natgillin/translations-raw huggingface dataset:
Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/kg/day or greater in non-iron-loaded animals.
Atrofija timusa, limfoidnog tkiva i testisa, te hipertrofija nadbubrežnih žlijezda prijavljeni su pri dozama od 100 mg/kg/dan ili višim u životinja ne opterećenih željezom.
Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
Treba prekinuti primjenu deferiprona ako se opaze neurološki poremećaji (vidjeti dijelove 4.8 i 4.9).
Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Pojava bolova u zglobovima i oticanje kretala se od blage boli u jednom ili više zglobova do teške onesposobljenosti.
There are no data available on the use of deferiprone in patients with end stage renal disease or severe hepatic impairment (see section 5.2).
Nema dostupnih podataka o primjeni deferiprona u bolesnika sa završnim stadijem bolesti bubrega ili teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
BOCE OD 250 ML I 500 ML ORALNE OTOPINE
A positive correlation between MRI T2* values and cardiac function (as measured by Left Ventricular Ejection Fraction (LVEF)) has been documented.
Dokumentirana je pozitivna korelacija između MR T2* vrijednost i funkcije srca (mjerenjem ejekcijske frakcije lijevog ventrikula
Dose per kilogram body weight should be calculated to the nearest half tablet.
Dozu po kilogramu tjelesne težine treba izračunati do najbliže doze koja se postiže primjenom polovice tablete.
A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Također je korištena i metoda magnetske rezonancije (MR), T2*, za kvantitativno određivanje opterećenja miokarda željezom.
Please refer to the patient/carer reminder card attached to this leaflet.
Molimo pogledajte u karticu s podsjetnikom za bolesnika/njegovatelja pričvršćenu za ovu uputu.
To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.
Za određivanje doze od oko 75 mg/kg/dan, koristiti preporučeni broj tableta naveden u sljedećoj tablicama prema tjelesnoj težini bolesnika.
Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Savjetuje se pažljivo motrenje srčanih događaja kod bolesnika koji primaju kombiniranu terapiju (vidjeti dio 4.4).
Hypromellose 2910 USP/EP
Ovojnica hipromeloza 2910 USP/EP hidroksipropilceluloza makrogol titanijev dioksid
Patients should be aware to contact their physician if they experience any symptoms indicative of infection (such as fever, sore throat and flu-like symptoms).
Bolesnike treba upozoriti da se jave svom liječniku ako primijete bilo koji simptom koji može upućivati na infekciju (kao što je vrućica, grlobolja ili simptomi nalik gripi).
It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to be obtained for three consecutive weeks, to ensure that the patient recovers fully.
Nakon oporavka neutropenije preporučuje se kontrola KKS, broja leukocita, neutrofila i trombocita tijekom tri uzastopna tjedna kako bi se sa sigurnošću utvrdilo da se bolesnik u potpunosti oporavio.
Newly diagnosed cardiac dysfunction occurred in 13 (20.6%) deferoxamine-treated patients and in 2 (4.3%) Ferriprox-treated patients who were cardiac disease-free at the first assessment (p=0.013).
Novodijagnosticirana disfunkcija srca utvrđena je u 13 (20,6%) bolesnika liječenih deferoksaminom i u 2 (4,3%) bolesnika liječena Ferriproxom, a koji nisu imali bolest srca kod prve procjene (p=0,013).
Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Pokazalo se da deferipron uzrokuje neutropeniju, uključujući i agranulocitozu (vidjeti dio 4.8,
Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
Vrijednost AUC-a deferipron-3-O-glukuronida smanjila se za 10%, a Cmax-a za 20% u ispitanika s blagim i umjerenim oštećenjem funkcije jetre u usporedbi sa zdravim dobrovoljcima.
Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Ferriprox oralna otopina sadrži bojilo Sunset Yellow (E110) koje može uzrokovati alergijske reakcije.
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
4.2 Doziranje i način primjene Terapiju deferipronom treba započeti i provoditi liječnik iskusan u liječenju bolesnika s talasemijom.
Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
Ferriprox oralna otopina sadrži Sunset Yellow (E110) Sunset Yellow (E110) je bojilo koje može uzrokovati alergijske reakcije.
At the same time point, LVEF had increased from baseline by 3.07 ± 3.58 absolute units (%) in the Ferriprox group and by 0.32 ± 3.38 absolute units (%) in the deferoxamine group (difference between groups; p=0.003).
3,07 ± 3,58 apsolutnih jedinica (%) u skupini koja je primala Ferriprox i za 0,32 ± 3,38 apsolutnih jedinica (%) u skupini koja je primala deferoksamin (razlika između skupina; p=0,003).
Very common side effects (may affect more than 1 in 10 people):
Vrlo česte nuspojave (mogu se pojaviti kod više od 1 na 10 ljudi): - bol u trbuhu
In females, an effect on the oestrous cycle delayed time to confirmed mating at all doses tested.
Za potvrdu parenja kod ženki je učinjen test odgođenog ciklusa estrusa pri svim dozama.
The maximum difference between the LS means of the therapeutic dose and placebo was 3.01 ms (95% one-sided UCL: 5.01 ms), and between the LS means of the supratherapeutic dose and placebo was 5.23 ms (95% one-sided UCL: 7.19 ms).
Maksimalna razlika između LS srednjih vrijednosti terapijske doze i placeba bila je 3,01 ms (gornja granica jednostranog 95%-tnog intervala pouzdanosti: 5,01 ms), a između LS srednjih vrijednosti supraterapijske doze i placeba bila je 5,23 ms (gornja granica jednostranog 95%-tnog intervala pouzdanosti: 7,19 ms).
Clinical studies have demonstrated that Ferriprox is effective in promoting iron excretion and that a dose of 25 mg/kg three times per day can prevent the progression of iron accumulation as assessed by serum ferritin, in patients with transfusion-dependent thalassaemia.
Klinička ispitivanja pokazala su da je Ferriprox učinkovit u poboljšanju izlučivanja željeza, i da u dozi od 25 mg/kg tri puta na dan može spriječiti progresiju akumulacije željeza, a što je dokazivo mjerenjem feritina u serumu, u bolesnika s talasemijom ovisnom o transfuziji.
Sunset Yellow (E110)
Sunset Yellow (E110) sukraloza (E955)
Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Smeđe boce od polietilentereftalata (PET) sa sigurnosnim zatvaračem za djecu (polipropilen), i graduiranom odmjernom čašom (polipropilen).
Number of 1000 mg tablets* Morning
Broj tableta od 1000 mg*
HIV positive or other immunocompromised patients No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients.
Nema dostupnih podataka o primjeni deferiprona u HIV pozitivnih ili drugih imunokompromitiranih bolesnika.
If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay.
Ako bolesnik tijekom liječenja deferipronom razvije infekciju, liječenje treba odmah prekinuti i bez odgađanja provjeriti apsolutni broj neutrofila.
For patients whose Ferriprox has not been interrupted during the first year of therapy due to any decrease in the neutrophil count, the frequency of ANC monitoring may be extended to the patient's blood transfusion interval (every 2-4 weeks) after one year of deferiprone therapy.
Nakon godinu dana liječenja deferipronom, u bolesnika u kojih liječenje Ferriproxom tijekom te prve godine liječenja nije bilo prekidano zbog bilo kakvog smanjenja broja neutrofila, učestalost kontroliranja ABN-a može se produljiti na interval u kojem bolesnik prima transfuzije krvi (svaka 2-4 tjedna).
Deferiprone AUCs did not differ between treatment groups, but Cmax was decreased by 20% in mildly or moderately hepatically impaired subjects compared with healthy volunteers.
Vrijednosti AUC-a deferiprona nisu se razlikovale unutar liječenih skupina, ali Cmax je bio smanjen za 20% u ispitanika s blagim i umjerenim oštećenjem funkcije jetre u usporedbi sa zdravim dobrovoljcima.
Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.
Pokažite tu karticu svom liječniku ako razvijete simptome infekcije kao što su vrućica, grlobolja ili simptomi nalik gripi.
PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
OBLIK I SADRŽAJ 250 ml oralne otopine
ml of oral solution (three times/day)
ml oralne otopine (tri puta/dan)
Sixty-one patients with cardiac iron overload, previously treated with deferoxamine, were randomized to continue deferoxamine (average dose 43 mg/kg/day; N=31) or to switch to Ferriprox (average dose 92 mg/kg/day N=29).
Šezdeset jedan bolesnik s preopterećenjem srca željezom, prethodno liječenih deferoksaminom, randomizirano je u skupinu koja je nastavila primati deferoksamin (prosječna doza 43 mg/kg/dan; n=31), odnosno u skupinu koja se prebacila na Ferriprox (prosječna doza 92 mg/kg/dan n=29).
Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Ferriprox 1000 mg filmom obložene tablete EU/1/99/108/004
To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox.
Radi nadziranja neutropenije, Vaš liječnik će od Vas tijekom liječenja Ferriproxom tražiti da redovito radite krvne pretrage (kako bi se provjerio broj bijelih krvnih stanica).
Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Ferriprox se koristi se za liječenje preopterećenja željezom uzrokovanog čestim transfuzijama krvi u bolesnika s talasemijom major kada je trenutna kelacijska terapija kontraindicirana ili neodgovarajuća.
Following a dose of 25 mg/kg, lower peak serum concentrations have been detected in patients in the fed state (85 µmol/l) than in the fasting state (126 µmol/l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
(85 µmol/l) nego u onih natašte (126 µmol/l), premda nije bilo smanjenja u količini apsorbiranog deferiprona ako se davao s hranom.
Myocardial MRI T2* values of less than 20 ms represent iron overload in the heart.
vrijednosti miokarda manje od 20 ms predstavljaju preopterećenje srca željezom.
− if you have a history of agranulocytosis (very low white blood cell (neutrophil) count).
− ako ste u povijesti bolesti imali agranulocitozu (vrlo niski broj bijelih krvnih stanica (neutrofila)).
To obtain a dose of about 75 mg/kg/day, use the volume of oral solution suggested in the following table for the body weight of the patient.
Za određivanje doze od oko 75 mg/kg/dan, koristiti preporučeni volumen oralne otopine naveden u sljedećoj tablici prema tjelesnoj težini bolesnika.
500 ml oral solution
500 ml oralne otopine
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
Na temelju rezultata ovog ispitivanja, nije potrebna prilagodba režima doziranja lijeka Ferriprox u bolesnika s oštećenjem funkcije bubrega.
Clear, reddish orange-coloured liquid.
Bistra, crvenkasto narančasta tekućina.
After one year of study therapy, patients on concurrent chelation therapy had experienced a significantly greater reduction in serum ferritin (1574 µg/l to 598 µg/l with concurrent therapy vs. 1379 µg/l to 1146 µg/l with deferoxamine monotherapy, p<0.001), significantly greater reduction in myocardial iron overload, as assessed by an increase in MRI T2* (11.7 ms to 17.7 ms with concurrent therapy vs. 12.4 ms to 15.7 ms with deferoxamine monotherapy, p=0.02) and significantly greater reduction in liver iron concentration, also assessed by an increase in MRI T2* (4.9 ms to 10.7 ms with concurrent therapy vs. 4.2 ms to 5.0 ms with deferoxamine monotherapy, p< 0.001).
Nakon jedne godine terapije u ispitivanju, bolesnici na istodobnoj kelacijskoj terapiji doživjeli su značajno veće smanjenje serumskog feritina (1574 µg/l do 598 µg/l s istodobnom terapijom naspram 1379 µg/l do 1146 µg/l s monoterapijom deferoksaminom, p<0,001), značajno veće smanjenje u opterećenju miokarda željezom, što je procijenjeno povećanjem u MR T2* (11,7 ms do 17,7 ms s istodobnom terapijom naspram 12,4 ms do 15,7 ms s monoterapijom deferoksaminom,
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with mildly or moderately impaired hepatic function.
Na temelju rezultata ovog ispitivanja, nije potrebna prilagodba režima doziranja lijeka Ferriprox u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
- Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
- Zbog nepoznatog mehanizma nastanka neutropenije izazvane deferipronom, bolesnici ne smiju uzimati lijekove za koje je poznato da su povezani s neutropenijom ili lijekove koji mogu uzrokovati agranulocitozu (vidjeti dio 4.5).
Subjects were categorized into 4 groups based on estimated glomerular filtration rate (eGFR): healthy volunteers (eGFR ≥ 90 mL/min/1.73m2), mild renal impairment (eGFR 60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Ispitanici su na temelju procijenjene brzine glomerularne filtracije (eGFR) bili podijeljeni u 4 skupine: zdravi dobrovoljci (eGFR ≥ 90 ml/min/1,73m2), ispitanici s blagim oštećenjem funkcije bubrega (eGFR 60-89 ml/min/1,73m2), ispitanici s umjerenim oštećenjem funkcije bubrega (eGFR 30-59 ml/min/1,73m2) i ispitanici s teškim oštećenjem funkcije bubrega (eGFR 15-29 ml/min/1,73m2).
Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti dio 5.2).
The other ingredients are: purified water; hydroxyethylcellulose; glycerol (E422); hydrochloric acid, concentrated (for pH adjustment); artificial cherry flavour; peppermint oil; Sunset Yellow (E110); sucralose (E955).
koncentrirana (za prilagodbu pH); umjetna aroma trešnje; ulje paprene metvice; Sunset Yellow (E110); sukraloza (E955).
Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Odmah prijavite svom liječniku bilo koje simptome infekcije poput: vrućice, grlobolje ili simptoma nalik gripi.
Pack size of 50 tablets.
Veličina pakiranja: 50 tableta.
• To increase patient awareness of the importance of regular monitoring of the neutrophil count during treatment with deferiprone
• podizanje razine osviještenosti bolesnika o važnosti redovitog praćenja broja neutrofila tijekom liječenja deferipronom
The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Najozbiljnija nuspojava prijavljena u kliničkim ispitivanjima s deferipronom je agranulocitoza (neutrofili <0,5x109/l), s incidencijom od 1,1% (0,6 slučajeva na 100 bolesnika-godina liječenja)
Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. Do not store above 30ºC.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „EXP“.
Suggested management of cases of neutropenia is outlined below.
Preporučeno liječenje slučajeva neutropenije navedeno je u nastavku.
The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Najozbiljnija nuspojava Ferriproxa je vrlo nizak broj bijelih krvnih stanica (neutrofila).
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Monoterapija Ferriproxom indicirana je za liječenje preopterećenja željezom u bolesnika s talasemijom major kada je trenutna kelacijska terapija kontraindicirana ili neodgovarajuća.
Name and address of the manufacturers responsible for batch release Eurofins PROXY Laboratories B.V.
Proizvođač odgovoran za puštanje serije lijeka u promet: Eurofins PROXY Laboratories B.V.
Do not take aluminium-based antacids at the same time as taking Ferriprox.
Nemojte uzimati antacide na bazi aluminija za vrijeme liječenja s lijekom Ferriprox.
Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
ZA ŽENE REPRODUKTIVNE DOBI Nemojte uzimati Ferriprox ako ste trudni ili nastojite zatrudnjeti.
An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Ferriprox.
Provedeno je otvoreno, nerandomizirano kliničko ispitivanje s paralelnim skupinama kako bi se procijenio učinak oštećenja funkcije bubrega na sigurnost, podnošljivost i farmakokinetiku jedne peroralne doze Ferriproxa od 33 mg/kg.
What Ferriprox contains The active substance is deferiprone.
Što Ferripox sadrži Djelatna tvar je deferipron.
- History of recurrent episodes of neutropenia.
- Rekurentne epizode neutropenije u anamnezi.
Regardless of the degree of renal impairment, the majority of the dose of Ferriprox was excreted in the urine over the first 24 hours as deferiprone 3-O-glucuronide.
Bez obzira na stupanj oštećenja bubrega, većina doze Ferriproxa izlučuje se putem urina tijekom prvih
Neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been observed in children with standard doses of deferiprone.
Neurološki poremećaji (kao što je nevoljno drhtanje, poremećaji hodanja, dvoslika, nevoljno grčenje mišića, problemi s koordinacijom pokreta) prijavljeni su kod djece kojoj je dobrovoljno propisivana više od dvostruko puta veća doza od maksimalno preporučene doze od 100 mg/kg/dan tijekom nekoliko godina no opaženi su i kod standardnih doza deferiprona u djece.
Pack size of 100 tablets.
Veličina pakiranja: 100 tableta.
- Breast-feeding (see section 4.6).
- Dojenje (vidjeti dio 4.6).
You must use effective contraception while you are taking Ferriprox.
Dok uzimate Ferriprox morate koristiti učinkovitu kontracepciju.
Tel: + 385 1 4874 500
Providens d.o.o. Tel: + 385 1 4874 500
Each 500 mg tablet contains 500 mg deferiprone.
Svaka tableta od 500 mg sadrži 500 mg deferiprona.
In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
U slučaju zatajenja srca induciranog željezom, potrebno je terapiji s deferoksaminom dodati Ferriprox od 75-100 mg/kg/dan.
The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Pomoćne tvari su: Jezgra tablete: mikrokristalična celuloza, magnezijev stearat, koloidni silicijev dioksid.
Important Safety Reminders for Patients taking Ferriprox (deferiprone) Prescribing doctor: _________________ Phone No: ________________________
Važni sigurnosni podsjetnik za bolesnike koji uzimaju Ferriprox (deferipron)
Abdominal Pain Vomiting
Poremećaji probavnog sustava mučnina bol u abdomenu povraćanje proljev
The patient's absolute neutrophil count (ANC) should be monitored every week during the first year of therapy.
Tijekom prve godine liječenja, bolesniku se apsolutni broj neutrofila (ABN) mora kontrolirati svaki tjedan.
Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Ovojnica: hipromeloza, hidroksipropilceluloza, makrogol, titanijev dioksid.
Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
Tijekom terapije deferipronom potrebno je pratiti funkciju bubrega i jetre u ovoj populaciji bolesnika.
However, neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Ipak, neurološki poremećaji (poput cerebelarnih simptoma, diplopije, lateralnog nistagmusa, psihomotornog usporavanja, nevoljnih pokreta ruku i aksijalne hipotonije) opaženi su u djece kojoj je dobrovoljno propisivana više od 2,5 puta veća doza od maksimalno preporučene doze od 100 mg/kg/dan tijekom nekoliko godina.
EXP After first opening use within 50 days.
EXP Nakon prvog otvaranja upotrijebiti unutar 50 dana.
Do not take Ferriprox
Nemojte uzimati Ferriprox:
MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Ferriprox 500 mg filmom obložene tablete EU/1/99/108/001
Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section
Zbog nepoznatog mehanizma nastanka neutropenije izazvane deferipronom, bolesnici ne smiju uzimati lijekove za koje se zna da su povezani s neutropenijom ili lijekove koji mogu uzrokovati agranulocitozu (vidjeti dio 4.3).
After first opening use within 50 days.
Nakon prvog otvaranja upotrijebiti unutar 50 dana.
After first opening use within 35 days.
Nakon prvog otvaranja upotrijebiti unutar 35 dana.
EXP After first opening use within 35 days.
EXP Nakon prvog otvaranja upotrijebiti unutar 35 dana.
Coating: Hypromellose, Macrogol, Titanium dioxide.
Ovojnica: hipromeloza, makrogol, titanijev dioksid.
Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years.
Neurološki poremećaji (poput cerebelarnih simptoma, diplopije, lateralnog nistagmusa, psihomotornog usporavanja, nevoljnih pokreta ruku i aksijalne hipotonije) opaženi su u djece kojoj je dobrovoljno propisivana više od 2,5 puta veća doza od maksimalno preporučene doze od 100 mg/kg/dan tijekom nekoliko godina.
How to take Ferriprox
Kako uzimati Ferriprox
Tablet core: Methylcellulose, crospovidone, magnesium stearate.
Pomoćne tvari su: Jezgra tablete: metilceluloza, krospovidon, magnezijev stearat.
Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone.
Ferriprox 1000 mg filmom obložene tablete Svaka tableta sadrži 1000 mg deferiprona.
LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
Sadrži boju Sunset Yellow (E110); za dodatne informacije vidjeti Uputu o lijeku.
Each 1000 mg tablet contains 1000 mg deferiprone.
Svaka tableta od 1000 mg sadrži 1000 mg deferiprona.
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane povećan apetit
INFORMATION IN BRAILLE Ferriprox 100 mg/ml
16. PODACI NA BRAILLEOVOM PISMU Ferriprox 100 mg/ml
INFORMATION IN BRAILLE Ferriprox 1000 mg
16. PODACI NA BRAILLEOVOM PISMU Ferriprox 1000 mg
Neutropenia/Agranulocytosis
Neutropenija/agranulocitoza
Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
Tablica doziranja za Ferriprox 1000 mg filmom obložene tablete Tjelesna težina (kg)