FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppighederne er defineret som: meget almindelige (≥ 1/10), almindelige (≥ 1/100 til 1/10), ikke almindelige (≥ 1/1.000 til < 1/100).
English: The primary efficacy endpoint was overall survival.
Danish: Det primære endepunkt for virkning var samlet overlevelse.
English: This booklet was last revised in {MM/YYYY}.
Danish: Denne brochure blev senest ændret {MM/ÅÅÅÅ}.
English: Other factors such as concomitant use of steroids may further increase the risk of fracture.
Danish: Andre faktorer, såsom samtidig anvendelse af steroider, kan yderligere øge risikoen for frakturer.
English: Xofigo is administered as an intravenous injection and is thus 100% bioavailable.
Danish: Xofigo administreres som en intravenøs injektion, og er derved 100 % biotilgængelig.
English: SSE composite endpoint a
Danish: SSE sammensatte endepunkt a
English: Xofigo should be handled in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Xofigo skal håndteres på en måde, som både opfylder kravene for strålingssikkerhed og farmaceutisk kvalitet.
English: Xofigo is not indicated in women.
Danish: Xofigo er ikke indiceret til kvinder.
English: You will not have to store this medicine.
Danish: Det er ikke nødvendigt, at du opbevarer dette lægemiddel.
English: • 87% of patients enrolled had an ECOG performance status score of 0-1.
Danish: • 87 % af de inkluderede patienter havde en ECOG-score på 0-1.
English: Adverse reactions from clinical trials are classified according to their frequencies.
Danish: Bivirkninger fra kliniske studier klassificeres i henhold til deres frekvenser.
English: At 4 hours, about 4% of the injected activity remained in the blood, decreasing to less than 1% at 24 hours after the injection.
Danish: 4 timer efter var ca. 4 % af den injicerede aktivitet tilbage i blodet, og det var reduceret til under 1 % 24 timer efter injektionen.
English: In general, radionuclides are considered to be genotoxic and carcinogenic.
Danish: Generelt anses radionuklider for at være genotoksiske og karcinogene.
English: Faecal excretion is the major route of elimination from the body.
Danish: Fækal udskillelse er kroppens største eliminationsvej.
English: If you are already taking one of those medicines, please tell your doctor.
Danish: Hvis du allerede tager et af disse lægemidler, skal du fortælle det til lægen.
English: Figure 2: Kaplan-Meier overall survival curves (updated analysis)
Danish: Figur 2: Kaplan-Meier samlede overlevelseskurver (opdateret analyse)
English: No overall differences in safety or efficacy were observed between elderly (aged ≥ 65 years) and younger patients (aged < 65 years) in the phase III study.
Danish: Samlet set blev der ikke observeret nogen forskel i sikkerhed og virkning mellem ældre (i alderen ≥ 65 år) og yngre patienter (i alderen < 65 år) i fase III-studiet.
English: No dose adjustment is necessary if you are 65 years of age or older or if you have reduced kidney or liver function.
Danish: Det er ikke nødvendigt at justere dosis, hvis du er 65 år eller derover eller hvis du har nedsat nyre- eller leverfunktion.
English: Fifteen minutes post injection, about 20% of the injected activity remained in the blood.
Danish: Femten minutter efter injektion var ca. 20 % af den injicerede aktivitet tilbage i blodet.
English: About 5% is excreted in the urine and there is no evidence of hepatobiliary excretion.
Danish: Ca. 5 % udskilles i urinen, og der er ikke evidens for hepatobiliær udskillelse.
English: b Hazard ratio (Xofigo over placebo) < 1 favours Xofigo.
Danish: b Hazard ratio (Xofigo over placebo) < 1 favoriserer Xofigo.
English: Before starting treatment and before each subsequent dose your doctor will perform blood tests.
Danish: Før du starter behandlingen, og før hver efterfølgende dosis vil lægen tage blodprøver.
English: Symptomatic skeletal event (SSE)
Danish: Symptomatiske skeletrelaterede hændelser (SSE)
English: The testes seemed to otherwise be functioning normally and the epididymides revealed a normal content of spermatocytes.
Danish: Testikler fungerede ellers tilsyneladende normalt, og bitestiklerne afdækkede et normalt indhold spermatocytter.
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Danish: Efterfølgende systemisk cancerbehandling må ikke påbegyndes i mindst 30 dage efter den sidste administration af Xofigo.
English: The specific activity of radium-223 is 1.9 MBq/ng.
Danish: Den specifikke aktivitet af radium-223 er 1,9 MBq/ng.
English: The external radiation exposure associated with handling of patient doses is considerably lower in comparison to other radiopharmaceuticals for therapeutic purposes as the administered radioactivity will usually be below 8 MBq.
Danish: Den eksterne strålingseksponering forbundet med håndtering af patientdoser er betydeligt lavere sammenlignet med andre radioaktive lægemidler til terapeutiske formål, da den administrerede radioaktivitet normalt vil være under 8 MBq.
English: Total ALP progression c
Danish: Total BASP-progression c
English: Clear, colourless isotonic solution with pH between 6.0 and 8.0.
Danish: Klar, farveløs, isotonisk opløsning med en pH-værdi mellem 6,0 og 8,0.
English: Your doctor will perform blood tests before starting treatment and before each injection to check your number of blood cells and platelets (see also section 2).
Danish: Din læge vil tage blodprøver før behandlingen påbegyndes, og før hver indsprøjtning for at kontrollere dit antal blodlegemer og blodplader (se også punkt 2).
English: d Defined as a ≥ 25% increase and an increase in absolute value of ≥ 2 ng/mL compared to baseline/nadir.
Danish: d Defineret som ≥ 25 % forhøjelse og en forhøjelse i absolut værdi på ≥ 2 ng/ml, sammenlignet med baseline/nadir.
English: The whole body measurements at 7 days after injection (after correcting for decay) indicate that a median of 76% of administered activity was excreted from the body.
Danish: Helkropsmålinger 7 dage efter injektionen (efter korrektion for henfald) indikerer, at en median på 76 % af den administrerede aktivitet blev udskilt fra kroppen.
English: The amount of radioactivity in the dispensed volume shall be confirmed by measurement in a properly calibrated activimeter.
Danish: Mængden af radioaktivitet i det udmålte volumen skal bekræftes ved måling i en korrekt kalibreret dosiskalibrator.
English: In particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased.
Danish: Især kan risikoen for osteosarkomer, myelodysplastisk syndrom og leukæmi være øget.
English: The risk for patients to develop osteosarcomas with exposure to radium-223 is unknown at present.
Danish: Risikoen for, at patienterne udvikler osteosarkomer ved eksponering over for radium-223 er aktuelt ukendt.
English: The absorbed radiation dose calculation was performed based on clinical biodistribution data.
Danish: Beregningen af den absorberede strålingsdosis blev udført baseret på kliniske biodistributionsdata.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Danish: Dette præparat vil udelukkende blive givet til dig af kvalificeret personale, der er uddannet til at bruge det på sikker vis.
English: The exact mechanism for induction of retinal detachment is unknown, but literature data suggests that radium is specifically taken up in the tapetum lucidum of the canine eye.
Danish: Den nøjagtige mekanisme for induktion af retinaløsning er ukendt, men data fra litteraturen tyder på, at radium optages specifikt i tapetum lucidum i hundenes øjne.
English: However, in keeping with the ALARA (“As Low As Reasonably Achievable”) principle, for minimisation of radiation exposure, it is recommended to minimise the time spent in radiation areas, to maximise the distance to radiation sources, and to use adequate shielding.
Danish: I henhold til ALARA-princippet (”As Low As Reasonably Achievable”) anbefales det imidlertid for at minimere strålingseksponeringen at minimere den tid, der tilbringes i strålingsområder, maksimere afstanden til strålekilder, samt at anvende tilstrækkelig afskærmning.
English: This may be related to spatial distribution of alpha particle radiation resulting in non-uniform radiation dose to the red marrow.
Danish: Dette kan være relateret til den rumlige fordeling af strålingen fra alfapartikler, som fører til en ikke-uniform strålingsdosis i den røde knoglemarv.
English: Radium-223 is an isotope which decays and is not metabolised.
Danish: Radium-223 er en isotop, som henfalder, og ikke metaboliseres.
English: Distribution and organ uptake
Danish: Fordeling og organoptagelse
English: The overall safety profile of Xofigo is based on data from 600 patients treated with Xofigo in the phase III study.
Danish: Den samlede sikkerhedsprofil for Xofigo er baseret på data fra 600 patienter behandlet med Xofigo i fase III-studiet.
English: At 4 hours post injection, the mean percentage of the radioactive dose present in bone and intestine was approximately 61% and 49%, respectively.
Danish: Fire timer efter injektionen var den gennemsnitlige procentdel af den radioaktive dosis, der var til stede i knogler og tarm, henholdsvis 61 % og 49 %.
English: In clinical studies, patients with fewer than 6 bone metastases had an increased risk of fractures and did not have a statistically significant survival benefit.
Danish: I kliniske studier havde patienter med færre end 6 knoglemetastaser en øget risiko for frakturer, og de havde ikke en statistisk signifikant overlevelsesfordel.
English: At 10 minutes post injection, activity was observed in the bone and in the intestine.
Danish: 10 minutter efter injektionen blev der observeret aktivitet i knoglerne og tarmen.
English: Interim analysis
Danish: Interimanalyse
English: Coefficient of variation
Danish: Variationskoefficient
English: Genotoxicity / Carcinogenicity
Danish: Genotoksicitet/karcinogenicitet
English: Xofigo is only used when the disease has spread to the bone but is not known to have spread to other internal organs, and is causing symptoms (e.g. pain).
Danish: Xofigo anvendes kun, når sygdommen har spredt sig til knoglerne, men ikke menes at have spredt sig til andre indre organer, og giver symptomer (f.eks. smerter).
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, faeces, vomiting etc.
Danish: Administrationen af radioaktive lægemidler indebærer risici for andre personer fra ekstern stråling eller kontaminering fra spildt urin, fæces, opkast etc.
English: You may wish to seek advice on conservation of sperm before treatment starts.
Danish: Du kan have behov for at søge rådgivning om opbevaring af sæd før behandlingen starter.
English: Pharmacotherapeutic group: Therapeutic radiopharmaceuticals, other therapeutic radiopharmaceuticals, various therapeutic radiopharmaceuticals, ATC code: V10XX03
Danish: Farmakoterapeutisk klassifikation: Radiofarmaka til terapeutisk brug, andre radiofarmaka til terapeutisk brug, diverse radiofarmaka til terapeutisk brug, ATC-kode: V10XX03
English: Risk of dehydration: tell your doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urination or dry skin as these can all be symptoms of dehydration.
Danish: Risiko for dehydrering: Du skal fortælle din læge, hvis du har nogen af følgende symptomer: Svimmelhed, øget tørst, nedsat urinproduktion eller tør hud, da alle disse kan være symptomer på dehydrering.
English: In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded.
Danish: Hos patienter behandlet med bisfosfonater og Xofigo kan en øget risiko for udvikling af osteonekrose af kæberne (ONJ) ikke udelukkes.
English: Crohn's disease and ulcerative colitis
Danish: Crohns sygdom og ulcerøs kolitis
English: Therefore, if you suffer from these conditions your doctor will carefully consider if you can be treated with Xofigo.
Danish: Hvis du derfor lider af disse sygdomme, vil din læge omhyggeligt overveje, om du kan blive behandlet med Xofigo.
English: For details on the calculation of the volume to be administered see section 12.
Danish: For detaljer om beregning af administreret volumen, se pkt.
English: Male patients should seek advice on conservation of sperm prior to treatment.
Danish: Mandlige patienter skal søge rådgivning om opbevaring af sæd før behandling.
English: Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy.
Danish: Yderligere virkninger på tumorens mikromiljø herunder osteoblaster og osteoklaster bidrager også til in vivo-virkningen.
English: Treatment of patients with asymptomatic or mildly symptomatic bone metastases
Danish: Behandling af patienter med asymptomatiske eller let symptomatiske knoglemetastaser
English: Therefore, haematological evaluation of patients must be performed at baseline and prior to every dose of Xofigo.
Danish: Derfor skal den hæmatologiske evaluering af patienterne udføres ved baseline og før hver dosis Xofigo.
English: DK factor  1100 kBq/mL
Danish: DK-faktor  1100 kBq/ml
English: A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP < 220 U/L.
Danish: En præspecificeret undergruppeanalyse viste også, at den samlede overlevelse ikke var signifikant forbedret hos patienter med et totalt alkalisk fosfatase < 220 E/l.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Danish: Specialisten er ansvarlig for at opbevare lægemidlet under passende forhold.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Danish: Radioaktive lægemidler bør kun modtages, anvendes og administreres af autoriseret personale i dertil godkendte afdelinger.
English: Health Related Quality of Life (HRQOL) was assessed in the phase III ALSYMPCA study using specific questionnaires: the EQ-5D (generic instrument) and the FACT-P (prostate cancer specific instrument).
Danish: Health Related Quality of Life (HRQOL) blev vurderet i fase III ALSYMPCA-studiet ved hjælp af specifikke spørgeskemaer: EQ-5D (generisk instrument) og FACT-P (specifikt instrument for prostatacancer).
English: The haematological adverse reactions observed in the clinical studies with Xofigo are much lower in frequency and severity than what could be expected from the calculated absorbed doses to the red marrow.
Danish: De hæmatologiske bivirkninger, der blev observeret i kliniske studier med Xofigo, har en meget mindre hyppighed og sværhedsgrad, end hvad der kunne forventes fra de beregnede absorberede doser i den røde knoglemarv.
English: Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
Danish: Radium-223 udsender alfapartikler med en halveringstid på 11,4 dage.
English: In the event of an inadvertent overdose, general supportive measures, including monitoring for potential haematological and gastrointestinal toxicity should be undertaken.
Danish: I tilfælde af en utilsigtet overdosering skal der udføres generelle understøttende handlinger, herunder overvågning for mulig hæmatologisk toksicitet og mave-tarm-toksicitet.
English: No significant QTc prolonging effects were observed after intravenous injection of Xofigo in comparison with placebo in a subgroup of 29 patients in the phase III study (ALSYMPCA).
Danish: Ingen signifikant QTc-forlængelse blev observeret efter intravenøs injektion af Xofigo sammenlignet med placebo i en undergruppe på 29 patienter i fase III-studiet (ALSYMPCA).
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering).
English: Administration of Xofigo and conduct of the procedure Xofigo will be injected slowly via a needle into one of your veins (intravenously).
Danish: Administration af Xofigo og sådan udføres proceduren Xofigo bliver indsprøjtet langsomt via en kanyle i én af dine vener (intravenøst).
English: It is supplied in a colourless glass vial closed with a grey rubber stopper and aluminium seal.
Danish: Det leveres i et farveløst hætteglas, der er lukket med en grå gummiprop og en aluminiumsforsegling.
English: Demographic and baseline disease characteristics (interim analysis population) were similar between the Xofigo and placebo groups and are shown below for Xofigo:
Danish: Demografi og sygdomskarakteristika ved baseline (interimanalyse-populationen) var sammenlignelige mellem Xofigo og placebogrupperne, og vises nedenfor for Xofigo:
English: No significant uptake was seen in other organs such as heart, liver, kidneys, urinary bladder and spleen at 4 hours post injection.
Danish: Der blev ikke set signifikant optagelse i andre organer, såsom hjerte, lever, nyre, urinblære og milt 4 timer efter injektionen.
English: Table 4: Calculated absorbed radiation doses to organs Target Organ
Danish: Tabel 4: Beregnede absorberede strålingsdoser til organer Målorgan
English: In case there is no recovery in these values within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after a careful benefit/risk evaluation.
Danish: Hvis disse værdier ikke forbedres i løbet af 6 uger efter den sidste administration af Xofigo trods standardbehandling, bør yderligere behandling med Xofigo kun fortsætte efter en nøje evaluering af fordele og risici.
English: The alpha particle range from radium-223 is less than 100 µm (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.
Danish: Rækkevidden for alfapartikler fra radium-223 er under 100 µm (under 10 cellediametre), hvilket minimerer skaderne på det omgivende normale væv.
English: Due to the presence of osteolysis of trabecular bone in other bone locations of treated animals in varying degree, a spontaneous fracture in the context of osteolysis cannot be excluded.
Danish: På grund af osteolyse i varierende omfang i trabekulært knoglevæv andre steder på de behandlede dyr, kan en spontan fraktur i forbindelse med osteolyse ikke udelukkes.
English: Depending on the volume administered, this medicine can contain up to 54 mg sodium (main component of cooking/table salt) per dose.
Danish: Afhængig af den mængde, du får, kan denne medicin indeholde op til 54 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. dosis.
English: No histological changes were observed in organs involved in the excretion of radium-223 dichloride.
Danish: Der blev ikke observeret nogen histologiske ændringer i organer, der er involveret i udskillelsen af radium-223 dichlorid.
English: Duration of the procedure - Xofigo is given once every 4 weeks for a total of 6 injections.
Danish: Behandlingens varighed - Xofigo gives én gang hver 4. uge i alt 6 gange.
English: - The other ingredients are: water for injections, sodium citrate, sodium chloride and hydrochloric acid (see end of Section 2 for further information on sodium).
Danish: - Øvrige indholdsstoffer: Vand til injektionsvæsker, natriumcitrat, natriumchlorid og saltsyre (se sidst i punkt 2 for yderligere oplysninger om natrium).
English: Red marrow Osteogenic cells Skin
Danish: Pankreas Rød marv Osteogene celler Hud
English: - Decay correction (DK) factor to correct for physical decay of radium-223.
Danish: - Faktoren for henfaldskorrektion (decay correction, DK) for at korrigere for det fysiske henfald af radium-223.
English: Care should be used when handling materials, such as bed linen, that come into contact with such body fluids.
Danish: Der bør udvises forsigtighed ved håndtering af f.eks. sengetøj, der kommer i kontakt med sådanne kropsvæsker.
English: Xofigo is for intravenous use.
Danish: Xofigo er til intravenøs anvendelse.
English: Osteosarcomas, a known effect of bone-seeking radionuclides, were observed at clinically relevant doses in rats 7 - 12 months after start of treatment.
Danish: Osteosarkomer, en kendt bivirkning af knoglesøgende radionuklider, blev observeret ved klinisk relevante doser hos rotter 7-12 måneder efter start af behandlingen.
English: Patients with visceral metastases and malignant lymphadenopathy exceeding 3 cm were excluded.
Danish: Patienter med viscerale metastaser og malign lymfadenopati over 3 cm var ekskluderet.
English: 1As there was no uptake of radium-223 in most of the soft tissues observed, the alpha contribution to the total organ dose was set to zero for these organs.
Danish: 1Da der ikke var nogen radium-223 - optagelse i de fleste observerede bløde væv, blev alfa-bidraget til den totale organdosis sat til nul for de fleste organer.
English: Because of potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo.
Danish: Grundet de mulige virkninger på spermatogenesen i forbindelse med stråling skal mænd rådes til at anvendes sikker kontraception i løbet af og i op til 6 måneder efter behandling med Xofigo.
English: Oral intake and fluid status of patients should be carefully monitored.
Danish: Det orale indtag og væskebalancen bør nøje følges.
English: Pharmacokinetic, biodistribution and dosimetry data have been obtained from 3 phase I studies.
Danish: Data fra farmakokinetik, biodistribution og dosimetri blev indsamlet fra 3 fase I-studier.
English: - Xofigo is not recommended if cancer in your bones is not causing symptoms, such as pain.
Danish: - Xofigo bør ikke anvendes, hvis din kræft i knoglerne ikke giver dig symptomer, såsom smerter.
English: Subgroup survival analysis
Danish: Overlevelsesanalyser i undergrupperne
English: Xofigo is a ready-to-use solution and should not be diluted or mixed with any other solutions.
Danish: Xofigo er en opløsning, som er klar til brug, og den må ikke fortyndes eller blandes med andre opløsninger.
English: The adverse reactions observed with Xofigo are represented in the table below (see Table 1).
Danish: Bivirkningerne, der blev observeret med Xofigo, vises i den nedenstående tabel (se tabel 1).
English: Best standard of care included e.g. local external beam radiotherapy, bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine or ketoconazole.
Danish: Bedste standardbehandling omfattede f.eks. lokal ekstern strålebehandling, bisfosfonater, kortikosteroider, antiandrogener, østrogener, estramustin eller ketoconazol.
English: Studies on reproductive and developmental toxicity have not been performed.
Danish: Der er ikke udført reproduktions- og udviklingstoksicitetsstudier.
English: In general, radionuclides induce reproductive and developmental effects.
Danish: Generelt inducerer radionuklider bivirkninger på reproduktion og embryonal udvikling.
English: The presence of neoplastic changes, other than osteosarcomas, was also reported in the longer term (12 to 15 months) rat toxicity studies (see section 4.8).
Danish: Tilstedeværelsen af neoplastiske ændringer ud over osteosarkomer blev også rapporteret i længerevarende (12 til 15 måneders) toksicitetsstudier hos rotter (se pkt.
English: During the treatment period, 83% of patients received luteinising hormone-releasing hormone (LHRH) agonists and 21% of patients received anti-androgens concomitantly.
Danish: I løbet af behandlingsperioden fik 83 % af patienterne gonadotropinfrigørende hormon-agonister (LHRHagonister), og 21 % af patienterne fik samtidig behandling med antiandroger.
English: Osteosarcomas were not observed in dog studies.
Danish: Der blev ikke observeret osteosarkomer i studier med hunde.