FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood pressure decreased
Danish: Lavt blodtryk
English: Some medicines or substances can affect the way that this medicine works.
Danish: Nogle lægemidler og præparater kan påvirke den måde, dette lægemiddel virker på.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De får dette lægemiddel bliver, da den indeholder vigtige oplysninger.
English: To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Danish: For at gøre det muligt at handle straks i akutte tilfælde skal de nødvendige lægemidler og det nødvendige udstyr, såsom endotrakeal tube og respirator, være umiddelbart tilgængelige.
English: When Striascan is used, you are exposed to small amounts of radioactivity.
Danish: Når De får Striascan, eksponeres De for en lille mængde radioaktivitet.
English: Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system, ATC code: V09AB03.
Danish: Farmakoterapeutisk klassifikation: Radiofarmaka til diagnostisk brug; centralnervesystemet, ATC-kode: V09AB03.
English: Children and adolescents Striascan is not recommended for children and adolescents aged 0 to 18 years.
Danish: Børn og unge Striascan anbefales ikke til børn og unge i alderen 0 til 18 år.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Danish: Den nuklearmedicinske læge vil informere Dem, hvis De skal tage nogen særlige forholdsregler, efter at De har fået dette lægemiddel.
English: As the effective dose is 4.6 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 4,6 mSv, når den maksimalt anbefalede aktivitet på 185 MBq indgives, forventes det, at sandsynligheden for, at disse bivirkninger forekommer, er lav.
English: Angular sampling should preferably be not less than 120 views over 360 degrees.
Danish: Vinklede optagelser bør foretrækkes at være på mindst 120 registreringer over 360 grader.
English: Please refer to section 2 “Striascan contains ethanol.”
Danish: Se afsnit 2 “Striascan indeholder ethanol.”
English: Very common (1/10) Common
Danish: Meget almindelig (1/10) Almindelig
English: I) adopted by ICRP 128 ((International Commission on Radiological Protection ,2015) assumes initial uptake of 31% of the administered activity in the liver, 11% in the lungs, and 4% in the brain.
Danish: I) i henhold til ICRP 128 ((International Commission on Radiological Protection, 2015) er baseret på en formodet indledningsvis optagelse på 31 % af den indgivne aktivitet i leveren, 11 % i lungerne og 4 % i hjernen.
English: This is because the child may receive some of the radioactivity.
Danish: Barnet kan få tilført noget af radioaktiviteten.
English: The complete Summary of Product Characteristics (SmPC) of Striascan is provided as a separate document in the product packaging, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Danish: Det fuldstændige produktresumé for Striascan er indlagt som et separat dokument i pakningen med det formål at give sundhedspersonalet yderligere videnskabelig og praktisk information om administration og brug af dette radioaktive præparat.
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 serotonintransportøren på 5-HT-neuroner, men med lavere affinitet (ca. 10 gange).
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 striatum-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: Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with Striascan 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 Striascan-billeddannelse, og anvendelsen af disse kan derfor fortsættes, hvis det ønskes.
English: Striascan should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia.
Danish: Striascan bør kun anvendes til voksne patienter, som er henvist af læger med erfaring inden for behandling af bevægelsessygdomme og/eller demens.
English: Absorbed radiation dose µGy/MBq
Danish: Absorberet strålingsdosis µGy / MBq
English: At the chemical concentrations used for diagnostic examinations, Striascan does not appear to have any pharmacodynamic activity.
Danish: Ved de kemiske koncentrationer, der anvendes til diagnostiske undersøgelser, har Striascan tilsyneladende ingen farmakodynamisk aktivitet.
English: The quantity to be administered usually recommended for an adult ranges from 110 to 185 MBq (megabecquerel or MBq, the unit used to measure radioactivity).
Danish: Den mængde, der sædvanligvis anbefales indgivet til en voksen, ligger i intervallet fra 110 til 185 MBq (megabequerel eller MBq, som er den enhed, der anvendes til at udtrykke radioaktivitet).
English: EXP: 7 h post-ref.
Danish: EXP: 7 timer post-ref.
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: The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation.
Danish: Patienten skal hydreres tilstrækkeligt inden undersøgelsen og opfordres til at lade vandet så ofte som muligt i de første timer efter undersøgelsen for at reducere strålingen.
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: The effective dose (E) resulting from administration of 185 MBq of Striascan injection is 4.6 mSv (per 70 kg individual).
Danish: Den effektive dosis (E) som følge af indgift af 185 MBq Striascan-injektion er 4,6 mSv (per person på 70 kg).
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: 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 manglende halvmåneform.
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 advice before you are given this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge den nuklearmedicinske læge til råds, før De får dette lægemiddel.
English: Before administration of Striascan you should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.
Danish: Før indgivelse af Striascan bør De drikke masser af vand inden undersøgelsens start, så De kan lade vandet så ofte som muligt i de første timer efter undersøgelsen.
English: (1/100 to <1/10)
Danish: (1/100 til <1/10)
English: Striascan is contraindicated in pregnancy (see section 4.3).
Danish: Striascan er kontraindiceret ved graviditet (se pkt.
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: Administrationsprocedurerne skal udføres på en sådan måde, at risikoen for lægemiddelkontaminering og bestråling af personalet minimeres.
English: This has been reported among patients receiving this product into a small vein.
Danish: Dette er blevet rapporteret hos patienter, der fik dette lægemiddel i en lille blodåre.
English: Injection site pain (intense pain or burning sensation following administration into small veins)
Danish: Smerter på injektionsstedet (intens smerte eller brændende fornemmelse efter indgift i små årer)
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Danish: Dette radioaktive præparat afgiver lave mængder ioniserende stråling, der forbindes med den laveste risiko for cancer og arvelige abnormiteter.
English: The safety and efficacy of Striascan in children and adolescents aged 0 to 18 years has not been established.
Danish: Striascans sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er ikke klarlagt.
English: Route Nationale 306
Danish: CIS bio international Route Nationale 306
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Danish: Indgivelse af radioaktive præparater indebærer risiko for andre personer fra ekstern stråling eller kontaminering fra spild af urin, opkast osv.
English: About 30% of the whole brain activity is attributed to striatal uptake.
Danish: Omkring 30 % af aktiviteten i hele hjernen kan tilskrives optagelse i corpus striatum.
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: Active substances that bind to the dopamine transporter with high affinity may therefore interfere with Striascan diagnosis.
Danish: Aktive stoffer, som binder med høj affinitet til dopamintransporteren, kan derfor interferere med Striascan-diagnosen.
English: Administration of Striascan and conduct of the procedure Before you receive Striascan, your nuclear medicine doctor will ask you to take some tablets or liquid that contain iodine.
Danish: Indgivelse af Striascan og undersøgelsens udførelse Før De får Striascan, vil Deres nuklearmedicinske læge bede Dem om at tage tabletter eller væske, der indeholder jod.
English: Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Danish: Prækliniske data for ioflupan viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkelte og gentagne doser samt genotoksicitet.
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 Striascan.
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 Striascan injiceres.
English: Talk to your nuclear medicine doctor before using this medicine if you have moderate or severe problems with your kidneys or liver.
Danish: Kontakt den nuklearmedicinske læge, før De bruger dette lægemiddel, hvis De har moderate eller svære problemer med nyrer eller lever.
English: During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded.
Danish: I denne periode skal modermælken udmalkes med regelmæssige mellemrum, og den udmalkede mælk skal kasseres.
English: 5 mL vial 48 hours from the end of synthesis (20 hours from the activity reference time stated on the label)
Danish: 5 ml hætteglas 48 timer fra afslutning af syntese (20 timer fra referencetidspunktet for aktivitet angivet på etiketten)
English: Saclay BP 32
Danish: Saclay B.P. 32
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 Lewybody-demens og Alzheimers sygdom.
English: Method of administration Striascan is for intravenous use.
Danish: Administration Striascan er til intravenøs anvendelse.
English: Activity in the liver is excreted according to the Publication 53 gallbladder model (ICRP, 1987), where 30% is eliminated via the gallbladder and the remainder passes directly into the small intestine.
Danish: Aktiviteten i leveren bliver udskilt i henhold til galdeblæremodellen i publikation 53 (ICRP, 1987), hvor 30 % elimineres via galdeblæren, og resten passerer direkte over i tyndtarmen.
English: Precautions to be taken before handling or administering the medicinal product Striascan should be used without dilution.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Striascan skal anvendes uden fortynding.
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 parese.
English: 2.5 mL vial 35 hours from the end of synthesis (7 hours from the activity reference time stated on the label)
Danish: 2,5 ml hætteglas 35 timer fra afslutning af syntese (7 timer fra referencetidspunktet for aktivitet angivet på etiketten)
English: For an administered activity of 185 MBq the typical radiation dose to the target organ (brain) is 3 mGy and the typical radiation doses to the critical organs: liver and colon wall are 16 mGy and 11 mGy, respectively.
Danish: Ved indgift af aktivitet på 185 MBq er den typiske strålingsdosis til målorganet (hjernen) 3 mGy, og de typiske strålingsdoser til de kritiske organer, lever og kolonvæg, er henholdsvis 16 mGy og 11 mGy.
English: Erythema, pruritus, rash, urticaria, hyperhidrosis
Danish: Erythem, kløe, udslæt, urticaria, hyperhidrose
English: Volume: 5 mL
Danish: Volumen: 5 ml
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of Striascan to be used in your case.
Danish: Den nuklearmedicinske læge, der overvåger undersøgelsen, afgør hvilken mængde Striascan, der skal bruges i undersøgelsen af Dem.
English: Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been performed.
Danish: Der er ikke gennemført studier af reproduktionstoksicitet eller med henblik på vurdering af ioflupans karcinogenicitet.
English: I): 74 MBq/mL at reference time
Danish: I): 74 MBq/ml på referencetidspunktet.
English: These include: - amfetamine, - benzatropine, - bupropion, - cocaine, - mazindol, - methylphenidate, - phentermine and - sertraline.
Danish: Dette gælder for: - amfetamin, - benzatropin, - bupropion, - cocain, - mazindol, - methylphenidat, - phentermin og - sertralin.
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: Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window.
Danish: Billederne skal optages med et gammakamera, der er udstyret med en kollimator med høj opløsning og kalibreret til 159 keV photopeak ± 10 % energivindue.
English: Clinical efficacy has been demonstrated across the range 110 to 185 MBq.
Danish: Der er påvist klinisk virkning i intervallet 110 til 185 MBq.
English: In the absence of data, Striascan is not recommended in cases of moderate to severe renal or hepatic impairment.
Danish: I fravær af data fra sådanne studier anbefales Striascan ikke i tilfælde af moderat til svær nyre-eller leverfunktionsnedsættelse.
English: Excipient with known effect This medicinal product contains 39.5 g/L ethanol.
Danish: Hjælpestof, som behandleren skal være opmærksom på Dette lægemiddel indeholder 39,5 g ethanol pr. liter.
English: This medical product is for use in hospitals or in designated nuclear medicine facilities only.
Danish: Dette lægemiddel er udelukkende beregnet til brug på hospitaler eller nuklearmedicinske klinikker.
English: EXP: 20 h post-ref.
Danish: EXP: 20 timer post-ref.
English: If you are breast-feeding, your nuclear medicine doctor may delay the use of this product or ask you to stop breast-feeding.
Danish: Hvis De ammer, kan den nuklearmedicinske læge eventuelt udsætte anvendelsen af dette lægemiddel eller bede Dem om at ophøre med at amme.
English: Medicinal products shown in animal studies not to interfere with Striascan imaging include pergolide.
Danish: Lægemidler, som i dyreforsøg har vist sig ikke at interferere med Striascan-billeddannelse, inkluderer pergolid.
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 vol %) alkohol pr. liter, dvs. op til 197 mg pr. dosis, svarende til 5 ml øl eller 2 ml vin.
English: The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter)
Danish: Værdierne er beregnet under forudsætning af urinblæretømning hver 4.8 time og passende thyreoideablokerende behandling (Iod-123 er en kendt Auger elektron emitter).
English: I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection.
Danish: I) forsvinder hurtigt fra blodet efter intravenøs injektion; 5 minutter efter injektionen er kun 5 % af den indgivne aktivitet tilbage i helblod.
English: When this medicine is injected into a patient, it is carried around the body in the blood and collects in a small area of your brain.
Danish: Efter indsprøjtning fordeles lægemidlet i kroppen via blodet og samler sig i små områder af hjernen.
English: Dizziness, formication (paraesthesia), dysgeusia
Danish: Svimmelhed, myrekryb (paræstesi), dysgeusi
English: I) you are given is passed into breast milk.
Danish: I), De får, går over i brystmælken.
English: In the event of administration of a radiation overdose, frequent micturition and defaecation should be encouraged in order to minimise radiation dose to the patient.
Danish: I tilfælde af indgivelse af strålingsoverdosis bør man tilskynde til hyppig vandladning og afføring for at minimere strålingsdosis til patienten.
English: Striascan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:
Danish: Striascan er indiceret til bestemmelse af tab af dopaminerge nerveender i striatum:
English: Symbol of radioactivity
Danish: Radioaktivitetssymbol
English: 25.0 µSv/MBq
Danish: 25,0 μSv/MBq
English: In a 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 ioflupane (
Danish: Kliniske forsøg hos patienter med Lewy-body-demens I et klinisk forsøg, der omfattede evaluering af 288 patienter med Lewy-body-demens (DLB) (144 patienter), Alzheimers sygdom (124 patienter), vaskulær demens (9 patienter) eller anden sygdom (11 patienter), blev resultaterne af en uafhængig, blindet visuel vurdering af ioflupan (
English: Striascan is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.
Danish: Striascan er ikke i stand til at differentiere mellem Parkinsons sygdom, multipel systemisk atrofi og progressiv supranukleær parese.
English: Formal studies have not been carried out in patients with significant renal or hepatic impairment.
Danish: Der er ikke udført formelle studier hos patienter med signifikant nedsat nyre- eller leverfunktion.
English: Analyses in which both possible and probable DLB patients were compared with nonDLB dementia patients demonstrated values for the sensitivity of ioflupane (
Danish: Analyser, i hvilke både mulige og sandsynlige DLB-patienter blev sammenlignet med ikke-DLB-demenspatienter, viste sensitivitetsværdier for ioflupan (
English: Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia.
Danish: Striascan er ikke i stand til at differentiere mellem Lewy-body-demens og demens ved Parkinsons sygdom.
English: Active substances shown during clinical trials not to interfere with Striascan imaging include: - amantadine, - trihexyphenidyl, - budipine, - levodopa, - metoprolol, - primidone, - propranolol and - selegiline.
Danish: Aktive stoffer, der i kliniske studier er påvist ikke at påvirke Striascan-billeddannelsen, inkluderer: - amantadin, - trihexyphenidyl, - budipin, - levodopa, - metoprolol, - primidon, - propanolol og - selegilin.
English: I) images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
Danish: billeder sammenholdt med den kliniske diagnose, som var blevet stillet af læger med erfaring i behandling og diagnostik af demenstilstande.
English: - Hypersensitivity (allergic) - Shortness of breath - Redness of the skin - Itching - Rash - Hives (urticaria) - Excessive sweating - Vomiting - Low blood pressure - Feeling hot.
Danish: - Overfølsomhed (allergi) - Åndenød - Rødme af huden - Kløe - Udslæt - Nældefeber (urticaria) - Øget svedtendens - Opkastning - Lavt blodtryk - Varmefølelse
English: Tell your nuclear medicine doctor if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til den nuklearmedicinske læge, hvis De bruger anden medicin eller har gjort det for nylig.
English: 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as non-DLB patients.
Danish: Endvidere viste analyserne specificitet fra 81,3 % til 83,9 %, når de mulige DLB-patienter blev inkluderet som ikke-DLBpatienter.
English: The vial is placed into a lead container for protective shielding and packed in a metal box.
Danish: Hætteglasset er anbragt i en beskyttende blybeholder og leveres i en metalæske.
English: E 1510 (see leaflet for further information), E 260, E 262, E 338, water for injections.
Danish: E1510 (se indlægssedlen for yderligere oplysninger), E260, E262, E338, vand til injektionsvæsker.
English: 15 mL amber glass vial sealed with a rubber closure and metal overseal.
Danish: Ravgule 15 ml hætteglas forseglet med et gummilukke og metalforsegling.
English: After administration of Striascan, you should urinate frequently in order to eliminate the product from your body.
Danish: Efter indgivelse af Striascan skal De lade vandet hyppigt, så lægemidlet kan komme ud af kroppen.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Danish: Hvis gravide udsættes for undersøgelser med radionukleider, involverer det også strålingsdoser til fosteret.