FrancophonIA/ELRC3.0 huggingface dataset:
English: The phase II trial (study 001/007) enrolled only women who: - Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,
Danish: Fase II-studiet (studie 001/007) inkluderede kun kvinder, som: - var testet negative for onkogent HPV-DNA af typerne 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
English: Cervarix Control
Danish: Cervarix Kontrol
English: If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Danish: Hvis du glemmer at komme til efterfølgende vaccination på den aftalte tid, skal du spørge lægen til råds.
English: The secondary endpoints included 6- and 12-month persistent infection.
Danish: De sekundære endepunkter inkluderede 6- og 12-måneders persisterende infektion.
English: • if you have any disease which reduces your resistance to infection such as HIV infection.
Danish: • hvis du har en sygdom, som f.eks. hiv-infektion, der nedsætter modstandskraften over for infektioner
English: Control
Danish: Kontrol
English: Cervarix contains sodium chloride.
Danish: Cervarix indeholder natriumchlorid
English: How the vaccine is given
Danish: Sådan gives vaccinen
English: Unlike histopathological endpoints, virological endpoints are less confounded by multiple infections.
Danish: I modsætning til histopatologiske endepunkter bliver virologiske endepunkter kun i mindre grad påvirket af co-infektioner.
English: However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation.
Danish: En lettere infektion, f.eks. forkølelse, er imidlertid ikke kontraindikation for vaccination.
English: On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 9 to 14 years of age.
Danish: På basis af disse immunogenicitetsdata konkluderes det, at Cervarix har effekt hos aldersgruppen fra 9 til 14 år.
English: 4.9 Overdose No case of overdose has been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering.
English: The immune response after 2 doses in females aged 9 to 14 years was non-inferior to the response after 3 doses in women aged 15 to 25 years.
Danish: Immunresponset efter 2 doser hos piger i alderen 9-14 år var non-inferiørt i forhold til responset efter 3 doser hos kvinder i alderen 15-25 år.
English: If not used immediately, the vaccine should be stored in a refrigerator (2°C - 8°C).
Danish: Hvis den ikke anvendes straks, skal vaccinen opbevares i køleskab (2 °C - 8 °C).
English: Vaccine efficacy at study conclusion is summarised in the following table.
Danish: Effekten af vaccinen ved afslutningen af studiet, er opsummeret i den følgende tabel.
English: Second injection: given between 5 and 13 months after first injection If you are 15 years old or above
Danish: Anden injektion: gives mellem 5 og 13 måneder efter den første injektion Hvis du er 15 år eller derover
English: The vaccine should never be given into a vein.
Danish: Vaccinen må aldrig gives i en blodåre.
English: The study was not powered to demonstrate a difference between the vaccine and the placebo group for these endpoints.
Danish: Studiet var ikke designet til at demonstrere en forskel mellem vaccine- og placebogruppen for disse endepunkter.
English: Turbid white suspension.
Danish: Uklar, hvid suspension.
English: In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection.
Danish: I placebogruppen var der fire tilfælde af 6-månederspersisterende infektion og ét tilfælde af 12-måneders-persisterende infektion.
English: As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Danish: Som for andre vacciner, der administreres intramuskulært, skal Cervarix gives med forsigtighed til personer med trombocytopeni eller andre koagulationsforstyrrelser, da der kan forekomme blødning efter en intramuskulær administration hos disse personer.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: The efficacy estimates are lower in the TVC as this cohort includes women with pre-existing infections/lesions, which are not expected to be impacted by Cervarix.
Danish: Den beregnede effekt er lavere i TVC-kohorten, da denne kohorte inkluderer kvinder med præeksisterende infektioner/celleforandringer, som ikke forventes at blive påvirket af Cervarix.
English: Cervarix may not have an optimal effect if used with medicines that suppress the immune system.
Danish: Cervarix vil muligvis ikke have en optimal virkning, hvis den gives sammen med medicin, der svækker immunforsvaret.
English: You will receive 3 injections:
Danish: Skal du have 3 injektioner:
English: Data in pregnant women collected as part of pregnancy registries, epidemiological studies and inadvertent exposure during clinical trials are insufficient to conclude whether or not vaccination with Cervarix affects the risk of adverse pregnancy outcomes including spontaneous abortion.
Danish: Data, som er indsamlet fra graviditetsregistre, epidemiologiske studier og kliniske studier med utilsigtet eksponering af gravide kvinder, er utilstrækkelige til at konkludere, hvorvidt vaccination med Cervarix påvirker risikoen for negativt graviditetsudfald, herunder spontan abort.
English: HPV DNA status, cytology and serostatus at baseline.
Danish: HPV-DNA-status, cytologi og serologisk status ved baseline.
English: Very common Headache Uncommon Dizziness
Danish: Meget almindelig Hovedpine Ikke almindelig Svimmelhed
English: No information exists about protection against persistent infection or precancerous lesions among HIV infected women.
Danish: Der findes ingen oplysninger om beskyttelse mod persisterende infektion eller præmaligne celleforandringer blandt hiv-inficerede kvinder.
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 ingen effekt på aktive HPV-infektioner eller eksisterende klinisk sygdom.
English: Anti-HBs geometric mean antibody concentrations were significantly lower on co-administration, but the clinical relevance of this observation is not known since the seroprotection rates remain unaffected.
Danish: Den geometriske middelantistofkoncentration af anti-HB var signifikant lavere efter samtidig administration, men den kliniske betydning af denne observation er ikke kendt, idet seroprotektionsraten forblev upåvirket.
English: Not known* Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema
Danish: Allergiske reaktioner (inklusive anafylaktiske og anafylaktoide reaktioner), angioødem
English: The limits of the confidence interval around the vaccine efficacy were calculated.
Danish: Grænserne for konfidensintervalet for vaccineeffekten er beregnet.
English: The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies.
Danish: Virkningen på børn, der bliver ammet af mødre, som har fået Cervarix, er ikke vurderet i kliniske studier.
English: As with other vaccines, an adequate immune response may not be elicited in these individuals.
Danish: Som for andre vacciner vil et tilstrækkeligt immunrespons muligvis ikke blive fremkaldt hos disse personer.
English: Overall, the proportions of pregnant subjects who experienced specific outcomes (e.g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups.
Danish: Samlet set var andelen af gravide, som oplevede specifikke hændelser (f.eks.: normalt spædbarn, abnormt spædbarn, herunder medfødte abnormiteter, for tidlig fødsel og spontan abort) sammenlignelig i de to behandlingsgrupper.
English: The second dose given between 5 and 13 months after the first dose
Danish: Den anden dosis gives mellem 5 og 13 måneder efter første dosis
English: % Efficacy (96.2% CI)
Danish: % Effekt (96,2 % CI)
English: Antibody titers peaked at month 7 then gradually declined up to month 18 and stabilized to reach a plateau up to month 84.
Danish: Antistoftiterne var højest ved måned 7 og faldt derefter gradvist frem til måned 18 og stabiliserede sig derefter på et plateau frem til måned 84.
English: The TVC may approximate to the general population of women in the age range of 15-25 years.
Danish: TVC-kohorten svarer skønsmæssigt til den generelle population af kvinder i aldersgruppen 15-25 år.
English: Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM02
Danish: Farmakoterapeutisk klassifikation: Vaccine, papillomvirusvaccine, J07BM02
English: • pain or discomfort at the injection site
Danish: • smerte og ubehag ved injektionssted
English: Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness.
Danish: Vaccination med Cervarix bør udskydes hos personer, der har en svær akut febril sygdom.
English: Immune response to Cervarix after the primary vaccination course
Danish: Immunrespons over for Cervarix efter det primære vaccinationsprogram
English: 12-month persistent infection
Danish: 12-måneders persisterende infektion
English: When a female or a male individual is vaccinated with Cervarix, the immune system (the body's natural defence system) will make antibodies against HPV types 16 and 18.
Danish: Når en kvindelig eller mandlig person vaccineres med Cervarix, vil immunsystemet (kroppens naturlige forsvarssystem) danne antistoffer mod HPV-type 16 og 18.
English: Immunogenicity in males was assessed in 2 clinical trials HPV-011 (N=173) and HPV-040 (N=556).
Danish: Immunogeniciteten hos drenge og unge mænd blev vurderet i 2 kliniske studier HPV-011 (N = 173) og HPV-040 (N = 556).
English: You should continue to follow your doctor's advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.
Danish: Du skal fortsat følge din læges råd om livmoderhalsprøver (smear/Pap-test; en test som påviser evt. celleforandringer i livmoderhalsen forårsaget af en HPVinfektion), samt om forebyggende og beskyttende foranstaltninger.
English: Immunization and schedule
Danish: Immunisering og program
English: Bridging the efficacy of Cervarix from young adult women to adolescents
Danish: Sammenkobling af effekt af Cervarix hos yngre voksne kvinder og piger.
English: Cervarix does not protect against all HPV types.
Danish: Cervarix beskytter ikke mod alle HPV-typer.
English: In study 023 (a subset of study 001/007), the immune response continued to be evaluated up to 113 months.
Danish: I studie 023 (en undergruppe fra studie 001/007) blev immunresponset fortsat evalueret i op til 113 måneder.
English: As with all vaccines, Cervarix may not fully protect all people who are vaccinated.
Danish: Som det gælder for alle andre vacciner, giver Cervarix ikke nødvendigvis alle, som bliver vaccineret, fuld beskyttelse.
English: 1Human Papillomavirus = HPV 2adjuvanted by AS04 containing:
Danish: 1Humant papillomvirus = HPV 2adjuveret med AS04 indeholdende:
English: Other oncogenic HPV types can also cause ano-genital cancers (approximately 30%).
Danish: Også andre onkogene HPV-typer kan forårsage anogenital cancer (ca. 30 %).
English: Control (N = 7,305)
Danish: Kontrol (N = 7.305)
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 adskillige neurologiske tegn fx kortvarige synsforstyrrelser, paræstesier og tonisk-kloniske bevægelser af ekstremiteter under opvågningen.
English: As a precautionary measure, it is preferable to avoid the use of Cervarix during pregnancy.
Danish: Som en sikkerhedsforanstaltning anbefales det at undlade at vaccinere med Cervarix under graviditet.
English: Since no vaccine is 100% effective and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Danish: Da ingen vaccine er 100 % effektiv, og da Cervarix ikke giver beskyttelse mod alle HPV-typer eller mod eksisterende HPV-infektioner, er regelmæssig cervikal screening fortsat meget vigtig og skal følge de lokale anbefalinger.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cervarix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Cervarix
English: Cervarix should under no circumstances be administered intravascularly or intradermally.
Danish: Cervarix må under ingen omstændigheder administreres intravaskulært eller intradermalt.
English: • if you have a bleeding problem or bruise easily.
Danish: • hvis du har blødningsforstyrrelser eller let får blå mærker
English: 6-month persistent infection
Danish: 6-måneders persisterende infektion
English: 4.2 Posology and method of administration
Danish: 4.2 Dosering og administration Dosering
English: First injection: at chosen date
Danish: Første injektion: på en udvalgt dag
English: In study HPV-020, conducted in South Africa, 22 HIV uninfected and 42 HIV infected subjects (WHO clinical stage 1; ATP cohort for immunogenicity) received Cervarix.
Danish: I HPV-020-studiet, som blev udført i Sydafrika, fik 22 ikke-hiv-inficerede personer og 42 hivinficerede personer (WHO klinisk trin 1; ATP-kohorten for immunogenicitet) Cervarix.
English: These reactions will usually occur before leaving the doctor's surgery.
Danish: Disse bivirkninger optræder oftest inden klinikken forlades.
English: There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix.
Danish: Der er ikke evidens for, at brug af hormonel prævention har nogen indflydelse på effekten af Cervarix.
English: Age at the time of the first injection
Danish: Alder ved første injektion
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Danish: Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for fertilitet, graviditet, embryo/fosterudvikling, fødsel eller postnatal udvikling (se pkt.
English: Persistent infection that lasts for at least 6 months has also been shown to be a relevant surrogate marker for cervical cancer in women aged 15 to 25 years.
Danish: Persisterende infektion, som varer mindst 6 måneder, er også vist, at være en relevant surrogatmarkør for cervixcancer hos kvinder i alderen 15 til 25 år.
English: When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete vaccination course.
Danish: Når Cervarix er givet som første dosis, anbefales det at fortsætte med Cervarix (og ikke en anden vaccine mod HPV) i hele vaccinationsprogrammet.
English: The analysis against the primary endpoint was confounded by multiple co-infections in the CIN2+ lesions.
Danish: Analysen af det primære endepunkt var påvirket af adskillige co-infektioner i CIN2+ celleforandringerne.
English: Overall, 74% of women enrolled were naïve to both HPV-16 and HPV-18 (i.e. DNA negative and seronegative at study entry).
Danish: I alt var 74 % af de inkluderede kvinder naive over for både HPV-16 og HPV-18 (dvs. DNA-negative og seronegative ved inkludering i studiet).
English: Tell your doctor if you are taking, have recently taken, might take any other medicines, or have recently received any other vaccine.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, eller hvis du for nylig er blevet vaccineret med en anden vaccine.
English: However, if your child gets any of these symptoms you should contact a doctor urgently.
Danish: Hvis du får nogle af disse symptomer, skal lægen straks kontaktes.
English: Immunogenicity in males aged 10 to 18 years
Danish: Immunogenicitet hos drenge og unge mænd i alderen 10 til 18 år
English: EXP After first opening, use immediately or within 6 hours if stored in a refrigerator
Danish: EXP Skal anvendes straks efter anbrud eller opbevares i køleskab i op til 6 timer
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this vaccine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen til råds, før du får denne vaccine.
English: These can be recognised by: itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness.
Danish: Disse har følgende kendetegn: kløende udslæt på hænder og fødder hævelse af øjne og ansigt åndenød eller synkebesvær pludseligt blodtryksfald og tab af bevidsthed.
English: The need for a booster dose has not been established (see section 5.1).
Danish: Behovet for en boosterdosis er endnu ikke fastlagt (se pkt.
English: Overall impact of the vaccine on cervical HPV disease burden
Danish: Samlet effekt af vaccinen på cervikal-HPV-sygdomsbelastning
English: Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 (CIN2/3) and cervical adenocarcinoma in situ (AIS) were used in the clinical trials as surrogate markers for cervical cancer.
Danish: Cervikal intraepitelial neoplasi (CIN) grad 2 og 3 (CIN2/3) og cervikal adenokarcinom in situ (AIS) blev anvendt i de kliniske studier som en surrogatmarkør for cervixcancer.
English: The immunogenicity induced by three doses of Cervarix has been evaluated in 5,465 female subjects from 9 to 55 years of age and over 800 male subjects aged 10 to 18 years.
Danish: Immunogeniciteten, induceret efter 3 doser Cervarix, er vurderet hos 5.465 piger og kvinder i alderen 9 til 55 år, og hos over 800 drenge og unge mænd i alderen 10 til 18 år.
English: Cervarix is not infectious and so, it cannot cause HPV related diseases.
Danish: Cervarix smitter ikke og kan derfor ikke forårsage HPV-relaterede sygdomme.
English: In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
Danish: I en forud defineret undergruppe af personer (Cervarix = 8.130 sammenlignet med kontrol = 5.786) blev alle bivirkninger overvåget i 30 dage efter hver injektion.
English: HPV 45, -31 and -33 are the 3 most common non-vaccine HPV types identified in squamous cervical carcinoma (12.1%) and adenocarcinoma (8.5%).
Danish: HPV-45, -31 og -33 er de tre almindeligste, ikke-vaccine HPV-typer identificeret i forbindelse med planocellulær cervikal karcinom (12,1 %) og adenokarcinom (8,5 %).
English: HPV-31, 33 and 45 showed consistent cross-protection for 6-month persistent infection and CIN2+ endpoints in all study cohorts.
Danish: HPV-31, 33 og 45 viste vedvarende krydsbeskyttelse mod 6-måneders persisterende infektion og CIN2+ i alle studiekohorter.
English: Cervarix is not recommended for use below 9 years of age.
Danish: Cervarix anbefales ikke til børn under 9 år.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
Danish: Der findes ingen sikkerheds-, immunogenicitets- eller effektdata, der støtter udskiftning af Cervarix med andre HPV-vacciner i løbet af et vaccinationsprogram.
English: Efficacy against ≥ASC-US (abnormal cytology) associated with oncogenic non-vaccine types was 37.2% (96.2% CI [21.3; 50.1]) (ATP).
Danish: Effekt overfor ≥ ASC-US (abnorm cytologi) forbundet med ikke-vaccine onkogene typer var 37,2 % (96,2 % CI [21,3; 50,1]) (ATP).
English: N = number of subjects included in each group n = number of cases (1) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of
Danish: N = antal inkluderede personer i hver gruppe n = antal tilfælde (1) TVC-kohorte: inkluderede alle vaccinerede personer (som havde fået mindst en vaccinedosis) uanset
English: • upper respiratory tract infection (infection of the nose, throat or trachea)
Danish: • infektion i de øvre luftveje (infektion i næse, hals eller luftrør)
English: • fever (≥38°C)
Danish: • feber (38 °C eller derover).
English: As Cervarix will not protect against all types of Human Papillomavirus, appropriate precautions against exposure to HPV and sexually transmitted diseases should continue to be used.
Danish: Da Cervarix ikke beskytter mod alle typer af humant papillomvirus, bør relevant forebyggende beskyttelse mod HPV og seksuelt overførte sygdomme fortsat anvendes.
English: Cross protective efficacy
Danish: Effekt af krydsbeskyttelse
English: Contents of the pack and other information What Cervarix contains - The active substances are: Human Papillomavirus1 type 16 L1 protein2,3,4
Danish: Pakningsstørrelser og yderligere oplysninger Cervarix indeholder: - Aktive stoffer: Humant papillomvirus1 type 16 L1-protein2,3,4
English: When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Danish: Når en flerdosisbeholder anvendes, skal hver dosis (0,5 ml) udtages med en steril kanyle og injektionssprøjte; der skal tages forholdsregler for at undgå kontaminering.
English: However, individuals already infected (HPV DNA positive) with one of the vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the other vaccine HPV type.
Danish: Dog blev de personer, som allerede forud for vaccination havde en infektion (var HPV-DNA-positive) med en af vaccine-HPV-typerne, beskyttet mod klinisk sygdom forårsaget af den anden vaccine-HPV-type.
English: There is no evidence whether prevention of persistent infection that lasts for at least 6 months is a relevant surrogate marker for cervical cancer prevention in women aged 26 years and above.
Danish: Der er ingen beviser for, om forebyggelse af pesisterende infektion, der varer i mindst 6 måneder, er en relevant surrogatmarkør for forebyggelse af cervixcancer hos kvinder i alderen 26 år eller derover.
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut BE-1330 Rixensart Belgium
Danish: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut BE-1330 Rixensart Belgien
English: No data are available on subcutaneous administration of Cervarix.
Danish: Der findes ingen tilgængelige data for subkutan administration af Cervarix.
English: Study 001/007, which included women from 15 to 25 years of age at the time of vaccination, evaluated the immune response against HPV-16 and HPV-18 up to 76 months after administration of the first vaccine dose.
Danish: I studie 001/007, som inkluderede kvinder i alderen fra 15 til 25 år på vaccinationstidspunktet, blev immunresponset vurderet over for HPV-16 og HPV-18 i op til 76 måneder efter administration af første vaccinedosis.
English: 1 adjuvanted by AS04 containing: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)2
Danish: 1adjuveret med AS04 indeholdende: 3-O-desacyl-4'- monophosphoryl-lipid A (MPL)2
English: Case counting for the ATP cohort started on day 1 after the third dose of vaccine.
Danish: Registreringen af tilfælde i ATP-kohorten startede på dag 1 efter tredje vaccinedosis.
English: Cervarix is not used to treat HPV related diseases already present at the time of vaccination.
Danish: Cervarix bruges ikke til at behandle HPV-relaterede sygdomme, som allerede er tilstede i kroppen på vaccinationstidspunktet.
English: The use of Cervarix should be in accordance with official recommendations.
Danish: Administration af Cervarix skal være i overensstemmelse med officielle anbefalinger.