FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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).
English: 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).
Danish: 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.
English: • 14 mg per kilogram body weight for adult patients not receiving regular blood transfusions,
Danish: • 14 mg pr. kg kropsvægt for voksne patienter, der ikke får regelmæssige blodtransfusioner,
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: In these patients, closer monitoring of LIC and serum ferritin is essential to avoid over-chelation (see section 4.4).
Danish: Det er vigtigt at udføre en omhyggelig monitorering af LIC og serumferritin hos disse patienter for at undgå overkelering (se pkt.
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: 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.
Danish: Det anbefales at hyperammoniæmisk encefalopati overvejes og ammoniakniveauet måles hos patienter, som udvikler uforklarlige ændringer i mental status under behandling med Deferasirox Mylan.
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 (see section 4.4).
Danish: 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.
English: 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).
Danish: 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.
English: Maximum dose 28 mg/kg/day Consider interruption
Danish: Maksimal dosis 28 mg/kg/dag Overvej afbrydelse
English: 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).
Danish: 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).
English: How much Deferasirox Mylan to take The dose of Deferasirox Mylan is related to body weight for all patients.
Danish: Hvor meget Deferasirox Mylan skal du tage Dosis af Deferasirox Mylan filmovertrukne tabletter afhænger for alle patienter af kropsvægten.
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, see also section 4 “Possible side effects”).
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, se også afsnit 4 ”Bivirkninger”).
English: 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%).
Danish: 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 %).
English: 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.
Danish: Deferasirox er næsten udelukkende bundet til serum-albumin, og har et lavt fordelingsvolumen på omkring 14 liter i voksne.
English: Blood and lymphatic system disorders Not known:
Danish: Lidelser i blod og lymfe Ikke kendt:
English: - This medicine has been prescribed only for you or your child. Do not pass it on to others.
Danish: - Lægen har ordineret dette lægemiddel til dig personligt eller til dit barn.
English: Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Danish: Eksponeringen var øget med 2,8-gange hos en person med svært nedsat leverfunktion (Child-Pugh Class C) (se pkt.
English: 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).
Danish: 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.
English: Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Deferasirox Mylan anbefales ikke til patienter med svært nedsat leverfunktion (Child-Pugh Class C).
English: Standard procedures for management of overdose may be indicated as well as symptomatic treatment, as medically appropriate.
Danish: Såfremt det er klinisk hensigtsmæssigt, kan standardprocedurer til behandling af overdosering og symptomatisk behandling være nødvendig.
English: 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).
Danish: 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.
English: constipation, indigestion
Danish: forstoppelse, fordøjelsesbesvær
English: LIC is the preferred method of iron overload determination.
Danish: LIC er den foretrukne metode til bestemmelse af jernophobning.
English: As a consequence, Deferasirox Mylan therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
Danish: Som konsekvens heraf skal behandling med Deferasirox Mylan monitoreres omhyggeligt hos pædiatriske patienter for at opdage bivirkninger og følge jernophobningen.
English: • Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi
Danish: • Vedvarende uregelmæssigheder i en anden markør af den renale funktion (fx proteinuri,
English: There have been reports of ulcers complicated with digestive perforation.
Danish: Der har været rapporter om sår kompliceret med perforering af fordøjelsessystemet.
English: Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 4.8).
Danish: Der har været observeret auditive (nedsat hørelse) og visuelle (uklarheder i linsen) forstyrrelser (se pkt.
English: 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).
Danish: 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).
English: Cases of acute renal failure have been reported following post-marketing use of deferasirox (see section 4.8).
Danish: Der er efter markedsføringen rapporteret tilfælde af akut nyresvigt ved brug af deferasirox (se pkt.
English: - if you notice a marked decrease in your urine output (sign of kidney problem).
Danish: - hvis du opdager en markant nedsættelse af din urinmængde (tegn på nyreproblem).
English: As a consequence, treatment with Deferasirox Mylan is not recommended in these patients.
Danish: Som konsekvens af dette kan det ikke anbefales at behandle disse patienter med Deferasirox Mylan.
English: In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% CI: 8% - 26%).
Danish: I et studie med raske frivillige, resulterede samtidig behandling med deferasirox dispergible tabletter og midazolam (et CYP3A4 test-substrat) i et fald i eksponering for midazolam på 17 % (90 % CI: 8 %-26 %).
English: On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in patients treated with placebo (p<0.001).
Danish: I gennemsnit faldt jernkoncentrationen i leveren med 3,80 mg Fe/g tørvægt hos patienter, der blev behandlet med deferasirox dispergible tabletter (startdosis 10 mg/kg/dag), og steg med 0,38 mg Fe/g tørvægt hos patienter, der fik placebo (p < 0,001).
English: Monthly monitoring of serum ferritin is recommended in order to assess the patient's response to therapy and to avoid over-chelation (see section 4.2).
Danish: Månedlig monitorering af serumferritin anbefales for at kunne vurdere patientens respons på behandlingen og for at undgå overkelering (se pkt.
English: Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy have been reported in patients treated with deferasirox, mainly in children.
Danish: Der er efter markedsføring rapporteret om svære tilfælde af tubulopati (fx. Fanconis syndrom) og nyresvigt forbundet med ændringer i bevidstheden i sammenhæng med hyperammoniæmisk encefalopati hos patienter behandlet med deferasirox, hovedsageligt hos børn.
English: Maximum dose 14 mg/kg/day 7 mg/kg/day
Danish: Maksimal dosis 14 mg/kg/dag 7 mg/kg/dag
English: • Patient information pack
Danish: • Informationspakke til patienten
English: Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1).
Danish: Der er meget begrænsede data om børn med ikke-transfusionsafhængig talassæmi (se pkt.
English: Non-transfusion-dependent thalassaemia syndromes
Danish: Ikke-transfusionsafhængige talassæmi-syndromer
English: Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin <300 µg/l), treatment should be stopped.
Danish: Behandlingen skal ophøre, når der er opnået et tilfredsstillende jernniveau i kroppen (LIC < 3 mg Fe/g tørvægt eller serumferritin < 300 µg/l).
English: Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Danish: Deferasirox Mylan er indiceret til behandling af kronisk jernophobning forårsaget af hyppige blodtransfusioner (≥ 7 ml/kg/måned pakkede røde blodceller) hos patienter i alderen 6 år og ældre, der har beta-talassæmi major.
English: • Medication errors due to switching between formulations available on the market by different
Danish: • Medicineringsfejl på grund af skift mellem formuleringer, som er tilgængelige på markedet fra forskellige indehavere af markedsføringstilladelser (dispergible tabletter og filmovertrukne tabletter/granulat)
English: Non-transfusion-dependent thalassaemia syndromes:
Danish: Ikke-transfusionsafhængige talassæmi-syndromer:
English: Interaction with theophylline and other agents metabolised by CYP1A2
Danish: Interaktion med theofyllin og andre lægemidler metaboliseret af CYP1A2
English: Postmarketing cases of hepatic failure, sometimes fatal, have been reported in patients treated with deferasirox.
Danish: Efter markedsføring er leversvigt, som nogle gange var fatalt, blevet rapporteret med deferasirox.
English: 6.1 List of excipients
Danish: 6.1 Liste over hjælpestoffer
English: For paediatric patients
Danish: Til pædiatriske patienter
English: Monthly thereafter.
Danish: Herefter månedligt.
English: In a healthy volunteer study, the concomitant administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent UGT inducer, rifampicin, (repeated dose of 600 mg/day) resulted in a decrease of deferasirox exposure by 44% (90% CI: 37% - 51%).
Danish: I et studie hos raske frivillige, resulterede samtidig administration af deferasirox (enkeltdosis på 30 mg/kg, dispergibel tablet-formulering) og den potente UGT-inducer, rifampicin, (gentagen dosis på 600 mg/dag) i en nedsat eksponering for deferasirox med 44 % (90 % CI: 37 % - 51 %).
English: It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4).
Danish: Det anbefales, at serumferritin monitoreres hver måned for at kunne vurdere patientens respons på behandlingen, og for at minimere risikoen for overkelering (se pkt.
English: A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Danish: Det kan være, at lægen - afhængigt af dit behov - anbefaler en højere eller lavere startdosis.
English: The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Danish: Den anbefalede daglige initialdosis af Deferasirox Mylan filmovertrukne tabletter hos patienter med ikke-transfusionsafhængige talassæmi-syndromer er 7 mg/kg kropsvægt.
English: Creatinine clearance in transfusional iron overload
Danish: Kreatininclearance ved transfusionsbetinget jernophobning
English: Skin rashes may appear during Deferasirox Mylan treatment.
Danish: Der kan forekomme hududslæt ved behandling med Deferasirox Mylan.
English: If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take Deferasirox Mylan”).
Danish: Hvis du holder op med at tage Deferasirox Mylan, vil det overskydende jern ikke længere blive fjernet fra din krop (se også ovenstående pkt.
English: In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) and 1.6-fold (90% CI [1.42-1.84]), respectively.
Danish: I et studie med raske frivillige blev det påvist, at administration af deferasirox, som moderat CYP2C8hæmmer (30 mg/kg daglig, dispergibel tablet-formulering) samtidig med repaglinid, et CYP2C8substrat givet som enkeltdosis på 0,5 mg, øgede AUC og Cmax for repaglinid med henholdsvis ca. 2,3-gange (90 % CI [2,03-2,63]) og 1,6-gange (90 % CI [1,42-1,84]).
English: - if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”).
Danish: - hvis du udvikler alvorlige udslæt, vejrtrækningsbesvær og svimmelhed eller oplever hævelse hovedsageligt i ansigtet og på halsen (tegn på alvorlig allergisk reaktion, se også punkt 4
English: Serum ferritin
Danish: Serumferritin
English: Twice (2×)
Danish: Inden behandlingsstart To gange (2×)
English: Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Danish: Deferasirox Mylan anbefales ikke til patienter med alvorligt nedsat leverfunktion (Child-Pugh Class C) (se pkt.
English: Deferasirox Mylan 360 mg film-coated tablets are also available in blister packs of 300 tablets.
Danish: Deferasirox Mylan 360 mg filmovertrukne tabletter er også tilgængelige i blisterpakninger med 300 tabletter.
English: It appeared from a post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to ≥50 mg/kg), the non-inferiority criteria were achieved.
Danish: I en post-hoc-analyse af dette studie blev non-inferioritets-kriteriet opnået i undergruppen af patienter med leverjernkoncentration ≥ 7 mg Fe/g biopsi-tørvægt behandlet med deferasirox dispergible tabletter (20 og 30 mg/kg) eller deferoxamin (35 til ≥ 50 mg/kg).
English: Once the cause of the liver function test abnormalities has been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose followed by gradual dose escalation may be considered.
Danish: En forsigtig genstart af behandling ved lavere dosis efterfulgt af en gradvis dosisforøgelse kan overvejes, når årsagen til leverfunktionstest-uregelmæssigheder er blevet klarlagt, eller når der igen er normale niveauer.
English: When this results in a daily dose less than 14 mg/kg body weight, the patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Danish: Når dette resulterer i en daglig dosis, der er mindre end 14 mg/kg kropsvægt, skal patientens respons monitoreres.
English: • If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes,
Danish: • Hvis du oplever en kombination af ethvert af de følgende symptomer: udslæt, rød hud, blærer på læberne, øjne eller mund, hudafskalninger, høj feber, influenzalignende symptomer, forstørrede lymfekirtler (tegn på alvorlig hudreaktion),
English: Serum ferritin assessed by monthly monitoring reflected changes in liver iron concentration indicating that trends in serum ferritin can be used to monitor response to therapy.
Danish: Serumferritin, der blev vurderet ved månedlig monitorering, afspejlede ændringer i lever-jernkoncentration.
English: <7 mg Fe/g dw or ≤2,000 µg/l
Danish: < 7 mg Fe/g tørvægt eller ≤ 2.000 µg/l
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: - Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: • The usual daily dose for Deferasirox Mylan film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Danish: • Den sædvanlige daglige dosis af Deferasirox Mylan filmovertrukne tabletter ved behandlingsstart for patienter, der ikke får regelmæssige blodtransfusioner, er 7 mg pr. kg kropsvægt.
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations.
Danish: Deferasirox filmovertrukne tabletter udviser højere biotilgængelighed sammenlignet med deferasirox dispergible tabletter.
English: • The usual daily dose for Deferasirox Mylan film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Danish: • Den sædvanlige dosis af Deferasirox Mylan filmovertrukne tabletter ved behandlingsstart for patienter, der får regelmæssige blodtransfusioner, er 14 mg pr. kg kropsvægt.
English: If serum ferritin falls consistently below 500 µg/l (in transfusional iron overload) or below 300 µg/l (in non-transfusion-dependent thalassaemia syndromes), an interruption of treatment should be considered.
Danish: Det skal overvejes at afbryde behandlingen, hvis serumferritin falder konsekvent under 500 µg/l (ved transfusionsbetinget jernophobning) eller under 300 µg/l (ved ikke-transfusionsafhængige talassæmi-syndromer).
English: Deferasirox Mylan is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.
Danish: Deferasirox Mylan anvendes også til behandling af kronisk jernophobning, når deferoxamin ikke kan benyttes eller ikke har tilstrækkelig virkning til patienter med beta-talassæmi major med jernophobning forårsaget af sjældne blodtransfusioner, til patienter med andre typer af anæmier og til børn i alderen 2 til 5 år.
English: What Deferasirox Mylan is used for
Danish: Hvad Deferasirox Mylan anvendes til
English: • Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating,
Danish: • Mave-tarm-lidelser, såsom kvalme, opkastning, diarré, smerter i mave/underliv, oppustethed,
English: Stevens-Johnson syndrome
Danish: Stevens-Johnson syndrom 1, hypersensitiv vaskulitis
English: • Sore throat
Danish: • Ondt i halsen
English: Caution should be exercised in patients who are taking Deferasirox Mylan 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/mm³ (50 × 10
Danish: kortikosteroider eller orale bisfosfonater, hos patienter, som bruger antikoagulantia, og hos patienter med blodpladetal under 50.000/mm³ (50 × 10
English: In patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and Deferasirox Mylan must be used with caution in such patients.
Danish: Hos patienter med moderat nedsat leverfunktion (Child-Pugh Class B) bør dosis reduceres betydeligt efterfulgt af gradvis dosisøgning op til en grænse på 50 % (se pkt.