FrancophonIA/ELRC3.0 huggingface dataset:
English: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Gardasil in the base study were followed.
Slovenian: V dolgotrajnem podaljšanju študije po protokolu 019 so spremljali 685 žensk, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 24 do 45 let.
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Slovenian: Učinkovitost cepiva GARDASIL proti bradavicam na zunanjih spolovilih zaradi HPV 6, 11, 16 oz. 18 je bila 68,1 % (95 % IZ: 48,8, 79,3).
English: In Protocol 012 the efficacy of Gardasil against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7% (95% CI: 95.1, 99.8) and 100.0% (95% CI: 93.2, 100.0) for HPV 18 respectively, after a follow-up of up to 4 years (mean of 3.6 years).
Slovenian: V protokolu 012 je bila učinkovitost cepiva Gardasil na podlagi 6 mesečne definicije persistentne okužbe [pozitiven vzorec na dveh ali več zaporednih obiskih v vsaj 6 mesečnem razmiku (± 1 mesec)] po 4 letnem spremljanju (povprečno 3,6 let) za HPV 16 98,7 % (95-odstotni IZ: 95,1, 99,8), za HPV 18 pa 100,0 % (95-odstotni IZ: 93,2, 100,0).
English: Efficacy in men 16 through 26 years
Slovenian: Učinkovitost pri moških, starih od 16 do 26 let
English: Efficacy** at end of study (95% CI)
Slovenian: Gardasil Placebo učinkovitosti** na koncu študije (95-odstotni IZ)
English: At end of study analysis for anal lesions in the MSM population (median duration of follow-up was 2.15 years), the preventive effect against HPV 6-, 11-, 16-, 18-related AIN 2/3 was 74.9% (95 % CI: 8.8, 95.4; 3/194 versus 13/208) and against HPV 16- or 18-related AIN 2/3 86.6% (95 % CI: 0.0, 99.7; 1/194 versus 8/208).
Slovenian: V analizi analnih lezij ob koncu študije v populaciji MSM (mediani čas spremljanja je bil 2,15 leta) je bil zaščitni učinek proti s HPV 6, 11, 16 in 18 povezanimi AIN 2/3 74,9 % (95 % IZ 8,8; 95,4; 3/194 proti 13/208), proti s HPV 16 ali 18 povezanimi AIN 2/3 pa 86,6 % (95 % IZ 0,0; 99,7; 1/194 proti
English: Overall, 67% of individuals were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Slovenian: 67 % vseh oseb ob vključitvi še ni bilo izpostavljeno nobenemu od 4 tipov HPV (PCR negativne in seronegativne).
English: Gardasil induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Slovenian: Cepivo Gardasil je v vseh starostnih skupinah 1 mesec po prejemu 3. odmerka povzročilo pojav visokih geometrijskih srednjih titrov antiHPV.
English: When Gardasil was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.
Slovenian: Pri sočasnem cepljenju (ob istem obisku) s cepivom Gardasil in obnovitvenim odmerkom mešanega cepiva proti davici, tetanusu, oslovskemu kašlju [acelularno, komponentno cepivo] in otroški ohromelosti [inaktivirano cepivo] je bilo več glavobolov in otekanj na mestu injekcije.
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)).
Slovenian: Primarne analize učinkovitosti, ki se nanašajo na tipe HPV v cepivu (tip HPV 6, 11, 16 in 18), so bile izvedene v PPE (per-protocol efficacy) populaciji (tj. vsa 3 cepljenja v 1 letu po vključitvi, brez večjih odklonov od protokola študije in neizpostavljenost zadevnemu tipu (zadevnim tipom) HPV pred 1. odmerkom in tekom 1 meseca po 3. odmerku (7. mesec).
English: - Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: • Zdravila za parenteralno uporabo morate pred dajanjem vizualno pregledati glede delcev ali spremembe barve.
English: Fourteen years after vaccination, 91%, 91%, 98% and 52% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 98%, 100% and 94% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Slovenian: Štirinajst let po cepljenju je bilo 91 %, 91 %, 98 % oziroma 52 % oseb seropozitivnih po metodi cLIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18, v tem zaporedju, ter 98 %, 98 %, 100 % oziroma 94 % oseb seropozitivnih po metodi IgG LIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18, v tem zaporedju.
English: 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.
Slovenian: Učinkovitost so ocenili proti bradavicam na zunanjih spolovilih, penilnim/perinealnim/perianalnim intraepiteljiskim neoplazijam (PIN) stopenj 1/2/3 in persistentni okužbi, povzročenimi s HPV 6, 11, 16 oz. 18.
English: Naïve to ≥ 1 HPV Type
Slovenian: Negativne za ≥ 1 tip HPV Sestavljeni opazovani dogodek
English: Like all vaccines and medicines, Gardasil can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva ima lahko tudi cepivo Gardasil neželene učinke, ki pa se ne pojavijo pri vseh osebah.
English: Women vaccinated with Gardasil at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Slovenian: Ženske, cepljene s cepivom Gardasil v starosti od 24 do 45 let v izhodiščni študiji po protokolu 019, so spremljali v podaljšanju študije.
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.
Slovenian: V preglednici 6 je podana primerjava geometrijskih srednjih titrov anti-HPV 6, 11, 16 in 18 1 mesec po prejemu tretjega odmerka za 9 do 15 let stare deklice in 16- do 26-letne ženske.
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 86%, 79%, 100% and 83% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Slovenian: Deset let po cepljenju je bilo 79 %, 85 %, 94 % oziroma 36 % oseb seropozitivnih po metodi cLIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18, ter 86 %, 79 %, 100 % oziroma 83 % oseb seropozitivnih po metodi IgG LIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18.
English: Gardasil is given as an injection by your doctor.
Slovenian: Cepivo Gardasil v obliki injekcije da zdravnik.
English: 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.
Slovenian: 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. Imunogenost je bila povezana s starostjo, ravni anti-HPV 7. mesec pa so bile pri mlajših osebah značilno večje.
English: In the PPE population, no cases of HPV types 6/11 related genital warts, HPV 6/11/16/18 external genital lesions or HPV 6/11/16/18 high grade AIN in MSM were observed through 11.5 years (median follow-up of 9.5 years).
Slovenian: V PPE populaciji v obdobju 11,5 let (mediani čas spremljanja 9,5 let) niso odkrili primerov s HPV tipoma 6/11 povezanih bradavic na spolovilih, s HPV 6/11/16/18 povezanih lezij na zunanjih spolovilih ali s HPV 6/11/16/18 povezanih AIN visoke stopnje pri MSM.
English: Individuals 9 to and including 13 years of age Gardasil can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1).
Slovenian: Cepivo Gardasil se lahko aplicira v skladu z 2-odmerno shemo cepljenja (0,5 ml v 0. in 6. mesecu) (glejte poglavje 5.1).
English: Men vaccinated with Gardasil at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Slovenian: Moške, cepljene s cepivom Gardasil v starosti od 16 do 26 let v izhodiščni študiji po protokolu 020, so spremljali v podaljšanju študije.
English: In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Gardasil in the base study were followed.
Slovenian: V dolgotrajnem podaljšanju študije po protokolu 018 so spremljali 369 deklic, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 9 do 15 let.
English: If you forget one dose of Gardasil:
Slovenian: Če enega odmerka cepiva Gardasil niste prejeli
English: Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20
Slovenian: Gardasil suspenzija za injiciranje - enoodmerna viala, pakiranje po 1, 10, 20
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Gardasil in the base study were followed.
Slovenian: V dolgotrajnem podaljšanju študije po protokolu 020 so spremljali 917 moških, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 16 do 26 let.
English: In a subset of 598 men (GARDASIL = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated.
Slovenian: Učinkovitost proti analnim intraepitelijskim neoplazijam (AIN stopnje 1/2/3) in analnemu raku ter persistentni intraanalni okužbi so v Protokolu 020 ocenili v podskupini 598 moških (GARDASIL= 299, placebo = 299), ki so sami navedli, da imajo spolne odnose z moškimi (populacija MSM).
English: 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.
Slovenian: Populacija za analizo vseh podatkov (znana tudi kot ITT populacija) je vključevala ženske ne glede na status HPV 1. dan, ki so prejele vsaj 1 odmerek cepiva, štetje primerov pa se je začelo 1. dan. Glede na prevalenco okužb s HPV in bolezni ob vključitvi ta populacija približno ustreza splošni populaciji žensk.
English: HPV 16/18related CIN 2/3 or AIS HPV 16/18related CIN 3
Slovenian: CIN 2/3 ali AIS, povezana s HPV 16/18 CIN 3,
English: Gardasil should be administered according to a 3-dose schedule: - First injection: at chosen date - Second injection: 2 months after first injection - Third injection: 6 months after first injection The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Slovenian: • Tretja injekcija: 6 mesecev po prvi injekciji Drugi odmerek je treba dati vsaj en mesec po prvem odmerku, tretji odmerek pa vsaj 3 mesece po drugem odmerku.
English: Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study.
Slovenian: Ženske, cepljene s cepivom Gardasil v starosti od 16 do 23 let v izhodiščni študiji po protokolu 015, so spremljali v podaljšanju študije.
English: How to store Gardasil
Slovenian: Shranjevanje cepiva Gardasil
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Gardasil in the base study were followed.
Slovenian: V dolgotrajnem podaljšanju študije po protokolu 018 so spremljali 326 dečkov, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 9 do 15 let.
English: Gardasil, suspension for injection in a pre-filled syringe :
Slovenian: Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi:
English: In the PPE population no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 14 years (median followup of 11.9 years).
Slovenian: V PPE populaciji v obdobju do približno 14 let (mediani čas spremljanja 11,9 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezana CIN visoke stopnje).
English: Gardasil suspension for injection in a pre-filled syringe
Slovenian: Gardasil suspenzija za injiciranje Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi
English: Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100%
Slovenian: Deset let po cepljenju je bilo 79 %, 80 %, 95 % oziroma 40 % oseb seropozitivnih po metodi cLIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18, ter 92 %, 92 %, 100 % oziroma 92 % oseb seropozitivnih po metodi IgG LIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18.
English: 20 single dose vials, 0.5 ml each.
Slovenian: suspenzija za injiciranje 1 enoodmerna viala, 0,5 ml 10 enoodmernih vial, vsaka 0,5 ml 20 enoodmernih vial, vsaka 0,5 ml
English: In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Slovenian: V kliničnih študijah pri ženskah, starih od 24 do 45 let, je bilo 1 mesec po prejemu tretjega odmerka cepiva Gardasil anti-HPV 6 seropozitivnih 98,4 % oseb, anti-HPV 11 seropozitivnih 98,1 % oseb, anti-HPV 16 seropozitivnih 98,8 % oseb in anti-HPV 18 seropozitivnih 97,4 % oseb.
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Slovenian: • učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanim CIN (1, 2, 3) ali AIS 96,0 % (95-odstotni IZ: 92,3; 98,2);
English: In the clinical studies in women 16 to 26 years of age, 99.8%, 99.8%, 99.8%, and 99.5% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3.
Slovenian: V kliničnih študijah pri ženskah, starih 16 do 26 let, je bilo 1 mesec po prejemu tretjega odmerka cepiva Gardasil anti-HPV 6 seropozitivnih 99,8 % oseb, anti-HPV 11 seropozitivnih 99,8 % oseb, anti-HPV 16 seropozitivnih 99,8 % oseb in anti-HPV 18 seropozitivnih 99,5 % oseb.
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95% CI: 78.1, 94.8).
Slovenian: Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 88,7 % (95-odstotni IZ: 78,1; 94,8).
English: Sodium chloride L-histidine Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid L-histidin polisorbat 80 natrijev borat voda za injekcije
English: 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 14 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
Slovenian: V teh študijah so bile po 14-letnem spremljanju žensk, starih od 16 do 23 let, 10-letnem spremljanju žensk, starih od 24 do 45 let in 10-letnem spremljanju moških, starih od 16 do 26 let, osebe, ki so bile po metodi cLIA seronegativne za anti-HPV 6, anti-HPV 11, anti-HPV 16 in anti-HPV 18, še vedno zaščitene pred klinično boleznijo.
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median followup of 9.9 years).
Slovenian: V PPE populaciji v obdobju 10,6 leta (mediani čas spremljanja 9,9 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezane lezije na zunanjih spolovilih).
English: Gardasil suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Slovenian: Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6% (95% CI: 24.3, 55.2).
Slovenian: Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 41,6 % (95-odstotni IZ: 24,3; 55,2).
English: Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Slovenian: Gardasil suspenzija za injiciranje - napolnjena injekcijska brizga z 1 iglo, pakiranje po 1, 10, 20
English: In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Slovenian: V klinični študiji pri moških, starih od 16 do 26 let, je med tistimi, ki so prejeli cepivo Gardasil, postalo v 1 mesecu po 3. odmerku anti-HPV 6 seropozitivnih 98,9 %, anti-HPV 11 seropozitivnih 99,2 %, anti-HPV 16 seropozitivnih 98,8 % in anti-HPV 18 seropozitivnih 97,4 %.
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 47.2% (95% CI: 33.5, 58.2).
Slovenian: Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 47,2 % (95-odstotni IZ: 33,5; 58,2).
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7% (95% CI: 67.5, 93.7).
Slovenian: Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 84,7 % (95-odstotni IZ: 67,5; 93,7)
English: The following side effects can be seen after the use of Gardasil:
Slovenian: Po uporabi cepiva Gardasil so poročali o naslednjih neželenih učinkih:
English: Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Slovenian: Gardasil suspenzija za injiciranje - napolnjena injekcijska brizga brez igle, pakiranje po 1, 10,
English: Frequency Adverse Events
Slovenian: Opazovani dogodek
English: Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Slovenian: Gardasil suspenzija za injiciranje - napolnjena injekcijska brizga z 2 iglama, pakiranje po 1, 10,
English: Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Slovenian: Gardasil suspenzija za injiciranje adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
English: types - genital warts (condyloma acuminata) causally related to specific HPV types.
Slovenian: raka materničnega vratu in raka anusa, ki so vzročno povezani z določenimi onkogenimi tipi humanih papilomavirusov (HPV) - bradavic na spolovilih (koničasti kondilomi), ki so vzročno povezane s specifičnimi tipi HPV.
English: The efficacy of Gardasil in 16- through 26 year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Slovenian: Učinkovitost cepiva Gardasil pri ženskah, starih 16 do 26 let, je bila ovrednotena v 4-ih s placebom nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II.
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median follow-up of 10.0 years).
Slovenian: V PPE populaciji v obdobju 10,7 leta (mediani čas spremljanja 10,0 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezana CIN katere koli stopnje in bradavice na spolovilih).
English: At end of study and in the combined protocols, • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Slovenian: • učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanim CIN 1 95,9 % (95-odstotni IZ: 91,4; 98,4);
English: Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Slovenian: Gardasil suspenzija za injiciranje Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
English: The efficacy of Gardasil in 16- through 26 year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Slovenian: Učinkovitost cepiva Gardasil pri moških v starosti od 16 do 26 let so ocenili v 1 s placebom kontrolirani, dvojno slepi randomizirani klinični študiji faze III (Protokol 020).
English: Suspension for injection in a pre-filled syringe.
Slovenian: Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi i.m.
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Slovenian: • učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanimi bradavicami 99,0 % (95-odstotni IZ: 96,2; 99,9).
English: 1 dose (0.5 ml) contains: HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 odmerek, 0,5 ml napolnjena injekcijska brizga z 2 iglama 10 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 2 iglama 20 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 2 iglama
English: EU/1/06/357/007 - pack of 1 EU/1/06/357/008 - pack of 10 EU/1/06/357/021 - pack of 20
Slovenian: EU/1/06/357/007 - pakiranje po 1 EU/1/06/357/008 - pakiranje po 10 EU/1/06/357/021 - pakiranje po 20
English: EU/1/06/357/003 - pack of 1 EU/1/06/357/004 - pack of 10 EU/1/06/357/019 - pack of 20
Slovenian: EU/1/06/357/003 - pakiranje po 1 EU/1/06/357/004 - pakiranje po 10 EU/1/06/357/019 - pakiranje po 20
English: EU/1/06/357/005 - pack of 1 EU/1/06/357/006 - pack of 10 EU/1/06/357/020 - pack of 20
Slovenian: EU/1/06/357/005 - pakiranje po 1 EU/1/06/357/006 - pakiranje po 10 EU/1/06/357/020 - pakiranje po 20
English: EU/1/06/357/001 - pack of 1 EU/1/06/357/002- pack of 10 EU/1/06/357/018- pack of 20
Slovenian: EU/1/06/357/001 - pakiranje po 1 EU/1/06/357/002 - pakiranje po 10 EU/1/06/357/018 - pakiranje po 20
English: cases cases
Slovenian: primeri primeri
English: Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Slovenian: Pri brejih podganah je cepivo Gardasil po enkratnem ali večkratnem intramuskularnem injiciranju sprožilo odziv v obliki pojava specifičnih protiteles proti tipom 6, 11, 16 in 18 HPV.
English: Gardasil suspension for injection IM use.
Slovenian: Gardasil suspenzija za injiciranje i.m.
English: 10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 odmerek, 0,5 ml napolnjena injekcijska brizga z 1 iglo 10 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 1 iglo 20 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 1 iglo