natgillin/translations-raw huggingface dataset:
Non-intervention post-authorisation safety study (PASS): Indehaveren af markedsføringstilladelsen skal udføre og indsende resultater af et sikkerhedsstudie gennemført i henhold til en protokol accepteret af CHMP, for at vurdere sikkerheden af deferasirox filmovertrukne tabletter i den pædiatriske population (særligt, når tabletterne knuses)
Interventional post-authorisation safety study (PASS): In order to assess the safety of deferasirox film-coated tablets in the paediatric population (especially when the tablets are crushed), the MAH shall conduct and submit the results of a safety study conducted according to an agreed protocol.
EXJADE 250 mg dispergible tabletter Pakningerne indeholder 28, 84 eller 252 dispergible tabletter.
EXJADE 250 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
EXJADE 180 mg filmovertrukne tabletter
EXJADE 180 mg film-coated tablets
3,5 - 7 mg/kg/dag 5-10 mg/kg/dag
3.5 - 7 mg/kg/day 5-10 mg/kg/day
Multipakningen indeholder 30 (10 pakninger med 30) filmovertrukne tabletter.
The multipacks contain 300 (10 packs of 30) film-coated tablets.
EXJADE indeholder lactose
EXJADE contains lactose
EXJADE 90 mg filmovertrukne tabletter EXJADE 180 mg filmovertrukne tabletter EXJADE 360 mg filmovertrukne tabletter Deferasirox
EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets Deferasirox
14 mg/kg/dag 20 mg/kg/dag
14 mg/kg/day 20 mg/kg/day
Sådan skal du tage EXJADE
How to take EXJADE
Selvom der ikke blev observeret en stigning af bivirkninger i nyrerne efter dosisoptrapning af EXJADE dispergible tabletter til doser over 30 mg/kg i kliniske studier, kan det ikke udelukkes, at der er en øget risiko for bivirkninger i nyrerne ved EXJADE dispergible tabletdoser over 30 mg/kg.
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with EXJADE dispersible tablet doses above 30 mg/kg cannot be excluded.
Selvom der ikke blev observeret en stigning af bivirkninger i nyrerne efter dosisoptrapning af EXJADE dispergible tabletter til doser over 30 mg/kg i kliniske studier, kan det ikke udelukkes, at der er en øget risiko for bivirkninger i nyrerne ved filmovertrukne tablet-doser over 21 mg/kg.
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded.
Omtrentlige tabletdimensioner 15 mm x 4,7 mm.
Approximate tablet dimensions 15 mm x 4.7 mm.
Hvornår skal du tage EXJADE
When to take EXJADE
• Brug ikke lægemidlet efter den udløbsdato, der står på blister og pakningen efter EXP og
• Do not use this medicine after the expiry date which is stated on the blister and the carton after
EXJADE anvendes til at behandle kronisk jernophobning hos patienter i alderen 6 år og derover med beta-talassæmi major forårsaget af hyppige blodtransfusioner.
EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
28 mg/kg/dag 40 mg/kg/dag
28 mg/kg/day 40 mg/kg/day
EXJADE 90 mg filmovertrukne tabletter
EXJADE 90 mg film-coated tablets
I tillæg, producerede deferasirox dispergible tabletter i dosis op til 20 og 30 mg/kg et fald i leverjernkoncentration og serum-ferritin sammenlignelig med det opnået hos patienter med beta-talassæmi.
In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia.
Granulatet bør indtages ved at drysse hele dosen ud over blød mad, som fx yoghurt eller æblemos.
The granules should be administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple).
EXJADE 360 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 360 mg deferasirox.
EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox.
Det kan ikke anbefales at tage deferasirox-granulat 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 granules with aluminium-containing antacid preparations.
Startdosis Anbefalet startdosis for EXJADE granulat er 14 mg/kg kropsvægt.
Starting dose The recommended initial daily dose of EXJADE granules is 14 mg/kg body weight.
EXJADE 180 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 180 mg deferasirox.
EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox.
EXJADE 180 mg granulat EU/1/06/356/021
EXJADE 180 mg granules EU/1/06/356/021
I tilfælde af behandlingsskift fra dispergible tabletter til granulat, skal dosis for granulatet være 30% lavere end dosis for dispergible tabletter, afrundet til nærmeste hele brev.
In case of switching from dispersible tablets to granules, the dose of the granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole sachet.
Selvom der ikke blev observeret en stigning af bivirkninger i nyrerne efter dosisoptrapning af EXJADE dispergible tabletter til doser over 30 mg/kg i kliniske studier, kan det ikke udelukkes, at der er en øget risiko for bivirkninger i nyrerne ved granulat-doser over 21 mg/kg.
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with granule doses above 21 mg/kg cannot be excluded.
Startdosis Anbefalet startdosis for EXJADE filmovertrukne tabletter er 14 mg/kg kropsvægt.
Starting dose The recommended initial daily dose of EXJADE film-coated tablets is 14 mg/kg body weight.
EXJADE 90 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 90 mg deferasirox.
EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox.
Når dette resulterer i en daglig dosis, der er mindre end 20 mg/kg kropsvægt, skal patientens respons monitoreres.
When this results in a daily dose less than 20 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).
EXJADE granulat udviser højere biotilgængelighed sammenlignet med EXJADE dispergible tabletter.
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Mørkeblå, ovale, bikonvekse, filmovertrukne tabletter med skrå kanter og prægning (NVR på den ene side og 360 på den anden side).
Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other).
EXJADE 360 mg granulat EU/1/06/356/022
EXJADE 360 mg granules EU/1/06/356/022
EXJADE 90 mg granulat i brev EXJADE 180 mg granulat i brev EXJADE 360 mg granulat i brev Deferasirox
EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet Deferasirox
EXJADE 180 mg filmovertrukne tabletter EU/1/06/356/014
EXJADE 180 mg film-coated tablets EU/1/06/356/014
EXJADE 90 mg granulat EU/1/06/356/020
EXJADE 90 mg granules EU/1/06/356/020
Natriumlaurilsulfat Silica, kolloid vandfri Magnesiumstearat
Sodium laurilsulfate Silica, colloidal anhydrous
• At deferasirox forårsager stigninger i serum-kreatinin hos visse patienter o Nødvendigheden af at monitorere serum-kreatinin To gange før påbegyndelse af behandling Hver uge den første måned ved påbegyndelse af behandling eller efter ændring af behanding
• That deferasirox causes rises in serum creatinine in some patients o The need to monitor serum creatinine
Mellemblå, ovale, bikonvekse, filmovertrukne tabletter med skrå kanter og prægning (NVR på den ene side og 180 på den anden side).
Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other).
EXJADE anvendes også til ikke-transfusionsafhængige patienter i alderen 10 år eller derover, der har fået jernophobning i forbindelse med deres talassæmi-syndromer, når deferoxamin-behandling er kontraindiceret eller utilstrækkelig.
EXJADE is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent.
EXJADE 360 mg filmovertrukne tabletter EU/1/06/356/017
EXJADE 360 mg film-coated tablets EU/1/06/356/017
EXJADE 125 mg dispergible tabletter
EXJADE 125 mg dispersible tablets
EXJADE 90 mg filmovertrukne tabletter EU/1/06/356/011
EXJADE 90 mg film-coated tablets EU/1/06/356/011
Exjade 180 mg granulat deferasirox
Exjade 180 mg granules deferasirox
Exjade 360 mg granulat deferasirox
Exjade 360 mg granules deferasirox
Ikke vurderet og ≤2.000 µg/l
10 mg/kg/day For adults not assessed and ≤2,000 µg/l
YDRE ÆSKE TIL DELPAKNING AF MULTIPAKNING (uden blå boks)
INTERMEDIATE CARTON OF MULTIPACK (without blue box)
EXJADE anvendes også til behandling af kronisk jernophobning, når deferoxamin ikke kan benyttes eller ikke har tilstrækkelig virkning hos patienter med beta-talassæmi major med jernophobning forårsaget af sjældne blodtransfusioner.
EXJADE 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.
EXJADE dispergible tabletter skal tages én gang dagligt på tom mave mindst 30 minutter før et måltid, helst på samme tidspunkt hver dag (se pkt.
EXJADE dispersible tablets must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2).
3,5 - 7 mg/kg/dag 5-10 mg/kg/dag Nedsat dosis
3.5 - 7 mg/kg/day 5-10 mg/kg/day Decrease
Exjade 360 mg filmovertrukne tabletter deferasirox
Exjade 360 mg film-coated tablets deferasirox
YDRE ÆSKE TIL MULTIPAKNING (INKLUSIV BLÅ PAKNING)
OUTER CARTON OF MULTIPACK (including blue box)
EXJADE 500 mg dispergible tabletter
EXJADE 500 mg dispersible tablets
Den anbefalede daglige initialdosis af EXJADE dispergible tabletter hos patienter med ikketransfusionsafhængige talassæmi-syndromer er 10 mg/kg kropsvægt.
The recommended initial daily dose of EXJADE dispersible tablets in patients with non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight.
Lyseblå, ovale, bikonvekse, filmovertrukne tabletter med skrå kanter og prægning (NVR på den ene side og 90 på den anden side).
Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
EXJADE 360 mg granulat Hvert brev indeholder 360 mg deferasirox.
EXJADE 360 mg granules Each sachet contains 360 mg deferasirox.
forstørrede lymfekirtler (tegn på alvorlige hudreaktioner)
(signs of severe skin reactions),
I de tilfælde, hvor afbrydelse af behandling kan være nødvendig, kan behandlingen påbegyndes igen efter udslættet er væk.
When interruption of treatment may be necessary, treatment may be reintroduced after resolution of the rash, at a lower dose followed by gradual dose escalation.
• Hvert brev med EXJADE 360 mg granulat indeholder 360 mg deferasirox.
• Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox.
EXJADE 180 mg granulat Hvert brev indeholder 180 mg deferasirox.
EXJADE 180 mg granules Each sachet contains 180 mg deferasirox.
Den bløde mad med granulatet skal tages med eller uden et let måltid én gang dagligt, helst på samme tidspunkt hver dag (se pkt.
The soft food containing the granules should be taken with or without a light meal, once a day,
Exjade 180 mg filmovertrukne tabletter deferasirox
Exjade 180 mg film-coated tablets deferasirox
EXJADE filmovertrukne tabletter udviser højere biotilgængelighed sammenlignet med EXJADE dispergible tabletter (se pkt.
EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Den anbefalede daglige initialdosis af EXJADE granulat hos patienter med ikketransfusionsafhængige talassæmi-syndromer er 7 mg/kg kropsvægt.
The recommended initial daily dose of EXJADE granules in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
EXJADE 90 mg granulat Hvert brev indeholder 90 mg deferasirox.
EXJADE 90 mg granules Each sachet contains 90 mg deferasirox.
Den anbefalede daglige initialdosis af EXJADE filmovertrukne tabletter hos patienter med ikketransfusionsafhængige talassæmi-syndromer er 7 mg/kg kropsvægt.
The recommended initial daily dose of EXJADE film-coated tablets in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
EXJADE 125 mg dispergible tabletter Hver dispergibel tablet indeholder 125 mg deferasirox.
EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox.
Hvide til svagt gule, runde, flade tabletter med skrå kanter og prægning (NVR på den ene side og J 125 på den anden side).
White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
• Hvert brev med EXJADE 180 mg granulat indeholder 180 mg deferasirox.
• Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox.
EXJADE 125 mg dispergible tabletter EU/1/06/356/001
EXJADE 125 mg dispersible tablets EU/1/06/356/001
Hvide til svagt gule, runde, flade tabletter med skrå kanter og prægning (NVR på den ene side og J 250 på den anden side).
White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
EXJADE 250 mg dispergible tabletter
EXJADE 250 mg dispersible tablets
Dobbeltbestemmelse inden behandling.
• On two occasions prior to initiation of treatment
EXJADE 90 mg granulat i brev EXJADE 180 mg granulat i brev EXJADE 360 mg granulat i brev
EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet
Exjade 90 mg filmovertrukne tabletter deferasirox
Exjade 90 mg film-coated tablets deferasirox
Hvide til svagt gule, runde, flade tabletter med skrå kanter og prægning (NVR på den ene side og J 500 på den anden side).
White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
EXJADE 250 mg dispergible tabletter EU/1/06/356/003
EXJADE 250 mg dispersible tablets EU/1/06/356/003
Hver dispergibel tablet indeholder 125 mg deferasirox.
Each dispersible tablet contains 125 mg of deferasirox.
EXJADE 250 mg dispergible tabletter Hver dispergibel tablet indeholder 250 mg deferasirox.
EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox.
EXJADE 500 mg dispergible tabletter EU/1/06/356/005
EXJADE 500 mg dispersible tablets EU/1/06/356/005
Enkeltpakningerne indeholder 30 breve.
Unit packs containing 30 sachets.
• Hvert brev med EXJADE 90 mg granulat indeholder 90 mg deferasirox.
• Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox.
EXJADE 500 mg dispergible tabletter Hver dispergibel tablet indeholder 500 mg deferasirox.
EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox.
EXJADE 125 mg dispergible tabletter deferasirox
EXJADE 125 mg dispersible tablets deferasirox
Eksempelvis kan en patient, der modtager 40 mg/kg/dag af deferoxamin fem dage om ugen (eller tilsvarende), overføres til en daglig startdosis på 20 mg/kg/dag af EXJADE dispergible tabletter.
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE dispersible tablets that is numerically half that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/kg/day of EXJADE dispersible tablets).
Hver filmovertrukken tablet af EXJADE180 mg indeholder 180 mg deferasirox.
• Each film-coated tablet of EXJADE 180 mg contains 180 mg deferasirox.
EXJADE granulat udviser højere biotilgængelighed sammenlignet med EXJADE dispergible tabletter (se pkt.
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Hver filmovertrukken tablet af EXJADE360 mg indeholder 360 mg deferasirox.
• Each film-coated tablet of EXJADE 360 mg contains 360 mg deferasirox.
EXJADE 500 mg dispergible tabletter deferasirox
EXJADE 500 mg dispersible tablets deferasirox
Afbrydelse af behandlingen skal overvejes, hvis serum-ferritin falder konsekvent under 500 µg/l (se pkt.
If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should be considered (see section 4.4).
Hver filmovertrukken tablet af EXJADE90 mg indeholder 90 mg deferasirox.
• Each film-coated tablet of EXJADE 90 mg contains 90 mg deferasirox.
EXJADE 250 mg dispergible tabletter deferasirox
EXJADE 250 mg dispersible tablets deferasirox
En startdosis på 30 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 30 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).
Eksempelvis kan en patient, der modtager 40 mg/kg/dag af deferoxamin fem dage om ugen (eller tilsvarende), overføres til en daglig startdosis på 14 mg/kg/dag af EXJADE granulat.
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE granules that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE granules).
30 mg/kg/dag
30 mg/kg/day
En startdosis på 10 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 10 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).
10 mg/kg/dag
10 mg/kg/day
Pancytopeni1, trombocytopeni1, forværret anæmi1, neutropeni1
Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, erythema multiforme
Eksempelvis kan en patient, der modtager 40 mg/kg/dag af deferoxamin fem dage om ugen (eller tilsvarende), overføres til en daglig startdosis på 14 mg/kg/dag af EXJADE filmovertrukne tabletter.
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE film-coated tablets).
Hver EXJADE dispergibel tablet 125 mg indeholder 125 mg deferasirox.
• Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Hver dispergibel tablet indeholder 500 mg deferasirox.
Each dispersible tablet contains 500 mg of deferasirox.
Hver dispergibel tablet indeholder 250 mg deferasirox.
Each dispersible tablet contains 250 mg of deferasirox.
Hver tablet indeholder 180 mg of deferasirox.
Each tablet contains 180 mg of deferasirox.
Hver tablet indeholder 90 mg deferasirox.
Each tablet contains 90 mg of deferasirox.
EXJADE er yderligere indiceret til behandling af kronisk jernophobning, forårsaget af blodtransfusioner, i de tilfælde hvor deferoxamin-behandling er kontraindiceret eller utilstrækkelig.
EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.
• Den sædvanlige daglige dosis af EXJADE granulat ved start af behandlingen for patienter, der ikke får regelmæssige blodtransfusioner, er 7 mg pr. kg kropsvægt.
• The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Hver tablet indeholder 360 mg of deferasirox.
Each tablet contains 360 mg of deferasirox.
Hver EXJADE dispergibel tablet 250 mg indeholder 250 mg deferasirox.
• Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
EU/1/06/356/022 30 breve
EU/1/06/356/022 30 sachets
• Den sædvanlige daglige dosis af EXJADE filmovertrukne tabletter ved start af behandlingen for patienter, der ikke får regelmæssige blodtransfusioner, er 7 mg pr. kg kropsvægt.
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
• Den sædvanlige dosis af EXJADE granulat ved start af behandling for patienter, der får regelmæssige blodtransfusioner er 14 mg pr. kg kropsvægt.
• The usual daily dose for EXJADE granules at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
• Den sædvanlige dosis af EXJADE dispergible tabletter ved start af behandlingen for patienter, der får regelmæssige blodtransfusioner, er 20 mg pr. kg kropsvægt.
• The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients receiving regular blood transfusions is 20 mg per kilogram body weight.
• Den sædvanlige daglige dosis af EXJADE dispergible tabletter ved start af behandlingen for patienter, der ikke får regelmæssige blodtransfusioner, er 10 mg pr. kg kropsvægt.
• The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 mg per kilogram body weight.
Målinterval
Target range
Hver EXJADE dispergibel tablet 500 mg indeholder 500 mg deferasirox.
• Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox.
EU/1/06/356/020 30 breve
EU/1/06/356/020 30 sachets
• Den sædvanlige dosis af EXJADE filmovertrukne tabletter ved start af behandling for patienter, der får regelmæssige blodtransfusioner er 14 mg pr. kg kropsvægt.
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
EU/1/06/356/021 30 breve
EU/1/06/356/021 30 sachets
Exjade 360 mg granulat i brev deferasirox
Exjade 360 mg granules in sachet deferasirox
Exjade 180 mg granulat i brev deferasirox
Exjade 180 mg granules in sachet deferasirox
Inden behandling.
Prior to therapy.
Dosis må ikke overstige 10 mg/kg hos patienter, hvor LIC ikke blev bestemt, og serumferritin er ≤ 2000 µg/l.
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
1, nefrolitiasis
1, hypersensitivity vasculitis
EXJADE udleveres som filmovertrukne tabletter.
What EXJADE looks like and contents of the pack EXJADE is supplied as film-coated tablets.
Det skal du vide, før du begynder at tage EXJADE Sådan skal du tage EXJADE Bivirkninger
What EXJADE is and what it is used for What you need to know before you take EXJADE How to take EXJADE
Exjade 90 mg granulat i brev deferasirox
Exjade 90 mg granules in sachet deferasirox
Exjade 90 mg granulat deferasirox Oral anvendelse
Exjade 90 mg granules deferasirox