FrancophonIA/ELRC3.0 huggingface dataset:
English: - Do not use after the expiry date which is stated on the box, shield label and vial label after
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på æsken, forseglingsetiketten og hætteglassets etiket efter ”EXP” .
English: Sensitivity and specificity to estimate beta-amyloid deposition of florbetaben (18F) was further investigated in one additional study, in which a different set of 5 electronically-trained blinded readers interpreted images from 54 subjects followed to autopsy in the pivotal study.
Danish: Sensitivitet og specificitet for at estimere beta-amyloidaflejring af florbetaben (18F) blev yderligere undersøgt i endnu et studie, hvor en anden gruppe på 5 elektronisk trænede, blindede aflæsere fortolkede billederne fra 54 forsøgspersoner efterfulgt af obduktion i pivotalstudiet.
English: Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view.
Danish: Patienten skal ligge i rygleje med hovedet anbragt, så hjernen centreres, inklusive cerebellum, i PETscannerens synsfelt.
English: The recommended activity for an adult is 300 MBq florbetaben (18F).
Danish: Den anbefalede aktivitet til en voksen er 300 MBq florbetaben (18F).
English: • Relevant information on Neuraceq as anβ-amyloid PET tracer, including the approved indication according to the SmPC, limitations of Neuraceq use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of Neuraceq;
Danish: • Relevant information om Neuraceq som PET sporingsstof for β-amyloid, inklusive den godkendte indikation ifølge produktresuméet, begrænsninger for anvendelse af Neuraceq, fortolkningsfejl, sikkerhedsinformation og resultaterne af kliniske forsøg, der informerer om den diagnostiske anvendelse af Neuraceq
English: Upper large intestine Heart
Danish: Øvre tyktarm Hjerte
English: For each patient, the radiation exposure must be justified by the likely benefit.
Danish: Stråleeksponeringen skal begrundes med den sandsynlige fordel for hver patient.
English: The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Danish: Ampullen må ikke åbnes, før proppen er desinficeret, væsken skal trækkes ud gennem proppen med en enkeltdosissprøjte med egnet, beskyttende afskærmning og en steril engangskanyle, eller ved anvendelse af et godkendt, automatisk injektionssystem.
English: Based on in vitro investigations florbetaben (18F) is metabolised predominantly by CYP2J2 and CYP4F2.
Danish: Baseret på in vitro-undersøgelser omsættes florbetaben (18F) hovedsageligt af CYP2J2 og CYP4F2.
English: In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to help remove radioactivity from your body.
Danish: Især kan den læge, der er ansvarlig for proceduren, finde måder at øge vandladning og afføring på, så radioaktiviteten hurtigere kan fjernes fra kroppen.
English: Florbetaben (18F) is eliminated from plasma of AD patients with a mean biological half-life of about 1 hour.
Danish: Florbetaben (18F) elimineres fra plasma hos Alzheimer-patienter med en gennemsnitlig, biologisk halveringstid på ca. 1 time.
English: A brain scan is usually taken 90 minutes after Neuraceq is given.
Danish: Hjernescanningen foretages normalt 90 minutter efter indsprøjtning af Neuraceq.
English: Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Danish: Der er ikke udført ekstensive studier af dosisvariation og -justering med dette lægemiddel hos hverken normale eller særlige populationer.
English: The European Medicines Agency has waived the obligation to submit the results of studies with florbetaben (18F) in all subsets of the paediatric population as the disease or condition for which the specific medicinal product is intended only occurs in adult population, and the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med florbetaben (18F) i alle undergrupper af den pædiatriske population, da den sygdom eller tilstand i den godkendte indikation kun forekommer i den voksne population, og det specifikke lægemiddel ikke udviser signifikant terapeutisk fordel i forhold til eksisterende behandlinger til pædiatriske patienter (se pkt.
English: Neuralgia Headache Burning sensation Tremor
Danish: Brændende fornemmelse Tremor
English: Studies on reproduction toxicity have not been performed.
Danish: Der er ikke udført undersøgelser af reproduktionstoksiciteten.
English: Neuraceq contains ethanol and sodium ascorbate
Danish: Neuraceq indeholder ethanol og natriumascorbat
English: Seibersdorf Labor GMBH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Austria
Danish: Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Østrig
English: It is hypothesised that unspecific binding of the radiopharmaceutical to the lipid-containing myelin sheath may contribute to white matter retention.
Danish: Hypotesen er, at uspecificeret binding af det radioaktive lægemiddel til den lipidholdige myelinskede kan bidrage til retention i den hvide substans.
English: Tracer uptake (i.e., signal intensity) in grey matter in the region is lower than in white matter.
Danish: Optagelse af sporstoffet (dvs. signalintensiteten) i den grå substans i området er lavere end i den hvide substans.
English: • The training material should include Neuraceq PET demonstration cases with correct PET scan interpretation by an experienced reader Neuraceq-PET scans for self-assessment and a selfqualification procedure to be offered to each trainee.
Danish: • Uddannelsesmaterialet bør inkludere Neuraceq PET-scanningscases med korrekt fortolkning af PET-scanningen foretaget af en erfaren aflæser af Neuraceq-PET-scanninger til selvevaluering og en selvkvalificerende procedure, der skal tilbydes hver person i oplæring.
English: For precautions with respect to environmental hazard, see section 6.6.
Danish: 6.6 vedrørende miljørisici.
English: Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F).
Danish: Neuraceq-billeder må kun fortolkes af fagpersoner, der er oplært i at fortolke PET-billeder med florbetaben (18F).
English: Figure 1: Neuraceq PET cases showing examples of negative florbetaben (18F) PET scan (top row) and positive scan (bottom row).
Danish: Figur 1:Neuraceq PET-cases viser eksempeler på en negativ florbetaben (18F) PET-scanning (øverste række) og en positiv scanning (nederste række).
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: 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: Hvis der skal administreres radioaktive lægemidler til en kvinde i den fertile alder, er det vigtigt at afgøre, om kvinden er gravid.
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Dette skal tages i betragtning hos gravide og ammende kvinder, børn samt patienter i højrisikogruppe såsom patienter med leversygdom eller epilepsi.
English: Cortical SUV ratios (SUVRs, relative to cerebellar cortex) are higher in AD patients compared with those of healthy volunteer subjects.
Danish: Kortikale SUV-ratioer (SUVR, i forhold til cortex cerebelli) er højere hos Alzheimer-patienter sammenlignet med hos raske frivillige forsøgspersoner.
English: At 12 hours post-injection, up to approximately 30% of the injected radioactivity is excreted with urine.
Danish: 12 timer efter injektion er op til ca. 30 % af den injicerede radioaktivitet udskilt med urin.
English: The in vivo binding of florbetaben (18F) to other amyloid structures or other brain structures or receptors remains unknown.
Danish: Bindingen in vivo af florbetaben (18F) til andre amyloidstrukturer eller andre hjernestrukturer eller receptorer kendes ikke.
English: Rule for assessment
Danish: Regel for vurdering
English: The volume of Neuraceq to be injected can be from 0.5 to 10 mL in order to provide the target activity of 300 MBq at the time of intravenous administration.
Danish: Den mængde Neuraceq, der skal injiceres, kan være 0,5-10 ml for at opnå en målaktivtet på 300 MBq på tidspunktet for den intravenøse administration.
English: This medicinal product is for diagnostic use only.
Danish: Dette lægemiddel er udelukkende beregnet til diagnostisk brug.
English: Uptake of radioactivity in the brain is rapid, reaching about 6% of injected radioactivity at 10 minutes post injection.
Danish: Optagelse af radioaktivitet i hjernen sker hurtigt og når ca. 6 % af den injicerede radioaktivitet 10 min. efter injektion.
English: Pain in extremity Limb discomfort
Danish: Smerter i ekstremitet Ubehag i ekstremitet
English: Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU United Kingdom
Danish: Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU Storbritannien
English: Table 4: Estimated radiation absorbed doses from intravenous injection of Neuraceq to Caucasian subjects
Danish: Skema 4: Estimeret stråledosis absorberet fra intravenøs injektion af Neuraceq hos hvide forsøgspersoner
English: 1 (No tracer uptake)
Danish: 1 (Ingen optagelse af sporstof)
English: Interpretation of the images is made visually comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
Danish: Billederne fortolkes visuelt ved at sammenligne aktiviteten i den kortikale grå substans med aktiviteten i den tilstødende, kortikale hvide substans.
English: For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy.
Danish: I tilfælde hvor der er usikkerhed om placeringen af den grå substans og af grænsen mellem den grå/hvide substans på PET-scanningen, og der foreligger et nyligt samregistreret CT- eller MR-billede, bør fortolkeren undersøge det kombinerede PET/CT- eller PET/MR-billede for at klargøre forholdet mellem radioaktivitet på PETbilledet og anatomien af den grå substans.
English: Table 2: Definitions of brain amyloid plaque load (BAPL) Assessment
Danish: Skema 2:Definitioner på mængde amyloidplak i hjernen (BAPL) Vurdering
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Danish: Lægen i nuklearmedicin vil oplyse dig om, hvor længe proceduren varer.
English: Neuraceq is a clear, colourless solution for injection.
Danish: Neuraceq er en klar, farveløs væske til indsprøjtning..
English: The biophysical basis of the white matter retention of florbetaben (18F) in the living human brain cannot be definitively explained.
Danish: Det biofysiske grundlag for retention af florbetaben (18F) i den hvide substans i den levende menneskehjerne kan ikke forklares definitivt.
English: Talk to your nuclear medicine doctor before you are given Neuraceq if you: - have kidney problems - have liver problems - are pregnant or think you may be pregnant - are breast-feeding
Danish: Kontakt lægen i nuklearmedicin, før du får Neuraceq: - hvis du har nyreproblemer - hvis du har leverproblemer - hvis du er gravid eller har mistanke om, at du er gravid - hvis du ammer
English: A PET scan with florbetaben (18F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders.
Danish: PET-scanninger med florbetaben (18F) skal ordineres af klinikere med erfaring i klinisk behandling af neurodegenerative sygdomme.
English: Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Spain
Danish: Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Spanien
English: Pregnant
Danish: Graviditet
English: The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Danish: Aflæseren skal sammenligne signalintensiteten i den kortikale grå substans med den maksimale signalintensitet i den hvide substans.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Yderligere information om dette lægemiddel fås ved at kontakte indehaveren af markedsføringstilladelsen:
English: Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) France
Danish: Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) Frankrig
English: This medicinal product contains up to 33 mg sodium per dose, equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder op til 33 mg natrium pr. dosis, svarende til 1,6 % af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Danish: Derfor skal forsigtighedsregler for strålebeskyttelse overholdes i overensstemmelse med nationale bestemmelser.
English: Neuraceq is given as an injection into your vein (intravenous injection) followed by a flush of sodium chloride solution to ensure full delivery of the dose.
Danish: Neuraceq gives som en indsprøjtning i en vene (intravenøs injektion) efterfulgt af en saltvandsskylning for at sikre, at hele dosen er indsprøjtet.
English: The dose is administered by intravenous slow bolus injection (6 sec/mL) followed by a flush of approximately 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
Danish: Dosis administreres som intravenøs, langsom bolusinjektion (6 sek/ml) efterfulgt af en gennemskylning med ca. 10 ml natriumchloridopløsning 9 mg/ml (0,9 %) til injektion for at sikre, at hele dosen indgives.
English: In a longitudinal study, 45 subjects clinically diagnosed with mild cognitive impairment (MCI), underwent baseline florbetaben (18F) PET scans, and were followed for 24 months to evaluate the relationship between florbetaben (18F) imaging and changes in diagnostic status.
Danish: I et longitudinelt studie fik 45 forsøgspersoner, som var klinisk diagnosticeret med mild kognitiv funktionsnedsættelse (MCI, "mild cognitive impairment"), florbetaben (18F) PET-scanninger ved baseline og blev kontrolleret i 24 måneder for at evaluere forholdet mellem billeddiagnostik med florbetaben (18F) og ændringer i diagnosestatus.
English: The PET results were compared with the maximal neuritic plaque density measured on sections of middle frontal gyrus, superior and middle temporal gyri, inferior parietal lobe, hippocampus and other brain regions at the patient's autopsy.
Danish: Resultaterne af PET-scanningerne blev sammenlignet med den maksimale tæthed af neuritisk plak målt i snit af midt frontal, gyrus, superiore og midttemporale gyri, inferiore isselap, hippocampus og andre hjerneområder under obduktion af patienten.
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 (AD, Lewy body dementia, Parkinson's disease dementia).
Danish: En positiv scanning kan ikke være eneste grundlag for at diagnosticere Alzheimers eller en anden kognitiv sygdom, eftersom der kan være aflejring af neuritisk plak i den grå substans hos ældre uden symptomer og ved visse neurodegenerative demenssygdomme (Alzheimers sygdom, Lewy body demens, demens ved Parkinsons sygdom).
English: RCTU score 1 in each of the 4 brain regions (lateral temporal lobes, frontal lobes, posterior cingulate/precuneus, parietal lobes)
Danish: RCTU-score 1 i hvert af de 4 hjerneområder (tindingelapper, frontallapper, posterior cingulate cortex/precuneus, isselapper)
English: Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment.
Danish: Neuraceq er et radioaktivt lægemiddel, der er indiceret til PET-scanning (positronemissionstomografi) af densiteten af neuritisk β-amyloidplak i hjernen hos voksne patienter med kognitiv funktionsnedsættelse, der bedømmes for Alzheimers sygdom og andre årsager til kognitiv funktionsnedsættelse.
English: Neuraceq contains the active substance florbetaben (18F).
Danish: Neuraceq indeholder det aktive stof florbetaben (18F).
English: A large confluent area of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin and involving the entire region including the majority of slices within the respective region.
Danish: Et stort sammenhængende område med optagelse af sporstof er lige så stort eller større end i den hvide substans og udvider sig ud over randen på den hvide substans til den ydre kortikale margin, omfattende hele området, inklusive størstedelen af snittene inden for det pågældende område.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Danish: Dette lægemiddel er radioaktivt og er kun beregnet til diagnostisk brug.
English: Uptake has also been identified in some cases in extracerebral structures such as face, scalp and bone.
Danish: I visse tilfælde er der også set optagelse i ekstracerebrale strukturer som f.eks. ansigt, hovedbund og knogle.
English: A Neuraceq PET scan, along with other brain function tests, can help your doctor determine whether or not you may have β-amyloid plaques in your brain.
Danish: En Neuraceq PET-scanning kan sammen med andre hjernefunktionsundersøgelser hjælpe lægen med at afgøre, om du har β-amyloidplak i hjernen eller ej. Lægemidlet er kun beregnet til voksne.
English: Common (may affect up to 1 in 10 people): - Injection site reactions: injection site pain, redness of the skin at injection site (injection /
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer): - Reaktioner på indsprøjtningsstedet: smerter på indsprøjtningsstedet, rødme af huden på indsprøjtningsstedet
English: The injection of florbetaben (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
Danish: Injektion af florbetaben (18F) skal være intravenøs for at undgå bestråling pga. lokal ekstravasation samt billedartefakter.
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4).
Danish: Den aktivitet, der skal administreres, skal nøje overvejes, da der er risiko for øget stråleeksponering hos disse patienter (se pkt.
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Danish: Der er set fejlfortolkning af billeder i estimering af tætheden af neuritisk β-amyloidplak i hjernen, herunder falsk negative og falsk positive.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Contents of the pack and other information What Neuraceq contains
Danish: Pakningsstørrelser og yderligere oplysninger Neuraceq indeholder:
English: It is supplied in a colourless 15 mL glass vial, sealed with a rubber stopper and aluminium seal.
Danish: Det leveres i et farveløst 15 ml hætteglas af glas forseglet med en gummiprop og et aluminiumssegl.
English: If the injection volume ranges between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used and the syringe needs to be flushed out with sodium chloride solution.
Danish: Hvis injektionsvolumen er mellem 0,5 og 1 ml, må der kun anvendes sprøjter af passende størrelse (1 ml), og sprøjterne skal gennemskylles med natriumchloridopløsning.
English: You must inform the nuclear medicine doctor before you are given Neuraceq if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Danish: Du skal give lægen i nuklearmedicin besked, inden du får Neuraceq, hvis der er en mulighed for, at du kan være gravid, hvis du er sprunget en menstruationsperiode over, eller hvis du ammer.
English: The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Danish: Florbetabens (18F) effektivitet i at kunne forudsige udvikling af Alzheimers sygdom eller overvåge reaktion på behandling er ikke fastsat (se pkt.
English: Withdrawals should be performed under aseptic conditions.
Danish: Lægemidlet skal trækkes ud under aseptiske forhold.
English: In addition, binding of florbetaben (18F) to β-amyloid plaques in post-mortem AD brain sections was demonstrated by autoradiography and supported by immunohistochemistry or Bielschowsky stain.
Danish: Derudover blev bindingen af florbetaben (18F) til β-amyloidplak i Alzheimers post mortemhjerneobduktion påvist ved autoradiografi og understøttet af hhv. immunhistokemi eller Bielschowsky-farvning.
English: Each of these brain regions, the lateral temporal, frontal, posterior cingulate, precuneus, and parietal lobes should be systematically visually assessed and scored according to the regional cortical tracer uptake (RCTU) score (Table 1).
Danish: Hvert af disse områder i hjernen, tindingelapper, frontallapper, posterior cingulate, precuneus og isselapper, skal vurderes visuelt på systematisk vis og scores i henhold til RCTU-skalaen (skala for optagelse af sporstof i kortikale områder) (Skema 1).
English: Avoid any close contact with young children and pregnant women for 24 hours following the injection.
Danish: Undgå tæt kontakt med små børn og gravide kvinder i 24 timer efter indsprøjtningen.
English: Sensitivity of florbetaben (18F) scan to show the MCI conversion rate to AD in 19 converters was 100%, specificity in 26 non-converters was 61.5% (95% CI: 42.8-80.2%) and positive likelihood ratio was 2.60 (1.60-4.23).
Danish: Sensitiviteten af florbetaben (18F) scanninger, der viser MCI-konverteringsraten hos 19 konverterede patienter, var 100 %, specificiteten for de 26 ikke-konverterede var 61,5 % (95 % KI: 42,8-80,2 %), og sandynlighedsratioen for positive var 2,60 (1,60-4,23).
English: - This medicine contains up to 33 mg sodium (main component of cooking/table salt) in each dose.
Danish: - Dette lægemiddel indeholder op til 33 mg natrium (hoved komponent af madlavnings-/bordsalt) pr.
English: A subject is classified as “positive” or “negative” based on the brain amyloid plaque load (BAPL) score (Table 2) which is derived from RCTU scores in the four brain regions (Table 1).
Danish: En patient klassificeres som "amyloidpositiv" eller "amyloid-negativ" baseret på BAPL-skalaen (mængde amyloidplak i hjernen) (skema 2), der er afledt af RCTU-skalaen for de fire hjerneområder (skema 1).