FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Silgard in children below 9 years of age have not been established.
Danish: Silgards sikkerhed og virkning hos børn under 9 år er ikke klarlagt.
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Danish: Som med alle injicerbare vacciner skal relevant medicinsk behandling være umiddelbart tilgængelig for det tilfælde, at der opstår sjældne anafylaktiske reaktioner efter indgivelse af vaccinen.
English: Safety was evaluated in either the entire study population (6 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Silgard or placebo.
Danish: Sikkerheden blev vurderet i enten hele studiepopulationen (6 studier) eller i en prædefineret undergruppe af studiepopulationen (ét studie) via overvågning ved hjælp af vaccinationsrapporteringskort i 14 dage efter hver injektion af enten Silgard eller placebo.
English: Use of hormonal contraceptives did not appear to affect the immune response to Silgard.
Danish: Brug af hormonale antikonceptionsmidler lod ikke til at påvirke immunresponset over for Silgard.
English: A subset of the study participants from the 2-dose group (n=50) were followed 5-years post-vaccination (Month 60 Postdose 1).
Danish: En undergruppe af studiedeltagerne fra gruppen med 2 doser (n=50) blev fulgt i 5 år efter vaccination (måned 60 efter 1. dosis).
English: Table 1 presents vaccine-related adverse reactions which were observed among recipients of Silgard at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Danish: Tabel 1 viser vaccinerelaterede bivirkninger, der blev observeret hos Silgard-recipienter med en hyppighed på mindst 1,0 % og også med større hyppighed, end der blev observeret blandt placeborecipienter.
English: However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Danish: Let feber eller øvre luftvejsinfektion (for eksempel forkølelse) er i sig selv ikke grund til at udsætte vaccination.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: - genital warts (condyloma acuminata) causally related to specific HPV types.
Danish: - kondylomer (condyloma acuminata) kausalt relateret til specifikke HPV-typer.
English: The GMTs were somewhat lower than those reported in non-HIV infected subjects of the same age in other studies.
Danish: GMT´erne var noget lavere end rapporteret i studier med ikke-hiv-inficerede forsøgspersoner på samme alder.
English: Vaccination should be postponed
Danish: Vaccination bør udsættes til graviditeten
English: Among 15,706 individuals who received Silgard and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Silgard group and 15 in the placebo group.
Danish: Blandt 15.706 personer, der fik Silgard, og 13.617 personer, der fik placebo, blev der rapporteret 39 tilfælde af uspecifik artritis/artropati, 24 af tilfældene optrådte i Silgardgruppen og 15 af tilfældene i placebogruppen.
English: When Silgard is given as your first dose, the completion of the vaccination course should be done with Silgard, and not with another HPV vaccine.
Danish: Hvis du får Silgard som første dosis, skal vaccinationsforløbet fuldføres med Silgard og ikke en anden HPV-vaccine.
English: 20 micrograms 40 micrograms 40 micrograms 20 micrograms.
Danish: 20 mikrogram 40 mikrogram 40 mikrogram 20 mikrogram
English: These methods of administration are not recommended (see section 6.6).
Danish: Disse indgivelsesmetoder kan derfor ikke anbefales (se pkt.
English: However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
Danish: Dog sås en tendens til lavere anti-HPV GMT i gruppen med samtidig indgivelse.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: D. BETINGELSER ELLER BEGRÆSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy.
Danish: I løbet af den kliniske udvikling forud for godkendelsen rapporterede 3.819 kvinder (vaccine = 1.894, placebo = 1.925) imidlertid mindst ét tilfælde af graviditet.
English: Silgard will be given as an injection through the skin into the muscle (preferably the muscle of the
Danish: Silgard indgives som en injektion gennem huden ind i musklen (helst en muskel i overarmen eller
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Danish: Denne kan være ledsaget af adskillige neurologiske symptomer, såsom forbigående synsforstyrrelser, paræstesier og toniske-kloniske kramper under opvågningen.
English: Nine cases (0.06%) of urticaria were reported in the Silgard group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
Danish: Der blev rapporteret ni tilfælde (0,06 %) af urticaria i Silgard-gruppen og 20 tilfælde (0,15 %) i gruppen, der fik adjuvansholdigt placebo.
English: Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
Danish: Effekt over for sygdoms-endepunkter forårsaget af præspecificerede kombinationer af ikke-vaccine-HPV-typer blev målt.
English: Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
Danish: Typespecifikke immunanalyser, kompetitiv Luminex-baseret immunanalyse (cLIA) med typespecifikke standarder blev brugt til at vurdere immunogenicitet for hver af vaccinetyperne.
English: (95% CI: 67.2, 100) and 100% (95% CI: 55.4, 100), respectively,
Danish: (95 % CI: 67,2; 100) og 100 % (95 % CI: 55,4; 100),
English: There were no treatment related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Danish: Der var ingen behandlingsrelaterede effekt på afkommets udvikling, opførsel, reproduktion eller fertilitet.
English: There have been reports of administration of higher than recommended doses of Silgard.
Danish: Der har været rapporter om, at der er indgivet flere doser af Silgard end anbefalet.
English: In addition, vaccine immunogenicity was comparable among breast-feeding mothers and women who did not breast-feed during the vaccine administration.
Danish: Endvidere var vaccine-immunogeniciteten sammenlignelig blandt ammende mødre og kvinder, der ikke ammede i forbindelse med indgivelsen af vaccinen.
English: You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Danish: Du skal blive ved med at følge din læges anvisninger vedrørende livmoderhalsundersøgelser/Pap-tests og forebyggende
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Danish: Selv om besvimelsesepisoder er ualmindelige, skal patienterne holdes under opsyn i 15 minutter efter de er
English: There was no evidence of protection from disease caused by vaccine HPV types for which women were PCR positive at day 1.
Danish: Der var ingen evidens for beskyttelse imod sygdom forårsaget af vaccine-HPV-typer, over for hvilke kvinder var PCR-positive på dag 1.
English: In general, the adverse event profile reported with overdose was comparable to recommended single
Danish: Den bivirkningsprofil, der rapporteredes ved overdosering, var sammenlignelig med den, der blev set
English: Like all vaccines and medicines, Silgard can cause side effects, although not everybody gets them.
Danish: Silgard kan som alle vacciner og medicin give bivirkninger, men ikke alle får bivirkninger.
English: MSM are at higher risk of anal HPV infection compared to the general population; the absolute benefit of vaccination in terms of prevention of anal cancer in the general population is expected to be very low.
Danish: MSM har en større risiko for anal HPV-infektion i forhold til den almene befolkning, og den absolutte gevinst ved vaccination med henblik på forebyggelse af analcancer i den almene befolkning forventes
English: In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Silgard used hormonal contraceptives during the vaccination period.
Danish: I kliniske studier brugte 57,5 % af kvinderne i alderen 16 til 26 år og 31,2 % af kvinderne i alderen 24 til 45 år, der fik Silgard, hormonale kontraceptionsmidler i vaccinationsperioden.
English: Administration of Silgard should be postponed in individuals suffering from an acute severe febrile illness.
Danish: Indgivelse af Silgard skal udsættes hos personer, der lider af akut sygdom med feber.
English: Immune Responses to Silgard using a 2-dose schedule in individuals 9-13 years of age
Danish: Immunresponser på Silgard ved brug af et program med 2 doser hos personer i alderen 9-13 år
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Silgard or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Danish: I 7 kliniske studier (6 placebo-kontrollerede) blev Silgard eller placebo givet til personer på inklusionsdagen og cirka 2 og 6 måneder senere.
English: The efficacy for all other endpoints is based on protocols 007, 013, and 015.
Danish: Effekten for alle øvrige endepunkter er baseret på protokollerne 007, 013 og 015.
English: Table 3: Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Danish: Tabel 3: Effekt af Silgard imod high-grade cervixlæsioner i den modificerede ITT-population, der inkluderer kvinder uanset baseline HPV-status
English: The most common adverse reactions observed were injection-site adverse reactions (77.1% of vaccinees within 5 days following any vaccination visit) and headache (16.6% of the vaccinees).
Danish: De almindeligste bivirkninger var reaktioner på injektionsstedet (77,1 % af de vaccinerede inden for 5 dage efter vaccination) og hovedpine (16,6 % af de vaccinerede).
English: The full recommended dose of the vaccine should be used.
Danish: Hele den anbefalede dosis af vaccinen skal bruges.
English: The final end-of-study results for the combined incidence of CIN 2/3 or AIS in this population after a median follow-up of 3.7 years are shown in Table 4.
Danish: De endelige resultater ved studieafslutning for den kombinerede incidens af CIN 2/3 eller AIS i denne population efter en median opfølgningstid på 3,7 år er vist i tabel 4.
English: Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
Danish: På dag 1 havde sammenlagt 12 % af den kombinerede studiepopulation en abnorm Pap-test, der kunne indikere CIN.
English: • you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “other ingredients”- see section 6).
Danish: • Hvis du eller dit barn er allergisk over for de aktive stoffer eller nogen af de øvrige indholdsstoffer i Silgard (se pkt.
English: EXP MM/YYYY
Danish: EXP MM/ÅÅÅÅ
English: The clinical relevance of the lower response is unknown.
Danish: Den kliniske relevans af det lavere respons er ikke kendt.
English: In only 1 of 11 specimens HPV 16 was found (at Month 32.5) and was not detected in tissue excised during LEEP (Loop Electro-Excision Procedure).
Danish: HPV 16 blev kun fundet i 1 af 11 prøver (ved måned 32,5) og blev ikke påvist i væv, der blev udtaget under LEEP (Loop Electro-Excision Procedure).
English: Syncope (fainting), sometimes associated with falling, can occur following, or even before, any vaccination, especially in adolescents as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse) til tider ledsaget af fald kan forekomme inden eller efter alle vaccinationer, især hos teenagere, som en psykogen reaktion på injektionen.
English: Seroconversion to all four antigens occurred in more than ninety-six percent of the subjects.
Danish: Serokonversion over for alle fire antigener forekom hos flere end 96 % af forsøgspersonerne.
English: The clinical significance of this observation is not known.
Danish: Den kliniske betydning af denne observation kendes ikke.
English: Immune Responses to Silgard at 1 month post dose 3
Danish: Immunrespons over for Silgard 1 måned efter 3. dosis
English: Silgard is given as an injection by your doctor.
Danish: Silgard gives af din læge som injektion.
English: Silgard was efficacious against HPV disease caused by each of the four vaccine HPV types.
Danish: Silgard var effektiv mod HPV-sygdom forårsaget af hver af de fire vaccine-HPV-typer.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: N Number of cases HPV 6/11/16/18-related external genital lesions
Danish: N Antal tilfælde HPV 6/11/16/18-relaterede eksterne genitale læsioner
English: In the clinical studies, individuals in the Safety Population reported any new medical conditions during the follow-up.
Danish: I opfølgningsperioden af de kliniske studier indberettede forsøgspersonerne i de kliniske studiers sikkerhedspopulation alle nye medicinske tilstande.
English: Silgard induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Danish: Silgard fremkaldte høje anti-HPV geometriske middeltitre (GMT'er) én måned efter 3. dosis i alle testede aldersgrupper.
English: The vaccine should not be mixed in the same syringe with any other vaccines and solutions.
Danish: Vaccinen må ikke blandes med andre vacciner eller opløsninger i samme sprøjte.
English: Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
Danish: Meget sjældne (forekommer hos færre end 1 ud af 10.000 patienter): Åndedrætsproblemer (bronkospasme) er blevet rapporteret.
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Silgard (see section 4.8).
Danish: Dette er baseret på resultaterne fra et klinisk studie, hvor en kombineret TdaP-IPV-vaccine blev indgivet samtidig med den første dosis Silgard (se pkt.
English: The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs >10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Danish: Serobeskyttelsesforholdet (andelen af personer der når et serobeskyttende niveau anti-HBs > 10 mIE/ml) var upåvirket (96,5 % ved samtidig vaccination, og 97,5 % ved hepatitis B vaccine alene).
English: During clinical trials, dizziness was observed as a common adverse reaction in females.
Danish: I de kliniske studier blev der observeret svimmelhed som en almindelig bivirkning hos kvinder.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af indflydelsen på evnen til at føre motorkøretøjer eller betjene maskiner.
English: Depending on HPV type, 60-96% and 78-98% of subjects were seropositive by cLIA and IgG LIA respectively 10 years after vaccination (see Table 8).
Danish: Afhængigt af HPV-type var henholdsvis 60-96% og 78-98% af forsøgspersoner seropositive ved cLIA og IgG LIA 10 år efter vaccinationen (se tabel 8).
English: The median duration of follow-up for this study was 4.0 years.
Danish: Median opfølgningstid var 4,0 år.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Danish: Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke
English: The median duration of follow-up for these studies was 4.0, 3.0, 3.0, and 3.0 years for Protocol 005, Protocol 007, Protocol 013, and Protocol 015, respectively.
Danish: Median opfølgningstid i disse studier var 4,0; 3,0; 3,0 og 3,0 år for henholdsvis protokol 005, protokol 007, protokol 013 og protokol 015.
English: It is also not intended to prevent progression of other established HPV-related lesions.
Danish: Den er heller ikke beregnet til forebyggelse af progression af andre manifeste HPV-relaterede læsioner.
English: The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Danish: Median opfølgningstid i de kombinerede protokoller (005, 007, 013 og 015) var 3,6 år.
English: Furthermore, anti-HPV levels (GMTs) in vaccinated individuals remained at or above serostatus cut-off during the long-term followup of the phase III studies (see below under Persistence of Immune Response of Silgard).
Danish: Hertil kommer, at anti-HPV-niveauerne (GMT'er) hos vaccinerede personer forblev på eller over serostatuscut-off under langtidsopfølgningen i fase III-studierne (se afsnittet om ”Persistens af Silgards
English: HPV types 6 and 11 are responsible for approximately 90% of
Danish: HPV-typerne 6 og 11 er ansvarlige for cirka 90 % af tilfældene af kønsvorter.
English: At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3 doses, n = 86) for all 4 HPV types.
Danish: Ved opfølgning ved måned 36 forblev GMT hos piger (2 doser, n=86) non-inferior til GMT hos kvinder (3 doser, n=86) for alle 4 HPV-typer.
English: Safety and immunogenicity of the vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV) (see section 5.1).
Danish: Vaccinens sikkerhed og immunogenicitet er vurderet hos personer i alderen fra 7 til 12 år, som var inficeret med humant immundefektvirus (hiv) (se pkt.
English: Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm.
Danish: Luftveje, thorax og mediastinum: Meget sjælden: Bronkospasme
English: For composite endpoints, statistically significant efficacy against disease was demonstrated against HPV types phylogenetically related to HPV 16 (primarily HPV 31) whereas no statistically significant efficacy was observed for HPV types phylogenetically related to HPV 18 (including HPV 45).
Danish: For de sammensatte endepunkter blev der påvist en statistisk signifikant effekt over for sygdom forårsaget af HPV-typer, der fylogenetisk var relateret til HPV 16 (primært HPV 31), mens der ikke sås nogen statistisk signifikant effekt for HPV-typer, der fylogenetisk var relateret til HPV 18 (herunder HPV 45).
English: Silgard is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Danish: Silgard er udelukkende beregnet til profylaktisk anvendelse og har ingen effekt på aktive HPVinfektioner eller eksisterende klinisk sygdom.
English: The concomitant administration of Silgard with vaccines other than the ones above has not been studied.
Danish: Samtidig indgivelse af Silgard med andre vacciner end de herover anførte, er ikke blevet undersøgt.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du eller dit barn oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals below 12 years of age than in those above that age.
Danish: Immunogenicitet var relateret til alder, og anti-HPV-niveauer ved måned 7 var signifikant højere i unge personer under 12-års alderen end i dem, der var over denne alder.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and
Danish: • Træk en 0,5 ml dosis af vaccinen ud af hætteglasset med en steril nål og sprøjte.
English: HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
Danish: HPV 6 og 11 er ansvarlige for cirka 90 % af alle kondylomer og 10 % af tilfældene af low-grade cervikal intraepitelial neoplasi (CIN 1).
English: At end of study, individuals enrolled in the two Phase-III studies (Protocol013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Danish: Ved studieafslutning blev de personer, der var rekrutteret til de to fase III-studier (protokol 013 og protokol 015), fulgt i op til 4 år (median 3,7 år).
English: Administration of Silgard at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
Danish: Indgivelse af Silgard samtidigt (men, i tilfælde af vacciner til injektion, på forskellige injektionssteder) med hepatitis B (rekombinant) vaccine forstyrrede ikke immunresponset over for HPV-typerne.
English: Silgard cannot cause the diseases it protects against.
Danish: Silgard kan ikke forårsage de sygdomme, som vaccinen beskytter imod.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: Derfor skal du fortælle det til lægen eller sygeplejersken, hvis du tidligere er besvimet i forbindelse
English: Silgard administered to male rats at the full human dose (120 mcg total protein) had no effects on reproductive performance including fertility, sperm count, and sperm motility, and there were no vaccine-related gross or histomorphologic changes on the testes and no effects on testes weights.
Danish: Silgard indgivet til hanrotter med fuld human dosis (120 mikrogram total protein) havde ingen indflydelse på reproduktionsevne, herunder fertilitet, spermtal eller spermmotilitet og der var ingen betydelige vaccine-relaterede eller histomorfologiske ændringer i testiklerne og ingen effekt på
English: An academic study documenting safety and immunogenicity of Silgard has been performed in 126 HIV infected subjects aged from 7 to 12 years (of which 96 received Silgard).
Danish: Et studie, som dokumenterer Silgards sikkerhed og immunogenicitet, blev gennemført med 126 hivinficerede forsøgspersoner i alderen fra 7 til 12 år (hvoraf 96 fik Silgard).
English: In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/18-related CIN 3 and
Danish: I en supplerende analyse blev Silgards effekt mod HPV 16/18-relateret CIN 3 og AIS evalueret.
English: Do not use this vaccine after the expiry date which is stated on the syringe label and the outer carton (after EXP).
Danish: Brug ikke denne vaccine efter den udløbsdato, der står på mærkaten på hætteglasset og på pakningen (efter Exp).
English: Efficacy was based on reductions in HPV 31-related CIN 2/3 or AIS Efficacy was based on reductions in HPV 31-, 33-, 52-, and 58-related CIN 2/3 or AIS Includes assay-identified non-vaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59.
Danish: Effekt var baseret på reduktion af HPV 31-relateret CIN 2/3 eller AIS Effekt var baseret på reduktion af HPV 31-, 33-, 52- og 58-relateret CIN 2/3 eller AIS Inkluderer assay-identificerede ikke-vaccine-HPV-typer 31, 33, 35, 39, 45, 51, 52, 56, 58 og 59.
English: Very common At the injection site: erythema, pain, swelling
Danish: På injektionsstedet: erytem, smerter, hævelser
English: Silgard should be used in accordance with official guidelines.
Danish: Silgard skal anvendes i overensstemmelse med officielle retningslinjer.
English: As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.
Danish: Som med enhver anden vaccine kan Silgard ikke nødvendigvis beskytte 100 % af dem, der får
English: Duration of protection of a 2-dose schedule of Silgard has not been established.
Danish: Det vides ikke, hvor længe beskyttelsen varer efter et program med 2 doser Silgard.