FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).
Danish: Forebyggelse af knoglerelaterede hændelser (patologisk fraktur, strålebehandling af knogle, rygmarvskompression eller operation af knogle) hos voksne med fremskreden malignitet med involvering af knogle (se pkt.
English: In this study, 1,718 multiple myeloma patients with at least one bone lesion were randomised to receive 120 mg XGEVA subcutaneously every 4 weeks (Q4W) or 4 mg zoledronic acid intravenously (IV) every 4 weeks (dose-adjusted for renal function).
Danish: I dette studie blev 1.718 patienter med multipelt myelom med mindst én knoglelæsion randomiseret til at få 120 mg XGEVA subkutant hver 4. uge (Q4W) eller 4 mg zoledronsyre intravenøst (i.v.)
English: The median time to ONJ was 18.7 months (range: 1 - 44).
Danish: Mediantiden indtil ONJ var 18,7 måneder (interval: 1 - 44).
English: In subjects with giant cell tumour of bone who received 120 mg every 4 weeks with a loading dose on days 8 and 15, steady-state levels were achieved within the first month of treatment.
Danish: Hos patienter med kæmpecelletumorer i knogle, der fik 120 mg hver 4. uge med en loading-dosis på dag 8 og 15, blev steady state-niveauerne nået inden for den første behandlingsmåned.
English: Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons
Danish: Hyperkalcæmi efter seponering af behandlingen hos patienter med kæmpecelletumorer i knogle og hos patienter med voksende skelet
English: Other medicines and XGEVA
Danish: Brug af anden medicin sammen med XGEVA
English: Disease progression was similar between XGEVA and zoledronic acid in all three studies and in the pre-specified analysis of all three studies combined.
Danish: Sygdomsprogression og overall survival med knoglemetastaser fra solide tumorer Sygdomsprogressionen var ens for XGEVA og zoledronsyre i alle tre studier og i den forudbestemte analyse af alle tre studier samlet.
English: Please tell your doctor immediately if you have spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness while being treated with XGEVA.
Danish: Fortæl det straks til din læge, hvis du får muskelspasmer, muskelspjæt eller muskelkramper og/eller oplever følelsesløshed eller prikken i dine fingre eller tæer eller omkring munden og/eller får krampeanfald, bliver forvirret eller besvimer, mens du er i behandling med XGEVA.
English: Drug related hypersensitivity reactions
Danish: Lægemiddelrelaterede overfølsomhedsreaktioner
English: You should also take calcium and vitamin D supplements while being treated with XGEVA unless you have an excess of calcium in the blood.
Danish: Du skal også tage tilskud af calcium og D-vitamin, mens du er i behandling med XGEVA, medmindre du har for meget calcium i blodet.
English: In the post-marketing setting, events of hypersensitivity, including rare events of anaphylactic reactions, have been reported in patients receiving XGEVA.
Danish: Efter markedsføring af præparatet er der indberettet hændelser med overfølsomhed, herunder sjældne tilfælde af anafylaktiske reaktioner, hos patienter, der fik XGEVA.
English: 71.6% (95% CI: 64.6, 77.9) of patients (table 4) assessed by any of the modalities, with the majority of responses defined by a reduction in fluorodeoxyglucose PET activity or increase in density measured in CT/HU, only 25.1% of the patients had a response per RECIST.
Danish: Samlet set medførte XGEVA objektivt tumorrespons hos 71,6% (95% CI: 64,6; 77,9) af patienterne (tabel 4), vurderet med en hvilken som helst af modaliteterne, hvor størstedelen af responserne var defineret som en reduktion i fluordeoxyglucose-PET-aktivitet eller en stigning i densitet, målt i CT/HU; kun 25,1% af patienterne havde respons i henhold til RECIST-kriterierne.
English: Knockout mouse studies suggest absence of RANKL during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3).
Danish: Undersøgelser på knockout mus tyder på, at mangel på RANKL under graviditet kan bryde ind i maturationen af mælkekirtlen og medføre forringet amning post partum (se pkt.
English: Clinical efficacy and safety in patients with bone metastases from solid tumours
Danish: Klinisk virkning og sikkerhed hos patienter med knoglemetastaser fra solide tumorer
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Danish: Patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) eller i dialyse har øget risiko for at udvikle hypokalcæmi.
English: • poor oral hygiene, periodontal disease, poorly fitting dentures, pre-existing dental disease, invasive dental procedures (e.g. tooth extractions).
Danish: • ringe mundhygiejne, parodontal sygdom, dårligt tilpassede tandproteser, tidligere tandsygdom, invasive tandbehandlinger (fx tandudtrækninger).
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Dette lægemiddel bør ikke anvendes til patienter med sjælden arvelig fruktoseintolerans.
English: In clinical trials, XGEVA has been administered in combination with standard anti-cancer treatment and in subjects previously receiving bisphosphonates.
Danish: XGEVA er blevet indgivet i kliniske studier i kombination med almindelig kræftbehandling til patienter, som tidligere har fået bisfosfonater.
English: First radiation to bone Median time (months)
Danish: Første stråling på knogle Mediantid (mdr.)
English: Study 3 prostate cancer
Danish: Studie 3 prostatacancer
English: XGEVA was studied in an open-label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone.
Danish: XGEVA blev undersøgt i et åbent studie med deltagelse af 18 knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle.
English: Denosumab 120 mg Q4W (N = 859) Zoledronic Acid 4 mg Q4W (N = 859)
Danish: Denosumab 120 mg Q4W (N = 859) Zoledronsyre 4 mg Q4W (N = 859)
English: Clinically significant hypercalcaemia requiring hospitalisation and complicated by acute renal injury has been reported in XGEVA-treated patients with giant cell tumour of bone weeks to months following treatment discontinuation.
Danish: Der er indberettet klinisk signifikant hyperkalcæmi, som krævede hospitalsindlæggelse og blev kompliceret af akut nyreskade, hos XGEVA-behandlede patienter med kæmpecelletumorer uger til måneder efter behandlingsophør.
English: In phase III clinical trials of patients with advanced malignancies involving bone, median uNTx/Cr reductions of approximately 80% were maintained through 49 weeks of XGEVA treatment (120 mg every Q4W).
Danish: I kliniske fase III-studier med patienter med fremskreden malignitet med involvering af knogle blev median reduktion i uNTx/Cr på cirka 80% opretholdt under behandling med XGEVA i 49 uger (120 mg hver 4QW).
English: The risk of developing hypocalcaemia during XGEVA treatment is greater with increasing degree of renal impairment.
Danish: Risikoen for at få hypokalcæmi under behandling med XGEVA stiger i takt med en øget grad af nyrefunktionsnedsættelse.
English: In a phase III trial in patients with non-metastatic prostate cancer (a patient population for which XGEVA is not indicated), with longer treatment exposure of up to 7 years, the patient-year adjusted incidence of confirmed ONJ was 1.1% during the first year of treatment, 3.0% in the second year, and 7.1% per year thereafter.
Danish: I et fase III-studie med patienter med ikke-metastatisk prostatacancer (en patientpopulation, som XGEVA ikke er indiceret til) med en længere behandlingstid på op til 7 år var forekomsten af bekræftet ONJ, justeret for patientår, 1,1% i det første år af behandlingen, 3,0% i det andet år og 7,1% om året derefter.
English: LIST OF EXCIPIENTS Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Iseddike, natriumhydroxid, sorbitol (E420), polysorbat 20 og vand til injektion.
English: In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at systemic exposures 12-fold higher than the human dose, there were increased stillbirths and postnatal mortality; abnormal bone growth resulting in reduced bone strength, reduced haematopoiesis, and tooth malalignment; absence of peripheral lymph nodes; and decreased neonatal growth.
Danish: I et andet studie med cynomolgusaber, der fik denosumab under hele drægtigheden med systemiske eksponeringer, der var 12 gange højere end ved den humane dosis, var der øget forekomst af dødfødsler og postnatal mortalitet; unormal knoglevækst medførte nedsat knoglestyrke, reduceret hæmatopoiese og forkert tandstilling, manglende perifere lymfeknuder samt nedsat neonatal vækst.
English: Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults.
Danish: Behandling af knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle, som er ikkeresekterbare, eller hvor kirurgisk resektion sandsynligvis vil medføre svær morbiditet: Doseringen er den samme som hos voksne.
English: Supplementation with calcium and vitamin D is required in all patients unless hypercalcaemia is present (see section 4.2).
Danish: Tilskud af calcium og D-vitamin er påkrævet for alle patienter, medmindre hyperkalcæmi forekommer (se pkt.
English: Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Danish: Behandling af voksne og knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle, som er ikke-resekterbare, eller hvor kirurgisk resektion sandsynligvis vil medføre svær morbiditet.
English: Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone
Danish: Klinisk virkning og sikkerhed hos voksne og knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle
English: Your doctor should delay the start of your treatment if you have unhealed wounds in your mouth from dental procedures or oral surgery.
Danish: Lægen bør udsætte din behandling, hvis du har sår i munden efter tand- eller mundkirurgi, der ikke er ophelede.
English: The median time to ONJ was 19.4 months (range: 11 - 40).
Danish: Mediantiden indtil ONJ var 19,4 måneder (interval: 11-40).
English: Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe renal impairment or receiving dialysis.
Danish: Der er også observeret ledsagende stigning i parathyreoideahormon hos patienter, der fik XGEVA, og som havde svært nedsat nyrefunktion eller var i dialyse.
English: 2 RECIST 1.1: Modified Response Evaluation Criteria in Solid Tumours to evaluate tumour burden based on computed tomography (CT)/magnetic resonance imaging (MRI) 3 EORTC: Modified European Organisation for Research and Treatment of Cancer criteria to evaluate metabolic response using fluorodeoxyglucose positron emission tomography (FDG-PET) 4 Density/Size: Modified Inverse Choi criteria to evaluate tumour size and density using Hounsfield units based on CT/MRI
Danish: 3 EORTC: Modified European Organisation for Research and Treatment of Cancer-kriterier til vurdering af den metaboliske respons ved anvendelse af fluordeoxyglucose-positron-emissions-tomografi (FDG-PET) 4 Densitet/størrelse: Modified Inverse Choi-kriterier til vurdering af tumorstørrelse og -tæthed ved anvendelse af Hounsfield-enheder (HU) og baseret på CT/MR-scanning
English: Giant cell tumour of bone
Danish: Kæmpecelletumorer i knogle
English: Overall survival was longer for XGEVA in non-small cell lung cancer (hazard ratio [95% CI] of 0.79 [0.65, 0.95]; n = 702) and longer for zoledronic acid in multiple myeloma (hazard ratio [95% CI] of 2.26 [1.13, 4.50]; n = 180) and similar between XGEVA and zoledronic acid in other tumour types (hazard ratio [95% CI] of 1.08 (0.90, 1.30); n = 894).
Danish: Overall survival var længere for XGEVA ved ikke-småcellet lungecancer (hazard ratio [95% CI] på 0,79 [0,65; 0,95]; n = 702) og længere for zoledronsyre ved multipelt myelom (hazard ratio [95% CI] på 2,26 [1,13; 4,50]; n = 180) og ens for XGEVA og zoledronsyre ved andre tumortyper (hazard ratio [95% CI] på 1,08 (0,90; 1,30); n = 894).
English: A side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving XGEVA injections for cancer-related conditions.
Danish: Der er i almindelige tilfælde (det kan ske for 1 ud af 10 personer) indberettet en bivirkning, der kaldes for osteonekrose i kæben (beskadigelse af knoglen i kæben) hos patienter, der fik injektioner af XGEVA på grund af en kræftrelateret tilstand.
English: There is no need for renal monitoring with XGEVA dosing.
Danish: Det er ikke nødvendigt at monitorere nyrefunktionen ved behandling med XGEVA.
English: You should take calcium and vitamin D supplements while being treated with XGEVA unless your blood calcium is high.
Danish: Du bør tage tilskud af calcium og D-vitamin, mens du er i behandling med XGEVA, medmindre dit indhold af calcium i blodet er højt.
English: In three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, hypocalcaemia was reported in 9.6% of patients treated with XGEVA and 5.0% of patients treated with zoledronic acid.
Danish: I tre aktivt-kontrollerede, kliniske fase III-studier med patienter med fremskreden malignitet med involvering af knogle blev hypokalcæmi rapporteret for 9,6% af patienter behandlet med XGEVA, og for 5,0% af patienter behandlet med zoledronsyre.
English: What you need to know before you use XGEVA
Danish: Det skal du vide, før du begynder at bruge XGEVA
English: Women of child-bearing potential should use effective methods of contraception while being treated with XGEVA and for at least 5 months after stopping treatment with XGEVA.
Danish: Fertile kvinder skal bruge sikre præventionsformer, mens de er i behandling med XGEVA og i mindst 5 måneder efter behandlingen med XGEVA er stoppet.
English: Atypical femoral fracture1
Danish: Atypisk femurfraktur1
English: ZA = Zoledronic Acid 4 mg Q4W
Danish: ZA = Zoledronsyre 4 mg Q4W
English: The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone.
Danish: XGEVAs sikkerhed og virkning er ikke klarlagt hos pædiatriske patienter (< 18 år), bortset fra knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle.
English: The median time to ONJ was 20.6 months (range: 4 - 53).
Danish: Mediantiden indtil ONJ var 20,6 måneder (interval 4-53).
English: In preclinical studies knockout mice lacking RANK or RANKL had an absence of lactation due to inhibition of mammary gland maturation (lobulo-alveolar gland development during pregnancy) and exhibited impairment of lymph node formation.
Danish: I prækliniske studier havde knockout mus, som manglede RANK eller RANKL, ingen mælkeproduktion på grund af hæmmet maturation af mælkekirtlen (udvikling af den lobulo-alveolære kirtel under drægtighed) og udviste forringet dannelse af lymfeknuder.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Each 1.7 mL of solution contains 78 mg sorbitol (E420).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver 1,7 ml injektionsvæske indeholder 78 mg sorbitol (E420).
English: Osteonecrosis of the jaw (ONJ)
Danish: Osteonekrose i kæben (ONJ)
English: Women should be advised not to become pregnant during and for at least 5 months after treatment with XGEVA.
Danish: Kvinder skal frarådes at blive gravide under behandling med XGEVA og i mindst 5 måneder efter behandlingen.
English: Musculoskeletal pain1
Danish: Muskuloskeletale smerter1
English: At the completion of the double-blind treatment phase of this trial, the patient-year adjusted incidence (number of events per 100 patient years) of confirmed ONJ in the XGEVA group (median exposure of 19.4 months; range 1 - 52), was 2.0% during the first year of treatment, 5.0% in the second year, and 4.5% per year thereafter.
Danish: Ved afslutningen af dette studies dobbeltblindede behandlingsfase var incidensen af bekræftet ONJ, justeret for patientår (antal hændelser pr. 100 patientår), i XGEVA-gruppen (median eksponering 19,4 måneder; interval 1 - 52) 2,0% i det første år med behandling, 5,0% i det andet år og efterfølgende 4,5% pr. år.
English: In studies 1, 2 and 3, overall survival was balanced between XGEVA and zoledronic acid in patients with advanced malignancies involving bone: patients with breast cancer (hazard ratio and 95% CI was 0.95 [0.81, 1.11]), patients with prostate cancer (hazard ratio and 95% CI was 1.03 [0.91, 1.17]), and patients with other solid tumours or multiple myeloma (hazard ratio and 95% CI was 0.95 [0.83, 1.08]).
Danish: I studie 1, 2 og 3 blev overall survival afstemt mellem XGEVA og zoledronsyre hos patienter med fremskreden malignitet med involvering af knogle: patienter med brystcancer (hazard ratio og 95% CI var 0,95 [0,81; 1,11]), patienter med prostatacancer (hazard ratio og 95% CI var 1,03 [0,91; 1,17]) og patienter med andre solide tumorer eller multipelt myelom (hazard ratio og 95% CI var 0,95 [0,83; 1,08]).
English: In a clinical study of patients without advanced cancer with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis, there was a greater risk of developing hypocalcaemia in the absence of calcium supplementation.
Danish: I et klinisk studie med patienter uden fremskreden cancer, men med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) eller i dialyse, var der en øget risiko for at udvikle hypokalcæmi, når der ikke blev givet calciumtilskud.
English: active-controlled studies, in IV-bisphosphonate naïve patients with advanced malignancies involving bone: adults with breast cancer (study 1), other solid tumours or multiple myeloma (study 2), and castrate-resistant prostate cancer (study 3).
Danish: bisfosfonater: voksne med brystcancer (studie 1), andre solide tumorer eller multipelt myelom (studie 2) og kastrationsresistent prostatacancer (studie 3).
English: Hypocalcaemia was reported in 16.9% of patients treated with XGEVA and 12.4% of patients treated with zoledronic acid.
Danish: Hypokalcæmi blev rapporteret hos 16,9% af patienterne, der blev behandlet med XGEVA, og hos 12,4% af patienterne, der blev behandlet med zoledronsyre.
English: Your healthcare professional will not administer XGEVA to you if you have unhealed wounds from dental or oral surgery.
Danish: Sundhedspersonalet vil ikke give dig XGEVA, hvis du har sår efter tand- eller mundkirurgi, der ikke er ophelede.
English: Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing setting in paediatric patients (see section 4.4).
Danish: Efter markedsføring er der indberettet klinisk signifikant hyperkalcæmi efter behandlingsophør hos pædiatriske patienter (se pkt.
English: In the double-blind treatment phase of this trial, ONJ was confirmed in 5.9% of patients treated with XGEVA (median exposure of 19.4 months; range 1 52) and in 3.2% of patients treated with zoledronic acid.
Danish: I den dobbeltblindede behandlingsfase af dette studie blev ONJ bekræftet hos 5,9% af patienterne, der blev behandlet med XGEVA (median eksponering 19,4 måneder; interval 1 - 52), og hos 3,2% af patienterne, der blev behandlet med zoledronsyre.
English: The patient-year adjusted overall incidence (number of events per 100 patient years) of confirmed ONJ was 1.1% during the first year of treatment, 3.7% in the second year and 4.6% per year thereafter.
Danish: Den overordnede incidens af bekræftet ONJ, justeret for patientår (antal hændelser pr. 100 patientår), var 1,1% i det første år med behandling, 3,7% i det andet år og efterfølgende 4,6% om året.
English: Do not inject the solution if it is cloudy or discoloured.
Danish: Injektionsvæsken må ikke injiceres, hvis den er grumset eller misfarvet.
English: • spasms, twitches, cramps in your muscles, numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness.
Danish: • muskelspasmer, muskelspjæt eller muskelkramper, følelsesløshed i fingre eller tæer eller rundt om munden og/eller krampeanfald, forvirring eller besvimelse.
English: Reduced bone growth, altered growth plates and impaired tooth eruption were also seen in studies of neonatal rats administered RANKL inhibitors, and these changes were partially reversible when dosing of RANKL inhibitor was discontinued.
Danish: Reduceret knoglevækst, ændrede vækstplader og forringet tandfrembrud blev også observeret i undersøgelser af neonatale rotter, som fik indgift af RANKL-hæmmere.
English: ONJ has been reported commonly in patients receiving XGEVA (see section 4.8).
Danish: ONJ er blevet rapporteret med frekvensen almindelig hos patienter, der fik XGEVA (se pkt.
English: Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies.
Danish: Patienter med tidligere tilfælde af ONJ eller osteomyelitis i kæben, aktiv tand- eller kæbelidelse, hvor mundkirurgi var påkrævet, ikke-ophelet tand-/mundkirurgi eller planlagt invasiv tandprocedure var ikke egnede til deltagelse i disse studier.
English: Hypocalcaemia can be severe and symptomatic (see section 4.8 - description of selected adverse reactions).
Danish: Hypokalcæmi kan være alvorlig og symptomatisk (se pkt.
English: XGEVA contains sodium
Danish: XGEVA indeholder natrium
English: In two phase II single-arm clinical trials in patients with giant cell tumour of bone, ONJ occurred in 2.3% (12 of 523) of patients treated with XGEVA (median overall exposure of 20.3 months; range: 0 - 83.4).
Danish: I to enkeltarmede kliniske fase II-studier med patienter med kæmpecelletumorer i knogle forekom ONJ hos 2,3% (12 ud af 523) af de patienter, der blev behandlet med XGEVA (en samlet median eksponering på 20,3 måneder; interval: 0-83,4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION XGEVA 120 mg injection denosumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) XGEVA 120 mg injektionsvæske denosumab s.c.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 120 mg denosumab i 1,7 ml injektionsvæske (70 mg/ml).
English: In the primary treatment phases of three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, ONJ was confirmed in 1.8% of patients treated with XGEVA (median exposure of 12.0 months; range: 0.1 - 40.5) and 1.3% of patients treated with zoledronic acid.
Danish: I de primære behandlingsfaser i tre aktivt-kontrollerede, kliniske fase III-studier med patienter med fremskreden malignitet med involvering af knogle blev ONJ bekræftet hos 1,8% af patienterne, der blev behandlet med XGEVA (median eksponering 12,0 måneder; interval: 0,1-40,5), og hos 1,3% af patienterne, der blev behandlet med zoledronsyre.