natgillin/translations-raw huggingface dataset:
In all clinical trials individuals who had received immunoglobulin or blood products within 3 months prior to the first vaccine dose were excluded.
Osebe, ki so v zadnjih 3 mesecih pred cepljenjem s prvim odmerkom cepiva prejele imunoglobuline ali zdravila iz krvi, so bile izključene iz vseh kliničnih preskušanj.
3 Use with other vaccines
Uporaba z drugimi cepivi
Data have not been generated on the concomitant administration of Cervarix and other vaccines.
Podatki o sočasni uporabi cepiva Cervarix in drugih cepiv niso bili pridobljeni.
In clinical efficacy studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Hormonske kontraceptive je v študijah klinične učinkovitosti uporabljalo približno 60% žensk, ki so bile cepljene s cepivom Cervarix.
As with other vaccines it may be expected that, in patients receiving immunosuppressive treatment, an adequate response may not be elicited.
Podobno kot pri cepljenju z drugimi cepivi lahko pričakujemo, da pri bolnikih, ki se zdravijo z imunosupresivnimi oblikami zdravljenja, zadosten odziv morda ne bo dosežen.
During the pre-licensure clinical development program, a total of 1,737 pregnancies were reported including 870 in women who had received Cervarix.
V času kliničnega razvojnega programa pred pridobitvijo dovoljenja za promet so poročali o 1. 737 primerih nosečnosti, vključno z 870 ženskami, ki so bile cepljene s cepivom Cervarix.
Overall, the proportions of pregnant subjects who experienced specific outcomes (e. g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups.
Na splošno je bil delež nosečnic s posebnim izidom (npr. normalen otrok, nenormalen otrok s prirojenimi anomalijami, prezgodnji porod in spontani splav) podoben v obeh skupinah.
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).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na plodnost, nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Vaccination should, therefore, be postponed until after completion of pregnancy.
Ti podatki ne zadostujejo, da bi lahko priporočili uporabo cepiva Cervarix med nosečnostjo, zato je treba cepljenje odložiti do konca nosečnosti.
4.7 Effects on the ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 subjects whilst 13,811 subjects received control.
Cepivo Cervarix je prejelo 16. 142 oseb, 13. 811 oseb pa kontrolo.
In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
Pri vnaprej določeni podskupini oseb (Cervarix = 8. 130, kontrola = 5. 786) so pojav neželenih dogodkov spremljali 30 dni po vsakem cepljenju.
The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
Najpogostejši neželeni učinek po cepljenju je bila bolečina na mestu injiciranja, ki se je pojavila po cepljenju z 78% vseh odmerkov cepiva.
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
4 Neželeni učinki, ki bi lahko vsaj bili povezani s cepljenjem, so navedeni po pogostnosti.
4 Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100 do < 1/ 10) Občasni (≥ 1/ 1. 000 do < 1/ 100)
Very common: headache Uncommon: dizziness
Občasni: omotica.
Common: gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Pogosti: prebavni simptomi, vključno z navzeo, bruhanjem, drisko in bolečino v trebuhu.
Common: itching/ pruritus, rash, urticaria
Pogosti: srbenje, izpuščaj, urtikarija.
Very common: myalgia Common: arthralgia
Pogosti: artralgija.
Uncommon: upper respiratory tract infection
Občasni: okužba zgornjih dihal.
General disorders and administration site conditions:
Zelo pogosti: reakcije na mestu injiciranja, vključno z bolečino, rdečino in oteklino.
Very common: injection site reactions including pain, redness, swelling; fatigue Common: fever (≥ 38°C) Uncommon: other injection site reactions such as induration, local paraesthesia
Občasni: druge reakcije na mestu injiciranja, kot so induracija in lokalna parestezija.
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.
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 je bil opažen enak profil neželenih učinkov.
Papillomavirus vaccines, ATC code:
Cepiva proti virusom papiloma, oznaka ATC:
Cervarix is a non-infectious recombinant vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Cepivo Cervarix je nekužno rekombinantno cepivo, pripravljeno iz visoko prečiščenih virusu podobnih delcev (VLPs; “ virus- like particles ”) velike plaščne L1 beljakovine onkogenih genotipov 16 in 18 HPV.
HPV-16 and HPV-18 are responsible for approximately 70% of cervical cancers across all regions worldwide.
HPV- 16 in HPV- 18 sta odgovorna za približno 70% primerov raka materničnega vratu po vsem svetu.
The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
5 Učinkovitost cepiva Cervarix je bila ovrednotena v dveh nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II. in III. faze, v kateri je bilo skupaj vključenih 19. 778 žensk, starih od 15 do 25 let.
The phase II trial (study 001/ 007) enrolled only women who:
V preskušanje II. faze (študija 001/ 007) so bile vključene le ženske, ki:
- 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,
58, 59, 66 and 68
39, 45, 51, 52, 56, 58, 59, 66 in 68,
- Were seronegative for HPV-16 and HPV-18 and
- so bile seronegativne za HPV- 16 in HPV- 18, in
- Had normal cytology
- so imele normalen citološki izvid.
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.
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 serološki in DNA status.
The primary efficacy endpoint was CIN2+ associated with HPV-16 and/ or HPV-18.
Primarni opazovani dogodek učinkovitosti je bil CIN2+, povezan s HPV- 16 in/ ali HPV- 18.
The secondary endpoints included 12-month persistent infection.
Sekundarni opazovani dogodek je vključeval 12- mesečno persistentno okužbo.
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 was used in the clinical trials as a surrogate marker for cervical cancer.
V kliničnih preskušanjih je bila cervikalna intraepitelijska neoplazija (CIN) stopnje 2 in 3 uporabljena kot nadomestni označevalec raka materničnega vratu.
The term “ premalignant cervical lesions” in section 4.1 corresponds to high-grade Cervical Intraepithelial Neoplasia (CIN 2/ 3).
Izraz “ predrakave spremembe na materničnem vratu ”, uporabljen v poglavju 4. 1, se nanaša na cervikalno intraepitelijsko neoplazijo visoke stopnje (CIN 2/ 3).
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
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.
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) po cepljenju s prvim odmerkom (srednji čas spremljanja 5, 9 let).
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.
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/ 18 infection was 100% (95% CI:
V študiji 007 je bila učinkovitost cepiva Cervarix proti 12- mesečni persistentni okužbi s HPV - 16/ 18 100% (95% interval zaupanja:
There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
Vsi primeri so se pojavili v kontrolni skupini.
Prophylactic efficacy in women naïve to HPV-16 and/ or HPV-18
Učinkovitost profilakse pri ženskah, ki še niso bile izpostavljene HPV- 16 in/ ali HPV- 18
In study 008 the primary analyses of efficacy were conducted in the total vaccinated cohort (TVC-1).
V študiji 008 je bila primarna analiza učinkovitosti izvedena v kohorti vseh cepljenih oseb (TVC- 1; “ total vaccinated cohort ”).
This cohort included only women who were HPV DNA negative and seronegative to the relevant HPV type (HPV-16 or HPV-18) at study entry and had received at least one dose of Cervarix or the control.
Ta kohorta je vključevala le ženske, ki so bile ob vključitvi v študijo HPV DNA negativne in seronegativne na relevantne genotipe HPV (HPV- 16 ali HPV- 18) ter so prejele vsaj en odmerek cepiva Cervarix ali kontrolne učinkovine.
Women with high-grade or missing cytology (0.5%) were excluded from the efficacy analysis.
Ženske s citološkimi izvidi sprememb visoke stopnje in ženske pri katerih rezultati citoloških izvidov niso bili na voljo (0, 5%), so bile izključene iz analize učinkovitosti.
Overall, 74.0% of women enrolled were naïve to both HPV-16 and HPV-18 at study entry.
74, 0% vseh v študijo vključenih žensk do vključitve v študijo še ni bilo izpostavljenih HPV- 16 ali HPV- 18.
The efficacy of Cervarix in the prevention of CIN2+ associated with HPV-16 and/ or HPV-18 as assessed up to 15 months after the last dose of vaccine or control and the rates of 12-month persistent infection in the TVC-1 cohort are presented in the table below:
V spodnji tabeli je prikazana učinkovitost cepiva Cervarix pri preprečevanju CIN2+, povezane s HPV - 16 in/ ali HPV- 18, kot je bilo ovrednoteno do 15 mesecev po prejemu zadnjega odmerka cepiva ali kontrolne učinkovine in deleže 12- mesečne persistentne okužbe v TVC- 1 kohorti.
Study 008
Študija 008
(97.9% CI) CIN2+ (primary endpoint)
(97, 9% interval CIN2+ (primarni opazovani dogodek)
n N
n
n
N n 6
7788 6701
zaupanja)
90.4 (53.4; 99.3) 93.3 (47.0; 99.9)
HPV- 16 in/ ali 18 * HPV- 16 HPV- 18
HPV-18
7. 788 6. 701 7. 221
1
2 1 1
7258
7. 838 21 6. 717 15 7. 258 6
83.3 (< 0.0; 99.9)
90, 4 (53, 4; 99, 3) 93, 3 (47, 0; 99, 9) 83, 3 (< 0, 0; 99, 9)
12-month persistent infection (secondary endpoint) HPV-16 and/ or 18* HPV-16 HPV-18
12- mesečna persistentna okužba (sekundarni opazovani dogodek) HPV- 16 in/ ali 18 * HPV- 16 HPV- 18
3386 11 3437 46 2945 7 2972 35 3143 4 3190 12
3. 437 46 7 2. 972 35 4 3. 190 12
N = number of subjects included in each group of TVC-1 cohort n = number of cases *protocol-specified endpoints
N = število oseb, vključenih v vsako skupino TVC- 1 kohorte n = število primerov * s protokolom določeni opazovani dogodki
All endpoints reached statistical significance for HPV-16.
Pri HPV- 16 so vsi opazovani dogodki dosegli statistično pomembnost.
For HPV-18, the difference between the vaccine and control groups was not statistically significant for CIN2+ and 12 month persistent infection (TVC-1 cohort).
Pri HPV- 18 razlika med skupino, ki je prejemala cepivo, in skupino, ki je prejemala kontrolno učinkovino, ni bila statistično pomembna za CIN2+ in 12- mesečno persistentno okužbo (TVC- 1 kohorta).
However, in a pre-specified analysis (TVC-2) that was identical to the
Vendar pa pri vnaprej določeni analizi (TVC- 2), ki je bila identična TVC- 1 analizi, le da so bile ženske z nenormalnim citološkim izvidom izločene ob času vključitve v študijo, je opazovani dogodek 12- mesečne persistentne okužbe za HPV- 18 dosegel statistični pomen.
6 TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
Učinkovitost cepiva je bila 89, 9% (97, 9% interval zaupanja:
One case was observed in the vaccine group versus 10 cases in the control group.
Poročali so o enem primeru v skupini, ki je prejemala cepivo, in desetih primerih v skupini, ki je prejemala kontrolno učinkovino.
Several of the CIN2+ lesions contained multiple oncogenic types (including non-vaccine HPV types).
Pri več CIN2+ spremembah so bili prisotni različni onkogeni genotipi (vključno z genotipi, ki jih cepivo ne vsebuje).
An additional analysis was conducted to determine vaccine efficacy against lesions likely to be causally associated with HPV-16 and/ or HPV-18.
Izvedena je bila dodatna analiza, ki je vrednotila učinkovitost cepiva proti spremembam, ki bi lahko bile vzročno povezane s HPV- 16 in/ ali HPV- 18.
This post-hoc analysis (clinical case assignment) assigned causal association of an HPV type with the lesion based on the presence of the HPV type in cytology samples prior to detection of the lesion.
Ta post hoc analiza (ocena kliničnih primerov) je določila vzročno povezanost genotipa HPV s spremembo na osnovi prisotnosti genotipa HPV v citološkem vzorcu pred pojavom spremembe.
Based on this case assignment, the analysis excluded 3 CIN2+ cases (2 in the vaccine group and 1 in the control group) which were not considered to be causally associated with HPV-16 or HPV-18 infections acquired during the trial.
Na osnovi teh ocen primerov je analiza izključila 3 CIN2+ primere (dva v skupini, ki je prejemala cepivo, in enega v skupini, ki je prejemala kontrolno učinkovino), ki niso bili vzročno povezani z okužbo s HPV- 16 ali HPV- 18 v času študije.
Based on this analysis there were no cases in the vaccine group and 20 cases in the control group (Efficacy 100%; 97.9% CI:
Na osnovi te analize primeri v skupini, ki je prejemala cepivo, niso bili ugotovljeni, v skupini, ki je prejemala kontrolno učinkovino pa je bilo ugotovljenih 20 primerov (učinkovitost 100%; 97, 9% interval zaupanja:
Prophylactic efficacy in women with current or prior infection
Učinkovitost profilakse pri ženskah s trenutno ali predhodno okužbo
There was no evidence of protection from disease caused by the HPV types for which subjects were HPV DNA positive at study entry.
Ni dokazov o zaščiti pred boleznijo zaradi genotipov HPV na katere so bile osebe HPV DNA pozitivne ob vključitvi v študijo.
However, individuals already infected with one of the vaccine- related HPV types prior to vaccination were protected from clinical disease caused by the remaining HPV type.
Vendar pa so osebe, ki so bile pred cepljenjem, okužene z enim genotipom HPV, ki ga vsebuje cepivo, zaščitene pred klinično boleznijo zaradi drugega genotipa HPV.
In study 008, approximately 26% of women had evidence of current and/ or prior infection.
V študiji 008 je približno 26% žensk imelo znake trenutne in/ ali predhodne okužbe.
HPV-16 and/ or HPV-18 seropositive).
Znaki predhodne okužbe (to je seropozitivnost na HPV- 16 in/ ali HPV- 18) so bili prisotni pri dvajsetih odstotkih žensk.
HPV-16 and/ or HPV-18 DNA positive) of which only 0.5% were DNA positive for both types.
V času cepljenja je bilo okuženih (to je HPV- 16 in/ ali HPV- 18 DNA pozitivnih) sedem odstotkov žensk, od katerih jih je le 0, 5% bilo DNA pozitivnih za oba genotipa.
The antibody response to HPV-16 and HPV-18 was measured using a type-specific ELISA which was shown to correlate with the pseudovirion-based neutralisation assay.
Protitelesni odziv proti HPV- 16 in HPV- 18 je bil ovrednoten z uporabo genotipsko specifičnih ELISA testov, za katere je bilo dokazana soodvisnost s testom nevtralizacije psevdoviriona.
The immunogenicity induced by three doses of Cervarix has been evaluated in 5,303 female subjects from 10 to 55 years of age.
Imunogenost treh odmerkov cepiva Cervarix je bila ovrednotena pri 5. 303 osebah ženskega spola, starih od 10 do 55 let.
In clinical trials, 99.9% 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 99, 9% oseb, ki so bile v začetku seronegativne.
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 7 geometrijski srednji titri IgG so bili znatno večji od titrov pri predhodno okuženih ženskah, pri katerih je okužba s HPV izzvenela (naravna okužba).
Study 001/ 007, which included women from 15 to 25 years of age at the time of vaccination, evaluated the immune response against HPV-16 and HPV-18 up to 76 months post dose 1.
Študija 001/ 007, v katero so bile vključene ženske, ki so bile v času cepljenja stare od 15 do 25 let, je vrednotila imunski odziv proti HPV- 16 in HPV- 18 do 76 mesecev po cepljenju s prvim odmerkom cepiva.
Vaccine-induced IgG Geometric Mean Titres (GMT) for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the end of the follow-up (month 76).
S cepivom povzročeni srednji geometrijski titri IgG proti obema, HPV- 16 in HPV- 18, so dosegli vrh v 7. mesecu in se nato manjšali ter v 18. mesecu dosegli konstantno raven, ki se je ohranila do konca spremljanja (76. mesec).
At the end of the follow-up period, GMTs for both HPV-16 and HPV-18 were still at least 11-fold higher than titres observed in women previously infected but who cleared HPV infection and > 98% of the women were still seropositive for both antigens.
Ob koncu spremljanja je bilo več kot 98% žensk še vedno seropozitivnih na oba antigena.
In study 008, immunogenicity at month 7 was similar to the response observed in study 001.
V študiji 008 je bila imunogenost v 7. mesecu podobna odzivu, opaženem v študiji 001.
The GMTs were, however, lower in women above 25 years.
V drugem kliničnem preskušanju (študija 014), izvedenem pri ženskah, starih od 15 do 55 let, se je po cepljenju s tretjim odmerkom cepiva (v 7. mesecu) serokonverzija na oba genotipa 16 in 18 HPV pojavila pri vseh osebah, vendar pa so bili pri ženskah, starejših od 25 let, geometrijski srednji titri nižji.
7 Bridging the efficacy of Cervarix from young adult women to adolescents
Primerjava učinkovitosti cepiva Cervarix pri mlajših odraslih ženskah in mladostnicah
In two clinical trials performed in girls and adolescents aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years.
Srednji geometrijski titri so bili vsaj 2- krat večji kot pri ženskah, starih od 15 do 25 let.
On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 10 to 14 years of age.
Na osnovi teh podatkov o imunogenosti, lahko sklepamo o učinkovitosti cepiva Cervarix pri osebah, starih od 10 do 14 let.
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.
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.
Sodium chloride (NaCl) Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
natrijev klorid (NaCl) natrijev dihidrogenfosfat dihidrat (NaH2PO4. 2 H2O) voda za injekcije
6.3 Shelf life
8 6. 3 Rok uporabnosti
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.
0, 5 ml suspenzije v viali (steklo tipa I) za en odmerek z zamaškom (butilna guma) v pakiranjih po 1, 10 in 100.
8 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.
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.
Rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 B- 1330 Rixensart, Belgija
20 September 2007.
20. september 2007
Cervarix suspension for injection, multidose Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix suspenzija za injiciranje, večodmerna Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
See section 6.5 for the number of doses per vial.
Za število odmerkov na vialo glejte poglavje 6. 5.
The recommended vaccination schedule is 0, 1, 6 months.
10 Priporočena shema cepljenja je 0., 1. in 6. mesec.
10 The need for a booster dose has not been established (see section 5.1).
Potrebnost obnovitvenega odmerka ni bila dokazana (glejte poglavje 5. 1).
It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
Pri osebah, ki so bile cepljene s prvim odmerkom cepiva Cervarix priporočamo, da se tudi cepljenje s preostalima dvema odmerkoma opravi s cepivom Cervarix (glejte poglavje 4. 4).
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
11 Podatki o varnosti, imunogenosti ali učinkovitosti cepljenja v primeru zamenjave cepiva Cervarix z drugimi cepivi proti HPV niso na voljo.
11 In all clinical trials individuals who had received immunoglobulin or blood products within 3 months prior to the first vaccine dose were excluded.
Osebe, ki so v zadnjih 3 mesecih pred cepljenjem s prvim odmerkom cepiva prejele imunoglobuline ali zdravila iz krvi, so bile izključene iz vseh kliničnih preskušanj.
The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
12 Najpogostejši neželeni učinek po cepljenju je bila bolečina na mestu injiciranja, ki se je pojavila po cepljenju z 78% vseh odmerkov cepiva.
12 Frequencies are reported as:
Pogostnost je navedena kot:
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100 do < 1/ 10) Občasni (≥ 1/ 1. 000 do < 1/ 100)
13
13 Klinične študije
Study 008
14 Študija 008
(97.9% CI)
(97, 9% interval CIN2+ (primarni opazovani dogodek)
n N
n N n