natgillin/translations-raw huggingface dataset:
To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long as your doctor prescribes it for you.
Nadaljevanje prejemanja zdravila Ibandronska kislina Accord Za najboljši izkoristek zdravljenja je pomembno, da nadaljujete s prejemanjem zdravila Ibandronska kislina Accord vsake 3 mesece, dokler vam je zdravljenje predpisal Ibandronska kislina Accord.
Ocular inflammatio
raztopina za injiciranje
NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion
Ibandronska kislina Accord 2 mg koncentrat za raztopino za infundiranje Ibandronska kislina Accord 6 mg koncentrat za raztopino za infundiranje
Ibandronic acid Accord contains sodium
Izgled zdravila Ibandronska kislina Accord in vsebina pakiranja
Up to now there is no experience of acute poisoning with Ibandronic acid Accord concentrate for solution for infusion.
Ni poročil o primerih akutnega prevelikega odmerjanja s koncentratom za raztopino za infundiranje Ibandronska kislina Accord.
= serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
= koncentracija kalcija v serumu (mg/dl) + 0,8 x [4albumin (g/dl)] Če želimo korigirani kalcij v serumu, izražen v mmol/l, pretvoriti v mg/dl, vrednost pomnožimo s 4.
One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).
Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline (v obliki natrijevega monohidrata) v 3 ml raztopine.
Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Sekundarni rezultati učinkovitosti (bolniki z rakom dojke in metastatično boleznijo kosti) Placebo n = 158
Ibandronic acid Accord may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference.
S tem kostno maso poveča pri večini bolnic, ki ga jemljejo, čeprav same ne bodo videle ali čutile razlike.
Angioedema, Facial swelling/oedema, Urticaria
Bolezni kože in podkožja izpuščaj angioedem, otekanje obraza/edem, urtikarija
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 2 mg ibandronske kisline (v obliki natrijevega monohidrata).
Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.
Koncentrat za raztopino za infundiranje Ibandronska kislina Accord je treba dajati intravensko.
6 mg (6 ml of concentrate for solution for infusion)
≥50 CLcr < 80 6 mg (6 ml koncentrata za raztopino za infundiranje)
Other medicines and Ibandronic Acid Accord
Shranjevanje zdravila Ibandronska kislina Accord
Calcium containing solutions should not be mixed with Ibandronic acid Accord concentrate for solution for infusion.
Koncentrata za raztopino za infundiranje Ibandronska kislina Accord ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
• pelvic pain, discharge, itching or pain in the vagina
• bolečina v medenici, izcedek iz nožnice, srbenje ali bolečina v nožnici;
How to store Ibandronic acid Accord 6.
5 Shranjevanje zdravila Ibandronska kislina Accord 6.
Nervous system disorders
Bolezni endokrinega sistema okvara obščitnice
What Ibandronic acid Accord looks like and contents of the pack Ibandronic acid Accord 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Ibandronska kislina Accord 3 mg raztopina za injiciranje v napolnjeni injekcijski brizgi je bistra, brezbarvna raztopina.
* Note albumin-corrected serum calcium concentrations are calculated as follows: Albumin-corrected serum calcium (mmol/l)
* Opomba: koncentracije korigiranega kalcija v serumu izračunamo po naslednji formuli:
Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections
6.1 Seznam pomožnih snovi natrijev klorid ocetna kislina (ledocet) natrijev acetat trihidrat voda za injekcije
Your doctor may do regular blood tests while you are receiving Ibandronic acid Accord.
Med zdravljenjem z zdravilom Ibandronska kislina Accord bo zdravnik verjetno naredil običajne preiskave krvi, da bo preveril, če prejemate pravi odmerek zdravila .
• persistent eye pain and inflammation
Bolezni živčevja glavobol Očesne bolezni vnetje oči
The solution is irritant, therefore strict adherence to the intravenous route of administration is important.
Raztopina je dražeča, zato moramo zdravilo dajati izključno intravensko.
Talk to your doctor before receiving Ibandronic acid Accord:
Preden boste prejeli zdravilo Ibandronska kislina Accord, se posvetujte z zdravnikom:
Atypical subtrochanteric and diaphyseal femoral fractures†
Presnovne in prehranske motnje hipokalciem ija**
Hypocalcaemia*
Hipokalcemija
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
• simptomi, podobni gripi, vključno s povišano telesno temperaturo, drgetanjem in mrazenjem,
Date of first authorisation: 20 September 2006 Date of latest renewal: 27 July 2011
Datum prve odobritve: 20. september 2006 Datum zadnjega podaljšanja: 27. julij 2011
Efficacy against PIN grades 1/2/3 was not demonstrated.
Učinkovitost proti PIN stopenj 1/2/3 ni bila dokazana.
Gardasil should be administered as soon as possible after being removed from the refrigerator.
Cepivo Gardasil je treba uporabiti čim prej potem, ko ga vzamete iz hladilnika.
Vaccination should be postponed until completion of pregnancy.
Cepljenje je treba odložiti do konca nosečnosti.
[Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
[Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do  1/10); občasni (≥ 1/1.000 do  1/100); redki (≥ 1/10.000 do  1/1.000); zelo redki ( 1/10.000)]
In this study, a durable protection was statistically demonstrated to approximately 12 years.
V tej študiji je bilo trajanje zaščite statistično ocenjeno na približno 12 let.
Consequently, the frequency of these adverse events is qualified as "not known".
Zato je pogostnost teh neželenih učinkov opredeljena kot "neznana".
Other medicines or vaccines and Gardasil
Druga zdravila ali cepiva in cepivo Gardasil
The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
* Post Marketing adverse events (frequency cannot be estimated from the available data).
* Neželeni učinki v obdobju trženja zdravila (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Še naprej morate upoštevati zdravnikova navodila o brisih materničnega vratu/Pap testih in preventivnih ter zaščitnih ukrepih.
What you need to know before you receive Gardasil
Kaj morate vedeti, preden boste prejeli cepivo Gardasil
The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
Pri odločitvi za cepljenje posamezne osebe je treba upoštevati tveganje za predhodno izpostavitev HPV in potencialno korist cepljenja.
N Number of cases
N število primerov
16- to 26-Year-Old Women (Protocols 013 and 015)
Ženske, stare od 16 do 26 let (Protokola 013 in 015)
Long-term follow-up studies were conducted to determine the duration of protection.
Za določitev trajanja zaščite so bile izvedene študije dolgoročnega spremljanja.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to cepivo.
The safety and efficacy of Gardasil in children below 9 years of age have not been established.
Varnost in učinkovitost cepiva Gardasil pri otrocih, mlajših od 9 let, nista bili dokazani.
IM use.
uporaba.
The data on Gardasil administered during pregnancy did not indicate any safety signal.
Podatki o uporabi cepiva Gardasil med nosečnostjo niso pokazali nobenega signala glede varnosti.
However, these data are insufficient to recommend use of Gardasil during pregnancy.
Vendar pa ti podatki ne zadostujejo za priporočilo uporabe cepiva Gardasil med nosečnostjo.
Gardasil may not have an optimal effect if: • used with medicines that suppress the immune system.
Optimalni učinek cepiva Gardasil morda ne bo dosežen: • v primeru sočasne uporabe zdravil, ki zavirajo imunski sistem.
Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Študije toksičnosti pri enkratnem in ponavljajočih se odmerkih ter tolerančne študije ne kažejo posebnega tveganja za človeka.
Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Gardasil worldwide.
Preglednica 1 vključuje tudi dodatne neželene učinke, o katerih so spontano poročali v obdobju trženja cepiva Gardasil po vsem svetu.
CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
CIN 3 in AIS sta potrjeno neposredni predstopnji invazivne oblike raka materničnega vratu.
Use of hormonal contraceptives did not appear to affect the immune response to Gardasil.
Kaže, da uporaba hormonskih kontraceptivov ni vplivala na imunski odziv na cepivo Gardasil.
• you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”- see section 6).
• če ste vi ali vaš otrok alergični (preobčutljivi) na katero koli zdravilno učinkovino ali drugo sestavino cepiva Gardasil (navedene so pod “Pomožne snovi so”- glejte poglavje 6);
In 7 clinical trials (6 placebo-controlled), individuals were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
V 7 kliničnih preskušanjih (6 nadzorovanih s placebom) so osebe cepivo Gardasil ali placebo prejele na dan vključitve in nato približno čez 2 in 6 mesecev.
Administer the entire dose as per standard protocol.
Aplicirajte celotni odmerek cepiva kot po standardnem protokolu.
Gardasil is intended to prevent these diseases.
Cepivo Gardasil je namenjeno preprečitvi teh bolezni.
If you are from 14 years of age
Če ste stari 14 let ali več
The use of Gardasil in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.
Pri uporabi cepiva Gardasil pri odraslih ženskah je treba upoštevati variabilnost v razširjenosti tipa HPV na različnih geografskih področjih.
The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
Nastajanje tipsko specifičnih protiteles povzroči tudi pri 9 do 15 let starih otrocih in mladostnikih.
Since no vaccine is 100% effective and Gardasil 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 učinkovitost nobenega cepiva ni 100-odstotna in ker cepivo Gardasil ne ščiti pred vsemi tipi HPV oziroma pred že obstoječimi okužbami, rutinska presejanja raka materničnega vratu ostajajo kritičnega pomena in jih je treba izvajati v skladu z lokalnimi priporočili.
Patients were followed for up to 4 years (median 3.6 years).
Bolnice so spremljali do 4 leta (mediana 3,6 let).
The use of Gardasil should be in accordance with official recommendations.
Cepivo Gardasil je treba uporabljati v skladu z uradnimi priporočili.
AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of this observation is not known.
Geometrijski srednji titri protiteles anti-HB so bili pri sočasni uporabi nižji, vendar pa klinični pomen te ugotovitve ni znan.
Gardasil may be given to women who are breast-feeding or intend to breast-feed.
Cepivo Gardasil se lahko daje ženskam, ki dojijo ali nameravajo dojiti.
Gardasil is intended for adolescents and adults from 9 years of age onwards.
Cepivo Gardasil je namenjeno za mladostnike in odrasle od 9. leta starosti dalje.
The duration of immunity following a 3-dose series has been observed for up to 14 years post-vaccination.
Trajanje imunosti po cepljenju s 3 odmerki so opazili do 14 let po cepljenju.
HIV infected subjects
Osebe, okužene s HIV
Among 15,706 individuals who received Gardasil and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Gardasil group and 15 in the placebo group.
Med 15.706 osebami, ki so prejele Gardasil, in 13.617 osebami, ki so prejele placebo, je bilo 39 poročil o primeru nespecifičnega artritisa/artropatije: 24 v skupini, ki je prejela Gardasil, in 15 v skupini, ki je prejela placebo.
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Med kliničnimi preskušanji peroralni ali drugi kontraceptivi (npr. kontracepcijske tablete) niso zmanjšali zaščite, dosežene s cepivom Gardasil.
Post-Marketing Experience
Izkušnje v obdobju trženja
Persistence of Immune Response of Gardasil
Persistenca imunskega odziva cepiva Gardasil
Gardasil has not been shown to have a therapeutic effect.
Ni bilo dokazano, da bi cepivo Gardasil imelo terapevtski učinek.
In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Gardasil used hormonal contraceptives during the vaccination period.
V kliničnih študijah je 57,5 % žensk, starih 16 do 26 let, in 31,2 % žensk, starih 24 do 45 let, ki so prejele cepivo Gardasil, v obdobju cepljenja uporabljalo hormonske kontraceptive.
Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions*
Neznana preobčutljivostne reakcije vključno z anafilaktičnimi/anafilaktoidnimi reakcijami*
Gardasil is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Cepivo Gardasil je samo za profilaktično uporabo in nima učinka na aktivne okužbe s HPV ali na dokazano klinično bolezen.
At the end of this period Gardasil should be used or discarded.
Ob koncu tega obdobja je treba cepivo Gardasil ali uporabiti ali zavreči.
An academic study documenting safety and immunogenicity of Gardasil has been performed in 126 HIV infected subjects aged from 7-12 years (of which 96 received Gardasil).
Akademska študija, v kateri so dokumentirali varnost in imunogenost cepiva Gardasil, je bila izvedena pri 126 s HIV okuženih osebah, starih od 7 do 12 let (od katerih jih je 96 prejelo cepivo Gardasil).
What Gardasil looks like and contents of the pack 1 dose of Gardasil suspension for injection contains 0.5 ml.
Izgled cepiva Gardasil in vsebina pakiranja 1 odmerek cepiva Gardasil suspenzija za injiciranje vsebuje 0,5 ml suspenzije.
The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
Srednji geometrijski titri so bili nekoliko nižji od tistih, poročanih pri enako starih s HIV neokuženih osebah v drugih študijah.
Efficacy in women 24 through 45 years
Učinkovitost pri ženskah, starih 24 do 45 let
Duration of protection of a 2-dose schedule of Gardasil has not been established.
Trajanje zaščite po 2-odmerni shemi cepljenja s cepivom Gardasil ni bilo ugotovljeno.
HPV only infects humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP vaccines is mediated by the development of a humoral immune response.
S HPV se okuži le človek, vendar pa študije z analognimi papilomavirusi na živalih kažejo, da je učinkovitost L1 VLP cepiv posledica spodbujanja humoralnega imunskega odziva.
Gardasil cannot cause the diseases it protects against.
Cepivo Gardasil ne more povzročiti bolezni, pred katerimi ščiti.
HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
HPV tipa 6 in 11 sta odgovorna za približno 90 % primerov bradavic na spolovilih.
B. PACKAGE LEAFLET (VIAL)
B. NAVODILO ZA UPORABO (VIALA)
1 dose, 0.5 ml.
1 odmerek, 0,5 ml
What other important information should you or your child know about Gardasil
Drugi pomembni podatki o cepivu Gardasil, ki jih morate vi ali vaš otrok poznati
Gardasil is a vaccine.
Gardasil je cepivo.
The studies were not powered to assess efficacy against disease caused by individual HPV types.
Študije niso omogočale vrednotenja učinkovitosti proti boleznim, ki jih povzročajo posamezni tipi HPV.
There are no safety, immunogenicity or efficacy data to support change during vaccination with Gardasil to other HPV vaccines which do not cover the same HPV types.
Podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi med obdobjem cepljenja s cepivom Gardasil podpirali zamenjavo z drugimi cepivi proti HPV, ki ne vključujejo enakih tipov HPV, ni na voljo.
Placebo % Efficacy at 2 years
Gardasil Placebo učinkovitosti po 2 letih odstotni IZ)
Safety was evaluated in either the entire study population (6 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil or placebo.
Varnost so vrednotili bodisi pri celotni populaciji, vključeni v študijo (6 študij), bodisi pri vnaprej določeni podskupini (1 študija) v študijo vključene populacije, na osnovi 14-dnevnega nadzora po vsakem injiciranju cepiva Gardasil ali placeba s pomočjo kartončkov za poročanje (vaccination report card (VRC)-aided surveillance).
At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3doses, n = 86) for all 4 HPV types.
Pri spremljanju v 36. mesecu je GMT pri deklicah (2 odmerka, n = 86) ostal neinferioren od GMT pri ženskah (3 odmerki, n = 86) za vse 4 tipe HPV.
Not known Injection-site cellulitis *
Neznana celulitis na mestu injiciranja*
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Not known Idiopathic thrombocytopenic purpura*, lymphadenopathy*
Neznana idiopatska trombocitopenična purpura*, limfadenopatija*
Not all pack sizes are marketed.
Na trgu ni vseh navedenih pakiranj.
9- to 15-Year-Old Boys
Dečki, stari od 9 do 15 let
No effects on male fertility were observed in rats (see section 5.3).
Pri podganah niso ugotovili učinkov na plodnost samcev (glejte poglavje 5.3).
Immune Responses to Gardasil at 1 month post dose 3
Imunski odziv na cepivo Gardasil 1 mesec po 3. odmerku
Gardasil must not be injected intravascularly.
Cepiva Gardasil se ne sme injicirati intravaskularno.
This population approximates to the general population of men with respect to prevalence of HPV infection or disease at enrolment.
Ta populacija je približek splošne populacije moških glede na prevalenco okužbe s HPV ali bolezni zaradi HPV ob vključitvi.
adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
20 μg adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,225 mg Al)
Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (See section 5.1).
Cepivo Gardasil ščiti le pred boleznimi, ki jih povzročajo tipi 6, 11, 16 in 18 HPV, ter v določeni meri pred boleznimi, ki jih povzročajo določeni sorodni tipi HPV (glejte poglavje 5.1).
Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.
Osebe, pri katerih se po prejemu odmerka cepiva Gardasil pojavijo simptomi preobčutljivosti, nadaljnjih odmerkov cepiva Gardasil ne smejo prejeti.
Common Pain in extremity Not known Arthralgia*, Myalgia*
Pogosti bolečine v okončini Neznana artralgija*, mialgija*
When Gardasil is given as your first dose, the completion of the vaccination course should be done with Gardasil, and not with another HPV vaccine.
Če kot prvi odmerek prejmete cepivo Gardasil, morate cepljenje dokončati s cepivom Gardasil in ne s katerim drugim cepivom proti HPV.
Gardasil does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Cepivo Gardasil ne učinkuje pri osebah, ki že imajo persistentno okužbo ali bolezen, povezano s katerim koli tipom HPV, ki ga vsebuje cepivo.
Clinical Studies
Klinične študije
• you or your child developed an allergic reaction after receiving a dose of Gardasil.
• če se je pri vas ali vašem otroku po cepljenju z odmerkom cepiva Gardasil pojavila alergijska reakcija;
Table 1: Adverse Events Following Administration of Gardasil from Clinical Trials and PostMarketing Surveillance
Preglednica 1: Neželeni učinki po uporabi cepiva Gardasil med kliničnimi preskušanji in spremljanjem v obdobju trženja
At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Gardasil (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Gardasil (at 0, 2, 6 months).
V 7. mesecu je bil imunski odziv v populaciji per protocol pri deklicah, starih od 9 do 13 let (n = 241), ki so prejele 2 odmerka cepiva Gardasil (v 0. in 6. mesecu), neinferioren in je bil številčno večji kot imunski odziv pri ženskah, starih od 16 do 26 let (n = 246), ki so prejele 3 odmerke cepiva Gardasil (v 0., 2. in 6. mesecu).
At end of study, individuals enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Na koncu študije je bil čas spremljanja oseb, vključenih v dve študiji III. faze (Protokol 013 in Protokol 015), do 4 leta (mediana 3,7 let).
It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil (see section 4.4).
Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Gardasil, cepljenje dokončajo s cepivom Gardasil (glejte poglavje 4.4).
In addition, a subset of vaccinated women who received a challenge dose of Gardasil 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Razen tega so pri cepljenih ženskah, ki so 5 let po začetku cepljenja prejele obnovitveni odmerek cepiva Gardasil opazili hiter in močan anamnestični odziv, ki je presegel srednje geometrijske titre anti HPV, opažene 1 mesec po cepljenju s 3. odmerkom.
The concomitant administration of Gardasil with vaccines other than the ones above has not been studied.
Sočasnega cepljenja s cepivom Gardasil in z drugimi cepivi (razen z zgoraj naštetimi) niso raziskali.
Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.
Ženske, ki so pred cepljenjem že bile okužene z enim ali več tipi HPV, ki jih vsebuje cepivo, so bile zaščitene pred klinično boleznijo zaradi preostalih tipov HPV, ki jih vsebuje cepivo.
Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Preglednica 4: Rezultati za CIN 2/3 ali AIS pri osebah, ki še niso bile okužene s tipsko specifičnimi HPV
The vaccine is therefore, not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts.
Cepivo torej ni indicirano za zdravljenje raka na materničnem vratu, cervikalnih, vulvarnih in vaginalnih displastičnih sprememb visoke stopnje ali bradavic na spolovilih.
Intramuscular (IM) use.
Intramuskularna (i.m.)