FrancophonIA/ELRC3.0 huggingface dataset:
English: This can lead to the decrease of the different types of blood cells, most importantly, red blood cells (responsible for transporting the oxygen from the lungs to the different organs), platelets (a special cell which helps the blood to clot), and other blood cells such as white blood cells (helps to fight infection).
Danish: Dette kan føre til faldet af de forskellige typer af blodlegemer, vigtigst af alt, røde blodlegemer (ansvarlig for transport af ilt fra lungerne til de forskellige organer), blodplader (en særlig celle, der hjælper blodet til at størkne) og andre blodceller som hvide blodlegemer (hjælper med at bekæmpe infektion).
English: Therefore, glucocorticosteroids should be avoided as preventive anti-emetic treatment.
Danish: Derfor bør glukokortikosteroider undgås som forebyggende antiemetisk behandling.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din nuklearmedicinske læge til råds, før du bruger dette lægemiddel.
English: Patients should be instructed to drink substantial quantities of water (1 glass every hour) on the day of infusion and the day after to facilitate elimination.
Danish: Patienterne skal instrueres til at drikke betydelige mængder vand (1 glas hver time) på dagen for infusion samt dagen efter for at lette udskillelsen.
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares under 25 °C.
English: PFS Time (months)
Danish: PFS Tid (måneder)
English: Before each administration and during the treatment, biological tests are required to re-assess the patient's condition and adapt the therapeutic protocol if necessary (dose, infusion interval, number of infusions).
Danish: Før hver administration og under behandlingen skal der foretages biologiske tests for at revurdere patientens tilstand og tilpasse den terapeutiske protokol, om nødvendigt (dosis, infusionsinterval, antal infusioner).
English: Lutathera binds with these receptors and emits radioactivity directly into the tumour cells, causing their death.
Danish: Lutathera binder med disse receptorer og udsender radioaktivitet direkte ind i tumorcellerne, hvilket forårsager deres død.
English: Healthcare personnel are advised to limit the time of close contact with patients injected with Lutathera.
Danish: Sundhedsvæsenet rådes til at begrænse tiden for tæt kontakt med patienter injiceret med Lutathera.
English: The infusion should be stopped once the radioactivity emission from the vial becomes stable for several minutes (or during two consecutive measurements).
Danish: Infusionen skal standses, når den radioaktive udstråling fra hætteglasset forbliver stabilt i adskillige minutter (eller under to konsekutive målinger).
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Danish: Administration af produktet skal ske på en måde, der minimerer risikoen for kontaminering af lægemidlet og bestråling af operatørerne.
English: Physical disability
Danish: Fysisk handicap
English: Based on the results, your doctor may decide to delay or stop your treatment with this medicine if necessary.
Danish: Baseret på resultaterne kan din læge beslutte at udskyde eller stoppe behandlingen med dette lægemiddel om nødvendigt.
English: During the first 2 days following administration of this medicinal product, special precautions should be taken with patients with urinary incontinence to avoid spread of radioactive contamination.
Danish: I løbet af de første 2 dage efter administration af dette lægemiddel skal der træffes særlige forholdsregler hos patienter med urininkontinens for at undgå spredning af radioaktiv forurening.
English: Monitor biological parameters every 2 weeks, and treat appropriately if needed; in case of renal failure, good hydration is recommended if not otherwise contraindicated.
Danish: Monitorer biologiske parametre hver 2. uge, og behandl i overenstemmelse hermed, om nødvendigt; i tilfælde af nyresvigt anbefales opretholdelse af en god væskebalance, såfremt dette ikke er kontraindiceret.
English: The following conclusions on treatment with Lutathera were determined from radiation dosimetry evaluations performed in clinical studies:
Danish: Følgende konklusioner om behandling med Lutathera blev bestemt ud fra strålingsdosimetrievalueringer udført i kliniske studier:
English: • Information that PPRT can cause serious side effects during or after treatment and that any side effect should be reported to the physician.
Danish: • Information om, at PRRT kan forsage alvorlige bivirkninger under eller efter behandlingen, og at alle bivirkninger skal rapporteres til lægen.
English: Radiation dose to specific organs, which may not be the target organ of therapy, can be influenced significantly by pathophysiological changes induced by the disease process.
Danish: Strålingsdosis til specifikke organer, som måske ikke er målorganet for behandlingen, kan påvirkes signifikant ved patofysiologiske ændringer induceret af sygdomsprocessen.
English: Lu) oxodotreotide) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity.
Danish: Lu)-oxodotreotid) afslører ingen særlig fare for mennesker baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved gentagen dosering, genotoksicitet.
English: oxodotreotide is rapidly cleared from the blood.
Danish: Lu)-oxodotreotid hurtigt forsvinder fra blodet.
English: If for any reason you require emergency medical assistance or unplanned hospitalisation occurs during the 3 months after your treatment, you should inform the medical providers about the nature, the date and the dose of your radioactive treatment.
Danish: Hvis du af en eller anden grund har brug for akut lægehjælp eller uplanlagt indlæggelse i løbet af 3 måneder efter din behandling, skal du informere lægerne om arten, datoen og dosen af din radioaktive behandling.
English: Includes Hypertension and Hypertensive crisis
Danish: Inkluderer hypertension og hypertensive kriser
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by response evaluation criteria in solid tumours (RECIST 1.1), based on independent radiology assessment.
Danish: Det primære endepunkt for undersøgelsen var progressionsfri overlevelse (PFS) evalueret ved responsevalueringskriterier i faste tumorer (RECIST 1.1) baseret på uafhængig radiologisk vurdering.
English: The adequate position of the catheter should be checked before and during infusion.
Danish: Den relevante placering af katetret skal kontrolleres før og under infusion.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Danish: De pågældende vil drage særlig omsorg for, at produktet anvendes på sikker måde, og vil holde dig orienteret om, hvad de foretager sig.
English: Pancreatic 133 7 5% 74 56% 47 35% 81 61% 52% 69% 16.3 12.1 21.8 Foregut** 12 1 8% 6 50% 4 33% 7 58% 28% 85% 22.3 0.0 38.0 Midgut
Danish: Bugspytkirtel 133 7 5 % 74 56 % 47 35 % 81 61 % 52 % 69 % 16,3 12.1 21.8 Fortarm ** 12 1 8 % 6 50 % 4 33 % 58 % 28 % 28 % 85 % 22,3 0,0 38,0 Midttarm 183 3 2% 58 32% 115 63% 61 33% 27% 41% 15,3 10,5 17,7 Bagtarm 13 0 0% 6 46% 6 46% 6 46% 19% 75% 17,8 6,2 29.9
English: You must avoid close contact with people who live with you, and should try to keep a distance of at least one meter for 7 days after you receive Lutathera.
Danish: Du skal undgå tæt kontakt med personer, der bor hos dig, samt forsøge at holde en afstand på mindst en meter i 7 dage, efter du har modtaget Lutathera.
English: Genetic consultation is recommended if you wish to have children after treatment.
Danish: Genkonsultation anbefales, hvis du ønsker at få børn efter behandling.
English: As a consequence, a decrease in the various blood cell types may put you at risk for bleeding, fatigue, shortness of breath, and infection.
Danish: Som følge heraf kan et fald i de forskellige blodlegemetyper bringe dig i risiko for blødning, træthed, åndenød og infektion.
English: If you are taking somatostatin analogues you might be asked to stop and/or adapt your treatment for a short period of time.
Danish: Hvis du tager somatostatinanaloger, kan du blive bedt om at stoppe og/eller tilpasse din behandling i en kort periode.
English: 2.2 mm (mean penetration range of 0.67 mm), which is sufficient to kill targeted tumour cells with a limited effect on neighbouring normal cells.
Danish: 2,2 mm (gennemsnitligt penetrationsområde på 0,67 mm), hvilket er tilstrækkeligt til at dræbe målrettede tumorceller med en begrænset virkning på nærliggende normale celler.
English: The tumour needs to have somatostatin receptors on the surface of its cells in order for the medicine to be effective.
Danish: Tumoren skal have somatostatinreceptorer på overfladen af sine celler for at lægemidlet kan virke.
English: Nevertheless, the general condition of the patient and the possible adverse reactions to treatment must be taken into account before driving or using machines.
Danish: Ikke desto mindre skal patientens generelle tilstand og de mulige bivirkninger ved behandlingen tages i betragtning inden kørsel eller brug af maskiner.
English: <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighed er kategoriseret som følger: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1 / 10.000 til < 1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra de tilgængelige data).
English: Considering the high quantity of amino acids and the significant volume that commercially available solutions may require to meet the above specifications, the compounded solution is considered the medicinal product of choice, due to its lower total volume to be infused and lower osmolarity.
Danish: I betragtning af den høje mængde aminosyrer og den signifikante volumen, som kommercielt tilgængelige opløsninger muligvis kræver for at imødekomme ovenstående specifikationer, anses blandingsopløsningen for den foretrukne lægemiddelform på grund af den lavere infusionsvolumen og den lavere osmolaritet.
English: Therefore, it is recommended to monitor ALAT, ASAT, bilirubin and albumin serum during treatment (see section 4.2).
Danish: Det anbefales derfor at monitorere ALAT, ASAT, bilirubin- og albumin-serum under behandlingen (se pkt.
English: The Nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine.
Danish: Din nuklearmedicinske læge vil oplyse dig om, hvorvidt du skal tage nogen særlige forholdsregler, efter du har fået denne medicin.
English: It is considered unlikely that Lutathera will affect your ability to drive or to use machines; however, your general condition and the possible adverse reactions to treatment must be taken into account to assess this ability before driving or using machines.
Danish: Det anses for usandsynligt, at Lutathera vil påvirke din evne til at køre eller bruge maskiner, men din generelle tilstand og de mulige bivirkninger af behandlingen skal tages i betragtning for at vurdere denne evne, før du kører eller bruger maskiner.
English: The nuclear medicine physician should determine when the patient can leave the controlled area of the hospital, i.e. when the radiation exposure to third parties does not exceed regulatory thresholds.
Danish: Lægen med speciale i nuklearmedicin skal afgøre, hvornår patienten kan forlade det kontrollerede område af hospitalet, dvs. når strålingseksponeringen af tredjeparter ikke overstiger de lovbestemte grænseværdier.
English: This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Danish: Produktet må kun håndteres og gives til dig af personale, der er oplært i og kvalificerede til at anvende det på en sikker måde.
English: Quality controls
Danish: Kvalitetskontrol
English: N Patients with events Censored patients Median months (95%-CI)
Danish: N Patienter med bivirkninger Censurerede patienter Median måneder (95 % CI)
English: Overdose is unlikely with Lutathera as this medicinal product is supplied as a “single dose” and “ready to use” product containing a predefined amount of radioactivity.
Danish: Overdosering er usandsynligt med Lutathera, da dette lægemiddel leveres som et "enkeltdosis" og "brugsklart" -produkt, der indeholder en foruddefineret mængde radioaktivitet.
English: • Previous oncologic radiometabolic therapies with 131I-compounds or any other therapy using unshielded radioactive sources;
Danish: • Tidligere onkologiske, radiometaboliske behandlinger med 131I-blandinger eller enhver anden behandling ved brug af uafskærmede radioaktive kilder;
English: Toxicological studies with rats have demonstrated that a single intravenous injection of up to 4,550 MBq/kg was well tolerated and no deaths were observed.
Danish: Toksikologiske undersøgelser med rotter har vist, at en enkelt intravenøs injektion på op til 4.550 MBq/kg var godt tolereret, og der blev ikke observeret dødsfald.
English: • Either in a container made of polymethyl methacrylate (PMMA), a transparent radioprotection container that allows a direct visual inspection of the vial,
Danish: • Enten i en pakning fremstillet af polymetylmetakrylat (PMMA), en transparent pakning til beskyttelse mod radioaktiv stråling, der tillader en direkte visuel inspektion af hætteglasset,
English: There is no efficacy data in patients with known brain metastases therefore individual benefit-risk must be assessed in these patients.
Danish: Der findes ingen effektdata hos patienter med kendte hjernemetastaser, hvorfor individuel fordel/risiko skal vurderes hos disse patienter.
English: It is also recommended to perform these tests every 4 weeks for at least 3 months after the last infusion of Lutathera and every 6 months thereof, in order to be able to detect possible delayed adverse reactions (see section 4.8).
Danish: Det anbefales også at foretage disse tests hver 4. uge i mindst 3 måneder efter den sidste infusion af Lutathera og hver 6. måned derefter for at være i stand til at detektere mulige forsinkede bivirkninger (se pkt.
English: For minimising radiation exposure, always use the principles of time, distance and shielding (reducing the manipulation of the vial and using the material already supplied par the manufacturer).
Danish: For at minimere strålingseksponering anvender man tidspunkterne for tid, afstand og afskærmning (reduktion af hætteglassets manipulation og anvendelse af det materiale, der allerede er leveret til fabrikanten).
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Danish: Din læge og nuklearmedicinske læge har vurderet, at den kliniske gavn af proceduren med et radioaktivt lægemiddel er større end risikoen forbundet med stråling.
English: Lutathera should be administered over 20 to 30 minute time span.
Danish: Lutathera skal administreres i løbet af et tidsrum på 20-30 minutter.
English: Prior to launch of Lutathera in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden markedsføringstilladelsen af Lutathera opnås i hver medlemsstat, skal indehaveren af markedsføringstilladelsen aftale indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmediet, distributionsmodaliteterne og alle andre aspekter af programmet med de nationale myndigheder.
English: The recommended dose is 7,400 MBq (megabecquerel, the unit used to express radioactivity) in a single infusion, which is given at 4 times once every 8 weeks.
Danish: Den anbefalede dosis er 7.400 MBq (megabecquerel, den enhed der anvendes til at udtrykke radioaktivitet) i en enkelt infusion, som gives 4 gange en gang hver 8 uge.
English: Ionizing radiation is dangerous for the foetus, therefore pregnancy is contraindicated.
Danish: Ioniserende stråling er farlig for fosteret, derfor er graviditet kontraindiceret.
English: As long as the patient's skin is not contaminated, such as from the leakage of the infusion system or because of urinary incontinence, radioactivity contamination is not expected on the skin and in the vomited mass.
Danish: Så længe patientens hud ikke er kontamineret, som f.eks. fra lækage i infusionssystemets eller på grund af urininkontinens, forventes der ikke radioaktivitetskontaminering på huden og i den opkastede masse.
English: • Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin,
Danish: • Leverfunktion (enlanin-aminotransferase [ALAT], aspartat-aminotransferase [ASAT], albumin,
English: Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10XX04
Danish: Farmakoterapeutisk klassifikation: Andre terapeutiske radiofarmaceutika, ATC-kode: V10XX04
English: At the concentration used (about 10 μg/mL in total, for both free and radiolabeled forms), the peptide oxodotreotide does not exert any clinically relevant pharmacodynamic effect.
Danish: Ved den anvendte koncentration (ca. 10 μg/ml i alt, for både fri og radioaktivt mærket form) udøver peptidoxodotreotiden ingen klinisk relevant farmakodynamisk virkning.
English: Dose-modifying toxicity (DMT) criteria
Danish: Kriterier for dosis-modificerende toksicitet (DMT)
English: Men and women of child-bearing potential must refrain from procreation by using effective contraceptive methods during the treatment and for 6 months after.
Danish: Mænd og kvinder i den fødedygtige alder skal afstå fra forplantning ved at anvende effektive præventionsmetoder under behandlingen samt i 6 måneder derefter.
English: Lutathera is a radiopharmaceutical medicine used for the treatment of certain tumours (gastroenteropancreatic neuroendocrine tumours), which cannot be completely removed from your body by surgery, have spread in your body (metastatic) and does not respond more to your current treatment.
Danish: Lutathera er et radiofarmaceutisk lægemiddel, der anvendes til behandling af visse tumorer (gastroenteropankreatiske neuroendokrine tumorer), som ikke kan fjernes fuldstændigt fra din krop ved kirurgi, der har spredt sig i din krop (metastatisk) og som ikke længere reagerer på din nuværende behandling.
English: Occurrence of an intercurrent disease (e.g. urinary tract infection), which according to the physician could increase the risks associated to Lutathera administration.
Danish: Forekomst af en interkurrent sygdom (f.eks. urinvejsinfektion), som i henhold til lægen kan forøge risici forbundet med administration af Lutathera.
English: The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Danish: Strålingsdosis som følge af terapeutisk eksponering kan resultere i højere forekomst af kræft og mutationer.
English: Cryopreservation of sperm or eggs can be discussed as an option to patients before the treatment.
Danish: Kryopræservering af sæd eller æg kan diskuteres som en mulighed for patienter før behandlingen.
English: - Wash your underwear, pyjamas, sheets and any clothes that contain sweat, blood or urine separately from the laundry of other members of your household, using a standard washing cycle.
Danish: - Vask dit undertøj, pyjamas, lagner samt alt tøj, der indeholder sved, blod eller urin separat fra vasketøjet fra andre medlemmer af din husstand ved hjælp af en standardvask.
English: Renal toxicity defined as an estimated creatinine clearance < 40 mL/min, or a 40% increase compare to the baseline serum creatinine level with a decrease of over 40% compared to the baseline creatinine clearance.
Danish: Nyretoksicitet defineret som en estimeret kreatinin-clearance < 40 ml/min, eller en 40 %forøgelse sammenlignet med baseline-serumkreatinin-niveau med en reduktion på over 40 %sammenlignet med baseline-kreatininclearance.
English: The long-term trend of progressive glomerular filtration function deterioration demonstrated in the clinical studies confirms that Lutathera-related nephropathy is a chronic kidney disease that develops progressively over months or years after exposure.
Danish: Den langsigtede tendens med progressiv forringelse af glomerulær filtrationsfunktion demonstreret i de kliniske undersøgelser bekræfter, at Lutathera-relateret nefropati er en kronisk nyresygdom, der udvikler sig gradvist i løbet af måneder eller år efter eksponering.
English: Because this medicine is radioactive, you will have to follow the instructions described below to minimize radiation exposure to others.
Danish: Da dette lægemiddel er radioaktivt, skal du følge instruktionerne nedenfor for at minimere strålingseksponering for andre.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Danish: Radioaktive lægemidler må kun modtages, anvendes og administreres af autoriserede personer i specielt indrettede kliniske lokaler.
English: Includes Headache and migraine
Danish: Inkluderer hovedpine og migræne
English: Tumour type n % n % N % n % 95%CI Median 95%CI
Danish: N % n % N % n % 95 %CI Median 95%CI
English: It is necessary to use protective high quality (latex/nitrile) gloves to avoid direct contact with the radiopharmaceutical (vial/syringe).
Danish: Det er nødvendigt at bruge beskyttelseshandsker af høj kvalitet (latex/nitril) for at undgå direkte kontakt med det radioaktive lægemiddel (hætteglas/sprøjten).
English: This will equilibrate pressure thus reducing any risk of leakage.
Danish: Dette udligner trykket, hvilket reducerer risikoen for lækage.
English: The most common adverse reactions in patients receiving Lutathera treatment were nausea and vomiting which occurred at the beginning of the infusion in 58.9% and 45.5% of patients, respectively.
Danish: De mest almindelige bivirkninger hos patienter, der fik Lutathera, var kvalme og opkastninger, som forekom ved infusionens begyndelse hos henholdsvis 58,9 % og 45,5 % af patienterne.
English: • Information on the precautions the patient should take before, during and after the administration procedure, at the hospital and at home, to limit unnecessary exposure to radiations of themselves and their entourage.
Danish: • Information om de forholdsregler patienten skal tage inden, under og efter administrationsproceduren, på hospitalet og i hjemmet, for at begrænse unødvendig strålingseksponering over for dem selv og de personer, der omgiver dem.
English: Patients with a history of chronic use of glucocorticosteroids should be carefully evaluated for sufficient somatostatin receptor expression.
Danish: Patienter med historik med kronisk brug af glukokortikosteroider bør evalueres omhyggeligt for tilstrækkelig somatostatinreceptorekspression.
English: Total activity administered is equal to the activity in the vial before infusion minus the activity remaining in the vial after the infusion.
Danish: Total administrationsaktivitet svarer til aktiviteten i hætteglasset før infusion minus den resterende aktivitet i hætteglasset efter infusionen.
English: Travel Keep the discharge letter with you whenever you are travelling for at least 3 months after treatment.
Danish: Rejser Tag udskrivningsbrevet med dig, hvis du rejser i mindst 3 måneder efter behandlingen.
English: Hyperbilirubinaemia9
Danish: Hyperbilirubinæmi9
English: Specification of commercially available amino acid solutions Characteristic
Danish: Specifikationer for kommercielt tilgængelige aminosyreopløsninger Karakteristika
English: The pharmacokinetics profile in elderly patients (≥ 75 years) has not been established.
Danish: Den farmakokinetiske profil hos ældre patienter (≥ 75 år) eller ikke fastlagt.