natgillin/translations-raw huggingface dataset:
Let feber eller øvre luftvejsinfektion (for eksempel forkølelse) er i sig selv ikke grund til at udsætte vaccination.
However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
- kondylomer (condyloma acuminata) kausalt relateret til specifikke HPV-typer.
- genital warts (condyloma acuminata) causally related to specific HPV types.
GMT´erne var noget lavere end rapporteret i studier med ikke-hiv-inficerede forsøgspersoner på samme alder.
The GMTs were somewhat lower than those reported in non-HIV infected subjects of the same age in other studies.
Vaccination bør udsættes til graviditeten
Vaccination should be postponed
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.
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.
Hvis du får Silgard som første dosis, skal vaccinationsforløbet fuldføres med Silgard og ikke en anden HPV-vaccine.
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.
20 mikrogram 40 mikrogram 40 mikrogram 20 mikrogram
20 micrograms 40 micrograms 40 micrograms 20 micrograms.
Disse indgivelsesmetoder kan derfor ikke anbefales (se pkt.
These methods of administration are not recommended (see section 6.6).
Dog sås en tendens til lavere anti-HPV GMT i gruppen med samtidig indgivelse.
However, a trend of lower anti-HPV GMTs was observed in the concomitant group.
D. BETINGELSER ELLER BEGRÆSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
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.
During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy.
Silgard indgives som en injektion gennem huden ind i musklen (helst en muskel i overarmen eller
Silgard will be given as an injection through the skin into the muscle (preferably the muscle of the
Denne kan være ledsaget af adskillige neurologiske symptomer, såsom forbigående synsforstyrrelser, paræstesier og toniske-kloniske kramper under opvågningen.
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Der blev rapporteret ni tilfælde (0,06 %) af urticaria i Silgard-gruppen og 20 tilfælde (0,15 %) i gruppen, der fik adjuvansholdigt placebo.
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.
Effekt over for sygdoms-endepunkter forårsaget af præspecificerede kombinationer af ikke-vaccine-HPV-typer blev målt.
Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
Typespecifikke immunanalyser, kompetitiv Luminex-baseret immunanalyse (cLIA) med typespecifikke standarder blev brugt til at vurdere immunogenicitet for hver af vaccinetyperne.
Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
(95 % CI: 67,2; 100) og 100 % (95 % CI: 55,4; 100),
(95% CI: 67.2, 100) and 100% (95% CI: 55.4, 100), respectively,
Der var ingen behandlingsrelaterede effekt på afkommets udvikling, opførsel, reproduktion eller fertilitet.
There were no treatment related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Der har været rapporter om, at der er indgivet flere doser af Silgard end anbefalet.
There have been reports of administration of higher than recommended doses of Silgard.
Endvidere var vaccine-immunogeniciteten sammenlignelig blandt ammende mødre og kvinder, der ikke ammede i forbindelse med indgivelsen af vaccinen.
In addition, vaccine immunogenicity was comparable among breast-feeding mothers and women who did not breast-feed during the vaccine administration.
Du skal blive ved med at følge din læges anvisninger vedrørende livmoderhalsundersøgelser/Pap-tests og forebyggende
You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Selv om besvimelsesepisoder er ualmindelige, skal patienterne holdes under opsyn i 15 minutter efter de er
Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Der var ingen evidens for beskyttelse imod sygdom forårsaget af vaccine-HPV-typer, over for hvilke kvinder var PCR-positive på dag 1.
There was no evidence of protection from disease caused by vaccine HPV types for which women were PCR positive at day 1.
Den bivirkningsprofil, der rapporteredes ved overdosering, var sammenlignelig med den, der blev set
In general, the adverse event profile reported with overdose was comparable to recommended single
Silgard kan som alle vacciner og medicin give bivirkninger, men ikke alle får bivirkninger.
Like all vaccines and medicines, Silgard can cause side effects, although not everybody gets them.
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
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.
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.
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.
Indgivelse af Silgard skal udsættes hos personer, der lider af akut sygdom med feber.
Administration of Silgard should be postponed in individuals suffering from an acute severe febrile illness.
Immunresponser på Silgard ved brug af et program med 2 doser hos personer i alderen 9-13 år
Immune Responses to Silgard using a 2-dose schedule in individuals 9-13 years of age
I 7 kliniske studier (6 placebo-kontrollerede) blev Silgard eller placebo givet til personer på inklusionsdagen og cirka 2 og 6 måneder senere.
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.
Effekten for alle øvrige endepunkter er baseret på protokollerne 007, 013 og 015.
The efficacy for all other endpoints is based on protocols 007, 013, and 015.
Tabel 3: Effekt af Silgard imod high-grade cervixlæsioner i den modificerede ITT-population, der inkluderer kvinder uanset baseline HPV-status
Table 3: Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
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).
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).
Hele den anbefalede dosis af vaccinen skal bruges.
The full recommended dose of the vaccine should be used.
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.
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.
På dag 1 havde sammenlagt 12 % af den kombinerede studiepopulation en abnorm Pap-test, der kunne indikere CIN.
Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
• Hvis du eller dit barn er allergisk over for de aktive stoffer eller nogen af de øvrige indholdsstoffer i Silgard (se pkt.
• 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).
EXP MM/ÅÅÅÅ
EXP MM/YYYY
Den kliniske relevans af det lavere respons er ikke kendt.
The clinical relevance of the lower response is unknown.
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).
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).
Synkope (besvimelse) til tider ledsaget af fald kan forekomme inden eller efter alle vaccinationer, især hos teenagere, som en psykogen reaktion på injektionen.
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.
Serokonversion over for alle fire antigener forekom hos flere end 96 % af forsøgspersonerne.
Seroconversion to all four antigens occurred in more than ninety-six percent of the subjects.
Den kliniske betydning af denne observation kendes ikke.
The clinical significance of this observation is not known.
Immunrespons over for Silgard 1 måned efter 3. dosis
Immune Responses to Silgard at 1 month post dose 3
Silgard gives af din læge som injektion.
Silgard is given as an injection by your doctor.
Silgard var effektiv mod HPV-sygdom forårsaget af hver af de fire vaccine-HPV-typer.
Silgard was efficacious against HPV disease caused by each of the four vaccine HPV types.
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
N Antal tilfælde HPV 6/11/16/18-relaterede eksterne genitale læsioner
N Number of cases HPV 6/11/16/18-related external genital lesions
I opfølgningsperioden af de kliniske studier indberettede forsøgspersonerne i de kliniske studiers sikkerhedspopulation alle nye medicinske tilstande.
In the clinical studies, individuals in the Safety Population reported any new medical conditions during the follow-up.
Silgard fremkaldte høje anti-HPV geometriske middeltitre (GMT'er) én måned efter 3. dosis i alle testede aldersgrupper.
Silgard induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Vaccinen må ikke blandes med andre vacciner eller opløsninger i samme sprøjte.
The vaccine should not be mixed in the same syringe with any other vaccines and solutions.
Meget sjældne (forekommer hos færre end 1 ud af 10.000 patienter): Åndedrætsproblemer (bronkospasme) er blevet rapporteret.
Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
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.
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).
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).
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).
I de kliniske studier blev der observeret svimmelhed som en almindelig bivirkning hos kvinder.
During clinical trials, dizziness was observed as a common adverse reaction in females.
Der er ikke foretaget studier af indflydelsen på evnen til at føre motorkøretøjer eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
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).
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).
Median opfølgningstid var 4,0 år.
The median duration of follow-up for this study was 4.0 years.
Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
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.
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.
Den er heller ikke beregnet til forebyggelse af progression af andre manifeste HPV-relaterede læsioner.
It is also not intended to prevent progression of other established HPV-related lesions.
Median opfølgningstid i de kombinerede protokoller (005, 007, 013 og 015) var 3,6 år.
The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
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
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).
HPV-typerne 6 og 11 er ansvarlige for cirka 90 % af tilfældene af kønsvorter.
HPV types 6 and 11 are responsible for approximately 90% of
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.
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.
Vaccinens sikkerhed og immunogenicitet er vurderet hos personer i alderen fra 7 til 12 år, som var inficeret med humant immundefektvirus (hiv) (se pkt.
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).
Luftveje, thorax og mediastinum: Meget sjælden: Bronkospasme
Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm.
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).
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).
Silgard er udelukkende beregnet til profylaktisk anvendelse og har ingen effekt på aktive HPVinfektioner eller eksisterende klinisk sygdom.
Silgard is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Samtidig indgivelse af Silgard med andre vacciner end de herover anførte, er ikke blevet undersøgt.
The concomitant administration of Silgard with vaccines other than the ones above has not been studied.
Hvis du eller dit barn oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
If you get any side effects, talk to your doctor or pharmacist.
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.
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.
• Træk en 0,5 ml dosis af vaccinen ud af hætteglasset med en steril nål og sprøjte.
• Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and
HPV 6 og 11 er ansvarlige for cirka 90 % af alle kondylomer og 10 % af tilfældene af low-grade cervikal intraepitelial neoplasi (CIN 1).
HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
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).
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).
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.
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.
Silgard kan ikke forårsage de sygdomme, som vaccinen beskytter imod.
Silgard cannot cause the diseases it protects against.
Derfor skal du fortælle det til lægen eller sygeplejersken, hvis du tidligere er besvimet i forbindelse
Therefore tell the doctor or nurse if you fainted with a previous injection.
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
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.
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).
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).
I en supplerende analyse blev Silgards effekt mod HPV 16/18-relateret CIN 3 og AIS evalueret.
In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/18-related CIN 3 and
Brug ikke denne vaccine efter den udløbsdato, der står på mærkaten på hætteglasset og på pakningen (efter Exp).
Do not use this vaccine after the expiry date which is stated on the syringe label and the outer carton (after EXP).
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.
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.
På injektionsstedet: erytem, smerter, hævelser
Very common At the injection site: erythema, pain, swelling
Silgard skal anvendes i overensstemmelse med officielle retningslinjer.
Silgard should be used in accordance with official guidelines.
Som med enhver anden vaccine kan Silgard ikke nødvendigvis beskytte 100 % af dem, der får
As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.
Det vides ikke, hvor længe beskyttelsen varer efter et program med 2 doser Silgard.
Duration of protection of a 2-dose schedule of Silgard has not been established.
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.
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.
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.
There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated individuals.
Vaccinen bør gives som intramuskulær injektion.
The vaccine should be administered by intramuscular injection.
Tabel 5: Effekt af Silgard imod eksterne genitale læsioner hos PPE*-populationen af mænd på 16-26
Table 5: Efficacy of Silgard against external genital lesions in the PPE* population of 16-26 year old
Der kan opstå besvimelser, sommetider ledsaget af fald, efter enhver injektion (især hos teenagere).
Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection.
Sikkerhedsprofilen var sammenlignelig med den set i studier med forsøgspersoner, som ikke var inficeret med hiv.
The safety profile was similar to non-HIV infected subjects in other studies.
Denne analyse måler antistoffer imod en enkelt neutraliserende epitop for hver enkelt af HPV-typerne.
This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
UDLØBSDATO
No data
Det anbefales, at personer der modtager første dosis af Silgard fuldfører hele vaccinationsforløbet med
It is recommended that individuals who receive a first dose of Silgard complete the vaccination course
De kan ikke inficere celler, reproducere sig eller forårsage sygdom.
The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicinal product, please contact the local representative of the
Hos mænd blev svimmelhed ikke observeret hyppigere hos vaccinerede end hos placebopatienter.
In males, dizziness was not observed at a greater frequency in vaccine recipients than in placebo recipients.
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.
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.
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).
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).
Silgard må ikke injiceres intravaskulært.
Silgard must not be injected intravascularly.