natgillin/translations-raw huggingface dataset:
Da mange af indberetningerne omfattet af gennemgangen har kendetegn svarende til CFS, og da nogle patienter både havde diagnosen POTS og CFS, blev disse resultater anses for relevante for den aktuelle vurdering.
As many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS, these results were considered relevant for the current evaluation.
Brug af disse vacciner forventes at forebygge mange tilfælde af cervixcancer og forskellige andre cancerformer og sygdomme forårsaget af HPV.
Use of these vaccines is expected to prevent many cases of cervical cancer and various other cancers and conditions caused by HPV.
Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P. Bivalent human papillomavirusvaccine og risikoen for kronisk træthedssyndrom hos unge piger i Det Forenede Kongerige.
2 Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
PRAC bemærkede, at nogle symptomer på disse syndromer kan overlappe med kronisk træthedssyndrom (CFS, også kendt som myalgisk encephalomyelitis eller ME).
The PRAC noted that some symptoms of these syndromes may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
Dette er i overensstemm else med den rådgivende videnskabelige gruppes konklusioner om, at størstedelen af de gennemgåede rapporter om POTS bedre svarer til definitionen af CFS eller i det mindste har nogle af kendetegnene på CFS.
This is in accordance with the Scientific advisory group conclusions that most of the reviewed reports of POTS could better correspond to the definition of CFS or at least include some features of CFS.
Brinth, LS, Pors, K, Theibel, AC, Mehlsen, J.: Ortostatisk intolerance og postural takykardisyndrom som formodede bivirkninger af vaccination mod humant papillomavirus; Vaccine, 2015; 33(22):2602-5.
Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus; Vaccine, 2015; 33(22):2602-5.
Indsættende symptomer på CRPS er vanskelige at definere, da syndromet sædvanligvis først diagnosticeres fra det tidspunkt, hvor den normale helbredelse af det oprindelige traume skulle have fundet sted, og da det sædvanligvis først opdages på et senere tidspunkt hos personer med efterfølgende vedholdende smerter.
The onset of symptoms of CRPS is difficult to define because the syndrome is usually only diagnosed from the point when normal recovery from the initiating trauma should have occurred, and is usually only recognised sometime later among those with continuing pain afterwards.
• PRAC tog til efterretning, at CRPS og POTS forekommer i den almindelige ikke-vaccinerede befolkning og er beskrevet i den medicinske litteratur før indførelse af HPV-vacciner
• The PRAC took note of the fact that CRPS and POTS occur in the general unvaccinated population and have been described in the medical literature before HPV vaccines were introduced.
Centret har for nylig offentliggjort flere oplysninger om disse rapporter, som tyder på, at nogle af de pågældende personer sandsynligvis havde kronisk træthedssyndrom (CFS).
This centre has recently published more information on these reports, suggesting that some of these individuals were likely to have had chronic fatigue syndrome (CFS).
Ved gennemgangen fandtes intet bevis på, at den samlede forekomst af disse syndromer hos vaccinerede piger adskilte sig fra den forventede i disse aldersgrupper, selv når tages hensyn til eventuel underindberetning.
The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting.
CHMP noterede sig de anbefalinger til markedsføringstilladelsesindehaverne, der er fremsat af PRAC vedrørende fremtidig overvågning.
The CHMP noted the recommendations to the MAHs that had been made by the PRAC in terms of future monitoring.
POTS-patienter udviser typisk vedholdende takykardi i længere tid end 10 minutter, når de rejser sig op, og en stigning i hjertefrekvens til over 120 slag/min eller med ≥ 30 slag/min og hos børn og unge under i 19 år med ≥ 40 slag/min, uden ledsagende arteriel hypotension.
POTS patients typically show persistent tachycardia for more than 10 minutes upon standing, as well as an increase in heart rate to above 120 bpm or by ≥ 30bpm, and in children and juveniles below 19 years of age by ≥ 40bpm, without arterial hypotension.
Symptomerne på CRPS og POTS kan overlappe, hvilket vanskeliggør diagnosen både hos denalmindelige befolkning og hos vaccinerede personer.
Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals.
Den rådgivende ekspertgruppe konkluderede også, at de fleste indberetninger af CRPS omfattet af gennemgangen ikke syntes at opfylde de anerkendte diagnostiske kriterier for CRPS.
The SAG also concluded that most of the reports of CRPS under review did not appear to fulfil the established diagnostic criteria for CRPS.
I en undersøgelse udført af Donegan et al. (2013)2 med et design bestående af selvkontrollerede caseserier (hvilket omgår problemet med forskellig diagnostisk praksis hos vaccinerede og ikkevaccinerede) vurderedes CFS-diagnoser såvel som henvisninger fra almen praksis for endnu ikke diagnosticerede symptomer på kronisk træthed og udmattelse samt diagnoser af fibromyalgi, postviralt syndrom og neurasteni.
A study by Donegan and colleagues (2013)2, using self-controlled case series design (and therefore avoiding the issue of differential diagnostic practice in vaccinated and unvaccinated), evaluated diagnoses of CFS, as well as referrals from general practice for as yet undiagnosed symptoms of chronic fatigue and exhaustion, as well as diagnoses for fibromyalgia, post viral syndrome and neurasthenia.
CRPS defineres som vedholdende smerter, som er ude af proportioner med den udløsende hændelse, som kan være forbundet med dysautonome tegn og symptomer og som sædvanligvis er begrænset til en enkelt ekstremitet.
CRPS is defined as continuing pain that is disproportionate to the inciting event and may be associated with dysautonomic signs and symptoms and is usually confined to a single limb.
Der blev foretaget analyser af iagttagne kontra forventede antal spontane indberetninger, der dækkede en bred række scenarier bestående af underindberetning (fra 1 til 100 % indberetning) og medtagelse af indberetninger, der ikke fuldstændig opfyldte de diagnostiske kriterier for syndromet.
Analyses of observed versus expected number of spontaneous reports were undertaken, covering a wide range of scenarios regarding underreporting (from 1 - 100 % reporting) and including reports that did not fully meet the diagnostic criteria for the syndrome.
PRAC anmodede markedsføringstilladelsesindehaverne om data og analyser vedrørende CRPS og POTS fra kliniske forsøg og sikkerhedsdata efter markedsføring, og tog i betragtning en litteraturgennemgang, data fra EudraVigilance, rapporter indsendt af flere medlemsstater, herunder Danmark, og oplysninger fra Japan samt frivilligt indsendte oplysninger fra offentligheden.
The PRAC requested data and analyses from the MAHs regarding CRPS and POTS from clinical trials and post-marketing safety data, and took into account literature review, data from Eudravigilance, reports submitted by member states, including Denmark, as well as information from Japan and information submitted voluntarily by the public.
I gennemgangen af data fra kliniske forsøg blev der i alt inkluderet 60 594 personer for Gardasil/Silgard og Gardasil 9, og 42 047 personer for Cervarix.
In the review of clinical trial data a total of 60,594 subjects were included for Gardasil/Silgard and Gardasil 9 and 42,047 subjects for Cervarix.
CRPS følger typisk efter en traumeepisode, herunder håndledsfraktur, operation for karpaltunnelsyndrom eller immobilisering af ekstremiteten.
CRPS typically follows an episode of trauma including fracture of the wrist or carpal tunnel syndrome surgery, or immobilisation of the limb.
Heri indgik besvarelserne fra indehaverne af markedsføringstilladelse, den offentliggjorte litteratur, EudraVigilance-data og input fra den videnskabelige rådgivende gruppe vedrørende vacciner samt data indsendt af medlemsstaterne og oplysninger indsendt af offentligheden
This included the responses submitted by the marketing authorisation holders, published literature, Eudravigilance data, and the outcome of the Scientific advisory group (SAG) on vaccines as well as data submitted by member states and information submitted by the public.
Overordnet var forekomsten af disse syndromer hos vaccinerede piger sammenfaldende med den forventede forekomst hos disse aldersgrupper
Overall, in these analyses the rates of these syndromes in vaccinated girls were consistent with expected rates in these age groups.
Denne gruppes ekspertise blev suppleret med andre europæiske eksperter vedrørende disse symptomer og vedrørende neurologi, kardiologi og farmakoepidemiologi.
The advice of the Scientific advisory group (SAG) on vaccines was sought; the expertise of this group was supplemented with additional European experts on these syndromes and on neurology, cardiology and pharmacoepidemiology.
• PRAC tog i betragtning, at der gennem analyser af iagttagelser kontra det forventede var taget hensyn til en lang række scenarier med underindberetning og var medtaget indberetninger, der ikke fuldt ud opfylder de diagnostiske kriterier for syndromerne.
• The PRAC considered that the observed versus expected analyses took into account a wide range of scenarios regarding underreporting and included reports that did not fully meet the diagnostic criteria for the syndromes.
Ved rutinemæssig overvågning af indberetninger om formodede bivirkninger er der rejst spørgsmål om den potentielle sammenhæng mellem brug af vaccinerne og navnlig to syndromer, der henholdsvis betegnes refleksdystrofi (Complex regional pain syndrome (CRPS)) og posturalt ortostatisk takykardisyndrom (POTS).
Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of the vaccines and two syndromes in particular, which are known as Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
• PRAC tog desuden hensyn til, at mange af de gennemgåede indberetninger om POTS havde kendetegn tilfælles med kronisk træthedssyndrom (CFS).
• The PRAC also noted that many of the reviewed reports of POTS had features in common with chronic fatigue syndrome (CFS).
Ved undersøgelsen fandtes ingen sammenhæng mellem HPV-vaccine og nogen af de undersøgte sygdomme.
The study found no association between HPV vaccine and any of the conditions studied.
De foreliggende skøn anslår, at blandt en million piger og unge kvinder i den almindelige befolkning mellem 10 og 19 år kan 150 udvikle CRPS pr. år.
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.
Hertil hører opfølgning på indberetninger om CRPS eller POTS til fastlæggelse af de relevante kliniske karakteristika, udpegelse af mulige tilfælde af POTS og CRPS ved brede søgestrategier, herunder detaljer om udfald, og sammenholdelse af indberetningsfrekvenser med de foreliggende oplysninger om den kendte epidemiologi af POTS og CRPS.
This should include follow-up of CRPS or POTS reports to determine relevant clinical characteristics, to identify possible cases of POTS and CRPS based on broad search strategies including outcome details and to compare reporting rates against available information on the known epidemiology of POTS and CRPS.
Sammenholdelse af observerede kontra forventede antal spontane indberetninger med samme scenarier som beskrevet for CRPS tyder overordnet ikke på en øget forekomst af POTS i forbindelse med HPV-vacciner.
Overall, comparisons of observed versus expected number of spontaneous reports, with the same scenarios as described above for CRPS, do not suggest an increased occurrence of POTS in relation to the HPV vaccines.
Andre symptomer (fx synkope, træthed, hovedpine, svimmelhed, svedtendens, tremor, palpitationer, manglende evne til fysisk aktivitet, synkopelignende anfald, når man rejser sig) er forskellige for forskellige patienter og i øvrigt uspecifikke.
A diagnosis of POTS cannot solely rely on these criteria; other symptoms (e.g. syncope, fatigue, headaches, lightheadedness, diaphoresis, tremor, palpitations, exercise intolerance, near syncope upon standing upright) vary across patients and are otherwise non-specific.
Ud fra alle de foreliggende oplysninger konkluderede PRAC, at evidensen ikke støtter, at HPV-vacciner (Cervarix, Gardasil, Gardasil 9, Silgard) er årsag til CRPS eller POTS.
Taking into account the totality of the available information the PRAC concluded that the evidence does not support that HPV vaccines (Cervarix, Gardasil, Gardasil 9, Silgard) cause CRPS or POTS.
konkluderede udvalget efter at have gennemgået alle de foreliggende oplysninger, at evidensen ikke underbygger en årsagssammenhæng mellem HPV-vaccination og CRPS og/eller POTS.
The Committee, having considered all the information available, concluded that the evidence does not support a causal association between HPV vaccination and CRPS and/or POTS.
Der var enighed om vigtigheden af brede søgestrategier til at identificere mulige tilfælde af CRPS og POTS, og af løbende sammenholdelse af indberetningsfrekvensen med de foreliggende oplysninger om den kendte epidemiologi af CRPS og POTS.
It was agreed that employing broad search strategies to identify possible cases of CRPS and POTS and ongoing comparison of reporting rates against available information on the known epidemiology of CRPS and POTS is important.
Resultaterne af en stor publiceret undersøgelse2 viste ingen sammenhæng mellem HPV-vaccine og CFS.
The results of a large published study2 showed no link between HPV vaccine and CFS.
• PRAC gennemgik samtlige forelagte data vedrørende en mulig sammenhæng mellem HPVvaccination og forekomsten af refleksdystrofi (CRPS) og postural ortostatisk takykardisyndrom (POTS).
• The PRAC considered the totality of the data submitted with regard to a potential association between HPV vaccination and the occurrence of Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
CHMP fastslog som konsekvens heraf, at benefit/risk-forholdet for HPV-vacciner (Cervarix, Gardasil, Gardasil 9 og Silgard) fortsat er positivt, og anbefaler derfor opretholdelse af markedsføringstilladelserne.
The CHMP, as a consequence, considers that the benefit-risk balance of HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and therefore recommends the maintenance of the marketing authorisations.
Incidensen af POTS i de kliniske Gardasil/Silgard- og Gardasil 9-forsøg var mindre end ét tilfælde pr. 10 000 personår og sammenlignelig i Gardasil/Silgard- og Gardasil 9-gruppen og de tilsvarende placebogrupper.
The incidence of POTS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard/Gardasil 9 and corresponding placebo cohorts.
PRAC fastslog, at benefit/risk-forholdet for HPV-vacciner (Cervarix, Gardasil, Gardasil 9 og Silgard) fortsat er positivt og anbefaler opretholdelse af markedsføringstilladelserne.
The PRAC confirmed that the benefit-risk balance of the HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and recommends the maintenance of the marketing authorisations.
Desuden viste den detaljerede gennemgang af indberetningerne intet sammenhængende mønster i tid til indsætten efter vaccination, eller i kliniske kendetegn.
Furthermore, the detailed review of the reports did not show a consistent pattern regarding time-toonset (TTO) following vaccination or clinical characteristics.
Sammenholdelse af observerede kontra forventede antal spontane indberetninger tyder overordnet ikke på øget forekomst af CRPS i forbindelse med HPV-vaccinerne.
Overall, the comparisons of observed versus expected number of spontaneous reports do not suggest an increased occurrence of CRPS in relation to the HPV vaccines.
Desuden viste den detaljerede gennemgang af indberetningerne om CRPS intet sammenhængende mønster i tid til indsætten efter vaccination eller kliniske kendetegn.
Furthermore, the detailed review of the reports of CRPS did not show a consistent pattern regarding time-to-onset (TTO) following vaccination or clinical characteristics.
Incidensen af CRPS i de kliniske forsøg med Gardasil/Silgard og Gardasil 9 var mindre end ét tilfælde per 10 000 personår og sammenlignelig med incidensen i de tilsvarende placebogrupper.
The incidence of CRPS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard and Gardasil 9 and corresponding placebo cohorts.
I de foreliggende skøn anslås det imidlertid, at CRPS årligt udvikles hos omkring 150 piger og unge kvinder per million i alderen 10-19 år i den almindelige befolkning, og at mindst 150 piger og kvinder om året udvikler POTS.
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.
Overordnet støtter de foreliggende data ikke en kausal sammenhæng mellem HPV-vacciner og POTS.
Overall, available data do not provide support for a causal relation between HPV vaccines and POTS.
Overordnet støtter de foreliggende data ikke en kausal sammenhæng mellem HPV-vacciner og CRPS.
Overall, available data do not provide support for a causal association between HPV vaccines and CRPS.
En stor publiceret undersøgelse, der ikke viste sammenhæng mellem HPV-vaccine og CFS, blev derfor fundet relevant for denne gennemgang af PRAC
The PRAC therefore considered the results of a large published study which showed no link between HPV vaccine and CFS, as relevant for the current review.
POTS er et systemisk syndrom, som har været kendt i lang tid under forskellige navne, og som der stadig savnes indsigt i. De foreliggende skøn peger på, at mindst 150 piger og unge kvinder per million kan udvikle POTS per år.
POTS is a systemic syndrome which has been known for a long time under different names and is still poorly understood.
Lenvima fik en markedsføringstilladelse med gyldighed i hele EU den 28. maj 2015.
Lenvima received a marketing authorisation valid throughout the EU on 28 May 2015.
Yderligere information om Lenvima findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Lenvima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lægemidlet fås som kapsler (4 mg og 10 mg).
The medicine is available as capsules (4 mg and 10 mg).
Behandlingen fortsætter, så længe patienten har fordel af den uden for mange bivirkninger.
Treatment is continued as long as the patient continues to benefit from it without too many side effects.
Hvad er Lenvima, og hvad anvendes det til?
What is Lenvima and what is it used for?
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lenvima?
What measures are being taken to ensure the safe and effective use of Lenvima?
Som for alle lægemidler, er data vedrørende brug af Lenvima løbende overvåget.
As for all medicines, data on the use of Lenvima are continuously monitored.
Andre oplysninger om Lenvima
Other information about Lenvima
En oversigt over Lenvima og hvorfor det er godkendt i EU
An overview of Lenvima and why it is authorised in the EU
Hvorfor blev Lenvima godkendt i EU?
Why is Lenvima authorised in the EU?
Lenvima anvendes, når kræften er fremskreden eller har bredt sig lokalt eller til andre dele af kroppen og ikke reagerer på behandling med radioaktivt iod.
Lenvima is used when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine.
Ved at blokere disse enzymer kan lenvatinib standse dannelsen af nye blodkar og derved afskære kræftcellernes blodforsyning, der gør det muligt for dem at blive ved med at vokse.
By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth.
Lenvima må ikke anvendes af kvinder, der ammer.
Lenvima must not be taken by breastfeeding women.
Virkningen blev hovedsagelig målt på, hvor længe patienterne overlevede uden forværring af sygdommen: For de patienter, der fik Lenvima, var dette i gennemsnit 18,3 måneder sammenholdt med 3,6 måneder for dem, der fik placebo.
The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo.
Lenvima indeholder det aktive stof lenvatinib.
Lenvima contains the active substance lenvatinib.
Bivirkninger rapporteret for Lenvima vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Lenvima are carefully evaluated and any necessary action taken to protect patients.
Til behandling af hepatocellulært karcinom er den anbefalede daglige dosis enten 8 eller 12 mg, afhængigt af legemsvægten.
For treatment of hepatocellular carcinoma, the recommended daily dose is either 8 or 12 mg depending on bodyweight.
For mere information om brug af Lenvima, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
For more information about using Lenvima, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Lenvima opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Lenvima's benefits are greater than its risks and it can be authorised for use in the EU.
Lenvima udleveres kun efter recept, og behandlingen skal indledes og overvåges af en læge med erfaring i brug af kræftmedicin.
Lenvima can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Hvis der opstår bivirkninger, kan lægen beslutte at nedsætte dosis eller midlertidigt standse behandlingen.
To manage side effects, the doctor may decide to reduce the dose or stop treatment temporarily.
Patienter, der fik Lenvima, levede i gennemsnit 13,6 måneder sammenholdt med 12,3 måneder for dem, der fik sorafenib.
Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib.
Lenvima er et kræftlægemiddel, der anvendes som enebehandling til:
Lenvima is a cancer medicine used on its own to treat:
Det aktive stof i Lenvima, lenvatinib, er en "tyrosinkinasehæmmer".
The active substance in Lenvima, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Hvad sikkerheden angår, fandt agenturet, at størstedelen af bivirkningerne ved Lenvima kan håndteres tilfredsstillende ved at nedsætte dosis eller holde pause i behandlingen.
Regarding safety, the Agency considered that the majority of adverse effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment.
Hvilke risici er der forbundet med Lenvima?
What are the risks associated with Lenvima?