FrancophonIA/ELRC3.0 huggingface dataset:
English: Among men who were naïve to 14 common HPV types, administration of Gardasil reduced the incidence of external genital lesions caused by vaccine- or non-vaccine HPV types by 81.5% (95% CI: 58.0, 93.0).
Croatian: Među muškarcima koji do sada nisu imali infekciju s 14 uobičajenih HPV tipova, primjena cjepiva Gardasil smanjila je incidenciju vanjskih genitalnih lezija uzrokovanih HPV tipovima iz cjepiva ili HPV tipovima koji nisu povezani s cjepivom za 81% (95% CI: 58,0; 93,0).
English: Anti-HPV responses at Month 7 among 9- to 15-year-old girls were non-inferior to anti-HPV responses in 16- to 26-year-old women for whom efficacy was established in the Phase III studies.
Croatian: Odgovor na HPV u djevojčica u dobi od 9 do 15 godina u 7. mjesecu ispitivanja nije bio inferioran od onoga u mladih žena u dobi od 16 do 26 godina u kojih je zaštitna djelotvornost cjepiva utvrđena u III. fazi ispitivanja.
English: Among the girls receiving 2 doses of the vaccine, 96%, 100%, 100%, and 84% remained seropositive to anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18, respectively, in the cLIA.
Croatian: Među djevojčicama koje su primile 2 doze cjepiva, 96% ih je još uvijek bilo seropozitivno na anti-HPV 6, 100% na anti-HPV 11, 100% na anti-HPV 16 i 84% na anti-HPV 18, na temelju nalaza cLIA testa.
English: For the 12 month definition of persistent infection, efficacy against HPV 16 was 100.0 % (95% CI: 93.9, 100.0) and 100.0% (95% CI: 79.9, 100.0) for HPV 18 respectively.
Croatian: Kod perzistentne infekcije u trajanju od 12 mjeseci, djelotvornost protiv tipa 16 HPV-a iznosila je 100,0 % (95% CI: 93,9; 100,0), a protiv tipa 18 HPV-a 100,0 % (95% CI: 79,9; 100,0).
English: Marketing Authorisation Holder MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon
Croatian: Nositelj odobrenja MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon Francuska
English: Gardasil, suspension for injection.
Croatian: Gardasil, suspenzija za injekciju.
English: HPV 16/18related AIS
Croatian: AIS povezan s HPV 16/18
English: In Protocol 012 the efficacy of Gardasil against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7% (95% CI: 95.1, 99.8) and 100.0% (95% CI: 93.2, 100.0) for HPV 18 respectively, after a follow-up of up to 4 years (mean of 3.6 years).
Croatian: Protokolu 012, djelotvornost cjepiva Gardasil protiv 6 mjesečne perzistentne infekcije [uzorci pozitivni na dva ili više uzastopnih pregleda u razmaku od 6 mjeseci (±1 mjesec) ili dulje] povezane s tipom 16 HPV-a iznosila je 98,7 % (95% CI: 95,1; 99,8), a protiv infekcije tipom 18 HPV-a iznosila je 100,0% (95% CI: 93,2; 100,0) nakon razdoblja praćenja u trajanju do 4 godine (prosječno 3,6 godine).
English: Gardasil, suspension for injection :
Croatian: Gardasil, suspenzija za injekciju:
English: Girls and boys vaccinated with Gardasil at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Croatian: Djevojčice i dječaci cijepljeni cjepivom Gardasil u dobi od 9 do 15 godina u temeljnom ispitivanju prema Protokolu 018 bili su praćeni u produžetku ispitivanja.
English: L1 protein in the form of virus like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Croatian: L1 protein u obliku čestica nalik virusu proizvedenih u stanicama kvasca (Saccharomyces cerevisiae CANADE 3C-5 (soj 1895)) tehnologijom rekombinantne DNA. adsorbiran na adjuvans amorfni aluminijev hidroksifosfat sulfat (0,225 miligrama Al).
English: In the long-term extension study of Protocol 015, 2,536 women 16-23 years old during vaccination with Gardasil in the base study were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 015, praćeno je 2536 žena cijepljenih cjepivom Gardasil koje su uključene u temeljno ispitivanje u dobi od 16 do 23 godine.
English: The efficacy of Gardasil in 16- through 26 year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Croatian: Djelotvornost cjepiva Gardasil u žena u dobi od 16 do 26 godina ocijenjena je u 4 placebom kontrolirana, dvostruko slijepa, randomizirana klinička ispitivanja faze II i III obuhvaćajući ukupno 20 541 žena, koje su uključene i cijepljene bez prethodnoga probirnog testiranja na infekciju HPV om.
English: 9- to 15-Year-Old Boys
Croatian: Dječaci u dobi od 9 do 15 godina Muškarci u dobi od 16 do 26 godina
English: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Gardasil in the base study were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 019, praćeno je 685 žena cijepljenih cjepivom Gardasil koje su uključene u temeljno ispitivanje u dobi od 24 do 45 godina.
English: • Gardasil may appear as a clear liquid with a white precipitate prior to agitation.
Croatian: • Prije nego što se promućka, Gardasil može izgledati kao bistra tekućina s bijelim talogom.
English: Naïve to ≥ 1 HPV Type
Croatian: Nisu bili izloženi ≥ 1 HPV tipu
English: Gardasil should be administered according to a 3-dose schedule: - First injection: at chosen date - Second injection: 2 months after first injection - 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: Druga injekcija: 2 mjeseca nakon prve injekcije 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: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Croatian: Djelotvornost cjepiva Gardasil protiv vanjskih genitalnih bradavicama povezanih s HPV tipovima 6, 11, 16, 18 bila je 68,1% (95% CI: 48,8; 79,3).
English: Efficacy was based on reductions in HPV 31-related CIN 2/3 or AIS Efficacy was based on reductions in HPV 31-, 33-, 52-, and 58-related CIN 2/3 or AIS Includes assay-identified non-vaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59.
Croatian: Djelotvornost se temeljila na smanjenju broja CIN-a 2/3 odnosno AIS-a povezanih s tipovima HPV-a 31, 33, 52 i 58
English: At end of study analysis for anal lesions in the MSM population (median duration of follow-up was 2.15 years), the preventive effect against HPV 6-, 11-, 16-, 18-related AIN 2/3 was 74.9% (95 % CI: 8.8, 95.4; 3/194 versus 13/208) and against HPV 16- or 18-related AIN 2/3 86.6% (95 % CI: 0.0, 99.7; 1/194 versus 8/208).
Croatian: Na kraju analize podataka iz ispitivanja analnih lezija u populaciji muškaraca koji su imali spolne odnose sa drugim muškarcima (medijan trajanja praćenja 2,15 godina), preventivni učinak protiv AIN 2/3 povezanih s HPV 6, 11, 16, 18 bio je 74,9% (95% CI 8,8; 95,4; 3/194 naspram 13/208) a protiv AIN 2/3 povezanih s HPV 16 i 18 bio je 86,6% (95% CI 0,0; 99,7 u 1/194 naspram 8/208).
English: The efficacy of Gardasil in 16- through 26 year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Croatian: Djelotvornost primjene cjepiva Gardasil u muškaraca u dobi od 16 do 26 godina procijenjena je u 1 placebom kontroliranom, dvostruko slijepom, randomiziranom ispitivanju faze III (Protokol 020) koje je obuhvatilo ukupno 4055 muškaraca koji su bili uključeni i cijepljeni bez prethodnog testiranja na prisutnost HPV infekcije.
English: Efficacy*** at end of study (95% CI)
Croatian: Placebo djelotvornosti*** na kraju ispitivanja (95% CI)
English: How Gardasil is given
Croatian: Kako primjenjivati Gardasil
English: Table 7 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15-year-old boys with those in 16- to 26-year-old men.
Croatian: U tablici 7. prikazana je usporedba geometrijskog srednjeg titra HPV tipova 6, 11, 16 i 18 mjesec dana nakon primjene 3. doze cjepiva u dječaka u dobi od 9 do 15 godina i mladih muškaraca u dobi od 16 do 26 godina.
English: B. PACKAGE LEAFLET (PREFILLED SYRINGE)
Croatian: UPUTA O LIJEKU (NAPUNJENA ŠTRCALJKA)
English: Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
Croatian: Drugi sastojci suspenzije cjepiva su: Natrijev klorid, L-histidin, polisorbat 80, natrijev tetraborat te voda za injekcije.
English: Placebo % Efficacy at 2 years
Croatian: Placebo djelotvornosti nakon 2. godine (95% CI)
English: 1 Type 6 L1 protein
Croatian: humani papilomavirus 1 tip 6 L1 protein
English: Efficacy** at end of study (95% CI)
Croatian: Placebo djelotvornosti** na kraju ispitivanja (95% CI)
English: Efficacy** at 2 years (95% CI)
Croatian: Placebo djelotvornosti** nakon 2 godine (95% CI)
English: In the HPV naïve population (naïve to 14 common HPV types), Gardasil reduced the proportion of men who had a biopsy by 54.2% (95% CI: 28.3, 71.4) and who were treated by 47.7% (95% CI: 18.4, 67.1) at end of study.
Croatian: populaciji koja do sada nije imala HPV infekciju (bez infekcije s bilo kojim od 14 HPV tipova), Gardasil je smanjio udio muškaraca koji su imali biopsiju za 54,2% (95% CI: 28,3; 71,4) i onih koji su bili liječeni za 47,7% (95% CI: 18,4; 67,1) na kraju ispitivanja.
English: - Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: - Parenteralne lijekove treba vizualno pregledati prije primjene da ne sadrže vidljive čestice i da nisu promijenili boju.
English: In the PPE population, no cases of HPV types 6/11 related genital warts, HPV 6/11/16/18 external genital lesions or HPV 6/11/16/18 high grade AIN in MSM were observed through 11.5 years (median follow-up of 9.5 years).
Croatian: U PPE populaciji nisu bili opaženi slučajevi genitalnih bradavica povezanih s HPV tipovima 6/11 , vanjskih genitalnih lezija povezanih s HPV tipovima 6/11/16/18 ili AIN-a visokog stupnja povezanog s HPV tipovima 6/11/16/18 u muškaraca koji imaju spolne odnose s muškarcima tijekom 11,5 godina (medijan praćenja od 9,5 godina).
English: HPV 16- or HPV 18related CIN 2/3 or AIS HPV 16/18related CIN
Croatian: CIN 2/3 ili AIS povezani s HPV-om tipa 16/18 CIN 3 povezan s HPV-om tipa 16/18 AIS povezan s HPV-om tipa 16/18
English: Women vaccinated with Gardasil at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Croatian: Žene cijepljene cjepivom Gardasil u dobi od 24 do 45 godina u temeljnom ispitivanju prema Protokolu 019 bile su praćene u produžetku ispitivanja.
English: In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Gardasil in the base study were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 018, praćeno je 369 djevojčica cijepljenih cjepivom Gardasil koje su uključene u temeljno ispitivanje u dobi od 9 do 15 godina.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
Croatian: • Pomoću sterilne igle i štrcaljke izvucite 0,5 ml doze cjepiva iz jednodozne bočice.
English: Individuals 9 to and including 13 years of age Gardasil can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1).
Croatian: Gardasil se može primijeniti prema rasporedu za 2 doze (0,5 ml primijenjeno sa 0 i 6 mjeseci) (vidjeti dio 5.1).
English: Gardasil, suspension for injection in a pre-filled syringe.
Croatian: Gardasil, suspenzija za injekciju u napunjenoj štrcaljki.
English: The efficacy results for relevant endpoints analysed at 2 years post-enrolment and at end of study (median duration of follow-up = 3.6 years) in the per-protocol population are presented in the Table 2.
Croatian: 2 godine nakon uključenja u ispitivanje i na kraju ispitivanja (medijan trajanja praćenja = 3,6 godina) u populaciji koja je završila ispitivanje po protokolu.
English: In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Croatian: U kliničkom ispitivanju u žena u dobi od 24 do 45 godina, 98,4%, žena koje su primile Gardasil postalo je seropozitivno na HPV 6, 98,1% na HPV 11, 98,8% na HPV 16 i 97,4% na HPV 18 mjesec dana nakon 3. doze.
English: Table 6 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15 year-old girls with those in 16- to 26-year old women.
Croatian: U Tablici 6 uspoređuju se geometrijski srednji titri protutijela na HPV tipa 6, 11, 16 i 18 u djevojčica od 9 do 15 godina starosti te u mladih žena u dobi od 16 do 26 godina izmjerenih mjesec dana nakon 3. primljene doze cjepiva.
English: Men vaccinated with Gardasil at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Croatian: Muškarci cijepljeni cjepivom Gardasil u dobi od 16 do 26 godina u temeljnom ispitivanju prema Protokolu 020 bili su praćeni u produžetku ispitivanja.
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Gardasil in the base study were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 018, praćeno je 326 dječaka cijepljenih cjepivom Gardasil koji su uključeni u temeljno ispitivanje u dobi od 9 do 15 godina.
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related AIN 2/3 and HPV 16- or 18-related AIN 2/3, in the MSM substudy, was 54.2% (95% CI: 18.0, 75.3; 18/275 versus 39/276) and 57.5% (95% CI: -1.8, 83.9; 8/275 versus 19/276 cases), respectively.
Croatian: Djelotvornost cjepiva Gardasil protiv AIN 2/3 povezanih s HPV tipovima 6, 11, 16, 18 bila je 54,2% (95% CI: 18,0; 75,3; 18/275 u usporedbi s 39/276 slučajeva) dok je djelotvornost cjepiva protiv AIN 2/3 povezanih s HPV tipovima 16 ili 18, u podispitivanju s muškarcima koji imaju spolne odnose s muškarcima, bila 57,5% (95% CI: -1,8; 83,9; 8/275 u usporedbi s 19/276 slučajeva).
English: Overall, 73% of women were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Croatian: Pri uključenju u ispitivanje sveukupno 73% žena nije bilo izloženo nijednom od 4 tipa HPV-a (PCR negativno i seronegativno).
English: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Croatian: Cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: Gardasil, suspension for injection in a pre-filled syringe:
Croatian: Gardasil, suspenzija za injekciju u napunjenoj štrcaljki:
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Gardasil in the base study were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 020, praćeno je 917 muškaraca cijepljenih cjepivom Gardasil koji su uključeni u temeljno ispitivanje u dobi od 16 do 26 godina.
English: Fourteen years after vaccination, 91%, 91%, 98% and 52% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 98%, 100% and 94% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Croatian: Četrnaest godina nakon cijepljenja, 91% bilo je seropozitivno na tip 6 HPV-a, 91% na tip 11; 98% na tip 16 i 52% na tip 18, na temelju nalaza cLIA testa, a na temelju nalaza IgG LIA testa 98% bilo je seropozitivno na tip 6 HPV-a, 98% na tip 11; 100% na tip 16 i 94% na tip 18.
English: In the PPE population no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 14 years (median followup of 11.9 years).
Croatian: U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (visoki stupanj CIN-a povezan s tipovima HPV-a 6/11/16/18) u razdoblju od približno 14 godina (medijan trajanja praćenja od 11,9 godina).
English: Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study.
Croatian: Žene cijepljene cjepivom Gardasil u dobi od 16 do 23 godina u temeljnom ispitivanju prema Protokolu 015 praćene su u produžetku ispitivanja.
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median followup of 9.9 years).
Croatian: U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (vanjske genitalne lezije povezane s HPV tipovima 6/11/16/18) tijekom 10,6 godina (medijan praćenja od 9,9 godina).
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 86%, 79%, 100% and 83% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Croatian: Deset godina nakon cijepljenja, 79% bilo je seropozitivno na tip 6 HPV-a, 85% na tip 11, 94% na tip 16 i 36% na tip 18, na temelju nalaza cLIA testa, a na temelju nalaza IgG LIA testa 86% bilo je seropozitivno na tip 6 HPV-a, 79% na tip 11, 100% na tip 16 i 83% na tip 18.
English: Efficacy in Men naïve to the relevant vaccine HPV types
Croatian: Djelotvornost u muškaraca koji do sada nisu bili u kontaktu s relevantnim tipovima HPV-a sadržanim u cjepivu
English: cases cases
Croatian: slučajevi slučajevi
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Croatian: • djelotvornost cjepiva Gardasil protiv CIN-a (1, 2, 3) ili AIS-a povezanih s HPV-om tipova 6, 11, 16 i 18 iznosila je 96,0% (95% CI: 92,3; 98,2),
English: In the clinical studies in women 16 to 26 years of age, 99.8%, 99.8%, 99.8%, and 99.5% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3.
Croatian: U kliničkim ispitivanjima u žena u dobi od 16 do 26 godina, 99,8% postalo ih je seropozitivno na HPV 6, 99,8% na HPV 11, 99,8% na HPV 16 te 99,5% na HPV 18 mjesec dana nakon 3. doze.
English: At end of study and in the combined protocols, • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Croatian: • djelotvornost cjepiva Gardasil protiv CIN-a 1 povezanog s HPV-om tipova 6, 11, 16 i 18 iznosila je 95,9 % (95% CI: 91,4; 98,4),
English: Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20
Croatian: Gardasil, suspenzija za injekciju - jednodozna bočica, pakiranje od 1, 10, 20
English: Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100%
Croatian: Deset godina nakon cijepljenja, 79% bilo je seropozitivno na tip 6 HPV-a, 80% na tip 11; 95% na tip 16 i 40% na tip 18, na temelju nalaza cLIA testa, a na temelju nalaza IgG LIA testa 92% bilo je seropozitivno na tip 6 HPV-a, 92% na tip 11; 100% na tip 16 i 92% na tip 18.
English: Sodium chloride L-histidine Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid L-histidin polisorbat 80 natrijev tetraborat voda za injekcije
English: Gardasil may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine.
Croatian: Gardasil se može primijeniti istodobno s kombiniranim cjepivom docjepljivanja koje sadrži difteriju (d) i tetanus (T) zajedno s pertusisom [acelularni, komponentni] (ap) i/ili poliomijelitisom
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6% (95% CI: 24.3, 55.2).
Croatian: Djelotvornost cjepiva Gardasil s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s HPV-om 16 ili 18 iznosila je 41,6% (95% CI: 24,3; 55,2).
English: Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Croatian: Gardasil, suspenzija za injekciju- napunjena štrcaljka bez igle, pakiranje od 1, 10, 20
English: The efficacy of Gardasil against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Croatian: Nakon medijana trajanja praćenja od 3,7 godine (na kraju ispitivanja), analizirani su objedinjeni podaci ispitivanja faze III (N = 17 599) u kojima je ispitana djelotvornost cjepiva Gardasil protiv CINa (bez obzira na stupanj) i CIN-a 2/3 ili AIS-a uzrokovanih s 10 HPV tipova koji nisu sadržani u cjepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strukturno povezanih s HPV-om 16 odnosno 18.
English: Longer term follow-up studies were conducted to determine the duration of protection.
Croatian: Provedena su ispitivanja s dugotrajnim praćenjem kako bi se odredilo trajanje zaštite (vidjeti dio 5.1).
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95% CI: 78.1, 94.8).
Croatian: Djelotvornost cjepiva Gardasil s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s tipovima HPV-a 6, 11, 16 ili 18 iznosila je 88,7% (95% CI: 78,1; 94,8).
English: In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Croatian: U kliničkom ispitivanju u muškaraca u dobi od 16 do 26 godina, 98,9% postalo je seropozitivno na HPV 6, 99,2% na HPV 11, 98,8% na HPV 16 te 97,4% na HPV 18 mjesec dana nakon 3. doze.
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7% (95% CI: 67.5, 93.7).
Croatian: Djelotvornost cjepiva Gardasil s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s tipovima HPV-a 16 ili 18 iznosila je 84,7% (95% CI: 67,5; 93,7).
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median follow-up of 10.0 years).
Croatian: U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (bilo koji stupanj CIN-a povezan s HPV tipovima 6/11/16/18 i genitalne bradavice) tijekom 10,7 godina (medijana praćenja od 10,0 godina).
English: On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old boys is inferred.
Croatian: Djelotvornost cjepiva Gardasil u dječaka u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.
English: On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old girls is inferred.
Croatian: Djelotvornost cjepiva Gardasil u djevojčica u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.
English: 1 Type 16 L1 protein
Croatian: 40 mikrograma humani papilomavirus 1 tip 16 L1 protein
English: Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Croatian: Gardasil, suspenzija za injekciju- napunjena štrcaljka s 2 igle, pakiranje od 1, 10, 20