FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinical trial showed that among girls who received 2 doses of HPV vaccine 6 months apart, antibody responses to the 4 HPV types, one month after the last dose were non-inferior to those among young women who received 3 doses of the vaccine within 6 months.
Danish: Et klinisk forsøg viste, at hos piger, som fik 2 doser HPV-vaccine med 6 måneders mellemrum, var antistofresponset på de 4 HPV-typer en måned efter den sidste dosis non-inferiort til antistofresponset hos unge kvinder, som fik 3 doser af vaccinen inden for 6 måneder.
English: There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated individuals.
Danish: Der var ingen signifikant forskel i typen af medfødte misdannelser eller i hyppigheden af graviditeter med komplikationer hos personer, der fik Silgard, og personer, der fik placebo.
English: The vaccine should be administered by intramuscular injection.
Danish: Vaccinen bør gives som intramuskulær injektion.
English: Table 5: Efficacy of Silgard against external genital lesions in the PPE* population of 16-26 year old
Danish: Tabel 5: Effekt af Silgard imod eksterne genitale læsioner hos PPE*-populationen af mænd på 16-26
English: Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection.
Danish: Der kan opstå besvimelser, sommetider ledsaget af fald, efter enhver injektion (især hos teenagere).
English: The safety profile was similar to non-HIV infected subjects in other studies.
Danish: Sikkerhedsprofilen var sammenlignelig med den set i studier med forsøgspersoner, som ikke var inficeret med hiv.
English: This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
Danish: Denne analyse måler antistoffer imod en enkelt neutraliserende epitop for hver enkelt af HPV-typerne.
English: No data
Danish: UDLØBSDATO
English: It is recommended that individuals who receive a first dose of Silgard complete the vaccination course
Danish: Det anbefales, at personer der modtager første dosis af Silgard fuldfører hele vaccinationsforløbet med
English: The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Danish: De kan ikke inficere celler, reproducere sig eller forårsage sygdom.
English: For any information about this medicinal product, please contact the local representative of the
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: In males, dizziness was not observed at a greater frequency in vaccine recipients than in placebo recipients.
Danish: Hos mænd blev svimmelhed ikke observeret hyppigere hos vaccinerede end hos placebopatienter.
English: The indication is based on the demonstration of efficacy of Silgard in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Silgard in 9- to 15-year old children and adolescents.
Danish: Indikationen er baseret på demonstration af Silgards virkning hos kvinder i alderen 16-45 år og hos mænd i alderen 16-26 år og på demonstration af Silgards immunogenicitet hos børn og unge i alderen 9-15 år.
English: In the same study, in girls aged 9-13 years, the immune response after a 2-dose schedule was numerically lower than after a 3-dose schedule (n = 248 at Month 7; n = 82 at Month 36).
Danish: I det samme studie var immunresponset hos piger i alderen 9-13 år efter et program med 2 doser numerisk lavere end efter et program med 3 doser (n=248 ved måned 7, n=82 ved måned 36).
English: Silgard must not be injected intravascularly.
Danish: Silgard må ikke injiceres intravaskulært.
English: Efficacy in women (16 to 45 years) with evidence of a prior infection with a vaccine HPV type (seropositive) that was no longer detectable at vaccination onset (PCR negative)
Danish: Effekt hos kvinder (16-45 år) med tegn på tidligere HPV-infektion med en af vaccinetyperne (seropositiv), men som ikke længere var detekterbar (PCR-negativ) på starttidspunktet for vaccination
English: There are no safety, immunogenicity or efficacy data to support change during vaccination with Silgard to other HPV vaccines which do not cover the same HPV types.
Danish: Der findes ingen data vedrørende sikkerhed, immunogenicitet eller effekt, der kan understøtte udskiftning af Silgard med andre HPV-vacciner i løbet af vaccinationsprogrammet.
English: Evidence of an anamnestic response was seen in vaccinated women who were seropositive to relevant HPV type(s) prior to vaccination.
Danish: Der sås evidens for immunhukommelsesrespons hos vaccinerede kvinder, som var seropositive over for de(n) relevante HPV-type(r) forud for vaccination.
English: In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Danish: I vaccinegruppen blev 99,1 til 100 % seropositive for alle vaccine-serotyper 1 måned efter 3. dosis.
English: As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.
Danish: Som for andre vacciner er der blevet rapporteret bivirkninger i forbindelse med brugen, herunder hævede lymfekirtler (hals, armhule eller lyske); muskelsvaghed, unormale fornemmelser, prikken i arme, ben og overkrop eller konfusion (Guillain-Barrés-syndrom, akut dissemineret encefalomyelitis); svimmelhed, opkastning, ledsmerter, ømme muskler, unormal træthedsfølelse eller svaghed, kuldegysninger, en generel følelse af utilpashed, blødning eller en øget tendens til at få blå mærker samt infektion i huden på injektionsstedet.
English: Silgard does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination (see section 5.1).
Danish: Silgard forebygger ikke læsioner, forårsaget af en vaccine-HPV-type, hos personer inficeret med denne HPV-type på vaccinationstidspunktet (se pkt.
English: As with any vaccine, vaccination with Silgard may not result in protection in all vaccine recipients.
Danish: Ligesom med andre vacciner vil vaccination med Silgard ikke nødvendigvis yde beskyttelse til alle vaccinemodtagere.
English: • Shake well before use to make a suspension.
Danish: • Omrystes omhyggeligt før brug så det bliver en suspension.
English: The vaccine is therefore not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts.
Danish: Vaccinen er derfor ikke indiceret til behandling af cancer i livmoderhalsen, high-grade dysplastiske læsioner i cervix, vulva, vagina eller kondylomer.
English: Shake well before use.
Danish: Omrystes omhyggeligt før brug.
English: However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Danish: En mild infektion såsom mild øvre luftvejsinfektion eller let feber er dog ikke en kontraindikation for
English: Silgard will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (see section 5.1).
Danish: Silgard vil kun yde beskyttelse imod sygdomme, som skyldes HPV-typerne 6, 11, 16 og 18 og i en begrænset udstrækning imod sygdomme forårsaget af visse relaterede HPV-typer (se pkt.
English: Overall, 83% of men (87% of heterosexual subjects and 61% of MSM subjects) were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Danish: I alt var 83 % af mændene (87 % af de heteroseksuelle mænd og 61 % af MSM) naive (PCR-negative og seronegative) over for alle 4 HPV-typer på rekrutteringstidspunktet.
English: Overall, 73% of women were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Danish: I alt var 73 % af kvinderne naive (PCR-negative og seronegative) over for alle 4 HPV-typer på rekrutteringstidspunktet.
English: In the ITT population the corresponding reduction was 23.9% (95% CI: 15.2, 31.7).
Danish: I ITT-populationen var den tilsvarende reduktion 23,9 % (95 % CI: 15,2; 31,7).
English: • Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Danish: • Fastgør nålen ved at dreje med uret, indtil nålen sidder godt fast i sprøjten.
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Danish: Vaccinationen påvirkede ikke CD4% eller plasma
English: Silgard does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Danish: Silgard har ingen effekt hos personer, som allerede har en infektion eller sygdom, der skyldes nogle af HPV-typerne i vaccinen.
English: Silgard is a vaccine for use from the age of 9 years for the prevention of: - premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV)
Danish: Silgard er en vaccine til brug fra 9 års alderen til forebyggelse af: - præmaligne, genitale læsioner (cervikale, vulvale og vaginale), præmaligne anale læsioner, cervixcancer og analcancer kausalt relateret til visse onkogene typer af human papillomavirus
English: • Inspect the suspension visually for particulate matter and discolouration prior to administration.
Danish: • Inspicér suspensionen visuelt for partikler og misfarvning før administration.
English: Bridging the Efficacy of Silgard from Men to Boys
Danish: Silgards effekt hos mænd overført til drenge
English: The efficacy of Silgard against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Danish: Silgards virkning over for CIN (af enhver grad) og CIN 2/3 eller AIS forårsaget af 10 ikke-vaccineHPV-typer (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59), der er strukturelt relateret til HPV 16 eller HPV 18, blev evalueret i den kombinerede fase III-effektdatabase (N = 17.599) efter en median opfølgningstid på 3,7 år (ved studieafslutning).
English: If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Danish: Hvis den anden vaccinedosis indgives tidligere end 6 måneder efter den første dosis, bør en tredje dosis altid indgives.
English: Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV
Danish: Kvinder, som allerede var inficeret med en eller flere vaccinerelaterede HPV-typer forud for vaccination, var beskyttet imod klinisk sygdom forårsaget af de
English: Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals.
Danish: Immunogenicitet var relateret til alder, og anti-HPV-niveauet ved måned 7 var signifikant højere hos
English: AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of
Danish: Anti-HBS geometrisk antistofmiddeltitre var lavere ved co-administration.
English: Discard the vaccine if particulates are present and/or if it appears discoloured.
Danish: Bortskaf vaccinen, hvis der er partikler til stede, og/eller hvis den fremstår misfarvet.
English: • Silgard may appear as a clear liquid with a white precipitate prior to agitation.
Danish: • Silgard kan fremstå som en klar væske med et hvidt præcipitat (bundfald) før omrystning.
English: B. Tabulated summary of adverse reactions
Danish: B. Tabeloversigt over bivirkninger
English: • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient's size and weight.
Danish: - Hvis der medfølger 2 kanyler af forskellig længde i pakningen, skal man vælge den kanyle, hvis længde kan sikre intramuskulær injektion afhængig af patientens størrelse og vægt.
English: The use of Silgard should be in accordance with official recommendations.
Danish: Silgard bør anvendes i overensstemmelse med officielle rekommandationer.
English: The individuals who were monitored using VRC-aided surveillance included 10,088 individuals (6,995 females 9 to 45 years of age and 3,093 males 9 to 26 years of age at enrolment) who received Silgard and 7,995 individuals (5,692 females and 2,303 males) who received placebo.
Danish: De personer, der blev monitoreret ved hjælp af vaccinationsrapporteringskort, omfattede 10.088 personer (6.995 kvinder i alderen 9 til 45 år og 3.093 mænd i alderen 9 til 26 år på rekrutteringstidspunktet), der fik Silgard, og 7.995 personer (5.692 kvinder og 2.303 mænd), der fik placebo.
English: Bridging the Efficacy of Silgard from Women to Girls
Danish: Silgards effekt hos kvinder overført på piger
English: The immunogenicity of Silgard was assessed in 20,132 (Silgard n = 10,723; placebo n = 9,409) girls and women 9 to 26 years of age, 5,417 (Silgard n = 3,109; placebo n = 2,308) boys and men 9 to 26 years of age and 3,819 women 24 to 45 years of age (Silgard n = 1,911, placebo n = 1,908).
Danish: Silgards immunogenicitet vurderedes hos 20.132 (Silgard n = 10.723; placebo n = 9.409) piger og kvinder i alderen 9 til 26 år, hos 5.417 (Silgard n = 3.109; placebo n = 2.308) drenge og mænd i alderen 9 til 26 år samt hos 3.819 kvinder mellem 24 til 45 år (Silgard n = 1.911, placebo n = 1.908).
English: Evidence of Anamnestic (Immune Memory) Response
Danish: Evidens for immunhukommelsesrespons (anamnestisk respons)
English: The impact of Silgard against the overall risk for external genital lesions was evaluated after the first dose in 2,545 individuals enrolled in the Phase III efficacy trial (Protocol 020).
Danish: Silgards indflydelse på den overordnede risiko for eksterne genitale læsioner blev evalueret efter den første dosis hos 2.545 personer rekrutteret i fase III-effektstudiet (Protokol 020).
English: The studies were not powered to assess efficacy against disease caused by individual HPV types.
Danish: Studierne var ikke designet til at vurdere effekten over for sygdom forårsaget af individuelle HPV-typer.
English: The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Danish: Det foretrukne injektionssted er i regio deltoidea på overarmen eller i det øvre anterolaterale område på låret.
English: The use of Silgard in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.
Danish: Brugen af Silgard hos voksne kvinder bør ske under hensyntagen til geografiske variationer i
English: The impact of Silgard against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Danish: Silgards virkning på den overordnede risiko for cervikal HPV-sygdom (dvs. sygdom forårsaget af enhver HPV-type) blev evalueret fra og med 30 dage efter den første dosis hos 17.599 personer rekrutteret til de to fase III-effektstudier (protokollerne 013 og 015).
English: A clinical study (Protocol 016) compared the immunogenicity of Silgard in 10- to 15-year-old girls to those in 16- to 23-year-old women.
Danish: Et klinisk studie (Protokol 016) sammenlignede Silgards immunogenicitet i 10- til 15-årige piger, med den der sås i 16- til 23-årige kvinder.
English: Silgard produces type-specific antibodies and has been shown in clinical trials to prevent HPV 6-, 11-, 16-, and 18-related diseases in women 16-45 years of age and in men 16-26 years of age.
Danish: Silgard afstedkommer produktion af type-specifikke antistoffer og har i kliniske studier vist sig at kunne forebygge HPV 6-, 11-, 16-, og 18-relaterede sygdomme hos kvinder i alderen 16-45 år og hos mænd i alderen 16-26 år.
English: IM use.
Danish: brug.
English: Table 2: Analysis of efficacy of Silgard against high grade cervical lesions in the PPE population Silgard Placebo % Efficacy at 2 years
Danish: Tabel 2: Analyse af Silgards effekt imod high-grade cervixlæsioner i PPE-populationen Silgard Placebo
English: Prior to agitation, Silgard may appear as a clear liquid with a white precipitate.
Danish: Før omrystning kan Silgard fremstå som en klar væske med et hvidt bundfald.
English: In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 9 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
Danish: I disse studier var personer, der var seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16 og antiHPV 18 ved cLIA, stadig beskyttet mod klinisk sygdom efter opfølgning i 9 år for kvinder i alderen 16-23 år, 10 år for kvinder i alderen 24-45 år og 10 år for mænd i alderen 16-26 år.
English: In addition, a subset of vaccinated women who received a challenge dose of Silgard 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Danish: Desuden udviste en undergruppe af de vaccinerede kvinder, som modtog en belastningsdosis af Silgard 5 år efter påbegyndelsen af vaccinationerne en hurtig og kraftig immunhukommelsesrespons.
English: Three clinical studies (Protocols 016, 018 and 020) were used to compare the immunogenicity of Silgard in 9- to 15-year-old boys to 16- to 26-year-old men.
Danish: Tre kliniske studier (Protokollerne 016, 018 og 020) blev brugt til at sammenligne Silgards immunogenicitet hos 9-15-årige drenge med den, der sås hos 16-26-årige mænd.
English: Silgard will not protect against every type of Human Papillomavirus.
Danish: Silgard beskytter ikke mod alle former for HPV.
English: The vaccine is not used to treat HPV related diseases.
Danish: Vaccinen anvendes ikke til at behandle HPVrelaterede sygdomme.
English: Silgard will not protect against other diseases that are not caused by Human Papillomavirus.
Danish: Silgard beskytter ikke mod andre sygdomme, der ikke er forårsaget af HPV.
English: The duration of protection against anal cancer is currently unknown.
Danish: Beskyttelsens varighed mod analcancer er på nuværende tidspunkt ukendt.
English: Efficacy in women with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Danish: Effekt hos kvinder med tegn på HPV 6-, 11-, 16- eller 18-infektion eller sygdom på dag 1
English: The impact of Silgard on rates of biopsy and treatment of EGL regardless of causal HPV types was evaluated in 2,545 individuals enrolled in Protocol 020.
Danish: Silgards indflydelse på frekvensen af biopsi og behandling af EGL, uanset kausal HPV-type blev evalueret hos 2.545 personer rekrutteret til Protokol 020.
English: Efficacy was evaluated against HPV 6-, 11-, 16-, 18-related external genital warts, penile/perineal/perianal intraepithelial neoplasia (PIN) grades 1/2/3, and persistent infection.
Danish: Effekten blev vurderet imod HPV 6-, 11-, 16-, 18-relaterede kondylomer, penil/perineal/perianal intraepitelial neoplasi (PIN) grad 1/2/3 og persisterende infektion.
English: The active substances are: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16, and 18).
Danish: De aktive stoffer er: højtrenset ikke-smitsomt protein for hver af human papillomavirus-typerne (6, 11, 16 og 18).
English: When Silgard was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.
Danish: Når Silgard blev givet sammen med en kombineret difteri, tetanus, pertussis [acellulær, komponent] og poliomyelitis [inaktiveret] boostervaccine under det samme besøg, var hovedpine og hævelser på
English: Very commonly (more than 1 in 10 patients), side effects found at the injection site include: pain, swelling and redness.
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter): Bivirkninger på injektionsstedet, herunder smerte, hævelse og rødme.
English: In the vaccine group, 97.4 to 99.9% became seropositive to all vaccine serotypes by 1 month Postdose 3.
Danish: I vaccinegruppen blev 97,4 til 99,9 % seropositive over for alle vaccine-serotyper 1 måned efter 3. dosis.
English: In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Silgard concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that there was more injection-site swelling and headache reported following concomitant administration.
Danish: I et klinisk studie med i alt 843 raske drenge og piger i alderen fra 11-17 år viste indgivelse af den første dosis af Silgard samtidig med en kombineret difteri, tetanus, pertussis [acellulær, komponent] og poliomyelitis [inaktiveret] boostervaccine, at der var flere tilfælde af hævelser på injektionsstedet og hovedpine ved samtidig indgivelse.
English: Alternatively, Silgard can be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Danish: Alternativt kan Silgard indgives efter et program med 3 doser (0,5 ml ved måned 0, 2 og 6).
English: As expected for women 24 to 45 years of age (Protocol 019), the observed antibody titres were lower than that seen in women 16 to 26 years.
Danish: Som forventet var de observerede antistoftitre lavere hos kvinder fra 24 til 45 år (protokol 019) end hos kvinder fra 16 til 25 år.
English: Silgard induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Danish: Silgard inducerede et specifikt antistofrespons mod HPV-type 6, 11, 16 og 18 i drægtige rotter efter en eller flere intramuskulære injektioner.
English: The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/3), high-grade vulvar intraepithelial neoplasia (VIN 2/3) and highgrade vaginal intraepithelial neoplasia (VaIN 2/3).
Danish: 4.1, refererer til high-grade cervikal intraepitelial neoplasi (CIN 2/3), high-grade vulval intraepitelial neoplasi (VIN 2/3) og high-grade vaginal intraepitelial neoplasi (VaIN 2/3).
English: Vaccination with Silgard is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
Danish: Vaccination med Silgard sker med henblik på at beskytte imod sygdomme og infektioner forårsaget af human papillomavirus (HPV) type 6, 11, 16 og 18.
English: Cervical Intraepithelial Neoplasia (CIN) Grade 2/3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
Danish: Cervikal intraepitelial neoplasi (CIN) grad 2/3 (moderat til high-grade dysplasi) og adenocarcinoma in situ (AIS) blev anvendt som en surrogatmarkør for cervikal cancer i de kliniske studier.
English: Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Danish: Beskyttelse imod den overordnede byrde af cervikal HPV-sygdom hos 16- til 26-årige kvinder
English: Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du eller dit barn bruger anden medicin eller har brugt det for nyligt.