FrancophonIA/ELRC3.0 huggingface dataset:
English: Among 15,706 individuals who received Gardasil and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Gardasil group and 15 in the placebo group.
Slovenian: Med 15.706 osebami, ki so prejele Gardasil, in 13.617 osebami, ki so prejele placebo, je bilo 39 poročil o primeru nespecifičnega artritisa/artropatije: 24 v skupini, ki je prejela Gardasil, in 15 v skupini, ki je prejela placebo.
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Slovenian: Med kliničnimi preskušanji peroralni ali drugi kontraceptivi (npr. kontracepcijske tablete) niso zmanjšali zaščite, dosežene s cepivom Gardasil.
English: Post-Marketing Experience
Slovenian: Izkušnje v obdobju trženja
English: Persistence of Immune Response of Gardasil
Slovenian: Persistenca imunskega odziva cepiva Gardasil
English: Gardasil has not been shown to have a therapeutic effect.
Slovenian: Ni bilo dokazano, da bi cepivo Gardasil imelo terapevtski učinek.
English: In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Gardasil used hormonal contraceptives during the vaccination period.
Slovenian: V kliničnih študijah je 57,5 % žensk, starih 16 do 26 let, in 31,2 % žensk, starih 24 do 45 let, ki so prejele cepivo Gardasil, v obdobju cepljenja uporabljalo hormonske kontraceptive.
English: Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions*
Slovenian: Neznana preobčutljivostne reakcije vključno z anafilaktičnimi/anafilaktoidnimi reakcijami*
English: Gardasil is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Slovenian: Cepivo Gardasil je samo za profilaktično uporabo in nima učinka na aktivne okužbe s HPV ali na dokazano klinično bolezen.
English: At the end of this period Gardasil should be used or discarded.
Slovenian: Ob koncu tega obdobja je treba cepivo Gardasil ali uporabiti ali zavreči.
English: An academic study documenting safety and immunogenicity of Gardasil has been performed in 126 HIV infected subjects aged from 7-12 years (of which 96 received Gardasil).
Slovenian: Akademska študija, v kateri so dokumentirali varnost in imunogenost cepiva Gardasil, je bila izvedena pri 126 s HIV okuženih osebah, starih od 7 do 12 let (od katerih jih je 96 prejelo cepivo Gardasil).
English: What Gardasil looks like and contents of the pack 1 dose of Gardasil suspension for injection contains 0.5 ml.
Slovenian: Izgled cepiva Gardasil in vsebina pakiranja 1 odmerek cepiva Gardasil suspenzija za injiciranje vsebuje 0,5 ml suspenzije.
English: The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
Slovenian: Srednji geometrijski titri so bili nekoliko nižji od tistih, poročanih pri enako starih s HIV neokuženih osebah v drugih študijah.
English: Efficacy in women 24 through 45 years
Slovenian: Učinkovitost pri ženskah, starih 24 do 45 let
English: Duration of protection of a 2-dose schedule of Gardasil has not been established.
Slovenian: Trajanje zaščite po 2-odmerni shemi cepljenja s cepivom Gardasil ni bilo ugotovljeno.
English: HPV only infects humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP vaccines is mediated by the development of a humoral immune response.
Slovenian: S HPV se okuži le človek, vendar pa študije z analognimi papilomavirusi na živalih kažejo, da je učinkovitost L1 VLP cepiv posledica spodbujanja humoralnega imunskega odziva.
English: Gardasil cannot cause the diseases it protects against.
Slovenian: Cepivo Gardasil ne more povzročiti bolezni, pred katerimi ščiti.
English: HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
Slovenian: HPV tipa 6 in 11 sta odgovorna za približno 90 % primerov bradavic na spolovilih.
English: B. PACKAGE LEAFLET (VIAL)
Slovenian: B. NAVODILO ZA UPORABO (VIALA)
English: 1 dose, 0.5 ml.
Slovenian: 1 odmerek, 0,5 ml
English: What other important information should you or your child know about Gardasil
Slovenian: Drugi pomembni podatki o cepivu Gardasil, ki jih morate vi ali vaš otrok poznati
English: Gardasil is a vaccine.
Slovenian: Gardasil je cepivo.
English: The studies were not powered to assess efficacy against disease caused by individual HPV types.
Slovenian: Študije niso omogočale vrednotenja učinkovitosti proti boleznim, ki jih povzročajo posamezni tipi HPV.
English: There are no safety, immunogenicity or efficacy data to support change during vaccination with Gardasil to other HPV vaccines which do not cover the same HPV types.
Slovenian: Podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi med obdobjem cepljenja s cepivom Gardasil podpirali zamenjavo z drugimi cepivi proti HPV, ki ne vključujejo enakih tipov HPV, ni na voljo.
English: Placebo % Efficacy at 2 years
Slovenian: Gardasil Placebo učinkovitosti po 2 letih odstotni IZ)
English: Safety was evaluated in either the entire study population (6 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil or placebo.
Slovenian: Varnost so vrednotili bodisi pri celotni populaciji, vključeni v študijo (6 študij), bodisi pri vnaprej določeni podskupini (1 študija) v študijo vključene populacije, na osnovi 14-dnevnega nadzora po vsakem injiciranju cepiva Gardasil ali placeba s pomočjo kartončkov za poročanje (vaccination report card (VRC)-aided surveillance).
English: At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3doses, n = 86) for all 4 HPV types.
Slovenian: Pri spremljanju v 36. mesecu je GMT pri deklicah (2 odmerka, n = 86) ostal neinferioren od GMT pri ženskah (3 odmerki, n = 86) za vse 4 tipe HPV.
English: Not known Injection-site cellulitis *
Slovenian: Neznana celulitis na mestu injiciranja*
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Not known Idiopathic thrombocytopenic purpura*, lymphadenopathy*
Slovenian: Neznana idiopatska trombocitopenična purpura*, limfadenopatija*
English: Not all pack sizes are marketed.
Slovenian: Na trgu ni vseh navedenih pakiranj.
English: 9- to 15-Year-Old Boys
Slovenian: Dečki, stari od 9 do 15 let
English: No effects on male fertility were observed in rats (see section 5.3).
Slovenian: Pri podganah niso ugotovili učinkov na plodnost samcev (glejte poglavje 5.3).
English: Immune Responses to Gardasil at 1 month post dose 3
Slovenian: Imunski odziv na cepivo Gardasil 1 mesec po 3. odmerku
English: Gardasil must not be injected intravascularly.
Slovenian: Cepiva Gardasil se ne sme injicirati intravaskularno.
English: This population approximates to the general population of men with respect to prevalence of HPV infection or disease at enrolment.
Slovenian: Ta populacija je približek splošne populacije moških glede na prevalenco okužbe s HPV ali bolezni zaradi HPV ob vključitvi.
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
Slovenian: 20 μg adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,225 mg Al)
English: Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (See section 5.1).
Slovenian: Cepivo Gardasil ščiti le pred boleznimi, ki jih povzročajo tipi 6, 11, 16 in 18 HPV, ter v določeni meri pred boleznimi, ki jih povzročajo določeni sorodni tipi HPV (glejte poglavje 5.1).
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.
Slovenian: Osebe, pri katerih se po prejemu odmerka cepiva Gardasil pojavijo simptomi preobčutljivosti, nadaljnjih odmerkov cepiva Gardasil ne smejo prejeti.
English: Common Pain in extremity Not known Arthralgia*, Myalgia*
Slovenian: Pogosti bolečine v okončini Neznana artralgija*, mialgija*
English: When Gardasil is given as your first dose, the completion of the vaccination course should be done with Gardasil, and not with another HPV vaccine.
Slovenian: Če kot prvi odmerek prejmete cepivo Gardasil, morate cepljenje dokončati s cepivom Gardasil in ne s katerim drugim cepivom proti HPV.
English: Gardasil does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Slovenian: Cepivo Gardasil ne učinkuje pri osebah, ki že imajo persistentno okužbo ali bolezen, povezano s katerim koli tipom HPV, ki ga vsebuje cepivo.
English: Clinical Studies
Slovenian: Klinične študije
English: • you or your child developed an allergic reaction after receiving a dose of Gardasil.
Slovenian: • če se je pri vas ali vašem otroku po cepljenju z odmerkom cepiva Gardasil pojavila alergijska reakcija;
English: Table 1: Adverse Events Following Administration of Gardasil from Clinical Trials and PostMarketing Surveillance
Slovenian: Preglednica 1: Neželeni učinki po uporabi cepiva Gardasil med kliničnimi preskušanji in spremljanjem v obdobju trženja
English: At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Gardasil (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Gardasil (at 0, 2, 6 months).
Slovenian: V 7. mesecu je bil imunski odziv v populaciji per protocol pri deklicah, starih od 9 do 13 let (n = 241), ki so prejele 2 odmerka cepiva Gardasil (v 0. in 6. mesecu), neinferioren in je bil številčno večji kot imunski odziv pri ženskah, starih od 16 do 26 let (n = 246), ki so prejele 3 odmerke cepiva Gardasil (v 0., 2. in 6. mesecu).
English: At end of study, individuals enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Slovenian: Na koncu študije je bil čas spremljanja oseb, vključenih v dve študiji III. faze (Protokol 013 in Protokol 015), do 4 leta (mediana 3,7 let).
English: It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Gardasil, cepljenje dokončajo s cepivom Gardasil (glejte poglavje 4.4).
English: In addition, a subset of vaccinated women who received a challenge dose of Gardasil 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Slovenian: Razen tega so pri cepljenih ženskah, ki so 5 let po začetku cepljenja prejele obnovitveni odmerek cepiva Gardasil opazili hiter in močan anamnestični odziv, ki je presegel srednje geometrijske titre anti HPV, opažene 1 mesec po cepljenju s 3. odmerkom.
English: The concomitant administration of Gardasil with vaccines other than the ones above has not been studied.
Slovenian: Sočasnega cepljenja s cepivom Gardasil in z drugimi cepivi (razen z zgoraj naštetimi) niso raziskali.
English: Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.
Slovenian: Ženske, ki so pred cepljenjem že bile okužene z enim ali več tipi HPV, ki jih vsebuje cepivo, so bile zaščitene pred klinično boleznijo zaradi preostalih tipov HPV, ki jih vsebuje cepivo.
English: Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Slovenian: Preglednica 4: Rezultati za CIN 2/3 ali AIS pri osebah, ki še niso bile okužene s tipsko specifičnimi HPV
English: The vaccine is therefore, not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts.
Slovenian: Cepivo torej ni indicirano za zdravljenje raka na materničnem vratu, cervikalnih, vulvarnih in vaginalnih displastičnih sprememb visoke stopnje ali bradavic na spolovilih.
English: Intramuscular (IM) use.
Slovenian: Intramuskularna (i.m.)
English: This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
Slovenian: Test je določal protitelesa proti posameznim nevtralizirajočim epitopom vsakega posameznega tipa HPV.
English: What Gardasil is and what it is used for
Slovenian: Kaj je cepivo Gardasil in za kaj ga uporabljamo
English: The indication is based on the demonstration of efficacy of Gardasil in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents.
Slovenian: Indikacija temelji na dokazu učinkovitosti cepiva Gardasil pri ženskah, starih 16 do 45 let, in moških, starih 16 do 26 let, ter dokazu imunogenosti cepiva Gardasil pri 9 do 15 let starih otrocih in mladostnikih.
English: As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, Acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.
Slovenian: Kot pri drugih cepivih so tudi pri splošni uporabi tega cepiva poročali o oteklih bezgavkah (vratnih, pazdušnih in dimeljskih), oslabelosti mišic, nenormalnih občutkih, mravljinčenju v rokah, nogah in zgornjem delu telesa ali zmedenosti (Guillain-Barréjev sindrom, akutni diseminirani encefalomielitis), omotici, bruhanju, bolečinah v sklepih, bolečinah v mišicah, nenavadni utrujenosti ali šibkosti, mrzlici, splošnemu slabemu počutju, večjemu nagnjenju h krvavitvam ali modricam ter vnetju kože na mestu injiciranja.
English: In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil.
Slovenian: Profil neželenih dogodkov, o katerih so poročali pri prevelikem odmerjanju, je bil na splošno primerljiv s profilom pri priporočenem enkratnem odmerku cepiva Gardasil.
English: Very common At the injection site: erythema, pain, swelling Common Pyrexia At the injection site: hematoma, pruritus Not known Asthenia*, chills*, fatigue*, malaise*
Slovenian: Zelo pogosti na mestu injiciranja: eritem, bolečina, oteklost Pogosti pireksija na mestu injiciranja: hematom, srbenje Neznana astenija*, mrzlica*, utrujenost*, splošno slabo počutje*
English: In a supplemental analysis, the efficacy of Gardasil was evaluated against HPV 16/18-related CIN 3 and AIS.
Slovenian: Z dodatno analizo je bila ovrednotena še učinkovitost cepiva Gardasil proti CIN 3 in AIS zaradi HPV 16/18.
English: Table 5: Efficacy of Gardasil against external genital lesions in the PPE* population of 16-26 year old men
Slovenian: Preglednica 5: Učinkovitost cepiva Gardasil proti lezijam na zunanjih spolovilih v populaciji PPE* moških, starih od 16 do 26 let
English: Administration of Gardasil at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
Slovenian: Dajanje cepiva Gardasil sočasno (vendar na različna mesta, če gre za cepiva, ki se injicirajo) in rekombinantnega cepiva proti hepatitisu B ni vplivalo na imunski odziv na tipe HPV.
English: Musculoskeletal and Connective Tissue Disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Gardasil will not protect against every type of Human Papillomavirus.
Slovenian: Cepivo Gardasil ne ščiti pred vsakim tipom humanih papilomavirusov.
English: 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 Gardasil).
Slovenian: 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 imunskega odziva cepiva Gardasil).
English: 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 9-15 years of age cLIA
Slovenian: Preglednica 8: Dolgoročni podatki o imunogenosti (populacija per-protokol) na podlagi odstotkov seropozitivnih oseb, izmerjeno s cLIA in IgG LIA (protokol 018) po 10 letih pri deklicah in dečkih, starih od 9 do 15 let cLIA
English: The other ingredients in the vaccine suspension are:
Slovenian: Pomožne snovi cepilne suspenzije so:
English: Common Nausea Not known Vomiting*
Slovenian: Pogosti navzea Neznana bruhanje*
English: In the Full Analysis Set (FAS) population, the benefit of the vaccine with respect to the overall incidence of EGL was lower, with a reduction of 59.3% (95% CI: 40.0, 72.9), as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Slovenian: V populaciji celotnega nabora za analizo (FAS) je bila korist cepiva glede celotne incidence lezij na zunanjih spolovilih manjša, z zmanjšanjem za 59,3 % (95 % IZ: 40,0; 72,9), ker cepivo Gardasil ne vpliva na potek okužb ali bolezni, ki so prisotne ob začetku cepljenja.
English: If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Slovenian: Če se z drugim odmerkom cepiva cepi prej kot 6 mesecev po prvem odmerku, je treba vedno cepiti še s tretjim odmerkom.
English: GARDASIL administered to male rats at the full human dose (120 mcg total protein) had no effects on reproductive performance including fertility, sperm count, and sperm motility, and there were no vaccine-related gross or histomorphologic changes on the testes and no effects on testes weights.
Slovenian: Cepivo Gardasil, uporabljeno pri podganjih samcih v polnem odmerku za človeka (skupno 120 mikrogramov beljakovin), ni vplivalo na reproduktivno zmogljivost, vključno s plodnostjo, številom semenčic in gibljivostjo semenčic; ugotovili niso nobenih s cepivom povezanih makroskopskih ali histomorfoloških sprememb mod in nobenih učinkov na maso mod.
English: Table 2: Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population Gardasil
Slovenian: Preglednica 2: Analiza učinkovitosti cepiva Gardasil proti spremembam na materničnem vratu visoke stopnje v PPE populaciji
English: The immunogenicity of Gardasil was assessed in 20,132 (Gardasil n = 10,723; placebo n = 9,409) girls and women 9 to 26 years of age, 5,417 (Gardasil n = 3,109; placebo n = 2,308) boys and men 9 to 26 years of age and 3,819 women 24 to 45 years of age (Gardasil n = 1,911, placebo n = 1,908).
Slovenian: Imunogenost cepiva Gardasil je bila ocenjena pri 20.132 (Gardasil n = 10.723; placebo n = 9.409) deklicah in ženskah, starih 9 do 26 let, 5.417 (Gardasil n = 3.109; placebo n = 2.308) dečkih in moških, starih 9 do 26 let, in 3.819 ženskah, starih 24 do 45 let (Gardasil n = 1.911, placebo n = 1.908).
English: Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
Slovenian: Cepivo morate neposredno pred uporabo temeljito pretresti, da zagotovite enakomernost suspenzije.
English: Gardasil will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Slovenian: Oseba, ki bo cepljena, bo cepivo Gardasil prejela v obliki injekcije skozi kožo v mišico (po možnosti v mišico nadlakti ali stegna).
English: This leaflet was last revised in: {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL.
English: The efficacy of Gardasil against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Slovenian: Učinkovitost cepiva Gardasil proti CIN (vseh stopenj) in CIN 2/3 ali AIS, povzročenimi z 10 tipi HPV, ki niso v cepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in so strukturno podobni HPV 16 ali HPV 18 so vrednotili v kombinirani podatkovni bazi učinkovitosti študije III. faze (N = 17.599) po medianem času spremljanja 3,7 leta (na koncu študije).
English: As with any vaccine, Gardasil may not fully protect 100% of those who get the vaccine.
Slovenian: Kot katero koli drugo cepivo tudi cepivo Gardasil morda ne bo popolnoma zaščitilo vseh (100 %) cepljenih oseb.
English: Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Administration of Gardasil should be postponed in individuals suffering from an acute severe febrile illness.
Slovenian: Cepljenje s cepivom Gardasil je treba odložiti pri osebah, ki imajo hujšo akutno bolezen z zvišano telesno temperaturo.
English: A clinical study (Protocol 016) compared the immunogenicity of Gardasil in 10- to 15-year-old girls to those in 16- to 23 year old women.
Slovenian: Klinična študija (Protokol 016) je primerjala imunogenost cepiva Gardasil pri 10- do 15-letnih deklicah z imunogenostjo pri 16- do 23-letnih ženskah.
English: Three clinical studies (Protocols 016, 018 and 020) were used to compare the immunogenicity of Gardasil in 9- to 15-year-old boys to 16- to 26-year-old men.
Slovenian: Tri klinične študije (Protokoli 016, 018 in 020) so bile uporabljene za primerjavo imunogenosti cepiva Gardasil pri dečkih, starih od 9 do 15 let, in pri moških, starih od 16 do 26 let.
English: There have been reports of administration of higher than recommended doses of Gardasil.
Slovenian: Poročali so o dajanju odmerkov cepiva Gardasil, ki so bili večji od priporočenih.
English: N Number of cases HPV 6/11/16/18-related external genital lesions External genital lesions 1394 Genital warts PIN1/2/3
Slovenian: N število primerov s HPV 6/11/16/18 povezane lezije na zunanjih spolovilih lezije na zunanjih spolovilih bradavice na spolovilih 1394 PIN1/2/3
English: Gardasil will not protect against other diseases that are not caused by Human Papillomavirus.
Slovenian: Cepivo Gardasil ne ščiti pred boleznimi, katerih povzročitelji niso humani papilomavirusi.
English: Table 1 presents vaccine-related adverse reactions which were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Slovenian: V preglednici I so navedeni s cepivom povezani neželeni učinki, opaženi pri osebah, ki so prejele cepivo Gardasil, katerih pogostnost je bila vsaj 1,0 % in tudi večja od pogostnosti pri osebah, ki so prejele placebo.
English: There were no treatmentrelated effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Slovenian: Pri mladičih niso opazili učinkov cepiva na razvoj, obnašanje, sposobnost za razmnoževanje ali plodnost.
English: The individuals who were monitored using VRC-aided surveillance included 10,088 individuals (6,995 females 9 to 45 years of age and 3,093 males 9 to 26 years of age at enrolment) who received Gardasil and 7,995 individuals (5,692 females and 2,303 males) who received placebo.
Slovenian: S pomočjo kartončkov za poročanje je bilo nadziranih 10.088 oseb, ki so prejele cepivo Gardasil (6.995 žensk, ki so bile ob vključitvi stare 9 do 45 let in 3.093 moških, ki so bili ob vključitvi stari 9 do 26 let), ter 7.995 oseb (5.692 žensk in 2.303 moških), ki so prejele placebo.