FrancophonIA/ELRC3.0 huggingface dataset:
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 12 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 12 godina.
English: Tlf: + 45 4482 4000 dkmail@merck.com
Croatian: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: Efficacy in men with or without prior infection or disease due to HPV 6, 11, 16, or 18
Croatian: Djelotvornost u muškaraca s ili bez prethodne infekcije ili bolesti uzrokovane HPV-om 6, 11, 16 ili 18
English: The efficacy results for relevant endpoints analysed at end of study (median duration of follow-up 2.4 years) in the per-protocol population are presented in the Table 5.
Croatian: Podaci o djelotvornosti za relevantne ishode analizirani na kraju ispitivanja (medijan trajanja praćenja 2,4 godine) u populaciji koja je završila ispitivanje u skladu s protokolom prikazani su u Tablici 5. Djelotvornost protiv PIN-a stupnjeva 1/2/3 nije bila prikazana.
English: An academic study documenting safety and immunogenicity of Silgard has been performed in 126 HIV infected subjects aged from 7 to 12 years (of which 96 received Silgard).
Croatian: U 126 osoba u dobi od 7 do 12 godina zaraženih virusom HIV-a (od kojih je 96 primilo Silgard) provedeno je akademsko ispitivanje koje je dokumentiralo sigurnost i imunogenost cjepiva Silgard.
English: Among women who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Silgard reduced the incidence of CIN 2/3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI: 23.7, 57.3) and of genital warts by 82.8% (95% CI: 74.3, 88.8) at end of study.
Croatian: Primjena cjepiva Silgard u žena koje nikad nisu bile izložene nekom od 14 čestih tipova HPV-a i s negativnim nalazima Papa testa 1-og dana ispitivanja, smanjila je incidenciju CIN-a 2/3 odnosno AISa uzrokovanog HPV-om, bez obzira radi li se o tipovima sadržanim u cjepivu ili ne, za 42,7% (95% CI: 23,7; 57,3) te genitalnih bradavica za 82,8% (95% CI: 74,3; 88,8) na kraju ispitivanja.
English: CI)
Croatian: U
English: The GMTs were somewhat lower than those reported in non-HIV infected subjects of the same age in other studies.
Croatian: Geometrijski srednji titar bio je nešto niži nego geometrijski srednji titar zabilježen u drugim ispitivanjima u osoba iste dobi koje nisu
English: Efficacy against HPV 6-, 11-, 16-, 18-related VIN 2/3 was 73.3% (95% CI: 40.3, 89.4), against HPV 6-, 11-, 16-, 18-related VaIN 2/3 was 85.7% (95% CI: 37.6, 98.4), and against HPV 6-, 11-, 16-, 18-related genital warts was 80.3% (95% CI: 73.9, 85.3) in the combined protocols at end of study.
Croatian: Djelotvornost protiv VIN-a 2/3 povezanog s HPV-om tipova 6, 11, 16 i 18 iznosila je 73,3% (95% CI: 40,3; 89,4), protiv VaIN-a 2/3 povezanog s HPV-om tipova 6, 11, 16 i 18 iznosila je 85,7% (95% CI: 37,6; 98,4), a protiv genitalnih bradavica povezanih s HPV-om tipova 6, 11, 16 i 18 iznosila je 80,3% (95% CI: 73,9; 85,3) na kraju ispitivanja u svim protokolima zajedno.
English: Women vaccinated with Silgard at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Croatian: Žene cijepljene cjepivom Silgard 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 015, 2,084 women 16-23 years old during vaccination with Silgard in the base study, were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 015, praćeno je 2084 žena cijepljenih cjepivom Silgard koje su uključene u temeljno ispitivanje u dobi od 16 do 23 godine.
English: The efficacy of Silgard 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 Silgard 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: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Silgard in the base study, were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 019, praćeno je 685 žena cijepljenih cjepivom Silgard koje su uključene u temeljno ispitivanje u dobi od 24 do 45 godina.
English: • Silgard may appear as a clear liquid with a white precipitate prior to agitation.
Croatian: • Prije nego što se promućka, Silgard može izgledati kao bistra tekućina s bijelim talogom.
English: Among women with an abnormal Pap test at Day 1 who were naïve to the relevant vaccine HPV types at Day 1, efficacy of the vaccine remained high.
Croatian: Među ženama s patološkim nalazima Papa testa 1-og dana ispitivanja, djelotvornost cjepiva pokazala se visokom u onih koje do ulaska u ispitivanje nisu bile izložene odgovarajućim tipovima HPV-a sadržanim u cjepivu.
English: In the HPV naïve population (naïve to 14 common HPV types), Silgard 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: U populaciji koja do sada nije imala HPV infekciju (bez infekcije s bilo kojim od 14 HPV tipova), Silgard 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: *Number of individuals with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
Croatian: *Ispitanice s najmanje jednim kontrolnim pregledom 30 dana nakon 1-og dana ispitivanja.
English: Efficacy in women with and without prior infection or disease due to HPV 6, 11, 16, or 18
Croatian: Djelotvornost u žena sa i bez prethodne infekcije ili bolesti prouzročene HPV-om 6, 11, 16 ili 18
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;
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 primary analyses of efficacy were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Croatian: Primarne analize djelotvornosti provele su se u populaciji prema protokolu za djelotvornost (PPE) (tj. sva 3 cijepljenja u roku od 1 godine od uključenja, bez većih odstupanja od protokola i bez kontakta s odgovarajućim tipom/tipovima HPV-a prije 1. doze cjepiva pa do 1 mjesec nakon 3. doze (7. mjesec ispitivanja).
English: Men vaccinated with Silgard at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Croatian: Muškarci cijepljeni cjepivom Silgard 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, 369 girls 9-15 years old during vaccination with Silgard in the base study, were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 018, praćeno je 369 djevojčica cijepljenih cjepivom Silgard koje su uključene u temeljno ispitivanje u dobi od 9 do 15 godina.
English: Silgard, suspension for injection in a pre-filled syringe:
Croatian: Silgard, suspenzija za injekciju u napunjenoj štrcaljki:
English: Silgard, suspension for injection in a pre-filled syringe.
Croatian: Silgard, suspenzija za injekciju u napunjenoj štrcaljki.
English: Individuals 9 to and including 13 years of age Silgard can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1).
Croatian: Silgard se može primijeniti prema rasporedu za 2 doze (0,5 ml primijenjeno sa 0 i 6 mjeseci) (vidjeti dio 5.1).
English: Alternatively, Silgard can be administered according to a 3-dose schedule:
Croatian: Silgard se također može primijeniti i prema rasporedu za 3 doze:
English: The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, 18), were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Croatian: Primarne analize djelotvornosti, s obzirom na tipove HPV-a sadržane u cjepivu (HPV 6, 11, 16, 18) provedene su u populaciji kod koje je ispitivanje provedeno u skladu s protokolom za djelotvornost (PPE) (tj. primili su sve 3 doze cjepiva unutar jedne godine od uključenja, bez devijacija u protokolu i koji nisu imali infekciju s relevantnim tipovima HPV-a prije primjene 1. doze i do mjesec dana nakon primjene 3. doze (7. mjesec)).
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: Efficacy*** at end of study (95% CI)
Croatian: Silgard Placebo djelotvornosti*** na kraju ispitivanja (95% CI)
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
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
English: Efficacy in women with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Croatian: Djelotvornost u žena s infekcijom ili bolešću izazvanom HPV-om tipova 6, 11, 16 ili 18 dokazanom 1-og dana ispitivanja
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
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: However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
Croatian: Međutim, u skupini koja je istodobno primila ta cjepiva primijećen je trend sniženja srednjeg geometrijskog titra protutijela na HPV.
English: 1 Type 16 L1 protein
Croatian: humani papilomavirus 1 tip 6 L1 protein
English: Efficacy** at end of study (95% CI)
Croatian: Silgard Placebo djelotvornosti** na kraju ispitivanja (95% CI)
English: Table 6: Immunogenicity bridging between 9- to 15-year-old girls and 16- to 26-year-old women (perprotocol population) based on titres as measured by cLIA
Croatian: Tablica 6: Povezivanje dokaza imunogenosti između mladih žena u dobi 16-26 godina i djevojčica u dobi 9-15 godina (populacija prema protokolu) na temelju titra izmjerenog cLIA testom Djevojčice 9-15 godina (Protokoli 016 i 018)
English: • Two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular (IM) administration depending on your patient's size and weight.
Croatian: Odaberite odgovarajuću iglu ovisno o veličini i težini bolesnika kako biste osigurali intramuskularnu (i.m.) primjenu.
English: In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Silgard 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 žena u dobi od 24 do 45 godina, 98,4%, žena koje su primile Silgard 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: The efficacy of Silgard 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 Silgard 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: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Silgard in the base study, were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 018, praćeno je 326 dječaka cijepljenih cjepivom Silgard koji su uključeni u temeljno ispitivanje u dobi od 9 do 15 godina.
English: 16- to 26-Year-Old Men
Croatian: Dječaci u dobi od 9 do 15 godina Muškarci u dobi od 16 do 26 godina
English: Side effects that have been reported during marketed use include:
Croatian: Nakon stavljanja u promet bile su zabilježene sljedeće nuspojave:
English: Any unused product or waste material should be disposed of in accordance with
Croatian: Neiskorišteno cjepivo ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: • Inspect the suspension visually for particulate matter and discolouration prior to administration.
Croatian: • Prije primjene, vizualno pregledajte suspenziju da ne sadrži vidljive čestice i da nije promijenila boju.
English: Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Croatian: Silgard, suspenzija za injekciju cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: Read all of this leaflet carefully before you or your child are vaccinated.
Croatian: Pažljivo pročitajte cijelu uputu prije nego
English: Silgard 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: Silgard se može primijeniti istodobno s kombiniranim cjepivom docjepljivanja koje sadrži difteriju (d) i tetanus (T) zajedno s pertusisom [acelularni, komponentni] (ap) i/ili poliomijelitisom [inaktivirani]
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Silgard in the base study, were followed.
Croatian: U dugotrajnom produžetku ispitivanja prema Protokolu 020, praćeno je 917 muškaraca cijepljenih cjepivom Silgard koji su uključeni u temeljno ispitivanje u dobi od 16 do 26 godina.
English: Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Croatian: Silgard, suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
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 10.1 years (median follow-up of 8.7 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 10,1 godine (medijan praćenja od 8,7 godina).
English: 1 Type 18 L1 protein
Croatian: 40 mikrograma humani papilomavirus 1 tip 18 L1 protein
English: Nine years after vaccination, 94%, 96%, 99% and 60% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 96%, 100% and 91% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive
Croatian: Devet godina nakon cijepljenja, 94% bilo je seropozitivno na tip 6 HPV-a, 96% na tip 11; 99% na tip 16 i 60% na tip 18, na temelju nalaza cLIA testa, a na temelju nalaza IgG LIA testa 98% bilo je seropozitivno na tip 6 HPV-a, 96% na tip 11; 100% na tip 16 i 91% na tip 18.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and
Croatian: • Pomoću sterilne igle i štrcaljke izvucite 0,5 ml doze cjepiva iz jednodozne bočice.
English: Consequently, the frequency of these adverse events is
Croatian: Prema tome, učestalost tih štetnih događaja je kvalificirana kao "nepoznato".
English: The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, and 18), were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Croatian: Primarne analize djelotvornosti s obzirom na tipove HPV-a sadržane u cjepivu (HPV 6, 11, 16 i 18) provedene su u populaciji kod koje je ispitivanje djelotvornosti provedeno u skladu s planom ispitivanja [engl. per-protocol efficacy (PPE)] (tj. sve 3 doze cjepiva primijenjene su u roku od 1 godine od uključenja, nije bilo velikih odstupanja od plana ispitivanja, sudionice ispitivanja nisu bile izložene relevantnim tipovima HPV-a prije 1. prve doze i do mjesec dana nakon 3. doze (7. mjesec)).
English: Silgard, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Croatian: Silgard, suspenzija za injekciju- napunjena štrcaljka bez igle, pakiranje od 1, 10, 20
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
English: In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI: 7.0, 28.4) and 62.5% (95% CI: 54.0, 69.5), respectively, as Silgard does not impact the course of infections or disease that are present at vaccination onset.
Croatian: sa smanjenjem od 18,4% (95% CI: 7,0; 28,4) za CIN 2/3 i AIS odnosno 62,5% (95% CI: 54,0; 69,5) za genitalne bradavice, budući da Silgard ne utječe na tijek infekcije odnosno bolesti koje su bile prisutne na početku cijepljenja.
English: 1 Type 11 L1 protein
Croatian: 20 mikrograma humani papilomavirus 1 tip 11 L1 protein
English: Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100% and 92% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG
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: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, anti-HPV 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: Discard the product if particulates are present or if it appears discoloured.
Croatian: Bacite cjepivo ako ste opazili čestice ili promjenu boje.
English: Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Croatian: Silgard, suspenzija za injekciju- napunjena štrcaljka s 2 igle, pakiranje od 1, 10, 20
English: 20 single doses, 0.5 ml pre-filled syringes without needles.
Croatian: 20 jednokratnih doza, napunjene štrcaljke od 0,5 ml bez igala.
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Croatian: • djelotvornost cjepiva Silgard 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: The primary efficacy endpoints included the combined incidence of HPV 6-, 11-, 16- or 18-related and the combined incidence of HPV 16- or HPV 18-related persistent infection (6 month definition), genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers.
Croatian: Primarni ishodi djelotvornosti bili su kombinirana incidencija perzistentne infekcije (koja traje 6 mjeseci), 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 i kombinirana incidencija tih promjena povezanih s tipom 16 ili tipom 18 HPV-a.
English: 1 dose, 0.5 ml pre-filled syringe with 1 needle.
Croatian: 1 doza, napunjena štrcaljka od 0,5 ml s 1 iglom.
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 Silgard 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: Efficacy in women naïve to the relevant vaccine HPV type(s)
Croatian: Djelotvornost u žena koje nisu bile izložene odgovarajućem(im) tipu(ovima) HPV-a iz cjepiva
English: 1 dose, 0.5 ml pre-filled syringe with 2 needles.
Croatian: 1 doza, napunjena štrcaljka od 0,5 ml s 2 igle.
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 follow-up of
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: 10 single doses, 0.5 ml pre-filled syringes without needles.
Croatian: 10 jednokratnih doza, napunjene štrcaljke od 0,5 ml bez igala.
English: Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Croatian: Silgard, suspenzija za injekciju- napunjena štrcaljka s 1 iglom, pakiranje od 1, 10, 20
English: At end of study and in the combined protocols, • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Croatian: • djelotvornost cjepiva Silgard 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: On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old boys is inferred.
Croatian: Djelotvornost cjepiva Silgard u dječaka u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.