FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no safety, immunogenicity or efficacy data to support change during vaccination with Silgard to other HPV vaccines which do not cover the same HPV types.
Croatian: Nema saznanja o sigurnosti, imunogenosti ili djelotvornosti koji bi govorili u prilog zamjenjivosti cjepiva Silgard drugim cjepivima protiv HPV-a, koji ne sadrže iste HPV tipove.
English: Vaccination is not a substitute for routine cervical screening.
Croatian: Cijepljenje nije zamjena za rutinski pregled vrata maternice.
English: Rarely (less than 1 in 1000 patients): hives (urticaria).
Croatian: Rijetko (manje od 1 na 1000 osoba): koprivnjača (urtikarija).
English: Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection.
Croatian: Nesvjestica, ponekad povezana s padom, može se javiti (većinom u adolescenata) nakon bilo kojeg uboda iglom.
English: Silgard should be used in accordance with official guidelines.
Croatian: Silgard se mora primjenjivati u skladu sa službenim smjernicama.
English: In addition, vaccine immunogenicity was comparable among breast-feeding mothers and women who did not breast-feed during the vaccine administration.
Croatian: Dodatno, imunogenost cjepiva je bila usporediva između majki dojilja i majki koje nisu dojile za vrijeme cijepljenja.
English: Number of cases Number of individuals*
Croatian: Broj slučajeva Broj ispitanica*
English: HPV only infects humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP vaccines is mediated by the development of a humoral immune response.
Croatian: HPV inficira samo ljude, no ispitivanja analognih papilomavirusa u životinja upućuju na to da je djelotvornost cjepiva s L1 česticama nalik virusu povezana s razvojem humoralnog imunološkog
English: Prior to agitation, Silgard may appear as a clear liquid with a white precipitate.
Croatian: Prije protresanja, Silgard može izgledati kao bistra tekućina s bijelim talogom.
English: Silgard will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (see section 5.1).
Croatian: Silgard će zaštititi samo od onih bolesti koje su uzrokovane HPV-om tipova 6, 11, 16 i 18 i do određene granice od bolesti uzrokovanih nekim srodnim tipovima HPV-a (vidjeti dio 5.1).
English: Therefore, vaccinees should be observed for approximately 15 minutes after vaccine administration.
Croatian: Stoga je cijepljenu osobu potrebno pažljivo nadgledati otprilike 15 minuta nakon primjene cjepiva.
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by
Croatian: U kliničkim ispitivanjima oralna ili druga sredstva za sprječavanje trudnoće (npr. pilula) nisu smanjile razinu zaštite koju pruža Silgard.
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
Croatian: adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,225 mg Al).
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Croatian: Cijepljenje nije utjecalo na CD 4% ili HIV RNA u plazmi.
English: Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Croatian: Zabilježena je nesvjestica, ponekad praćena drhtanjem ili ukočenošću.
English: Silgard is a vaccine.
Croatian: Silgard je cjepivo.
English: A subset of the study participants from the 2-dose group (n=50) were followed 5-years post-vaccination (Month 60 Postdose 1).
Croatian: Podskupina sudionika u ispitivanju iz skupine koja je primila 2 doze (n=50) bila je praćena 5. godine nakon cijepljenja (60. mjesec nakon 1. doze).
English: Safety was evaluated in either the entire study population (6 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Silgard or placebo.
Croatian: Sigurnost je procijenjena bilo u cjelokupnoj populaciji u ispitivanju (6 ispitivanja), bilo u unaprijed određenoj podskupini (jedno ispitivanje) populacije u ispitivanju praćene pomoću kartice za izvještavanje o cijepljenju kroz 14 dana nakon svake injekcije cjepiva Silgard odnosno placeba.
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Croatian: Premda nesvjestice nisu uobičajene, osobu koja je bila cijepljena treba pratiti 15 minuta nakon što se cijepi cjepivom protiv
English: Furthermore, anti-HPV levels (GMTs) in vaccinated individuals remained at or above serostatus cut-off during the long-term followup of the phase III studies (see below under Persistence of Immune Response of Silgard).
Croatian: Nadalje, razine anti-HPV protutijela (GMT) u cijepljenih ispitanika zadržale su se na graničnoj vrijednosti ili iznad nje tijekom dugotrajnog praćenja u ispitivanjima faze III (vidjeti niže, Trajnost imunološkog odgovora na Silgard).
English: The most common adverse reactions observed were injection-site adverse reactions (77.1% of vaccinees within 5 days following any vaccination visit) and headache (16.6% of the vaccinees).
Croatian: Najčešće zabilježene nuspojave bile su nuspojave na mjestu injiciranja (u 77,1% cijepljenih osoba unutar 5 dana nakon bilo kojeg cijepljenja) i glavobolja (16,6% cijepljenih osoba).
English: The need for a booster dose has not been established.
Croatian: Nije ustanovljena potreba za dozom docjepljivanja.
English: Immune Responses to Silgard using a 2-dose schedule in individuals 9-13 years of age
Croatian: Imunološki odgovori na Silgard prema rasporedu cijepljenja sa 2 doze u pojedinaca u dobi od 9 do
English: The vaccine should be administered by intramuscular injection.
Croatian: Cjepivo treba primijeniti intramuskularnom injekcijom.
English: Table 5: Efficacy of Silgard against external genital lesions in the PPE* population of 16-26 year old
Croatian: Tablica 5: Djelotvornost cjepiva Silgard protiv vanjskih genitalnih lezija u PPE* populaciji, muškarci u dobi od 16 do 26 godina
English: The following side effects can be seen after the use of Silgard:
Croatian: Niže navedene nuspojave mogu se pojaviti nakon cijepljenja cjepivom Silgard:
English: Silgard does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination (see section 5.1).
Croatian: Silgard neće spriječiti lezije uzrokovane tipom HPV-a koji je sadržan u cjepivu u osoba koje su u vrijeme primjene cjepiva zaražene tim tipom HPV-a (vidjeti dio 5.1).
English: • The vaccine should be used as supplied.
Croatian: • Cjepivo treba primijeniti u dostavljenom obliku.
English: Silgard must not be injected intravascularly.
Croatian: Silgard se ne smije primjenjivati intravaskularno.
English: Administration of Silgard should be postponed in individuals suffering from an acute severe febrile illness.
Croatian: Primjenu cjepiva Silgard treba odgoditi u osoba koje imaju tešku akutnu bolest praćenu vrućicom.
English: Table 1: Adverse Events Following Administration of Silgard from Clinical Trials and Post-Marketing
Croatian: Tablica 1: Štetni događaji zabilježeni nakon primjene cjepiva Silgard tijekom kliničkih ispitivanja i praćenjem nakon stavljanja u promet
English: Use of hormonal contraceptives did not appear to affect the immune response to Silgard.
Croatian: Primjena hormonskih kontraceptiva nije vidljivo utjecala na imunološki odgovor na
English: MSM are at higher risk of anal HPV infection compared to the general population; the absolute benefit of vaccination in terms of prevention of anal cancer in the general population is expected to be very low.
Croatian: U muškaraca koji imaju spolne odnose sa drugim muškarcima postoji veći rizik od analne HPV infekcije u odnosu na opću populaciju; očekuje se da će potpuna korist od cijepljenja opće populacije u smislu prevencije analnog karcinoma biti vrlo niska.
English: The efficacy for all other endpoints is based on protocols 007, 013, and 015.
Croatian: Djelotvornost za ostale ishode temelji se na protokolima 007, 013 i 015.
English: Administration of Silgard at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
Croatian: Istodobna primjena cjepiva Silgard (ali s različitim mjestom primjene cjepiva koja se injiciraju) i cjepiva protiv hepatitisa B (rekombinantnog) nije utjecala na imunološki odgovor na HPV tipove.
English: When Silgard is given as your first dose, the completion of the vaccination course should be done with Silgard, and not with another HPV vaccine.
Croatian: Nakon što se prvi put cijepite cjepivom Silgard, trebate dovršiti cijepljenje cjepivom Silgard, a ne nekim drugim cjepivom protiv HPV-a.
English: Silgard induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Croatian: Silgard je izazvao povećanje geometrijskog srednjeg titra (GMT) anti-HPV protutijela mjesec dana nakon 3. doze u svih ispitivanih dobnih skupina.
English: A clinical trial showed that among girls who received 2 doses of HPV vaccine 6 months apart, antibody responses to the 4 HPV types, one month after the last dose were non-inferior to those among young women who received 3 doses of the vaccine within 6 months.
Croatian: Jedno kliničko ispitivanje pokazalo je da, u djevojčica koje su primile 2 doze cjepiva protiv HPV-a u razmaku od 6 mjeseci, odgovor protutijela na 4 tipa HPV-a mjesec dana nakon posljednje doze nije bio inferioran odgovoru u mladih žena koje su primile 3 doze cjepiva unutar 6 mjeseci.
English: The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Croatian: Ove čestice nalik virusu ne sadrže virusnu DNA, ne mogu inficirati stanice, umnožavati se ili uzrokovati bolest.
English: There were no treatment related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Croatian: Nije zamijećen učinak cjepiva na razvoj, ponašanje, razmnožavanje odnosno plodnost mladunčadi.
English: As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.
Croatian: Kao i pri primjeni svih drugih cjepiva, nuspojave zabilježene tijekom opće primjene cjepiva uključivale su: otečene žlijezde (vrat, pazuh ili prepone); mišićna slabost, poremećaj osjeta, trnci u rukama, nogama i gornjem dijelu tijela, ili smetenost (Guillain-Barréov sindrom, akutni diseminirani encefalomijelitis); omaglica, povraćanje, bolni zglobovi, tupi bolovi u mišićima, neuobičajen umor ili slabost, zimice, opće loše osjećanje i veća sklonost krvarenju i modricama nego obično, infekcija kože
English: There have been reports of administration of higher than recommended doses of Silgard.
Croatian: Zabilježeni su slučajevi primjene veće doze cjepiva Silgard od preporučene.
English: Neither subcutaneous nor intradermal administration has been studied.
Croatian: Supkutana i intradermalna primjena nisu ispitane.
English: Silgard has not been shown to have a therapeutic effect.
Croatian: Nije utvrđeno da Silgard djeluje terapijski.
English: How Silgard is given
Croatian: Kako primjenjivati Silgard
English: The safety profile was similar to non-HIV infected subjects in other studies.
Croatian: Sigurnosni profil bio je sličan onome zabilježenom u drugim ispitivanjima u osoba koje nisu zaražene virusom HIV-a.
English: In the clinical studies, individuals in the Safety Population reported any new medical conditions during the follow-up.
Croatian: U kliničkim ispitivanjima, ispitanici iz populacije u kojoj je praćena sigurnost primjene prijavljivali su bilo koje nove tegobe.
English: However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Croatian: Međutim, manja infekcija poput blage upale gornjih dišnih puteva ili blage vrućice nisu kontraindikacije za imunizaciju.
English: HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
Croatian: HPV tipovi 6 i 11 odgovorni su za oko 90% slučajeva genitalnih bradavica te 10% cervikalnih intraepitelnih neoplazija niskoga stupnja (CIN 1).
English: However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Croatian: Međutim, blaga vrućica ili blaga infekcija gornjih dišnih putova (kao npr. prehlada) nije razlog za odgađanje cijepljenja.
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Silgard should not receive further doses of Silgard.
Croatian: Osobe u kojih se nakon primitka doze cjepiva Silgard jave simptomi koji ukazuju na preosjetljivost ne smiju primiti sljedeće doze cjepiva Silgard.
English: In a subset of 598 men (SILGARD = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated.
Croatian: U podskupini od 598 muškaraca (Silgard=299; placebo=299) u Protokolu 020 koji su sami označili da su imali spolne odnose sa muškarcima (MSM), bila je procijenjena djelotvornost cjepiva protiv analne intraepitelijalne neoplazije (AIN stupanj 1/2/3) i karcinoma anusa, te intraanalne perzistentne
English: Table 3: Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Croatian: Tablica 3: Djelotvornost cjepiva Silgard spram cervikalnih lezija visokog stupnja u modificiranoj ITT populaciji uključujući žene bez obzira na početni HPV status
English: They are ranked under headings of frequency using the following convention:
Croatian: Svrstane su u kategorije učestalosti prema sljedećim stupnjevima:
English: Nine cases (0.06%) of urticaria were reported in the Silgard group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
Croatian: Silgard skupini prijavljeno je 9 slučajeva urtikarije (0,06%), a u skupini placeba s adjuvansom 20 slučajeva (0,15%).
English: The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Croatian: Medijan trajanja praćenja u svim protokolima (005, 007, 013 i 015) zajedno iznosio je 3,6 godina.
English: For composite endpoints, statistically significant efficacy against disease was demonstrated against HPV types phylogenetically related to HPV 16 (primarily HPV 31) whereas no statistically significant efficacy was observed for HPV types phylogenetically related to HPV 18 (including HPV 45).
Croatian: Za složene ishode, statistički značajna djelotvornost protiv bolesti utvrđena je za tipove HPV-a koji su filogenetski srodni s HPV-om 16 (ponajviše HPV 31), dok za tipove HPV-a filogenetski povezane s HPV-om 18 (uključujući HPV 45) statistički značajna djelotvornost nije utvrđena.
English: Impact on Definitive Cervical Therapy Procedures
Croatian: Utjecaj na konačne postupke terapije vrata maternice
English: • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient's size and weight.
Croatian: • Ukoliko se u pakiranju nalaze 2 igle različite duljine, odaberite odgovarajuću iglu ovisno o veličini i tjelesnoj težini bolesnika kako biste osigurali i.m. primjenu.
English: Silgard does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Croatian: Silgard nema nikakvog učinka u osoba koje već imaju trajnu infekciju ili bolest izazvanu nekim tipom HPV-a koji se nalazi u cjepivu.
English: Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Croatian: Pričvrstite iglu okrećući je u smjeru kazaljke na satu sve dok igla ne bude sigurno pričvršćena na štrcaljku.
English: Silgard administered to male rats at the full human dose (120 mcg total protein) had no effects on reproductive performance including fertility, sperm count, and sperm motility, and there were no vaccine-related gross or histomorphologic changes on the testes and no effects on testes weights.
Croatian: Primjena cijele ljudske doze (ukupno 120 mg proteina) cjepiva Silgard mužjacima štakora nije imala učinak na reproduktivnu sposobnost, uključujući plodnost, broj i pokretljivost spermija i nije uzrokovala patoanatomske ili histomorfološke promjene na testisima ili imala učinak na težinu testisa povezane s primjenom cjepiva.
English: At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Silgard (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Silgard (at 0, 2,
Croatian: U 7. mjesecu ispitivanja, u populaciji prema protokolu, imunološki odgovor u djevojčica u dobi od 9 do 13 godina (n=241) koje su primile 2 doze cjepiva Silgard (prema rasporedu 0 i 6 mjeseci) bio je neinferioran i brojčano viši od imunološkog odgovora žena u dobi od 16 do 26 godina (n=246) koje su primile 3 doze cjepiva Silgard (prema rasporedu 0, 2, 6 mjeseci).
English: IM use.
Croatian: I DOHVATA
English: The studies were not powered to assess efficacy against disease caused by individual HPV types.
Croatian: Ispitivanja nisu imala snagu da ocijene djelotvornost protiv bolesti uzrokovanih pojedinim tipovima HPV-a.
English: The indication is based on the demonstration of efficacy of Silgard in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Silgard in 9- to 15-year old children and adolescents.
Croatian: Ova se indikacija temelji na djelotvornosti koju je Silgard pokazao u žena u dobi od 16 do 45 godina i u muškaraca u dobi od 16 do 26 godina i na imunogenosti koju je Silgard pokazao u djece i adolescenata u dobi od 9 do 15 godina.
English: Efficacy in women (16 to 45 years) with evidence of a prior infection with a vaccine HPV type (seropositive) that was no longer detectable at vaccination onset (PCR negative)
Croatian: Djelotvornost u žena (u dobi od 16 do 45 godina) s dokazanom prethodnom infekcijom tipom HPV-a koji se nalazi u cjepivu (seropozitivne), čija se prisutnost nije mogla utvrditi na početku cijepljenja (PCR negativne)
English: The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs >10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Croatian: Nije došlo do promjena u stopama seroprotekcije (udio ispitanika koji su dosegli seroprotektivnu razinu anti-HBs protutijela ≥10 mIU/ml) pri istodobnom cijepljenju bio je 96,5%, odnosno 97,5% samo s cjepivom protiv hepatitisa B.
English: Merck Sharp & Dohme Ltd, Hertford Road,
Croatian: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST NA KARTONSKOJ KUTIJI
English: In the same study, in girls aged 9-13 years, the immune response after a 2-dose schedule was numerically lower than after a 3-dose schedule (n = 248 at Month 7; n = 82 at Month 36).
Croatian: U istom ispitivanju u djevojčica u dobi od 9 do 13 godina imunološki odgovor nakon cijepljenja sa 2 doze bio je brojčano niži nego nakon cijepljenja sa 3 doze (n=248 u 7. mjesecu ispitivanja; n=82 u 36. mjesecu).
English: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
Croatian: Prilikom odlučivanja o cijepljenju pojedinaca potrebno je uzeti u obzir i njihov dotadašnji rizik od kontakta s HPV-om i moguću korist od cijepljenja.
English: Efficacy in women 16 through 26 years
Croatian: Djelotvornost u žena u dobi od 16 do 26 godina
English: The concomitant administration of Silgard with vaccines other than the ones above has not been studied.
Croatian: Nije ispitana istodobna primjena cjepiva Silgard s ostalim cjepivima, osim gore navedenim.
English: Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
Croatian: Natrijev klorid, L-histidin, polisorbat 80, natrijev tetraborat, voda za injekcije.
English: Silgard is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18.
Croatian: Silgard je adjuvantno neinfektivno četverovalentno rekombinantno cjepivo pripremljeno od visoko pročišćenih čestica nalik virusu glavnog L1 proteina kapside HPV-a tipova 6, 11, 16 i 18.
English: • Third injection: 6 months after first injection The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Croatian: • Treća injekcija: 6 mjeseci nakon prve injekcije Druga doza mora se primijeniti najmanje mjesec dana nakon prve doze, a treća se doza mora primijeniti najmanje 3 mjeseca nakon druge doze.
English: Table 1 presents vaccine-related adverse reactions which were observed among recipients of Silgard at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Croatian: Tablica 1 prikazuje nuspojave povezane s cjepivom, koje su opažene u osoba koje su primile Silgard, s učestalošću od najmanje 1,0%, i s većom učestalosti nego u ispitanika koji su primili placebo.
English: - If you have any further questions, please ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Croatian: Tablica 4: Rezultati za CIN 2/3 odnosno AIS u pojedinaca koji nisu bili izloženi specifičnom tipu HPV(konačni rezultati ispitivanja)
English: Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV
Croatian: Žene koje su prije cijepljenja već bile inficirane jednim ili više tipova HPV-a sadržanim u cjepivu bile su zaštićene od kliničke bolesti prouzročene preostalim tipovima HPV-a sadržanim u cjepivu.
English: HPV 11 885 HPV 16 882 HPV 18 887
Croatian: HPV 6 915 HPV 11 915 HPV 16 913 HPV 18 920
English: The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Croatian: Drugu dozu treba primijeniti najmanje mjesec dana nakon prve doze, a treću dozu treba primijeniti najmanje 3 mjeseca nakon druge doze.
English: This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
Croatian: Ovaj test mjeri protutijela na jedan neutralizacijski epitop za svaki pojedini tip HPV-a.
English: The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
Croatian: Djelatne tvari su: visoko pročišćeni neinfektivni protein svakog pojedinog tipa humanog papilomavirusa (6, 11, 16 i 18).
English: In only 1 of 11 specimens HPV 16 was found (at Month 32.5) and was not detected in tissue excised during LEEP (Loop Electro-Excision Procedure).
Croatian: Od 11 uzoraka samo u jednome je pronađen HPV tip 16 (u 32,5 mjesecu praćenja) te nije pronađen u tkivu dobivenom elektrokirurškom ekscizijom s pomoću petlje (LEEP).