FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised when combining burosumab with calcimimetic medicinal products (i.e. agents that mimic the effect of calcium on tissues by activating the calcium receptor).
Danish: Der bør udvises forsigtighed, når burosumab kombineres med lægemidler med en calcimimetisk virkning (dvs. stoffer, der imiterer calciums virkning i vævet ved at aktivere calciumreceptoren).
English: There is no experience with overdose of burosumab.
Danish: Der er ingen erfaring med overdosering af burosumab.
English: Table 1 gives the adverse reactions observed from clinical trials.
Danish: Tabel 1 angiver bivirkninger observeret i kliniske studier.
English: Burosumab absorption from subcutaneous injection sites to blood circulation is nearly complete.
Danish: Absorptionen af burosumab fra subkutane injektionssteder til blodbanen er næsten fuldstændig.
English: CRYSVITA contains the active substance burosumab.
Danish: CRYSVITA indeholder det aktive stof burosumab.
English: • severe swelling of eyelids, mouth or lips (angio-oedema)
Danish: • svær hævelse af øjenlågene, munden eller læberne (angioødem)
English: Patient's fasting serum phosphate level should be monitored due to the risk of hyperphosphatemia.
Danish: Patientens fastende fosfatniveau i serum skal overvåges på grund af risikoen for hyperfosfatæmi.
English: • FGF23 lowers the amount of phosphate in the blood.
Danish: • FGF23 sænker mængden af fosfat i blodet.
English: If a dose is missed, talk to your doctor straight away.
Danish: Hvis der glemmes en dosis, skal du straks kontakte lægen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with CRYSVITA in one or more subsets of the paediatric population in treatment of X-linked hypophosphataemia.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med CRYSTIVA i en eller flere undergrupper af den pædiatriske population ved behandling af X-bundet hypofosfatæmi.
English: Local reactions (e.g. injection site urticaria, erythema, rash, swelling, bruising, pain, pruritus, and haematoma) have occurred at the site of injection.
Danish: Lokale reaktioner (f.eks. urticaria på injektionsstedet, erytem, udslæt, hævelse, blå mærker, smerter, pruritus og hæmatom) er forekommet på injektionsstedet.
English: RGI-C Global Score LS Mean score (SE)
Danish: RGI-C global score LS gennemsnitlig score (SE)
English: • People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
Danish: • Personer med XLH har højere niveauer af et hormon, der kaldes fibroblastvækstfaktor 23
English: Burosumab was detected in serum from fetuses indicating that burosumab was transported across the placenta to the fetus.
Danish: Burosumab blev detekteret i serum fra fostre, hvilket indikerer, at burosumab blev transporteret over placenta til fosteret.
English: Following subcutaneous administration, the time to reach maximum serum concentrations (Tmax) of burosumab is approximately 5-10 days.
Danish: Efter subkutan administration er tiden til opnåelse af de maksimale serumkoncentrationer (Tmax) for burosumab ca. 5-10 dage.
English: Burosumab may have a minor influence on the ability to drive and use machines.
Danish: Burosumab kan evt. i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Burosumab is composed solely of amino acids and carbohydrates as a native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Danish: Burosumab er udelukkende sammensat af aminosyrer og kulhydrater som et nativt immunoglobulin, og det er ikke sandsynligt, at det elimineres via metaboliske mekanismer i leveren.
English: Monitoring of urine calcium and phosphate is suggested every 3 months.
Danish: Det foreslås at overvåge calcium og fosfat i urin hver 3. måned.
English: It is possible that CRYSVITA could cause dizziness and affect you being able to ride a bike, use any tools or machines or to drive.
Danish: Det er muligt, at CRYSVITA kan forårsage svimmelhed og påvirke din evne til at cykle, betjene værktøj eller maskiner eller føre motorkøretøj.
English: Burosumab did not promote abnormal bone development, as no changes in femur length or bone strength were noted in juvenile animals.
Danish: Burosumab fremkaldte ikke unormal knogleudvikling, da der ikke blev bemærket nogen ændringer i længden af femur eller knoglestyrken hos unge dyr.
English: These changes were a consequence of higher than normal serum phosphate levels, which accelerated bone turnover and also led to periosteal hyperostosis and a decrease in bone strength in adult animals, but not in juvenile animals at the doses tested.
Danish: Disse ændringer var en følgevirkning af højere end normale fosfatniveauer i serum, hvilket accelererede knogleomsætningen samt førte til periosteal hyperostose og en reduceret knoglestyrke hos voksne dyr, men ikke hos unge dyr ved de undersøgte doser.
English: 2132NP Hoofddorp The Netherlands medinfo@kyowakirin.com
Danish: 2132NP Hoofddorp Holland medinfo@kyowakirin.com
English: Your doctor will check the phosphate level in your blood and urine and may also do a renal ultrasound during your treatment in order to reduce the risk of hyperphosphataemia (too much phosphate in the blood) and ectopic mineralisation (a build up of calcium in tissues such as the kidneys).
Danish: Lægen vil kontrollere fosfatniveauet i dit blod og din urin og kan også udføre en ultralydsscanning af nyrerne i løbet af din behandling for at reducere risikoen for hyperfosfatæmi (for meget fosfat i blodet) og ektopisk mineralisering (en ophobning af calcium i vævet, såsom nyrerne).
English: Monitoring for signs and symptoms of nephrocalcinosis, e.g. by renal ultrasonography, is recommended at the start of treatment and every 6 months for the first 12 months of treatment, and annually thereafter.
Danish: Overvågning for tegn og symptomer på nefrocalcinose, f.eks. ved renal ultrasonografi, anbefales ved behandlingsstart og hver 6. måned i de første 12 måneder af behandlingen og derefter årligt.
English: Oral phosphate and vitamin D analogues should be discontinued 1 week prior to initiation of treatment.
Danish: Oralt fosfat og D-vitaminanaloger skal seponeres 1 uge før behandlingen påbegyndes.
English: The patient must have fasting serum phosphate below the reference range for age to restart burosumab at approximately half of the previous dose.
Danish: Patienten skal have fastende serum-fosfat under referenceintervallet for alder for at genstarte burosumab med ca. halvdelen af den tidligere dosis.
English: CRYSVITA is not recommended in pregnancy.
Danish: CRYSVITA bør ikke anvendes under graviditet.
English: Adverse reactions reported in paediatric patients with XLH (N=65)
Danish: Tabel 1: Bivirkninger rapporteret hos pædiatriske patienter med XLH (N=65)
English: The AUC for the change from baseline in serum phosphate, TmP/GFR and 1,25(OH)2D increased linearly with increasing burosumab AUC.
Danish: AUC for ændringen fra baseline i serum-fosfat, TmP/GFR og 1,25(OH)2D steg lineært med stigende burosumab-AUC.
English: No significant difference has been observed in paediatric patient pharmacokinetics or pharmacodynamics as compared with PK/PD in the adult population.
Danish: Der er ikke blevet observeret nogen signifikant forskel i farmakokinetikken eller farmakodynamikken hos pædiatriske patienter sammenlignet med farmakokinetikken/farmakodynamikken i den voksne population.
English: o redness or rash o pain or itching o swelling o bleeding or bruising
Danish: o rødme eller udslæt o smerter eller kløe o hævelse o blødning eller blå mærker
English: Figure 1: Serum Phosphate Concentration (mmol/L) over Time in the Phase 2 Paediatric Study in Children 5-12 years Receiving Burosumab Every 2 Weeks (Q2W)
Danish: Figur 1: Fosfatkoncentration i serum (mmol/l) over tid i det pædiatriske fase II-studie hos børn i alderen 5-12 år, der fik burosumab hver 2. uge (Q2W)
English: After initiation of treatment with burosumab, fasting serum phosphate should be measured every 2 weeks for the first month of treatment, every 4 weeks for the following 2 months and thereafter as appropriate.
Danish: Efter behandlingen med burosumab er påbegyndt, skal fastende serum-fosfat måles hver 2. uge i løbet af den første måneds behandling, hver 4. uge i de følgende 2 måneder og derefter efter behov.
English: Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).
Danish: Injektionsstederne skal skifte, og tegn på mulige reaktioner skal overvåges nøje (se pkt.
English: In paediatric patients, the most frequent potential hypersensitivity events were rash (22%), injection site rash (6%), and urticaria (4%).
Danish: Hos pædiatriske patienter var de hyppigste potentielle overfølsomhedshændelser udslæt (22 %), udslæt på injektionsstedet (6 %) og urticaria (4 %).
English: • Tooth abscess (infection)
Danish: • Tandbyld (infektion)
English: This conventional therapy was discontinued 2-4 weeks prior to burosumab initiation.
Danish: Denne konventionelle behandling blev seponeret 2-4 uger før, burosumab blev påbegyndt.
English: How much CRYSVITA you will be given
Danish: Hvor meget CRYSVITA vil du få?
English: Table 2: Rickets Response in Children 5-12 years Receiving Burosumab in Study UX023-CL201
Danish: Tabel 2: Rakitisrespons hos børn i alderen 5-12 år, der fik burosumab i studie UX023-CL201
English: X-Linked Hypophosphataemia (XLH) is a genetic disease.
Danish: X-bundet hypofosfatæmi (XLH) er en genetisk sygdom.
English: Monitoring of plasma alkaline phosphatases, Calcium, PTH and creatinine is recommended every 6 months (every 3 months for children 1- 2 years) or as indicated.
Danish: Overvågning af basisk fosfatase, calcium, paratyreoideahormon (PTH) og kreatinin i plasma anbefales hver 6. måned (hver 3. måned for børn i alderen 1-2 år) eller som indiceret.
English: This conventional therapy was discontinued 2-6 weeks prior burosumab initiation.
Danish: Denne konventionelle behandling blev seponeret 2-6 uger før burosumab blev påbegyndt.
English: Burosumab is a recombinant human monoclonal antibody (IgG1) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23).
Danish: Burosumab er et rekombinant humant monoklonalt antistof (IgG1), der binder til og hæmmer aktiviteten af fibroblast-vækstfaktor 23 (FGF23).
English: Each vial contains either 10, 20 or 30 mg of burosumab.
Danish: Hvert hætteglas indeholder enten 10, 20 eller 30 mg burosumab.
English: The active substance is burosumab.
Danish: Aktivt stof: burosumab.
English: Burosumab should be administered using aseptic technique and sterile disposable syringes and injection needles.
Danish: Burosumab skal administreres ved anvendelse af en aseptisk teknik og sterile sprøjter og injektionskanyler til engangsbrug.
English: The recommended starting dose is 0.4 mg/kg of body weight and the normal maintenance dose is 0.8 mg/kg burosumab given every two weeks.
Danish: Den anbefalede startdosis er 0,4 mg/kg legemsvægt, og den normale vedligeholdelsesdosis er 0,8 mg/kg burosumab, der gives hver 2. uge.
English: Bone effects seen in adult and juvenile monkeys included changes in bone metabolism markers, increases in thickness and density of cortical bone, increased density of total bone and thickening of long bone.
Danish: De observerede knoglevirkninger hos voksne og unge aber omfattede ændringer i markører for knoglemetabolisme, øget tykkelse og densitet af kortikal knogle, øget densitet af total knogle og fortykkelse af rørknogler.
English: If fasting serum phosphate is within the reference range for age, the same dose should be maintained.
Danish: Hvis fastende serum-fosfat er inden for referenceintervallet for alder, skal den samme dosis opretholdes.
English: The burosumab dose was adjusted to target a fasting serum phosphorous concentration of 1.13 to 1.62 mmol/L.
Danish: Dosis af burosumab blev justeret til et mål for fastende fosforkoncentration i serum på 1,13 til 1,62 mmol/l.
English: Studies in rabbits and adult and juvenile cynomolgus monkeys demonstrated dose-dependent elevations of serum phosphate and 1,25 (OH)2D confirming the pharmacologic actions of burosumab in these species.
Danish: Studier af kaniner og voksne og unge cynomolgusaber viste dosisafhængige stigninger i serum-fosfat og 1,25(OH)2D, hvilket bekræfter den farmakologiske virkning af burosumab hos disse arter.
English: Burosumab must not be given to patients with severe or end stage renal disease (see section 4.3).
Danish: Burosumab må ikke gives til patienter med svær nyresygdom eller nyresygdom i slutstadiet (se pkt.
English: Talk to your doctor before taking CRYSVITA if you are taking:
Danish: Kontakt lægen, før du tager CRYSVITA, hvis du tager:
English: If you could get pregnant, you must use an effective method of contraception (birth control) while using CRYSVITA.
Danish: Hvis du kan blive gravid, skal du bruge en sikker præventionsmetode, mens du bruger CRYSVITA.
English: The safety and efficacy of burosumab in children aged less than one year have not been established.
Danish: Burosumabs sikkerhed og virkning hos bør under 1 år er ikke klarlagt.
English: If fasting serum phosphate is above the reference range for age, the next dose should be withheld and the fasting serum phosphate reassessed within 4 weeks.
Danish: Hvis fastende serum-fosfat er over referenceintervallet for alder, skal den næste dosis tilbageholdes, og fastende serum-fosfat skal revurderes inden for 4 uger.
English: Patients with severe renal impairment or end stage renal disease.
Danish: Patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from CRYSVITA therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med CRYSVITA seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Bone changes were consistent with the pharmacology of burosumab and the role of phosphate in bone mineralization, metabolism and turnover.
Danish: Knogleændringerne var i overensstemmelse med farmakologien for burosumab og fosfats rolle i knoglemineralisering, metabolisme og omsætning.
English: By inhibiting FGF23, burosumab increases tubular reabsorption of phosphate from the kidney and increases serum concentration of 1, 25 dihydroxy-Vitamin D.
Danish: Ved at hæmme FGF23 øger burosumab den tubulære reabsorption af fosfat fra nyrerne, og øger serumkoncentrationen af 1,25-dihydroxy-D-vitamin.
English: CRYSVITA attaches to FGF23 in the blood which stops FGF23 from working and increases the phosphate levels in the blood so that normal levels of phosphate can be achieved.
Danish: CRYSVITA binder til FGF23 i blodet, hvilket stopper virkningen af FGF23 og øger fosfatniveauerne i blodet, så der kan opnås normale niveauer af fosfat.
English: In a murine model of XLH, a significant reduction in the incidence of ectopic mineralisation was observed at equivalent levels of serum phosphate, suggesting that the risk of mineralisation is less in the presence of excess FGF23.
Danish: I en murin model af XLH blev der observeret en signifikant reduktion i forekomsten af ektopisk mineralisering ved ækvivalente niveauer af serum-fosfat, hvilket tyder på, at risikoen for mineralisering er mindre, hvis der er overskydende FGF23 til stede.
English: • you already have a high level of phosphate in your blood (“hyper-phosphataemia”)
Danish: • du allerede har et højt niveau af fosfat i blodet (”hyperfosfatæmi”) • du har svær nyresygdom eller nyresvigt.
English: Dizziness may occur following administration of burosumab.
Danish: Der kan opstå svimmelhed efter administration af burosumab.
English: Serum burosumab and phosphate concentrations, as well as TmP/GFR, increased and decreased in parallel and reached maximum levels at approximately the same time point after each dose, supporting a direct PK-PD relationship.
Danish: Koncentrationerne af burosumab og fosfat i serum samt TmP/GFR steg og faldt parallelt og nåede maksimale niveauer på ca. det samme tidspunkt efter hver dosis, hvilket støtter et direkte farmakokinetisk-farmakodynamisk forhold.
English: CRYSVITA is indicated for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
Danish: CRYSVITA er indiceret til behandling af X-bundet hypofosfatæmi (XLH) med radiografisk evidens for knoglesygdom hos børn i alderen 1 år og ældre og unge med skeletvækst.
English: In XLH patients, the observed volume of distribution of burosumab approximates the volume of plasma, suggesting limited extravascular distribution.
Danish: Hos XLH-patienter er det observerede fordelingsvolumen tilnærmelsesvis plasmavolumenet, hvilket tyder på begrænset ekstravaskulær fordeling.
English: These effects were consistent with an exaggerated response to the inhibition of normal FGF23 levels resulting in a supraphysiologic increase in serum phosphate beyond the upper limit of normal.
Danish: Disse virkninger var i overensstemmelse med en overdreven respons på hæmningen af normale FGF23-niveauer, hvilket fører til en suprafysiologisk stigning i serum-fosfat over den øvre normalgrænse.
English: The most common adverse drug reaction (ADR) reported in paediatric patients up to 64 weeks was injection site reactions (57%), headache (54%), pain in extremity (42%), vitamin D decreased (28%), rash (23%), toothache (19%), tooth abscess (14%), myalgia (14%), and dizziness (11%) (See section 4.4 and ‘Description of selected adverse reactions' below).
Danish: De mest almindelige bivirkninger rapporteret hos pædiatriske patienter i alderen op til 64 uger var reaktioner på injektionsstedet (57 %), hovedpine (54 %), smerter i ekstremiteter (42 %), nedsat D-vitamin (28 %), udslæt (23 %), tandpine (19 %), tandbyld (14 %), myalgi (14 %) og svimmelhed (11 %) (se pkt.
English: Each vial contains 45.91 mg sorbitol.
Danish: Hvert hætteglas indeholder 45,91 mg sorbitol.
English: If fasting serum phosphate is below the reference range for age, the dose may be increased stepwise by 0.4 mg/kg up to a maximum dose of 2.0 mg/kg (maximum dose of 90 mg).
Danish: Hvis fastende serum-fosfat er under referenceintervallet for alder, kan dosis øges trinvist med 0,4 mg/kg op til en maksimal dosis på 2,0 mg/kg (maksimal dosis på 90 mg).
English: The peak serum concentration (Cmax) and area under the concentration-time curve (AUC) of serum burosumab is dose proportional over the dose range of 0.1-2.0 mg/kg.
Danish: Den maksimale serumkoncentration (Cmax) og arealet under kurven for koncentration som funktion af tid (AUC) for serum-burosumab er dosisproportional over dosisintervallet fra 0,1-2,0 mg/kg.
English: The maximum dose you will be given is 90 mg.
Danish: Du vil maksimalt få en dosis på 90 mg.
English: Patients received burosumab at a dose of 0.8 mg/kg every two weeks.
Danish: Patienterne fik burosumab med en dosis på 0,8 mg/kg hver 2. uge.
English: The clearance of burosumab is dependent on body weight and estimated to be 0.290 L/day and 0.136 L/day in a typical adult (70 kg) and paediatric (30 kg) XLH patient, respectively, with corresponding disposition half-life (t1/2) in the serum of approximately 19 days.
Danish: Clearance af burosumab er afhængig af legemsvægten, og den estimeres til at være 0,290 l/dag og 0,136 l/dag for hhv. en typisk voksen (70 kg) og pædiatrisk (30 kg) XLH-patient med en tilhørende fordelingshalveringstid (t1/2) i serum på ca. 19 dage.
English: Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23 and is produced by recombinant DNA technology using Chinese hamster ovary (CHO) mammalian cell culture.
Danish: Burosumab er et rekombinant humant monoklonalt IgG1-antistof mod FGF23, som fremstilles ved rekombinant dna-teknologi i en mammaliacellekultur med ovarieceller fra kinesiske hamstre (Chinese hamster ovary, CHO).
English: Neither new or clinically meaningful worsening of nephrocalcinosis nor ectopic mineralisation have been observed in clinical trials of patients with XLH treated with burosumab to achieve normal serum phosphate levels.
Danish: Der er hverken blevet observeret ny eller klinisk relevant forværring af nefrocalcinose eller ektopisk mineralisering i kliniske studier af patienter med XLH, der blevet behandlet med burosumab for at opnå normale fosfatniveauer i serum.
English: Increases in serum parathyroid hormone have been observed in some XLH patients during treatment with burosumab.
Danish: Der er blevet observeret forhøjelser i paratyreoideahormon i serum hos nogle XLH-patienter under behandlingen med burosumab.
English: Vitamin D decreased
Danish: Nedsat D-vitamin
English: Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia (see section 4.3).
Danish: Samtidig administration af burosumab og oralt fosfat og D-vitaminanaloger er kontraindiceret, da det kan føre til en øget risiko for hyperfosfatæmi og hypercalcæmi (se pkt.
English: Clear glass vial with butyl rubber stopper, and aluminium seal.
Danish: Hætteglas af klart glas med en prop af butylgummi og en aluminiumsforsegling.
English: Burosumab has not been studied in patients with renal impairment.
Danish: Burosumab er ikke blevet undersøgt hos patienter med nedsat nyrefunktion.
English: Shortening of the gestation period and associated increased incidence of premature births were observed in pregnant monkeys at doses of ≥ 0.3 mg/kg which corresponded to burosumab exposures that are ≥0.875- to 1.39-fold anticipated clinical levels.
Danish: En forkortet drægtighedsperiode og en forbundet øget forekomst af præmature fødsler blev observeret hos drægtige aber ved doser på ≥0,3 mg/kg, hvilket svarede til burosumab-eksponeringer, der var ≥0,875 til 1,39 gange forventede kliniske niveauer.
English: In adult clinical trials no dose limiting toxicity has been observed using doses up to 1.0 mg/kg or a maximal total dose of 128 mg every 4 weeks.
Danish: I kliniske studier med voksne er der ikke blevet observeret nogen dosisbegrænsende toksicitet ved brug af doser på op til 1,0 mg/kg eller en maksimal total dosis på 128 mg hver 4. uge.
English: Periodic measurement of post prandial serum phosphate is advised.
Danish: Der rådes til periodiske målinger af postprandial serum-fosfat.
English: Concurrent administration with oral phosphate, vitamin D analogues (see section 4.5).
Danish: Administration sammen med oral fosfat, D-vitaminanaloger (se pkt.
English: LS Mean change (SE) from baseline in total score a
Danish: LS (mindste kvadraters gennemsnit, least squares) gennemsnitlig ændring (standardfejl, SE) fra baseline i total score a
English: CRYSVITA is used to treat X-linked hypophosphataemia (XLH).
Danish: CRYSVITA anvendes til at behandle X-bundet hypofosfatæmi (XLH).
English: Hydrochloric acid, 10% (for pH adjustment) Water for injections
Danish: Saltsyre, 10 % (til pH-justering) Vand til injektionsvæsker
English: What is X-Linked Hypophosphataemia (XLH)
Danish: Hvad er X-bundet hypofosfatæmi (XLH)
English: CRYSVITA is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: CRYSVITA bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: CRYSVITA should be given by injection under the skin in the arm, abdomen, buttock or thigh by your doctor or a trained healthcare provider.
Danish: CRYSVITA skal gives som en injektion under huden i armen, maven, bagdelen eller låret af lægen eller trænet sundhedspersonale.
English: United Kingdom allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Danish: Storbritannien allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
English: In Study UX023-CL201, the RSS was scored using a predefined scale looking at specific abnormalities in the wrists and knees.
Danish: I studie UX023-CL201 blev RSS bedømt ved anvendelse af en prædefineret skala, der vurderer specifikke anomalier i håndled og knæ.
English: Do not shake before use.
Danish: Må ikke omrystes før brug.