FrancophonIA/ELRC3.0 huggingface dataset:
English: After every 3 to 6 months of treatment, a dose increase in increments of 3.5 to 7 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well.
Estonian: Pärast 3 kuni 6 ravikuud tuleks kaaluda annuse suurendamist 3,5 kuni 7 mg/kg võrra juhul, kui patsiendi LIC on ≥7 mg Fe/g dw või seerumi ferritiini tase on püsivalt >2000 µg/l ega näita langustrendi ning kui patsient talub ravimpreparaati hästi.
English: If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible.
Estonian: Kui üle 30 mg/kg annuste korral ei saavutata piisavat ravivastust, ei tohiks selliste annustega ravi jätkata ning võimalusel tuleks kaaluda alternatiivseid raviviise.
English: The granules should be administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple).
Estonian: Graanuleid manustatakse lisades kogu annus pehme toidu sisse, nt jogurti või õunapüree sisse.
English: EXJADE dispersible tablets must therefore be taken on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.2 and 5.2).
Estonian: Seetõttu peab EXJADE dispergeeruvaid tablette võtma tühja kõhuga vähemalt 30 minutit enne sööki, eelistatavalt iga päev samal kellaajal (vt lõigud 4.2 ja 5.2).
English: 28 mg/kg/day 40 mg/kg/day
Estonian: 28 mg/kg/ööpäevas 40 mg/kg/ööpäevas
English: 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%).
Estonian: Koostoime teofülliini ja teiste CYP1A2 vahendusel metaboliseeritavate ravimitega Tervetel vabatahtlikel teostatud uuringus suurendas deferasiroksi kui CYP1A2 inhibiitori (korduvad annused suuruses 30 mg/kg kehakaalu kohta ööpäevas, dispergeeruvad tabletid) ja CYP1A2 substraadi teofülliini (120 mg suurune üksikannus) samaaegne manustamine teofülliini AUC väärtust 84% (90% CI: 73...95%).
English: If you are switching from the film-coated tablets or granules to these dispersible tablets, you will need an adjustment of the dose.
Estonian: Kui te saite ravi õhukese polümeerikattega tablettide või graanulitega, kuid hakkate saama dispergeeruvaid tablette, tuleb ravimi annust kohandada.
English: Interruption of EXJADE therapy should be considered in patients who develop metabolic acidosis.
Estonian: Metaboolse atsidoosi välja kujunemisel tuleb patsiendil kaaluda EXJADE-ravi katkestamist.
English: After every 3 to 6 months of treatment, a dose increase in increments of 5 to 10 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well.
Estonian: Pärast 3 kuni 6 ravikuud tuleks kaaluda annuse suurendamist 5 kuni 10 mg/kg võrra juhul, kui patsiendi LIC on ≥7 mg Fe/g dw või seerumi ferritiini tase on püsivalt >2000 µg/l ega näita langustrendi ning kui patsient talub ravimpreparaati hästi.
English: When the granules were administered with apple sauce or yogurt, a food effect was absent.
Estonian: Toidu mõju puudus, kui graanuleid manustati koos õunapüree või jogurtiga.
English: For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Estonian: Patsientidel, kellel on annust suurendatud kuni >10 mg/kg, tuleks annust vähendada kuni 10 mg/kg või väiksemaks juhul, kui LIC on <7 mg Fe/g dw või seerumi ferritiini tase on ≤2000 µg/l.
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg.
Estonian: Patsientidel, kellel ei ole määratud LIC ja kelle seerumi ferritiini tase on ≤2000 µg/l, ei tohiks annus ületada 7 mg/kg.
English: For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Estonian: Patsientidel, kellel on annust suurendatud kuni >7 mg/kg, tuleks annust vähendada kuni 7 mg/kg või väiksemaks juhul, kui LIC on <7 mg Fe/g dw või seerumi ferritiini tase on ≤2000 µg/l.
English: Multipack: 300 (10 packs of 30) film-coated tablets
Estonian: Hulgipakend: 300 (10 pakendit, igas 30) õhukese polümeerikattega tabletti
English: Cardiac function should be monitored in patients with severe iron overload during long-term treatment with EXJADE.
Estonian: Pikaajalise EXJADE-ravi ajal tuleb raua raske ülekoormusega patsientidel kontrollida südametalitlust.
English: OUTER CARTON OF MULTIPACK (including blue box)
Estonian: HULGIPAKENDI KARP (SEALHULGAS BLUE BOX)
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Estonian: HULGIPAKENDI KARP (sealhulgas blue box)
English: Cellulose, microcrystalline Crospovidone Povidone
Estonian: Mikrokristalliline tselluloos Krospovidoon
English: 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).
Estonian: Ravimit EXJADE dispergeeruvad tabletid tuleb võtta üks kord ööpäevas tühja kõhuga vähemalt 30 minutit enne sööki, eelistatavalt iga päev samal ajal (vt lõigud 4.5 ja 5.2).
English: Changes in weight of paediatric patients over time must be taken into account when calculating the dose.
Estonian: Annuse arvutamisel tuleb arvesse võtta lapse aja jooksul muutuvat kaalu.
English: Approximate tablet dimensions 15 mm x 4.7 mm.
Estonian: Tableti ligikaudsed mõõtmed on 15 mm x 4,7 mm.
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
Estonian: Patsientidel, kellel ei ole määratud LIC ja kelle seerumi ferritiini tase on ≤2000 µg/l, ei tohiks annus ületada 10 mg/kg.
English: “NVR” on the other.
Estonian: „90” ühele küljele ja „NVR” teisele küljele.
English: • Low urine output
Estonian: • Uriinierituse vähenemine
English: EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
Estonian: EXJADE graanulite kogu annus lisada pehme toidu sisse, nt jogurti või õunapüree sisse.
English: Elimination
Estonian: Vähendamine
English: • EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and
Estonian: • EXJADE 180 mg õhukese polümeerikattega tabletid on sinised ning tablettidel on märgitu
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Aeg-ajalt:
English: EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Estonian: EXJADE õhukese polümeerikattega tablettidel on suurem biosaadavus kui EXJADE dispergeeruvatel tablettidel.
English: If you are switching from the dispersible tablets to these granules, you will need an adjustment of the dose.
Estonian: Kui te saite ravi dispergeeruvate tablettidega, kuid hakkate saama graanuleid, tuleb ravimi annust kohandada.
English: constipation, indigestion
Estonian: kõhukinnisus, seedehäire
English: 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.
Estonian: EXJADEt kasutatakse ka nende 10-aastaste ja vanemate patsientide raviks, kellel on talasseemia sündroomiga seostatud raua ülekoormus, aga kes ei ole sõltuvad vereülekannetest juhul, kui ravi deferoksamiiniga on vastunäidustatud või ebapiisav.
English: EXJADE 180 mg granules EU/1/06/356/021
Estonian: EXJADE 180 mg graanulid EU/1/06/356/021
English: EXJADE 90 mg granules EU/1/06/356/020
Estonian: EXJADE 90 mg graanulid EU/1/06/356/020
English: The recommended initial daily dose of EXJADE dispersible tablets in patients with non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight.
Estonian: EXJADE dispergeeruvate tablettide soovituslik päevane algannus vereülekannetest mittesõltuva talasseemia sündroomi korral on 10 mg/kg kehakaalu kohta.
English: ≥7 mg Fe/g dw or >2,000 µg/l
Estonian: ≥7 mg Fe/g dw või >2000 µg/l
English: EXJADE 125 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
Estonian: EXJADE 125 mg dispergeeruvad tabletid 28, 84 või 252 dispergeeruvat tabletti pakendis.
English: EXJADE 360 mg granules EU/1/06/356/022
Estonian: EXJADE 360 mg graanulid EU/1/06/356/022
English: 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).
Estonian: Patsientide puhul, kes alluvad hästi ravile deferoksamiiniga, võib kaaluda EXJADE dispergeeruvate tablettide algannuse kasutamist, mis on arvuliselt poole väiksem deferoksamiini annusest (nt deferoksamiini annuse 40 mg/kg ööpäevas 5 päeval nädalas (või samaväärne) võib asendada EXJADE dispergeeruvate tablettide algannusega 20 mg/kg ööpäevas).
English: EXJADE 250 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
Estonian: EXJADE 250 mg dispergeeruvad tabletid 28, 84 või 252 dispergeeruvat tabletti pakendis.
English: There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules were administered with food.
Estonian: EXJADE graanulite manustamisel koos toiduga ei muutunud oluliselt deferasiroksi farmakokineetika.
English: Magnesium stearate Silica, colloidal anhydrous Poloxamer
Estonian: Magneesiumstearaat Kolloidne veevaba ränidioksiid Poloksameer
English: EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
Estonian: EXJADE on näidustatud sagedastest vereülekannetest tingitud raua kroonilise ülekoormuse raviks raske beetatalasseemiaga patsientidel vanuses alates 6 aasta vanusest.
English: If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose.
Estonian: Kui te saite ravi dispergeeruvate tablettidega, kuid hakkate saama õhukese polümeerikattega tablette, tuleb ravimi annust kohandada.
English: In patients not adequately controlled with doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 28 mg/kg may be considered.
Estonian: Patsientidel, kellel 21 mg/kg annused ei avalda piisavat toimet (nt seerumi ferritiini tase on püsivalt üle 2500 µg/l, mis aja jooksul ei alane), võib kaaluda kuni 28 mg/kg annuste kasutamist.
English: 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.
Estonian: Kuigi kliinilistes uuringutes ei täheldatud renaalseid kõrvaltoimeid pärast EXJADE dispergeeruvate tablettide annuse tõstmist üle 30 mg/kg, ei saa EXJADE dispergeeruvate tablettide üle 30 mg/kg annuste korral välistada renaalsete kõrvaltoimete tekke riski suurenemist.
English: Non-transfusion-dependent thalassaemia syndromes
Estonian: Vereülekannetest mittesõltuva talasseemia sündroom
English: 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).
Estonian: Patsientide puhul, kes alluvad hästi ravile deferoksamiiniga, võib kaaluda EXJADE graanulite algannuse kasutamist, mis on arvuliselt üks kolmandik deferoksamiini annusest (nt deferoksamiini annuse 40 mg/kg ööpäevas 5 päeval nädalas (või samaväärne) võib asendada EXJADE graanulite algannusega 14 mg/kg ööpäevas).
English: 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.
Estonian: Kuigi kliinilistes uuringutes ei täheldatud renaalseid kõrvaltoimeid pärast EXJADE dispergeeruvate tablettide annuse tõstmist üle 30 mg/kg, ei saa graanulite üle 21 mg/kg annuste korral välistada renaalsete kõrvaltoimete tekke riski suurenemist.
English: In patients not adequately controlled with doses of 30 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 40 mg/kg may be considered.
Estonian: Patsientidel, kellel 30 mg/kg annused ei avalda piisavat toimet (nt seerumi ferritiini tase on püsivalt üle 2500 µg/l, mis aja jooksul ei alane), võib kaaluda kuni 40 mg/kg annuste kasutamist.
English: Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving deferasirox.
Estonian: Deferasiroksi saavatel patsientidel, kaasa arvatud lastel ja noorukitel, on kirjeldatud seedetrakti ülemise osa haavandeid ja hemorraagiat.
English: • A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia)
Estonian: punaste vereliblede vähesus (aneemia süvenemine), valgete vereliblede vähesus (neutropeenia)
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Estonian: EXJADE graanulitel on suurem biosaadavus kui EXJADE dispergeeruvatel tablettidel.
English: EXJADE 90 mg film-coated tablets
Estonian: EXJADE 90 mg õhukese polümeerikattega tabletid
English: EXJADE 360 mg film-coated tablets EU/1/06/356/017
Estonian: EXJADE 360 mg õhukese polümeerikattega tabletid EU/1/06/356/017
English: EXJADE 250 mg dispersible tablets
Estonian: EXJADE 250 mg dispergeeruvad tabletid
English: EXJADE 180 mg film-coated tablets EU/1/06/356/014
Estonian: EXJADE 180 mg õhukese polümeerikattega tabletid EU/1/06/356/014
English: In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg.
Estonian: Vereülekannetest mittesõltuva talasseemia sündroomiga lastel ei tohiks annus ületada 10 mg/kg.
English: EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox.
Estonian: EXJADE 125 mg dispergeeruvad tabletid Üks dispergeeruv tablett sisaldab 125 mg deferasiroksi (deferasiroxum).
English: Each tablet contains 360 mg of deferasirox.
Estonian: Üks kotike sisaldab 360 mg deferasiroksi.
English: 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.
Estonian: Kuigi kliinilistes uuringutes ei täheldatud renaalseid kõrvaltoimeid pärast EXJADE dispergeeruvate tablettide annuse tõstmist üle 30 mg/kg, ei saa õhukese polümeerikattega tablettide üle 21 mg/kg annuste korral välistada renaalsete kõrvaltoimete tekke riski suurenemist.
English: In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 7 mg/kg.
Estonian: Vereülekannetest mittesõltuva talasseemia sündroomiga lastel ei tohiks annus ületada 7 mg/kg.
English: EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets
Estonian: EXJADE 90 mg õhukese polümeerikattega tabletid EXJADE 180 mg õhukese polümeerikattega tabletid EXJADE 360 mg õhukese polümeerikattega tabletid
English: In case of switching from film-coated tablets/granules to dispersible tablets, the dose of dispersible tablets should be 40% higher than the dose of film-coated tablets/granules, rounded to the nearest whole tablet.
Estonian: Kui patsient viiakse õhukese polümeerikattega tablett/graanulravilt üle ravile dispergeeruvate tablettidega, tuleb dispergeeruvate tablettide korral kasutada 40% suuremat annust, mis tuleb ümardada lähimale terve tableti annusele.
English: Creatinine clearance in transfusional iron overload
Estonian: Annustamissoovitused vereülekandest tingitud raua ülekoormuse korral
English: Coating material:
Estonian: Tabletikatte koostis:
English: 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).
Estonian: Patsientide puhul, kes alluvad hästi ravile deferoksamiiniga, võib kaaluda EXJADE õhukese polümeerikattega tablettide algannuse kasutamist, mis on arvuliselt üks kolmandik deferoksamiini annusest (nt deferoksamiini annuse 40 mg/kg ööpäevas 5 päeval nädalas (või samaväärne) võib asendada EXJADE õhukese polümeerikattega tablettidega algannusega 14 mg/kg ööpäevas).
English: • Obligation to conduct post-authorisation measures
Estonian: • Riski minimeerimise lisameetmed
English: EXJADE 125 mg dispersible tablets EU/1/06/356/001
Estonian: EXJADE 125 mg dispergeeruvad tabletid EU/1/06/356/001
English: In severe cases this reintroduction could be conducted in combination with a short period of oral steroid administration.
Estonian: Rasketel juhtudel võib ravi uuesti alustamisel kasutada lühiajaliselt suukaudset hormoonravi.
English: EXJADE 90 mg film-coated tablets EU/1/06/356/011
Estonian: EXJADE 90 mg õhukese polümeerikattega tabletid EU/1/06/356/011
English: Interruption
Estonian: Annustamine
English: Each dispersible tablet contains 125 mg of deferasirox.
Estonian: Üks dispergeeruv tablett sisaldab 125 mg deferasiroksi.
English: The multipacks contain 300 (10 packs of 30) film-coated tablets.
Estonian: Hulgipakendis on 300 (10 pakendit, igas 30) õhukese polümeerikattega tabletti.
English: EXJADE 500 mg dispersible tablets EU/1/06/356/005
Estonian: EXJADE 500 mg dispergeeruvad tabletid EU/1/06/356/005
English: EXJADE 125 mg dispersible tablets
Estonian: EXJADE 125 mg dispergeeruvad tabletid
English: EXJADE 250 mg dispersible tablets EU/1/06/356/003
Estonian: EXJADE 250 mg dispergeeruvad tabletid EU/1/06/356/003
English: Unit packs containing 30 sachets.
Estonian: Üksikpakendis on 30 kotikest.
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Estonian: Valged kuni õrnkollased, ümmargused, lamedad, kaldservade ja markeeringuga tabletid (NVR ühel ja J 125 teisel küljel).
English: The recommended initial daily dose of EXJADE film-coated tablets in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Estonian: EXJADE õhukese polümeerikattega tablettide soovituslik päevane algannus vereülekannetest mittesõltuva talasseemia sündroomi korral on 7 mg/kg kehakaalu kohta.
English: EXJADE 250 mg dispersible tablets deferasirox
Estonian: EXJADE 250 mg dispergeeruvad tabletid deferasiroxum
English: EXJADE 125 mg dispersible tablets deferasirox
Estonian: EXJADE 125 mg dispergeeruvad tabletid deferasiroxum
English: EXJADE 500 mg dispersible tablets
Estonian: EXJADE 500 mg dispergeeruvad tabletid
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with EXJADE.
Estonian: Renaalse tubulopaatia teket on kirjeldatud peamiselt EXJADEiga ravitavatel beetatalasseemiaga lastel ja noorukitel.
English: Each tablet contains 90 mg of deferasirox.
Estonian: Üks kotike sisaldab 90 mg deferasiroksi.
English: EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox.
Estonian: EXJADE 250 mg dispergeeruvad tabletid Üks dispergeeruv tablett sisaldab 250 mg deferasiroksi (deferasiroxum).
English: EU/1/06/356/022 30 sachets
Estonian: EU/1/06/356/022 30 kotikest
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).
Estonian: Ööpäevase algannuse 7 mg/kg kasutamist võib kaaluda patsientidel, kes ei vaja organismi rauasisalduse vähendamist ning kes saavad ka erütrotsüütide massi vähem kui 7 ml/kg/kuus (ligikaudu <2 ühikut/kuus täiskasvanu puhul).
English: EXJADE 500 mg dispersible tablets deferasirox
Estonian: EXJADE 500 mg dispergeeruvad tabletid deferasiroxum
English: Each tablet contains 180 mg of deferasirox.
Estonian: Üks kotike sisaldab 180 mg deferasiroksi.
English: Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
Estonian: Helesinised, ovaalsed, kaksikkumerad, kaldservade ja markeeringuga õhukese polümeerikattega tabletid (NVR ühel ja 90 teisel küljel).
English: EXJADE 360 mg granules Each sachet contains 360 mg deferasirox.
Estonian: EXJADE 360 mg graanulid Üks kotike sisaldab 360 mg deferasiroksi (deferasiroxum).
English: EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets Deferasirox
Estonian: EXJADE 90 mg õhukese polümeerikattega tabletid EXJADE 180 mg õhukese polümeerikattega tabletid EXJADE 360 mg õhukese polümeerikattega tabletid deferasiroks (deferasiroxum)
English: EXJADE 90 mg granules Each sachet contains 90 mg deferasirox.
Estonian: EXJADE 90 mg graanulid Üks kotike sisaldab 90 mg deferasiroksi (deferasiroxum).
English: EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox.
Estonian: EXJADE 500 mg dispergeeruvad tabletid Üks dispergeeruv tablett sisaldab 500 mg deferasiroksi (deferasiroxum).
English: 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).
Estonian: Ööpäevase algannuse 10 mg/kg kasutamist võib kaaluda patsientidel, kes ei vaja organismi rauasisalduse vähendamist ning kes saavad ka erütrotsüütide massi vähem kui 7 ml/kg/kuus (ligikaudu <2 ühikut/kuus täiskasvanu puhul).
English: 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l
Estonian: ≥5 mg Fe/g dw või >800 µg/l
English: Target range
Estonian: Eesmärkvah emik
English: EU/1/06/356/020 30 sachets
Estonian: EU/1/06/356/020 30 kotikest
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).
Estonian: Ööpäevase algannuse 21 mg/kg kasutamist võib kaaluda patsientidel, kes vajavad organismi suurenenud rauasisalduse vähendamist ning kes saavad ka erütrotsüütide massi üle 14 ml/kg/kuus (ligikaudu >4 ühikut/kuus täiskasvanu puhul).
English: EU/1/06/356/021 30 sachets
Estonian: EU/1/06/356/021 30 kotikest
English: • Tiredness
Estonian: • Neerukivid
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
Estonian: Valged kuni õrnkollased, ümmargused, lamedad, kaldservade ja markeeringuga tabletid (NVR ühel ja J 250 teisel küljel).
English: The bioavailability (AUC) of deferasirox was moderately (approx. 13-25%) elevated when taken 30 minutes before meals with normal or high fat content.
Estonian: Kui ravimit võeti 30 minutit enne tavalise või suure rasvasisaldusega einet, siis suurenes deferasiroksi biosaadavus (AUC) mõõdukalt (ligikaudu 13...25%).