FrancophonIA/ELRC3.0 huggingface dataset:
English: In breast-feeding mothers given Gardasil or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breast-fed infant were comparable between the vaccination and the placebo groups.
Icelandic: Hjá konum með börn á brjósti sem var gefið Gardasil eða lyfleysa á bólusetningartímabili í klínískum rannsóknum var tíðni aukaverkana hjá móður og barni á brjósti sambærileg hjá bólusetningar- og lyfleysuhópunum.
English: HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases, 75-80% of anal cancer cases; 70% of HPV-related pre-cancerous lesions of the vulva and vagina, 75% of HPV related pre-cancerous lesions of the anus.
Icelandic: 16 og 18 er ábyrg fyrir u.þ.b. 70% af leghálskrabbameinum, 75-80% krabbameina í endaþarmi, 70% af HPV-tengdum forstigum krabbameins í vefskemmdum á sköpum og leggöngum og 75% af HPV-tengdum forstigum krabbameins í vefskemmdum á endaþarmi.
English: However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil can still protect against diseases associated with the other HPV types in the vaccine.
Icelandic: Hins vegar getur Gardasil veitt einstaklingum sem eru þegar sýktar af einni eða fleiri gerð HPV í bóluefninu vörn gegn sjúkdómum er tengjast öðrum HPV gerðum í bóluefninu.
English: Gardasil can be given with a Hepatitis B vaccine or with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.
Icelandic: B eða samhliða endurbólusetningu með samsettu bóluefni sem inniheldur barnaveiki (d) og stífkrampa (T) ásamt kíghósta [ekki frumutengt] (ap) og/eða mænusótt [óvirkjuð] (IPV) (dTap, dT-IPV, dTap-IPV bóluefnum) á annan stungustað (annan líkamshluta, t.d. hinn handlegginn eða fótlegginn) í sömu læknisskoðun.
English: Anal Intraepithelial Neoplasia (AIN) Grade 2/3 (moderate to high-grade dysplasia) was used in the clinical trials as a surrogate marker for anal cancer.
Icelandic: Þekjufrumubreytingar í endaþarmi (AIN) á stigi 2/3 (á miðstigi til háu stigi) voru notaðar sem klínískt auðkenni fyrir krabbamein í endaþarmi.
English: For the 12 month definition of persistent infection, efficacy against HPV 16 was 100.0 % (95% CI: 93.9, 100.0) and 100.0% (95% CI: 79.9, 100.0) for HPV 18 respectively.
Icelandic: Ef litið er til 12 mánaða skilgreiningar á viðvarandi sýkingu, þá var virkni gegn HPV 16 sýkingu 100,0% (95% CI: 93,9; 100,0) og 100,0% (95% CI:
English: Gardasil induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Icelandic: Gardasil kallaði fram háa HPV mótefnatítra (GMT) 1 mánuði eftir
English: In the PPE population, no cases of HPV types 6/11 related genital warts, HPV 6/11/16/18 external genital lesions or HPV 6/11/16/18 high grade AIN in MSM were observed through 11.5 years (median follow-up of 9.5 years).
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik af HPV 6/11 tengdum kynfæravörtum, HPV 6/11/16/18 tengdum ytri kynfærasárum eða þekjufrumubreytingum í endaþarmi (AIN) á háu stigi hjá samkynhneigðum karlmönnum af gerð HPV 6/11/16/18 í 11,5 ár (við eftirfylgni með miðgildi 9,5 ár).
English: What Gardasil contains
Icelandic: Gardasil inniheldur
English: Gardasil may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine.
Icelandic: Gardasil má gefa samhliða endurbólusetningu með samsettu bóluefni við barnaveiki (d) og stífkrampa (T), með annað hvort kíghósta [ekki frumutengt] (ap) og/eða mænusótt [óvirkjuð] (IPV) (dTap, dTIPV, dTap-IPV bóluefni) án marktækra áhrifa á mótefnasvar hvors bóluefnis fyrir sig.
English: In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Gardasil in the base study were followed.
Icelandic: Í langtímaframhaldshluta rannsóknaráætlunar 018 var fylgst með 369 stúlkum sem bólusettar voru með Gardasil á aldrinum 9-15 ára í grunnrannsókninni.
English: Overall, 67% of individuals were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Icelandic: 67% einstaklingar ekki áður fengið neinar af 4 HPV gerðunum (PCR neikvæðir og mótefnaneikvæðir) við skráningu.
English: Table 6 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15 year-old girls with those in 16- to 26-year old women.
Icelandic: Tafla 6 ber saman HPV 6, HPV 11, HPV 16 og HPV 18 1 mánuði eftir 3. skammt hjá 15- 19 ára gömlum stúlkum við 16- 26 ára konur.
English: Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions*
Icelandic: Tíðni ekki þekkt Ónæmisviðbrögð, m.a. bráðaofnæmi/bráðaofnæmislík viðbrögð*
English: Administration of Gardasil should be postponed in individuals suffering from an acute severe febrile illness.
Icelandic: Fresta skyldi inngjöf Gardasil hjá einstaklingum sem þjást af bráðum og alvarlegum sjúkdómi sem fylgir hiti.
English: The efficacy of Gardasil in 16- through 26 year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Icelandic: Virkni Gardasil hjá konum á aldrinum 16 til 26 ára var metin í 4 tvíblindum lyfleysustýrðum, slembuðum samanburðarrannsóknum á stigi II og III sem samanstóðu af 20.541 konum sem var gefið Gardasil án þess að áður hafi farið fram leit að HPV sýkingu.
English: Impact on Biopsy and Definitive Therapy Procedures
Icelandic: Áhrif á töku vefjasýna og meðferð
English: Use with other vaccines
Icelandic: Notkun ásamt öðrum bóluefnum
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Gardasil in the base study were followed.
Icelandic: Í langtímaframhaldshluta rannsóknaráætlunar 018 var fylgst með 326 drengjum sem bólusettir voru með Gardasil á aldrinum 9-15 ára í grunnrannsókninni.
English: The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, 18), were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Icelandic: Fyrstu greiningar á virkni með tilliti til HPV bóluefnisstofna (HPV 6, 11, 16 og 18) voru gerðar á þátttakendum sem fylgdu rannsóknaráætlun (PPE) (þ.e. fengu allar 3 bólusetningarnar innan árs frá inntöku í rannsóknina, engin mikilvæg frávik frá rannsóknaráætlun og höfðu ekki áður smitast af viðkomandi HPV stofni (stofnum) fyrir fyrsta skammtinn og í 1 mánuð eftir 3. skammtinn (7. mánuð)).
English: What Gardasil looks like and contents of the pack 1 dose of Gardasil suspension for injection contains 0.5 ml.
Icelandic: Lýsing á útliti Gardasil og pakkningastærðir 1 skammtur Gardasil stungulyfs, dreifu inniheldur 0,5 ml.
English: In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil.
Icelandic: Yfirleitt voru aukaverkanir sem tilkynnt var um í sambandi við ofskömmtun sambærilegar við þær sem fram komu eftir ráðlagða staka skammta af Gardasil.
English: 1 dose vial, 0.5 ml.
Icelandic: 1 skammtur í hettuglasi, 0,5 ml.
English: However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Icelandic: Hins vegar er sýking eins og væg öndunarfærasýking eða vægur hiti ekki frábending hvað varðar ónæmisaðgerð.
English: In the clinical studies in women 16 to 26 years of age, 99.8%, 99.8%, 99.8%, and 99.5% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3.
Icelandic: Í klínísku rannsóknunum á konum á aldrinum 16 til 26 ára, urðu 99,8%, 99,8%, 99,8% og 99,5% þeirra einstaklinga sem fengu Gardasil sermisjákvæðir varðandi mótefni gegn HPV 6, HPV 11, HPV 16 og HPV 18, í þessari röð, 1 mánuði eftir 3. skammt.
English: Gardasil is available in packs of 1, 10 or 20 pre-filled syringes.
Icelandic: Gardasil fæst í pakkningum með 1, 10 eða 20 áfylltum sprautum, með nálarhylki (öryggisbúnaður).
English: This population approximates to the general population of women with respect to prevalence of HPV infection or disease at enrolment.
Icelandic: Þetta þýði endurspeglar almennan fjölda kvenna með tillitit til tíðni HPV sýkinga eða sjúkdóma við skráningu í rannsóknina.
English: 20 single dose vials, 0.5 ml each.
Icelandic: 20 stakir skammtar í hettuglasi, 0,5 ml hver.
English: Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.
Icelandic: Konur sem voru þegar sýktar af HPV stofnum (einum eða fleirum), sem eru í bóluefninu fyrir bólusetningu, verndaðar gegn sýkingum af völdum annarra HPV stofna í bóluefninu.
English: Bridging the Efficacy of Gardasil from Men to Boys
Icelandic: Bilið milli virkni Gardasil hjá drengjum og körlum brúað
English: The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, and 18), were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrollment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Icelandic: Fyrstu greiningar á virkni með tilliti til HPV-gerða í bóluefninu (HPV 6, 11, 16 og 18) voru gerðar hjá rannsóknarþýði samkvæmt rannsóknaráætlun um virkni (þ.e. hjá einstaklingum þar sem allar 3 bólusetningarnar voru gerðar innan árs frá skráningu, engin mikilvæg frávik voru frá rannsóknaráætlun og viðkomandi höfðu ekki smitast af viðkomandi HPV gerð fyrir fyrsta skammtinn og í 1 mánuð eftir 3. skammtinn ( 7. mánuð)).
English: The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
Icelandic: Hreinsað, smitlaust prótein fyrir hverja mannapapillomaveirugerð (6, 11, 16 og 18).
English: In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Icelandic: Í klínísku rannsókninni hjá körlum á aldrinum 16 til 26 ára, urðu 98,9%, 99,2%, 98,8% og 97,4% þeirra einstaklinga sem fengu Gardasil urðu sermisjákvæðir varðandi mótefni gegn HPV 6, HPV 11, HPV 16 og HPV 18, í þessari röð, 1 mánuði eftir 3. skammt.
English: • you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”- see section 6).
Icelandic: Gardasil (kemur fram undir „önnur innihaldsefni“ - sjá kafla 6).
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Icelandic: virkni Gardasil gegn HPV 6-, 11-, 16-, 18-tengdum CIN (1, 2, 3) eða AIS var 96,0% (95% CI:
English: The efficacy of Gardasil in 16- through 26 year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Icelandic: Virkni Gardasil hjá körlum á aldrinum 16 til 26 ára var metin í í einni tvíblindri, slembiraðaðri III. stigs klínískri samanburðarrannsókn með lyfleysu (rannsóknaráætlun 020) hjá samtals 4.055 körlum sem voru skráðir og bólusettir á þess að áður hafi farið fram skimun að HPV sýkingu.
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Gardasil in the base study were followed.
Icelandic: langtímaframhaldshluta rannsóknar samkvæmt rannsóknaráætlun 020 var fylgst með 917 karlmönnum sem bólusettir voru með Gardasil á aldrinum 16-26 ára í upphaflegu rannsókninni.
English: The impact of Gardasil against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two Phase III efficacy trials (Protocols 013 and 015).
Icelandic: Áhrif Gardasil á heildaráhættu á HPV sjúkdómi í leghálsi (þ.e. sjúkdómi af völdum hvaða gerðar HPV sem er) voru metin hjá 17.599 einstaklingum sem tóku þátt í III.
English: 1 Type 6 L1 protein
Icelandic: 1 af stofni 6 L1 prótein
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Icelandic: • virkni Gardasil gegn HPV 6-, 11-, 16-, 18-tengdum CIN 1 var 95,9% (95% CI:
English: Among men who were naïve to 14 common HPV types, administration of Gardasil reduced the incidence of external genital lesions caused by vaccine- or non-vaccine HPV types by 81.5% (95% CI: 58.0, 93.0).
Icelandic: Á meðal karla sem ekki höfðu fengið 14 algengar gerðir HPV, dró lyfjagjöf með Gardasil úr tilfellum vefskemmda á kynfærum af völdum HPV gerða sem er bólusett fyrir og ekki bólusett fyrir um 81,5% (95% CI:
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6% (95% CI: 24.3, 55.2).
Icelandic: Virkni Gardasil gegn samanlagðri tíðni af HPV 16- eða 18- tengdum þrálátum sýkingum, kynfæravörtum, vefskemmdum á sköpum og leggöngum, CIN af öllum gerðum AIS og leghálskrabbameini var 41,6% (95% CI: 24,3; 55,2).
English: Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Icelandic: 1. degi sem voru þegar með sýkingu af völdum bóluefnisstofna HPV á 1. degi, kom ekki fram nein virkni bóluefnisins.
English: Suspension for injection in a pre-filled syringe.
Icelandic: Stungulyf, dreifa í áfylltri sprautu.
English: 10 single dose vials, 0.5 ml each.
Icelandic: 10 stakir skammtar í hettuglasi, 0,5 ml hver.
English: Fourteen years after vaccination, 91%, 91%, 98% and 52% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 98%, 100% and 94% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Icelandic: Fjórtán árum eftir bólusetningu voru 91% þeirra sermisjákvæðar hvað varðar HPV 6 mótefni, 91% hvað varðar HPV 11 mótefni, 98% hvað varðar HPV 16-mótefni og 52% hvað varðar HPV 18-mótefni mælt með cLIA.
English: % of seropositive subjects n % of seropositive subjects
Icelandic: % sermisjákvæðra þátttakenda
English: In Protocol 012 the efficacy of Gardasil against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7% (95% CI: 95.1, 99.8) and 100.0% (95% CI: 93.2, 100.0) for HPV 18 respectively, after a follow-up of up to 4 years (mean of 3.6 years).
Icelandic: Í rannsóknaráætlun 012 þar sem virkni Gardasil gegn viðvarandi sýkingu var skilgreind var með 6 mánaða tímabili [jákvæð sýni í 2 eða fleiri heimsóknum í röð með 6 mánuðum á milli (±1 mánuð) eða lengur] þá var virkni gegn HPV 16 sýkingu 98,7% (95% CI:
English: At end of study analysis for anal lesions in the MSM population (median duration of follow-up was 2.15 years), the preventive effect against HPV 6-, 11-, 16-, 18-related AIN 2/3 was 74.9% (95 % CI: 8.8, 95.4; 3/194 versus 13/208) and against HPV 16- or 18-related AIN 2/3 86.6% (95 % CI: 0.0, 99.7; 1/194 versus 8/208).
Icelandic: 88; 95,4; 3/194 miðað við 13/208) og gegn HPV 16 eða 18 tengdum AIN 2/3, 86,6% (95% CI 0,0, 99,7; 1/194 miðað við 8/208).
English: Very common Headache Not known Acute disseminated encephalomyelitis*, Dizziness
Icelandic: Tíðni ekki þekkt Sjálfvakinn blóðflagnafæðarpurpuri*, eitlastækkun*
English: Gardasil, suspension for injection in a pre-filled syringe:
Icelandic: Gardasil stungulyf, dreifa í áfylltri sprautu:
English: Among women who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Gardasil reduced the incidence of CIN 2/3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI: 23.7, 57.3) and of genital warts by 82.8% (95% CI: 74.3, 88.8) at end of study.
Icelandic: Á meðal kvenna sem höfðu ekki áður fengið 14 algengar gerðir HPV og fengu neikvætt Pap próf á 1. degi, minnkaði gjöf Gardasil tíðni CIN 2/3 eða AIS af völdum HPV gerða í bóluefninu eða gerða sem ekki eru í bóluefninu um 42,7% (95% CI :
English: Table 5: Efficacy of Gardasil against external genital lesions in the PPE* population of 16-26 year old men
Icelandic: Greining á virkni Gardasil gegn vefskemmdum á kynfærum hjá körlum á aldrinum 16-26 ára sem fylgdu rannsóknaráætlun (PPE)*
English: Gardasil, suspension for injection:
Icelandic: Gardasil stungulyf, dreifa:
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.1 years (median follow-up of 8.7 years).
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV 6/11/16/18 tengdar leghálsfrumubreytingar af öllum gerðum og kynfæravörtur) í 10,1 ár (við eftirfylgni með miðgildi 8,7 ár).
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Icelandic: Virkni GARDASIL gegn HPV 6-, 11-, 16-, 18-tengdum kynfæravörtum var 68,1% (95% CI:
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Icelandic: Gardasil eða lyfleysu á fyrsta degi rannsóknarinnar og svo u.þ.b. 2 og 6 mánuðum seinna.
English: *, Guillain-Barré syndrome*, syncope sometimes accompanied by tonic-clonic movements*
Icelandic: Tíðni ekki þekkt Bráð, dreifð heila- og mænubólga*, sundl Guillain-Barré heilkenni*, aðsvif sem stundum fylgir vöðvakippavöðvaþanshreyfingar*
English: In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Icelandic: til 45 ára, urðu 98,4%, 98,1%, 98,8% og 97,4% þeirra einstaklinga sem fengu Gardasil sermisjákvæðir varðandi mótefni gegn HPV 6, HPV 11, HPV 16 og HPV 18, í þessari röð, 1 mánuði eftir 3. skammt.
English: Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Icelandic: Gardasil, stungulyf, dreifa - áfyllt sprauta án nálar, pakkning með 1, 10 eða 20 einingum
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median follow-up of 10.0 years).
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV-6/11/16/18 tengdar leghálsfrumubreytingar af öllum gerðum og kynfæravörtur) í 10,7 ár (við eftirfylgni með miðgildi 10,0 ár).
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median followup of 9.9 years).
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV- 6/11/16/18 tengd sár á ytri kynfærum) í 10,6 ár (við eftirfylgni með miðgildi 9,9 ár).
English: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Icelandic: Bóluefni gegn mannapapillomaveiru (HPV) [af gerðum 6, 11, 16, 18] (raðbrigða, aðsogað).
English: Gardasil suspension for injection in a pre-filled syringe
Icelandic: Gardasil stungulyf, dreifa í áfylltri sprautu
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
Icelandic: CIN 3 og staðbundið kirtilþekjukrabbamein (AIS) eru viðurkenndir undanfarar ífarandi leghálskrabbameins.
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95% CI: 78.1, 94.8).
Icelandic: Virkni Gardasil gegn samanlagðri tíðni HPV 6-, 11-, 16-, eða 18-tengdum þrálátum sýkingum, kynfæravörtum, vefskemmdum á sköpum og leggöngum, CIN af öllum gerðum, AIS og leghálskrabbameini var 88,7% (95% CI:
English: Evidence of Anamnestic (Immune Memory) Response
Icelandic: Vísbending um ónæmisminnissvörun
English: What you need to know before you receive Gardasil
Icelandic: Áður en byrjað er að nota Gardasil
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 86%, 79%, 100% and 83% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Icelandic: Tíu árum eftir bólusetningu voru 79% þeirra sermisjákvæðar hvað varðar HPV 6-mótefni, 85% hvað varðar HPV 11-mótefni, 94% hvað varðar HPV 16 mótefni og 36% hvað varðar HPV 18 mótefni mælt með cLIA.
English: Efficacy in men 16 through 26 years
Icelandic: Virkni hjá körlum á aldrinum 16 til 26 ára
English: N Number of cases HPV 6/11/16/18-related external genital lesions External genital lesions 1394 Genital warts PIN1/2/3
Icelandic: N Fjöldi einstaklinga HPV 6/11/16/18-tengdar vefskemmdir á kynfærum
English: Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Icelandic: Gardasil, stungulyf, dreifa - áfyllt sprauta með tveimur lausum nálum, pakkning með 1, 10 eða 20 einingum
English: Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18.
Icelandic: Gardasil er raðbrigða ónæmisglætt bóluefni sem veldur ekki sýkingu, er fjórþætt og er framleitt úr háhreinsuðum veirulíkum ögnum (VLP) úr mikilvægum próteinum veiruskurnar HPV gerða 6, 11, 16 og 18. VLP agnirnar innihalda ekkert veiru DNA, þær geta ekki smitað frumur, fjölgað sér eða valdið sjúkdómi.
English: Gardasil, suspension for injection in a pre-filled syringe.
Icelandic: Gardasil fæst í tilbúnum áfylltum sprautum til stungulyfjagjafar í vöðva (i.m.).
English: In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI: 7.0, 28.4) and 62.5% (95% CI: 54.0, 69.5), respectively, as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Icelandic: Í aðlagaða meðferðarákvörðunar ITT þýðinu var ávinningur af bóluefninu með tilliti til heildartíðni CIN 2/3 eða AIS (af völdum allra HPV gerða) og kynfæravartna miklu minni, með lækkun um 18,4% (95% CI:
English: In the PPE population no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 14 years (median followup of 11.9 years).
Icelandic: Hjá rannsóknarþýði skv. rannsóknaráætlun komu ekki fram nein tilvik HPV-sjúkdóma (HPV-6/11/16/18 tengdar leghálsfrumubreytingar á háu stigi) í allt að u.þ.b. 14 ár (miðgildi eftirfylgni var 11,9 ár).
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related AIN 2/3 and HPV 16- or 18-related AIN 2/3, in the MSM substudy, was 54.2% (95% CI: 18.0, 75.3; 18/275 versus 39/276) and 57.5% (95% CI: -1.8, 83.9; 8/275 versus 19/276 cases), respectively.
Icelandic: Virkni GARDASIL gegn HPV 6-, 11-, 16- ,18-tengdum AIN 2/3 og HPV 16- eða 18 tengdum AIN 2/3, í undirrannsókninni hjá samkynhneigðum var 54,2% (95% CI:
English: Not known Injection-site cellulitis *
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA