FrancophonIA/ELRC3.0 huggingface dataset:
English: During the administration only disposable materials should be used.
Danish: Der må kun anvendes engangsmaterialer under administrationen.
English: • Kidney is not a critical organ if a co-infusion of an appropriate amino acids solution is performed.
Danish: • Nyre er ikke et kritisk organ, hvis der udføres en samtidig infusion af en passende aminosyreopløsning.
English: It binds to malignant cells which overexpress sst2 receptors.
Danish: Det binder til maligne celler, som overudtrykker sst2-receptorer.
English: The most common side effect seen in patients being treated with Lutathera is the impact on the bone marrow.
Danish: Den mest almindelige bivirkning, der ses hos patienter behandlet med Lutathera, er virkningen på knoglemarven.
English: Breast-feeding should be avoided during treatment with this medicinal product.
Danish: Amning skal undgås under behandlingen med dette lægemiddel.
English: The pole height should be adjusted in order to compensate any increase or reduction of pressure inside the vial.
Danish: Stativhøjden skal justeres for at kompensere for en evt. forøgelse eller reduktion af trykket i hætteglasset.
English: Depending on the situation, the nuclear medicine physician should inform the patient about the risks linked to extravasation injury, and give advice about potential treatment and necessary follow-up requirements.
Danish: Afhængig af situationen bør lægen med speciale i nuklearmedicin informere patienten om risici forbundet med ekstravasationsskader og rådgive om mulige behandlingsformer og nødvendige krav til opfølgning.
English: Close contact with other people should be restricted during 7 days following an administration of Lutathera, and for children and pregnant women it should be limited to less than 15 minutes for each day while keeping a distance of at least 1 meter.
Danish: Tæt kontakt med andre personer skal begrænses i de første 7 dage efter administration af Luthera, og for børn og gravide bør den være begrænset til mindre end 15 minutter for hver dag, mens der holdes en afstand på mindst 1 meter.
English: Secondary endpoints included objective response rate (ORR), overall survival (OS), time to tumour progression (TTP), safety and tolerability of the medicinal product and quality of life (QoL).
Danish: Sekundære endepunkter inkluderede objektiv responsrate (ORR), samlet overlevelse (OS), tid indtil tumorprogression (TTP), sikkerhed og tolerabilitet af lægemidlet og livskvalitet (QoL).
English: General rule
Danish: Generel regel
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette inkluderer eventuelle bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered, hence radioprotection rules should be followed (section 4.4).
Danish: Dette kan være til bekymring for den nærmeste familie af de personer, der undergår behandling eller offentligheden afhængigt af administrationsniveauet, og derfor skal strålebeskyttelsesreglerne følges (pkt.
English: This will allow for the complete extraction of the radiopharmaceutical solution.
Danish: Dette tillader komplet ekstraktion af den radiofarmaceutiske opløsning.
English: − One (1) Long needle (90 - 100 mm)
Danish: − En (1) lang nål (90-100 mm)
English: The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each.
Danish: Den anbefalede behandlingsform med Lutathera til voksne består af 4 infusioner af 7.400 MBq hver.
English: Two hundred thirty-one (231) patients have been randomized to receive either Lutathera (n=117) or octreotide LAR (n=114).
Danish: Tohundredeogenogtredve (231) patienter er randomiseret til at modtage enten Lutathera (n = 117) eller octreotid LAR (n = 114).
English: The nuclear medicine physician and the radiopharmacist should be informed.
Danish: Lægen med speciale i nuklearmedicin og radiofarmaceuten skal informeres.
English: • Kidney function (creatinine and creatinine clearance)
Danish: • Nyrefunktion (kreatinin og kreatinin-clearance)
English: In some circumstances, it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after the first administration or even discontinue the treatment (see Table 3 - Table 5 and Figure 1).
Danish: I nogle tilfælde kan det være nødvendigt at sætte behandlingen med Lutathera midlertidigt i bero, tilpasse dosis efter den første administration eller sågar seponere behandlingen (se Tabel 3 - Tabel 5 og Figur 1).
English: It is not known if there is of interaction between glucocorticosteroids used intermittently for the prevention of nausea and vomiting during Lutathera administration.
Danish: Det vides ikke, om der findes interaktion mellem glukokortikosteroider, der anvendes intermitterende til forebyggelse af kvalme og opkastning under administration af Lutathera.
English: However, it is recommended that when conducting standard care or exams with medical devices or other instruments which contact the skin (e.g. electrocardiogram (ECG)), basic protection measures should be observed such as wearing gloves, installing the material/electrode before the start of radiopharmaceutical infusion, changing the material/electrode after measurement, and eventually monitoring the radioactivity of equipment after use.
Danish: Det anbefales dog, at når der udføres standardpleje eller undersøgelser med medicinske apparater eller andre instrumenter, der kommer i kontakt med huden (f.eks. elektrokardiogram EKG)), skal der overholdes grundlæggende beskyttelsesforanstaltninger såsom brug af handsker, montering af materiale/elektrode inden påbegyndelsen af infusion af det radioaktive lægemiddel, skift af materiale/ elektrode efter måling og efterfølgende overvågning af udstyrsradioaktivitet efter brug.
English: However, since increased risk of presenting haematotoxicity has been described in elderly patients (≥ 70 years old), a close follow up allowing for prompt dose adaptation (DMT) in this population is advisable.
Danish: Eftersom en forøget hæmatotoksicitetsrisiko er blevet beskrevet hos ældre patienter (≥ 70 år), anbefales en tæt opfølgning, der tillader en prompte tilpasning af dosis (DMT) i denne population.
English: If this does occur to you, your doctor may decide to delay or stop the treatment administration.
Danish: Hvis dette sker for dig, kan din læge beslutte at udskyde eller stoppe behandlingen.
English: Dishes and bathroom accessories Take special precautions during the 7 days after treatment: - Flush all wipes and/or toilet paper down the toilet immediately after use, - Always wash your hands well after using the toilet, - Take a shower every day, - Flush any tissues or any other items that contain anything from your body, such as blood, urine and faeces down the toilet.
Danish: Tallerkner og badeværelse tilbehør Tag særlige forholdsregler i løbet af de 7 dage efter behandlingen: - Skyl alle vådservietter og/eller toiletpapir ud i toilettet umiddelbart efter brug, - Vask altid dine hænder grundigt efter brug af toilettet - Tag et bad hver dag - Skyl alle papirservietter eller andre genstande, der indeholder noget fra din krop, såsom blod, urin og fæces, ud i toilettet.
English: This medicinal product contains up to 3.5 mmol (81.1 mg) sodium per dose.
Danish: Dette lægemiddel indeholder op til 3,5 mmol (81,1 mg) natrium pr. dosis.
English: Unless your doctor has considered that the clinical benefit of the treatment overcomes the possible risks, you will not be given this medicine: - if you have received a previous external radiation therapy on more than 25% of your bone marrow - if you heart is seriously impaired - if you have seriously affected blood cell counts - if your liver is seriously impaired - if it appears that your tumour does not have sufficient somatostatin receptors
Danish: Medmindre din læge har overvejet, at den kliniske fordel ved behandlingen opvejer de mulige risici, vil du ikke få denne medicin: - Hvis du har modtaget en tidligere ekstern strålebehandling på mere end 25 %af dit knoglemarv - Hvis dit hjerte er alvorligt svækket - Hvis du har alvorligt berørte blodlegemer - Hvis din lever er alvorligt nedsat - Hvis det ser ud til, at din tumor ikke har tilstrækkelige somatostatinreceptorer
English: Organ absorbed dose (mGy/MBq) (n = 20)
Danish: Orgabsorberet dosis (mGy/MBq) (N = 20)
English: The use of Lutathera does involve exposure to amounts of radioactivity.
Danish: Anvendelsen af Lutathera indebærer eksponering for mængder af radioaktivitet.
English: In the event of administration of a radiation overdose with Lutathera, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding during the first 48 hours after infusion.
Danish: I tilfælde af administration af en strålingsdosis med Lutathera bør den absorberede dosis til patienten om muligt reduceres ved at øge udskillelsen af radionuklidet fra kroppen ved hyppig mikturering eller ved tvungen diurese og hyppig blæretømning i de første 48 timer efter infusion.
English: The MAH shall ensure that in each Member State where Lutathera is marketed, all patients/carers who are expected to be administered Lutathera have access to/are provided with a patient educational material containing:
Danish: Indehaveren af markedsføringstilladelsen skal sørge for, i alle de medlemslande hvor Lutathera markedsføres, at alle patienter/plejegivere, som forventes at blive behandlet med/håndterer Lutathera, har adgang til/får udleveret patientuddannelsesmateriale, som indeholder:
English: In the case of the use of special medical equipment such as catheters, colostomy bags bedpan, water nozzle, or anything that could be contaminated by your body fluids these must be emptied immediately in the toilet and then cleaned.
Danish: I tilfælde af brug af særligt medicinsk udstyr som katetre, kolostomiposer, stomiposer, vanddyser eller andet, der kan blive forurenet af dine kropsvæsker, skal disse straks tømmes i toilettet og derefter rengøres.
English: • Patient guide
Danish: • Patientvejledningen
English: All the administration device materials should be kept in order to measure the residual radioactivity and the activity actually administered and eventually the absorbed dose should be determined.
Danish: Alle materialer til administrationsanordninger skal beholdes for at måle resterende radioaktivitet og den faktisk administrerede aktivitet, og eventuelt absorberet dosis skal fastslås.
English: Blood creatinine increased GGT* increased ALAT** increased ASAT*** increased Blood ALP**** increased
Danish: Forhøjet blodkreatinin Forhøjet GGT* Forhøjet ALAT** Forhøjet ASAT*** Forhøjet blod ALP****
English: The amino acid solution can be prepared as a compounded product, in compliance with the hospital's sterile medicinal product preparation good practices and according to the composition specified in Table 1.
Danish: Aminosyreopløsningen kan forberedes som et blandingsprodukt i overensstemmelse med hospitalets retningslinjer for forberedelse af sterile lægemidler og i henhold til sammensætningen angivet i Tabel
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem:
English: Other very common adverse reactions reported include fatigue (27.7%) and decreased appetite
Danish: Andre indberettede meget almindelige bivirkninger omfatter træthed (27,7 %) og nedsat appetit (13,4
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 September 2017
Danish: Dato for første markedsføringstilladelse: 26 september 2017
English: Moving the patient's arm position should be avoided if possible (extreme flexion or extension which could lead to vein compression).
Danish: Justering af placeringen af patientens arm bør undgås om muligt (voldsom fleksion eller ekstension kan forårsage venekompression).
English: The recommended infusion method for administration of Lutathera is the gravity method.
Danish: Den anbefalede infusionsmetode til administration af Lutathera er gravitationsmetoden.
English: b. If the observed toxicity resolves within 16 weeks after the last infusion, it is possible to continue the treatment with Lutathera by infusing a half dose (3,700 MBq)*.
Danish: b. Hvis den observerede toksicitet forsvinder 16 uger efter den sidste infusion, er det muligt at fortsætte behandlingen med Lutathera i form af infusion af en halv dosis (3.700 MBq)*.
English: • Or in the lead container in which Lutathera is delivered.
Danish: • eller i en pakning med blyafskærmning, hvori Lutathera leveres.
English: Urine and faeces should be disposed according to the national regulations.
Danish: Urin og fæces skal bortskaffes i henhold til de nationale bestemmelser.
English: The educational programme is aimed at increasing patients' awareness on the risk of radiotoxicity by occupational exposure and inadvertent exposure to peptide receptor radionuclide therapy, and at providing information concerning the necessary precautions to take to limit unnecessary exposure to themselves and the people around them.
Danish: Formålet med uddannelsesprogrammet er at øge patienternes bevidsthed omkring risikoen for strålingstoksicitet under erhvervsmæssig eksponering og utilsigtet eksponering over for behandling med peptidreceptorradionuklider og at tilvejebringe oplysninger vedrørende de nødvendige forholdsregler, der skal tages, for at begrænse unødvendig eksponering af dem selv og de personer, der omgiver dem.
English: Toxicity with four repeated administrations, once every 2 weeks, of 1,250 µg/kg of the cold compound in rats and 80 µg/kg in dogs was not observed.
Danish: Toksicitet med fire gentagne indgivelser, hver anden uge på 1.250 μg/kg af koldforbindelsen i rotter, og 80 μg/kg hos hunde, blev ikke observeret.
English: Electrocardiogram QT prolonged
Danish: Elektrokardiogram QTforlænget
English: The use of Lutathera is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the risk associated with the ionizing radiation (see section 4.3).
Danish: Brug af Lutathera er kontraindiceret under etableret eller formodet graviditet, eller når graviditeten ikke er udelukket på grund af risikoen forbundet med ioniserende stråling (se pkt.
English: In addition to administration of Lutathera, an infusion with amino acids will be given to you in order to protect your kidneys.
Danish: Ud over administration af Lutathera vil der blive givet en infusion med aminosyrer for at beskytte dine nyrer.
English: The absence of inhibition or significant induction of the human CYP450 enzymes, the absence of specific interaction with P-glycoprotein (efflux transporter) as well as OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 and BCRP transporters in pre-clinical studies suggest that Lutathera has a low probability of causing significant other drug-drug interactions.
Danish: Fraværet af inhibering eller signifikant induktion af de humane CYP450-enzymer, fraværet af specifik interaktion med P-glycoprotein (efflux-transportør) samt OAT1, OAT3, OCT2, OATP1B1, OATP1B3, OCT1 og BCRP-transportører i prækliniske undersøgelser indikerer, at Lutathera har en lav sandsynlighed for at forårsage signifikante andre lægemiddelinteraktioner.
English: Treatment with Lutathera can have an impact on blood cells, liver and kidneys (see section 4).
Danish: Behandling med Lutathera kan påvirke blodlegemer, lever og nyrer (se afsnit 4).
English: • Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Danish: • Graviditet eller formodning om graviditet eller hvis graviditet ikke kan udelukkes (se pkt.
English: (75x103/mm3), or leucocytes < 2 G/L (2,000/mm3) (except lymphopenia);
Danish: (75x103/mm3) eller leukocyttal < 2 g/l (2.000/mm3) (undt.
English: Lutathera contains sodium
Danish: Lutathera indeholder natrium
English: The results indicate an improvement in the overall global health-related quality of life up to week 84, for patients on Lutathera treatment as compared to patients on Octreotide LAR arm.
Danish: Resultaterne indikerer en forbedring af den samlede, overordnede sundhedsrelaterede livskvalitet indtil uge 84, for patienter i Lutathera-behandling sammenlignet med patienter i Octreotide LARgruppen.
English: Before the patient is released, the nuclear physician should explain the necessary radioprotection rules of interacting with family members and third parties, and the general precautions the patient must follow during daily activities after treatment (as given in next paragraph and the package leaflet) to minimize radiation exposure to others.
Danish: Før patienten udskrives, skal lægen med speciale i nuklearmedicin forklare de nødvendige strålebeskyttelsesregler, der skal følges ved interaktion med familiemedlemmer og tredjeparter, samt generelle forsigtighedsregler, som patienten skal følge i forbindelse med daglige aktiviteter efter behandlingen (som anført i næste afsnit og på indlægssedlen) for at minimere strålingseksponering af andre personer.
English: The median PFS for Lutathera was not reached at the time of analysis whereas the one of octreotide LAR was 8.5 months.
Danish: Median PFS for Lutathera blev ikke nået på tidspunktet for analysen, mens den ene for octreotid LAR var 8,5 måneder.
English: The complete SmPC of Lutathera 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 Lutathera 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: • Blood chemistry monitoring: serum creatinine and glycaemia.
Danish: • Overvågning af blodkemi: Serumkreatinin og glykæmi.
English: Health Related Quality of Life (HRQOL) was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (generic instrument) and its neuroendocrine tumour module (EORTC QLQ-GI.NET-21).
Danish: Sundhedsrelateret livskvalitet (Health Related Quality of Life, HRQOL) blev vurderet ved hjælp af et spørgeskema om livskvalitet fra European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) (generisk instrument) og dets neuroendokrine tumormodul (EORTC QLQGI.NET-21).
English: − One (1) sterile tubing line with a clamp to regulate or stop the flow
Danish: − En (1) steril slangeforbindelse med en klemme til at regulere eller standse tilførslen
English: In the case of overdose, an increase in the frequency of the adverse reactions related to radiotoxicity is expected.
Danish: I tilfælde af overdosering forventes en stigning i hyppigheden af bivirkningerne relateret til radioaktivitet.
English: Store in the original package to protect from radiation.
Danish: Opbevares i den originale pakning for at beskytte mod stråling.
English: Cryopreservation of sperm or eggs may be offered to you before the treatment.
Danish: Kryopræservering af sæd eller æg kan eventuelt tilbydes til dig før behandlingen.
English: It is strongly recommended to limit contact with children and pregnant women for 7 days after the administration.
Danish: Kontakt med børn og gravide Det anbefales på kraftigste at begrænse kontakt med børn og gravide i 7 dage efter administrationen.
English: Subsequent checks of the radioactivity emission should be performed approximately every 5 minutes at the level of the patient's thorax and vial.
Danish: Efterfølgende kontroller af den radioaktive udstråling skal udføres ca. hvert 5. minut på niveau med patientens thorax og hætteglasset.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Udsættelse for ioniserende stråling er forbundet med kræftfremkaldelse og risiko for udvikling af arvelige defekter.
English: • The critical organ is the bone marrow, however, with the recommended Lutathera cumulative dose of 29,600 MBq (4 administrations of 7,400 MBq), no correlation between hematologic toxicity and the total radioactivity administered or bone marrow absorbed dose has been observed either in Erasmus phase I/II or in NETTER-1 phase III study.
Danish: • Det kritiske organ er knoglemarven, men med den anbefalede Lutathera-kumulative dosis på 29.600 MBq (4 administrationer på 7.400 MBq), er der ikke observeret nogen sammenhæng mellem hæmatologisk toksicitet og den totale indgivne radioaktivitet eller knoglemarvsabsorberede dosis enten i Erasmus fase I/II eller i NETTER-1 fase III-studie.
English: Talk to your doctor before you are given Lutathera as it may cause: - secondary blood cancer (myelodisplastic syndrome or acute leukaemia) which can rarely occur several years after you have completed Lutathera treatment.
Danish: Tal med din læge, før du får Lutathera, da det kan forårsage: - Sekundær blodkræft (myelodisplastisk syndrom eller akut leukæmi), som i sjældne tilfælde kan forekomme flere år efter, at du har afsluttet Lutathera-behandlingen.
English: Lutathera side effects are mainly linked to radioactivity.
Danish: Bivirkninger fra Lutathera er hovedsageligt forbundet med radioaktivitet.
English: The flow of Lutathera from the vial to the patient should be monitored during the entire infusion.
Danish: Tilførslen af Lutathera fra hætteglasset til patienten skal monitoreres under hele infusionen.
English: In the Erasmus phase I/II study 188 patients (52%) received and 172 (48%) did not receive concomitant octreotide LAR during Lutathera treatment.
Danish: I Erasmus-fase I/II-studiet modtog 188 patienter (52 %) og 172 (48 %) ikke samtidig octreotid LAR under behandling med Lutathera.
English: Store below 25°C.
Danish: Opbevares under 25 °C.
English: Two intravenous plastic catheters should be inserted into patient's peripheral veins, one on each arm.
Danish: To intravenøse plastkatetre anlægges i hver af patientens arme.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Danish: Opbevaring af lægemidlet sker under ansvar af specialuddannet personale i særlige lokaler.
English: 9 Includes Blood bilirubin increased and Hyperbilirubinaemia
Danish: 9 Inkluderer forhøjet blodbilirubin og hyperbilirubinæmi
English: You must inform the nuclear medicine doctor before the administration of Lutathera if there is a possibility you might be pregnant or if you have missed your period or if you are breast-feeding.
Danish: Du skal informere den nuklearmedicinske læge før administration af Lutathera, hvis der en mulighed for, at du måske er gravid, hvis du har sprunget en menstruation over eller hvis du ammer.
English: The vial must not be opened.
Danish: Hætteglasset må ikke åbnes.
English: Abdominal distension Diarrhoea
Danish: Abdominal distension Diarré
English: During the administration the recommended precaution measures should be undertaken (see section 6.6).
Danish: Under administrationen skal det sikres, at de anbefalede forholdsregler overholdes (se pkt.
English: No statistically significant difference in PFS was observed between the subgroup of patients who did not receive octreotide LAR (25.4 months [95% CI 22.8-30.6]) versus the subgroup who did receive concomitant treatment with octreotide LAR (30.9 months [95% CI 25.6-34.8]) (p= 0.747).
Danish: Der blev ikke observeret nogen statistisk signifikant forskel i PFS mellem undergruppen af patienter, som ikke modtog octreotid LAR (25,4 måneder [95 % CI 22,830,6]) versus undergruppen, som fik samtidig behandling med octreotid LAR (30,9 måneder [95 % CI 25,6 - 34,8] (P = 0,747).