natgillin/translations-raw huggingface dataset:
Læs denne indlægsseddel grundigt, inden du eller dit barn vaccineres, da den indeholder vigtige oplysninger for dig eller dit barn. 
Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child. - Keep this leaflet.
Selv om besvimelse er ualmindeligt, skal patienter observeres i 15 minutter, efter de har fået HPV-vaccine. 
Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Type-specifikke immunanalyser med type-specifikke standarder blev brugt til at vurdere immunogenicitet for hver vaccine-HPV-type. 
Type-specific immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type.
Den kliniske signifikans af denne observation kendes ikke. 
The clinical significance of this observation is not known.
cLIA= Kompetitiv Luminex-baseret immunanalyse. 
cLIA= Competitive Luminex Immunoassay.
% Effekt** (95% CI) 
%Efficacy** (95% CI)
Stabilitetsdata indikerer, at vaccinens komponenter er stabile i 72 timer, når den opbevares ved temperaturer på mellem 8 °C og 25 °C eller mellem 0 °C og 2 °C. 
Stability data indicate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 25°C or from 0°C to 2°C.
I de langsigtede forlængelser af de kliniske studier Protokol 001 og 002 blev effektiviteten observeret i PPE-populationen. 
In the long-term extensions of clinical studies Protocols 001 and 002, effectiveness was observed in the PPE population.
Brug sammen med hormonelle præventionsmidler 
Use with hormonal contraceptives
Alle tre doser skal gives inden for en periode på 1 år. 
All three doses should be given within a 1-year period.
Der blev ikke rapporteret om vaccinerelaterede alvorlige uønskede hændelser hos spædbørn, som blev ammet i vaccinationsperioden. 
There were no vaccine-related serious adverse experiences reported in infants who were breast-feeding during the vaccination period.
qHPV-vaccinen blev brugt som en aktiv kontrol under det kliniske udviklingsprogram for Gardasil 9. 
The qHPV vaccine was used as an active control during the clinical development program for Gardasil 9.
Tabel 1: Bivirkninger efter administration af Gardasil 9, der opstod med en hyppighed på mindst 1,0 % i kliniske forsøg* 
Table 1: Adverse reactions following administration of Gardasil 9 occurring with a frequency of at least 1.0% from clinical trials*
Specifikke studier af Gardasil 9 hos gravide kvinder er ikke blevet udført. 
Specific studies of Gardasil 9 in pregnant women were not conducted.
Den kliniske relevans af det lavere respons er ukendt. 
The clinical relevance of the lower response is unknown.
Personer med overfølsomhed efter tidligere administration af Gardasil 9 eller Gardasil/Silgard bør ikke få Gardasil 9. 
Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil/Silgard should not receive Gardasil 9.
Synkope (besvimelse), nogle gange ledsaget af fald, kan forekomme efter eller endog før en vaccination, især hos unge 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.
Effekt og/eller immunogenicitet af Gardasil 9 blev vurderet i ti kliniske studier. 
Efficacy and/or immunogenicity of Gardasil 9 were assessed in ten clinical studies.
Gardasil 9 beskytter ikke mod alle typer Human papillomavirus. 
Gardasil 9 will not protect against every type of Human Papillomavirus.
Man skal udvise forsigtighed, hvis vaccinen gives til personer med trombocytopeni eller andre koagulationsforstyrrelser, da der kan opstå blødning efter intramuskulær administration hos disse personer. 
This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Pyreksi, træthed På injektionsstedet: pruritus, hæmatom 
Pyrexia, fatigue, At the injection site: pruritus, bruising
Derudover var profilen for uønskede hændelser for ammende kvinder sammenlignelig med profilen for kvinder i den generelle sikkerhedspopulation. 
In addition, the adverse experience profile for breast-feeding women was comparable to that of the women in the overall safety population.
• har et svækket immunforsvar, f.eks. pga. en genetisk defekt, hiv-smitte eller medicin, som påvirker immunforsvaret; 
• has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system;
Sikkerheden blev evalueret via overvågning vha. et vaccinationsrapporteringskort (VRC) i 14 dage efter hver injektion af Gardasil 9. 
Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil 9.
Vaccinen er kun til profylaktisk anvendelse og har ikke nogen effekt på aktive HPV-infektioner eller eksisterende klinisk sygdom. 
The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
16 til 26 år 
16 to 26 year old men
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
I en post hoc-analyse for HPV 6 og 11 var GMT-ratioerne henholdsvis 0,76 og 0,81. 
In a post hoc analysis for HPV 6 and 11, the GMT ratios were 0.76 and 0.81 respectively.
Vaccinen vil kun beskytte mod sygdomme forårsaget af HPV-typer targeteret af vaccinen (se pkt. 
The vaccine will only protect against diseases that are caused by HPV types targeted by the vaccine (see section 5.1).
En stor mængde data fra gravide kvinder (mere end 1.000 graviditeter) indikerer ingen misdannelser eller føtal/neonatal toksicitet af Gardasil 9 (se pkt. 
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor foeto/neonatal toxicity of Gardasil 9 (see section 5.1).
I det langsigtede, forlængede registerstudie med kvinder på 16-23 år (n = 2.084) blev ingen tilfælde af high grade CIN observeret i op til ca. 12 år. 
In the long-term extension registry study for 16-23 year old women (n = 2,084), no cases of high grade CIN were observed up to approximately 12 years.
LEEP (Loop Electro-Excision Procedure) eller konisering 
Loop electrosurgical excision procedure (LEEP) or conisation.
Efter grundig omrystning bliver det til en hvid, uklar væske. 
After thorough agitation, it is a white, cloudy liquid.
Immunogenicitet hos hiv-inficerede forsøgspersoner 
Immunogenicity in HIV infected subjects
Der opstod serokonvertering til alle fire antigener hos flere end 96% af forsøgspersonerne. 
Seroconversion to all four antigens occurred in more than 96% of the subjects.
Sikkerhedsprofilen var lig profilen hos ikke-hiv-inficerede forsøgspersoner i andre studier. 
The safety profile was similar to non-HIV infected subjects in other studies.
Dyreundersøgelser viser ikke nogen skadelig påvirkning på fertiliteten (se pkt. 
Animal studies do not indicate harmful effects on fertility (see section 5.3).
Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 6 måneder efter godkendelsen. 
The marketing authorisation holder shall submit the first periodic safety update report for this medicinal product within 6 months following authorisation.
Eftersom vacciner ikke er 100% effektiv, og Gardasil 9 ikke yder beskyttelse mod alle HPV-typer eller mod eksisterende HPVinfektioner på vaccinationstidspunktet, er rutinemæssig cervikal screening stadigt yderst vigtigt og skal udføres i overensstemmelse med lokale anbefalinger. 
Since no vaccine is 100% effective and Gardasil 9 will not provide protection against every HPV type, or against HPV infections present at the time of vaccination, routine cervical screening remains critically important and should follow local recommendations.
Personer med svækket immunforsvar pga. enten anvendelse af stærk immunsuppressiv terapi, en genetisk defekt, humant immundefektvirus (HIV) infektion eller af andre årsager vil muligvis ikke reagere på vaccinen. 
Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to the vaccine.
Som forventet for kvinder i alderen 27 til 45 år (Protokol 004) var de observerede GMT'er lavere end dem, som blev set hos kvinder i alderen 16 til 26 år. 
As expected for women 27 to 45 years of age (Protocol 004), the observed GMTs were lower than those seen in women aged 16 to 26 years.
Immunogenicitet blev målt ved (1) procentdelen af personer, der var seropositive for antistoffer mod den relevante vaccine-HPV-type og (2) den geometriske middeltiter (GMT). 
Immunogenicity was measured by (1) the percentage of individuals who were seropositive for antibodies against the relevant vaccine HPV type, and (2) the Geometric Mean Titre (GMT).
Kliniske studier, der evaluerede effekten af Gardasil 9 i forhold til placebo, var ikke acceptable, fordi HPV-vaccination anbefales og implementeres i mange lande til beskyttelse mod HPV-smitte og sygdom. 
Clinical studies evaluating the efficacy of Gardasil 9 against placebo were not acceptable because HPV vaccination is recommended and implemented in many countries for protection against HPV infection and disease.
Den er heller ikke beregnet til at forebygge progression af andre eksisterende HPV-relaterede læsioner. 
It is also not intended to prevent progression of other established HPV-related lesions.
Indikationen for Gardasil 9 er baseret på: 
The indication of Gardasil 9 is based on:
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 Marketing Authorisation Holder.
Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Holland 
Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Høj immunogenicitet hos MSM i alderen 16 til 26 år blev også observeret, selv om den var lavere end hos HM, lig den for qHPV-vaccine. 
High immunogenicity in MSM aged 16 to 26 years was also observed, although lower than in HM, similarly to qHPV vaccine.
Skalaen for hver af disse analyser er unik for hver HPV-type, så man kan ikke sammenligne på tværs af typer og med andre analyser. 
The scales for these assays are unique to each HPV type; thus, comparisons across types and to other assays are not appropriate.
Antistoffer mod alle 9 HPV-typer blev overført til afkommet under drægtighed og amning. 
Antibodies against all 9 HPV types were transferred to the offspring during gestation and lactation.
Sikkerhedserfaringen efter markedsføring med qHPV-vaccine er relevant for Gardasil 9, da vaccinerne indeholder L1 HPV proteiner af 4 af de samme HPV-typer. 
The postmarketing safety experience with qHPV vaccine is relevant to Gardasil 9 since the vaccines contain L1 HPV proteins of 4 of the same HPV types.
Den anden dosis skal administreres mellem 5 og 13 måneder efter den første dosis. 
The second dose should be administered between 5 and 13 months after the first dose.
De mest almindelige bivirkninger, der blev observeret med Gardasil 9, var reaktioner på injektionsstedet (84,8% af de vaccinerede inden for 5 dage efter et vaccinationsbesøg) og hovedpine (13,2% af de vaccinerede) inden for 15 dage efter et vaccinationsbesøg. 
The most common adverse reactions observed with Gardasil 9 were injection-site adverse reactions (84.8% of vaccinees within 5 days following any vaccination visit) and headache (13.2% of the vaccinees within 15 days following any vaccination visit).
Hormonelle præventionsmidler (f.eks. p-piller) nedsatte ikke den beskyttelse, man opnåede ved at tage Gardasil 9. 
Hormonal contraceptives (for example the pill) did not reduce the protection obtained by Gardasil 9.
Som med andre vacciner inkluderer rapporterede bivirkninger ved generel brug: hævede kirtler (nakke, armhule eller lyske); muskelsvaghed, unormale fornemmelser, prikken i arme, ben og overkrop eller forvirring (Guillain-Barrés syndrom, akut dissemineret encephalomyelitis); opkastning, ledsmerte, ømme muskler, unormal træthed eller svaghed, kuldegysninger, generel utilpashed, mere blødning eller lettere ved at få blå mærker end normalt samt hudinfektion ved injektionsstedet. 
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); 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.
Når en person er vaccineret med Gardasil 9, stimuleres immunforsvaret (kroppens naturlige forsvar) til at producere antistoffer mod de ni vaccine-HPV-typer, hvilket hjælper med at beskytte mod sygdomme forårsaget af disse virus. 
When an individual is vaccinated with Gardasil 9, the immune system (the body's natural defence system) stimulates production of antibodies against the nine vaccine HPV types, to help protect against the diseases caused by these viruses.
Der er set evidens for anamnestisk respons hos vaccinerede kvinder, der var seropositive over for relevante HPV-type(r) før vaccination. 
Evidence of an anamnestic response was seen in vaccinated women who were seropositive to relevant HPV type(s) prior to vaccination.
Gardasil 9 vil muligvis ikke have en optimal effekt, hvis det bruges sammen med medicin, der undertrykker immunforsvaret. 
Gardasil 9 may not have an optimal effect if used with medicines that suppress the immune system.
Langtidsvarende opfølgningsstudier pågår for at fastslå varigheden af beskyttelse (se pkt. 
Long-term follow-up studies are currently ongoing to determine the duration of protection.
Polysorbat 80 
Polysorbate 80 Borax
N=Antal personer randomiseret til den respektive vaccinationsgruppe, som fik mindst en injektion. 
N=Number of individuals randomised to the respective vaccination group who received at least one injection.
De geometriske middeltitre (GMT'er) var noget lavere end dem, der blev rapporteret hos ikke-hiv-inficerede forsøgspersoner i samme alder i andre studier. 
The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
GMT'er var højere hos piger og drenge end hos kvinder i alderen 16 til 26 år, og højere hos drenge end hos piger og kvinder. 
GMTs were higher in girls and boys than in women aged 16 to 26 years, and higher in boys than in girls and women.
Yderligere evaluering af effekten af Gardasil 9 mod vaccine-HPV-typerne Da effekten af Gardasil 9 ikke kunne blive evalueret mod placebo, blev følgende eksplorative analyser udført. 
Additional efficacy evaluation of Gardasil 9 against vaccine HPV types Since the efficacy of Gardasil 9 could not be evaluated against placebo, the following exploratory analyses were conducted.
Kontakt lægen eller sundhedspersonalet, hvis du eller dit barn: 
Talk to your doctor or nurse if you or your child:
Desuden udviste kvinder (n=150), som havde fået 3 doser Gardasil 9 i Protokol 001 og en dosis til udfordring af vaccinationen 5 år senere, et hurtigt og højt anamnestisk respons, der var højere end de GMTer for anti-HPV, der blev observeret 1 måned efter dosis 3. 
In addition, women (n = 150) who received 3 doses of Gardasil 9 in Protocol 001 and a challenge dose 5 years later, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month postdose 3.
I forsøgene var vaccine immunogeniciteten sammenlignelig for ammende kvinder og kvinder, der ikke ammede. 
In the studies, vaccine immunogenicity was comparable between breast-feeding women and women who did not breast-feed.
Gardasil 9 skal bruges i overensstemmelse med officielle retningslinjer. 
Gardasil 9 should be used in accordance with official guidelines.
I den langsigtede opfølgningsforlængelse af de kliniske studier Protokol 001 og 002 blev der observeret persistent antistofrespons: 
In long-term follow-up extension of clinical studies Protocols 001 and 002, persistence of antibody responses was observed:
• udvikler en allergisk reaktion efter at have fået en dosis Gardasil eller Silgard (HPV-type 6, 11, 16 og 18) eller Gardasil 9. 
• developed an allergic reaction after receiving a dose of Gardasil or Silgard (HPV types 6, 11, 16, and 18) or Gardasil 9.
Det foretrukne sted er i deltoidområdet i overarmen eller i det øvre anterolaterale område af låret. 
The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Følgende bivirkninger kan opstå efter brug af Gardasil 9: 
The following side effects can be seen after the use of Gardasil 9:
I 7 kliniske forsøg blev Gardasil 9 administreret til personer på inklusionsdagen og ca. 2 og 6 måneder derefter. 
In 7 clinical trials, individuals were administered Gardasil 9 on the day of enrolment and approximately 2 and 6 months thereafter.
Klar væske med hvidt præcipitat (bundfald). 
Clear liquid with white precipitate.
• I pakninger med nåle er der to nåle med forskellig længde pr. injektionssprøjte. 
• In packs with needles, two needles of different lengths are provided per syringe.
Dette kan være ledsaget af flere neurologiske tegn såsom forbigående synsforstyrrelse, paræstesi og tonisk-klonisk bevægelse af arme og ben under bedring. 
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Disse resultater understøtter effekten af Gardasil 9 hos den mandlige population. 
These results support the efficacy of Gardasil 9 in the male population.
Gardasil 9 er indiceret til aktiv immunisering af personer i alderen fra 9 år mod følgende HPVsygdomme: 
Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Gardasil 9 gives som en injektion gennem huden ind i musklen (helst musklen i overarmen eller låret). 
Gardasil 9 will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Der foreligger ingen sikkerheds-, immunogenicitets- eller effektdata, som understøtter Gardasil 9's udskiftelighed med bivalente eller kvadrivalente HPV-vacciner. 
There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 with bivalent or quadrivalent HPV vaccines.
Effekt og langsigtet effektivitet af qHPV-vaccine mod HPV 6-, 11-, 16- og 18-relaterede sygdomsendepunkter er påvist i kliniske studier hos PPE (Per Protocol Efficacy)-populationen. 
The efficacy and long-term effectiveness of qHPV vaccine against HPV 6-, 11-, 16-, and 18-related disease endpoints have been demonstrated in clinical studies in the PPE (Per Protocol Efficacy) population.
• i mindst 5 år hos piger og drenge på 9-15 år på tidspunktet for vaccination med Gardasil 9; afhængigt af HPV-type var 90 til 99% af forsøgspersonerne seropositive. 
• for at least 5 years in girls and boys who were aged 9 to 15 years at time of vaccination with Gardasil 9; depending on HPV type, 90 to 99 % of subjects were seropositive.
Typen af abnormiteter eller hyppigheden af graviditeter, som havde et negativt udfald, var sammenlignelig hos personer, som fik Gardasil 9 eller qHPV-vaccine, og konsistent med den almene befolkning. 
The types of anomalies or proportion of pregnancies with an adverse outcome in individuals who received Gardasil 9 or qHPV vaccine were comparable and consistent with the general population.
Hvis du har glemt at tage en dosis Gardasil 9 
If you forget one dose of Gardasil 9
Gardasil 9 er en adjuveret, ikke-infektiøs rekombinant 9-valent vaccine. 
Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine.
Forsøgspersoner blev fulgt op til 67 måneder efter dosis 3 med en gennemsnitlig varighed på 43 måneder efter dosis 3. 
Subjects were followed up to 67 months postdose 3 with a median duration of 43 months postdose 3.
Administration af Gardasil 9 til personer, som tidligere er blevet vaccineret med qHPV-vaccine 
Administration of Gardasil 9 to individuals previously vaccinated with qHPV vaccine
Følgende uønskede hændelser er blevet spontant indberettet ved brug af qHPV-vaccine efter godkendelse og kan muligvis også ses efter markedsføring med Gardasil 9. 
The following adverse experiences have been spontaneously reported during post-approval use of qHPV vaccine and may also be seen in post-marketing experience with Gardasil 9.
n=Antal personer, der bidrog til analysen. 
n= Number of individuals contributing to the analysis.
Immunrespons målt som GMT for Gardasil 9 var ikke-inferiør over for immunresponser over for Gardasil (Tabel 3). 
Immune responses, measured by GMT, for Gardasil 9 were non-inferior to immune responses for Gardasil (Table 3).
n=Antal personer der bidrog til analysen. 
n=Number of individuals contributing to the analysis.
*Bivirkningerne, som er inkluderet i denne tabel, er fra 7 kliniske forsøg (PN 001, 002, 003, 005, 006, 007 og 009, N=15.776 personer) (se pkt. 
*Adverse reactions included in this table are from 7 clinical trials (PN 001, 002, 003, 005, 006, 007 and 009, N=15,776 individuals) (see section 5.1 for description of the clinical trials).
Meget almindelig På injektionsstedet: smerte, hævelse, erytem 
Very common At the injection site: pain, swelling, erythema
Gardasil 9 kan ikke forårsage HPV-relaterede sygdomme. 
Gardasil 9 cannot cause HPV-related diseases.
Gardasil 9 beskytter mod de HPV-typer, der forårsager de fleste af disse sygdomme. 
Gardasil 9 protects against the HPV types that cause most cases of these diseases.
Gardasil 9 indeholder natriumchlorid 
Gardasil 9 contains sodium chloride
GMT=Geometriske middeltitre. 
GMT=Geometric Mean Titres.
60 µg HPV-type 31, 33, 45, 52 og 58 L1-protein 20 µg adsorberet på amorf aluminiumhydroxyphosphat-sulfat (0,5 mg Al). 
60 µg HPV Type 31, 33, 45, 52 and 58 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.5 mg Al).
Hvis du eller dit barn allerede har fået en HPV-vaccine, skal du spørge din læge, om Gardasil 9 er rigtig for dig. 
If you or your child already received an HPV vaccine, ask your doctor if Gardasil 9 is right for you.
Den anden dosis skal administreres mindst en måned efter den første dosis, og den tredje dosis skal administreres 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.
Meget almindelig (kan påvirke flere end 1 ud af 10 personer): bivirkninger på injektionsstedet (smerte, hævelse og rødmen) og hovedpine. 
Very common (may affect more than 1 in 10 people): side effects found at the injection site (pain, swelling, and redness) and headache.
1 dosis Gardasil 9 suspension til injektion indeholder 0,5 ml. 
1 dose of Gardasil 9 suspension for injection contains 0.5 ml.
Idiopatisk trombocytopenisk purpura, lymfadenopati 
Idiopathic thrombocytopaenic purpura, lymphadenopathy
Som med enhver vaccine vil Gardasil 9 måske ikke yde fuld beskyttelse for alle, som får vaccinen. 
As with any vaccine, Gardasil 9 may not fully protect all of those who get the vaccine.
Sikkerheden og immunogeniciteten af en qHPV-vaccine er blevet vurderet hos personer i alderen 7 til 12 år, som vides at være inficeret med humant immundefektvirus (HIV) (se pkt. 
Safety and immunogenicity of a qHPV vaccine have been assessed in individuals aged 7 to 12 years who are known to be infected with Human Immunodeficiency Virus (HIV) (see section 5.1).
Gardasil 9 er beregnet til at beskytte mod disse sygdomme. 
Gardasil 9 is intended to prevent these diseases.
Disse analyser målte antistoffer mod neutraliserende epitoper for hver HPV-type. 
These assays measured antibodies against neutralising epitopes for each HPV type.