natgillin/translations-raw huggingface dataset:
Ferriprox is an iron chelator, a type of medicine that removes excess iron from the body.
Zdravilo Ferriprox je kelator železa - vrsta zdravila, ki iz telesa odstrani odvečno železo.
In these patients careful monitoring of liver histology is recommended.
Pri teh bolnikih je priporočljivo pazljivo histološko nadzorovanje jeter.
Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients.
Najvišjo koncentracijo v serumu doseže 45 do 60 minut po enkratnem odmerku pri bolnikih, ki zdravilo vzamejo na tešče.
The risk of agranulocytosis and neutropenia is higher if the baseline ANC is less than 1.5x109/l.
Nevarnost agranulocitoze in nevtropenije je višja, če je osnovno ANC manjše od 1,5 x 109/l.
Ferriprox was concluded to produce no significant prolongation of the QT interval.
Ugotovljeno je bilo, da zdravilo Ferriprox ne podaljšuje bistveno intervala QT.
It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Priporočamo, da se ta postopek izpelje, preden se pri katerem koli bolniku uvede zdravljenje z deferipronom.
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.
Pri bolnikih, pri katerih je bilo zdravljenje z zdravilom Ferriprox v prvem letu prekinjeno zaradi zmanjšanja števila nevtrofilcev, je dovoljeno pogostnost spremljanja ANC po enem letu zdravljenja z deferipronom podaljšati na bolnikov interval za transfuzijo krvi (vsake 2-4 tedne).
Since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
Ker pa se deferipron veže na kovinske katione, obstaja možnost interakcij med deferipronom in zdravili s trivalentnimi kationi, kot so antacidi, ki vsebujejo aluminijeve spojine.
A fatal outcome was observed in 8.3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience.
Smrtni izid so opazili pri 8,3 % epizod agranulocitoze iz kliničnih preskušanj in izkušenj v obdobju trženja, o katerih so poročali.
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).
Zdravilo Ferriprox je v kombinaciji z drugim kelatorjem (glejte poglavje 4.4) indicirano pri bolnikih s talasemijo major, če je monoterapija s katerim koli kelatorjem železa neučinkovita, ali kadar preprečevanje ali zdravljenje življenjsko nevarnih posledic preobremenitve z železom (predvsem srčne preobremenitve) opravičuje hiter ali intenziven popravek (glejte poglavje 4.2).
In thalassaemia patients there is an association between liver fibrosis and iron overload and/or hepatitis C. Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal.
Pri bolnikih s talasemijo je dokazana povezava med fibrozo jeter in prekomerno količino železa v telesu in/ali hepatitisom C. Posebno pozorno je potrebno preveriti, da je keliranje železa pri bolnikih s hepatitisom C optimalno.
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).
Ferriprox in deferoksamin sta si bila enakovredna pri stabilizaciji ali zmanjševanju količine železa v telesu navkljub neprekinjeni transfuzijski aplikaciji železa pri teh pacientih (brez razlike v deležu pacientov z negativno tendenco pri serumskem feritinu med dvema obravnavanima skupinama pri analizi regresije; p > 0,05).
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.
V študiji LA37-1111 je bil ocenjevan učinek enkratnega terapevtskega (33 mg/kg) in supraterapevtskega (50 mg/kg) peroralnega odmerka deferiprona na trajanje intervala QT pri zdravih preiskovancih.
What Ferriprox is and what it is used for What you need to know before you take Ferriprox How to take Ferriprox
Kaj je zdravilo Ferriprox in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ferriprox Kako jemati zdravilo Ferriprox
• To increase patient awareness of the significance of any symptoms of infection while taking deferiprone
• za informiranje bolnikov o pomembnosti vsakršnih simptomov okužbe med jemanjem deferiprona;
The levels normalised with oral zinc supplementation.
Vrednosti so se normalizirale s peroralnim dopolnjevanjem cinka.
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.
Prilagoditve odmerka pri uporabi z drugimi kelatorji železa Pri bolnikih, pri katerih je monoterapija neprimerna, se zdravilo Ferriprox lahko uporablja z deferoksaminom v standardnem odmerku (75 mg/kg/dan), vendar ne sme preseči 100 mg/kg/dan.
Systemic exposure to deferiprone and to its metabolite deferiprone 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.
Sistemska izpostavljenost deferipronu in njegovemu presnovku deferipron 3-O-glukuronidu je bila ocenjena s farmakokinetičnima parametroma Cmax in AUC.
No carcinogenicity studies in animals have been conducted with deferiprone.
Študije o karcinogenem delovanju deferiprona pri živalih niso bile izvedene.
− if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil)
− če ste kdaj imeli ponavljajoče se epizode nevtropenije (znižana koncentracija belih krvničk
Dose per kilogram body weight should be calculated to the nearest half tablet.
Odmerek na kilogram telesne mase naj se izračuna do najbližje polovice tablete natančno.
A variable amount of elimination via the faeces has been reported.
Poročali so tudi o spremenljivi količini izločanja v blatu.
The higher rate of “Cardiac disorders" reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy.
Višja stopnja »srčnih bolezni«, o katerih so poročali med kombinirano terapijo, v primerjavi z monoterapijo, je verjetno posledica večje pojavnosti obstoječih srčnih bolezni pri bolnikih, ki so prejemali kombinirano terapijo.
The influence of severe hepatic impairment on the pharmacokinetics of deferiprone and deferiprone 3-O-glucuronide has not been evaluated.
Vpliva hude jetrne okvare na farmakokinetiko deferiprona in deferiprona 3-O-glukuronida niso ovrednotili.
PATIENT/CARER REMINDER CARD ((Front Cover))
OPOZORILNA KARTICA ZA BOLNIKA/SKRBNIKA ((naslovna stran))
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.
Varnostni profil sočasnega zdravljenja (deferiprona in deferoksamina), ki so ga opazili v kliničnih preskušanjih, pri izkušnjah v času trženja zdravila ali v objavljeni literaturi, se je skladal s tistim, ki je značilen za monoterapijo.
Discoloration of urine
Sprememba barve urina
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).
Študija LA12-9907 je primerjala obstoj, pojav in napredovanje srčne bolezni pri 129 pacientih z veliko talasemijo, ki so jih vsaj 4 leta zdravili z zdravilom Ferriprox (N = 54) ali deferoksaminom (N = 75).
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).
Pojavnost neželenih učinkov pri 18 otrocih in 97 odraslih, zdravljenih s kombinirano terapijo, se med starostnima skupinama ni bistveno razlikovala, razen v pojavnosti artropatije (11,1 % pri otrocih v primerjavi z 0 % pri odraslih, p = 0,02).
Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of Ferriprox with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
V študijah LA16-0102, LA-01 in LA08-9701 so primerjali učinkovitost zdravila Ferriprox in deferoksamina pri nadziranju serumskega feritina pri pacientih s talasemijo, ki so odvisni od transfuzije.
Should any evidence of infection develop concurrently with the neutropenia, the appropriate cultures and diagnostic procedures should be performed and an appropriate therapeutic regimen instituted.
Če se hkrati z nevtropenijo pojavijo kakršnikoli znaki okužbe, je treba odvzeti kužnine za kulturo, opraviti primerne diagnostične postopke ter vpeljati primerno zdravljenje.
The neurological disorders progressively regressed after deferiprone discontinuation.
Nevrološke funkcije so se progresivno izboljšale po prekinitvi jemanja deferiprona.
Data from the published literature are consistent with the results from the Apotex studies, demonstrating less heart disease and/or increased survival in Ferriprox-treated patients than in those treated with deferoxamine.
Podatki iz objavljene literature se ujemajo z rezultati študij Apotexa, kjer so ugotovili manj srčnih bolezni in/ali povečano stopnjo preživetja pri pacientih, ki so jemali Ferriprox namesto deferoksamina.
If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay.
Če se pri bolniku, ki jemlje deferipron, razvije okužba, je treba zdravljenje prekiniti in takoj preveriti ANC.
Deferiprone must not be used by breast-feeding mothers.
Deferiprona ne smejo jemati doječe matere.
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.
Klinične študije so pokazale, da je Ferriprox učinkovit pri spodbujanju izločanja železa in da lahko odmerek 25 mg/kg trikrat na dan prepreči naraščanje akumulacije železa (ocenjeno z merjenjem serumskega feritina) pri bolnikih s talasemijo, ki so odvisni od transfuzije.
Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Zato ni priporočljivo sočasno jemanje antacidov, ki vsebujejo aluminijeve spojine, in deferiprona.
Agranulocytosis and neutropenia usually resolve upon discontinuation of Ferriprox, but fatal cases of agranulocytosis have been reported.
Agranulocitoza in nevtropenija navadno izzvenita po prekinitvi zdravljenja z zdravilom Ferriprox, so pa poročali o smrtnih primerih agranulocitoze.
Your white blood cell count must be checked within 24 hours in order to detect potential agranulocytosis.
V 24 urah je treba preveriti število belih krvnih celic, da bi prepoznali morebitno agranulocitozo.
It is packaged in bottles of 250 ml or 500 ml.
Pakirana je v plastenkah po 250 ml ali 500 ml.
Patients should be informed that their urine may show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex.
Bolnike je potrebno poučiti o možnosti, da lahko njihov urin postane rdečkastorjavo obarvan zaradi izločanja kompleksa železo-deferipron.
Deferiprone is metabolised predominantly to a glucuronide conjugate.
Deferipron se v glavnem presnavlja v konjugiran glukuronid.
Keep the bottle tightly closed in order to protect from moisture.
Steklenička naj bo trdno zaprta, da je vsebina zaščitena pred vlago.
Do not take this medicine if you are pregnant or if you are trying to become pregnant.
Zdravila ne jemljite, če ste noseči ali poskušate zanositi.
Data from the published literature on iron balance studies in patients with thalassaemia major show that the use of Ferriprox concurrently with deferoxamine (coadministration of both chelators during the same day, either simultaneously or sequentially, e.g., Ferriprox during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Podatki iz objavljene literature o raziskavah ravnovesja železa pri bolnikih s talasemijo major kažejo, da je uporaba zdravila Ferriprox sočasno z deferoksaminom (sočasna uporaba obeh kelatorjev v istem dnevu, bodisi hkrati bodisi zaporedoma; npr. Ferriprox podnevi in deferoksamin ponoči) spodbuja večje izločanje železa kot samo uporaba ene vrste zdravila.
The patient's absolute neutrophil count (ANC) should be monitored every week during the first year of therapy.
V prvem letu zdravljenja je treba pri bolniku tedensko spremljati absolutno število nevtrofilcev (ANC).
The MAH should provide a patient/carer reminder card in each pack, the text of which is included in the Package Leaflet.
Imetnik dovoljenja za promet naj pri vsakem pakiranju priloži opozorilno kartico za bolnika/skrbnika, katere besedilo je vključeno v navodilo za uporabo.
Limited data are available on the combined use of Ferriprox and deferasirox, and caution should be applied when considering the use of such combination.
O sočasni uporabi zdravila Ferriprox in deferasiroksa so na voljo le omejeni podatki, zato je potrebna previdnost pri odločanju o uvedbi takega zdravljenja.
Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Najvišje koncentracije glukuronida v serumu nastopijo 2 do 3 ure po dajanju deferiprona.
Number of 1000 mg tablets* Morning
Število 1000 mg tablet*
The children recovered from these symptoms after Ferriprox discontinuation.
Ti simptomi so se pri otrocih popravili po prekinitvi jemanja zdravila Ferriprox.
Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.
Deferipron je povezan z nevtropenijo in agranulocitozo, zato se zdravljenja ne sme uvesti pri bolnikih ki imajo prizadet imunski sistem, razen če potencialne koristi prevladajo nad tveganji.
After starting Ferriprox therapy, it is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load.
Po pričetku terapije z zdravilom Ferriprox je priporočljivo koncentracijo serumskega feritina ali drugih pokazateljev količine železa v telesu meriti na vsake dva do tri mesece, da se lahko določi dolgotrajno učinkovitost zdravljenja s kelacijo pri nadzorovanju količine železa v telesu.
A positive correlation between MRI T2* values and cardiac function (as measured by Left Ventricular Ejection Fraction (LVEF)) has been documented.
Ugotovljena je bila pozitivna odvisnost med vrednostmi MRI T2* in srčno funkcijo (izmerjeno z iztisnim deležem levega prekata (LVEF)).
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.
Na podlagi poročil o možni interakciji med deferoksaminom in vitaminom C se svetuje dodatna previdnost pri sočasnem dajanju deferiprona in vitamina C.
Concurrent use of iron chelators is not recommended in patients whose serum ferritin falls below 500 µg/l due to the risk of excessive iron removal.
Sočasna uporaba kelatorjev železa ni priporočljiva pri bolnikih, pri katerih je vrednost feritina v serumu padla pod 500 µg/l, saj obstaja nevarnost prekomerne odstranitve železa.
− If you have any further questions, ask your doctor or pharmacist.
− Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Tudi metoda magnetne resonance (MRI), T2*, je bila uporabljena za določitev količine miokardnega železa.
If you get any symptoms of infection such as fever, sore throat or flu-like symptoms, immediately seek medical attention.
Če se pri vas pojavijo kakršni koli simptomi okužbe, kot so zvišana telesna temperatura, vneto grlo ali gripi podobni simptomi, takoj poiščite zdravniško pomoč.
The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
Na učinkovitost zdravila Ferriprox pri zmanjševanju količine železa v telesu neposredno vplivata odmerek in stopnja presežne količine železa.
Other medicines and Ferriprox
Druga zdravila in zdravilo Ferriprox
− increase in liver enzymes
- povečanje jetrnih encimov
Following randomization, 32 patients received deferoxamine (34.9 mg/kg/day for 5 days/week) and Ferriprox (75 mg/kg/day) and 33 patients received deferoxamine monotherapy (43.4 mg/kg/day for 5 days/week).
Po randomizaciji je 32 bolnikov prejelo deferoksamin (34,9 mg/kg/dan, 5 dni/teden) in zdravilo Ferripox (75 mg/kg/dan), 33 bolnikov pa je prejelo monoterapijo z deferoksaminom (43,4 mg/kg/dan,
Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Absorpcija Deferipron se hitro absorbira iz zgornjega dela prebavnega trakta.
Over the 12-month duration of the study, Ferriprox was superior to deferoxamine in decreasing cardiac iron load.
V času dvanajstmesečne študije se je Ferriprox izkazal za učinkovitejšega od deferoksamina pri zmanjševanju presežne količine železa v srcu.
A randomized, placebo-controlled, double-blind trial evaluated the effect of concurrent therapy with Ferriprox and deferoxamine in patients with thalassaemia major, who previously received the standard chelation monotherapy with subcutaneous deferoxamine and had mild to moderate cardiac iron loading (myocardial T2* from 8 to 20 ms).
V randomiziranem, s placebom kontroliranem, dvojno slepim preskušanjem so ovrednotili učinek sočasnega zdravljenja z zdravilom Ferriprox in deferoksaminom pri bolnikih s talasemijo major, ki so pred tem prejeli standardno kelacijsko monoterapijo s podkožno injiciranim deferoksaminom, in so imeli blago do zmerno obremenitev srca z železom (miokardni T2 * od 8 do 20 ms).
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.
Prvo leto zdravljenja z zdravilom Ferriprox redno hodite na preiskave za spremljanje krvne slike, nato pa tako pogosto, kot vam priporoči zdravnik.
− low white blood cell count (agranulocytosis and neutropenia)
- nizka koncentracija belih krvničk (agranulocitoza in nevtropenija)
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).
Pomožne snovi so: prečiščena voda; hidroksietilceluloza; glicerol (E422); klorovodikova kislina, koncentrirana (za uravnavanje pH); umetna aroma češnje; olje poprove mete; oranžno FCF (E110);
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).
Bolniki morajo vedeti, da morajo svojega zdravnika obvestiti o vsakršnih simptomih, ki kažejo na okužbo (kot so zvišana telesna temperatura, vneto grlo ali simptomi, podobni gripi).
Discolored urine is a very common effect and is not harmful.
Sprememba barve urina se pogosto pojavi, vendar ni škodljiva.
Fertility No effects on fertility or early embryonic development were noted in animals (see section 5.3).
Učinki na plodnost ali zgodnji razvoj ploda pri živalih niso bile zabeležene (glejte poglavje 5.3).
(≥1/100 to <1/10)
POGOSTI (≥ 1/100
The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Nevrološke funkcije so se progresivno izboljšale po prekinitvi jemanja deferiprona (glejte poglavji 4.4 in 4.9).
If you experience nausea or vomiting, it may help to take your Ferriprox with some food.
Če se pri vas pojavita slabost ali bruhanje, bo morda pomagalo, če vzamete zdravilo Ferriprox skupaj s hrano.
Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”).
Ne jemljite zdravil, za katera je znano, da povzročajo nevtropenijo ali agranulocitozo (glejte poglavje »Ne jemljite zdravila Ferriprox«).
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.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli poleg oznake EXP.
Take your second dose midday.
Prvi odmerek vzemite zjutraj, drugi odmerek opoldne, tretjega pa zvečer.
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.
Zdravilo Ferriprox se uporablja za zdravljenje prenasičenosti z železom, ki jo povzročijo pogoste transfuzije krvi pri bolnikih s talasemijo major, če je trenutna kelacijska terapija kontraindicirana ali nezadostna.
Iron overload causes concentration-dependent MRI T2* signal loss, thus, increased myocardial iron reduces myocardial MRI T2* values.
Zaradi presežne količine železa pride do izgube signala pri MRI T2*, ki je odvisen od nasičenosti; na ta način povečana količina miokardnega železa zmanjša vrednosti MRI T2*.
There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Ferriprox, which may lead to a serious infection.
Obstaja majhna možnost, da med jemanjem zdravila Ferriprox pride do agranulocitoze (zelo nizko število belih krvničk), ki lahko vodi do resne okužbe.
You must use effective contraception while you are taking Ferriprox.
Med jemanjem tega zdravila morate uporabljati učinkovito kontracepcijo.
PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 100 filmsko obloženih tablet
The incidences of “Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders" were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders" was higher during combination therapy than monotherapy.
Pojavnost »bolezni mišično-skeletnega sistema in vezivnega tkiva« in »bolezni sečil« je bila nižja med kombinirano terapijo kot med monoterapijo, medtem ko je bila pojavnost »srčnih bolezni« višja med kombinirano terapijo kot med monoterapijo.
If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Ferriprox zanosite, ga takoj prenehajte jemati in obvestite zdravnika.
If you forget to take Ferriprox
Če ste pozabili vzeti zdravilo Ferriprox
The tablet is scored.
Tableta ima razdelilno zarezo.
Renal or hepatic impairment and liver fibrosis
Bolniki z motnjami v delovanju jeter oziroma ledvic in fibrozo jeter
Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
En ml peroralne raztopine vsebuje 0,4 mg barvila sončno rumeno FCF (E110).
Hypromellose 2910 USP/EP
Obloga hipromeloza 2910 USP/EP hidroksipropilceluloza makrogol titanov dioksid
Provide protective isolation and if clinically indicated, admit patient to the hospital.
Zagotovite izolacijo bolnika in bolnika hospitalizirajte, če je to klinično indicirano.
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
oznaka ATC: V03AC02
PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
FARMACEVTSKA OBLIKA IN VSEBINA 250 ml peroralne raztopine