natgillin/translations-raw huggingface dataset:
Gardasil 9 (godkendt i juni 2015) anvendes på samme måde, men indeholder antigener svarende til 9 virustyper (type 6, 11, 16, 18, 31, 33, 45, 52 og 58).
Gardasil 9 (approved in June 2015) is used similarly but contains antigens for 9 types of the virus (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).
Indberetningerne efter HPV-vaccination svarer til det forventede i denne aldersgruppe
Reports after HPV vaccination consistent with what would be expected in this age group
Syndromerne vides at optræde i den almindelige befolkning, herunder unge, uafhængigt af vaccination.
The syndromes are recognised to occur in the general population, including adolescents, regardless of vaccination.
Det anslås, at over 63 mio. piger og kvinder verden over er vaccineret med Gardasil/Silgard Silgard, og 19 mio. med Cervarix.
It is estimated that more than 63 million girls and women worldwide have been vaccinated with Gardasil/Silgard and more than 19 million with Cervarix.
HPV-vacciner forventes at forebygge mange tilfælde af sådanne sygdomme.
HPV vaccines are expected to prevent many cases of such conditions.
Det indeholder antigener svarende til type 16 og 18 af virusset.
It contains antigens for types 16 and 18 of the virus.
De er beskrevet i den almindelige befolkning siden før HPV-vacciner kom på markedet.
They have been reported in the general population since before HPV vaccines became available.
• Der har været indberetninger om to symptomkomplekser, CRPS og POTS, hos piger, der har fået HPV-vaccine.
• There have been reports of two syndromes, CRPS and POTS, in girls who have been given HPV vaccines.
HPV-vacciner markedsføres i Den Europæiske Union under navnene Gardasil/Silgard, Gardasil 9 og Cervarix.
HPV vaccines are available in the European Union under the names Gardasil/Silgard, Gardasil 9, and Cervarix.
• Patienter med POTS (postural ortostatisk takykardisyndrom) udviser typisk unormale stigninger i hjertefrekvens, når de rejser sig op, uden ortostatisk hypotension.
• Patients with POTS (postural orthostatic tachycardia syndrome) typically show abnormal increases in heart rate on standing, without orthostatic hypotension.
Fordelene ved HPV-vacciner opvejer derfor fortsat de kendte bivirkninger.
The benefits of HPV vaccines therefore continue to outweigh the known side effects.
Det indeholder antigener (proteiner, der stimulerer til dannelse af antistoffer) mod fire typer HPV (type 6, 11, 16 og 18).
It contains antigens (proteins that help product antibodies) against 4 types of HPV (types 6, 11, 16 and 18).
PRAC's konstateringer blev overgivet til agenturets Udvalg for Lægemidler til Mennesker (CHMP) sammen med yderligere bidrag fra grupper af patienter.
The findings of the PRAC were passed to the Agency's Committee for Medicinal Products for Human Use (CHMP), along with further representations from patient groups.
Ovennævnte anbefalinger er baseret på analyser af data fra kliniske undersøgelser og data efter markedsføring og omfattede en gennemgang af publiceret litteratur, spontane indberetninger af formodede bivirkninger, rapporter fra medlemsstaterne samt oplysninger fra andre lande og oplysninger frivilligt indsendt af for offentligheden.
The above recommendations are based on analyses of clinical trial and post-marketing data and included review of published literature, spontaneous reports of suspected adverse effects, reports submitted by Member States as well as information from other countries, and information submitted voluntarily by the public.
• Rutineovervågning af formodede indberettede bivirkninger har givet anledning til spørgsmålet om en mulig sammenhæng mellem brugen af HPV-vacciner og to syndromer, CRPS og POTS.
• Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of HPV vaccines and two syndromes, CRPS and POTS.
Dette ledsages af symptomer (f.eks. svimmelhed, synkope, svaghed, hovedpine, kroniske smerter, gastrointestinale symptomer og træthed) som er forskellige mellem patienterne.
These are accompanied by symptoms (e.g. light-headedness, syncope, weakness, headaches, chronic aches and pains, gastrointestinal symptoms and fatigue) which differ between patients.
Gennemgangen medtog også tilfælde, der ikke var indberettet som CRPS og POTS, men hvor der var tegn og symptomer, der tydede på disse sygdomme.
The review took into account cases not reported as CRPS and POTS but with signs and symptoms suggestive of these conditions.
Disse syndromer er kendt for hos nogle piger at være langvarige og påvirke livskvaliteten svært.
It is recognised that in some affected girls these syndromes can be long lasting and severely impact quality of life.
Fordelene ved HPV-vacciner opvejer fortsat risiciene.
The benefits of HPV vaccines continue to outweigh their risks.
I overensstemmelse med sine oprindelige anbefalinger bekræftede EMA, at der ikke er dokumentation for en årsagssammenhæng mellem vaccinerne (Cervarix, Gardasil/Silgard og Gardasil 9) og CRPS eller POTS.
In line with its initial recommendations, EMA confirmed that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil 9) and development of CRPS or POTS.
Mange af de gennemgåede indberetninger havde kendetegn som ved CFS, og nogle patienter havde både diagnosen POTS og CFS.
Many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS.
• En nøje gennemgang af den foreliggende dokumentation har vist, at forekomsten af CRPS og POTS hos vaccinerede piger ikke er højere end forventet blandt piger i den almindelige befolkning (ca. 150 tilfælde af CRPS og mindst 150 af POTS pr. million om året), og at der ikke er dokumentation for, at vaccinerne kan udløse disse syndromer.
• A careful review looking at the available evidence has concluded that the occurrence of CRPS and POTS in vaccinated girls is no higher than would be expected in girls in the general population (around 150 cases of CRPS and at least 150 of POTS per million each year), and that there is no evidence that the vaccines can trigger these syndromes.
Ved gennemgangen fandtes intet bevis for, at den samlede forekomst af disse syndromer hos vaccinerede piger adskilte sig fra den forventede i denne aldersgruppe, heller ikke når man tager hensyn til eventuel underindberetning.
The review found no evidence that the overall occurrence of these syndromes in vaccinated girls were different from expected occurrence in these age groups, even taking into account possible underreporting.
Agenturets gennemgang omfattede både offentliggjort forskning, data fra kliniske undersøgelser og indberetninger om formodede bivirkninger fra patienter og sundhedspersonale foruden oplysninger fra medlemsstaterne.
The Agency's review included published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States.
• Symptomerne, navnlig ved POTS, kan overlappe med andre sygdomme såsom kronisk træthedssyndrom, og patienterne kan have en diagnose på både kronisk træthedssyndrom og POTS.
• Symptoms, in particular of POTS, may overlap with other conditions such as chronic fatigue syndrome, and patients may have a diagnosis of both chronic fatigue syndrome and POTS.
Symptomerne overlapper ofte andre sygdomme såsom kronisk træthedssyndrom.
Symptoms often overlap with other conditions such as chronic fatigue syndrome.
Udvalget anbefalede derfor ikke ændringer af betingelserne for markedsføringstilladelserne eller produktinformationen for disse lægemidler.
It therefore did not recommend any changes to the terms of licensing or the product information for these medicines.
Ved gennemgangen blev det bemærket, at nogle af symptomerne på disse syndromer kan ligne symptomerne ved kronisk træthedssyndrom (CFS, der også kendes som myalgisk encephalomyelitis eller ME).
The review noted that some symptoms of CRPS and POTS may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
• Ved gennemgangen fandtes ingen evidens for, at den samlede forekomst af disse syndromer hos vaccinerede piger er forskellig fra den forventede i aldersgruppen, også ved forskellige mulige scenarier for underindberetning og indberetninger, der ikke fuldt ud opfylder de diagnostiske kriterier for disse syndromer.
• The review found no evidence that the overall occurrence of these syndromes in vaccinated girls was different from that expected in these age groups, even taking into account a variety of possible scenarios for underreporting and reports that did not fully meet diagnostic criteria for these syndromes.
PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
• HPV (vortevirus eller humant papillomavirus) er en vigtig årsag til livmoderhalskræft og visse andre kræfttyper såsom kønsvorter.
• HPV (human papillomavirus) is a major cause of cancer of the cervix (neck of the womb) and some other cancers, as well as other conditions such as genital warts.
Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Der er derfor ingen grund til at ændre den måde, vaccinerne anvendes på, eller ændre den nuværende produktinformation.
Therefore there is no reason to change the way the vaccines are used or amend the current product information.
• CRPS (refleksdystrofi) defineres som vedholdende smerter, som er ude af proportioner med den udløsende hændelse (typisk et traume eller immobilisering af en ekstremitet), og som er forbundet med sensoriske, sudomotoriske, motoriske og dystrofiske ændringer.
• CRPS (chronic regional pain syndrome) is defined as continuing pain that is disproportionate to the inciting event (typically an episode of trauma or limb immobilisation), and is associated with sensory, sudomotor, motor and dystrophic changes.
Eftersom mange af indberetningerne har kendetegn svarende til kronisk træthedssyndrom, blev evidens bestående i en stor offentliggjort undersøgelse1, der ikke viste nogen sammenhæng mellem kronisk træthedssyndrom og HPV-vacciner, også anset for relevant.
Given that many reports have features of chronic fatigue syndrome, evidence including a large published study1 that showed no link between chronic fatigue syndrome and HPV vaccines was also considered relevant.
Anvendelsen af disse vacciner forventes at forebygge mange tilfælde af livmoderhalskræft (som er ansvarlig for over 20 000 dødsfald om året i Europa) og en række andre kræftformer og andre lidelser, der forårsages af HPV.
Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.
Den 19. november afsluttede EMA sin gennemgang af rapporterne med dokumentationen for to syndromer hos unge kvinder, der vaccineres mod humant papillomavirus (HPV): refleksdystrofi, der også kaldes komplekst regionalt smertesyndrom (CRPS), og postural ortostatisk takykardisyndrom (POTS).
On 19 November EMA completed its review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines.
• Der er derfor ingen anbefalinger om at ændre produktinformationen eller den måde, HPV-vacciner anvendes på.
• There are therefore no recommendations to amend the product information or to change the way HPV vaccines are used.
CHMP var enig i, at den foreliggende dokumentation ikke støtter, at HPV-vacciner er årsag til CRPS og POTS.
The CHMP concurred that the available evidence does not support that CRPS and POTS are caused by HPV vaccines.
Resultaterne af en stor offentliggjort undersøgelse viste ingen sammenhæng mellem HPV-vaccine og CFS.
Results of a large published study that showed no link between HPV vaccine and CFS were therefore particularly relevant.
Cervarix har været godkendt siden september 2007 til anvendelse hos kvinder og piger til beskyttelse mod forstadier til kræft, livmoderhalskræft og kræft omkring kønsdelene.
Cervarix has been approved since September 2007 for use in women and girls to protect against precancerous growths and cancer in the cervix and genital area.
Disse vacciner anvendes til at beskytte mod livmoderhalskræft og andre HPV-relaterede kræftformer og forstadier til kræft.
These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions.
I de foreliggende skøn anslås det imidlertid, at CRPS årligt udvikles hos omkring 150 piger og unge kvinder pr. million i alderen 10-19 i den almindelige befolkning, og at mindst 150 piger og unge kvinder om året udvikler POTS.
However, available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
Brug af disse vacciner forventes at forebygge mange tilfælde af livmoderhalskræft og en række andre kræftformer og lidelser forårsaget af HPV.
Use of these vaccines is expected to prevent many cases of cervical cancer as well as various other cancers and conditions caused by HPV.
Gardasil har været godkendt siden september 2006 og er godkendt til anvendelse hos mænd og kvinder til forebyggelse af forstadier til kræft, livmoderhalskræft og kræft i endetarmsåbningen
Gardasil has been authorised since September 2006, and is approved for use in males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts.
Udvalget baserede også sine anbefalinger på rådføring med en
In reaching its recommendations, it also consulted a group of leading experts in the field, and took into
• I de foreliggende skøn anslås der at forekomme 150 CRPS-tilfælde om året pr. million piger og unge kvinder i alderen 10-19 år i den almindelige befolkning, mens 150 piger og unge kvinder pr. million årligt kan udvikle POTS.
• Available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year and at least 150 girls and young women per million may develop POTS each year.
CRPS bevirker langvarige smerter i en arm eller et ben, og POTS er forbundet med en stigning i puls, når man rejser sig op, foruden andre symptomer såsom svimmelhed, svaghed, smerter, kvalme og træthed.
CRPS produces long-lasting pain affecting a limb, and POTS is associated with an increase in heart rate on standing up, together with various symptoms including dizziness, weakness, pain, feeling sick, and fatigue.
Refleksdystrofi (CRPS) er et kronisk smertesyndrom, der rammer et ben eller en arm, mens POTS er en sygdom, hvor pulsen stiger abnormt, når man sætter sig op eller rejser sig, og er ledsaget af symptomer såsom svimmelhed, besvimelsesanfald og svaghed foruden hovedpine, smerter, kvalme og træthed.
CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue.
Den indledende gennemgang blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) was responsible for the initial review.
• Der er derfor ingen anbefalinger om at ændre den måde, vaccinerne bruges på, og produktinformationen for vaccinerne er ikke ændret.
• There are therefore no recommendations to change the way in which the vaccines are used and no changes have been made to the prescribing information for these vaccines.
Diagnosen er derfor vanskelig, både i den almindelige befolkning og hos vaccinerede.
Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals.
Disse data er blevet indberettet på basis af over 400 mio. doser distribueret på verdensplan.
These data were reported based on more than 400 million doses distributed worldwide.
Eksponeringen blev estimeret til 171.000 spædbørn pr. år.
Exposure was estimated at 171,000 infants per year.
Dato for første markedsføringstilladelse: 11. maj 2006 Dato for seneste fornyelse: 11. maj 2011
Date of first authorisation: 11 May 2006 Date of latest renewal: 11 May 2011
• Gråd.
• Crying.
Intervallet mellem 2 doser bør være mindst 4 uger.
The interval between 2 doses should be at least 4 weeks.
Ikke-gravide teenagepiger og voksne kvinder
Non-pregnant adolescent and adult females
I 297 rapporter kunne et klart tidspunkt for indtræden fastsættes.
In 297 reports a clear time to onset could be determined.
Symptomerne kan varer ved i månedsvis eller i sjældne tilfælde årevis.
Symptoms may persist for a matter of months or on rare occasions for years.
71% af rapporterne (212 af 297) omhandlede gråd, hvor tiden til indtræden var mere end 24 timer.
71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours.
Selv hos ældre kvinder (35-45 år) tåles disse reaktioner generelt godt og påvirker sjældent normale aktiviteter.
Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Aktiv ubehandlet tuberkulose.
Active untreated tuberculosis.
Alle bivirkninger blev vurderet hos 1940 børn.
All adverse reactions were evaluated in 1940 children.
Anden dosis kan gives mindst 4 uger efter den første dosis i overensstemmelse med officielle anbefalinger.
A second dose may be administered at least 4 weeks after the first dose in accordance with official recommendation.
Vaccinen kan indeholde spor af rekombinant humant albumin (rHA).
The vaccine may contain traces of recombinant human albumin (rHA).
Vaccination skal udsættes under enhver sygdom med feber > 38,5° C.
Vaccination should be postponed during any illness with fever >38.5°C.
De fleste tilfælde af gråd forekom 6 til 10 dage efter vaccinationen.
The majority of the crying occurred 6 to 10 days after vaccination.
Ukendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data)*
Not known (Frequency cannot be estimated from the available data)*
Sikkerhedsprofilen efter dosis 1 og 2 var generelt sammenlignelig for alle aldersgrupper.
The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Den anden dosis er beregnet til personer, som af ukendt årsag ikke responderede på den første dosis.
The second dose is intended for individuals who did not respond to the first dose for any reason.
Udbredt anvendelse af et vaccinationsprogram med 2 doser i USA og lande såsom Finland og Sverige har resulteret i en reduktion af incidensen på >99 % for hver af de 3 målsygdomme.
Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Personer på 12 måneder eller ældre bør gives én dosis på en given dato.
Individuals 12 months or older should receive one dose at an elected date.
Personens serologiske status kan evalueres for at afgøre, hvorvidt yderligere doser af vaccinen er nødvendigt.
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Sådanne spædbørn bør revaccineres i 12-15-måneders alderen.
Such infants should be revaccinated at 12 to 15 months of age.
Der er ikke gennemført nogen ikke-kliniske undersøgelser.
Non-clinical studies have not been conducted.
M-M-RVAXPRO skal anvendes på basis af officielle anbefalinger.
M-M-RVAXPRO is to be used on the basis of official recommendations.
Serobeskyttelsesrater [95% CI]
Seroprotection rates [95% CI]
Aktuel immunsuppresiv behandling (herunder høje doser kortikosteroider).
Current immunosuppressive therapy (including high doses of corticosteroids).
Antistofferne medvirker til at beskytte mod infektioner forårsaget af disse vira.
The antibodies help protect against infections caused by these viruses.
Efter rekonstitution indeholder 1 dosis (0,5 ml):
After reconstitution, one dose (0.5 ml) contains:
Kvinder, der planlægger graviditet, bør rådes til at vente.
Women who intend to become pregnant should be advised to delay.
Effektivitet
Effectiveness
Rekonstitutionsvejledning tiltænkt læger og sundhedspersonale er medtaget sidst i indlægssedlen.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the package leaflet.
Denne vaccine indeholder en spormængde af neomycin.
This vaccine contains a trace amount of neomycin.
Denne latensperiode synes at korrespondere med tiden for indtræden af generel utilpashed, som ofte forekommer efter MFR-vaccination.
This latency period appears to correspond with the time to onset of general malaise that often occurs after the MMR vaccination.
Hvis vaccinen derimod gives få dage inden udsættelse for smitte, kan den give betydelig beskyttelse.
If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
• Irritabilitet.
• Irritability.
• Feber (38,5 °C eller derover).
• Fever (38.5°C or higher).
Hos unge piger synes reaktionerne at ligge midt imellem incidensen hos børn og voksne kvinder.
In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Efter vaccination af børn er reaktionerne i led generelt usædvanlige (0-3 %) og af kort varighed.
Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Nogle af disse tilfælde kan være en følge af ikke erkendte mæslinger i det første leveår eller eventuelt af mæslingevaccinationen.
Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Interaktion med laboratorieprøver: Se pkt.
Interference with laboratory tests: see section 4.5.
Vaccination af personer udsat for vildtypemæslinger kan give nogen beskyttelse, hvis vaccinen kan gives inden for 72 timer efter eksponering.
Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure.
Læs denne indlægsseddel grundigt, inden De eller Deres barn vaccineres, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Samtidig brug af andre vacciner
Use with other vaccines
• Patienter får blå mærker eller bløder lettere end normalt.
• Bruising or bleeding more easily than normal.
• Betændelse i retina (øjets nethinde) med ændringer af synet.
• Inflammation of the retina (in the eye) with changes in sight.
Den generelle sikkerhedsprofil var sammenlignelig for de to administrationsveje, selv om reaktioner på injektionsstedet var mindre hyppige i i.m.-gruppen (15,8 %) end i s.c.-gruppen (25,8 %).
The general safety profile of either administration routes were comparable, although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
[Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til ≤ 1/100), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)]