FrancophonIA/ELRC3.0 huggingface dataset:
English: Add more distilled water or sodium chloride as needed for subsequent use always maintaining some undissolved sodium chloride at the bottom of the chamber.)
Danish: Tilsæt efter behov mere destilleret vand eller natriumklorid ved senere anvendelse for altid at have noget uopløst natriumklorid på bunden af karret.)
English: CAUTION: Do not allow the sides of the strip to contact the side of the tank.
Danish: ADVARSEL: Siderne af strippene må ikke komme i berøring med karrene.
English: These receptors are hyper-expressed by malignant tumours.
Danish: Disse receptorer er overeksprimerede ved maligne tumorer.
English: Solid sodium chloride should remain at the bottom of the jar; if there is no residue, add more solid sodium chloride and shake again for 10 to 15 minutes.
Danish: Fast natriumklorid bør forblive på bunden af karret, hvis der ikke er nogen rest tilbage, tilsæt mere fast natriumklorid og ryst igen i 10 til 15 minutter.
English: Technetium-99m disintegrates by isomeric transition with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium-99, which can be regarded as quasi stable.
Danish: Technetium-99m disintegrerer ved isomerisk transition under emission af gammastråling med en energi på 140 keV og en halveringstid på 6 timer til technetium-99, som kan anses for at være kvasi
English: Due to the short, six-hour half-life of technetium-99m, less than 0.1% of the radioactivity remains
Danish: På grund af den korte, seks timers halveringstid af technetium-99m, findes mindre en 0,1% af radioaktiviteten 60 timer efter administrationen.
English: For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse events will occur with low frequency because of the low radiation doses incurred.
Danish: For diagnostiske nuklearmedicinske undersøgelser tyder de nuværende beviser på, at disse bivirkninger vil opstå med lav hyppighed, på grund af den lave strålingsdosis, patienterne
English: Care should be exercised in patients with reduced liver function.
Danish: Forsigtighed bør udvises hos patienter med nedsat leverfunktion.
English: SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99mTc-depreotide injection are required for optimal image interpretation.
Danish: SPECT (Single Photon Emission Computed Tomography) billeder opnået mellem 2 og 4 timer efter 99mTc-depreotid injektion er nødvendig for optimal billedtydning.
English: Instructions for the preparation of 99mTc-depreotide:
Danish: Instruktioner for tilberedning af 99mTc-depreotid:
English: The activity of 99mTc-depreotide administered to the patient should be measured using a suitably calibrated dose calibrator immediately prior to administration to the patient.
Danish: 99mTc-depreotid aktivitet administreret til patienten bør måles ved anvendelse af egnet kalibreret dosiskalibrator umiddelbart før administration til patienten.
English: Based on human data, the absorbed radiation doses by individual organs of an average human adult (70 kg) from an intravenous injection of the agent are listed below.
Danish: Baseret på humane data er den absorberede stråledosis, i de enkelte organer hos en gennemsnits voksen (70 kg) fra en intravenøs injektion af stoffet fremstillet i nedenstående tabel.
English: Stannous chloride dihydrate 50 micrograms (essential excipient)
Danish: Stannochloriddihydrat 50 mikrogram (essentielt hjælpestof)
English: Therapy with octreotide acetate can produce severe hypoglycaemia in patients with insulinomas, and other somatostatin analogues are known to impair glucose tolerance.
Danish: Behandling med octreotidacetat kan medføre alvorlig hypoglykæmi hos patienter med insulinomer, og andre somatostatin analoger er kendt for at nedsætte glucose tolerance.
English: One 1 ml syringe and 21-gauge needle Suitable counting equipment
Danish: Én 1 ml sprøjte og 21-gauge kanyle Passende målingsudstyr
English: May be prepared by adding about five grams of sodium chloride to the bottom of one chromatography chamber; add approximately 10 millilitres of distilled water to the solid sodium chloride and shake periodically during 10 to 15 minutes.
Danish: Kan fremstilles ved, at tilsætte cirka fem gram natriumklorid til bunden af det ene kromatografikar; tilsæt cirka 10 milliliter destilleret vand til det faste natriumklorid og ryst periodisk i 10 til 15 minutter.
English: In the absence of incompatibility studies, 99mTc-depreotide must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør 99mTc-depreotid ikke blandes med andre lægemidler.
English: Testes
Danish: Testikler
English: Mark two Gelman ITLC-SG strips with a light pencil at 1 cm from the bottoms of each.
Danish: Markér to Gelman ITLC-SG strips med en blyant 1 cm fra bunden af hver strip.
English: SPECIAL STORAGE CONDITIONS Store in a freezer at or below -10 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i dybfryser ved -10°C eller derunder.
English: Safety and effectiveness of 99mTc-depreotide were established using investigational material shown to have a radiochemical purity of at least 90% by ITLC prior to administration to patients
Danish: Sikkerhed og effektivitet af 99mTc-depreotid blev fastslået ved at bruge undersøgelsesmateriale med en strålingskemisk renhed på mindst 90% ved ITLC før administrationen til patienter i
English: Add distilled water up to the 50 ml mark, mix thoroughly.
Danish: Tilsæt destilleret vand op til 50 ml mærket, bland godt.
English: For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Danish: Til scintigrafisk billedfremstilling ved mistanke om maligne tumorer i lungen efter initial påvisning, i kombination med CT-scanning eller røntgen af thorax hos patienter med isolerede lungeknuder.
English: Two Gelman ITLC-SG strips (2 cm x 10 cm) Two developing tanks and covers
Danish: To Gelman ITLC-SG strips (2 cm x 10 cm) To udviklingskar og låg
English: Plasma radioactivity is predominantly (>90%) in parent form, i.e. as 99mTc-depreotide.
Danish: Plasma radioaktiviteten er overvejende (>90%) i den oprindelig form, d.v.s. som 99mTc-depreotid.
English: The labelling reaction involved in the preparation of 99mTc-depreotide depends upon maintaining tin in the divalent (reduced) state.
Danish: Mærkningsreaktionen involveret i fremstillingen af 99mTc-depreotid er afhængig af opretholdelse af tin i divalent (reduceret) form.
English: The evaluation also includes examinations by CT-scan
Danish: Vurderingen inkluderer også undersøgelse med CT-scanner eller røntgen af
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Danish: Hvis en bivirkning bliver alvorlig eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge.
English: Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG MAM strip
Danish: Radioaktivitet i bunden af stykket af ITLC-SG MAM strippen (Rf 0 - 0,40) A = 100 x -----------------------------------------------------------------------------------------Total radioaktivitet i begge stykker af ITLC-SG MAM strippen
English: However, histology was predominantly obtained by fine needle aspiration (FNA) with 5 out of 49 patients having open thoracotomies.
Danish: Imidlertid udførtes histologi ved hjælp af finnålsaspiration (FNA) med 5 af 49 patienter, som undergik åben thoracotomi.
English: Percent technetium (99mTc) pertechnetate, technetium-99m labelled glucoheptonate and
Danish: Procent technetium (99mTc) pertechnetat, technetium-99m mærket glucoheptonat og technetium
English: Most frequently reported were headache, nausea, vomiting, diarrhoea, abdominal pain, dizziness, flushing and fatigue.
Danish: De hyppigst rapporterede var hovedpine, kvalme, opkastning, diarré, smerter
English: 99mTc-depreotide, must be handled with care, and appropriate safety measures should be used to minimise radiation exposure to clinical personnel.
Danish: 99mTc-depreotid bør behandles med forsigtighed, og tilfredsstillende sikkerhedsforanstaltninger skal anvendes for at minimere strålingseksponering af personale.
English: Place the strips upright in the respective developing solvent such that the spot is above the solvent line and the top of each strip leans against the side of the tank.
Danish: Anbring strippene i opret position i de respektive udviklingsvæsker, så pletten er over væskelinjen, og toppen af hver strip læner sig op ad siden
English: The negative predictive value was 87.5% (CI 66.5-96.7%) for all lesions and 87.5% for lesions equal to or less than 3cm.
Danish: Negativ prædiktiv værdi var 87,5% (konfidensinterval 66,596,7%) for alle læsioner, og 87,5% for læsioner af størrelsen 3 cm eller mindre.
English: 18 months.
Danish: 6.3 Opbevaringstid 18 måneder.
English: Radiolabelled NeoSpect is administered as a single injection into a vein.
Danish: Radioaktivt mærket NeoSpect gives som en enkelt indsprøjtning i en vene.
English: 99mTc-depreotide was not mutagenic in vitro in the Ames test or mouse lymphoma test, and it was not clastogenic in vivo in the mouse micronucleus test.
Danish: 99mTc-depreotid var ikke mutagent in vitro i Ames test eller i muselymfom test, og det var ikke clastogent in vivo i muse micronucleus testen.
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the local competent official organisations.
Danish: Modtagelse, opbevaring, brug, transport og bortskaffelse skal udføres i henhold til regulativer og/eller
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Danish: Hvis du tager eller for nylig har taget andre lægemidler, bør du oplyse din læge eller apoteket herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.
Danish: Brugeren bør hele tiden anvende vandtætte handsker og anvende afskærmning under håndtering af hætteglas og sprøjter indeholdende den radioaktive
English: Remove the strip from the tank and allow the strip to dry behind a lead shield.
Danish: Fjern strippen fra karret og lad den tørre bag en blyafskærmning.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke lavet undersøgelser vedrørende påvirkningen af evnen til at føre bil eller betjene maskiner.
English: Do not use bacteriostatic sodium chloride solution for injection as a diluent for pertechnetate, because it might adversely affect the radiochemical purity and, hence, the biological distribution of the
Danish: Anvend ikke bakteriostatisk natriumklorid injektionsvæske, opløsning som fortynder til pertechnetat, da det kan have en negativ påvirkning på den strålekemiske renhed og dermed den
English: After reconstitution, store at 15 °C - 25 °C and use within 5 hours.
Danish: Efter rekonstitution, opbevaring ved 15°C - 25°C og anvendelse indenfor 5 timer.
English: 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.
Danish: Den indgivne aktivitet skal resultere i en strålingsdosis, der er så lav som muligt, men samtidig stor nok til, at det ønskede diagnostiske resultat kan opnås.
English: Care should also be taken to minimise radiation exposure to the patient, consistent with proper patient management.
Danish: Forsigtighed skal også udvises for at formindske strålingseksponering af patienten, i henhold til korrekt patientbehandling.
English: - The other ingredients are sodium glucoheptonate dihydrate, stannous chloride dihydrate,
Danish: - De øvrige indholdsstoffer er natriumglucoheptonatdihydrat, stannochlorid-dihydrat,
English: The binding affinity of 99mTc-depreotide to SSTR was shown in studies of pancreatic tumours in Lewis rats and in vitro in human tumour membranes.
Danish: 99mTc-depreotids bindings affinitet til SSTR er påvist i studier af pancreastumorer på Lewis rotter og in vitro i humane tumormembraner.
English: In vitro data and studies in laboratory animals indicate that 99mTc-depreotide binds with high affinity to somatostatin receptor (SSTR) subtypes 2, 3
Danish: In vitro data og studier på forsøgsdyr viser, at 99mTc-depreotid binder med høj affinitet til somatostatin receptorerne (SSTR) subtyperne 2, 3 og 5.
English: In the pivotal studies, the negative predictive value for NeoSpect in association with CT for solitary pulmonary nodules (SPNs) was 90-96% at a disease prevalence of 30-50%.
Danish: I de tilgrundlæggende studier var den negative prædiktiv værdi for NeoSpect i forbindelse med CT for isolerede lungeknuder (SPN- Solitary Pulmonary Nodules) 90-96% ved en sygdomsprævalens på 3050%.
English: Since depreotide also binds to somatostatin receptors, caution should be exercised when administering this medicinal product to patients with insulinomas or diabetes mellitus.
Danish: Eftersom depreotid også binder til somatostatin receptorer, bør forsigtighed udvises, når produktet administreres til patienter med
English: Prepare a boiling water bath containing a lead vial shield standing in and equilibrated with the boiling water bath.
Danish: Forbered et kogende vandbad indeholdende en blyafskærmning stående i og kalibreret med det kogende vandbad.
English: Technetium (99mTc) depreotide solution for injection is a diagnostic radiopharmaceutical based upon a synthetic peptide that binds to somatostatin receptors.
Danish: Technetium (99mTc) depreotid injektionsvæske, opløsning er et diagnostisk radioaktivt lægemiddel baseret på et syntetisk peptid, der binder sig til somatostatin receptorer.
English: * diarrhoea
Danish: * diarré
English: Radioactivity in top piece of ITLC-SG SSCS strip (Rf 0.75-1.0) B = 100 x -----------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG SSCS Strip
Danish: Radioaktivitet i toppen af stykket af ITLC-SG MNO strippen (Rf 0,75 - 1,0) B = 100 x ----------------------------------------------------------------------------------------Total radioaktivitet i begge stykker af ITLC-SG MNO strippen
English: NeoSpect is for diagnostic use only.
Danish: NeoSpect er alene til anvendelse ved diagnostiske formål.
English: 99mTc-depreotide is therefore contraindicated in pregnancy.
Danish: 99mTc-depreotid er derfor kontraindiceret ved graviditet.
English: 99mTc-depreotide is administered intravenously in a single dose.
Danish: 99mTc-depreotid administreres intravenøst i en enkelt dosis.
English: ITLC-SG MAM: cut the strip at Rf 0.40 (40% of the distance from the origin to the solvent
Danish: ITLC-SG MAM: Klip strippen ved Rf 0,40 (40% afstand fra starten af væskefronten).
English: disodium edetate and hydrochloric acid and/or sodium hydroxide to adjust pH.
Danish: dinatriumedetat og saltsyre og/eller natriumhydroxid til justering af pH.
English: Your doctor may recommend that you drink plenty of fluids to speed removal of traces of the radiopharmaceutical from your body.
Danish: Din læge kan anbefale, at du drikker meget væske for at øge den hastighed, hvormed rester af radioaktivitet
English: The solution may be diluted with sodium chloride 0.9% w/v solution for injection for more convenient injection.
Danish: Opløsningen kan fortyndes med natriumklorid 0,9% w/v injektionsvæske, opløsning for at opnå en mere bekvem injektion.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: NeoSpect is used to provide pictures which show the location of suspected malignant cancer tissue (a tumour) in the lung.
Danish: NeoSpect anvendes til at fremstille billeder, som viser lokalisationen af mistænkt kræftvæv i lungen.
English: Allow the vial kit to warm to 15 °C - 30 °C and place it in a suitable shielding container and sanitise the rubber septum with sanitising alcohol swab.
Danish: Lad hætteglas sættet opvarme til 15°C - 30°C, anbring det i en passende afskærmningsbeholder og rengør gummiproppen med en spritholdig renseserviet.
English: To minimise the dose of radiation absorbed by the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection.
Danish: For at formindske strålingsdosis absorberet af blæren, bør tilstrækkelig hydrering anbefales for at sikre hyppig vandladning af blæren gennem de første timer efter injektionen.
English: The product is a kit for radiopharmaceutical preparation.
Danish: Produktet er et radiofarmaceutisk præparationssæt.
English: Before removing the syringe from the vial, withdraw a volume of gas from above the solution equal to the volume of pertechnetate added in order to normalise the pressure inside the vial.
Danish: Før sprøjten fjernes fra hætteglasset udtrækkes et volumen luft over blandingen tilsvarende det volumen pertechnetat, der er tilført, for at udligne trykket i hætteglasset.
English: The contents of the NeoSpect vial are sterile.
Danish: Indholdet af NeoSpect hætteglasset er sterilt og pyrogenfrit.
English: Sodium chloride 0.9% w/v solution for injection must be used as the diluent.
Danish: Natriumklorid 0,9% w/v injektionsvæske, opløsning skal anvendes som fortyndingsmiddel.
English: Patients with a negative FNA should be followed up clinically as some FNA biopsies may give false negative results.
Danish: Patienter med negativ FNA bør følges op klinisk, idet nogle FNA
English: Any oxidant present in the sodium pertechnetate (99mTc) solution for injection might adversely affect the quality of the preparation.
Danish: Enhver oxidant tilstede i natriumpertechnetat (99mTc) injektionsvæske kan påvirke kvaliteten af opløsningen negativt.
English: ITLC-SG SSCS: cut the strip at Rf 0.75 (75% of the distance from the origin to the solvent
Danish: ITLC-SG MNO: Klip strippen ved Rf 0,75 (75% afstand fra starten af væskefronten).
English: In a recent clinical study with a prevalence of malignancy of 49%, the positive predictive value for NeoSpect in association with CT/chest X-ray was 84% (CI 63.1-94.7%) for all SPNs and 81.8% for lesions equal to or less than 3cm.
Danish: I et nyligt studie med en malignitetsprævalens på 49% var positiv prædiktiv værdi for NeoSpect i forbindelse med CT/thorax røntgen 84% (konfidensinterval 63,1-94,7%) for alle SPN og 81,8% for læsioner af størrelse 3 cm eller mindre.
English: Store the reconstituted solution for injection for no more than 5 hours at 15 °C - 25 °C using appropriate radiation shielding.
Danish: Opbevar ikke den fremstillede injektionsvæske, opløsning i mere end 5 timer ved 15°C - 25°C bag passende strålingsafskærmning.
English: NeoSpect is a radiopharmaceutical product used for diagnostic purposes.
Danish: NeoSpect er et radioaktivt lægemiddel til diagnostisk anvendelse.
English: The data indicate that the 99mTc-depreotide displays high-affinity binding to somatostatin receptors.
Danish: Data indikerer, at 99mTc-depreotid viser høj affinitets binding til somatostatin receptorer.
English: Add approximately 15 ml of distilled water to the flask, stopper, and swirl to dissolve the solid.
Danish: Tilsæt cirka 15 ml destilleret vand til målekolben, prop til og sving rundt for at opløse det faste stof.
English: Allow the vial to cool to body temperature (about 15 minutes) at room temperature before proceeding.
Danish: Inkubér under disse betingelser i 10 min. Afkøl derefter hætteglasset til kropstemperatur (i cirka 15 minutter) før proceduren fortsættes.
English: Place one ITLC-SG strip in the MAM developing solvent.
Danish: Anbring en ITLC-SG strip i karret med MAM som udviklingsvæske.
English: Store in a freezer at or below -10 °C.
Danish: Opbevares i dybfryser ved -10°C eller derunder.
English: Pharmacotherapeutic group: Diagnostic radiopharmaceutical for use in tumour detection
Danish: Farmakoterapeutisk klassifikation: Diagnostisk radioaktivt lægemiddel til brug ved påvisning af
English: - if you are allergic (hypersensitive) to depreotide or any of the other ingredients of NeoSpect or - if there is any possibility that you are pregnant.
Danish: - Hvis du er allergisk (overfølsom) over for depreotid eller et af de øvrige indholdsstofferne i
English: NeoSpect is not recommended for use in children under 18 years of age, as data are not available for this age group.
Danish: NeoSpect anbefales ikke til børn under 18 år, da det ikke foreligger data for denne aldersgruppe.
English: 99mTc-depreotide is not recommended for use in patients below the age of 18 as data are not available for this age group.
Danish: 99mTc-depreotid anbefales ikke anvendt til patienter under 18 år, da der ikke foreligger data for denne
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Your doctor will then take a picture (scan) of your lungs using a special camera.
Danish: Ved hjælp af et specielt kamera vil lægen tage et billede af dine lunger.
English: The administration of radiopharmaceutical creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc. Local regulations for radioactive materials must be applied in the radiation protection precautions and waste disposal.
Danish: Administrationen af radioaktive lægemidler skaber risiko for andre personer ved ekstern bestråling eller ved kontaminering fra spildt urin, opkastning o.lign.
English: - The active substance is 47 micrograms depreotide as depreotide trifluoroacetate.
Danish: - Det aktive stof er 47 mikrogram depreotid som depreotidtrifluoroacetat.
English: Sodium α-D-glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate, hydrochloric
Danish: Natrium- α-D-glucoheptonatdihydrat, stannochloriddihydrat, dinatriumedetat, saltsyre og/eller
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Der er ikke foretaget specifikke interaktionsstudier med andre lægemidler, og der er meget få data
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 47 micrograms depreotide as depreotide trifluoroacetate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 47 mikrogram depreotid som depreotidtrifluoroacetat.
English: Spot one drop (approximately 5-10 microlitres) of 99mTc-depreotide at the origin of each strip using the hypodermic needle.
Danish: Afsæt en dråbe (ca. 5-10 microliter) af 99mTc-depreotid med en subkutan kanyle i begyndelsen
English: No dose adjustment is required.
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig.
English: Hydrochloric acid and/or sodium hydroxide (pH adjustment) 6.2 Incompatibilities
Danish: Saltsyre og/eller natriumhydroxid, (pH justering)
English: 1 vial containing 47 micrograms of depreotide.
Danish: 1 hætteglas som indeholder 47 mikrogram depreotid.
English: NeoSpect is not recommended for use in children under 18 years of age because data are not available
Danish: NeoSpect anbefales ikke anvendt til børn under 18 år, da der ikke foreligger data for denne
English: When injected, the radiolabelled compound binds to malignant cancer tissue.
Danish: Ved injektion vil det radioaktivt mærkede stof binde til kræftvæv.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Hvis en bivirkning bliver alvorlig eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge.