FrancophonIA/ELRC3.0 huggingface dataset:
English: Deferasirox Mylan can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over.
Slovenian: Zdravilo Deferasiroks Mylan se lahko uporablja pri otrocih in mladostnikih, ki prejemajo redne transfuzije krvi, starih 2 leti ali več, in pri otrocih in mladostnikih, ki ne prejemajo rednih transfuzij krvi, starih 10 let ali več.
English: As a consequence, Deferasirox Mylan therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
Slovenian: Posledično je treba zdravljenje z zdravilom Deferasiroks Mylan skrbno spremljati z namenom odkrivanja neželenih učinkov in slediti obremenitvi z železom pri pediatrični populaciji.
English: The concomitant administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal haemorrhage.
Slovenian: Sočasna uporaba deferasiroksa z antikoagulanti lahko tudi poveča tveganje za gastrointestinalne krvavitve.
English: In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
Slovenian: Pri preostali tretjini bolnikov se zvišanje koncentracije kreatinina v serumu ni vedno odzvalo na zniževanje odmerka ali prekinitev zdravljenja.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skaldu z lokalnimi predpisi.
English: When this results in a daily dose less than 14 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).
Slovenian: Če to pomeni dnevni odmerek, ki bi bil nižji od 14 mg/kg telesne mase, je treba spremljati bolnikov odziv in v primerih, ko ne pride do zadostne učinkovitosti, razmisliti o zvišanju odmerka (glejte poglavje 5.1).
English: • A warning on the risk of overchelation and on the necessity of close monitoring of serum ferritin levels and renal and hepatic function.
Slovenian: • opozorilo glede tveganja za prekomerno kelacijo in potrebo po skrbnem spremljanju vrednosti feritina v serumu ter ledvične in jetrne funkcije;
English: It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the initiation of treatment, every 2 weeks during the first month and monthly thereafter.
Slovenian: Transaminaze v serumu, bilirubin in alkalno fosfatazo je priporočljivo pregledovati pred začetkom zdravljenja, nato pa v prvem mesecu vsaka 2 tedna, kasneje pa enkrat mesečno.
English: Patients should be referred to a renal specialist, and further specialised investigations (such as renal biopsy) may be considered if the following occur despite dose reduction and interruption:
Slovenian: Bolnika je treba napotiti k nefrologu in pretehtati možnost nadaljnjih specialističnih preiskav (kot je ledvična biopsija), če kljub znižanju odmerka in prekinitvi zdravljenja pride do naslednjega:
English: Treatment cessation
Slovenian: Prekinitev zdravljenja
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03
Slovenian: Farmakoterapevtska skupina: kelirajoča sredstva za zdravljenje akutnih zastrupitev z železom, oznaka ATC: V03AC03
English: Table 4 Summary of safety monitoring recommendations
Slovenian: Preglednica 4 Povzetek varnostnih priporočil za spremljanje bolnika Preiskava
English: Although deferasirox has a lower affinity for aluminium than for iron, it is not recommended to take deferasirox tablets with aluminium-containing antacid preparations.
Slovenian: Čeprav ima deferasiroks manjšo afiniteto do aluminija kot do železa, ni priporočljivo jemati tablet z deferasiroksom sočasno z antacidi, ki vsebujejo aluminij.
English: Multiple ulcers have been observed in some patients (see section 4.8).
Slovenian: Pri nekaterih bolnikih so opažali številne ulkuse (glejte poglavje 4.8).
English: Deferasirox has been investigated in 411 adult (age ≥16 years) and 292 paediatric patients (aged 2 to <16 years) with chronic iron overload due to blood transfusions.
Slovenian: Deferasiroks so raziskovali pri 411 odraslih (starih 16 let ali več) in 292 pediatričnih bolnikih (starih od 2 do 16 let) s kronično preobremenitvijo z železom zaradi transfuzij krvi.
English: Therefore, it must not be combined with other iron chelator therapies (see section 4.3).
Slovenian: Zato se ga ne sme uporabljati v kombinaciji z drugimi kelatorji železa (glejte poglavje 4.3).
English: • If you experience frequent abdominal pain, particularly after eating or taking Deferasirox
Slovenian: • če vas pogosto boli trebuh, posebno po uživanju hrane ali po jemanju zdravila Deferasiroks
English: No fertility data is available for humans.
Slovenian: Podatkov o vplivu na plodnost pri človeku ni na voljo.
English: The patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Slovenian: Bolnikov odziv je treba spremljati in v primerih, ko ne pride do zadostne učinkovitosti, razmisliti o zvišanju odmerka (glejte poglavje 5.1).
English: Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months).
Slovenian: Testiranje sluha in vida (vključno s fundoskopijo) je priporočljivo pred začetkom zdravljenja in nato v rednih intervalih (vsakih 12 mesecev).
English: The principal analysis of the pivotal comparative study in 586 patients suffering from betathalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox dispersible tablets to deferoxamine in the analysis of the total patient population.
Slovenian: Osnovna analiza podatkov ključne primerjalne študije s 586 bolniki z beta talasemijo in s preobremenitvijo z železom zaradi transfuzij ni dokazala neinferiornosti deferasiroksa v obliki disperzibilnih tablet v primerjavi z deferoksaminom v analizi celotne populacije bolnikov.
English: In severe cases, this reintroduction could be conducted in combination with a short period of oral steroid administration.
Slovenian: V hudih primerih je mogoče ponovno uvesti zdravljenje v kombinaciji s kratkotrajno uporabo peroralnih steroidov.
English: Dose reduction or closer monitoring of renal and hepatic function, and serum ferritin levels are recommended during periods of treatment with high doses and when serum ferritin levels are close to the target range.
Slovenian: Znižanje odmerka oziroma natančnejše spremljanje ledvične in jetrne funkcije ter vrednosti feritina v serumu je priporočeno v obdobjih zdravljenja z visokimi odmerki in takrat, ko so vrednosti feritina v serumu blizu okvira ciljnih vrednosti.
English: The primary efficacy parameter was the change in liver iron concentration (LIC) from baseline after 12 months of treatment.
Slovenian: Primarni parameter učinkovitosti je bila sprememba koncentracije železa v jetrih od izhodiščne vrednosti po 12 mesecih študije.
English: What Deferasirox Mylan is and what it is used for What you need to know before you take Deferasirox Mylan How to take Deferasirox Mylan Possible side effects
Slovenian: Kaj je zdravilo Deferasiroks Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Deferasiroks Mylan Kako jemati zdravilo Deferasiroks Mylan Možni neželeni učinki
English: • If you get reduced hearing, tell your doctor as soon as possible.
Slovenian: • če se vam poslabša sluh, čimprej obvestite svojega zdravnika.
English: Once the cause of the liver function test abnormalities has been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose followed by gradual dose escalation may be considered.
Slovenian: Po razjasnitvi vzroka za nenormalne vrednosti testov jetrne funkcije ali po vrnitvi na normalne vrednosti je mogoče pretehtati previdno ponovno uvedbo zdravljenja z nižjim odmerkom in kasnejšim postopnim zviševanjem odmerka.
English: Show them the pack of tablets.
Slovenian: Zdravniku pokažite škatlo zdravila.
English: In children with transfusional iron overload aged between 2 and 5 years, exposure is lower than in adults (see section 5.2).
Slovenian: Pri otrocih s preobremenitvijo z železom zaradi transfuzij, starih med 2 in 5 let, je izpostavljenost zdravilu nižja kot pri odraslih (glejte poglavje 5.2).
English: The absolute bioavailability of the film-coated tablet formulation has not been determined.
Slovenian: Absolutne biološke uporabnosti zdravila v obliki filmsko obloženih tablet niso določali.
English: Single events of increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 145 patients who completed the study.
Slovenian: O enkratnem zvišanju vrednosti alanin aminotransferaze so poročali pri 20,0 %, o enkratnem zvišanju vrednosti aspartat aminotransferaze pa pri 8,3 % od 145 bolnikov, ki so v celoti zaključili študijo.
English: Serum ferritin assessed by monthly monitoring reflected changes in liver iron concentration indicating that trends in serum ferritin can be used to monitor response to therapy.
Slovenian: Vrednost feritina v serumu, ki so jo spremljali mesečno, je odražala spremembe v koncentraciji železa v jetrih, kar nakazuje, da se lahko trende vrednosti feritina v serumu uporabi za spremljanje odziva na zdravljenje.
English: Gastrointestinal disorders
Slovenian: Gastrointestinalne bolezni
English: The film-coated tablets should be taken once a day, preferably at the same time each day, and may be taken on an empty stomach or with a light meal (see sections 4.5 and 5.2).
Slovenian: Filmsko obložene tablete je treba vzeti enkrat na dan, najbolje vsak dan ob istem času, bolnik pa ga lahko zaužije na prazen želodec ali z lahkim obrokom (glejte poglavji 4.5 in 5.2)
English: In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome.
Slovenian: Po poročilih iz obdobja trženja zdravila je do primerov metabolne acidoze v velikem deležu prišlo pri otrocih v sklopu Fanconijevega sindroma.
English: The concomitant administration of deferasirox and aluminium-containing antacid preparations has not been formally studied.
Slovenian: Sočasna uporaba deferasiroksa in antacidov, ki vsebujejo aluminij, ni bila uradno proučena.
English: If disturbances are noted during the treatment, dose reduction or interruption may be considered.
Slovenian: Ob odkritju motenj med zdravljenjem je potrebno razmisliti o zmanjšanju odmerka ali o prekinitvi zdravljenja.
English: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using Deferasirox Mylan.
Slovenian: Priporočeno je, da ženske v rodni dobi v času uporabe zdravila Deferasiroks Mylan uporabljajo dodatne ali druge nehormonske metode kontracepcije.
English: Therefore, the concomitant use of Deferasirox Mylan with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in Deferasirox Mylan efficacy.
Slovenian: Zato lahko sočasna uporaba zdravila Deferasiroks Mylan z močnimi induktorji UGT (kot so rifampicin, karbamazepin, fenitoin, fenobarbital, ritonavir) zmanjša učinkovitost zdravila Deferasiroks Mylan.
English: Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated:
Slovenian: O znižanju odmerka ali prekinitvi zdravljenja velja razmisliti tudi v primeru patoloških vrednosti označevalcev tubulne funkcije in/ali če je to klinično indicirano:
English: The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes, DiamondBlackfan syndrome, aplastic anaemia and other very rare anaemias).
Slovenian: Osnovne bolezni, zaradi katerih so bile potrebne transfuzije, so vključevale beta talasemijo, srpastocelično anemijo in druge prirojene in pridobljene anemije (mielodisplastični sindrom, Diamond-Blackfan sindrom, aplastično anemijo in druge zelo redke anemije).
English: OUTER CARTON (BLISTER AND BOTTLE)
Slovenian: ZUNANJA ŠKATLA (PRETISNI OMOT IN PLASTENKA)
English: Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels of these metals.
Slovenian: Deferasiroks ima nizko afiniteto do cinka in bakra in ne povzroča trajno nizkih serumskih koncentracij teh kovin.
English: In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated for 24 weeks.
Slovenian: V študiji za oceno varnosti uporabe deferoksamina v obliki filmsko obloženih tablet in disperzibilnih tablet so 173 odraslih in pediatričnih bolnikov s talasemijo, odvisno od transfuzij, ali z mielodisplastičnim sindromom zdravili 24 tednov.
English: An interaction between deferasirox and other CYP1A2 substrates cannot be excluded.
Slovenian: Interakcije med deferasiroksom in drugimi substrati CYP1A2 ni mogoče izključiti.
English: Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median time to maximum plasma concentration (tmax) of about 1.5 to 4 hours.
Slovenian: Deferasiroks (v obliki disperzibilnih tablet) se po zaužitju absorbira do največje koncentracije v plazmi (tmax) v medianem času približno 1,5 do 4 ure.
English: In animals, no adverse effects on male or female fertility were found (see section 5.3).
Slovenian: Na živalih niso ugotovili nobenih neželenih učinkov na plodnost samcev ali samic (glejte poglavje 5.3).
English: Deferasirox Mylan has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Deferasiroks Mylan ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: Cases of serious acute pancreatitis were observed without documented underlying biliary conditions.
Slovenian: Opažali so tudi primere hudega akutnega pankreatitisa brez dokumentiranih predhodnih bolezni žolčevodov.
English: The most frequent reactions reported during chronic treatment in clinical studies conducted with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash.
Slovenian: Najpogostejši učinki, zabeleženi med kroničnim zdravljenjem v izvedenih kliničnih študijah z disperzibilnimi tabletami z deferasiroksom pri odraslih in pediatričnih bolnikih, vključujejo gastrointestinalne motnje (predvsem navzeo, bruhanje, diarejo ali bolečino v trebuhu) in kožni izpuščaj.
English: Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of non-ironloaded rats at lethal doses.
Slovenian: Testi genotoksičnosti in vitro so bili negativni (Amesov test, test kromosomskih aberacij) medtem ko je deferasiroks v smrtonosnih odmerkih in vivo povzročil tvorbo mikronukleusov v kostnem mozgu, ne pa v jetrih pri podganah, ki niso bile obremenjene z železom.
English: Approximate tablet dimensions 17 mm × 6.7 mm.
Slovenian: Približna velikost tablete je 17 mm x 6,7 mm.
English: Serum creatinine at Day - X
Slovenian: pred uvedbo zdravljenja kreatinin v serumu na dan - X
English: Additional periodic distributions after launch should be performed, notably after substantial safety modifications of the product information justifying educational material updates.
Slovenian: Po prihodu zdravila na trg je treba občasno ponovno razdeliti izobraževalna gradiva, zlasti kadar jih je treba posodobiti zaradi pomembnih sprememb informacij v informacijah o zdravilu glede varnosti.
English: Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting.
Slovenian: Zgodnji znaki akutnega prevelikega odmerjanja so učinki na prebavila, kot so bolečine v trebuhu, diareja, navzea in bruhanje.
English: • That rises in serum transaminases may occur in patients treated with Deferasirox Mylan ◦ The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated ◦ Not to prescribe to patients with pre-existing severe hepatic disease ◦ The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted.
Slovenian: • dejstvo, da pri bolnikih, ki se zdravijo z zdravilom Deferasiroks Mylan, lahko pride do zvišanja vrednosti serumskih transaminaz, o potreba po izvajanju testov delovanja jeter preden se predpiše zdravilo, nato pa v mesečnih intervalih ali bolj pogosto, če je klinično indicirano, o opozorilo, da se bolnikom s predhodno hudo boleznijo jeter zdravila ne sme predpisati, o potrebnost prekinitve zdravljenja, če pride do persistentnega in progresivnega zvišanja vrednosti jetrnih encimov;
English: • If you notice a marked decrease in your urine output (sign of kidney problem),
Slovenian: • če opazite izrazito zmanjšanje izločanja urina (znak težav z ledvicami),
English: Deferasirox Mylan may decrease the efficacy of hormonal contraceptives (see section 4.5).
Slovenian: Zdravilo Deferasiroks Mylan lahko zmanjša učinkovitost hormonskih kontraceptivov (glejte poglavje 4.5).
English: Therefore, due to a possible decrease in efficacy, caution should be exercised when deferasirox is combined with substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive agents, bepridil, ergotamine).
Slovenian: Zato je zaradi možnosti zmanjšanega delovanja zdravil potrebna previdnost pri kombiniranju deferasiroksa s snovmi, katerih presnova poteka s CYP3A4 (na primer s ciklosporinom, s simvastatinom, s hormonskimi kontraceptivi, z bepridilom in z ergotaminom).
English: Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1).
Slovenian: Podatki pri otrocih s talasemijo, neodvisno od transfuzij, so zelo omejeni (glejte poglavje 5.1).
English: Medical treatment may be necessary.
Slovenian: Morda boste potrebovali nujno medicinsko pomoč.
English: UNITED KINGDOM
Slovenian: Velika Britanija
English: Deferasirox Mylan is not recommended - if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of blood cells by the bone marrow) or have advanced cancer.
Slovenian: Zdravilo Deferasiroks Mylan ni priporočeno - če imate napredovalo obliko mielodisplastičnega sindroma (MDS, zmanjšano nastajanje krvnih celic v kostnem mozgu) ali napredovalo obliko raka.
English: Marketing Authorisation Holder Mylan S.A.S, 117 Allée des Parcs, Saint-Priest, 69800, France
Slovenian: Imetnik dovoljenja za promet z zdravilom Mylan S.A.S, 117 Allée des Parcs, Saint-Priest, 69800, Francija
English: • Non-compliance of the posology and biological monitoring
Slovenian: • neupoštevanja priporočenega odmerjanja in spremljanja bioloških zdravil,
English: • 7 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.
Slovenian: • 7 mg na kilogram telesne mase za otroke in mladostnike, ki ne prejemajo rednih transfuzij krvi.
English: Annually thereafter.
Slovenian: • kasneje pa enkrat mesečno;
English: Cardiac dysfunction is a known complication of severe iron overload.
Slovenian: Motnje delovanja srca so znan zaplet pri hudi preobremenitvi z železom.
English: Cellulose, microcrystalline Crospovidone (Type A) Povidone (K30) Magnesium stearate Silica, colloidal anhydrous Poloxamer (P188)
Slovenian: mikrokristalna celuloza krospovidon (tip A) povidon (K30) magnezijev stearat brezvoden koloidni silicijev dioksid poloksamer (P188)
English: The overall exposure of adolescents (12 to ≤17 years) and children (2 to <12 years) to deferasirox after single and multiple doses was lower than that in adult patients.
Slovenian: Celotna izpostavljenost deferasiroksu po enkratnem in po večkratnih odmerkih je bila pri mladostnikih (12 do ≤17 let) in otrocih (2 do <12 let) nižja kot pri odraslih bolnikih.
English: Pancytopenia
Slovenian: pancitopenija
English: The tablet coating material contains: hypromellose, titanium dioxide (E171), macrogol/PEG (6000), talc, iron oxide yellow (E172), iron oxide red (E172).
Slovenian: Obloga tablete vsebuje: hipromelozo, titanov dioksid (E171), makrogol/PEG (6000), smukec, rumen železov oksid (E172), rdeč železov oksid (E172).
English: Daily doses of 10 mg/kg (dispersible tablet formulation) for one year could maintain liver iron and serum ferritin levels and induce net iron balance in patients receiving infrequent transfusions or exchange transfusions.
Slovenian: Dnevni odmerek 10 mg/kg (v obliki disperzibilnih tablet) v obdobju enega leta je lahko vzdrževal koncentraciji železa v jetrih in feritina v serumu ter vzpostavil neto ravnovesje železa pri bolnikih, ki so poredko prejemali transfuzije ali so prejeli izmenjalne transfuzije.
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: ◦ Information that only one course of treatment is proposed for NTDT patients ◦ A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population ◦ A warning on the currently unknown safety consequences of long-term treatment in the paediatric population
Slovenian: • priporočila za zdravljenje sindromov talasemije, neodvisnih od transfuzij: o informacija, da je predlagan le en cikel zdravljenja za bolnike, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij, o opozorilo glede potrebe po natančnejšem spremljanju koncentracije železa v jetrih in serumskega feritina pri pediatrični populaciji, o opozorilo glede trenutno še neznanih posledic dolgotrajnega zdravljenja pri pediatrični populaciji.
English: • Disturbance in liver function tests
Slovenian: • nenormalni izvidi testov jetrne funkcije
English: It is recommended that serum ferritin be monitored every month and that the dose of Deferasirox be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin.
Slovenian: Priporočeno je spremljanje vrednosti feritina v serumu vsak mesec in prilagajanje odmerka zdravila Deferasiroks Mylan po potrebi vsakih 3 do 6 mesecev glede na trend vrednosti feritina v serumu.
English: Studies in animals have shown some reproductive toxicity at maternally toxic doses (see section 5.3).
Slovenian: Študije na živalih so pokazale določen vpliv na sposobnost razmnoževanja ob odmerkih, ki so bili toksični za mater (glejte poglavje 5.3).
English: If serum ferritin falls consistently below 500 µg/l, an interruption of treatment should be considered (see section 4.4).
Slovenian: Če feritin v serumu večkrat pade pod 500 µg/l, je treba razmisliti o prekinitvi zdravljenja (glejte poglavje 4.4).
English: The dosing recommendations for paediatric patients aged 2 to 17 years with transfusional iron overload are the same as for adult patients (see section 4.2).
Slovenian: Priporočeno odmerjanje za pediatrične bolnike, ki so stari od 2 do 17 let in imajo preobremenitev z železom zaradi transfuzij, je enako kot za odrasle (glejte poglavje 4.2).
English: The transporters MRP2 and MXR (BCRP) are involved in the biliary excretion of deferasirox.
Slovenian: V izločanje deferasiroksa z žolčem sta vključena prenašalca MRP2 in MXR (BCRP).
English: However, as a general precautionary measure in the management of paediatric patients with transfusional iron overload, body weight, height and sexual development should be monitored prior to therapy and at regular intervals (every 12 months).
Slovenian: Vendar pa je pri pediatričnih bolnikih s preobremenitvijo z železom zaradi transfuzij kot splošni previdnostni ukrep treba izmeriti telesno maso in telesno višino ter oceniti spolno dozorevanje pred začetkom zdravljenja in jih nato spremljati v rednih intervalih (vsakih 12 mesecev).