FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall safety profile of Lutathera is based on pooled data from patients from clinical trials (NETTER-1 phase III and Erasmus phase I/II Dutch patients) and from compassionate use programs.
Danish: Den samlede sikkerhedsprofil for Lutathera er baseret på puljedata fra patienter fra kliniske forsøg (NETTER 1 fase III og Erasmus fase I/II hos hollandske patienter) og fra compassionate useprogrammer.
English: Lutathera has no or negligible influence on the ability to drive and use machines.
Danish: Lutathera påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
Danish: Lutathera er til behandling af inoperable eller metastatiske, progressive, veldifferentierede (G1 og G2), somatostatin-receptor-positive, gastroenteropankreatiske, neuroendokrine tumorer (GEP-NET) i voksne patienter.
English: If in any doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Danish: Ved tvivl om kvindens eventuelle graviditet (hvis hun har sprunget en menstruation over, hvis menstruationen er meget uregelmæssig osv.), skal patienten tilbydes alternative teknikker uden brug af ioniserende stråling (hvis de forefindes).
English: Cases of irreversible hematological pathologies, i.e., premalignant and malignant blood neoplasms (i.e., myelodysplastic syndrome and acute myeloid leukemia, respectively) have been reported following Lutathera treatment.
Danish: Tilfælde af irreversible hæmatologiske patologier, dvs. premaligne og ondartede blodlegemer (dvs. myelodysplastisk syndrom og henholdsvis akut myeloid leukæmi) er blevet rapporteret efter behandling med Lutathera.
English: Visual controls of the solution levels should be repeated during the administration by direct visual control (when PMMA container is used) or using a pair of tongs to handle the vial when the lead shipping container is used.
Danish: Visuelle kontroller af opløsningsniveauerne skal gentages under administrationen ved hjælp af direkte visuel kontrol (ved brug af PMMA-pakning) eller hjælp af en tang til håndtering af hætteglasset ved brug af en forsendelsespakning med blyafskærmning.
English: a. If the observed toxicity continues beyond 16 weeks after the last infusion, treatment with Lutathera must be definitively stopped.
Danish: a. Hvis den observerede toksicitet fortsætter 16 uger efter den sidste infusion, skal behandlingen med Lutathera seponeres permanent.
English: • Bone metastasis;
Danish: • Knoglemetastase;
English: Overall, the results of the dosimetric analysis performed in the NETTER-1 phase III dosimetry substudy and in the Erasmus phase I/II study are in agreement and indicate that Lutathera dose regimen (4 administrations of 7,400 MBq) is safe.
Danish: Samlet set er resultaterne af den dosimetriske analyse, der blev udført i NETTER-1 fase IIIdosimetrisubstudiet og i Erasmus fase I/II-studiet overensstemmende og angiver, at dosisregimet for Lutathera (4 administrationer på 7.400 MBq) er sikkert.
English: There is some evidence that corticosteroids can induce down-regulation of SST2 receptors.
Danish: Der findes evidens for, at kortikosteroider kan inducere nedregulering af SST2-receptorer.
English: Patients should be encouraged to empty their bladder as frequently as possible during the administration of amino acids and the hours after administration.
Danish: Patienterne bør opfordres til at lade vandet så ofte som muligt under administration af aminosyre og i timerne efter administration.
English: Wait 12 weeks after the date of surgery to administer Lutathera.
Danish: Vent 12 uger efter datoen for operationen, før Lutathera administreres.
English: With respect to overall survival OS, at the time of interim analysis (24 July 2015), there were 17 deaths in the Lutathera arm and 31 in octreotide LAR 60 mg arm and the hazard ratio was 0.459 in favour of Lutathera, but did not reach the level of significance for interim analysis (HR 99.9915% CI: 0.140, 1.506).
Danish: Med hensyn til den overordnede OS-overlevelse var der ved midtvejsanalysen (24. juli 2015) 17 dødsfald i Lutathera-armen og 31 i octreotid LAR 60 mg-armen, og fareforholdet var 0,459 til fordel for Lutathera, men nåede ikke signifikansniveauet for foreløbig analyse (HR 99,9915 %CI: 0,140, 1,506).
English: • Urinary incontinence;
Danish: • Urininkontinens;
English: The patient should also be encouraged to defecate every day and to use laxative if needed.
Danish: Patienten skal også opfordres til at have afføring hver dag og til at bruge afføringsmiddel, hvis det er nødvendigt.
English: Recommended measures in case of extravasation
Danish: Anbefalede foranstaltninger ved ekstravasation
English: • Or hypoalbuminemia < 30 g/L with a decreased prothrombin ratio < 70%.
Danish: • eller hypoalbuminemi < 30 g/l med et reduceret protrombinforhold < 70 %.
English: This should be taken into consideration in patient on controlled sodium diet.
Danish: Dette bør tages i betragtning hos patienter på kontrolleret natriumdiæt.
English: In spite of an observed significant selective B-cell depletion, no increase in the rate of infectious complications occurs after PRRT.
Danish: På trods af en observeret signifikant selektiv B-celleudtømning forekommer ingen stigning i frekvensen af infektiøse komplikationer efter peptidreceptor-radionuklid-terapi (PRRT).
English: It is not recommended to decrease the amount of amino acid solution in case of Lutathera dose adaptation.
Danish: Det anbefales at reducere mængden af aminosyreopløsning i tilfælde af dosistilvænning af Lutathera.
English: − The floor and the furniture should be covered with tissue paper to avoid any accidental contamination
Danish: − Gulv og inventar skal overdækkes med silkepapir for at undgå utilsigtet kontaminering.
English: Administration of Lutathera and conduct of the procedure Lutathera is administered directly into a vein.
Danish: Administration af Lutathera og gennemførelse af proceduren Lutathera indgives direkte i en vene.
English: In the case where the treatments previously provided for nausea and vomiting are insufficient, a single dose of corticosteroids can be used, as long as it is not given before initiating or within one hour after the end of Lutathera infusion.
Danish: I de tilfælde hvor behandlinger, der førhen er givet mod kvalme og opkastning, er utilstrækkelige, kan en enkeltdosis af glukokortikosteroider anvendes, så længe den ikke gives før eller en time efter en infusion med Lutathera.
English: Radioactivity in the Lutathera vial should be measured immediately before infusion using a calibrated radioactivity measurement system.
Danish: Radioaktivitet i Lutathera-hætteglasset skal måles umiddelbart før infusion ved hjælp af et kalibreret radioaktivitetsmålingssystem.
English: You can also report side effects directly via the national reporting system:
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem:
English: The vial must not be opened or the solution transferred to another container.
Danish: Hætteglasset må ikke været åbent, og opløsningen må ikke overføres til en anden pakning.
English: Vasodilatation Peripheral coldness Pallor
Danish: Vasodilatation Perifer kulde Bleghed
English: Items that cannot be flushed down the toilet, such as menstrual pads and bandages, must be placed in specific trash plastic bags (according to the recommendation stated in section "Trash recommendations" below).
Danish: Varer, der ikke kan skylles ud i toilettet, såsom menstruationsbind og bandager, skal placeres i specifikke affaldsposer (i henhold til anbefalingen i punktet "Affaldshåndtering" nedenfor).
English: • The flow of the radiopharmaceutical solution should be regulated with the clamps.
Danish: • Tilførslen af den radiofarmaceutiske opløsning reguleres vha. klemmerne.
English: Anxiety Hallucination Disorientation
Danish: Hallucination Desorientering
English: The posology can be adapted according to the patient's status at the discretion of the physician.
Danish: Doseringen kan tilpasses i forhold til patientens status efter lægens skøn.
English: − Two (2) peripheral intravenous plastic catheters
Danish: − To (2) perifere IV-plastkatetre
English: Rates lower than 320 mL/h are not recommended for commercial solutions.
Danish: Infusionshastigheder under 320 ml/t anbefales ikke for normale opløsninger.
English: • Care supplies and equipment:
Danish: • Sundhedsplejetilbehør og -udstyr:
English: Infusion rate (mL/h)
Danish: Infusionshastighed (ml/t)
English: Amino acid solution, either extemporaneously compounded (1 L) or commercial (1.5 L to 2.2 L)
Danish: Aminosyreopløsning, enten uforberedt blandingsopløsning (1 l) eller kommerciel opløsning (1,5-2,2 l)
English: • Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL), platelets < 75 G/L
Danish: • Svækket hæmatologisk funktion med enten Hb < 4,9 mmol/l (8 g/dl), trombocyttal < 75 g/l
English: Hormonal crises related to bioactive substances release (probably due to lysis of the neuroendocrine tumour cells) have rarely been observed and resolved after appropriate medical treatment (section 4.4).
Danish: Hormonale kriser relateret til frigivelse af bioaktive stoffer (sandsynligvis på grund af lysis af de neuroendokrine tumorceller) er sjældent blevet observeret og løses efter passende medicinsk behandling (se pkt.
English: When the recommended concomitant amino acids infusion is delivered over a 4 hour time span, a mean reduction in kidney radiation exposure of about 47% has been reported.
Danish: Når den anbefalede, ledsagende aminosyreinfusion er blevet administreret i løbet af et tidsrum på 4 timer, er der blevet rapporteret en gennemsnitlig reduktion i nyrebestrålingseksponering på ca. 47 %.
English: The amount of radioactivity in the vial must be measured prior to infusion using a suitable radioactivity calibration system in order to confirm that the actual amount of radioactivity to be administered is equal to the planned amount at the infusion time.
Danish: Mængden af radioaktivitet i hætteglasset skal måles inden infusion ved hjælp af et passende radioaktivitetskalibreringssystem for at bekræfte, at den faktiske mængde radioaktivitet, der skal indgives, er lig med den planlagte mængde ved infusionstiden.
English: according to somatostatin receptor imaging.
Danish: < 2) i henhold til somatostatin-receptor-imagografi.
English: • Patients with somatostatin receptor negative or mixed visceral lesions (tumour uptake score < 2)
Danish: • Patienter med negativ somatostatin-receptor eller blandede viscerale læsioner (tumoroptagsscore
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Danish: Opbevaring af radioaktive lægemidler skal overholde national lovgivning om radioaktive materialer.
English: Crises due to excessive release of hormones or bioactive substances may occur following treatment with Lutathera, therefore observation of patients by overnight hospitalisation should be considered in some cases (e.g. patients with poor pharmacologic control of symptoms).
Danish: Forstyrrelser på grund af forhøjet afgivelse af hormoner eller bioaktive stoffer forekommer efter behandling med Lutathera, og derfor bør observation af patienterne i form af indlæggelse natten over overvejes i visse tilfælde (f.eks. for patienter med ringe farmakologisk symptombehandling).
English: Therefore, administration of long acting somatostatin analogues should be avoided within 30 days prior to the administration of this medicinal product.
Danish: Administration af langtidsvirkende somatostatinanaloger bør derfor undgås i 30 dage før administration af dette lægemiddel.
English: Due to the bone marrow toxicity of Lutathera, the most expected adverse reactions were related to haematological toxicity: thrombocytopenia (25%), lymphopenia (22.3%), anaemia (13.4%), pancytopenia (10.2%).
Danish: På grund af knoglemarvstoksiciteten af Lutathera var de mest forventede bivirkninger relateret til hæmatologisk toksicitet: trombocytopeni (25 %), lymfopeni (22,3 %), anæmi (13,4 %), pancytopeni
English: Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion.
Danish: I betragtning af den entydige volumetriske aktivitet på 370 MBq/ml på kalibreringsdatoen og -tidspunktet skal opløsningens volumen justeres mellem 20,5 ml og 25 ml for at opnå den påkrævede mængde radioaktivitet på infusionsdatoen og -tidspunktet.
English: When testing the cold compound (non-radioactive lutetium (175Lu) oxodotreotide) as a single intravenous injection in rats and dogs at doses up to 20,000 µg/kg (rats) and 3,200 µg/kg (dogs), the compound was well tolerated in both species and no deaths were observed.
Danish: I forbindelse med test af koldforbindelsen (ikke- radioaktivt lutetium (175Lu)-oxodotreotid som en enkelt intravenøs injektion hos rotter og hunde i doser op til 20.000 μg/kg (rotter) og 3.200 μg/kg (hunde), var forbindelsen godt tolereret hos begge arter, og der blev ikke observeret dødsfald.
English: Lutathera is for intravenous use.
Danish: Lutathera er beregnet til intravenøs brug.
English: Store in the original package to protect from ionizing radiation (lead shielding).
Danish: Opbevares i den originale pakning for at beskytte mod ioniserende stråling (blyafskærmning).
English: • Hematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia;
Danish: • Hæmatologisk toksicitet højere end eller lig med stadie 2 (CTCAE) før behandling, med undtagelse af lymfopeni;
English: The following information is intended for the specialist only.
Danish: Oplysningerne nedenfor er kun beregnet til det specialuddannede personale.
English: Factors such as age >70 years, impaired renal function, baseline cytopenias, prior number of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior radiotherapy are suggested as potential risks and/or predictive factors for MDS/AL.
Danish: Faktorer såsom aldersgruppen > 70 år, nyrebeskadigelse, baseline-cytopeni, tidligere antal behandlinger, tidligere eksponering for kemoterapeutika (herunder især alkylerende midler) og tidligere strålebehandling nævnes som mulige risici og/eller forudsigende faktorer for MDS/AL.
English: Refractory cytopenia with multilineage dysplasia (Myelodysplastic syndrome)
Danish: Refraktær cytopeni med multilineardysplasi (myelodysplastisk syndrom)
English: • The short needle should be then connected to the pre-filled infusion set.
Danish: • Den korte nål forbindes derefter med det forfyldte infusionssæt.
English: Volume
Danish: Volumen
English: As this medicinal product is known to be substantially excreted by the kidneys, patients with mild to moderate impaired renal function should be more frequently monitored during the treatment.
Danish: Eftersom dette lægemiddel er kendt for hovedsageligt at blive udskilt via nyrerne, skal patienter med mild til moderat nyrebeskadigelse monitoreres regelmæssigt under behandlingen.
English: This medicinal product must not be injected as a bolus.
Danish: Dette lægemiddel skal injiceres som en bolusindsprøjtning.
English: Spouse and people in the family circle
Danish: Ægtefælle og familiemedlemmer
English: Hospitalisation and Emergency Care
Danish: Hospitalsindlæggelse og akut behandling
English: p-value of Log-rank test Hazard ratio (95%-CI)
Danish: P-værdi af Log-rank-test Fareforhold (95 % CI)
English: Should you have any further question on the use of this medicine, please ask the nuclear medicine doctor who supervises the procedure.
Danish: Hvis du har yderligere spørgsmål om brugen af lægemidlet, skal du spørge den nuklearmedicinske læge, der har tilsyn med undersøgelsen.
English: − One (1) Short needle
Danish: − En (1) kort nål
English: Lutetium-177 (177Lu) is a β- emitting radionuclide with a maximum penetration range in tissue of
Danish: Lutetium 177 (177Lu) er et β-emitterende radionuklid med et maksimalt penetrationsområde i væv på
English: Ionizing radiations of lutetium (177Lu) oxodotreotide may potentially have temporary toxic effects on female and male gonads.
Danish: Ioniserende stråling af lutetium (177Lu)-oxodotreotid kan potentielt have midlertidige toksiske virkninger på kvindelige og mandlige gonader.
English: Includes Leukopenia and White blood cell count decreased 6 Includes Neutropenia and Neutrophil count decreased
Danish: Inkluderer leukopeni og reduktion af hvide blodlegemer 6 Inkluderer neutropeni og reduceret neutrofiltal
English: Injection site reaction11
Danish: Reaktion på injektionsstedet11
English: Since many patients referred for Lutathera therapy have hepatic metastasis, it may be common to observe patients with altered baseline liver function.
Danish: Eftersom mange patienter, som har fået ordineret behandling med Lutathera, har levermetastaser, er det ikke ualmindeligt, at observere patienter med forandret leverfunktion ved baseline.
English: The patient treated with Lutathera should be kept away from others during the administration and up to reaching the radiation emission limits stipulated by applicable laws, usually within the 4-5 hours following medicinal product administration.
Danish: Patienter behandlet med Lutathera skal afskærmes fra kontakt med andre personer under administration af lægemidlet og frem til opnåelse af de angivne udstrålingsgrænseværdier i gældende lovgivning inden for et tidsrum på 4-5 timer efter administration af lægemidlet.
English: It is strongly recommended to move your bowels every day and use a laxative if necessary.
Danish: Det anbefales kraftigt at have afføring hver dag og bruge et afføringsmiddel, hvis det er nødvendigt.
English: • Liver impairment with either total bilirubinemia > 3 times the upper limit of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%;
Danish: • Leverbeskadigelse med enten total bilirubinæmi > 3 gange den øvre normalgrænse eller albuminæmi < 30 g/l og protrombin-forhold reduceret til < 70 %;
English: − Two (2) infusion poles
Danish: − To (2) infusionsstativer
English: If treatment with Lutathera during breast-feeding is necessary, the child must be weaned.
Danish: Hvis behandling med Lutathera under amning er nødvendig, skal barnet afvænnes.
English: Bone marrow toxicity (myelo-/hematotoxicity) manifested with reversible / transient reductions in blood counts affecting all lineages (cytopenias in all combinations, i.e., pancytopenia, bicytopenias, isolated monocytopenias - anemia, neutropenia, lymphocytopenia, and thrombocytopenia).
Danish: Knoglemarvstoksicitet (myelo-/hæmatotoksicitet) manifesteret med reversible/forbigående reduktioner i blodtal, der påvirker alle linjer (cytopenier i alle kombinationer, dvs. pancytopeni, bicytopenier, isolerede monocytopenier - anæmi, neutropeni, lymfocytopeni og trombocytopeni).
English: The co-administration of amino acid solution decreases the kidney uptake, enhancing the elimination of radioactivity (see section 4.4).
Danish: Coadministration af aminosyreopløsning nedsætter nyreoptagelsen, hvilket forbedrer udskillelsen af radioaktivitet (se pkt.
English: The amino acids solution will help to decrease reabsorption of lutetium (177Lu)
Danish: Aminosyreopløsningen vil være medvirkende til at reducere reabsorptionen af lutetium (177Lu)
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 din nuklearmedicinske læge, som vil overvåge proceduren.
English: 25 g Sodium chloride 9 mg/mL (0.9%) solution for injection 1 L Alternatively, some commercially available amino acid solutions can be used if compliant with the specification described in Table 2.
Danish: 25 g Natriumklorid 9 mg/ml (0,9 %) infusionsvæske, opløsning 1 L Alternativt kan der anvendes nogle kommercielt tilgængelige aminosyreopløsninger, hvis disse er i overensstemmelse med specifikationerne beskrevet i Tabel 2.
English: This might induce nausea and vomiting; you will also receive an injection before the start of the treatment to reduce these symptoms.
Danish: Du vil også modtage en injektion inden behandlingens begyndelse for at reducere disse symptomer.
English: Vial No.: {X}
Danish: : {DD MM ÅÅÅÅ tt: mm UTC}
English: Treatment monitoring
Danish: Behandlingsmonitorering
English: Hypersensitivity to the active substance or to any of the excipients of this medicinal product When specific adverse reactions to this medicinal product persist or reoccur, such as delayed grade 3-4 (G3-G4) hematotoxicity (see Table 5).
Danish: Overfølsomhed over for det aktive stof eller et vilkårligt hjælpestof i dette lægemiddel Hvis specifikke bivirkninger som følge af behandling med dette lægemiddel vedbliver eller gentages, såsom forsinket stadie 3-4 (G3-G4) hæmatotoksicitet (se Tabel 5).
English: Any other CTCAE grade 3 or grade 4 toxicity** possibly related to Lutathera.
Danish: Enhver anden CTCAE-toksicitet på stadie 3 eller 4** muligvis forbundet med Lutathera.
English: The causality of nausea / vomiting is confounded by the emetic effect of the concomitant amino acids infusion administered for renal protection.
Danish: Kausaliteten af kvalme/opkastning forstyrres af den emetiske virkning af den samtidige aminosyreinfusion administreret for nyrebeskyttelse.
English: * The concomitant amino acids infusion is always administered at full dose (see section 4.4).
Danish: * Den ledsagende aminosyreinfusion administreres altid som en fuld dosis (se pkt.
English: Before starting treatment with Lutathera, somatostatin receptor imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake (tumour uptake score ≥ 2).
Danish: Før start af behandling med Lutathera, skal der udføres somatostatin-receptor-imagografi (scintigrafi eller positronemissionstomografi [PET]) for at bekræfte overekspression for disse receptorer i tumorvævet med et tumoroptag mindst på højde med normalt leveroptag (tumoroptagsscore ≥ 2).
English: To be taken into consideration by patients on controlled sodium diet.
Danish: Skal tages i betragtning af patienter med kontrolleret natriumdiæt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lutathera in all subsets of the paediatric population in the treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Lutathera i alle undergrupper af den pædiatriske population til behandling af GEP - NET'er (undtagen neuroblastom, neuroganglioblastom, phaeochromocytom).
English: • The long needle should be connected to the pre-filled tubing line and then inserted into the Lutathera vial, so that it touches the bottom of the vial.
Danish: • Den lange nål forbindes med den forfyldte slangeforbindelse og indsættes derefter i Lutatherahætteglasset, indtil den rører ved bunden af hætteglasset.
English: Erasmus phase I/II study was a monocentric single arm open-label study to evaluate the efficacy of Lutathera (7,400 MBq administered for 4 times every 8 weeks) co-administered with amino acid solution in patients with somatostatin receptor positive tumours.
Danish: Erasmus fase I/II-studiet var et monocentrisk enkeltarmet open- label-studie til evaluering af effekten af Lutathera (7.400 MBq administreret 4 gange hver 8. uge) co-administreret med aminosyreopløsning hos patienter med somatostatinreceptorpositive tumorer.