FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if any of these apply to you.
Danish: Fortæl det til lægen, hvis noget af dette gælder for Dem.
English: Bq/mmol) at reference time.
Danish: Bq/mmol) på referencetidspunktet.
English: Iodine-123 has a physical half-life of 13.2 hours.
Danish: Iod-123 har en fysisk halveringstid på 13,2 timer.
English: There are strict laws on the use, handling and disposal of radioactivity.
Danish: Der er streng lovgivning om anvendelse, håndtering og bortskaffelse af radioaktivitet.
English: Each dose contains up to 197 mg alcohol.
Danish: Hver dosis indeholder op til 197 mg alkohol.
English: This is because the child may receive some of the radioactivity.
Danish: Dette er, fordi barnet muligvis kan få tilført noget af radioaktiviteten.
English: The following information is intended for the specialist only:
Danish: Følgende information er udelukkende beregnet for specialisten:
English: Prior to administration appropriate resuscitation equipment should be available.
Danish: Før indgivelse skal passende genoplivningsudstyr være til rådighed.
English: A scan will give your doctor information about any changes in this area of your brain.
Danish: En scanning vil give Deres læge information om enhver ændring i dette område af Deres hjerne.
English: 5612 AP, Eindhoven The Netherlands
Danish: 5612 AP, Eindhoven Holland
English: I) which is used to help identify (diagnose) conditions in the brain.
Danish: I), der anvendes som hjælp til at identificere (diagnosticere) sygdomme i hjernen.
English: The amount of radioactivity in the body from DaTSCAN is very small.
Danish: Mængden af radioaktivitet i kroppen fra DaTSCAN er meget lille.
English: Ioflupane is a cocaine analogue.
Danish: Ioflupan er en cocain analog.
English: I) (specific activity range 2.5 to
Danish: I) (specifik aktivitetsinterval 2,5 til
English: It is important that you take the tablets or liquid as the doctor tells you.
Danish: Det er vigtigt, at De tager tabletterne eller væsken, som lægen giver Dem besked om.
English: 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) and 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This exposure is less than in some types of X-ray investigation.
Danish: Denne eksponering er mindre end under visse former for røntgenundersøgelser.
English: I) is excreted in human milk.
Danish: I) udskilles i human mælk.
English: Some medicines may reduce the quality of the picture obtained.
Danish: Visse lægemidler kan reducere den opnåede billedkvalitet.
English: This scan will show exactly where the radioactivity is inside the organ and the body.
Danish: Dette scanningsbillede vil vise præcist, hvor radioaktiviteten befinder sig inden i organet eller i kroppen.
English: You will not have to store this medicine.
Danish: De skal ikke opbevare dette lægemiddel.
English: It belongs to a group of medicines called “radiopharmaceuticals”, which contain a small amount of radioactivity.
Danish: Det tilhører en gruppe lægemidler, der kaldes ”radioaktive lægemidler”, som indeholder en lille mængde radioaktivitet.
English: Changes in this area of the brain occur in:
Danish: Forandringer i denne del af hjernen forekommer ved:
English: • Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras.
Danish: • Da det indeholder en lille mængde radioaktivitet, kan det påvises udefra ved anvendelse af specielle kameraer.
English: Any woman who has missed a period should be assumed pregnant until proven otherwise.
Danish: Enhver kvinde, som har sprunget en menstruation over, skal opfattes som gravid, indtil det modsatte er bevist.
English: Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.
Danish: Hospitalets personale sørger for, at produktet opbevares og bortskaffes korrekt og ikke anvendes efter udløbsdatoen angivet på etiketten.
English: This is about the same as 5 ml beer, or 2 ml wine.
Danish: Dette er ca. det samme som 5 ml øl eller 2 ml vin.
English: This is normal practice with medicines like DaTSCAN.
Danish: Dette er normal praksis for lægemidler som DaTSCAN.
English: It will only be handled and given to you by people who are trained and qualified to use it safely.
Danish: Det vil kun blive håndteret og givet til Dem af personer med træning og kvalifikationer i at anvende det sikkert.
English: Common: may affect up to 1 in 10 people - Headache
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 behandlede - Hovedpine
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dette lægemiddel bliver anvendt til Dem, da den indeholder vigtige oplysninger.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/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: It is used only to identify illness.
Danish: Den bruges kun til at identificere sygdom.
English: The doctor may ask you to stop taking them for a short time before you receive DaTSCAN.
Danish: Lægen vil eventuelt bede Dem om at holde op med at tage dem i en kort periode, inden De får DaTSCAN.
English: Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system, ATC code: V09AB03.
Danish: Farmakoterapeutisk gruppe: Diagnostisk radioaktivt lægemiddel centralnervesystemet, ATC kode: V09AB03.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og hætteglasset efter Exp.
English: Remaining organs Effective Dose (µSv/MBq)
Danish: Resterende organer Effektiv dosis (µSv/MBq)
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.
Danish: Dets modtagelse, opbevaring, anvendelse, overdragelse og bortskaffelse er underlagt regler og passende tilladelser fra de lokale, kompetente, officielle myndigheder.
English: DaTSCAN contains alcohol (ethanol) 5 % by volume.
Danish: DaTSCAN indeholder alkohol (ethanol), 5 volumen%.
English: Ioflupane binds to the dopamine transporter.
Danish: Ioflupan binder sig til dopamin-transporteren.
English: Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment.
Danish: Deres læge kan synes, at den viden, scanningen har givet, kan hjælpe med til at finde ud af mere om Deres tilstand og ved beslutningen om mulig behandling.
English: Not known: Feeling hot
Danish: Ikke kendt: Varmefølelse
English: For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15cm).
Danish: For højopløsnings collimatorer bør rotationsradius være overensstemmende og så lille som mulig (typisk 11 - 15 cm).
English: Children and adolescents DaTSCAN is not recommended for children aged 0 to 18 years
Danish: Børn og unge DaTSCAN anbefales ikke til børn i alderen 0 til 18 år
English: No interaction studies have been performed in humans.
Danish: Der er ikke udført interaktionsundersøgelser hos mennesker.
English: Resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available.
Danish: Genoplivningsmedicin og -udstyr (f.eks. endotrakealtube og ventilator) skal være til umiddelbar rådighed.
English: Your nuclear medicine doctor will decide the dose that is best for you.
Danish: Deres nuklearmedicinske læge vil fastsætte den dosis, der passer bedst til Dem.
English: Do not exceed 185 MBq and do not use when the activity is below 110 MBq.
Danish: Overstig ikke 185 MBq og anvend ikke DaTSCAN, hvis aktiviteten er under 110 MBq.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ØVRIGE BETINGELSER OG KRAV TIL MARKEDSFØRINGSTILLADELSEN
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 these small amounts of radiation.
Danish: Deres læge og den nuklearmedicinske læge har vurderet at de kliniske fordele ved denne undersøgelse med det "radioaktive lægemiddel", overstiger risikoen for at blive udsat for disse små mængder stråling.
English: • You should not breast-feed your child for 3 days after DaTSCAN is given.
Danish: • De bør ikke amme Deres barn de første 3 dage efter, at der er givet DaTSCAN.
English: I) can be used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
Danish: I) anvendes som surrogat-markør til undersøgelse af de dopaminergiske nigrostriate neuroners integritet.
English: • When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a short time.
Danish: • Når et radioaktivt lægemiddel, injiceres, samler det sig sammen i et specifikt organ eller bestemte dele af kroppen i kort tid.
English: The camera pictures are usually taken 3 to 6 hours after the injection of DaTSCAN.
Danish: Kamerabillederne bliver normalt taget 3 til 6 timer efter injektionen af DaTSCAN.
English: I) results in an absorbed dose to the uterus of 3.0 mGy.
Danish: I) giver en absorberet dosis til uterus på 3,0 mGy.
English: The frequency of side effects is:
Danish: Hyppigheden af bivirkninger er:
English: Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine.
Danish: Deres nuklearmedicinske læge vil foreslå, at De drikker meget væske for at hjælpe kroppen med at slippe af med medicinen.
English: The recommended radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to measure radioactivity).
Danish: Den anbefalede radioaktivitet ved en enkelt injektion er mellem 111 og 185 MBq (megabequerel eller MBq er en enhed, som anvendes til at måle radioaktivitet).
English: Tell your nuclear medicine doctor if you think you might be pregnant.
Danish: Informer den nuklearmedicinske læge, hvis De tror, De kunne være gravid.
English: Angular sampling should preferably be not less than 120 views over 360 degrees.
Danish: Vinklede optagelser bør foretrækkes at være på mindre end 120 registreringer over 360 grader.
English: Ioflupane also binds to the serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
Danish: Ioflupan bindes også til serotonin transportøren på 5-HT neuroner, men med lavere affinitet (ca. 10 gange).
English: Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity.
Danish: Normale optagelser karakteriseres ved to symmetriske halvmåneformede områder af ens intensitet.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøjer eller betjene maskiner
English: Clinical categorisation into the respective dementia group was based on a standardised and comprehensive clinical and neuropsychiatric evaluation.
Danish: Den kliniske klassifikation til den respektive demensgruppe var baseret på en standardiseret og omfattende klinisk og neuropsykiatrisk evaluering.
English: DaTSCAN is contraindicated in pregnancy (see section 4.3).
Danish: DaTSCAN er kontraindiceret ved graviditet (se pkt.
English: Fertility No fertility studies have been performed.
Danish: Fertilitet Der er ikke udført fertilitetsundersøgelser.
English: Animal reproductive toxicity studies have not been performed with this product.
Danish: Undersøgelser om reproduktionstoksicitet hos dyr er ikke udført med dette produkt.
English: Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.
Danish: DaTSCAN kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated.
Danish: Hvis der opstår overfølsomhedsreaktioner, skal indgivelse af lægemidlet straks afbrydes, og om nødvendigt skal intravenøs behandling påbegyndes.
English: I) Intravenous use
Danish: I) Intravenøs anvendelse
English: This is harmful for those suffering from alcoholism and needs to be taken into account in pregnant or breastfeeding women, children and high risk groups such as patients with liver disease or epilepsy.
Danish: Dette er skadeligt for dem, der lider af alkoholisme, og det skal tages med i overvejelserne ved anvendelse hos gravide eller ammende kvinder, børn og højrisikogrupperne, såsom patienter med leversygdom eller epilepsi.
English: The above data are valid in normal pharmacokinetic behaviour.
Danish: Ovennævnte data er valide for normal farmakokinetik.
English: This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer or 2 ml wine.
Danish: Dette lægemiddel indeholder 39,5 g (5 volumen%) ethanol (alkohol) pr. liter, op til 197 mg pr. dosis, svarende til 5 ml øl eller 2 ml vin.
English: • In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer's disease.
Danish: • hos voksne patienter for at hjælpe med til at differentiere mellem sandsynlig demens med Lewy legemer og Alzheimers sygdom.
English: General warning Normal safety precautions for handling radioactive materials should be observed.
Danish: Generel advarsel Normale sikkerhedsforanstaltninger for håndtering af radioaktive stoffer skal overholdes.
English: Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.
Danish: Abnorme optagelser er enten asymmetriske eller med uens intensitet og/eller tab af halvmåneform.
English: SPECT imaging should take place between three and six hours post-injection.
Danish: SPECT billeddannelse skal finde sted mellem tre og seks timer efter injektionen.
English: As the effective dose is 4.63 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.
Danish: Da den effektive dosis er 4,63 mSv, når den maksimalt anbefalede aktivitet på 185 MBq indgives, forventes det, at sandsynligheden for, at disse bivirkninger forekommer, er lav.
English: In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB) (144 subjects), Alzheimer's disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects), the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
Danish: I en udslagsgivende klinisk undersøgelse, der omfattede evaluering af 288 patienter med Lewylegeme-demens (DLB) (144 patienter), Alzheimers sygdom (124 patienter), vaskulær demens (9 patienter) eller andre (11 patienter), blev resultaterne af en uafhængig, blindet visuel vurdering af DaTSCAN-billeder sammenholdt med den kliniske diagnose, som var blevet stillet af læger med erfaring i behandling og diagnostik af demenstilstande.
English: Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant.
Danish: De må ikke få DaTSCAN, hvis De er gravid eller tror, at De muligvis kan være gravid.
English: Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk.
Danish: Inden man indgiver et radioaktivt lægemiddel til en ammende kvinde, bør det overvejes om undersøgelsen med rimelighed kunne udskydes, indtil moderen er ophørt med at amme og om det mest hensigtsmæssige radioaktive lægemiddel er valgt, idet man må tænke på udskillelsen af radioaktivitet i modermælk.
English: You will need to be careful with the water (urine) that you pass - your doctor will tell you what to do.
Danish: De skal være omhyggelig med det vand (urin), De laderDeres læge vil fortælle Dem, hvad De skal gøre.
English: Before you receive DaTSCAN, your nuclear medicine doctor will ask you to take some tablets or liquid that contain iodine.
Danish: Før De får DaTSCAN, vil Deres nuklearmedicinske læge bede Dem om at tage tabletter eller væske, der indeholder jod.
English: When DaTSCAN is injected into an adult, it is carried around the body in the blood.
Danish: Når en voksen får injiceret DaTSCAN, bliver det ført rundt i kroppen med blodet.
English: When DaTSCAN is used, you are exposed to small amounts of radioactivity.
Danish: Når De får DaTSCAN, eksponeres De for en lille mængde radioaktivitet.
English: Contaminated material must be disposed of as radioactive waste via an authorised route.
Danish: Forurenet materiale skal bortskaffes som radioaktivt affald på en autoriseret måde.
English: This has been reported among patients receiving DaTSCAN into a small vein.
Danish: Dette er blevet rapporteret hos patienter, der får DaTSCAN i en lille blodåre.
English: If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding.
Danish: Hvis indgift betragtes som nødvendig, bør amningen afbrydes i 3 dage og erstattes af modermælkserstatning.
English: DaTSCAN is given to you as an injection, usually into a vein in your arm.
Danish: De vil få DaTSCAN som en injektion, sædvanligvis i en blodåre i armen.
English: To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Danish: Bør tages i betragtning hos højrisikogrupper som f.eks. patienter med leversygdom eller epilepsi.
English: To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is recommended.
Danish: For at minimere eventuel smerte ved injektionsstedet anbefales langsom intravenøs injektion i en vene i armen (ikke mindre end 15 til 20 sekunder).
English: Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired.
Danish: Dopaminagonister og antagonister, der virker på de post-synaptiske dopamin-receptorer, forventes ikke at interferere med DaTSCAN billeddannelse og anvendelsen af disse kan derfor fortsættes, hvis det ønskes.
English: Uptake in the brain is rapid, reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours.
Danish: Optagelse i hjernen sker hurtigt, af størrelsesorden omkring 7% af den injicerede aktivitet 10 minutter efter injektionen faldende til 3% efter 5 timer.
English: If you get any side effects, talk to your nuclear medicine doctor.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres nuklearmedicinske læge.
English: The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established.
Danish: DaTSCANs sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1 to 4 hours prior to injection of DaTSCAN.
Danish: Patienterne skal have passende thyreoideablokerende behandling inden injektionen for at minimere optagelse af radioaktivt iod i thyreoidea, f.eks. oral indgift af ca. 120 mg kaliumiodid 1-4 timer, inden DaTSCAN injiceres.
English: After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with the conditions specified by the local competent authority.
Danish: Efter brug skal alt materiale anvendt ved tilberedning og indgift af radioaktive lægemidler, inklusive ethvert ubrugt produkt og dets beholder, dekontamineres eller behandles som radioaktivt affald og bortskaffes i henhold til de betingelser, der er specificeret af den lokale, kompetente myndighed.
English: Experimental studies with a striatal phantom, suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5-4.5 mm for those systems currently in use.
Danish: Forsøg med hjerne fantom har vist at optimale billeder opnås ved at vælge matrix størrelse og zoomfaktorer der giver en pixel-størrelse på 3,5 - 4,5 mm for nuværende systemer.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Eksponering for ioniserende stråling sættes i forbindelse med cancerinduktion og risiko for udvikling af arvelige defekter.
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Danish: Opbevaring af radioaktive lægemidler foregår i henhold til nationale bestemmelser vedrørende radioaktive materialer.
English: DaTSCAN should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia.
Danish: DaTSCAN bør kun anvendes til voksne patienter, som er henvist af læger med erfaring inden for behandling af bevægelsessygdomme og/eller demens.
English: I) is passed into breast milk.
Danish: I) går over i brystmælken.
English: Absorbed radiation dose Gy/MBq
Danish: Absorberet strålingsdosis Gy/MBq
English: Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis.
Danish: Lægemidler som binder med høj affinitet til dopamintransporteren, kan derfor interferere med DaTSCAN diagnosen.
English: The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.63 mSv (per 70 kg individual).
Danish: Den effektive dosis som følge af indgift af 185 MBq DaTSCAN injektion er 4,63 mSv (per 70 kg person).
English: At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.
Danish: 48 timer efter injektionen er ca. 60% af den injicerede radioaktivitet udskilt i urinen, og den fækale udskillelse er beregnet til ca. 14%.
English: The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value from 86.1% to 88.7%.
Danish: Den positive prædiktive værdi varierede fra 78,9% til 84,4% og den negative prædiktive værdi fra 86,1% til 88,7%.
English: When renal or hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be increased.
Danish: Når nyre-eller leverfunktionen er nedsat, kan den effektive dosis og den afsatte stråledosis til organerne muligvis være øget.
English: • In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
Danish: • hos voksne patienter med klinisk usikker Parkinsonisme, f.eks. patienter med tidlige symptomer - med henblik på at differentiere mellem essentiel tremor og Parkinsonisme relateret til idiopatisk Parkinson sygdom, multipel systemisk atrofi og progressiv supranukleær lammelse.