natgillin/translations-raw huggingface dataset:
Anvendelsen baseres på den påviste effekt af Cervarix hos kvinder i alderen 15- 25 år og dets immunogenicitet (dets evne til at få immunsystemet til at respondere på vaccinen) hos piger og kvinder i alderen 10- 25 år.
This use is based on demonstration of the effectiveness of Cervarix in women aged 15 to 25 years, and of its immunogenicity (its ability to make the immune system respond to the vaccine) in girls and women aged 10 to 25 years.
Cervarix gives til personer på 10 år eller derover i form af tre doser, hvor der skal gå én måned mellem første og anden dosis og fem måneder mellem anden og tredje dosis.
Cervarix is given to individuals aged 10 years or older, as three doses, with one month between the first and second doses, and five months between the second and third doses.
Det anbefales, at personer, som får den første dosis af Cervarix, får samtlige tre doser af Cervarix.
It is recommended that individuals who receive the first dose of Cervarix should complete all three doses with Cervarix.
Vaccinen gives som en injektion i overarmsmusklen.
The vaccine is given as an injection into the muscle of the upper arm.
Cervarix bør ikke anvendes til piger i alderen under 10 år, da der mangler oplysninger om sikkerheden og immunogeniciteten hos denne aldersgruppe.
Cervarix is not recommended for use in girls aged below 10 years, due to a lack of information on safety and immunogenicity in this group.
Der findes over 100 typer papillomavirus, og nogle af disse typer er forbundet med kræft i kønsorganerne.
There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
70% af alle tilfældene af livmoderhalskræft.
HPV types 16 and 18 cause approximately 70% of cervical cancers.
Alle papillomavira har en skal, eller et 'kapsid', der består af såkaldte ’ L1- proteiner ’.
All papillomaviruses have a shell or ‘ capsid’, which is made up of proteins called ‘ L1 proteins’.
Cervarix indeholder oprensede L1- proteiner fra to af HPV- typerne: type 16 og 18.
Cervarix contains purified L1 proteins for two of the types of HPV: types 16 and 18.
Proteinerne i Cervarix er fremstillet ved hjælp af en metode, der kaldes 'rekombinant DNA- teknologi': de dannes af celler, som har fået et gen (DNA), der gør dem i stand til at producere L1- proteinerne.
The proteins in Cervarix are produced by a method known as ‘ recombinant DNA technology’: they are made by a cell that has received a gene (DNA) that makes it able to produce the L1 proteins.
Proteinerne er samlede i 'viruslignende partikler' (strukturer, der ser ud som HPV, så kroppen kan genkende dem).
The proteins are assembled in ‘ virus-like particles’ (structures that look like HPV, so that the body can recognise them
Det forstærker 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. immunsystemets (det system, der bekæmper sygdomme) respons på vaccinen.
Reproduction is authorised provided the source is acknowledged. easily).
Vaccinen 'adsorberes', hvilket betyder, at de viruslignende L1- proteinpartikler og MPL bindes af en aluminiumholdig forbindelse, hvorved immunreaktionen forstærkes.
The vaccine is ‘ adsorbed’, which means that the L1 protein virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.
Når vaccinen gives til en patient, producerer immunsystemet antistoffer mod l1- proteinerne.
When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Antistofferne er med til at ødelægge virus.
The antibodies help to destroy the virus.
Efter vaccinationen er immunsystemet i stand til at producere antistoffer hurtigere, hvis det udsættes for disse vira.
After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the viruses.
Cervarix 'effekt blev undersøgt i eksperimentelle modeller, før det blev undersøgt hos mennesker.
The effects of Cervarix were first tested in experimental models before being studied in humans.
Hovedundersøgelsen omfattede hos næsten 19. 000 kvinder i alderen 15- 25 år.
The main study involved almost 19,000 women aged between 15 and 25 years.
Cervarix blev sammenlignet med en anden vaccine, som ikke er aktiv mod HPV (i dette tilfælde en vaccine mod hepatitis A- virus).
Cervarix was compared to another vaccine, which is not active against HPV (in this case, a vaccine against hepatitis A virus).
I undersøgelsen blev der set på, hvor mange kvinder af dem, der oprindeligt ikke var smittet med HPV- type 16 og 18, der udviklede forstadier til kræft i livmoderen, som var forbundet med en infektion med disse HPV- typer.
The study looked at how many women who were originally uninfected with HPV types 16 and 18 went on to develop precancerous lesions in the cervix linked to infection with these types of HPV.
Undersøgelsen var stadig i gang på det tidspunkt, hvor vurderingerne blev foretaget, og den fortsætter i op til fire år.
The study was still ongoing at the time of the assessment and will continue for up to four years.
Der blev også i to andre undersøgelser set på udviklingen af antistoffer mod HPV- type 16 og 18 hos 2 225 piger i alderen 10- 14 år.
An additional two studies also looked at the development of antibodies to HPV types 16 and 18 in 2,225 girls aged between 10 and 14 years.
I disse undersøgelser blev niveauet af antistoffer før vaccineringen sammenlignet med niveauet af antistoffer efter den tredje dosis (ved syvende måned).
The studies compared the levels of antibodies between before vaccination and after the third dose (at month seven).
Hvilken fordel viser undersøgelsen, at der ved Cervarix?
What benefit has Cervarix shown during the studies?
I hovedundersøgelsen, efter gennemsnitligt 15 måneder, udviklede 2 ud af de næsten 8 000 kvinder, som fik mindst én dosis Cervarix, og som ikke oprindeligt var smittet med HPV- type 16 eller 18, forstadier til kræft i livmoderen i forbindelse med disse HPV- typer.
In the main study, after an average of 15 months, two of the almost 8,000 women receiving at least one dose of Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in cervix linked to these HPV types.
Dette kan sammenlignes med 21 af de næsten 8 000 kvinder, der fik den anden vaccine.
This compared with 21 of the almost 8,000 women receiving the other vaccine.
De to andre undersøgelser viste, at alle pigerne i alderen 10- 14 år, som fik Cervarix, udviklede beskyttende niveauer af antistoffer mod HPV- type 16 og 18.
The additional studies showed that all of the girls aged 10 to 14 years who were given Cervarix developed protective levels of antibodies against HPV types 16 and 18.
Dette indikerede, at vaccinen sandsynligvis har en forebyggende virkning mod HPV- infektion hos piger fra 10- årsalderen.
This indicated that the vaccine is likely to be effective in preventing HPV infection in girls from the age of 10 years.
Hvilke risiko er der forbundet med Cervarix?
What is the risk associated with Cervarix?
De mest almindelige bivirkninger ved Cervarix (forekommer hos flere end 1 ud af 10 patienter) er hovedpine, myalgi (muskelsmerter), reaktioner på injektionsstedet, herunder smerter, rødme og hævelse, og træthed.
The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
Den fuldstændige liste over de indberettede bivirkninger ved Cervarix fremgår af indlægssedlen.
For the full list of all side effects reported with Cervarix, see the Package Leaflet.
Cervarix må ikke anvendes til personer, der kan være overfølsomme (allergiske) over for det aktive stof eller over for et eller flere af hjælpestofferne.
Cervarix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Cervarix er større end risiciene, når lægemidlet anvendes til forebyggelse af forstadier til kræft i livmoderen og livmoderhalskræft, som er årsagsmæssigt forbundet med HPV- type 16 og 18.
The Committee for Medicinal Products for Human Use (CHMP) decided that Cervarix’ s benefits are greater than its risks for the prevention of premalignant cervical lesions and cervical cancer causally related to HPV types 16 and 18.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Cervarix.
The Committee recommended that Cervarix be given marketing authorisation.
Yderligere oplysninger om Cervarix Europa- Kommissionen udstedte en markedsføringstilladelse, der var gyldig i hele Den Europæiske Union, for Cervarix til GlaxoSmithKline Biologicals s. a. den 20. september 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix to GlaxoSmithKline Biologicals s. a. on 20 September 2007.
Den fuldstændige EPAR) findes her.
The full EPAR for Cervarix can be found here.
EU- nummer.
EU Number
1 20 µg / 20 µg Humant papillomvirus - 16 / humant papillomvirus - 18 L 1 proteiner
20 µg/ 20 µg Human Papilloma Virus - 16/ Human Papilloma Virus -18 L 1 proteins
Human papillomvirusvaccine [type 16, 18] (rekombinant, adjuveret, adsorberet).
Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
1 dosis (0, 5 ml) indeholder:
1 dose (0.5 ml) contains:
Humant papillomvirus1 type 16 L1- protein2, 3, 4 Humant papillomvirus1 type 18 L1- protein2, 3, 4 1 Humant papillomvirus = HPV 2 adjuveret med AS04 indeholdende:
Human Papillomavirus1 type 16 L1 protein2,3,4 Human Papillomavirus1 type 18 L1 protein2,3,4 1 Human Papillomavirus = HPV 2 adjuvanted by AS04 containing:
20 mikrogram 20 mikrogram
20 micrograms 20 micrograms
3- O- desacyl- 4 ’ - monophosphoryl- lipid A (MPL) 3 3
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)3 3
adsorberet på aluminiumhydroxidhydrat (Al( OH) 3)
adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 4
0, 5 milligram A13+ totalt
0.5 milligrams Al3+ in total
L1 protein i form af ikke- smitsom viruslignende partikel (VLP) produceret ved hjælp af rekombinant DNA- teknologi med brug af et Baculovirussystem, som anvender Hi- 5- Rix4446- celler fra Trichoplusia ni.
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.
Ved opbevaring ses somme tider et fint hvidt bundfald med et klart, farveløst væskelag på overfladen.
Upon storage, a fine white deposit with a clear colourless supernatant may be observed.
5. 1).
Cervarix is a vaccine for the prevention of premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 (see section 5.1).
Indikationen er baseret på påvisningen af effekt hos kvinder i alderen fra 15 til 25 år efter vaccination med Cervarix, og på påvisning af vaccinens immunogenicitet hos piger og kvinder i alderen fra 10 til 25 år.
The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 10-25 years.
5. 1 for information om evidens for effekten af Cervarix til forbyggelse af premaligne cervikale celleforandringer (CIN grad 2 og 3) associeret med HPV- 16 og/ eller HPV- 18.
See section 5.1 for information on the evidence that supports the efficacy of Cervarix in prevention of premalignant cervical lesions associated with HPV-16 and/ or HPV-18.
Administration af Cervarix bør ske i overensstemmelse med de gældende officielle retningslinjer.
The use of Cervarix should be in accordance with official recommendations.
Det anbefalede vaccinationsprogram er 0, 1, 6 måneder.
The recommended vaccination schedule is 0, 1, 6 months.
5. 1).
The need for a booster dose has not been established (see section 5.1).
4. 4).
2 It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
Piger under 10 år:
Girls aged less than 10 years:
Cervarix bør ikke bruges til piger under 10 år på grund af manglende data om sikkerhed og immunogenicitet i denne aldersgruppe.
Cervarix is not recommended for use in girls below 10 years of age due to lack of data on safety and immunogenicity in this age-group.
Cervarix skal injiceres intramuskulært i regio deltoidea (se også pkt. 4. 4 og 4. 5)
Cervarix is for intramuscular injection in the deltoid region (see also sections 4.4 and 4.5).
Vaccination med Cervarix bør udskydes hos personer, der lider af en svær akut febril sygdom.
Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness.
En mindre infektion, f. eks. forkølelse, er imidlertid ingen kontraindikation for vaccination.
However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation.
Som for alle andre injicerbare vacciner, skal relevant medicinsk behandling og overvågning være umiddelbart tilgængelig for det tilfælde, at der opstår en sjælden anafylaktisk reaktion efter administration af vaccinen.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Cervarix må under ingen omstændigheder gives intravaskulært eller intradermalt.
Cervarix should under no circumstances be administered intravascularly or intradermally.
Vaccinationen erstatter ikke regelmæssig cervikal screening eller forholdsregler mod eksponering for HPV og seksuelt overførte sygdomme.
Vaccination is not a substitute for regular cervical screening or for precautions against exposure to HPV and sexually transmitted diseases.
Cervarix beskytter mod sygdomme forårsaget af HPV type 16 og 18.
Cervarix protects against disease caused by HPV types 16 and 18.
Andre onkogene HPV- typer kan også forårsage cervix- cancer, hvorfor regelmæssig cervikal screening forsat er af yderste vigtighed, og skal udføres i overensstemmelse med lokale retningslinjer.
Other oncogenic HPV types can also cause cervical cancer and therefore routine cervical screening remains critically important and should follow local recommendations.
Det er ikke påvist, at Cervarix har en terapeutisk effekt.
Cervarix has not been shown to have a therapeutic effect.
Vaccinen er derfor ikke indiceret til behandling af cervix- cancer, cervikal intraepitelialneoplasi (CIN), eller andre HPV- relaterede celleforandringer.
The vaccine is therefore not indicated for treatment of cervical cancer, cervical intraepithelial neoplasia (CIN) or any other established HPV- related lesions.
Cervarix beskytter ikke mod udvikling af HPV- relaterede celleforandringer hos kvinder, der er inficeret med HPV- 16 eller HPV- 18 på vaccinationstidspunktet.
Cervarix does not prevent HPV-related lesions in women who are infected with HPV-16 or HPV-18 at the time of vaccination.
Tidspunkt og behov for boosterdosis er ikke undersøgt.
Timing and need of booster dose(s) has not been investigated.
Der er ingen data vedrørende brugen af Cervarix til personer med svækket immunforsvar såsom hiv - patienter eller patienter i immunsuppresiv behandling.
There are no data on the use of Cervarix in subjects with impaired immune responsiveness such as HIV infected patients or patients receiving immunosuppressive treatment.
Der findes ingen sikkerheds -, immunogenicitets - eller effektdata, der støtter udskiftning af Cervarix med andre HPV- vacciner i løbet af et vaccinationsprogram.
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
Anvendelse sammen med andre vacciner
3 Use with other vaccines
Der er ikke udført interaktionsundersøgelser af Cervarix med andre vacciner.
Data have not been generated on the concomitant administration of Cervarix and other vaccines.
Anvendelse sammen med hormonelle præventionsmidler
Use with hormonal contraceptive
60% af kvinderne, som fik Cervarix, hormonel prævention.
In clinical efficacy studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Som for andre vacciner kan det forventes, at patienter der er i immunsuppressiv behandling, ikke opnår tilstrækkeligt respons.
As with other vaccines it may be expected that, in patients receiving immunosuppressive treatment, an adequate response may not be elicited.
Specifikke forsøg med vaccination af gravide kvinder er ikke udført.
Specific studies of the vaccine in pregnant women were not conducted.
Under det kliniske udviklingsprogram forud for godkendelse blev et samlet antal på 1737 graviditeter rapporteret, heriblandt 870 kvinder, som havde modtaget Cervarix.
During the pre-licensure clinical development program, a total of 1,737 pregnancies were reported including 870 in women who had received Cervarix.
Samlet set var forholdet af gravide, som oplevede specifikke hændelser (f. eks.: normalt spædbarn, abnormt spædbarn, herunder medfødte abnormiteter, for tidlig fødsel og spontane aborter) sammenligneligt for de to behandlingsgrupper.
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.
5. 3).
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).
Disse data er ikke tilstrækkelige til at anbefale brug af Cervarix under graviditet.
These data are insufficient to recommend use of Cervarix during pregnancy.
Vaccination bør derfor udsættes, til graviditeten er afsluttet.
Vaccination should, therefore, be postponed until after completion of pregnancy.
Virkningen på børn der bliver ammet af mødre, som har fået Cervarix, er ikke vurderet i kliniske forsøg.
The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies.
Cervarix bør kun gives i en ammeperiode, når mulige fordele opvejer mulige risici.
Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on the ability to drive and use machines
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive or use machines have been performed.
I kliniske forsøg med piger og kvinder i alderen fra 10 til 72 år (hvor 79, 2% var i alderen fra 10 til 25 år ved inklusion), blev Cervarix administreret til 16142 personer, mens 13811 personer modtog kontrolvaccine.
In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 subjects whilst 13,811 subjects received control.
Disse personer blev overvåget for alvorlige bivirkninger i hele forsøgsperioden.
These subjects were followed for serious adverse events over the entire study period.
I en forud defineret undergruppe af personer (Cervarix = 8130 sammenlignet med kontrol = 5786) blev alle bivirkninger overvåget i 30 dage efter hver injektion.
In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
Den mest almindelige bivirkning efter administration af vaccine var smerter på administrationsstedet, som blev set efter 78% af alle doser.
The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
Hovedparten af disse reaktioner var milde til moderate i sværhedsgrad og forsvandt efter kort tid.
The majority of these reactions were of mild to moderate severity and were not long lasting.
4 Hyppigheden er rapporteret som:
Frequencies are reported as:
Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 til < 1/ 10) Ikke almindelig (≥ 1/ 1000 til < 1/ 100)
4 Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Meget almindelig: hovedpine Ikke almindelig: svimmelhed
Very common: headache Uncommon: dizziness
Almindelige: gastrointestinale symptomer, herunder kvalme, opkastning, diaré og mavesmerter
Common: gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Almindelige: kløe/ pruritus, udslæt, nældefeber
Common: itching/ pruritus, rash, urticaria
Meget almindelig: myalgi Almindelig: artralgi
Very common: myalgia Common: arthralgia
Ikke almindelig: infektion i øvre luftveje
Uncommon: upper respiratory tract infection
Meget almindelige: reaktioner på administrationsstedet, herunder smerte, rødme og hævelse, samt træthed Almindelig: feber (≥ 38°C) Ikke almindelige: andre reaktioner på administrationsstedet såsom induration, lokal paræstesi
Very common: injection site reactions including pain, redness, swelling; fatigue Common: fever (≥ 38°C) Uncommon: other injection site reactions such as induration, local paraesthesia
En sammenlignelig sikkerhedsprofil er set for personer, der tidligere har haft eller har en HPV - infektion sammenlignet med personer, der var negative for onkogen HPV DNA eller seronegative for HPV- 16 og HPV- 18 antistof.
A similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies.
Farmakoterapeutisk klassifikation:
Papillomavirus vaccines, ATC code:
Papillomvirusvaccine, J07BM02
J07BM02
Cervarix er en ikke- smitsom rekombinant vaccine fremstillet af en højtoprenset viruslignende partikel (VLP) af kapsidproteinet L1 fra de onkogene HPV- typer 16 og 18.
Cervarix is a non-infectious recombinant vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Da VLP ikke indeholder viralt DNA, kan det ikke inficere celler, reproducere sig, eller forårsage sygdom.
Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Dyreforsøg har vist, at effekten af L1 VLP- vacciner i høj grad beror på udviklingen af humoralt immunrespons.
Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response.
70% af tilfældene af cervix- cancer på verdensplan.
HPV-16 and HPV-18 are responsible for approximately 70% of cervical cancers across all regions worldwide.
Virkningen af Cervarix blev undersøgt i 2 kontrollerede, dobbeltblinde, randomiserede fase II - og III - kliniske forsøg, som inkluderede i alt 19778 kvinder i alderen fra 15 til 25 år.
The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
5 Fase II- forsøget (forsøg 001/ 007) inkluderede kun kvinder, som:
The phase II trial (study 001/ 007) enrolled only women who:
- var testet negative for onkogent HPV DNA af typerne 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
- Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,
59, 66 og 68
58, 59, 66 and 68
- var seronegative for HPV- 16 og HPV- 18
- Were seronegative for HPV-16 and HPV-18 and
- havde normal cytologi
- Had normal cytology
Det primære endpoint for effekt var forbigående infektion med HPV- 16 og/ eller HPV- 18.
The primary efficacy endpoint was incident infection with HPV-16 and/ or HPV-18.
12 - måneders persisterende infektion blev evalueret som et yderligere endpoint for effekt.
Twelve-month persistent infection was evaluated as additional efficacy endpoint.
Fase III- forsøget (forsøg 008) inkluderede kvinder uden pre- screening for tilstedeværelsen af HPV - infektion, dvs. uden hensyntagen til cytologisk udgangspunkt, HPV- serologi og DNA- status.
The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i. e. regardless of baseline cytology and HPV serological and DNA status.