FrancophonIA/ELRC3.0 huggingface dataset:
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 arthritis, hypofosfatæmi) og i forbindelse med visse lægemidler (fx bisfosfonater, glukokortikoider, protonpumpehæmmere).
English: Concomitant treatment with other denosumab-containing medicinal products Patients being treated with Prolia should not be treated concomitantly with other denosumab-containing medicinal products (for prevention of skeletal related events in adults with bone metastases from solid tumours).
Danish: Patienter, der behandles med Prolia, bør ikke behandles samtidigt med andre lægemidler, der indeholder denosumab (til forebyggelse af knoglerelaterede hændelser hos voksne med knoglemetastaser fra solide tumorer).
English: You may notice a small air bubble in the pre-filled syringe.
Danish: Du vil muligvis kunne se en lille luftboble i den fyldte injektionssprøjte.
English: A decision on whether to abstain from breast-feeding or to abstain from therapy with Prolia should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Prolia therapy to the woman.
Danish: Beslutningen om, hvorvidt kvinden skal afstå fra at amme eller afstå fra behandling med Prolia, bør træffes under hensyntagen til fordelen ved amning for den nyfødte/spædbarnet og fordelen ved behandling med Prolia for kvinden.
English: Calcium levels were transiently decreased and parathyroid hormone levels transiently increased in ovariectomised monkeys treated with denosumab.
Danish: Calciumniveauerne faldt forbigående, og niveauerne af parathyreoideahormoner steg midlertidigt hos aber, der havde fået foretaget ovariektomi, og som blev behandlet med denosumab.
English: Urinary tract infection Upper respiratory tract infection Diverticulitis1
Danish: Urinvejsinfektion Infektion i øvre luftveje Diverticulitis1
English: Rarely, patients receiving Prolia may have low calcium levels in the blood (hypocalcaemia).
Danish: Patienter, der får Prolia, kan i sjældne tilfælde få lave niveauer af calcium i blodet (hypokalcæmi).
English: In a pooled analysis of data from all phase II and phase III placebo-controlled studies, Influenza-like illness was reported with a crude incidence rate of 1.2% for denosumab and 0.7% for placebo.
Danish: I en poolet analyse af data fra alle placebokontrollerede fase II- og fase III-studier blev der indberettet influenzalignende sygdom med en rå incidensrate på 1,2 % for denosumab og 0,7 % for placebo.
English: In a study of cynomolgus monkeys dosed with denosumab during the period equivalent to the first trimester at AUC exposures up to 99-fold higher than the human dose (60 mg every 6 months), there was no evidence of maternal or foetal harm.
Danish: I et studie med cynomolgusaber, der fik denosumab i en periode svarende til første trimester med AUC-eksponeringer op til 99 gange højere end ved den humane dosering (60 mg hver 6. måned), var der ingen tegn på skader hos moderen eller fosteret.
English: Prolia treatment rapidly reduced the rate of bone turnover, reaching a nadir for the bone resorption marker serum type 1 C-telopeptides (CTX) (85% reduction) by 3 days, with reductions maintained over the dosing interval.
Danish: Behandling med Prolia nedsatte hurtigt knogleomsætningen og når nadir for knogleresorptionsmarkøren, serum-type 1-C-telopeptider (CTX), (85 % reduktion) efter 3 dage og reduktionen fastholdes over doseringsintervallet.
English: In a prospectively planned exploratory analysis, significant increases in BMD were observed at the lumbar spine, total hip, femoral neck and the hip trochanter 1 month after the initial dose.
Danish: I en prospektivt planlagt eksploratorisk analyse blev der observeret signifikante stigninger i BMD i columna lumbalis, total hofte, lårbenshals og hoftetrochanter 1 måned efter den første dosis.
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Danish: Patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min), eller som er i dialyse, har øget risiko for at udvikle hypokalcæmi.
English: Two subpopulations were studied: glucocorticoid-continuing (≥ 7.5 mg daily prednisone or its equivalent for ≥ 3 months prior to study enrolment; n = 505) and glucocorticoid-initiating (≥ 7.5 mg daily prednisone or its equivalent for < 3 months prior to study enrolment; n = 290).
Danish: To underpopulationer blev undersøgt: patienter, som fortsatte med glukokortikoid (≥ 7,5 mg prednison eller tilsvarende dagligt i ≥ 3 måneder før indskrivning i studiet; n = 505) og patienter, som påbegyndte glukokortikoid (≥ 7,5 mg prednison eller tilsvarende dagligt i < 3 måneder før indskrivning i studiet; n = 290).
English: Remove the needle and let go of the skin.
Danish: Tag kanylen ud og slip huden.
English: България Амджен България ЕООД
Danish: Амджен България ЕООД Тел.
English: Long-term antiresorptive treatment (including both denosumab and bisphosphonates) may contribute to an increased risk for adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures due to significant suppression of bone remodelling (see section 4.2).
Danish: Antiresorptiv langtidsbehandling (herunder både denosumab og bisfosfonater) kan bidrage til en øget risiko for uønskede hændelser, for eksempel osteonekrose i kæben og atypiske femurfrakturer, på grund af den signifikante undertrykkelse af knogleremodelleringen (se pkt.
English: In male mice genetically engineered to express huRANKL (knock-in mice), which were subjected to a transcortical fracture, denosumab delayed the removal of cartilage and remodelling of the fracture callus compared to control, but biomechanical strength was not adversely affected.
Danish: Hos hanmus, der var genetisk manipulerede til at udtrykke huRANKL (”knockin”-mus), og som blev udsat for transkortikal fraktur, forsinkede denosumab fjernelsen af brusk og remodelleringen af frakturcallus sammenlignet med kontrolgruppen, mens den biomekaniske styrke ikke var negativt påvirket.
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: Lave niveauer af calcium i blodet kan desuden føre til en ændring i hjerterytmen, der kaldes for QT-forlængelse.
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Prolia or after stopping treatment.
Danish: Fortæl det straks til din læge og tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Prolia, eller efter at du er holdt op med behandlingen.
English: If needed, you may cover the injection site with a plaster.
Danish: Om nødvendigt kan du sætte et plaster på injektionsstedet.
English: • pain, tingling or numbness that moves down your leg (sciatica),
Danish: • smerter, prikken eller følelsesløshed, der går ned i benene (ischias),
English: • painful urination, frequent urination, blood in the urine, inability to hold your urine,
Danish: • smertefuld vandladning, hyppig vandladning, blod i urinen, ufrivillig vandladning
English: ONJ has been reported rarely, in 16 patients, in clinical trials in osteoporosis and in breast or prostate cancer patients receiving hormone ablation including a total of 23,148 patients (see section 4.4).
Danish: ONJ er blevet indberettet i sjældne tilfælde hos 16 patienter i kliniske studier med patienter med osteoporose og patienter med bryst- eller prostatacancer, der fik antihormonbehandling, inklusive i alt 23.148 patienter (se pkt.
English: Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use pre-filled syringe.
Danish: Prolia er en klar, farveløs til let gul injektionsvæske, opløsning, som leveres i en fyldt injektionssprøjte, der er klar til brug.
English: The mean lumbar spine BMD T-score at the end of the study was1.3 in patients treated for 10 years.
Danish: Denne gennemsnitlige columna lumbalis BMD T-score i slutningen af studiet var -1,3 hos patienter, der var blevet behandlet i 10 år.
English: Treatment of bone loss associated with systemic glucocorticoid therapy
Danish: Behandling af knogletab forbundet med systemisk glukokortikoidbehandling
English: One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle, with or without needle guard.
Danish: En ml opløsning i en fyldt injektionssprøjte til engangsbrug, der er fremstillet af type I-glas med en 27 gauge kanyle af rustfrit stål med eller uden kanylehætte.
English: This section contains information on how to use the Prolia pre-filled syringe.
Danish: Dette afsnit indeholder information om, hvordan man bruger den fyldte injektionssprøjte med Prolia.
English: Whilst being treated with Prolia you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever.
Danish: Mens du er i behandling med Prolia, kan du udvikle en hudinfektion med symptomer såsom et hævet, rødt område på huden, sædvanligvis nederst på benene, der føles varmt og ømt (cellulitis), og eventuelt ledsaget af feber.
English: In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at AUC exposures 119-fold higher than the human dose (60 mg every 6 months), 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 gennem hele drægtighedsperioden med AUC-eksponeringer 119 gange højere end ved den humane dosering (60 mg hver 6. måned), var der flere dødfødsler og større postnatal dødelighed; unormal knoglevækst resulterende i nedsat knoglestyrke, nedsat hæmatopoiese og forkert tandstilling; manglende perifere lymfeknuder og reduceret neonatal vækst.
English: Patients should be encouraged to report symptoms indicative of hypocalcaemia.
Danish: Patienterne skal informeres om at indberette symptomer, der kan være tegn på hypokalcæmi.
English: Thirteen adjudicated cases of osteonecrosis of the jaw (ONJ) and two adjudicated cases of atypical fractures of the femur occurred during the extension study.
Danish: Der opstod 13 bedømte tilfælde af osteonekrose i kæben (ONJ) og 2 bedømte tilfælde af atypiske femurfrakturer i forlængelsesstudiet.
English: In this study, foetal lymph nodes were not examined.
Danish: Lymfeknuder blev ikke undersøgt i dette studie.
English: In a post-hoc analysis in women > 75 years, a 62% relative risk reduction was observed with Prolia (1.4% absolute risk reduction, p < 0.01).
Danish: I en post hoc-analyse af kvinder > 75 år blev der observeret en relativ risikoreduktion på 62 % med Prolia (1,4 % absolut risikoreduktion, p < 0,01).
English: INFORMATION IN BRAILLE Prolia
Danish: INFORMATION I BRAILLESKRIFT
English: Declines of serum calcium levels (less than 1.88 mmol/l) were not reported in either the two phase III placebo-controlled clinical trials in patients receiving hormone ablation or the phase III placebo-controlled clinical trial in men with osteoporosis.
Danish: Der blev ikke indberettet fald i serumcalcium-niveauerne (mindre end 1,88 mmol/l) i de to placebokontrollerede, kliniske fase III-studier med patienter, der var i antihormonbehandling, eller i de placebokontrollerede, kliniske fase III-studier hos mænd med osteoporose.
English: The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm.
Danish: Den anbefalede dosis af Prolia er 60 mg, der indgives som en enkelt subkutan injektion i låret, abdomen eller overarmen, én gang hver 6. måned.
English: If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8 for symptoms) calcium levels should be measured.
Danish: Hvis der under behandlingen opstår mistanke om symptomer på hypokalcæmi, skal calciumniveauet måles (se pkt.
English: You do not have to remove the air bubble before injecting.
Danish: Du behøver ikke fjerne luftboblen inden injektionen.
English: This medicine contains 47 mg sorbitol in each mL of solution.
Danish: Dette lægemiddel indeholder 47 mg sorbitol pr. ml opløsning.
English: Adolescent primates dosed with denosumab at 27 and 150 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Danish: Yngre primater, der fik denosumabdoser, som var 27 og 150 gange den kliniske eksponering (10 og 50 mg/kg dosis), havde anormale epifyselinjer.
English: Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur.
Danish: Atypiske femurfrakturer kan opstå i femurs subtrokantære og diafyseale regioner efter minimalt eller intet traume.
English: Prolia demonstrated a 40% relative reduction (0.5% absolute risk reduction) in the risk of hip fracture over 3 years (p < 0.05).
Danish: Prolia var forbundet med en relativ reduktion på 40 % (0,5 % absolut risikoreduktion) af risikoen for hoftefraktur over et tidsrum på 3 år (p < 0,05).
English: Your doctor has prescribed a Prolia pre-filled syringe for injection into the tissue just under the skin (subcutaneous).
Danish: Din læge har ordineret Prolia i en fyldt injektionssprøjte til injektion i vævet lige under huden (subkutant).
English: The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin (subcutaneous).
Danish: Den anbefalede dosis er én fyldt injektionssprøjte med 60 mg, der gives én gang hver 6. måned som en enkelt injektion under huden (subkutant).
English: The primary efficacy variable was percent change in lumbar spine BMD, fracture efficacy was not evaluated.
Danish: Den primære effektvariabel var den procentvise ændring i BMD i columna lumbalis.
English: The solution should not be injected if it contains particles or if it is discoloured or cloudy.
Danish: Opløsningen må ikke injiceres, hvis den indeholder partikler, eller hvis den er misfarvet eller grumset.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for denosumab (indicated for osteoporosis and for bone loss associated with hormone ablation in prostate cancer), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for denosumab (indiceret for osteoporose og for knogletab forbundet med antihormonbehandling hos patienter med prostatakræft) er CHMP nået frem til følgende videnskabelige konklusioner:
English: If you stop using Prolia
Danish: Hvis du holder op med at bruge Prolia
English: 4 Includes clinical vertebral, hip, forearm, and humerus fractures, as defined by the WHO.
Danish: 4 Inkluderer kliniske frakturer i vertebrae, hofte, underarm og humerus ifølge WHO's definitioner.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of ONJ.
Danish: Kontakt straks din læge og tandlæge, hvis du får problemer med din mund eller dine tænder, for eksempel løse tænder, smerter eller hævelse eller manglende opheling af sår eller sekretion, da det kan være tegn på ONJ.
English: Prolia contains sodium
Danish: Prolia indeholder natrium
English: The effect of Prolia on the risk of clinical fractures over 3 years
Danish: Effekten af Prolia på risikoen for kliniske frakturer i løbet af 3 år Andel af kvinder med fraktur
English: If you forget to use Prolia
Danish: Hvis du har glemt at bruge Prolia
English: Prolia is not recommended for children and adolescents under 18 years of age.
Danish: Prolia anbefales ikke til børn og unge under 18 år, da Prolia ikke er blevet undersøgt hos børn og unge.
English: • ear infection,
Danish: • øreinfektion,
English: Other medicines and Prolia
Danish: Brug af anden medicin sammen med Prolia
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Danish: Sikkerheden og effekten af denosumab er ikke blevet undersøgt hos patienter med nedsat leverfunktion (se pkt.
English: Atypical fractures of the femur
Danish: Atypiske femurfrakturer
English: DO NOT touch the needle or push the plunger.
Danish: Rør IKKE ved kanylen og tryk IKKE stemplet ind.
English: EU/1/10/618/002
Danish: EU/1/10/618/001 EU/1/10/618/002 EU/1/10/618/003
English: Prolia is not recommended for use in pregnant women and women of child-bearing potential not using contraception.
Danish: Prolia frarådes til gravide kvinder og fertile kvinder, der ikke anvender antikonception.
English: Check the expiry date on the pre-filled syringe label (EXP).
Danish: Kontrollér udløbsdatoen (EXP) på injektionssprøjtens etiket.
English: The subject incidence of non-vertebral fracture was 4.3% (denosumab) versus 2.5% (risedronate).
Danish: Hyppigheden af ikke-vertebrale frakturer hos patienterne var 4,3 % (denosumab) kontra 2,5 % (risedronat).
English: For a 60 mg subcutaneous dose, maximum serum denosumab concentrations (Cmax) of 6 mcg/mL (range 1-17 μg/mL) occurred in 10 days (range 2-28 days).
Danish: For en subkutan dosis på 60 mg sås maksimale serumkoncentrationer af denosumab (Cmax) på 6 μg/ml (interval 1-17 μg/ml) efter 10 dage (interval 2-28 dage).
English: In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia (see section 4.4).
Danish: I det kliniske osteoporose-studieprogram blev der i sjældne tilfælde indberettet atypiske femurfrakturer hos patienter, der blev behandlet med Prolia (se pkt.
English: The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.
Danish: Farmakokinetikken for denosumab forventes ikke at være påvirket af en nedsat leverfunktion.
English: Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption (see section 5.3).
Danish: Hæmning af RANK/RANK-liganden (RANKL) har i dyrestudier været forbundet med hæmning af knoglevæksten og manglende tandfrembrud (se pkt.
English: • bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.
Danish: • knogletab, der er resultatet af langvarig behandling med glukokortikoider hos patienter, som har forhøjet risiko for knoglebrud.
English: Do not use Prolia
Danish: Brug ikke Prolia:
English: • osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures.
Danish: • osteoporose hos kvinder efter menopausen og hos mænd, der har øget risiko for knoglebrud (frakturer), for at nedsætte risikoen for knoglebrud i rygraden, i andre knogler end rygraden og i hofterne.
English: Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Danish: Kontakt din læge, hvis du får nye eller usædvanlige smerter i hofte, lyske eller lår.
English: Contact your doctor if you experience new or unusual pain in your hip, groin or thigh as this may be an early indication of a possible fracture of the thigh bone.
Danish: Kontakt din læge, hvis du får nye eller usædvanlige smerter i hofte, lyske eller lår, da det kan være et tidligt tegn på et eventuelt lårbensbrud.
English: At 1 year, the subject incidence of new radiological vertebral fracture was 2.7% (denosumab) versus 3.2% (risedronate).
Danish: Efter 1 år var hyppigheden af nye radiologiske vertebrale frakturer hos patienterne 2,7 % (denosumab) kontra 3,2 % (risedronat).
English: Skin infections leading to hospitalisation were reported in 0.1% (3 out of 4,041) of postmenopausal women with osteoporosis receiving placebo versus 0.4% (16 out of 4,050) of women receiving Prolia.
Danish: Hudinfektioner, der førte til hospitalsindlæggelse, blev indberettet for 0,1 % (3 ud af 4.041) af postmenopausale kvinder med osteoporose, der fik placebo, sammenlignet med 0,4 % (16 ud af 4.050) kvinder, der fik Prolia.
English: - The other ingredients are acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Danish: - Øvrige indholdsstoffer: eddikesyre, natriumhydroxid, sorbitol (E420), polysorbat 20 og vand til injektion.
English: In addition, as post-marketing experience including multiple cases with positive re-challenge, as well as non-clinical evidence of involvement of the RANK / RANKL signalling pathway in the hair growth cycle support a conclusion that denosumab may be causally associated with the development of alopecia, this new ADR should be added in section 4.8 of the SmPC and the Package Leaflet.
Danish: Da erfaringer efter markedsføringen, herunder flere tilfælde med positiv rechallenge, samt ikke-klinisk evidens for inddragelse af RANK / RANKL-signalvej i hårvækstcyklussen desuden understøtter konklusionen, at denosumab kan være kausalt forbundet med udviklingen af alopeci, skal denne nye ADR tilføjes i pkt.
English: If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Danish: Hvis der er en blodplet, kan du forsigtigt tørre den af med en tot vat eller en serviet.
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 studier af knoglekvaliteten hos aber i langtidsbehandling med denosumab var fald i knogleomsætningen forbundet med en forbedring af knoglestyrken og normal knoglehistologi.
English: Please tell your doctor immediately if you develop any of these symptoms while being on treatment with Prolia: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.
Danish: Fortæl det straks til din læge, hvis du udvikler et eller flere af følgende symptomer, mens du er i behandling med Prolia: hævet, rødt område i huden, som oftest nederst på benene, der føles varmt og ømt, eventuelt samtidig med symptomer på feber.
English: Effect on Bone Mineral Density (BMD)
Danish: Effekt på knoglemineraltætheden (BMD)
English: Hypocalcaemia1
Danish: Hypokalcæmi1
English: Elderly (age ≥ 65) No dose adjustment is required in elderly patients.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: Prolia demonstrated a significant relative risk reduction of new vertebral fractures: 85% (1.6% absolute risk reduction) at 1 year, 69% (2.2% absolute risk reduction) at 2 years and 62% (2.4% absolute risk reduction) at 3 years (all p < 0.01).
Danish: Prolia-behandling medførte en signifikant relativ reduktion af risikoen for nye vertebrale frakturer: 85 % (1,6 % absolut risikoreduktion) efter 1 år, 69 % (2,2 % absolut risikoreduktion) efter 2 år og 62 % (2,4 % absolut risikoreduktion) efter 3 år (alle p < 0,01).
English: In two phase III placebo-controlled clinical trials in postmenopausal women with osteoporosis, approximately 0.05% (2 out of 4,050) of patients had declines of serum calcium levels (less than 1.88 mmol/l) following Prolia administration.
Danish: I to placebokontrollerede, kliniske fase III-studier med postmenopausale kvinder med osteoporose havde cirka 0,05 % (2 ud af 4.050) af patienterne fald i calcium-niveauerne i serum (mindre end 1,88 mmol/l) efter indgivelse af Prolia.
English: The bones become weaker and break more easily.
Danish: Knoglerne bliver derved svagere og risikoen for brud stiger.