FrancophonIA/ELRC3.0 huggingface dataset:
English: If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Danish: Hvis der er tvivl om kvindens eventuelle graviditet (hvis kvinden ikke har fået menstruation, hvis menstruationen er meget uregelmæssig osv.), skal der tilbydes alternative teknikker, hvor der ikke anvendes ioniserende stråling (hvis alternativer findes).
English: Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Danish: Din læge og den nuklearmedicinske læge har vurderet, at fordelene ved denne undersøgelse med det radioaktive lægemiddel opvejer risikoen ved at blive udsat for stråling.
English: Review of images should be primarily in the transaxial orientation with access as needed to the sagittal and coronal planes.
Danish: Billederne bør primært gennemgås i transaksial retning med adgang til det sagittale og koronale plan efter behov.
English: Due to the small quantity of florbetapir (18F) in each dose, overdose is not expected to result in pharmacological effects.
Danish: Grundet den lille mængde florbetapir (18F) i hver enkelt dosis, forventes en overdosering ikke at medføre farmakologiske effekter.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Danish: Procedurer med radionuklider udført på gravide kvinder, indebærer ligeledes, at fostret udsættes for en stråledosis.
English: In all 59 subjects, a blinded PET reading by 5 nuclear medicine physicians resulted in a majority read sensitivity of 92% (95% CI: 78-98%) and specificity of 100% (95% CI: 80-100%).
Danish: Hos samtlige 59 forsøgspersoner resulterede en blindet PET-tolkning udført af 5 nuklearmedicinske læger i en flertalssensitivitet på 92 % (95 % CI: 78-98 %) og en specificitet på 100 % (95 % CI: 80-100 %).
English: This is the most common appearance of a positive scan; or b) One or more areas in which grey matter activity is intense and clearly exceeds activity in adjacent white matter.
Danish: Dette er den mest almindelige positive scanning; eller b) Et eller flere områder, hvor aktiviteten i den grå substans er intens og tydeligt overstiger aktiviteten i den tilstødende hvide substans.
English: Left to right panels show sagittal, coronal, and transverse PET image slices.
Danish: Fra venstre mod højre viser panelerne sagittale, koronale og transverse PET-billedsnit.
English: Amyvid, along with other brain function tests, may help your doctor find the reason for your memory problems.
Danish: Amyvid kan, sammen med andre hjernefunktionstest, hjælpe din læge med at finde årsagen til dine hukommelsesproblemer.
English: Animal toxicology and safety pharmacology
Danish: Dyretoksikologi og sikkerhedsfarmakologi
English: The average cortical to cerebellar SUVR values in AD patients show continual substantial increases from time zero through 30 minutes post-administration, with only small changes thereafter up to 90 minutes post-injection.
Danish: De gennemsnitlige kortikale til cerebellære SUVR-værdier hos ADpatienter viser kontinuerlige, væsentlige stigninger fra nulpunktet til 30 minutter efter administration med kun små ændringer derefter, indtil 90 minutter efter injektion.
English: No differences in SUVR results were noted in subjects taking common AD treatments relative to those not taking AD treatments.
Danish: Der blev ikke observeret nogen forskelle i SUVR-resultaterne for forsøgspersoner, der fik almindelig AD-behandling, i forhold til de der ikke fik AD-behandling.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Danish: Dette lægemiddel er et radioaktivt lægemiddel udelukkende til diagnostisk brug.
English: Method of preparation The package must be checked before use and the activity measured using an activimeter.
Danish: Pakningen skal kontrolleres før brug og aktiviteten måles ved hjælp af en radioaktivitetsmåler.
English: Adjunctive use of quantitative information for image interpretation:
Danish: Supplerende brug af kvantitative data i forbindelse med billedtolkning:
English: Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blur, which could lead to interpretation errors.
Danish: Visse scanninger kan være vanskelige at tolke på grund af billedstøj, atrofi med svind i hjernebarken eller sløret billede, hvilket kan medføre fejl i tolkningen.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Danish: Radioaktive lægemidler må udelukkende modtages, anvendes og administreres af autoriserede personer i dertil beregnede kliniske miljøer.
English: Amyvid must not be used - if you are allergic to florbetapir (18F) or any of the other ingredients of this medicine (listed in section 6).
Danish: Amyvid må ikke bruges - hvis du er allergisk over for florbetapir (18F) eller et af de øvrige indholdsstoffer i dette lægemiddel (anført i afsnit 6).
English: The cerebellum region should be examined to confirm the fit of the ROI and the level of grey/white contrast, which provides a standard for visual comparison to cortex.
Danish: Cerebellumregionen skal undersøges for at verificere tilpasningen af ROI'en og niveauet af grå/hvid kontrast, hvilket giver en standard for visuel sammenligning med cortex.
English: Agreement with baseline diagnosis of clinical AD
Danish: Overensstemmelse med baseline diagnosen klinisk AD
English: Some accumulation/excretion is also observed in the urinary bladder.
Danish: Der ses ydermere en vis akkumulation/udskillelse i urinblæren.
English: Fluorine (18F) decays to stable oxygen (18O) with a half-life of approximately 110 minutes by emitting a positron radiation of 634 keV, followed by photonic annihilation radiation of 511 keV.
Danish: Fluor (18F) henfalder til en stabil ilt-isotop (18O) med en halveringstid på ca. 110 minutter ved at udsende en positronstråling på 634 keV, efterfulgt af foton-annihileringsstråling på 511 keV.
English: The reason for this uptake is unknown, but may be due to accumulation of florbetapir (18F) or to any of its radioactive metabolites or to blood radioactivity.
Danish: Årsagen til dette optag kendes ikke, men kan skyldes akkumulation af florbetapir (18F) eller dets radioaktive metabolitter, eller radioaktivitet i blodet.
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology
Danish: • Gennemgang af kriterier for aflæsning af PET-billeder, herunder metoden for billedgennemgang, tolkningskriterier samt billeder, der demonstrerer den binære aflæsningsmetodologi.
English: The following side effects of Amyvid are uncommon (may affect up to 1 in 100 people): - feeling sick, - altered taste, - flushing, - itching, - rash, bleeding or pain where the injection is given or rash in other places.
Danish: Følgende bivirkninger er ikke almindelige (kan forekomme hos op til 1 ud af 100 behandlede): - kvalme, - ændret smag i munden, - rødme, - kløe, - udslæt, blødning eller smerter på injektionsstedet eller udslæt andre steder.
English: Readers should visually interpret the scan, then perform quantitation according to manufacturer's instructions, including quality checks of the quantitative process, and compare quantitation of scan with typical ranges for negative and positive scans.
Danish: Scanningen bør tolkes visuelt, hvorefter der udføres kvantificering i henhold til producentens anvisninger, inklusiv kvalitetskontroller af kvantificeringsprocessen, og en sammenligning af kvantificeringen med typiske områder for negative og positive scanninger.
English: The potential toxicity of 28 days of repeated intravenous injections of florbetapir was tested in rats and dogs, and the NOAEL was found to be at least 25 times the maximum human dose.
Danish: Ved test af den potentielle toksicitet ved gentagne intravenøse injektioner af florbetapir i 28 dage hos rotter og hunde fandt man, at NOAEL var mindst 25 gange større end den maksimale humane dosis.
English: It should be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Danish: Det skal tages i betragtning hos gravide og ammende kvinder samt høj-risiko grupper såsom patienter med leversygdom eller epilepsi.
English: Red marrow
Danish: Rød marv
English: Amyvid contains ethanol and sodium
Danish: Amyvid indeholder ethanol og natrium
English: Fertility No studies on fertility have been performed.
Danish: Fertilitet Der foreligger ingen data vedrørende fertilitet.
English: Interpretation of the image as negative or positive is made by visually comparing the activity in cortical grey matter with activity in adjacent white matter (see Figure 1).
Danish: Tolkning af billedet som negativt eller positivt udføres ved visuelt at sammenligne aktiviteten i den kortikale grå substans med aktiviteten i den tilstødende hvide substans (se Figur 1).
English: This amount may be harmful for those suffering from alcoholism, and should be taken into account in pregnant and breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Danish: Denne mængde kan være skadelig for personer, der lider af alkoholisme, og skal tages med i betragtning hos gravide og ammende kvinder, samt ved højrisiko-grupper såsom patienter med leversygdom eller epilepsi.
English: Method of administration Amyvid is for intravenous use and multidose use.
Danish: Administration Amyvid er kun til intravenøs brug og flerdosisbrug.
English: The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Danish: Den nuklearmedicinske læge vil kun indgive dette lægemiddel til gravide, hvis de forventede fordele opvejer risici.
English: It is hypothesised that slower clearance of the radiopharmaceutical may contribute to white matter retention since regional cerebral blood flow in white matter is less than half of that of cortex.
Danish: Hypotesen er, at en langsommere clearance af det radioaktive lægemiddel kan bidrage til retentionen i den hvide substans, idet den regionale cerebrale blodperfusion i den hvide substans er mindre en halvt så stor som den kortikale.
English: A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer's disease, Lewy body dementia, Parkinson's disease dementia).
Danish: En positiv scanning er ikke nok til at stille diagnosen AD eller andre kognitive sygdomme, idet neuritiske plak-aflejringer i den grå substans kan forekomme hos asymptomatiske ældre mennesker og ved visse neurodegenerative demens-sygdomme (Alzheimers sygdom, Lewy body demens, Parkinsons sygdom).
English: Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Danish: Inden radioaktive lægemidler administreres til en mor, der ammer, skal det overvejes, om administration af radionuklid kan udsættes, indtil moderen er ophørt med at amme, og hvilket radioaktivt lægemiddel, der er bedst egnet, idet der tages højde for aktivitetsudskillelsen i brystmælk.
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Danish: Når man har til hensigt at administrere radioaktive lægemidler til en kvinde i den fertile alder, er det vigtigt at fastslå, hvorvidt kvinden er gravid.
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radioaktive lægemidler bør behandles af brugeren på en måde, som tilfredsstiller både strålehygiejne og farmaceutiske kvalitetskrav.
English: Using non-AD cases (cognitively normal & MCI)
Danish: Kun non-AD tilfælde indgik (kognitiv normal & MCI)
English: If you have been given more Amyvid than you should An overdose is unlikely because you will only receive a single dose of Amyvid precisely controlled by the nuclear medicine doctor supervising the procedure.
Danish: En overdosis er usandsynlig, fordi du kun vil få en enkelt dosis Amyvid nøje kontrolleret af den ansvarlige nuklearmedicinske læge.
English: Using non-MCI cases (cognitively normal & clinical AD)
Danish: Kun non-MCI tilfælde indgik (kognitiv normal & klinisk AD)
English: If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded.
Danish: Hvis administration anses for nødvendig, skal amningen afbrydes i 24 timer og den udpumpede mælk kasseres.
English: A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Danish: En negativ scanning viser sparsom eller ingen densitet af kortikale β-amyloidplak.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Amyvid is marketed, at launch and after launch, all physicians who are expected to use Amyvid have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
Danish: Efter diskussion og aftale med den nationale myndighed i hvert medlemsland, hvor Amyvid markedsføres, skal indehaveren af markedsføringstilladelsen før og efter markedsføring sikre, at alle læger, som forventes at anvende Amyvid, har adgang til undervisningsmateriale, for at sikre præcis og pålidelig tolkning af PET-billederne.
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities (i.e. genetic diseases).
Danish: Dette radioaktive lægemiddel afgiver små mængder af ioniserende stråling, der er forbundet med den laveste risiko for cancer og arvelige misdannelser (f.eks. genetiske lidelser).
English: For an administered activity of 370 MBq the typical radiation dose to the target organ (brain) is 3.7 mGy.
Danish: Ved en administreret aktivitet på 370 MBq er den typiske stråledosis til målorganet (hjernen) 3,7 mGy.
English: Regional analyses show slightly higher levels of retention in the caudate, putamen and hippocampus.
Danish: Regionale analyser viser en anelse højere grad af retention i nucleus caudatus, putamen og hippocampus.
English: Amyvid is given to adults with memory problems so that doctors can perform a type of brain scan, called a PET scan.
Danish: Amyvid gives til voksne med hukommelsesproblemer, så læger kan foretage den type hjernescanning, som kaldes en PET-scanning.
English: Participating readers first evaluated a set of 96 PET scans, including 46 scans with autopsy standard of truth, using the visual qualitative read method to establish a baseline and were subsequently asked to re-evaluate the same set of scans with or without access to quantitative software information.
Danish: De deltagende radiologer evaluerede først et sæt bestående af 96 PET-scanninger, inklusive 46 scanninger med obduktion som faktisk bedømmelsesgrundlag, ved brug af den visuelle kvalitative aflæsningsmetode for at fastlægge en baseline, hvorefter de blev bedt om at evaluere samme sæt af scanninger igen med eller uden adgang til kvantitative softwaredata.
English: An Amyvid PET scan can help your doctor determine whether or not you may have β-amyloid plaques in your brain.
Danish: En Amyvid PET-scanning kan hjælpe lægen med at afklare, om du har β-amyloidplak i hjernen.
English: In this assay, florbetapir did not increase the number of micronucleated polychromatic erythrocytes at the highest achievable dose level, 372 µg/kg/day, when given twice daily for 3 consecutive days.
Danish: I denne analyse forøgede florbetapir ikke antallet af mikronucleerede polykromatiske erytrocytter ved det højest opnåelige dosisniveau, 372 µg/kg/dag, ved administration to gange dagligt i 3 på hinanden følgende dage.
English: Negative scans have more activity in white matter than in grey matter, creating clear grey-white contrast.
Danish: Negative scanninger har større aktivitet i den hvide substans end i den grå substans, hvilket danner en tydelig grå-hvid kontrast.
English: Potential in vivo genotoxicity of florbetapir was evaluated in a rat micronucleus study.
Danish: Florbetapirs potentielle in vivo-genotoksicitet blev vurderet i et mikronukleusstudie med rotter.
English: Injection of florbetapir (18F) through a short intravenous catheter (approximately 4 cm or less) minimises the potential for adsorption of the active substance to the catheter.
Danish: Injektion af florbetapir (18F) gennem et kort intravenøst kateder (ca. 4 mm eller kortere) minimerer risikoen for adsorption af det aktive stof til katederet.
English: Total body
Danish: Hele kroppen
English: Any unused material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt materiale skal bortskaffes i henhold til lokale retningslinjer.
English: Sensitivity of Amyvid scan to show the MCI conversion rate to AD in 9 converters was 66.7% (95% CI: 35-88%), specificity in 38 non-converters was 71.0% (95% CI: 55-83%) and positive likelihood ratio was 2.31 (95% CI: 1.2-4.5).
Danish: Amyvid-scanningens sensitivitet for at vise MCI-konversionsraten til AD i 9 konverterede patienter var 66,7 % (95 % CI: 35-88 %), specificiteten i 38 ikke-konverterede patienter var 71,0 % (95 % CI: 55 - 83 %), og den positive sandsynlighedsratio var 2,31 (95 % CI: 1,2 - 4,5).
English: The residual 18F in circulation during the 30-90 minute imaging window is principally in the form of polar 18F species.
Danish: Den residuale mængde af 18F i kredsløbet under den 30-90 minutter lange scanning findes hovedsageligt i form af polære 18F-arter.
English: You must stop breast-feeding for 24 hours after the injection and the maternal milk pumped must be discarded.
Danish: Du skal stoppe med at amme i 24 timer efter indsprøjtningen, og den udpumpede brystmælk skal bortskaffes.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Danish: Strålingseksponeringen skal kunne begrundes med den sandsynlige fordel for hver enkelt patient.
English: EXPIRY DATE EXP {DD/MM/YYYY} {hh:mm}{Time Zone}
Danish: UDLØBSDATO EXP {DD/MM/YYYY}{hh:mm}{ Tidszone}
English: In an in vitro bacterial reverse mutation assay (Ames test), increases in the number of revertant colonies were observed in 2 of the 5 strains exposed to florbetapir.
Danish: I en in vitro-analyse af tilbagemutation i bakterier (Ames-test) blev der observeret stigninger i antallet af tilbagemuterende kolonier i 2 af 5 stammer, som blev eksponeret for florbetapir.
English: For an administered activity of 370 MBq the typical radiation doses delivered to the critical organs, gallbladder, upper large intestine wall, lower large intestine wall, small intestine and liver are 53 mGy, 27.5 mGy, 10.3 mGy, 24.2 mGy and 23.8 mGy, respectively.
Danish: Ved en administreret aktivitet på 370 MBq er de typiske stråledoser til de kritiske organer, galdeblære, øvre tyktarmsvæg, nedre tyktarmsvæg, tyndtarm og lever henholdsvis 53 mGy, 27,5 mGy, 10,3 mGy, 24,2 mGy og 23,8 mGy.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/
English: Examination of sagittal images and co-registered CT or MR images could help to distinguish occipital bone from occipital grey matter.
Danish: Undersøgelse af sagittale billeder og samtidigt registrerede CT- eller MR-billeder kan bidrage til at skelne occipital knogle fra occipital grå substans.
English: A 10 minute PET image should be acquired starting approximately 30 to 50 minutes after intravenous injection of Amyvid.
Danish: Der skal optages et 10 minutters PET-billede med start ca. 30 til 50 minutter efter intravenøs injektion af Amyvid.
English: Cortical average SUV ratios (SUVRs, relative to cerebellum) are higher in AD patients compared with those of healthy volunteer subjects.
Danish: De gennemsnitlige, kortikale SUV-ratioer (SUVR'er i forhold til cerebellum) er højere hos AD-patienter, sammenlignet med raske frivillige forsøgspersoner.
English: In a study of 47 young (<40 years) healthy volunteers, presumed to be free of β-amyloid, all Amyvid PET scans were negative.
Danish: I et studie med 47 unge (< 40 år), raske forsøgspersoner, som formodedes ikke at have βamyloidaflejringer, var samtlige PET-scanninger med Amyvid negative.
English: The spatial normalisation and fit of the scan to the template should be re-checked to confirm the accuracy of the placement of the regions of interest (ROIs), search for CSF or bone within the ROI, and evaluate the potential impact of atrophy or ventriculomegaly on quantitation.
Danish: Scanningens spatiale normalisering og tilpasning (fit) til skabelonen skal kontrolleres igen for at verificere, at ROI'erne (regions of interest) er placeret præcist, søg efter CSF eller knogle inden for ROI'en og evaluer den potentielle indvirkning af atrofi eller ventrikulomegali på kvantificeringen.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP En opdateret RMP skal fremsendes:
English: Elimination occurs primarily by clearance through the liver and excretion into the gallbladder and the intestines.
Danish: Elimination sker primært ved hjælp af clearance via leveren og udskillelse til galdeblære og tarme.
English: The following side effect of Amyvid is common (may affect up to 1 in 10 people): - headache
Danish: Følgende bivirkninger er almindelige (kan forekomme hos op til 1 ud af 10 behandlede): - hovedpine
English: • Information on amyloid pathology in Alzheimer Disease; relevant information on Amyvid as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of Amyvid use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of Amyvid
Danish: • Information om amyloid-patologi ved Alzherimers sygdom; relevant information om Amyvids egenskaber som et β-amyloid PET-sporstof, herunder den godkendte indikation i henhold til produktresumeet, begrænsninger i anvendelsen af Amyvid, tolkningsfejl, sikkerhedsinformation samt resultaterne af kliniske studier med information om den diagnostiske anvendelse af Amyvid.
English: In AD subjects, as in controls, there is low retention in cerebellum and hippocampus and high retention in pons and centrum semiovale.
Danish: Hos AD-patienter så vel som hos raske kontrolpersoner, ses en lav retention i cerebellum og hippocampus, og en høj retention i pons og centrum semiovale.
English: Adjunctive use of quantitative information for image interpretation The feasibility and reliability of using CE-marked quantitative software as an adjunct to clinical qualitative interpretation was investigated in two studies using three different commercially available quantitative software packages.
Danish: Supplerende brug af kvantitative data i forbindelse med billedtolkning Anvendeligheden og pålideligheden af brug af CE-mærket kvantificeringssoftware som supplement til klinisk kvalitativ tolkning er blevet undersøgt i to studier, hvor der blev anvendt tre forskellige kommercielt tilgængelige kvantificeringssoftwarepakker.