FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • itching, red skin rash, hives (urticaria)
Slovenian: • srbenje, rdeč kožni izpuščaj, koprivnica (urtikarija),
English: (3) mean follow-up of 40 months post dose 3
Slovenian: (3) povprečno spremljanje 40 mesecev po 3. odmerku
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Slovenian: Med shranjevanjem viale se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
English: No data are available on subcutaneous administration of Cervarix (see section 4.4).
Slovenian: Podatki o subkutanem injiciranju cepiva Cervarix niso na voljo (glejte poglavje 4.4).
English: In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.
Slovenian: 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.
English: No efficacy study against anal premalignant lesions has been conducted with Cervarix.
Slovenian: Študij učinkovitosti proti predrakavim analnim spremembam s cepivom Cervarix niso izvedli.
English: Very common Injection site reactions including pain, redness, swelling, fatigue
Slovenian: Zelo pogosti reakcije na mestu injiciranja, vključno z bolečino, rdečino in oteklino; utrujenost
English: The primary endpoint was a combination of a virological and a histopathological endpoint: HPV16/18 related 6-month persistent infection and/or CIN1+.
Slovenian: Primarni opazovani dogodek je bil kombinacija virološkega in histopatološkega opazovanega dogodka: 6-mesečna persistentna okužba in/ali CIN1+, povezana s HPV-16/18.
English: 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.
Slovenian: 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.
English: Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness.
Slovenian: Cepljenje s cepivom Cervarix je treba odložiti pri osebah, ki imajo hujšo akutno bolezen s povišano telesno temperaturo.
English: How to store Cervarix
Slovenian: Kako uporabljati cepivo Cervarix
English: Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid (NaCl) natrijev dihidrogenfosfat dihidrat (NaH2PO4.2 H2O) voda za injekcije
English: ATP cohort(1) End of study analysis(2)
Slovenian: kohorta PP(1) analiza ob koncu študije(2)
English: If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Slovenian: Če ste na cepljenje s predvidenim odmerkom cepiva pozabili, se posvetujte s svojim zdravnikom.
English: ATP cohort(1) End of study analysis(3)
Slovenian: kohorta PP(1) analiza ob koncu študije(3)
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Slovenian: Kot velja za vsa cepiva tudi po cepljenju s tem cepivom zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah.
English: 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.
Slovenian: 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.
English: Women (N=1,113) were vaccinated in study 001 and evaluated for efficacy up to month 27.
Slovenian: V študiji 001 so učinkovitost pri cepljenih ženskah (N = 1.113) vrednotili do 27. meseca.
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Slovenian: 1 ml suspenzije v viali (steklo tipa I) za 2 odmerka z zamaškom (iz butilne gume).
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
English: Posology
Slovenian: Pokrovček
English: 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.
Slovenian: 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
English: Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Slovenian: KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
English: Cervarix is not likely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi cepivo Cervarix vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: All initially seropositive women remained seropositive for both anti-HPV-16 and anti-HPV-18 antibodies.
Slovenian: Vse ob vstopu seropozitivne ženske so ostale seropozitivne za protitelesa anti-HPV-16 in anti-HPV-18.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Cervarix is available in 2 dose vials (1 ml) in packs of 1, 10 and 100.
Slovenian: Cepivo Cervarix je na voljo v dvoodmernih vialah (1 ml) v pakiranjih po 1, 10 in 100.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GlaxoSmithKline Biologicals s.a.
English: 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.
Slovenian: 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.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (0,5 ml)
English: Deutschland GlaxoSmithKline GmbH & Co. KG
Slovenian: GlaxoSmithKline GmbH & Co.
English: 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.
Slovenian: 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
English: (2) mean follow-up of 44 months post dose 1
Slovenian: (2) povprečno spremljanje 44 mesecev po 1. odmerku
English: The vaccine should under no circumstances be administered intravascularly or intradermally.
Slovenian: Cepiva se v nobenem primeru ne sme injicirati v žilo ali v kožo.
English: The primary efficacy endpoint was incident infection with HPV-16 and/or HPV-18.
Slovenian: Primarni opazovani dogodek učinkovitosti je bila slučajna okužba s HPV-16 in/ali HPV-18.
English: Name and address of the manufacturers of the biological active substance
Slovenian: SPROŠČANJE SERIJE Ime in naslov izdelovalca biološke učinkovine
English: 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.
Slovenian: Prepoznati jih je mogoče po: srbečem izpuščaju na rokah in stopalih, oteklosti oči in obraza,
English: 6M PI and/or CIN1+ 6M PI
Slovenian: 6-mesečna p.o. in/ali CIN1+
English: Prophylactic efficacy against HPV-16/18 infection in a population naïve to oncogenic HPV types
Slovenian: Učinkovitost profilakse proti okužbi s HPV-16/18 v skupini oseb, ki še niso bile izpostavljene onkogenim genotipom HPV
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
Slovenian: PODATKI NA ZUNANJI OVOJNINI VEČODMERNA VIALA, PAKIRANJA PO 1, 10, 100
English: 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.
Slovenian: Pred cepljenjem morate vsebino viale, preden jo pretresete in po tem, pregledati glede morebitnih tujkov in/ali neobičajnega fizikalnega videza.
English: Cervarix is available in pre-filled syringes (0,5 ml) with or without needles in packs of 1 and 10.
Slovenian: Cepivo Cervarix je na voljo v napolnjenih injekcijskih brizgah (0,5 ml) z injekcijskimi iglami ali brez v pakiranjih po 1 in 10.
English: The primary efficacy endpoint was CIN2+ associated with HPV-16 and/or HPV-18 (HPV-16/18).
Slovenian: Primarni opazovani dogodek učinkovitosti je bil CIN2+, povezan s HPV-16 in/ali HPV-18 (HPV
English: At the event-triggered analysis the efficacy was 92.9% (96.1% CI: 79.9;98.3) against CIN2+ and 80%
Slovenian: 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+.
English: 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.
Slovenian: 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.
English: Suspension for injection
Slovenian: Suspenzija za injiciranje.
English: There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
Slovenian: Poročali so o šestnajstih primerih persistentne okužbe s HPV-16 in petih primerih persistentne okužbe s HPV-18.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: (3) mean follow-up of 44 months post dose 1
Slovenian: (3) povprečno spremljanje 44 mesecev po 1. odmerku
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (1 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 odmerka (1 ml)
English: • redness or swelling at the injection site
Slovenian: • rdečina ali oteklina na mestu injiciranja,
English: 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.
Slovenian: 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.
English: 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).
Slovenian: razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) z injekcijskimi iglami ali brez.
English: 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.
Slovenian: 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 %.
English: Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec GlaxoSmithKline Biologicals s.a.
English: Cervarix should under no circumstances be administered intravascularly or intradermally.
Slovenian: Cepiva Cervarix se pod nobenimi pogoji ne sme injicirati v žilo ali v kožo.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: ♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine):
Slovenian: ♦ Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100, vendar več kot 1 od
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/001 - pack of 1
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/419/001 - pakiranje po 1
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Slovenian: 0,5 ml suspenzije v viali (steklo tipa I) za en odmerek z zamaškom (butilna guma).
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: CIN3+
Slovenian: CIN2+ CIN3 +
English: 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.
Slovenian: 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.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains:
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN 1 odmerek (0,5 ml) vsebuje:
English: No data are available on subcutaneous administration of Cervarix.
Slovenian: Podatki o subkutanem injiciranju cepiva Cervarix niso na voljo.
English: NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Cervarix suspension for injection in a vial
Slovenian: Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi Cervarix suspenzija za injiciranje v viali
English: Initially seropositive and seronegative subjects reached similar titres after vaccination.
Slovenian: Po cepljenju so bili pri osebah, ki so bile v začetku seropozitivne, in osebah, ki so bile v začetku seronegativne, doseženi enaki titri.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL, PACK OF 1, 10, 100
Slovenian: PODATKI NA ZUNANJI OVOJNINI ENOODMERNA VIALA, PAKIRANJA PO 1, 10, 100
English: • swollen glands in the neck, armpit or groin
Slovenian: • povečane bezgavke na vratu, pod pazduho ali v dimljah,
English: 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.
Slovenian: 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.
English: Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection).
Slovenian: S cepivom povzročeni geometrijski srednji titri IgG so bili znatno večji od titrov pri predhodno okuženih ženskah,
English: • Official batch release
Slovenian: Uradna sprostitev serije:
English: Vaccine efficacy against CIN1+ associated with HPV 16/18 observed in the ATP cohort was 91.7% (96.1% CI: 82.4;96.7).
Slovenian: povezanemu s HPV 16/18, ugotovljena v kohorti PP, je bila 91,7 % (96,1 % IZ: 82,4;96,7).
English: Contents of the pack and other information What Cervarix contains - The active substances are:
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Cervarix
English: 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.
Slovenian: 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.
English: (2) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of HPV DNA status, cytology and serostatus at baseline.
Slovenian: (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.
English: ATP(1)
Slovenian: PP(1)
English: Other HPV types can also cause ano-genital cancers.
Slovenian: Raka materničnega vratu ali raka zadnjika lahko povzročijo tudi drugi tipi HPV.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/010 - pack of 1
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/419//010 - pakiranje po 1
English: Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100.
Slovenian: Cepivo Cervarix je na voljo v enoodmernih vialah (0,5 ml), ki so pakirane po 1, 10 in 100.
English: 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.
Slovenian: 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.
English: Contents of the pack and other information
Slovenian: Shranjevanje cepiva Cervarix Vsebina pakiranja in dodatne informacije
English: These cases are excluded in the
Slovenian: Štetje primerov za
English: The GMTs were, however, lower in women above 25 years.
Slovenian: Geometrijski srednji titri so bili vsaj 2-krat večji kot pri ženskah, starih od 15 do 25 let.