FrancophonIA/ELRC3.0 huggingface dataset:
English: Cervarix is an adjuvanted non-infectious recombinant vaccine prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Croatian: Cervarix je adjuvantno neinfektivno rekombinantno cjepivo pripremljeno od visokopročišćenih virusu sličnih čestica proteina L1, koji je glavni sastojak kapside onkogenih HPV tipova 16 i 18.
English: The phase II trial (study 001/007) enrolled only women who: - Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,
Croatian: - imale negativan test na DNA onkogenih HPV tipova 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
English: In study HPV-008, the primary analyses of efficacy were performed on the According to Protocol cohort (ATP cohort: including women who received 3 vaccine doses and were DNA negative and seronegative at month 0 and DNA negative at month 6 for the HPV type considered in the analysis).
Croatian: U ispitivanju HPV-008 primarne analize djelotvornosti izvedene su prema protokolnoj kohorti (ATP kohorta: uključujući žene koje su primile 3 doze cjepiva i bile DNA negativne i seronegativne u nultom mjesecu i DNA negativne u 6. mjesecu na HPV tipove promatrane u ispitivanju).
English: In the event of either being observed, discard the vaccine.
Croatian: U slučaju opažanja takvih pojava, zbrinite cjepivo u otpad.
English: PHARMACEUTICAL FORM Suspension for injection.
Croatian: OBLIK Suspenzija za injekciju.
English: The cross-protective efficacy of Cervarix against histopathological and virological endpoints (persistent infection) has been evaluated in study HPV-008 for 12 non-vaccine oncogenic HPV types.
Croatian: Križna zaštitna djelotvornost cjepiva Cervarix protiv histopatoloških i viroloških ishoda (perzistentna infekcija) procijenjena je u ispitivanju HPV-008 za 12 onkogenih tipova HPV-a koji nisu sadržani u cjepivu.
English: In study HPV-023, subjects from the Brazilian cohort (N=437) of study 001/007 were followed up to a mean of 8.9 years (standard deviation 0.4 years) after the first dose.
Croatian: U ispitivanju HPV-023, praćene su osobe iz ispitivanja 001/007 iz kohorte iz Brazila (N=437) kroz prosječno 8,9 godina (standardna devijacija 0,4 godine) od primitka prve doze.
English: 92 subjects in the vaccine group had immunogenicity data at the [M107M113] interval after the first vaccine dose with a median follow-up of 8.9 years.
Croatian: 92 ispitanica iz grupe cijepljenih su imale podatke o imunogenosti u intervalu od 107. do 113. mjeseca nakon prve doze cijepljenja, s medijanom praćenja od 8,9 godina.
English: 6.6 Special precautions for disposal and other handling Pre-filled syringe
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 doza (0,5 ml) sadrži:
English: BATCH NUMBER LOT:
Croatian: 13. BROJ SERIJE Lot
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cervarix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Cervarix
English: 470 subjects (142 aged 15-25 years, 172 aged 26-45 years and 156 aged 46-55 years) who completed study HPV-014 and received the 3 dose schedule were followed-up for up to 10 years in the extension study HPV-060.
Croatian: ispitanica (142 u dobi od 15 do 25 godina, 172 u dobi od 26 do 45 godina i 156 u dobi od 46 do 55 godina) koje su dovršile ispitivanje HPV-014 i primile 3 doze cjepiva prema rasporedu praćene su do 10 godina u nastavku ispitivanja pod nazivom HPV-060.
English: 1 adjuvanted by AS04 containing: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)2
Croatian: 1 s adjuvansom AS04, koji sadrži: 3-O-desacil-4'-monofosforil lipid A (MPL)2
English: It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types (see section 5.1 “Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.”).
Croatian: Također nije indiciran za prevenciju progresije drugih lezija jasno povezanih s HPV-om ili postojećih HPV infekcija sa 16 i 18 tipovima HPV-a ili ostalima (vidjeti dio 5.1 „Djelotvornost protiv HPV-16/18 u žena sa dokazanom HPV-16 ili HPV-18 infekcijom prilikom ulaska u ispitivanje.“).
English: No data are available on subcutaneous administration of Cervarix (see section 4.4).
Croatian: Nisu dostupni podaci o supkutanoj primjeni cjepiva Cervarix (vidjeti dio 4.4).
English: Pack sizes of 1, 10 and 100 vials.
Croatian: Pakiranja od 1, 10 i 100 bočica.
English: Cervarix is not used to treat HPV related diseases already present at the time of vaccination.
Croatian: Cervarix se ne koristi za liječenje bolesti uzrokovanih HPV-om, a koje postoje u vrijeme cijepljenja.
English: No fertility data are available.
Croatian: Plodnost Nisu dostupni podaci o utjecaju na plodnost.
English: The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related precancerous lesions of the vulva and vagina and 78% of HPV-related pre-cancerous lesions of the anus.
Croatian: Tipovi humanog papilomavirusa (HPV) koji su sadržani u cjepivu (HPV tipovi 16 i 18) odgovorni su za oko 70% slučajeva raka cerviksa, 90% slučajeva raka anusa, 70% s HPV-om povezanih prekanceroznih lezija stidnice i rodnice i 78% prekanceroznih lezija anusa povezanih s HPV-om.
English: Table 7 - Vaccine efficacy at study conclusion in study HPV-015 Endpoint
Croatian: Tablica 7: Djelotvornost cjepiva na kraju ispitivanja u ispitivanju HPV-015 Mjera ishoda
English: ATP cohort(1) End of study analysis(3)
Croatian: ATP kohorta(1) Analiza na kraju ispitivanja(3)
English: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Croatian: Nuspojave za koje se smatra da su barem moguće povezane s cijepljenjem navedene su prema učestalosti pojavljivanja.
English: ATP cohort(1) End of study analysis(2)
Croatian: ATP kohorta(1) Analiza na kraju ispitivanja (2)
English: Side effects that have been reported during marketed use of Cervarix include:
Croatian: Nuspojave koje su prijavljene nakon stavljanja cjepiva Cervarix u promet:
English: • swollen glands in the neck, armpit or groin
Croatian: • otečene žlijezde na vratu, u pazuhu ili preponama
English: Cervarix should be administered as soon as possible after being removed from the refrigerator.
Croatian: Nakon što je Cervarix izvađen iz hladnjaka treba se primijeniti što je prije moguće.
English: 4.9 Overdose No case of overdose has been reported.
Croatian: Nije prijavljen niti jedan slučaj predoziranja.
English: HPV type assignment analysis (see under Table).
Croatian: Ovi slučajevi su isključeni u HPV tipu analize (vidjeti ispod
English: In the Phase III study (HPV-015) in women 26 years and older all subjects seroconverted one month after the third dose.
Croatian: U ispitivanju faze III (HPV-015) u žena u dobi od 26 godina i više, u svih je ispitanica došlo do serokonverzije mjesec dana nakon treće doze.
English: In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
Croatian: (Cervarix = 8130 naspram kontrola = 5786) nuspojave su praćene tijekom 30 dana nakon svake injekcije.
English: All initially seropositive women remained seropositive for both anti-HPV-16 and anti-HPV-18 antibodies.
Croatian: Sve početno seropozitivne žene ostale su seropozitivne i na anti-HPV-16 i anti-HPV-18 protutijela.
English: In study 024 (a subset of study 001/007), a challenge dose of Cervarix was administered to 65 subjects at a mean interval of 6.8 years after the administration of the first vaccine dose.
Croatian: U ispitivanju 024 (podskup studije 001/007), 65 ispitanica primilo je dodatnu dozu cjepiva Cervarix u srednjem vremenskom razdoblju od 6,8 godina nakon primljene prve doze cjepiva.
English: • pain or discomfort at the injection site
Croatian: • bol ili neugoda na mjestu injiciranja
English: How to store Cervarix
Croatian: Kako primjenjivati Cervarix
English: 6M PI in subjects seropositive at baseline only
Croatian: 6M PI u ispitanica seropozitivnih samo na početku ispitivanja
English: If Cervarix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Croatian: Ako se Cervarix primjenjuje istodobno uz neka druga injicirajuća cjepiva, svako od pojedinačnih cjepiva je uvijek potrebno aplicirati na različita ubodna mjesta.
English: There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
Croatian: Zabilježeno je šesnaest slučajeva perzistentne HPV-16 infekcije i pet slučajeva perzistentne HPV-18 infekcije, a svi su se javili u kontrolnoj skupini.