocelularnog karcinoma preporučena dnevna doza iznosi 8 mg ili 12 mg, ovisno o tjelesnoj težini.
English: Treatment is continued as long as the patient continues to benefit from it without too many side effects.
Croatian: Liječenje se nastavlja tako dugo dok bolesnik ima koristi od liječenja bez mnogo nuspojava.
English: For treatment of differentiated thyroid carcinoma, the recommended dose is 24 mg taken once a day at approximately the same time every day.
Croatian: Za liječenje diferenciranog karcinoma štitnjače preporučena doza iznosi 24 mg i uzima se jedanput na dan otprilike u isto vrijeme.
English: These enzymes can be found in certain receptors (such as VEGF, FGFR and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Croatian: Ti se enzimi nalaze u određenim receptorima (kao što su receptori VEGF, FGFR i RET) u stanicama raka, gdje aktiviraju nekoliko procesa, uključujući diobu stanica i rast novih krvnih žila.
English: By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth.
Croatian: Inhibirajući te enzime, lenvatinib može onemogućiti formiranje novih krvnih žila i prekinuti opskrbu krvlju, što sprječava rast stanica raka i smanjuje njihov rast.
English: Lenvima is used when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine.
Croatian: Lenvima se primjenjuje kada je rak uznapredovao ili se lokalno proširio u druge dijelove tijela i ne reagira na liječenje radioaktivnim jodom.
English: The most important serious side effects are kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack, bleeding in the brain, a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision, liver failure, hepatic encephalopathy (brain damage due to liver failure), stroke and heart attack.
Croatian: Najvažnije ozbiljne nuspojave jesu zatajenje i oštećenje bubrega, problemi sa srcem i krvotokom, kao što su zatajenje srca, krvnih ugrušaka u arterijama, koji rezultiraju moždanim udarom i srčanim udarom, krvarenje u mozgu, sindrom poznat pod nazivom „posteriorni reverzibilni encefalopatijski sindrom”, za koji su svojstvene glavobolja, konfuzija, napadaji i gubitak vida, zatajenje jetre, hepatička encefalopatija (oštećenje mozga uzrokovano zatajenjem jetre), moždani udar i srčani udar.
English: Side effects reported with Lenvima are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Lenvima pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Lenvima authorised in the EU?
Croatian: Zašto je lijek Lenvima odobren u EU-u?
English: Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib.
Croatian: Bolesnici koji su primili lijek Lenvima živjeli su u prosjeku 13,6 mjeseci, u usporedbi s 12,3 mjeseca u bolesnika liječenih sorafenibom.