natgillin/translations-raw huggingface dataset:
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Kot velja za vsa cepiva tudi po cepljenju s tem cepivom zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah.
Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine.
Cervarix se lahko uporabi sočasno s kombiniranim obnovitvenim cepivom za davico (d), tetanus (T) in oslovski kašelj [brezcelično] (pa), z ali brez inaktivirane sestavine za poliomielitis (IPV), (cepivo dTpa, dTpa-IPV) brez klinično pomembnih interferenc z odzivom protiteles proti katerikoli sestavini enega ali drugega cepiva.
Women (N=1,113) were vaccinated in study 001 and evaluated for efficacy up to month 27.
V študiji 001 so učinkovitost pri cepljenih ženskah (N = 1.113) vrednotili do 27. meseca.
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
1 ml suspenzije v viali (steklo tipa I) za 2 odmerka z zamaškom (iz butilne gume).
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
Posology
Pokrovček
N = number of subjects included in each group (1) TVC naïve: includes all vaccinated subjects (who received at least one dose of vaccine) who had normal cytology, were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
N = število oseb, vključenih v vsako skupino (1) Naivna TVC: vključuje vse cepljene preiskovanke (ki so dobile vsaj en odmerek cepiva), ki so imele normalno citologijo, so bile HPV-DNA-negativne za 14 onkogenih tipov HPV in seronegativne za HPV-16 in
Cervarix is not likely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi cepivo Cervarix vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
End of study vaccine efficacy against 6-month persistent infection and CIN2+ associated with individual non-vaccine oncogenic HPV types is presented in Table 6 (ATP cohort).
Učinkovitost cepiva ob koncu študije proti 6-mesečni persistentni okužbi in CIN2+, povezani s posameznimi onkogenimi tipi HPV, ki jih ni v cepivu, je prikazana v preglednici 6 (kohorta PP).
In clinical trials (HPV-070 and HPV-048) performed in girls aged 9 to 14 years receiving a 2-dose schedule (0, 6 months or 0, 12 months) and young women aged 15-25 years receiving Cervarix according to the standard 0, 1, 6 months schedule, all subjects seroconverted to both HPV types 16 and 18 one month after the second dose.
V kliničnih študijah (HPV-070 in HPV-048), izvedenih pri deklicah, starih od 9 do 14 let, ki so bile cepljene po shemi z dvema odmerkoma (0 in 6 mesecev ali 0 in 12 mesecev) in mladih ženskah starih od 15 do 25 let, ki so prejele Cervarix skladno s standardno shemo 0, 1 in 6 mesecev, se je 1 mesec po drugem odmerku pojavila serokonverzija za HPV tipa 16 in 18 pri vseh osebah.
All initially seropositive women remained seropositive for both anti-HPV-16 and anti-HPV-18 antibodies.
Vse ob vstopu seropozitivne ženske so ostale seropozitivne za protitelesa anti-HPV-16 in anti-HPV-18.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
Cervarix is available in 2 dose vials (1 ml) in packs of 1, 10 and 100.
Cepivo Cervarix je na voljo v dvoodmernih vialah (1 ml) v pakiranjih po 1, 10 in 100.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GlaxoSmithKline Biologicals s.a.
At end of study analysis, there were 2 cases of VIN2+ or VaIN2+ in the vaccine group and 7 cases in the control group in the ATP cohort associated with HPV-16 or HPV-18.
V analizi ob koncu študije sta bila v cepljeni skupini 2 primera, v kontrolni skupini v kohorti PP pa 7 primerov VIN2+ ali VaIN2+, povezanih s HPV-16 ali HPV-18.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (0,5 ml)
0.5 milligrams Al3+ in total 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni. For the full list of excipients, see section 6.1.
0,5 miligrama Al3+v celoti 4L1 protein v obliki nekužnih virusu podobnih delcev (VLPs, “virus-like particles”), pridobljenih s tehnologijo rekombinantne DNA s pomočjo bakulovirusnega ekspresijskega sistema na osnovi Hi
(2) mean follow-up of 44 months post dose 1
(2) povprečno spremljanje 44 mesecev po 1. odmerku
The vaccine should under no circumstances be administered intravascularly or intradermally.
Cepiva se v nobenem primeru ne sme injicirati v žilo ali v kožo.
The primary efficacy endpoint was incident infection with HPV-16 and/or HPV-18.
Primarni opazovani dogodek učinkovitosti je bila slučajna okužba s HPV-16 in/ali HPV-18.
Name and address of the manufacturers of the biological active substance
SPROŠČANJE SERIJE Ime in naslov izdelovalca biološke učinkovine
These can be recognised by: itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness.
Prepoznati jih je mogoče po: srbečem izpuščaju na rokah in stopalih, oteklosti oči in obraza,
6M PI and/or CIN1+ 6M PI
6-mesečna p.o. in/ali CIN1+
Prophylactic efficacy against HPV-16/18 infection in a population naïve to oncogenic HPV types
Učinkovitost profilakse proti okužbi s HPV-16/18 v skupini oseb, ki še niso bile izpostavljene onkogenim genotipom HPV
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
PODATKI NA ZUNANJI OVOJNINI VEČODMERNA VIALA, PAKIRANJA PO 1, 10, 100
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Pred cepljenjem morate vsebino viale, preden jo pretresete in po tem, pregledati glede morebitnih tujkov in/ali neobičajnega fizikalnega videza.
Cervarix is available in pre-filled syringes (0,5 ml) with or without needles in packs of 1 and 10.
Cepivo Cervarix je na voljo v napolnjenih injekcijskih brizgah (0,5 ml) z injekcijskimi iglami ali brez v pakiranjih po 1 in 10.
The primary efficacy endpoint was CIN2+ associated with HPV-16 and/or HPV-18 (HPV-16/18).
Primarni opazovani dogodek učinkovitosti je bil CIN2+, povezan s HPV-16 in/ali HPV-18 (HPV
At the event-triggered analysis the efficacy was 92.9% (96.1% CI: 79.9;98.3) against CIN2+ and 80%
Z dogodki prožena analiza je pokazala učinkovitost 92,9 % (96,1 % IZ: 79,9; 98,3) proti CIN2+ in 80 % (96,1 % IZ: 0,3;98,1) proti CIN3+.
All subjects were seropositive in the ELISA assay to both HPV 16 and 18 one month after the third dose (at Month 7) and the seropositivity for HPV 16 and 18 was maintained up to Month 12.
Vse preiskovanke so bile en mesec po tretjem odmerku (7. mesec) na preskusu ELISA seropozitivne za HPV 16 in 18; seropozitivnost za HPV 16 in HPV 18 se je ohranila do 12. meseca.
Suspension for injection
Suspenzija za injiciranje.
There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
Poročali so o šestnajstih primerih persistentne okužbe s HPV-16 in petih primerih persistentne okužbe s HPV-18.
Ten years after administration of the first dose, 100% of subjects in the 15-25 years group, 99.2% in the 26-45 years group and 96.3% in the 46-55 years group were still seropositive for HPV-16, and 99.2%, 93.7% and 83.8% for HPV-18, respectively.
10 let po cepljenju s prvim odmerkom je bilo 100 % preiskovank iz starostne skupine 15-25 let, 99,2 % iz starostne skupine 26-45 let in 96,3 % iz starostne skupine 46-55 let še vedno seropozitivnih za genotip HPV-16.
Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), or with a meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Druga zdravila in cepivo Cervarix Cervarix se lahko da skupaj s kombiniranim obnovitvenim cepivom za davico (d), tetanus (T) in oslovski kašelj [brezcelično] (pa), z ali brez inaktivirane sestavine za poliomielitis (IPV), (cepivo dTpa, dTpa-IPV), skupaj s kombiniranim cepivom proti hepatitisu A in hepatitisu B (Twinrix), ali s cepivom proti hepatitisu B (Engerix B) ali s cepivom proti meningokoknim seroskupinam A, C, W135, Y vezanih na tetanusni toksoid (MenACWY-TT) ob isti priložnosti, vendar na drugem mestu injiciranja (na drugem delu telesa, npr. na drugi roki).
In clinical trials, more than 99% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
V kliničnih preskušanjih se je en mesec po prejemu tretjega odmerka serokonverzija na oba genotipa 16 in 18 HPV pojavila pri več kot 99 % oseb, ki so bile v začetku seronegativne.
(3) mean follow-up of 44 months post dose 1
(3) povprečno spremljanje 44 mesecev po 1. odmerku
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (1 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 odmerka (1 ml)
• redness or swelling at the injection site
• rdečina ali oteklina na mestu injiciranja,
However, studies conducted in girls aged 9 to 14 years (study HPV-071) and in women aged 18 to 45 years (study HPV-010) have consistently shown a higher immune response with Cervarix than with the comparator for which efficacy data against anal premalignant lesions are conclusive and have shown protection.
45 let (študija HPV-010), so dosledno pokazale večji imunski odziv na cepivo Cervarix kot na primerjalno cepivo, za katero so podatki o učinkovitosti proti analnim predrakavim spremembam trdni in so pokazali zaščito.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) z injekcijskimi iglami ali brez.
At the 84-month time point, i.e. 78 months after completion of the full vaccination course, 99.3% and 95.9% of initially seronegative women remained seropositive for anti-HPV-16 and anti-HPV-18 antibodies, respectively.
Med ženskami, ki so bile ob vstopu v študijo seronegativne, so po 84 mesecih (tj. 78 mesecev po koncu celotnega cepljenja) ugotovili še prisotno seropozitivnost za protitelesa anti-HPV-16 pri 99,3 % in za anti-HPV-18 pri 95,9 %.
Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Imetnik dovoljenja za promet z zdravilom in izdelovalec GlaxoSmithKline Biologicals s.a.
Cervarix should under no circumstances be administered intravascularly or intradermally.
Cepiva Cervarix se pod nobenimi pogoji ne sme injicirati v žilo ali v kožo.
In a pooled analysis (HPV-029,-30 & -48), 99.7% and 100% of females aged 9 years seroconverted to HPV types 16 and 18, respectively after the third dose (at month 7) with GMTs at least 1.4-fold and 2.4-fold higher as compared to females aged 10-14 years and 15 to 25 years, respectively.
V kumulativni analizi (HPV-029, -30 in -48) se je po tretjem odmerku (7. mesec) pri 9-letnih deklicah serokonverzija za HPV tipa 16 pojavila pri 99,7 % deklic in za HPV tipa 18 pri 100 % deklic; geometrijski srednji titri so bili vsaj 1,4-krat višji kot pri deklicah v starosti od 10 do 14 let in vsaj 2,4krat višji kot pri ženskah v starosti od 15 do 25 let.
The primary analyses of efficacy were performed on the ATP cohort for efficacy and the TVC which included a subset of up to 15% of women with a history of HPV-associated infection or disease (defined as two or more abnormal smears in sequence, abnormal colposcopy, or biopsy or treatment of the cervix after abnormal smear or colposcopy findings).
15 % preiskovank z anamnezo okužbe ali bolezni, povezane s HPV (opredeljeno kot dva ali več zaporednih nenormalnih brisov, nenormalno kolposkopijo, biopsijo ali zdravljenje materničnega vratu po nenormalnem brisu ali izvidu kolposkopije).
♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine):
♦ Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100, vendar več kot 1 od
MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/001 - pack of 1
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/419/001 - pakiranje po 1
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
0,5 ml suspenzije v viali (steklo tipa I) za en odmerek z zamaškom (butilna guma).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
CIN3+
CIN2+ CIN3 +
The Total Vaccinated Cohort (TVC) included all subjects who received at least one dose of the vaccine, irrespective of their HPV DNA status, cytology and serostatus at baseline.
Celotna cepljena kohorta (TVC) je zajela vse preiskovanke, ki so prejele vsaj en odmerek cepiva, ne glede na njihovo izhodiščno stanje HPV-DNA, izhodiščno citologijo ali izhodiščno serološko stanje.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains:
NAVEDBA ENE ALI VEČ UČINKOVIN 1 odmerek (0,5 ml) vsebuje:
No data are available on subcutaneous administration of Cervarix.
Podatki o subkutanem injiciranju cepiva Cervarix niso na voljo.
NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Cervarix suspension for injection in a vial
Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi Cervarix suspenzija za injiciranje v viali
Initially seropositive and seronegative subjects reached similar titres after vaccination.
Po cepljenju so bili pri osebah, ki so bile v začetku seropozitivne, in osebah, ki so bile v začetku seronegativne, doseženi enaki titri.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL, PACK OF 1, 10, 100
PODATKI NA ZUNANJI OVOJNINI ENOODMERNA VIALA, PAKIRANJA PO 1, 10, 100
• swollen glands in the neck, armpit or groin
• povečane bezgavke na vratu, pod pazduho ali v dimljah,
In clinical trials a similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies.
V kliničnih študijah je bil pri osebah s predhodno ali trenutno okužbo s HPV in osebah, negativnih za DNA onkogenih HPV ali seronegativnih za protitelesa proti HPV-16 in HPV-18, opažen podoben profil neželenih učinkov.
Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection).
S cepivom povzročeni geometrijski srednji titri IgG so bili znatno večji od titrov pri predhodno okuženih ženskah,
• Official batch release
Uradna sprostitev serije:
Vaccine efficacy against CIN1+ associated with HPV 16/18 observed in the ATP cohort was 91.7% (96.1% CI: 82.4;96.7).
povezanemu s HPV 16/18, ugotovljena v kohorti PP, je bila 91,7 % (96,1 % IZ: 82,4;96,7).
Contents of the pack and other information What Cervarix contains - The active substances are:
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Cervarix
Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in the ATP cohort at the end of study is presented in Table 2.
Učinkovitost cepiva glede na virološka opazovana dogodka (6-mesečna in 12-mesečna persistentna okužba) v zvezi s HPV-16/18, ugotovljena v kohorti PP ob koncu študije, je prikazana v preglednici 2.
(2) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of HPV DNA status, cytology and serostatus at baseline.
(2) TVC: vključuje vse cepljene preiskovanke (ki so dobile vsaj en odmerek cepiva), ne glede na njihovo izhodiščno stanje HPV-DNA, izhodiščno citologijo ali izhodiščno serološko stanje.
ATP(1)
PP(1)
Other HPV types can also cause ano-genital cancers.
Raka materničnega vratu ali raka zadnjika lahko povzročijo tudi drugi tipi HPV.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/010 - pack of 1
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/419//010 - pakiranje po 1
Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100.
Cepivo Cervarix je na voljo v enoodmernih vialah (0,5 ml), ki so pakirane po 1, 10 in 100.
Anti-HBs geometric mean antibody concentrations were significantly lower on co-administration, but the clinical relevance of this observation is not known since the seroprotection rates remain unaffected.
Med uporabo cepiva Cervarix hkrati s cepivom Twinrix ni bilo klinično pomembnih medsebojnih vplivov na odziv protiteles proti antigenoma HPV in hepatitisa A. Geometrična sredina koncentracij protiteles anti-HBs je bila med sočasno uporabo značilno manjša, toda klinični pomen tega izsledka ni znan, ker so deleži serološke zaščite ostali neokrnjeni.
Contents of the pack and other information
Shranjevanje cepiva Cervarix Vsebina pakiranja in dodatne informacije
These cases are excluded in the
Štetje primerov za
The GMTs were, however, lower in women above 25 years.
Geometrijski srednji titri so bili vsaj 2-krat večji kot pri ženskah, starih od 15 do 25 let.
N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV
N = število oseb, vključenih v vsako skupino n = število primerov (1) PP: vključuje ženske, ki so prejele 3 odmerke cepiva ter so bile ob mesecu 0 DNA-negativne in seronegativne ter ob mesecu 6 DNA-negativne za zadevni tip HPV (HPV-16 ali HPV-18)
% Efficacy (96.2% CI)
Cervarix Kontrola % učinkovitosti (96,2 % IZ)
4.4 Special warnings and precautions for use As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Pri cepljenju je, tako kot pri vseh cepivih, ki se jih injicira, treba zagotoviti ustrezno obliko zdravljenja in nadzora, ki morata biti v takšnem primeru nemudoma na voljo.
A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Med shranjevanjem napolnjene injekcijske brizge se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
Prophylactic efficacy against HPV-16/18 in women naïve to HPV-16 and/or HPV-18
Učinkovitost profilakse proti HPV-16/18 pri ženskah, ki še niso bile izpostavljene HPV-16 in/ali HPV-18
In a supplemental analysis, the efficacy of Cervarix was evaluated against HPV-16/18-related CIN3+.
V dodatni analizi so ocenili učinkovitost cepiva Cervarix proti CIN3+, povezanemu s
• gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
• prebavni simptomi, vključno s siljenjem na bruhanje, bruhanjem, drisko in bolečinami v trebuhu,
When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete vaccination course.
Cervarix (in ne z drugim cepivom proti HPV).
- This medicine has been prescribed for you only.
- Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm. How much is given
Kako se daje to cepivo Cepivo Cervarix vam bo dal zdravnik ali medicinska sestra v obliki injekcije v mišico nadlakti.
Instructions for administration of the vaccine in pre-filled syringe
Navodila za injiciranje cepiva v napolnjeni injekcijski brizgi
Needle protector
Ščitnik igle
Data in pregnant women collected as part of pregnancy registries, epidemiological studies and inadvertent exposure during clinical trials are insufficient to conclude whether or not vaccination with Cervarix affects the risk of adverse pregnancy outcomes including spontaneous abortion.
Podatkov o nosečnicah, zbranih iz registrov nosečnosti, epidemioloških študij in nenamernih izpostavljenosti med kliničnimi preskušanji,
At study completion, there were no cases of infection or histopathological lesions associated with HPV-16 or HPV-18 in the vaccine group in study HPV-023.
Ob dokončanju študije v cepljeni skupini v študiji HPV-023 ni bilo primerov okužbe ali histopatoloških sprememb, povezanih s HPV-16 ali HPV-18.
Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Če je okužba z genotipoma 16 ali 18 humanih virusov papiloma v času cepljenja že prisotna, cepivo Cervarix ne more ščititi pred boleznimi, ki so posledica okužbe z genotipoma 16 ali 18 HPV.
N Cases
N Primeri
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10, vendar več kot 1 od
This leaflet was last revised in {month YYYY} Other sources of information
Navodilo je bilo nazadnje revidirano dne
9 to and including 14 years* Two doses each of 0.5 ml.
Cepljenje in shema Od 9 do vključno 14 let* Dva odmerka po 0,5 ml. Cepljenje z drugim odmerkom se opravi od 5 do 13 mesecev po prvem odmerku.
HPV type 18 L1 protein1,2
L1 protein genotipa 18 HPV1,2
Suspension for injection in pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
HPV type 16 L1 protein1,2
L1 protein genotipa 16 HPV1,2
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10
NAPOLNJENA INJEKCIJSKA BRIZGA Z INJEKCIJSKO IGLO ALI BREZ, PAKIRANJA PO 1, 10
Cervarix is not recommended for use in children below 9 years of age due to lack of data on safety and immunogenicity in this age-group.
Zaradi pomanjkanja podatkov o varnosti in imunogenosti uporaba cepiva Cervarix pri otrocih, mlajših od 9 let, ni priporočljiva.
These diseases include: - cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer, - precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer).
- predrakave cervikalne, vulvarne, vaginalne in analne spremembe (spremembe v celicahspolovila ali zadnjika, iz katerih se lahko razvije rak).
100 vials 100 x 1 dose (0.5 ml)
100 vial 100 x 1 odmerek (0,5 ml)
On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 9 to 14 years of age.
Na osnovi teh podatkov o imunogenosti, lahko sklepamo o učinkovitosti cepiva Cervarix pri osebah,
Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in TVC at end of study is presented in Table 4.
(2) povprečno spremljanje 44 mesecev po 1. odmerku Učinkovitost cepiva proti virološkima opazovanima dogodkoma (6-mesečna in 12-mesečna persistentna okužba), povezana s HPV-16/18, ugotovljena v TVC ob koncu študije, je prikazana v preglednici 4.
Gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Pogosti prebavni simptomi, vključno z navzeo, bruhanjem, drisko in bolečino v trebuhu
Not known* Lymphadenopathy
limfadenopatija
10 vials 10 x 1 dose (0.5 ml)
10 vial 10 x 1 odmerek (0,5 ml)