natgillin/translations-raw huggingface dataset:
The most serious adverse reaction reported in clinical trials with deferiprone was agranulocytosis, defined as an absolute neutrophil count less than 0.5 x 109/l, which occurred in approximately 1% of patients.
Najhujši stranski učinek pri kliničnih testiranjih z deferipronom je bila agranulocitoza, določena z absolutno količino nevtrofilcev manjšo od 0,5 x 109/l, do katere je prišlo pri približno 1% pacientov.
Myocardial MRI T2* values of less than 20 ms represent iron overload in the heart.
Miokardne vrednosti MRI T2*, ki znašajo manj kot 20 ms, kažejo, da gre za presežno količino železa v srcu.
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.
Bele krvničke pomagajo braniti pred okužbo, zato lahko zaradi nizke koncentracije nevtrofilcev tvegate resno in življenjsko nevarno okužbo.
Study LA16-0102 compared the efficacy of Ferriprox with that of deferoxamine in decreasing cardiac iron overload and in improving cardiac function (as measured by LVEF) in transfusion-dependent thalassaemia patients.
V študiji LA16-0102 je bila primerjana učinkovitost zdravila Ferriprox in deferoksamina pri zmanjševanju presežne količine kardialnega železa in izboljševanju delovanja srca (izmerjeno z LVEF) pri pacientih s talasemijo, ki so odvisni od transfuzije.
No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Pri sistemski izpostavljenosti deferipronu pomembnega učinka ledvične okvare niso opazili.
Dose (mg, three times/day)
Odmerek (mg, trikrat/dan)
Data from the pooled safety database from clinical trials (1343 patient-years exposure to Ferriprox monotherapy and 244 patient-years exposure to Ferriprox and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders", "Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders".
Podatki iz združenih varnostnih podatkov iz kliničnih preskušanj (1343 bolnikov-let izpostavljenosti monoterapiji s Ferriproxom in 244 bolnikov-let izpostavljenosti Ferriproxu in deferoksaminu) so pokazali statistično značilne razlike (p<0,05) v pojavnosti neželenih učinkov glede na organske sisteme, in sicer za »srčne bolezni«, »bolezni mišično-skeletnega sistema in vezivnega tkiva« in »bolezni sečil«.
Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Peroralna raztopina Ferriprox vsebuje sončno rumeno FCF (E110), ki lahko povzroči alergijsko reakcijo.
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.
Najpogosteje omenjeni stranski učinki med terapijo pri kliničnem testiranju z deferipronom pri več kot 10 % vseh pacientov so bili slabost, bruhanje, bolečine v trebuhu in kromaturija.
Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Pri bolnikih s kombiniranim zdravljenjem je potrebno skrbno spremljanje srčnih dogodkov (glejte poglavje 4.4).
No prenatal and postnatal reproductive studies have been conducted in animals.
Na živalih ni bilo izvedenih prenatalnih in postnatalnih študij vpliva na sposobnost razmnoževanja.
Ferriprox is packaged in bottles of 50 tablets.
Ferriprox je pakiran v plastenkah po 50 tablet.
Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.
To kartico pokažite zdravniku, če se pri vas pojavijo simptomi okužbe, kot je zvišana telesna temperatura, vneto grlo ali gripi podobni simptomi.
Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Ferriprox 1000 mg filmsko obložene tablete EU/1/99/108/004
There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs. 16% for deferoxamine).
Znatna razlika v deležu pacientov s kardialno disfunkcijo pri prvem ocenjevanju ni bila opažena (13% pri Ferriproxu proti
- 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).
- 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 4.5).
LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
SEZNAM POMOŽNIH SNOVI Vsebuje sončno rumeno FCF (E110); dodatne informacije najdete v priloženih navodilih.
Increased liver enzymes
Preiskave povišane vrednosti jetrnih encimov
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja deferiprona (glejte poglavje 5.3).
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), kot pri bolnikih, ki so zdravilo vzeli na tešče (126 µmol/l); čeprav se absorpcija deferiprona ni zmanjšala, če je bolnik zdravilo vzel s hrano.
Abdominal Pain Vomiting
Bolezni prebavil navzea abdominalna bolečina bruhanje
The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Druge sestavine so: Jedro tablete: mikrokristalna celuloza, magnezijev stearat, koloiden silicijev dioksid.
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 odmerek približno 75 mg/kg/dan uporabite količino peroralne raztopine, priporočene v naslednji preglednici za telesno maso bolnika.
Please refer to the patient/carer reminder card attached to this leaflet.
Glejte opozorilno kartico za bolnika/skrbnika, priloženo temu navodilu.
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.
Zdravnik vam bo naročil, da morate med zdravljenjem z zdravilom Ferriprox redno na krvne preiskave za spremljanje nevtropenije (za preverjanje števila belih krvnih celic), ki vam jih bodo opravili morda celo vsak teden.
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Monoterapija z zdravilom Ferriprox je indicirana za zdravljenje preobremenjenosti z železom pri bolnikih s talasemijo major, če je trenutna kelacijska terapija kontraindicirana ali nezadostna.
− fatigue
- utrujenost
However, chelation therapy may not necessarily protect against iron-induced organ damage.
da bo terapija s keliranjem zaščitila organe pred poškodbami, ki jih povzroča železo.
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 doseganje odmerka 75 mg/kg/dan glede na telesno maso bolnika uporabite število tablet po naslednjih preglednicah.
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).
Naključno so izbrali 61 pacientov s presežno količino kardialnega železa, ki so se prej zdravili z deferoksaminom, da so nadaljevali z deferoksaminom (povprečen odmerek 43 mg/kg/dan; N = 31) ali pa prešli na Ferriprox (povprečen odmerek 92 mg/kg/dan; N = 29).
Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
Pri bolnikih s končno ledvično odpovedjo ali hudo okvarjenim delovanjem jeter je potrebna previdnost.
Each 500 mg tablet contains 500 mg deferiprone.
Vsaka 500 mg tableta vsebuje 500 mg deferiprona.
Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
Zdravila Ferriprox ne jemljite, če ste noseči ali poskušate zanositi.
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).
O uporabi deferiprona pri bolnikih s končno ledvično odpovedjo ali hudo jetrno okvaro podatki niso na voljo (glejte poglavje 5.2).
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).
(20,6 %) pacientih, ki so jih zdravili z deferoksaminom in pri 2 (4,3 %) pacientih, ki so jemali Ferriprox in niso imeli srčne bolezni pri prvem ocenjevanju (p = 0,013).
- Pregnancy (see section 4.6).
- Anamneza agranulocitoze - Nosečnost (glejte poglavje 4.6) - Dojenje (glejte poglavje 4.6)
In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
V primeru srčnega popuščanja zaradi železa je treba terapiji z deferoksaminom dodati zdravilo Ferriprox 75-100 mg/kg/dan.
Pack size of 50 tablets.
Pakiranje po 50 tablet.
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.
Opravljeno je bilo odprto, nerandomizirano klinično preskušanje z vzporednima skupinama, da bi ocenili učinek okvarjenega delovanja ledvic na varnost, prenašanje in farmakokinetiko enkratnega peroralnega odmerka zdravila Ferriprox 33 mg/kg.
MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX
SPREMLJANJE ŠTEVILA BELIH KRVNIČK MED JEMANJEM ZDRAVILA FERRIPROX
Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Rumenkastorjave polietilentereftalatne (PET) plastenke z zamaškom, ki otrokom onemogoča odpiranje (polipropilen), in merilno posodico (polipropilen).
The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Običajen odmerek je 25 mg/kg trikrat na dan; s tem se doseže skupen dnevni odmerek 75 mg/kg.
Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
Imetnik dovoljenja za izdelavo zdravila: Eurofins PROXY Laboratories B.V.
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).
ženskega in moškega spola, ki niso bile obremenjene z železom in so prejemale deferipron peroralno v odmerkih do 75 mg/kg dvakrat dnevno 28 dni (samci) ali 2 tedna (samice) pred parjenjem, in do terminacije (samci) ali skozi zgodnjo gestacijo (samice), učinka na plodnost ali zgodnji razvoj ploda ni bilo zaznati.
500 ml oral solution
500 ml peroralne raztopine
Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Preskušanci so bili razvrščeni v 3 skupine na podlagi rezultata po razvrstitvi Child-Pugh: zdravi prostovoljci, blaga jetrna okvara (razred A: 5-6
Deferiprone has been shown to cause neutropenia, including agranulocytosis (see section 4.8 ‘Description of selected adverse reactions').
Dokazano je, da deferipron povzroča nevtropenijo, tudi agranulocitozo (glejte poglavje 4.8
− the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count.
− Najresnejši neželeni učinek, ki se lahko pojavi ob jemanju zdravila Ferriprox, je zelo nizka koncentracija belih krvničk (nevtrofilcev) v krvi.
Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Pred jemanjem vitamina C ob zdravilu Ferriprox se posvetujte z zdravnikom ali farmacevtom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ferriprox 500 mg filmsko obložene tablete Ena tableta vsebuje 500 mg deferiprona.
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).
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.
The tablets are scored and breakable in half.
Tablete imajo zarezo, po kateri se lahko prepolovijo.
Each 1000 mg tablet contains 1000 mg deferiprone.
Vsaka 1000 mg tableta vsebuje 1000 mg deferiprona.
Driving and using machines Not relevant.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Podatek ni potreben.
Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
Pri teh populacijah bolnikov je treba med zdravljenjem z deferipronom spremljati delovanje ledvic in jeter.
Coating: Hypromellose, Macrogol, Titanium dioxide.
Obloga: hipromeloza, makrogol, titanov dioksid.
Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Obloga: hipromeloza, hidroksipropilceluloza, makrogol, titanov dioksid.
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).
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
How to take Ferriprox
Kako jemati zdravilo Ferriprox
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).
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
Do not take aluminium-based antacids at the same time as taking Ferriprox.
Sočasno z zdravilom Ferriprox ne jemljite antacidov na osnovi aluminija.
EXP After first opening use within 35 days.
EXP Po odprtju porabite v 35 dneh.
EXP After first opening use within 50 days.
EXP Po odprtju porabite v 50 dneh.
Limited information is available regarding rechallenge.
O ponovni uporabi zdravila je na voljo malo podatkov.
Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Bolečine in otekanje sklepov se lahko pojavijo v razponu od blagih bolečin v enem ali več sklepih do hudih bolečin, ki ovirajo gibljivost.
In females, an effect on the oestrous cycle delayed time to confirmed mating at all doses tested.
Pri samicah je pri vseh odmerkih učinek na estrogenski ciklus zamaknil čas parjenja.
After first opening use within 50 days.
Po odprtju porabite v 50 dneh.
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.
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,
The safety and pharmacokinetics of Ferriprox in patients with severe hepatic impairment are unknown.
Varnost in farmakokinetika zdravila Ferriprox pri bolnikih s hudo jetrno okvaro nista znani.
If taken during pregnancy, Ferriprox may seriously harm the unborn baby.
Jemanje zdravila med nosečnostjo lahko resno škoduje nerojenemu otroku.
Do not take Ferriprox
»Ne jemljite zdravila Ferriprox«).
− This medicine has been prescribed for you only.
− Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
MARKETING AUTHORISATION NUMBER Ferriprox 500 mg film-coated tablets EU/1/99/108/001
Ferriprox 500 mg filmsko obložene tablete EU/1/99/108/001
After first opening use within 35 days.
Po odprtju porabite v 35 dneh.
Ferriprox is packaged in bottles of 100 tablets.
Ferriprox je na voljo v plastenkah po 100 tablet.
Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
En ml peroralne raztopine vsebuje 100 mg deferiprona (25 g deferiprona v 250 ml in 50 g deferiprona v 500 ml).
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
Na podlagi rezultatov te študije pri bolnikih z okvarjenim delovanjem ledvic prilagoditev režima odmerjanja zdravila Ferriprox ni potrebna.
Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
Če se pojavijo nevrološke motnje, je treba prenehati z uporabo deferiprona (glejte poglavji 4.8 in 4.9).
Sample body weights at 10 kg increments are listed.
Navedeni so primeri telesnih mas s koraki po 10 kg.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema nevtropenija agranulocitoza
Pack size of 100 tablets.
Pakiranje po 100 tablet.
What Ferriprox contains The active substance is deferiprone.
Kaj vsebuje zdravilo Ferriprox Učinkovina je deferipron.
HIV positive or other immunocompromised patients No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients.
Ni podatkov o uporabi deferiprona pri bolnikih, ki so pozitivni za HIV oziroma imajo drugače prizadet imunski sistem.
INFORMATION IN BRAILLE Ferriprox 1000 mg
PODATKI V BRAILLOVI PISAVI Ferriprox 1000 mg
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).
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).
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
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).
Tablet core: Methylcellulose, crospovidone, magnesium stearate.
Druge sestavine so: Jedro tablete: metilceluloza, krospovidon, magnezijev stearat.
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.
Odmerjanje Deferipron se običajno jemlje po 25 mg/kg telesne mase peroralno trikrat dnevno, celotni dnevni odmerek pa znaša 75 mg/kg telesne mase.
In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Glede na rezultate genotoksičnosti se ne izključuje možnosti karcinogenega delovanja deferiprona
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj koprivnica
What you need to know before you take Ferriprox
Kaj morate vedeti, preden boste vzeli zdravilo Ferriprox Ne jemljite zdravila Ferriprox
Each pack contains one bottle of 250 ml or 500 ml oral solution.
V vsaki embalaži je ena plastenka po 250 ml ali 500 ml peroralne raztopine.
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).
Vrednosti so se vrnile na osnovno raven brez prekinitve zdravljenja ali zmanjšanja odmerka deferiprona (glejte poglavje 4.4).
Ferriprox 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone.
Ferriprox 1000 mg filmsko obložene tablete Ena tableta vsebuje 1000 mg deferiprona.
− If you get any side effects, talk to your doctor or pharmacist.
− Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment.
Pri enem bolniku z zmerno jetrno okvaro so opazili resen neželeni dogodek akutne poškodbe jeter in ledvic.
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.
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.
INFORMATION IN BRAILLE Ferriprox 500 mg
PODATKI V BRAILLOVI PISAVI Ferriprox 500 mg
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).
59 ml/min/1,73 m2) in huda ledvična okvara (eGFR 15-29 ml/min/1,73 m2).
Neutropenia/Agranulocytosis
Nevtropenija/agranulocitoza
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.
Zdravljenje pričnite na dan odkritja dogodka, nato pa ga dajajte dnevno, dokler se stanje ne popravi.
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.
vrednost Cmax pri bolnikih z blago ali zmerno jetrno okvaro pa je bila zmanjšana za 20 % primerjavi z zdravimi prostovoljci.
Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
če je monoterapija s katerim koli kelatorjem ustrezna ali če feritin v serumu pade pod 500 µg/l.
INFORMATION IN BRAILLE Ferriprox 100 mg/ml
PODATKI V BRAILLOVI PISAVI Ferriprox 100 mg/ml
Very common side effects (may affect more than 1 in 10 people): - abdominal pain - nausea - vomiting - reddish/brown discoloration of urine
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - nizka koncentracija belih krvničk (agranulocitoza in nevtropenija)
− Attached to this leaflet you will find a patient/carer reminder card. You should detach,
− Temu navodilu je priložena kartica, ki je namenjena bolniku/skrbniku kot opomnik.
Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
Sončno rumeno FCF (E110) je barvilo, ki lahko povzroči alergijsko reakcijo.
− nausea
Jetrna okvara