natgillin/translations-raw huggingface dataset:
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.
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.
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).
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.
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.
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.
CI)
U
The GMTs were somewhat lower than those reported in non-HIV infected subjects of the same age in other studies.
Geometrijski srednji titar bio je nešto niži nego geometrijski srednji titar zabilježen u drugim ispitivanjima u osoba iste dobi koje nisu
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.
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.
Women vaccinated with Silgard at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Žene cijepljene cjepivom Silgard u dobi od 24 do 45 godina u temeljnom ispitivanju prema Protokolu 019 bile su praćene u produžetku ispitivanja.
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.
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.
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.
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.
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.
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.
• Silgard may appear as a clear liquid with a white precipitate prior to agitation.
• Prije nego što se promućka, Silgard može izgledati kao bistra tekućina s bijelim talogom.
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.
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.
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.
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.
*Number of individuals with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
*Ispitanice s najmanje jednim kontrolnim pregledom 30 dana nakon 1-og dana ispitivanja.
Efficacy in women with and without prior infection or disease due to HPV 6, 11, 16, or 18
Djelotvornost u žena sa i bez prethodne infekcije ili bolesti prouzročene HPV-om 6, 11, 16 ili 18
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;
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).
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)).
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).
Men vaccinated with Silgard at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Muškarci cijepljeni cjepivom Silgard u dobi od 16 do 26 godina u temeljnom ispitivanju prema Protokolu 020 bili su praćeni u produžetku ispitivanja.
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.
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.
Silgard, suspension for injection in a pre-filled syringe:
Silgard, suspenzija za injekciju u napunjenoj štrcaljki:
Silgard, suspension for injection in a pre-filled syringe.
Silgard, suspenzija za injekciju u napunjenoj štrcaljki.
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).
Silgard se može primijeniti prema rasporedu za 2 doze (0,5 ml primijenjeno sa 0 i 6 mjeseci) (vidjeti dio 5.1).
Alternatively, Silgard can be administered according to a 3-dose schedule:
Silgard se također može primijeniti i prema rasporedu za 3 doze:
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)).
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)).
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Parenteralne lijekove treba vizualno pregledati prije primjene da ne sadrže vidljive čestice i da nisu promijenili boju.
Efficacy*** at end of study (95% CI)
Silgard Placebo djelotvornosti*** na kraju ispitivanja (95% CI)
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.
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
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.
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
Efficacy in women with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Djelotvornost u žena s infekcijom ili bolešću izazvanom HPV-om tipova 6, 11, 16 ili 18 dokazanom 1-og dana ispitivanja
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
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).
However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
Međutim, u skupini koja je istodobno primila ta cjepiva primijećen je trend sniženja srednjeg geometrijskog titra protutijela na HPV.
1 Type 16 L1 protein
humani papilomavirus 1 tip 6 L1 protein
Efficacy** at end of study (95% CI)
Silgard Placebo djelotvornosti** na kraju ispitivanja (95% CI)
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
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)
• 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.
Odaberite odgovarajuću iglu ovisno o veličini i težini bolesnika kako biste osigurali intramuskularnu (i.m.) primjenu.
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.
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.
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.
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).
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.
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.
16- to 26-Year-Old Men
Dječaci u dobi od 9 do 15 godina Muškarci u dobi od 16 do 26 godina
Side effects that have been reported during marketed use include:
Nakon stavljanja u promet bile su zabilježene sljedeće nuspojave:
Any unused product or waste material should be disposed of in accordance with
Neiskorišteno cjepivo ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
• Inspect the suspension visually for particulate matter and discolouration prior to administration.
• Prije primjene, vizualno pregledajte suspenziju da ne sadrži vidljive čestice i da nije promijenila boju.
Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Silgard, suspenzija za injekciju cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
Read all of this leaflet carefully before you or your child are vaccinated.
Pažljivo pročitajte cijelu uputu prije nego
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.
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]
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.
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.
Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Silgard, suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
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).
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).
1 Type 18 L1 protein
40 mikrograma humani papilomavirus 1 tip 18 L1 protein
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
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.
• Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and
• Pomoću sterilne igle i štrcaljke izvucite 0,5 ml doze cjepiva iz jednodozne bočice.
Consequently, the frequency of these adverse events is
Prema tome, učestalost tih štetnih događaja je kvalificirana kao "nepoznato".
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)).
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)).
Silgard, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Silgard, suspenzija za injekciju- napunjena štrcaljka bez igle, pakiranje od 1, 10, 20
Efficacy in Men naïve to the relevant vaccine HPV types
Djelotvornost u muškaraca koji do sada nisu bili u kontaktu s relevantnim tipovima HPV-a sadržanim
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.
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.
1 Type 11 L1 protein
20 mikrograma humani papilomavirus 1 tip 11 L1 protein
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
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.
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.
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.
Discard the product if particulates are present or if it appears discoloured.
Bacite cjepivo ako ste opazili čestice ili promjenu boje.
Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Silgard, suspenzija za injekciju- napunjena štrcaljka s 2 igle, pakiranje od 1, 10, 20
20 single doses, 0.5 ml pre-filled syringes without needles.
20 jednokratnih doza, napunjene štrcaljke od 0,5 ml bez igala.
• the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
• 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),
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.
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.
1 dose, 0.5 ml pre-filled syringe with 1 needle.
1 doza, napunjena štrcaljka od 0,5 ml s 1 iglom.
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.
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.
Efficacy in women naïve to the relevant vaccine HPV type(s)
Djelotvornost u žena koje nisu bile izložene odgovarajućem(im) tipu(ovima) HPV-a iz cjepiva
1 dose, 0.5 ml pre-filled syringe with 2 needles.
1 doza, napunjena štrcaljka od 0,5 ml s 2 igle.
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
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).
10 single doses, 0.5 ml pre-filled syringes without needles.
10 jednokratnih doza, napunjene štrcaljke od 0,5 ml bez igala.
Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Silgard, suspenzija za injekciju- napunjena štrcaljka s 1 iglom, pakiranje od 1, 10, 20
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,
• 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),
On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old boys is inferred.
Djelotvornost cjepiva Silgard u dječaka u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.
In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 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.
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.
The efficacy of Silgard 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).
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 Silgard protiv CIN-a (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.
At the injection site: hematoma, pruritus Not known Asthenia*, chills*, fatigue*, malaise*
Opći poremećaji i reakcije na vrlo često na mjestu injiciranja: eritem, bol, oticanje na mjestu injiciranja: hematom, pruritus nepoznato astenija*, zimica*, umor*, malaksalost*
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
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).
No data
N Broj slučajeva
20 single doses, 0.5 ml pre-filled syringes with 2 needles each.
20 jednokratnih doza, napunjene štrcaljke od 0,5 ml svaka s 2 igle.
1 dose, 0.5 ml pre-filled syringe without needle.
1 doza, napunjena štrcaljka od 0,5 ml bez igle.
20 single doses, 0.5 ml pre-filled syringes with 1 needle each.
20 jednokratnih doza, napunjene štrcaljke od 0,5 ml svaka sa po 1 iglom.