natgillin/translations-raw huggingface dataset:
Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
Merili so učinkovitost proti opazovanim boleznim, povzročenimi z vnaprej določenimi kombinacijami tipov HPV, ki jih cepivo ne vsebuje.
If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Če se z drugim odmerkom cepiva cepi prej kot 6 mesecev po prvem odmerku, je treba vedno cepiti še
It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses.
Pomembno je, da navodila o ponovnem obisku zaradi cepljenja z naslednjim odmerkom cepiva natančno upoštevate.
0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconized FluroTec-coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and a tip cap (bromobutyl) without needle or with one or two needle(s) - pack size of 1, 10 or 20.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (s silikoniziranim FluroTec-om obloženi bromobutilni elastomer ali neobloženi klorobutilni elastomer) in pokrovčkom konice (bromobutil), brez igle ali z eno oziroma dvema iglama - pakiranje po 1, 10 ali 20.
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.
V post hoc analizah posameznikov (ki so bili cepljeni vsaj enkrat) s potrjeno predhodno okužbo s tipom HPV, ki ga vsebuje cepivo (seropozitivni) in ki se ga ob začetku cepljenja ni dalo več določiti (PCR negativni), je bila učinkovitost cepiva Silgard pri preprečitvi stanj zaradi ponovne prisotnosti istega tipa HPV 100 % (95-odstotni IZ: 62,8; 100,0; 0 oz. 12 primerov [n = 2.572 iz združenih študij pri mladih ženskah]) proti s HPV 6, 11,16 in 18 povezane CIN 2/3, VIN 2/3, VaIN 2/3 in bradavice na spolovilih pri ženskah, starih 16 do 26 let.
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.
Med potekom cepljenja v kliničnih preskušanjih, v katerih so doječe matere prejele cepivo Silgard ali placebo, je bil odstotek neželenih učinkov pri materi in dojenem otroku v skupini, ki je prejela cepivo, primerljiv z odstotkom v skupini, ki je prejela placebo.
Silgard produces type-specific antibodies and has been shown in clinical trials to prevent HPV 6-, 11-, 16-, and 18-related diseases in women 16-45 years of age and in men 16-26 years of age.
Cepivo Silgard povzroči nastanek tipsko specifičnih protiteles in je v kliničnih študijah preprečil s HPV 6, 11, 16 in 18 povezane bolezni pri ženskah, starih od 16 do 45 let, in moških, starih od 16 do 26 let.
The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
Zdravilna učinkovina je visoko prečiščeni nekužni protein vsakega od tipov humanega papilomavirusa (6, 11, 16 in 18).
Silgard is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18.
Silgard je nekužno rekombinantno štirivalentno cepivo z adjuvansom, pripravljeno iz visoko prečiščenih virusu podobnih delcev (VLPs - virus-like particles) velike (L1) plaščne beljakovine tipov 6, 11, 16 in 18 HPV.
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Iglo pritrdite tako, da jo zavrtite v smeri urnega kazalca, dokler ni zanesljivo pritrjena na injekcijsko brizgo.
*Number of individuals with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
* Število oseb z vsaj enim kontrolnim obiskom po 30 dneh po 1. dnevu.
Furthermore, anti-HPV levels (GMTs) in vaccinated individuals remained at or above serostatus cut-off during the long-term followup of the phase III studies (see below under Persistence of Immune Response of Silgard).
Pri cepljenih osebah so vrednosti anti-HPV (GMT-ji) ostale enake ali nad zaščitnim nivojem protiteles v serumu (cut-off vrednost) tudi med dolgotrajnim spremljanjem v študijah III. faze (glejte spodaj pod Persistenca
Silgard was efficacious against HPV disease caused by each of the four vaccine HPV types.
Cepivo Silgard je bilo učinkovito proti boleznim zaradi HPV, ki jih povzroča kateri koli od tipov HPV, ki jih vsebuje cepivo.
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.
Populacija celotnega nabora za analizo (Full Analysis Set) je vključila moške ne glede na izhodiščno stanje HPV 1. dan, ki so prejeli vsaj eno cepljenje in pri katerih se je štetje primera začelo 1. dan.
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 opazovani dogodki so zajemali s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane spremembe na vulvi in nožnici (bradavice na spolovilih, VIN, VaIN) ter CIN katere koli stopnje in raka na materničnem vratu (Protokol 013, FUTURE I), s HPV 16 ali HPV 18 povezane CIN 2/3, AIS in raka na materničnem vratu (Protokol 015, FUTURE II), s HPV 6, HPV 11, HPV 16 ali HPV 18 povezano persistentno okužbo in bolezen (Protokol 007) in s HPV 16 povezano persistentno okužbo (Protokol 005).
Silgard can be given with a Hepatitis B vaccine or 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) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.
Cepivo Silgard se lahko ob istem obisku da sočasno s cepivom proti hepatitisu B ali z obnovitvenim odmerkom mešanega cepiva proti davici (d) in tetanusu (T) ter oslovskemu kašlju [acelularno, komponentno cepivo] (ap) in/ali otroški ohromelosti [inaktivirano cepivo] (IPV) (cepiva dTap, dT-IPV, dTap-IPV), vendar pa na drugo vbodno mesto (drugi del telesa, npr. v drugo roko ali nogo).
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.
Modificirana ITT (intention-to-treat) populacija je vključevala ženske ne glede na HPV status 1. dan, ki so prejele vsaj en odmerek cepiva, štetje primerov pa se je začelo 1 mesec po cepljenju s 1. odmerkom.
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.
V populaciji, ki še ni bila v stiku s HPV (negativna na 14 pogostih tipov HPV in negativen Pap test na 1. dan), je cepivo Silgard na koncu študije zmanjšalo delež žensk, pri katerih je bil opravljen definitivni terapevtski poseg na materničnem vratu (“Loop Electro-Excision Procedure” ali “Cold-Knife Conization”) za 41,9 % (95-odstotni IZ: 27,7; 53,5).
On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old boys is inferred.
Na osnovi imunogenosti se lahko sklepa o učinkovitosti cepiva Silgard pri 9- do 15-letnih deklicah.
Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection.
Po katerem koli injiciranju z iglo se lahko (predvsem pri mladostnikih) pojavi omedlevica, včasih povezana s padcem.
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.
Pri ženskah, ki so imele 1. dan nenormalni Pap test in do tega dne še niso bile v stiku z relevantnimi tipi HPV, ki jih vsebuje cepivo, je učinkovitost cepiva ostala visoka.
HPV 16 and HPV 18 are estimated to be responsible for approximately 70% of cervical cancers and 75-80% of anal cancers; 80% of adenocarcinoma in situ (AIS); 45-70% of high-grade cervical intraepithelial neoplasia (CIN 2/3); 25% of low grade cervical intraepithelial neoplasia (CIN 1); approximately 70% of HPV related high-grade vulvar (VIN 2/3) and vaginal (VaIN 2/3) intraepithelial neoplasia and 80% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia.
HPV 16 in HPV 18 sta po ocenah odgovorna za približno 70 % primerov raka materničnega vratu in 75-80 % primerov raka anusa, 80 % primerov adenokarcinoma in situ (AIS), 45-70 % primerov cervikalne intraepitelijske neoplazije visoke stopnje (CIN 2/3), 25 % primerov cervikalne intraepitelijske neoplazije nizke stopnje (CIN 1), približno 70 % primerov s HPV povezane intraepitelijske neoplazije visoke stopnje na vulvi (VIN 2/3) in nožnici (VaIN 2/3) ter 80 % primerov s HPV povezane intraepitelijske neoplazije visoke stopnje na anusu (AIN 2/3).
HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases, 75-80% of anal cancer cases; 70% of HPV-related pre-cancerous lesions of the vulva and vagina; 75% of HPV related pre-cancerous lesions of the anus.
HPV tipa 16 in 18 sta vzrok za približno 70 % primerov raka materničnega vratu, 75-80 % primerov raka zadnjika, 70 % s HPV povezanih predrakavih sprememb na vulvi in nožnici, 75 % s HPV povezanih predrakavih sprememb na zadnjiku.
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.
Učinkovitost proti s HPV 16/18 povezanim CIN 2/3 ali AIS temelji na podatkih iz protokolov 005 (le s HPV 16 povezani opazovani dogodki) in 007, 013 ter 015.
Silgard is available in packs of 1, 10 or 20 pre-filled syringes.
Cepivo Silgard je na voljo v pakiranjih z 1, 10 ali 20 napolnjenimi injekcijskimi brizgami.
This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
Test je določal protitelesa proti posameznim nevtralizirajočim epitopom vsakega
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.
Preglednica 5 prikazuje rezultate učinkovitosti za relevantne opazovane dogodke, analizirane na koncu študije (mediani čas spremljanja = 2,4 leta) v populaciji po protokolu.
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
Preglednica 6: Primerjava imunogenosti med 9- do 15-letnimi deklicami ter 16- do 26-letnimi ženskami (per-protokol populacija) na osnovi titrov, določenih s cLIA
Silgard can be administered according to a 2-dose schedule:
Cepivo Silgard se lahko uporablja v skladu z 2-odmerno shemo:
In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/18-related CIN 3 and
Z dodatno analizo je bila ovrednotena še učinkovitost cepiva Silgard proti CIN 3 in AIS zaradi HPV 16/18.
As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.
Kot katero koli drugo cepivo tudi cepivo Silgard morda ne bo popolnoma zaščitilo vseh (100 %)
As with any vaccine, vaccination with Silgard may not result in protection in all vaccine recipients.
Tako kot druga cepiva tudi cepivo Silgard morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
However, in individuals who are already infected with one or more of the vaccine HPV types, Silgard can still protect against diseases associated with
Vendar pa lahko cepivo Silgard osebe, ki so že okužene z enim ali več tipi HPV, ki jih vsebuje cepivo, še vedno ščiti pred boleznimi, ki so
Bridging the Efficacy of Silgard from Men to Boys
Primerjava učinkovitosti cepiva Silgard pri moških in dečkih
In addition, vaccine immunogenicity was comparable among breast-feeding mothers and women who did not breast-feed during the vaccine administration.
Pri doječih materah in ženskah, ki med cepljenjem niso dojile, je bila imunogenost cepiva primerljiva.
*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
* Posamezniki v populaciji PPE so prejeli vse tri odmerke cepiva v enem letu po vključitvi, niso imeli večjih odklonov od protokola in niso bili v stiku z relevantnim tipom/relevantnimi tipi HPV pred 1. odmerkom in do
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.
Oseba mora drugi odmerek cepiva prejeti vsaj 1 mesec po prejemu prvega odmerka, tretji odmerek cepiva pa vsaj 3 mesece po prejemu drugega odmerka.
Vaccination with Silgard is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
Cepljenje s cepivom Silgard je namenjeno za zaščito pred boleznimi, ki jih povzročajo tipi 6, 11, 16 in 18 humanih papilomavirusov (HPV).
Please speak to your doctor for more information.
Za več informacij se posvetujte z
Vaccination is not a substitute for routine cervical screening.
Cepljenje ne nadomesti običajnih presejalnih testov na materničnem vratu.
Impact on Definitive Cervical Therapy Procedures
Vpliv na definitivne terapevtske posege na materničnem vratu
The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
), najbolje v deltoidni predel nadlakti ali visoko v anterolateralni predel stegna.
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.
Pri drugem opaženem primeru CIN 3 pri bolnici z okužbo s HPV 51 na 1. dan (v 2 od 9 vzorcev) je bil v 51. mesecu z biopsijo odkrit HPV 16 (v 1 od 9 vzorcev), v 52. mesecu pa je bil v 3 od 9 vzorcev pri eksciziji tkiva s postopkom LEEP odkrit HPV 56.
GMT (95% CI)
GST (95 % IZ)
Alternatively, Silgard can be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Druga možnost je uporaba cepiva Silgard v skladu s 3-odmerno shemo cepljenja (0,5 ml v 0., 2. in 6. mesecu).
Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was
Pri ženskah, ki so imele 1. dan nenormalni Pap test in so do tega dne že bile okužene z relevantnimi tipi HPV, ki jih vsebuje cepivo, pa niso opazili nobene učinkovitosti cepiva.
After thorough agitation, it is a white, cloudy liquid.
Ko jo dobro pretresete, nastane bela, motna tekočina.
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.
Odzivi anti-HPV so bili po 7 mesecih pri dečkih, starih od 9 do 15 let, neinferiorni odzivom anti-HPV pri moških, starih od 16 do 26 let, pri katerih je bila učinkovitost ugotovljena v študijah faze III.
Consequently, the frequency of these adverse events is
Zato je pogostnost teh neželenih učinkov opredeljena kot "neznana".
Silgard is given as an injection by your doctor.
Cepivo Silgard v obliki injekcije da zdravnik.
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.
Učinkovitost cepiva Silgard pri ženskah, starih 24 do 45 let, je bila ovrednotena v 1 s placebom nadzorovani, dvojno slepi, randomizirani klinični študiji III. faze (Protokol 019, FUTURE III), v katero je bilo vključenih 3.817 žensk, ki so bile v študijo vključene in cepljene brez predhodnega
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).
Med moškimi, ki še niso bili v stiku s 14 pogostimi tipi HPV, je uporaba cepiva Silgard zmanjšala incidenco lezij na zunanjih spolovilih, povzročenih s tipi HPV, ki so ali niso vsebovani v cepivu, za 81,5 % (95 % IZ: 58,0; 93,0).
No data
Podatkov ni na
16- to 26-Year-Old Women (Protocols 013 and 015) GMT (95% CI)
Ženske, stare od 16 do 26 let (Protokola 013 in 015)
• Shake well before use, the pre-filled syringe, to make a suspension.
• Napolnjeno injekcijsko brizgo pred uporabo dobro pretresite, da nastane suspenzija.
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
Preglednica 7: Primerjava imunogenosti pri dečkih, starih od 9 do 15 let, in moških, starih od 16 do 26 let, (populacija po protokolu) na podlagi titrov, izmerjenih s cLIA
• Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
• Iglo namestite tako, da jo zavrtite v smeri urnega kazalca, dokler ni zanesljivo pritrjena na injekcijsko brizgo.
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 v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C-5 (sev 1895)) adsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (0,225 miligramov Al)
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,
Ob koncu študije in v kombinaciji protokolov je bila • učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanim CIN 1 95,9 % (95-odstotni
If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Če predvidenega odmerka niste prejeli, bo čas cepljenja z izpuščenim odmerkom določil zdravnik.
Syncope (fainting), sometimes associated with falling, can occur following, or even before, any vaccination, especially in adolescents as a psychogenic response to the needle injection.
Predvsem pri mladostnikih se lahko po katerem koli cepljenju ali celo pred njim, kot psihogeni odziv na injiciranje z iglo, pojavi sinkopa (omedlevica), včasih povezana s padcem.
• the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related VIN2/3 and VaIN 2/3 was 100%
• učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanim VIN 2/3 oz. VaIN 2/3 100 %
Efficacy in women with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Učinkovitost pri ženskah s potrjeno okužbo s HPV 6, 11, 16 ali 18 ali z boleznijo na 1. dan
Silgard is a vaccine for use from the age of 9 years for the prevention of: - premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV)
Silgard je cepivo za uporabo od 9. leta starosti dalje za preprečevanje: - predrakavih genitalnih lezij (cervikalnih, vulvarnih in vaginalnih), predrakavih analnih lezij,
Silgard, suspension for injection:
Silgard suspenzija za injiciranje:
Discard the vaccine if particulates are present and/or if it appears discoloured.
V primeru prisotnosti delcev in/ali spremembe barve cepivo zavrzite.
Depending on HPV type, 60-96% and 78-98% of subjects were seropositive by cLIA and IgG LIA respectively 10 years after vaccination (see Table 8).
Odvisno od tipa HPV je bilo 10 let po cepljenju seropozitivnih po metodi cLIA od 60 do 96 % oseb in po metodi IgG LIA od 78 do 98 % oseb (glejte preglednico 8).
Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity.
Pogosti (pri več kot 1 od 100 cepljenih oseb): neželeni učinki na mestu vboda: modrica, srbenje, bolečine v okončinah.
Very commonly (more than 1 in 10 patients), side effects found at the injection site include: pain, swelling and redness.
Zelo pogosti (pri več kot 1 od 10 cepljenih oseb): neželeni učinki na mestu vboda: bolečina, oteklina in rdečina.
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 bolezni vključujejo predrakave spremembe na ženskih spolovilih (maternični vrat, vulva in nožnica), predrakave spremembe na zadnjiku in bradavice na spolovilih pri moških in ženskah, rak materničnega vratu in rak zadnjika.
Silgard does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination (see section 5.1).
Pri osebah, ki so v času cepljenja okužene z določenim tipom HPV, ki ga vsebuje cepivo, cepivo Silgard ne prepreči sprememb, ki nastanejo zaradi tega tipa HPV (glejte poglavje 5.1).
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.
Pri 9- do 15-letnih deklicah so bili anti HPV odzivi v 7. mesecu enakovredni anti-HPV odzivom pri 16- do 26-letnih ženskah, pri katerih je bila učinkovitost dokazana v študijah III. faze.
• Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and
• S sterilno iglo in injekcijsko brizgo iz enoodmerne viale izvlecite 0,5 ml odmerek cepiva.
• the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
• učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanim CIN (1, 2, 3) ali AIS 96,0 %
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.
Pri ženskah, ki so bile negativne na 14 pogostih tipov HPV in so imele 1. dan negativni Pap test, se je na koncu študije s cepivom Silgard pojavnost CIN 2/3 ali AIS zaradi tipov HPV, ki jih ali jih ne vsebuje cepivo, zmanjšala za 42,7 % (95-odstotni IZ: 23,7; 57,3), pojavnost bradavic na spolovilih pa za 82,8 % (95-odstotni IZ: 74,3; 88,8).
• Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
• Zdravila za parenteralno uporabo morate pred dajanjem vizualno pregledati glede delcev ali spremembe barve.
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.
V populaciji, ki še ni bila v stiku s HPV (s 14 pogostimi tipi HPV), je cepivo Silgard na koncu študije zmanjšalo delež moških, ki so jim naredili biopsijo, za 54,2 % (95 % IZ: 28,3; 71,4) in moških, ki so bili zdravljeni, za 47,7 % (95 % IZ: 18,4; 67,1).
In all populations (women 9 - 45 years, men 9 - 26 years), peak anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs cLIA were observed at Month 7.
V obeh populacijah (ženske 9-45 let, moški 9-26 let) so najvišje geometrijske srednje titre cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16 in anti-HPV 18 opažali v 7. mesecu.