FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure that in each Member State where Axumin is marketed, all Healthcare professionals who are expected to use Axumin have access to self-training educational material in order to reduce the risk of PET imaging interpretation errors.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at sundhedspersonale, der forventes at håndtere Axumin i de medlemsstater, hvor Axumin markedsføres, har adgang til selvstudiemateriale, så risikoen for fortolkningsfejl ved PET-scanningen reduceres.
English: - avoid any close contact with young children and pregnant women for the 12 hours following the injection - urinate frequently in order to eliminate the product from your body.
Danish: - undgå enhver tæt kontakt med børn og gravide kvinder i 12 timer efter injektionen - sørg for at lade vandet hyppigt, så lægemidlet kan komme ud af kroppen igen.
English: Uptake by tumours is rapid, with the highest tumour-to-normal tissue contrast between 4 and 10 minutes after injection and continuing for around 30 minutes, with a 61% reduction in mean tumour uptake at 90 minutes after injection.
Danish: Optagelsen i tumorer sker hurtigt, idet den største forskel mellem optagelse i tumorer og optagelse i normalt væv ses 4-10 minutter efter injektion og opretholdes i ca. 30 minutter; den gennemsnitlige optagelse i en tumor er faldet med 61 % 90 minutter efter injektion.
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radioaktive lægemidler skal klargøres på en sådan måde, at såvel kravene til strålesikkerhed som kravene til lægemiddelkvalitet opfyldes.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Danish: Den indgivne aktivitet skal under alle omstændigheder være den lavest mulige, der er nødvendig for at opnå den nødvendige diagnostiske information.
English: Elderly No dose adjustment required.
Danish: Ældre Dosisjustering er ikke nødvendig.
English: If the injection volume is between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used.
Danish: Hvis injektionsvolumenen ligger mellem 0,5-1,0 ml, skal man sikre sig, at der anvendes en passende sprøjte (1 ml).
English: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria.
Danish: Seibersdorf Labor GmbH, 2444 Seibersdorf, Østrig.
English: Paediatric population For information on use in the paediatric population, see section 4.2.
Danish: Pædiatrisk population For oplysninger om anvendelse i den pædiatriske population, se pkt.
English: The quantity to be administered usually recommended for an adult is 370 MBq (megabecquerel, the unit used to express radioactivity).
Danish: Den sædvanligt anbefalede mængde til en voksen er 370 MBq (mega-becquerel er den enhed, der anvendes til at udtrykke radioaktivitet).
English: Axumin should be administered as a bolus intravenous injection.
Danish: Axumin skal administreres som en intravenøs bolusinjektion.
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Danish: Dette radioaktive lægemiddel afgiver små mængder ioniserende stråling, der er forbundet med en meget lille risiko for kræft og arvelige abnormiteter.
English: In the event of administration of a radiation overdose with fluciclovine (18F) the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis, frequent micturition and defecation.
Danish: Hvis patienten får en stråleoverdosis ved administration af fluciclovin (18F), skal den absorberede dosis om muligt reduceres ved at øge eliminationen af den radioaktive isotop fra kroppen ved forceret diurese, hyppig vandladning og tarmtømning.
English: If you have previously had treatment for prostate cancer and information from other tests (e.g. prostate specific antigen, PSA) indicates that the cancer may have returned, an Axumin PET scan can help your doctor find the locations where the cancer has come back.
Danish: Hvis du tidligere er blevet behandlet for prostatakræft, og hvis andre testresultater (f.eks. værdierne for prostataspecifikt antigen) viser, at kræften kan være vendt tilbage, kan en PETscanning med Axumin hjælpe med at finde de steder, hvor kræften er vendt tilbage.
English: Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible.
Danish: Nedsat nyrefunktion Benefit/risk-forholdet hos disse patienter skal overvejes nøje, da en øget stråleeksponering er mulig.
English: Mechanism of action Fluciclovine (18F) is a synthetic amino acid which is transported across mammalian cell membranes by amino acid transporters such as LAT-1 and ASCT2.
Danish: Fluciclovin (18F) er en syntetisk aminosyre, der transporteres gennem mammale cellemembraner via aminosyretransportører som f.eks. LAT-1 og ASCT2.
English: Axumin is for multidose use.
Danish: Axumin er til flerdosisanvendelse.
English: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIA
Danish: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf Østrig
English: Axumin has no or negligible influence on the ability to drive and use machines.
Danish: Axumin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Axumin is supplied in a 10 mL or 15 mL type 1 glass vial sealed with a fluoro-coated chlorobutyl, chlorobutyl or bromobutyl rubber closure and aluminium overseal.
Danish: Axumin leveres i et 10 ml eller 15 ml hætteglas af type 1-glas med en fluorcoated chlorbutyl, chlorbutyl eller brombutyl-gummiprop og aluminiumsforsegling.
English: True positive (%) False positive (%) True negative (%) False negative (%) Sensitivity [95% CI] Specificity [95% CI]
Danish: Sand-positiv (%) Falsk-positiv (%) Sand-negativ (%) Falsk-negativ (%) Følsomhed [95 % KI] Specificitet [95 % KI]
English: For an administered activity of 370 MBq the typical radiation doses to the critical organs, pancreas, the cardiac wall and uterine wall are 37.8 mGy, 19.1 mGy and 16.5 mGy, respectively.
Danish: Ved en administreret aktivitet på 370 MBq er den stråledosis, der typisk optages af de kritiske organer, pancreas, hjertevæg og uterusvæg, henholdsvis 37,8 mGy, 19,1 mGy og 16,5 mGy.
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Danish: Den aktivitet, der skal administreres, skal nøje overvejes, da der er risiko for øget stråleeksponering hos disse patienter.
English: For small lesions (<1 cm diameter) focal uptake greater than blood pool should be considered suspicious for cancer.
Danish: Ved små læsioner (< 1 cm i diameter) bør fokal optagelse, der er højere end i blood pool, give mistanke om cancer.
English: Using the findings of other relevant imaging modalities and clinical follow-up as reference standard in the recruited population, patient-based sensitivity and specificity of fluciclovine (18F) PET-CT for detection of prostate/prostate bed recurrences were 94.7% (89/94) (95%CI: 88.0-98.3%) and 54.8% (17/31) (95%CI:36-72.7%), respectively.
Danish: Baseret på fund ved andre relevante billeddiagnostiske procedurer og klinisk opfølgning som referencestandard i den rekrutterede population var den patientbaserede følsomhed og specificitet ved PET-CT-scanninger med fluciclovin (18F) til detektion af recidiv i prostata/prostataleje henholdsvis 94,7 % (89/94) (95 % KI: 88,0-98,3 %) og 54,8 % (17/31) (95 % KI: 36-72,7 %).
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Danish: Der skal derfor træffes foranstaltninger til strålebeskyttelse i henhold til nationale bestemmelser.
English: Axumin is administered intravenously as an injection into your vein followed by a flush of sodium chloride solution to ensure that you receive the full dose.
Danish: Axumin administreres intravenøst som en indsprøjtning i en blodåre efterfulgt af gennemskylning med natriumchlorid-injektionsvæske (saltvand) for at sikre, at du får hele dosis.
English: Fluciclovine (18F) is not indicated for use in women.
Danish: Fluciclovin (18F) er ikke indiceret til brug hos kvinder.
English: Adequate shielding is mandatory.
Danish: Passende afskærmning er et ufravigeligt krav.
English: False-positive cases have been also described in association with an inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy.
Danish: Falsk-positive tilfælde er også blevet beskrevet i forbindelse med et antiinflammatorisk respons efter kryoterapi og strålingsartefakter hos patienter, der tidligere har fået strålebehandling.
English: It is recommended that image acquisition should start from mid-thigh and proceed to the base of the skull.
Danish: Det anbefales, at billedoptagelsen starter midt på låret og fortsætter op til kraniebunden.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Danish: De vil være særligt omhyggelige med at sikre forsvarlig brug af lægemidlet, og de vil fortælle dig, hvad der sker undervejs.
English: The activities of LAT-1 and ASCT2 are known to be upregulated in prostate cancer, providing a mechanism for the enhanced accumulation of fluciclovine (18F) in prostate cancer.
Danish: Man ved, at aktiviteten af LAT-1 og ASCT2 opreguleres ved prostatakræft og udgør en mekanisme til at øge akkumulationen af fluciclovin (18F) i prostatakræft.
English: - if you are allergic to fluciclovine (18F) or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for fluciclovin (18F) eller et af de øvrige indholdsstoffer i Axumin (angivet i punkt 6).
English: The pivotal efficacy data derives from 115 patients recruited into the BED-001 study at Emory
Danish: De pivotale effektdata stammer fra 115 forsøgspersoner, der blev rekrutteret til BED-001-studiet ved Emory University.
English: o Physiological distribution of fluciclovine o Image interpretation guidelines o Examples of incidental findings on PET-CT with fluciclovine o Examples of positive and negative findings on PET-CT with fluciclovine o Demonstration cases with image interpretation provided by an expert
Danish: o Beskrivelse af fluciclovins fysiologiske fordeling o Retningslinjer for fortolkning af billederne o Eksempler på tilfældige fund ved PET/CT-scanning med fluciclovin o Eksempler på positive og negative fund ved PET/CT-scanning med fluciclovin o Demonstrationsforløb med en eksperts fortolkning af billeder
English: DATE OF REVISION OF THE TEXT 11.
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: - The other ingredients are sodium citrate, concentrated hydrochloric acid, sodium hydroxide, water for injections (see section 2 "Axumin contains sodium")
Danish: - Øvrige indholdsstoffer: natriumcitrat, koncentreret saltsyre, natriumhydroxid, vand til injektionsvæsker (se punkt 2 "Axumin indeholder natrium").
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal der tages højde for hos patienter på natriumfattig diæt.
English: N True positive n (%) False positive n (%) True negative n (%) False negative n (%) Sensitivity [95% CI] Specificity [95% CI] Positive likelihood ratio [95% CI] Negative likelihood ratio [95% CI]
Danish: N Sand-positiv n (%) Falsk-positiv n (%) Sand-negativ n (%) Falsk-negativ n (%) Følsomhed [95 %-KI] Specificitet [95 %-KI] Positiv sandsynlighedsratio [95 %-KI] Negativ sandsynlighedsratio [95 %-KI]
English: In in vitro studies, fluciclovine (18F) was not taken up by common drug transporters indicating a negligible potential for drug interactions.
Danish: I in vitro-studier blev fluciclovin (18F) ikke optaget af de almindelige lægemiddeltransportører, hvilket tyder på, at potentialet for lægemiddelinteraktioner er ubetydeligt.
English: From a microbiological point of view, unless the method of opening/ dose withdrawal/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel bør præparatet anvendes med det samme, medmindre metoden til åbning/optrækning i sprøjten/fortynding udelukker risiko for kontaminering med mikroorganismer.
English: Method of administration Axumin is for intravenous use.
Danish: Administration Axumin er til intravenøs anvendelse.
English: It should be recommended to the patient that they do not undertake any significant exercise for at least a day before the fluciclovine (18F) scan.
Danish: Patienterne skal informeres om, at de ikke må dyrke nævneværdig motion i mindst et døgn forud for fluciclovin (18F)-scanningen.
English: Activity: {YYYY} MBq in {xx.x}mL at {hh:mm}{Time Zone} {DD/MM/YYYY}
Danish: Aktivitet: {YYYY} MBq i {xx,x} ml kl. {tt.mm}{tidszone} {DD/MM/ÅÅÅÅ}
English: Other medicines and Axumin
Danish: Brug af anden medicin sammen med Axumin
English: The effective half-life of fluciclovine (18F) equates to the radioactive half-life of fluorine (18F), which is approximately 110 minutes.
Danish: Den effektive halveringstid for fluciclovin (18F) svarer til halveringstiden for den radioaktive isotop af fluor (18F), der er på ca. 110 minutter.
English: Paediatric population There is no relevant use of fluciclovine (18F) in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende fluciclovin (18F) hos den pædiatriske population.
English: Pharmacotherapeutic group: Other diagnostic radiopharmaceuticals for tumour detection, ATC code:
Danish: Farmakoterapeutisk klassifikation: Andre diagnostiske radiofarmaka til tumordetektion, ATC-kode: V09IX12
English: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL UK
Danish: GE Healthcare Ltd, The Grove Centre, White Lion Road, Amersham HP7 9LL, Storbritannien
English: For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for cancer.
Danish: Ved større læsioner bør optagelse, der er lig med eller højere end i knoglemarven, give mistanke om cancer.
English: The detection of prostate cancer recurrence in prostate/prostate bed, regional lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported.
Danish: Der er rapporteret om detektion af recidiv af prostatakræft i prostata/prostataleje, regionale lymfeknuder, knogler, bløddele og ikke-regionale lymfeknuder ved hjælp af fluciclovin (18F).
English: The impact of anti-mitotic agents and colony stimulating factors on uptake of fluciclovine in patients with prostate cancer has not been studied.
Danish: Indvirkningen af antimitotika og kolonistimulerende faktorer på optagelsen af fluciclovin hos patienter med prostatakræft er ikke blevet undersøgt.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in sections 6.6 and 12.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to facilitate the removal of radioactivity from your body.
Danish: Den nuklearmedicinske læge kan f.eks. give dig lægemidler, der fremmer vandladning og afføring, så radioaktiviteten kommer hurtigere ud af kroppen.
English: If at any time in the preparation of this medicinal product the integrity of the vial is compromised it should not be used.
Danish: Hvis hætteglasset beskadiges under klargøringen af lægemidlet, uanset hvornår, må det ikke anvendes.
English: Axumin has not been studied in patients with renal or hepatic impairment.
Danish: Axumin er ikke undersøgt hos patienter med nedsat nyre- eller leverfunktion.
English: Distant metastases involved distal lymph nodes, soft tissue and bone.
Danish: Fjernmetastaser involverede distale lymfeknuder, bløddele og knogler.
English: Axumin should only be used when the injection volume is greater than 0.5 mL (approximately 2 hours after time of calibration for Axumin 1600 MBq/mL and 4 hours after time of calibration for Axumin 3200 MBq/mL).
Danish: Axumin bør kun anvendes ved en injektionsvolumen over 0,5 ml (ca. 2 timer efter tidspunktet for kalibrering for Axumin 1600 MBq/ml og ca. 4 timer efter tidspunktet for kalibrering for Axumin 3200 MBq/ml).
English: Concentrated hydrochloric acid Sodium hydroxide Water for injections
Danish: Natriumcitrat Koncentreret saltsyre Natriumhydroxid Vand til injektionsvæsker
English: Patients were adult and elderly men presenting with suspected recurrence, based on elevated blood PSA levels after primary curative treatment of localized prostate cancer and with negative bone scintigraphy.
Danish: Patienterne var voksne og ældre mænd med formodet recidiv baseret på forhøjet PSA-niveau i blodet efter primær kurativ behandling af lokaliseret prostatakræft og med negativ knoglescintigrafi.
English: Withdrawals should be performed under aseptic conditions.
Danish: Optrækning i sprøjten skal ske under aseptiske forhold.
English: The estimated absorbed radiation doses for adult patients following intravenous injection of fluciclovine (18F) are shown in Table 3.
Danish: Den estimerede absorberede stråledosis hos voksne patienter efter intravenøs injektion af fluciclovin (18F) er vist i tabel 3.
English: Chemical and physical in-use stability has been demonstrated for Axumin 1600 MBq/mL for 8 hours and for Axumin 3200 MBq/mL for 10 hours.
Danish: Der er påvist kemisk og fysisk i-brug-stabilitet i 8 timer for Axumin 1600 MBq/ml og i 10 timer for Axumin 3200 MBq/ml.
English: Contents of the pack and other information What Axumin contains
Danish: Pakningsstørrelser og yderligere oplysninger Axumin indeholder:
English: A quantitative correlation between fluciclovine uptake and enhanced fluciclovine influx into cells was not assessed in vivo in healthy volunteers or prostate cancer patients.
Danish: En kvantitativ korrelation mellem optagelse af fluciclovin og øget fluciclovin-indstrømning i cellerne er ikke vurderet in vivo hos raske forsøgspersoner eller patienter med prostatakræft.
English: Activity: {YYYY} MBq Volume: {xx.x] mL
Danish: Aktivitet: {YYYY} MBq Volumen: {xx.x] ml
English: Location
Danish: Lokation
English: What you need to know before Axumin is used 3.
Danish: Det skal du vide, før du får Axumin 3.
English: Fluciclovine (18F) accumulates in prostate cancer and other types of cancer but also in normal tissues and some other prostate pathologies (such as benign prostatic hyperplasia, chronic prostatitis, high grade prostatic intraepithelial hyperplasia).
Danish: Fluciclovine (18F) akkumuleres i prostatakræft og andre typer kræft (men også i normalt væv og i visse andre prostatapatologier (f.eks. benign prostatahyperplasi, kronisk prostatitis og høj-grads intraepitelial prostatahyperplasi).
English: Fluciclovine (18F) is preferentially taken up into prostate cancer cells compared with surrounding normal tissues.
Danish: Fluciclovin (18F) optages fortrinsvist i prostatakræftceller sammenlignet med det omgivende normale væv.
English: No. subjects in analysis
Danish: Antal forsøgspersoner i analysen
English: Extraprostatic (pelvic and distal recurrence)
Danish: Uden for prostata (recidiv i bækken og distalt)
English: Interpretation of fluciclovine (18F) images and limitations of use Fluciclovine (18F) images should be interpreted by appropriately trained personnel.
Danish: Fortolkning af fluciclovin (18F)-billederne og begrænsninger for anvendelse Fluciclovin (18F)-billederne skal fortolkes af specialuddannet personale.
English: Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland
Danish: Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square, Dublin 2, Irland
English: With increasing time post injection, distributed uptake is apparent and is mostly associated with skeletal muscle.
Danish: Som tiden går efter injektionen, bliver det tydeligere, hvor aktiviteten bliver optaget, og det sker primært i skeletmuskulaturen.
English: The solution should be inspected visually prior to use.
Danish: Injektionsvæsken skal kontrolleres visuelt inden brug.
English: The adult effective dose resulting from the administration of the recommended activity of 370 MBq of fluciclovine (18F) is 8.2 mSv.
Danish: Den effektive dosis hos voksne patienter efter administration af den anbefalede aktivitet på 370 MBq fluciclovin (18F) er 8,2 mSv.
English: How Axumin is used 4.
Danish: Sådan får du Axumin 4.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Danish: Den nuklearmedicinske læge vil fortælle dig, hvor lang tid undersøgelsen tager.
English: Suspicion of cancer in sites typical for prostate cancer recurrence is based on fluciclovine (18F) uptake in comparison with tissue background.
Danish: Mistanke om cancer på steder, der er typiske for recidiv af prostatakræft, er baseret på optagelsen af fluciclovin (18F) sådanne steder sammenholdt med optagelsen i det omgivende væv.
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Danish: Opbevaring af radioaktive lægemidler vil ske i overensstemmelse med den nationale lovgivning for radioaktive materialer.
English: The use of either intravenous iodinated CT contrast or oral contrast media is not required to interpret fluciclovine (18F) PET images.
Danish: Det er ikke nødvendigt at anvende intravenøse iodholdige CT-kontrastmidler eller orale kontrastmidler for at fortolke fluciclovin-billeder ved (18F) PET-scanning.
English: For the limitations in the interpretation of a positive scan, see section 4.4 and 5.1.
Danish: For begrænsninger ved fortolkningen af positive scanninger, se pkt.
English: What you need to know before Axumin is used Axumin must not be used:
Danish: Det skal du vide, før du får Axumin Du må ikke få Axumin:
English: Fluciclovine (18F) PET-CT was restricted to the abdomino-pelvic region.
Danish: PET-CT-scanning med fluciclovin (18F) var begrænset til abdominal-pelvis-regionen.
English: Axumin is a clear, colourless solution stored in a glass vial.
Danish: Axumin er en klar, farveløs injektionsvæske, der leveres i et hætteglas.
English: Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet er receptpligtigt (jf.Bilag I: Produktresumé; pkt.
English: Prior to administration of fluciclovine (18F), patients should not eat or drink for at least 4 hours (other than small amounts of water for taking medicinal products).
Danish: Patienten bør ikke spise eller drikke i mindst 4 timer inden administration af fluciclovin (18F) (bortset fra små mængder vand i forbindelse med indtagelse af medicin).
English: Fluciclovine (18F) uptake is not specific for prostate cancer and may occur with other types of cancer, prostatitis and benign prostatic hyperplasia.
Danish: Optagelse af fluciclovin (18F) er ikke specifik for prostatakræft, men kan også ses ved andre typer cancer, prostatitis og benign prostatahyperplasi.
English: The diagnostic performance of fluciclovine (18F) PET-CT for the detection of recurrence overall (at any location), and in 3 different locations (prostate/bed, pelvic lymph nodes, and distant metastases) is shown in Table 1.
Danish: Diagnostiseringseffektiviteten ved PET-CT-scanning med fluciclovin (18F) til detektion af recidiverende prostatakræft generelt (alle lokationer) samt 3 forskellige lokationer (prostata/prostataleje, lymfeknuder i bækkenet og fjernmetastaser) er vist i tabel 1.
English: - The active substance is fluciclovine (18F).
Danish: - Aktivt stof: fluciclovin (18F).
English: Before administration of Axumin you should
Danish: Før du får Axumin, skal du
English: The injection should be followed by an intravenous flush of sterile sodium chloride 9 mg/ml (0.9%) solution for injection to ensure full delivery of the dose.
Danish: Injektionen skal efterfølges af intravenøs skylning med 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske for at sikre, at hele dosis administreres.