natgillin/translations-raw huggingface dataset:
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.
Spørg lægen eller apotekspersonalet, hvis der er mere du vil vide.
Please speak to your doctor for more information.
• effekten af Silgard imod HPV 6-, 11-, 16-, 18-relateret CIN 1 95,9 % (95 % CI: 91,4; 98,4),
At end of study and in the combined protocols, • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Silgard, injektionsvæske, suspension- fyldt sprøjte med én kanyle, pakning med 1, 10, 20
Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
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 EGL lavere i fuldt analysesæt (full analysis set FAS)-populationen med en reduktion på 59,3 %
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 Silgard does not impact the course of infections or disease that are present at vaccination onset.
Silgard, injektionsvæske, suspension - hætteglas med én dosis, pakning med 1, 10, 20 stk.
Silgard, suspension for injection - single dose vial, pack of 1, 10, 20
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 Silgard, anti-HPV 6-, anti
In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 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.
5.2 Farmakokinetiske egenskaber
PHARMACEUTICAL PARTICULARS
Der er set bivirkninger efter markedsføring.
Side effects that have been reported during marketed use include:
Silgards effekt hos kvinder i alderen fra 16 til 26 år blev vurderet i 4 placebo-kontrollerede, dobbeltblindede, randomiserede kliniske fase II og III studier.
The efficacy of Silgard 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.
Lægemidlets navn blev ændret til Trevicta den 26. maj 2016.
The name of the medicine was changed to Trevicta on 26 May 2016.
Denne tilladelse byggede på den tilladelse, som blev udstedt for Xeplion i 2011 ("informeret samtykke").
This authorisation was based on the authorisation granted to Xeplion in 2011 (‘informed consent').
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trevicta.
This is a summary of the European public assessment report (EPAR) for Trevicta.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Trevicta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Trevicta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette gør, at virkningen af lægemidlet holder sig længe.
This gives the medicine a long duration of action.
Der er udført to undersøgelser med Trevicta, indgivet hver tredje måned.
Two studies have been conducted with Trevicta given every 3 months.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Paliperidone Janssen den 5. december 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Paliperidone Janssen on 5 December 2014.
Andre oplysninger om Trevicta
Other information about Trevicta
Der er udarbejdet en risikostyringsplan for at sikre, at Trevicta anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Trevicta is used as safely as possible.
1 Tidligere kendt som Paliperidone Janssen.
1 Previously known as Paliperidone Janssen.