FrancophonIA/ELRC3.0 huggingface dataset:
English: After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [
Danish: Efter en enkelt 90 mg dosis af [14C]-ledipasvir hos raske personer, var forholdet af [14C]-radioaktivitet mellem blod og plasma fra
English: a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: a. Nævneren for recidiv er antallet af patienter med HCV-rna <LLOQ ved deres seneste vurdering under behandling.
English: ↑ Cmin 1.15 (0.90, 1.46)
Danish: ↑ AUC 1,50 (1,42; 1,59)
English: Table 12: Response rates in study ION-2 LDV/SOF
Danish: Tabel 12: Responsrater i studie ION-2 LDV/SOF
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in post-liver transplant patients with compensated liver disease (SOLAR-1), none (n = 8) of the patients with baseline NS5A RAVs conferring a ledipasvir fold-change of > 100 relapsed.
Danish: Efter behandling med ledipasvir/sofosbuvir sammen med ribavirin i 12 uger hos levertransplanterede patienter med kompenseret leversygdom (SOLAR-1) var der ikke nogen (n = 8) af patienterne med NS5A-RAVs ved baseline, der gav >100 gange nedsat følsomhed for ledipasvir, som recidiverede.
English: Treatment and duration
Danish: Virkning og anvendelse
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Danish: Elvitegravir/ cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat (150 mg/ 150 mg/ 200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Danish: H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)
English: Median (range)
Danish: Median (interval)a
English: 12 weeks (n = 217)
Danish: 12 uger (n = 217)
English: In these healthy volunteer studies, there were no untoward effects observed at these dose levels, and adverse reactions were similar in frequency and severity to those reported in the placebo groups.
Danish: Den højeste dokumenterede dosis af ledipasvir og sofosbuvir var hhv. 120 mg to gange dagligt i 10 dage, og en enkeltdosis på 1.200 mg. I disse studier med raske frivillige blev der ikke dokumenteret nogen uønskede virkninger ved disse dosisniveauer, og bivirkningerne var sammenlignelige med hensyn til hyppighed og sværhedsgrad med dem, der blev rapporteret i placebogrupperne.
English: Relapse b
Danish: Recidiv b
English: (listed in section 6 of this leaflet).
Danish: 5.1 for detaljer om dette studie).
English: Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12.
Danish: Ændring i CPT: 59 % (79/133) og 34 % (45/133) havde hhv. en forbedring eller ingen ændring af CPT-scores fra baseline til uge 12 efter behandlingen.
English: SVR Outcome for patients without SVR On-treatment virologic failure a
Danish: SVR Resultat for patienter uden SVR Virologisk svigt under behandling
English: Harvoni is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med rifabutin, en kraftig P-gp-inducer i tarmen (se pkt.
English: Harvoni is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med rifampicin, en kraftig P-gp-inducer i tarmen (se pkt.
English: Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Danish: Når Harvoni anvendes i kombination med ribavirin, henvises også til produktresuméet for ribavirin for patienter med kreatininclearance (CrCl) <50 ml/min (se pkt.
English: H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)
Danish: Famotidin (40 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis)
English: C]-radioactivity ranged between 0.51 and 0.66.
Danish: 0,51 til 0,66.
English: In vitro data indicate that ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1.
Danish: In vitro data indikerer, at ledipasvir kan være en svag inducer af metaboliserende enzymer, såsom
English: Emtricitabine ↔ Cmax 1.02 (0.96, 1.08) ↔ AUC 1.04 (1.00, 1.08) ↔ Cmin 1.03 (0.97, 1.10)
Danish: Emtricitabin ↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,05 (1,02; 1,08) ↔ Cmin 1,06 (0,97; 1,15)
English: Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Danish: ↑ Cmin 1,47 (1,38; 1,57) Ledipasvir ↑ Cmax 1,68 (1,54; 1,84)
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Danish: Abacavir/ lamivudin (600 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Danish: Samtidig administration af lægemidler, der er potente P-glykoprotein (P-gp)-inducere i tarmen (rifampicin, rifabutin, perikon [Hypericum perforatum], carbamazepin, phenobarbital og phenytoin) vil nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og kan medføre manglende virkning af Harvoni (se pkt.
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)
Danish: HIV ANTIVIRALE STOFFER: HIV PROTEASEHÆMMERE Atazanavir boostet med ritonavir (300 mg/ 100 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: Omeprazole dosed simultaneously with Harvoni
Danish: Famotidin doseret sammen med Harvonid
English: GS-331007 ↓ Cmax 0.73 (0.65, 0.83) ↔ AUC 1.04 (0.89, 1.22)
Danish: GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22) IMMUNOSUPPRIMERENDE MIDLER Ciclosporin g
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)
Danish: HIV ANTIVIRALE STOFFER: REVERS TRANSKRIPTASEHÆMMERE Efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat (600 mg/ 200 mg/ 300 mg/ én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: Pravastating
Danish: Amning
English: NS5B transient replicons Median (range)
Danish: Stabile replikoner NS5B transitoriske replikoner
English: Table 7: Response rates in study ION-3 LDV/SOF
Danish: Tabel 7: Responsrater i ION-3-studiet LDV/SOV
English: Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Danish: Atazanavir ↔ Cmax 1,07 (0,99; 1,14)
English: ↑ Ledipasvir ↔ Sofosbuvir
Danish: ↑ Dabigatran ↔ Ledipasvir ↔ Sofosbuvir
English: Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Danish: Ledipasvir ↓ Cmax 0,65 (0,56; 0,76) ↓ AUC 0,41 (0,36; 0,48)
English: Ledipasvir ↑ Cmax 1.81 (1.69, 2.94)
Danish: Ledipasvir ↑ Cmax 1,81 (1,69; 2,94) ↑ AUC 1,92 (1,77; 2,07)
English: Tenofovir ↑ Cmax 1.64 (1.54, 1.74) ↑ AUC 1.50 (1.42, 1.59) ↑ Cmin 1.59 (1.49, 1.70)
Danish: Ledipasvir ↑ Cmax 1,63 (1,51; 1,75) ↑ AUC 1,78 (1,64; 1,94) ↑ Cmin 1,91 (1,76; 2,08)
English: ↔ Cmin 1.07 (0.89, 1.28)
Danish: ↔ AUC 1,09 (0,87; 1,37)
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Danish: Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)
English: ↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Danish: ↑ Cmin 1,63 (1,45; 1,84) Ritonavir ↔ Cmax 0,86 (0,79; 0,93)
English: ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC
Danish: Behandlingsnaive voksne med eller uden cirrose - ION-1 (studie 0102) - genotype 1 ION-1 var et randomiseret, åbent studie der undersøgte 12 og 24 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin hos 865 behandlingsnaive patienter med CHC foråsaget af infektion med HCV af genotype 1, herunder patienter med cirrose (randomiseret 1:1:1:1).
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Danish: ↔ Cmin 1,08 (0,98; 1,20) Ritonavir ↔ Cmax 1,17 (1,01; 1,35)
English: ↔ Cmin 0.97 (0.86, 1.10)
Danish: ↔ AUC 0,94 (0,67; 1,33)
English: Relapse
Danish: Træthed
English: The safety of these vaccines should continue to be carefully monitored.
Danish: Sikkerheden af disse vacciner bør fortsat overvåges nøje.
English: The vast majority of POTS reports came from a centre in Denmark (Brinth et al, 2015)1.
Danish: Størstedelen af indberetningerne om POTS kom fra et center i Danmark (Brinth et al, 2015)1.
English: More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination.
Danish: Over 80 mio. piger og kvinder verden over har nu fået disse vacciner, som i nogle europæiske lande er blevet givet hos 90 % af den aldersgruppe, som vaccination anbefales for.
English: On 09 July 2015 the European Commission therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the EMA to assess these concerns.
Danish: Den 9. juli 2015 iværksatte Europa-Kommissionen derfor en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004 som et resultat af lægemiddelovervågningsdata, og anmodede EMA om at vurdere disse betænkeligheder.
English: These syndromes have been subject to previous repeated review by PRAC.
Danish: Disse syndromer er tidligere gentagne gange blevet gennemgået af PRAC.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 20 of Regulation (EC) No 726/2004 for HPV vaccines.
Danish: • Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC) behandlede proceduren i henhold til artikel 20 af forordning (EF) nr. 726/2004 for HPV-vacciner
English: In this respect, the CHMP commented that these comparisons should take into account likely increasing awareness of these syndromes to ensure appropriate interpretation of emerging data.
Danish: I denne forbindelse kommenterede CHMP, at man ved sådanne sammenholdelser bør tage den formentlig stigende viden om disse syndromer i betragtning for at sikre korrekt fortolkning af nye data.
English: Human papillomavirus (HPV) vaccines have been authorised in the European Union since 2006 for the prevention of cervical and various other cancers caused by HPV infection.
Danish: Vacciner mod humant papillomavirus (HPV) har været godkendt i EU siden 2006 til forebyggelse af cervixcancer og forskellige andre cancerformer, der skyldes infektion med HPV.
English: No cases were identified in the Cervarix and comparator cohorts.
Danish: Der blev ikke konstateret tilfælde i Cervarix- eller sammenligningsgruppen.
English: 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.
Danish: 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.
English: Use of these vaccines is expected to prevent many cases of cervical cancer and various other cancers and conditions caused by HPV.
Danish: Brug af disse vacciner forventes at forebygge mange tilfælde af cervixcancer og forskellige andre cancerformer og sygdomme forårsaget af HPV.
English: 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.
Danish: 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.
English: The PRAC noted that some symptoms of these syndromes may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
Danish: PRAC bemærkede, at nogle symptomer på disse syndromer kan overlappe med kronisk træthedssyndrom (CFS, også kendt som myalgisk encephalomyelitis eller ME).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: • 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.
Danish: • 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
English: 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).
Danish: Centret har for nylig offentliggjort flere oplysninger om disse rapporter, som tyder på, at nogle af de pågældende personer sandsynligvis havde kronisk træthedssyndrom (CFS).
English: 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.
Danish: 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.
English: The CHMP noted the recommendations to the MAHs that had been made by the PRAC in terms of future monitoring.
Danish: CHMP noterede sig de anbefalinger til markedsføringstilladelsesindehaverne, der er fremsat af PRAC vedrørende fremtidig overvågning.
English: 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.
Danish: 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.
English: Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals.
Danish: Symptomerne på CRPS og POTS kan overlappe, hvilket vanskeliggør diagnosen både hos denalmindelige befolkning og hos vaccinerede personer.
English: The SAG also concluded that most of the reports of CRPS under review did not appear to fulfil the established diagnostic criteria for CRPS.
Danish: Den rådgivende ekspertgruppe konkluderede også, at de fleste indberetninger af CRPS omfattet af gennemgangen ikke syntes at opfylde de anerkendte diagnostiske kriterier for CRPS.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: CRPS typically follows an episode of trauma including fracture of the wrist or carpal tunnel syndrome surgery, or immobilisation of the limb.
Danish: CRPS følger typisk efter en traumeepisode, herunder håndledsfraktur, operation for karpaltunnelsyndrom eller immobilisering af ekstremiteten.
English: 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.
Danish: 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
English: Overall, in these analyses the rates of these syndromes in vaccinated girls were consistent with expected rates in these age groups.
Danish: Overordnet var forekomsten af disse syndromer hos vaccinerede piger sammenfaldende med den forventede forekomst hos disse aldersgrupper
English: 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.
Danish: Denne gruppes ekspertise blev suppleret med andre europæiske eksperter vedrørende disse symptomer og vedrørende neurologi, kardiologi og farmakoepidemiologi.
English: • 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.
Danish: • 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.
English: 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).
Danish: 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).
English: • The PRAC also noted that many of the reviewed reports of POTS had features in common with chronic fatigue syndrome (CFS).
Danish: • PRAC tog desuden hensyn til, at mange af de gennemgåede indberetninger om POTS havde kendetegn tilfælles med kronisk træthedssyndrom (CFS).
English: The study found no association between HPV vaccine and any of the conditions studied.
Danish: Ved undersøgelsen fandtes ingen sammenhæng mellem HPV-vaccine og nogen af de undersøgte sygdomme.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.