FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of XGEVA therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit-risk assessment.
Danish: Det bør overvejes at seponere XGEVA hos patienter, hvor der er mistanke om en atypisk femurfraktur, mens patienten evalueres på basis af en individuel vurdering af fordele kontra risici.
English: XGEVA is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).
Danish: XGEVA bruges til voksne personer med fremskreden kræft for at forebygge alvorlige komplikationer på grund af knoglemetastaser (for eksempel knoglebrud, tryk på rygmarven eller behov for strålebehandling eller operation).
English: In a post-hoc analysis of the combined dataset, the median time to worsening pain (> 4-point worst pain score) in patients with mild or no pain at baseline was delayed for XGEVA compared to zoledronic acid (198 versus 143 days) (p = 0.0002).
Danish: I en post hoc-analyse af det kombinerede datasæt blev mediantiden indtil forværring af smerter (> 4 point score for værste smerte) hos patienter med milde eller ingen smerter ved baseline forsinket for XGEVA sammenlignet med zoledronsyre (198 vs. 143 dage) (p = 0,0002).
English: XGEVA is not recommended for use in pregnant women and women of child-bearing potential not using contraception.
Danish: XGEVA anbefales ikke til gravide kvinder og fertile kvinder, der ikke anvender antikonception.
English: In studies demonstrating superiority of XGEVA to zoledronic acid, patients were offered open-label XGEVA in a pre-specified 2-year extension treatment phase.
Danish: I studier hvor XGEVA blev vist superiørt i forhold til zoledronsyre, blev patienterne tilbudt XGEVA som åben behandling i en foruddefineret 2-årig forlængelsesfase.
English: Patients being treated with XGEVA should not be treated concomitantly with other denosumab containing medicinal products (for osteoporosis indications).
Danish: Patienter, der behandles med XGEVA, bør ikke samtidig behandles med andre lægemidler, der indeholder denosumab (til indikationer med osteoporose).
English: Proportion (%) (95% CI)1
Danish: Andel (%) (95% CI)1
English: Unhealed lesions from dental or oral surgery.
Danish: Ikke-ophelede læsioner fra tand- eller mundkirurgi.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin, har gjort det for nylig eller forventer at gøre det.
English: These could be signs that you have low calcium levels in the blood.
Danish: Dette kan være tegn på, at du har et lavt calciumniveau i blodet.
English: Efficacy results for XGEVA compared to zoledronic acid in patients with newly diagnosed multiple myeloma
Danish: Effektresultater for XGEVA sammenlignet med zoledronsyre hos patienter med nyligt diagnosticeret multipelt myelom
English: Baseline pre-treatment analgesic use in cohort 1 and cohort 2 was graded on a seven point scale, where 74.8% of patients reported no or mild analgesic use (i.e. analgesic score ≤ 2) and 25.2% of patients used strong opioids (i.e. analgesic score 3 to 7).
Danish: Anvendelsen af analgetika ved baseline og inden behandlingen i kohorte 1 og kohorte 2 blev vurderet på en 7-punktsskala, hvor 74,8% af patienterne indberettede ingen eller lille anvendelse af analgetika (dvs. en score for analgetika på ≤ 2), og 25,2% af patienterne anvendte stærke opioider (dvs. en score for analgetika på 3-7).
English: Giant cell tumours of bone are characterised by neoplastic stromal cells expressing RANK ligand and osteoclast-like giant cells expressing RANK.
Danish: Kæmpecelletumorer i knogle er kendetegnet ved neoplastiske stromalceller, der udtrykker RANK-liganden, og osteoklast-lignende kæmpeceller, der udtrykker RANK.
English: In clinical trials, the incidence of ONJ was higher with longer duration of exposure; ONJ has also been diagnosed after stopping treatment with XGEVA with the majority of cases occurring within 5 months after the last dose.
Danish: I kliniske studier steg forekomsten af ONJ i takt med længerevarende eksponering; ONJ er desuden diagnosticeret efter ophør af behandling med XGEVA, hvor størstedelen af tilfældene er opstået inden for 5 måneder efter den sidste dosis.
English: In a mouse model of mammary tumour induction, RANK-Fc reduced hormone-induced proliferation in mammary epithelium and delayed tumour formation.
Danish: I en musemodel af induktion af mammatumorer reducerede RANK-Fc hormoninduceret proliferation i mammaepithel og forsinkede tumordannelsen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/703/001
English: Kaplan-Meier plot for time to first on-study SRE in patients with newly diagnosed multiple myeloma
Danish: Kaplan-Meier plot af tiden indtil første KRH i studiet hos patienter med nyligt diagnosticeret multipelt myelom
English: Severe, untreated hypocalcaemia (see section 4.4).
Danish: Alvorlig, ubehandlet hypokalcæmi (se pkt.
English: An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
Danish: En KRH blev defineret som én af følgende: patologisk fraktur (vertebral eller non-vertebral), strålebehandling af knogle (herunder brug af radioisotoper), knoglekirurgi eller rygmarvskompression.
English: New primary malignancy
Danish: Nye primære maligniteter
English: This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 120 mg, dvs. at det er stort set ‘natriumfrit'.
English: Within these active-controlled clinical trials, safety was evaluated in 5,931 patients.
Danish: Sikkerheden blev undersøgt hos 5.931 patienter inden for disse aktivt-kontrollerede kliniske studier.
English: In subjects who discontinued 120 mg every 4 weeks, the mean half-life was 28 days (range 14 to 55 days).
Danish: For de patienter, der seponerede behandling med 120 mg hver 4. uge, var den gennemsnitlige halveringstid 28 dage (inden for intervallet 14 til 55 dage).
English: Hypocalcaemia can occur at any time during therapy with XGEVA.
Danish: Hypokalcæmi kan opstå når som helst under behandling med XGEVA.
English: Maternal mammary gland development was normal.
Danish: Udvikling af mælkekirtlerne hos mødrene var normal.
English: Adverse reactions reported in patients with advanced malignancies involving bone, multiple myeloma, or with giant cell tumour of bone MedDRA system organ class Frequency category
Danish: Bivirkninger rapporteret hos patienter med fremskreden malignitet, der involverer knogle, multipelt myelom eller med kæmpecelletumorer i knogle MedDRA-systemorganklasse Hyppighed
English: Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation, which is seen by electrocardiogram (ECG).
Danish: Et lavt calciumniveau i blodet kan desuden føre til en ændring i hjerterytmen, der kaldes for QT-forlængelse.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENT LÆGEMIDDEL SAMT AFFALD HERAF
English: Across both study arms, 54.5% of patients intended to undergo autologous PBSC transplantation, 95.8% patients utilised/planned to utilise a novel anti-myeloma agent (novel therapies include bortezomib, lenalidomide, or thalidomide) in first-line therapy, and 60.7% of patients had a previous SRE.
Danish: I begge studiearme skulle 54,5% af patienterne gennemgå autolog PBSC-transplantation, 95,8% af patienterne brugte/havde planer om at bruge et nyt anti-myelom middel (nye behandlinger omfatter bortezomib, lenalidomid eller thalidomid) som førstelinjebehandling, og 60,7% af patienterne havde tidligere haft en KRH.
English: • Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Danish: • Kontakt straks din læge og tandlæge, hvis du får problemer med din mund eller dine tænder, for eksempel løse tænder eller smerter og hævelse, manglende opheling af sår eller sekretion, da det kan være tegn på osteonekrose i kæben.
English: First radiation to bone Hazard ratio (95% CI)
Danish: Første stråling på knogle Hazard ratio (95% CI)
English: • allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin).
Danish: • allergiske reaktioner (for eksempel hvæsende vejrtrækning eller vejrtrækningsbesvær, hævelse af ansigt, læber, tunge, hals eller andre kropsdele, udslæt, kløe eller nældefeber på huden).
English: In subjects with multiple myeloma who received 120 mg every 4 weeks, median trough levels varied by less than 8% between months 6 and 12.
Danish: Hos patienter med multipelt myelom, som fik 120 mg hver 4. uge, varierede median dalværdi med mindre end 8% mellem 6. og 12. måned.
English: Available clinical data does not suggest an increased risk of malignancy in giant cell tumour of bone patients treated with XGEVA.
Danish: De tilgængelige kliniske data tyder ikke på øget risiko for malignitet hos patienter med kæmpecelletumorer i knogle, der behandles med XGEVA.
English: In the clinical trial programme, atypical femoral fractures have been reported uncommonly in patients treated with XGEVA and the risk increased with longer duration of treatment.
Danish: I det kliniske studieprogram er der med hyppigheden ikke almindelig blevet indberettet atypiske femurfrakturer hos patienter, der blev behandlet med XGEVA, og risikoen øgedes ved længere behandlingsvarighed.
English: Study 1*
Danish: Studie 1*
English: In 190 subjects evaluable for objective tumour response, 55 subjects had giant cell tumour of bone surgery, out of which 40 subjects had complete resections.
Danish: Af 190 patienter, der var evaluerbare for så vidt angår objektiv tumorrespons, gennemgik 55 patienter operation for kæmpecelletumorer i knogle, og heraf fik 40 komplet resektion.
English: You may have low levels of calcium in your blood.
Danish: Det kan være, at du har et lavt niveau af calcium i blodet.
English: The use of XGEVA has not been studied in children and adolescents with other cancers that have spread to bone.
Danish: XGEVA er ikke blevet undersøgt hos børn og unge med andre kræftformer, der har bredt sig til knogler.
English: The trials in patients with breast or prostate cancer included an XGEVA extension treatment phase (median overall exposure of 14.9 months; range: 0.1 - 67.2).
Danish: Studierne med patienter med bryst- eller prostatacancer inkluderede en forlængelsesfase med XGEVA-behandling (samlet median eksponering 14,9 måneder; interval: 0,1-67,2).
English: 1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.
Danish: 1,7 ml injektionsvæske i et engangshætteglas (type I-glas) med prop (fluoropolymer-belagt elastomer) og forsegling (aluminium) med flipoff-hætte.
English: Atypical femoral fractures have also been reported in patients with certain co-morbid conditions (e.g. vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors).
Danish: Der er desuden indberettet atypiske femurfrakturer hos patienter med visse komorbide tilstande (fx vitamin D-mangel, reumatoid artritis, hypofosfatasi) og i forbindelse med visse lægemidler (fx bisfosfonater, glukokortikoider, protonpumpehæmmere).
English: Marketing Authorisation Holder Amgen Europe B.V.
Danish: Indehaver af markedsføringstilladelse Amgen Europe B.V.
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Danish: • fortæl det til lægen, hvis du får ørepine, udflåd fra øret og/eller en øreinfektion.
English: XGEVA is not recommended in patients with growing skeletons (see section 4.2).
Danish: XGEVA anbefales ikke til patienter med voksende skelet (se pkt.
English: The primary outcome measure was demonstration of non-inferiority of time to first on study skeletal related event (SRE) as compared to zoledronic acid.
Danish: Det primære udfaldsmål var påvisning af noninferioritet mth. tid indtil første knoglerelaterede hændelse (KRH) i studiet sammenlignet med zoledronsyre.
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Danish: Sikkerheden og virkningen af denosumab er ikke blevet undersøgt hos patienter med nedsat leverfunktion (se pkt.
English: Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption, and these changes were partially reversible upon cessation of RANKL inhibition (see section 5.3).
Danish: Hæmning af RANK/RANK-liganden (RANKL) er i dyrestudier blevet forbundet med hæmning af knoglevækst og manglende tandfrembrud, og disse ændringer var delvis reversible efter standsning af RANKL-hæmningen (se pkt.
English: In subjects with advanced cancer, who received multiple doses of 120 mg every 4 weeks an approximate 2-fold accumulation in serum denosumab concentrations was observed and steady-state was achieved by 6 months, consistent with time-independent pharmacokinetics.
Danish: Hos patienter med fremskreden cancer, der fik gentagne doser på 120 mg hver 4. uge, blev der observeret en omtrent fordoblet akkumulering af serumkoncentrationerne af denosumab, og steady state blev opnået efter 6 måneder, svarende til en tidsuafhængig farmakokinetik.
English: XGEVA contains sorbitol
Danish: XGEVA indeholder sorbitol
English: • While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
Danish: • Når du er i behandling, skal du sørge for hele tiden at have god mundhygiejne og gå jævnligt til tandlægen.
English: In patients with giant cell tumour of bone, denosumab binds to RANK ligand, significantly reducing or eliminating osteoclast-like giant cells.
Danish: Hos patienter med kæmpecelletumorer i knogle binder denosumab til RANK-liganden med signifikant reduktion eller elimination af osteoklast-lignende kæmpeceller til følge.
English: HR (95% CI) / RRR (%) Superiority p-value
Danish: HR (95% CI)/RRR (%) P-værdi for superioritet
English: Zoledronic Acid (N = 859)
Danish: Zoledronsyre (N = 859)
English: • high calcium levels in the blood (hypercalcaemia) after stopping treatment in patients with giant cell tumour of the bone,
Danish: • høje niveauer af calcium i blodet (hyperkalcæmi) efter ophør af behandlingen hos patienter med kæmpecelletumorer i knogle,
English: In a combined pre-specified analysis from studies 1, 2 and 3, overall survival was similar between XGEVA and zoledronic acid (hazard ratio and 95% CI 0.99 [0.91, 1.07]).
Danish: I en kombineret forudbestemt analyse fra studie 1, 2 og 3 var den overall survival ens for XGEVA og zoledronsyre (hazard ratio og 95% CI 0,99 [0,91; 1,07]).
English: The patient-year adjusted incidence of ONJ was 0.2% during the first year of treatment and 1.7% in the second year.
Danish: Incidensen af ONJ, justeret for patientår, var 0,2% i det første år af behandling og 1,7% i det andet år.
English: Please tell your doctor and dentist immediately if you experience any of these symptoms while being treated with XGEVA or after stopping treatment (may affect up to 1 in 10 people):
Danish: Fortæl det straks til din læge og tandlæge, hvis du får et eller flere af følgende symptomer, mens du er i behandling med XGEVA, eller efter ophør af behandlingen (kan ramme op til 1 ud af 10 personer):
English: In preclinical bone quality studies in monkeys on long-term denosumab treatment, decreases in bone turnover were associated with improvement in bone strength and normal bone histology.
Danish: I prækliniske undersøgelser af knoglekvaliteten hos aber i langtidsbehandling med denosumab var reduktion i knogleomsætningen forbundet med en forbedring af knoglestyrken og normal knoglehistologi.
English: There were no clinically-relevant alterations in trough serum concentration and pharmacodynamics of denosumab (creatinine adjusted urinary N-telopeptide, uNTx/Cr) by concomitant chemotherapy and/or hormone therapy or by previous intravenous bisphosphonate exposure.
Danish: Der var ingen klinisk relevante ændringer i minimumskoncentrationerne i serum eller farmakodynamikken af denosumab (kreatininjusteret N-telopeptid i urin, uNTx/Cr) ved samtidig kemoterapi og/eller hormonel behandling eller tidligere eksponering for intravenøse bisfosfonater.
English: In mouse bone metastasis models of oestrogen receptor positive and negative human breast cancer, prostate cancer and non-small cell lung cancer, OPG-Fc reduced osteolytic, osteoblastic, and osteolytic/osteoblastic lesions, delayed formation of de novo bone metastases, and reduced skeletal tumour growth.
Danish: I musemodeller af knoglemetastaser af østrogen receptorpositiv og -negativ human brystcancer, prostatacancer og ikke-småcellet lungecancer nedsatte OPG-Fc osteolytiske, osteoblastiske og osteolytiske/osteoblastiske læsioner, forsinkede dannelsen af de novo knoglemetastaser og reducerede den skeletale tumorvækst.
English: Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, who do not receive routine dental care, have gum disease or who are smokers, may have a higher risk of developing osteonecrosis of the jaw.
Danish: Patienter, som får kemoterapi og/eller strålebehandling, er i behandling med steroider eller antiangiogene lægemidler (til behandling af kræft), som får lavet en tandoperation, som ikke regelmæssigt går til tandlæge, som har en tandkødssygdom, eller som ryger, kan have øget risiko for at udvikle osteonekrose i kæben.
English: XGEVA is not recommended for children and adolescents under 18 years of age except for adolescents with giant cell tumour of the bone whose bones have stopped growing.
Danish: XGEVA anbefales ikke til børn og unge under 18 år, bortset fra unge, som har kæmpecelletumorer i knogle, og hvis knogler er færdige med at vokse.
English: Study 3*
Danish: Studie 3*
English: Study 6 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease.
Danish: I studie 6 deltog 507 voksne eller knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle og evidens for målbar aktiv sygdom.
English: Anaphylactic reaction1
Danish: Anafylaktisk reaktion1
English: Symptoms of hypocalcaemia in clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.
Danish: I kliniske studier har symptomerne på hypokalcæmi omfattet paræstesier eller muskelstivhed, muskelspjæt, spasmer og muskelkramper.
English: In the post-marketing setting, musculoskeletal pain, including severe cases, has been reported in patients receiving XGEVA.
Danish: Efter markedsføring er der indberettet smerter i bevægeapparatet, herunder alvorlige tilfælde, hos patienter, der har fået XGEVA.
English: • The vial should not be re-entered.
Danish: • Kanylen må ikke genindføres i hætteglasset.
English: Difference in median time (months)
Danish: Forskel i mediantid (mdr.)
English: The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.
Danish: Den anbefalede dosis af XGEVA er 120 mg som en enkelt subkutan injektion én gang hver 4. uge i lår, abdomen eller overarm, med yderligere doser på 120 mg på dag 8 og 15 i den første behandlingsmåned.
English: The recommended dose of XGEVA is 120 mg administered once every 4 weeks, as a single injection under the skin (subcutaneous).
Danish: Den sædvanlige dosis af XGEVA er 120 mg, der gives én gang hver 4. uge som en enkelt injektion under huden (subkutant).
English: In a clinical study in patients without advanced cancer, 19% of patients with severe renal impairment (creatinine clearance < 30 mL/min) and 63% of patients receiving dialysis developed hypocalcaemia despite calcium supplementation.
Danish: I et klinisk studie med patienter uden fremskreden cancer fik 19% af patienterne med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) og 63% af dialysepatienterne hypokalcæmi på trods af calciumtilskud.
English: In single and repeated dose toxicity studies in cynomolgus monkeys, denosumab doses resulting in 2.7 to 15 times greater systemic exposure than the recommended human dose had no impact on cardiovascular physiology, male or female fertility, or produced specific target organ toxicity.
Danish: I undersøgelser af toksiciteten efter enkelte og gentagne doser til cynomolgusaber havde doser, der medførte 2,7 til 15 gange større systemisk eksponering end den anbefalede humane dosis, ingen virkning på den kardiovaskulære fysiologi eller på hanners eller hunners fertilitet og udløste ingen specifik toksicitet i målorganer.
English: - The other ingredients are acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Danish: - Øvrige indholdsstoffer: iseddike, natriumhydroxid, sorbitol (E420), polysorbat 20 og vand til injektion.
English: It may contain trace amounts of clear to white particles.
Danish: Det kan indeholde spormængder af gennemsigtige til hvide partikler.
English: The highest incidence of hypocalcaemia was observed in a phase III trial in patients with multiple myeloma.
Danish: Den højeste incidens af hypokalcæmi blev observeret i et fase III-studie hos patienter med multipelt myelom.
English: Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4).
Danish: Alle patienter skal have tilskud af mindst 500 mg calcium og 400 IE D-vitamin dagligt, medmindre hyperkalcæmi forekommer (se pkt.
English: The highest incidence of ONJ was observed in a phase III trial in patients with multiple myeloma.
Danish: Den højeste incidens af ONJ blev observeret i et fase III-studie hos patienter med multipelt myelom.
English: In phase II clinical studies of patients with advanced malignancies involving bone, subcutaneous (SC) dosing of XGEVA administered either every 4 weeks (Q4W) or every 12 weeks resulted in a rapid reduction in markers of bone resorption (uNTx/Cr, serum CTx), with median reductions of approximately 80% for uNTx/Cr occurring within 1 week regardless of prior bisphosphonate therapy or baseline uNTx/Cr level.
Danish: I kliniske fase II-studier med patienter med fremskreden malignitet med involvering af knogle medførte subkutan (s.c.) dosering af XGEVA enten hver 4. uge (Q4W) eller hver 12. uge en hurtig reduktion i markører for knogleresorption (uNTx/Cr, serum-CTx) med median reduktion indenfor en uge på cirka 80% for uNTx/Cr, uanset tidligere behandling med bisfosfonater eller uNTx/Cr-niveau ved baseline.
English: In a study of cynomolgus monkeys dosed with denosumab during the period equivalent to the first trimester of pregnancy, denosumab doses resulting in 9 times greater systemic exposure than the recommended human dose did not induce maternal toxicity or foetal harm during a period equivalent to the first trimester, although foetal lymph nodes were not examined.
Danish: I et studie med cynomolgusaber, der fik denosumab i den periode, der svarer til første trimester, inducerede doser af denosumab, som medførte en 9 gange større systemisk eksponering end den anbefalede humane dosis, ingen maternel toksicitet eller fosterskade i en periode svarende til det første trimester, omend lymfeknuder hos fosteret ikke blev undersøgt.