FrancophonIA/ELRC3.0 huggingface dataset:
English: Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Slovenian: Dokazano je, da deferipron povzroča nevtropenijo, tudi agranulocitozo (glejte poglavje 4.8
English: − the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count.
Slovenian: − Najresnejši neželeni učinek, ki se lahko pojavi ob jemanju zdravila Ferriprox, je zelo nizka koncentracija belih krvničk (nevtrofilcev) v krvi.
English: Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Slovenian: Pred jemanjem vitamina C ob zdravilu Ferriprox se posvetujte z zdravnikom ali farmacevtom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ferriprox 500 mg filmsko obložene tablete Ena tableta vsebuje 500 mg deferiprona.
English: Of patients with cardiac dysfunction at first assessment, none treated with deferiprone compared with four (33%) treated with deferoxamine had worsening of their cardiac status (p=0.245).
Slovenian: Pri pacientih s srčno disfunkcijo pri prvem ocenjevanju ni prišlo do poslabšanja srčnega statusa (p = 0,245), če so jih zdravili z deferipronom, v primerjavi s štirimi (33 %), ki so se zdravili z deferoksaminom.
English: The tablets are scored and breakable in half.
Slovenian: Tablete imajo zarezo, po kateri se lahko prepolovijo.
English: Each 1000 mg tablet contains 1000 mg deferiprone.
Slovenian: Vsaka 1000 mg tableta vsebuje 1000 mg deferiprona.
English: Driving and using machines Not relevant.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Podatek ni potreben.
English: Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
Slovenian: Pri teh populacijah bolnikov je treba med zdravljenjem z deferipronom spremljati delovanje ledvic in jeter.
English: Coating: Hypromellose, Macrogol, Titanium dioxide.
Slovenian: Obloga: hipromeloza, makrogol, titanov dioksid.
English: Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Slovenian: Obloga: hipromeloza, hidroksipropilceluloza, makrogol, titanov dioksid.
English: 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).
Slovenian: bistveno večje zmanjšanje miokardne preobremenitve z železom, ocenjeno s povečanjem MRI T2* (11,7 ms do 17,7 ms s sočasnim zdravljenjem, v primerjavi z 12,4 ms do 15,7 ms pri monoterapiji z deferoksaminom, p = 0,02) in bistveno večje zmanjšanje koncentracije železa v jetrih, kar bilo prav tako ocenjeno s povečanjem MRI T2* (4,9 ms do 10,7 ms s sočasnim zdravljenjem, v primerjavi z
English: How to take Ferriprox
Slovenian: Kako jemati zdravilo Ferriprox
English: 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).
Slovenian: Preskušanci so bili razvrščeni v 4 skupine na podlagi ocenjene hitrosti glomerularne filtracije (eGFR): zdravi prostovoljci (eGFR ≥ 90 ml/min/1,73 m2), blaga levična okvara (eGFR 60-89 ml/min/1,73 m2), zmerna ledvična okvara (eGFR 30
English: Do not take aluminium-based antacids at the same time as taking Ferriprox.
Slovenian: Sočasno z zdravilom Ferriprox ne jemljite antacidov na osnovi aluminija.
English: EXP After first opening use within 35 days.
Slovenian: EXP Po odprtju porabite v 35 dneh.
English: EXP After first opening use within 50 days.
Slovenian: EXP Po odprtju porabite v 50 dneh.
English: Limited information is available regarding rechallenge.
Slovenian: O ponovni uporabi zdravila je na voljo malo podatkov.
English: Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Slovenian: Bolečine in otekanje sklepov se lahko pojavijo v razponu od blagih bolečin v enem ali več sklepih do hudih bolečin, ki ovirajo gibljivost.
English: In females, an effect on the oestrous cycle delayed time to confirmed mating at all doses tested.
Slovenian: Pri samicah je pri vseh odmerkih učinek na estrogenski ciklus zamaknil čas parjenja.
English: After first opening use within 50 days.
Slovenian: Po odprtju porabite v 50 dneh.
English: The most common findings in non-iron-loaded animals at doses of 100 mg/kg/day and above were hematologic effects such as bone marrow hypocellularity, and decreased WBC, RBC and/or platelet counts in peripheral blood.
Slovenian: Najpogostejši odkriti pojavi pri živalih, neobremenjenih z železom, pri odmerku 100 mg/kg/dan in več, so bili hematološki učinki, kot npr. hipoceličnost kostnega mozga, znižano število levkocitov,
English: The safety and pharmacokinetics of Ferriprox in patients with severe hepatic impairment are unknown.
Slovenian: Varnost in farmakokinetika zdravila Ferriprox pri bolnikih s hudo jetrno okvaro nista znani.
English: If taken during pregnancy, Ferriprox may seriously harm the unborn baby.
Slovenian: Jemanje zdravila med nosečnostjo lahko resno škoduje nerojenemu otroku.
English: Do not take Ferriprox
Slovenian: »Ne jemljite zdravila Ferriprox«).
English: − This medicine has been prescribed for you only.
Slovenian: − Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Slovenian: Ferriprox 500 mg filmsko obložene tablete EU/1/99/108/001
English: After first opening use within 35 days.
Slovenian: Po odprtju porabite v 35 dneh.
English: Ferriprox is packaged in bottles of 100 tablets.
Slovenian: Ferriprox je na voljo v plastenkah po 100 tablet.
English: Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
Slovenian: En ml peroralne raztopine vsebuje 100 mg deferiprona (25 g deferiprona v 250 ml in 50 g deferiprona v 500 ml).
English: Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
Slovenian: Na podlagi rezultatov te študije pri bolnikih z okvarjenim delovanjem ledvic prilagoditev režima odmerjanja zdravila Ferriprox ni potrebna.
English: Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
Slovenian: Če se pojavijo nevrološke motnje, je treba prenehati z uporabo deferiprona (glejte poglavji 4.8 in 4.9).
English: Sample body weights at 10 kg increments are listed.
Slovenian: Navedeni so primeri telesnih mas s koraki po 10 kg.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija agranulocitoza
English: Pack size of 100 tablets.
Slovenian: Pakiranje po 100 tablet.
English: What Ferriprox contains The active substance is deferiprone.
Slovenian: Kaj vsebuje zdravilo Ferriprox Učinkovina je deferipron.
English: HIV positive or other immunocompromised patients No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients.
Slovenian: Ni podatkov o uporabi deferiprona pri bolnikih, ki so pozitivni za HIV oziroma imajo drugače prizadet imunski sistem.
English: INFORMATION IN BRAILLE Ferriprox 1000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ferriprox 1000 mg
English: 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).
Slovenian: 5,01 ms), med med povprečnimi vrednostmi (po metodi najmanjših kvadratov) supraterapevtskega odmerka in placeba pa 5,23 ms (enostranska 95-odstotna zgornja meja zaupanja: 7,19 ms).
English: 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
Slovenian: Zaradi neznanega mehanizma nastanka nevtropenije, ki jo povzroči deferipron, bolniki ne smejo jemati zdravil, povezanih z nevtropenijo, ali takšnih, ki lahko povzročijo agranulocitozo (glejte poglavje 4.3).
English: Tablet core: Methylcellulose, crospovidone, magnesium stearate.
Slovenian: Druge sestavine so: Jedro tablete: metilceluloza, krospovidon, magnezijev stearat.
English: Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight.
Slovenian: Odmerjanje Deferipron se običajno jemlje po 25 mg/kg telesne mase peroralno trikrat dnevno, celotni dnevni odmerek pa znaša 75 mg/kg telesne mase.
English: In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Slovenian: Glede na rezultate genotoksičnosti se ne izključuje možnosti karcinogenega delovanja deferiprona
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj koprivnica
English: What you need to know before you take Ferriprox
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ferriprox Ne jemljite zdravila Ferriprox
English: Each pack contains one bottle of 250 ml or 500 ml oral solution.
Slovenian: V vsaki embalaži je ena plastenka po 250 ml ali 500 ml peroralne raztopine.
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).
Slovenian: Vrednosti so se vrnile na osnovno raven brez prekinitve zdravljenja ali zmanjšanja odmerka deferiprona (glejte poglavje 4.4).
English: Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone.
Slovenian: Ferriprox 1000 mg filmsko obložene tablete Ena tableta vsebuje 1000 mg deferiprona.
English: − If you get any side effects, talk to your doctor or pharmacist.
Slovenian: − Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment.
Slovenian: Pri enem bolniku z zmerno jetrno okvaro so opazili resen neželeni dogodek akutne poškodbe jeter in ledvic.
English: 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.
Slovenian: Nevrološke motnje (kot so cerebelarni simptomi, diplopija, lateralni nistagmus, upočasnjena psihomotorika, premikanje rok in aksialna hipotonija) so opazili pri otrocih - prostovoljcih, ki so jim nekaj let predpisovali več kot 2,5-kratni največji priporočen odmerek 100 mg/kg/dan.
English: INFORMATION IN BRAILLE Ferriprox 500 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ferriprox 500 mg
English: 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).
Slovenian: 59 ml/min/1,73 m2) in huda ledvična okvara (eGFR 15-29 ml/min/1,73 m2).
English: Neutropenia/Agranulocytosis
Slovenian: Nevtropenija/agranulocitoza
English: Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
Slovenian: Zdravljenje pričnite na dan odkritja dogodka, nato pa ga dajajte dnevno, dokler se stanje ne popravi.
English: 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.
Slovenian: vrednost Cmax pri bolnikih z blago ali zmerno jetrno okvaro pa je bila zmanjšana za 20 % primerjavi z zdravimi prostovoljci.
English: Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
Slovenian: če je monoterapija s katerim koli kelatorjem ustrezna ali če feritin v serumu pade pod 500 µg/l.
English: INFORMATION IN BRAILLE Ferriprox 100 mg/ml
Slovenian: PODATKI V BRAILLOVI PISAVI Ferriprox 100 mg/ml
English: Very common side effects (may affect more than 1 in 10 people): - abdominal pain - nausea - vomiting - reddish/brown discoloration of urine
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - nizka koncentracija belih krvničk (agranulocitoza in nevtropenija)
English: − Attached to this leaflet you will find a patient/carer reminder card. You should detach,
Slovenian: − Temu navodilu je priložena kartica, ki je namenjena bolniku/skrbniku kot opomnik.
English: Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
Slovenian: Sončno rumeno FCF (E110) je barvilo, ki lahko povzroči alergijsko reakcijo.
English: − nausea
Slovenian: Jetrna okvara
English: Subjects were categorized into 4 groups based on estimated glomerular filtration rate
Slovenian: Preskušanci so bili razvrščeni v 4 skupine na podlagi ocenjene hitrosti glomerularne filtracije (eGFR): zdravi prostovoljci (eGFR
English: The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.
Slovenian: Varnost in farmakokinetika zdravila Ferriprox pri bolnikih s končno ledvično odpovedjo nista znani.
English: The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Slovenian: Najresnejši neželeni učinek jemanja zdravila Ferriprox je zelo nizka koncentracija belih krvnih celic
English: Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded pregnant rats and rabbits at doses at least as low as 25 mg/kg/day.
Slovenian: V študijah vpliva na sposobnost razmnoževanja pri brejih podganah in kuncih, ki niso bili obremenjeni z železom, je bil deferipron teratogen in embriotoksičen že pri odmerkih 25 mg/kg/dan.
English: 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.
Slovenian: Na podlagi rezultatov te študije pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditev režima odmerjanja zdravila Ferriprox ni potrebna.
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE), ki so opremljene z otrokom varno zaporko iz polipropilena.
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
Slovenian: En ml peroralne raztopine vsebuje 100 mg deferiprona (25 g deferiprona v 250 ml).
English: ml of oral solution (three times/day)
Slovenian: ml peroralne raztopine (trikrat/dan)
English: Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone.
Slovenian: Pri bolnikih, ki so se zdravili z deferipronom, je bila opažena tudi driska, večinoma blaga in prehodnega značaja.
English: Ferriprox 100 mg/ml oral solution deferiprone
Slovenian: Ferriprox 100 mg/ml peroralna raztopina deferipron
English: Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
Slovenian: V primerjavi preskušancev z blago ali zmerno okvaro z zdravimi prostovoljci je bila vrednost AUC deferipron-3-O-glukuronida zmanjšana za 10 % in vrednost Cmax za 20 %.
English: Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Slovenian: Pri manjšem številu bolnikov so pri jemanju deferiprona ugotovili nizke plazemske vrednosti cinka.
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.
Slovenian: Pri bolnikih, ki so se zdravili z deferipronom, so poročali tudi o artropatijah, ki so variirale od blage bolečine v enem ali več sklepih do resnega artritisa z izcedkom in znatno omejeno gibljivostjo.
English: Ferriprox can be taken with or without food however, you may find it easier to remember to take Ferriprox if you take it with your meals.
Slovenian: Zdravilo Ferriprox se boste morda lažje spomnili vzeti, če ga boste jemali ob obrokih.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v sklepih
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE), ki so opremljene z otrokom varno zaporko iz polipropilena in vsebujejo sušilo.
English: 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.
Slovenian: Te preiskave ponavljajte vsak dan. Priporočljivo je, da se po okrevanju od nevtropenije opravljajo tedenske preiskave kompletne krvne slike, števila levkocitov, nevtrofilcev in trombocitov tri tedne zaporedoma.
English: MARKETING AUTHORISATION HOLDER Apotex B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Apotex B.V.
English: Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
Slovenian: En ml peroralne raztopine vsebuje 100 mg deferiprona (50 g deferiprona v 500 ml).
English: What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Slovenian: Peroralna raztopina Ferriprox je prozorna, rdečeoranžna tekočina.
English: 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).
Slovenian: (vrednost nevtrofilcev < 0,5 x 109/l) s pojavnostjo 1,1 % (0,6 pojavov bolezni na 100 bolnikov-let zdravljenja) (glejte poglavje 4.4).
English: What Ferriprox looks like and contents of the pack Ferriprox 1000 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Slovenian: Ferriprox 1000 mg tablete so bele do sivobele filmsko obložene tablete, v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »1000«, druga stran je gladka.
English: Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Slovenian: Odmerek na kilogram telesne mase je treba izračunati na 2,5 ml. Priporočljive odmerke za telesne mase na vsakih 10 kg najdete v spodnji preglednici.
English: If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Slovenian: Če se vrednost serumske alanin-aminotransferaze
English: There are no reports of acute overdose with Ferriprox.
Slovenian: Če ste vzeli večji odmerek zdravila Ferriprox, kot bi smeli Ni poročil o akutnem prevelikem odmerjanju zdravila Ferriprox.
English: Dose table for Ferriprox 1000 mg film-coated tablets Body weight (kg)
Slovenian: Preglednica odmerkov za filmsko obložene tablete Ferriprox 1000 mg Telesna masa (kg)
English: What Ferriprox looks like and contents of the pack Ferriprox 500 mg tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Slovenian: Ferriprox 500 mg tablete so bele do sivobele filmsko obložene tablete, v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »500«, druga stran je gladka.
English: Hypersensitivity reactions
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Slovenian: Bele do sivobele, filmsko obložene tablete v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »1000«, druga stran je gladka.
English: Tablet core
Slovenian: Preglednica odmerkov
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.
Slovenian: V obdobju trženja zdravila so pri otrocih, ki so prejemali standardne odmerke deferiprona, poročali o epizodah hipotonije, nestabilnosti, nezmožnosti za hojo in hipertonije z nezmožnostjo gibanja udov.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1000 mg film-coated tablets
Slovenian: Ferriprox 500 mg filmsko obložene tablete Ferriprox 1000 mg filmsko obložene tablete
English: Each ml of oral solution contains 100 mg deferiprone.
Slovenian: Ena ml peroralne raztopine vsebuje 100 mg deferiprona.
English: Not known (frequency cannot be estimated from the available data): − allergic reactions including skin rash or hives
Slovenian: Neznana pogostost (pogostosti ni mogoče določiti iz razpoložljivih podatkov): - alergijske reakcije, vključno s kožnim izpuščajem in koprivnico Bolečine in otekanje sklepov se lahko pojavijo v razponu od blagih bolečin v enem ali več sklepih do hudih bolečin, ki ovirajo gibljivost.
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Slovenian: Bele do sivobele, filmsko obložene tablete v obliki kapsule; na eni strani je odtisnjeno »APO« zareza »500«, druga stran je gladka.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
Slovenian: IME ZDRAVILA Ferriprox 100 mg/ml peroralna raztopina
English: SYSTEM ORGAN CLASS VERY COMMON
Slovenian: KLASIFIKACIJA PO ORGANSKIH SISTEMIH
English: How to store Ferriprox
Slovenian: Shranjevanje zdravila Ferriprox
English: Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic prilagoditev odmerka ni potrebna (glejte poglavje
English: Ferriprox 1000 mg film-coated tablets
Slovenian: Ferriprox 1000 mg filmsko obložene tablete
English: Do not take Ferriprox if you are breast-feeding.
Slovenian: Ne jemljite zdravila Ferriprox, če dojite.
English: Ferriprox 500 mg film-coated tablets
Slovenian: Ferriprox 500 mg filmsko obložene tablete
English: Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Slovenian: Če raven feritina v serumu pade pod 500 µg/l, je treba razmisliti o prekinitvi zdravljenja z deferipronom.
English: Titanium dioxide
Slovenian: Obloga hipromeloza makrogol titanov dioksid
English: Fatalities and life-threatening situations (caused by agranulocytosis) have been reported with deferiprone in combination with deferoxamine.
Slovenian: Pri sočasnem zdravljenju z deferipronom in deferoksaminom so poročali o smrtnih žrtvah in življenjsko nevarnih situacijah, ki jih povzročajo agranulocitoze.
English: Ferriprox 1000 mg film-coated tablets deferiprone
Slovenian: Ferriprox 1000 mg filmsko obložene tablete deferipron
English: Treatment with deferiprone should not be initiated if the patient is neutropenic.
Slovenian: Če ima bolnik nevtropenijo, zdravljenja z deferipronom ne smemo začeti.