natgillin/translations-raw huggingface dataset:
In accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. 
V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. 
To lahko spremljajo različni nevrološki znaki, npr. prehodna motnja vida, parestezije in tonično-klonični gibi udov med okrevanjem.
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) 
Pogostnost je navedena kot: Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100)
The study was not powered to assess efficacy against disease caused by individual HPV types. 
Moč študije ni bila izračunana za oceno učinkovitosti proti bolezni, povzročeni s posameznim tipom HPV.
This cohort included women with normal or low-grade cytology at baseline and excluded only women with high-grade cytology (0.5% of the total population). 
Ta kohorta je vključila ženske z izhodiščno normalno ali nizkostopenjsko citologijo in je izključila le ženske z visokostopenjsko citologijo (0,5 % celotne populacije).
If you do not finish the complete vaccination course (two or three injections depending on your age at vaccination), you may not get the best response and protection from the vaccination. 
Če niste prejeli vseh predvidenih odmerkov cepiva (dva ali tri odmerke, odvisno od vaše starosti v času cepljenja), sta odziv na cepljenje in zaščita lahko slabša.
Cross-protective efficacy 
Učinkovitost navzkrižne zaščite
However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix. 
Vendar so v času kliničnega razvojnega programa poročali o 10.476 primerih nosečnosti, vključno s 5.387 ženskami, ki so bile cepljene s cepivom Cervarix.
4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive or use machines have been performed. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
Other oncogenic HPV types can also cause ano-genital cancers (approximately 30%). 
Drugi onkogeni tipi HPV prav tako lahko povzročijo anogenitalne oblike raka (približno 30 %).
Turbid white suspension. 
Motna bela suspenzija.
The use of Cervarix should be in accordance with official recommendations. 
Cepivo Cervarix je treba uporabljati v skladu z uradnimi priporočili.
It is important that procedures are in place to avoid injury from faints. 
Pomembno je zagotoviti ukrepe za preprečitev poškodb v primeru omedlevice.
The total number of injections you will receive depends on your age at the time of the first injection. 
Skupno število odmerkov, ki jih boste prejeli je odvisno od vaše starosti, ko boste prejeli prvi odmerek.
% Efficacy (95% CI) 
% učinkovitosti (95 % IZ)
What Cervarix is and what it is used for 
Kaj je cepivo Cervarix in za kaj ga uporabljamo
This cohort included women with or without current and/or prior HPV infection. 
Ta kohorta je vključila ženske z ali brez trenutne in/ali predhodne okužbe s HPV.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težave z dihanjem in otekanje obraza ali jezika.
You will receive 2 injections: 
Prejeli boste 2 odmerka:
Antibody titers peaked at month 7 then gradually declined up to month 18 and stabilized to reach a plateau up to month 84. 
Titri protiteles so dosegli vrh 7. mesec, nato so se postopoma zniževali do 18. meseca in so se stabilizirali ter dosegli plato do 84. meseca.
Please speak to your doctor for more information. 
Za več podatkov se posvetujte s svojim zdravnikom.
Cervarix Control 
Cervarix kontrola
No fertility data are available. 
Podatkov o vplivu na plodnost ni na voljo.
The vaccine is therefore not indicated for treatment of cervical cancer or cervical intraepithelial neoplasia (CIN). 
Cepivo torej ni indicirano za zdravljenje raka materničnega vratu ali cervikalne intraepitelijske neoplazije (CIN).
If not used at the end of this period the vaccine should be discarded. 
Če se cepiva ne uporabi do konca tega obdobja, ga je treba zavreči.
A minor infection such as a cold should not be a problem, but talk to the doctor first. 
Blažje okužbe, kot je prehlad, ne bi smele biti težava, vendar se pred cepljenjem vseeno posvetujte z zdravnikom.
The vaccination schedule depends on the age of the subject. 
Odmerjanje Shema cepljenja je odvisna od starosti oseb.
You will receive 3 injections: 
Prejeli boste 3 odmerke:
Date of latest renewal: 17 September 2012. 
Datum pridobitve dovoljenja za promet: 20. september 2007 Datum zadnjega podaljšanja: 17. september 2012
Control (N = 7,305) 
kontrola (N = 7.305)
Immunogenicity in males aged 10 to 18 years 
Imunogenost pri moških, starih od 10 do 18 let
First injection: at chosen date 
Prvi odmerek: na izbrani dan
There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix. 
Ni dokazov, da bi uporaba hormonskih kontraceptivov vplivala na učinkovitost cepiva Cervarix.
It might be necessary to postpone the vaccination until recovery. 
V tem primeru bo cepljenje morda treba odložiti do ozdravitve.
Not known* Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema 
alergijske reakcije (vključno z anafilaktično in anafilaktoidno reakcijo), angioedem
Unlike histopathological endpoints, virological endpoints are less confounded by multiple infections. 
V nasprotju s histopatološkimi opazovanimi dogodki virološke opazovane dogodke manj motijo multiple okužbe.
Overall impact of the vaccine on cervical HPV disease burden 
Celotni vpliv cepiva na cervikalno breme bolezni HPV
Tell your doctor if you are taking, have recently taken, might take any other medicines, or have recently received any other vaccine. 
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
For adjuvants, see section 2. 
Za adjuvanse glejte poglavje 2.
Use with systemic immunosuppressive medicinal products See section 4.4. 
Uporaba s sistemskimi imunosupresivi Glejte poglavje 4.4.
The efficacy estimates are lower in the TVC as this cohort includes women with pre-existing infections/lesions, which are not expected to be impacted by Cervarix. 
Ocene učinkovitosti v TVC so nižje, ker ta kohorta vključuje ženske s predhodno obstoječimi okužbami/spremembami, za katere ni pričakovati, da bi cepivo Cervarix nanje vplivalo.
Very common Myalgia Common 
Zelo pogosti mialgija
HPV 45, -31 and -33 are the 3 most common non-vaccine HPV types identified in squamous cervical carcinoma (12.1%) and adenocarcinoma (8.5%). 
HPV 45, -31 in -33 so 3 najpogostejši tipi HPV, ki niso v cepivu, pa jih odkrijejo v ploščatoceličnem cervikalnem karcinomu (12,1 %) in adenokarcinomu (8,5 %).
The majority of these reactions were of mild to moderate severity and were not long lasting. 
Neželeni učinki so bili večinoma blagi do zmerni in kratkotrajni.
Except for asymptomatic human immunodeficiency virus (HIV) infected subjects for whom limited immunogenicity data are available (see section 5.1), there are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment. 
Razen za asimptomatske preiskovance, okužene z virusom humane imunske pomankljivosti (HIV), za katere je na voljo malo podatkov o imunogenosti (glejte poglavje 5.1), podatkov o uporabi cepiva Cervarix pri osebah z okvaro imunskega odziva, kot so bolniki, ki se zdravijo z imunosupresivnimi oblikami zdravljenja, ni na voljo.
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.
The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease. 
To cepivo je namenjeno samo za profilaktično uporabo in ne vpliva na aktivne okužbe s HPV ali na razvito klinično bolezen.
Do not throw away any medicines via wastewater or household waste. 
Zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM02 
Farmakoterapevtska skupina: Cepiva, Cepiva proti virusom papiloma, oznaka ATC: J07BM02 Mehanizem delovanja
If not used immediately, the vaccine should be stored in a refrigerator (2°C - 8°C). 
Če ni uporabljeno takoj, ga je treba shraniti v hladilniku (pri temperaturi od 2 °C do 8 °C).
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.
In study 023 (a subset of study 001/007), the immune response continued to be evaluated up to 113 months. 
V študiji 023 (podskupina študije 001/007) so imunski odziv ocenjevali do 113 mesecev.
The vaccine should never be given into a vein. 
Cepiva se ne sme nikoli injicirati v žilo.
Case counting for the TVC started on day 1 after the first dose. 
TVC se je začelo na dan 1 po prvem odmerku.
However, individuals already infected (HPV DNA positive) with one of the vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the other vaccine HPV type. 
Vendar pa so bile posameznice, ki so bile že pred cepljenjem okužene (HPV-DNA-pozitivne) z enim od tipov HPV v cepivu, zaščitene pred klinično boleznijo, ki jo povzroča drugi tip HPV v cepivu.
1Human Papillomavirus = HPV 2adjuvanted by AS04 containing: 
1humani virus papiloma = HPV 2z adjuvansom AS04, ki vsebuje:
However, it is unknown whether vaccine-induced antibodies are excreted in human breast milk. 
Ni znano, če se s cepivom povzročena protitelesa izločajo z mlekom pri ženski.
The data showed comparable immunogenicity in males and females. 
Podatki so pokazali, da je imunogenost pri moških podobna kot pri ženskah.
92 subjects in the vaccine group had immunogenicity data at the [M107M113] interval after the first vaccine dose with a median follow-up of 8.9 years. 
92 preiskovancev v cepljeni skupini je imelo podatke o imunogenosti za obdobje [M107-M113] po prvem odmerku cepiva in mediano spremljanje 8,9 let.
Case counting for the ATP cohort started on day 1 after the third dose of vaccine. 
Štetje primerov za kohorto PP se je začelo na dan 1 po tretjem odmerku cepiva.
The immunogenicity induced by three doses of Cervarix has been evaluated in 5,465 female subjects from 9 to 55 years of age and over 800 male subjects aged 10 to 18 years. 
Imunogenost treh odmerkov cepiva Cervarix je bila ovrednotena pri 5.465 osebah ženskega spola, starih od 9 do 55 let, in več kot 800 osebah moškega spola, starih od 10 do 18 let.
It is important that you follow the instructions of your doctor or nurse regarding return visits. 
Pomembno je, da natančno upoštevate navodila zdravnika ali medicinske sestre o cepljenju z naslednjim odmerkom cepiva.
• upper respiratory tract infection (infection of the nose, throat or trachea) 
• okužba zgornjih dihal (okužba nosu, žrela in sapnika),
If necessary, the vaccination schedule can be more flexible. 
Shemo cepljenja se po potrebi lahko tudi prilagodi.
Includes 15% of subjects with previous history of HPV disease/infection 
Vključuje 15 % preiskovank z anamnezo bolezni/okužbe s HPV.
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.
Since no vaccine is 100% effective and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations. 
Ker nobeno cepivo ni 100 % učinkovito in ker cepivo Cervarix ne zagotavlja zaščite pred vsemi tipi HPV ali proti že obstoječim okužbam s HPV, ostajajo redni presejalni pregledi materničnega vratu ključnega pomena in jih mora ženska opravljati v skladu z lokalnimi priporočili.
There is no evidence whether prevention of persistent infection that lasts for at least 6 months is a relevant surrogate marker for cervical cancer prevention in women aged 26 years and above. 
Ni bilo ugotovljeno, ali je preprečevanje persistentnih okužb, ki trajajo vsaj 6 mesecev, ustrezen nadomestni označevalec preprečevanja raka materničnega vratu pri ženskah, starih 26 let in več.
The efficacy against CIN3 was only demonstrated for HPV-31 and there was no evidence of protection against AIS for any of the HPV types. 
Učinkovitost proti CIN3 je bila ugotovljena le za HPV-31; zaščita proti AIS ali kateremu drugemu HPV tipu ni bila dokazana.
See section 4. 
(glejte poglavje 4.
Bridging the efficacy of Cervarix from young adult women to adolescents 
Primerjava učinkovitosti cepiva Cervarix pri mlajših odraslih ženskah in mladostnicah
• aching muscles, muscle tenderness or weakness (not caused by exercise) 
• bolečine v mišicah in občutljivost ali slabotnost mišic (ki niso posledica telesne aktivnosti),
HPV-31, 33 and 45 showed consistent cross-protection for 6-month persistent infection and CIN2+ endpoints in all study cohorts. 
HPV-31, 33 in 45 so pokazali dosledno navzkrižno zaščito pri naslednjih opazovanih dogodkih: 6mesečna persistentna okužba in CIN2+ v vseh študijskih kohortah.
However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines. 
omenjeni v poglavju 4.8, začasno vplivajo na sposobnost vožnje ali upravljanja strojev.
As with all vaccines, Cervarix may not fully protect all people who are vaccinated. 
Kot druga cepiva tudi cepivo Cervarix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
What Cervarix is and what it is used for What you need to know before you receive Cervarix How Cervarix is given 
Kaj je cepivo Cervarix in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Cervarix Kako uporabljati cepivo Cervarix
• pain or discomfort at the injection site 
• bolečina ali neugodje na mestu injiciranja,
Efficacy against HPV types 16 and 18 in women with and without prior infection or disease. 
Učinkovitost proti tipoma HPV 16 in 18 pri ženskah z ali brez predhodne okužbe ali bolezni
Cervarix is a turbid white suspension. 
Cepivo Cervarix je motna bela suspenzija.
Immunogenicity in males was assessed in 2 clinical trials HPV-011 (N=173) and HPV-040 (N=556). 
Imunogenost pri moških so ocenili v dveh kliničnih preskušanjih: HPV-011 (N = 173) in HPV-040
Women who are pregnant or trying to become pregnant, are advised to postpone or interrupt vaccination until completion of pregnancy. 
Nosečnicam in ženskam, ki poskušajo zanositi, je treba svetovati naj cepljenje odložijo ali prekinejo do konca nosečnosti.
- Keep this leaflet. 
(glejte pod preglednico).
As a precautionary measure, it is preferable to avoid the use of Cervarix during pregnancy. 
Iz previdnosti se je uporabi cepiva Cervarix med nosečnostjo bolje izogniti.
• fever (≥38°C) 
• zvišana telesna temperatura (≥ 38 °C).
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. 
Omedlevica se lahko pojavi (predvsem pri mladostnikih) po vsakem injiciranju z iglo ali celo pred njim.
The study was not powered to demonstrate a difference between the vaccine and the control group for these endpoints. 
Moč študije ni bila zasnovana tako, da bi dokazala razliko med cepljeno skupino in kontrolno skupino za te opazovane dogodke.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. 
Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), zlasti pri mladostnikih kot psihološki odziv na injiciranje z iglo.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC ODGOVOREN ZA
In two clinical studies that enrolled males aged 10 to 18 years, 2,617 males received Cervarix and were followed-up with active safety surveillance. 
V dveh kliničnih študijah, v katerih so bili vključeni moški, stari od 10 do 18 let, je 2.617 moških prejelo cepivo Cervarix; sledilo je aktivno spremljanje varnosti.
The immune response after 2 doses in females aged 9 to 14 years was non-inferior to the response after 3 doses in women aged 15 to 25 years. 
Imunski odziv po dveh odmerkih pri deklicah, starih od 9 do 14 let, ni bil nič slabši od odziva po treh odmerkih pri mladih ženskah, starih od 15 do 25 let.
The antibody response to HPV-16 and HPV-18 was measured using a type-specific direct ELISA (version 2, MedImmune methodology, modified by GSK) which was shown to correlate with the pseudovirion-based neutralisation assay (PBNA). 
Protitelesni odziv proti HPV-16 in HPV-18 je bil ovrednoten z uporabo genotipsko specifičnih direktnih ELISA testov (različica 2, metodologija MedImmune, spremenjena s strani GSK), za katere je bila dokazana soodvisnost s testom nevtralizacije psevdoviriona (PBNA - pseudovirion-based neutralisation assay).
Ask your pharmacist how to throw away medicines you no longer use. 
O načinu odstranjevanja zdravil, ki jih ne potrebujete več, se posvetujte s farmacevtom.
The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies. 
Vpliva na dojene otroke, katerih matere so bile cepljene s cepivom Cervarix, v kliničnih študijah niso raziskovali.
You should continue to follow your doctor's advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures. 
Kljub cepljenju morate še naprej upoštevati navodila svojega zdravnika o preiskavah brisa materničnega vratu (test Pap - presejalni test za odkrivanje sprememb v celicah materničnega vratu, ki so posledica okužbe s HPV) in drugih preventivnih ter zaščitnih ukrepih.
As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. 
Kot druga cepiva za intramuskularno uporabo je tudi cepivo Cervarix treba uporabljati previdno pri osebah s trombocitopenijo ali katerokoli motnjo strjevanja krvi, saj se pri teh osebah po dajanju cepiva v mišico lahko pojavi krvavitev.
In study HPV-023, subjects from the Brazilian cohort (N=437) of study 001/007 were followed up to a mean of 8.9 years (standard deviation 0.4 years) after the first dose. 
V študiji HPV-023 so preiskovance iz brazilske kohorte (n = 437) študije 001/007 spremljali do povprečno 8,9 leta (standardni odklon 0,4 leta) po prvem odmerku.
However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation. 
Blažja okužba, npr. prehlad, ni kontraindikacija za cepljenje.
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 after administration of the first vaccine dose. 
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 efficacy at study conclusion is summarised in the following table. 
Učinkovitost cepiva ob dokončanju študije povzema naslednja preglednica.
Table 7 - Vaccine efficacy at study conclusion in study HPV-015 Endpoint 
Preglednica 7: Učinkovitost cepiva ob koncu študije HPV-015
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 odmerek (0,5 ml) vsebuje:
Bridging of clinical efficacy against anal lesions and cancers 
Premostitev klinične učinkovitosti proti analnim spremembam in rakom
Cervarix is not used to treat HPV related diseases already present at the time of vaccination. 
Cepiva Cervarix se ne sme uporabljati za zdravljenje s HPV povezanih bolezni, ki so v času cepljenja že prisotne.
12-month persistent infection 
12-mesečna persistentna okužba
Timing and need of booster dose(s) has not been established. 
Časovnega okvira in potrebe po cepljenju z obnovitvenim odmerkom (obnovitvenimi odmerki) niso določili.
After first opening, immediate use is recommended. 
Cepivo je priporočljivo uporabiti takoj po prvem odprtju.
As with other vaccines, an adequate immune response may not be elicited in these individuals. 
Pri teh osebah zadosten imunski odziv morda ne bo dosežen.
No information exists about protection against persistent infection or precancerous lesions among HIV infected women. 
O zaščiti pred trajno okužbo ali predrakavimi spremembami pri ženskah, okuženih s HIV, ni podatkov.
Persistent infection that lasts for at least 6 months has also been shown to be a relevant surrogate marker for cervical cancer in women aged 15 to 25 years. 
Persistentne okužbe, ki trajajo vsaj 6 mesecev, so bile dokazano relevantni nadomestni označevalec raka materničnega vratu pri ženskah, starih od 15 do 25 let.
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this vaccine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, predno prejmete to cepivo.
Control (N = 8,708) 
kontrola (N = 8.708)
It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types (see section 5.1 “Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.”). 
Prav tako ni namenjeno za preprečevanje napredovanja drugih že prisotnih sprememb, povezanih s HPV, ali obstoječih okužb s HPV, naj gre za tip v cepivu ali ne (glejte poglavje 5.1, "Učinkovitost proti HPV16/18 pri ženskah, ki so imele ob vključitvi v študijo dokazano okužbo s HPV-16 ali HPV-18.
Cervarix is for intramuscular injection in the deltoid region (see also sections 4.4 and 4.5). 
Cepivo Cervarix je treba injicirati intramuskularno v deltoidni predel (glejte tudi poglavji 4.4 in 4.5).
• fainting sometimes accompanied by shaking or stiffness. 
• omedlevica, ki jo včasih spremlja tresenje ali togost.
The secondary endpoints included 6- and 12-month persistent infection. 
Sekundarni opazovani dogodek je vključeval 6- in 12-mesečno persistentno okužbo.
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine): 
♦ Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 odmerkov cepiva):
The term “premalignant ano-genital lesions” in section 4.1 corresponds to high-grade Cervical Intraepithelial Neoplasia (CIN2/3), high-grade vulvar intraepithelial neoplasia (VIN2/3), high-grade vaginal intraepithelial neoplasia (VaIN2/3) and high-grade anal intraepithelial neoplasia (AIN 2/3). 
Izraz "predrakave anogenitalne spremembe" v poglavju 4.1 ustreza visokostopenjski cervikalni intraepitelijski neoplaziji (CIN2/3), visokostopenjski vulvarni intraepitelijski neoplaziji (VIN2/3), visokostopenjski vaginalni intraepitelijski neoplaziji (VaIN2/3) in visokostopenjski analni intraepitelijski neoplaziji (AIN 2/3).
PHARMACEUTICAL FORM Suspension for injection. 
FARMACEVTSKA OBLIKA Suspenzija za injiciranje.
Administer the vaccine. 
Injicirajte cepivo.