natgillin/translations-raw huggingface dataset:
Medicinen bruges ved diagnosticering af: • bevægelsesforstyrrelser som dem, der ses ved Parkinsons sygdom og beslægtede sygdomme, hvor tab af nerveceller i striatum medfører rysten, gangforstyrrelser og muskelstivhed.
The medicine is used to help in the diagnosis of: • movement disorders such as those seen in Parkinson’ s disease and other related diseases, where a loss of striatal nerve cells in the brain leads to tremor (shaking), gait disturbance and stiffness of muscles.
De samme symptomer optræder imidlertid også ved "essentiel tremor" (rysten af ukendt årsag).
But these disorders can also occur in ‘ essential tremor’ (tremor whose cause is not known).
DaTSCAN anvendes til at skelne mellem Parkinsons sygdom og essentiel tremor. • demens (tab af intellektuel funktion):
DaTSCAN is used to help distinguish between Parkinson’ s disease and essential tremor. • dementia (loss of intellectual function):
DaTSCAN anvendes til at skelne mellem en form for demens, der kaldes "Lewy body demens", og Alzheimers sygdom.
DaTSCAN is used to help distinguish between a type of dementia known as ‘ dementia with Lewy bodies ’ from Alzheimer’ s disease.
DaTSCAN må kun anvendes til patienter, der er henvist af en læge med erfaring i behandling af bevægelsesforstyrrelser eller demens.
DaTSCAN should only be used in patients who have been referred by a doctor who has experience in the management of movement disorders or dementia.
DaTSCAN må kun håndteres og indgives af personer med erfaring i sikker håndtering af radioaktivt materiale.
DaTSCAN will only be handled and given by people who have experience in the safe handling of radioactive material.
Når patienterne får DaTSCAN, skal de også have anden medicin (såsom iodtabletter), der forhindrer skjoldbruskkirtlen i at optage iod fra DaTSCAN.
When receiving DaTSCAN, patients must also take another medicine (such as iodine tablets) to prevent their thyroid gland from taking up the iodine contained in DaTSCAN.
Denne medicin skal tages 1 til 4 timer før og 12 til 24 timer efter DaTSCAN.
This is taken 1 to 4 hours before and 12 to 24 hours after DaTSCAN.
Efter 3 til 6 timer foretages scanningen.
DaTSCAN is given by slow intravenous injection (not less than 15 to 20 seconds) into an arm vein, and a scan is taken 3 to 6 hours after the injection.
Det indeholder et stof, ioflupan, der er mærket med 123I (iod- 123), en radioaktiv form af grundstoffet iod.
It contains a substance, ioflupane, that has been labelled with 123I (iodine-123), a radioactive form of the chemical element iodine.
Ioflupan bindes specifikt til strukturer på overfladen af de terminaler af nervecellerne i hjernens striatum- område, der er ansvarlige for transport af dopamin.
Ioflupane binds specifically to structures on the surface of nerve cell endings in the striatum area of the brain that are responsible for the transport of dopamine.
Når DaTSCAN indsprøjtes i patienten, fordeler ioflupan (123I) sig i kroppen via blodbanen og samler sig i striatum, hvor det bindes til transportstrukturerne.
When DaTSCAN is injected into a patient, ioflupane (123I) is distributed in the body via the bloodstream and accumulates in the striatum, where it binds to the transporter structures.
Denne binding kan ses ved hjælp af en særlig billeddannelsesteknik, der kaldes enkeltfotonemissionstomografi (SPECT), som finder det radioaktive 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The binding can be seen using a special imaging technique called single photon emission computed tomography 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged iod- 123.
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Hvis der er sket tab af nerveceller indeholdende dopamin (som det typisk er tilfældet hos patienter med Parkinsons sygdom), vil billedet vise stærkt nedsat binding af DaTSCAN.
If there is a loss of nerve cells containing dopamine (as occurs typically in patients with Parkinson’ s disease) the binding of DaTSCAN is greatly reduced and this can be seen on the scan.
Til Parkinsons sygdom blev DaTSCAN undersøgt hos 254 patienter i to undersøgelser.
In Parkinson’ s disease, DaTSCAN has been studied in 254 patients in two studies.
I begge undersøgelser blev billederne fra raske forsøgspersoner (45 i alt) sammenholdt med billeder fra patienter med Parkinsons sygdom (180 patienter) eller essentiel tremor (29 patienter).
In both studies, images obtained in healthy volunteers (45 in total) were compared to those in patients with Parkinson’ s disease (180 patients) or essential tremor (29 patients).
Til demens er DaTSCAN undersøgt hos 288 patienter, der havde fået stillet diagnosen Lewy body demens, Alzheimers sygdom eller andre former for demens.
In dementia, DaTSCAN has been studied in 288 patients who had been diagnosed with either dementia with Lewy bodies or Alzheimer’ s disease, as well as some other forms of dementia.
I alle undersøgelserne blev virkningen bedømt ved at sammenligne diagnosen fra scanningen med en diagnose stillet af en speciallæge.
In all studies, the measure of effectiveness was the accuracy of the diagnosis based on the images from the scan compared to the diagnosis made by a specialist doctor.
Hvilken fordel viser undersøgelserne, der er ved DaTSCAN?
What benefit has DaTSCAN shown during the studies?
I hovedundersøgelsen af patienter med Parkinsons sygdom og essentiel tremor var følsomheden af DaTSCAN 96, 5%.
In the main study of patients with Parkinson’ s disease and essential tremor, the sensitivity of DaTSCAN was 96.5%.
Det vil sige, at den diagnose, lægerne havde stillet ved hjælp af billeder optaget med DaTSCAN, i 96, 5% af tilfældene svarede til den diagnose, patienterne havde i forvejen.
This means that the disease identified by the doctor reading the images obtained using DaTSCAN matched the existing diagnostic of the patients in 96.5% of cases.
Følsomheden af DaTSCAN til at skelne formodet Lewy body demens fra andre typer demens lå mellem 75, 0 og 80, 2%.
The values for the sensitivity of DaTSCAN to distinguish probable dementia caused by Lewy bodies from other types of dementia ranged from 75.0 to 80.2%.
Sædvanlige bivirkninger af DaTSCAN, er øget appetit, hovedpine, myrekryb og svimmelhed.
Common side effects observed with the use of DaTSCAN are increased appetite, headache, formication (a sensation of something crawling on or under the skin), and vertigo (a spinning sensation).
Den fuldstændige liste over de indberettede bivirkninger for DaTSCAN fremgår af indlægssedlen.
For the full list of all side effects reported with DaTSCAN, see the Package Leaflet.
DaTSCAN bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for ioflupan eller andre af indholdsstofferne, eller hos gravide kvinder.
DaTSCAN should not be used in people who may be hypersensitive (allergic) to ioflupane or any of the other ingredients, or in women who are pregnant.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved DaTSCAN opvejer risiciene som et diagnostisk hjælpemiddel, der gør det lettere at skelne essentiel tremor fra Parkinson - syndromer beslægtet med idiopatisk Parkinsons sygdom, multipel systematrofi og progressiv supranukleær lammelse, og at skelne formodet Lewy body demens fra Alzheimers demens.
The Committee for Medicinal products for Human Use (CHMP) decided that DaTSCAN’ s benefits are greater than its risks as a diagnostic agent to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’ s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy, and to help differentiate probable dementia with Lewy bodies from Alzheimer ’ s dementia.
Udvalget anbefalede udstedelse af markedsføringstilladelse for DaTSCAN.
The committee recommended that DaTSCAN be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for DaTSCAN til GE Healthcare Limited den 27. juli 2000.
The European Commission granted a marketing authorisation valid throughout the European Union for DaTSCAN to GE Healthcare Limited on 27 July 2000.
Denne tilladelse blev fornyet den 27. juli 2005.
The marketing authorisation was renewed on 27 July 2005.
Den fuldstændige EPAR for DaTSCAN kan ses her.
The full EPAR for DaTSCAN is available here.
Intravenøs anvendelse Hætteglas (glas)
Intravenous use
DaTSCAN 74 MBq/ ml injektionsvæske, opløsning
DaTSCAN 74 MBq/ ml solution for injection
Ioflupan (123I) 74 MBq/ ml på referencetidspunktet for aktivitet (0, 07 – 0, 13 μg/ ml af Ioflupan).
Ioflupane (123I) 74 MBq/ ml at reference time (0.07-0.13 μ g/ ml of ioflupane).
2, 5 ml hætteglas indeholder 185 MBq og 5 ml hætteglas indeholder 370 MBq ioflupan (123I) (specifik aktivitet området 2, 5 – 4, 5 x 1014 Bq/ mmol) på referencetidspunktet.
2.5 ml vials contain 185 MBq and 5 ml vials contain 370 MBq ioflupane (123I) (specific activity range 2.5-4.5 x 1014 Bq/ mmol) at reference time.
Dette lægemiddel indeholder 5 volumen% ethanol.
This medicinal product contains 5% volume ethanol.
Klar, farveløs opløsning.
Clear colourless solution
• hos patienter med klinisk usikker Parkinsonisme, med henblik på at skelne mellem essentiel tremor og Parkinsonisme relateret til idiopatisk Parkinson sygdom, multipel systemisk atrofi og progressiv supranukleær lammelse.
• In patients with clinically uncertain Parkinsonian Syndromes, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’ s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
DaTSCAN er ikke i stand til at skelne mellem Parkinsons sygdom, multipel systemisk atrofi og progressiv nukleær lammelse. • For at hjælpe med til at skelne mellem sandsynlig demens med Lewy legemer og Alzheimers sygdom.
DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. • To help differentiate probable dementia with Lewy bodies from Alzheimer’ s disease.
DaTSCAN er ikke i stand til at skelne mellem demens med Lewy legemer og demens ved Parkinsons sygdom.
DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’ s disease dementia.
DaTSCAN bør kun anvendes til patienter som er henvist af læger med erfaring indenfor behandling af bevægelsessygdomme og/ eller demens.
DaTSCAN should only be used in patients referred by physicians experienced in the management of movement disorders and/ or dementia.
Radioaktive lægemidler må kun anvendes af kvalificeret personale, med en af myndighederne godkendt autorisation til brug og håndtering af radionukleider i dertil indrettede kliniske omgivelser.
Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting.
DaTSCAN er en 5% (v/ v) ethanolopløsning til intravenøs injektion, og den skal bruges ufortyndet.
DaTSCAN is a 5% (v/ v) ethanolic solution for intravenous injection and should be used without dilution.
Der er påvist klinisk anvendelighed i området 111– 185 MBq.
Clinical efficacy has been demonstrated across the range 111-185 MBq.
Overstig ikke 185 MBq og anvend ikke, hvis aktiviteten er under 110 MBq.
Do not exceed 185 MBq and do not use when the activity is below 110 MBq.
I tilfælde af overdosering, henvises til afsnit 4. 9.
In the event of overdosage, refer to section 4.9.
2 For at minimere eventuel smerte ved injektionsstedet, anbefales en langsom intravenøs injektion via en armvene (ikke mindre end 15 – 20 sekunder).
To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15-20 seconds) via an arm vein is recommended.
Patienterne skal have passende thyreoideablokerende behandling forud for injektionen for at minimere skjoldbruskkirtelens optagelse af radioaktivt iod, for eksempel ved oral administration af cirka 120 mg kaliumiodid 1 – 4 timer inden injektion og igen 12 – 24 timer efter injektion af DaTSCAN.
2 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 1-4 hours prior to injection and again 12-24 hours post-injection of DaTSCAN.
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.
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.
Abnorme optagelser er enten asymmetriske eller med uens intensitet og/ eller tab af halvmåneform.
Abnormal images are either asymmetric or symmetric with unequal intensity and/ or loss of crescent.
DaTSCAN anbefales ikke til brug hos børn eller unge på grund af mangel på data vedrørende sikkerhed og effekt.
DaTSCAN is not recommended for use in children or adolescents due to a lack of data on safety and efficacy.
Der er ikke udført formelle studier på patienter med signifikant dårlig nyre- eller leverfunktion.
Formal studies have not been carried out in patients with significant renal or hepatic impairment.
I fravær af data fra sådanne studier, anbefales DaTSCAN ikke i tilfælde af moderat til svær nyre- eller leverfunktionsnedsættelse.
In the absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment.
Dette lægemiddel indeholder 5 volumen% ethanol (alkohol), op til 197 mg pr. dosis, svarende til 5 ml øl eller 2 ml vin.
This medicinal product contains 5% volume ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer, 2 ml wine.
Bør tages i betragtning hos højrisikogrupper som f. eks. patienter med leversygdom eller epilepsi.
To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Ioflupan binder sig til dopamin- transporteren.
Ioflupane binds to the dopamine transporter.
Dette gælder for amfetamin, benzatropin, buspiron, kokain, mazindol, methylphenidat, phentermin og sertralin.
These include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.
3 receptorer, forventes ikke at interferere med DaTSCAN billeddannelse og anvendelsen af disse kan derfor fortsættes, hvis det ønskes.
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.
Lægemidler, som i dyreforsøg har vist sig ikke at interferere med DaTSCAN billeddannelse, inkluderer pergolid.
Drugs shown in animal studies not to interfere with DaTSCAN imaging include pergolide.
DaTSCAN er kontraindiceret ved graviditet.
DaTSCAN is contraindicated in pregnancy.
Hvis gravide udsættes for undersøgelser med radionukleider medfører det også strålingsdoser til fosteret.
Radionuclide procedures carried out on pregnant women also involve
Indgift af ioflupan (123I) i en dosis på 185 MBq giver en absorberet dosis til uterus på 3, 0 mGy.
Administration of ioflupane (123I) at a dose of 185 MBq results in an absorbed dose to the uterus of 3.0 mGy.
En strålingsdosis over 0, 5 mGy vil blive betragtet som en mulig risiko for fosteret.
A radiation dose above 0.5 mGy would be regarded as a potential risk to the foetus.
Hvis det er nødvendigt at indgive radioaktive lægemidler til fødedygtige kvinder, skal der altid indhentes information om graviditet.
Where it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Enhver kvinde, som har sprunget en menstruation over, skal opfattes som gravid indtil det modsatte er bevist.
Any woman who has missed a period should be assumed pregnant until proven otherwise.
Hvor der er uvished, er det vigtigt, at udsættelsen for stråling bliver mindst mulig, foreneligt med at opnå tilfredsstillende optagelser.
Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving satisfactory imaging.
Alternative teknikker, som ikke medfører ioniserende stråling, bør overvejes.
Alternative techniques which do not involve ionising radiation should be considered.
Det vides ikke, om ioflupane [123I] udskilles i modermælk.
It is not known whether ioflupane (123I) is excreted in human milk.
4. 7 Virkninger på evnen til at føre motorkøretøjer eller betjene maskiner
4.7 Effects on ability to drive and use machines
Følgende almindelige (≥1/ 100 til < 1/ 10) bivirkninger er set i forbindelse med DaTSCAN:
The following common (≥ 1/ 100 to < 1/ 10) side effects are recognised for DaTSCAN:
Stofskiftesygdomme og ernæringsbetingede sygdomme Øget appetit
Metabolism and nutrition disorders Appetite increased
Sygdomme i nervesystemet Hovedpine Myrekryb (paræstesier)
Nervous system disorders Headache Formication (paraesthesia)
Sygdomme i det ydre og det indre øre Vertigo
Ear and labyrinth disorders Vertigo
Følgende usædvanlige (≥1/ 1. 000 til < 1/ 100) bivirkninger er set i forbindelse med DaTSCAN:
The following uncommon (≥ 1/ 1,000 to ≤ 1/ 100) side effects are recognised for DaTSCAN:
Almene lidelser og reaktioner på indgivelsesstedet Smerter på injektionsstedet (intens smerte efter indgift i små vener)
General disorders and administration site conditions Injection site pain (intense pain following administration into small veins)
For hver patient, bør udsættelsen for ioniserende stråling opvejes i forhold til det forventede udbytte.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Den indgivne aktivitet skal være af en sådan størrelse, at den totale strålingsdosis er så lav som det er muligt at opnå, under hensyntagen til opnåelse af det tilsigtede diagnostiske
The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.
Udsættelse for ioniserende stråling er forbundet med kræft fremkaldelse og risiko for udvikling af arvelige defekter.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Den aktuelle viden tyder på, at når det gælder diagnostiske nuklearmedicinske undersøgelser, vil disse bivirkninger være af minimal forekomst, på grund af den lave strålingsdosis, man udsættes for.
For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse events will occur with negligible frequency because of the low radiation dose incurred.
I tilfælde af overdosering af radioaktivitet, bør man tilskynde hyppig vandladning og afføring for at minimere strålingsdosis til patienten.
In cases of overdosage of radioactivity, frequent micturition and defaecation should be encouraged in order to minimise radiation dosage to the patient.
Diagnostisk radioaktivt lægemiddel til billeddannelse af centralnervesystemet, ATC kode:
Diagnostic radiopharmaceutical for central nervous system imaging, ATC code:
Ioflupan er en kokain analog.
Ioflupane is a cocaine analogue.
Dyrestudier har vist, at ioflupan binder med høj affinitet til den præsynaptiske dopamin- transporter, derfor kan radioaktivt mærket ioflupan (123I) anvendes som surrogat- markør til undersøgelse af de dopaminergiske nigrostriate neuroners integritet.
Studies in animals have shown that ioflupane binds with high affinity to the presynaptic dopamine transporter and so radiolabelled ioflupane (123I) can be used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
10 gange).
Ioflupane also binds to the serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
I en udslagsgivende klinisk undersøgelse, der omfattede evaluering af 288 patienter med Lewy- legeme- 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.
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.
DaTSCANs sensitivitetsværdier til bestemmelse af sandsynlig DLB fra ikke- DLB varierede fra 75, 0% til 80, 2% og specificiteten fra 88, 6% til 91, 4%.
The values for the sensitivity of DaTSCAN in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%.
Den positive prædiktive værdi varierede fra 78, 9% til 84, 4% og den negative prædiktive værdi fra 86, 1% til 88, 7%.
The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value from 86.1% to 88.7%.
Endvidere viste analyserne specificitet fra 81, 3% til 83, 9%, når de mulige DLB- patienter blev inkluderet som ikke- DLB- patienter.
Analyses in which both possible and probable DLB patients were compared with non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0% to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as non-DLB patients.
Når de mulige DLB- patienter blev inkluderet som DLB- patienter, varierede sensitiviteten mellem 60, 6% og 63, 4%, mens specificiteten varierede mellem 88, 6% og 91, 4%.
The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.
Omkring 30% af aktiviteten i hele hjernen kan tilskrives
About 30% of the whole brain activity is attributed to striatal uptake.
14%.
At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.
Akutte toksicitetsundersøgelser med ioflupan i doser på 0, 06 mg/ kg, over 6. 500 gange den maksimale humane enkeltdosis på basis af legemsvægt (70 kg), kunne ikke påvise nogen mortalitet eller tegn på systemisk toksicitet hos rotter eller kaniner.
Acute toxicity studies employing ioflupane at dosage levels of 0.06 mg/ kg, in excess of 6,500 times the maximum human (70 kg) single dose on a bodyweight basis, failed to reveal any mortality or signs of systemic toxicity in rats or rabbits.
I undersøgelser med 14 dages gentagen dosering blev der ikke observeret nogen tegn på toksicitet hos rotter eller kaniner efter daglige doser på 0, 6 mg/ kg ioflupan, mere end 65. 000 gange den maksimale humane enkeltdosis på basis af legemsvægt (70 kg).
In 14 day repeat dose studies no evidence of toxicity was observed in rats or rabbits following daily doses of 0.6 mg/ kg ioflupane, more than 65,000 times the maximum
I disse undersøgelser blev der observeret påvirkning af adfærd, som følge af farmakologisk aktivitet.
Behavioural effects due to pharmacological activity were observed in these studies.
Der er ikke udført undersøgelser om reproduktionstoksicitet.
Studies on reproductive toxicity have not been conducted.
Ioflupan viste ikke tegn på mutagent potentiale i in vitro eller in vivo mutagenicitets undersøgelser.
Ioflupane showed no evidence of mutagenic potential in in vitro or in vivo mutagenicity studies.
Der er ikke udført undersøgelser for at bestemme ioflupans carcinogene potentiale.
Studies to assess the carcinogenic potential of ioflupane have not been performed.