natgillin/translations-raw huggingface dataset:
Women (N=1,113) were vaccinated in study 001 and evaluated for efficacy up to month 27. 
U ispitivanju 001, žene su cijepljene (N=1113) i pratila se djelotvornost do 27. mjeseca.
Suspension for injection 1 multidose vial 2 doses (1 ml) 
Suspenzija za injekciju 1 višedozna bočica 2 doze (1 ml)
Do not use this vaccine after the expiry date which is stated on the carton. 
Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
EU/1/07/419/008 - pack of 1 without needle EU/1/07/419/009 - pack of 10 without needle EU/1/07/419/004 - pack of 1 with 1 needle EU/1/07/419/006 - pack of 10 with 10 needles EU/1/07/419/005 - pack of 1 with 2 needles EU/1/07/419/007 - pack of 10 with 20 needles 
EU/1/07/419/008 - pakiranje od 1 bez igle EU/1/07/419/009 - pakiranje od 10 bez igle EU/1/07/419/004 - pakiranje od 1 sa 1 iglom EU/1/07/419/006 - pakiranje od 10 sa 10 igala EU/1/07/419/005 - pakiranje od 1 sa 2 igle EU/1/07/419/007 - pakiranje od 10 sa 20 igala
Third injection: 6 months after first injection 
Druga injekcija: 1 mjesec nakon prve injekcije Treća injekcija: 6 mjeseci nakon prve injekcije
In a supplemental analysis, the efficacy of Cervarix was evaluated against HPV-16/18-related CIN3+. 
U dodatnoj analizi, djelotvornost cjepiva Cervarix je bila evaluirana prema HPV 16/18 povezanim CIN 3+.
The study was not powered to demonstrate a difference between the vaccine and the placebo group for these endpoints. 
Ispitivanje nije imalo snagu dokaza za pokazati razliku između skupine s cjepivom i one s placebom u tim ishodima.
As with any vaccine, a protective immune response may not be elicited in all vaccinees. 
Kao i kod drugih cjepiva, zaštitni imunološki odgovor možda se neće postići u svih cijepljenih osoba.
This cohort included women with or without current and/or prior HPV infection. 
Ova kohorta uključivala je žene sa prisutnom ili preboljenom HPV infekcijom.
The primary endpoint was a combination of a virological and a histopathological endpoint: HPV16/18 related 6-month persistent infection and/or CIN1+. 
Primarna mjera ishoda bila je kombinacija virološkog i histopatološkog ishoda: 6-mjesečna perzistentna infekcija povezana s HPV-16/18 i/ili CIN1+.
Cervarix is available in pre-filled syringes (0,5 ml) with or without needles in packs of 1 and 10. 
Cervarix je dostupan u napunjenim štrcaljkama (0,5 ml) s ili bez igala u pakiranjima od 1 i 10.
0.5 milligrams Al3+ in total 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni. For the full list of excipients, see section 6.1. 
4L1 protein u obliku neinfektivnih virusima sličnih čestica proizveden tehnologijom rekombinantne DNA sustavom ekspresije bakulovirusa koji koristi Hi-5 Rix4446 stanice dobivene iz insekta Trichoplusia ni.
Initially seropositive and seronegative subjects reached similar titres after vaccination. 
Osobe koje su na početku ispitivanja bile seropozitivne i one koje su bile seronegativne dosegnule su sličnu razinu titara nakon cijepljenja.
Table 5: Vaccine efficacy against high-grade cervical lesions irrespective of the HPV DNA type in the lesion 
Tablica 5: Djelotvornost cjepiva na cervikalne lezije visokog stupnja neovisno o HPV DNA tipu u leziji
Cervarix is not recommended for use in children below 9 years of age due to lack of data on safety and immunogenicity in this age-group. 
Pedijatrijska populacija (djeca u dobi od < 9 godina) Nije preporučljiva primjena cjepiva Cervarix u djece mlađe od 9 godina zbog nedostatka podataka o sigurnosti primjene i imunogenosti u ovoj dobnoj skupini.
Administer the vaccine. 
Primijenite cjepivo.
All subjects were seropositive in the ELISA assay to both HPV 16 and 18 one month after the third dose (at Month 7) and the seropositivity for HPV 16 and 18 was maintained up to Month 12. 
Sve ispitanice bile su seropozitivne u ELISA testu i za HPV16 i 18, jedan mjesec nakon treće doze (u mjesecu 7) te je seropozitivnost za HPV16 i 18 zadržana sve do mjeseca 12.
CIN3+ 
CIN2+ CIN3+
0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles. 
0,5 ml suspenzije u napunjenoj štrcaljki (staklo tip I) sa čepom klipa (butilna guma) s ili bez igle.
This leaflet was last revised in {month YYYY} Other sources of information 
Ova uputa je zadnji puta revidirana u
Gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain 
Poremećaji probavnog sustava često gastrointestinalni simptomi, uključujući mučninu, povraćanje, proljev i bol u abdomenu
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NAPUNJENA ŠTRCALJKA SA ILI BEZ IGLE, PAKIRANJE OD 1, 10
The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration. 
Sadržaj štrcaljke potrebno je i prije i nakon protresanja vizualno ispitati na eventualno prisustvo stranih čestica i/ili promjenu fizičkog izgleda cjepiva prije primjene.
At end of study analysis, there were 2 cases of VIN2+ or VaIN2+ in the vaccine group and 7 cases in the control group in the ATP cohort associated with HPV-16 or HPV-18. 
U analizi po završetku studije, u ATP kohorti bila su 2 slučaja VIN2+ ili VaIN2+ u grupi cijepljenih i 7 slučajeva u kontrolnoj grupi povezanih s HPV-16 ili HPV-18.
Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry. 
Djelotvornost protiv HPV-16/18 u žena sa dokazanom HPV-16 ili HPV-18 infekcijom kod ulaska u ispitivanje
In study HPV-011, all subjects seroconverted to both HPV-16 and 18 and GMT levels were non inferior to those observed in females aged 15 to 25 years in study HPV-012. 
U ispitivanju HPV-011, u svih je ispitanika došlo do serokonverzije i na HPV-16 i na HPV-18, dok su razine GMT-a bile neinferiorne u odnosu na razine opažene u djevojaka i žena u dobi od 15 do 25 godina u ispitivanju HPV-012.
Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination. 
Cervarix ne štiti od bolesti uzrokovanih infekcijom HPV tipovima 16 i 18, ako su žene već zaražene tim tipovima humanog papilomavirusa u vrijeme cijepljenja.
End of study analysis(2) 
Analiza na kraju ispitivanja(2)
Efficacy against ≥ASC-US (abnormal cytology) associated with oncogenic non-vaccine types was 37.2% (96.2% CI [21.3; 50.1]) (ATP). 
Djelotvornost protiv ≥ASC-US (abnormalan citološki nalaz) povezanog s onkogenim tipovima virusa koji nisu sadržani u cjepivu iznosila je 37,2% (96,2% CI [21,3; 50,1]) (ATP kohorta).
Overall, 74% of women enrolled were naïve to both HPV-16 and HPV-18 (i.e. DNA negative and seronegative at study entry). 
Ukupno 74% svih žena uključenih u studiju nije bilo izloženo HPV tipovima 16 i 18 (DNA negativne i seronegativne prilikom ulaska u ispitivanje).
The primary efficacy endpoint was CIN2+ associated with HPV-16 and/or HPV-18 (HPV-16/18). 
Primarna mjera djelotvornosti bio je nalaz CIN2+ povezan s HPV-16 i/ili HPV-18 (HPV-16/18).
♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine): 
• vrućica (≥38°C) ♦ Manje česte (nuspojave koje se mogu javiti kod manje od 1 na 100, ali više od 1 na 1000 doza cjepiva):
Two analyses of study HPV-008 have been performed: an event-triggered analysis performed once at least 36 CIN2+ cases associated with HPV-16/18 were accrued in the ATP cohort and an end-of study analysis. 
Dvije su analize napravljene u HPV-008 ispitivanju: u ATP kohorti učinjena je događajem potaknuta analiza jedanput u najmanje 36 CIN2+ slučajeva vezanih uz HPV-16/18 te analiza na kraju ispitivanja.
CIN3+ TVC-naïve(1) 
CIN3+ TVC-neizloženi (1)
End of study analysis(3) 
Analiza na kraju ispitivanja(3)
4.4 Special warnings and precautions for use As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. 
Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Kao i kod ostalih cjepiva za injiciranje, medicinski nadzor i odgovarajuće liječenje moraju biti odmah dostupni za slučaj rijetke anafilaktičke reakcije nakon primjene cjepiva.
End of study vaccine efficacy against 6-month persistent infection and CIN2+ associated with individual non-vaccine oncogenic HPV types is presented in Table 6 (ATP cohort). 
Djelotvornost cjepiva na kraju ispitivanja protiv 6-mjesečne perzistentne infekcije i CIN 2+ povezanog s pojedinačnim onkogenim HPV tipovima koji nisu sadržani u cjepivu, prikazana je u Tablici 6 (ATP kohorta).
Cervarix is intended for use from 9 years of age onwards. 
Cervarix je namijenjen osobama od navršene 9. godine života nadalje.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a. 
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Biologicals s.a.
CIN2+ TVC-naïve(1) 
CIN2+ TVC-neizloženi (1)
Cervarix may also be administered concomitantly with meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT); with combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B). 
Cervarix se također može primijeniti istodobno s cjepivom protiv meningokoka serogrupe A, C, W135, Y konjugiranim na tetanusni toksoid (MenACWY-TT); s kombiniranim hepatitis A (inaktiviranim) i hepatitis B (rDNA) cjepivom (Twinrix) ili s hepatitis B (rDNA) cjepivom (Engerix B).
In clinical trials (HPV-070 and HPV-048) performed in girls aged 9 to 14 years receiving a 2-dose schedule (0, 6 months or 0, 12 months) and young women aged 15-25 years receiving Cervarix according to the standard 0, 1, 6 months schedule, all subjects seroconverted to both HPV types 16 and 18 one month after the second dose. 
U kliničkim ispitivanjima (HPV-070 i HPV-048) provedenima u djevojčica u dobi od 9 do 14 godina koje su primile 2 doze cjepiva (prema rasporedu 0, 6 mjeseci ili 0, 12 mjeseci) te u mladih žena u dobi od 15 do 25 godina koje su Cervarix primile prema uobičajenom rasporedu cijepljenja 0, 1 i 6 mjeseci, u svih je ispitanica mjesec dana nakon druge doze došlo do serokonverzije i na HPV-16 i na HPV-18.
These diseases include: - cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer, - precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer). 
- rak cerviksa (rak vrata maternice tj. donjeg dijela maternice) i rak anusa (čmara) - prekancerozne lezije cerviksa, stidnice, rodnice i anusa (promjene na stanicama spolnih organa ili anusa za koje postoji rizik od prelaska u rak).
Bridging of clinical efficacy against anal lesions and cancers 
Posredno zaključivanje o kliničkoj djelotvornosti s obzirom na analne lezije i karcinome
The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years. 
Klinička djelotvornost u žena u dobi od 15 do 25 godina Djelotvornost cjepiva Cervarix je procjenjivana u dva kontrolirana, dvostruko slijepa randomizirana klinička ispitivanja faze II i III, u koja je ukupno uključeno 19 778 žena u dobi od 15 do 25 godina.
N Cases 
N Slučajevi
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (1 ml) 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 doze (1 ml)
Cervarix is available in 2 dose vials (1 ml) in packs of 1, 10 and 100. 
Cervarix je dostupan u dvodoznim bočicama (1 ml) u pakiranjima od 1, 10 i 100.
Post-marketing experience Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava nepoznato* limfadenopatija
Efficacy against CIN1+ irrespective of the HPV type detected in the lesion was 22.9% (96.2% CI [4.8; 37.7]) (TVC). 
Djelotvornost protiv CIN1+ neovisno o tipu HPV-a utvrđenom u leziji iznosila je 22,9% (96,2% CI [4,8; 37,7]) (TVC).
Prophylactic efficacy against HPV-16/18 infection in a population naïve to oncogenic HPV types 
Djelotvornost profilakse protiv infekcije HPV-16/18 u populaciji bez prethodne infekcije onkogenim tipovima HPV-a
The Total Vaccinated Cohort (TVC) included all subjects who received at least one dose of the vaccine, irrespective of their HPV DNA status, cytology and serostatus at baseline. 
Cjelokupno procijepljena kohorta (TVC) uključivala je sve ispitanike koji su primili bar jednu dozu cjepiva, neovisno o njihovom HPV DNA statusu, citologiji i serostatusu na početku ispitivanja.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml) 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 doza (0,5 ml)
In clinical trials a similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies. 
U kliničkim ispitivanjima u osoba s prijašnjom ili postojećom HPV infekcijom zabilježen je sličan profil nuspojava kao u osoba negativnih na DNA onkogenih HPV tipova ili seronegativnih na protutijela protiv HPV-16 i HPV-18.
There were five cases of 12-month persistent HPV-16/18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001. 
U ispitivanju 001 zabilježeno je pet slučajeva perzistentne 12- mjesečne infekcije s HPV-16/18 (4 slučaja HPV-16, 1 slučaj HPV-18) u kontrolnoj skupini i jedan slučaj HPV-16 infekcije u cijepljenoj skupini.
No data are available on subcutaneous administration of Cervarix. 
Nisu dostupni podaci o supkutanoj primjeni cjepiva Cervarix.
Further investigation of the cases with multiple HPV types considered the HPV types detected by Polymerase Chain Reaction (PCR) in at least one of the two preceding cytology samples, in addition to types detected in the lesion to distinguish the HPV type(s) most likely responsible to the lesion (HPV type assignment). 
Dodatno proučavanje slučajeva sa više prisutnih HPV tipova uzimalo je u obzir HPV tipove detektirane pomoću lančane reakcije polimerazom (PCR) u barem jednom od dva citološka uzorka,
HPV type 16 L1 protein1,2 
HPV tip 16 L1 protein1,2
Suspension for injection 
Suspenzija za injekciju.
In all age groups, GMTs remained at least 5- to 32-fold for HPV-16 and 3- to 14-fold for HPV-18 above those elicited in women who cleared a natural infection for both antigens. 
U svim su dobnim skupinama GMT-i protutijela na HPV-16 i dalje bili najmanje 5 do 32 puta viši, a na HPV-18 najmanje 3 do 14 puta viši od onih postignutih u žena u kojih se povukla prirodna infekcija s oba antigena.
Needle protector 
Štitnik za iglu
The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm. How much is given 
Kako će se cjepivo primijeniti Liječnik ili medicinska sestra dati će Cervarix injekcijom u mišić nadlaktice.
HPV type 18 L1 protein1,2 
HPV tip 18 L1 protein1,2
Suspension for injection in pre-filled syringe 1 pre-filled syringe 
Suspenzija za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka
NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Cervarix suspension for injection in a vial 
Cervarix suspenzija za injekciju u napunjenoj štrcaljki Cervarix suspenzija za injekciju u bočici
N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV-16 or HPV-18) (2) including 4 cases of CIN2+ and 2 cases of CIN3+ in which another oncogenic HPV type was identified in the lesion, concomitantly with HPV-16 or HPV-18. 
(1) ATP: uključuje žene koje su primile 3 doze cjepiva, bile DNA negativne i seronegativne u nultom mjesecu i DNA negativne u 6. mjesecu na relevantne HPV tipove (HPV-16 ili HPV-18) (2) uključujući 4 slučaja CIN2+ i 2 slučaja CIN3+ u kojemu je drugi onkogeni HPV tip identificiran u leziji, zajedno sa HPV-16 ili HPV-18.
The sequential administration of combined dTpa-IPV followed by Cervarix one month later tended to elicit lower anti-HPV-16 and anti-HPV-18 GMTs as compared to Cervarix alone. 
Sekvencijsko cijepljenje cjepivom Cervarix mjesec dana nakon cijepljenja kombiniranim cjepivom dTpa-IPV pokazuje trend pojave nižih geometrijskih srednjih titara (GMT) anti-HPV-16 i anti-HPV-18 antitijela, nego nakon cijepljenja samim cjepivom Cervarix.
At the event-triggered analysis the efficacy was 92.9% (96.1% CI: 79.9;98.3) against CIN2+ and 80% 
Temeljeno na događajem potaknutoj analizi, djelotvornost je bila 92,9% (96,1%-tni CI: 79,9:98,3) na CIN2+, odnosno 80% (96,1%-tni CI: 0,3; 98,1) na CIN3+.
Pre-filled syringe 
Napunjena štrcaljka
N = number of subjects included in each group (1) TVC naïve: includes all vaccinated subjects (who received at least one dose of vaccine) who had normal cytology, were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline. 
N = broj ispitanika uključenih u svaku skupinu (1) TVC neizloženi: uključuje sve cijepljene ispitanike (koji su primili bar jednu dozu cjepiva) koji imaju normalnu citologiju, gdje je HPV DNA negativan za 14 onkogenih HPV tipova i seronegativan za HPV-16 i HPV-18 na početku ispitivanja.
Timing and need of booster dose(s) has not been established. 
Vremenski okvir kao ni potreba za dozom(dozama)
In two clinical studies that enrolled males aged 10 to 18 years, 2,617 males received Cervarix and were followed-up with active safety surveillance. 
10 do 18 godina, Cervarix je primilo 2617 osoba muškog spola, u kojih se zatim provodilo aktivno praćenje sigurnosti.
(2) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of HPV DNA status, cytology and serostatus at baseline. 
(2) TVC: uključuje sve cijepljene ispitanike (koji su primili bar jednu dozu cjepiva) neovisno o HPV DNA statusu, citologiji i serostatusu na početku ispitivanja.
The vaccination schedule depends on the age of the subject. 
Doziranje Raspored cijepljenja ovisi o dobi primatelja.
Pre-filled syringe EU/1/07/419/004 EU/1/07/419/005 EU/1/07/419/006 EU/1/07/419/007 EU/1/07/419/008 EU/1/07/419/009 
Napunjena štrcaljka EU/1/07/419/004 EU/1/07/419/005 EU/1/07/419/006 EU/1/07/419/007 EU/1/07/419/008 EU/1/07/419/009
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl). 
Bočica 0,5 ml suspenzije u bočici (staklo tip I) za 1 dozu sa čepom (butilna guma).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠEDOZNA BOČICA, PAKIRANJE OD 1, 10, 100
The TVC-naïve is a subset of the TVC that includes women with normal cytology, and who were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline. 
„TVC-neizloženi“ je podskup TVC-a koji uključuje žene sa normalnom citologijom, koje su na početku ispitivanja bile HPV DNA negativne na 14 onkogenih tipova HPV-a i seronegativne na HPV-16 i HPV-18.
The primary efficacy endpoint was incident infection with HPV-16 and/or HPV-18. 
Primarna mjera ishoda djelotvornosti bila je slučajna infekcija virusima HPV-16 i/ili HPV-18.
Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Biologicals s.a.
Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), or with a meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT), at a separate injection site (another part of your body, e.g. the other arm) during the same visit. 
Cervarix se može primijeniti istodobno uz kombinirano cjepivo za docjepljivanje protiv difterije (d), tetanusa (T), pertusisa [acelularnog] (pa), sa ili bez inaktiviranog poliomijelitisa (IPV), (dTpa, dTpaIPV), ili sa kombiniranim hepatitis A i hepatitis B cjepivom (Twinrix) ili hepatitis B cjepivom (Engerix B), ili s cjepivom protiv meningokoka serogrupe A, C, W-135, Y konjugiranim na tetanusni toksoid (MenACWY-TT), na odvojenim mjestima aplikacije (drugi dio tijela, npr. druga ruka) tijekom iste posjete liječniku.
• redness or swelling at the injection site 
• crvenilo ili oticanje na mjestu injiciranja
Table 6: Vaccine efficacy for non-vaccine oncogenic HPV types 
Tablica 6: Djelotvornost cjepiva na onkogene tipove HPV-a koji nisu sadržani u cjepivu
Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection). 
Cjepivom inducirani geometrijski srednji titar (GMT) IgG protutijela bio je daleko viši od titara u prethodno zaraženih žena u kojih se
• itching, red skin rash, hives (urticaria) 
• svrbež, crveni osip kože, urtikarija • bol u zglobovima
At the 84-month time point, i.e. 78 months after completion of the full vaccination course, 99.3% and 95.9% of initially seronegative women remained seropositive for anti-HPV-16 and anti-HPV-18 antibodies, respectively. 
U 84. mjesecu, tj. 78 mjeseci nakon dovršetka cijelog ciklusa cijepljenja, 99,3% odnosno 95,9% početno seronegativnih žena ostalo je seropozitivno na anti
In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Osobe koje su u posljednja 3 mjeseca prije cijepljenja prvom dozom cjepiva primale imunoglobuline ili krvne derivate bile su isključene iz svih kliničkih ispitivanja.
Based on the HPV type assignment post-hoc analysis, there was 1 CIN2+ case in the vaccine group versus 92 cases in the control group (Efficacy 98.9% (95% CI: 93.8;100)) and no CIN3+ case in the vaccine group versus 22 cases in the control group (Efficacy 100% (95% CI: 81.8;100)) at the end of study analysis. 
92 slučajeva u kontrolnoj grupi (djelotvornost 98,9% (95% CI: 93,8; 100)) i bez CIN3+ slučajeva u cijepljenoj grupi naprema 22 slučajeva u kontrolnoj grupi (djelotvornost 100% (95% CI : 81,8; 100)) u analizi na kraju ispitivanja.
Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100. 
Cervarix je dostupan u jednodoznim bočicama (0,5 ml) u pakiranjima od 1, 10 i 100.
In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst 13,811 females received control. 
79,2% u vrijeme uključivanja bilo u dobi 10-25 godina), Cervarix je primijenjen u 16 142 djevojčice i žene, dok je 13 811 djevojčica i žena primilo kontrolno cjepivo.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
An anamnestic immune response to HPV-16 and HPV-18 (by ELISA) was observed one week and one month after the challenge dose, GMTs one month after the challenge dose exceeded those observed one month after the primary 3-dose vaccination. 
Anamnestički imunološki odgovor na HPV 16 i 18 (ELISA) uočen je jedan tjedan i jedan mjesec nakon primjene dodatne doze.
HPV-16/18 endpoint 
HPV-16/18 ishod
Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 observed in TVC at end of study is presented in Table 3. 
Djelotvornost cjepiva protiv cervikalnih lezija visokog stupnja, povezanih sa HPV-16/18, a koje su uočene u TVC na kraju ispitivanja, prikazana je u Tablici 3.
Vaccine efficacy against the primary endpoint CIN2+at the end of study is presented in Table 1. 
Djelotvornost cjepiva prema primarnom ishodu CIN 2+ prikazana je u Tablici 1.