FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of EXJADE in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Indehaveren af markedsføringstilladelsen skal inden lancering af EXJADE i hvert medlemsland komme til enighed med nationale myndighed om indholdet og formatet af uddannelsesprogrammet, inklusive kommunikationsmedia, distributionsmetode og et hvert andet aspekt af programmet.
English: The bioavailability of deferasirox was increased to a variable extent when taken along with food.
Danish: Biotilgængeligheden for deferasirox blev øget i varierende omfang, når det blev indtaget samtidigt med mad.
English: Table 3 Dose adjustment and interruption of treatment for renal monitoring
Danish: Tabel 3 Dosisiustering og afbrydelse af behandling ved monitorering af nyrefunktionen
English: What EXJADE is used for
Danish: Hvad EXJADE anvendes til
English: Although there was no significant effect (increase in the extent of absorption AUC by 18-19%; no change in Cmax) of a high-fat meal on deferasirox pharmacokinetics, it is recommended that deferasirox granules be taken either with or without a light meal (see section
Danish: Selvom der ikke var nogen signifikant virkning (stigning i graden af absorption AUC på 18-19%; ingen ændringer i Cmax) af et måltid med højt fedtindhold på farmokinetikken for deferasirox, er det anbefalet at deferasirox granulat tages enten med eller uden et let måltid (se pkt 5.2)
English: The dispersible tablets are dispersed by stirring in a glass of water or orange or apple juice (100 to 200 ml) until a fine suspension is obtained.
Danish: De dispergible tabletter opslæmmes i et glas vand eller appelsin- eller æblejuice (100 til 200 ml), og der omrøres, indtil en fin suspension er opnået.
English: In patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events, the benefit of EXJADE might be limited and may be inferior to risks.
Danish: Hos patienter med lav forventet levealder (fx højrisiko myelodysplastiske syndromer), specielt når comorbiditeter kan øge risikoen for bivirkninger, kan fordelen ved EXJADE være begrænset og inferiør over for risikoen.
English: Abnormal serum creatinine and creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively.
Danish: Unormale værdier for serumkreatinin og kreatininclearance blev indberettet hos henholdsvis 5,5% og 1,8% patienterne.
English: It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Exjade therapy.
Danish: Det anbefales at hyperammoniæmisk encefalopati skal overvejes og ammoniakniveauet måles hos patienter, som udvikler uforklarlige ændringer i mental status under behandling med Exjade.
English: Talk to your doctor or pharmacist before taking EXJADE: - if you have a kidney or liver problem.
Danish: Kontakt lægen eller apotekspersonalet, før du tager EXJADE - hvis du har nyre- eller leverproblemer.
English: • Medication errors due to switching between formulations (dispersible tablets and film-coated tablets/granules).
Danish: • Medicineringsfejl på grund af skift mellem formuleringer (dispergible tabletter og filmovertrukne tabletter/granulat)
English: The results of this study suggest that there is a positive impact of deferasirox on event-free survival (EFS, a composite endpoint including non-fatal cardiac or liver events) and serum ferritin levels.
Danish: Resultaterne af studiet antyder, at der er en positiv effekt af deferasirox på hændelsesfri overlevelsesrate (EFS, et sammensat endepunkt inklusive ikkedødelig hjerte- eller leverpåvirkning) og på serumferitinniveauer.
English: Consider interruption
Danish: Overvej afbrydelse
English: Interruption of EXJADE therapy should be considered in patients who develop metabolic acidosis.
Danish: Afbrydelse af behandling med EXJADE bør overvejes hos patienter, der udvikler metabolisk acidose.
English: • The rules for treatment dose adjustments and interruption when target serum ferritin +/- liver iron concentration are reached.
Danish: • Retningslinjerne for dosisjustering og seponering, når målet for serum-ferritin +/jernkoncentrationen i leveren er nået.
English: Total exposure (AUC) was approximately doubled when taken along with a high-fat breakfast (fat content >50% of calories) and by about 50% when taken along with a standard breakfast.
Danish: Total eksponering (AUC) var cirka fordoblet, når det blev taget samtidigt med høj-fedtholdig morgenmad (fedtindhold > 50% af kalorierne) og med omkring 50%, når det blev taget samtidigt med en almindelig morgenmad.
English: Do not chew, break or crush the tablets.
Danish: Du må ikke tygge, knække eller knuse tabletterne Du må ikke synke tabletterne hele.
English: In addition, before treating heavily iron-overloaded children with non-transfusion-dependent thalassaemia with EXJADE, the physician should be aware that the consequences of long-term exposure in such patients are currently not known.
Danish: Før svært jernoverskud hos børn med ikketransfusionsafhængig talassæmi behandles med EXJADE, skal lægen derudover være opmærksom på, at konsekvenserne af langtidsbehandling ikke er kendt hos disse patienter på nuværende tidspunkt.
English: Elevations of liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were reported in 1.8% of patients.
Danish: Stigninger i leveraminotransferaser til over 2 gange baseline og 5 gange den øvre grænse for normalværdien blev rapporteret hos 1,8% af patienterne.
English: Deferasirox has been investigated in 411 adult (age 16 years) and 292 paediatric patients (aged 2 to <16 years) with chronic iron overload due to blood transfusions.
Danish: Deferasirox er undersøgt hos 411 voksne (alder ≥ 16 år) og 292 pædiatriske patienter (alder 2 til < 16 år) med kronisk jernophobning forårsaget af blodtransfusioner.
English: The tablets are white to slightly yellow, round and flat.
Danish: Tabletterne er hvide til svagt gule, runde og flade.
English: Cardiac function should be monitored in patients with severe iron overload during long-term treatment with EXJADE.
Danish: Hjertefunktionen bør monitoreres hos patienter, der har alvorlig jernoverbelastning, og som er under længerevarende behandling med EXJADE.
English: Deferasirox has been studied only in patients with baseline serum creatinine within the age-appropriate normal range.
Danish: Deferasirox har kun været undersøgt hos patienter med baseline serum-kreatinin inden for det aldersbestemte normalområde.
English: Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil.
Danish: Breve af polyethylenterephthalat (PET)/Aluminium/polyethylen (PE) folie.
English: What EXJADE looks like and contents of the pack EXJADE granules are supplied as white to almost white granules in sachets.
Danish: Udseende og pakningsstørrelser EXJADE granulat er et hvidt til næsten hvidt granulat i breve.
English: The tablets must not be chewed or swallowed whole (see also section 6.2).
Danish: Tabletterne må ikke tygges eller synkes hele (se også pkt.
English: 1, anaemia aggravated neutropenia
Danish: 1, forværret anæmi
English: EXJADE is not recommended during pregnancy unless clearly necessary.
Danish: EXJADE frarådes under graviditet, medmindre det er strengt nødvendigt.
English: What EXJADE is
Danish: Hvad EXJADE er
English: EXJADE contains an active substance called deferasirox.
Danish: EXJADE indeholder et aktiv stof, der kaldes deferasirox.
English: After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively).
Danish: Efter indtagelse af et måltid med højt fedtindhold steg AUC og Cmax (18% og 29%, respektivt).
English: Not all pack sizes or strengths may be available in your country.
Danish: Ikke alle pakningsstørrelser eller styrker er nødvendigvis markedsført i dit land.
English: It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the initiation of treatment, every 2 weeks during the first month and monthly thereafter.
Danish: Det anbefales, at serum-aminotransferaser, bilirubin og alkalisk fosfatase måles inden initiering af behandling, hver 2. uge i den første måned og derefter månedligt.
English: As a precaution, it is recommended that EXJADE is not used during pregnancy unless clearly necessary.
Danish: Som en forholdsregel, frarådes det at anvende EXJADE under graviditet, medmindre det er strengt nødvendigt.
English: There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules were administered with food.
Danish: Der var ingen kliniske relevante ændringer i farmakokinetikken for deferasirox, når EXJADE granulat blev administreret sammen med mad.
English: Therefore, the concomitant use of EXJADE with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in EXJADE efficacy.
Danish: Derfor kan samtidig anvendelse af EXJADE med potente UGT-inducere (fx rifampicin, carbamazepin, phenytoin, phenobarbital, ritonavir) resultere i nedsat effekt af EXJADE.
English: The principal analysis of the pivotal comparative study in 586 patients suffering from beta-thalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox dispersible tablets to deferoxamine in the analysis of the total patient population.
Danish: Hovedanalysen af det afgørende sammenligningsstudie hos 586 patienter med beta-talassæmi og transfusionsbetinget jernophobning viste ikke non-inferiority af deferasirox dispergible tabletter sammenlignet med deferoxamin i analysen af den totale patientpopulation.
English: The absolute bioavailability of the granule formulation has not been determined.
Danish: Den absolutte biotilgængelighed af granulat-formuleringen er ikke fastlagt.
English: Serum creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to therapy, weekly in the first month after initiation or modification of therapy with EXJADE (including switch of formulation), and monthly thereafter.
Danish: Serumkreatinin, kreatinin-clearance (estimeret med Cockcroft-Gault eller MDRD-formlen hos voksne og med Schwartz-formlen for børn) og/eller plasma-cystatin C bør monitoreres inden behandlingsstart, ugentligt den første måned efter påbegyndelse eller ændring af behandling med EXJADE (inklusive skift til anden formulering).
English: The tablet coating material contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; indigo carmine aluminium lake (E132).
Danish: Tabletovertrækket indeholder: hypromellose, titandioxid (E171), macrogol (4000), talcum, indigocarminin aluminiumpigment (E132).
English: - if you have a low level of platelets or white blood cells in your blood test. - if you have blurred vision.
Danish: - hvis du har et lavt antal blodplader eller hvide blodceller i din blodprøve.
English: - if you experience frequent abdominal pain, particularly after eating or taking EXJADE.
Danish: - hvis du ofte oplever mavesmerter, specielt efter spisning eller indtag af EXJADE.
English: There is no specific antidote for deferasirox.
Danish: Der findes ingen specifik antidot for desferasirox.
English: Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older).
Danish: Ældre patienter Farmakokinetiken for deferasirox er ikke undersøgt for ældre patienter (65 år eller derover).
English: In addition to monthly serum ferritin assessments, LIC should be monitored every three months when serum ferritin is ≤800 µg/l.
Danish: I tillæg til månedlige serum-ferritin-målinger skal LIC monitoreres hver 3. måned, når serum-ferritin er ≤ 800 µg/l.
English: The bioavailability (AUC) of deferasirox was moderately (approx. 13-25%) elevated when taken 30 minutes before meals with normal or high fat content.
Danish: Biotilgængeligheden (AUC) for deferasirox var kun moderat (ca. 13-25%) forhøjet, når det blev taget 30 minutter før måltider med normalt eller højt fedtindhold.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTER ELLER STRIP
English: Caution should be exercised in patients who are taking EXJADE in combination with substances that have known ulcerogenic potential, such as NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients with platelet counts below 50,000/mm
Danish: Der skal iagttages forsigtighed hos patienter, som bruger EXJADE i kombination med substanser, som vides at have ulcerogent potentiale, såsom NSAID'er, kortikosteroider eller orale bisphosphonater, hos patienter, som bruger antikoagulantia, og hos patienter med blodpladetal under 50.000/mm
English: The increases in Cmax due to the change in formulation and due to the effect of a high-fat meal may be additive and therefore, it is recommended that the film-coated tablets should be taken either on an empty stomach or with a light meal.
Danish: Ændring af formuleringen og effekten af måltider med højt fedtindhold kan have en forstærkende effekt på stigningen i Cmax, hvorfor det anbefales at de filmovertrukne tabletter tages på tom mave eller med et let måltid.
English: Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median time to maximum plasma concentration (tmax) of about 1.5 to 4 hours.
Danish: Deferasirox (dispergibel tablet formulering) bliver absorberet efter oral administration med en mediantid til maximum plasmakoncentration (tmax) på omkring 1,5 til 4 timer.
English: Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided.
Danish: Da interaktionen ikke er blevet påvist med doser højere end 0,5 mg for repaglinid, skal samtidig brug af deferasirox og repaglinid undgås.
English: It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin.
Danish: Det anbefales, at serum-ferritin monitoreres hver måned, og at dosis af EXJADE justeres, hvis nødvendigt, hver 3. til 6. måned, ud fra udviklingen i serum-ferritin.
English: Other medicines and EXJADE
Danish: Brug af anden medicin sammen med EXJADE
English: The single dose Cmax was not affected, but an increase of theophylline Cmax is expected to occur with chronic dosing.
Danish: Efter enkeltdosis-behandling var Cmax ikke påvirket, men en øget theophyllin-Cmax kan forventes ved kronisk dosering.
English: Indigo carmine aluminium lake (E132)
Danish: Indigocarminin aluminiumpigment (E132)
English: In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk.
Danish: I dyrestudier blev det konstanteret, at deferasirox hurtigt og i udstrakt grad blev udskilt i mælken.
English: If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Danish: Hvis kombinationen er nødvendig, skal der udføres nøje klinisk overvågning samt monitorering af blodglukose (se pkt.
English: Deferasirox promotes excretion of iron, primarily in the faeces.
Danish: Deferasirox fremmer ekskretionen af jern, primært i fæces.
English: Anxiety, sleep disorder
Danish: Angst, søvnforstyrrelser
English: A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and transfusional iron overload.
Danish: Der blev udført et placebo-kontrolleret randomiseret studie hos 225 patienter med MDS (lav/int-1 risiko) og transfusionsbetinget jernophobning.
English: or >1,000 µg/l
Danish: eller >1.000 µg/l
English: EXJADE may decrease the efficacy of hormonal contraceptives (see section 4.5).
Danish: EXJADE kan nedsætte effekten af hormonale kontraceptiva (se pkt.
English: • A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia)
Danish: • Et fald i antallet af celler, der er involveret i blodets evne til at størkne (trombocytopeni), i antallet af røde blodlegemer (forværret anæmi), i antallet af hvide blodlegemer (neutropeni)
English: Cataract, maculopathy
Danish: Katarakt, makulopati
English: Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months).
Danish: Det anbefales, at foretage auditive tests og synstests (inklusive fundoskopi) før påbegyndelse af behandling, og skal derefter udføres med regelmæssige mellemrum (hver 12. måned).
English: - if you have diarrhoea or vomiting.
Danish: - hvis du har diarré eller kaster op.
English: Treatment with EXJADE will be overseen by a doctor who is experienced in the treatment of iron overload caused by blood transfusions.
Danish: Behandling med EXJADE vil blive overvåget af en læge, der har erfaring med behandling af jernophobning forårsaget af blodtransfusioner.
English: The MAH shall ensure that, at launch, in each Member State where EXJADE is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use EXJADE are provided with the following educational package for all available formulations (e.g. dispersible tablets, film-coated tablets and granules) for all indications:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at ved lancering i hvert medlemsland, hvor EXJADE er markedsført, vil alt sundhedspersonale og patienter, som forventes at udskrive, udlevere og anvende EXJADE få udleveret følgende uddannelsespakke for alle tilgængelige formuleringer (fx dispergible tabletter, filmovertrukne tabletter og granulat) for alle indikationer:
English: Therefore, due to a possible decrease in efficacy, caution should be exercised when deferasirox is combined with substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive agents, bepridil, ergotamine).
Danish: Derfor bør forsigtighed udvises, grundet en mulig nedsat effekt, når deferasirox kombineres med stoffer, der metaboliseres af CYP3A4 (fx ciclosporin, simvastatin, hormonelle antikoceptiva, bepridil og ergotamin).
English: - if you have a cardiac problem due to iron overload.
Danish: - hvis du har hjerteproblemer, der er forårsaget af jernoverbelastning.
English: • Take the EXJADE dispersible tablets on an empty stomach.
Danish: • Tag EXJADE dispergible tabletter på tom mave.
English: • If you experience frequent abdominal pain, particularly after eating or taking EXJADE,
Danish: • Hvis du ofte oplever mavesmerter, specielt efter spisning eller indtag af EXJADE
English: Agents that may decrease EXJADE systemic exposure Deferasirox metabolism depends on UGT enzymes.
Danish: Lægemidler, der kan øge den systemiske eksponering af EXJADE Deferasiroxmetabolisme afhænger af UGT-enzymer.
English: • Take EXJADE film-coated tablets either on an empty stomach or with a light meal.
Danish: • Tag EXJADE filmovertrukne tabletter på tom mave eller med et let måltid.
English: You may experience effects such as abdominal pain, diarrhoea, nausea and vomiting and kidney or liver problems that can be serious.
Danish: Du kan opleve bivirkninger såsom mavesmerter, diarré, kvalme og opkast og nyre eller lever problemer, som kan være alvorlige.
English: , tubulointerstitial nephritis
Danish: , tubolointerstitial nefritis
English: An interaction between deferasirox and other CYP1A2 substrates cannot be excluded.
Danish: Interaktion mellem deferasirox og andre CYP1A2substrater kan ikke udelukkes.
English: As well as the requirements in the legislation, the following serious ADRs should be forwarded on an expedited basis to the appropriate competent authority as well as summarised in the above reports: o Increase in hepatic enzymes >10x ULN o Serious rise in creatinine o Results of renal biopsies, if available o Cataracts o Hearing loss o Gallstones
Danish: Udover hvad der kræves i henhold til lovgivningen, bør følgende alvorlige bivirkninger sendes som hastesag til de relevante myndigheder, og de bør ligeledes opsummeres i de ovenfor nævnte rapporter: o Stigninger i leverenzymer > 10xULN o Alvorlige stigninger i kreatinin o Resultater af nyrebiopsier, hvis sådanne foreligger o Katarakter o Tab af hørelsen o Galdesten
English: • That rises in serum transaminases may occur in patients treated with EXJADE o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted.
Danish: • At stigninger i transaminaser kan forekommer hos patienter, der er blevet behandlet med Exjade o Nødvendigheden af at foretage leverfunktionstests før udskrivning, og derefter med månedlige intervaller eller hyppigere hvis klinisk indiceret o Ikke at udskrive EXJADE til patienter med allerede eksisterende alvorlig leversygdom o Nødvendigheden af at afbryde behandlingen, hvis der ses vedvarende og progressiv stigning i leverenzym.
English: Deferasirox should not be reintroduced in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock (see section 4.3).
Danish: Behandling med deferasirox må ikke genoptages hos patienter, der har oplevet en overfølsomhedsreaktion, på grund af risikoen for anafylaktisk shock (se pkt.
English: It is recommended that treatment be started after the transfusion of approximately 20 units (about 100 ml/kg) of packed red blood cells (PRBC) or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 µg/l).
Danish: Det anbefales, at behandlingen påbegyndes efter transfusion af omkring 20 enheder (cirka 100 ml/kg) pakkede røde blodceller (PRBC), eller når klinisk monitorering afdækker tegn på, at kronisk jernophobning er til stede (fx serum-ferritin > 1.000 µg/l).
English: Film-coated tablets/granules
Danish: Filmovertrukne tabletter/granulat
English: *LIC is the preferred method of iron overload determination.
Danish: *LIC er den foretrukne metode til bestemmelse af jernophobning.
English: Renal excretion of deferasirox and its metabolites is minimal (8% of the dose).
Danish: Renal udskillelse af deferasirox og dets metabolitter er minimal (8% af dosis).
English: Post-marketing cases of hepatic failure, some of which were fatal, have been reported.
Danish: Der er efter markedsføring rapporteret tilfælde af leversvigt, hvoraf nogle havde dødelig udgang.
English: • Description of available deferasirox formulations (e.g. dispersible tablets, film-coated tablets and granules) o Different posology regimen o Different conditions of administration o Dose conversion table when switching from one formulation to another
Danish: • Beskrivelse af tilgængelige formuleringer af deferasirox (fx dispergible tabletter, filmovertrukne tabletter og granulat) o Forskellige doseringsregime o Forskellige betingelser til administration o Tabel med dosiskonvertering, når der skiftes fra en formulering til en anden
English: How much EXJADE to take The dose of EXJADE is related to body weight for all patients.
Danish: Hvor meget EXJADE skal du tage Dosis af EXJADE afhænger for alle patienter af kropsvægten.
English: • The maximum recommended daily dose for EXJADE granules:
Danish: • Den maksimale anbefalede daglige dosis af EXJADE granulat er: