FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment.
Croatian: Gastrointestinalni učinci su učestaliji na početku terapije i kod većine bolesnika prolaze unutar nekoliko tjedana bez prekidanja liječenja.
English: Number of tablets (three times/day)
Croatian: Broj tableta (tri puta/dan)
English: ((Inside 2))
Croatian: ((Unutrašnja strana 2))
English: However, chelation therapy may not necessarily protect against iron-induced organ damage.
Croatian: Ipak, kelacijska terapija ne mora nužno štititi protiv organskih oštećenja izazvanih željezom.
English: Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Neklinička ispitivanja provedena su na životinjskim vrstama, uključujući miševe, štakore, kuniće, pse i majmune.
English: In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Croatian: Imajući u vidu rezultate ispitivanja genotoksičnosti, karcinogeni potencijal deferiprona ne može se isključiti (vidjeti dio 5.3).
English: Ferriprox is an iron chelator, a type of medicine that removes excess iron from the body.
Croatian: Ferriprox je kelator željeza, vrsta lijeka koja uklanja višak željeza iz tijela.
English: - Pregnancy (see section 4.6).
Croatian: - Trudnoća (vidjeti dio 4.6).
English: Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
Croatian: U nekih bolesnika javila se progresija fibroze povezana s povećanjem preopterećenja željezom ili hepatitisom C.
English: What Ferriprox is and what it is used for
Croatian: Što je Ferriprox i za što se koristi
English: The neurological disorders progressively regressed after deferiprone discontinuation.
Croatian: Neurološki poremećaji progresivno su se povlačili nakon prekida primjene deferiprona.
English: Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.
Croatian: Budući da deferipron može biti povezan s neutropenijom i agranulocitozom, u imunokompromitiranih bolesnika se ne smije započeti s terapijom osim ako se ne utvrdi da potencijalne koristi liječenja nadmašuju potencijalne rizike.
English: If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Croatian: Ako zatrudnite dok uzimate Ferriprox, odmah prestanite uzimati lijek i odmah to recite svom liječniku.
English: If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Croatian: Ako postoji neprestano povišenje alaninaminotransferaze (ALT) u serumu, treba razmotriti prekid terapije deferipronom.
English: A low white blood cell count can be associated with a serious and potentially life-threatening infection.
Croatian: Nizak broj bijelih krvnih stanica može biti povezan s ozbiljnom i potencijalno po život opasnom infekcijom.
English: − if you are pregnant or breast-feeding.
Croatian: − ako ste trudni ili dojite.
English: Plasma Zn2+ concentration
Croatian: Koncentracija Zn2+ u plazmi
English: Limited data are available on the combined use of Ferriprox and deferasirox, and caution should be applied when considering the use of such combination.
Croatian: Dostupni su ograničeni podaci o kombiniranoj primjeni Ferriproxa i deferasiroksa, i potreban je oprez ako se razmatra primjena takve kombinacije.
English: For agranulocytosis (ANC < 0.5x109/l):
Croatian: Za agranulocitozu (ABN < 0,5x109/l):
English: complete, read the card carefully and carry it with you.
Croatian: Karticu trebate odvojiti, ispuniti, pažljivo pročitati i nositi sa sobom.
English: Deferiprone is metabolised predominantly to a glucuronide conjugate.
Croatian: Deferipron se metabolizira prvenstveno na glukuronid konjugat.
English: Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Croatian: Preporučuje se praćenje koncentracije Zn2+ u plazmi i u slučaju deficita njegova nadoknada.
English: Cardiac endpoints were assessed by echocardiogram, electrocardiogram, the New York Heart Association classification and death due to cardiac disease.
Croatian: Krajnji kardijalni ishodi procjenjivani su na temelju ehokardiograma, elektrokardiograma, klasifikacije NYHA (New York Heart Association) i smrti zbog bolesti srca.
English: Mild arthropathies are generally transient.
Croatian: Blage artropatije u pravilu su prolazne.
English: The genotoxic potential of deferiprone was evaluated in a set of in vitro and in vivo tests.
Croatian: Genotoksični potencijal deferiprona procijenjen je u seriji in vitro i in vivo testova.
English: The product information of deferoxamine should be consulted.
Croatian: Potrebno je proučiti informacije o lijeku deferoksamina.
English: What Ferriprox is and what it is used for What you need to know before you take Ferriprox How to take Ferriprox
Croatian: Što je Ferriprox i za što se koristi Što morate znati prije nego uzmete Ferriprox Kako uzimati Ferriprox
English: The median time to onset of the first episode of agranulocytosis was 190 days (ranged 22 days- 17.6 years) and median duration was 10 days in clinical trials.
Croatian: Medijan vremena do pojave prve epizode agranulocitoze bio je 190 dana (u rasponu od 22 dana do 17,6 godina) a medijan trajanja epizode u kliničkim ispitivanjima bio je 10 dana.
English: Do not store above 30ºC.
Croatian: Ne čuvati na temperaturi iznad 30 °C.
English: The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Croatian: Neurološki poremećaji progresivno su se povlačili nakon prekida primjene deferiprona (vidjeti dijelove 4.4 i 4.9).
English: Agranulocytosis and neutropenia usually resolve upon discontinuation of Ferriprox, but fatal cases of agranulocytosis have been reported.
Croatian: Agranulocitoza i neutropenija obično se povuku nakon prekida primjene Ferriproxa, ali prijavljeni su i smrtni slučajevi agranulocitoze.
English: Discolored urine is a very common effect and is not harmful.
Croatian: Promjena boje mokraće je vrlo česta i nije štetna.
English: ((Inside 1))
Croatian: ((Unutrašnja strana 1))
English: Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection.
Croatian: Budući da bijele krvne stanice pomažu u borbi protiv infekcije, nizak broj neutrofila može Vas staviti u rizik od razvoja ozbiljne, i potencijalno po život opasne, infekcije.
English: Take your second dose midday.
Croatian: Drugu dozu uzmite u podne.
English: In the majority of these patients, the increase was asymptomatic and transient, and returned to baseline without discontinuation or decreasing the dose of deferiprone (see section 4.4).
Croatian: U većine od tih bolesnika povišenje je bilo asimptomatsko i prolazno, a razine su se vratile na početne vrijednosti bez prekidanja uzimanja ili smanjenja doze deferiprona (vidjeti dio 4.4).
English: PATIENT/CARER REMINDER CARD ((Front Cover))
Croatian: KARTICA S PODSJETNIKOM ZA BOLESNIKA/NJEGOVATELJA ((Prednja strana))
English: The risk of agranulocytosis and neutropenia is higher if the baseline ANC is less than 1.5x109/l.
Croatian: Rizik od agranulocitoze i neutropenije je viši ako su početne vrijednosti ABN-a manje od 1,5x109/l.
English: Not known (frequency cannot be estimated from the available data): − allergic reactions including skin rash or hives
Croatian: Nije poznato (učestalost se ne može utvrditi iz dostupnih podataka) - alergijske reakcije uključujući kožni osip i koprivnjaču
English: Evaluation of rate of reactions per 100 patient-years of exposure showed that only the rate of diarrhoea was significantly higher in children (11.1) than in adults (2.0, p=0.01).
Croatian: Procjena stope reakcija na 100 bolesnikgodina izloženosti pokazala je da je samo stopa proljeva bila značajno viša kod djece (11,1) nego kod odraslih (2,0, p=0,01).
English: If you get any symptoms of infection such as fever, sore throat or flu-like symptoms, immediately seek medical attention.
Croatian: Ako dobijete bilo koji simptom infekcije, kao što je vrućica, grlobolja ili simptomi nalik gripi, odmah potražite medicinsku pomoć.
English: Have your blood monitored on a weekly basis for the first one year of treatment with Ferriprox and as regularly as your doctor recommends thereafter.
Croatian: Kontrolirajte krvnu sliku svakog tjedna tijekom prve godine liječenja Ferriproxom, a nakon toga onoliko često koliko Vam liječnik propiše.
English: Limited information is available regarding rechallenge.
Croatian: Dostupne su ograničene informacije koji se odnose na ponovnu primjenu deferiprona.
English: No carcinogenicity studies in animals have been conducted with deferiprone.
Croatian: Nisu provedena ispitivanja karcinogenosti deferiprona na životinjama.
English: Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients.
Croatian: Vršna koncentracija u serumu dostiže se za 45 do 60 minuta nakon jednokratne doze u bolesnika natašte.
English: Other medicines and Ferriprox
Croatian: Drugi lijekovi i Ferriprox
English: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Croatian: Svaki ml oralne otopine sadrži 0,4 mg boje Sunset Yellow (E110).
English: There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs. 16% for deferoxamine).
Croatian: Nije bilo značajne razlike u postotku bolesnika s disfunkcijom srca na prvoj procjeni (13% za Ferriprox naspram 16% za deferoksamin).
English: Dose (mg, three times/day)
Croatian: Doza (mg, tri puta/dan)
English: In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
Croatian: U ljudi deferipron se uglavnom eliminira putem bubrega; prijavljeno je da se 75% do 90% unesene doze može se utvrditi u mokraći u prvih 24 sata, i to u obliku slobodnog deferiprona, metabolita glukuronida i kompleksa željezo-deferipron.
English: Neurological disorders have been observed in children treated with more than 2.5 times the maximum recommended dose for several years but have also been observed with standard doses of deferiprone.
Croatian: Neurološki poremećaji Neurološki poremećaji opaženi su u djece koja su liječena s više od 2,5 puta većom dozom od maksimalno preporučene doze tijekom nekoliko godina, no opaženi su i kod standardnih doza deferiprona.
English: It is not known whether deferiprone is excreted in human milk.
Croatian: Nije poznato izlučuje li se deferipron u majčino mlijeko u ljudi.
English: The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds iron in a 3:1 molar ratio.
Croatian: Djelatna tvar je deferipron (3-hidroksi-1,2-dimetilpiridin-4-on), bidentatni ligand koji veže željezo u molarnom omjeru 3:1.
English: A variable amount of elimination via the faeces has been reported.
Croatian: Prijavljeno je da količina eliminacije putem stolice varira.
English: Over the 12-month duration of the study, Ferriprox was superior to deferoxamine in decreasing cardiac iron load.
Croatian: Tijekom 12-mjesečnog trajanja ispitivanja, Ferriprox je bio superiorniji od deferoksamina u smanjivanju opterećenja srca željezom.
English: Treatment with deferiprone should not be initiated if the patient is neutropenic.
Croatian: Liječenje deferipronom ne smije se započinjati ako bolesnik ima neutropeniju.
English: − If you have any further questions, ask your doctor or pharmacist.
Croatian: − Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2).
Croatian: Ferriprox u kombinaciji s drugim kelatorom (vidjeti dio 4.4.) indiciran je kod bolesnika s talasemijom major kada je monoterapija s bilo kojim kelatorom željeza neučinkovita ili kada prevencija ili liječenje posljedica preopterećenja željezom opasnih po život (uglavnom srčano preopterećenje) opravdava brzu ili intenzivnu korekciju (vidjeti dio 4.2).
English: In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis.
Croatian: U kliničkim ispitivanjima tjedno praćenje broja neutrofila bilo je učinkovito u prepoznavanju slučajeva neutropenije i agranulocitoze.
English: Increased levels of serum liver enzymes have been reported in some patients taking deferiprone.
Croatian: Povišene razine jetrenih enzima u serumu prijavljene su u nekih bolesnika koji su uzimali deferipron.
English: The safety of concurrent use of deferiprone and vitamin C has not been formally studied.
Croatian: Sigurnost istodobne primjene deferiprona i vitamina C nije formalno ispitana.
English: Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Croatian: Događaji artropatije, koji su se kretali u rasponu od blage boli u jednom ili više zglobova do teškog artritisa s izljevom i značajnom onesposobljenošću, također su prijavljeni u bolesnika liječenih deferipronom.
English: Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended.
Croatian: Podsjećamo liječnike koji propisuju ovaj lijek da se primjena doza iznad 100 mg/kg/dan ne preporučuje.
English: Study LA37-1111 was conducted to evaluate the effect of single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral doses of deferiprone on the cardiac QT interval duration in healthy subjects.
Croatian: Ispitivanje LA37-1111 provedeno je kako bi se ocijenio učinak jedne terapijske (33 mg/kg) i supraterapijske (50 mg/kg) oralne doze deferiprona na trajanje QT intervala srca kod zdravih ispitanika.
English: Ferriprox was concluded to produce no significant prolongation of the QT interval.
Croatian: Zaključeno je da Ferriprox ne uzrokuje značajno produljenje QT intervala.
English: Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Croatian: Dozu po kilogramu tjelesne težine treba izračunati do najbliže doze koja se postiže primjenom 2,5 ml.
English: The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients.
Croatian: Najčešće nuspojave prijavljene tijekom terapije deferipronom u kliničkim ispitivanjima bile su mučnina, povraćanje, bol u abdomenu i kromaturija, a prijavljene su u više od 10% bolesnika.
English: If treatment is unavoidable, breast-feeding must be stopped (see section 4.3).
Croatian: Ako se liječenje na može izbjeći, dojenje se mora prekinuti (vidjeti dio 4.3).
English: No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Croatian: Nije primijećen značajan učinak oštećenja bubrega na sistemsku izloženost deferipronu.
English: The use of combination therapy should be considered on a case-by-case basis.
Croatian: Primjena kombinirane terapije treba se uzeti u obzir nakon procjene svakog pojedinog slučaja.
English: The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Croatian: Uobičajena doza je 25 mg/kg, 3 puta na dan, do ukupne dnevne doze od 75 mg/kg.
English: Provide protective isolation and if clinically indicated, admit patient to the hospital.
Croatian: Osigurajte zaštitnu izolaciju bolesnika i ako je to klinički indicirano,
English: Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Croatian: Stoga se ne preporučuje uzimati istodobno antacide na bazi aluminija i deferipron.
English: A fatal outcome was observed in 8.3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience.
Croatian: Smrtni ishod dogodio se u 8,3% epizoda agranulocitoze prijavljenih u kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: There are no reports of acute overdose with Ferriprox.
Croatian: Nema prijava o akutnom predoziranju Ferriproxom.
English: Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.
Croatian: Na temelju prijavljenih neželjenih interakcija koje mogu nastati između deferoksamina i vitamina C, potreban je oprez kod istodobne primjene deferiprona i vitamina C.
English: No effects on fertility or early embryonic development were noted in non-iron-loaded male and female rats that received deferiprone orally at doses of up to 75 mg/kg twice daily for 28 days (males) or 2 weeks (females) prior to mating and until termination (males) or through early gestation (females).
Croatian: Nisu uočeni učinci na plodnost ili rani embrionalni razvoj u željezom ne opterećenih mužjaka i ženki štakora koji su primali deferipron peroralno u dozama do 75 mg/kg dvaput dnevno kroz 28 dana (mužjaci) odnosno 2 tjedna (ženke) prije parenja, te do kraja parenja (mužjaci) odnosno tijekom rane gestacije (ženke).
English: Study LA12-9907 compared survival, incidence of cardiac disease, and progression of cardiac disease in 129 patients with thalassaemia major treated for at least 4 years with Ferriprox (N=54) or deferoxamine (N=75).
Croatian: Ispitivanje LA12-9907 uspoređivalo je preživljavanje, incidenciju bolesti srca i progresiju bolesti srca u 129 bolesnika s talasemijom major koji su liječeni najmanje 4 godine Ferriproxom (n=54) ili deferoksaminom (n=75).
English: Systemic exposure to deferiprone and to its metabolite deferiprone 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.
Croatian: Sistemska izloženost deferipronu i njegovu metabolitu deferipron 3-O-glukuronidu ocijenjena je pomoću farmakokinetičkih parametara Cmax i AUC.
English: Doses of Ferriprox in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Croatian: Doze Ferriproxa u tim ispitivanjima bile su u rasponu od 50 do 100 mg/kg/dan, a doze deferoksamina od 40 do 60 mg/kg/dan.
English: An increase in MRI T2* on treatment indicates that iron is being removed from the heart.
Croatian: Povećanje MR T2* vrijednosti tijekom liječenja ukazuju da se željezo uklanja iz srca.
English: Since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
Croatian: Ipak, budući da se deferipron veže za katione metala, postoji mogućnost interakcija između deferiprona i lijekova koji ovise o prisutnosti trivalentnih kationa, poput antacida na bazi aluminija.
English: • To increase patient awareness of the significance of any symptoms of infection while taking deferiprone
Croatian: • podizanje razine osviještenosti bolesnika o značaju bilo kojeg simptoma infekcije tijekom liječenja deferipronomom
English: The incidences of adverse reactions experienced by 18 children and 97 adults treated with combination therapy were not significantly different between the two age groups except in the incidence of arthropathy (11.1% in children vs. none in adults, p=0.02).
Croatian: Incidencije nuspojava koje su se pojavile u 18 djece i 97 odraslih osoba liječenih kombiniranom terapijom nisu bile značajno različite između dvije dobne skupine osim incidencije artropatije (11,1% kod djece naspram niti jednog slučaja kod odraslih, p=0,02).
English: Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Ferriprox may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
Croatian: Prilagodbe doza kada se koristi s drugim kelatorima željeza Kod bolesnika kod kojih je monoterapija neodgovarajuća, Ferriprox se može koristiti s deferoksaminom u standardnoj dozi (75 mg/kg/dan) ali doza ne bi smjela prijeći 100 mg/kg/dan.
English: The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterized for monotherapy.
Croatian: Sigurnosni profil kombinirane terapije (deferipron i deferoksamin) koji je opažen u kliničkim ispitivanjima, nakon stavljanja lijeka u promet ili u objavljenoj literaturi bio je u skladu s onim koji je opisan za monoterapiju.
English: What you need to know before you take Ferriprox
Croatian: Što morate znati prije nego uzmete Ferriprox
English: The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
Croatian: Učinak Ferriproxa na snižavanje razine željeza u tijelu izravno je ovisan o dozi i stupnju preopterećenja željezom.
English: Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Croatian: Niske razine cinka u plazmi povezane su s deferipronom u manjem broju bolesnika.
English: The influence of severe hepatic impairment on the pharmacokinetics of deferiprone and deferiprone 3-O-glucuronide has not been evaluated.
Croatian: Učinak teškog oštećenja funkcije jetre na farmakokinetiku deferiprona i deferipron 3-O-glukuronida nije procijenjen.
English: Carcinogenicity/mutagenicity
Croatian: Karcinogenost/mutagenost
English: Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement, have been reported in children in the post-marketing setting with standard doses of deferiprone.
Croatian: Epizode hipotonije, nestabilnosti, nemogućnosti hodanja te hipertonije s nemogućnošću pokretanja udova prijavljene su kod djece u periodu nakon stavljanja lijeka u promet sa standardnim dozama deferiprona.
English: • Whenever the risk management system is modified, especially as a result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Patients should be informed that their urine may show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex.
Croatian: Bolesnike treba informirati da njihova mokraća može promijeniti boju u crvenkasto/smeđu zbog izlučivanja kompleksa željezo-deferipron.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
Croatian: Farmakoterapijska skupina: lijekovi za kelaciju željeza, ATK oznaka: V03AC02 Mehanizam djelovanja
English: Immediately interrupt deferiprone if the patient experience infection.
Croatian: Odmah prekinite primjenu deferiprona ako je bolesnik dobio infekciju.
English: Ferriprox and deferoxamine were equivalent in promoting a net stabilization or reduction of body iron load, despite the continuous transfusional iron administration in those patients (no difference in proportion of patients with a negative trend in serum ferritin between the two treatment groups by regression analysis; p >0.05).
Croatian: Ferriprox i deferoksamin bili su jednaki u poboljšanju stabilizacije ili redukcije opterećenja tijela željezom unatoč kontinuiranoj primjeni željeza u transfuzijama u ovih bolesnika (nije bilo razlike u udjelu bolesnika s negativnim trendom feritina u serumu između dviju liječenih skupina dobivene regresijskom analizom; p >0,05).