natgillin/translations-raw huggingface dataset:
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. 
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.
Tabel 2 Anbefalet dosis til ikke-transfusionsafhængige talassæmi-syndromer 
Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes
Aktivt stof: deferasirox. 
The active substance is deferasirox.
Diarré er rapporteret oftere hos pædiatriske patienter i alderen 2 til 5 år end hos ældre patienter. 
Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients.
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. 
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).
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. 
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.
Kliniske studier omkring virkningen blev udført med deferasirox dispergible tabletter. 
Clinical efficacy studies were conducted with deferasirox dispersible tablets.
Renal tubulopati har hovedsagelig været rapporteret hos børn og unge med beta-talassæmi behandlet med Deferasirox Mylan. 
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with Deferasirox Mylan.
Klinisk studie hos patienter med ikke-transfusionsafhængige talassæmi-syndromer 
Clinical study in patients with non-transfusion-dependent thalassaemia syndromes
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. 
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.
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. 
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.
Deferasirox forårsagede lignende respons hos patienter med jernophobning med andre anæmier. 
Deferasirox induced similar responses in iron-overloaded patients with other anaemias.
• Patientvejledning 
• Patient guide
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. 
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.
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. 
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.
Omtrentlige tabletdimensioner 12,8 mm × 6,00 mm. 
Approximate tablet dimensions 12.8 mm × 6.00 mm.
In vitro blev der ikke observeret hæmning af deferasirox-metabolisme af hydroxyurea. 
No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro.
Der foreligger ikke kliniske data om eksponering for deferasirox under graviditet. 
No clinical data on exposed pregnancies are available for deferasirox.
Behandling med Deferasirox Mylan vil blive overvåget af en læge, der har erfaring med behandling af jernophobning forårsaget af blodtransfusioner. 
Treatment with Deferasirox Mylan will be overseen by a doctor who is experienced in the treatment of iron overload caused by blood transfusions.
Hvide HDPE tabletbeholdere med hvide gennemsigtige skruelåg af polypropylen (PP) med aluminiumsforsegling indeholdende 90 eller 300 filmovertrukne tabletter. 
White HDPE bottle with white opaque polypropylene (PP) screw cap with aluminum seal containing 90 or 300 film-coated tablets.
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. 
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.
Hos dyr er der ikke observeret utilsigtede påvirkninger af hanners eller hunners fertilitet (se pkt. 
In animals, no adverse effects on male or female fertility were found (see section 5.3).
• Afvigelser i analyser for leverfunktionen 
• Disturbance in liver function tests
Diarré rapporteres oftere hos pædiatriske patienter i alderen 2 til 5 år og hos ældre patienter. 
Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years and in the elderly.
• 28 mg pr. kg kropsvægt for patienter, der får regelmæssige blodtransfusioner, 
• 28 mg per kilogram body weight for patients receiving regular blood transfusions,
Derimod forårsagede deferasirox øget frekvens af skeletale forandringer og dødfødte unger hos rotter ved høje doser, der var stærkt toksiske for moderdyret uden jernophobning. 
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.
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 %). 
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).
• Voldsomme mavesmerter (pancreatitis) 
• Severe upper stomach pain (pancreatitis)
De primære fund var nyretoksicitet og linseuklarhed (katarakt). 
The main findings were kidney toxicity and lens opacity (cataracts).
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. 
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.
Renal tubulopati har hovedsagelig været rapporteret hos børn og unge med beta-talassæmi behandlet med deferasirox. 
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
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. 
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).
Behandling med Deferasirox Mylan skal påbegyndes og vedligeholdes af læger med erfaring i behandling af kronisk jernophobning. 
Treatment with Deferasirox Mylan should be initiated and maintained by physicians experienced in the treatment of chronic iron overload.
Interaktion med repaglinid og andre lægemidler metaboliseret af CYP2C8 
Interaction with repaglinide and other agents metabolised by CYP2C8
Interaktion med midazolam og andre lægemidler metaboliseret af CYP3A4 
Interaction with midazolam and other agents metabolised by CYP3A4
Meget almindelige (kan påvirke flere end 1 ud af 10 patienter) 
Very common (may affect more than 1 in 10 people)
Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller toilettet eller skraldespanden. 
Do not throw away any medicines via wastewater or household waste.
Deferasirox Mylan frarådes under graviditet, medmindre det er strengt nødvendigt. 
Deferasirox Mylan is not recommended during pregnancy unless clearly necessary.
• Hvis du ofte oplever mavesmerter, specielt efter spisning eller indtagelse af Deferasirox Mylan, 
• If you experience frequent abdominal pain, particularly after eating or taking Deferasirox
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. 
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.
◦ 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. 
• 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.
Tidlige tegn på akut overdosering er bivirkninger relateret til mave-tarm-kanalen såsom mavesmerter, diarré, kvalme og opkastning. 
Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting.
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. 
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.
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. 
Do not stop taking Deferasirox Mylan unless your doctor tells you to.
Tabel 1 Anbefalet dosis til jernophobning grundet transfusioner 
Table 1 Recommended doses for transfusional iron overload
Derfor anbefales det ikke at bruge deferasirox samtidigt med theofyllin. 
Therefore, the concomitant use of deferasirox with theophylline is not recommended.
Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, povidon, magnesiumstearat, kolloid vandfri silica og poloxamerer. 
The other ingredients are microcrystalline cellulose, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica and poloxamer.
Dette gælder specielt: - andre jernkelatorer, som ikke må tages sammen med Deferasirox Mylan, - syreneutraliserende medicin (medicin til behandling af halsbrand), der indeholder aluminium, 
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,
I gennemsnit faldt serumferritin med 222,0 µg/l hos patienter, der blev behandlet med deferasirox dispergible tabletter (startdosis 10 mg/kg/dag), og steg med 115 µg/l hos patienter, der fik placebo (p < 0,001). 
On average, serum ferritin decreased by 222.0 µg/l in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in patients treated with placebo (p<0.001).
For patienter, som ikke kan sluge hele tabletter, kan Deferasirox Mylan filmovertrukne tabletter knuses og indtages ved at drysse hele dosis over blød mad, som fx yoghurt eller æblemos. 
For patients who are unable to swallow whole tablets, Deferasirox Mylan film-coated tablets may be crushed and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
• 14 mg pr. kg kropsvægt for voksne patienter, der ikke får regelmæssige blodtransfusioner, 
• 14 mg per kilogram body weight for adult patients not receiving regular blood transfusions,
En startdosis på 7 mg/kg kan tages i betragtning for patienter, der ikke har brug for reduktion af jernniveauer i kroppen, og som også modtager mindre end 7 mg/kg/måned pakkede røde blodceller (omkring < 2 enheder/måned for en voksen). 
An initial daily dose of 7 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
Deferasirox Mylan fås i klare, transparente PVC/PVDC/aluminium blisterpakninger, der indeholder 30 eller 90 filmovertrukne tabletter, og som blisterdoseringer med 30 tabletter, samt i hvide tabletbeholdere af plastik med hvide, gennemsigtige skruelåg med aluminiumsforsegling, der indeholder 90 og 300 tabletter. 
Deferasirox Mylan is available in clear, transparent PVC/PVdC /aluminium blister packs containing 30 or 90 film-coated tablets, in unit dose blister pack of 30 tablets and in white, plastic bottles with white opaque screw cap with aluminium seal containing 90 and 300 tablets.
Det er vigtigt at udføre en omhyggelig monitorering af LIC og serumferritin hos disse patienter for at undgå overkelering (se pkt. 
In these patients, closer monitoring of LIC and serum ferritin is essential to avoid over-chelation (see section 4.4).
- hvis du ofte oplever mavesmerter, specielt efter spisning eller indtagelse af Deferasirox Mylan. 
- if you experience frequent abdominal pain, particularly after eating or taking Deferasirox
Det anbefales at hyperammoniæmisk encefalopati overvejes og ammoniakniveauet måles hos patienter, som udvikler uforklarlige ændringer i mental status under behandling med Deferasirox Mylan. 
It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Deferasirox Mylan.
Hovedparten af disse patienter havde nedsat nyrefunktion, renal tubulopati (Fanconis syndrom), eller diarré, eller forhold, hvor syre-base-ubalance er en kendt komplikation (se pkt. 
The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication (see section 4.4).
Efter markedsføring er leversvigt, som nogle gange var fatalt, blevet rapporteret med deferasirox dispergibel tablet-formuleringen, specielt hos patienter med allerede eksisterende levercirrose (se pkt. 
During post-marketing experience, hepatic failure, sometimes fatal, has been reported with the deferasirox dispersible tablet formulation, especially in patients with pre-existing liver cirrhosis (see section 4.4).
Maksimal dosis 28 mg/kg/dag Overvej afbrydelse 
Maximum dose 28 mg/kg/day Consider interruption
En startdosis på 21 mg/kg kan tages i betragtning for patienter, der har brug for reduktion af forhøjede jern-niveauer, og som også modtager mere end 14 ml/kg/måned pakkede røde blodceller (omkring > 4 enheder/måned for en voksen). 
An initial daily dose of 21 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult).
Hvor meget Deferasirox Mylan skal du tage Dosis af Deferasirox Mylan filmovertrukne tabletter afhænger for alle patienter af kropsvægten. 
How much Deferasirox Mylan to take The dose of Deferasirox Mylan is related to body weight for all patients.
- 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, se også afsnit 4 ”Bivirkninger”). 
- 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, see also section 4 “Possible side effects”).
Der var ingen klinisk relevante forskelle i sikkerhed og tolerance for deferasirox hos pædiatriske patienter i alderen 2 til < 6 år sammenlignet med den samlede population af voksne og ældre børn, inklusive stigning i serum-kreatinin på > 33 % og over den øvre normalgrænse ved ≥ 2 på hinanden følgende målinger (3,1 %) samt stigning i alanin-aminotransferase (ALAT) til mere end 5 gange den øvre normalgrænse (4,3 %). 
In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of deferasirox in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%).
Deferasirox er næsten udelukkende bundet til serum-albumin, og har et lavt fordelingsvolumen på omkring 14 liter i voksne. 
Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and has a small volume of distribution of approximately 14 litres in adults.
Lidelser i blod og lymfe Ikke kendt: 
Blood and lymphatic system disorders Not known:
- Lægen har ordineret dette lægemiddel til dig personligt eller til dit barn. 
- This medicine has been prescribed only for you or your child. Do not pass it on to others.
Eksponeringen var øget med 2,8-gange hos en person med svært nedsat leverfunktion (Child-Pugh Class C) (se pkt. 
Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Der er rapporteret alvorlige kutane bivirkninger (SCAR), herunder Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) og lægemiddelreaktioner med eosinofili og systemiske symptomer (DRESS) ved brug af Deferasirox Mylan (se pkt. 
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Deferasirox Mylan (see section 4.4).
Deferasirox Mylan anbefales ikke til patienter med svært nedsat leverfunktion (Child-Pugh Class C). 
Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Såfremt det er klinisk hensigtsmæssigt, kan standardprocedurer til behandling af overdosering og symptomatisk behandling være nødvendig. 
Standard procedures for management of overdose may be indicated as well as symptomatic treatment, as medically appropriate.
For patienter, som ikke er i stand til at sluge hele tabletter, kan filmovertrukne tabletter knuses og indtages ved at drysse hele dosen ud over blød mad som fx yoghurt eller æblemos. 
For patients who are unable to swallow whole tablets, the film-coated tablets may be crushed and administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple).
forstoppelse, fordøjelsesbesvær 
constipation, indigestion
LIC er den foretrukne metode til bestemmelse af jernophobning. 
LIC is the preferred method of iron overload determination.
Som konsekvens heraf skal behandling med Deferasirox Mylan monitoreres omhyggeligt hos pædiatriske patienter for at opdage bivirkninger og følge jernophobningen. 
As a consequence, Deferasirox Mylan therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
• Vedvarende uregelmæssigheder i en anden markør af den renale funktion (fx proteinuri, 
• Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi
Der har været rapporter om sår kompliceret med perforering af fordøjelsessystemet. 
There have been reports of ulcers complicated with digestive perforation.
Der har været observeret auditive (nedsat hørelse) og visuelle (uklarheder i linsen) forstyrrelser (se pkt. 
Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 4.8).
Hos patienter behandlet med doser over 21 mg/kg bør dosisreduktion i trin på 3,5 til 7 mg/kg overvejes, når der er opnået kontrol (fx serumferritinniveauer permanent under 2.500 µg/l og med en faldende tendens over tid). 
In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
Der er efter markedsføringen rapporteret tilfælde af akut nyresvigt ved brug af deferasirox (se pkt. 
Cases of acute renal failure have been reported following post-marketing use of deferasirox (see section 4.8).
- hvis du opdager en markant nedsættelse af din urinmængde (tegn på nyreproblem). 
- if you notice a marked decrease in your urine output (sign of kidney problem).
Som konsekvens af dette kan det ikke anbefales at behandle disse patienter med Deferasirox Mylan. 
As a consequence, treatment with Deferasirox Mylan is not recommended in these patients.