natgillin/translations-raw huggingface dataset:
No cases of cervical cancer, VIN2/3, vulvar and vaginal cancer were diagnosed in the PPE population.
V populaciji PPE ni bilo odkritih primerov raka materničnega vratu, VIN2/3, raka vulve ali nožnice.
Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule.
Cepivo Gardasil 9 se lahko aplicira v skladu s 3-odmerno shemo cepljenja (0., 2. in 6. mesec).
The other ingredients in the vaccine suspension are: sodium chloride, histidine, polysorbate 80, borax and water for injections.
Druge sestavine cepilne suspenzije so: natrijev klorid, histidin, polisorbat 80, boraks in voda za injekcije.
Gardasil 9 can be used during breast-feeding.
Cepivo Gardasil 9 se v obdobju dojenja lahko uporablja.
Suspension for injection 1 vial (0.5 ml).
suspenzija za injiciranje 1 viala (0,5 ml)
• 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
• dokazani učinkovitosti proti persistentni okužbi in bolezni, povezani s tipi HPV 31, 33, 45, 52 in 58 pri deklicah in ženskah, starih 16 do 26 let, in
It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9 (see section 4.4).
Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Gardasil 9, cepljenje dokončajo s cepivom Gardasil 9 (glejte poglavje 4.4).
Gardasil 9 will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Cepljena oseba bo cepivo Gardasil 9 prejela v obliki injekcije skozi kožo v mišico (po možnosti v mišico nadlakti ali stegna).
High immunogenicity in MSM aged 16 to 26 years was also observed, although lower than in HM, similarly to qHPV vaccine.
Veliko imunogenost so ugotovili tudi pri moških, ki imajo spolne odnose z moškimi, starih 16 do 26 let, čeprav je bila manjša od tiste pri HM, podobno kot pri qHPV cepivu.
Immune response to Gardasil 9 at Month 7
Imunski odziv na cepivo Gardasil 9 v 7. mesecu
No human data on the effect of Gardasil 9 on fertility are available.
Podatkov o vplivu cepiva Gardasil 9 na plodnost pri človeku ni.
What you need to know before you or your child receive Gardasil 9
Kaj morate vedeti, preden boste vi ali vaš otrok dobili cepivo Gardasil 9
Immune responses to Gardasil 9 using a 2-dose schedule in individuals 9 through 14 years of age
Imunski odziv na cepivo Gardasil 9 po 2-odmerni shemi cepljenja pri posameznikih, starih 9 do 14 let
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).
Osebe, predhodno cepljene s 3 odmerki štirivalentnega cepiva proti HPV s tipi 6, 11, 16 in 18 (cepivo Gardasil), v nadaljevanju qHPV (quadrivalent HPV) cepivo, lahko prejmejo 3 odmerke cepiva Gardasil 9 (glejte poglavje 5.1).
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.
Če kot prvi odmerek prejmete cepivo Gardasil 9, morate cepljenje dokončati s cepivom Gardasil 9 in ne katerim koli drugim cepivom proti HPV.
As with any vaccine, Gardasil 9 may not fully protect all of those who get the vaccine.
Kot katero koli drugo cepivo tudi cepivo Gardasil 9 morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil 9 can still protect against diseases associated with the other HPV types in the vaccine.
Vendar pa lahko cepivo Gardasil 9 osebe, ki so že okužene z enim ali več tipi HPV, ki jih vsebuje cepivo, še vedno ščiti pred boleznimi, povezanimi z ostalimi tipi HPV v cepivu.
Table 3: Comparison of immune responses (based on cLIA) between Gardasil 9 and qHPV vaccine for HPV types 6, 11, 16, and 18 in the PPI (Per Protocol Immunogenicity)* population of 9 to 15 year-old girls and 16 to 26 year old women and men
Preglednica 3: Primerjava imunskih odzivov (na podlagi cLIA) med cepivom Gardasil 9 in qHPV cepivom za tipe HPV 6, 11, 16 in 18 v populaciji PPI (Per Protocol Immunogenicity)* deklic, starih 9 do 15 let, ter žensk in moških, starih 16 do 26 let
Impact of Gardasil 9 against cervical biopsy and definite therapy related to vaccine HPV types in the PPE
Vpliv cepiva Gardasil 9 glede biopsij materničnega vratu in definitivnih posegov, povezanih s tipi HPV v cepivu, v populaciji PPE
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.
V protokolu 004 so bili GMT protiteles proti HPV v 7. mesecu pri ženskah, starih 27 do 45 let, neinferiorni GMT protiteles proti HPV v 7. mesecu pri deklicah in ženskah, starih 16 do 26 let, za tipe HPV 16, 18, 31, 33, 45, 52 in 58 z GMT razmerjem med 0,66 in 0,73.
• Shake the pre-filled syringe well before use, to make a suspension.
• Napolnjeno injekcijsko brizgo pred uporabo dobro pretresite, da nastane suspenzija.
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).
Učinkovina je: visoko prečiščeni nekužni protein vsakega od tipov humanega papilomavirusa (6, 11, 16, 18, 31, 33, 45, 52 in 58).
Clinical studies for Gardasil 9
Klinične študije s cepivom Gardasil 9
There were no vaccine-related serious adverse experiences reported in infants who were breast-feeding during the vaccination period.
Pri dojenčkih, ki so bili dojeni v obdobju cepljenja, niso poročali o nobenem resnem neželenem učinku povezanim s cepivom.
Gardasil 9 can be administered according to a 3-dose schedule: First injection: at chosen date Second injection: 2 months after first injection (not earlier than one month after the first dose) Third injection: 6 months after first injection (not earlier than 3 months after the second dose) All three doses should be given within a 1-year period.
Cepivo Gardasil 9 se lahko uporablja v skladu s 3-odmerno shemo: - Prva injekcija: ob izbranem času - Druga injekcija: 2 meseca po prvi injekciji (ne prej kot 1 mesec po prvem odmerku) - Tretja injekcija: 6 mesecev po prvi injekciji (ne prej kot 3 mesece po drugem odmerku) Vse tri odmerke je treba dati v obdobju 1 leta.
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).
V dolgoročno podaljšanih kliničnih študijah niso opazili primerov intraepitelijske neoplazije visoke stopnje in genitalnih bradavic: - v obdobju 10,7 leta pri deklicah (n = 369) in v obdobju 10,6 leta pri dečkih (n = 326), ob cepljenju starih 9 do 15 let (mediani čas spremljanja deklic 10,0 leta in mediani čas spremljanja dečkov 9,9 leta); - v obdobju 11,5 leta pri moških (n = 917), ob cepljenju starih 16 do 26 let (mediani čas spremljanja 9,5 leta); v obdobju 10,1 leta pri ženskah (n = 685), ob cepljenju starih 24 do 45 let (mediani čas spremljanja 8,7 leta).
A statistical analysis of non-inferiority was performed at Month 7 comparing cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs between individuals administered Gardasil 9 and individuals administered Gardasil.
Statistično analizo neinferiornosti so opravili v 7. mesecu s primerjavo GMT (na podlagi cLIA) za anti-HPV 6, anti-HPV 11, anti-HPV 16 in anti-HPV 18 med osebami, ki so prejele cepivo Gardasil 9, in osebami, ki so prejele cepivo Gardasil.
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.
0,5 ml suspenzije v viali (steklo) z zamaškom (halobutil) in plastičnim pokrovčkom (z aluminijastim obročkom) v pakiranju po 1.
Animal studies do not indicate reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
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).
Prav tako je cepivo Gardasil 9 zmanjšalo pojavnost s HPV 31, 33, 45, 52 in 58 povezanih nenormalnih testov Pap, posegov (tj. biopsij) na materničnem vratu in zunanjih spolovilih ter definitivnih terapevtskih posegov na materničnem vratu (preglednica 4).
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.
Primerjavo cepiva Gardasil 9 in qHPV cepiva glede tipov HPV 6, 11, 16 in 18 so izvedli v populaciji žensk, starih 16 do 26 let, iz Protokola 001, populaciji deklic, starih 9 do 15 let, iz GDS01C/Protokola 009 in populaciji moških, starih 16 do 26 let, iz GDS07C/Protokola 020.
Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Poročali so o omedlevici, včasih s spremljajočim tresenjem ali odrevenelostjo.
After thorough agitation, it is a white, cloudy liquid.
Ko ga dobro pretresemo, je bela, motna tekočina.
Excipients: Sodium chloride, histidine, polysorbate 80, borax, water for injections.
Pomožne snovi: natrijev klorid, histidin, polisorbat 80, boraks in voda za injekcije
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.
Ker učinkovitosti cepiva Gardasil 9 ni bilo mogoče ovrednotiti v primerjavi s placebom, so bile izvedene naslednje eksplorativne analize.
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.
Pri deklicah in dečkih, ki so prejeli 2 odmerka v razmiku 6 mesecev ali 12 mesecev (+/- 1 mesec), je bilo trajanje odziva protiteles dokazano tekom 36. meseca; glede na tip HPV je bilo seropozitivnih 81 % do 99 % deklic in dečkov, ki so prejeli 2 odmerka v razmiku 6 mesecev ter 88 % do 100 % deklic in dečkov, ki so prejeli 2 odmerka v razmiku 12 mesecev.
If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Če pri sebi ali pri otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Protokol 006 je ovrednotil imunogenost cepiva Gardasil 9 pri 921 deklicah in ženskah (starih 12 do 26 let), predhodno cepljenih s qHPV cepivom.
Suspension for injection 10 pre-filled syringes (0.5 ml)
suspenzija za injiciranje 10 napolnjenih injekcijskih brizg (0,5 ml)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH besedilo na nalepki napolnjene injekcijske brizge
Immune responses, measured by GMT, for Gardasil 9 were non-inferior to immune responses for Gardasil (Table 3).
Z GMT merjeni imunski odziv na cepivo Gardasil 9 je bil neinferioren imunskemu odzivu na cepivo Gardasil (preglednica 3).
In Protocol 002 extension study, no cases of high-grade intraepithelial neoplasia or genital warts were observed through 6.4 years postdose 3 (median follow-up of 5.9 years) in girls (n = 753) or boys (n=227) who were aged 9 to 15 years at time of vaccination with Gardasil 9.
V podaljšani študiji Protokol 002 niso opazili primerov intraepitelijske neoplazije visoke stopnje ali genitalnih bradavic tekom 6,4 let po 3. odmerku (mediani čas spremljanja 5,9 leta) pri deklicah (n = 753) ali dečkih (n = 227), ob cepljenju s cepivom Gardasil 9 starih 9 do 15 let.
Gardasil 9 has been studied in males 9 to 26 years of age and females 9 to 45 years of age.
Cepivo Gardasil 9 je raziskano pri moških, starih od 9 do 26 let, in ženskah, starih od 9 do 45 let.
Administration of Gardasil 9 to individuals previously vaccinated with qHPV vaccine
Uporaba cepiva Gardasil 9 pri osebah, predhodno cepljenih s qHPV cepivom
Studies supporting the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58
Študije, ki potrjujejo učinkovitost cepiva Gardasil 9 proti tipom HPV 31, 33, 45, 52 in 58
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).
Učinkovitost cepiva Gardasil 9 pri ženskah, starih 16 do 26 let, so ocenili v dvojno slepi, randomizirani klinični študiji (Protokol 001), nadzorovani s primerjalno učinkovino, v katero je bilo vključenih 14.204 žensk (Gardasil 9 = 7.099, qHPV cepivo = 7.105).
It uses the same amorphous aluminium hydroxyphosphate sulfate adjuvant as qHPV vaccine.
Kot adjuvans je uporabljen enak amorfni aluminijev hidroksifosfat sulfat kot v qHPV cepivu.
The genotypes for the vaccine comprised of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 will be referred to as vaccine HPV types.
Cepivo vsebuje HPV genotipe 6, 11, 16, 18, 31, 33, 45, 52, 58, ki bodo v nadaljevanju navajani kot tipi HPV v cepivu.
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
Preglednica 4: Analiza učinkovitosti cepiva Gardasil 9 proti tipom HPV 31, 33, 45, 52 in 58 v populaciji PPE ‡ žensk, starih 16 do 26 let
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).
Pri ženskah, starih 24 do 45 let (N = 3.817), je bila učinkovitost proti s HPV 6, 11, 16 in 18 povezanimi persistentnimi okužbami, genitalnimi bradavicami, spremembami na vulvi in nožnici, CIN katere koli stopnje, AIS in rakom materničnega vratu 88,7 % (95 % IZ: 78,1; 94,8).
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),
Na podlagi epidemioloških študij se pričakuje, da cepivo Gardasil 9 varuje pred tipi HPV, ki povzročijo približno: 90 % primerov raka materničnega vratu, več kot 95 % primerov adenokarcinoma in situ (AIS), 75-85 % primerov cervikalne intraepitelijske neoplazije visoke stopnje (CIN 2/3), 85-90 % primerov s HPV povezanega raka vulve, 90-95 % primerov s HPV povezane intraepitelijske neoplazije visoke stopnje na vulvi (VIN 2/3), 80-85 % primerov s HPV povezanega raka nožnice, 75-85 % primerov s HPV povezane intraepitelijske neoplazije visoke stopnje na nožnici (VaIN 2/3), 90-95 % primerov s HPV povezanega raka anusa, 85-90 % primerov s HPV povezane intraepitelijske neoplazije visoke stopnje anusa (AIN 2/3) in 90 % primerov genitalnih bradavic.
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.
Posamezniki, stari 15 let ali več, ob prejemu prve injekcije Cepivo Gardasil 9 je treba aplicirati v skladu s 3-odmerno shemo cepljenja (0., 2. in 6. mesec).
If you are from 15 years of age at time of first injection Gardasil 9 should be administered according to a 3-dose schedule: First injection: at chosen date Second injection: 2 months after first injection (not earlier than one month after the first dose) Third injection: 6 months after first injection (not earlier than 3 months after the second dose) All three doses should be given within a 1-year period.
Če ste ob prejemu prve injekcije stari 15 let ali več Cepivo Gardasil 9 je treba uporabljati v skladu s 3-odmerno shemo: - Prva injekcija: ob izbranem času - Druga injekcija: 2 meseca po prvi injekciji (ne prej kot 1 mesec po prvem odmerku) - Tretja injekcija: 6 mesecev po prvi injekciji (ne prej kot 3 mesece po drugem odmerku) Vse tri odmerke je treba dati v obdobju 1 leta.
p-value <0.001.
mME = mili-Merckove enote vrednost p < 0,001
HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥6 Months HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥12 Months HPV 31-, 33-, 45-, 52-, 58-related ASC-US HR-HPV Positive or Worse Pap Abnormality
Persistentna okužba, ≥ 6 mesecev povezana s HPV 31, 33, 45, 52 in 58 Persistentna okužba ≥ 12 mesecev povezana s HPV 31, 33, 45, 52 in 58 ASC-US pozitivne na HPV-HR, povezane s HPV 31, 33, 45, 52 ali 58 ali hujši nenormalni Pap Definitivni terapevtski posegi na materničnem vratu
L1 protein in the form of virus like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
L1 protein v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C-5 (sev 1895)) adsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (0,5 miligrama Al)
• 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.
• dokazani neinferiorni imunogenosti za tipe HPV v cepivu Gardasil 9 pri dečkih in deklicah, starih 9 do 15 let, moških, starih 16 do 26 let, in ženskah, starih 27 do 45 let, v primerjavi z deklicami in ženskami, starimi 16 do 26 let.
1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 2 needles each
1 napolnjena injekcijska brizga (0,5 ml) z 2 iglama 10 napolnjenih injekcijskih brizg (0,5 ml) z 2 iglama
These diseases include pre-cancerous lesions and cancers of the female genitals (cervix, vulva, and vagina), pre-cancerous lesions and cancers of the anus and genital warts in males and females.
Med te bolezni spadajo predrakave spremembe in rak na ženskih spolovilih (maternični vrat, vulva in nožnica), predrakave spremembe in rak zadnjika ter bradavice na spolovilih pri moških in ženskah.
Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil 9.
Varnost so ovrednotili s 14-dnevnim spremljanjem po vsaki injekciji cepiva Gardasil 9 na podlagi izkaznic o cepljenju (VRC - vaccination report card).
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).
V ključni študiji Protokol 001 so učinkovitost cepiva Gardasil 9 proti tipom HPV 31, 33, 45, 52 in 58 ovrednotili v primerjavi s qHPV cepivom pri ženskah, starih 16 do 26 let (N = 14.204: 7.099 jih je prejelo cepivo Gardasil 9 in 7.105 qHPV cepivo).
A total of 15,776 individuals (10,495 subjects aged 16 to 26 years and 5,281 adolescents aged 9 to 15 years at enrolment) received Gardasil 9.
Cepivo Gardasil 9 je skupno prejelo 15.776 oseb (10.495 oseb, ki so bile ob vključitvi stare 16 do 26 let, in 5.281 mladostnikov, ki so bili ob vključitvi stari 9 do 15 let).
Do not use this vaccine after the expiry date which is stated on the carton and vial label after EXP.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
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.
S cepivom Gardasil 9 se lahko cepi sočasno s kombiniranim obnovitvenim cepivom proti davici (d) in tetanusu (T) ter oslovskemu kašlju [acelularno, komponentno cepivo] (ap) in/ali otroški ohromelosti [inaktivirano cepivo] (IPV) (cepiva dTap, dT-IPV, dTap-IPV) in pri tem ne pride do nobenih pomembnih navzkrižij med odzivi protiteles na katero koli komponento katerega koli cepiva.
As with any vaccine, vaccination with Gardasil 9 may not result in protection in all vaccine recipients.
Tako kot velja za vsa cepiva, tudi cepivo Gardasil 9 morda ne bo zaščitilo vseh cepljenih oseb.
Efficacy of qHPV vaccine against HPV types 6, 11, 16, 18
Učinkovitost qHPV cepiva proti HPV tipom 6, 11, 16, 18
• 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.
• dokazani učinkovitosti qHPV cepiva pri preprečevanju persistentne okužbe in bolezni, povezani s tipi HPV 6, 11, 16 in 18 pri ženskah, starih 16 do 45 let, in moških, starih 16 do 26 let,
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).
GDS01C/Protokol 009 je ovrednotil imunogenost cepiva Gardasil 9 pri deklicah, starih 9 do 15 let (N = 600; 300 jih je prejelo cepivo Gardasil 9 in 300 qHPV cepivo).
On the basis of this immunogenicity bridging, the efficacy of Gardasil 9 in girls and boys aged 9 to 15 years is inferred.
Na osnovi primerjave imunogenosti lahko sklepamo o učinkovitosti cepiva Gardasil 9 pri deklicah in dečkih, starih 9 do 15 let.
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.
Cepivo Gardasil 9 se lahko ob istem obisku uporabi sočasno s kombiniranim obnovitvenim cepivom proti davici (d) in tetanusu (T) ter oslovskemu kašlju [acelularno, komponentno cepivo] (ap) in/ali otroški ohromelosti [inaktivirano cepivo] (IPV) (cepiva dTap, dT-IPV, dTap-IPV), vendar na drugem vbodnem mestu (drugem delu telesa, npr. na drugi roki ali nogi).
Persistence of immune response to Gardasil 9
Trajanje imunskega odziva na cepivo Gardasil 9
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).
GDS07C/Protokol 020 je ovrednotil imunogenost cepiva Gardasil 9 pri moških, starih 16 do 26 let (N = 500; 249 jih je prejelo cepivo Gardasil 9 in 251 qHPV cepivo).
Do not receive Gardasil 9 if you or your child
Cepiva Gardasil 9 vi ali vaš otrok ne smete prejeti
Do not use this vaccine after the expiry date which is stated on the carton and syringe label after EXP.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki injekcijske brizge poleg oznake EXP. Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
If a scheduled injection is missed, your doctor will decide when to give the missed dose.
Če izpustite predvideni odmerek, bo čas cepljenja z izpuščenim odmerkom določil zdravnik.
• Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine
• predrakavim lezijam in rakom materničnega vratu, vulve, nožnice in anusa, ki jih povzročajo tipi HPV, vsebovani v cepivu,