natgillin/translations-raw huggingface dataset:
HPV 6/11/16/18-relaterede eksterne genitale læsioner Eksterne genitale læsioner Kondylomer PIN 1/2/3
N Number of cases HPV 6/11/16/18-related external genital lesions External genital lesions 1394 Genital warts PIN1/2/3
% Effekt** Ved 2 år (95 % CI)
Efficacy** at 2 years (95% CI)
På grundlag af denne immunogenicitetssammenligning antages der at være en sammenlignelig effekt af Gardasil hos 9- til 15-årige piger.
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old girls is inferred.
HPV 16/18relateret AIS
HPV 16/18related AIS
Personer fra 9 år til og med 13 år Gardasil kan indgives efter et program med 2 doser (0,5 ml ved måned 0 og 6) (se pkt.
Individuals 9 to and including 13 years of age Gardasil can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1).
% Effekt*** ved studiets afslutning (95 % CI)
Efficacy*** at end of study (95% CI)
Gardasils effekt hos kvinder fra 24 til 45 år blev vurderet i et klinisk, placebo-kontrolleret, dobbeltblindet, randomiseret fase III-studie (protokol 019, FUTURE III) med i alt 3.817 kvinder, som blev inkluderet og vaccineret uden forudgående screening for tilstedeværelsen af HPV-infektion.
The efficacy of Gardasil in 24- through 45 year-old women was assessed in 1 placebo-controlled, double-blind, randomised Phase III clinical study (Protocol 019, FUTURE III) including a total of 3,817 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
• effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relateret VIN2/3 og VaIN 2/3 henholdsvis
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related VIN2/3 and VaIN 2/3 was 100%
På grundlag af denne immunogenicitetssammenligning antages der at være sammenlignelig effekt af Gardasil hos 9-15-årige drenge.
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old boys is inferred.
Effekt hos kvinder fra 16 til 26 år
Efficacy in women 16 through 26 years
* Personerne i PPE-populationen fik alle 3 vaccinationer inden for 1 år efter rekruttering, havde ingen væsentlige afvigelser, og var naive over for de(n) relevante HPV-type(r) forud for første dosis og indtil 1 måned efter 3. dosis (måned 7).
*The individuals in the PPE population received all 3 vaccinations within 1 year of enrolment, had no major protocol deviations, and were naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7).
Gardasil indeholder:
What Gardasil contains
I den HPV-naive population (naive over for 14 almindeligt forekommende HPV-typer og med negativ Paptest ved dag 1) reducerede Gardasil antallet af kvinder, som fik foretaget en definitiv cervikal behandlingsprocedure (Loop Electro-Excision Procedure eller koldknivskonisering) med 41,9 % (95 % CI: 27,7; 53,5).
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Gardasil reduced the proportion of women who experienced a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI: 27.7, 53.5) at end of study.
HPV 16- eller HPV 18-relateret CIN 2/3 eller AIS HPV 16/18relateret CIN 3
HPV 16- or HPV 18related CIN 2/3 or AIS HPV 16/18related CIN
Effekt** ved studiets afslutning (95 % CI)
Efficacy** at end of study (95% CI)
Gardasils effekt hos 16-26-årige mænd blev vurderet i et klinisk, placebo-kontrolleret, dobbeltblindet, randomiseret fase III-studie (Protokol 020) med i alt 4.055 mænd, der blev inkluderet og vaccineret uden forudgående screening for tilstedeværelse af HPV-infektion.
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.
- Parenterale lægemidler skal inspiceres visuelt for tilstedeværelse af partikler og misfarvning forud for indgivelse.
- Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Hætteglasset skal omrystes grundigt umiddelbart før indgivelsen for at der ikke dannes bundfald i vaccinen.
Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
Effekt hos mænd fra 16 til 26 år
Efficacy in men 16 through 26 years
Ved rekruttering ligner denne population den generelle kvindelige befolkning med hensyn til prævalens af HPV-infektion eller sygdom.
This population approximates to the general population of women with respect to prevalence of HPV infection or disease at enrolment.
Hos kvinder, som var naive over for 14 almindeligt forekommende HPV-typer, og som havde en negativ Pap-test ved dag 1, havde Gardasil ved studieafslutning reduceret incidensen af CIN 2/3 eller AIS forårsaget af vaccine- eller ikke-vaccine-HPV-typer med 42,7 % (95 % CI: 23,7; 57,3) og af kondylomer med 82,8 % (95 % CI:
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.
Tabel 8: Langtidsimmunogenicitetsdata (per protokol population, piger og drenge i alderen 9-15 år) baseret på procentdele af seropositive forsøgspersoner, målt ved cLIA og IgG LIA (protokol 018) efter 10 år.
Table 8: Long-term immunogenicity data (per-protocol population) based on percentage of seropositive subjects as measured by cLIA and IgG LIA (Protocol 018) at 10 years, in girls and boys 9-15 years of age cLIA
Virkning og anvendelse Det skal du vide, før du får Gardasil Sådan gives Gardasil
What Gardasil is and what it is used for What you need to know before you receive Gardasil How Gardasil is given
For 12-måneders definitionen af persisterende infektion, var effekten henholdsvis 100 % (95 % CI: 93,9; 100) for HPV 16, og 100 % (95 % CI: 79,9; 100) for HPV 18.
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.
Vaccinen består af højtoprensede viruslignende partikler (VLP'er) af det vigtigste kapsidprotein L1 fra HPV-typerne 6, 11, 16 og 18.
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.
I langtidsopfølgningsstudiet af protokol 015 blev 2.536 kvinder i alderen 16-23 år fulgt gennem Gardasil-vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 015, 2,536 women 16-23 years old during vaccination with Gardasil in the base study were followed.
I protokol 012 var effekten af Gardasil med udgangspunkt i 6-måneders definitionen af persisterende infektion [prøver positive ved 2 eller flere følgende besøg efter hinanden med et interval på 6 måneder (±1 måned) eller længere] henholdsvis 98,7 % (95 % CI: 95,1; 99,8) for HPV 16, og 100 % (95 % CI: 93,2; 100) for HPV 18 efter en opfølgning på op til 4 år (gennemsnitligt 3,6 år).
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).
Det anbefales, at personer, som har fået Gardasil som første dosis, fuldender hele vaccinationsprogrammet med Gardasil (se pkt.
It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil (see section 4.4).
Du/dit barn må ikke få Gardasil:
Do not receive Gardasil if:
HPV-typerne 16 og 18 er ansvarlige for cirka 70 % af tilfældene af livmoderhalskræft, 75-80% af tilfældene af endetarmskræft, 70 % af HPV-relaterede forstadier til kræft i de ydre kønsorganer og skeden og 75% af HPV relaterede forstadier til kræftlæsioner i endetarmen.
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.
I PPE-populationen blev der ikke observeret nogen tilfælde af HPV typer 6/11 relaterede kønsvorter, HPV 6/11/16/18 ydre læsioner eller HPV 6/11/16/18 highgrade AIN hos MSM gennem 11,5 år (median opfølgning på 9,5 år).
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).
Gardasils effekt imod HPV 6-, 11-, 16-, 18-relaterede AIN 2/3 og HPV 16- eller 18-relaterede AIN 2/3 i MSM-substudiet var 54,2 % (95 % CI: 18,0; 75,3; 18/275 versus 39/276) og 57,5 % (95 % CI: -1,8; 83,9; 8/275 versus 19/276 tilfælde).
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.
Tabel 6 sammenligner anti-HPV 6, 11, 16 og 18 GMT'er 1 måned efter 3. dosis hos 9 til 15-årige piger med de tilsvarende værdier for 16 til 26-årige kvinder.
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.
Effekt imod HPV 6-, 11-, 16-, 18-relateret VIN 2/3 var 73,3 % (95 % CI: 40,3; 89,4), imod HPV 6-, 11-, 16-, 18-relateret VaIN 2/3 var den 85,7 % (95 % CI: 37,6; 98,4) og imod HPV 6-, 11-, 16-, 18relaterede kondylomer 80,3 % (95 % CI: 73,9; 85,3) i de kombinerede protokoller ved studieafslutning.
Efficacy against HPV 6-, 11-, 16-, 18-related VIN 2/3 was 73.3% (95% CI: 40.3, 89.4), against HPV 6-, 11-, 16-, 18-related VaIN 2/3 was 85.7% (95% CI: 37.6, 98.4), and against HPV 6-, 11-, 16-, 18-related genital warts was 80.3% (95% CI: 73.9, 85.3) in the combined protocols at end of study.
På rekrutteringstidspunktet var i alt 67 % af personerne naive (PCR-negative og seronegative) over for alle 4 HPV-typer.
Overall, 67% of individuals were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Trafik- og arbejdssikkerhed Der er ikke undersøgt om Gardasil påvirker evnen til at køre bil og bruge maskiner.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
I langtidsopfølgningsstudiet af protokol 019 blev 685 kvinder i alderen 24-45 år fulgt gennem Gardasil-vaccinationsprogrammet i basisstudiet.
In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Gardasil in the base study were followed.
Ved studieafslutning viste analysen for anallæsioner i MSM-populationen (median opfølgningstid var 2,15 år) en forebyggende effekt imod HPV 6-, 11-, 16-, 18-relateret AIN 2/3 74,9 % (95 % CI 8,8; 95,4; 3/194 versus 13/208) og imod HPV 16 - eller 18-relateret AIN 2/3 86,6 % (95 % CI 0,0; 99,7; 1/194 versus 8/208).
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).
Ikke kendt Akut dissemineret encefalomyelitis*, Svimmelhed
Very common Headache Not known Acute disseminated encephalomyelitis*, Dizziness
Der blev ikke set nogen vaccineeffekt hos kvinder, som havde en abnorm Pap-test ved dag 1, og som allerede var inficeret med de relevante vaccine-HPV-typer ved dag 1.
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.
Denne indlægsseddel blev senest ændret: MM/ÅÅÅÅ.
This leaflet was last revised in: {MM/YYYY}.
Natriumklorid, L-histidin, polysorbat 80, natriumborat og vand til injektionsvæsker.
Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
Brug ikke lægemidlet efter den udløbsdato, der står på mærkaten på sprøjten og på pakningen (efter Exp) Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this vaccine after the expiry date which is stated on the vial label and the outer carton (after EXP).
Gardasils effekt imod HPV 6-, 11-, 16-, 18-relaterede kondylomer var 68,1 % (95 % CI: 48,8; 79,3).
The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
• effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relateret CIN (1, 2, 3) eller AIS 96,0 % (95 %
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Piger og drenge vaccineret med Gardasil i 9-15-års-alderen i protokol 018-basisstudiet blev fulgt i et udvidet studie.
Girls and boys vaccinated with Gardasil at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Andelen af bivirkninger/uønskede hændelser hos moderen og det ammede barn var sammenlignelige for vaccinegruppen og placebogruppen.
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.
Hvis du er fra 9 år til og med 13 år gammel Gardasil kan gives som et program med 2 doser: Første injektion: på den valgte dato Anden injektion: 6 måneder efter første injektion Hvis den anden vaccinedosis bliver givet tidligere end 6 måneder efter den første dosis, bør der altid gives en tredje dosis.
Gardasil can be administered according to a 2-dose schedule: - First injection: at chosen date - Second injection: 6 months after first injection If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Kvinder vaccineret med Gardasil i 24-45-års-alderen i protokol 019-basisstudiet blev fulgt i et udvidet studie.
Women vaccinated with Gardasil at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Alternativt kan Gardasil gives efter et program med 3 doser: - Første injektion: på den valgte dato Anden injektion: 2 måneder efter første injektion Tredje injektion: 6 måneder efter første injektion
Alternatively, Gardasil can be administered according to a 3-dose schedule: - First injection: at chosen date - Second injection: 2 months after first injection - Third injection: 6 months after first injection 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.
14 år efter vaccination var henholdsvis 91%, 91%, 98% og 52% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 98%, 98%, 100% og 94% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
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.
Tabel 6: Immunogenicitetssammenligning mellem 9- til 15-årige piger og 16- til 26-årige kvinder (per-protokol-population) baseret på titre målt med cLIA
Table 6: Immunogenicity bridging between 9- to 15-year-old girls and 16- to 26-year-old women (perprotocol population) based on titres as measured by cLIA 9- to 15-Year-Old Girls (Protocols 016 and 018)
Eftersom Gardasil ikke påvirker forløbet af infektioner eller sygdom, som er til stede ved vaccinationens påbegyndelse, var fordelen ved vaccinen for så vidt angår den overordnede forekomst af CIN 2/3 eller AIS (forårsaget af enhver HPV-type) og af kondylomer meget lavere i den modificerede ITT-population med en reduktion på henholdsvis 18,4 % (95 % CI: 7,0; 28,4) og 62,5 % (95 % CI: 54,0; 69,5).
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.
10 år efter vaccination var henholdsvis 79%, 85%, 94% og 36% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 86%, 79%, 100% og 83% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
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.
tilfælde tilfælde
cases cases
I det udvidede langtidsstudie af Protokol 020 blev 917 mænd i alderen 16-26 år fulgt gennem Gardasilvaccinationsprogrammet i basisstudiet.
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.
B. INDLÆGSSEDDEL (HÆTTEGLAS)
B. PACKAGE LEAFLET (VIAL)
Gardasil injektionsvæske, suspension Intramuskulær brug.
Gardasil suspension for injection IM use.
Mænd vaccineret med Gardasil i 16-26-års-alderen i protokol 020-basisstudiet blev fulgt i et udvidet studie.
Men vaccinated with Gardasil at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
I PPE-populationen blev der ikke set tilfælde af HPVsygdom (HPV-typer 6/11/16/18-relateret high-grade CIN) i op til ca. 14 år (median opfølgning på 11,9 år).
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).
I langtidsopfølgningsstudiet af protokol 018 blev 369 piger i alderen 9-15 år fulgt gennem Gardasilvaccinationsprogrammet i basisstudiet.
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.
I det kliniske studie af kvinder mellem 24 og 45 år, blev 98,4 %, 98,1 %, 98,8 % og 97,4 % af de kvinder, der fik Gardasil, henholdsvis anti-HPV 6, anti-HPV 11, antiHPV 16 og anti-HPV 18 seropositive én måned efter 3. dosis.
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.
I PPE-populationen blev der ikke set tilfælde af HPV-sygdom (HPV-typer 6/11/16/18-relateret eksterne genitale læsioner) gennem 10,6 år (median opfølgning på 9,9 år).
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).
Gardasil, injektionsvæske, suspension:
Gardasil, suspension for injection :
HPV 16/18-relateret CIN 2/3 eller AIS
HPV 16/18related CIN 2/3 or AIS HPV 16/18related CIN 3
Gardasil, injektionsvæske, suspension.
Gardasil, suspension for injection.
Eftersom Gardasil ikke påvirker forløbet af infektioner eller sygdom, som er til stede ved vaccinationens påbegyndelse, var fordelen ved vaccinen for så vidt angår den overordnede forekomst af EGL lavere i fuldt analysesæt (full analysis set FAS)-populationen med en reduktion på 59,3 % (95 % CI: 40,0; 72,9).
In the Full Analysis Set (FAS) population, the benefit of the vaccine with respect to the overall incidence of EGL was lower, with a reduction of 59.3% (95% CI: 40.0, 72.9), as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
I langtidsopfølgningsstudiet af protokol 018 blev 326 drenge i alderen 9-15 år fulgt gennem Gardasilvaccinationsprogrammet i basisstudiet.
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.
Kvinder vaccineret med Gardasil i 16-23-års-alderen i protokol 015-basisstudiet blev fulgt i et udvidet studie.
Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study.
I de kliniske studier af kvinder mellem 16 og 26 år blev i alt 99,8 %, 99,8 %, 99,8 % og 99,5 % af de kvinder, der fik Gardasil, henholdsvis anti-HPV 6, anti-HPV 11, anti-HPV 16 og anti-HPV-18 seropositive én måned efter 3. dosis.
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.
1 dosis hætteglas på 0,5 ml.
1 dose vial, 0.5 ml.
I det kliniske studie af mænd mellem 16 til 26 år blev i alt 98,9 %, 99,2 %, 98,8 % og 97,4 % af de personer, der fik Gardasil, anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive én måned efter 3. dosis.
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.
I PPE-populationen, blev der ikke set tilfælde af HPV-sygdom (HPV-typer 6/11/16/18-relateret CIN alle grader og kondylomer) gennem 10,7 år (median opfølgning på 10,0 år).
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).
I PPE-populationen blev der ikke set tilfælde af HPVsygdom (HPV-typer 6/11/16/18-relateret CIN alle grader og kondylomer) gennem 10,1 år (median opfølgning på 8,7 år).
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).
I kliniske studier blev den beskyttelse, som opnåedes med Gardasil, ikke nedsat af præventionsmidler i tabletform (f.eks. p-piller) eller andre svangerskabsforebyggende midler.
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
20 enkeltdoser hætteglas på 0,5 ml.
20 single dose vials, 0.5 ml each.
Gardasil, injektionsvæske, suspension i fyldt injektionssprøjte.
Gardasil, suspension for injection in a pre-filled syringe.
Effekten af Gardasil imod den kombinerede forekomst af HPV 6-, 11-, 16- og 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancer var 88,7 % (95 % CI: 78,1; 94,8).
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).
• effekten af Gardasil imod HPV 6-, 11-, 16-, 18-relaterede kondylomer 99,0 % (95 % CI: 96,2;
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Effekten af Gardasil imod den kombinerede forekomst af HPV 16- eller 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancere var 41,6 % (95 % CI: 24,3; 55,2).
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).
Effekten imod anal intraepitelial neoplasi (AIN grad 1/2/3) og analcancer samt intraanal persisterende infektion blev vurderet i en undergruppe på 598 mænd (GARDASIL = 299; placebo = 299) i Protokol
In a subset of 598 men (GARDASIL = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated.