FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the adverse experience profile for breast-feeding women was comparable to that of the women in the overall safety population.
Danish: Derudover var profilen for uønskede hændelser for ammende kvinder sammenlignelig med profilen for kvinder i den generelle sikkerhedspopulation.
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system;
Danish: • har et svækket immunforsvar, f.eks. pga. en genetisk defekt, hiv-smitte eller medicin, som påvirker immunforsvaret;
English: Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil 9.
Danish: Sikkerheden blev evalueret via overvågning vha. et vaccinationsrapporteringskort (VRC) i 14 dage efter hver injektion af Gardasil 9.
English: The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Danish: Vaccinen er kun til profylaktisk anvendelse og har ikke nogen effekt på aktive HPV-infektioner eller eksisterende klinisk sygdom.
English: 16 to 26 year old men
Danish: 16 til 26 år
English: Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In a post hoc analysis for HPV 6 and 11, the GMT ratios were 0.76 and 0.81 respectively.
Danish: I en post hoc-analyse for HPV 6 og 11 var GMT-ratioerne henholdsvis 0,76 og 0,81.
English: The vaccine will only protect against diseases that are caused by HPV types targeted by the vaccine (see section 5.1).
Danish: Vaccinen vil kun beskytte mod sygdomme forårsaget af HPV-typer targeteret af vaccinen (se pkt.
English: 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).
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditeter) indikerer ingen misdannelser eller føtal/neonatal toksicitet af Gardasil 9 (se pkt.
English: 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.
Danish: 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.
English: Loop electrosurgical excision procedure (LEEP) or conisation.
Danish: LEEP (Loop Electro-Excision Procedure) eller konisering
English: After thorough agitation, it is a white, cloudy liquid.
Danish: Efter grundig omrystning bliver det til en hvid, uklar væske.
English: Immunogenicity in HIV infected subjects
Danish: Immunogenicitet hos hiv-inficerede forsøgspersoner
English: Seroconversion to all four antigens occurred in more than 96% of the subjects.
Danish: Der opstod serokonvertering til alle fire antigener hos flere end 96% af forsøgspersonerne.
English: The safety profile was similar to non-HIV infected subjects in other studies.
Danish: Sikkerhedsprofilen var lig profilen hos ikke-hiv-inficerede forsøgspersoner i andre studier.
English: Animal studies do not indicate harmful effects on fertility (see section 5.3).
Danish: Dyreundersøgelser viser ikke nogen skadelig påvirkning på fertiliteten (se pkt.
English: The marketing authorisation holder shall submit the first periodic safety update report for this medicinal product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 6 måneder efter godkendelsen.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: It is also not intended to prevent progression of other established HPV-related lesions.
Danish: Den er heller ikke beregnet til at forebygge progression af andre eksisterende HPV-relaterede læsioner.
English: The indication of Gardasil 9 is based on:
Danish: Indikationen for Gardasil 9 er baseret på:
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Danish: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Holland
English: High immunogenicity in MSM aged 16 to 26 years was also observed, although lower than in HM, similarly to qHPV vaccine.
Danish: 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.
English: The scales for these assays are unique to each HPV type; thus, comparisons across types and to other assays are not appropriate.
Danish: 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.
English: Antibodies against all 9 HPV types were transferred to the offspring during gestation and lactation.
Danish: Antistoffer mod alle 9 HPV-typer blev overført til afkommet under drægtighed og amning.
English: 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.
Danish: Sikkerhedserfaringen efter markedsføring med qHPV-vaccine er relevant for Gardasil 9, da vaccinerne indeholder L1 HPV proteiner af 4 af de samme HPV-typer.
English: The second dose should be administered between 5 and 13 months after the first dose.
Danish: Den anden dosis skal administreres mellem 5 og 13 måneder efter den første dosis.
English: 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).
Danish: 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.
English: Hormonal contraceptives (for example the pill) did not reduce the protection obtained by Gardasil 9.
Danish: Hormonelle præventionsmidler (f.eks. p-piller) nedsatte ikke den beskyttelse, man opnåede ved at tage Gardasil 9.
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); 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 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.
English: 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.
Danish: 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.
English: Evidence of an anamnestic response was seen in vaccinated women who were seropositive to relevant HPV type(s) prior to vaccination.
Danish: Der er set evidens for anamnestisk respons hos vaccinerede kvinder, der var seropositive over for relevante HPV-type(r) før vaccination.
English: Gardasil 9 may not have an optimal effect if used with medicines that suppress the immune system.
Danish: Gardasil 9 vil muligvis ikke have en optimal effekt, hvis det bruges sammen med medicin, der undertrykker immunforsvaret.
English: Long-term follow-up studies are currently ongoing to determine the duration of protection.
Danish: Langtidsvarende opfølgningsstudier pågår for at fastslå varigheden af beskyttelse (se pkt.
English: Polysorbate 80 Borax
Danish: Polysorbat 80
English: N=Number of individuals randomised to the respective vaccination group who received at least one injection.
Danish: N=Antal personer randomiseret til den respektive vaccinationsgruppe, som fik mindst en injektion.
English: The GMTs were somewhat lower than reported in non-HIV infected subjects of the same age in other studies.
Danish: De geometriske middeltitre (GMT'er) var noget lavere end dem, der blev rapporteret hos ikke-hiv-inficerede forsøgspersoner i samme alder i andre studier.
English: GMTs were higher in girls and boys than in women aged 16 to 26 years, and higher in boys than in girls and women.
Danish: 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.
English: 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.
Danish: 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.
English: Talk to your doctor or nurse if you or your child:
Danish: Kontakt lægen eller sundhedspersonalet, hvis du eller dit barn:
English: 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.
Danish: 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.
English: In the studies, vaccine immunogenicity was comparable between breast-feeding women and women who did not breast-feed.
Danish: I forsøgene var vaccine immunogeniciteten sammenlignelig for ammende kvinder og kvinder, der ikke ammede.
English: Gardasil 9 should be used in accordance with official guidelines.
Danish: Gardasil 9 skal bruges i overensstemmelse med officielle retningslinjer.
English: In long-term follow-up extension of clinical studies Protocols 001 and 002, persistence of antibody responses was observed:
Danish: I den langsigtede opfølgningsforlængelse af de kliniske studier Protokol 001 og 002 blev der observeret persistent antistofrespons:
English: • developed an allergic reaction after receiving a dose of Gardasil or Silgard (HPV types 6, 11, 16, and 18) or Gardasil 9.
Danish: • udvikler en allergisk reaktion efter at have fået en dosis Gardasil eller Silgard (HPV-type 6, 11, 16 og 18) eller Gardasil 9.
English: The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Danish: Det foretrukne sted er i deltoidområdet i overarmen eller i det øvre anterolaterale område af låret.
English: The following side effects can be seen after the use of Gardasil 9:
Danish: Følgende bivirkninger kan opstå efter brug af Gardasil 9:
English: In 7 clinical trials, individuals were administered Gardasil 9 on the day of enrolment and approximately 2 and 6 months thereafter.
Danish: I 7 kliniske forsøg blev Gardasil 9 administreret til personer på inklusionsdagen og ca. 2 og 6 måneder derefter.
English: Clear liquid with white precipitate.
Danish: Klar væske med hvidt præcipitat (bundfald).
English: • In packs with needles, two needles of different lengths are provided per syringe.
Danish: • I pakninger med nåle er der to nåle med forskellig længde pr. injektionssprøjte.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Danish: Dette kan være ledsaget af flere neurologiske tegn såsom forbigående synsforstyrrelse, paræstesi og tonisk-klonisk bevægelse af arme og ben under bedring.
English: These results support the efficacy of Gardasil 9 in the male population.
Danish: Disse resultater understøtter effekten af Gardasil 9 hos den mandlige population.
English: Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
Danish: Gardasil 9 er indiceret til aktiv immunisering af personer i alderen fra 9 år mod følgende HPVsygdomme:
English: Gardasil 9 will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Danish: Gardasil 9 gives som en injektion gennem huden ind i musklen (helst musklen i overarmen eller låret).
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 with bivalent or quadrivalent HPV vaccines.
Danish: Der foreligger ingen sikkerheds-, immunogenicitets- eller effektdata, som understøtter Gardasil 9's udskiftelighed med bivalente eller kvadrivalente HPV-vacciner.
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: If you forget one dose of Gardasil 9
Danish: Hvis du har glemt at tage en dosis Gardasil 9
English: Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine.
Danish: Gardasil 9 er en adjuveret, ikke-infektiøs rekombinant 9-valent vaccine.
English: Subjects were followed up to 67 months postdose 3 with a median duration of 43 months postdose 3.
Danish: Forsøgspersoner blev fulgt op til 67 måneder efter dosis 3 med en gennemsnitlig varighed på 43 måneder efter dosis 3.
English: Administration of Gardasil 9 to individuals previously vaccinated with qHPV vaccine
Danish: Administration af Gardasil 9 til personer, som tidligere er blevet vaccineret med qHPV-vaccine
English: 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.
Danish: Følgende uønskede hændelser er blevet spontant indberettet ved brug af qHPV-vaccine efter godkendelse og kan muligvis også ses efter markedsføring med Gardasil 9.
English: n= Number of individuals contributing to the analysis.
Danish: n=Antal personer, der bidrog til analysen.
English: Immune responses, measured by GMT, for Gardasil 9 were non-inferior to immune responses for Gardasil (Table 3).
Danish: Immunrespons målt som GMT for Gardasil 9 var ikke-inferiør over for immunresponser over for Gardasil (Tabel 3).
English: n=Number of individuals contributing to the analysis.
Danish: n=Antal personer der bidrog til analysen.
English: *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).
Danish: *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.
English: Very common At the injection site: pain, swelling, erythema
Danish: Meget almindelig På injektionsstedet: smerte, hævelse, erytem
English: Gardasil 9 cannot cause HPV-related diseases.
Danish: Gardasil 9 kan ikke forårsage HPV-relaterede sygdomme.
English: Gardasil 9 protects against the HPV types that cause most cases of these diseases.
Danish: Gardasil 9 beskytter mod de HPV-typer, der forårsager de fleste af disse sygdomme.
English: Gardasil 9 contains sodium chloride
Danish: Gardasil 9 indeholder natriumchlorid
English: GMT=Geometric Mean Titres.
Danish: GMT=Geometriske middeltitre.
English: 60 µg HPV Type 31, 33, 45, 52 and 58 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.5 mg Al).
Danish: 60 µg HPV-type 31, 33, 45, 52 og 58 L1-protein 20 µg adsorberet på amorf aluminiumhydroxyphosphat-sulfat (0,5 mg Al).
English: If you or your child already received an HPV vaccine, ask your doctor if Gardasil 9 is right for you.
Danish: Hvis du eller dit barn allerede har fået en HPV-vaccine, skal du spørge din læge, om Gardasil 9 er rigtig for dig.
English: 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.
Danish: 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.
English: Very common (may affect more than 1 in 10 people): side effects found at the injection site (pain, swelling, and redness) and headache.
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer): bivirkninger på injektionsstedet (smerte, hævelse og rødmen) og hovedpine.
English: 1 dose of Gardasil 9 suspension for injection contains 0.5 ml.
Danish: 1 dosis Gardasil 9 suspension til injektion indeholder 0,5 ml.
English: Idiopathic thrombocytopaenic purpura, lymphadenopathy
Danish: Idiopatisk trombocytopenisk purpura, lymfadenopati
English: As with any vaccine, Gardasil 9 may not fully protect all of those who get the vaccine.
Danish: Som med enhver vaccine vil Gardasil 9 måske ikke yde fuld beskyttelse for alle, som får vaccinen.
English: 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).
Danish: 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.
English: Gardasil 9 is intended to prevent these diseases.
Danish: Gardasil 9 er beregnet til at beskytte mod disse sygdomme.
English: These assays measured antibodies against neutralising epitopes for each HPV type.
Danish: Disse analyser målte antistoffer mod neutraliserende epitoper for hver HPV-type.
English: Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for Gardasil 9.
Danish: Der er ikke udført studier med et blandet regime (udskiftelighed) af HPV-vacciner for Gardasil 9.
English: If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du eller dit barn oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Do not receive Gardasil 9 if you or your child
Danish: Du eller dit barn må ikke få Gardasil 9, hvis du eller dit barn
English: These results support the efficacy of Gardasil 9 in women aged 27 to 45 years.
Danish: Disse resultater understøtter effekten af Gardasil 9 hos kvinder i alderen 27 til 45 år.
English: Gardasil 9 must not be injected intravascularly, subcutaneously or intradermally.
Danish: Gardasil 9 må ikke injiceres intravaskulært, subkutant eller intradermalt.
English: Name and address of the manufacturer(s) of the biological active substance(s) Merck Sharp & Dohme Corp.
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Merck Sharp & Dohme Corp.
English: 1 dose (0.5 ml): HPV Type 6 L1 protein
Danish: 1 dosis (0,5 ml): HPV-type 6 L1-protein
English: The use of Gardasil 9 should be in accordance with official recommendations.
Danish: Gardasil 9 skal anvendes i overensstemmelse med officielle anbefalinger.
English: Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule.
Danish: Gardasil 9 kan administreres i overensstemmelse med en 3-dosis (0, 2, 6 måneder) tidsplan.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om denne vaccine findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The following side effects have been reported with GARDASIL or SILGARD and may also be seen after getting GARDASIL 9:
Danish: Følgende bivirkninger er blevet rapporteret med GARDASIL eller SILGARD og kan muligvis også opstå, efter man har fået GARDASIL 9:
English: • Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation.
Danish: • Gardasil 9 kan fremstå som en klar væske med et hvidt præcipitat (bundfald) før omrystning.
English: Therefore, the pivotal clinical study (Protocol 001) evaluated the efficacy of Gardasil 9 using qHPV vaccine as a comparator.
Danish: Derfor evaluerede det afgørende kliniske studie (Protokol 001) effekten af Gardasil 9 vha. qHPVvaccine som komparator.