FrancophonIA/ELRC3.0 huggingface dataset:
English: Antibodies against all 9 HPV types were transferred to the offspring during gestation and lactation.
Icelandic: Mótefni gegn öllum 9 HPV gerðum bóluefnisins bárust til afkvæmis á meðgöngu og hugsanlega við mjólkurgjöf.
English: GMT Ratio
Icelandic: GMT Hlutfall
English: Gardasil 9 suspension for injection in a pre-filled syringe Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Icelandic: Gardasil 9 stungulyf, dreifa í áfylltri sprautu 9-gilt bóluefni gegn mannapapillomaveiru (raðbrigði, aðsogað)
English: • Shake well before use to make a suspension.
Icelandic: Hristið vel fyrir notkun til að útbúa dreifu.
English: In Protocol 020/GDS07C, anti-HPV antibody GMTs at Month 7 among boys and men (HM) aged 16 to 26 years were comparable to anti-HPV antibody GMTs among boys and men (HM) aged 16 to 26 years administered with the qHPV vaccine for HPV 6, 11, 16 and 18.
Icelandic: Í Protocol 020/GDS07C var margfeldismeðaltal mótefnastyrks gegn HPV í mánuði 7 hjá drengjum og körlum (gagnkynhneigðir) á aldrinum 16 til 26 ára sambærilegt við margfeldismeðaltal mótefnastyrks gegn HPV hjá drengjum og körlum(gagnkynhneigðir) á aldrinum
English: The vaccine should be administered by intramuscular injection.
Icelandic: Bóluefnið á að gefa með inndælingu í vöðva.
English: Gardasil 9 injection IM
Icelandic: Gardasil 9 stungulyf i.m.
English: 1 Type 33 L1 protein
Icelandic: 1 af gerð 33 L1 prótein
English: 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).
Icelandic: Rannsókn var gerð á öryggi og ónæmingargetu fjórgilds HPV-bóluefnis hjá 126 HIV-smituðum einstaklingum á aldrinum 7 til 12 ára með upphafsgildi CD4% ≥15 og eftir a.m.k.
English: Efficacy of qHPV vaccine against HPV types 6, 11, 16, 18
Icelandic: Virkni fjórgilds HPV-bóluefnis gegn HPV-gerðum 6, 11, 16 og 18
English: The genotypes for the vaccine comprised of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 will be referred to as vaccine HPV types.
Icelandic: Vísað verður til arfgerðanna fyrir bóluefnið, sem samanstendur af HPV-gerðum 6, 11, 16, 18, 31, 33, 45, 52, 58, sem HPV-bóluefnis gerðir.
English: 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.
Icelandic: Sýnt var fram á virkni og langtímaáhrif fjórgilds bóluefnis gegn sjúkdómsendapunktum sem tengjast HPV 6, 11, 16 og 18 í klínískum rannsóknum hjá þeim sem fylgdu rannsóknaráætluninni.
English: Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine.
Icelandic: Gardasil 9 er ónæmisglætt, raðbrigða 9-gilt bóluefni sem veldur ekki sýkingu.
English: HPV 31-, 33-, 45-, 52-, 58-related CIN 2/3 or AIS
Icelandic: HPV 31-, 33-, 45-, 52-, 58-tengdar CIN 2/3 eða AIS
English: Common (may affect up to 1 in 10 people): side effects found at the injection site (bruising, and itching), fever, tiredness, dizziness and nausea.
Icelandic: Aukaverkanir sem fram koma á stungustað (mar, og kláði), hiti, þreyta, sundl og ógleði.
English: If you are pregnant, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum áður en bóluefnið er notað.
English: 1 Type 45 L1 protein
Icelandic: 1 af gerð 45 L1 prótein
English: Immunogenicity bridging from qHPV Vaccine to Gardasil 9 for HPV types 6, 11, 16, 18
Icelandic: Virkni fjórgilds HPV-bóluefnis yfirfærð á Gardasil 9 fyrir HPV-gerðir 6, 11, 16 og 18
English: 1 Type 52 L1 protein
Icelandic: 1 af gerð 52 L1 prótein
English: The duration of protection is not yet known.
Icelandic: Ekki er vitað hversu lengi bólusetningin virkar.
English: Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm and urticaria
Icelandic: Ónæmisviðbrögð, m.a. bráðaofnæmi/bráðaofnæmislík viðbrögð, berkjukrampi og ofsakláði
English: 1 Type 11 L1 protein
Icelandic: 1 af gerð 11 L1 prótein
English: Persistence of immune response to Gardasil 9
Icelandic: Varanleiki ónæmissvars við Gardasil 9
English: Administration of Gardasil 9 to individuals previously vaccinated with qHPV vaccine
Icelandic: Notkun Gardasil 9 hjá einstaklingum sem hafa áður verið bólusettir með fjórgildu
English: 1 Type 58 L1 protein
Icelandic: 1 af gerð 58 L1 prótein
English: How to store Gardasil 9
Icelandic: Hvernig geyma á Gardasil 9
English: 1 Type 18 L1 protein
Icelandic: 1 af gerð 18 L1 prótein
English: The PPE population consisted of individuals who received all 3 vaccinations with qHPV vaccine in the base study within 1 year of enrolment without major deviations from the study protocol, were seronegative to the relevant HPV type(s) (types 6, 11, 16, and 18) prior to dose 1, and among subjects 16 years and older at enrolment in the base study, PCR negative to the relevant HPV type(s) prior to dose 1 through one month postdose 3 (Month 7).
Icelandic: HPVbóluefni í grunnrannsókninni innan árs frá upphafi rannsóknar án meiriháttar frávika frá rannsóknaráætluninni, voru sermisneikvæðir gegn viðkomandi HPV-gerð (gerðir 6, 11, 16 og 18) fyrir 1. skammt og þeir sem voru 16 ára og eldri við upphaf grunnrannsóknarinnar og PCR-neikvæðir gegn viðkomandi HPV-gerð fyrir 1. skammt á fyrsta mánuði eftir 3. skammt (mánuður 7).
English: Anti-HPV 11 9 to 15 year old girls
Icelandic: Mótefni gegn HPV 11 9 til 15 ára stúlkur
English: Nausea
Icelandic: frávik
English: In the long-term extension registry study for 16-23 year old women (n = 2,084), no cases of high grade CIN were observed up to approximately 12 years.
Icelandic: Í langtíma framhaldsskráningarrannsókn hjá konum 16 til 23 ára (n=2.084) var ekki greint frá CIN á háu stigi í allt að 12 ár. Í rannsókninni var tölfræðilega sýnt fram á vernd í u.þ.b. 10 ár.
English: Very common At the injection site: pain, swelling, erythema
Icelandic: Á stungustað: verkur, bólga, roði
English: 1 Type 6 L1 protein
Icelandic: 1 af gerð 6 L1 prótein
English: Clinical trials
Icelandic: Klínískar rannsóknir
English: Gardasil 9 suspension for injection Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Icelandic: Gardasil 9 stungulyf, dreifa 9-gilt bóluefni gegn mannapapillomaveiru (raðbrigði, aðsogað)
English: Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Icelandic: 9-gilt bóluefni gegn mannapapillomaveiru (raðbrigði, aðsogað)
English: Gardasil 9 suspension for injection in a pre-filled syringe:
Icelandic: Gardasil 9 stungulyf, dreifa í áfylltri sprautu:
English: The PPE population consisted of individuals: - who received all 3 vaccinations within 1 year of enrolment, without major deviations from the study protocol, - who were seronegative to the relevant vaccine HPV type(s) prior to dose 1 and among women aged 16 to 26 years, PCR negative to the relevant vaccine HPV type(s) prior to dose 1 through one month postdose 3 (Month 7).
Icelandic: Þýðið sem fylgdi rannsóknaráætluninni samanstóð af einstaklingum: - sem fengu allar 3 bólusetningarnar innan 1 árs frá skráningu, án meiriháttar frávika frá rannsóknaráætluninni - sem voru sermisneikvæðir fyrir viðkomandi gerðum HPV-bóluefnis fyrir 1. skammt og meðal kvenna á aldrinum 16 til 26 ára, PCR-neikvæðar fyrir viðkomandi gerðum HPV-bóluefnis fyrir 1. skammt að einum mánuði eftir 3. skammt (7. mánuður).
English: Therefore, vaccinees should be observed for approximately 15 minutes after vaccination.
Icelandic: Því skal fylgjast með bólusettum einstaklingum í u.þ.b. 15 mínútur eftir bólusetningu.
English: Asthenia, chills, malaise
Icelandic: Þróttleysi, kuldahrollur, lasleiki
English: In the pivotal study Protocol 001, the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 was evaluated compared to qHPV vaccine in women aged 16 to 26 years (N=14,204: 7,099 receiving Gardasil 9; 7,105 receiving qHPV vaccine).
Icelandic: Í lykilrannsókninni Protocol 001, var virkni Gardasil 9 gegn HPV-gerðum 31, 33, 45, 52 og 58 metin með samanburði við fjórgilt HPV-bóluefni hjá konum á aldrinum 16 til 26 ára (N=14.204:
English: Anti-HPV 18 9 to 15 year old girls
Icelandic: Mótefni gegn HPV 18 9 til 15 ára stúlkur
English: The efficacy of L1 VLP vaccines is thought to be mediated by the development of a humoral immune response.
Icelandic: L1 VLP-bóluefna sé tilkomin vegna þróunar á vessaónæmissvörun.
English: Table 3: Comparison of immune responses (based on cLIA) between Gardasil 9 and qHPV vaccine for HPV types 6, 11, 16, and 18 in the PPI (Per Protocol Immunogenicity)* population of 9 to 15 year-old girls and 16 to 26 year old women and men
Icelandic: Samanburður á ónæmisviðbrögðum (samkvæmt cLIA) milli Gardasil 9 og fjórgilds HPVbóluefnis fyrir HPV-gerðir 6, 11, 16 og 18 hjá 9 til 15 ára stúlkum og 16 til 26 ára konum og körlum í þýðinu sem fylgdi rannsóknaráætluninni*
English: 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.
Icelandic: HPV-bóluefni var samþykkt og þær gætu einnig komið fram við reynslu eftir markaðssetningu Gardasil 9. Reynsla af öryggi eftir markaðssetningu fjórgilds HPV-bóluefnis er sambærileg við Gardasil 9 þar sem bóluefnin innihalda L1 HPV-prótein af 4 sömu HPV-gerðunum.
English: 1 Type 31 L1 protein
Icelandic: 1 af gerð 31 L1 prótein
English: Administer the entire dose as per standard protocol.
Icelandic: Nota skal allan ráðlagðan skammt bóluefnisins.
English: Second injection: given between 5 and 13 months after first injection If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
Icelandic: Ef seinni skammturinn er gefinn áður en 5 mánuðir eru liðnir frá fyrri skammti skal alltaf gefa þriðja skammt.
English: 1 Type 16 L1 protein
Icelandic: 1 af gerð 16 L1 prótein
English: Anti-HPV 6 9 to 15 year old girls
Icelandic: Mótefni gegn HPV 6 9 til 15 ára stúlkur
English: HPV 31-, 33-, 45-, 52-, 58-related CIN2
Icelandic: HPV 31-, 33-, 45-, 52-, 58-tengdar CIN2
English: HPV 31-, 33-, 45-, 52-, 58-related CIN3
Icelandic: HPV 31-, 33-, 45-, 52-, 58-tengdar CIN3
English: High immunogenicity in MSM aged 16 to 26 years was also observed, although lower than in HM, similarly to qHPV vaccine.
Icelandic: Einnig kom fram mikil mótefnamyndun hjá körlum sem hafa mök við karla á aldrinum 16 til 26 ára, þó lægri en hjá gagnkynhneigðum körlum, en svipuð og með fjórgildu HPV-bóluefni.
English: Gardasil 9 induced robust anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 responses measured at Month 7, in
Icelandic: Gardasil 9 kallaði fram sterka mótefnasvörun gegn HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 og HPV 58 sem mæld var í mánuði 7, í Protocol 001, 002, 004, 005, 007 og GDS01C/Protocol 009.
English: • Inject immediately using the intramuscular (IM) route, preferably in the deltoid are of the upper arm or in the higher anterolateral area of the thigh.
Icelandic: Sprautið lyfinu strax í vöðva (i.m.), helst í axlarvöðva upphandleggs eða hliðlægt framan á lærvöðva.
English: Anti-HPV 16 9 to 15 year old girls
Icelandic: Mótefni gegn HPV 16 9 til 15 ára stúlkur
English: IM
Icelandic: N
English: Pyrexia, fatigue, At the injection site: pruritus, bruising
Icelandic: Hiti, þreyta Á stungustað: kláði, mar
English: Additional efficacy evaluation of Gardasil 9 against vaccine HPV types Since the efficacy of Gardasil 9 could not be evaluated against placebo, the following exploratory analyses were conducted.
Icelandic: Þar sem ekki var hægt að meta virkni Gardasil 9 á móti lyfleysu, voru eftirfarandi könnunargreiningar gerðar.
English: Gardasil 9 must not be injected intravascularly, subcutaneously or intradermally.
Icelandic: Gardasil 9 má ekki gefa í æð, undir húð eða í húð.
English: Table 4: Analysis of efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 in the PPE population of 16 to 26 year old women
Icelandic: Greining á virkni Gardasil 9 gegn HPV-gerðum 31, 33, 45, 52 og 58 hjá konum 16 til 26 ára í þýðinu sem fylgdi rannsóknaráætluninni
English: 30 micrograms
Icelandic: 30 míkrógrömm
English: The efficacy of Gardasil 9 against cervical biopsy related to vaccine HPV types compared to qHPV vaccine was 95.9% (95% CI 92.7, 97.9) with 11/6,016 versus 262/6,018 cases.
Icelandic: Áhrif Gardasil 9 gegn vefjasýni úr leghálsi og ákveðinni meðferð sem tengist HPV-bóluefnis gerðum hjá þýðinu sem fylgdi rannsóknaráætluninni Virkni Gardasil 9 gegn vefjasýnum úr leghálsi sem tengjast HPV-bóluefnis gerðum samanborið við fjórgilt HPV-bóluefni var 95,9% (95% CI 92,7; 97,9) með 11/6.016 á móti 262/6.018 tilvikum.
English: Efficacy evaluation of Gardasil 9 against cervical high grade diseases caused by vaccine HPV types in the PPE
Icelandic: Mat á virkni Gardasil 9 gegn illkynja sjúkdómum í leghálsi af völdum HPV-bóluefnis gerðum hjá þýðinu sem fylgdi rannsóknaráætluninni
English: Gardasil 9 can be administered according to a 3-dose schedule: First injection: at chosen date Second injection: 2 months after first injection (not earlier than one month after the first dose) Third injection: 6 months after first injection (not earlier than 3 months after the second dose) All three doses should be given within a 1-year period.
Icelandic: - Þriðja sprauta: 6 mánuðum eftir fyrstu sprautu (ekki fyrr en 3 mánuðum eftir annan skammt)
English: HPV types.
Icelandic: Fjórgilt HPV bóluefni
English: Gardasil 9 suspension for injection:
Icelandic: Gardasil 9 stungulyf, dreifa:
English: Idiopathic thrombocytopaenic purpura, lymphadenopathy
Icelandic: Sjálfvakinn blóðflagnafæðarpurpuri, eitlakvilli
English: 2778 South East Side Highway
Icelandic: 770 Sumneytown
English: Human Papillomavirus 9-valent Vaccine
Icelandic: 9-gilt bóluefni gegn mannapapillomaveiru
English: HPV Type 11 and 18 L1 protein
Icelandic: HPV af gerð 11 og 18
English: Injection-site cellulitis
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Protocol 003 evaluated immunogenicity of Gardasil 9 in men aged 16 to 26 years and women aged 16 to 26 years (N=2,515:1,103 Heterosexual Men [HM]; 313 Men Who Have Sex with Men [MSM]; and 1,099 women receiving Gardasil 9).
Icelandic: 1.103 gagnkynhneigðum mönnum [HM], 313 körlum sem hafa kynmök við karla [MSM] og 1.099 konum sem fengu Gardasil 9).
English: Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.
Icelandic: Ef þú ert 15 ára eða eldri við fyrstu bólusetningu Gardasil 9 skal gefið samkvæmt þriggja skammta bólusetningaráætlun:
English: - If you have any further questions, please ask your doctor, pharmacist or nurse.
Icelandic: - Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum.
English: What you need to know before you or your child receive Gardasil 9
Icelandic: Áður en þú eða barnið byrjið að nota Gardasil 9
English: The efficacy of Gardasil 9 against cervical definitive therapy (including loop electrosurgical excision procedure [LEEP] or conisation) related to vaccine HPV types compared to qHPV vaccine was 90.7% (95% CI 76.3, 97.0) with 4/6,016 versus 43/6,018 cases.
Icelandic: [LEEP] eða keiluskurði) sem tengist HPV-bóluefnis gerðum samanborið við fjórgilt HPV-bóluefni var 90,7% (95% CI 76,3; 97,0) með 4/6.016 á móti 43/6.018 tilvikum.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél: +32 (0) 27766211 dpoc_belux@merck.com
Icelandic: +32 (0) 27766211 dpoc_belux@merck.com
English: Protocol 006 evaluated administration of Gardasil 9 to girls and women aged 12 to 26 years previously vaccinated with qHPV vaccine (N=921; 615 receiving Gardasil 9 and 306 receiving placebo).
Icelandic: HPV-bóluefni (N=921, 615 fengu Gardasil 9 og 306 fengu lyfleysu).
English: qHPV Vaccine
Icelandic: HPV-bóluefni
English: Very common (may affect more than 1 in 10 people): side effects found at the injection site (pain, swelling, and redness) and headache.
Icelandic: Aukaverkanir sem fram koma á stungustað (sársauki, bólga og roði) og höfuðverkur.
English: Gardasil 9 injection
Icelandic: Gardasil 9 inniheldur
English: Impact of Gardasil 9 against cervical biopsy and definite therapy related to vaccine HPV types in the PPE
Icelandic: Viðbótarmat á virkni Gardasil 9 gegn HPV-bóluefnis gerðum
English: Disease Endpoint
Icelandic: Endapunktar sjúkdóms
English: Protocol 002 evaluated immunogenicity of Gardasil 9 in girls and boys aged 9 to 15 years and women aged 16 to 26 years (N=3,066: 1,932 girls; 666 boys; and 468 women receiving Gardasil 9).
Icelandic: Í Protocol 002 var ónæmingargeta Gardasil 9 metin hjá stúlkum og drengjum á aldrinum 9 til 15 ára og konum á aldrinum 16 til 26 ára (N=3.066:
English: A total of 15,776 individuals (10,495 subjects aged 16 to 26 years and 5,281 adolescents aged 9 to 15 years at enrolment) received Gardasil 9.
Icelandic: Öryggi var metið með því að nota tilkynningarspjöld í tengslum við bólusetningu (VRC) í 14 daga eftir hverja inndælingu Gardasil 9. Alls fengu 15.776 einstaklingar (10.495 einstaklingar á aldrinum 16 til 26 ára og 5.281 unglingar á aldrinum 9 til 15 ára við upphaf rannsóknar)
English: Specific studies of Gardasil 9 in pregnant women were not conducted.
Icelandic: á Gardasil 9 hjá þunguðum konum.
English: Gardasil 9 suspension for injection.
Icelandic: Gardasil 9 inniheldur natríumklóríð.
English: - If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Icelandic: - Látið lækninn, lyfjafræðing eða hjúkrunarfræðinginn vita um allar aukaverkanir sem þú eða barnið finnið fyrir.
English: Protocol 004 evaluated immunogenicity of Gardasil 9 in women aged 16 to 45 years (N=1,210: 640 women aged 27 to 45 years and 570 women aged 16 to 26 years).
Icelandic: Í Protocol 004 var ónæmingargeta Gardasil 9 metin hjá konum á aldrinum 16 til 45 ára (N=1.210:
English: HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥6 Months HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥12 Months HPV 31-, 33-, 45-, 52-, 58-related ASC-US HR-HPV Positive or Worse Pap Abnormality
Icelandic: HPV 31-, 33-, 45-, 52-, 58-tengt ASC-US HR-HPV jákvætt eða alvarlegra Pap
English: HPV 31-, 33-, 45-, 52-, 58-related cervical definitive therapy procedures
Icelandic: HPV 31-, 33-, 45-, 52-, 58-tengd endanleg meðferð við leghálskrabbameini
English: For subjects receiving Gardasil 9 after receiving 3 doses of qHPV vaccine, there was an interval of at least 12 months between completion of vaccination with qHPV vaccine and the start of vaccination with Gardasil 9 with a 3-dose regimen (the time interval ranged from approximately 12 to 36 months).
Icelandic: HPV-bóluefni og upphafsbólusetningar með Gardasil 9 í 3-skammta bólusetningaráætlun (lengd millibils var allt frá u.þ.b. 12 til 36 mánuðum).
English: Fertility
Icelandic: Bórax
English: Polysorbate 80 Borax
Icelandic: Pólýsorbat 80
English: Suspension for injection 1 vial (0.5 ml).
Icelandic: Stungulyf, dreifa 1 hettuglas (0,5 ml).
English: • Inspect the suspension visually for particulate matter and discolouration prior to administration.
Icelandic: Skoðið dreifuna sjónrænt með tilliti til agna og mislitunar fyrir gjöf.
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32 (0) 27766211 dpoc_belux@merck.com
Icelandic: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel:
English: ASC-US=Atypical squamous cells of undetermined significance.
Icelandic: Afbrigðilegar flögufrumur af óljósu mikilvægi.
English: Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for Gardasil 9.
Icelandic: Rannsóknir hafa ekki verið gerðar með Gardasil 9 þar sem notuð er blönduð meðferðaráætlun (jafngild) með HPV-bóluefnum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: The GMTs to HPV types 6, 11, 16, 18 were higher than in the population who had not previously received qHPV vaccine in other studies whereas the
Icelandic: Virkni gegn HPV-gerðum 6, 11, 16 og 18 var einkum metin með tengiaðferð sem sýndi fram á sambærilega ónæmingargetu (mæld með margfeldismeðaltalstíter [GMT])
English: Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM03
Icelandic: Bóluefni, papillomaveirubóluefni, ATC flokkur:
English: Exposure was estimated at 171,000 infants per year.
Icelandic: Útsetning var metin sem 171.000 ungbörn á ári.
English: The interval between 2 doses should be at least 4 weeks.
Icelandic: Bilið á milli tveggja skammta skal vera minnst 4 vikur.
English: Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Icelandic: Jafnvel eldri konur (35-45 ára) þola viðbrögð þessi yfirleitt vel og þau trufla mjög sjaldan dagleg störf.
English: 71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours.
Icelandic: Í 71% skýrslnanna (212 af 297) var um grát að ræða sem byrjaði eftir meira en 24 klst.
English: Individuals 12 months of age or older:
Icelandic: Einstaklingar 12 mánaða og eldri:
English: Seroprotection rates [95% CI]
Icelandic: Hlutfall mótefnavarnar [95% CI]
English: One dose is given at an elected date usually from 12 months of age.
Icelandic: Einn skammtur er gefinn tiltekinn dag, yfirleitt eftir 12 mánaða aldur.
English: Such infants should be revaccinated at 12 to 15 months of age.
Icelandic: Þessi ungbörn skal endurbólusetja við 12 til 15 mánaða aldur.
English: The second dose is intended for individuals who did not respond to the first dose for any reason.
Icelandic: Seinni skammturinn er ætlaður til ónæmingar á þeim sem svöruðu ekki fyrri skammti af einhverjum ástæðum.
English: • Fever (38.5°C or higher).
Icelandic: Hiti (38,5°C eða hærri).
English: • Crying.
Icelandic: Grátur.
English: After reconstitution, one dose (0.5 ml) contains:
Icelandic: Eftir blöndun inniheldur einn skammtur (0,5 ml):
English: The majority of the crying occurred 6 to 10 days after vaccination.
Icelandic: Í flestum tilvikum átti hann sér stað 6 til 10 dögum eftir bólusetningu.
English: Date of first authorisation: 11 May 2006 Date of latest renewal: 11 May 2011
Icelandic: 11. maí 2006 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: In 297 reports a clear time to onset could be determined.
Icelandic: Í 297 skýrslum var hægt að ákvarða með skýrum hætti hvenær viðbrögðin kom fram.
English: - Keep this leaflet.
Icelandic: - Geymdu fylgiseðilinn.
English: Individuals 12 months or older should receive one dose at an elected date.
Icelandic: Einstaklingar 12 mánaða og eldri eiga að fá einn skammt á tilteknum degi.
English: Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Icelandic: Eftir bólusetningu í börnum eru viðbrögð í liðum yfirleitt sjaldgæf (0-3%) og standa stutt.
English: • Bruising or bleeding more easily than normal.
Icelandic: Mar eða blæðingar algengari en eðlilegt er.
English: These data were reported based on more than 400 million doses distributed worldwide.
Icelandic: Þessi gögn eru byggð á yfir 400 milljón skömmtum um heim allan.
English: Symptoms may persist for a matter of months or on rare occasions for years.
Icelandic: Einkenni geta staðið mánuðum saman eða stöku sinnum árum saman.
English: Vaccination should be postponed during any illness with fever >38.5°C.
Icelandic: Fresta skal bólusetningu við öll veikindi með hita > 38,5°C.
English: If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
Icelandic: Sé bóluefnið hins vegar gefið nokkrum dögum fyrir útsetningu, má veita umtalsverða vörn.
English: produced in WI-38 human diploid lung fibroblasts.
Icelandic: er framleidd í WI-38 tvílitna lungnatrefjakímfrumum úr mönnum.
English: The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Icelandic: Öryggissnið eftir 1. og 2. skammt var sambærilegt hjá öllum aldurshópum.