natgillin/translations-raw huggingface dataset:
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.
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 %).
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%).
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).
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).
Månedlig monitorering af serumferritin anbefales for at kunne vurdere patientens respons på behandlingen og for at undgå overkelering (se pkt.
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).
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.
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.
Maksimal dosis 14 mg/kg/dag 7 mg/kg/dag
Maximum dose 14 mg/kg/day 7 mg/kg/day
• Informationspakke til patienten
• Patient information pack
Der er meget begrænsede data om børn med ikke-transfusionsafhængig talassæmi (se pkt.
Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1).
Ikke-transfusionsafhængige talassæmi-syndromer
Non-transfusion-dependent thalassaemia syndromes
Behandlingen skal ophøre, når der er opnået et tilfredsstillende jernniveau i kroppen (LIC < 3 mg Fe/g tørvægt eller serumferritin < 300 µg/l).
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.
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.
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.
• Medicineringsfejl på grund af skift mellem formuleringer, som er tilgængelige på markedet fra forskellige indehavere af markedsføringstilladelser (dispergible tabletter og filmovertrukne tabletter/granulat)
• Medication errors due to switching between formulations available on the market by different
Ikke-transfusionsafhængige talassæmi-syndromer:
Non-transfusion-dependent thalassaemia syndromes:
Interaktion med theofyllin og andre lægemidler metaboliseret af CYP1A2
Interaction with theophylline and other agents metabolised by CYP1A2
Efter markedsføring er leversvigt, som nogle gange var fatalt, blevet rapporteret med deferasirox.
Postmarketing cases of hepatic failure, sometimes fatal, have been reported in patients treated with deferasirox.
6.1 Liste over hjælpestoffer
6.1 List of excipients
Til pædiatriske patienter
For paediatric patients
Herefter månedligt.
Monthly thereafter.
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 %).
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%).
Det anbefales, at serumferritin monitoreres hver måned for at kunne vurdere patientens respons på behandlingen, og for at minimere risikoen for overkelering (se pkt.
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).
Det kan være, at lægen - afhængigt af dit behov - anbefaler en højere eller lavere startdosis.
A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Den anbefalede daglige initialdosis af Deferasirox Mylan filmovertrukne tabletter hos patienter med ikke-transfusionsafhængige talassæmi-syndromer er 7 mg/kg kropsvægt.
The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Kreatininclearance ved transfusionsbetinget jernophobning
Creatinine clearance in transfusional iron overload
Der kan forekomme hududslæt ved behandling med Deferasirox Mylan.
Skin rashes may appear during Deferasirox Mylan treatment.
Hvis du holder op med at tage Deferasirox Mylan, vil det overskydende jern ikke længere blive fjernet fra din krop (se også ovenstående pkt.
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”).
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]).
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.
- 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
- 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”).
Serumferritin
Serum ferritin
Inden behandlingsstart To gange (2×)
Twice (2×)
Deferasirox Mylan anbefales ikke til patienter med alvorligt nedsat leverfunktion (Child-Pugh Class C) (se pkt.
Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Deferasirox Mylan 360 mg filmovertrukne tabletter er også tilgængelige i blisterpakninger med 300 tabletter.
Deferasirox Mylan 360 mg film-coated tablets are also available in blister packs of 300 tablets.
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).
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.
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.
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.
Når dette resulterer i en daglig dosis, der er mindre end 14 mg/kg kropsvægt, skal patientens respons monitoreres.
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).
• 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),
• 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,
Serumferritin, der blev vurderet ved månedlig monitorering, afspejlede ændringer i lever-jernkoncentration.
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.
< 7 mg Fe/g tørvægt eller ≤ 2.000 µg/l
<7 mg Fe/g dw or ≤2,000 µg/l
- Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
- If you get any side effects, talk to your doctor or pharmacist.
• Den sædvanlige daglige dosis af Deferasirox Mylan filmovertrukne tabletter ved behandlingsstart for patienter, der ikke får regelmæssige blodtransfusioner, er 7 mg pr. kg kropsvægt.
• 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.
Deferasirox filmovertrukne tabletter udviser højere biotilgængelighed sammenlignet med deferasirox dispergible tabletter.
Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations.
• Den sædvanlige dosis af Deferasirox Mylan filmovertrukne tabletter ved behandlingsstart for patienter, der får regelmæssige blodtransfusioner, er 14 mg pr. kg kropsvægt.
• 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.
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).
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.
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.
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.
Hvad Deferasirox Mylan anvendes til
What Deferasirox Mylan is used for
• Mave-tarm-lidelser, såsom kvalme, opkastning, diarré, smerter i mave/underliv, oppustethed,
• Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating,
Stevens-Johnson syndrom 1, hypersensitiv vaskulitis
Stevens-Johnson syndrome
• Ondt i halsen
• Sore throat
kortikosteroider eller orale bisfosfonater, hos patienter, som bruger antikoagulantia, og hos patienter med blodpladetal under 50.000/mm³ (50 × 10
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
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.
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.
1, nefrolitiasis
1, nephrolithiasis
Almindelige (kan påvirke op til 1 ud af 10 patienter)
Common (may affect up to 1 in 10 people)
Startdosis Anbefalet startdosis for Deferasirox Mylan filmovertrukne tabletter er 14 mg/kg kropsvægt.
The recommended initial daily dose of Deferasirox Mylan film-coated tablets is 14 mg/kg body weight.
Der skal udvises forsigtighed hos alle patienter under kelationsbehandling for at minimere risikoen for overkelering (se pkt.
Caution should be taken during chelation therapy to minimise the risk of over-chelation in all patients (see section 4.4).
Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
If you get any side effects, talk to your doctor or pharmacist.
Indikationen gælder for de følgende patientgrupper: - pædiatriske patienter med beta-talassæmi major med jernophobning forårsaget af regelmæssige blodtransfusioner (≥ 7 ml/kg/måned af pakkede røde blodceller) i alderen 2 til 5 år, - voksne og pædiatriske patienter med beta-talassæmi major med jernophobning forårsaget af sjældne blodtransfusioner (< 7 ml/kg/måned pakkede røde blodceller) i alderen 2 år og derover, - voksne og pædiatriske patienter med andre anæmier i alderen 2 år og derover.
Deferasirox Mylan is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older.
Hos patienter med lever-jernkoncentration < 7 mg Fe/g biopsi-tørvægt, der blev behandlet med deferasirox dispergible tabletter (5 og 10 mg/kg) eller deferoxamin (20 eller 35 mg/kg), blev non-inferioritet imidlertid ikke opnået.
However, in patients with liver iron concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Generics [UK] Limited
Generics [UK] Limited Station Close Potters Bar
Leversvigt
Dizziness
Øget dosis 3,5 - 7 mg/kg/dag
Increase 3.5 - 7 mg/kg/day
• Hvis du oplever en kombination af døsighed, smerter i den øvre højre del af maven, gulfarvning af din hud eller øjne og mørk urin (tegn på leverproblemer),
• If you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems),
- hvis du oplever en kombination af døsighed, smerter i den øvre højre del af maven, gulfarvning af din hud eller øjne og mørk urin (tegn på leverproblemer).
- if you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems).
Lægemidler, der kan øge den systemiske eksponering af Deferasirox Mylan
Agents that may decrease Deferasirox Mylan systemic exposure
Udseende og pakningsstørrelser for Deferasirox Mylan Deferasirox Mylan udleveres som filmovertrukne tabletter.
What Deferasirox Mylan looks like and contents of the pack Deferasirox Mylan is supplied as film-coated tablets.
Fanconis syndrom).
Syndrome).
Det skal du vide, før du begynder at tage Deferasirox Mylan
What you need to know before you take Deferasirox Mylan
Det kan ikke anbefales at tage deferasirox-tabletter sammen med aluminiumholdige antacidapræparater, selvom deferasirox har en lavere affinitet for aluminium end for jern.
Although deferasirox has a lower affinity for aluminium than for iron, it is not recommended to take deferasirox tablets with aluminium-containing antacid preparations.
I et studie med raske frivillige blev det påvist, at samtidig administration af deferasirox som CYP1A2hæmmer (gentagen dosis på 30 mg/kg daglig, dispergibel tablet-formulering) og CYP1A2-substratet theofyllin (enkeltdosis på 120 mg) øgede theofyllins-AUC med 84 % (90 % CI: 73 % til 95 %).
In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor (repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 73% to 95%).
≥ 5 mg Fe/g tørvægt eller > 800 µg/l
≥5 mg Fe/g dw or >800 µg/l
Transfusionsbetinget jernophobning:
Transfusional iron overload:
Aldersrelateret ULN
> age appropriate ULN