FrancophonIA/ELRC3.0 huggingface dataset:
English: Gardasil 9 should be used in accordance with official guidelines.
Croatian: Gardasil 9 se mora primjenjivati u skladu sa službenim smjernicama.
English: N=Number of individuals randomised to the respective vaccination group who received at least one injection.
Croatian: N=broj osoba randomiziranih u tu skupinu koje su primile najmanje jednu injekciju cjepiva. n=broj osoba uključenih u analizu.
English: No clinical study of Gardasil 9 was conducted in HIV-infected individuals.
Croatian: Nisu provedena klinička isptivanja cjepiva Gardasil 9 u osoba zaraženih HIV-om.
English: • Shake well before use to make a suspension.
Croatian: • Prije uporabe dobro protresti kako bi se dobila suspenzija.
English: Human Papillomavirus = HPV.
Croatian: 20 mikrograma humani papilomavirus = HPV.
English: 30 µg
Croatian: 30 μg
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).
Croatian: Preporučuje se da osobe koje prime prvu dozu cjepiva Gardasil 9 završe cijepljenje sa cjepivom Gardasil 9 (vidjeti dio 4.4).
English: Persistence of immune response to Gardasil 9
Croatian: Trajnost imunološkog odgovora na Gardasil 9
English: Post-marketing experience
Croatian: Iskustvo nakon stavljanja cjepiva u promet
English: Gardasil 9 will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Croatian: Gardasil 9 se daje u obliku injekcije kroz kožu u mišić (po mogućnosti u mišić nadlaktice ili bedra).
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).
Croatian: U tom istom ispitivanju, u djevojčica i dječaka u dobi od 9 do 14 godina GMT-ovi su mjesec dana nakon posljednje doze cjepiva bili brojčano niži za neke tipove virusa u cjepivu nakon cijepljenja prema rasporedu za 2 doze nego nakon cijepljenja prema rasporedu za 3 doze (tj. tipovi HPV-a 18, 31, 45 i 52 nakon 0, 6 mjeseci i tip HPV-a 45 nakon 0, 12 mjeseci).
English: Gardasil 9 is given as an injection by your doctor.
Croatian: Gardasil 9 Vam daje liječnik injekcijom.
English: The clinical relevance of these findings is unknown.
Croatian: Nije poznata klinička značajnost ovih nalaza.
English: Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child. - Keep this leaflet.
Croatian: Vi ili Vaše dijete primite cjepivo jer sadrži Vama ili Vašem djetetu važne podatke.
English: Administration of Gardasil 9 to individuals previously vaccinated with qHPV vaccine
Croatian: Primjena cjepiva Gardasil 9 u osoba koje su prethodno cijepljene cjepivom qHPV
English: Suspension for injection 10 pre-filled syringes (0.5 ml)
Croatian: Suspenzija za injekciju 10 napunjenih štrcaljki (0,5 ml)
English: Clinical studies for Gardasil 9
Croatian: Klinička ispitivanja cjepiva Gardasil 9
English: Gardasil 9 may be given to women who are breast-feeding or intend to breast-feed.
Croatian: Cjepivom Gardasil 9 mogu se cijepiti žene koje doje ili namjeravaju dojiti.
English: Gardasil 9 administered to female rats had no effects on mating performance, fertility, or embryonic/foetal development.
Croatian: Gardasil 9 primijenjen u ženki štakora nije imao učinke na sposobnost parenja, plodnost ili embriofetalni razvoj.
English: Seropositivity to vaccine HPV types in the per protocol population ranged from 98.3 to 100% by Month 7 in individuals who received Gardasil 9.
Croatian: Seropozitivnost na tipove HPV-a sadržane u cjepivu u populaciji cijepljenoj prema protokolu bila je u rasponu od 98,3 do 100% do 7. mjeseca u osoba koje su primile Gardasil 9.
English: Anti-HPV responses at Month 7 among girls/boys aged 9 to 15 years were comparable to anti-HPV responses in women aged 16 to 26 years in the combined database of immunogenicity studies for Gardasil 9.
Croatian: Odgovori protutijela na HPV u 7. mjesecu u djevojčica/dječaka u dobi od 9 do 15 godina bili su usporedivi s odgovorima protutijela na HPV u žena u dobi od 16 do 26 godina u kombiniranoj bazi podataka ispitivanja imunogenosti cjepiva Gardasil 9.
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).
Croatian: Ispitanici koji su prethodno bili cijepljeni prema 3-doznom režimu kvadrivalentnog cjepiva protiv tipova 6, 11, 16 i 18 HPV-a (Gardasil), u daljnjem tekstu qHPV cjepivom, mogu primiti 3 doze cjepiva Gardasil 9 (vidjeti dio 5.1).
English: Amorphous aluminium hydroxyphosphate sulfate is included in the vaccine as an adjuvant.
Croatian: Amorfni aluminijev hidroksifosfat sulfat uključen je u cjepivo kao adjuvans.
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.
Croatian: 0,5 ml suspenzije u bočici (staklo) s čepom (halobutil) i plastičnim "flip-off" zatvaračem (s aluminijskim prstenom) u pakiranju od 1 bočice.
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).
Croatian: Djelatne tvari su: visokopročišćeni neinfektivni protein svakog pojedinog tipa humanog papilomavirusa (6, 11, 16, 18, 31, 33, 45, 52 i 58).
English: These results support the efficacy of Gardasil 9 in women aged 27 to 45 years.
Croatian: Ovi rezultati podupiru djelotvornost cjepiva Gardasil 9 u žena u dobi od 27 do 45 godina.
English: 40 µg
Croatian: 40 μg
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.
Croatian: Protokolu 006 ocijenjena je imunogenost cjepiva Gardasil 9 u 921 djevojaka i žena (u dobi od 12 do 26 godina) koje su prethodno bile cijepljene cjepivom qHPV.
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
Croatian: • dokazanoj djelotvornosti protiv perzistentne infekcije i bolesti povezane s tipovima 31, 33, 45, 52 i 58 HPV-a u djevojaka i žena u dobi od 16 do 26 godina; i
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.
Croatian: U kliničkom ispitivanju na 1053 zdrava adolescenta u dobi od 11 do 15 godina prijavljeno je više reakcija na mjestu primjene (oticanje, eritem), glavobolja i pireksija nakon primjene prve doze cjepiva Gardasil 9 istodobno s docjepljivanjem kombiniranim cjepivom protiv difterije, tetanusa, pertusisa [acelularno, komponentno] i poliomijelitisa [inaktivirano].
English: Gardasil 9 can be used during breast-feeding.
Croatian: Gardasil 9 može se primijeniti tijekom dojenja.
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
Croatian: Tablica 4: Analiza djelotvornosti cjepiva Gardasil 9 protiv tipova 31, 33, 45, 52 i 58 HPV-a u PPE populaciji žena u dobi od 16 do 26 godina
English: Prior to agitation, Gardasil 9 may appear as a clear liquid with a white precipitate.
Croatian: Prije protresanja, Gardasil 9 može izgledati kao bistra tekućina s bijelim talogom.
English: The other ingredients in the vaccine suspension are: sodium chloride, histidine, polysorbate 80, borax and water for injections.
Croatian: Drugi sastojci suspenzije cjepiva su: natrijev klorid, histidin, polisorbat 80, natrijev tetraborat i voda za injekcije.
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.
Croatian: Protokolu 004, GMT-ovi protutijela na HPV u 7. mjesecu u žena u dobi od 27 do 45 godina nisu bili inferiorni u odnosu na GMT-ove protutijela na HPV u djevojčica i žena u dobi od 16 do 26 godina za tipove 16, 18, 31, 33, 45, 52 i 58 HPV-a, pri čemu su omjeri GMT-ova bili između 0,66 i 0,73.
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.
Croatian: Nakon što se prvi put cijepite cjepivom Gardasil 9, cijepljenje treba i dovršiti cjepivom Gardasil 9, a ne nekim drugim cjepivom protiv HPV-a.
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.
Croatian: U djevojčica i dječaka koji su primili 2 doze u razmaku od 6 ili 12 mjeseci (+/- 1 mjesec) dokazano je trajanje odgovora protutijela tijekom 36 mjeseci; ovisno o tipu HPV-a, seropozitivno je bilo 81 do 99% djevojčica i dječaka koji su primili 2 doze u razmaku od 6 mjeseci te 88 do 100% djevojčica i dječaka koji su primili 2 doze u razmaku od 12 mjeseci.
English: There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness.
Croatian: Nema podataka o primjeni cjepiva Gardasil 9 u osoba s narušenim imunološkim odgovorom.
English: • Withdraw the 0.5 ml dose of vaccine from the vial using a sterile needle and syringe.
Croatian: • Izvucite dozu cjepiva od 0,5 ml iz bočice pomoću sterilne igle i štrcaljke.
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.
Croatian: U Protokolu 001, geometrijski srednji titri za HPV tipove 6, 11, 16 i 18 bili su usporedivi u ispitanika koji su primili qHPV cjepivo ili Gardasil 9 tijekom najmanje 3,5 godine.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
Croatian: • Izvucite dozu cjepiva od 0,5 ml iz bočice s jednom dozom pomoću sterilne igle i štrcaljke.
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).
Croatian: Pripremljeno je od visokopročišćenih čestica nalik virusu glavnog L1 proteina kapside četiri tipa HPV-a (6, 11, 16 i 18) kakva sadrže cjepiva qHPV i 5 dodatnih tipova HPV-a (31, 33, 45, 52 i 58).
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).
Croatian: Gardasil 9 je također smanjio incidenciju abnormalnih nalaza Papatesta povezanih s tipovima 31, 33, 45, 52 i 58 HPV-a, postupaka na cerviksu i vanjskim spolnim organima (tj, biopsija) i konačnih terapijskih postupaka na cerviksu (Tablica 4).
English: Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine.
Croatian: Gardasil 9 je adjuvantno neinfektivno 9-valentno rekombinantno cjepivo.
English: Gardasil 9 can be given 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, for example the other arm or leg) during the same visit.
Croatian: Gardasil 9 se može primijeniti kod docjepljivanja kombiniranim cjepivom protiv difterije (d) i tetanusa (T) zajedno s cjepivom protiv hripavca [acelularno, komponento] (ap) i/ili poliomijelitisa [inaktivirano] (IPV) (dTap, dT-IPV, dTap-IPV cjepiva), ali u različito mjesto injiciranja (drugi dio tijela, na primjer u drugu ruku ili nogu), i to tijekom istog posjeta liječniku.
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.
Croatian: Usporedba između cjepiva Gardasil 9 i cjepiva qHPV u pogledu tipova 6, 11, 16 i 18 HPV-a provedena je u populaciji žena u dobi od 16 do 26 godina iz Protokola 001, djevojčica u dobi od 9 do 15 godina iz GDS01C/Protokola 009 te muškaraca u dobi od 16 do 26 godina iz GDS07C/Protokola
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).
Croatian: Djelotvornost cjepiva Gardasil 9 u žena u dobi od 16 do 26 godina bila je ocijenjena u dvostruko slijepom, randomiziranom, kliničkom ispitivanju kontroliranom aktivnim komparatorom (Protokol 001) koje je uključilo ukupno 14 204 žena (Gardasil 9=7099; cjepivo qHPV=7105).
English: Do not use this vaccine after the expiry date which is stated on the carton and syringe label after EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici štrcaljke iza oznake "EXP".
English: • demonstration of non-inferior immunogenicity against the Gardasil 9 HPV types in boys and girls aged 9 to 15 years, men aged 16 to 26 years and women aged 27 to 45 years, compared to girls and women aged 16 to 26 years.
Croatian: • dokazanoj neinferiornoj imunogenosti protiv tipova HPV-a u cjepivu Gardasil 9 u dječaka i djevojčica u dobi od 9 do 15 godina, muškaraca u dobi od 16 do 26 godina i žena u dobi od 27 do 45 godina, u usporedbi s djevojkama i ženama u dobi od 16 do 26 godina.
English: Excipients: Sodium chloride, histidine, polysorbate 80, borax, water for injections.
Croatian: Pomoćne tvari: natrijev klorid, histidin, polisorbat 80, natrijev tetraborat, voda za injekcije.
English: The following side effects can be seen after the use of Gardasil 9:
Croatian: Mogu se pojaviti sljedeće nuspojave nakon primjene cjepiva Gardasil 9:
English: When Gardasil 9 was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more injection-site swelling.
Croatian: Kad se Gardasil 9 davao kod docjepljivanja kombiniranim cjepivom protiv difterije, tetanusa, hripavca [acelularno, komponentno] i poliomijelitisa [inaktivirano] prilikom istog posjeta liječniku, bilo je više oticanja na mjestu primjene injekcije.
English: GMT Ratio
Croatian: GMT omjer
English: If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
Croatian: Ako se druga doza cjepiva primijeni prije nego što je prošlo 5 mjeseci od prve doze, uvijek se mora primijeniti treća doza.
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.
Croatian: Budući da se djelotvornost cjepiva Gardasil 9 nije mogla ocijeniti u odnosu na placebo, provedene su sljedeće eksplorativne analize.
English: It is given to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Croatian: Daje se radi zaštite od bolesti uzrokovanih ljudskim papilomavirusom (HPV) tipa 6, 11, 16, 18, 31, 33, 45, 52 i 58.
English: Gardasil 9 does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination.
Croatian: Gardasil 9 neće spriječiti lezije uzrokovane tipom HPV-a koji je sadržan u cjepivu u osoba koje su u vrijeme cijepljenja zaražene tim tipom HPV-a.
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).
Croatian: U dugotrajnim nastavcima kliničkih ispitivanja, nisu opaženi slučajevi intraepitelnih neoplazija visokog stupnja ili genitalnih bradavica: - tijekom 10,7 godina u djevojčica (n=369) i 10,6 godina u dječaka (n=326), koji su u vrijeme cijepljenja bili u dobi od 9 do 15 godina (medijan praćenja 10,0 godina u djevojčica odnosno 9,9 godina u dječaka); - tijekom 11,5 godina u muškaraca (n=917), koji su u vrijeme cijepljenja bili u dobi od 16 do 26 godina (medijan trajanja praćenja 9,5 godina) i tijekom 10,1 godine u žena (n=685) koje su u vrijeme cijepljenja bile u dobi od 24 do 45 godina (medijan trajanja praćenja 8,7 godina).
English: Based on epidemiology studies, Gardasil 9 is anticipated to protect against the HPV types that cause approximately: 90% of cervical cancers, more than 95% of adenocarcinoma in situ (AIS), 75-85% of high-grade cervical intraepithelial neoplasia (CIN 2/3), 85-90% of HPV related vulvar cancers, 90-95% of HPV related high-grade vulvar intraepithelial neoplasia (VIN 2/3), 80-85% of HPV related vaginal cancers, 75-85% of HPV related high-grade vaginal intraepithelial neoplasia (VaIN 2/3),
Croatian: Na temelju epidemioloških ispitivanja očekuje se da će Gardasil 9 štititi protiv tipova HPV-a koji uzrokuju približno 90% raka cerviksa, više od 95% adenokarcinoma in situ (AIS); 75-85% cervikalnih intraepitelnih neoplazija visokoga stupnja (CIN 2/3); 85-90% raka vulve povezanih s HPV-om; 9095% vulvarnih intraepitelnih neoplazija visokoga stupnja povezanih s HPV-om (VIN 2/3), 80-85% raka vagine povezanih s HPV-om, 75-85% vaginalnih intraepitelnih neoplazija visokog stupnja povezanih s HPV-om (VaIN 2/3), 90-95% raka anusa povezanih s HPV-om, 85-90% analnih intraepitelnih neoplazija visokog stupnja povezanih s HPV-om (AIN 2/3) i 90% genitalnih bradavica.
English: As with any vaccine, vaccination with Gardasil 9 may not result in protection in all vaccine recipients.
Croatian: Kao i sa bilo kojim cjepivom, cijepljenje cjepivom Gardasil 9 ne mora pružiti zaštitu svima koji su primili cjepivo.
English: GDS01C/Protocol 009 evaluated immunogenicity of Gardasil 9 in girls aged 9 to 15 years (N=600; 300 receiving Gardasil 9 and 300 receiving qHPV vaccine).
Croatian: GDS01C/Protokol 009 ocijenio je imunogenost cjepiva Gardasil 9 u djevojčica u dobi od 9 do 15 godina (N=600; 300 je primilo Gardasil 9, a 300 je primilo cjepivo qHPV).
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).
Croatian: U žena u dobi od 24 to 45 godina (N=3817), djelotvornost protiv perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i raka cerviksa povezanih s HPV tipovima 6, 11, 16 i 18 iznosila je 88,7% (95% CI: 78,1; 94,8).
English: In the pivotal study Protocol 001, the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 was evaluated compared to qHPV vaccine in women aged 16 to 26 years (N=14,204: 7,099 receiving Gardasil 9; 7,105 receiving qHPV vaccine).
Croatian: U pivotalnom ispitivanju Protokol 001, djelotvornost cjepiva Gardasil 9 protiv tipova 31, 33, 45, 52 i 58 HPV-a ocijenjena je u usporedbi s cjepivom qHPV u žena u dobi od 16 do 26 godina (N=14 204: 7099 primilo je Gardasil 9; 7105 primilo je cjepivo qHPV).
English: • demonstration of efficacy of qHPV vaccine to prevent persistent infection and disease related to HPV types 6, 11, 16 and 18 in females aged 16 to 45 years and males aged 16 to 26 years.
Croatian: • dokazanoj djelotvornosti cjepiva qHPV u sprječavanju perzistentne infekcije i bolesti povezane s tipovima 6, 11, 16 i 18 HPV-a u žena u dobi od 16 do 45 godina i muškaraca u dobi od 16 do 26 godina.
English: Table 1: Adverse reactions following administration of Gardasil 9 occurring with a frequency of at least 1.0% from clinical trials*
Croatian: Tablica 1: Nuspojave nakon primjene cjepiva Gardasil 9 koje su se javile s učestalošću od najmanje 1,0% iz kliničkih ispitivanja* Klasifikacija organskih sustava Učestalost
English: Protocol 004 evaluated immunogenicity of Gardasil 9 in women aged 16 to 45 years (N=1,210: 640 women aged 27 to 45 years and 570 women aged 16 to 26 years).
Croatian: Protokolu 004 ocijenjena je imunogenost cjepiva Gardasil 9 u žena u dobi od 16 do 45 godina (N=1210: 640 žena u dobi od 27 do 45 godina i 570 žena u dobi od 16 do 26 godina).
English: • demonstration of non-inferior immunogenicity between Gardasil 9 and the qHPV vaccine for HPV types 6, 11, 16 and 18 in girls aged 9 to 15 years, women and men aged 16 to 26 years; efficacy for Gardasil 9 against persistent infection and disease related to HPV types 6, 11, 16, or 18 can be inferred to be comparable to that of the qHPV vaccine.
Croatian: • dokazanoj neinferiornoj imunogenosti između cjepiva Gardasil 9 i cjepiva qHPV protiv tipova 6, 11, 16 i 18 HPV-a u djevojčica u dobi od 9 do 15 godina, žena i muškaraca u dobi od 16 do 26 godina; posljedično se može zaključiti da je djelotvornost cjepiva Gardasil 9 protiv perzistentne infekcije i bolesti povezane s tipovima 6, 11, 16 ili 18 HPV-a usporediva s onom cjepiva qHPV.
English: Suspension for injection 1 vial (0.5 ml).
Croatian: Suspenzija za injekciju 1 bočica (0,5 ml).
English: Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.
Croatian: Pojedinci u dobi od 15 godina i stariji u vrijeme prve injekcije Gardasil 9 teba primijeniti prema rasporedu za 3 doze (0, 2, 6 mjeseci).
English: GDS07C/Protocol 020 evaluated immunogenicity of Gardasil 9 in men aged 16 to 26 years (N=500; 249 receiving Gardasil 9 and 251 receiving qHPV vaccine).
Croatian: GDS07C/Protokol 020 ocijenio je imunogenost cjepiva Gardasil 9 u muškaraca u dobi od 16 do 26 godina (N=500; 249 je primilo Gardasil 9, a 251 je primilo cjepivo qHPV).
English: In a clinical trial, persistence of antibody response has been demonstrated for at least 5 years in girls aged 9 to13 years who received 2 doses of qHPV vaccine.
Croatian: U kliničkom je ispitivanju dokazano da odgovor protutijela u djevojčica u dobi od 9 do 13 godina koje su primile 2 doze cjepiva qHPV traje najmanje 5 godina.
English: Gardasil 9 may be administered concomitantly 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) with no significant interference with antibody response to any of the components of either vaccine.
Croatian: Gardasil 9 može se istodobno primijeniti kod docjepljivanja kombiniranim cjepivom koje sadrži difteriju (d) i tetanus (T) zajedno s pertusisom [acelularni, komponentni] (ap) i/ili poliomijelitisom [inaktivirani] (IPV) (dTap, dT-IPV i dTap-IPV cjepiva), pri čemu odgovor protutijela ni na jednu komponentu jednog ili drugog cjepiva neće biti značajno promijenjen.