FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant administration of deferasirox and aluminium-containing antacid preparations has not been formally studied.
Danish: Samtidig administration af deferasirox og aluminiumholdige antacidapræparater er ikke formelt undersøgt.
English: Other information
Danish: Anden information
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 Deferasirox Mylan 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 Deferasirox Mylan være begrænset og inferiør i forhold til risikoen.
English: • If you get blurred or cloudy eyesight,
Danish: • Hvis du får utydeligt eller sløret syn,
English: Severe forms associated with changes in consciousness in the context of hyperammonaemic encephalopathy have been reported.
Danish: Svære former forbundet med ændringer i bevidstheden i sammenhæng med hyperammoniæmisk encefalopati er blevet rapporteret.
English: It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload).
Danish: En jernkelator er et lægemiddel, som anvendes for at fjerne overskud af jern fra kroppen (også kaldet jernophobning).
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 steady-state-tilstande.
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: ◦ Information that only one course of treatment is proposed for NTDT patients ◦ A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population ◦ 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) ◦ Information om, at der kun anbefales ét behandlingforløb hos patienter med ikketransfusionsafhængige talassæmi-syndromer ◦ En advarsel om nødvendigheden af en hyppigere monitoring jern-koncentrationen i leveren og serum ferritin hos den pædiatriske population ◦ En advarsel om manglende viden omkring sikkerhedsproblemerne ved langtidsbehandling hos den pædiatriske population på nuværende tidspunkt.
English: The most frequent reactions reported during chronic treatment in clinical studies conducted with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash.
Danish: De hyppigste reaktioner, der er rapporteret i de udførte kliniske forsøg under kronisk behandling med deferasirox dispergible tabletter hos voksne og pædiatriske patienter, inkluderer gastrointestinale forstyrrelser (hovedsageligt kvalme, opkastning, diarré eller abdominale smerter) og hududslæt.
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 antikonceptiva, bepridil og ergotamin).
English: In addition, before treating heavily iron-overloaded children with non-transfusion-dependent thalassaemia with Deferasirox Mylan, the physician should be aware that the consequences of long-term exposure in such patients are currently not known.
Danish: Før svært jernophobning hos børn med ikke-transfusionsafhængig talassæmi behandles med Deferasirox Mylan, skal lægen derudover være opmærksom på, at konsekvenserne af langtidsbehandling ikke er kendt hos disse patienter på nuværende tidspunkt.
English: • If you vomit blood and/or have black stools,
Danish: • Hvis du kaster blod op/eller har sort afføring,
English: These will monitor the amount of iron in your body (blood level of ferritin) to see how well Deferasirox Mylan 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 Deferasirox Mylan virker.
English: Monthly thereafter
Danish: Månedligt derefter
English: Deferasirox also comes as “dispersible” tablets.
Danish: Deferasirox fås også som ”dispergible” tabletter.
English: Marketing Authorisation Holder Mylan S.A.S, 117 Allée des Parcs, Saint-Priest, 69800, France
Danish: Indehaver af markedsføringstilladelsen Mylan S.A.S., 117 Allée des Parcs, Saint-Priest, 69800, Frankrig
English: Also, there have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had haematological malignancies and/or low platelet counts.
Danish: Der har også været rapporter om letale gastrointestinale blødninger, specielt hos ældre patienter der havde hæmatologiske maligniteter og/eller lavt antal blodplader.
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 serumferritin > 1.000 µg/l).
English: Diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
Danish: Diarré, forstoppelse, opkastning, kvalme, abdominalsmerter, abdominal udspiling af maven, dyspepsi
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 (dispergibel tablet-formulering) på 10 mg/kg i et år kunne opretholde leverjern og serumferritinniveauer og forårsage netto jernbalance hos patienter, der sjældent modtog transfusioner eller udskiftningstransfusioner.
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: It traps and removes excess iron which is then excreted mainly in the stools.
Danish: Det binder og fjerner det overskydende jern, som derefter udskilles med afføringen.
English: • Description of available deferasirox formulations on the market (e.g. dispersible tablets, filmcoated tablets and granules) ◦ Different posology regimen ◦ Different conditions of administration ◦ Dose conversion table when switching from one formulation to another
Danish: • Beskrivelse af tilgængelige markedsførte formuleringer af deferasirox (fx dispergible tabletter, filmovertrukne tabletter og granulat) ◦ Forskellige doseringsregime ◦ Forskellige betingelser til administration ◦ Tabel med dosiskonvertering, når der skiftes fra en formulering til en anden
English: Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)).
Danish: Gentagne blodtransfusioner kan være nødvendige hos patienter med forskellige slags anæmier (blodmangel) (fx talassæmi, seglcelleanæmi eller myelodysplastiske syndromer (MDS)).
English: Patients experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or operating machines (see section 4.8).
Danish: Patienter, som oplever den usædvanlige bivirkning svimmelhed, bør udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner (se pkt.
English: The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
Danish: Farmakokinetikken af deferasirox blev ikke påvirket af lever-aminotransferaseværdier på op til 5 gange den øvre grænse af normalområdet.
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 levercirrose.
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 kreatinin med bedring efter seponering af behandlingen.
English: In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox for up to 5 years were not affected (see section 4.4).
Danish: I to kliniske studier blev vækst og kønsudvikling hos pædiatriske patienter, der blev behandlet med deferasirox i op til 5 år, ikke påvirket (se pkt.
English: 1, thrombocytopenia
Danish: 1, trombocytopeni
English: • If you experience frequent heartburn,
Danish: • Hvis du ofte oplever halsbrand,
English: Studies in animals have shown some reproductive toxicity at maternally toxic doses (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet ved doser, der var toksiske for moderen (se pkt.
English: While no increase in renal adverse events was observed after dose escalation of deferasirox dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded.
Danish: Selvom der ikke blev observeret en stigning af bivirkninger i nyrerne efter dosisoptrapning af deferasirox dispergible tabletter til doser over 30 mg/kg i kliniske studier, kan det ikke udelukkes, at der er en øget risiko for bivirkninger i nyrerne ved filmovertrukne tabletter i doser over 21 mg/kg.
English: For patients well managed on deferoxamine
Danish: Til velbehandlede deferoxaminpatienter
English: It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is numerically half of the deferoxamine dose).
Danish: Det fremgik af prækliniske og kliniske studier, at deferasirox dispergible tabletter kunne være lige så aktive som deferoxamin, når de blev administreret i en dosisratio på 2:1 (det vil sige en dosis deferasirox dispergible tabletter, der numerisk er halvdelen af deferoxamindosis).
English: Tablet core:
Danish: Tabletkernen:
English: ◦ The need to reduce by 10 mg/kg the dose if serum creatinine rises: Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits.
Danish: ◦ Nødvendigheden af at reducere dosis med 10 mg/kg hvis serum-kreatinin stiger: Voksne: > 33 % over baseline og kreatinin-clearance < LLN (90 ml/min) Børn: enten > ULN eller kreatinin-clearance falder til < LLN ved to på hinanden følgende besøg
English: Gastrointestinal disorders
Danish: Gastrointestinale lidelser
English: There have been post-marketing reports of metabolic acidosis.
Danish: Der er efter markedsføring rapporteret om metabolisk acidose.
English: There have been post-marketing reports of leukopenia, thrombocytopenia or pancytopenia (or aggravation of these cytopenias) and of aggravated anaemia in patients treated with deferasirox.
Danish: Efter markedsføring har der været indberetninger af leukopeni, trombocytopeni eller pancytopeni (eller forværring af disse cytopenier) og af forværret anæmi hos patienter behandlet med deferasirox.
English: The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes, DiamondBlackfan syndrome, aplastic anaemia and other very rare anaemias).
Danish: De underliggende tilstande, der krævede blodtransfusion, inkluderede beta-talassæmi, seglcelleanæmi og andre medfødte og erhvervede anæmier (myelodysplastiske syndromer, DiamondBlackfan-syndrom, aplastisk anæmi og andre meget sjældne anæmier).
English: Talk to your doctor or pharmacist before taking Deferasirox Mylan: - if you have a kidney or liver problem.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Deferasirox Mylan: - hvis du har nyre- eller leverproblemer.
English: Approximate tablet dimensions 17 mm × 6.7 mm.
Danish: Omtrentlige tabletdimensioner 17 mm × 6,7 mm.
English: If any SCAR is suspected, Deferasirox Mylan should be discontinued immediately and should not be reintroduced.
Danish: Hvis der er mistanke om SCAR, skal Deferasirox Mylan seponeres øjeblikkeligt, og behandlingen bør ikke genoptages.
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 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 bisfosfonater kan øge risikoen for gastrointestinal toksicitet (se pkt.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: 10. SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: • Guide for healthcare professionals
Danish: • Vejledning til sundhedspersoner
English: In children with transfusional iron overload aged between 2 and 5 years, exposure is lower than in adults (see section 5.2).
Danish: Hos børn med transfusionsbetinget jernophobning mellem 2 og 5 år er eksponeringen mindre end hos voksne (se pkt.
English: • Sleep disorder
Danish: • Søvnforstyrrelser
English: After adjustment of the strength, the film-coated tablet formulation (360 mg strength) was equivalent to deferasirox dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Danish: Efter justering af styrken var den filmovertrukne tablet-formulering (360 mg) ækvivalent med deferasirox dispergible tabletter (500 mg), hvad angik det gennemsnitlige areal under tidskurven for plasmakoncentrationen (AUC) under faste.
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: If any of these affects you severely, tell your doctor.
Danish: Hvis nogen af disse bivirkninger påvirker dig alvorligt, så fortæl det til din læge.
English: The maximum recommended daily dose for Deferasirox Mylan film-coated tablets is:
Danish: • Den maksimale anbefalede daglige dosis af Deferasirox Mylan filmovertrukne tabletter er:
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: Dekonjungering af glucuronider i tarmen og efterfølgende reabsorption (enterohepatisk recirkulation) vil sandsynligvis forekomme: 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: Deferasirox Mylan 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: Deferasirox Mylan 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: These reactions are dosedependent, 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: Deferasirox promotes excretion of iron, primarily in the faeces.
Danish: Deferasirox fremmer udskillelsen af jern, primært i fæces.
English: Therefore, it must not be combined with other iron chelator therapies (see section 4.3).
Danish: Derfor må det ikke kombineres med andre jernkelatorer (se pkt.
English: Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, diarrhoea).
Danish: Der skal udvises forsigtighed hos ældre patienter på grund af en højere frekvens af bivirkninger (specielt diarré).
English: • Take Deferasirox Mylan film-coated tablets either on an empty stomach or with a light meal.
Danish: • Tag Deferasirox Mylan filmovertrukne tabletter på tom mave eller med et let måltid.
English: Proteinuria
Danish: Proteinuri
English: The availability of long-term efficacy and safety data from clinical studies conducted with deferasirox dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation).
Danish: Der er på nuværende tidspunkt begrænsede langtidseffekt- og sikkerhedsdata fra udførte kliniske forsøg for deferasirox dispergible tabletter anvendt ved doser over 30 mg/kg (264 patienter fulgt i gennemsnitlig 1 år efter dosisoptrapning).
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 serumferritinniveauer i perioder, hvor der behandles med høje doser, og når serumferritinniveauerne ligger tæt på målintervallet.
English: >14 ml/kg/month of PRBC (approx. >4 units/month for an adult)
Danish: > 14 ml/kg/måned af PRBC (ca. > 4 enheder/måned for en voksen)
English: The tablet coating material contains: hypromellose, titanium dioxide (E171), macrogol/PEG (6000), talc, iron oxide yellow (E172), iron oxide red (E172).
Danish: Tablettens filmovertræk indeholder: hypromellose, titandioxid (E171), macrogol/PEG (6000), talcum, gul jernoxid (E172), rød jernoxid (E172).
English: Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion.
Danish: Glucoronidering er den primære metaboliske vej for deferasirox, med efterfølgende udskillelse i galden.
English: - if you have a cardiac problem due to iron overload.
Danish: - hvis du har hjerteproblemer, der er forårsaget af jernophobning.
English: Monthly
Danish: Månedligt
English: An interaction between deferasirox and other CYP2C8 substrates like paclitaxel cannot be excluded.
Danish: Der kan ikke udelukkes interaktion mellem deferasirox og andre CYP2C8-substrater som paclitaxel.
English: Psychiatric disorders Uncommon:
Danish: Psykiatriske lidelser Ikke almindelig:
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 MR, indikerer, at behandling med deferasirox 10 - 30 mg/kg/dag (dispergibel tablet-formulering) i 1 år også kan reducere jernniveauer i hjertet (i gennemsnit, MR T2* øget fra 18,3 til 23,0 millisekunder).
English: Multiple ulcers have been observed in some patients (see section 4.8).
Danish: Multiple ulcus er rapporteret hos nogle patienter (se pkt.
English: - ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis), - simvastatin (used to lower cholesterol), - certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), - oral bisphosphonates (used to treat osteoporosis), - anticoagulant medicines (used to prevent or treat blood clotting), - hormonal contraceptive agents (birth control medicines), - bepridil, ergotamine (used for heart problems and migraines), - repaglinide (used to treat diabetes), - rifampicin (used to treat tuberculosis), - phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), - ritonavir (used in the treatment of HIV infection), - paclitaxel (used in cancer treatment), - theophylline (used to treat respiratory diseases such as asthma), - clozapine (used to treat psychiatric disorders such as schizophrenia), - tizanidine (used as a muscle relaxant), - cholestyramine (used to lower cholesterol levels in the blood).
Danish: kortikosteroider), - orale bisfosfonater (bruges til behandling af osteoporose), - antikoagulerende medicin (bruges til at modvirke eller behandling af blodpropper), - hormonelle graviditetsforebyggende midler, - bepridil, ergotamin (bruges til behandling af hjerteproblemer og migræne), - repaglinid (bruges til at behandle sukkersyge), - rifampicin (bruges til at behandle tuberkulose), - phenytoin, phenobarbital, carbamazepin (bruges til at behandle epilepsi), - ritonavir (bruges i behandlingen af HIV-infektion), - paclitaxel (bruges i kræftbehandling), - theofyllin (bruges til at behandle af lungesygdomme såsom astma), - clozapin (bruges til at behandle af psykiske sygdomme såsom skizofreni), - tizanidin (virker muskelafslappende), - cholestyramin (bruges til at sænke kolesterolniveauet i blodet).
English: The dosing recommendations for paediatric patients aged 2 to 17 years with transfusional iron overload are the same as for adult patients (see section 4.2).
Danish: Dosisrekommendationer for pædiatriske patienter i alderen 2 til 17 år med transfusionsbetinget jernophobning er de samme som for ældre patienter (se pkt.
English: The study compared the efficacy of two different deferasirox dispersible tablet regimens (starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients).
Danish: Studiet sammenlignede virkningen af to forskellige deferasirox-behandlinger med dispergible tabletter (startdoser på 5 og 10 mg/kg/dag, 55 patienter i hver arm) og tilsvarende placebo (56 patienter).
English: Anxiety, sleep disorder Nervous system disorders Common:
Danish: Angst, søvnforstyrrelser Lidelser i det centrale og perifere nervesystem Almindelig:
English: If you take more Deferasirox Mylan than you should If you have taken too much Deferasirox Mylan, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away.
Danish: Hvis du har taget for meget Deferasirox Mylan, eller hvis nogen ved et uheld kommer til at tage dine tabletter, så kontakt med det samme din læge eller skadestuen.
English: If disturbances are noted during the treatment, dose reduction or interruption may be considered.
Danish: En dosisreduktion eller afbrydelse kan overvejes, hvis der ses forstyrrelser under behandlingen.
English: Deferasirox Mylan may decrease the efficacy of hormonal contraceptives (see section 4.5).
Danish: Deferasirox Mylan kan nedsætte effekten af hormonale antikonceptiva (se pkt.
English: For deferasirox film-coated tablets, a dose ratio of 3:1 can be considered (i.e. a dose of deferasirox film-coated tablets that is numerically one third of the deferoxamine dose).
Danish: For deferasirox filmovertrukne tabletter kan en dosisratio på 3:1 overvejes (det vil sige en dosis af deferasirox filmovertrukne tabletter, der numerisk er en tredjedel af deferoxamindosis).