natgillin/translations-raw huggingface dataset:
Symptoms may include difficulty breathing, wheezing, hives and/or rash.
Simptomi lahko vključujejo težko dihanje, piskanje, koprivnico in/ali izpuščaj.
Since no vaccine is 100% effective and Gardasil 9 will not provide protection against every HPV type, or against HPV infections present at the time of vaccination, routine cervical screening remains critically important and should follow local recommendations.
Ker učinkovitost nobenega cepiva ni 100-odstotna in ker cepivo Gardasil 9 ne ščiti pred vsemi tipi HPV oziroma pred okužbami s HPV, prisotnimi v času cepljenja, redni presejalni pregledi materničnega vratu ostajajo ključnega pomena in jih je treba izvajati v skladu z lokalnimi priporočili.
These assays measured antibodies against neutralising epitopes for each HPV type.
Ti preizkusi so merili protitelesa proti nevtralizirajočim epitopom za vsak tip HPV.
Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Zato je treba previdnostne ukrepe za preprečevanje prenosa spolno prenosljivih bolezni še naprej izvajati.
Use of hormonal contraceptives did not appear to affect the type-specific immune responses to Gardasil 9.
Kaže, da uporaba hormonskih kontraceptivov ni vplivala na tipsko specifične imunske odzive na cepivo Gardasil 9.
Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Cepivo Gardasil 9 je indicirano za aktivno imunizacijo oseb od 9. leta starosti dalje proti naslednjim boleznim zaradi HPV:
GMT (95% CI) mMU
GMT (95 % IZ) mME §/ml
In 7 clinical trials, individuals were administered Gardasil 9 on the day of enrolment and approximately 2 and 6 months thereafter.
V 7 kliničnih preskušanjih so osebe cepivo Gardasil 9 prejele na dan vključitve in nato približno čez 2 in 6 mesecev.
The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
GMT-ji so bili nekoliko nižji kot pri enako starih, s HIV-om neokuženih osebah iz drugih študij.
The postmarketing safety experience with qHPV vaccine is relevant to Gardasil 9 since the vaccines contain L1 HPV proteins of 4 of the same HPV types.
Izkušnje v obdobju trženja glede varnosti qHPV cepiva so pomembne za cepivo Gardasil 9, ker to cepivo vsebuje protein L1 HPV štirih istih tipov HPV.
In addition, the adverse experience profile for breast-feeding women was comparable to that of the women in the overall safety population.
Poleg tega je bil tudi profil neželenih učinkov pri doječih ženskah podoben kot pri ženskah v celotni populaciji, v kateri so spremljali varnost.
The efficacy and long-term effectiveness of qHPV vaccine against HPV 6-, 11-, 16-, and 18-related disease endpoints have been demonstrated in clinical studies in the PPE (Per Protocol Efficacy) population.
Učinkovitost in dolgoročna učinkovitost qHPV cepiva proti s HPV 6, 11, 16 in 18 povezanimi opazovanimi dogodki bolezni sta bili dokazani v kliničnih študijah pri populaciji PPE (Per Protocol Efficacy).
• for at least 5 years in girls and boys who were aged 9 to 15 years at time of vaccination with Gardasil 9; depending on HPV type, 90 to 99 % of subjects were seropositive.
• vsaj 5 let pri deklicah in dečkih, starih 9 do 15 let v času cepljenja s cepivom Gardasil 9; v odvisnosti od tipa HPV je bilo 90 do 99 % oseb seropozitivnih.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
At the end of this period Gardasil 9 should be used or discarded.
Ob koncu tega obdobja je treba cepivo Gardasil 9 ali uporabiti ali zavreči.
GMT Ratio
GMT razmerje
Gardasil 9 has no or negligible influence on the ability to drive or use machines.
Cepivo Gardasil 9 nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Table 2: Adverse reactions reported from Post-marketing experience with qHPV vaccine System organ class
Preglednica 2: Neželeni učinki, o katerih so poročali v izkušnjah v obdobju trženja pri qHPV cepivu Organski sistem
1 dose (0.5 ml): HPV Type 6 L1 protein
1 odmerek (0,5 ml): L1 protein HPV tipa 6
The clinical relevance of the lower response is unknown.
Klinični pomen manjšega odziva ni znan.
Individuals with impaired immune responsiveness, due to either 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 okvarjeno imunsko odzivnostjo zaradi agresivnega imunosupresivnega zdravljenja, genetske okvare, okužbe z virusom humane imunske pomanjkljivosti (HIV) ali drugih vzrokov odziv na cepljenje morda ne bo dosežen.
In addition, women (n = 150) who received 3 doses of Gardasil 9 in Protocol 001 and a challenge dose 5 years later, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month postdose 3.
Poleg tega so ženske (n = 150), ki so prejele 3 odmerke cepiva Gardasil 9 v Protokolu 001 in obnovitveni odmerek 5 let kasneje, razvile hiter in močan anamnestični odziv, ki je presegel geometrične sredine titrov (GMT) anti-HPV, opažene 1 mesec po cepljenju s 3. odmerkom.
Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
Daljše študije, ki bodo pokazale, če je potreben dodaten odmerek, so v teku.
The CD4% or plasma HIV RNA was not affected by vaccination.
Cepljenje ni vplivalo na CD4% ali vrednost HIV RNA v plazmi.
Evidence of an anamnestic response was seen in vaccinated women who were seropositive to relevant HPV type(s) prior to vaccination.
Dokaz anamnestičnega odziva so zasledili pri cepljenih ženskah, ki so bile pred cepljenjem seropozitivne za zadevni tip (zadevne tipe) HPV.
GMTs were higher in girls and boys than in women aged 16 to 26 years, and higher in boys than in girls and women.
GMT so bili pri deklicah in dečkih višji kot pri ženskah, starih 16 do 26 let, ter pri dečkih višji kot pri deklicah in ženskah.
Gardasil 9 must not be injected intravascularly, subcutaneously or intradermally.
Cepiva Gardasil 9 se ne sme injicirati intravaskularno, subkutano ali intradermalno.
• In packs with needles, two needles of different lengths are provided per syringe.
• V pakiranju z iglami sta dve različno dolgi igli za eno injekcijsko brizgo.
A study documenting safety and immunogenicity of qHPV vaccine has been performed in 126 HIV infected subjects aged 7 to12 years with baseline CD4% ≥15 and at least 3 months of highly active antiretroviral therapy (HAART) for subjects with a CD4% <25 (of which 96 received qHPV vaccine).
Študijo, v kateri so beležili varnost in imunogenost qHPV cepiva, so izvedli pri 126 osebah okuženih s HIV, starih 7 do 12 let, z izhodiščem CD4% ≥ 15 ter z vsaj trimesečnim visokoaktivnim protiretrovirusnim zdravljenjem (HAART - highly active antiretroviral therapy) pri osebah z izhodiščem CD4% < 25 (od katerih jih je 96 prejelo qHPV cepivo).
Table 1: Adverse reactions following administration of Gardasil 9 occurring with a frequency of at least 1.0% from clinical trials*
Preglednica 1: Neželeni učinki, ki so se po uporabi cepiva Gardasil 9 v kliničnih preskušanjih pojavili s pogostnostjo vsaj 1,0 %*
However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination.
Rahlo zvišana telesna temperatura ali okužba zgornjih dihal (na primer prehlad) nista razlog za odložitev cepljenja.
Idiopathic thrombocytopaenic purpura, lymphadenopathy
Neznana idiopatska trombocitopenična purpura, limfadenopatija
Gardasil 9 is available in a pack of 1.
Cepivo Gardasil 9 je na voljo v pakiranju po 1.
There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 with bivalent or quadrivalent HPV vaccines.
Podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi podpirali zamenljivost cepiva Gardasil 9 z dvovalentnimi ali štirivalentnimi cepivi proti HPV, ni na voljo.
Gardasil 9 is available in packs of 1 or 10 pre-filled syringes.
Cepivo Gardasil 9 je na voljo v pakiranjih z 1 ali 10 napolnjenimi injekcijskimi brizgami.
1 dose of Gardasil 9 suspension for injection contains 0.5 ml.
1 odmerek cepiva Gardasil 9 suspenzija za injiciranje vsebuje 0,5 ml.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré syndrome, acute disseminated encephalomyelitis); vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal and skin infection at the injection site.
Tako kot pri drugih cepivih so tudi med splošno uporabo tega cepiva poročali o: oteklih bezgavkah (vratnih, pazdušnih ali dimeljskih), oslabelosti mišic, nenormalnih občutkih in mravljinčenju v rokah, nogah in zgornjem delu telesa ali zmedenosti (Guillain-Barréjev sindrom, akutni diseminirani encefalomielitis), bruhanju, bolečinah v sklepih, bolečinah v mišicah, nenavadni utrujenosti ali šibkosti, mrzlici, splošnem slabem počutju, večjem nagnjenju h krvavitvam in modricam ter okužbah kože na mestu injiciranja.
These results support the efficacy of Gardasil 9 in women aged 27 to 45 years.
Ti rezultati podpirajo učinkovitost cepiva Gardasil 9 pri ženskah, starih 27 do 45 let.
Loop electrosurgical excision procedure (LEEP) or conisation.
elektrokirurška ekscizija z zanko (LEEP - loop electrosurgical excision procedure) ali konizacija
Gardasil 9 cannot cause HPV-related diseases.
Cepivo Gardasil 9 ne more povzročiti bolezni, povezanih s HPV.
The second dose should be administered between 5 and 13 months after the first dose.
Drugi odmerek cepiva je treba aplicirati med 5. in 13. mesecem po prejemu prvega odmerka.
Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm and urticaria
Neznana preobčutljivostne reakcije, vključno z anafilaktičnimi/anafilaktoidnimi reakcijami, bronhospazmom in urtikarijo
60 µg HPV Type 31, 33, 45, 52 and 58 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.5 mg Al).
60 µg L1 protein HPV tipa 31, 33, 45, 52 in 58 20 µg adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,5 mg Al).
In the studies, vaccine immunogenicity was comparable between breast-feeding women and women who did not breast-feed.
V teh študijah je bila imunogenost cepiva pri doječih ženskah podobna kot pri ženskah, ki niso dojile.
These results support the efficacy of Gardasil 9 in the male population.
Ti rezultati potrjujejo učinkovitost cepiva Gardasil 9 v moški populaciji.
Subjects were followed up to 67 months postdose 3 with a median duration of 43 months postdose 3.
Osebe so spremljali do 67 mesecev po 3. odmerku, z medianim časom spremljanja 43 mesecev po 3. odmerku.
Arthralgia, myalgia
Neznana artralgija, mialgija
Gardasil 9 is a vaccine for children and adolescents from 9 years of age and adults.
Cepivo Gardasil 9 je cepivo za otroke in mladostnike od 9. leta starosti in za odrasle.
Gardasil 9 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 9 ne učinkuje pri osebah, ki že imajo persistentno okužbo ali bolezen, povezano s katerim koli tipom HPV, ki ga vsebuje cepivo.
If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
Če je drugi odmerek cepiva apliciran prej kot v 5 mesecih po prejemu prvega odmerka, je treba vedno aplicirati še tretji odmerek.
Gardasil 9 protects against the HPV types that cause most cases of these diseases.
Cepivo Gardasil 9 varuje pred tistimi tipi HPV, ki povzročijo največ primerov teh bolezni.
Gardasil 9 may be given to women who are breast-feeding or intend to breast-feed.
Cepivo Gardasil 9 se lahko daje ženskam, ki dojijo ali nameravajo dojiti.
However, the presence of a minor infection, such as a mild upper respiratory tract infection or lowgrade fever, is not a contraindication for immunisation.
Vendar pa blažja okužba, kot sta blaga okužba zgornjih dihal ali rahlo zvišana telesna temperatura, ni kontraindikacija za cepljenje.
When an individual is vaccinated with Gardasil 9, the immune system (the body's natural defence system) stimulates production of antibodies against the nine vaccine HPV types, to help protect against the diseases caused by these viruses.
Cepljenje s cepivom Gardasil 9 povzroči, da imunski sistem (naravna obramba telesa) spodbudi nastajanje protiteles proti devetim tipom HPV v cepivu, kar pomaga ščititi pred boleznimi, ki jih povzročajo ti virusi.
Specific studies of Gardasil 9 in pregnant women were not conducted.
Posebnih študij o uporabi cepiva Gardasil 9 pri nosečnicah niso izvedli.
Gardasil 9 contains sodium chloride
Cepivo Gardasil 9 vsebuje natrijev klorid
During the clinical development of Gardasil 9; 2,586 women (1,347 in the Gardasil 9 group vs. 1,239 in the qHPV vaccine group) reported at least one pregnancy.
Med programom kliničnega razvoja cepiva Gardasil 9 so pri 2.586 ženskah (1.347 v skupini s cepivom Gardasil 9 in 1.239 v skupini s qHPV cepivom) poročali o vsaj eni nosečnosti.
Type-specific immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type.
Za oceno imunogenosti za vsak tip HPV v cepivu so bili uporabljeni tipsko specifični imunski preizkusi s tipsko specifičnimi standardi.
The vaccine is therefore not indicated for treatment of cervical, vulvar, vaginal and anal cancer, high-grade cervical, vulvar, vaginal and anal dysplastic lesions or genital warts.
Cepivo torej ni indicirano za zdravljenje raka materničnega vratu, vulve, nožnice in anusa, cervikalnih, vulvarnih, vaginalnih in analnih displastičnih sprememb visoke stopnje ali genitalnih bradavic.
This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Gardasil 9 (see section 4.8).
Opažanje temelji na rezultatih kliničnega preskušanja, v katerem so sočasno cepili s kombiniranim cepivom dTap-IPV in prvim odmerkom cepiva Gardasil 9 (glejte poglavje 4.8).
Very common At the injection site: pain, swelling, erythema
Zelo pogosti na mestu injiciranja: bolečina, oteklost, eritem
Protocols 005 and 007 evaluated Gardasil 9 concomitantly administered with vaccines recommended routinely in girls and boys aged 11 to 15 years (N=2,295).
Protokola 005 in 007 sta ovrednotila cepivo Gardasil 9, uporabljeno sočasno s cepivi, rutinsko priporočenimi za dečke in deklice, stare 11 do 15 let (N = 2.295).
What Gardasil 9 is and what it is used for What you need to know before you or your child receive Gardasil 9 How Gardasil 9 is given
Kaj je cepivo Gardasil 9 in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi ali vaš otrok dobili cepivo Gardasil 9 Kako uporabljati cepivo Gardasil 9
In a clinical trial, persistence of antibody response has been demonstrated for at least 5 years in girls aged 9 to13 years who received 2 doses of qHPV vaccine.
V kliničnih preskušanjih je bilo trajanje odziva protiteles dokazano za vsaj 5 let pri deklicah, starih 9 do 13 let, ki so prejele 2 odmerka qHPV cepiva.
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.
Drugi odmerek cepiva je treba aplicirati vsaj 1 mesec po prejemu prvega odmerka in tretji odmerek vsaj 3 mesece po prejemu drugega odmerka.
If you or your child already received an HPV vaccine, ask your doctor if Gardasil 9 is right for you.
Če ste vi ali vaš otrok že dobili kakšno cepivo proti HPV, se z zdravnikom posvetujte, ali je cepivo Gardasil 9 primerno za vas oz. otroka.
Very common (may affect more than 1 in 10 people): side effects found at the injection site (pain, swelling, and redness) and headache.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): neželeni učinki na mestu injiciranja (bolečina, oteklina in rdečina) in glavobol.
Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for Gardasil 9.
Študij z uporabo mešane sheme (zamenljivosti) s cepivi proti HPV za cepivo Gardasil 9 niso izvedli.
Duration of protection of a 2-dose schedule of Gardasil 9 has not been established.
Trajanje zaščite po 2-odmerni shemi cepljenja s cepivom Gardasil 9 ni bilo določeno.
• for at least 5 years in women who were aged 16 to 26 years at time of vaccination with Gardasil 9, depending on HPV type, 78 to100 % of subjects were seropositive; however, efficacy was maintained in all subjects regardless of seropositivity status for any vaccine HPV type through the end of the study (up to 67 months postdose 3, median follow-up duration of 43 months postdose 3),
• vsaj 5 let pri ženskah, starih 16 do 26 let v času cepljenja s cepivom Gardasil 9; v odvisnosti od tipa HPV je bilo 78 do 100 % oseb seropozitivnih; učinkovitost se je ohranila do konca študije (do 67 mesecev po 3. odmerku; mediani čas spremljanja 43 mesecev po 3. odmerku) pri vseh preiskovancih, ne glede na stanje seropozitivnosti za kateri koli tip HPV,
Other medicines and Gardasil 9
Druga zdravila in cepivo Gardasil 9
Efficacy against HPV types 6, 11, 16, and 18 was primarily assessed using a bridging strategy that demonstrated comparable immunogenicity (as measured by Geometric Mean Titres [GMT]) of Gardasil 9 compared with qHPV vaccine (Protocol 001, GDS01C/Protocol 009 and GDS07C/Protocol
Učinkovitost proti tipom HPV 6, 11, 16 in 18 so v prvi vrsti ocenili z uporabo premostitvene strategije, ki je pokazala primerljivo imunogenost (merjeno z geometrično sredino titrov [GMT]) cepiva Gardasil 9 v primerjavi s qHPV cepivom (Protokol 001, GDS01C/Protokol 009 in GDS07C/Protokol 020).
Name and address of the manufacturer(s) responsible for batch release Merck Sharp & Dohme B.V.
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Merck Sharp & Dohme B.V.
Gardasil 9 may not have an optimal effect if used with medicines that suppress the immune system.
Optimalni učinek cepiva Gardasil 9 morda ne bo dosežen v primeru sočasne uporabe zdravil, ki zavirajo imunski sistem.
Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials.
V kliničnih preskušanjih niso raziskovali varnosti in imunogenosti pri posameznikih, ki so v obdobju 3 mesecev pred cepljenjem prejeli imunoglobulin ali zdravila iz krvi.
Gardasil 9 will not protect against every type of Human Papillomavirus.
Cepivo Gardasil 9 ne ščiti pred vsakim tipom humanih papilomavirusov.
Name and address of the manufacturer(s) of the biological active substance(s) Merck Sharp & Dohme Corp.
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Merck Sharp & Dohme Corp.
- If you have any further questions, please ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Vaccination is not a substitute for routine cervical screening.
Cepljenje ni nadomestilo za običajne presejalne preglede materničnega vratu.
Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil/Silgard should not receive Gardasil 9.
Osebe s preobčutljivostjo po predhodni uporabi cepiva Gardasil 9 ali cepiva Gardasil/Silgard ne smejo prejeti cepiva Gardasil 9.
In the same study, in girls and boys aged 9 to14 years, GMTs at one month after the last vaccine dose were numerically lower for some vaccine types after a 2-dose schedule than after a 3-dose schedule (i.e., HPV types 18, 31, 45, and 52 after 0, 6 months and HPV type 45 after 0, 12 months).
V isti študiji, pri deklicah in dečkih, starih 9 do 14 let, so bili GMT 1 mesec po zadnjem odmerku cepiva številčno nižji za nekatere tipe v cepivu po 2-odmerni shemi kot po 3-odmerni shemi cepljenja (tj. tipov HPV 18, 31, 45 in 52 po 0., 6. mesecu ter tipov HPV 45 po 0., 12. mesecu).
(see section 5.1).
- 12. mesec) (glejte poglavje 5.1).
It is also not intended to prevent progression of other established HPV-related lesions.
Cepivo prav tako ni namenjeno za preprečevanje napredovanja drugih sprememb, potrjeno povezanih s HPV.
Gardasil 9 administered to female rats had no effects on development, behaviour, reproductive performance or fertility of the offspring.
Cepivo Gardasil 9, uporabljeno pri podganjih samicah, ni vplivalo na razvoj, obnašanje, sposobnost za razmnoževanje ali plodnost mladičev.
In a clinical trial of 1,053 healthy adolescents aged 11 to 15 years, administration of the first dose of Gardasil 9 concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that more injection-site reactions (swelling, erythema), headache and pyrexia were reported.
V kliničnem preskušanju pri 1.053 zdravih mladostnikih, starih 11 do 15 let, so pri sočasnem cepljenju s prvim odmerkom cepiva Gardasil 9 in kombiniranim obnovitvenim odmerkom cepiva proti davici, tetanusu, oslovskemu kašlju [acelularno, komponentno cepivo] in otroški ohromelosti [inaktivirano cepivo] poročali o več primerih reakcij na mestu injiciranja (otekanje, pordelost), glavobola in zvišane telesne temperature.
In clinical studies, 60.2% of women aged 16 to 26 years who received Gardasil 9 used hormonal contraceptives during the vaccination period of the clinical studies.
V kliničnih študijah je 60,2 % žensk, starih 16 do 26 let, ki so prejele cepivo Gardasil 9, v obdobju cepljenja uporabljalo hormonske kontraceptive.
0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconised FluroTec-laminated bromobutyl elastomer) and a tip cap (synthetic isoprene-bromobutyl blend) in pack sizes of 1 or 10 with needles or in a pack size of 10 without needles.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z batom (s silikoniziranim FluoroTec-om obloženi bromobutilni elastomer) in pokrovčkom konice (sintetična izopren-brombutilna mešanica) ter v pakiranjih po 1 ali 10 z iglami ali v pakiranju po 10 brez igel.
The following side effects have been reported with GARDASIL or SILGARD and may also be seen after getting GARDASIL 9:
O naslednjih neželenih učinkih so poročali pri cepivih GARDASIL ali SILGARD in se lahko pojavijo tudi po cepljenju s cepivom Gardasil 9:
There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness.
Podatkov o uporabi cepiva Gardasil 9 pri osebah z okvarjeno imunsko odzivnostjo ni.
If you or your child receive a first dose of Gardasil 9, you have to complete the full vaccination course with Gardasil 9.
Če vi ali vaš otrok prejmete prvi odmerek cepiva Gardasil 9, je treba celotno cepljenje dokončati s cepivom Gardasil 9.
It is prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein from the same four HPV types (6, 11, 16, 18) in qHPV vaccine and from 5 additional HPV types (31, 33, 45, 52, 58).
Pripravljeno je iz visoko prečiščenih virusu podobnih delcev (VLP - virus-like particles) velike plaščne (L1) beljakovine istih štirih tipov HPV (6, 11, 16 in 18) kot qHPV cepivo in petih dodatnih tipov HPV (31, 33, 45, 52, 58).
In Protocol 001, GMTs for HPV-6, -11, -16 and -18 were comparable in subjects who received qHPV vaccine or Gardasil 9 for at least 3.5 years.
V Protokolu 001 so bili GMT-ji za HPV 6, 11, 16 in 18 primerljivi vsaj 3,5 let pri osebah, ki so prejele qHPV cepivo ali Gardasil 9.
What Gardasil 9 looks like and contents of the pack
Izgled cepiva Gardasil 9 in vsebina pakiranja
Amorphous aluminium hydroxyphosphate sulfate is included in the vaccine as an adjuvant.
Amorfni aluminijev hidroksifosfat sulfat je v cepivo dodan kot adjuvans.
One month following the last dose of the assigned regimen, between 97.9% and 100% of subjects across all groups became seropositive for antibodies against the 9 vaccine HPV types.
En mesec po prejemu zadnjega odmerka predpisanega režima, je med 97,9 % in 100 % preiskovancev iz vseh skupin, postalo seropozitivnih za protitelesa proti 9 tipom HPV v cepivu.