FrancophonIA/ELRC3.0 huggingface dataset:
English: You should discuss the results of the test with the doctor that requested the scan.
Danish: Du bør drøfte resultaterne af undersøgelsen med den læge, der har ordineret scanningen.
English: Neuraceq should be used in conjunction with a clinical evaluation.
Danish: Neuraceq skal bruges sammen med en klinisk evaluering.
English: The maximum dose should not exceed 360 MBq and not fall below 240 MBq at time of administration.
Danish: Den maksimale dosis bør ikke overstige 360 MBq og ikke ligge under 240 MBq på administrationstidspunktet.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Danish: Inden markedsføring i hvert medlemsland skal indehaveren af markedsføringstilladelsen godkende det endelige uddannelsesprogram sammen med den nationale relevante myndighed.
English: Adequate shielding is mandatory.
Danish: Tilstrækkelig afdækning er obligatorisk.
English: Table 3: List of adverse reactions System Organ Class
Danish: Skema 3: Liste over bivirkninger Systemorganklasse
English: PET images are read in a transaxial orientation using a grey scale.
Danish: PET-billeder læses i transaksial retning ved brug af en gråskala.
English: The requirement for submission of periodic safety update report for this medicinal product are set out in the line of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2011/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Effective dose (mSv/MBq)
Danish: Virksom dosis (mSv/MBq)
English: February 2014 Date of latest renewal: 20.
Danish: Dato for første markedsføringstilladelse: 20. februar 2014 Dato for seneste fornyelse: 20. november 2018
English: This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,6 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: The nuclear medicine doctor supervising the procedure will decide on the amount of Neuraceq to be used in your case.
Danish: Den læge i nuklearmedicin, der tilser proceduren, vil bestemme den mængde Neuraceq, der skal bruges i dit tilfælde.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Danish: Administrationsproceduren skal udføres på en måde, der minimerer risiko for kontamination af lægemidlet og bestråling af operatøren.
English: The use of Neuraceq does involve exposure to small amounts of radioactivity.
Danish: Brug af Neuraceq indebærer, at man udsættes for små mængder radioaktivitet.
English: - if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for florbetaben (18F) eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Limitations of use
Danish: Begrænsninger for brug
English: Chronic studies and carcinogenicity studies have not been carried out, since the medicinal product is not intended for regular or continuous administration.
Danish: Der er ikke udført vedvarende undersøgelser eller karcinogenicitetsundersøgelser, eftersom lægemidlet ikke er beregnet til regelmæssig eller kontinuerlig administration.
English: Elderly No dose adjustment is recommended based on age.
Danish: Ældre Der anbefales ikke aldersbaseret dosisjustering.
English: The administration of radiopharmaceuticals creates risks for other persons (including pregnant healthcare professionals) from external radiation or contamination from spill of urine, vomiting, etc.
Danish: Administration af radioaktive lægemidler medfører en risiko for andre personer (herunder gravide kvinder blandt sundhedspersonalet) for ekstern stråling eller kontamination fra spild af urin, opkast, osv.
English: Express breast milk during this period and discard the breast milk you have expressed.
Danish: Pump mælken ud i dette tidsrum og kasser den mælk, du har pumpet ud.
English: RCTU score 2 in any or all of the 4 brain regions and no score 3 in these 4 brain regions
Danish: RCTU-score 2 i et eller alle af de 4 hjerneområder og ingen score 3 i disse 4 områder
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkle og gentagne doser og genotoksicitet.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images from the PET scan.
Danish: Fortæl lægen i nuklearmedicin, hvis du tager, har taget for nylig eller muligvis tager nogen anden medicin, da de kan forstyrre fortolkningen af billederne fra PET-scanningen.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsenvia det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: An overdose is unlikely since you will only receive a single dose of Neuraceq precisely controlled by the nuclear medicine doctor supervising the procedure.
Danish: Det er ikke sandsynligt, at du får en overdosis, da du kun vil få en enkelt dosis Neuraceq, som kontrolleres nøje af den læge i nuklearmedicin, der tilser proceduren.
English: In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defecation.
Danish: I tilfælde af administration af en overdosis stråling bør den dosis, som patienten har absorberet, reduceres så vidt muligt ved at øge eliminationen af radionuklidet fra kroppen ved hyppig miktion og tarmudtømning.
English: If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionising radiation will increase in an amount dependent on the settings used in the CT acquisition.
Danish: Hvis der samtidigt udføres en CT-scanning som del af PETproceduren, vil udsættelse for ioniserende stråling øges med en mængde, der afhænger af de indstillinger, der anvendes til CT-optagelsen.
English: As a result of differences in the manufacturing process, it is possible that some vials are distributed with punctured rubber stoppers.
Danish: Forskelle i fremstillingsprocessen kan resultere i, at nogle ampuller distribueres med punkterede gummipropper.
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Danish: Din læge og lægen i nuklearmedicin har besluttet, at den kliniske fordel ved denne procedure med det radioaktive lægemiddel opvejer risikoen for at blive udsat for stråling.
English: METALLIC BOX (with Blue Box)
Danish: METALÆSKE - (med blå æske)
English: Due to the small quantity of florbetaben (18F) in each dose, overdose is not expected to result in pharmacological effects.
Danish: Grundet den lille mængde florbetaben (18F) i hver dosis forventes overdosering ikke at resultere i farmakologisk virkning.
English: The reason for this accumulation is unknown, but maybe due to accumulation of florbetaben (18F) or to any of its radioactive metabolites, or to blood radioactivity.
Danish: Årsagen til denne ophobning kendes ikke, men det kan måske skyldes ophobning af florbetaben (18F) eller en af dens radioaktive metabolitter, eller radioaktivitet i blodet.
English: Neuraceq has no influence on the ability to drive and use machines.
Danish: Neuraceq påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advise before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen i nuklearmedicin til råds, før du bruger dette lægemiddel.
English: A positive scan indicates moderate to frequent density.
Danish: En positiv scanning indikerer moderat til udbredt tæthed.
English: Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blurs, which could lead to interpretation errors.
Danish: Visse scanninger kan være vanskelige at fortolke pga. billedstøj, atrofi med fortyndet kortikalt bånd eller slørede billeder, hvilket kan føre til fejlfortolkning.
English: Fluorine (18F) has a physical half-life of 110 minutes.
Danish: Fluor(18F) har en fysisk halveringstid på 110 minutter.
English: No radioactivity could be measured in blood at about 4 hours post injection.
Danish: Der kunne ikke måles nogen radioaktivitet i blodet ca. 4 timer efter injektion.
English: RCTU score 3 at least in one of 4 brain regions
Danish: RCTU-score 3 i mindst et af de 4 hjerneområder
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Udsættelse for ioniserende stråling er forbundet med cancerinduktion og potentiale for udvikling af arvelige defekter.
English: The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Danish: Designet af dette studie muliggør ikke estimering af risikoen for MCIprogression til klinisk Alzheimers sygdom.
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: At 12 hours post injection 98.93% of the activity is decayed, at 24 hours post injection 99.99 % of the activity is decayed.
Danish: 12 timer efter injektion er 98,93 % af aktiviteten henfaldet, og 24 timer efter injektion er 99,99 % af aktiviteten henfaldet.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Danish: VEJLEDNING I FORBEREDELSE AF RADIOAKTIVE LÆGEMIDLER
English: No in vivo interaction studies have been performed.
Danish: Der er ikke udført in vivo interaktionsundersøgelser.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Danish: Lægen i nuklearmedicin vil oplyse dig, om du behøver at træffe nogen særlige forholdsregler, når du har fået medicinen.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Danish: Lægemidlet opbevares under de rette forhold af de ansvarlige specialister.
English: Paediatric population There is no relevant use of Neuraceq in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevant anvendelse af Neuraceq hos børn.
English: Contact your nuclear medicine doctor if you have any questions.
Danish: Kontakt lægen i nuklearmedicin, hvis du har spørgsmål.
English: The complete SmPC of Neuraceq is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Danish: Det komplette produktresume for Neuraceq fås som et separat dokument med det formål at give sundhedspersonale anden, yderligere, videnskabelig og praktisk information om administration og anvendelse af dette radioaktive lægemiddel.
English: Inter-rater agreement using Fleiss' kappa values ranged from 0.68 to 0.87.
Danish: Overensstemmelsen mellem aflæserne ved brug af Fleiss' kappaværdier lå mellem 0,68 og 0,87.
English: For an administered activity of 360 MBq the typical radiation dose to the target organ (brain) is 4.5 mGy.
Danish: Ved en administreret aktivitet på 360 MBq er den typiske stråledosis for målorganet (hjernen) 4,5 mGy.
English: Individual benefit/risk justification
Danish: Begrundelse for individuelt risk-benefit-forhold
English: Positive scan
Danish: Positiv scanning
English: In radioligand binding assays using a broad panel of animal and human receptors, ion channels and transporters no significant binding was found.
Danish: I analyser af radioligand binding, hvor der blev anvendt et bredt panel af receptorer, ionkanaler og transportere fra dyr og mennesker, blev der ikke fundet nogen signifikant binding.
English: The potential toxicity of 28 days of repeated intravenous injections of florbetaben (18F) was tested in rats and dogs, and the NOAEL was found to be at least 20 times the maximum human dose.
Danish: Den potentielle toksicitet ved 28 dages gentagen intravenøs injektion af florbetaben (18F) blev undersøgt hos rotter og hunde, og NOAEL blev fundet at være mindst 20 gange højere end den maksimale, humane dosis.
English: The quantity to be administered usually recommended for an adult is 300 MBq (megabecquerel, the unit used to express radioactivity).
Danish: Den mængde, der sædvanligvis anbefales til en voksen, er 300 MBq, (megabecquerel er den enhed, der bruges til at udtrykke radioaktivitet).
English: 29 (64.4%) of MCI patients were positive by florbetaben (18F) PET scan.
Danish: 29 (64,4 %) af MCI-patienterne var positive for florbetaben (18F) PET-scanning.
English: The overall decision of the visual PET scan assessment is subject-based and based on a binary outcome as ‘positive' or ‘negative‘.
Danish: Den samlede afgørelse for den visuelle vurdering af PET-scanningen baseres på den individuelle patient og på et binært resultat som "positiv" eller "negativ".
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 stabilt oxygen (18O) med en halveringstid på ca. 110 minutter ved at udsende en positronstråling på 634 keV efterfulgt af foton-annihilationsstråling på 511 keV.
English: Residual activity in the midsagittal sinus can be sometimes observed likely due to the presence of tracer in the blood pool.
Danish: Restaktivitet i midtsagittale sinus kan nogle gange ses, sandsynligvis pga. tilstedeværelsen af sporstof i det poolede blod.
English: EXP {DD/MM/YYYY} {XX}h{XX} {Time zone}
Danish: EXP {DD/MM/ÅÅÅÅ} kl. {XX}:{XX} {tidszone}
English: Note: For a score of tracer uptake in the cortex, the finding should have been present in the majority of the slices within the region in question.
Danish: Bemærk: En score for optagelse af sporstof i cortex kræver, at fundet skal være til stede i størstedelen af snittene inden for det pågældende område.
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 en mulig graviditet (hvis kvinden har sprunget en menstruation over, hvis menstruationen er uregelmæssig osv.), skal patienten tilbydes en anden teknik uden brug af ioniserende stråling (hvis en sådan forefindes).
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the read methodology;
Danish: • Gennemgang af kriterierne for aflæsning af PET-scanningen, inklusive metode for billedgennemgang, kriterier for fortolkning og billeder, der viser aflæsningsmetoden
English: Florbetaben (18F) should not be diluted.
Danish: Florbetaben (18F) skal ikke fortyndes.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where Neuraceq is marketed, at launch and after launch, all physicians who are expected to use Neuraceq have access to a training programme in order to ensure accurate and reliable interpretation of the PET images.
Danish: Indehaveren af markedsføringstilladelsen skal efter drøftelse og godkendelse med den nationale relevante myndighed i hvert medlemsland, hvor Neuraceq markedsføres, sikre, ved godkendelse og efter godkendelse, at alle læger, der forventes at bruge Neuraceq, har adgang til et uddannelsesprogram for at sikre nøjagtig og pålidelig fortolkning af PET-billederne.
English: The effective dose resulting from the administration of a maximal recommended activity of 360 MBq dose for an adult weighing 70 kg is about 7.0 mSv.
Danish: Den effektive dosis ved administration af en maksimal anbefalet aktivitet på 360 MBq til en voksen, der vejer 70 kg, er ca. 7,0 mSv.
English: Store in the original package to protect from ionizing radiation (lead shielding).
Danish: Opbevares i den originale yderpakning for at beskytte mod ioniserende stråling (blyafskærmning).
English: The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Danish: Lægen i nuklearmedicin giver kun denne medicin under graviditet, hvis fordelen forventes at kunne opveje risiciene.
English: Neuraceq should not be diluted.
Danish: Neuraceq må ikke fortyndes.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Danish: Radioaktive lægemidler må kun modtages, anvendes og administreres af autoriserede personer i dertil beregnede kliniske omgivelser.
English: Florbetaben (18F) is highly bound to plasma proteins (>98.5%).
Danish: Florbetaben (18F) bindes i høj grad til plasmaproteiner (>98,5 %).
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radioaktive lægemidler skal forberedes, så kravene til både strålingssikkerhed og farmaceutisk kvalitet overholdes.
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Danish: Dette radioaktive lægemiddel giver lave mængder ioniserende stråling, der er forbundet med den laveste risiko for kræft og arvelige misdannelser.
English: Blood creatinine increased
Danish: Forhøjet creatinin i blodet
English: If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded.
Danish: Hvis det anses som nødvendigt at administrere lægemidlet, bør amning afbrydes i 24 timer, og den udpumpede mælk skal kasseres.
English: Method of administration Neuraceq is for intravenous use and for multidose use.
Danish: Administration Neuraceq er til intravenøs anvendelse og til flerdosis.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Danish: En nøje overvejelse af risk-benefit-forholdet er nødvendig for disse patienter, da der er risiko for øget stråleeksponering.
English: As the effective dose is about 5.8 mSv when the maximum recommended activity of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a low probability.
Danish: Da den effektive dosis er ca. 5,8 mSv, når den maksimale anbefalede aktivitet på 300 MBq florbetaben (18F) administreres, forventes disse bivirkninger at forekomme ved lav sandsynlighed.
English: Act.: ≤ 3000 MBq at ToC (see outer label)
Danish: : ≤ 3000 MBq Ved ToC (se ydre emballage)
English: The estimated absorbed radiation doses to organs are listed in Table 3, providing data from Caucasian healthy volunteers (n=17).
Danish: De stråledoser, der estimeres at blive absorberet af organer, er anført i Skema 3, der indeholder data fra raske, hvide frivillige (n=17).
English: A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of florbetaben (18F).
Danish: Der skal optages et 20-minutters PET-billede begyndende ca. 90 minutter efter intravenøs injektion af florbetaben (18F).
English: Negative scan
Danish: Negativ scanning
English: LEAD POT (without Blue Box)
Danish: BLYPOTTE - (uden blå æske)
English: Method of preparation The package must be checked before use and the activity measured using an activimeter.
Danish: Forberedelse Pakningen skal efterses inden brug, og aktiviteten skal måles med et dosimeter.
English: Diarrhoea Nausea
Danish: Diaré Kvalme
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Danish: Radionuklide procedurer, der udføres på en gravid kvinde, udsætter også fosteret for stråling.
English: Red marrow Osteogenic cells Skin
Danish: Rød knoglemarv Osteogene celler Hud
English: The activity of florbetaben (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
Danish: Aktiviteten af florbetaben (18F) skal måles med et dosimeter (dosiskalibrator) umiddelbart inden injektion.
English: Healthy controls show relatively low levels of florbetaben (18F) retention in cortex.
Danish: Raske kontrolpersoner viser relativt lave niveauer af florbetaben (18F) retention i cortex.
English: A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Danish: En negativ scanning indikerer sparsom eller ingen tæthed af kortikal β-amyloidplak.
English: Neuraceq is given to people with memory problems so that doctors can perform a type of brain scan, called a PET scan.
Danish: Neuraceq gives til mennesker med hukommelsesproblemer, så læger kan udføre en hjernescanning, der kaldes en PET-scanning.
English: In AD subjects, cortical regions and striatal regions show significantly greater uptake compared to controls.
Danish: Hos Alzheimerforsøgspersoner viser de kortikale og striatale områder signifikant højere optagelse sammenlignet med hos kontrolpersoner.
English: For an administered activity of 360 MBq the typical radiation doses delivered to the critical organs, gallbladder, urinary bladder, upper large intestine wall, lower large intestine wall, small intestine and liver are 49.3 mGy, 25.0 mGy, 13.8 mGy, 12.6 mGy, 11.3 mGy and 13.9 mGy, respectively.
Danish: Ved en administreret aktivitet på 360 MBq er den typiske stråledosis, der leveres til de livsvigtige organer, galdeblære, blære, væggen i øvre tyktarm, væggen i nedre tyktarm, tyndtarm og lever hhv. 49,3 mGy, 25,0 mGy, 13,8 mGy, 12,6 mGy, 11,3 mGy og 13,9 mGy.
English: After intravenous bolus injection a radioactivity concentration of 2-3% injected dose/L is achieved in arterial plasma 10 minutes after injection.
Danish: Efter intravenøs bolusinjektion opnås en radioaktiv koncentration på 2-3 % injiceret dosis/l i arterielt plasma 10 minutter efter injektion.
English: The results were lower than the results obtained in the pivotal trial: a sensitivity range between 77.5% to 90% and specificity range between 62.5-85.7%.
Danish: Resultaterne var lavere end de resultater, der blev opnået i pivotalstudiet: Sensitiviteten lå mellem 77,5 og 90 %, og specificiteten mellem 62,5 og 85,7 %.
English: Reducing head movement with tape or other flexible head restraints may be employed.
Danish: Hovedbevægelser kan minimeres ved brug af tape eller anden fleksibel hovedfiksering.
English: It is unknown whether florbetaben (18F) is excreted in human milk.
Danish: Det vides ikke, om florbetaben (18F) udskilles i human mælk.