FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Gardasil worldwide.
Croatian: Tablica 1 također uključuje dodatne štetne događaje koji su bili spontano prijavljeni nakon stavljanja cjepiva Gardasil u promet u svijetu.
English: 16- to 26-Year-Old Women (Protocols 013 and 015)
Croatian: Žene 16-26 godina (Protokoli 013 i 015)
English: Gardasil is intended to prevent these diseases.
Croatian: Gardasil je namijenjen sprječavanju tih bolesti.
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
Croatian: CIN 3 i AIS općenito se smatraju izravnim prethodnicima invazivnog raka vrata maternice.
English: What Gardasil contains
Croatian: Što Gardasil sadrži
English: Use of hormonal contraceptives did not appear to affect the immune response to Gardasil.
Croatian: Primjena hormonskih kontraceptiva nije vidljivo utjecala na imunološki odgovor na Gardasil.
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: The data on Gardasil administered during pregnancy did not indicate any safety signal.
Croatian: Podaci o primjeni cjepiva Gardasil za trajanja trudnoće nisu ukazali na bilo koji sigurnosni signal.
English: Since no vaccine is 100% effective and Gardasil will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Croatian: Budući da nijedno cjepivo nije 100% učinkovito, ni Gardasil neće pružiti zaštitu od svih tipova HPV-a, ili od već postojećih HPV infekcija, rutinski pregled vrata maternice od ključne je važnosti i treba ga provoditi u skladu s lokalnim preporukama.
English: What Gardasil looks like and contents of the pack 1 dose of Gardasil suspension for injection contains 0.5 ml.
Croatian: Kako Gardasil izgleda i sadržaj pakiranja Jedna doza Gardasil suspenzije za injekciju sadrži 0,5 ml.
English: The median duration of follow-up for this study was 4.0 years.
Croatian: Medijan trajanja praćenja u ovom ispitivanju iznosio je 4,0 godina.
English: Duration of protection of a 2-dose schedule of Gardasil has not been established.
Croatian: Trajanje zaštite cijepljenja sa 2 doze cjepiva Gardasil nije ustanovljeno.
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Croatian: U kliničkim ispitivanjima oralna ili druga sredstva za sprječavanje trudnoće (npr. pilula) nisu smanjile razinu zaštite koju pruža Gardasil.
English: The use of Gardasil in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.
Croatian: Prilikom primjene cjepiva Gardasil u odraslih žena potrebno je uzeti u obzir razlike u prevalenciji tipova HPV-a na različitim geografskim područjima.
English: Human Papillomavirus = HPV.
Croatian: humani papilomavirus = HPV.
English: Therefore, Gardasil can be used during breast-feeding.
Croatian: Gardasil se stoga može koristiti tijekom dojenja.
English: Gardasil cannot cause the diseases it protects against.
Croatian: Gardasil ne može prouzročiti bolesti od kojih Vas štiti.
English: Immune Responses to Gardasil at 1 month post dose 3
Croatian: Imunološki odgovori na Gardasil 1 mjesec nakon 3. doze
English: Immune Responses to Gardasil using a 2-dose schedule in individuals 9-13 years of age
Croatian: Imunološki odgovori na Gardasil prema rasporedu cijepljenja sa 2 doze u pojedinaca u dobi od 9 do 13 godina
English: Persistence of Immune Response of Gardasil
Croatian: Trajnost imunološkog odgovora na Gardasil
English: If you forget one dose of Gardasil:
Croatian: Ako ste zaboravili primiti jednu dozu cjepiva Gardasil
English: Cross-protective efficacy
Croatian: Djelotvornost ukrižene zaštite
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.
Croatian: U kliničkim ispitivanjima, 57,5% žena u dobi od 16 do 26 godina i 31,2% žena u dobi od 24 do 45 godina, cijepljenih cjepivom Gardasil uzimalo je hormonske kontraceptive tijekom perioda cijepljenja.
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.
Croatian: Unutar 15 706 ispitanika koji su primili Gardasil te 13 617 ispitanika koji su primili placebo, prijavljeno je 39 slučajeva nespecifičnog artritisa/artropatije, 24 u Gardasil skupini i 15 u placebo skupini.
English: Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm.
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja: Vrlo rijetko: bronhospazam.
English: Efficacy in women 24 through 45 years
Croatian: Djelotvornost u žena u dobi od 24 do 45 godina
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.
Croatian: HPV inficira samo ljude, no ispitivanja analognih papilomavirusa u životinja upućuju na to da je djelotvornost cjepiva s L1 česticama nalik virusu povezana s razvojem humoralnog imunološkog odgovora.
English: Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate.
Croatian: Prije protresanja, Gardasil može izgledati kao bistra tekućina s bijelim talogom.
English: Like all vaccines and medicines, Gardasil can cause side effects, although not everybody gets them.
Croatian: Kao i sva cjepiva i lijekovi, Gardasil može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Croatian: U 7 kliničkih ispitivanja (6 placebom kontroliranih) ispitanici su primili Gardasil odnosno placebo na dan uključenja u ispitivanje i otprilike 2 i 6 mjeseci nakon toga.
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Croatian: Premda nesvjestice nisu uobičajene, osobu koja je bila cijepljena treba pratiti 15 minuta nakon što se cijepi cjepivom protiv HPV-a.
English: It is also not intended to prevent progression of other established HPV-related lesions.
Croatian: Također nije namijenjeno sprječavanju progresije drugih već postojećih lezija uzrokovanih HPV-om.
English: There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Gardasil and placebo treated individuals.
Croatian: Nije bilo značajnih razlika u vrsti anomalija ili udjelu trudnoća s nepovoljnim ishodom između pojedinaca koji su primili Gardasil i koji su primili placebo.
English: AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of this observation is not known.
Croatian: Srednji geometrijski titar protutijela na HBs bio je niži kod istodobne primjene, ali značaj ovog opažanja za kliničku primjenu nije poznat.
English: Gardasil is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Croatian: Gardasil je namijenjen samo za profilaktičku primjenu i ne djeluje na aktivne HPV infekcije ili klinički razvijenu bolest.
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.
Croatian: Nakon 36 mjeseci praćenja, GMT u djevojčica (2 doze, n=86) ostao je neinferioran GMT-u u žena (3 doze, n=86) za sva 4 tipa HPV-a.
English: Gardasil will not protect against other diseases that are not caused by Human Papillomavirus.
Croatian: Gardasil ne štiti od drugih bolesti koje ne uzrokuje ljudski papilomavirus.
English: Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Upravljanje vozilima i strojevima Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada sa strojevima.
English: Gardasil should be used in accordance with official guidelines.
Croatian: Gardasil se mora primjenjivati u skladu sa službenim smjernicama.
English: Long-term follow-up studies were conducted to determine the duration of protection.
Croatian: Provedena su dugoročna ispitivanja kako bi se odredilo trajanje zaštite cijepljenjem.
English: If you are from 9 to and including 13 years of age
Croatian: Pojedinci u dobi od 9 do uključujući i 13 godina
English: This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Croatian: Cjepivo treba oprezno primjenjivati u osoba s trombocitopenijom odnosno bilo kojim poremećajem u zgrušavanju krvi, budući da intramuskularna primjena cjepiva u ovih osoba može dovesti do krvarenja.
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).
Croatian: Nadalje, razine anti-HPV protutijela (GMT) u cijepljenih ispitanika zadržale su se na graničnoj vrijednosti ili iznad nje tijekom dugotrajnog praćenja u ispitivanjima faze III (vidjeti niže, Trajnost imunološkog odgovora na Gardasil).
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).
Croatian: Na kraju ispitivanja, ispitanici uključeni u dva ispitivanja III faze (protokoli 013 i 015) praćeni su do 4 godine (medijan 3,7 godina).
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.
Croatian: Sigurnost je procijenjena bilo u cjelokupnoj populaciji u ispitivanju (6 ispitivanja), bilo u unaprijed određenoj podskupini (jedno ispitivanje) populacije u ispitivanju praćene pomoću kartice za izvještavanje o cijepljenju kroz 14 dana nakon svake injekcije cjepiva Gardasil odnosno placeba.
English: Gardasil will not protect against every type of Human Papillomavirus.
Croatian: Gardasil Vas neće zaštititi od svih tipova ljudskog papilomavirusa.
English: Gardasil has not been shown to have a therapeutic effect.
Croatian: Nije utvrđeno da Gardasil djeluje terapijski.
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).
Croatian: 1 doza (0,5 ml) sadržava: HPV tip 6 L1 protein 20 μg HPV tip 11 L1 protein 40 μg HPV tip 16 L1 protein 40 μg HPV tip 18 L1 protein 20 μg adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,225 mg Al).
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.
Croatian: Nema saznanja o sigurnosti, imunogenosti ili djelotvornosti koji bi govorili u prilog zamjenjivosti cjepiva Gardasil drugim cjepivima protiv HPV-a, koji ne sadrže iste HPV tipove.
English: The following side effects can be seen after the use of Gardasil:
Croatian: Niže navedene nuspojave mogu se pojaviti nakon cijepljenja cjepivom Gardasil:
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).
Croatian: Gardasil će zaštititi samo od onih bolesti koje su uzrokovane HPV-om tipova 6, 11, 16 i 18 i do određene granice od bolesti uzrokovanih nekim srodnim tipovima HPV-a (vidjeti dio 5.1).
English: Gardasil may be given to women who are breast-feeding or intend to breast-feed.
Croatian: Cjepivom Gardasil mogu se cijepiti žene koje doje ili namjeravaju dojiti.
English: Mechanism of Action
Croatian: Mehanizam djelovanja
English: Table 1: Adverse Events Following Administration of Gardasil from Clinical Trials and PostMarketing Surveillance
Croatian: Tablica 1: Štetni događaji zabilježeni nakon primjene cjepiva Gardasil tijekom kliničkih ispitivanja i praćenjem nakon stavljanja u promet
English: Table 5: Efficacy of Gardasil against external genital lesions in the PPE* population of 16-26 year old men
Croatian: Tablica 5: Djelotvornost cjepiva Gardasil protiv vanjskih genitalnih lezija u PPE* populaciji, muškarci u dobi od 16 do 26 godina
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.
Croatian: Kao i pri primjeni svih drugih cjepiva, nuspojave zabilježene tijekom opće primjene cjepiva uključivale su: otečene žlijezde (vrat, pazuh ili prepone); mišićna slabost, poremećaj osjeta, trnci u rukama, nogama i gornjem dijelu tijela, ili smetenost (Guillain-Barréov sindrom, akutni diseminirani encefalomijelitis); omaglica, povraćanje, bolni zglobovi, tupi bolovi u mišićima, neuobičajen umor ili slabost, zimice, opće loše osjećanje i veća sklonost krvarenju i modricama nego obično, infekcija kože na mjestu primjene injekcije.
English: Administration of Gardasil should be postponed in individuals suffering from an acute severe febrile illness.
Croatian: Primjenu cjepiva Gardasil treba odgoditi u osoba koje imaju tešku akutnu bolest praćenu vrućicom.
English: There were no treatmentrelated effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Croatian: Nije zamijećen učinak cjepiva na razvoj, ponašanje, razmnožavanje odnosno plodnost mladunčadi.
English: In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil.
Croatian: Općenito, zabilježeni štetni događaji vezani uz predoziranje bili su slični onima vezanim uz preporučene doze cjepiva Gardasil.
English: Gardasil 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).
Croatian: Gardasil neće spriječiti lezije uzrokovane tipom HPV-a koji je sadržan u cjepivu u osoba koje su u vrijeme primjene cjepiva zaražene tim tipom HPV-a (vidjeti dio 5.1).
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.
Croatian: U podskupini od 598 muškaraca (GARDASIL=299; placebo= 299) u Protokolu 020 koji su sami označili da su imali spolne odnose sa muškarcima (MSM), bila je procijenjena djelotvornost cjepiva protiv analne intraepitelijalne neoplazije (AIN stupanj 1/2/3) i karcinoma anusa, te intraanalne perzistentne infekcije.
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.
Croatian: Istodobna primjena cjepiva Gardasil (ali s različitim mjestom primjene cjepiva koja se injiciraju) i cjepiva protiv hepatitisa B (rekombinantnog) nije utjecala na imunološki odgovor na HPV tipove.
English: A clinical trial showed that among girls who received 2 doses of HPV vaccine 6 months apart, antibody responses to the 4 HPV types, one month after the last dose were non-inferior to those among young women who received 3 doses of the vaccine within 6 months.
Croatian: Jedno kliničko ispitivanje pokazalo je da, u djevojčica koje su primile 2 doze cjepiva protiv HPV-a razmaku od 6 mjeseci, odgovor protutijela na 4 tipa HPV-a mjesec dana nakon posljednje doze nije bio inferioran odgovoru u mladih žena koje su primile 3 doze cjepiva unutar 6 mjeseci.
English: Table 2: Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population Gardasil
Croatian: Tablica 2: Analiza djelotvornosti cjepiva Gardasil protiv lezija visokog stupnja vrata maternice u PPE populaciji
English: It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil (see section 4.4).
Croatian: Preporučuje se da osobe koje prime prvu dozu cjepiva Gardasil završe seriju cijepljenja također s cjepivom Gardasil (vidjeti dio 4.4).
English: However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil can still protect against diseases associated with the other HPV types in the vaccine.
Croatian: Međutim, pojedince koji su već zaraženi jednim ili više tipova HPV-a sadržanim u cjepivu, Gardasil i dalje može zaštititi od bolesti prouzročenih preostalim tipovima HPV-a sadržanih u cjepivu.
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).
Croatian: U 7. mjesecu ispitivanja, u populaciji prema protokolu, imunološki odgovor u djevojčica u dobi od 9 do 13 godina (n=241) koje su primile 2 doze cjepiva Gardasil (prema rasporedu 0 i 6 mjeseci) bio je neinferioran i brojčano viši od imunološkog odgovora žena u dobi od 16 do 26 godina (n=246) koje su primile 3 doze cjepiva Gardasil (prema rasporedu 0, 2, 6 mjeseci).
English: Gardasil must not be injected intravascularly.
Croatian: Gardasil se ne smije primjenjivati intravaskularno.
English: Gardasil induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Croatian: Gardasil je izazvao povećanje geometrijskog srednjeg titra (GMT) anti-HPV protutijela mjesec dana nakon 3. doze u svih ispitivanih dobnih skupina.
English: Table 3: Efficacy of Gardasil in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Croatian: Tablica 3: Djelotvornost cjepiva Gardasil spram cervikalnih lezija visokog stupnja u modificiranoj ITT populaciji uključujući žene bez obzira na početni HPV status
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.
Croatian: Ova se indikacija temelji na djelotvornosti koju je Gardasil pokazao u žena u dobi od 16 do 45 godina i u muškaraca u dobi od 16 do 26 godina i na imunogenosti koju je Gardasil pokazao u djece i adolescenata u dobi od 9 do 15 godina.
English: What Gardasil is and what it is used for What you need to know before you receive Gardasil How Gardasil is given
Croatian: Što je Gardasil i za što se koristi Što morate znati prije nego primite Gardasil Kako primjenjivati Gardasil Moguće nuspojave
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.
Croatian: Osobe u kojih se nakon primitka doze cjepiva Gardasil jave simptomi koji ukazuju na preosjetljivost ne smiju primiti sljedeće doze cjepiva Gardasil.
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.
Croatian: Žene koje su prije cijepljenja već bile inficirane jednim ili više tipova HPV-a sadržanim u cjepivu bile su zaštićene od kliničke bolesti prouzročene preostalim tipovima HPV-a sadržanim u cjepivu.
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.
Croatian: Nakon što se prvi put cijepite cjepivom Gardasil, trebate dovršiti cijepljenje cjepivom Gardasil, a ne nekim drugim cjepivom protiv HPV-a.
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.
Croatian: Gardasil nema nikakvog učinka u osoba koje već imaju trajnu infekciju ili bolest izazvanu nekim tipom HPV-a koji se nalazi u cjepivu.
English: Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
Croatian: Potrebno je dobro protresti neposredno prije primjene kako bi se održala suspenzija cjepiva.
English: Nine cases (0.06%) of urticaria were reported in the Gardasil group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
Croatian: Gardasil skupini prijavljeno je 9 slučajeva urtikarije (0,06%), a u skupini placeba s adjuvansom 20 slučajeva (0,15%).
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.
Croatian: Tablica 1 prikazuje nuspojave povezane s cjepivom, koje su opažene u osoba koje su primile Gardasil, s učestalošću od najmanje 1,0%, i s većom učestalosti nego u ispitanika koji su primili placebo.
English: Gardasil 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.
Croatian: Gardasil je adjuvantno neinfektivno četverovalentno rekombinantno cjepivo pripremljeno od visoko pročišćenih čestica nalik virusu glavnog L1 proteina kapside HPV-a tipova 6, 11, 16 i 18.
English: There have been reports of administration of higher than recommended doses of Gardasil.
Croatian: Zabilježeni su slučajevi primjene veće doze cjepiva Gardasil od preporučene.
English: Individuals 14 years of age and older Gardasil should be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Croatian: Pojedinci u dobi od 14 godina i stariji Gardasil treba primijeniti prema rasporedu za 3 doze (0,5 ml primijenjeno sa 0, 2 i 6 mjeseci).
English: (HPV 31/45) (HPV 31/33/45/52/58) 10 non-vaccine HPV Types HPV-16 related types (A9 species) HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 HPV-18 related types (A7 species) HPV 39 HPV 45 HPV 59 A5 species (HPV 51) A6 species (HPV 56)
Croatian: (HPV 31/45) (HPV 31/33/45/52/58) 10 tipova HPV-a koji nisu sadržani u cjepivu Tipovi povezani s HPVom 16 (vrsta A9) HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 Tipovi povezani s HPVom 18 (vrsta A7) HPV 39
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.
Croatian: Primjena cijele ljudske doze (ukupno 120 mg proteina) cjepiva Gardasil mužjacima štakora nije imala učinak na reproduktivnu sposobnost, uključujući plodnost, broj i pokretljivost spermija i nije uzrokovala patoanatomske ili histomorfološke promjene na testisima ili imala učinak na težinu testisa povezane s primjenom cjepiva.