natgillin/translations-raw huggingface dataset:
The primary efficacy endpoints included HPV 6-, 11-, 16-, or 18-related vulvar and vaginal lesions (genital warts, VIN, VaIN) and CIN of any grade and cervical cancers (Protocol 013, FUTURE I), HPV 16- or 18-related CIN 2/3 and AIS and cervical cancers (Protocol 015, FUTURE II), HPV 6-, 11-, 16-, or 18-related persistent infection and disease (Protocol 007), and HPV 16-related persistent infection (Protocol 005).
Primarni ishodi djelotvornosti obuhvatili su lezije povezane s HPV tipovima 6, 11, 16 ili 18 stidnice i rodnice (genitalne bradavice, VIN, VaIN), CIN bez obzira na stupanj i karcinome vrata maternice (Protokol 013, FUTURE I), CIN 2/3, AIS i karcinom vrata maternice povezane s HPV tipovima 16 ili 18 (Protokol 015, FUTURE II), perzistentnu infekciju i bolest povezanu s HPV tipovima 6, 11, 16 ili 18 (Protokol 007) te perzistentnu infekciju povezanu s HPV-om tipa 16 (Protokol 005).
Table 2: Analysis of efficacy of Silgard against high grade cervical lesions in the PPE population Silgard Placebo % Efficacy at 2 years
Tablica 2: Analiza djelotvornosti cjepiva Silgard protiv lezija visokog stupnja vrata maternice u PPE populaciji
In breast-feeding mothers given Silgard or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breast-fed infant were comparable between the vaccination and the placebo groups.
Za trajanja cijepljenja u okviru kliničkih ispitivanja bilo cjepivom Silgard ili placebom, stope nuspojava u dojilja i dojene dojenčadi bile su podjednake u skupinama koje su primile cjepivo i onima koje su primile placebo.
0.5 ml suspension in a vial (glass) with stopper (FluroTec-coated or Teflon-coated chlorobutyl elastomer) and flip-off plastic cap (aluminium crimp band) in a pack size of 1, 10 or 20.
0,5 ml suspenzije u bočici (staklo) s čepom (klorobutil elastomer obložen FluroTecom ili Teflonom) i plastičnim "flip-off" zatvaračem (s aluminijskim prstenom) u pakiranjima od 1, 10 ili 20 bočica.
If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Ako se druga doza cjepiva primjenjuje nakon manje od 6 mjeseci od primjene prve doze, tada se mora primijeniti i treća doza cjepiva.
In this study, a durable protection was statistically demonstrated to approximately 10 years.
U tom je ispitivanju statistički pokazano da zaštita
Silgard induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Silgard je potaknuo specifični odgovor protutijela na HPV tipova 6, 11, 16 i 18 kod skotnih ženki štakora, nakon jednokratne, odnosno višekratne intramuskularne injekcije.
These data are intended to guide healthcare professionals in case of temporary temperature excursion
Ovi su podaci namijenjeni kao smjernica zdravstvenim radnicima samo u slučaju privremenog povišenja ili sniženja
Silgard, suspension for injection:
Silgard, suspenzija za injekciju:
16- to 26-Year-Old Women (Protocols 013 and 015) GMT (95% CI)
Žene 16-26 godina (Protokoli 013 i 015)
Table 8: Long-term immunogenicity data (per-protocol population) based on percentage of seropositive subjects as measured by cLIA and IgG LIA (Protocol 018) at 10 years, in girls and boys
Tablica 8: Podaci o dugotrajnoj imunogenosti (populacija prema protokolu) na temelju postotka seropozitivnih ispitanika izmjerenog cLIA i IgG LIA testovima (Protokol 018) nakon 10 godina među djevojčicama i dječacima u dobi od 9 do 15 godina
The efficacy for HPV 16/18 related CIN 2/3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Djelotvornost za CIN 2/3 ili AIS povezanih s tipom 16/18 HPV-a temelji se na podacima iz protokola 005 (ishodi povezani samo s tipom 16), 007, 013 i 015.
The impact of Silgard against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Utjecaj cjepiva Silgard na ukupni rizik od bolesti vrata maternice uzrokovane HPV-om (tj. bolest uzrokovana bilo kojim tipom HPV-a) procijenjen je u 17 599 ispitanika uključenih u dva ispitivanja djelotvornosti faze III (Protokoli 013 i 015), počevši 30 dana nakon primitka prve doze cjepiva.
In post hoc analyses of individuals (who received at least one vaccination) with evidence of a prior infection with a vaccine HPV type (seropositive) no longer detectable (PCR negative) at vaccination onset, the efficacy of Silgard to prevent conditions due to the recurrence of the same HPV type was 100% (95% CI: 62.8, 100.0; 0 vs. 12 cases [n = 2572 from pooled studies in young women]) against HPV 6-, 11-, 16-, and 18-related CIN 2/3, VIN 2/3, VaIN 2/3, and genital warts in women 16 to 26 years.
U post hoc analizama žena (koje su primile najmanje jednu dozu cjepiva) s dokazanom prethodnom infekcijom tipom HPV-a iz cjepiva (seropozitivne) koja se nije mogla utvrditi (PCR negativne) na početku cijepljenja, djelotvornost cjepiva Silgard u sprječavanju povratka istog tipa HPV-a bila je 100% (95% CI: 62,8; 100,0; 0 naspram 12 slučajeva [n = 2572 iz svih ispitivanja u mladih žena]) kad se radilo o CIN-u 2/3, VIN-u 2/3, VaIN-u 2/3 i genitalnim bradavicama povezanima s tipovima HPV-a 6, 11, 16 i 18 u žena u dobi od 16 do 26 godina.
The duration of protection is currently unknown.
Zasada nije poznato koliko traje zaštita cijepljenjem.
In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 9 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
U tim su ispitivanjima osobe u kojih je cLIA test pokazao da su seronegativne na tipove HPV-a 6, 11, 16 i 18 i dalje bile zaštićene od kliničke bolesti nakon 9 godina praćenja žena u dobi od 16 do 23 godine, 10 godina praćenja žena u dobi od 24 do 45 godina te 10 godina praćenja muškaraca u dobi od 16 do 26 godina.
At end of study, individuals enrolled in the two Phase-III studies (Protocol013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Na kraju ispitivanja, ispitanici uključeni u dva ispitivanja III faze (protokoli 013 i 015) praćeni su do 4
The final end-of-study results for the combined incidence of CIN 2/3 or AIS in this population after a median follow-up of 3.7 years are shown in Table 4.
U Tablici 4 prikazani su konačni rezultati s kraja ispitivanja koji objedinjuju incidenciju CIN-a 2/3 i AIS-a u ovoj populaciji nakon medijana trajanja praćenja od 3,7 godina.
In the second CIN 3 case observed in a patient infected with HPV 51 at Day 1 (in 2 of 9 specimens); HPV 16 was detected at a Month 51 biopsy (in 1 of 9 specimens) and HPV 56 was detected in 3 of 9 specimens at Month 52 in tissue excised during LEEP. ***Patients were followed for up to 4 years (median 3.6 years) Note: Point estimates and confidence intervals are adjusted for person-time of follow-up.
U drugom CIN 3 slučaju zabilježenom u bolesnice inficirane tipom 51 HPV-a 1-og dana ispitivanja (u 2 od 9 uzoraka), ustanovljeni su HPV 16 biopsijom u 51-om mjesecu (u 1 od 9 uzoraka) i HPV 56 u 3 od 9 uzoraka u 52-om mjesecu u tkivu uzetom ekscizijom tijekom LEEP.
Silgard, suspension for injection.
Silgard, suspenzija za injekciju.
The modified intention to treat (ITT) population included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at 1 month Postdose 1.
Modificiranu populaciju predviđenu za liječenje (ITT) činile su žene bez obzira na njihov HPV status 1-og dana ispitivanja, koje su primile barem jednu dozu cjepiva i u kojih je brojanje slučajeva počelo 1 mjesec nakon 1. doze.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
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.
U Tablici 2 prikazani su rezultati ispitivanja djelotvornosti s obzirom na relevantne ishode analizirane 2 godine nakon uključenja u ispitivanje i na kraju ispitivanja (medijan trajanja praćenja = 3,6 godina) u populaciji koja je završila ispitivanje po protokolu.
Suspension for injection in a pre-filled syringe.
Suspenzija za injekciju u napunjenoj štrcaljki.
Silgard can be administered according to a 2-dose schedule:
Silgard se može primijeniti prema rasporedu za 2 doze:
Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
Izmjerena je djelotvornost s obzirom na ishode bolesti uzrokovane unaprijed određenim kombinacijama HPV tipova koji nisu sadržani u cjepivu.
In the vaccine group, 97.4 to 99.9% became seropositive to all vaccine serotypes by 1 month Postdose 3.
U skupini koja je primila cjepivo, 97,4 do 99,9% ispitanika postalo je seropozitivno na sve serotipove do mjesec
• Shake well before use, the pre-filled syringe, to make a suspension.
• Prije primjene dobro protresite napunjenu štrcaljku kako bi se dobila suspenzija.
Protection Against the Overall Burden of HPV disease in 16- Through 26-Year-Old Men
Zaštita od cjelokupnog opterećenja HPV bolesti u muškaraca u dobi od 16 do 26 godina
In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/18-related CIN 3 and
U dopunskoj analizi ocijenjena je djelotvornost cjepiva Silgard protiv CIN-a 3 i AIS-a povezanih s HPV tipovima 16 i 18.
These diseases include pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); precancerous lesions of the anus and genital warts in males and females; cervical and anal cancers.
Te bolesti uključuju oštećenja sluznice ženskoga spolovila (vrata maternice, stidnice i rodnice) koja prethode raku (prekancerozne lezije); prekancerozne lezije anusa (čmara) i bradavice na spolovilu u muškaraca i žena; rak vrata maternice i anusa.
*Number of individuals with at least one follow-up visit after Month 7 **Based on virologic evidence, the first CIN 3 case in a patient chronically infected with HPV 52 is likely to be causally related to HPV 52.
**Na temelju virološkog nalaza, prvi slučaj CIN-a 3 u bolesnice kronično inficirane HPV-om tip 52 vjerojatno je uzročno povezan s HPV-om tip 52.
Total IgG Luminex Immunoassay (IgG LIA) was used to assess the persistence of immune response in addition to cLIA.
Uz cLIA test, za procjenu trajnosti imunološkog odgovora koristio se i Luminex imunološki test za određivanje ukupnih IgG (IgG LIA).
Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals below 12 years of age than in those above that age.
Mjerenja provedena u 7. mjesecu ispitivanja ukazala su na povezanost dobi i imunogenosti budući da su razine protutijela na HPV bile značajno više u osoba mlađih od 12 godina nego li u starijih od 12 godina.
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Silgard reduced the proportion of women who experienced a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI: 27.7, 53.5) at end of study.
U populaciji koja nikada nije bila izložena HPV-u (bez prethodnog kontakta s 14 uobičajenih tipova HPV-a i s negativnim Papa testom 1-og dana ispitivanja), Silgard je smanjio udio žena koje su bile podvrgnute konačnim postupcima terapije vrata maternice (elektrokirurškoj eksciziji s pomoću petlje ili klasičnoj konizaciji) za 41,9% (95% CI: 27,7; 53,5) na kraju ispitivanja.
Table 7: Immunogenicity bridging between 9- to 15-year-old boys and 16- to 26-year-old men (perprotocol population) based on titres as measured by cLIA
Tablica 7: Povezivanje dokaza imunogenosti između mladih muškaraca u dobi od 16 do 26 godina i dječaka u dobi od 9-15 godina (populacija prema protokolu) na temelju titra izmjerenog cLIA
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Tekst na naljepnici napunjene štrcaljke
6.1 List of excipients
6.1 Popis pomoćnih tvari natrijev klorid
The Full Analysis Set population included men regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at Day 1.
Analiza cjelokupne uključene populacije uključivala je muškarce bez obzira na njihov početni HPV status 1-og dana ispitivanja, koji su primili barem jednu dozu cjepiva i u kojih je računanje započelo 1og dana.
A clinical study (Protocol 016) compared the immunogenicity of Silgard in 10- to 15-year-old girls to those in 16- to 23-year-old women.
U kliničkome ispitivanju (Protokol 016) uspoređena je imunogenost cjepiva Silgard između skupine djevojčica u dobi od 10 do 15 godina i skupine mladih žena u dobi od 16 do 23 godine.
Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals.
Mjerenja provedena u 7. mjesecu ispitivanja ukazala su na povezanost dobi i imunogenosti budući da su razine protutijela na HPV bile značajno više u mlađih pojedinaca.
Girls and boys vaccinated with Silgard at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Djevojčice i dječaci cijepljeni cjepivom Silgard u dobi od 9 do 15 godina u temeljnom ispitivanju prema Protokolu 018 bili su praćeni u produžetku ispitivanja.
Among men who were naïve to 14 common HPV types, administration of Silgard reduced the incidence of external genital lesions caused by vaccine- or non-vaccine HPV types by 81.5% (95% CI: 58.0, 93.0).
Među muškarcima koji do sada nisu imali infekciju s 14 uobičajenih HPV tipova, primjena cjepiva Silgard 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).
Bridging the Efficacy of Silgard from Women to Girls
Ekstenzija (engl. bridging) dokaza o djelotvornosti cjepiva Silgard u mladih žena na djevojčice
Efficacy was evaluated against HPV 6-, 11-, 16-, 18-related external genital warts, penile/perineal/perianal intraepithelial neoplasia (PIN) grades 1/2/3, and persistent infection.
Ocijenjena je djelotvornost protiv HPV tipova 6,11,16 i 18 povezanih s pojavom vanjskih genitalnih bradavica, intraepitelijalne neoplazije penisa/perinealne/perianalne regije (PIN) stupnjeva 1/2/3 i
• Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
• Iglu spojite zavrtanjem u smjeru kazaljke na satu sve dok ne bude čvrsto spojena sa štrcaljkom.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
Bridging the Efficacy of Silgard from Men to Boys
Ekstenzija (engl. bridging) dokaza o djelotvornosti cjepiva Silgard u mladih muškaraca na dječake
Overall, 73% of women were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Ukupno 67% žena nije bilo izloženo (PCR negativni i seronegativni nalazi) niti jednom od 4 tipa HPV-a u trenutku uključenja u ispitivanje.
No minimum antibody level associated with protection has been identified for HPV vaccines.
Za cjepiva protiv HPV-a dosada nije utvrđena najniža razina protutijela povezana sa zaštitnim djelovanjem.
Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Zaštita od ukupnoga opterećenja bolešću vrata maternice uzrokovane HPV-om u žena u dobi od 16 do
The clinical significance of this observation is not known.
Značaj ovog opažanja za kliničku primjenu nije poznat.
Silgard should be administered according to a 3-dose schedule:
Silgard treba primijeniti prema rasporedu za 3 doze:
Women vaccinated with Silgard at 16-23 years of age in Protocol 015 base study will be followed up to 14 years in an extension study.
Žene cijepljene cjepivom Silgard u dobi od 16 do 23 godina u temeljnom ispitivanju prema Protokolu 015 bit će praćene do 14 godina u produžetku ispitivanja.
HPV types 6 and 11 are responsible for approximately 90% of
Tipovi 6 i 11 odgovorni su za oko 90% slučajeva bradavica na spolovilu.
The Full Analysis Set population (also known as the ITT population) included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at Day 1.
Analiza cjelokupne populacije (tzv. populacije previđene za liječenje - ITT) uključuje žene bez obzira na njihov HPV status 1. dana ispitivanja, koje su primile najmanje jednu dozu cjepiva i u kojih je brojenje slučajeva počelo 1. dana.
Thorough agitation immediately before administration is necessary to maintain
Potrebno je dobro protresti neposredno prije primjene kako bi se
Discard the vaccine if particulates are present and/or if it appears discoloured.
Bacite cjepivo ako ste opazili čestice i/ili promjenu boje.
In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Od osoba koje su primile cjepivo, njih 99,1% do 100% postali su seropozitivni na sve serotipove cjepiva unutar
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
• Silgard je dostupan u napunjenoj štrcaljki spremnoj za primjenu u mišić (i.m.), poželjno u
Cervical Intraepithelial Neoplasia (CIN) Grade 2/3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
U kliničkim su se ispitivanjima cervikalna intraepitelna neoplazija (CIN) stupnja 2/3 (umjerena do teška displazija) te adenokarcinom in situ (AIS) koristili kao zamjenski markeri raka vrata maternice.
• 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.
As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.
Kao i ostala cjepiva, Silgard neće nužno zaštititi sve osobe koje su primile cjepivo.
All three doses should be given within
Sve tri doze treba primijeniti unutar godine dana.
*The individuals in the PPE population received all 3 vaccinations within 1 year of enrolment, had no major protocol deviations, and were naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3
*Pojedinci iz PPE populacije koji su primili sve 3 doze cjepiva unutar jedne godine nakon uključenja, nisu imali većih devijacija u protokolu i nikada prije nisu bili u kontaktu s relevantnim tipom(ovima) HPV-a prije primanja prve doze cjepiva i do mjesec dana nakon primitka 3. doze cjepiva (mjesec 7).
The efficacy of Silgard in 24- through 45-year-old women was assessed in 1 placebo-controlled, double-blind, randomised Phase III clinical study (Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Djelotvornost cjepiva Silgard u žena u dobi od 24 do 45 godina ocijenjena je u 1 placebom kontroliranom, dvostruko slijepom, randomiziranom kliničkom ispitivanju III faze (Protokol 019, FUTURE III) koje je obuhvatilo ukupno 3817 žena, koje su bile uključene i cijepljene bez prethodnog probirnog testiranja na prisutnost infekcije HPV-om.
The efficacy of Silgard against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Djelotvornost cjepiva Silgard protiv vanjskih genitalnih bradavicama povezanih s HPV tipovima 6, 11, 16, 18 bila je 68,1% (95% CI: 48,8; 79,3).
Anti-HPV responses at Month 7 among 9- to 15-year-old boys were non-inferior to anti-HPV responses in 16- to 26-year-old men for whom efficacy was established in the Phase III studies.
Odgovor na HPV u dječaka u dobi od 9 do 15 godina u 7. mjesecu ispitivanja nije bio inferioran od onog u mladih muškaraca u dobi od 16 do 26 godina u kojih je zaštitna djelotvornost cjepiva utvrđena u ispitivanjima faze III.
In Protocol 012 the efficacy of Silgard 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).
Protokolu 012, djelotvornost cjepiva Silgard 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).
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
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).
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano).
L1 protein in the form of virus like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
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).
Anti-HPV levels in placebo individuals who had cleared an HPV infection (seropositive and PCR
Razine protutijela na HPV u ispitanika koji su primili placebo, a koji su preboljeli HPV infekciju (seropozitivni s negativnim PCR nalazom) bile su značajno niže nego li one potaknute cjepivom.
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.
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.
After thorough agitation, it is a white, cloudy liquid.
Nakon što se temeljito promućka, tekućina je bijela i zamućena.
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.
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
The efficacy of Silgard 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.
Djelotvornost cjepiva Silgard 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.
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.
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.
Efficacy in men with or without prior infection or disease due to HPV 6, 11, 16, or 18
Djelotvornost u muškaraca s ili bez prethodne infekcije ili bolesti uzrokovane HPV-om 6, 11, 16 ili 18