natgillin/translations-raw huggingface dataset:
Cervarix will only protect against diseases that are caused by HPV types 16 and 18 and to some extent against diseases caused by certain other oncogenic related HPV types (see section 5.1).
Cepivo Cervarix varuje le pred boleznimi, ki jih povzročata genotipa 16 in18 HPV, in do neke mere pred boleznimi, ki jih povzročajo določeni drugi sorodni onkogeni genotipi HPV (glejte poglavje 5.1).
In the TVC and TVC-naïve cohorts, the vaccine's efficacy was demonstrated against high-grade cervical lesions at end of study (Table 5).
V kohortah TVC in naivni TVC so ob koncu študije učinkovitost cepiva dokazali proti visokostopenjskim spremembam materničnega vratu (preglednica 5).
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Preglednica neželenih učinkov Neželeni učinki, ki bi lahko vsaj bili povezani s cepljenjem, so navedeni po pogostnosti.
Overall, 74% of women enrolled were naïve to both HPV-16 and HPV-18 (i.e. DNA negative and seronegative at study entry).
V celoti 74 % vključenih žensk še ni bilo izpostavljenih tako HPV-16 kot HPV-18 (tj. DNAnegativnih in seronegativnih ob vstopu v študijo).
Efficacy against ≥ASC-US (abnormal cytology) associated with oncogenic non-vaccine types was 37.2% (96.2% CI [21.3; 50.1]) (ATP).
Učinkovitost proti ≥ ASC-US (nenormalen citološki izvid) povezanimi z onkogeni, ki niso v cepivu, je bila 37,2 % (96,2 % IZ [21,3; 50,1]) (v kohorti PP).
Cervarix is not recommended for use below 9 years of age.
Uporaba cepiva Cervarix ni priporočljiva pri osebah, mlajših od 9 let.
In study HPV-008, the incidence of high grade cervical lesions was compared between the placebo and vaccine group irrespective of the HPV DNA type in the lesion.
V študiji HPV-008 so incidenco visokostopenjskih sprememb materničnega vratu primerjali med skupino s placebom in cepljeno skupino ne glede na tip HPV DNA v spremembi.
In the event of either being observed, discard the vaccine.
Če opazite karkoli od navedenega, cepivo zavrzite.
Remove the needle protector, which on occasion can be a little stiff.
Včasih je odstranjevanje ščitnika nekoliko težje.
EU/1/07/419/008 - pack of 1 without needle EU/1/07/419/009 - pack of 10 without needle EU/1/07/419/004 - pack of 1 with 1 needle EU/1/07/419/006 - pack of 10 with 10 needles EU/1/07/419/005 - pack of 1 with 2 needles EU/1/07/419/007 - pack of 10 with 20 needles
EU/1/07/419/008 - pakiranje po 1 brez injekcijske igle EU/1/07/419/009 - pakiranje po 10 brez injekcijskih igel EU/1/07/419/004 - pakiranje po 1 z 1 injekcijsko iglo EU/1/07/419/006 - pakiranje po 10 z 10 injekcijskimi iglami EU/1/07/419/005 - pakiranje po 1 z 2 injekcijskima iglama EU/1/07/419/007 - pakiranje po 10 z 20 injekcijskimi iglami
CIN2+ 1/1,852 6/1,818
6-mesečna p.o. CIN2+ 1/1.852 6/1.818
The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix given alone.
Delež oseb, ki so dosegle anti-HBs ≥ 10 mi.e./ml, je bil 98,3 % v primeru sočasnega cepljenja in 100 % v primeru cepljenja s cepivom
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
Minimalna vrednost protiteles, ki je povezana z zaščito pred CIN stopnje 2 ali 3 ali pred persistentno okužbo v povezavi z genotipi, ki jih vsebuje cepivo, za cepiva proti HPV ni bila ugotovljena.
The cross-protective efficacy of Cervarix against histopathological and virological endpoints (persistent infection) has been evaluated in study HPV-008 for 12 non-vaccine oncogenic HPV types.
Učinkovitost navzkrižne zaščite cepiva Cervarix proti histopatološkim in virološkim opazovanim dogodkom (persistentna okužba) so ocenili v študiji HPV-008 za 12 onkogenih tipov HPV, ki niso v cepivu.
4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant
4L1 protein v obliki nekužnih virusu podobnih delcev (VLPs, “virus-like particles”),
The analysis against the primary endpoint was confounded by multiple co-infections in the CIN2+ lesions.
Analizo glede primarnega opazovanega dogodka so motile multiple sookužbe v spremembah CIN2+.
470 subjects (142 aged 15-25 years, 172 aged 26-45 years and 156 aged 46-55 years) who completed study HPV-014 and received the 3 dose schedule were followed-up for up to 10 years in the extension study HPV-060.
470 preiskovank (142 preiskovank, starih 15-25 let, 172 preiskovank, starih 26-45 let, in 156 preiskovank, starih 46-55 let), ki so zaključile študijo HPV-014 in so bile cepljene po shemi s 3 odmerki, so spremljali 10 let v podaljšani študiji HPV-060.
CIN3+ TVC-naïve(1)
CIN3+ Naivna TVC(1)
Age at the time of the first injection
Starost pri prvem odmerku
If Cervarix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites (see section 4.5).
Če je treba cepivo Cervarix dati hkrati s kakšnim drugim cepivom za injiciranje, je treba cepivi vedno injicirati na dveh različnih mestih (glejte poglavje 4.5).
When a female or a male individual is vaccinated with Cervarix, the immune system (the body's natural defence system) will make antibodies against HPV types 16 and 18.
Po cepljenju posameznice ali posameznika s cepivom Cervarix imunski sistem (naravni obrambni sistem telesa) tvori protitelesa proti genotipoma 16 in 18 HPV.
Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening.
Cepljenje sicer lahko zaščiti pred rakom materničnega vratu, vendar pa ne more nadomestiti rednih presejalnih pregledov za preprečevanje raka materničnega vratu.
Further investigation of the cases with multiple HPV types considered the HPV types detected by Polymerase Chain Reaction (PCR) in at least one of the two preceding cytology samples, in addition to types detected in the lesion to distinguish the HPV type(s) most likely responsible to the lesion (HPV type assignment).
Dodatne preiskave primerov z več tipi HPV so poleg tipov, ugotovljenih v spremembi, vključevale tipe HPV, ugotovljene z verižno reakcijo s polimerazo (PCR) v vsaj enem od dveh predhodnih citoloških vzorcev, da bi razlikovali tip(e) HPV, najverjetneje odgovoren/odgovorne za spremembo
In study HPV-020, conducted in South Africa, 22 HIV uninfected and 42 HIV infected subjects (WHO clinical stage 1; ATP cohort for immunogenicity) received Cervarix.
Imunogenost pri ženskah, okuženih s HIV V študiji HPV-020, ki so jo izvedli v Južni Afriki, je cepivo Cervarix prejemalo 22 s HIV neokuženih preiskovank in 42 s HIV okuženih preiskovank (klinični stadij 1 po ZSO; kohorta PP za imunogenost).
Efficacy against CIN1+ irrespective of the HPV type detected in the lesion was 22.9% (96.2% CI [4.8; 37.7]) (TVC).
Učinkovitost proti CIN1+ ne glede na tip HPV, zaznanega v leziji, je bila 22,9 % (96,2 % IZ [4,8; 37,7]) (v TVC).
CIN2+ TVC-naïve(1)
CIN2+ Naivna TVC(1)
There was no evidence of protection from disease caused by the HPV types for which subjects were HPV DNA positive at study entry.
Ugotovili niso nobene zaščite pred boleznijo, povzročeno s tipoma HPV, za katera so bile preiskovanke ob vstopu v študijo HPV-DNA-pozitivne.
Similar results were observed when Cervarix was given concomitantly with Engerix B with 97.9% of subjects reaching anti-HBs ≥ 10mIU/ml compared to 100% for Engerix B given alone.
Podobne rezultate so ugotovili, ko je bilo cepivo Cervarix uporabljeno sočasno s cepivom Engerix B: anti-HBs ≥ 10 mi.e./ml je doseglo 97,9 % preiskovancev, s samim cepivom Engerix B pa 100 %.
HPV type
Tip HPV
In the Phase III study (HPV-015) in women 26 years and older all subjects seroconverted one month after the third dose.
V študiji III. faze (HPV-015) pri ženskah, starih 26 let in več, se je serokonverzija pojavila pri vseh osebah en mesec po tretjem odmerku.
In study HPV-008, the primary analyses of efficacy were performed on the According to Protocol cohort (ATP cohort: including women who received 3 vaccine doses and were DNA negative and seronegative at month 0 and DNA negative at month 6 for the HPV type considered in the analysis).
V študiji HPV-008 so bile primarne analize učinkovitosti opravljene v kohorti po protokolu (kohorta PP: vključno z ženskami, ki so prejele 3 odmerke cepiva in so bile ob mesecu 0 DNA-negativne in seronegativne ter ob mesecu 6 DNA-negativne za tip HPV, upoštevan v analizi).
In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection.
V skupini s placebom so bili 4 primeri 6-mesečne persistentne okužbe in
• if you have any disease which reduces your resistance to infection such as HIV infection.
• težave s krvavitvami ali hitrim pojavom modric, • katerokoli bolezen, ki zmanjšuje odpornost proti okužbam, npr. okužbo z virusom HIV,
In all age groups, GMTs remained at least 5- to 32-fold for HPV-16 and 3- to 14-fold for HPV-18 above those elicited in women who cleared a natural infection for both antigens.
V vseh starostnih skupinah so geometrijski srednji titri ostali vsaj 5- do 32-krat za HPV-16 in 3- do 14-krat za HPV-18 nad ravnjo, ki je bila izzvana pri ženskah, pri katerih je naravna okužba izzvenela za oba antigena.
The study was not powered to demonstrate a difference between the vaccine and the placebo group for these endpoints.
Moč študije ni bila izračunana tako, da bi dokazala razliko med cepljeno skupino in skupino s placebom za ta opazovana dogodka.
Side effects that have been reported during marketed use of Cervarix include:
Med neželenimi učinki, opisanimi med obdobjem, ko je cepivo Cervarix na trgu, so:
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 (CIN2/3) and cervical adenocarcinoma in situ (AIS) were used in the clinical trials as surrogate markers for cervical cancer.
V kliničnih preskušanjih sta bili cervikalna intraepitelijska neoplazija (CIN) stopnje 2 in 3 (CIN2/3) in cervikalni adenokarcinom in situ (AIS) uporabljena kot nadomestna označevalca raka materničnega vratu.
These subjects were followed for serious adverse events over the entire study period.
Pri teh osebah so ves čas trajanja študije spremljali morebiten pojav resnih neželenih dogodkov.
It is recommended that subjects who receive a first dose of Cervarix complete the vaccination course with Cervarix (see section 4.4).
Pri osebah, ki so bile cepljene s prvim odmerkom cepiva Cervarix priporočamo, da se cepljenje zaključi s cepivom Cervarix (glejte poglavje 4.4).
In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by Cervarix.
V kliničnih preskušanjih peroralni kontraceptivi (kontracepcijske tablete) niso zmanjšali zaščite,
1 dose (0.5 ml)
1 odmerek (0,5 ml)
• other injection site reactions such as hard lump, tingling or numbness.
• druge reakcije na mestu injiciranja, kot so zatrdlina, zbadanje ali odrevenelost.
Of these subjects, 100% (95% CI: 96.1;100) remained seropositive for HPV-16 and HPV-18 in the ELISA assay.
Od teh preiskovancev jih je 100 % (95 % IZ: 96,1, 100) ostalo seropozitivnih za HPV-16 in HPV-18, določena s preizkusom ELISA.
The second dose given between 5 and 13 months after the first dose
Drugi odmerek: prejeli ga boste od 5 do 13 mesecev po prvem odmerku
Multidose vial
Večodmerna viala
To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock.
Iglo namestite na brizgo tako, da iglo zasučete v smeri urnega kazalca na brizgo, dokler se ne zaskoči.
HPV-16 and HPV-18 are estimated to be responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related high grade vulvar and vaginal intraepithelial neoplasia and 78% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia.
Ocenjujejo, da sta HPV-16 in HPV-18 odgovorna za približno 70 % primerov raka materničnega vratu, 90 % primerov raka anusa, 70 % primerov visokostopenjskih vulvarnih in vaginalnih intraepitelijskih neoplazij, povezanih s HPV, in 78 % primerov visokostopenjskih analnih (AIN 2/3) intraepitelijskih neoplazij, povezanih s HPV.
Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Ker virusu podobni delci ne vsebujejo virusne DNA, ne morejo okužiti celic,
From 15 years and above Three doses each of 0.5 ml at 0, 1, 6 months** *If the second vaccine dose is administered before the 5th month after the first dose, a third dose should always be administered.
Trije odmerki po 0,5 ml pri 0, 1 in 6 mesecih** *Če je cepljenje z drugim odmerkom opravljeno prej kot v roku 5 mesecev po prvem odmerku, je vedno potrebno opraviti tudi cepljenje s tretjim odmerkom.
A subset of women (N=776) vaccinated in study 001 was followed in study 007 up to 6.4 years (approximately 77 months) after the first dose (mean follow-up of 5.9 years).
Podskupino v študiji 001 cepljenih žensk (N = 776) so v študiji 007 spremljali še do 6,4 let (približno 77 mesecev)
As Cervarix will not protect against all types of Human Papillomavirus, appropriate precautions against exposure to HPV and sexually transmitted diseases should continue to be used.
Cepivo Cervarix ne ščiti pred vsemi genotipi humanih virusov papiloma, zato morate še vedno skrbeti za ustrezne previdnostne ukrepe za preprečitev okužbe s HPV in drugimi spolno prenosljivimi boleznimi.
Serological data suggest a transfer of anti-HPV-16 and anti-HPV-18 antibodies via the milk during the lactation period in rats.
Serološki podatki kažejo, da se anti-HPV-16 in anti-HPV-18 protitelesa pri doječih podganah izločajo z mlekom.
4.9 Overdose No case of overdose has been reported.
Ni poročil o primerih prevelikega odmerjanja.
Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.
Učinkovitost proti HPV-16/18 pri ženskah z ugotovljeno okužbo s HPV-16 ali HPV-18 ob vstopu v študijo.
Sodium dihydrogen phosphate dihydrate Water for injections
SEZNAM POMOŽNIH SNOVI natrijev klorid natrijev dihidrogenfosfat dihidrat voda za injekcije
Two analyses of study HPV-008 have been performed: an event-triggered analysis performed once at least 36 CIN2+ cases associated with HPV-16/18 were accrued in the ATP cohort and an end-of study analysis.
Opravljeni sta bili dve analizi študije HPV-008: z dogodki prožena analiza, opravljena, ko je bilo v kohorti PP zbranih vsaj 36 s HPV-16/18 povezanih primerov CIN2+, in analiza ob koncu študije.
Cervarix is not infectious and so, it cannot cause HPV related diseases.
Cepivo Cervarix ni kužno in ne more povzročiti s HPV povezanih bolezni.
Cervarix is a vaccine intended to protect from the age of 9 years against the diseases caused by infection with Human Papillomaviruses (HPV).
Cepivo Cervarix je namenjeno za zaščito pred boleznimi, ki so posledica okužbe s humanimi virusi papiloma (HPV), od 9. leta naprej.
Cervarix will not protect against other diseases that are not caused by Human Papillomavirus.
Cepivo Cervarix ne ščiti pred boleznimi, ki jih ne povzročajo humani virusi papiloma.
The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i.e. regardless of baseline cytology and HPV serological and DNA status.
V preskušanje III. faze (študija 008) so bile vključene ženske, pri katerih presejanje za prisotnost okužbe s HPV ni bilo izvedeno, to je ne glede na citološki izvid ob izhodišču in ne glede na HPV
The efficacy results at the event-triggered analysis were 94.3% (96.1% CI: 91.5;96.3) against 6-month persistent infection and 91.4% (96.1% CI: 89.4;95.4) against 12-month persistent infection.
(2) povprečno spremljanje 40 mesecev po 3. odmerku Z dogodki prožena analiza je pokazala učinkovitost 94,3 % (96,1 % IZ: 91,5; 96,3) proti 6-mesečni persistentni okužbi in 91,4 % (96.1 % IZ: 89,4; 95,4) proti 12-mesečni persistentni okužbi.
In study HPV-011, all subjects seroconverted to both HPV-16 and 18 and GMT levels were non inferior to those observed in females aged 15 to 25 years in study HPV-012.
V študiji HPV-011 se je pri vseh preiskovancih pojavila serokonverzija za HPV-16 in 18, geometrična sredina titrov pa ni bila nižja od opažene pri ženskah, starih od 15 do 25 let, v študiji HPV-012.
The phase II trial (study 001/007) enrolled only women who: - Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,
- so bile negativne pri testiranju na prisotnost DNA onkogenih genotipov HPV 16, 18, 31, 33, 35,
Pack sizes of 1 and 10 pre-filled syringes with or without needles.
Pakiranja po 1 in 10 napolnjenih injekcijskih brizg z injekcijskimi iglami ali brez.
58, 59, 66 and 68 - Were seronegative for HPV-16 and HPV-18 and - Had normal cytology
39, 45, 51, 52, 56, 58, 59, 66 in 68, - so bile seronegativne za HPV-16 in HPV-18, in - so imele normalen citološki izvid.
2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
2 adsorbiran na hidratirani aluminijev hidroksid (Al(OH)3)
Pack sizes of 1, 10 and 100 vials.
Pakiranja po 1, 10 in 100 vial.
Cervarix may also be administered concomitantly with meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT); with combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B).
Cepivo Cervarix se lahko da hkrati s cepivom proti meningokoknim seroskupinam A, C, W-135, Y vezanih na tetanusni toksoid (MenACWY-TT), kombiniranim cepivom proti hepatitisu A (inaktiviranim) in hepatitisu B (rDNA) (Twinrix) ali s cepivom proti hepatitisu B (rDNA) (Engerix B).
End of study analysis(2)
analiza ob koncu študije(2)
The sequential administration of combined dTpa-IPV followed by Cervarix one month later tended to elicit lower anti-HPV-16 and anti-HPV-18 GMTs as compared to Cervarix alone.
Zaporedna uporaba kombiniranega dTpa-IPV, ki mu je en mesec pozneje sledil Cervarix, je praviloma izzvala manjši geometrični sredini titrov anti-HPV-16 in anti-HPV-18 kot uporaba cepiva Cervarix samega.
There were five cases of 12-month persistent HPV-16/18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001.
V študiji 001 so poročali o petih primerih 12-mesečne persistentne okužbe s HPV-16/18 (4 primeri HPV-16; 1 primer HPV-18) v skupini, ki je prejemala kontrolno učinkovino, in o enem primeru HPV-16 v skupini, ki je prejemala cepivo.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih se odmerkih, lokalnega prenašanja, plodnosti, toksičnosti za zarodek/plod in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
Table 6: Vaccine efficacy for non-vaccine oncogenic HPV types
Preglednica 6: Učinkovitost cepiva proti onkogenim tipom HPV, ki jih ni v cepivu
Twelve-month persistent infection was evaluated as additional efficacy endpoint.
Kot dodaten opazovani dogodek učinkovitosti je bila vrednotena dvanajstmesečna persistentna okužba.
The vaccine should be well shaken before use.
Pred uporabo cepivo dobro pretresite.
DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. - The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
pridobljenih s tehnologijo rekombinantne DNA s pomočjo bakulovirusnega ekspresijskega sistema na osnovi Hi-5 Rix4446 celic, pridobljenih iz žuželke Trichoplusia ni. - Pomožne snovi so natrijev klorid (NaCl), natrijev dihidrogenfosfat dihidrat (NaH2PO4.2 H2O) in voda za injekcije.
Persistence of Immune Response to Cervarix
Trajnost imunskega odziva na cepivo Cervarix
Cervarix is an adjuvanted non-infectious recombinant vaccine prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Cepivo Cervarix je nekužno rekombinantno cepivo z adjuvansom, pripravljeno iz visoko prečiščenih virusu podobnih delcev (VLPs; “virus-like particles”) velike plaščne L1 beljakovine onkogenih genotipov 16 in 18 HPV.
3adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
3adsorbiran na hidratirani aluminijev hidroksid (Al(OH)3)
Vaccination is not a substitute for routine cervical screening.
Cepljenje ni nadomestilo za redne presejalne preglede materničnega vratu.
Vaccine-induced IgG GMTs for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the [M107-M113] interval with ELISA GMTs for both HPV-16 and HPV-18 at least still 10-fold higher than the ELISA GMTs observed in women who cleared a natural HPV infection.
S cepivom povzročeni geometrijski srednji titri IgG proti obema, HPV-16 in HPV-18, ki so dosegli vrh v 7. mesecu in se nato manjšali ter od 18. meseca do obdobja [M107-M113] dosegli konstantno raven ELISA geometrijskih srednjih titrov obeh HPV-16 in HPV-18, so še vedno najmanj 10-krat višji od ELISA geometrijskega srednjega titra pri ženskah, pri katerih je naravna okužba s HPV izzvenela.
• itching, red skin rash, hives (urticaria)
• srbenje, rdeč kožni izpuščaj, koprivnica (urtikarija),
(3) mean follow-up of 40 months post dose 3
(3) povprečno spremljanje 40 mesecev po 3. odmerku
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Med shranjevanjem viale se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
No data are available on subcutaneous administration of Cervarix (see section 4.4).
Podatki o subkutanem injiciranju cepiva Cervarix niso na voljo (glejte poglavje 4.4).
In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Osebe, ki so v zadnjih 3 mesecih pred cepljenjem s prvim odmerkom cepiva prejele imunoglobuline ali izdelke iz krvi, so bile izključene iz vseh kliničnih preskušanj.
No efficacy study against anal premalignant lesions has been conducted with Cervarix.
Študij učinkovitosti proti predrakavim analnim spremembam s cepivom Cervarix niso izvedli.
Very common Injection site reactions including pain, redness, swelling, fatigue
Zelo pogosti reakcije na mestu injiciranja, vključno z bolečino, rdečino in oteklino; utrujenost
The primary endpoint was a combination of a virological and a histopathological endpoint: HPV16/18 related 6-month persistent infection and/or CIN1+.
Primarni opazovani dogodek je bil kombinacija virološkega in histopatološkega opazovanega dogodka: 6-mesečna persistentna okužba in/ali CIN1+, povezana s HPV-16/18.
The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related precancerous lesions of the vulva and vagina and 78% of HPV-related pre-cancerous lesions of the anus.
Tipa humanega virusa papiloma (HPV), vsebovana v cepivu (HPV tipa 16 in 18), sta odgovorna za približno 70 % vseh primerov raka materničnega vratu, 90 % primerov raka zadnjika, 70 % primerov s HPV povezanih predrakavih sprememb vulve in nožnice ter 78 % primerov s HPV povezanih predrakavih sprememb zadnjika.
Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness.
Cepljenje s cepivom Cervarix je treba odložiti pri osebah, ki imajo hujšo akutno bolezen s povišano telesno temperaturo.
How to store Cervarix
Kako uporabljati cepivo Cervarix
Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
6.1 Seznam pomožnih snovi natrijev klorid (NaCl) natrijev dihidrogenfosfat dihidrat (NaH2PO4.2 H2O) voda za injekcije
ATP cohort(1) End of study analysis(2)
kohorta PP(1) analiza ob koncu študije(2)
If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Če ste na cepljenje s predvidenim odmerkom cepiva pozabili, se posvetujte s svojim zdravnikom.
ATP cohort(1) End of study analysis(3)
kohorta PP(1) analiza ob koncu študije(3)