FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant administration of deferasirox with substances that have known ulcerogenic potential, such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4).
Danish: Samtidig indgift af deferasirox med substanser, der har kendt ulcerogent potentiale, såsom NSAID'er (inklusive acetylsalicylsyre i høj dosis), kortikosteroider eller orale bisphosphonater kan øge risokoen for gastrointestinal toksicitet (se pkt.
English: Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine increased with recovery after treatment discontinuation.
Danish: Lever- og nyresygdomme er blevet rapporteret, herunder tilfælde af øget leverenzym og kreatin med bedring efter seponering af behandlingen.
English: Gastrointestinal disorders
Danish: Gastrointestinale reaktioner
English: Granules in sachet (granules)
Danish: Granulat i brev (granulat)
English: Each blister pack contains 30 or 90 film-coated tablets.
Danish: Hver blisterpakning indeholder 30 eller 90 filmovertrukne tabletter.
English: In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome.
Danish: I rapporter efter markesdsføring, blev det set at en stor del af tilfældende af metabolisk acidose forekom hos børn i forbindelse med Fanconis syndrom.
English: Diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
Danish: Diarré, forstoppelse, opkastning, kvalme, abdominalsmerter, abdominal udspiling, dyspepsi
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: o Information that only one course of treatment is proposed for NTDT patients o A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population o A warning on the currently unknown safety consequences of long-term treatment in the paediatric population
Danish: • Anbefalinger til behandlingen af ikke-transfusionsafhængige talassæmi-syndromer (NTDT) o Information om, at der kun anbefales ét behandlingforløb hos patienter med ikketransfusionsafhængige talassæmi-syndromer o En advarsel om nødvendigheden af en hyppigere monitoring jern-koncentrationen i leveren og serum ferritin hos den pædiatriske population o En advarsel om manglende viden omkring sikkerhedsproblemerne ved langtidsbehandling hos den pædiatriske population på nuværende tidspunkt.
English: The average Cmax of deferasirox in subjects with mild or moderate hepatic impairment was increased by 22%.
Danish: Den gennemsnitlige Cmax af deferasirox hos personer med let til moderat nedsat leverfunktion var øget med 22%.
English: Most reports of hepatic failure involved patients with significant morbidities including pre-existing liver cirrhosis.
Danish: De fleste rapporter om leversvigt involverede patienter med signifikante komorbiditeter inklusive allerede eksisterende levercirrhose.
English: Prior to launch of deferasirox film-coated tablets, healthcare professionals will receive introductory notification letters as follows:
Danish: Sundhedspersonale vil inden lancering af deferasirox filmovertrukne tabletter modtage lanceringsbrev som beskrevet:
English: In patients treated with doses >21 mg/kg/day
Danish: Til patienter behandlet med doser >21 mg/kg/dag
English: • When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).
Danish: • Når serum-kreatinin er forhøjet og hvis der er set andre abnormaliteter (såsom proteinuri, tegn på Fanconi's Syndrom)
English: The Cmax of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal.
Danish: Cmax for deferasirox filmovertrukne tabletter blev øget (med 29%), når de blev indtaget samtidigt med mad.
English: Not all strengths may be available in your country.
Danish: Ikke alle styrker er nødvendigvis markedsført i dit land.
English: Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose).
Danish: Deferasirox og dets metabolitter bliver primært udskilt i fæces (84% af dosis).
English: The Cmax was increased by 34% (90% CI: 27.9% - 40.3%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Danish: Cmax steg med 34% (90% CI: 27,9%-40,3%), men den kliniske dosis-respons-analyse viste intet bevis på nogen klinisk relevant effekt af en sådan stigning.
English: and/or Decreases <LLN* (<90 ml/min)
Danish: Faldende <LLN* (<90 ml/min)
English: The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose.
Danish: Den absolutte biotilgængelighed (AUC) af deferasirox (dispergibel tablet-formulering) er omkring 70% sammenlignet med en intravenøs dosis.
English: Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of chronic iron overload.
Danish: Behandling med EXJADE skal påbegyndes og vedligeholdes af læger med erfaring i behandling af kronisk jernophobning.
English: Skin rashes may appear during EXJADE treatment.
Danish: Der kan forekomme hududslæt ved EXJADE-behandling.
English: Do not swallow whole or chew.
Danish: Må ikke synkes hele eller tygges.
English: 1, nephrolithiasis renal tubular necrosis General disorders and administration site conditions Uncommon:
Danish: 1, renal tubulær nekrose Almene symptomer og reaktioner på administrationsstedet Ikke almindelig:
English: Clinical efficacy and safety Clinical efficacy studies were conducted with deferasirox dispersible tablets.
Danish: Klinisk virkning og sikkerhed Kliniske studier omkring virkningen blev udført med deferasirox dispergible tabletter.
English: How to take EXJADE:
Danish: Hvordan EXJADE tages:
English: PVC/PE/PVDC/Aluminium blisters.
Danish: PVC/PE/PCDC/Aluminium blisterpakninger.
English: Deferasirox also comes as “film-coated” tablets and granules.
Danish: Deferasirox fås også som ”filmovertrukne” tabletter og granulat.
English: If you stop taking EXJADE
Danish: Hvis du holder op med at tage EXJADE
English: The Cmax was increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Danish: Cmax steg med 30% (90% CI: 20,3%40,0%), men den kliniske dosis-respons-analyse viste intet bevis på nogen klinisk relevant effekt af en sådan stigning.
English: Characteristics in patients
Danish: Karakteristika i patienter
English: Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC).
Danish: Dekonjugering af glukuronider i tarmen og efterfølgende reabsorption (enterohepatisk recirkulation) er sandsynlig: i et studie med raske frivillige resulterede administration af cholestyramin efter en enkelt dosis deferasirox i en 45% nedsættelse i eksponeringen (AUC) af deferasirox.
English: EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over.
Danish: EXJADE kan anvendes til børn og unge i alderen 2 år og derover, der får regelmæssige blodtransfusioner, samt hos børn og unge i alderen 10 år og derover, der ikke får regelmæssige blodtransfusioner.
English: The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes [MDS], Diamond-Blackfan syndrome, aplastic anaemia and other very rare anaemias).
Danish: De underliggende tilstande, der krævede blodtransfusion, inkluderede betatalassæmi, seglcelleanæmi og andre medfødte og erhvervede anæmier (myelodysplastiske syndromer [MDS], Diamond-Blackfan-syndrom, aplastisk anæmi og andre meget sjældne anæmier).
English: These will monitor the amount of iron in your body (blood level of ferritin) to see how well EXJADE is working.
Danish: Lægerne vil kontrollere blodprøvernes mængde af jern, og dermed mængden af jern i kroppen (ferritin-niveau i blodet) for at se, hvor godt EXJADE virker.
English: Non-interventional post-authorisation safety study (PASS): In order to assess the long-term exposure and safety of deferasirox dispersible and film-coated tablets, the MAH should conduct an observational cohort study in paediatric non-transfusion-dependent thalassaemia patients over 10 years old for whom deferoxamine is contraindicated or inadequate conducted according to a CHMP-agreed protocol.
Danish: Non-intervention post-authorisation safety study (PASS): For at vurdere langtidseksponering og sikkerhed af deferasirox dispergible og filmovertrukne tabletter skal indehaveren af markedsføringstilladelsen udføre et observationelt kohortestudie hos pædiatriske ikketransfusionsafhængige talassæmi-patienter, der er over 10 år gamle, og hvor deferoxamin er kontraindiceret eller utilstrækkeligt udført i henhold til en protokol, accepteret af CHMP.
English: Adjustment steps (every 3-6 months)
Danish: 3.-6. måned)
English: Deferasirox was not teratogenic, but caused increased frequency of skeletal variations and stillborn pups in rats at high doses that were severely toxic to the non-iron-overloaded mother.
Danish: Derimod forårsagede deferasirox øget frekvens af skeletale forandringer og dødfødte unger hos rotter ved høje doser, der var stærkt toksiske for den ikke-jernophobede moder.
English: Before initiation of therapy
Danish: Inden behandlingsstart
English: Each pack contains 30 sachets.
Danish: Hver pakning indeholder 30 breve.
English: Renal and urinary disorders Very common:
Danish: Nyrer og urinveje Meget almindelig:
English: • The maximum recommended daily dose for EXJADE dispersible tablets is 40 mg per kilogram body weight for patients receiving regular blood transfusions, 20 mg per kilogram body weight for adult patients not receiving regular blood transfusions and 10 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.
Danish: • Den maksimale anbefalede daglige dosis af EXJADE dispergible tabletter er 40 mg pr. kg kropsvægt for patienter, der får regelmæssige blodtransfusioner, 20 mg pr. kg kropsvægt for voksne patienter, der ikke får regelmæssige blodtransfusioner, og 10 mg pr. kg kropsvægt for børn og unge, der ikke får regelmæssige blodtransfusioner.
English: Renal tubular disorder
Danish: Renale tubulære forstyrrelser
English: In these patients, closer monitoring of LIC and serum ferritin is essential to avoid overchelation (see section 4.4).
Danish: Det er vigtigt at udføre en omhyggelig monitorering af LIC og serum-ferritin hos disse patienter for at undgå overkelering (se pkt.
English: Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 µg/l).
Danish: Kelatbehandling må kun initieres, når der er påviseligt jernoverskud (jernkoncentration i leveren [LIC] ≥ 5 mg Fe/g tørvægt eller serum-ferritin konsekvent > 800 µg/l).
English: Your doctor will calculate the dose you need and tell you how many sachets to take each day.
Danish: Din læge vil beregne den dosis, der passer til dig, og fortælle dig hvor mange breve, du skal tage hver dag.
English: The pharmacokinetics of deferasirox have not been studied in patients with renal impairment.
Danish: Farmakokinetiken for deferasirox er ikke undersøgt hos patienter med nedsat nyrefunktion.
English: If you have taken too much EXJADE, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away.
Danish: Hvis du har taget for meget EXJADE, eller hvis nogen ved et uheld kommer til at tage dine tabletter, så kontakt med det samme din læge eller skadestuen.
English: • Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome).
Danish: • Vedvarende uregelmæssigheder i en anden markør af den renale funktion (fx proteinuria, Fanconis syndrom).
English: Other markers of renal tubular function (such as glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria)
Danish: Andre markører på renal tubulær funktion (fx glukosuri hos ikkediabetikere og lave niveauer af serumkalium, fosfat, magnesium eller urat, fosfaturi, aminoaciduri)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://laegemiddelstyrelsen.dk
English: • If you vomit blood and/or have black stools,
Danish: • Hvis du kaster blod op/eller har sort afføring
English: The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication.
Danish: Hovedparten af disse patienter havde nedsat nyrefunktion, renal tubulopati (Fanconis syndrom), eller diarré, eller forhold, hvor syre-base ubalance er en kendt komplikation.
English: Elevations of liver transaminases were reported as an adverse reaction in 2% of patients.
Danish: Forhøjelser af levertransaminase blev rapporteret som bivirkning hos 2%.
English: The MAH shall use distinct outer cartons, blisters and tablets for all formulations (dispersible tablets and film-coated tablets/granules).
Danish: Indehaveren af markedsføringstilladelsen skal anvende specifikke yderkartoner, blister og tabletter for alle formuleringer (dispergible tabletter og filmovertrukne tabletter/granulat).
English: Patient guide should contain the following key elements: o Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin o Information that renal biopsy may be considered if significant renal abnormalities occur o Availability of several oral formulations (e.g. dispersible tablets, film-coated tablets and granules) and the main differences associated with these formulations (i.e., different posology regimen, different conditions of administration notably with food)
Danish: Vejledning til patienten skal indeholde følgende nøgleelementer: o Information om nødvendigheden af regelmæssig monitorering af serum-kreatinin, kreatinin-clearance, proteinuri, leverenzymer, ferritin, og hvornår denne skal udføres o Information om, at man vil overveje at udføre nyrebiopsi, hvis der opstår signifikante nyreabnormaliteter o Tilgængeligheden af flere orale formuleringer (fx dispergible tabletter, filmovertrukne tabletter og granulat) og de væsentligste forskelligheder på disse formuleringer (fx dosis anbefalinger, forskellige krav til indtagelse, særlig i forbindelse med mad)
English: Doses (in mg/kg) must be calculated and rounded to the nearest whole sachet size.
Danish: Doser (i mg/kg) skal beregnes og afrundes til nærmeste hele brev.
English: Care should be taken to maintain adequate hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), particularly in children with acute illness.
Danish: Det skal sikres, at passende hydrering opretholdes hos patienter, som oplever volumen-depleterende tilstande (fx. diarré og opkasning), særligt hos børn med akut sygdom.
English: Cellulose, microcrystalline Crospovidone Povidone
Danish: Cellulose, mikrokrystallisk Crospovidon
English: Monitoring - First month after start of therapy or dose modification (including switch of formulation)
Danish: Monitorering - Første måned efter behandlingsstart eller dosisjustering (inklusive skift til anden formulering)
English: Dose reduction or closer monitoring of renal and hepatic function, and serum ferritin levels are recommended during periods of treatment with high doses and when serum ferritin levels are close to the target range.
Danish: Der anbefales dosisreduktion eller nøje monitorering af nyre- og leverfunktionen, og serum-ferritinniveauer, i perioder, hvor der behandles med høje doser, og når serum-ferritinniveauer ligger tæt på målintervallet.
English: 252 dispersible tablets
Danish: 252 dispergible tabletter
English: These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.
Danish: Reaktionerne er generelt forbigående, og de holder for det meste op, selvom behandlingen fortsættes.
English: If you forget to take EXJADE
Danish: Hvis du har glemt at tage EXJADE
English: • If you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems and lead to a change in your brain function),
Danish: • Hvis du oplever problemer med at tænke klart, huske information eller løse opgaver, er mindre opmærksom eller bevidst eller er meget træt og har lavt energiniveau (tegn på et højt niveau af ammoniak i dit blod, hvilket kan være forbundet med nyre- eller leversygdomme og kan medføre ændring i hjernefunktionen)
English: EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: EXJADE anbefales ikke til patienter med svært nedsat leverfunktion (Child-Pugh Class C).
English: • If you experience frequent heartburn,
Danish: • Hvis du ofte oplever halsbrand
English: Clinical study in patients with non-transfusion-dependent thalassaemia syndromes In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea (7.3%) were the most frequent study drug-related adverse events.
Danish: Klinisk studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromert I et 1-årigt studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromer og jernophobning (dispergible tabletter med en dosis på 10 mg/kg/day) var diarré (9,1%), udslæt (9,1%) og kvalme (7,3%) de hyppigste bivirkninger ved forsøgslægemidlet.
English: EXJADE 500 mg dispersible tablets are also available in multipacks containing 294 (3 packs of 98) dispersible tablets.
Danish: EXJADE 500 mg dispergible tabletter er også tilgængelig i multipakning med 294 (3 pakninger med 98) dispergible tabletter.
English: Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone
Danish: Lactosemonohydrat Crospovidon type A Cellulose, mikrokrystallinsk Povidon
English: The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state conditions.
Danish: Cmax og AUC0-24t for deferasirox øgedes næsten lineært med dosis ved ligevægtstilstande.
English: 28 dispersible tablets 84 dispersible tablets 252 dispersible tablets
Danish: 28 dispergible tabletter 84 dispergible tabletter 252 dispergible tabletter
English: If you have taken too much EXJADE, or if someone else accidentally takes your granules, contact your doctor or hospital for advice straight away.
Danish: Hvis du har taget for meget EXJADE, eller hvis nogen ved et uheld kommer til at tage dit granulat, så kontakt med det samme din læge eller skadestuen.
English: EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance <60 ml/min (see sections 4.3 and 4.4).
Danish: EXJADE har ikke været undersøgt hos patienter med nedsat nyrefunktion og er kontraindiceret hos patienter med estimeret kreatinin-clearance < 60 ml/min (se pkt.
English: Daily doses of 10 mg/kg (dispersible tablet formulation) for one year could maintain liver iron and serum ferritin levels and induce net iron balance in patients receiving infrequent transfusions or exchange transfusions.
Danish: Daglige doser på 10 mg/kg (dispergibel tablet-formulering) i et år kunne opretholde leverjern og serum-ferritinniveauer og forårsage netto jernbalance hos patienter, der sjældent modtog transfusioner eller udskiftningstransfusioner.
English: >33% above pretreatment average and Decreases <LLN* (<90 ml/min)
Danish: Forbliver >33% over gennemsnittet fra før behandling og/eller Faldende <LLN* (<90 ml/min)
English: Monthly and Monthly
Danish: Månedligt og
English: 98 dispersible tablets.
Danish: 98 dispergible tabletter.
English: 1, toxic epidermal necrolysis (TEN)
Danish: 1, toksisk epidermal nekrolyse
English: The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium laurilsulfate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Danish: Øvrige indholdsstoffer: Lactosemonohydrat, crospovidon type A, povidon, natriumlaurilsulfat, mikrokrystallinsk cellulose, kolloid vandfri silica, og magnesiumstearat.
English: How long to take EXJADE
Danish: Hvor længe skal du tage EXJADE
English: As a consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
Danish: Som konsekvens heraf skal EXJADE-behandling monitoreres omhyggeligt hos pædiatriske patienter for at opdage bivirkninger og følge jernmængden.
English: Weekly and Weekly
Danish: Ugentligt og
English: Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds).
Danish: Begrænsede kliniske data (29 patienter med normal hjertefunktion ved baseline), der blev opnået med MRI, indikerer, at behandling med deferasirox 10-30 mg/kg/dag (dispergibel tablet-formulering)i 1 år også kan reducere jern-niveauer i hjertet (i gennemsnit, MRI T2* øget fra 18,3 til 23,0 millisekunder).
English: What you need to know before you take EXJADE
Danish: Det skal du vide, før du begynder at tage EXJADE
English: In animals, no adverse effects on male or female fertility were found (see section 5.3).
Danish: Hos dyr er der ikke observeret utilsigtede påvirkninger af hanner eller hunners fertilitet (se pkt.
English: In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four open label studies of up to five years' duration, a mean creatinine clearance decrease of 13.2% in adult patients (95% CI: -14.4% to -12.1%; n=935) and 9.9% (95% CI: -11.1% to -8.6%; n=1,142) in paediatric patients was observed during the first year of treatment.
Danish: Kreatininclearance ved transfusionsbetinget jernophobning I en retrospektiv meta-analyse af 2.102 voksne og pædiatriske beta talassæmi-patienter med transfusionsbetinget jernophobning, der blev behandlet med deferasirox dispergible tabletter i to randomiserede og fire åbne studier af op til fem års varighed, blev der i løbet af det første behandlingsår observeret et gennemsnitligt fald i kreatinin-clearance på 13,2% hos voksne patienter (95% CI: -14,4% til -12,1%; n=935) og på 9,9% (95% CI: -11,1% til -8,6%; n=1.142) hos pædiatriske patienter.
English: Dose adjustments may be made in steps of 5 to 10 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden).
Danish: Dosisjusteringer kan gøres i trin af 5 til 10 mg/kg, og skal skræddersys til den enkelte patients respons og terapeutiske mål (vedligeholdelse eller reduktion af jernophobning).
English: Bioavailability of deferasirox granules was 52% greater than that with dispersible tablets.
Danish: Biotilgængeligheden af deferasirox granulat var 52% højere end den for dispergible tabletter.
English: Doses above 40 mg/kg are not recommended because there is only limited experience with doses above this level.
Danish: Doser over 40 mg/kg anbefales ikke, da der kun er begrænset erfaring med doser over dette niveau.