natgillin/translations-raw huggingface dataset:
Allergic reaction in the eye, cataract, darkening of the eyelashes, darkening of the iris colour, dizziness, high blood pressure, an increase in blood test results that show how your liver is working, cold, effects on the heart beat, heart failure, increased heart rate, low blood pressure, skin rash, cough, dry mouth, hair loss, nightmares, reduced sexual urge, memory loss, tiredness, ringing in the ears and a worsening of myasthenia gravis (increased muscle weakness).
Naslednje neželene učinke so opazili, pri uporabi bimatoprosta ali timolola in se lahko pojavijo tudi pri zdravilu GANFORT: alergijske reakcije v očesu, katarakta, temnenje trepalnic, temnenje irisa (šarenice), omotica, visok krvni tlak, povišane vrednosti krvnih testov, ki kažejo delovanje jeter, prehlad, vpliv na srčni utrip, srčno popuščanje, pospešen srčni utrip, nizek krvni tlak, kožni izpuščaj, kašelj, suha usta, izpadanje las, nočne more, zmanjšana spolna sla, izguba spomina, utrujenost, zvonjenje v ušesih in poslabšanje miastenije gravis (povečanje mišične oslabelosti).
HOW TO STORE GANFORT
SHRANJEVANJE ZDRAVILA GANFORT
Do not use GANFORT after the expiry date which is stated on the bottle label and the carton after EXP:.
Zdravila GANFORT ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in plastenki, za oznako » EXP: «.
What GANFORT contains
Kaj vsebuje zdravilo GANFORT
• The active substances are bimatoprost 0.3 mg/ ml and timolol 5 mg/ ml corresponding to timolol maleate 6.8 mg/ ml.
• Zdravilni učinkovini sta bimatoprost 0, 3 mg/ ml in timolol 5 mg/ ml, v obliki 6, 8 mg/ ml timololijevega maleata.
Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH level.
Dodana je lahko majhna količina klorovodikove kisline ali natrijevega hidroksida za uravnavanje vrednosti pH.
What GANFORT looks like and contents of the pack GANFORT is a colourless, clear eye drop solution in a plastic bottle.
Izgled zdravila GANFORT in vsebina pakiranja Zdravilo GANFORT je brezbarvna, prozorna tekočina v plastenki.
Each bottle is about half full and contains 3 millilitres of solution.
Vsako pakiranje vsebuje 1 ali 3 plastenke, z navojno zaporko.
This is enough for 4 weeks’ usage.
To zadošča za 4- tedensko uporabo.
Marketing Authorisation Holder and Manufacturer Allergan Pharmaceuticals Ireland Castlebar Road Westport Co.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Allergan Pharmaceuticals Ireland Castlebar Road Westport Co.
België/ Belgique/ Belgien Allergan n. v.
Belgija Allergan n. v.
8 1164 София
8
Тел.: +359 2 962 12 00 E-mail: uk_medinfo@allergan. com
1164 София Тел.: +359 2 962 12 00 E- mail: uk_ medinfo@ allergan. com
24 España Allergan S. A. U Edificio la Encina Plaza de la Encina, 10-11 E-28760 Tres Cantos Madrid Tel: + 34 91 807 6130 E-mail: uk_medinfo@allergan. com
24 Espana Allergan S. A. U Edificio la Encina Plaza de la Encina, 10- 11 E- 28760 Tres Cantos Madrid Tel: + 34 91 807 6130 E- mail: uk_ medinfo@ allergan. com
Strength
jakost -- 1
1 pre-filled syringe with needle guard
1 napolnjena injekcijska brizga z varovalom za iglo
10 pre-filled syringes with needle guard
10 napolnjenih injekcijskih brizg z varovalom za iglo
20 pre-filled syringes with needle guard
20 napolnjenih injekcijskih brizg z varovalom za iglo
1 pre-filled syringe with needle guard + 1 needle
1 napolnjena injekcijska brizga z varovalom za iglo + 1 igla
0.5 ml
napolnjena injekcijska 0, 5 ml brizga
10 pre-filled syringes with needle guard + 10 needles
10 napolnjenih injekcijskih brizg z varovalom za iglo + 10 igel
20 pre-filled syringes with needle guard + 20 needles
20 napolnjenih injekcijskih brizg z varovalom za iglo + 20 igel
1 pre-filled syringe with needle guard + 2 needles
1 napolnjena injekcijska brizga z varovalom za iglo + 2 igli
10 pre-filled syringes with needle guard + 20 needles
10 napolnjenih injekcijskih brizg z varovalom za iglo + 20 igel
0.5 ml
napolnjena injekcijska 0, 5 ml
20 pre-filled syringes with needle guard + 40 needles
20 napolnjenih injekcijskih
approximately:
1 odmerek (0, 5 ml) vsebuje približno:
Human Papillomavirus¹ Type 6 L1 protein², ³ Human Papillomavirus¹ Type 11 L1 protein², ³ Human Papillomavirus¹ Type 16 L1 protein², ³ Human Papillomavirus¹ Type 18 L1 protein², ³
L1 protein2, 3 humanega papilomavirusa1 tipa 6 L1 protein2, 3 humanega papilomavirusa1 tipa 11 L1 protein2, 3 humanega papilomavirusa1 tipa 16 L1 protein2, 3 humanega papilomavirusa1 tipa 18 1 humani papilomavirus = HPV 2
² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
L1 protein v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C- 5 (sev 1895)) 3 adsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (225 mikrogramov Al)
It is a suspension for injection that contains purified proteins from four types of the human papillomavirus (types 6, 11, 16 and 18).
Gre za suspenzijo za injiciranje, ki vsebuje prečiščene beljakovine iz štirih tipov humanih papilomavirusov (tipe 6, 11, 16 in 18).
What is Gardasil used for?
Kaj je zdravilo Gardasil?
Gardasil is used to vaccinate against precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina), cancer of the cervix and genital warts that are caused by infection with the human papillomavirus (HPV) types 6, 11, 16 or 18.
Zdravilo Gardasil se uporablja za cepljenje proti predrakavim lezijam (nenormalni rasti celic) na področju genitalij (materničnega vratu, zunanjega ali notranjega ženskega spolovila), raku materničnega vratu in bradavicam na spolovilu, ki jih povzroča okužba s humanimi papilomavirusi (HPV) tipov 6, 11, 16 in 18.
The effectiveness of Gardasil has been studied in women aged 16 to 26 years, and its immunogenicity (its ability to make the immune system respond to the viruses) has been studied in children and adolescents aged nine to 15 years.
Učinkovitost zdravila Gardasil so preučevali pri ženskah, starih od 16 do 26 let, njegovo imunogenost (sposobnost, da vzbudi odziv imunskega sistema) pa so preučevali pri deklicah in mladostnicah, starih od 9 do 15 let.
Its protective effectiveness has not been studied in males.
Pri moških zaščitnega učinka zdravila niso preučevali.
Gardasil is given to individuals aged nine years or older, as three doses, with two months between the first and second doses, and four months between the second and third doses.
Zdravilo Gardasil se daje posameznicam, starim devet let ali več, v obliki treh odmerkov, pri čemer sledi drugi odmerek dva meseca po prvem, tretji pa štiri mesece po drugem.
If a different schedule is needed, there should be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Če je potrebna drugačna shema cepljenja, mora oseba drugi odmerek cepiva prejeti vsaj en mesec po prejemu prvega odmerka, tretji odmerek cepiva pa vsaj tri mesece po prejemu drugega odmerka, vse tri odmerke pa v obdobju enega leta.
It is recommended that individuals who receive the first dose of Gardasil should complete all three doses with Gardasil.
Priporočeno je, da posameznica, ki prejme prvi odmerek zdravila Gardasil, prejme vse tri odmerke zdravila Gardasil.
The vaccine is given as an injection into a muscle, preferably in the upper arm or the thigh.
Cepivo se injicira v mišico, po možnosti v nadlaket ali stegno.
Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Papilomavirusi so virusi, ki povzročajo bradavice in nenormalno rast tkiva.
There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Obstaja več kot 100 tipov papilomavirusov, nekatere med njimi pa povezujejo z raki genitalnega predela.
HPV types 16 and 18 cause approximately 70% of cervical cancers and HPV types 6 and 11 cause approximately 90% of genital warts.
HPV tipov 16 in 18 povzročijo približno 70% rakov materničnega vratu, HPV tipov 6 in 11 pa približno 90% bradavic na spolovilih.
All papillomaviruses have a shell, or ‘ capsid’, that is made up of proteins called ‘ L1 proteins’.
Vsi papilomavirusi imajo plašč ali „ kapsido “, ki je sestavljena iz beljakovin, imenovanih „ beljakovine L1 “.
Gardasil contains the purified L1 proteins for four of the types of human papillomavirus: types 6, 11, 16, and 18.
Zdravilo Gardasil vsebuje prečiščene beljakovine L1 za štiri tipe humanih papilomavirusov: tipe 6, 11, 16 in 18.
The proteins in Gardasil are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the L1 proteins.
Ti
Reproduction is authorised provided the source is acknowledged. that the body can recognise them easily).
Reproduction is authorised provided the source is acknowledged. tvorijo virusu podobne delce (strukture, ki so podobne virusu HPV, tako da jih telo zlahka prepozna).
The vaccine also contains an ‘ adjuvant ’ (a compound containing aluminium) to stimulate a better response.
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za stimulacijo boljšega odziva.
When a patient is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these proteins.
Ko bolnik prejme cepivo, prične imunski sistem (sistem, ki ščiti telo pred boleznimi) tvoriti protitelesa za te beljakovine.
The antibodies help to block the virus from infecting cells in the body.
Protitelesa pomagajo preprečiti okužbo celic telesa z virusom.
After vaccination, the immune system is able to produce antibodies quickly when it is exposed to the real viruses.
Po cepljenju je imunski sistem zmožen ob ponovni izpostavitvi dejanskim virusom hitreje izdelati protitelesa.
The effects of Gardasil were first tested in experimental models before being studied in humans.
Učinki zdravila Gardasil so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The four main studies in humans involved almost 21,000 women aged between 16 and 26 years.
V štirih glavnih študijah, izvedenih na ljudeh, je sodelovalo več kot 21 000 žensk, starih med 16 in 26 let.
Gardasil was compared with placebo (a dummy vaccine).
Zdravilo Gardasil so primerjali s placebom (cepivom brez zdravilne učinkovine).
The studies looked at how many women developed genital lesions or warts that were due to HPV infection.
Študije so preučevale, pri koliko ženskah se razvijejo genitalne lezije ali bradavice, povezane z okužbami s HPV.
The women were followed up for around three years after the third dose of the vaccine.
Spremljanje žensk je trajalo okoli tri leta po prejemu tretjega odmerka cepiva.
Gardasil was effective against precancerous genital lesions of the cervix, vulva and vagina, cervical cancer, and warts related to HPV types 6, 11, 16 and 18.
Zdravilo Gardasil je bilo učinkovito proti predrakavim genitalnim lezijam materničnega vratu, zunanjega in notranjega ženskega spolovila, raku materničnega vratu in bradavicam na spolovilih, povezanim s HPV tipov 6, 11, 16 in 18.
Looking at the results of all four studies together, in women who had never been infected by HPV types 6, 11, 16 or 18 before, and who received the full course of vaccination, one woman out of over 8,000 vaccinated with Gardasil developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Skupna obravnava rezultatov vseh štirih študij je pokazala, da so se v skupini žensk, ki predhodno niso bile okužene s HPV tipov 6, 11, 16 in 18 in ki so prejele celoten ciklus cepljenja, pri eni bolnici od več kot 8000 žensk, cepljenih z zdravilom Gardasil, pojavile predrakave lezije na materničnem vratu, ki bi lahko bile povezane s HPV tipov 16 ali 18.
In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Za razliko od tega so se lezije, ki jih je povzročila okužba s tema dvema tipoma HPV, pojavile pri 85 bolnicah od več kot 8000 žensk, ki so prejemale placebo.
A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Podoben učinek zdravila Gardasil so opazili v analizi, ki je vključevala tudi lezije materničnega vratu, povzročene z okužbo z drugima dvema tipoma HPV (tipoma 6 in 11).
For external genital lesions due to HPV types 6, 11, 16 or 18 (including warts and precancerous lesions of the vulva or the vagina), the results of three of the studies were looked at together.
Za lezije na zunanjih spolovilih, povzročene z okužbo s HPV tipov 6, 11, 16 ali 18 (vključno z bradavicami in predrakavimi lezijami zunanjega ali notranjega ženskega spolovila) so analizirali rezultate vseh treh študij.
Two women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Pri dveh bolnicah med skoraj 8000 ženskami v skupini, ki je prejemala zdravilo Gardasil, so se pojavile bradavice na spolovilih, ni pa bilo primerov predrakavih lezij na zunanjem ali notranjem spolovilu.
In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Za razliko od tega so med skoraj 8000 ženskami iz skupine, ki je prejemala placebo, zabeležili 189 primerov lezij na zunanjih spolovilih.
In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were pyrexia (fever) and reactions at the site of the injection (redness, pain and swelling).
V okviru študij so bili najpogostejši neželeni učinki zdravila Gardasil (opaženi pri več kot 1 bolnici izmed 10) povišana telesna temperatura in reakcije na mestu injiciranja (rdečina, bolečina in oteklina).
For the full list of all side effects reported with Gardasil, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Gardasil, glejte navodilo za uporabo.
Gardasil should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Zdravila Gardasil ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
If a patient shows signs of an allergy after a dose of Gardasil, she should not receive further doses of the vaccine.
Če bolnica po prejemu odmerka zdravila Gardasil kaže znake alergije, potem nadaljnjih odmerkov cepiva ne sme prejeti.
Vaccination should be postponed in patients who are ill with a high fever.
Pri bolnicah, ki so bolne in imajo visoko telesno temperaturo, je potrebno cepljenje odložiti.
The Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil’ s benefits are greater than its risks as a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to HPV types 6, 11, 16 and 18.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Gardasil kot cepiva za preprečevanje predrakavih genitalnih lezij (na materničnem vratu, zunanjih in notranjih ženskih spolovilih), raka materničnega vratu in bradavic na zunanjih spolovilih (koničastih kondilomov), ki so vzročno povezani s HPV tipov 6, 11, 16 in 18, večje od z njim povezanih tveganj.
The Committee recommended that Gardasil be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Gardasil odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil to Sanofi Pasteur MSD SNC on 20 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Gardasil, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD SNC dne 20. septembra 2006.
The full EPAR for Gardasil can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Gardasil je na voljo tukaj.
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
IME ZDRAVILA
1 dose (0.5 ml) contains approximately:
1 odmerek (0, 5 ml) vsebuje približno:
2
L1 protein2, 3 humanega papilomavirusa1 tipa 6 L1 protein2, 3 humanega papilomavirusa1 tipa 11 L1 protein2, 3 humanega papilomavirusa1 tipa 16 L1 protein2, 3 humanega papilomavirusa1 tipa 18 1 humani papilomavirus = HPV 2
L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
tehnologijo rekombinantne DNA na celični 1895))
3 adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al).
adsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (225 mikrogramov Al)
Gardasil is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).
Gardasil je cepivo za preprečevanje predrakavih genitalnih lezij (cervikalnih, vulvarnih in vaginalnih), raka materničnega vratu in bradavic na zunanjih spolovilih (koničasti kondilomi), ki so vzročno povezani s tipi 6, 11, 16 in 18 humanih papilomavirusov (HPV) (glejte poglavje 5. 1).
The indication is based on the demonstration of efficacy of Gardasil in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents.
Indikacija temelji na dokazu učinkovitosti cepiva Gardasil pri odraslih ženskah, starih od 16 do 26 let, in dokazu imunogenosti cepiva Gardasil pri 9 do 15 let starih otrocih in mladostnikih.
Protective efficacy has not been evaluated in males (see section 5.1).
Pri moških zaščitnega učinka niso preučevali (glejte poglavje 5. 1).
0, 2, 6 months.
Osnovno cepljenje je treba opraviti s tremi posameznimi 0, 5 ml odmerki cepiva, ki se jih aplicira po shemi 0., 2., 6. mesec.
If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Če je potrebna alternativna shema cepljenja, mora oseba drugi odmerek cepiva prejeti vsaj 1 mesec po prejemu prvega odmerka, tretji odmerek cepiva pa vsaj 3 mesece po prejemu drugega odmerka.
The need for a booster dose has not been established.
Potrebnost obnovitvenega odmerka ni bila dokazana.
2 Paediatric population:
2 Otroci:
Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy (see section 5.1).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba cepiva Gardasil pri otrocih, mlajših od 9 let, ni priporočljiva (glejte poglavje 5. 1).
Gardasil must not be injected intravascularly.
Cepiva Gardasil se ne sme vbrizgati intravaskularno.
These methods of administration are not recommended (see section 6.6).
Subkutano in intradermalno dajanje cepiva ni bilo proučeno, zato takšnega dajanja ne priporočamo (glejte poglavje 6. 6).
It is recommended that subjects who receive a first dose of Gardasil complete the 3-dose vaccination course with Gardasil (see section 4.4).
Pri osebah, ki so že prejele prvi odmerek cepiva Gardasil je priporočljivo, da se cepljenje dokonča s cepivom Gardasil in osebe tako prejmejo vse 3 odmerke istega cepiva (glejte poglavje 4. 4).
Administration of Gardasil should be postponed in subjects suffering from an acute severe febrile illness.
Cepljenje s cepivom Gardasil je treba odložiti pri osebah, ki imajo hujšo akutno bolezen z zvišano telesno temperaturo.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults.
Predvsem pri mladostnikih in mlajših odraslih se lahko po kateremkoli cepljenju pojavi sinkopa (omedlevica).
Syncope, sometimes associated with falling, has occurred after vaccination with Gardasil (See section 4.8).
Sinkopa, včasih skupaj s padcem, se je pojavila po cepljenju s cepivom Gardasil (glejte poglavje 4. 8).
Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of Gardasil.
Zato je po cepljenju s cepivom Gardasil cepljene osebe potrebno skrbno opazovati približno 15 minut.
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).
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 hude stopnje ali bradavic na spolovilih.
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.
There are no data on the use of Gardasil in subjects with impaired immune responsiveness.
Podatki o uporabi cepiva Gardasil pri osebah z okvarjenim imunskim odzivom niso na voljo.
Individuals with impaired immune responsiveness, whether due to the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to the vaccine.
Pri osebah z imunsko pomanjkljivostjo zaradi agresivnega imunosupresivnega zdravljenja, genetske okvare, okužbe z virusom humane imunske pomanjkljivosti (HIV) ali drugih vzrokov odziv na cepljenje morda ne bo dosežen.
This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Pri osebah s trombocitopenijo ali katerokoli motnjo strjevanja krvi je potrebna previdnost, saj se po dajanju cepiva v mišico lahko pojavi krvavitev.
The duration of protection is currently unknown.
3 Trajanje zaščite trenutno ni znano.
Sustained protective efficacy has been observed for 3 4.5 years after completion of the 3-dose series.
Ugotovljena je bila persistentna zaščitna učinkovitost, ki je trajala 4, 5 let po dokončanju cepljenja s 3 odmerki.
Longer term follow-up studies are ongoing (see section 5.1).
Študije z dolgotrajnejšim spremljanjem še potekajo (glejte poglavje 5. 1).
There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil with other HPV vaccines.
Podatki o varnosti, imunogenosti ali učinkovitosti, ki bi podpirali zamenljivost cepiva Gardasil z drugimi cepivi proti HPV, niso na voljo.
The seroprotection rates (proportion of subjects reaching seroprotective level anti-HBs > 10 mIU/ ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Odstotek serozaščite (delež oseb, pri katerih je bila dosežena raven serozaščite anti- HBs > 10 mi. e. / ml) je ostal nespremenjen (96, 5% pri sočasnem cepljenju in 97, 5% pri cepljenju samo s cepivom proti hepatitisu B).
Anti-HBs 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.
The concomitant administration of Gardasil with vaccines other than hepatitis B (recombinant) vaccine has not been studied.
Sočasnega cepljenja s cepivom Gardasil in z drugimi cepivi (razen z rekombinantnim cepivom proti hepatitisu B) niso raziskali.