FrancophonIA/ELRC3.0 huggingface dataset:
English: Lesion-detection rate was 75% (3/4) in the subgroup of patients with unknown primary tumour site of the prospective study of Frilling et al. 2010.
Danish: Læsionsdetektionsraten var 75 % (3/4) i undergruppen af patienter med ukendt primært tumorsted i det prospektive Frilling et al. studie (2010).
English: • Galli Ad, 0.74 - 1.85 GBq, radionuclide generator (IRE-Elit).
Danish: • Galli Ad, 0,74 - 1,85 GBq, radionuklidgenerator (IRE-Elit)
English: However, even taking as worst case reference the limits for genotoxic and carcinogenic impurities, the risk related to the trace amounts of 1,10-phenanthroline in SomaKit TOC formulation is considered negligible at the dose to be administered in patients: the exposure to 1,10-phenanthroline (5 µg/dose) is 24 fold lower than the acceptable daily intake for a genotoxic impurity (120 µg/day for exposures <1 month).
Danish: Men selv om man tager grænserne for genotoksiske og karcinogene urenheder som worst case-grundlag, anses risikoen relateret til spormængderne af 1,10phenanthrolin i SomaKit TOC-præparatet for ubetydelig ved den dosis, der indgives til patienter: eksponeringen for 1,10-phenanthrolin (5 µg/dosis) er 24 gange lavere end den acceptable daglige indtagelse for en genotoksisk urenhed (120 µg/dag for eksponeringer på < 1 måned).
English: - A glass vial with yellow flip-off cap containing a clear and colourless solution.
Danish: - Et hætteglas med gul flip-off hætte indeholdende en klar og farveløs opløsning.
English: Sample Analysis a. The TLC developing tank is prepared by pouring the mobile phase to a depth of 3 to 4 mm. Cover the tank and allow to equilibrate.
Danish: Analyse af prøve a. TLC-elueringsbeholderen klargøres ved at påfylde den mobile fase til en dybde på 3 til 4 mm. Tildæk beholderen og lad det ækvilibrere.
English: • GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator (Eckert & Ziegler Radiopharma GmbH),
Danish: • GalliaPharm, 0,74-1,85 GBq, radionuklidgenerator (Eckert & Ziegler Radiopharma GmbH),
English: Genotoxicity studies on 1,10-phenanthroline available in the literature show negative results in bacterial mutation assay (Ames test), while in a mouse lymphoma assay an indication of possible genotoxicity was obtained at concentrations 750 times higher than the maximum 1,10-phenanthroline blood concentration achievable in patients.
Danish: De genotoksicitetsstudier af 1,10-phenanthrolin, som er tilgængelige i litteraturen, viser negative resultater i en bakteriel mutationstest (Ames test), mens en muselymfomtest indikerede mulig genotoksicitet ved koncentrationer 750 gange højere end den maksimale 1,10-phenanthrolinkoncentration i blodet, der opnås hos patienter.
English: Radiopharmaceuticals should be received, used and administered only by authorized persons in designated clinical settings.
Danish: Radioaktive lægemidler må kun modtages, anvendes og administreres af autoriserede personer i specielt indrettede lokaler.
English: The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection.
Danish: Den anbefalede dosis til voksne, der vejer 70 kg, er 100 til 200 MBq, som indgives ved direkte, langsom intravenøs injektion.
English: Before administering radiopharmaceuticals to a mother who is breastfeeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Danish: Inden administration af radioaktive lægemidler til en kvinde, som ammer, skal der tages hensyn til, om det er muligt at udsætte administration af radionuklidet, indtil kvinden er ophørt med at amme, og hvilket radioaktive lægemiddel der er bedst egnet under hensyntagen til udskillelse af aktivitet i mælk.
English: Local tolerance assessment resulted in mild to moderate inflammation signs in the perivascular region of some animals which can be attributed to the acidic pH of the solution.
Danish: En vurdering af lokal tolerance påviste tegn på let til moderat inflammation i det perivaskulære område hos nogle dyr, hvilket kan henføres til den lave pH (sur reaktion) i injektionsvæsken.
English: - If you get any side effects, talk to your nuclear medicine doctor.
Danish: Hvis du oplever nogen bivirkninger, bør du tale med den nuklearmedicinske læge.
English: c. Place the ITLC strip in the developing tank and allow it to develop for a distance of 9 cm from the point of application.
Danish: c. Anbring ITLC-strimlen i elueringsbeholderen og lad det eluere til en afstand på 9 cm fra applikationsstedet.
English: A schematic representation of the radiolabelling procedure is shown in Figure 2.
Danish: En skematisk oversigt over proceduren til radioaktiv mærkning er vist i Figur 2.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Danish: Hvis der forekommer overfølsomhedsreaktioner eller anafylaktiske reaktioner, skal administrationen af lægemidlet omgående stoppes og intravenøs behandling om nødvendigt iværksættes.
English: Administration of SomaKit TOC and conduct of the procedure After radiolabelling, SomaKit TOC is administered by intravenous injection.
Danish: Administration af SomaKit TOC og gennemførelse af undersøgelsen Efter radioaktiv mærkning bliver SomaKit TOC administreret ved intravenøs injektion.
English: The labelling efficiency is calculated by integration of peak with Rf = 0 to 0.1 that must be ≤ 3%.
Danish: Mærkningseffektiviteten beregnes ved at integrere toppunktet med Rf = 0 til 0,1, der skal være ≤ 3 %.
English: Precautions to be taken before handling or administration of the medicinal product For instructions on radiolabelling of the medicinal product before administration, see section 12.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet For instruktioner om radioaktiv mærkning af lægemidlet før administration, se pkt.
English: - if you have others medical conditions, such as high level of cortisol in the body (Cushing syndrome), inflammation, thyroid disease, other type of tumour (of pituitary gland, lung, brain, breast, immune system, thyroid, adrenal gland or others) or disease of spleen that may affect the interpretation of the images; - if you have been taking other medicines, such as somatostatin analogues and glucocorticoids, which may interact with SomaKit TOC; - if you are pregnant or believe you may be pregnant; - If you are breast-feeding.
Danish: - hvis du har andre helbredsproblemer, såsom højt niveau af cortisol i kroppen (Cushings syndrom), betændelseslignende tilstande (inflammation), sygdom i skjoldbruskkirtlen, andre typer af tumorer (i hypofyse, lunger, hjerne, bryst, immunsystem, skjoldbruskkirtel, binyrer eller andet) eller sygdom i milten, som kan påvirke tolkningen af billederne; - hvis du har taget andre lægemidler, såsom somatostatin-analoger og glukokortikoider, som kan interagere med SomaKit TOC; - hvis du er gravid eller tror, at du måske er gravid; - hvis du ammer.
English: Your nuclear medicine doctor will inform you if you need to take any other special precaution before or after using SomaKit TOC.
Danish: Den nuklearmedicinske læge vil oplyse dig om, hvorvidt du skal tage andre særlige forholdsregler før eller efter, at du har fået SomaKit TOC.
English: The recommended time for imaging is 40 to 90 minutes post injection.
Danish: Det anbefales, at scanningen foretages 40 til 90 minutter efter injektion.
English: Distribution After intravenous injection, gallium (68Ga) edotreotide is rapidly cleared from the blood following bi exponential elimination of activity with half-lives of 2.0 ± 0.3 min and 48 ± 7 min respectively.
Danish: Fordeling Efter intravenøs injektion elimineres gallium (68Ga)-edotreotid hurtigt fra blodet efter en bi eksponentiel eliminering af aktiviteten med halveringstider på hhv. 2,0 ± 0,3 min. og 48 ± 7 min.
English: For administration, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Danish: Ved administration skal injektionsvæsken trækkes op gennem proppen med en enkeltdosissprøjte forsynet med passende beskyttende afskærmning og en steril engangskanyle eller ved hjælp af et autoriseret automatiseret applikationssystem.
English: SomaKit TOC contains sodium (see section 2).
Danish: SomaKit TOC indeholder natrium (se punkt 2).
English: An increased uptake of gallium (68Ga) edotreotide is not specific for GEP-NET.
Danish: En øget optagelse af gallium (68Ga)-edotreotid er ikke specifik for GEP-NET.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Danish: Denne medicin er et radioaktivt lægemiddel, der udelukkende bruges diagnostisk.
English: Elute the generator directly into the Vial 1 (through the needle) according to the generator manufacturer instructions for use, in order to reconstitute the powder with the eluate.
Danish: Eluer generatoren direkte ind i hætteglas 1 (gennem nålen) i henhold til instruktionerne fra generatorens producent for at rekonstituere pulveret med eluatet.
English: Approximately 16% of gallium (68Ga) edotreotide activity is removed from the body in the urine within 2 to 4 hours.
Danish: Cirka 16% af gallium (68Ga)-edotreotid-aktiviteten udskilles med urinen inden for 2 til 4 timer.
English: The dosimetry of gallium (68Ga) edotreotide was calculated by Sandstrom et al. (2013), using
Danish: Dosimetrien af gallium (68Ga)-edotreotid er beregnet af Sandstrom et al. (2013) ved brug af
English: - Reaction buffer: the vial contains a clear, colourless solution.
Danish: - Reaktionsbuffer: hætteglasset indeholder en klar, farveløs opløsning.
English: Powder: 1,10-phenanthroline, gentisic acid, mannitol (E421) Buffer: formic acid, sodium hydroxide (E524), water for injections See leaflet for further information.
Danish: Pulver: 1,10-phenanthrolin, gentisinsyre, mannitol (E421) Buffer: myresyre, natriumhydroxid (E524), vand til injektionsvæsker Se indlægssedlen for yderligere oplysninger
English: Do not store above 25°C after radiolabelling.
Danish: Må ikke opbevares ved temperaturer over 25°C efter radioaktiv mærkning.
English: Gallium (68Ga) edotreotide contains a small amount of radioactivity.
Danish: Gallium (68Ga)-edotreotid indeholder en lille mængde radioaktivitet.
English: Only essential investigations should be carried out during pregnancy, when the likely benefit far exceeds any risk to the mother and foetus.
Danish: Undersøgelsen må kun udføres hos gravide, hvis den forventede fordel langt overstiger risikoen for moderen og fosteret.
English: As an example, an increase in somatostatin receptor density can also occur in the following pathological conditions: subacute inflammations (areas of lymphocyte concentrations), thyroid diseases (e.g. thyroid autonomy and Hashimoto's disease), tumours of the pituitary gland, neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (e.g. Hodgkin's disease and non-Hodgkin lymphomas) and tumours arising from tissue embryologically derived from the neural crest (e.g. paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas).
Danish: Som et eksempel kan en forøgelse af densiteten af somatostatin-receptorer også forekomme ved følgende patologiske tilstande: subakutte inflammationer (områder med lymfocyt-koncentrationer), sygdomme i skjoldbruskkirtlen (fx skjoldbruskkirtel-autonomi og Hashimotos sygdom), hypofysetumorer, neoplasmer i lungerne (småcellet karcinom), meningeomer, brystcancer, lymfoproliferativ sygdom (fx Hodgkins sygdom og non-Hodgkins lymfomer) og tumorer opstået fra væv, der embryologisk stammer fra crista neuralis (fx paragangliomer, modullære tyroide karcinomer, neuroblastomer, fæokromocytom).
English: Elute the generator directly into the Vial 1 (through the needle).
Danish: Eluér generatoren direkte i hætteglasset 1 (gennem nålen).
English: Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and fœtus.
Danish: Hos gravide bør sådanne undersøgelser derfor kun udføres, når de er altafgørende, og når den forventede fordel langt overstiger den risiko, der påføres moderen og fosteret.
English: Only syringe and syringe needles able to minimise trace metal impurity levels (for example, non-metallic or coated with silicone needles - not supplied -) should be used.
Danish: Kun sprøjter og kanyler, som kan minimere spormetalurenheder (fx ikke-metalliske eller siliconecoatede kanyler - medfølger ikke) bør anvendes.
English: In the study by Gabriel et al. 2009 pre-PRRT gallium (68Ga) edotreotide was compared with CT or MRI using the Response Evaluation Criteria in Solid Tumors (RECIST).
Danish: I Gabriel et al. studiet (2009) blev præ-PRRT gallium (68Ga)-edotreotid sammenlignet med CT- eller MR-scanning ved hjælp af Response Evaluation Criteria in Solid Tumors (RECIST).
English: The retrospective study of Kroiss et al. 2013 in 249 NET patients showed that PRRT does not significantly influence semiquantitative uptake of gallium (68Ga) edotreotide PET, except in liver metastases of patients with NET, but the study lacked histological confirmation.
Danish: Det retrospektive Kroiss et al. studie (2013) med 249 NET-patienter viste, at PRRT ikke har nogen signifikant indvirkning på semikvantitativ optagelse af gallium (68Ga)-edotreotid PET, undtagen i levermetastaser hos patienter med NET, men studiet manglede histologisk bekræftelse.
English: (70%) and discrepancies in 14 patients (30%) presenting 9 with progressive disease and 5 with remission.
Danish: scanning viste overensstemmende resultater hos 32 patienter (70 %) og uoverensstemmelser hos 14 patienter (30 %), hvoraf 9 patienter havde fremadskridende sygdom, og 5 patienter var i remission.
English: Gallium (68Ga) edotreotide detected 35/35 (100%) lesions vs 19/35=54% for indium (111In) pentetreotide SPECT/CT.
Danish: Gallium (68Ga)-edotreotid detekterede 35/35 (100 %) læsioner versus 19/35=54 % for indium (111In)-pentetreotid SPECT/CTscanning.
English: The quantity to be administered usually recommended for an adult ranges from 100 MBq to 200 MBq (megabecquerel, the unit used to express radioactivity).
Danish: Den dosis, der normalt anbefales til voksne, er mellem 100 og 200 MBq (megabecquerelmåleenheden for radioaktivitet).
English: The labelling efficiency is calculated by integration of peak with Rf = 0.9 to 1.0 that must be ≤ 2%.
Danish: Mærkningseffektiviteten beregnes ved at integrere toppunktet med Rf = 0,9 til 1,0, der skal være ≤ 2
English: Gallium (68Ga) edotreotide has no or negligible influence on the ability to drive and use machines.
Danish: Gallium (68Ga)-edotreotid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Driving and using machines It is considered unlikely that SomaKit TOC will affect your ability to drive or to use machines.
Danish: Det anses for usandsynligt, at SomaKit TOC vil påvirke din evne til at køre motorkøretøj og betjene maskiner.
English: If you have been given more SomaKit TOC than you should An overdose is unlikely because you will only receive a single dose under controlled conditions by the nuclear medicine doctor supervising the procedure.
Danish: Det er ikke sandsynligt, at du vil få en overdosis, da du får en enkel dosis under kontrol af den nuklearmedicinske læge, der har tilsyn med undersøgelsen.
English: About 50 minutes after intravenous administration, gallium (68Ga) edotreotide accumulation shows plateauing in all organs.
Danish: Omkring 50 minutter efter intravenøs administration stagnerer gallium (68Ga)-edotreotid-akkumuleringen i alle organer.
English: The following information is intended for healthcare professionals only: The complete SmPC of SomaKit TOC is provided as a separate document in the product package, 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 SomaKit TOC er indlagt separat i pakningen, så læger og sundhedspersonale kan få supplerende videnskabelige og praktiske oplysninger om administration og anvendelse af dette radioaktive lægemiddel.
English: The gallium (68Ga) edotreotide solution for intravenous injection must be prepared according to aseptic procedure, local regulation and the following instructions.
Danish: Gallium (68Ga)-edotreotid intravenøs injektionsvæske skal fremstilles i henhold til aseptiske procedurer, lokale regler og følgende instruktioner.
English: At the time of administration, the product must be aseptically withdrawn and the radioprotection standards must be followed.
Danish: På tidspunktet for administration skal injektionsvæsken trækkes op under aseptiske forhold, og gældende standarder for strålingsbeskyttelse skal følges.
English: SomaKit TOC must not be used - if you are allergic to edotreotide or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få SomaKit TOC - hvis du er allergisk over for edotreotid eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Intravenous use after radiolabelling.
Danish: Intravenøs anvendelse efter radioaktiv mærkning.
English: The gallium (68Ga) edotreotide solution must be prepared in accordance with radioprotection and pharmaceutical quality standards, especially concerning aseptic technique.
Danish: Gallium (68Ga)-edotreotid-injektionsvæsken skal fremstilles i overensstemmelse med standarderne for strålingsbeskyttelse og farmaceutisk kvalitet, især hvad angår aseptisk teknik.
English: At the end of the elution, disconnect the generator from the Vial 1 withdrawing the needle from the rubber septum and immediately add the reaction buffer previously dosed in the 1 ml sterile syringe.
Danish: Ved afslutning af elueringen kobles generatoren fra hætteglas 1 ved at trække nålen ud af gummimembranen og straks tilsætte den reaktionsbuffer, der tidligere er trukket op i en 1 ml steril sprøjte.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including somatostatin analogues, glucocorticoids (also called corticosteroids), since they may interfere with the interpretation of the images.
Danish: Brug af anden medicin sammen med SomaKit TOC Fortæl den nuklearmedicinske læge, hvis du tager anden medicin, eller har gjort der for nylig, herunder somatostatin-analoger og glukokortikoider (også kaldet kortikosteroider), da de kan forstyrre tolkningen af billederne.
English: However, lesions of GEP-NET not expressing sufficient density of somatostatin receptors cannot be visualised with gallium (68Ga) edotreotide.
Danish: Dog kan læsioner af GEP-NET, der ikke udtrykker tilstrækkelig densitet af somatostatin-receptorer, ikke visualiseres med gallium (68Ga)-edotreotid.
English: The injection of gallium (68Ga) edotreotide must be administered intravenously in order to avoid local extravasation resulting in inadvertent radiation to the patient and imaging artefacts.
Danish: Gallium (68Ga)-edotreotid skal injiceres intravenøst for at undgå lokal ekstravasation, der kan medføre utilsigtet bestråling af patienten og billeddannelsesartefakter.
English: 13040 Saluggia (VC) Italy
Danish: Via Crescentino 13040 Saluggia (VC) Italien
English: This medicinal product should be radiolabelled before administration to the patient.
Danish: Dette lægemiddel skal mærkes radioaktivt, før det indgives til patienten.
English: Figure 2: Radiolabelling procedure when using Galli Ad generator
Danish: Figur 2: Procedure til radioaktiv mærkning ved brug af Galli Ad generator
English: You must inform the nuclear medicine doctor before the administration of SomaKit TOC if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Danish: Du skal fortælle den nuklearmedicinske læge, før du får SomaKit TOC, hvis der en mulighed for, at du måske er gravid, hvis du har sprunget en menstruation over, eller hvis du ammer.
English: SomaKit TOC is supplied as a kit containing two vials.
Danish: SomaKit TOC leveres som et sæt indeholdende to hætteglas.
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Danish: Hvis du er i tvivl, er det vigtigt, at du rådfører dig med den nuklearmedicinske læge, som har tilsyn med undersøgelsen.
English: Assay the vial radioactivity using a suitable radioactivity calibration system and record the result.
Danish: Mål radioaktiviteten i hætteglasset ved brug af et egnet kalibreringssystem og registrer resultatet.
English: A prospective intra-individual comparison showed that gallium (68Ga) edotreotide is able to detect lesions better than indium (111In) pentetreotide.
Danish: En prospektiv intra-individuel sammenligning viste, at gallium (68Ga)-edotreotid var bedre til at detektere læsioner end indium (111In)-pentetreotid.
English: For storage conditions after radiolabelling of the medicinal product, see section 6.3.
Danish: Vedrørende opbevaringsforhold efter radioaktiv mærkning af lægemidlet, se pkt.
English: Radiolabelled SomaKit TOC is suitable for PET medical imaging.
Danish: Radioaktivt mærket SomaKit TOC er velegnet til medicinsk PET-scanning.
English: m. Assay the vial radioactivity using a suitable radioactivity calibration system and record the result.
Danish: m. Mål radioaktiviteten i hætteglasset ved brug af et egnet kalibreringssystem og registrer resultatet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 40 micrograms of edotreotide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 40 mikrogram edotreotid.
English: MARKETING AUTHORISATION HOLDER Advanced Accelerator Applications 20 rue Diesel
Danish: Indehaver af markedsføringstilladelsen Advanced Accelerator Applications 20 rue Diesel
English: Before it can be used, the powder in the vial is mixed with a radioactive substance called gallium (68Ga) chloride to make gallium (68Ga) edotreotide (this procedure is called radiolabelling).
Danish: Før det kan anvendes, skal pulveret i hætteglasset blandes med en radioaktiv substans, som hedder gallium (68Ga)-chlorid, for at fremstille gallium (68Ga)-edotreotid (dette kaldes radioaktiv mærkning).
English: Regarding the novel excipient (1,10-phenanthroline), during the toxicity study conducted with the kit formulation of SomaKit TOC including 1,10-phenanthroline at a dose 400 fold higher than the human dose, no toxicity signs were observed.
Danish: Med hensyn til det specielle hjælpestof (1,10-phenanthrolin), blev 1,10-phenanthrolin undersøgt i toksicitetsstudiet af SomaKit TOC-præparatet i en dosering, der er 400 gange højere end den humane dosis, og der blev ikke observeret nogen tegn på toksicitet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) SomaKit TOC
English: Recommended method for determining labelling efficiency of gallium (68Ga) edotreotide:
Danish: Anbefalet metode til bestemmelse af mærkningseffektiviteten af gallium (68Ga)-edotreotid:
English: PET images with gallium (68Ga) edotreotide should be interpreted visually, and semiquantitative measurement of gallium (68Ga) edotreotide uptake should not be used for clinical interpretation of images.
Danish: PET-billeder med gallium (68Ga)-edotreotid bør fortolkes visuelt, og semikvantitativ måling af optagelsen af gallium (68Ga)-edotreotid bør ikke anvendes til klinisk fortolkning af billederne.