natgillin/translations-raw huggingface dataset:
Ledipasvir/sofosbuvirs virkning er ikke blevet undersøgt hos HCV-genotype 5- og 6-inficerede patienter med dekompenseret cirrose, og/eller som venter på levertransplantation eller har gennemgået en levertransplantation. 
Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated.
også kaldet ”E110”, før du tager denne medicin. 
before taking this medicine.
Det skal du vide, før du begynder at tage Harvoni Tag ikke Harvoni 
What you need to know before you take Harvoni
• Fortæl det til lægen, hvis du er overfølsom over for sunset yellow FCF aluminiumpigment, 
• Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110”
Resultat for patienter uden SVR Virologisk svigt under behandling Recidiv b 
Outcome for patients without SVR On-treatment virologic failure Relapse b
ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)d 
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Kan ikke fortolkes a. En patient i behandlingsarmen med 24 ugers LDV/SOF og en patient i behandlingsarmen med 24 ugers LDV/SOV+RBV havde oplevet svigt af en tidligere behandling med et non-pegyleret interferonbaseret regimen. 
a. One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon based regimen.
b. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up). 
b. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Tacrolimus (5 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis) 
Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)
Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ sofosbuvir (400 mg én gang dagligt) 
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Resultat for patienter uden SVR Virologisk svigt under behandling 
Outcome for patients without SVR On-treatment virologic failure
Lægemidler, der er potente P-gp-inducere (rifampicin, rifabutin, prikbladet perikon, carbamazepin, phenobarbital og phenytoin), kan nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og føre til en reduceret terapeutisk virkning af ledipasvir/sofosbuvir. 
Medicinal products that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Efter behandling med ledipasvir/sofosbuvir sammen med ribavirin i 12 uger hos patienter med dekompenseret sygdom (uanset levertransplantationsstatus) var der 3/7 patienter med NS5A-RAV ved baseline, der gav >100 gange nedsat følsomhed for ledipasvir, som recidiverede, sammenlignet med 4/68 af patienterne uden baseline-RAVs eller -RAVs, der gav ≤100 gange nedsat følsomhed for ledipasvir. 
Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in patients with decompensated disease (irrespective of liver transplantation status), 3/7 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir relapsed, as compared to 4/68 in those without any baseline RAVs or RAVs conferring ≤ 100-fold reduced susceptibility to ledipasvir.
Patienter, der venter på levertransplantation og efter levertransplantation - SOLAR-1 SOLAR-1 er et åbent, multicenterstudie, der evaluerer 12 og 24 ugers behandling med ledipasvir/sofosbuvir + ribavirin hos patienter med genotype 1 eller 4 CHC, der har fremskreden leversygdom og/eller som har gennemgået en levertransplantation. 
SOLAR-1 is an open-label, multicentre study evaluating 12 and 24 weeks of treatment with ledipasvir/sofosbuvir + ribavirin in patients with genotype 1 or 4 CHC who have advanced liver disease and/or who have undergone liver transplantation.
Tabel 13: Recidivrater for udvalgte undergrupper i studie ION-2 LDV/SOF 
Table 13: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Raltegravir (400 mg to gange dagligt)/ sofosbuvir (400 mg én gang dagligt)d 
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)
HIV ANTIVIRALE STOFFER: INTEGRASEHÆMMERE Raltegravir (400 mg to gange dagligt)/ ledipasvir (90 mg én gang dagligt)d 
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)
Harvoni indeholder sunset yellow FCF aluminiumpigment (E110) 
Harvoni contains sunset yellow FCF aluminium lake (E110)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 90 mg ledipasvir og 400 mg sofosbuvir. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis) 
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)
Indeholder lactose og sunset yellow FCF aluminiumpigment (E110). 
LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110).
skyldtes den systemiske eksponering næsten udelukkende udgangsstoffet (>98 %). 
Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
b. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling. 
b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Ændring i MELD-score (model for end stage liver disease): 53 % (72/135) og 21 % (28/135) havde hhv. en forbedring eller ingen ændring i MELD-score fra baseline til uge 4 efter behandlingen. 
Change in MELD score: 53% (72/135) and 21% (28/135) had an improvement or no change of MELD score from baseline to post-treatment week 4, respectively; of the 35 patients whose MELD score was ≥ 15 at baseline, 63% (22/35) had a MELD score < 15 at post-treatment week 12.
24 uger (n = 217) 
24 weeks (n = 217)
Tabel 10: Responsrater i ION-1-studiet LDV/SOF 
Table 10: Response rates in study ION-1 LDV/SOF
Harvoni + ribavirin i 24 uger (se pkt. 
Harvoni + ribavirin for 24 weeks (see sections 4.4 and 5.1).
Efter en enkelt 90 mg dosis af [14C]-ledipasvir hos raske personer, var forholdet af [14C]-radioaktivitet mellem blod og plasma fra 
After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [
a. Nævneren for recidiv er antallet af patienter med HCV-rna <LLOQ ved deres seneste vurdering under behandling. 
a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
↑ AUC 1,50 (1,42; 1,59) 
↑ Cmin 1.15 (0.90, 1.46)
Tabel 12: Responsrater i studie ION-2 LDV/SOF 
Table 12: Response rates in study ION-2 LDV/SOF
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. 
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.
Virkning og anvendelse 
Treatment and duration
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) 
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis) 
Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Median (interval)a 
Median (range)
12 uger (n = 217) 
12 weeks (n = 217)
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. 
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.
Recidiv b 
Relapse b
5.1 for detaljer om dette studie). 
(listed in section 6 of this leaflet).
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. 
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.
SVR Resultat for patienter uden SVR Virologisk svigt under behandling 
SVR Outcome for patients without SVR On-treatment virologic failure a
Harvoni er kontraindiceret sammen med rifabutin, en kraftig P-gp-inducer i tarmen (se pkt. 
Harvoni is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Harvoni er kontraindiceret sammen med rifampicin, en kraftig P-gp-inducer i tarmen (se pkt. 
Harvoni is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Når Harvoni anvendes i kombination med ribavirin, henvises også til produktresuméet for ribavirin for patienter med kreatininclearance (CrCl) <50 ml/min (se pkt. 
Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Famotidin (40 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis) 
H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)
0,51 til 0,66. 
C]-radioactivity ranged between 0.51 and 0.66.
In vitro data indikerer, at ledipasvir kan være en svag inducer af metaboliserende enzymer, såsom 
In vitro data indicate that ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1.
Emtricitabin ↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,05 (1,02; 1,08) ↔ Cmin 1,06 (0,97; 1,15) 
Emtricitabine ↔ Cmax 1.02 (0.96, 1.08) ↔ AUC 1.04 (1.00, 1.08) ↔ Cmin 1.03 (0.97, 1.10)
↑ Cmin 1,47 (1,38; 1,57) Ledipasvir ↑ Cmax 1,68 (1,54; 1,84) 
Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Abacavir/ lamivudin (600 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d 
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
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. 
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).
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 
HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)
Famotidin doseret sammen med Harvonid 
Omeprazole dosed simultaneously with Harvoni
GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22) IMMUNOSUPPRIMERENDE MIDLER Ciclosporin g 
GS-331007 ↓ Cmax 0.73 (0.65, 0.83) ↔ AUC 1.04 (0.89, 1.22)
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 
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)
Amning 
Pravastating
Stabile replikoner NS5B transitoriske replikoner 
NS5B transient replicons Median (range)
Tabel 7: Responsrater i ION-3-studiet LDV/SOV 
Table 7: Response rates in study ION-3 LDV/SOF
Atazanavir ↔ Cmax 1,07 (0,99; 1,14) 
Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
↑ Dabigatran ↔ Ledipasvir ↔ Sofosbuvir 
↑ Ledipasvir ↔ Sofosbuvir
Ledipasvir ↓ Cmax 0,65 (0,56; 0,76) ↓ AUC 0,41 (0,36; 0,48) 
Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Ledipasvir ↑ Cmax 1,81 (1,69; 2,94) ↑ AUC 1,92 (1,77; 2,07) 
Ledipasvir ↑ Cmax 1.81 (1.69, 2.94)
Ledipasvir ↑ Cmax 1,63 (1,51; 1,75) ↑ AUC 1,78 (1,64; 1,94) ↑ Cmin 1,91 (1,76; 2,08) 
Tenofovir ↑ Cmax 1.64 (1.54, 1.74) ↑ AUC 1.50 (1.42, 1.59) ↑ Cmin 1.59 (1.49, 1.70)
↔ AUC 1,09 (0,87; 1,37) 
↔ Cmin 1.07 (0.89, 1.28)
Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis) 
Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
↑ Cmin 1,63 (1,45; 1,84) Ritonavir ↔ Cmax 0,86 (0,79; 0,93) 
↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
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). 
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
↔ Cmin 1,08 (0,98; 1,20) Ritonavir ↔ Cmax 1,17 (1,01; 1,35) 
↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
↔ AUC 0,94 (0,67; 1,33) 
↔ Cmin 0.97 (0.86, 1.10)
Træthed 
Relapse
Sikkerheden af disse vacciner bør fortsat overvåges nøje. 
The safety of these vaccines should continue to be carefully monitored.
Størstedelen af indberetningerne om POTS kom fra et center i Danmark (Brinth et al, 2015)1. 
The vast majority of POTS reports came from a centre in Denmark (Brinth et al, 2015)1.
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. 
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.
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. 
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.
Disse syndromer er tidligere gentagne gange blevet gennemgået af PRAC. 
These syndromes have been subject to previous repeated review by PRAC.
• Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC) behandlede proceduren i henhold til artikel 20 af forordning (EF) nr. 726/2004 for HPV-vacciner 
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 20 of Regulation (EC) No 726/2004 for HPV vaccines.
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. 
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.
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. 
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.
Der blev ikke konstateret tilfælde i Cervarix- eller sammenligningsgruppen. 
No cases were identified in the Cervarix and comparator cohorts.
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.