FrancophonIA/ELRC3.0 huggingface dataset:
English: Deferasirox Mylan is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
Slovenian: Zdravilo Deferasiroks Mylan uporabljamo za zdravljenje kronične preobremenitve z železom zaradi pogostih transfuzij krvi pri bolnikih z beta talasemijo major, starih 6 let ali več.
English: Deferasirox Mylan 360 mg film-coated tablets are also available in blister pack of 300 tablets.
Slovenian: Deferasiroks Mylan 360 mg filmsko obložene tablete so na voljo tudi v pretisnem omotu s 300 tabletami.
English: Deferasirox Mylan 90 mg
Slovenian: deferasiroks mylan 90 mg
English: Psychiatric disorders Uncommon:
Slovenian: Psihiatrične motnje občasni:
English: Deferasirox Mylan 180 mg
Slovenian: deferasiroks mylan 180 mg
English: Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)).
Slovenian: Za kaj uporabljamo zdravilo Deferasiroks Mylan Bolniki z različnimi vrstami slabokrvnosti (npr. s talasemijo, z boleznijo srpastih celic ali z mielodisplastičnim sindromom - MDS), lahko potrebujejo večkratne transfuzije krvi.
English: Creatinine clearance in transfusional iron overload
Slovenian: Očistek kreatinina pri preobremenitvi z železom zaradi transfuzij krvi
English: Deferasirox Mylan 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.
Slovenian: Zdravilo Deferasiroks Mylan poleg tega uporabljamo tudi, kadar je zdravljenje z deferasiroksom kontraindicirano ali neprimerno pri bolnikih, ki so stari 10 let ali več in imajo preobremenitev z železom in sindrome talasemije, vendar ti niso posledica transfuzij.
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 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 7 mg/kg.
English: Elevations of liver transaminases have been reported.
Slovenian: Poročali so o zvišanju vrednosti jetrnih aminotransferaz.
English: 1, anaemia aggravated
Slovenian: 1, akutni pankreatitis
English: Patients with pre-existing renal conditions and patients who are receiving medicinal products that depress renal function may be more at risk of complications.
Slovenian: Tveganje za zaplete je večje pri bolnikih s predhodno ledvično boleznijo in pri bolnikih, ki prejemajo zdravila, ki zmanjšujejo delovanje ledvic.
English: Since dosing is individually adjusted according to response this is not expected to have clinical consequences.
Slovenian: Kliničnih posledic zaradi tega ni pričakovati, ker se odmerjanje individualno prilagaja glede na odziv.
English: These will monitor the amount of iron in your body (blood level of ferritin) to see how well Deferasirox Mylan is working.
Slovenian: Spremljanje vašega zdravljenja z zdravilom Deferasiroks Mylan 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 Deferasiroks Mylan.
English: 1, hypersensitivity vasculitis
Slovenian: Stevens-Johnsonov sindrom 1, preobčutljivostni vaskulitis urtikarija
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 Deferasirox Mylan (see section 4.4).
Slovenian: Pri uporabi zdravila Deferasiroks Mylan 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: >14 ml/kg/month of PRBC (approx. >4 units/month for an adult)
Slovenian: >14 ml/kg/mesec koncentriranih eritrocitov (približno >4 enote/mesec pri odraslem) <7 ml/kg/mesec koncentriranih eritrocitov (približno <2 enoti/mesec pri odraslem)
English: • Patient information pack
Slovenian: • Paket izobraževalnih gradiv za bolnike
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations.
Slovenian: Zdravilo Deferasiroks Mylan filmsko obložene tablete imajo večjo biološko uporabnost v primerjavi z deferasiroksom v obliki disperzibilnih tablet.
English: Care should be taken to maintain adequate hydration in patients who experience volumedepleting 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: Skin rashes may appear during Deferasirox Mylan treatment.
Slovenian: Med zdravljenjem z zdravilom Deferasiroks Mylan se lahko pojavijo kožni izpuščaji.
English: Changes in weight of paediatric patients over time must be taken into account when calculating the dose.
Slovenian: Pri izračunavanju odmerka je treba upoštevati razvojne spremembe telesne mase.
English: >33% above pretreatment average and Decreases <LLN
Slovenian: >33 % nad povprečjem vrednosti pred zdravljenjem nad starostno ustrezno zgornjo mejo normale in in/ali znižanje pod spodnjo mejo normale (<90ml/min)
English: • The usual daily dose for Deferasirox Mylan film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Slovenian: • Za bolnike, ki prejemajo redne transfuzije krvi, je običajni dnevni odmerek zdravila Deferasiroks Mylan v obliki filmsko obloženih tablet na začetku zdravljenja 14 mg na kilogram telesne mase.
English: Transaminases increased
Slovenian: perforacija prebavil
English: 4.8 Undesirable effects
Slovenian: Preglednica 5: Neželeni učinki
English: Elevations of liver transaminases were reported as an adverse reaction in 2% of patients.
Slovenian: Pri 2 % bolnikov so opisovali neželene učinke zdravila v obliki zvišanja vrednosti jetrnih transaminaz.
English: 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).
Slovenian: V obdobju trženja so pri bolnikih, ki so se zdravili z deferasiroksom v obliki disperzibilnih tablet, posebno pri tistih, ki so imeli že prej cirozo jeter, poročali o odpovedi jeter, ki se je včasih končala s smrtjo (glejte poglavje 4.4).
English: Hepatic failure Skin and subcutaneous tissue disorders Common:
Slovenian: Bolezni kože in podkožja pogosti:
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulation (see section 5.2).
Slovenian: Zdravilo Deferasiroks Mylan filmsko obložene tablete imajo večjo biološko uporabnost v primerjavi z deferasiroksom v obliki disperzibilne tablete (glejte poglavje 5.2).
English: Decrease 3.5 - 7 mg/kg/day
Slovenian: >2.000 μg/l zniževanje 3,5 - 7 mg/kg/dan
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations (see section 5.2).
Slovenian: Zdravilo Deferasiroks Mylan filmsko obložene tablete imajo večjo biološko uporabnost v primerjavi z deferasiroksom v obliki disperzibilnih tablet (glejte poglavje 5.2).
English: • The usual daily dose for Deferasirox Mylan film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Slovenian: • Za bolnike, ki ne prejemajo rednih transfuzij krvi, je običajni dnevni odmerek zdravila Deferasiroks Mylan v obliki filmsko obloženih tablet na začetku zdravljenja 7 mg na kilogram telesne mase.
English: Pigmentation disorder
Slovenian: motnje pigmentacije redki:
English: Uncommon:
Slovenian: neznana pogostnost:
English: Skin disorders
Slovenian: Kožne bolezni
English: Non-transfusion-dependent thalassaemia syndromes:
Slovenian: Sindromi talasemije, neodvisni od transfuzij:
English: (<90 ml/min)
Slovenian: znižanje pod spodnjo mejo normale (<90 ml/min)
English: ◦ The need to interrupt treatment after a dose reduction if serum creatinine rises: Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min)
Slovenian: • pri odraslih in pediatričnih bolnikih: ostane >33% nad izhodiščno vrednostjo ali pa očistek kreatinina ostane pod SMN (90 ml/min);
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets
Slovenian: Deferasiroks Mylan 90 mg filmsko obložene tablete Deferasiroks Mylan 180 mg filmsko obložene tablete Deferasiroks Mylan 360 mg filmsko obložene tablete
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets deferasirox
Slovenian: Deferasiroks Mylan 90 mg filmsko obložene tablete Deferasiroks Mylan 180 mg filmsko obložene tablete Deferasiroks Mylan 360 mg filmsko obložene tablete deferasiroks
English: Dizziness
Slovenian: omotičnost
English: Each film-coated tablet contains 90 mg deferasirox.
Slovenian: Ena filmsko obložena tableta vsebuje 90 mg deferasiroksa.
English: Deferasirox Mylan is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusiondependent thalassaemia syndromes aged 10 years and older.
Slovenian: Zdravilo Deferasiroks Mylan 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: • Each film-coated tablet of Deferasirox Mylan 360 mg contains 360 mg deferasirox.
Slovenian: Ena filmsko obložena tableta zdravila Deferasiroks Mylan 360 mg vsebuje 360 mg deferasiroksa.
English: • Sore throat
Slovenian: bolečina v grlu
English: Hypromellose Titanium dioxide (E171) Macrogol/PEG (6000) Talc
Slovenian: Sestavine obloge tablete: hipromeloza titanov dioksid (E171) makrogol/PEG (6000) smukec rumen železov oksid (E172) rdeč železov oksid (E172)
English: <7 mg Fe/g dw or ≤2,000 µg/l
Slovenian: <7 mg Fe/g suhe teže ali
English: Table 3 Dose adjustment and interruption of treatment for renal monitoring
Slovenian: Preglednica 3 Prilagajanje odmerkov in prekinitev zdravljenja pri spremljanju delovanja ledvic kreatinin v serumu očistek kreatinina pred začetkom zdravljenja dvakrat (2x)
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov)
English: • If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes,
Slovenian: • če opazite kombinacijo katerih koli izmed naslednjih simptomov: izpuščaj, rdeča koža,
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov)
English: Care should be taken to maintain adequate hydration in patients who develop diarrhoea or vomiting.
Slovenian: Pri bolnikih, pri katerih pride do diareje ali bruhanja, je treba poskrbeti za zadostno hidriranost organizma.
English: • Each film-coated tablet of Deferasirox Mylan 90 mg contains 90 mg deferasirox.
Slovenian: Ena filmsko obložena tableta zdravila Deferasiroks Mylan 90 mg vsebuje 90 mg deferasiroksa.
English: • If you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems),
Slovenian: porumenevanje ali rumena obarvanost kože ali oči in temna barva urina (znaki težav z jetri),
English: • Each film-coated tablet of Deferasirox Mylan 180 mg contains 180 mg deferasirox.
Slovenian: Ena filmsko obložena tableta zdravila Deferasiroks Mylan 180 mg vsebuje 180 mg deferasiroksa.
English: There have been reports of ulcers complicated with digestive perforation.
Slovenian: Poročali so o ulkusih, pri katerih se je kot zaplet pojavila perforacija prebavil.
English: Reduction of daily dose by 7 mg/kg/day (film-coated tablet formulation), if following renal parameters are observed at two consecutive visits and cannot be attributed to other causes
Slovenian: <60 ml/min spremljanje prvi mesec po začetku zdravljenja ali spremembi odmerka (tudi po prehodu z ene formulacije na drugo) kasneje enkrat na teden enkrat na mesec in in enkrat na teden enkrat na mesec znižanje dnevnega odmerka za 7 mg/kg/dan (v obliki filmsko obloženih tablet), če je znižanje navedenih parametrov ledvične funkcije prisotno pri dveh zaporednih obiskih in ga ni mogoče pripisati drugim vzrokom odrasli bolniki pediatrični bolniki
English: Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving deferasirox.
Slovenian: Pri bolnikih, ki so jemali deferasiroks, vključno z otroci in mladostniki, so opisovali ulceracije in krvavitve v zgornjem delu gastrointestinalnega trakta.
English: Severe forms associated with changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients treated with deferasirox, particularly in children.
Slovenian: Pri bolnikih, ki prejemajo deferasiroks, zlasti pri otrocih, lahko pride do hudih oblik ledvične odpovedi v povezavi z motnjami zavesti v okviru hiperamoniemične encefalopatije.
English: 90 film-coated tablets 300 film-coated tablets
Slovenian: 90 filmsko obloženih tablet 300 filmsko obloženih tablet
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 Deferasiroks Mylan prispeva k nastopu citopenije ali jo poslabša.
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 deferasirox in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%).
Slovenian: V 5-letni opazovalni študiji, v kateri je deferasiroks prejemalo 267 otrok, ki so bili ob vključitvi stari od 2 do 6 let in so imeli transfuzijsko hemosiderozo, ni bilo klinično pomembnih razlik v profilih varnosti in prenašanja deferasiroksa med pediatričnimi bolniki v starosti od 2 do 6 let in celotno populacijo odraslih ter starejših pediatričnih bolnikov.
English: • Medication errors due to switching between formulations available on the market by different
Slovenian: • napak pri uporabi zdravil različnih imetnikov dovoljenj za promet z zdravili, ki vsebujejo deferasiroks, zaradi prehoda med formulacijami deferasiroksa, ki so dostopna na trgu (z disperzibilnih tablet na filmsko obložene tablete oziroma zrnca ali obratno).
English: Twice (2×)
Slovenian: (50 x 10
English: 30 film-coated tablets 90 film-coated tablets
Slovenian: 30 filmsko obloženih tablet 90 filmsko obloženih tablet
English: • Swelling of arms or legs
Slovenian: • otekanje rok ali nog
English: Table 2 Recommended doses for non-transfusion-dependent thalassaemia syndromes
Slovenian: Preglednica 2 Priporočeni odmerki pri sindromih talasemije, ki niso odvisni od transfuzij filmsko obložene tablete koncentracija železa v jetrih*
English: - if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”).
Slovenian: • Če dobite hud izpuščaj ali pride do težav z dihanjem in omotičnosti ali otekanja pretežno v obraz in grlo/žrelo (znaki hude alergijske reakcije),
English: How to take Deferasirox Mylan
Slovenian: Kako jemati zdravilo Deferasiroks Mylan
English: ≥7 mg Fe/g dw or >2,000 µg/l
Slovenian: ≥7 mg Fe/g suhe teže ali
English: Anxiety, sleep disorder Nervous system disorders Common:
Slovenian: 1, poslabšanje anemije nevtropenija1 Bolezni imunskega sistema neznana pogostnost:
English: • Tiredness
Slovenian: • srbenje
English: Vision and hearing
Slovenian: Vid in sluh
English: In clinical studies, elderly patients experienced a higher frequency of adverse reactions than younger patients (in particular, diarrhoea) and should be monitored closely for adverse reactions that may require a dose adjustment.
Slovenian: V kliničnih študijah je pri starejših bolnikih pogosteje prihajalo do neželenih učinkov kot pri mlajših bolnikih (zlasti do diareje).
English: Every 2 weeks during first month of therapy.
Slovenian: • vsak teden v prvem mesecu po uvedbi ali spremembi zdravljenja,
English: - if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes
Slovenian: mehurčast izpuščaj na ustnicah, očeh ali v ustih, luščenje kože, močno zvišana telesna temperatura, gripi podobni simptomi, povečane bezgavke (znaki hude kožne reakcije),
English: Before initiating treatment
Slovenian: • dvakrat pred uvedbo zdravljenja,
English: The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Slovenian: Pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, je priporočen začetni odmerek zdravila Deferasiroks Mylan v obliki filmsko obloženih tablet 7 mg/kg telesne mase.
English: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Slovenian: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Madžarska Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Deferasirox Mylan therapy.
Slovenian: Pri bolnikih, pri katerih v času zdravljenja z zdravilom Deferasiroks Mylan pride do nepojasnjenih sprememb duševnega stanja, je priporočeno upoštevati možnost, da gre za hiperamoniemično encefalopatijo, in jim meriti koncentracijo amonijaka.
English: 1, urticaria erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 Renal and urinary disorders Very common:
Slovenian: 1, toksična epidermalna nekroliza (TEN)
English: Adjustment Steps (every 3
Slovenian: >800 μg/l spremljanje enkrat na mesec koraki za prilagajanje (vsakih 3-6 mesecev)
English: In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
Slovenian: Ko bolniki, ki se zdravijo z odmerki nad 21 mg/kg, dosežejo urejenost (na primer koncentracijo feritina v serumu vztrajno pod 2.500 µg/l skupaj s trendom zniževanja s časom), je treba razmisliti o postopnem zniževanju odmerka v korakih po 3,5 do 7 mg/kg.
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Slovenian: gluhost Bolezni dihal, prsnega koša in mediastinalnega prostora občasni:
English: It traps and removes excess iron which is then excreted mainly in the stools.
Slovenian: Zdravilo Deferasiroks Mylan veže in odstrani presežno železo, ki se potem večinoma izloči z blatom.
English: 500 - 1,000 µg/l
Slovenian: 500-1.000 µg/l koraki za prilagajanje (vsakih 3-6 mesecev)
English: It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Deferasirox Mylan.
Slovenian: Pri bolnikih, pri katerih v času zdravljenja z zdravilom Deferasiroks Mylan pride do nepojasnjenih sprememb duševnega stanja,
English: Deferasirox Mylan 180 mg film-coated tablets deferasirox
Slovenian: Deferasiroks Mylan 180 mg filmsko obložene tablete deferasiroks
English: Deferasirox Mylan 360 mg film-coated tablets deferasirox
Slovenian: Deferasiroks Mylan 360 mg filmsko obložene tablete deferasiroks
English: Each film-coated tablet contains 360 mg deferasirox.
Slovenian: Ena tableta vsebuje 360 mg deferasiroksa.
English: Breast-feeding is not recommended during treatment with Deferasirox Mylan.
Slovenian: Med zdravljenjem z zdravilom Deferasiroks Mylan dojenje ni priporočljivo.
English: Interruption of treatment should be considered in patients who develop unexplained cytopenia.
Slovenian: Pri bolnikih, pri katerih pride do nepojasnjene citopenije, je treba razmisliti o prekinitvi zdravljenja.
English: How to store Deferasirox Mylan
Slovenian: Shranjevanje zdravila Deferasiroks Mylan
English: Coating material:
Slovenian: proteinurija občasni:
English: When to take Deferasirox Mylan
Slovenian: Kdaj jemati zdravilo Deferasiroks Mylan
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
Slovenian: Deferasiroks Mylan 180 mg filmsko obložene tablete Ovalna bikonveksna filmsko obložena tableta marelične barve z vtisnjeno oznako “ ” na eni strani tablete in ‘DF 1' na drugi strani.
English: Optic neuritis Ear and labyrinth disorders Uncommon:
Slovenian: optični nevritis Ušesne bolezni, vključno z motnjami labirinta občasni:
English: Deferasirox Mylan 90 mg film-coated tablets deferasirox
Slovenian: Deferasiroks Mylan 90 mg filmsko obložene tablete deferasiroks
English: Non-transfusion-dependent thalassaemia syndromes
Slovenian: Sindromi talasemije, neodvisni od transfuzij
English: Each film-coated tablet contains 180 mg deferasirox.
Slovenian: Ena tableta vsebuje 180 mg deferasiroksa.
English: Blood creatinine increased
Slovenian: zvišana koncentracija kreatinina v krvi pogosti:
English: ≥5 mg Fe/g dw or >800 µg/l
Slovenian: ≥5 mg Fe/g suhe teže ali
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI
English: 30 film-coated tablets 90 film -coated tablets 300 film-coated tablets
Slovenian: filmsko obložena tableta (tableta) 90 filmsko obloženih tablet 300 filmsko obloženih tablet
English: ◦ The need to reduce by 10 mg/kg the dose if serum creatinine rises: Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits.
Slovenian: • pri odraslih: >33% od izhodiščne vrednosti, očistek kreatinina pa pade pod SMN (spodnjo mejo normale: 90 ml/min)
English: What Deferasirox Mylan contains
Slovenian: Kaj vsebuje zdravilo Deferasiroks Mylan
English: Gastrointestinal disorders Common:
Slovenian: glikozurija neznana pogostnost:
English: • Patient guide
Slovenian: • Vodnik za bolnika
English: For adults not assessed and ≤2,000 µg/l
Slovenian: 14 mg/kg/dan 7 mg/kg/dan pri odraslih pri pediatričnih bolnikih ni ocenjeno in ≤2.000 µg/l prekinitev zdravljenja
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 over-chelation (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: <2,500 µg/l
Slovenian: ≤2.000 µg/l najvišji odmerek
English: What Deferasirox Mylan is
Slovenian: Kaj je zdravilo Deferasiroks Mylan