natgillin/translations-raw huggingface dataset:
4.1 refererer til high-grade anal intraepitelial neoplasi (AIN 
The term "premalignant anal lesions" in section 4.1 corresponds to high-grade anal intraepithelial neoplasia (AIN 2/3).
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. 
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.
Ved rekruttering ligner denne population den generelle mandlige befolkning med hensyn til prævalens af HPV-infektion ellersygdom. 
This population approximates to the general population of men with respect to prevalence of HPV infection or disease at enrolment.
Silgards effekt imod HPV 6-, 11-, 16-, 18-relaterede kondylomer var 68,1 % (95 % CI: 48,8; 79,3). 
The efficacy of Silgard against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Piger og drenge vaccineret med Silgard i 9-15-års-alderen i protokol 018-basisstudiet blev fulgt i et udvidet studie. 
Girls and boys vaccinated with Silgard at 9-15 years of age in Protocol 018 base study were followed up in an extension study.
Vaccinen består af højtoprensede viruslignende partikler (VLP'er) af det vigtigste kapsidprotein L1 fra HPV-typerne 6, 11, 16 og 18. 
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.
Adsorberet på amorft aluminium-hydroxyl-fosfat-sulfat (0,225 mg Al) 
adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
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 
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.
Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet) 
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Effekt hos kvinder med og uden tidligere infektion eller sygdom, som skyldes HPV 6, 11, 16 eller 18 
Efficacy in women with and without prior infection or disease due to HPV 6, 11, 16, or 18
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; 
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.
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. 
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.
Effekt hos mænd med eller uden forudgående infektion eller sygdom på grund af HPV 6, 11, 16 eller 
Efficacy in men with or without prior infection or disease due to HPV 6, 11, 16, or 18
Almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter): Bivirkninger på injektionsstedet, herunder blåt mærke, kløe, smerte i arme eller ben. 
Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity.
Adsorberet på amorf aluminiumhydroxyphosphat-sulfat-adjuvans (0,225 milligram Al) 
adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
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
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. 
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.
I langtids-opfølgningsstudiet af protokol 015 blev 2.084 kvinder i alderen 16-23 år fulgt gennem Silgard-vaccinationsprogrammet i basisstudiet. 
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.
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Storbritannien 
Merck Sharp & Dohme Ltd, Hertford Road,
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. 
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.
Kvinder vaccineret med Silgard i 24-45-års-alderen i protokol 019-basisstudiet blev fulgt i et udvidet studie. 
Women vaccinated with Silgard at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
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. 
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.
5.3 Prækliniske sikkerhedsdata 
6.1 List of excipients
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
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.
I langtids-opfølgningsstudiet af protokol 019 blev 685 kvinder i alderen 24-45 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet. 
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.
Alle tre doser bør gives inden for en periode på et år. 
All three doses should be given within
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ. 
This leaflet was last revised in {MM/YYYY}.
Opbevar beholderen i den ydre karton for at beskytte mod lys. 
Keep the syringe in the outer carton in order to protect from light.
Den anden dosis bør gives mindst en måned efter den første dosis, og tredje dosis bør gives mindst 3 måneder efter den anden dosis. 
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.
Mænd vaccineret med Silgard i 16-26-års-alderen i protokol 020-basisstudiet blev fulgt i et udvidet studie. 
Men vaccinated with Silgard at 16-26 years of age in Protocol 020 base study were followed up in an extension study.
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
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. 
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.
Efter grundig omrystning, er den en hvid, uklar væske. 
After thorough agitation, it is a white, cloudy
Andelen af bivirkninger/uønskede hændelser hos moderen og det ammede barn var sammenlignelige for vaccinegruppen og placebogruppen. 
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.
Silgard, injektionsvæske, suspension. 
Silgard, suspension for injection.
- 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.
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. 
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.
Vaccinen afstedkommer også produktion af typespecifikke antistoffer hos 9 
The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
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. 
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.
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). 
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.
• Injiceres straks intramuskulært (IM), helst i deltoidområdet i overarmen eller i det øvre 
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
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)). 
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)).
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)). 
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)).
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). 
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)).
Silgard, suspension til injektion Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet) 
Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
I langtids-opfølgningsstudiet af protokol 018 blev 369 piger i alderen 9-15 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet. 
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.
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). 
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 det udvidede langtidsstudie af Protokol 020 blev 917 mænd i alderen 16-26 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet. 
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.
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. 
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
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. 
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
• effekten af Silgard imod HPV 6-, 11-, 16-, 18-relateret CIN (1, 2, 3) eller AIS 96,0 % (95 % CI: 
• the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
• Den forfyldte injektionssprøjte omrystes omhyggeligt før brug, så det bliver en suspension. 
• Shake well before use, the pre-filled syringe, to make a suspension.
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, 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.
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 % 
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.
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. 
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.
Ikke anvendte lægemidler samt affald heraf bør bortskaffes i overensstemmelse med lokale 
Any unused product or waste material should be disposed of in accordance with
Lægen kan give 
Patients 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; 
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;
I langtids-opfølgningsstudiet af protokol 018 blev 326 drenge i alderen 9-15 år fulgt gennem Silgardvaccinationsprogrammet i basisstudiet. 
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.
De non-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle studier af enkelt og gentagen dosistoksicitet og lokal tolerance. 
Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
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 
• 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.
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 % 
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%
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 
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
Silgard, injektionsvæske, suspension i fyldt sprøjte Human papillomavirusvaccine [type 6, 11, 16, 18] (rekombinant, adsorberet) 
Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
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 
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
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 
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
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 cervixcancere var 41,6 
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 41.6%
Injektionsvæske, suspension i fyldt sprøjte. 
Suspension for injection in a pre-filled syringe.
10 enkeltdoser på 0,5 ml i fyldte sprøjter uden kanyler. 
10 single doses, 0.5 ml pre-filled syringes without needles.
20 enkeltdoser på 0,5 ml i fyldte sprøjter uden kanyler. 
20 single doses, 0.5 ml pre-filled syringes without needles.
Silgard, injektionsvæske, suspension i fyldt sprøjte. 
Silgard, suspension for injection in a pre-filled syringe.
Κύπρος 
Posology
1 dosis på 0,5 ml i fyldt sprøjte med 1 kanyle. 
1 dose, 0.5 ml pre-filled syringe with 1 needle.
I kliniske studier blev den beskyttelse, som opnåedes med Silgard, 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
Alternativt kan Silgard 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 
• Second injection: 2 months after first injection
Silgard bør 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 Den anden dosis bør gives mindst en måned efter den første dosis, og tredje dosis bør gives mindst 3 måneder efter den anden dosis. 
• 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.
Silgard, injektionsvæske, suspension i fyldt injektionssprøjte: 
Silgard, suspension for injection in a pre-filled syringe:
• effekten af Silgard imod HPV 6-, 11-, 16-, 18-relaterede kondylomer 99,0 % (95 % CI: 96,2; 
• the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Silgard, injektionsvæske, suspension- fyldt sprøjte uden kanyle, pakning med 1, 10, 20 
Silgard, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Derfor skal relevant beskyttelse mod seksuelt 
Therefore appropriate precautions against sexually transmitted disease should continue to be used.
10 enkeltdoser på 0,5 ml i fyldte sprøjter med 1 kanyle til hver. 
10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
20 enkeltdoser på 0,5 ml i fyldte sprøjter med 1 kanyle til hver. 
20 single doses, 0.5 ml pre-filled syringes with 1 needle each.
1 dosis på 0,5 ml i fyldt sprøjte uden kanyle. 
1 dose, 0.5 ml pre-filled syringe without needle.
Silgard, injetionsvæske, suspension- fyldt sprøjte med to kanyler, pakning med 1, 10, 20 
Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
1 dosis på 0,5 ml i fyldt sprøjte med 2 kanyler. 
1 dose, 0.5 ml pre-filled syringe with 2 needles.
20 enkeltdoser på 0,5 ml i fyldte sprøjter med 2 kanyler til hver. 
20 single doses, 0.5 ml pre-filled syringes with 2 needles each.
10 enkeltdoser på 0,5 ml i fyldte sprøjter med 2 kanyler til hver. 
10 single doses, 0.5 ml pre-filled syringes with 2 needles each.