FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased osteoclast activity, stimulated by RANKL, is a key mediator of bone destruction in metastatic bone disease and multiple myeloma.
Danish: Øget osteoklast-aktivitet, der er stimuleret af RANKL, er en central mediator af knogledestruktion i forbindelse med metastatisk knoglesygdom og multipelt myelom.
English: XGEVA should be administered under the responsibility of a healthcare professional.
Danish: XGEVA skal indgives under ansvar af sundhedspersonale.
English: The following convention has been used for the classification of the adverse reactions based on incidence rates in four phase III, two phase II clinical studies and post-marketing experience (see table 1): very common (≥ 1/10), common (≥ 1/100 to < 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: Følgende konvention er anvendt til klassifikation af bivirkningerne på baggrund af incidensraterne i fire kliniske fase III-studier, to kliniske fase II-studier og efter markedsføring af præparatet (se tabel 1): 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 forhåndenværende data).
English: Based on duration of exposure, there are insufficient data in giant cell tumour of bone patients to assess risk of ONJ beyond 2 years.
Danish: Baseret på eksponeringsvarigheden er der ikke tilstrækkelige data fra patienter med kæmpecelletumorer i knogle til at vurdere risikoen for ONJ efter 2 år.
English: Adolescent primates dosed with denosumab at 2.7 and 15 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Danish: Yngre primater, der fik doser af denosumab, som var 2,7 og 15 gange (10 og 50 mg/kg dosis) den kliniske eksponering, havde anormale vækstplader.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab.
Danish: Undersøgelse af tænderne sammen med forebyggende tandbehandling og en individuel vurdering af fordele kontra risici anbefales inden behandling med denosumab.
English: Density/Size4
Danish: Densitet/størrelse4
English: Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving XGEVA.
Danish: Din læge vil overvåge, om du får tegn og symptomer på høje niveauer af calcium, efter at du er holdt op med at få XGEVA.
English: XGEVA is not recommended for use if you are pregnant.
Danish: XGEVA anbefales ikke, hvis du er gravid.
English: XGEVA will be injected into your thigh, abdomen or upper arm.
Danish: XGEVA vil blive injiceret ind i låret, maven eller en overarm.
English: Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Danish: Denosumab er udelukkende sammensat af aminosyrer og kulhydrater ligsom naturligt immunoglobulin, og det er usandsynligt, at det elimineres gennem metaboliske mekanismer i leveren.
English: It is not known whether XGEVA is excreted in breast milk.
Danish: Det vides ikke, om XGEVA udskilles i modermælk.
English: Of the 35 patients included in the efficacy analysis, 85.7% (95% CI: 69.7, 95.2) had a treatment response to XGEVA.
Danish: Ud af de 35 patienter, der blev inkluderet i effektanalysen, havde 85,7% (95% CI 69,7; 95,2) respons på behandling med XGEVA.
English: N = number of subjects randomised
Danish: N = antal randomiserede patienter
English: Elderly patients (age ≥ 65) No dose adjustment is required in elderly patients (see section 5.2).
Danish: Ældre patienter (≥ 65 år) Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: 22.8 (14.7, NE)
Danish: 22,8 (14,7; IE)
English: Your healthcare professional will not administer XGEVA to you if you have a very low level of calcium in your blood which has not been treated.
Danish: Sundhedspersonalet vil ikke give dig XGEVA, hvis du har et meget lavt niveau af calcium i blodet, som ikke er blevet behandlet.
English: XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.
Danish: XGEVA bruges også til behandling af kæmpecelletumorer i knogle, der ikke kan behandles kirurgisk, eller hvor en operation ikke er den bedste løsning, hos voksne og unge, hvis knogler er færdige med at vokse.
English: The median number of doses administered was 16 for XGEVA and 15 for zoledronic acid.
Danish: Medianantallet af indgivne doser var 16 for XGEVA og 15 for zoledronsyre.
English: Patients being treated with XGEVA should not be treated concomitantly with bisphosphonates.
Danish: Patienter, der behandles med XGEVA, bør ikke samtidig behandles med bisfosfonater.
English: The time to pain improvement (i.e. ≥ 2-point decrease from baseline in BPI-SF worst pain score) was similar for denosumab and zoledronic acid in each study and the integrated analyses.
Danish: Tiden indtil smertelindring (dvs. en reduktion på ≥ 2 point fra baseline i scoren for værste smerte på BPI-SF) var ens for denosumab og zoledronsyre i hvert studie og i de integrerede analyser.
English: A post-hoc analysis in study 2 (patients with other solid tumours or multiple myeloma) examined overall survival for the 3 tumour types used for stratification (non-small cell lung cancer, multiple myeloma, and other).
Danish: En post hoc-analyse i studie 2 (patienter med andre solide tumorer eller multipelt myelom) undersøgte overall survival for de tre tumortyper, der blev brugt til stratificering (ikke-småcellet lungecancer, multipelt myelom og andre).
English: However, the effects on lymph nodes and tooth malalignment persisted, and minimal to moderate mineralisation in multiple tissues was seen in one animal (relation to treatment uncertain).
Danish: Dog vedvarede effekterne på lymfeknuder og forkert tandstilling, og der blev observeret minimal til moderat mineralisering i flere væv hos et enkelt dyr (relation til behandlingen uvis).
English: Once removed from the refrigerator, XGEVA may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Danish: Efter at XGEVA er taget ud af køleskabet, kan det opbevares ved stuetemperatur (op til 25°C) i op til 30 dage i den originale beholder.
English: It is unknown whether denosumab is excreted in human milk.
Danish: Det er ukendt, om denosumab udskilles i human mælk.
English: Once your vial has been left to reach room temperature (up to 25°C), it must be used within 30 days.
Danish: Når hætteglasset har fået stuetemperatur (op til 25°C), skal det bruges inden for 30 dage.
English: Monitoring of calcium levels and adequate intake of calcium and vitamin D is especially important in patients with renal impairment (see section 4.4).
Danish: Monitorering af calciumniveauet og tilstrækkelig indtagelse af calcium og D-vitamin er særligt vigtigt for patienter med nedsat nyrefunktion (se pkt.
English: No specific study in patients with hepatic impairment was performed.
Danish: Der blev ikke udført noget specifikt studie med patienter med nedsat leverfunktion.
English: Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.
Danish: Patienter i fase II-studiet, der gennemgik komplet resektion af kæmpecelletumorer i knogle, fik yderligere 6 måneders behandling efter indgrebet i henhold til studieprotokollen.
English: Examples of clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (including coma) (see section 4.4).
Danish: Eksempler på kliniske manifestationer af alvorlig symptomatisk hypokalcæmi har været forlængelse af QT-intervallet, tetani, krampeanfald og ændret mental status (herunder coma) (se pkt.
English: No dose adjustment is required in elderly patients.
Danish: Dosisjustering til ældre patienter er ikke nødvendig.
English: Monitoring of calcium levels should be conducted (i) prior to the initial dose of XGEVA, (ii) within two weeks after the initial dose, (iii) if suspected symptoms of hypocalcaemia occur (see section 4.8 for symptoms).
Danish: Calciumniveauet bør monitoreres (i) inden første XGEVA-dosis, (ii) inden for to uger efter den første dosis, (iii) ved mistanke om symptomer på hypokalcæmi (se pkt.
English: Calcium and vitamin D supplementation
Danish: Tilskud af calcium og D-vitamin
English: Some people have developed unusual fractures in their thigh bone while being treated with XGEVA.
Danish: Nogle personer har udviklet usædvanlige brud i lårbenet, mens de blev behandlet med XGEVA.
English: New primary malignancy1
Danish: Ny primær malignitet1
English: Controlled clinical studies of XGEVA in patients with advanced malignancies involving bone over age 65 revealed similar efficacy and safety in older and younger patients.
Danish: Kontrollerede kliniske studier med XGEVA hos patienter over 65 år med fremskreden malignitet med involvering af knogle viste samme virkning og sikkerhed hos ældre og yngre patienter.
English: • Before administration, the XGEVA solution should be inspected visually.
Danish: • Opløsningen med XGEVA skal inden indgift inspiceres visuelt.
English: XGEVA was evaluated in an international, randomised (1:1), double-blind, active-controlled study comparing XGEVA with zoledronic acid in patients with newly diagnosed multiple myeloma, study 4.
Danish: XGEVA blev evalueret i et internationalt, randomiseret (1:1), dobbeltblindet, aktiv-kontrolleret studie, hvor XGEVA blev sammenlignet med zoledronsyre hos patienter med nyligt diagnosticeret multipelt myelom, studie 4.
English: XGEVA has been administered in clinical studies using doses up to 180 mg every 4 weeks and 120 mg weekly for 3 weeks.
Danish: XGEVA er blevet indgivet i kliniske studier med anvendelse af doser på op til 180 mg hver 4. uge og 120 mg hver uge i 3 uger.
English: A population pharmacokinetic analysis did not indicate clinically significant changes in the systemic exposure of denosumab at steady-state with respect to age (18 to 87 years), race/ethnicity (Blacks, Hispanics, Asians and Caucasians explored), gender or solid tumour types or patients with multiple myeloma.
Danish: En farmakokinetisk populationsanalyse viste ingen klinisk signifikante ændringer i den systemiske eksponering for denosumab ved steady state, hvad angår alder (18 til 87 år), race/etnisk tilhørsforhold (sort, latinamerikansk, asiatisk og kaukasisk), køn eller typen af solid tumor eller patienter med multipelt myelom.
English: When OPG-Fc was combined with hormonal therapy (tamoxifen) or chemotherapy (docetaxel) in these models, there was additive inhibition of skeletal tumour growth in breast, and prostate or lung cancer respectively.
Danish: Når OPG-Fc blev kombineret med hormonel behandling (tamoxifen) eller kemoterapi (docetaxel) på disse modeller, var der en additiv hæmning af skeletal tumorvækst ved henholdsvis bryst- og prostatacancer eller lungecancer.
English: XGEVA reduced the risk of developing a SRE, and developing multiple SREs (first and subsequent) in patients with bone metastases from solid tumours (see table 2).
Danish: XGEVA nedsatte risikoen for at udvikle en KRH og flere KRH'er (første og efterfølgende) hos patienter med knoglemetastaser fra solide tumorer (se tabel 2).
English: In Cohort 1 (patients with surgically unsalvageable disease), median time to disease progression was not reached, 21 of the 258 treated patients had disease progression.
Danish: I kohorte 1 (patienter med kirurgisk uhelbredelig sygdom) blev mediantiden indtil sygdomsprogression ikke nået - 21 ud af 258 behandlede patienter havde sygdomsprogression.
English: ** Including NSCLC, renal cell cancer, colorectal cancer, small cell lung cancer, bladder cancer, head and neck cancer, GI/genitourinary cancer and others, excluding breast and prostate cancer.
Danish: **Inklusive NSCLC, nyrecellecancer, kolorektal cancer, småcellet lungecancer, blærecancer, hoved- og halscancer, GI/genitourinær cancer m.fl., eksklusive bryst- og prostatacancer.
English: treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition.
Danish: Behandling med denosumab kan således nedsætte knoglevæksten hos børn med åbne vækstplader og hæmme frembruddet af tænder.
English: Number of patients who had SREs (%) Median time to SRE (months)
Danish: Antal patienter, som havde KRH'er (%) Mediantid indtil KRH (mdr.)
English: Your doctor may recommend a dental examination before you start treatment with XGEVA.
Danish: Lægen vil muligvis anbefale en tandundersøgelse, inden du starter behandlingen med XGEVA.
English: Since the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered (knockout) mice or use of other biological inhibitors of the RANK/RANKL pathway, such as OPG-Fc and RANK-Fc, were used to evaluate the pharmacodynamic properties of denosumab in rodent models.
Danish: Da den biologiske aktivitet af denosumab hos dyr er specifik for ikke-humane primater, blev der brugt genetisk manipulerede (knockout) mus eller andre biologiske hæmmere af RANK-/RANKL-banen, for eksempel OPG-Fc og RANK-Fc, til at undersøge de farmakodynamiske egenskaber for denosumab hos gnavermodeller.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apoteket eller sygeplejerske.
English: • new or unusual pain in your hip, groin or thigh (this may be an early indication of a possible fracture of the thigh bone),
Danish: • nye eller usædvanlige smerter i hofte, lyske eller lår (dette kan være et tidligt tegn på et eventuelt brud i lårbenet),
English: Pre-existing hypocalcaemia must be corrected prior to initiating therapy with XGEVA.
Danish: Eksisterende hypokalcæmi skal være korrigeret inden iværksættelse af behandling med XGEVA.
English: A decision must be made on whether to abstain from breast-feeding or to abstain from XGEVA therapy taking into account the benefit of breast-feeding to the newborn/infant and the benefit of therapy for the woman.
Danish: Der skal træffes en beslutning om, hvorvidt kvinden skal afstå fra at amme eller afstå fra behandling med XGEVA, under hensyntagen til fordelen ved amning for den nyfødte/spædbarnet og fordelen ved behandling for kvinden.
English: Clinically significant hypercalcaemia has also been reported in this patient group weeks to months following treatment discontinuation.
Danish: Der er ligeledes indberettet klinisk signifikant hyperkalcæmi hos denne patientgruppe uger til måneder efter behandlingsophør.
English: • rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions).
Danish: • udslæt, der kan forekomme på huden eller som sår i munden (lichenoid lægemiddeludslæt).
English: Clinical efficacy in patients with multiple myeloma
Danish: Klinisk virkning hos patienter med multipelt myelom
English: Efficacy results in patients with advanced malignancies involving bone Study 1 breast cancer
Danish: Effektresultater hos patienter med fremskreden malignitet, hvor knogle er involveret Studie 1 brystcancer
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, since it contains sorbitol (E420).
Danish: Kontakt din læge, inden du tager denne medicin, hvis du af din læge har fået at vide, at du ikke kan tåle visse sukkertyper, da dette produkt indeholder sorbitol (E420).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: The vial may be left outside the refrigerator to reach room temperature (up to 25°C) before injection.
Danish: Hætteglasset kan tages ud af køleskabet, så det får stuetemperatur (op til 25°C) inden injektion.
English: • To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to
Danish: • For at undgå ubehag på injektionsstedet bør hætteglasset have opnået stuetemperatur (op til
English: Low calcium levels in the blood
Danish: Lave calciumniveauer i blodet
English: Among subjects with confirmed ONJ, most (81% in both treatment groups) had a history of tooth extraction, poor oral hygiene, and/or use of a dental appliance.
Danish: Blandt patienterne med bekræftet ONJ havde de fleste (81% i begge behandlingsgrupper) tandekstraktion i anamnesen, ringe mundhygiejne og/eller anvendelse af tandregulering.
English: The safety and efficacy of XGEVA was studied in two phase II open-label, single-arm trials (studies 5 and 6) that enrolled 529 patients with giant cell tumour of bone that was either unresectable or for which surgery would be associated with severe morbidity.
Danish: XGEVAs sikkerhed og virkning blev undersøgt i to åbne, enkeltarmede fase II-studier (studie 5 og 6) med deltagelse af 529 patienter med kæmpecelletumorer i knogle, som enten var ikke-resekterbare, eller hvor operation ville være forbundet med svær morbiditet.
English: Malignancy in giant cell tumour of bone or progression to metastatic disease is an infrequent event and a known risk in patients with giant cell tumour of bone.
Danish: Malignitet i kæmpecelletumorer i knogle eller progression til metastatisk sygdom er sjælden, men en kendt risiko hos patienter med kæmpecelletumorer i knogle.
English: Talk to your doctor before using XGEVA.
Danish: Kontakt lægen, før du bruger XGEVA.
English: Neonatal RANK/RANKL knockout mice exhibited decreased body weight, reduced bone growth, altered growth plates and lack of tooth eruption.
Danish: Neonatale knockout RANK/RANKL-mus udviste nedsat kropsvægt, reduceret knoglevækst, ændrede vækstplader og manglende tandfrembrud.
English: Your doctor will then help you decide whether to stop breast-feeding or whether to stop taking XGEVA, considering the benefit of breast-feeding to the baby and the benefit of XGEVA to the mother.
Danish: Din læge vil så hjælpe dig med at finde ud af, om du skal holde op med at amme eller holde op med at tage XGEVA under hensyntagen til fordelen ved amning for barnet og fordelen for dig ved din anvendelse af XGEVA.
English: The European Medicines Agency has waived the obligation to submit the results of studies with XGEVA in all subsets of the paediatric population in the prevention of skeletal related events in patients with bone metastases and subsets of the paediatric population below the age of 12 in the treatment of giant cell tumour of bone (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med XGEVA i alle undergrupper af den pædiatriske population ved forebyggelse af knoglerelaterede hændelser hos patienter med knoglemetastaser og i undergrupper af den pædiatriske population under 12 år i behandlingen af kæmpecelletumorer i knogle (se pkt.
English: High calcium levels in the blood after stopping treatment with XGEVA Some patients with giant cell tumour of the bone have developed high calcium levels in the blood weeks to months after stopping treatment.
Danish: Høje niveauer af calcium i blodet efter ophør af behandling med XGEVA Nogle patienter med kæmpecelletumorer i knogle har udviklet høje niveauer af calcium i blodet uger til måneder efter ophør af behandlingen.
English: Superiority p-value
Danish: P-værdi for superioritet
English: First SRE
Danish: Første KRH
English: XGEVA is a solution for injection (injection).
Danish: XGEVA er en injektionsvæske, opløsning (injektion).
English: In two phase II single-arm clinical trials in patients with giant cell tumour of bone, hypocalcaemia was reported in 5.7% of patients.
Danish: I to enkeltarmede kliniske fase II-studier med patienter med kæmpecelletumorer i knogle blev hypokalcæmi indberettet hos 5,7% af patienterne.
English: In studies of denosumab (60 mg, n = 55 and 120 mg, n = 32) in patients without advanced cancer but with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab; thus dose adjustment for renal impairment is not required.
Danish: I studier med denosumab (60 mg, n = 55 og 120 mg, n = 32) med patienter, som ikke havde fremskreden cancer, men forskellige grader af nedsat nyrefunktion, herunder patienter i dialyse, havde graden af nyrefunktionsnedsættelsen ingen indvirkning på denosumabs farmakokinetik.
English: First and subsequent SRE Mean number of events/patient Rate ratio (95% CI) Skeletal morbidity rate per year
Danish: Første og efterfølgende KRH Gennemsnitligt antal hændelser/patient Hyppighedsratio (95% CI) Knoglemorbiditetshyppighed pr. år
English: In clinical trials, musculoskeletal pain was very common in both the denosumab and zoledronic acid treatment groups.
Danish: I kliniske studier var muskuloskeletale smerter meget almindeligt forekommende i både denosumab-gruppen og zoledronsyre-gruppen.
English: RRR (%)
Danish: CI)/RRR (%)
English: The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid, respectively.
Danish: Den kumulative incidens ved ét år var henholdsvis 1,1 % for denosumab og 0,6 % for zoledronsyre.
English: In Cohort 2 (patients with surgically salvageable disease whose planned surgery was associated with severe morbidity), 209 of the 228 evaluable patients treated with XGEVA had not undergone surgery by month 6.
Danish: I kohorte 2 (patienter med kirurgisk helbredelig sygdom, hvis planlagte operation var forbundet med svær morbiditet) var 209 af de 228 evaluerbare patienter, der blev behandlet med XGEVA, ikke opereret ved 6. måned.
English: First SRE or HCM Median time (months)
Danish: Første KRH eller HCM Mediantid (mdr.)
English: Upon enrolment of 282 patients, in Study 6 cohorts 1 and 2 combined, a clinically meaningful reduction in worst pain (i.e. ≥ 2-point decrease from baseline) was reported for 31.4% of patients at risk (i.e. those who had a worst pain score of ≥ 2 at baseline) within 1 week of treatment, and ≥ 50% at week 5.
Danish: Ved inklusionen af 282 patienter i studie 6, kohorte 1 og 2 kombineret, blev der indberettet en klinisk relevant reduktion i værste smerter (dvs. ≥ 2 punkters reduktion i forhold til baseline) hos 31,4% af de patienter, der havde en risiko (dvs. patienter med score for værste smerter på ≥ 2 ved baseline) inden for 1. uge efter behandlingsstart og ≥ 50% ved uge 5.
English: The risk of developing hypocalcaemia and accompanying elevations in parathyroid hormone increases with increasing degree of renal impairment.
Danish: Risikoen for at udvikle hypokalcæmi og ledsagende stigning i parathyreoidahormon øges i takt med graden af nyrefunktionsnedsættelse.
English: Study 5 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
Danish: I studie 5 deltog 37 voksne patienter med histologisk bekræftede, ikke-resekterbare eller recidiverende kæmpecelletumorer i knogle.
English: All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with denosumab.
Danish: Alle patienter skal opfordres til at opretholde god mundhygiejne og møde op til regelmæssige tandundersøgelser og til straks at indberette eventuelle mundsymptomer såsom tandmobilitet, smerter eller hævelse eller manglende opheling af sår eller sekretion under behandling med denosumab.
English: Please tell your doctor immediately if you develop any of these symptoms while being treated with XGEVA (may affect more than 1 in 10 people):
Danish: Fortæl det straks til din læge, hvis du udvikler et eller flere af følgende symptomer, mens du er i behandling med XGEVA (kan ramme flere end 1 ud af 10 personer):