FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking Deferasirox Mylan at the same time each day will also help you remember when to take your tablets.
Croatian: Uzimanje lijeka Deferasiroks Mylan svakoga dana u isto vrijeme pomoći će Vam da se sjetite kada uzeti tablete.
English: However, the initial dose should be the same as in adults, followed by individual titration.
Croatian: Početna doza, međutim, mora biti ista onoj za odrasle, a kasnije se može individualno titrirati.
English: An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment.
Croatian: Pogrešno primijenjena jednokratna doza od 90 mg/kg dovela je do Fanconijevog sindroma koji se povukao nakon liječenja.
English: Serum creatinine at Day - Y
Croatian: Serumski kreatinin na dan - Y
English: These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product.
Croatian: One su dobivene iz izvještaja nastalih spontanim prijavljivanjem za koje nije uvijek moguće pouzdano ustanoviti učestalost ili uzročnu povezanost s izloženošću lijeku.
English: Deferasirox did not cause other effects on fertility or reproduction.
Croatian: Deferasiroks nije uzrokovao druge učinke na plodnost ili reprodukciju.
English: • Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
Croatian: - Ovisno o Vašem odgovoru na liječenje, liječnik kasnije može prilagoditi liječenje višom ili nižom dozom.
English: If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose.
Croatian: Ako prelazite s tableta za oralnu suspenziju na ove filmom obložene tablete, bit će Vam potrebna prilagodba doze.
English: It traps and removes excess iron which is then excreted mainly in the stools.
Croatian: On hvata i uklanja višak željeza koje se potom izlučuje uglavnom stolicom.
English: Linearity / non-linearity
Croatian: Linearnost/nelinearnost
English: Keep this medicine out of the sight and reach of children.
Croatian: - Lijek čuvajte izvan pogleda i dohvata djece.
English: Manufacturer Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Croatian: Proizvođač Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Ujedinjeno Kraljevstvo
English: Additional tests may be required to monitor the blood levels of some of these medicines.
Croatian: Možda će biti potrebno napraviti dodatne pretrage za neke od ovih lijekova radi praćenja njihovih razina u krvi.
English: Pigmentation disorder
Croatian: poremećaj pigmentacije
English: However, repeated blood transfusions can cause a build-up of excess iron.
Croatian: No ponovljene transfuzije krvi mogu uzrokovati prekomjerno nakupljanje željeza.
English: However, this dosing recommendation was not prospectively assessed in the clinical studies.
Croatian: Međutim, ta preporuka o doziranju nije provjerena prospektivnim kliničkim ispitivanjima.
English: At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions, and be closely monitored.
Croatian: Kod propisivanja lijeka bolesnike je potrebno upozoriti na znakove i simptome teških kožnih reakcija te ih pažljivo nadzirati.
English: If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, deferasirox should be interrupted.
Croatian: Uoči li se ustrajno i progresivno povećanje razina serumskih transaminaza koje se ne može pripisati drugim uzrocima, primjena deferasiroksa mora se prekinuti.
English: The causes of the rises in serum creatinine have not been elucidated.
Croatian: Uzroci porasta serumskog kreatinina nisu razjašnjeni.
English: Annually thereafter.
Croatian: Poslije toga godišnje.
English: This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions.
Croatian: To se događa zato što krv sadrži željezo, a ne postoji prirodan način na koji bi tijelo uklonilo višak željeza primljen transfuzijama krvi.
English: You may also have MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver.
Croatian: Možda ćete obaviti i pretragu MR-om (snimanje magnetskom rezonancijom) kako bi se utvrdila količina željeza u Vašoj jetri.
English: Value 1
Croatian: Vrijednost 1
English: If you have questions about how long to take Deferasirox Mylan, talk to your doctor.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Deferasiroks Mylan, obratite se svom liječniku.
English: Of the paediatric patients 52 were aged 2 to 5 years.
Croatian: 52 pedijatrijska bolesnika bila su u dobi od 2 do 5 godina.
English: X and Y are the days (to be determined) when pre-treatment measurements should be performed.
Croatian: X i Y su dani (koji će biti određeni) prije početka liječenja kada je potrebno obaviti spomenuta mjerenja.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your Deferasirox Mylan treatment”).
Croatian: Vaše stanje kako bi provjerio ima li liječenje željeni učinak (pogledajte također dio 2: „Praćenje liječenja lijekom Deferasiroks Mylan”).
English: Do not take Deferasirox Mylan - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Deferasiroks Mylan - ako ste alergični na deferasiroks ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: These will monitor the amount of iron in your body (blood level of ferritin) to see how well Deferasirox Mylan is working.
Croatian: Njima će se pratiti količina željeza u Vašem tijelu (razina feritina u krvi) da se vidi kako dobro Deferasiroks Mylan djeluje.
English: Adverse reactions are ranked below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave su podijeljene prema učestalosti na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Interruption
Croatian: Prekid
English: Anxiety, sleep disorder Nervous system disorders Common:
Croatian: anksioznost, poremećaj spavanja Poremećaji živčanog sustava Često:
English: It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Croatian: To je trovalentni ligand koji veže željezo visokim afinitetom u omjeru 2:1.
English: However, the role of deferasirox as a contributing or aggravating factor cannot be excluded (see section 4.8).
Croatian: Međutim, uloga deferasiroksa kao faktora koji doprinosi ili pogoršava stanje ne može se isključiti (vidjeti dio 4.8).
English: If this applies to you, tell your doctor before taking Deferasirox Mylan.
Croatian: Ako se to odnosi na Vas, obavijestite svog liječnika prije nego počnete uzimati Deferasiroks Mylan.
English: Cataract, maculopathy
Croatian: katarakta, makulopatija
English: Elevations of liver transaminases have been reported.
Croatian: Prijavljena su povišenja jetrenih transaminaza.
English: Hertfordshire EN6 1TL
Croatian: EN6 1TL
English: , tubulointerstitial nephritis
Croatian: , tubulointersticijski nefritis
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.
Croatian: Ukupna izloženost deferasiroksu adolescenata (12 do ≤ 17 godina) i djece (2 do < 12 godina) nakon jednokratne i višestrukih doza bila je niža od one u odraslih bolesnika.
English: - if you have moderate or severe kidney disease.
Croatian: - ako imate umjerenu ili tešku bolest bubrega.
English: Hepatic function in all patients should be monitored before treatment, every 2 weeks during the first month and then every month (see section 4.4).
Croatian: U svih bolesnika mora se pratiti funkcija jetre prije liječenja, zatim svaka 2 tjedna tijekom prvog mjeseca liječenja, a nakon toga svaki mjesec (vidjeti dio 4.4).
English: For patients well managed on deferoxamine
Croatian: Za bolesnike dobro održavane na deferoksaminu
English: Prior to launch of Deferasirox Mylan in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Deferasiroks Mylan u promet u svakoj državi članici, nositelj odobrenja mora se dogovoriti oko sadržaja i formata edukacijskog programa s nacionalnim nadležnim tijelom, uključujući komunikacijske medije, načine distribucije i bilo koje druge aspekte programa.
English: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, France
Croatian: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, Francuska
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as Deferasirox Mylan may reduce the effectiveness of oral and patch contraceptives.
Croatian: Ako trenutno uzimate oralne kontraceptive ili koristite kontraceptive u obliku flastera radi sprječavanja trudnoće, morate koristiti dodatnu ili drugačiju vrstu kontracepcije (npr. prezervativ) budući da Deferasiroks Mylan može smanjiti učinkovitost oralnih kontraceptiva ili kontraceptiva u obliku flastera.
English: Cardiac dysfunction is a known complication of severe iron overload.
Croatian: Disfunkcija srca poznata je komplikacija teškog preopterećenja željezom.
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.
Croatian: Pojedinačni slučajevi porasta ALT-a i aspartat aminotransferaze prijavljeni su u 20,0% odnosno 8,3% od 145 bolesnika koji su završili ispitivanje.
English: The mean elimination half-life (t½) ranged from 8 to 16 hours.
Croatian: Srednja vrijednost poluvijeka eliminacije (t½) kretala se u rasponu od 8 do 16 sati.
English: At these same doses, the ratios of iron excretion: iron intake were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively.
Croatian: Pri istim dozama, omjeri izlučenog željeza i unesenog željeza bili su 1,02 (ukazuje na neto ravnotežu željeza) i 1,67 (ukazuje na neto uklanjanje željeza).
English: Acidbase balance should be monitored as clinically indicated in these populations.
Croatian: U toj populaciji se acido-bazna ravnoteža mora pratiti kako je klinički indicirano.
English: Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3.
Croatian: Glukuronidacija deferasiroksa uglavnom se zbiva posredstvom UGT1A1, a u manjoj mjeri i UGT1A3.
English: Cases of serious acute pancreatitis were observed without documented underlying biliary conditions.
Croatian: Zabilježeni su slučajevi ozbiljnog akutnog pankreatitisa bez dokumentiranih podležećih stanja žuči.
English: Value 2
Croatian: Vrijednost 2
English: (acquired Fanconi syndrome), glycosuria
Croatian: (stečeni Fanconijev sindrom), glikozurija
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).
Croatian: Međutim, kao opću mjeru predostrožnosti, pri liječenju pedijatrijskih bolesnika s preopterećenjem željezom zbog transfuzije potrebno je pratiti tjelesnu težinu, visinu i spolni razvoj prije terapije i u redovitim vremenskim razmacima (svakih 12 mjeseci).
English: Hepatitis, cholelithiasis
Croatian: hepatitis, kolelitijaza
English: It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload).
Croatian: To je kelator željeza, lijek koji se koristi za uklanjanje viška željeza iz tijela (također se zove preopterećenje željezom).
English: Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5).
Croatian: Kombinacija s drugim terapijama kelacije željeza jer sigurnost tih kombinacija nije ustanovljena (vidjeti dio 4.5).
English: Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided.
Croatian: Budući da interakcija nije bila ustanovljena s dozama višim od 0,5 mg repaglinida, treba izbjegavati istodobnu primjenu deferasiroksa s repaglinidom.
English: Generics [UK] Limited Station Close Potters Bar
Croatian: Generics [UK] Limited Station Close
English: There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended.
Croatian: Nema dostupnih podataka o ponovnom liječenju bolesnika u kojih, nakon što je postignuta zadovoljavajuća razina željeza u organizmu, dođe do ponovne akumulacije željeza te se stoga ponovno liječenje ne može preporučiti.
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
Croatian: Smanjenje dnevne doze za 7 mg/kg/dan (formulacija filmom obloženih tableta), ako su sljedeći bubrežni parametri uočeni tijekom dva uzastopna posjeta te se ne mogu pripisati drugim uzrocima
English: The dose should be immediately and completely consumed, and not stored for future use.
Croatian: Cijela doza se mora odmah uzeti i ne smije se pohraniti za buduću primjenu.
English: - First month after start of therapy or dose modification (including switch of formulation)
Croatian: - Prvi mjesec nakon uvođenja terapije ili izmjene doze (uključujući promjenu formulacije lijeka)
English: Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Croatian: gastrointestinalno krvarenje, želučani ulkus (uključujući višestruke ulkuse), duodenalni ulkus, gastritis
English: The increases in Cmax due to the change in formulation and due to the effect of a high-fat meal may be additive and therefore, it is recommended that the film-coated tablets should be taken either on an empty stomach or with a light meal.
Croatian: Povećanja Cmax uzrokovana promjenom formulacije lijeka i učinkom punomasnog obroka mogla bi biti aditivna pa se stoga preporučuje da se filmom obložene tablete uzimaju ili na prazan želudac ili uz lagani obrok.
English: Adult patients
Croatian: Odrasli bolesnici
English: There is no specific antidote for deferasirox.
Croatian: Nema specifičnog antidota za deferasiroks.
English: Table 4 Summary of safety monitoring recommendations
Croatian: Tablica 4 Sažetak sigurnosnih preporuka za praćenje
English: Serum transaminases, bilirubin, alkaline phosphatase
Croatian: Serumske transaminaze, bilirubin, alkalna fosfataza
English: 1, anaemia aggravated
Croatian: 1, pogoršanje anemije
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
English: Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and has a small volume of distribution of approximately 14 litres in adults.
Croatian: Deferasiroks se u visokom stupnju (99%) veže na proteine plazme, gotovo isključivo na serumski albumin te u odraslih ima mali volumen distribucije od približno 14 litara.
English: This age group may therefore require higher doses than are necessary in adults.
Croatian: U toj se dobnoj skupini, stoga, može pokazati potrebnim primjenjivati više doze nego u odraslih.
English: Decreases in mean creatinine clearance have been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the first year of treatment, but there is evidence that this does not decrease further in subsequent years of treatment.
Croatian: Smanjenja u srednjoj vrijednosti klirensa kreatinina zapažena su i u pedijatrijskih i u odraslih bolesnika s beta-talasemijom i preopterećenjem željezom tijekom prve godine liječenja, no postoji dokaz da se on ne smanjuje dalje u narednim godinama liječenja.
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).
Croatian: Kada to rezultira dnevnom dozom manjom od 14 mg/kg tjelesne težine, mora se pratiti odgovor bolesnika i razmotriti povećanje doze ako se ne postigne dovoljna djelotvornost (vidjeti dio 5.1).
English: In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
Croatian: U preostale trećine bolesnika povišene vrijednosti serumskog kreatinina nisu uvijek reagirale na smanjenje doze ni prekid doziranja.
English: The absolute bioavailability of the film-coated tablet formulation has not been determined.
Croatian: Apsolutna bioraspoloživost formulacije filmom obloženih tableta nije ustanovljena.
English: In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome.
Croatian: U izvješćima nakon stavljanja lijeka u promet pojavio se visok udio slučajeva metaboličke acidoze u djece u kontekstu Fanconijevog sindroma.
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.
Croatian: Preporučuje se provjeriti serumske transaminaze, bilirubin i alkalnu fosfatazu prije početka liječenja, svaka 2 tjedna tijekom prvog mjeseca te nakon toga jednom mjesečno.
English: The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
Croatian: Rezultate testova serumskog kreatinina, serumskog feritina i serumskih transaminaza potrebno je bilježiti i redovito procjenjivati trendove kretanja tih vrijednosti.
English: If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Croatian: Ako se čini da je ta kombinacija neophodna, treba oprezno pratiti kliničke znakove i glukozu u krvi (vidjeti dio 4.4).
English: Doses above 14 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes.
Croatian: Doze iznad 14 mg/kg ne preporučuju se zbog toga što nema iskustva s dozama iznad te razine u bolesnika sa sindromima talasemije neovisnim o transfuziji.
English: Weekly during first month of therapy or after dose modification (including switch of formulation).
Croatian: Tjedno tijekom prvog mjeseca terapije ili nakon izmjene doze (uključujući promjenu formulacije lijeka).
English: This includes in particular: - other iron chelators, which must not be taken with Deferasirox Mylan, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Mylan,
Croatian: To se posebno odnosi na: - druge kelatore željeza, koji se ne smiju uzimati s lijekom Deferasiroks Mylan, - antacide (lijekove koji se koriste za liječenje žgaravice) koji sadrže aluminij, koji se ne smiju uzimati u isto doba dana kada i Deferasiroks Mylan,
English: The safety of deferasirox in combination with other iron chelators has not been established.
Croatian: Sigurnost deferasiroksa u kombinaciji s drugim kelatorima željeza nije utvrđena.
English: Most of these patients had pre-existing haematological disorders that are frequently associated with bone marrow failure.
Croatian: Većina tih bolesnika je imala prethodne hematološke poremećaje koji su često povezani sa zatajenjem koštane srži.
English: If you feel dizzy after taking Deferasirox Mylan, do not drive or operate any tools or machines until you are feeling normal again.
Croatian: Ako nakon uzimanja lijeka Deferasiroks Mylan osjetite omaglicu, nemojte upravljati vozilima niti raditi s alatima ili strojevima sve dok se ponovno ne počnete osjećati normalno.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: If deferasirox and theophylline are used concomitantly, monitoring of theophylline concentration and theophylline dose reduction should be considered.
Croatian: Ako se deferasiroks i teofilin primjenjuju istodobno treba razmotriti praćenje koncentracije teofilina i smanjenje doze teofilina.
English: Hypersensitivity reactions (including anaphylactic reactions and angioedema) Metabolism and nutrition disorders Not known:
Croatian: reakcije preosjetljivosti (uključujući anafilaktičke reakcije i angioedem) Poremećaji metabolizma i prehrane Nepoznato:
English: Patients with estimated creatinine clearance <60 ml/min.
Croatian: Bolesnici s procijenjenim klirensom kreatinina < 60 ml/min.
English: Transfusions
Croatian: Transfuzije
English: Deferasirox Mylan is not recommended for children aged under 2 years.
Croatian: Deferasiroks Mylan se ne preporučuje za djecu mlađu od 2 godine.
English: The primary efficacy parameter was the change in liver iron concentration (LIC) from baseline after 12 months of treatment.
Croatian: Primarni parametar djelotvornosti bila je promjena koncentracije željeza u jetri (LIC) u odnosu na početnu vrijednost nakon 12 mjeseci liječenja.
English: Do not stop taking Deferasirox Mylan unless your doctor tells you to.
Croatian: Ne prekidajte uzimanje lijeka Deferasiroks Mylan, osim ako Vam to ne kaže liječnik.
English: Contraindicated
Croatian: Kontraindicirano
English: Safety monitoring schedules for renal and liver parameters are recommended.
Croatian: Preporučuje se napraviti rasporede sigurnosnog praćenja za bubrežne i jetrene parametre.
English: Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%).
Croatian: Povišenja transaminaza veća za 10 puta od gornje granice normalnog raspona, koja upućuju na hepatitis, bila su manje česta (0,3%).
English: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Croatian: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
English: One third of deferoxamine dose
Croatian: Jedna trećina doze deferoksamina
English: Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older).
Croatian: Stariji bolesnici Farmakokinetika deferasiroksa nije ispitivana u starijih bolesnika (u dobi od 65 godina ili starijih).
English: The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose.
Croatian: Apsolutna bioraspoloživost (AUC) deferasiroksa (formulacija tablete za oralnu suspenziju) je oko 70% u usporedbi s intravenskom dozom.
English: If such reactions occur, Deferasirox Mylan should be discontinued and appropriate medical intervention instituted.
Croatian: Ako nastupe takve reakcije, primjena lijeka Deferasiroks Mylan treba se prekinuti i poduzeti odgovarajuće medicinske intervencije.
English: The Cmax of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal.
Croatian: Cmax deferasiroks filmom obloženih tableta bila je povećana (za 29%) kada se lijek uzimao s obrokom s visokim sadržajem masnoća.
English: These were dose-dependent.
Croatian: Ta su povišenja ovisila o dozi.