natgillin/translations-raw huggingface dataset:
What Cerezyme looks like and contents of the pack Cerezyme, 200 U, is presented as a powder for concentrate for solution for infusion (in a vial- pack size of 1 or 25).
Izgled zdravila Cerezyme in vsebina pakiranja Cerezyme, 200 enot, je na voljo v obliki praška za koncentrat za raztopino za infundiranje (v vialah, pakiranih po 1 ali 25).
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, 1411 DD, Naarden, The Netherlands
Imetnik dovoljenja za promet z zdravilom Genzyme Europe B. V., Gooimeer 10, 1411 DD, Naarden, Nizozemska
Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Izdelovalec Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Združeno kraljestvo
30 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
30 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
España Genzyme, S. L., Tel: +34 91 6591670 France Genzyme S. A. S, Tél: + 33 (0) 825 825 863 Italia/ Malta Genzyme Srl (Italia/ Italja), Tel: +39 059 349811
España Genzyme, S. L., Tel: +34 91 6591670 France Genzyme S. A. S, Tél: + 33 (0) 825 825 863
This leaflet was last approved in:
Navodilo je bilo odobreno:
< ------------------------------------------------------------------------------------------------------------------------------
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju. ------------------------------------------------------------------------------------------------------------------------------
Instructions for use – reconstitution, dilution and administration Each vial of Cerezyme is for single use only.
Navodila za uporabo – priprava raztopine, redčenje in dajanje Vsaka viala zdravila Cerezyme je namenjena samo enkratni uporabi.
After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Po pripravi raztopine vsaka viala zdravila Cerezyme vsebuje 200 enot imigluceraze v 5, 0 ml (40 enot na ml).
31 Use Aseptic Technique Reconstitution Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Narahlo premešajte, da se raztopina ne bi začela peniti.
The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Volumen pripravljene raztopine v vsaki viali zadošča za natančen odvzem nominalnega volumna, ki je 5, 0 ml (ustreza 200 enotam).
Administration It is recommended that the diluted solution be administered within 3 hours.
Dajanje Razredčeno raztopino je priporočljivo uporabiti v 3 urah.
The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Z 0, 9% raztopino natrijevega klorida za intravensko uporabo razredčeno zdravilo je kemično stabilno 24 ur pri temperaturi od 2 do 8ºC in zaščiteno pred svetlobo; mikrobiološka neoporečnost zdravila pa zavisi od uporabe aseptične tehnike pri pripravi in redčenju raztopine.
32 PACKAGE LEAFLET:
32 NAVODILO ZA UPORABO
Cerezyme 400 U powder for concentrate for solution for infusion Imiglucerase
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Imigluceraza
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, and who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleeding easily (due to low numbers of platelets– a type of blood cell), spleen or liver enlargement or bone disease.
Zdravilo Cerezyme se uporablja za zdravljenje bolnikov, pri katerih so potrdili diagnozo Gaucherjeve bolezni tipa 1 ali tipa 3 in ki kažejo znake bolezni, kot so: anemija (nizko število rdečih krvničk), nagnjenost h krvavitvam (zaradi nizkega števila trombocitov – vrste krvnih celic), povečanja vranice ali jeter ali bolezen kosti.
Cerezyme is an artificial enzyme called imiglucerase -this can replace the natural enzyme β - glucocerebrosidase which is lacking or not active enough in patients with Gaucher disease.
Cerezyme je umetni encim, ki se imenuje imigluceraza in lahko nadomesti naravni encim β - glukocerebrozidazo, ki pri bolnikih z Gaucherjevo boleznijo manjka ali pa ni dovolj aktiven.
- Some patients with Gaucher disease have high blood pressure in the lungs (pulmonary
- Nekateri bolniki z Gaucherjevo boleznijo imajo visok krvni pritisk v pljučih (pljučna
33 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
34 If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.
34 Če opazite katerikoli resen neželeni učinek ali neželeni učinek, ki ni omenjen v tem navodilu, nemudoma obvestite svojega zdravnika.
Common side effects (occurring in more than 1 in 100 patients) are:
Pogosti neželeni učinki (pojavijo se pri več kot 1 od 100 bolnikov)
35 Medicines should not be disposed of via wastewater or household waste.
35 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Cerezyme looks like and contents of the pack Cerezyme, 400 U, is presented as a powder for concentrate for solution for infusion (in a vial- pack size of 1, 5 or 25).
Izgled zdravila Cerezyme in vsebina pakiranja Cerezyme, 400 enot, je na voljo v obliki praška za koncentrat za raztopino za infundiranje (v vialah, pakiranih po 1, 5 ali 25).
36 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
36 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Po pripravi raztopine vsaka viala zdravila Cerezyme vsebuje 400 enot imigluceraze v 10, 0 ml (40 enot na ml).
37 Use Aseptic Technique Reconstitution Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Narahlo premešajte, da se raztopina ne bi začela peniti.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Volumen pripravljene raztopine v vsaki viali zadošča za natančen odvzem nominalnega volumna, ki je 10, 0 ml (ustreza 400 enotam).
What is Cervarix?
Kaj je zdravilo Cervarix?
It is a suspension for injection that contains purified ‘ L1 proteins ’ for two types of the human papillomavirus (types 16 and 18).
Gre za suspenzijo za injiciranje, ki vsebuje prečiščene „ beljakovine L1 “ za dva tipa humanega papiloma virusa (tipov 16 in 18).
It is available in a vial or in a prefilled syringe.
Na voljo je v viali ali predhodno napolnjeni injekcijski brizgi.
What is Cervarix used for?
Za kaj se zdravilo Cervarix uporablja?
Cervarix is used to protect against precancerous lesions (abnormal cell growth) in the cervix and cancer of the cervix that are caused by infection with human papillomavirus (HPV) types 16 or 18.
Zdravilo Cervarix se uporablja za preprečevanje predrakavih sprememb (nenormalne rasti celic) na materničnem in raka materničnega vratu, ki jih povzroča okužba z humanim papiloma virusom (HPV) tipov 16 ali 18.
This use is based on demonstration of the effectiveness of Cervarix in women aged 15 to 25 years, and of its immunogenicity (its ability to make the immune system respond to the vaccine) in girls and women aged 10 to 25 years.
Ta uporaba temelji na prikazu učinkovitosti zdravila Cervarix pri ženskah, starih 15 do 25 let, in njegove imunogenosti (sposobnosti, da vzbudi odziv imunskega sistema na cepivo) pri dekletih in ženskah, starih od 10 do 25 let.
Cervarix is given according to official recommendations.
Zdravilo Cervarix se daje v skladu z uradnimi priporočili.
How is Cervarix used?
Kako se zdravilo Cervarix uporablja?
Cervarix is given to individuals aged 10 years or older, as three doses, with one month between the first and second doses, and five months between the second and third doses.
Zdravilo Cervarix se daje posameznicam, starim 10 let ali več, v obliki treh odmerkov, pri čemer sledi drugi odmerek en mesec po prvem, tretji pa pet mesecev po drugem.
It is recommended that individuals who receive the first dose of Cervarix should complete all three doses with Cervarix.
Priporočljivo je, da posameznice, ki prejmejo prvi odmerek cepiva Cervarix, dokončajo zdravljenje z vsemi tremi odmerki zdravila Cervarix.
The vaccine is given as an injection into the muscle of the upper arm.
Cepivo se daje z injekcijo v mišico nadlakti.
Cervarix is not recommended for use in girls aged below 10 years, due to a lack of information on safety and immunogenicity in this group.
Uporaba zdravila Cervarix pri dekletih, mlajših od 10 let, zaradi pomanjkanja informacij o varnosti in imunogenosti v tej skupini ni priporočljiva.
How does Cervarix work?
Kako zdravilo Cervarix deluje?
There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Obstaja več kot 100 tipov virusov papiloma, nekateri med njimi se povezujejo z raki genitalnega predela.
HPV types 16 and 18 cause approximately 70% of cervical cancers.
HPV tipov 16 in 18 povzročijo približno 70% vseh primerov raka materničnega vratu.
All papillomaviruses have a shell or ‘ capsid’, which is made up of proteins called ‘ L1 proteins’.
Vsi virusi papiloma imajo plašč ali „ kapsido “ iz beljakovin, imenovanih „ L1 beljakovine “.
Cervarix contains purified L1 proteins for two of the types of HPV: types 16 and 18.
Zdravilo Cervarix vsebuje prečiščene beljakovine L1 za dva tipa HPV, in sicer tipa 16 in 18.
The proteins in Cervarix are produced by a method known as ‘ recombinant DNA technology’: they are made by a cell that has received a gene (DNA) that makes it able to produce the L1 proteins.
Beljakovine v zdravilu Cervarix se proizvajajo po metodi, imenovani „ rekombinantnea DNK tehnologija “: tvori jih celica, ki je prejela gen (DNK), ki ji omogoča tvorjenje beljakovin L1.
The proteins are assembled in ‘ virus-like particles’ (structures that look like HPV, so that the body can recognise them
Beljakovine tvorijo virusu podobne delce (strukture, ki so podobne virusu HPV, tako da jih telo zlahka prepozna).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Cepivo se 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The vaccine is made using an ‘ adjuvant system ’ that contains MPL, a purified lipid (a fat-like substance) extracted from bacteria, which acts as an immunostimulant: it enhances the response of the immune system (the system that fights diseases) to the vaccine.
Reproduction is authorised provided the source is acknowledged. proizvaja ob uporabi „ adjuvansnega sistema “, ki vsebuje MPL, prečiščen bakterijski lipid (snov, podobno maščobam), pridobljen iz bakterije, ki učinkuje kot imunostimulant: ta stopnjuje odziv imunskega sistema (sistema, ki ščiti telo pred boleznimi) na cepivo.
The vaccine is ‘ adsorbed’, which means that the L1 protein virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.
Cepivo je adsorbirano, kar pomeni, da so virusu podobni delci z beljakovino L1 ter MPL vezani na aluminijevo spojino, kar spodbudi boljši imunski odziv.
When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Ko bolnica prejme cepivo, začne imunski sistem tvoriti protitelesa za beljakovine L1.
The antibodies help to destroy the virus.
Protitelesa pomagajo pri uničevanju virusa.
After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the viruses.
Po cepljenju je imunski sistem ob morebitni ponovni izpostavitvi virusom zmožen hitreje izdelati protitelesa.
How has Cervarix been studied?
Kako je bilo zdravilo Cervarix raziskano?
The effects of Cervarix were first tested in experimental models before being studied in humans.
Učinki zdravila Cervarix so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study involved almost 19,000 women aged between 15 and 25 years.
V glavno študijo je bilo vključenih skoraj 19 000 žensk, starih med 15 in 25 let.
Cervarix was compared to another vaccine, which is not active against HPV (in this case, a vaccine against hepatitis A virus).
Zdravilo Cervarix so primerjali z drugim cepivom, ki ni aktivno proti HPV (v tem primeru je šlo za cepivo proti virusu hepatitisa A).
The study looked at how many women who were originally uninfected with HPV types 16 and 18 went on to develop precancerous lesions in the cervix linked to infection with these types of HPV.
V študiji so ugotavljali, pri koliko ženskah, ki prvotno niso bile okužene s HPV tipov 16 in 18, so se pozneje pojavile predrakave spremembe na materničnem vratu, povezane z okužbo s tema dvema tipoma HPV.
The study was still ongoing at the time of the assessment and will continue for up to four years.
V času vrednotenja zdravila je študija še vedno potekala in se bo nadaljevala še največ štiri leta.
An additional two studies also looked at the development of antibodies to HPV types 16 and 18 in 2,225 girls aged between 10 and 14 years.
V dveh dodatnih študijah so prav tako preučevali razvoj protiteles za HPV tipov 16 in 18 pri 2 225 dekletih, starih od 10 do 14 let.
The studies compared the levels of antibodies between before vaccination and after the third dose (at month seven).
V študijah so primerjali ravni protiteles pred cepljenjem in po tretjem odmerku (v sedmem mesecu).
What benefit has Cervarix shown during the studies?
Kakšne koristi je zdravilo Cervarix izkazalo med študijami?
Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix.
Zdravilo Cervarix je bilo pri preprečevanju nenormalne rasti celic na materničnem vratu učinkovitejše od primerjalnega zdravila.
In the main study, after an average of 15 months, two of the almost 8,000 women receiving at least one dose of Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in cervix linked to these HPV types.
V glavni študiji so se v povprečju po 15 mesecih pri dveh od skoraj 8 000 žensk, ki so prejele vsaj en odmerek zdravila Cervarix in ki predhodno niso bile okužene s HPV tipov 16 ali 18, pojavile predrakave spremembe na materničnem vratu zaradi teh dveh tipov HPV.
This compared with 21 of the almost 8,000 women receiving the other vaccine.
To vrednost je treba primerjati z 21 od skoraj 8 000 žensk, ki so prejele drugo cepivo.
The additional studies showed that all of the girls aged 10 to 14 years who were given Cervarix developed protective levels of antibodies against HPV types 16 and 18.
Dodatni študiji sta pokazali, da so se pri vseh dekletih, starih od 10 do 14 let, ki so prejele zdravilo Cervarix, razvile zaščitne ravni protiteles proti HPV tipov 16 in 18.
This indicated that the vaccine is likely to be effective in preventing HPV infection in girls from the age of 10 years.
To nakazuje na verjetnost, da bi bilo cepivo učinkovito pri preprečevanju okužbe s HPV pri dekletih od 10. leta starosti dalje.
What is the risk associated with Cervarix?
Kakšna tveganja so povezana z zdravilom Cervarix?
The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Cervarix (opaženi pri več kot 1 bolnici od 10) so glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja, vključno z bolečino, rdečino in oteklino, ter utrujenost.
For the full list of all side effects reported with Cervarix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cervarix, glejte navodilo za uporabo.
Cervarix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Zdravila Cervarix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
Vaccination should be postponed in patients who are ill with a high fever.
Pri bolnikih, ki so bolni in imajo visoko vročino, je treba cepljenje odložiti.
Why has Cervarix been approved?
Zakaj je bilo zdravilo Cervarix odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cervarix’ s benefits are greater than its risks for the prevention of premalignant cervical lesions and cervical cancer causally related to HPV types 16 and 18.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Cervarix pri preprečevanju predrakavih sprememb na materničnem vratu in raka materničnega vratu, nastalega kot posledica HPV tipov 16 in 18, večje od z njim povezanih tveganj.
The Committee recommended that Cervarix be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Cervarix odobri dovoljenje za promet.
Other information about Cervarix:
Druge informacije o zdravilu Cervarix:
The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix to GlaxoSmithKline Biologicals s. a. on 20 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom Cervarix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 20. septembra 2007.
The full EPAR for Cervarix can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cervarix je na voljo tukaj.
Strength
Jakost -- 1
10 pre-filled syringes + 10 needles
10 napolnjenih injekcijskih brizg + 10
10 pre-filled syringes + 20 needles
injekcijskih brizg + 20
--1
-- 1 -- 1
1
1 20 µg / 20 µg humani virus papiloma - 16 / human virus papiloma - 18 L1 proteini
Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix suspenzija za injiciranje Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
1 dose (0.5 ml) contains:
1 odmerek (0, 5 ml) vsebuje:
Human Papillomavirus1 type 16 L1 protein2,3,4 Human Papillomavirus1 type 18 L1 protein2,3,4 1 Human Papillomavirus = HPV 2 adjuvanted by AS04 containing:
L1 protein2, 3, 4 genotipa 16 humanega virusa papiloma1 L1 protein2, 3, 4 genotipa 18 humanega virusa papiloma1 1 humani virus papiloma = HPV 2 z adjuvansom AS04, ki vsebuje:
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)3 3
3- O- desacil- 4 ’ - monofosforil lipid A (MPL) 3 3 adsorbiran na hidratirani aluminijev hidroksid (Al( OH) 3) 4
50 micrograms
50 mikrogramov 0, 5 miligrama Al3+ v celoti
0.5 milligrams Al3+ in total
L1 protein v obliki nekužnih virusu podobnih delcev (VLPs, “ virus- like particles ”), pridobljenih s tehnologijo rekombinantne DNA s pomočjo bakulovirusnega ekspresijskega sistema na osnovi Hi - 5 Rix4446 celic, pridobljenih iz Trichoplusia ni.
Upon storage, a fine white deposit with a clear colourless supernatant may be observed.
Med shranjevanjem se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
Cervarix is a vaccine for the prevention of premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 (see section 5.1).
Cepivo Cervarix je indicirano za preprečevanje predrakavih sprememb na materničnem vratu in raka materničnega vratu, ki so posledica okužbe z genotipoma 16 in 18 humanih virusov papiloma (HPV) (glejte poglavje 5. 1).
The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 10-25 years.
Indikacija temelji na dokazu učinkovitosti cepiva Cervarix po cepljenju pri ženskah, starih od 15 do 25 let, in dokazu imunogenosti cepiva pri ženskah, starih od 10 do 25 let.
See section 5.1 for information on the evidence that supports the efficacy of Cervarix in prevention of premalignant cervical lesions associated with HPV-16 and/ or HPV-18.
Za podatke o učinkovitost cepiva Cervarix pri preprečevanju predrakavih sprememb na materničnem vratu, povezanih s HPV- 16 in/ ali HPV- 18, glejte poglavje 5. 1.
The recommended vaccination schedule is 0, 1, 6 months.
Priporočena shema cepljenja je 0., 1. in 6. mesec.
The need for a booster dose has not been established (see section 5.1).
2 Potrebnost obnovitvenega odmerka ni bila dokazana (glejte poglavje 5. 1).
2 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).
Cervarix is not recommended for use in girls below 10 years of age due to lack of data on safety and immunogenicity in this age-group.
Deklice, mlajše od 10 let:
Cervarix is for intramuscular injection in the deltoid region (see also sections 4.4 and 4.5).
Zaradi pomanjkanja podatkov o varnosti in imunogenosti uporaba Cepiva Cervarix pri deklicah, mlajših od 10 let, ni priporočljiva.
Cervarix should under no circumstances be administered intravascularly or intradermally.
Cepiva Cervarix se v nobenem primeru ne sme injicirati v žilo ali v kožo.
Vaccination is not a substitute for regular cervical screening or for precautions against exposure to HPV and sexually transmitted diseases.
Cepljenje ne more nadomestiti rednih presejalnih testov za zgodnje odkrivanje raka materničnega vratu ali preventivnih ukrepov za preprečevanje okužbe s HPV in spolno prenosljivih bolezni.
Cervarix protects against disease caused by HPV types 16 and 18.
Cepivo Cervarix ščiti pred boleznimi, ki jih povzročata genotipa 16 in18 HPV.
Other oncogenic HPV types can also cause cervical cancer and therefore routine cervical screening remains critically important and should follow local recommendations.
Rak materničnega vratu lahko povzročijo tudi drugi onkogeni genotipi HPV, zato rutinska presejanja raka materničnega vratu ostajajo kritičnega pomena in jih je treba izvajati v skladu z lokalnimi priporočili.
Cervarix has not been shown to have a therapeutic effect.
Ni bilo dokazano, da bi cepivo Cervarix imelo terapevtski učinek.
The vaccine is therefore not indicated for treatment of cervical cancer, cervical intraepithelial neoplasia (CIN) or any other established HPV- related lesions.
Cepivo torej ni indicirano za zdravljenje raka materničnega vratu, cervikalne intraepitelijske neoplazije (CIN) ali drugih sprememb, povezanih s HPV.
Cervarix does not prevent HPV-related lesions in women who are infected with HPV-16 or HPV-18 at the time of vaccination.
Pri ženskah, ki so v času cepljenja že okužene s HPV- 16 ali HPV- 18, cepivo Cervarix ne more preprečiti razvoja s HPV povezanih sprememb.
Timing and need of booster dose(s) has not been investigated.
Časovnega okvira in potrebe po cepljenju z obnovitvenim odmerkom (obnovitvenimi odmerki) niso raziskovali.
There are no data on the use of Cervarix in subjects with impaired immune responsiveness such as HIV infected patients or patients receiving immunosuppressive treatment.
O uporabi cepiva Cervarix pri osebah z okvaro imunskega odziva, kot so bolniki, okuženi z virusom HIV, ali bolniki, ki se zdravijo z imunosupresivnimi oblikami zdravljenja, ni podatkov.