FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy results for relevant endpoints analysed at end of study (median duration of follow-up 2.4 years) in the per-protocol population are presented in the Table 5.
Croatian: Podaci o djelotvornosti za relevantne ishode analizirani na kraju ispitivanja (medijan trajanja praćenja 2,4 godine) u populaciji koja je završila ispitivanje u skladu s protokolom prikazani su u Tablici 5.
English: In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Gardasil concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that there was more injection-site swelling and headache reported following concomitant administration.
Croatian: U kliničkom ispitivanju u kojem je sudjelovalo 843 zdravih adolescenata oba spola u dobi od 11 do 17 godina u kojih se prva doza cjepiva Gardasil primijenila istodobno s docjepljivanjem kombiniranim cjepivom protiv difterije, tetanusa, pertusisa [acelularno, komponentno] i poliomijelitisa [inaktivirano] pokazalo se da je nakon istodobne primjene bilo prijavljeno više oticanja na mjestu primjene cjepiva i glavobolja.
English: Assays to Measure Immune Response
Croatian: Testovi za mjerenje imunološkog odgovora
English: How to store Gardasil
Croatian: Kako čuvati Gardasil
English: The impact of Gardasil against the overall risk for external genital lesions was evaluated after the first dose in 2,545 individuals enrolled in the Phase III efficacy trial (Protocol 020).
Croatian: Utjecaj cjepiva Gardasil protiv cjelokupnog rizika od vanjskih genitalnih lezija procjenjivan je nakon primjene prve doze u 2545 osoba uključenih u Fazu III ispitivanja djelotvornosti (Protokol 020).
English: % of seropositive subjects n % of seropositive subjects
Croatian: % seropozitivnih ispitanika
English: Gardasil was efficacious against HPV disease caused by each of the four vaccine HPV types.
Croatian: Gardasil se pokazao djelotvornim protiv bolesti uzrokovanih bilo kojim od četiri tipova HPV-a sadržanih u cjepivu.
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.
Croatian: Tri su se klinička ispitivanja (Protokoli 016, 018 i 020) koristila za usporedbu imunogenosti cjepiva Gardasil u dječaka u dobi od 9 do 15 godina i mladih muškaraca u dobi od 16 do 26 godina.
English: Depending on HPV type, 60-96% and 78-98% of subjects were seropositive by cLIA and IgG LIA respectively 10 years after vaccination (see Table 8).
Croatian: Ovisno o tipu HPV-a, 60-96% ispitanika bilo je seropozitivno na cLIA testu, a 78-98% na IgG LIA testu 10 godina nakon cijepljenja (vidjeti Tablicu 8).
English: HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
Croatian: Tipovi 6 i 11 odgovorni su za oko 90% slučajeva bradavica na spolovilu.
English: In all populations (women 9 - 45 years, men 9 - 26 years), peak anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 GMTs cLIA were observed at Month 7.
Croatian: U svim populacijama (žene u dobi od 9 do 45 godina, muškarci u dobi od 9 do 26 godina), vršni anti-HPV 6, anti-HPV 11, anti-HPV 16 i anti-HPV 18 GMT-ovi na cLIA testu bili su opaženi u 7. mjesecu ispitivanja.
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Gardasil.
Croatian: Nalaz se temelji na rezultatima kliničkog ispitivanja u kojem se kombinirano dTap-IPV cjepivo primijenilo istodobno s prvom dozom cjepiva Gardasil (vidjeti dio 4.8).
English: The concomitant administration of Gardasil with vaccines other than the ones above has not been studied.
Croatian: Nije ispitana istodobna primjena cjepiva Gardasil s ostalim cjepivima, osim gore navedenim.
English: Post-Marketing Experience
Croatian: Iskustvo nakon stavljanja lijeka u promet
English: 0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconized FluroTec-coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and a tip cap (bromobutyl ) without needle or with one or two needle(s) - pack size of 1, 10 or 20.
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklo) s čepom klipa (silikonizirani bromobutil elastomer obložen FluroTecom ili neobloženi klorobutil elastomer) i zatvaračem vrha (bromobutil), bez igle ili s jednom ili dvije igle, u pakiranjima od 1, 10 ili 20.
English: Intramuscular (IM) use.
Croatian: Za intramuskularnu primjenu (i.m.).
English: Gardasil will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Croatian: Gardasil se daje u obliku injekcije kroz kožu u mišić (po mogućnosti u mišić nadlaktice ili bedra).
English: N Number of cases HPV 6/11/16/18-related external genital lesions External genital lesions 1394 Genital warts PIN1/2/3
Croatian: N Broj slučajeva vanjske genitalne lezije povezane s HPV-om tipova 6/11/16/18 Vanjske genitalne lezije 1394 Genitalne bradavice 1394 PIN 1/2/3
English: Gardasil can be given with a Hepatitis B vaccine or with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.
Croatian: Gardasil se može primijeniti istovremeno s cjepivom protiv hepatitisa B ili kod docjepljivanja kombiniranim cjepivom protiv difterije (d) i tetanusa (T) zajedno s cjepivom protiv hripavca [acelularno, komponentno] (ap) i/ili poliomijelitisa [inaktivirano] (IPV) (dTap, dT-IPV, dTap-IPV cjepiva), ali u različito mjesto injiciranja (drugi dio tijela, npr. u drugu ruku ili nogu), i to tijekom istog posjeta liječniku.
English: Sodium chloride, L-histidine, polysorbate 80, sodium borate, water for injections.
Croatian: Natrijev klorid, L-histidin, polisorbat 80, natrijev tetraborat, voda za injekcije.
English: The impact of Gardasil on rates of biopsy and treatment of EGL regardless of causal HPV types was evaluated in 2,545 individuals enrolled in Protocol 020.
Croatian: Utjecaj cjepiva Gardasil na stope biopsije i liječenje vanjskih genitalnih lezija bez obzira na HPV tipove koji ih uzrokuju procjenjivana je u 2545 osoba koje su bile uključene u Protokol 020.
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.
Croatian: Usto je u jednoj podskupini cijepljenih žena koje su primile provokacijsku dozu (eng. challenge dose) cjepiva Gardasil 5 godina nakon početka cijepljenja zamijećen brz i snažan anamnestički odgovor koji je bio viši od geometrijskog srednjeg titra protutijela na HPV zabilježenog mjesec dana nakon 3. doze cjepiva.
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.
Croatian: Ukupno je 10 088 ispitanika koji su nadzirani pomoću kartice za izvještavanje o cijepljenju primilo je Gardasil (6995 žena u dobi od 9 do 45 godina i 3093 muškaraca u dobi od 9 do 26 godina u trenutku uključenja), dok je 7995 ispitanika (5692 žena i 2303 muškaraca) primilo placebo.
English: Gardasil is available in packs of 1, 10 or 20 vials.
Croatian: Gardasil je dostupan u pakiranju od 1, 10 ili 20 bočica.
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.
Croatian: U analizi cjelokupne uključene populacije korist od cjepiva u odnosu na cjelokupnu incidenciju pojave vanjskih genitalnih lezija bila je niža, uz smanjenje od 59,3% (95% CI: 40,0; 72,9) pošto Gardasil ne utječe na tijek infekcije ili bolesti prisutne na početku cijepljenja.
English: The use of Gardasil should be in accordance with official recommendations.
Croatian: Gardasil treba primjenjivati sukladno službenim preporukama.
English: 1 dose, 0.5 ml.
Croatian: 1 doza, 0,5 ml.
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).
Croatian: Imunogenost cjepiva Gardasil ispitala se u 20 132 (Gardasil n = 10 723; placebo n = 9409) djevojaka i žena u dobi od 9 do 26 godina, 5417 (Gardasil n = 3109; placebo n = 2308) dječaka i muškaraca u dobi od 9 do 26 godina i 3819 žena u dobi od 24 do 45 godina (Gardasil n = 1911, placebo n = 1908).
English: In a supplemental analysis, the efficacy of Gardasil was evaluated against HPV 16/18-related CIN 3 and AIS.
Croatian: U dopunskoj analizi ocijenjena je djelotvornost cjepiva Gardasil protiv CIN-a 3 i AIS-a povezanih s HPV tipovima 16 i 18.
English: As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients.
Croatian: Kao i sa bilo kojim cjepivom, cijepljenje cjepivom Gardasil ne mora pružiti zaštitu svima koji su primili cjepivo.
English: Gardasil is a vaccine for use from the age of 9 years for the prevention of: - premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV)
Croatian: Gardasil je cjepivo namijenjeno osobama od 9. godine starosti za prevenciju: - premalignih genitalnih lezija (vrata maternice, vulve i vagine), premalignih analnih lezija te raka vrata maternice i raka anusa prouzročenih određenim onkogenim tipovima humanog papilomavirusa (HPV) - genitalnih bradavica (condylomata acuminata) prouzročenih posebnim tipovima HPV-a.
English: Gardasil produces type-specific antibodies and has been shown in clinical trials to prevent HPV 6-, 11-, 16-, and 18-related diseases in women 16-45 years of age and in men 16-26 years of age.
Croatian: Gardasil potiče nastanak protutijela specifičnih na tip virusa i, kako je pokazano u kliničkim ispitivanjima, sprječava bolesti uzrokovane HPV tipovima 6, 11, 16 i 18 u žena u dobi od 16 do 45 godina i u muškaraca u dobi od 16 do 26 godina.
English: In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Croatian: Od osoba koje su primile cjepivo, njih 99,1% do 100% postali su seropozitivni na sve serotipove cjepiva unutar mjesec dana od 3. doze.
English: It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil.
Croatian: Preporučuje se da osobe koje prime prvu dozu cjepiva Gardasil završe seriju cijepljenja također s cjepivom Gardasil.
English: The impact of Gardasil on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 individuals enrolled in Protocol 007, Protocols 013 and 015.
Croatian: Utjecaj cjepiva Gardasil na stope konačnih postupaka terapije vrata maternice bez obzira koji je tip HPV-a uzročnik, procijenjen je u 18 150 ispitanika obuhvaćenih Protokolima 007, 013 i 015.
English: Gardasil is given as an injection by your doctor.
Croatian: Gardasil Vam daje liječnik injekcijom.
English: The vaccine is therefore, not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts.
Croatian: Stoga ovo cjepivo nije indicirano za liječenje raka vrata maternice, lezija visokog stupnja vrata maternice, stidnice i rodnice ili liječenje genitalnih bradavica.
English: Gardasil is available in packs of 1, 10 or 20 pre-filled syringes.
Croatian: Gardasil je dostupan u pakiranju od 1, 10 ili 20 napunjenih štrcaljki.
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
Croatian: Tablica 8: Podaci o dugotrajnoj imunogenosti (populacija prema protokolu) na temelju postotka seropozitivnih ispitanika izmjerenog cLIA i IgG LIA testovima (Protokol 018) nakon 10 godina među djevojčicama i dječacima u dobi od 9 do 15 godina cLIA
English: Alternatively, Gardasil can be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Croatian: Gardasil se također može primijeniti i prema rasporedu za 3 doze (0,5 ml primijenjeno sa 0, 2 i 6 mjeseci).
English: In the vaccine group, 97.4 to 99.9% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Croatian: U skupini koja je primila cjepivo, 97,4 do 99,9% ispitanika postalo je seropozitivno na sve serotipove do mjesec dana nakon 3. doze cjepiva.
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.
Croatian: Kad se Gardasil davao istovremeno kod docjepljivanja kombiniranim cjepivom protiv difterije, tetanusa, hripavca [acelularna komponenta] i poliomijelitisa [inaktivirano] prilikom istog posjeta liječniku, bilo je više glavobolja i otoka na mjestu primjene injekcije.
English: HIV infected subjects
Croatian: Osobe zaražene virusom HIV-a
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.
Croatian: Ocijenjena je djelotvornost protiv HPV tipova 6,11,16 i 18 povezanih s pojavom vanjskih genitalnih bradavica, intraepitelijalne neoplazije penisa/perinealne/perianalne regije (PIN) stupnjeva 1/2/3 i perzistentne infekcije.
English: Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Croatian: Gardasil je potaknuo specifični odgovor protutijela na HPV tipova 6, 11, 16 i 18 kod skotnih ženki štakora, nakon jednokratne, odnosno višekratne intramuskularne injekcije.
English: • Two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular (IM) administration depending on your patient's size and weight.
Croatian: - Ukoliko se u pakiranju nalaze 2 igle različite duljine, odaberite odgovarajuću iglu ovisno o veličini i tjelesnoj težini bolesnika kako biste osigurali i.m. primjenu.
English: Table 6: Immunogenicity bridging between 9- to 15-year-old girls and 16- to 26-year-old women (perprotocol population) based on titres as measured by cLIA 9- to 15-Year-Old Girls (Protocols 016 and 018)
Croatian: Tablica 6: Povezivanje dokaza imunogenosti između mladih žena u dobi 16-26 godina i djevojčica u dobi 9-15 godina (populacija prema protokolu) na temelju titra izmjerenog cLIA testom Djevojčice 9-15 godina (Protokoli 016 i 018)
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.
Croatian: U tim su ispitivanjima osobe u kojih je cLIA test pokazao da su seronegativne na tipove HPV-a 6, 11, 16 i 18 i dalje bile zaštićene od kliničke bolesti nakon 14 godina praćenja žena u dobi od 16 do 23 godine, 10 godina praćenja žena u dobi od 24 do 45 godina te 10 godina praćenja muškaraca u dobi od 16 do 26 godina.
English: In breast-feeding mothers given Gardasil or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breast-fed infant were comparable between the vaccination and the placebo groups.
Croatian: Za trajanja cijepljenja u okviru kliničkih ispitivanja bilo cjepivom Gardasil ili placebom, stope nuspojava u dojilja i dojene dojenčadi bile su podjednake u skupinama koje su primile cjepivo i onima koje su primile placebo.
English: In post hoc analyses of individuals (who received at least one vaccination) with evidence of a prior infection with a vaccine HPV type (seropositive) no longer detectable (PCR negative) at vaccination onset, the efficacy of Gardasil to prevent conditions due to the recurrence of the same HPV type was 100% (95% CI: 62.8, 100.0; 0 vs. 12 cases [n = 2572 from pooled studies in young women]) against HPV 6-, 11-, 16-, and 18-related CIN 2/3, VIN 2/3, VaIN 2/3, and genital warts in women 16 to 26 years.
Croatian: U post hoc analizama žena (koje su primile najmanje jednu dozu cjepiva) s dokazanom prethodnom infekcijom tipom HPV-a iz cjepiva (seropozitivne) koja se nije mogla utvrditi (PCR negativne) na početku cijepljenja, djelotvornost cjepiva Gardasil u sprječavanju povratka istog tipa HPV-a bila je 100% (95% CI: 62,8; 100,0; 0 naspram 12 slučajeva [n = 2572 iz svih ispitivanja u mladih žena]) kad se radilo o CIN-u 2/3, VIN-u 2/3, VaIN-u 2/3 i genitalnim bradavicama povezanima s tipovima HPV-a 6, 11, 16 i 18 u žena u dobi od 16 do 26 godina.
English: Bridging the Efficacy of Gardasil from Women to Girls
Croatian: Ekstenzija (engl. bridging) dokaza o djelotvornosti cjepiva Gardasil u mladih žena na djevojčice
English: The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
Croatian: Geometrijski srednji titar bio je nešto niži nego geometrijski srednji titar zabilježen u drugim ispitivanjima u osoba iste dobi koje nisu zaražene virusom HIV-a.
English: Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
Croatian: Gardasil je zaštita od bolesti uzrokovanih ljudskim papilomavirusom (HPV) tipova 6, 11, 16 i 18.
English: Bridging the Efficacy of Gardasil from Men to Boys
Croatian: Ekstenzija (engl. bridging) dokaza o djelotvornosti cjepiva Gardasil u mladih muškaraca na dječake
English: The impact of Gardasil against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two Phase III efficacy trials (Protocols 013 and 015).
Croatian: Utjecaj cjepiva Gardasil na ukupni rizik od bolesti vrata maternice uzrokovane HPV-om (tj. bolest uzrokovana bilo kojim tipom HPV-a) procijenjen je u 17 599 ispitanika uključenih u dva ispitivanja djelotvornosti faze III (Protokoli 013 i 015), počevši 30 dana nakon primitka prve doze cjepiva.
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.
Croatian: U kliničkome ispitivanju (Protokol 016) uspoređena je imunogenost cjepiva Gardasil između skupine djevojčica u dobi od 10 do 15 godina i skupine mladih žena u dobi od 16 do 23 godine.
English: Very common Headache Not known Acute disseminated encephalomyelitis*, Dizziness
Croatian: Poremećaji živčanog sustava vrlo često glavobolja nepoznato akutni diseminirani encefalomijelitis*, omaglica
English: As with any vaccine, Gardasil may not fully protect 100% of those who get the vaccine.
Croatian: Kao i ostala cjepiva, Gardasil neće nužno zaštititi sve osobe koje su primile cjepivo.
English: In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Gardasil reduced the proportion of women who experienced a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI: 27.7, 53.5) at end of study.
Croatian: U populaciji koja nikada nije bila izložena HPV-u (bez prethodnog kontakta s 14 uobičajenih tipova HPV-a i s negativnim Papa testom 1-og dana ispitivanja), Gardasil je smanjio udio žena koje su bile podvrgnute konačnim postupcima terapije vrata maternice (elektrokirurškoj eksciziji s pomoću petlje ili klasičnoj konizaciji) za 41,9% (95% CI: 27,7; 53,5) na kraju ispitivanja.
English: Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Croatian: Zaštita od ukupnoga opterećenja bolešću vrata maternice uzrokovane HPV-om u žena u dobi od 16 do 26 godina
English: In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI: 7.0, 28.4) and 62.5% (95% CI: 54.0, 69.5), respectively, as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Croatian: U modificiranoj ITT populaciji, korist od cijepljenja s obzirom na ukupnu incidenciju CIN-a 2/3 odnosno AIS-a (uzrokovanih bilo kojim tipom HPV-a) te na genitalne bradavice, bila je znatno manja, sa smanjenjem od 18,4% (95% CI: 7,0; 28,4) za CIN 2/3 i AIS odnosno 62,5% (95% CI: 54,0; 69,5) za genitalne bradavice, budući da Gardasil ne utječe na tijek infekcije odnosno bolesti koje su bile prisutne na početku cijepljenja.
English: Overall, 67% of individuals were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Croatian: Ukupno 67% žena nije bilo izloženo (PCR negativni i seronegativni nalazi) niti jednom od 4 tipa HPV-a u trenutku uključenja u ispitivanje.
English: Common Pain in extremity Not known Arthralgia*, Myalgia*
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva često bol u ekstremitetima nepoznato artralgija*, mijalgija*
English: *The individuals in the PPE population received all 3 vaccinations within 1 year of enrolment, had no major protocol deviations, and were naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7).
Croatian: *Pojedinci iz PPE populacije koji su primili sve 3 doze cjepiva unutar jedne godine nakon uključenja, nisu imali većih devijacija u protokolu i nikada prije nisu bili u kontaktu s relevantnim tipom(ovima) HPV-a prije primanja prve doze cjepiva i do mjesec dana nakon primitka 3. doze cjepiva (mjesec 7).
English: Clinical Studies
Croatian: KLINIČKI PODACI
English: Very common At the injection site: erythema, pain, swelling Common Pyrexia At the injection site: hematoma, pruritus Not known Asthenia*, chills*, fatigue*, malaise*
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često na mjestu injiciranja: eritem, bol, oticanje često pireksija na mjestu injiciranja: hematom, pruritus nepoznato astenija*, zimica*, umor*, malaksalost*
English: Common Nausea Not known Vomiting*
Croatian: Poremećaji probavnog sustava često mučnina nepoznato povraćanje*
English: Efficacy in men 16 through 26 years
Croatian: Djelotvornost u muškaraca u dobi od 16 do 26 godina
English: The efficacy of Gardasil in 24- through 45 year-old women was assessed in 1 placebo-controlled, double-blind, randomised Phase III clinical study (Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Croatian: Djelotvornost cjepiva Gardasil u žena u dobi od 24 do 45 godina ocijenjena je u 1 placebom kontroliranom, dvostruko slijepom, randomiziranom kliničkom ispitivanju III faze (Protokol 019, FUTURE III) koje je obuhvatilo ukupno 3817 žena, koje su bile uključene i cijepljene bez prethodnog probirnog testiranja na prisutnost infekcije HPV-om.
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).
Croatian: U 126 osoba u dobi od 7 do 12 godina zaraženih virusom HIV-a (od kojih je 96 primilo Gardasil) provedeno je akademsko ispitivanje koje je dokumentiralo sigurnost i imunogenost cjepiva Gardasil.