natgillin/translations-raw huggingface dataset:
Øvrige indholdsstoffer: Lactosemonohydrat, crospovidon type A, povidon, natriumlaurilsulfat, mikrokrystallinsk cellulose, kolloid vandfri silica, og magnesiumstearat.
The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium laurilsulfate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Hvor længe skal du tage EXJADE
How long to take EXJADE
Som konsekvens heraf skal EXJADE-behandling monitoreres omhyggeligt hos pædiatriske patienter for at opdage bivirkninger og følge jernmængden.
As a consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
Ugentligt og
Weekly and Weekly
Begrænsede kliniske data (29 patienter med normal hjertefunktion ved baseline), der blev opnået med MRI, indikerer, at behandling med deferasirox 10-30 mg/kg/dag (dispergibel tablet-formulering)i 1 år også kan reducere jern-niveauer i hjertet (i gennemsnit, MRI T2* øget fra 18,3 til 23,0 millisekunder).
Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds).
Det skal du vide, før du begynder at tage EXJADE
What you need to know before you take EXJADE
Hos dyr er der ikke observeret utilsigtede påvirkninger af hanner eller hunners fertilitet (se pkt.
In animals, no adverse effects on male or female fertility were found (see section 5.3).
Kreatininclearance ved transfusionsbetinget jernophobning 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 på 9,9% (95% CI: -11,1% til -8,6%; n=1.142) hos pædiatriske patienter.
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.
Dosisjusteringer kan gøres i trin af 5 til 10 mg/kg, og skal skræddersys til den enkelte patients respons og terapeutiske mål (vedligeholdelse eller reduktion af jernophobning).
Dose adjustments may be made in steps of 5 to 10 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden).
Biotilgængeligheden af deferasirox granulat var 52% højere end den for dispergible tabletter.
Bioavailability of deferasirox granules was 52% greater than that with dispersible tablets.
Doser over 40 mg/kg anbefales ikke, da der kun er begrænset erfaring med doser over dette niveau.
Doses above 40 mg/kg are not recommended because there is only limited experience with doses above this level.
• Hvis du oplever en kraftig nedsættelse af din urinproduktion (tegn på nyreproblemer)
• If you notice a marked decrease in your urine output (sign of kidney problem),
EXJADE indeholder
What EXJADE contains
Visse bivirkninger kan være alvorlige og kræve omgående lægehjælp Disse bivirkninger er ikke almindelige (kan påvirke op til 1 ud af 100 patienter) eller sjældne (kan påvirke op til 1 ud af 1.000 patienter).
These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).
Reduktion af daglig dosis med 10 mg/kg/dag (dispergible tablet), hvis følgende renale parametre er set ved to på hinanden følgende kontrolbesøg og ikke kan forklares af andre årsager
Reduction of daily dose by 10 mg/kg/day (dispersible tablet formulation), if following renal parameters are observed at two consecutive visits and cannot be attributed to other causes
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).
kortikosteroider), - orale bisphosphonater (bruges til behandling af osteoporose), - antikoagulerende medicin (bruges til at modvirke eller behandling af blodpropper), - hormonelle graviditetsforebyggende midler, - bepridil, ergotamin (bruges til behandling af hjerteproblemer og migræne), - repaglinid (bruges til at behandle sukkersyge), - rifampicin (bruges til at behandle tuberkulose), - phenytoin, phenobarbital, carbamazepin (bruges til at behandle epilepsi), - ritonavir (bruges i behandlingen af HIV-infektion), - paclitaxel (bruges i kræftbehandling), - theophyllin (bruges i behandlingen af lungesygdomme såsom astma), - clozapin (bruges til behandling af psykiske sygdomme såsom skizofreni), - tizanidin (virker muskelafslappende), - cholestyramin (bruges til at sænke kolesterolniveauet i blodet), - busulfan (bruges som behandling for at ødelægge den originale knoglemarv inden en transplantatation).
This includes in particular: - other iron chelators, which must not be taken with EXJADE, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as EXJADE, - ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis), - simvastatin (used to lower cholesterol), - certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), - oral bisphosphonates (used to treat osteoporosis), - anticoagulant medicines (used to prevent or treat blood clotting), - hormonal contraceptive agents (birth control medicines), - bepridil, ergotamine (used for heart problems and migraines), - repaglinide (used to treat diabetes), - rifampicin (used to treat tuberculosis), - phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), - ritonavir (used in the treatment of HIV infection), - paclitaxel (used in cancer treatment), - theophylline (used to treat respiratory diseases such as asthma), - clozapine (used to treat psychiatric disorders such as schizophrenia), - tizanidine (used as a muscle relaxant), - cholestyramine (used to lower cholesterol levels in the blood), - busulfan (used as a treatment prior to transplantation in order to destroy the original bone marrow before the transplant).
Studiet sammenlignede virkningen af to forskellige deferasirox dispergibel tabletbehandlinger (startdoser på 5 og 10 mg/kg/dag, 55 patienter i hver arm) og tilsvarende placebo (56 patienter).
The study compared the efficacy of two different deferasirox dispersible tablet regimens (starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients).
Døvhed Luftveje, thorax og mediastinum Ikke almindelig:
Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Pakningerne indeholder 28, 84 eller 252 dispergible tabletter og multipakninger indeholdende 294 (3 pakker med 98) dispergible tabletter.
Unit packs containing 28, 84 or 252 dispersible tablets and multipacks containing 294 (3 packs of 98) dispersible tablets.
Biotilgængeligheden af deferasirox filmovertrukne tabletter var 36% højere end den for dispergible tabletter.
Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets.
Dosisjusteringer kan gøres i trin af 3.5 til 7 mg/kg, og skal skræddersys til den enkelte patients respons og terapeutiske mål (vedligeholdelse eller reduktion af jernophobning).
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).
PVC/PVDC/Aluminium blisterpakninger
PVC/PVDC/Aluminium blisters.
Det fremgik af prækliniske og kliniske studier, at deferasirox dispergible tabletter kunne være ligeså aktivt som deferoxamin, når det blev administreret i en dosisratio på 2:1 (det vil sige en dosis af deferasirox dispergible tabletter, der numerisk er halvdelen af deferoxamindosis).
It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is numerically half of the deferoxamine dose).
forstørrede lymfekirtler (tegn på alvorlig hudreaktion, se også punkt 4 ”Bivirkninger”).
(signs of severe skin reaction, see also section 4 “Possible side effects”).
10 mg/kg/dag ≥5 mg Fe/g tørvægt eller >800 µg/l
10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l
Der var ingen klinisk relevante forskelle i sikkerhed og tolerabilitet af Exjade 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 Exjade 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%).
Efter justering af styrken var den filmovertrukne tablet-formulering (360 mg) ækvivalent med EXJADE dispergible tabletter (500 mg), hvad angik det gennemsnitlige areal under tidskurven for plasmakoncentrationen (AUC) under faste.
After adjustment of the strength, the film-coated tablet formulation (360 mg strength) was equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Månedlig monitorering af serum-ferritin 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 overchelation (see section 4.2).
Der er på nuværende tidspunkt begrænsede langtidseffekt- og sikkerhedsdata for EXJADE dispergible tabletter anvendt ved doser over 30 mg/kg (264 patienter fulgt i gennemsnitlig 1 år efter dosisoptrapning).
The availability of long-term efficacy and safety data with EXJADE dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation).
Kropsvægt, højde og seksuel udvikling Inden behandlingsstart.
Body weight, height and sexual development
I et klinisk studie, hvor der blev givet enkeltdoser på 20 mg/kg deferasirox dispergibel tabletter, var den gennemsnitlige eksponering øget med 16% hos personer med let nedsat leverfunktion (Child-Pugh 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.
Efter justering af styrken var granulat-formuleringen (4 x 90 mg) ækvivalent med EXJADE dispergible tabletter (500 mg), hvad angik det gennemsnitlige areal under tidskurven for plasmakoncentrationen (AUC) under faste.
After adjustment of the strength, the granules formulation (4 x 90 mg strength) was equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Der skal udvises forsigtighed hos alle patienter under kelatbehandling for at minimere risikoen for overkelering (se pkt.
Caution should be taken during chelation therapy to minimise the risk of overchelation in all patients (see section 4.4).
Efter markedsføring er leversvigt, som nogle gange var fatalt, blevet rapporteret med den dispergible tablet-formulering, specielt hos patienter med allerede eksisterende levercirrhosis (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).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Halv dosis af deferoxamin
Half of deferoxamine dose
Titandioxid (E171)
Titanium dioxide (E171) Macrogol (4000)
Der er på nuværende tidspunkt begrænsede langtidseffekt- og sikkerhedsdata fra udførte kliniske forsøg for EXJADE dispergible tabletter anvendt ved doser over 30 mg/kg (264 patienter fulgt i gennemsnitlig 1 år efter dosisoptrapning).
The availability of long-term efficacy and safety data from clinical studies conducted with EXJADE dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation).
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%).
De hyppigste reaktioner, der er rapporteret under kronisk behandling med deferasirox dispergible tabletter hos voksne og pædiatriske patienter, inkluderer gastrointestinale forstyrrelser (hovedsageligt kvalme, opkastning, diarré eller abdominale smerter) og hududslæt.
The most frequent reactions reported during chronic treatment with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash.
Magnesiumstearat Silica, kolloid vandfri Poloxamer
Magnesium stearate Silica, colloidal anhydrous Poloxamer
For patienter, som ikke kan sluge hele tabletter, kan EXJADE 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, EXJADE film-coated tablets may be crushed and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
Daglig behandling med den dispergible tablet-formulering 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 mg Fe/g lever (biopsi-tørvægt) i gennemsnit, og serum-ferritin 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.
Multipakning: 294 (3 pakninger med 98) dispergible tabletter
Multipack: 294 (3 packs of 98) dispersible tablets.
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).
Aktivt stof: Deferasirox.
The active substance is deferasirox.
• EXJADE 180 mg filmovertrukne tabletter er mellemblå præget med ”180” på den ene side og
• EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and
EXJADE 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 betatalassæmi major.
EXJADE 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.
EXJADE anbefales ikke til patienter med alvorligt nedsat leverfunktion (Child-Pugh Class C) (se pkt.
EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Tidlige tegn på akut overdosering er bivirkninger relateret til mave-tarm-kanalen såsom mavesmerter, diarré, kvalme og opkast.
Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting.
Under kliniske studier forekom dosisafhængige forhøjelser af serum-kreatinin hos omkring 36% af patienterne, selvom de fleste blev inden for normalområdet.
During clinical studies dose-dependent increases in serum creatinine occurred in about 36% of patients, though most remained within the normal range.
Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, povidon, magnesiumstearat, kolloid vandfri silica og poloxamer.
The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica and poloxamer.
EXJADE udleveres som dispergible (opløselige) tabletter.
EXJADE is supplied as dispersible tablets.
Doser over 20 mg/kg anbefales ikke, da der ikke er nogen erfaring med doser over dette niveau hos patienter med ikke-transfusionsafhængige talassæmi-syndromer.
Doses above 20 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes.
For deferasirox granulat kan en dosisratio på 3:1 overvejes (det vil sige at en dosis af deferasirox granulat, der numerisk er en tredjedel af deferoxamindosis).
For deferasirox granules, a dose ratio of 3:1 can be considered (i.e. a dose of deferasirox granules that is numerically one third of the deferoxamine dose).
Amning frarådes under behandling med EXJADE.
Breast-feeding is not recommended during treatment with EXJADE.
Interaktion med theophyllin og andre lægemidler metaboliseret af CYP1A2
Interaction with theophylline and other agents metabolised by CYP1A2
300 (10 pakker á 30) filmovertrukne tabletter
300 (10 packs of 30) film-coated tablets
Det vil også gøre det lettere for dig at huske, hvornår du skal tage dine tabletter.
Taking EXJADE at the same time each day will also help you remember when to take your tablets.
• Den ordinerende læge - et brev, som har følgende indhold: o En vejledning til den ordinerende læge, der informerer om skiftet mellem formulringer for at gøre opmærksom på den vigtige, mulige risiko for medicineringsfejl med deferasirox o En vejledning til patienten, som informerer om muligheden for samtidige formuleringer på EU-markedet og forskellen i mellem dem i forhold til deres administration.
• Prescribers - a letter including the following dossiers: o A prescribers' guide informing about the switch between formulations in order to address the important potential risk of medication error for deferasirox o A patient's guide informing about the possibility of co-existing formulations in the EU market, and the differences concerning their administration, in order to address the important potential risk of medication error for deferasirox Additionally, prescribers and pharmacists will be informed via a specific letter regarding the timelines for removing EXJADE dispersible tablets from the EU market.
Hos pædiatriske patienter med ikke-transfusionsafhængige talassæmi-syndromer bør dosis ikke overstige 10 mg/kg.
In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg.
Diarré er oftere set 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.
I et studie i metabolisk jernbalance hos voksne talassæmipatienter med jernophobning, forårsagede daglige defereasirox-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.
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.
84 dispergible tabletter
84 dispersible tablets
Pigmentforstyrrelser
Pigmentation disorder
Det anbefales, at serum-ferritin monitoreres hver måned for at kunne vurdere patientens repons 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).
Enkeltpakningerne indeholder 30 eller 90 filmovertrukne tabletter mens multipakningerne indeholder 300 (10 pakker á 30) filmovertrukne tabletter.
Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) film-coated tablets.
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.
EXJADE 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.