FrancophonIA/ELRC3.0 huggingface dataset:
English: • for at least 5 years in women who were aged 16 to 26 years at time of vaccination with Gardasil 9, depending on HPV type, 78 to100 % of subjects were seropositive; however, efficacy was maintained in all subjects regardless of seropositivity status for any vaccine HPV type through the end of the study (up to 67 months postdose 3, median follow-up duration of 43 months postdose 3),
Slovenian: • vsaj 5 let pri ženskah, starih 16 do 26 let v času cepljenja s cepivom Gardasil 9; v odvisnosti od tipa HPV je bilo 78 do 100 % oseb seropozitivnih; učinkovitost se je ohranila do konca študije (do 67 mesecev po 3. odmerku; mediani čas spremljanja 43 mesecev po 3. odmerku) pri vseh preiskovancih, ne glede na stanje seropozitivnosti za kateri koli tip HPV,
English: Other medicines and Gardasil 9
Slovenian: Druga zdravila in cepivo Gardasil 9
English: Efficacy against HPV types 6, 11, 16, and 18 was primarily assessed using a bridging strategy that demonstrated comparable immunogenicity (as measured by Geometric Mean Titres [GMT]) of Gardasil 9 compared with qHPV vaccine (Protocol 001, GDS01C/Protocol 009 and GDS07C/Protocol
Slovenian: Učinkovitost proti tipom HPV 6, 11, 16 in 18 so v prvi vrsti ocenili z uporabo premostitvene strategije, ki je pokazala primerljivo imunogenost (merjeno z geometrično sredino titrov [GMT]) cepiva Gardasil 9 v primerjavi s qHPV cepivom (Protokol 001, GDS01C/Protokol 009 in GDS07C/Protokol 020).
English: Name and address of the manufacturer(s) responsible for batch release Merck Sharp & Dohme B.V.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Merck Sharp & Dohme B.V.
English: Gardasil 9 may not have an optimal effect if used with medicines that suppress the immune system.
Slovenian: Optimalni učinek cepiva Gardasil 9 morda ne bo dosežen v primeru sočasne uporabe zdravil, ki zavirajo imunski sistem.
English: Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials.
Slovenian: V kliničnih preskušanjih niso raziskovali varnosti in imunogenosti pri posameznikih, ki so v obdobju 3 mesecev pred cepljenjem prejeli imunoglobulin ali zdravila iz krvi.
English: Gardasil 9 will not protect against every type of Human Papillomavirus.
Slovenian: Cepivo Gardasil 9 ne ščiti pred vsakim tipom humanih papilomavirusov.
English: Name and address of the manufacturer(s) of the biological active substance(s) Merck Sharp & Dohme Corp.
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Merck Sharp & Dohme Corp.
English: - If you have any further questions, please ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Vaccination is not a substitute for routine cervical screening.
Slovenian: Cepljenje ni nadomestilo za običajne presejalne preglede materničnega vratu.
English: Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil/Silgard should not receive Gardasil 9.
Slovenian: Osebe s preobčutljivostjo po predhodni uporabi cepiva Gardasil 9 ali cepiva Gardasil/Silgard ne smejo prejeti cepiva Gardasil 9.
English: In the same study, in girls and boys aged 9 to14 years, GMTs at one month after the last vaccine dose were numerically lower for some vaccine types after a 2-dose schedule than after a 3-dose schedule (i.e., HPV types 18, 31, 45, and 52 after 0, 6 months and HPV type 45 after 0, 12 months).
Slovenian: V isti študiji, pri deklicah in dečkih, starih 9 do 14 let, so bili GMT 1 mesec po zadnjem odmerku cepiva številčno nižji za nekatere tipe v cepivu po 2-odmerni shemi kot po 3-odmerni shemi cepljenja (tj. tipov HPV 18, 31, 45 in 52 po 0., 6. mesecu ter tipov HPV 45 po 0., 12. mesecu).
English: (see section 5.1).
Slovenian: - 12. mesec) (glejte poglavje 5.1).
English: It is also not intended to prevent progression of other established HPV-related lesions.
Slovenian: Cepivo prav tako ni namenjeno za preprečevanje napredovanja drugih sprememb, potrjeno povezanih s HPV.
English: Gardasil 9 administered to female rats had no effects on development, behaviour, reproductive performance or fertility of the offspring.
Slovenian: Cepivo Gardasil 9, uporabljeno pri podganjih samicah, ni vplivalo na razvoj, obnašanje, sposobnost za razmnoževanje ali plodnost mladičev.
English: In a clinical trial of 1,053 healthy adolescents aged 11 to 15 years, administration of the first dose of Gardasil 9 concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that more injection-site reactions (swelling, erythema), headache and pyrexia were reported.
Slovenian: V kliničnem preskušanju pri 1.053 zdravih mladostnikih, starih 11 do 15 let, so pri sočasnem cepljenju s prvim odmerkom cepiva Gardasil 9 in kombiniranim obnovitvenim odmerkom cepiva proti davici, tetanusu, oslovskemu kašlju [acelularno, komponentno cepivo] in otroški ohromelosti [inaktivirano cepivo] poročali o več primerih reakcij na mestu injiciranja (otekanje, pordelost), glavobola in zvišane telesne temperature.
English: In clinical studies, 60.2% of women aged 16 to 26 years who received Gardasil 9 used hormonal contraceptives during the vaccination period of the clinical studies.
Slovenian: V kliničnih študijah je 60,2 % žensk, starih 16 do 26 let, ki so prejele cepivo Gardasil 9, v obdobju cepljenja uporabljalo hormonske kontraceptive.
English: 0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconised FluroTec-laminated bromobutyl elastomer) and a tip cap (synthetic isoprene-bromobutyl blend) in pack sizes of 1 or 10 with needles or in a pack size of 10 without needles.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z batom (s silikoniziranim FluoroTec-om obloženi bromobutilni elastomer) in pokrovčkom konice (sintetična izopren-brombutilna mešanica) ter v pakiranjih po 1 ali 10 z iglami ali v pakiranju po 10 brez igel.
English: The following side effects have been reported with GARDASIL or SILGARD and may also be seen after getting GARDASIL 9:
Slovenian: O naslednjih neželenih učinkih so poročali pri cepivih GARDASIL ali SILGARD in se lahko pojavijo tudi po cepljenju s cepivom Gardasil 9:
English: There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness.
Slovenian: Podatkov o uporabi cepiva Gardasil 9 pri osebah z okvarjeno imunsko odzivnostjo ni.
English: If you or your child receive a first dose of Gardasil 9, you have to complete the full vaccination course with Gardasil 9.
Slovenian: Če vi ali vaš otrok prejmete prvi odmerek cepiva Gardasil 9, je treba celotno cepljenje dokončati s cepivom Gardasil 9.
English: It is prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein from the same four HPV types (6, 11, 16, 18) in qHPV vaccine and from 5 additional HPV types (31, 33, 45, 52, 58).
Slovenian: Pripravljeno je iz visoko prečiščenih virusu podobnih delcev (VLP - virus-like particles) velike plaščne (L1) beljakovine istih štirih tipov HPV (6, 11, 16 in 18) kot qHPV cepivo in petih dodatnih tipov HPV (31, 33, 45, 52, 58).
English: In Protocol 001, GMTs for HPV-6, -11, -16 and -18 were comparable in subjects who received qHPV vaccine or Gardasil 9 for at least 3.5 years.
Slovenian: V Protokolu 001 so bili GMT-ji za HPV 6, 11, 16 in 18 primerljivi vsaj 3,5 let pri osebah, ki so prejele qHPV cepivo ali Gardasil 9.
English: What Gardasil 9 looks like and contents of the pack
Slovenian: Izgled cepiva Gardasil 9 in vsebina pakiranja
English: Amorphous aluminium hydroxyphosphate sulfate is included in the vaccine as an adjuvant.
Slovenian: Amorfni aluminijev hidroksifosfat sulfat je v cepivo dodan kot adjuvans.
English: One month following the last dose of the assigned regimen, between 97.9% and 100% of subjects across all groups became seropositive for antibodies against the 9 vaccine HPV types.
Slovenian: En mesec po prejemu zadnjega odmerka predpisanega režima, je med 97,9 % in 100 % preiskovancev iz vseh skupin, postalo seropozitivnih za protitelesa proti 9 tipom HPV v cepivu.
English: No cases of cervical cancer, VIN2/3, vulvar and vaginal cancer were diagnosed in the PPE population.
Slovenian: V populaciji PPE ni bilo odkritih primerov raka materničnega vratu, VIN2/3, raka vulve ali nožnice.
English: Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule.
Slovenian: Cepivo Gardasil 9 se lahko aplicira v skladu s 3-odmerno shemo cepljenja (0., 2. in 6. mesec).
English: The other ingredients in the vaccine suspension are: sodium chloride, histidine, polysorbate 80, borax and water for injections.
Slovenian: Druge sestavine cepilne suspenzije so: natrijev klorid, histidin, polisorbat 80, boraks in voda za injekcije.
English: Gardasil 9 can be used during breast-feeding.
Slovenian: Cepivo Gardasil 9 se v obdobju dojenja lahko uporablja.
English: Suspension for injection 1 vial (0.5 ml).
Slovenian: suspenzija za injiciranje 1 viala (0,5 ml)
English: • demonstration of efficacy against persistent infection and disease related to HPV types 31, 33, 45, 52 and 58 in girls and women aged 16 to 26 years, and
Slovenian: • dokazani učinkovitosti proti persistentni okužbi in bolezni, povezani s tipi HPV 31, 33, 45, 52 in 58 pri deklicah in ženskah, starih 16 do 26 let, in
English: It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9 (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Gardasil 9, cepljenje dokončajo s cepivom Gardasil 9 (glejte poglavje 4.4).
English: Gardasil 9 will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Slovenian: Cepljena oseba bo cepivo Gardasil 9 prejela v obliki injekcije skozi kožo v mišico (po možnosti v mišico nadlakti ali stegna).
English: High immunogenicity in MSM aged 16 to 26 years was also observed, although lower than in HM, similarly to qHPV vaccine.
Slovenian: Veliko imunogenost so ugotovili tudi pri moških, ki imajo spolne odnose z moškimi, starih 16 do 26 let, čeprav je bila manjša od tiste pri HM, podobno kot pri qHPV cepivu.
English: Immune response to Gardasil 9 at Month 7
Slovenian: Imunski odziv na cepivo Gardasil 9 v 7. mesecu
English: No human data on the effect of Gardasil 9 on fertility are available.
Slovenian: Podatkov o vplivu cepiva Gardasil 9 na plodnost pri človeku ni.
English: What you need to know before you or your child receive Gardasil 9
Slovenian: Kaj morate vedeti, preden boste vi ali vaš otrok dobili cepivo Gardasil 9
English: Immune responses to Gardasil 9 using a 2-dose schedule in individuals 9 through 14 years of age
Slovenian: Imunski odziv na cepivo Gardasil 9 po 2-odmerni shemi cepljenja pri posameznikih, starih 9 do 14 let
English: Subjects previously vaccinated with a 3-dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9 (see section 5.1).
Slovenian: Osebe, predhodno cepljene s 3 odmerki štirivalentnega cepiva proti HPV s tipi 6, 11, 16 in 18 (cepivo Gardasil), v nadaljevanju qHPV (quadrivalent HPV) cepivo, lahko prejmejo 3 odmerke cepiva Gardasil 9 (glejte poglavje 5.1).
English: When Gardasil 9 is given as your first dose, the completion of the vaccination course should be done with Gardasil 9, and not another HPV vaccine.
Slovenian: Če kot prvi odmerek prejmete cepivo Gardasil 9, morate cepljenje dokončati s cepivom Gardasil 9 in ne katerim koli drugim cepivom proti HPV.
English: As with any vaccine, Gardasil 9 may not fully protect all of those who get the vaccine.
Slovenian: Kot katero koli drugo cepivo tudi cepivo Gardasil 9 morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
English: However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil 9 can still protect against diseases associated with the other HPV types in the vaccine.
Slovenian: Vendar pa lahko cepivo Gardasil 9 osebe, ki so že okužene z enim ali več tipi HPV, ki jih vsebuje cepivo, še vedno ščiti pred boleznimi, povezanimi z ostalimi tipi HPV v cepivu.
English: Table 3: Comparison of immune responses (based on cLIA) between Gardasil 9 and qHPV vaccine for HPV types 6, 11, 16, and 18 in the PPI (Per Protocol Immunogenicity)* population of 9 to 15 year-old girls and 16 to 26 year old women and men
Slovenian: Preglednica 3: Primerjava imunskih odzivov (na podlagi cLIA) med cepivom Gardasil 9 in qHPV cepivom za tipe HPV 6, 11, 16 in 18 v populaciji PPI (Per Protocol Immunogenicity)* deklic, starih 9 do 15 let, ter žensk in moških, starih 16 do 26 let
English: Impact of Gardasil 9 against cervical biopsy and definite therapy related to vaccine HPV types in the PPE
Slovenian: Vpliv cepiva Gardasil 9 glede biopsij materničnega vratu in definitivnih posegov, povezanih s tipi HPV v cepivu, v populaciji PPE
English: In Protocol 004, anti-HPV antibody GMTs at Month 7 among women aged 27 to 45 years were noninferior to anti-HPV antibody GMTs among girls and women aged 16 to 26 years for HPV 16, 18, 31, 33, 45, 52, and 58 with GMT ratios between 0.66 and 0.73.
Slovenian: V protokolu 004 so bili GMT protiteles proti HPV v 7. mesecu pri ženskah, starih 27 do 45 let, neinferiorni GMT protiteles proti HPV v 7. mesecu pri deklicah in ženskah, starih 16 do 26 let, za tipe HPV 16, 18, 31, 33, 45, 52 in 58 z GMT razmerjem med 0,66 in 0,73.
English: • Shake the pre-filled syringe well before use, to make a suspension.
Slovenian: • Napolnjeno injekcijsko brizgo pred uporabo dobro pretresite, da nastane suspenzija.
English: The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, 18, 31, 33, 45, 52, and 58).
Slovenian: Učinkovina je: visoko prečiščeni nekužni protein vsakega od tipov humanega papilomavirusa (6, 11, 16, 18, 31, 33, 45, 52 in 58).
English: Clinical studies for Gardasil 9
Slovenian: Klinične študije s cepivom Gardasil 9
English: There were no vaccine-related serious adverse experiences reported in infants who were breast-feeding during the vaccination period.
Slovenian: Pri dojenčkih, ki so bili dojeni v obdobju cepljenja, niso poročali o nobenem resnem neželenem učinku povezanim s cepivom.
English: Gardasil 9 can be administered according to a 3-dose schedule: First injection: at chosen date Second injection: 2 months after first injection (not earlier than one month after the first dose) Third injection: 6 months after first injection (not earlier than 3 months after the second dose) All three doses should be given within a 1-year period.
Slovenian: Cepivo Gardasil 9 se lahko uporablja v skladu s 3-odmerno shemo: - Prva injekcija: ob izbranem času - Druga injekcija: 2 meseca po prvi injekciji (ne prej kot 1 mesec po prvem odmerku) - Tretja injekcija: 6 mesecev po prvi injekciji (ne prej kot 3 mesece po drugem odmerku) Vse tri odmerke je treba dati v obdobju 1 leta.
English: In long-term extensions of clinical studies, no cases of high-grade intraepithelial neoplasia and no cases of genital warts were observed: - through 10.7 years in girls (n=369) and 10.6 years in boys (n = 326), 9-15 years of age at time of vaccination (median follow-up of 10.0 years and 9.9 years, respectively); - through 11.5 years in men (n=917), 16-26 years of age at time of vaccination (median follow-up of 9.5 years); and through 10.1 years in women (n = 685), 24-45 years of age at time of vaccination (median follow-up of 8.7 years).
Slovenian: V dolgoročno podaljšanih kliničnih študijah niso opazili primerov intraepitelijske neoplazije visoke stopnje in genitalnih bradavic: - v obdobju 10,7 leta pri deklicah (n = 369) in v obdobju 10,6 leta pri dečkih (n = 326), ob cepljenju starih 9 do 15 let (mediani čas spremljanja deklic 10,0 leta in mediani čas spremljanja dečkov 9,9 leta); - v obdobju 11,5 leta pri moških (n = 917), ob cepljenju starih 16 do 26 let (mediani čas spremljanja 9,5 leta); v obdobju 10,1 leta pri ženskah (n = 685), ob cepljenju starih 24 do 45 let (mediani čas spremljanja 8,7 leta).
English: A statistical analysis of non-inferiority was performed at Month 7 comparing cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs between individuals administered Gardasil 9 and individuals administered Gardasil.
Slovenian: Statistično analizo neinferiornosti so opravili v 7. mesecu s primerjavo GMT (na podlagi cLIA) za anti-HPV 6, anti-HPV 11, anti-HPV 16 in anti-HPV 18 med osebami, ki so prejele cepivo Gardasil 9, in osebami, ki so prejele cepivo Gardasil.
English: 0.5 ml suspension in a vial (glass) with stopper (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1.
Slovenian: 0,5 ml suspenzije v viali (steklo) z zamaškom (halobutil) in plastičnim pokrovčkom (z aluminijastim obročkom) v pakiranju po 1.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Gardasil 9 also reduced the incidence of HPV 31-, 33-, 45-, 52-, and 58-related Pap test abnormalities, cervical and external genital procedures (i.e., biopsies), and cervical definitive therapy procedures (Table 4).
Slovenian: Prav tako je cepivo Gardasil 9 zmanjšalo pojavnost s HPV 31, 33, 45, 52 in 58 povezanih nenormalnih testov Pap, posegov (tj. biopsij) na materničnem vratu in zunanjih spolovilih ter definitivnih terapevtskih posegov na materničnem vratu (preglednica 4).
English: Comparison of Gardasil 9 with qHPV vaccine with respect to HPV types 6, 11, 16, and 18 were conducted in a population of women aged 16 to 26 years from Protocol 001, girls aged 9 to 15 years from GDS01C/Protocol 009 and men aged 16 to 26 years from GDS07C/Protocol 020.
Slovenian: Primerjavo cepiva Gardasil 9 in qHPV cepiva glede tipov HPV 6, 11, 16 in 18 so izvedli v populaciji žensk, starih 16 do 26 let, iz Protokola 001, populaciji deklic, starih 9 do 15 let, iz GDS01C/Protokola 009 in populaciji moških, starih 16 do 26 let, iz GDS07C/Protokola 020.
English: Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Slovenian: Poročali so o omedlevici, včasih s spremljajočim tresenjem ali odrevenelostjo.
English: After thorough agitation, it is a white, cloudy liquid.
Slovenian: Ko ga dobro pretresemo, je bela, motna tekočina.
English: Excipients: Sodium chloride, histidine, polysorbate 80, borax, water for injections.
Slovenian: Pomožne snovi: natrijev klorid, histidin, polisorbat 80, boraks in voda za injekcije
English: Additional efficacy evaluation of Gardasil 9 against vaccine HPV types Since the efficacy of Gardasil 9 could not be evaluated against placebo, the following exploratory analyses were conducted.
Slovenian: Ker učinkovitosti cepiva Gardasil 9 ni bilo mogoče ovrednotiti v primerjavi s placebom, so bile izvedene naslednje eksplorativne analize.
English: In girls and boys receiving 2 doses at 6- or 12-month interval (+/- 1-month), persistence of antibody response was demonstrated through Month 36; depending on HPV type, 81% to 99% of girls and boys receiving 2 doses at 6-month interval and 88% to 100% of girls and boys receiving 2 doses at 12month interval were seropositive.
Slovenian: Pri deklicah in dečkih, ki so prejeli 2 odmerka v razmiku 6 mesecev ali 12 mesecev (+/- 1 mesec), je bilo trajanje odziva protiteles dokazano tekom 36. meseca; glede na tip HPV je bilo seropozitivnih 81 % do 99 % deklic in dečkov, ki so prejeli 2 odmerka v razmiku 6 mesecev ter 88 % do 100 % deklic in dečkov, ki so prejeli 2 odmerka v razmiku 12 mesecev.
English: If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če pri sebi ali pri otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Protocol 006 evaluated the immunogenicity of Gardasil 9 in 921 girls and women (aged 12 to 26 years) who had previously been vaccinated with qHPV vaccine.
Slovenian: Protokol 006 je ovrednotil imunogenost cepiva Gardasil 9 pri 921 deklicah in ženskah (starih 12 do 26 let), predhodno cepljenih s qHPV cepivom.
English: Suspension for injection 10 pre-filled syringes (0.5 ml)
Slovenian: suspenzija za injiciranje 10 napolnjenih injekcijskih brizg (0,5 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH besedilo na nalepki napolnjene injekcijske brizge
English: Immune responses, measured by GMT, for Gardasil 9 were non-inferior to immune responses for Gardasil (Table 3).
Slovenian: Z GMT merjeni imunski odziv na cepivo Gardasil 9 je bil neinferioren imunskemu odzivu na cepivo Gardasil (preglednica 3).
English: In Protocol 002 extension study, no cases of high-grade intraepithelial neoplasia or genital warts were observed through 6.4 years postdose 3 (median follow-up of 5.9 years) in girls (n = 753) or boys (n=227) who were aged 9 to 15 years at time of vaccination with Gardasil 9.
Slovenian: V podaljšani študiji Protokol 002 niso opazili primerov intraepitelijske neoplazije visoke stopnje ali genitalnih bradavic tekom 6,4 let po 3. odmerku (mediani čas spremljanja 5,9 leta) pri deklicah (n = 753) ali dečkih (n = 227), ob cepljenju s cepivom Gardasil 9 starih 9 do 15 let.
English: Gardasil 9 has been studied in males 9 to 26 years of age and females 9 to 45 years of age.
Slovenian: Cepivo Gardasil 9 je raziskano pri moških, starih od 9 do 26 let, in ženskah, starih od 9 do 45 let.
English: Administration of Gardasil 9 to individuals previously vaccinated with qHPV vaccine
Slovenian: Uporaba cepiva Gardasil 9 pri osebah, predhodno cepljenih s qHPV cepivom
English: Studies supporting the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58
Slovenian: Študije, ki potrjujejo učinkovitost cepiva Gardasil 9 proti tipom HPV 31, 33, 45, 52 in 58
English: The efficacy of Gardasil 9 in women aged 16 to 26 years was assessed in an active comparator-controlled, double-blind, randomised clinical study (Protocol 001) that included a total of 14,204 women (Gardasil 9 = 7,099; qHPV vaccine = 7,105).
Slovenian: Učinkovitost cepiva Gardasil 9 pri ženskah, starih 16 do 26 let, so ocenili v dvojno slepi, randomizirani klinični študiji (Protokol 001), nadzorovani s primerjalno učinkovino, v katero je bilo vključenih 14.204 žensk (Gardasil 9 = 7.099, qHPV cepivo = 7.105).
English: It uses the same amorphous aluminium hydroxyphosphate sulfate adjuvant as qHPV vaccine.
Slovenian: Kot adjuvans je uporabljen enak amorfni aluminijev hidroksifosfat sulfat kot v qHPV cepivu.
English: The genotypes for the vaccine comprised of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 will be referred to as vaccine HPV types.
Slovenian: Cepivo vsebuje HPV genotipe 6, 11, 16, 18, 31, 33, 45, 52, 58, ki bodo v nadaljevanju navajani kot tipi HPV v cepivu.
English: Table 4: Analysis of efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 in the PPE population of 16 to 26 year old women
Slovenian: Preglednica 4: Analiza učinkovitosti cepiva Gardasil 9 proti tipom HPV 31, 33, 45, 52 in 58 v populaciji PPE ‡ žensk, starih 16 do 26 let
English: In 24- through 45- year-old women (N=3,817) efficacy against HPV 6, 11, 16 and 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: Pri ženskah, starih 24 do 45 let (N = 3.817), je bila učinkovitost proti s HPV 6, 11, 16 in 18 povezanimi persistentnimi okužbami, genitalnimi bradavicami, spremembami na vulvi in nožnici, CIN katere koli stopnje, AIS in rakom materničnega vratu 88,7 % (95 % IZ: 78,1; 94,8).