FrancophonIA/ELRC3.0 huggingface dataset:
English: Thorough agitation immediately before administration is necessary to maintain
Danish: Hætteglasset skal omrystes grundigt umiddelbart før indgivelsen for at der
English: Among women who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Silgard 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.
Danish: Hos kvinder, som var naive over for 14 almindeligt forekommende HPV-typer, og som havde en negativ Pap-test ved dag 1, havde Silgard 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:
English: Talk to your doctor, pharmacist or nurse before vaccination if you or your child
Danish: Advarsler og forsigtighedsregler Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du eller dit barn:
English: Do not receive Silgard if:
Danish: Silgard indeholder:
English: 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
Danish: Tabel 8: Langtids-immunogenicitetsdata (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
English: Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Danish: Montér kanylen ved at dreje den med uret indtil kanylen sidder godt og sikkert på sprøjten.
English: In Protocol 012 the efficacy of Silgard 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).
Danish: I protokol 012 var effekten af Silgard 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).
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 12 years.
Danish: I PPE-populationen blev der ikke set tilfælde af HPVsygdom (HPV-typer 6/11/16/18-relateret high-grade CIN) i op til ca. 12 år.
English: The term "premalignant anal lesions" in section 4.1 corresponds to high-grade anal intraepithelial neoplasia (AIN 2/3).
Danish: 4.1 refererer til high-grade anal intraepitelial neoplasi (AIN
English: Tlf: + 45 4482 4000 dkmail@merck.com
Danish: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: Women vaccinated with Silgard at 16-23 years of age in Protocol 015 base study will be followed up to 14 years in an extension study.
Danish: Kvinder vaccineret med Silgard i 16-23-års-alderen i protokol 015-basisstudiet vil blive fulgt i op til 14 år i et udvidet studie.
English: This population approximates to the general population of men with respect to prevalence of HPV infection or disease at enrolment.
Danish: Ved rekruttering ligner denne population den generelle mandlige befolkning med hensyn til prævalens af HPV-infektion ellersygdom.
English: The efficacy of Silgard against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Danish: Silgards effekt imod HPV 6-, 11-, 16-, 18-relaterede kondylomer var 68,1 % (95 % CI: 48,8; 79,3).
English: Girls and boys vaccinated with Silgard at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Danish: Piger og drenge vaccineret med Silgard i 9-15-års-alderen i protokol 018-basisstudiet blev fulgt i et udvidet studie.
English: Silgard 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.
Danish: Vaccinen består af højtoprensede viruslignende partikler (VLP'er) af det vigtigste kapsidprotein L1 fra HPV-typerne 6, 11, 16 og 18.
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
Danish: Adsorberet på amorft aluminium-hydroxyl-fosfat-sulfat (0,225 mg Al)
English: 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.
Danish: 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
English: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Danish: Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: Efficacy in women with and without prior infection or disease due to HPV 6, 11, 16, or 18
Danish: Effekt hos kvinder med og uden tidligere infektion eller sygdom, som skyldes HPV 6, 11, 16 eller 18
English: The efficacy of Silgard 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.
Danish: Silgards 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;
English: Efficacy was 68.2% (95% CI: 17.9, 89.5; 6 vs. 20 cases [n = 832 from studies in young and adult women combined]) against HPV 16- and 18-related persistent infection in women 16 to 45 years.
Danish: Effekten mod HPV 16- og 18-relateret persisterende infektion var 68,2 % (95 % CI: 17,9, 89,5; 6 versus 20 tilfælde [n = 832 fra studier med unge og voksne kvinder]) hos kvinder 16-45 år.
English: Efficacy in men with or without prior infection or disease due to HPV 6, 11, 16, or 18
Danish: Effekt hos mænd med eller uden forudgående infektion eller sygdom på grund af HPV 6, 11, 16 eller
English: Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity.
Danish: Almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter): Bivirkninger på injektionsstedet, herunder blåt mærke, kløe, smerte i arme eller ben.
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
Danish: Adsorberet på amorf aluminiumhydroxyphosphat-sulfat-adjuvans (0,225 milligram Al)
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
Danish: 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.
English: The primary efficacy endpoints included the combined incidence of HPV 6-, 11-, 16- or 18-related and the combined incidence of HPV 16- or HPV 18-related persistent infection (6 month definition), genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers.
Danish: De primære effektmål omfattede den kombinerede forekomst af HPV 6-, 11-, 16- eller 18- samt HPV 16- eller 18-relateret persisterende infektion (6 måneders definition), kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancere.
English: In the long-term extension study of Protocol 015, 2,084 women 16-23 years old during vaccination with Silgard in the base study, were followed.
Danish: I langtids-opfølgningsstudiet af protokol 015 blev 2.084 kvinder i alderen 16-23 år fulgt gennem Silgard-vaccinationsprogrammet i basisstudiet.
English: Merck Sharp & Dohme Ltd, Hertford Road,
Danish: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Storbritannien
English: Table 7 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15-year-old boys with those in 16- to 26-year-old men.
Danish: Tabel 7 sammenligner anti-HPV 6, 11, 16 og 18 GMT'er 1 måned efter 3. dosis hos 9-15-årige drenge med de tilsvarende for 16-26-årige mænd.
English: Women vaccinated with Silgard at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Danish: Kvinder vaccineret med Silgard i 24-45-års-alderen i protokol 019-basisstudiet blev fulgt i et udvidet studie.
English: Among the girls receiving 2 doses of the vaccine, 96%, 100%, 100%, and 84% remained seropositive to anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18, respectively, in the cLIA.
Danish: Hos pigerne, som fik 2 doser af vaccinen, forblev henholdsvis 96%, 100%, 100% og 84% anti-HPV 6-, anti-HPV 11-, antiHPV 16- og anti-HPV 18-seropositive ved cLIA.
English: 6.1 List of excipients
Danish: 5.3 Prækliniske sikkerhedsdata
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
Danish: 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.
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.
Danish: 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.
English: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Silgard in the base study, were followed.
Danish: I langtids-opfølgningsstudiet af protokol 019 blev 685 kvinder i alderen 24-45 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet.
English: All three doses should be given within
Danish: Alle tre doser bør gives inden for en periode på et år.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ.
English: Keep the syringe in the outer carton in order to protect from light.
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys.
English: 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.
Danish: Den anden dosis bør gives mindst en måned efter den første dosis, og tredje dosis bør gives mindst 3 måneder efter den anden dosis.
English: Men vaccinated with Silgard at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
Danish: Mænd vaccineret med Silgard i 16-26-års-alderen i protokol 020-basisstudiet blev fulgt i et udvidet studie.
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
Danish: 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).
English: Among women with an abnormal Pap test at Day 1 who were naïve to the relevant vaccine HPV types at Day 1, efficacy of the vaccine remained high.
Danish: Vaccinens effekt forblev høj hos kvinder, som havde en abnorm Pap-test på dag 1, og som var naive over for de relevante vaccine-HPV-typer på dag 1.
English: After thorough agitation, it is a white, cloudy
Danish: Efter grundig omrystning, er den en hvid, uklar væske.
English: In breast-feeding mothers given Silgard 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.
Danish: Andelen af bivirkninger/uønskede hændelser hos moderen og det ammede barn var sammenlignelige for vaccinegruppen og placebogruppen.
English: Silgard, suspension for injection.
Danish: Silgard, injektionsvæske, suspension.
English: • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: - Parenterale lægemidler skal inspiceres visuelt for tilstedeværelse af partikler og misfarvning forud for indgivelse.
English: In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Danish: 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 Silgard, henholdsvis anti-HPV 6, anti-HPV 11, antiHPV 16 og anti-HPV 18 seropositive én måned efter 3. dosis.
English: The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
Danish: Vaccinen afstedkommer også produktion af typespecifikke antistoffer hos 9
English: These diseases include pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); precancerous lesions of the anus and genital warts in males and females; cervical and anal cancers.
Danish: Disse sygdomme inkluderer forstadier til kræft i kønsorganerne (livmoderhalsen, ydre kønsorganer og skeden); forstadier til kræftlæsioner i endetarmen og kønsvorter hos mænd og kvinder, livmoderhalskræft og endetarmskræft.
English: In a subset of 598 men (SILGARD = 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.
Danish: Effekten imod anal intraepitelial neoplasi (AIN grad 1/2/3) og analcancer samt intraanal persisterende infektion blev vurderet i en undergruppe på 598 mænd (Silgard = 299; placebo = 299) i Protokol 020, der identificerede sig selv som mænd, som har sex med mænd (MSM-population).
English: • Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
Danish: • Injiceres straks intramuskulært (IM), helst i deltoidområdet i overarmen eller i det øvre
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)).
Danish: De primære effektanalyser for vaccine-HPV-typer (HPV 6, 11, 16, 18) blev udført i per-protokol effekt (PPE)-populationen (dvs. alle 3 vaccinationer inden for 1 år efter rekruttering, ingen væsentlige afvigelser fra protokollen og naive over for de(n) relevante HPV-type(r) forud for første dosis og indtil 1 måned efter tredje dosis (måned 7)).
English: The primary analyses of efficacy 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)).
Danish: De primære effektanalyser blev udført i per-protokol effekt (PPE) populationen (dvs. alle 3 vaccinationer inden for 1 år efter rekruttering, ingen væsentlige afvigelser fra studieprotokollen og naive over for de(n) relevante HPV-type(r) forud for første dosis og indtil 1 måned efter tredje dosis (måned 7)).
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 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)).
Danish: De primære effektanalyser for vaccine-HPV-typer (HPV 6, 11, 16 og 18) blev udført i per-protokol effekt (PPE) populationen (dvs. alle tre vaccinationer inden for 1 år efter inkludering, ingen væsentlige afvigelser fra protokollen og naive over for de(n) relevante HPV-type(r) forud for første dosis og indtil 1 måned efter tredje dosis (måned 7).
English: Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Danish: Silgard, suspension til injektion Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Silgard in the base study, were followed.
Danish: I langtids-opfølgningsstudiet af protokol 018 blev 369 piger i alderen 9-15 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet.
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).
Danish: I PPE-populationen blev der ikke set tilfælde af HPV-sygdom (HPV-typer 6/11/16/18-relateret CIN alle grader og kondylomer) gennem 10,1 år (median opfølgning på 8,7 år).
English: In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Silgard in the base study, were followed.
Danish: I det udvidede langtidsstudie af Protokol 020 blev 917 mænd i alderen 16-26 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet.
English: Nine years after vaccination, 94%, 96%, 99% and 60% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 96%, 100% and 91% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive
Danish: 9 år efter vaccination var henholdsvis 94%, 96%, 99% og 60% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 98%, 96%, 100% og 91% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
English: Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100% and 92% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG
Danish: 10 år efter vaccination var henholdsvis 79%, 80%, 95%, og 40% anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved cLIA, og henholdsvis 92%, 92%, 100% og 92% var anti-HPV 6-, anti-HPV 11-, anti-HPV 16- og anti-HPV 18-seropositive ved IgG LIA.
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
Danish: • effekten af Silgard imod HPV 6-, 11-, 16-, 18-relateret CIN (1, 2, 3) eller AIS 96,0 % (95 % CI:
English: • Shake well before use, the pre-filled syringe, to make a suspension.
Danish: • Den forfyldte injektionssprøjte omrystes omhyggeligt før brug, så det bliver en suspension.
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, anti-HPV 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.
Danish: 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.
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 Silgard does not impact the course of infections or disease that are present at vaccination onset.
Danish: Eftersom Silgard 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 %
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 Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3.
Danish: 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 Silgard, henholdsvis anti-HPV 6, anti-HPV 11, anti-HPV 16 og anti-HPV-18 seropositive én måned efter 3. dosis.
English: Any unused product or waste material should be disposed of in accordance with
Danish: Ikke anvendte lægemidler samt affald heraf bør bortskaffes i overensstemmelse med lokale
English: Patients were followed
Danish: Lægen kan give
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;
Danish: 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;
English: In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Silgard in the base study, were followed.
Danish: I langtids-opfølgningsstudiet af protokol 018 blev 326 drenge i alderen 9-15 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet.
English: Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Danish: De non-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle studier af enkelt og gentagen dosistoksicitet og lokal tolerance.
English: • 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.
Danish: Silgard 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
English: The efficacy of Silgard 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 84.7%
Danish: Effekten af Silgard imod den kombinerede forekomst af HPV 16- eller 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancer var 84,7 %
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 follow-up of
Danish: 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
English: Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Danish: Silgard, injektionsvæske, suspension i fyldt sprøjte Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet)
English: The efficacy of Silgard 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
Danish: Effekten af Silgard imod den kombinerede forekomst af HPV 6-, 11-, 16- og 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner og alle grader af CIN, AIS og cervixcancere var