FrancophonIA/ELRC3.0 huggingface dataset:
English: Iron oxide yellow (E172) Iron oxide red (E172)
Danish: Gul jernoxid (E172) Rød jernoxid (E172)
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 ikke-diabetikere og lave niveauer af serumkalium, fosfat, magnesium eller urat, fosfaturi, aminoaciduri)
English: Serum creatinine
Danish: Serum-kreatinin
English: Cardiac function should be monitored in patients with severe iron overload during long-term treatment with Deferasirox Mylan.
Danish: Hjertefunktionen bør monitoreres hos patienter, der har alvorlig jernophobning, og som er under længerevarende behandling med Deferasirox Mylan.
English: In case of switching from dispersible tablets to film-coated tablets, the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole tablet.
Danish: I tilfælde af behandlingsskift fra dispergible tabletter til filmovertrukne tabletter, skal dosis for filmovertrukne tabletter være 30 % lavere end dosis for dispergible tabletter, afrundet til nærmeste hele tablet.
English: Care should be taken to maintain adequate hydration in patients who experience volumedepleting 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-reducerende tilstande (fx. diarré og opkastning), særligt hos børn med akut sygdom.
English: As a precaution, it is recommended that Deferasirox Mylan is not used during pregnancy unless clearly necessary.
Danish: Som en forholdsregel, frarådes det at anvende Deferasirox Mylan under graviditet, medmindre det er strengt nødvendigt.
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: Retreatment
Danish: Genbehandling
English: [Unit dose blisters] 30 × 1 film-coated tablets
Danish: [Blisterdoseringer] 30 × 1 filmovertrukne tabletter
English: What Deferasirox Mylan is and what it is used for What you need to know before you take Deferasirox Mylan How to take Deferasirox Mylan Possible side effects
Danish: Virkning og anvendelse, hvad er Deferasirox Mylan og hvad bruges det til Det skal du vide, før du begynder at tage Deferasirox Mylan Sådan skal du tage Deferasirox Mylan Bivirkninger
English: Dose adjustments may be made in steps of 3.5 to 7 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden).
Danish: 3,5 til 7 mg/kg, og skal skræddersys til den enkelte patients respons og terapeutiske mål (vedligeholdelse eller reduktion af jernophobning).
English: Approximate tablet dimensions 10.00 mm × 4.5 mm.
Danish: Omtrentlige tabletdimensioner 10,00 mm × 4,5 mm.
English: • If you notice a marked decrease in your urine output (sign of kidney problem),
Danish: • Hvis du oplever en kraftig nedsættelse af din urinproduktion (tegn på nyreproblemer),
English: Clear transparent PVC/PVDC/Aluminium blisters containing 30 or 90 film-coated tablets and unit dose blisters of 30 × 1 tablets.
Danish: Klare, transparente PVC/PVDC/aluminium blisterpakninger, der indeholder 30 eller 90 filmovertrukne tabletter og blisterdoseringer med 30 × 1 tabletter.
English: • The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance
Danish: • Kort oversigt over metoder til måling af kreatinin-clearance
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: The pharmacokinetics of deferasirox have not been studied in patients with renal impairment.
Danish: Farmakokinetikken for deferasirox er ikke undersøgt hos patienter med nedsat nyrefunktion.
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: Kelationsbehandling bør kun initieres, når der er påviseligt jernophobning (jernkoncentration i leveren [LIC] ≥ 5 mg Fe/g tørvægt eller serumferritin konsekvent > 800 µg/l).
English: - if you vomit blood and/or have black stools.
Danish: - hvis du kaster blod op/eller har sort afføring.
English: Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets.
Danish: Biotilgængeligheden af deferasirox filmovertrukne tabletter var 36 % højere end den for dispergible tabletter.
English: <7 ml/kg/month of PRBC (approx. <2 units/month for an adult)
Danish: < 7 ml/kg/måned af PRBC (ca. < 2 enheder/måned for en voksen)
English: There have been post-marketing reports of metabolic acidosis occurring during treatment with deferasirox.
Danish: Der er efter markedsføring rapporteret om metabolisk acidose opstået under behandling med deferasirox.
English: [Bottles]:
Danish: [Tabletbeholder]:
English: • 7 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.
Danish: • 7 mg pr. kg kropsvægt for børn og teenagere, der ikke får regelmæssige blodtransfusioner.
English: Particular attention should therefore be paid to monitoring of serum creatinine in patients who are concomitantly receiving medicinal products that depress renal function, and in patients who are receiving high doses of deferasirox and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or <2 units/month for an adult).
Danish: Speciel opmærksomhed bør derfor rettes mod monitorering af serum-kreatinin hos patienter, der samtidig får lægemidler, der undertrykker nyrefunktionen, og hos patienter, der får høje doser af deferasirox og/eller lav hyppighed af transfusioner (< 7 ml/kg/måned pakkede røde blodceller eller < 2 enheder/måned for en voksen).
English: Severe forms associated with changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients treated with deferasirox, particularly in children.
Danish: Svære tilfælde forbundet med ændringer i bevidstheden i sammenhæng med hyperammoniæmisk encefalopati kan forekomme hos patienter behandlet med deferasirox, særligt hos børn.
English: OUTER CARTON (BLISTER AND BOTTLE)
Danish: YDRE EMBALLAGE (BLISTER OG TABLETBEHOLDER)
English: UNITED KINGDOM
Danish: DET FORENEDE KONGERIGE (STORBRITANNIEN)
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: 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 9,9 % (95 % CI: −11,1 % til −8,6 %; n = 1.142) hos pædiatriske patienter.
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: - if you have a low level of platelets or white blood cells in your blood test. - if you have blurred vision - if you have diarrhoea or vomiting.
Danish: - hvis du har et lavt antal blodplader eller hvide blodceller i din blodprøve.
English: As with other iron chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been uncommonly observed in patients treated with deferasirox (see section 4.4).
Danish: Som ved anden jernkelaterende behandling har højfrekvent høretab og linseuigennemsigtighed (tidlig katarakt) sjældent været observeret hos patienter i behandling med deferasirox (se pkt.
English: If only very poor haemosiderosis control is achieved at doses up to 21 mg/kg, a further increase (to a maximum of 28 mg/kg) may not achieve satisfactory control, and alternative treatment options may be considered.
Danish: Hvis der kun er opnået meget dårlig kontrol med hæmosiderosen ved doser på op til 21 mg/kg, er det ikke sikkert, at tilfredsstillende kontrol kan opnås med en yderligere øgning af dosis (til et maksimum på 28 mg/kg), og alternative behandlingsmuligheder kan overvejes.
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 chok (se pkt.
English: 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: I et 1-årigt studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromer og jernophobning (dispergible tabletter med en dosis på 10 mg/kg/dag) var diarré (9,1 %), udslæt (9,1 %) og kvalme (7,3 %) de hyppigste bivirkninger ved forsøgslægemidlet.
English: Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes
Danish: Tabel 2 Anbefalet dosis til ikke-transfusionsafhængige talassæmi-syndromer
English: The active substance is deferasirox.
Danish: Aktivt stof: deferasirox.
English: Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients.
Danish: Diarré er rapporteret oftere hos pædiatriske patienter i alderen 2 til 5 år end hos ældre patienter.
English: The film-coated tablets should be taken once a day, preferably at the same time each day, and may be taken on an empty stomach or with a light meal (see sections 4.5 and 5.2).
Danish: De filmovertrukne tabletter skal tages én gang dagligt, helst på samme tidspunkt hver dag, og kan indtages på tom mave eller sammen med et let måltid (se pkt.
English: In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function.
Danish: I et klinisk studie, hvor der blev givet enkeltdoser på 20 mg deferasirox dispergible tabletter/kg, var den gennemsnitlige eksponering øget med 16 % hos personer med let nedsat leverfunktion (ChildPugh Class A) og med 76 % hos personer med moderat nedsat leverfunktion (Child-Pugh Class B) sammenlignet med personer med normal leverfunktion.
English: Clinical efficacy studies were conducted with deferasirox dispersible tablets.
Danish: Kliniske studier omkring virkningen blev udført med deferasirox dispergible tabletter.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with Deferasirox Mylan.
Danish: Renal tubulopati har hovedsagelig været rapporteret hos børn og unge med beta-talassæmi behandlet med Deferasirox Mylan.
English: Clinical study in patients with non-transfusion-dependent thalassaemia syndromes
Danish: Klinisk studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromer
English: In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 3.5 to 7 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation.
Danish: Hos patienter, hvis serumferritinniveauer har nået målet (som regel mellem 500 og 1.000 µg/l), bør det overvejes at foretage dosisreduktion i trin på 3,5 til 7 mg/kg for at vedligeholde serumferritinniveauer inden for det terapeutiske interval, og for at minimere risikoen for overkelering.
English: In patients not adequately controlled with doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 28 mg/kg may be considered.
Danish: Hos patienter, der ikke er tilstrækkeligt kontrolleret ved doser på 21 mg/kg (fx serumferritinniveauer vedvarende over 2.500 µg/l uden at vise en aftagende udvikling over tid), kan doser op til 28 mg/kg overvejes.
English: Deferasirox induced similar responses in iron-overloaded patients with other anaemias.
Danish: Deferasirox forårsagede lignende respons hos patienter med jernophobning med andre anæmier.
English: • Patient guide
Danish: • Patientvejledning
English: For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Danish: Hos patienter, hvor dosis er øget til > 7 mg/kg, anbefales det at reducere dosis til 7 mg/kg eller derunder, når LIC er < 7 mg Fe/g tørvægt eller serumferritin er ≤ 2000 µg/l.
English: Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in indicators of total body iron; liver iron concentration was reduced by about −0.4 and −8.9 mg Fe/g liver (biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about −36 and −926 µg/l on average, respectively.
Danish: Daglig behandling med den dispergible tablet-formulering for deferasirox med doser på 20 og 30 mg/kg i et år hos voksne og pædiatriske patienter med beta-talassæmi, som hyppigt modtog transfusioner, førte til reduktioner i indikatorer for totalt kropsjern; lever-jernkoncentrationen blev reduceret med henholdsvis omkring −0,4 og 8,9 mg Fe/g lever (biopsi-tørvægt) i gennemsnit, og serumferritin blev reduceret med henholdsvis omkring −36 og −926 µg/l i gennemsnit.
English: Approximate tablet dimensions 12.8 mm × 6.00 mm.
Danish: Omtrentlige tabletdimensioner 12,8 mm × 6,00 mm.
English: No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro.
Danish: In vitro blev der ikke observeret hæmning af deferasirox-metabolisme af hydroxyurea.
English: No clinical data on exposed pregnancies are available for deferasirox.
Danish: Der foreligger ikke kliniske data om eksponering for deferasirox under graviditet.
English: Treatment with Deferasirox Mylan will be overseen by a doctor who is experienced in the treatment of iron overload caused by blood transfusions.
Danish: Behandling med Deferasirox Mylan vil blive overvåget af en læge, der har erfaring med behandling af jernophobning forårsaget af blodtransfusioner.
English: White HDPE bottle with white opaque polypropylene (PP) screw cap with aluminum seal containing 90 or 300 film-coated tablets.
Danish: Hvide HDPE tabletbeholdere med hvide gennemsigtige skruelåg af polypropylen (PP) med aluminiumsforsegling indeholdende 90 eller 300 filmovertrukne tabletter.
English: During clinical studies, increases in serum creatinine of >33% on ≥2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients.
Danish: Der forekom forhøjelser i serumkreatinin på > 33 % i ≥ 2 på hinanden følgende tilfælde, og nogle gange over den øvre grænse for normalområdet hos omkring 36 % af patienterne i kliniske studier.
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 hanners eller hunners fertilitet (se pkt.
English: • Disturbance in liver function tests
Danish: • Afvigelser i analyser for leverfunktionen
English: Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years and in the elderly.
Danish: Diarré rapporteres oftere hos pædiatriske patienter i alderen 2 til 5 år og hos ældre patienter.
English: • 28 mg per kilogram body weight for patients receiving regular blood transfusions,
Danish: • 28 mg pr. kg kropsvægt for patienter, der får regelmæssige blodtransfusioner,
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 moderdyret uden jernophobning.
English: A food-effect study involving administration of the film-coated tablets to healthy volunteers under fasting conditions and with a low-fat (fat content <10% of calories) or high-fat (fat content >50% of calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal (by 11% and 16%, respectively).
Danish: Et studie om madens effekt på indtagelse af filmovertrukne tabletter hos raske, fastende forsøgspersoner sammen med et måltid med enten et lavt fedtindhold (fedtindhold < 10 % af kalorieindtaget) eller sammen med et måltid med et højt fedtindhold (fedtindhold > 50 % af kalorieindtaget), viste et lille fald i AUC og Cmax (henholdsvis 11 % og 16 %).
English: • Severe upper stomach pain (pancreatitis)
Danish: • Voldsomme mavesmerter (pancreatitis)
English: The main findings were kidney toxicity and lens opacity (cataracts).
Danish: De primære fund var nyretoksicitet og linseuklarhed (katarakt).
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life- threatening or fatal, have been reported.
Danish: Der er blevet rapporteret alvorlige kutane bivirkninger (SCAR), herunder Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) og lægemiddelreaktioner med eosinofili og systemiske symptomer (DRESS), som kan være livstruende eller dødelige.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
Danish: Renal tubulopati har hovedsagelig været rapporteret hos børn og unge med beta-talassæmi behandlet med deferasirox.
English: Deferasirox Mylan 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: Deferasirox Mylan har ikke været undersøgt hos patienter med nedsat nyrefunktion og er kontraindiceret hos patienter med estimeret kreatinin-clearance < 60 ml/min (se pkt.
English: Treatment with Deferasirox Mylan should be initiated and maintained by physicians experienced in the treatment of chronic iron overload.
Danish: Behandling med Deferasirox Mylan skal påbegyndes og vedligeholdes af læger med erfaring i behandling af kronisk jernophobning.
English: Interaction with repaglinide and other agents metabolised by CYP2C8
Danish: Interaktion med repaglinid og andre lægemidler metaboliseret af CYP2C8
English: Interaction with midazolam and other agents metabolised by CYP3A4
Danish: Interaktion med midazolam og andre lægemidler metaboliseret af CYP3A4
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan påvirke flere end 1 ud af 10 patienter)
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller toilettet eller skraldespanden.
English: Deferasirox Mylan is not recommended during pregnancy unless clearly necessary.
Danish: Deferasirox Mylan frarådes under graviditet, medmindre det er strengt nødvendigt.
English: • If you experience frequent abdominal pain, particularly after eating or taking Deferasirox
Danish: • Hvis du ofte oplever mavesmerter, specielt efter spisning eller indtagelse af Deferasirox Mylan,
English: In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, deferasirox at daily doses of 10, 20 and 40 mg/kg (dispersible tablet formulation) induced the mean net excretion of 0.119, 0.329 and 0.445 mg Fe/kg body weight/day, respectively.
Danish: I et studie i metabolisk jernbalance hos voksne talassæmipatienter med jernophobning, forårsagede daglige deferasirox-doser på 10, 20 og 40 mg/kg (dispergibel tablet-formulering) en gennemsnitlig nettoudskillelse på henholdsvis 0,119, 0,329 og 0,445 mg Fe/kg kropsvægt/dag.
English: • That rises in serum transaminases may occur in patients treated with Deferasirox Mylan ◦ The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated ◦ Not to prescribe to patients with pre-existing severe hepatic disease ◦ The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted.
Danish: ◦ Nødvendigheden af at foretage leverfunktionstests før udskrivning, og derefter med månedlige intervaller eller hyppigere hvis klinisk indiceret ◦ Ikke at udskrive Deferasirox Mylan til patienter med allerede eksisterende alvorlig leversygdom ◦ Nødvendigheden af at afbryde behandlingen, hvis der ses vedvarende og progressiv stigning i leverenzym.
English: Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting.
Danish: Tidlige tegn på akut overdosering er bivirkninger relateret til mave-tarm-kanalen såsom mavesmerter, diarré, kvalme og opkastning.
English: After every 3 to 6 months of treatment, a dose increase in increments of 3.5 to 7 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well.
Danish: Hver 3. til 6. måned bør det overvejes at øge dosis med 3,5 - 7 mg/kg, hvis patientens LIC er ≥ 7 mg Fe/g tørvægt, eller hvis serumferritin konsekvent er > 2.000 µg/l og ikke viser en nedadgående tendens, og hvis lægemidlet er veltolereret.
English: Do not stop taking Deferasirox Mylan unless your doctor tells you to.
Danish: Hvis du holder op med at tage Deferasirox Mylan Hold ikke op med at tage Deferasirox Mylan, medmindre din læge giver dig besked på det.
English: Table 1 Recommended doses for transfusional iron overload
Danish: Tabel 1 Anbefalet dosis til jernophobning grundet transfusioner
English: Therefore, the concomitant use of deferasirox with theophylline is not recommended.
Danish: Derfor anbefales det ikke at bruge deferasirox samtidigt med theofyllin.
English: The other ingredients are microcrystalline cellulose, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica and poloxamer.
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, povidon, magnesiumstearat, kolloid vandfri silica og poloxamerer.
English: This includes in particular: - other iron chelators, which must not be taken with Deferasirox Mylan, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Mylan,
Danish: Dette gælder specielt: - andre jernkelatorer, som ikke må tages sammen med Deferasirox Mylan, - syreneutraliserende medicin (medicin til behandling af halsbrand), der indeholder aluminium,