FrancophonIA/ELRC3.0 huggingface dataset:
English: It is usual to advise that breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv.
Danish: Normalt anbefales det, at amningen genoptages når aktiviteten i mælken ikke medfører en strålingsdosis til barnet større end 1mSv.
English: * Effective Dose Equivalent and Effective Dose are in units of µSv/MBq.
Danish: * Effektiv dosisækvivalent og effektiv dosis er opgivet i enheden μSv/MBq
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.
Danish: Dets modtagelse, lagerhold, brug, transport og bortskaffelse er underkastet lovgivning og/eller relevante godkendelser fra kompetente lokale statslige organisationer.
English: • If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you
Danish: • Hvis du ammer skal du ophøre med amning af dit barn i mindst 24 timer efter, at du har fået
English: • If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be
Danish: • Hvis den fremstillede opløsning af LeukoScan forekommer misfarvet eller indeholder partikler, må
English: Do not refrigerate or freeze.
Danish: Må hverken opbevares i køleskab eller nedfryses.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN C. SÆRLIGE FORPLIGTELSER, SOM SKAL OPFYLDES AF
English: SPECT acquisition parameters recommended are: 60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
Danish: Anbefalede SPECT optagelsesparametre er: 60 projektioner i 360° step- og fotograferteknik, 30 sekunder per optagelse i en matrix på mindst 64 x 64.
English: This will help the doctor determine whether there is infection in the bone and what kind of treatment to use.
Danish: Dette vil hjælpe din læge til at afgøre, om der er infektion i knoglen og hvilken slags
English: For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv.
Danish: For de fleste diagnostiske undersøgelser der anvender en nuklearmedicinsk procedure er den radioaktive dosis der gives (effektiv dosis/ EDE ) mindre end 20 mSv.
English: The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Danish: Type I hætteglasset er lukket med en grå butylgummiprop med et grønt flip-off segl.
English: The overall radiation dose received by the patient over time should also be taken into
Danish: Den totale stråledosis til patienten over tid skal også medtages i overvejelserne.
English: • You should not be given LeukoScan if you are pregnant.
Danish: • Du må ikke få LeukoScan, hvis du er gravid.
English: • If you have ever received LeukoScan or another product made from a mouse antibody, your doctor should take a sample of blood for testing to be sure that you have not developed an allergy to it.
Danish: • Hvis du tidligere har modtaget LeukoScan eller et andet produkt, der er fremstillet af museantistof, skal din læge tage en blodprøve for at undersøge, om du har udviklet allergi over for det.
English: The maximum amount of LeukoScan that can be administered has not been determined.
Danish: Den maksimale mængde af LeukoScan, som kan gives, er ikke blevet fastlagt.
English: LeukoScan is prepared for a single injection.
Danish: LeukoScan fremstilles til en enkelt indsprøjtning.
English: The eosinophil count increased from 2.7% preinjection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant.
Danish: Antallet af eosinofile celler steg fra 2.7% før injektion til 2.9% 24 timer efter indsprøjtning og til 3.9% 10 dage efter, størrelsesordenen af begge stigninger var statistisk signifikant.
English: An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body.
Danish: Et antistof er et naturligt stof, som produceres i din krop og som binder sig til fremmede substanser, for at fjerne/nedbryde dem i kroppen.
English: In vitro studies have demonstrated that LeukoScan has no effect on either up-regulation or downregulation of granulocytes, but LeukoScan does appear to bind more avidly to activated rather than resting
Danish: In vitro undersøgelser har vist at LeukoScan ikke har nogen virkning på hverken op- eller nedregulering af granulocyter, men LeukoScan ser ud til at bindes stærkere til aktiverede end til hvilende granulocyter.
English: For diagnostic nuclear medicine investigations, the current evidence suggests that the adverse effects will occur with low frequency because of the low radiation doses incurred.
Danish: For diagnostiske nuklearmedicinske undersøgelser antyder den nuværende dokumentation, at de utilsigtede virkninger optræder med lav frekvens som følge af de lave strålingsdoser, der
English: You will receive a single dose of 0.25 mg of LeukoScan.
Danish: Du vil få en enkelt dosis på 0,25 mg af LeukoScan.
English: When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Danish: Når det er nødvendigt at anvende radioaktive lægemidler til kvinder i den fødedygtige alder skal man altid indhente oplysninger om eventuel graviditet.
English: Before administering a radioactive medicinal product to a mother who is breast feeding, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of activity in breast milk.
Danish: Før administration af et radioaktivt lægemiddel til en mor der ammer bør man overveje om undersøgelsen med rimelighed kunne udsættes til moderen er ophørt med amning, og om det mest hensigtsmæssige radioaktive lægemiddel er blevet valgt under hensyntagen til udskillelse af radioaktivitet i modermælk.
English: Only very limited nonclinical studies have been performed with either the labeled or unlabeled agent.
Danish: Der er kun udført meget begrænsede prækliniske studier med enten mærket eller umærket stof .
English: Administration of 750 MBq LeukoScan will give an estimated absorbed dose of 4.1 mGy to an embryo or fetus at an early stage.
Danish: Indgivelse af 750 MBq LeukoScan vil give en estimeret absorberet dosis på 4.1 mGy til et embryo eller fetus på et tidligt stadie.
English: Patients with known allergies or hypersensitivity to mouse proteins.
Danish: Patienter med kendte allergier eller overfølsomhed overfor museproteiner.
English: The product is more sensitive (93.9% vs. 80.6%), but less specific (51.6% vs. 72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis.
Danish: Produktet er mere sensitivt (93,9% mod 80,6%), men mindre specifikt (51,6% mod 72,9%) til diagnose af osteomyelitis hos patienter med diabetisk fodsår end hos patienter med osteomyelitis i rørknogler.
English: At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
Danish: En time efter infusion var blod niveauet 34% af startniveauet, 17 % ved fire timer og 7% ved 24 timer.
English: Single photon emission computed tomography (SPECT) imaging can also be conducted and may aid in differentiating osteomyelitis from soft tissue infections.
Danish: Enkelt photon emissions computeriseret tomografi (SPECT) kan også udføres og kan hjælpe med at differentiere mellem osteomyelitis og infektioner i bløddele.
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Danish: Isotopundersøgelser, der foretages på gravide kvinder, involverer også en strålingsdosis til fosteret.
English: Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
Danish: Din læge vil fremstille LeukoScan og den radioaktive techniciumisotop i et volumen på 1,5 ml.
English: LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes.
Danish: LeukoScan (sulesomab) er en speciel type antistof, som binder sig til overfladen af visse typer blodceller, der kaldes leukocytter.
English: LeukoScan is used to determine the presence of infections in long bones.
Danish: LeukoScan bruges til at afgøre tilstedeværelsen af infektioner i lange rørknogler.
English: This difference is perhaps explained by the anatomically and pathophysiology more complicated clinical setting of osteomyelitis in the diabetic foot, making differentiation of soft tissue and bone infection more difficult than in other presentations of long bone osteomyelitis.
Danish: Denne forskel kan måske forklares ved den anatomiske og patofysiologisk mere komplicerede kliniske situation ved osteomyelitis i den diabetiske fod, der gør differentiering mellem infektion i bløddelsvæv og knogler mere vanskelig end ved andre former for osteomyelitis i rørknogler.
English: Appropriate cardiopulmonary resuscitation facilities and trained personnel should be available for immediate use in the event of an adverse reaction.
Danish: Passende genoplivningsudstyr og trænet personale bør være til stede til øjeblikkelig indgriben, hvis der skulle forekomme en anafylaktisk reaktion.
English: LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation.
Danish: LeukoScan [99mTc] kan bruges efter ti minutter og skal anvendes indenfor fire timer efter præparering.
English: The distribution half-life was approximately 1.5 hours; the route of excretion is essentially renal with 41% of the radiolabel excreted in urine over the first 24 hours after administration.
Danish: Fordelingshalveringstiden var ca. 1,5 timer, udskillelse sker hovedsageligt gennem nyrerne med 41% af radioaktiviteten udskilt i urin indenfor de første 24 timer efter administration.
English: When a bone scan is positive and imaging with LeukoScan is negative, infection is unlikely.
Danish: Når en knoglescanning er positiv, og undersøgelsen med LeukoScan er negativ, er infektion usandsynlig.
English: The radiolabelled solution should be administered as an intravenous injection.
Danish: Den radioaktivt mærkede opløsning skal gives som en intravenøs indsprøjtning.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier vedrørende påvirkning ved brug af maskiner og af evnen til at køre bil.
English: In 49.7% of the patients, LeukoScan was presumed to provide clinical benefit not achievable by other available diagnostic imaging methods, with the potential that the diagnosis could have been made by LeukoScan alone in 70.3% of the patients.
Danish: Hos 49,7% af disse patienter formodedes LeukoScan at give kliniske fordele, der ikke kunne opnås med andre tilgængelige diagnostiske undersøgelsesmetoder med det potentiale, at diagnosen kunne være opnået med LeukoScan alene hos 70,3% af patienterne.
English: Swirl and shake the vial contents gently for 30 seconds to insure dissolution.
Danish: Ryst hætteglassets indhold i 30 sekunder for at sikre fuldstændig opløsning.
English: In a single-group, open-label, uncontrolled study of 53 patients with acute or chronic infections of unknown origin or extent, doses of LeukoScan from 0.1 mg to 1.0 mg were studied.
Danish: I et enkeltgruppe, ublindet, ukontrolleret studie af 53 patienter med akutte eller kroniske infektioner af ukendt oprindelse og omfang blev doser af LeukoScan fra 0.1 mg til 1.0 mg afprøvet.
English: Formal studies have not been performed in patients with renal or hepatic impairment.
Danish: Der er ikke udført formelle undersøgelser med patienter med nyre- eller leversvækkelse.
English: Due to the short six-hour, half-life of 99mTc, a dose of less than 1 mSv in mother's milk can be expected 24 hours after the administration of LeukoScan [99mTc].
Danish: På grund af den korte 6 timers halveringstid for 99mTc kan en dosis på mindre end 1 mSv i modermælken forventes 24 timer efter administration af LeukoScan [99mTc].
English: Patients who have previously received murine monoclonal antibody products are more likely to have HAMA.
Danish: Patienter der tidligere har modtaget murine monoklonale antistoffer har øget sandsynlighed for HAMA.
English: On the basis of two controlled clinical trials of LeukoScan to demonstrate the safety and effectiveness of this product for defining the presence and location of osteomyelitis, in a total of 175 evaluable patients, LeukoScan had a sensitivity of 88.2%, a specificity of 65.6%, an accuracy of 76.6%, a positive predictive value of 70.8%, and a negative predictive value of 85.5%.
Danish: På grundlag af to kontrollerede kliniske afprøvninger med LeukoScan, der blev udført for at demonstrere sikkerhed og effektivitet af dette produkt til definering af tilstedeværelse og lokalisering af osteomyelitis i et samlet antal på 175 evaluerbare patienter, havde LeukoScan en sensitivitet på 882%, en specificitet på 65,6%, en præcision på 76,6%, en positiv prædikativ værdi på 70,8% og en negativ prædikativ værdi på
English: When the radioactive antibody binds to the white blood cells, your doctor can determine where the infection is located by using a special imaging camera that reveals areas of radioactivity.
Danish: Når det radioaktive antistof binder sig til de hvide blodlegemer, kan din læge afgøre, hvor der er betændelse ved at bruge et specielt gammakamera, der afbilder områder med radioaktivitet.
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
Danish: Iværksæt de nødvendige aseptiske forsigtighedsregler, idet man overholder kravene i Good Manufacturing Practices (GMP) for medicinalvarer.
English: Reconstituted and radiolabelled material - Do not store above 25ºC.
Danish: Må ikke nedfryses Rekonstitueret og radiomarkeret materiale - skal opbevares ved temperaturer under 25°C.
English: In clinical trials involving over 350 patients, no induction of human anti-mouse antibody (HAMA) to antibody fragments has been observed nor has there been any elevation of HAMA levels in patients with
Danish: I kliniske afprøvninger der involverede over 350 patienter er der ikke observeret induktion af human antimus antistof (HAMA) overfor antistof fragmenter, ej heller har der været nogen øgning af HAMA niveauet hos patienter med eksisterende HAMA.
English: The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection.
Danish: Antistoffet er i stand til at binde sig til overfladen af visse hvide blodlegemer, som infiltrerer betændelsesstedet.
English: Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer.
Danish: Tæl hvert rør i en gammascintillationstæller, dosiskalibrator eller radiokromatogramanalysator.
English: By contrast, in non-infected subjects, transient increases in WBC count were seen 24 hours after LeukoScan administration.
Danish: Derimod blev der i ikke inficerede patienter observeret forbigående stigning i antallet af leukocytter 24 timer efter administration af LeukoScan.
English: Statistically significant reductions in white blood cell (WBC) count were observed in the controlled studies at 24 hours post-injection, from a mean value of 8.9 to a mean value of 8.0 (× 103/mm3), but remained within the normal range, and returned to their pre-injection values by the time of the next measurement at 10 days.
Danish: Der konstateredes en statistisk signifikant reduktion af antallet af hvide blodlegemer (WBC) ved den kontrollerede undersøgelse 24 timer efter injektion, fra en middelværdi på 8.9 til en middelværdi på 8.0 (x103/mm3), men antallet holdt sig inden for det normale område og vendte tilbage til førinjektionsværdien ved næste måling efter 10 dage.
English: An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
Danish: En vurdering af LeukoScans potentielle kliniske betydning viste, at LeukoScan kunne ændre den kliniske behandling i 50,2% eller forbedre det kliniske resultat i 43,4% af de 175 evaluerbare patienter med mulig osteomyelitis.
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 givne aktivitetsmængde må være således at den resulterende stråledosis er så lav som mulig under hensyntagen til opnåelse af det ønskede diagnostiske resultat.
English: Since LeukoScan cross-reacts with CEA, it should be borne in mind that it may interact with CEA
Danish: Eftersom LeukoScan krydsreagerer med CEA, skal der gøres opmærksom på, at det kan reagere med CEA-producerende tumorer.
English: Do not store above 25°C.
Danish: Skal opbevares ved temperaturer under 25°C.
English: These dose estimates assume a urinary bladder voiding interval of two hours.
Danish: Dette dosisoverslag forudsætter blæretømning med et interval på to timer.
English: If the administration is considered necessary, breast feeding should be interrupted and the expressed feeds discarded.
Danish: Hvis anvendelsen anses for nødvendig skal amningen afbrydes og evt. udpumpet brystmælk skal kasseres.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1997
Danish: Dato for første makedsføringstilladelse: 14. februar 1997 Dato for sidste fornyelse af tilladelsen: 20.05.2007
English: Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [99mTc].
Danish: Umiddelbart før brug bliver indeholdet af hætteglasset rekonstitueret i den umærkede form med henblik på at fremstille LeukoScan [99mTc].
English: Technetium [99mTc] disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium [99Tc] which can be regarded as quasi stable.
Danish: Technicium [99mTc] henfalder under udsendelse af gammastråling med en energi på 140 keV og en halveringstid på 6 timer til technicium [99Tc], der kan betragtes som værende quasi-stabil.
English: Anaphylactic and other hypersensitivity reactions are possible whenever mouse protein materials are administered to patients.
Danish: Anafylaktiske og andre overfølsomhedsreaktioner er mulige, når stoffer udviklet af museprotein gives til patienter.
English: You must then not be given LeukoScan.
Danish: Du bør da ikke få LeukoScan.
English: Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
Danish: Hvor usikkerhed eksisterer er det vigtigt at udsættelsen for radioaktiv stråling reduceres til det minimum, der samtidig gør det muligt at opnå de ønskede kliniske oplysninger.
English: Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique.
Danish: Rekonstituerede radiofarmaka skal håndteres med vandtætte handsker, passende strålingsbeskyttelse og ved hjælp af aseptisk metode.
English: One to eight hours later you will be placed on a special table and pictures will be taken with standard nuclear cameras to see where the infections are located.
Danish: En til otte timer senere vil du blive anbragt på et specielt leje og billeder vil blive taget med et standard gammakamera for at lokalisere infektionen.
English: The antibody (IMMU-MN3) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker, carcinoembryonic antigen (CEA).
Danish: Antistoffet (IMMU-MN 3) genkender en antigen struktur, der er fælles for et overfladeglycoprotein (NCA-90) på granulocyter og tumor markøren carcino embryonalt antigen (CEA).
English: Total volume in vial equals 1.5 ml.
Danish: Det totale volumen i hætteglasset er 1,5 ml.
English: It is unknown whether the changes in WBC or eosinophil counts observed, although of no clinical significance, are due to a transient effect on WBC function.
Danish: Det vides ikke om de observerede forskelle i leukocyttal eller eosinofiltal, skønt uden klinisk betydning, skyldes en forbigående virkning på leukocytfunktionen.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: A. FREMSTILLER/FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG
English: Average Dose µGy/MBq
Danish: Gennemsnitlig dosis mGy/MBq
English: When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them.
Danish: Når det bindes til den radioaktive techniciumisotop og indsprøjtes, finder det en unormal ophobning af hvide blodlegemer og binder sig til dem.
English: If so, no inferences concerning the underlying mechanism(s) responsible may be derived from the clinical laboratory results.
Danish: Hvis dette er tilfældet kan man ikke på basis af de kliniske laboratorie resultater drage nogen konklusioner angående den til grund liggende mekanisme(r).
English: • After use, the container should be disposed of as radioactive waste.
Danish: • Efter brug skal beholderen bortskaffes som radioaktivt affald.
English: In subjects with HAMA, there may be a greater chance of hypersensitivity reactions and
Danish: For patienter med HAMA kan der være en større risiko for hypersensitivitetsreaktioner og formindsket effektivitet af undersøgelsen.
English: LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
Danish: LeukoScan er en steril, frysetørret formulering, som indeholder 0,31 mg sulesomab per hætteglas samt 0,22 mg stannoklorid, dihydrat, 3,2 mg natriumkaliumtartrat, tetrahydrat, 7,4 mg natriumacetat, trihydrat, 5,5 mg natriumklorid, iseddikesyre (Spor), saltsyre (Spor), 37,8 mg sakkarose, nitrogen (vacuum).
English: Readministration should only be considered in patients whose sera are negative for human anti-mouse antibody (HAMA) elevation in the fragment assay.
Danish: Gentagen administration skal kun overvejes for patienter hvis sera ikke viser en stigning i human antimus antistof (HAMA) i fragmenttesten.
English: Based on the activity measured in the activity calibrator, withdraw a sufficient amount of the product to provide the desired activity (750-1100 MBq of 99mTc, see Dosage and Administration).
Danish: På baggrund af den i dosiskalibratoren målte aktivitet udtages en tilstrækkelig mængde til at give den ønskede aktivitet (750-1100MBq 99mTc, se afsnittet om Dosering og indgivelse).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING (CONTAINER PACKAGE LABEL)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGEOGPÅ DEN INDRE EMBALLAGE
English: LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic
Danish: LeukoScan er indiceret til billeddiagnostisk fremstilling med henblik på at lokalisere og bedømme omfanget af infektion/inflammation i knogler hos patienter med mulig osteomyelitis inklusive patienter