FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE v obliki disperzibilnih tablet številčno enak polovici odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/kg/dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 20 mg/kg/dan zdravila EXJADE v obliki disperzibilnih tablet).
English: EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
Slovenian: Zrnca je treba odmerjati tako, da se celoten odmerek primeša mehki hrani, na primer jogurtu ali jabolčni kaši.
English: Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units (about 100 ml/kg) of PRBC
Slovenian: 14 mg/kg/dan 20 mg/kg/dan po 20 enotah (približno
English: • EXJADE 250 mg tablets are stamped “J 250” on one side and “NVR” on the other.
Slovenian: • Tablete zdravila EXJADE 250 mg imajo na eni strani vtisnjeno oznako “J 250”, na drugi pa
English: These will monitor the amount of iron in your body (blood level of ferritin) to see how well EXJADE is working.
Slovenian: Spremljanje vašega zdravljenja z zdravilom EXJADE Med zdravljenjem bodo z rednimi preiskavami krvi in urina spremljali količino železa v vašem telesu (vrednost feritina v krvi), da bi ugotovili, kako dobro učinkuje zdravilo EXJADE.
English: The multipacks contain 300 (10 packs of 30) film-coated tablets.
Slovenian: Skupno pakiranje vsebuje 300 (10 pakiranj po 30) filmsko obloženih tablet.
English: OUTER CARTON OF MULTIPACK (including blue box)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (vključno z modrim okencem)
English: Anxiety, sleep disorder
Slovenian: tesnoba, motnje spanja
English: Care should be taken to maintain adequate hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), particularly in children with acute illness.
Slovenian: Pri bolnikih s težavami, ki povzročajo izgubo tekočine, (kot sta diareja in bruhanje), zlasti pri otrocih z akutno boleznijo, je treba poskrbeti za zadostno hidriranost organizma.
English: EXJADE 90 mg film-coated tablets
Slovenian: EXJADE 90 mg filmsko obložene tablete
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Slovenian: Zdravilo EXJADE v obliki zrnc ima večjo biološko uporabnost v primerjavi z zdravilom EXJADE v obliki disperzibilnih tablet (glejte poglavje 5.2).
English: • EXJADE 500 mg tablets are stamped “J 500” on one side and “NVR” on the other.
Slovenian: • Tablete zdravila EXJADE 500 mg imajo na eni strani vtisnjeno oznako “J 500”, na drugi pa
English: >2,500 µg/l
Slovenian: zviševanje pri >2.500 µg/l
English: Dizziness
Slovenian: gluhost
English: Starting dose The recommended initial daily dose of EXJADE granules is 14 mg/kg body weight.
Slovenian: Začetni odmerek Priporočeni začetni dnevni odmerek zdravila EXJADE v obliki zrnc je 14 mg/kg telesne mase.
English: Starting dose The recommended initial daily dose of EXJADE film-coated tablets is 14 mg/kg body weight.
Slovenian: Priporočeni začetni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet je 14 mg/kg telesne mase.
English: Breast-feeding is not recommended during treatment with EXJADE.
Slovenian: Med zdravljenjem z zdravilom EXJADE dojenje ni priporočljivo.
English: 3.5 - 7 mg/kg/day 5-10 mg/kg/day Decrease
Slovenian: 3,5 - 7 mg/kg/dan 5-10 mg/kg/dan zniževanje
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.
Slovenian: Pri bolnikih, ki niso ustrezno urejeni ob zdravljenju z odmerkom 30 mg/kg (pri katerih na primer koncentracija feritina v serumu vztraja nad 2.500 µg/l in ne kaže trenda zniževanja s časom), je mogoče razmisliti o uporabi odmerkov do 40 mg/kg.
English: 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.
Slovenian: Zdravilo EXJADE je indicirano tudi za zdravljenje kronične preobremenitve z železom, ko je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri bolnikih, ki potrebujejo terapijo s kelacijo železa in so stari 10 let ali več ter imajo katerega od sindromov talasemije, neodvisnih od transfuzij.
English: EXJADE 180 mg film-coated tablets EU/1/06/356/014
Slovenian: EXJADE 180 mg filmsko obložene tablete EU/1/06/356/014
English: Most of these patients had pre-existing haematological disorders that are frequently associated with bone marrow failure.
Slovenian: Pri večini teh bolnikov so bile že prej prisotne hematološke bolezni, ki so pogosto povezane z depresijo kostnega mozga, vendar ni mogoče izključiti možnosti, da zdravilo EXJADE prispeva k nastopu citopenije ali jo poslabša.
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).
Slovenian: Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE v obliki filmsko obloženih tablet številčno enak eni tretjini odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/kg/dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 14 mg/kg/dan zdravila EXJADE v obliki filmsko obloženih tablet).
English: Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other).
Slovenian: Srednje modra ovalna bikonveksna filmsko obložena tableta z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in 180 na drugi strani).
English: EXJADE 180 mg granules EU/1/06/356/021
Slovenian: EXJADE 180 mg zrnca EU/1/06/356/021
English: 3.5 - 7 mg/kg/day Up to 28 mg/kg/day
Slovenian: 3,5 - 7 mg/kg/dan do 28 mg/kg/dan
English: • EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and
Slovenian: • Filmsko obložene tablete zdravila EXJADE 180 mg so srednje modre in imajo na eni strani vtisnjeno oznako “180”, na drugi pa “NVR“.
English: EXJADE 360 mg film-coated tablets EU/1/06/356/017
Slovenian: EXJADE 360 mg filmsko obložene tablete EU/1/06/356/017
English: EXJADE 360 mg granules EU/1/06/356/022
Slovenian: EXJADE 360 mg zrnca EU/1/06/356/022
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).
Slovenian: Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE v obliki zrnc številčno enak eni tretjini odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/kg/dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 14 mg/kg/dan zdravila EXJADE v obliki zrnc).
English: EXJADE 90 mg film-coated tablets EU/1/06/356/011
Slovenian: EXJADE 90 mg filmsko obložene tablete EU/1/06/356/011
English: There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules were administered with food.
Slovenian: Pri odmerjanju zdravila EXJADE v obliki zrnc skupaj s hrano ni prišlo do klinično pomembnih sprememb v farmakokinetiki deferasiroksa.
English: EXJADE 90 mg granules EU/1/06/356/020
Slovenian: EXJADE 90 mg zrnca EU/1/06/356/020
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.
Slovenian: Čeprav v kliničnih študijah po postopnem zviševanju odmerkov zdravila EXJADE v obliki disperzibilnih tablet nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri odmerkih zdravila EXJADE v obliki disperzibilnih tablet nad 30 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
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.
Slovenian: Čeprav v kliničnih študijah zdravila EXJADE v obliki disperzibilnih tablet po postopnem zviševanju odmerkov nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri uporabi zdravila v obliki filmsko obloženih tablet v odmerkih nad 21 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
English: EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet
Slovenian: EXJADE 90 mg zrnca v vrečici EXJADE 180 mg zrnca v vrečici EXJADE 360 mg zrnca v vrečici
English: EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet Deferasirox
Slovenian: EXJADE 90 mg zrnca v vrečici EXJADE 180 mg zrnca v vrečici EXJADE 360 mg zrnca v vrečici deferasiroks
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.
Slovenian: Bolnikom, ki ste jim odmerek zvišali na >10 mg/kg, je priporočljivo odmerek znižati na 10 mg/kg ali manj, če se jim koncentracija železa v jetrih zniža pod 7 mg Fe/g suhe teže ali imajo koncentracijo feritina v serumu ≤2.000 µg/l.
English: Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other).
Slovenian: Temno modra ovalna bikonveksna filmsko obložena tableta z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in 360 na drugi strani).
English: EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox.
Slovenian: EXJADE 500 mg disperzibilne tablete Ena disperzibilna tableta vsebuje 500 mg deferasiroksa.
English: EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox.
Slovenian: EXJADE 250 mg disperzibilne tablete Ena disperzibilna tableta vsebuje 250 mg deferasiroksa.
English: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of EXJADE (see section 4.4).
Slovenian: Pri uporabi zdravila EXJADE so poročali o hudih kožnih neželenih reakcijah (SCAR), med drugim o Stevens-Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in reakcijah na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
English: Gastrointestinal perforation 1, acute pancreatitis
Slovenian: 1, akutni pankreatitis
English: In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of 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%).
Slovenian: V 5-letni opazovalni študiji, v kateri je deferasiroks prejemalo 267 otrok, ki so bili ob vključitvi stari od 2 do manj kot 6 let in so imeli transfuzijsko hemosiderozo, ni bilo klinično pomembnih razlik v profilih varnosti in prenašanja zdravila Exjade med pediatričnimi bolniki v starosti od 2 do manj kot 6 let in celotno populacijo odraslih ter starejših pediatričnih bolnikov.
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Slovenian: Zdravilo EXJADE v obliki zrnc ima večjo biološko uporabnost v primerjavi z zdravilom EXJADE v obliki disperzibilnih tablet.
English: Exjade 360 mg film-coated tablets deferasirox
Slovenian: Exjade 360 mg filmsko obložene tablete deferasiroks
English: 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.
Slovenian: V primeru prehoda z disperzibilnih tablet na zrnca mora biti odmerek pri zrncih za 30 % nižji od prejšnjega odmerka v obliki disperzibilnih tablet, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele vrečice.
English: • Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox.
Slovenian: • Ena vrečica zdravila EXJADE 180 mg zrnca vsebuje 180 mg deferasiroksa.
English: EXJADE 125 mg dispersible tablets EU/1/06/356/001
Slovenian: EXJADE 125 mg disperzibilne tablete EU/1/06/356/001
English: 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l
Slovenian: 10 mg/kg/dan ≥5 mg Fe/g suhe teže ali
English: EXJADE 125 mg dispersible tablets
Slovenian: EXJADE 125 mg disperzibilne tablete
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.
Slovenian: Čeprav v kliničnih študijah zdravila EXJADE v obliki disperzibilnih tablet po postopnem zviševanju odmerkov nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri uporabi zdravila v obliki zrnc v odmerkih nad 21 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
English: Each dispersible tablet contains 125 mg of deferasirox.
Slovenian: Ena disperzibilna tableta vsebuje 125 mg deferasiroksa.
English: It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Exjade therapy.
Slovenian: Pri bolnikih, pri katerih v času zdravljenja z zdravilom Exjade pride do nepojasnjenih sprememb duševnega stanja, je priporočeno upoštevati možnost, da gre za hiperamoniemično encefalopatijo, in jim meriti koncentracijo amonijaka.
English: Exjade 180 mg film-coated tablets deferasirox
Slovenian: Exjade 180 mg filmsko obložene tablete deferasiroks
English: • Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox.
Slovenian: • Ena vrečica zdravila EXJADE 360 mg zrnca vsebuje 360 mg deferasiroksa.
English: Each tablet contains 360 mg of deferasirox.
Slovenian: Ena tableta vsebuje 360 mg deferasiroksa.
English: • Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Slovenian: Ena disperzibilna tableta zdravila EXJADE 125 mg vsebuje 125 mg deferasiroksa.
English: EXJADE 500 mg dispersible tablets
Slovenian: EXJADE 500 mg disperzibilne tablete
English: Multipack: 300 (10 packs of 30) film-coated tablets
Slovenian: filmsko obložene tablete Skupno pakiranje: 300 (10 pakiranj po 30) filmsko obloženih tablet
English: EXJADE 250 mg dispersible tablets
Slovenian: EXJADE 250 mg disperzibilne tablete
English: Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
Slovenian: Svetlo modra ovalna bikonveksna filmsko obložena tableta z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in 90 na drugi strani).
English: EXJADE 500 mg dispersible tablets EU/1/06/356/005
Slovenian: EXJADE 500 mg disperzibilne tablete EU/1/06/356/005
English: • Obligation to conduct post-authorisation measures
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj
English: • Each film-coated tablet of EXJADE 90 mg contains 90 mg deferasirox.
Slovenian: Ena filmsko obložena tableta zdravila EXJADE 90 mg vsebuje 90 mg deferasiroksa.
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Slovenian: Bele do nekoliko rumenkaste, okrogle, ploščate tablete z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in J 125 na drugi strani).
English: • Each film-coated tablet of EXJADE 180 mg contains 180 mg deferasirox.
Slovenian: Ena filmsko obložena tableta zdravila EXJADE 180 mg vsebuje 180 mg deferasiroksa.
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
Slovenian: Bele do nekoliko rumenkaste, okrogle, ploščate tablete z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in J 250 na drugi strani).
English: Exjade 90 mg film-coated tablets deferasirox
Slovenian: Exjade 90 mg filmsko obložene tablete deferasiroks
English: Magnesium stearate Silica, colloidal anhydrous Poloxamer
Slovenian: Jedro tablete: mikrokristalna celuloza krospovidon povidon magnezijev stearat brezvoden koloidni silicijev dioksid poloksamer
English: • Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox.
Slovenian: • Ena vrečica zdravila EXJADE 90 mg zrnca vsebuje 90 mg deferasiroksa.
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
Slovenian: Pri bolnikih brez izmerjene koncentracije železa v jetrih in s koncentracijo feritina v serumu ≤2.000 µg/l odmerek ne sme preseči 10 mg/kg.
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
Slovenian: Bele do nekoliko rumenkaste, okrogle, ploščate tablete z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in J 500 na drugi strani).
English: 5-10 mg/kg/day Up to 40 mg/kg/day Decrease 3.5 - 7 mg/kg/day 5-10 mg/kg/day
Slovenian: 3,5 - 7 mg/kg/dan 5-10 mg/kg/dan zniževanje 3,5 - 7 mg/kg/dan 5-10 mg/kg/dan <7 mg Fe/g suhe teže ali
English: Each tablet contains 180 mg of deferasirox.
Slovenian: Ena tableta vsebuje 180 mg deferasiroksa.
English: Each dispersible tablet contains 250 mg of deferasirox.
Slovenian: Ena disperzibilna tableta vsebuje 250 mg deferasiroksa.
English: Exjade 180 mg granules deferasirox
Slovenian: Exjade 180 mg zrnca deferasiroks peroralna uporaba
English: 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).
Slovenian: Začetni dnevni odmerek 30 mg/kg je lahko primeren za bolnike, pri katerih je treba znižati zvišano raven železa v organizmu in pri tem prejemajo več kot 14 ml/kg/mesec koncentriranih eritrocitov (približno >4 enote/mesec pri odraslem).
English: Each tablet contains 90 mg of deferasirox.
Slovenian: Ena tableta vsebuje 90 mg deferasiroksa.
English: • Each film-coated tablet of EXJADE 360 mg contains 360 mg deferasirox.
Slovenian: Ena filmsko obložena tableta zdravila EXJADE 360 mg vsebuje 360 mg deferasiroksa.
English: Each dispersible tablet contains 500 mg of deferasirox.
Slovenian: Ena disperzibilna tableta vsebuje 500 mg deferasiroksa.
English: • Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox.
Slovenian: Ena disperzibilna tableta zdravila EXJADE 500 mg vsebuje 500 mg deferasiroksa.
English: What EXJADE is used for
Slovenian: Za kaj uporabljamo zdravilo EXJADE
English: Exjade 360 mg granules deferasirox
Slovenian: Exjade 360 mg zrnca deferasiroks peroralna uporaba
English: 30 mg/kg/day
Slovenian: 30 mg/kg/dan
English: Exjade 360 mg granules in sachet deferasirox
Slovenian: Exjade 360 mg zrnca v vrečici deferasiroks
English: EXJADE 250 mg dispersible tablets EU/1/06/356/003
Slovenian: EXJADE 250 mg disperzibilne tablete EU/1/06/356/003
English: Exjade 180 mg granules in sachet deferasirox
Slovenian: Exjade 180 mg zrnca v vrečici deferasiroks
English: EXJADE 125 mg dispersible tablets deferasirox
Slovenian: EXJADE 125 mg disperzibilne tablete deferasiroks
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni:
English: EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA EXJADE 90 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 90 mg deferasiroksa.
English: • Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
Slovenian: Ena disperzibilna tableta zdravila EXJADE 250 mg vsebuje 250 mg deferasiroksa.
English: 10 mg/kg/day
Slovenian: 10 mg/kg/dan
English: Each sachet contains 360 mg of deferasirox.
Slovenian: Ena vrečica vsebuje 360 mg deferasiroksa.
English: Exjade 90 mg granules deferasirox
Slovenian: Exjade 90 mg zrnca deferasiroks peroralna uporaba
English: Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat krospovidon tipa A mikrokristalna celuloza povidon natrijev lavrilsulfat brezvoden koloidni silicijev dioksid magnezijev stearat
English: EXJADE 500 mg dispersible tablets deferasirox
Slovenian: EXJADE 500 mg disperzibilne tablete deferasiroks
English: Exjade 90 mg granules in sachet deferasirox
Slovenian: Exjade 90 mg zrnca v vrečici deferasiroks
English: Magnesium stearate
Slovenian: Delovanje jeter
English: In patients treated with doses >21 mg/kg/day
Slovenian: 3,5 - 7 mg/kg pri bolnikih, ki prejemajo odmerke >21 mg/kg/dan
English: • 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.
Slovenian: • Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila EXJADE v obliki disperzibilnih tablet na začetku zdravljenja 20 mg na kilogram telesne mase.
English: Each sachet contains 180 mg of deferasirox.
Slovenian: Ena vrečica vsebuje 180 mg deferasiroksa.
English: EXJADE contains lactose
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: • 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.
Slovenian: • Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet na začetku zdravljenja 14 mg na kilogram telesne mase.
English: It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4).
Slovenian: Za oceno bolnikovega odziva na zdravljenje in za zmanjšanje tveganja za prekomerno kelacijo je priporočeno vrednost feritina v serumu spremljati vsak mesec (glejte poglavje 4.4).
English: Each sachet contains 90 mg of deferasirox.
Slovenian: Ena vrečica vsebuje 90 mg deferasiroksa.
English: 1, urticaria erythema multiforme
Slovenian: 1, aktuni pankreatitis
English: Table 1 Recommended doses for transfusional iron overload
Slovenian: Preglednica 1 Priporočeni odmerki pri preobremenitvi z železom zaradi transfuzij filmsko obložene tablete/zrnca disperzibilne tablete transfuzije feritin v serumu začetni odmerek
English: EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA EXJADE 125 mg disperzibilne tablete Ena disperzibilna tableta vsebuje 125 mg deferasiroksa.
English: 1, anaemia aggravated neutropenia
Slovenian: 1, poslabšanje anemije nevtropenija Bolezni imunskega sistema neznana pogostnost: