natgillin/translations-raw huggingface dataset:
If treatment is unavoidable, breast feeding must be stopped.
Če je zdravljenje neizogibno, se mora dojenje prekiniti.
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).
Najresnejši neželen učinek zdravljenja v kliničnem preskušanju deferiprona je bila agranulocitoza (vrednost nevtrofilcev < 0, 5x109/ l) s pojavnostjo 1, 1% (0, 6 pojavov bolezni na 100 bolnikov- let zdravljenja) (glejte poglavje 4. 4).
The observed incidence of the less severe form of neutropenia (neutrophils < 1.5x109/ l) is 4.9% (2.5 cases per 100 patient-years).
Opažena pojavnost manj resne oblike nevtropenije (vrednost nevtrofilcev < 1, 5x109/ l) je 4, 9% (2, 5 pojavov bolezni na 100 bolnikov- let).
Increased levels of serum liver enzymes have been reported in patients taking deferiprone.
Pri večini teh bolnikov je bilo povečanje asimptomatsko in prehodno.
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).
5 Low plasma zinc levels have been associated with deferiprone, in a minority of patients.
Pri manjšem številu bolnikov so pri jemanju deferiprona ugotovili nizke plazemske vrednosti cinka.
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.
5 nekaj let predpisovali več kot 2, 5 kratni največji priporočen odmerek 100 mg/ kg/ dan.
The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.2, 4.4 and 4.9).
Nevrološke funkcije so se progresivno izboljšale po prekinitvi jemanja deferiprona (glejte poglavja 4. 2, 4. 4 in 4. 9)
Adverse reaction frequencies:
Pogostost neželenih učinkov:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100).
Zelo pogosti (≥1/ 10), Pogosti (≥1/ 100 do < 1/ 10), Občasni (≥1/ 1. 000 do < 1/ 100).
SYSTEM ORGAN CLASS Investigations Blood and lymphatic system disorders Nervous system disorders
KLASIFIKACIJA PO ORGANSKIH SISTEMIH
VERY COMMON (≥ 1/ 10)
ZELO POGOSTI (≥1/ 10)
COMMON (≥ 1/ 100 to < 1/ 10) Increased liver enzymes Neutropenia Agranulocytosis Headache
POGOSTI (≥1/ 100 DO < 1/ 10)
UNCOMMON (≥ 1/ 1,000 to < 1/ 100)
OBČASNI (≥1/ 1. 000 DO < 1/ 100)
Gastrointestinal disorders
Povišane vrednosti jeternih encimov
Nausea Abdominal Pain Vomiting
Nevtropenija Agranulocitoza Glavobol
Renal and urinary disorders
Navzea Abdominalna bolečina Bruhanje
Chromaturia
Diareja
Musculoskeletal and connective tissue disorders
Bolezni sečil Bolezni mišično - skeletnega sistema in vezivnega tkiva
Arthralgia
Kromaturija
Increased Appetite
Povečan apetit
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.
Nevrološke motnje (kot so cerebelarni simptomi, diplopija, lateralni nistagmus, upočasnjena pshihomotorika, 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.
In case of overdose, close clinical supervision of the patient is required.
V primeru predoziranja je potreben skrben klinični nadzor pacienta.
Iron chelating agents, ATC code:
Kelirajzoča sredstva za zdravljenje akutnih zastrupitev z železom, oznaka ATC:
The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds to iron in a 3:1 molar ratio.
Zdravilna učinkovina je deferipron (3- hidroksi- 1, 2- dimetilpiridin- 4- on), bidentaten ligand, ki veže železo v molskem razmerju 3: 1.
Clinical studies have demonstrated that deferiprone 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 deferipron 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.
However, chelation therapy may not necessarily protect against iron-induced organ damage.
Terapija s keliranjem pa ne ščiti pred poškodbami organov, ki jih povzroča železo.
6 Deferiprone has been investigated in 247 patients in two phase III trials and a compassionate use programme.
Deferipron so preizkusili na 247 bolnikih v dveh preskušanjih III faze in v t. i. "compassionate use" programu.
Serum ferritin was chosen as the primary efficacy criterion in the studies.
V eni od študij, ki je trajala dve leti, so deferipron primerjali z deferoksaminom.
In one study of two-year duration deferiprone was compared to deferoxamine.
Srednji nivo serumskega feritina se v obeh skupinah ni bistveno razlikoval, vendar pa izgleda, da se je srednja koncentracija železa pri
The mean serum ferritin levels were not significantly different in the two treatment groups, but mean hepatic iron concentration in deferiprone treated patients seems to increase more than in deferoxamine treated patients.
6 bolnikih, ki so se zdravili z deferipronom, povečala bolj kot pri bolnikih, zdravljenih z deferoksaminom.
Therefore deferiprone at the recommended dose could be less effective than deferoxamine.
Iz tega sledi, da je deferipron v priporočenih odmerkih lahko manj učinkovit kot deferoksamin.
The other study was a supportive open, non-comparative study.
Druga študija je bila podporna, odprta, ne primerjalna.
In this study patients maintained serum ferritin values at pre-study levels.
V tej študiji so se vrednosti serumskega feritina ohranile na ravni vrednosti pred začetkom študije.
The primary end-point was the incidence of agranulocytosis, which occurred at a frequency of 1.2%.
Primaren zaključek je bila incidenca agranulocitoze, s pogostnostjo 1, 2%.
Absorption Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Absorpcija Deferipron se hitro absorbira iz zgornjega dela prebavnega trakta.
Peak serum concentration is reported to occur 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.
Following a dose of 25 mg/ kg, lower peak serum concentrations have been detected in patients in the fed state (85 μ mol/ l) than in the fasting state (126 μ mol/ l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Po odmerku 25 mg/ kg je bila najvišja vrednost koncentracije v serumu nižja pri bolnikih, ki so že jedli (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.
Biotransformation Deferiprone is metabolised predominantly to a glucuronide conjugate.
Presnova Deferipron se v glavnem presnavlja v konjugiran glukuronid.
This metabolite lacks iron-binding capability due to inactivation of the 3-hydroxy group of deferiprone.
Ta presnovek nima sposobnosti vezave železa zaradi inaktivacije 3- hidroksilne skupine deferiprona.
Elimination In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
Kot kažejo poročila, se od 75% do 90% zaužitega odmerka pojavi v urinu v prvih 24 urah, in sicer v obliki prostega deferiprona, glukuronidnega presnovka in kompleksa železo- deferipron.
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 pojav 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, eritrocitov in/ ali trombocitov v periferni krvi.
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.
Pri odmerkih 100 mg/ kg/ dan in več so pri živalih, neobremenjenih z železom, zabeležili atrofije timusa, limfatičnih tkiv in mod ter hipertrofijo nadledvičnih žlez.
Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded rats and rabbits at doses at least as low as 25 mg/ kg/ day.
V študijah reprodukcije pri podganah in kuncih, ki niso bili obremenjeni z železom, je bil deferipron teratogen in embriotoksičen že pri odmerkih 25 mg/ kg/ dan.
Tablet core Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Jedro tablete mikrokristalna celuloza magnezijev stearat
5 years
5 leti
Do not store above 30ºC
Shranjujte pri temperaturi do 30 °C.
High density polyethylene (HDPE) bottles with child resistant closure (polypropylene).
Plastenkah iz polietilena velike gostote ki so opremljene z otrokom varno zaporko.
Each pack contains one bottle of 100 tablets.
V vsaki embalaži je ena steklenica po 100 tablete.
Darwinweg 20 2333 CR Leiden Netherlands
Darwinweg 20 2333 CR Leiden Nizozemska
Date of first authorisation:
Datum odobritve:
25/ 08/ 1999 Date of latest renewal:
25/ 08/ 1999 Datum zadnjega podaljšanja dovoljenje za promet:
Ferriprox 100 mg/ ml oral solution
Ferriprox 100 mg/ ml peroralna raztopina
Each ml of oral solution contains 100 mg deferiprone.
En ml peroralne raztopine vsebuje 100 mg deferiprona.
Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
En ml peroralne raztopine vsebuje 0, 4 mg oranžnega barvila E110.
Clear, reddish orange coloured liquid.
Prozorna, rdečeoranžna tekočina.
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.
Deferipron se običajno jemlje po 25 mg/ kg telesne mase peroralno trikrat dnevno, celotni dnevni odmerek pa znaša 75 mg/ kg telesne mase.
Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Odmerek na kilogram telesne mase je treba izračunati na 2, 5 ml.
Dose table
Tabela odmerkov
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 tabeli za telesno maso bolnika.
9
9 Telesna masa
ml of oral solution
ml peroralne raztopine
(mg, three times/ day) 500 750 1000 1250 1500 1750 2000 2250
(mg, trikrat/ dan) 500 750 1000 1250 1500 1750 2000 2250
times/ day) 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5
(trikrat/ dan) 5, 0 7, 5 10, 0 12, 5 15, 0 17, 5 20, 0 22, 5
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.
S tem se zagotovi, da bolnik popolnoma okreva.
10 In the event of severe neutropenia or agranulocytosis:
10 V primeru resne nevtropenije oziroma agranulocitoze:
Excipients Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Pomožne snovi Peroralna raztopina Ferriprox vsebuje oranžno barvilo E110, ki lahko povzroči alergijsko reakcijo.
11 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
However, 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, odvisnimi od trivalentnih kationov,
12 Low plasma zinc levels have been associated with deferiprone, in a minority of patients.
Pri manjšem številu bolnikov so pri jemanju deferiprona ugotovili nizke plazemske vrednosti cinka.
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.
12 Nevrološke motnje (kot so cerebelarni simptomi, diplopija, lateralni nistagmus, upočasnjena pshihomotorika, 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.
CLASS Investigations Blood and lymphatic system disorders Nervous system disorders
KLASIFIKACIJA PO ORGANSKIH SISTEMIH
(≥ 1/ 10)
ZELO POGOSTI (≥1/ 10)
(≥ 1/ 100 to < 1/ 10) Increased liver enzymes Neutropenia Agranulocytosis Headache
POGOSTI (≥1/ 100 DO < 1/ 10)
(≥ 1/ 1,000 to < 1/ 100)
OBČASNI (≥1/ 1. 000 DO < 1/ 100)
Iron chelating agents, ATC code:
Kelirajoča sredstva za zdravljenje akutnih zastrupitev z železom, oznaka ATC:
13 Deferiprone has been investigated in 247 patients in two phase III trials and a compassionate use programme.
Deferipron so preizkusili na 247 bolnikih v dveh preskušanjih III faze in v t. i. "compassionate use" programu.
Serum ferritin was chosen as the primary efficacy criterion in the studies.
V eni od študij,
In one study of two-year duration deferiprone was compared to deferoxamine.
13 ki je trajala dve leti, so deferipron primerjali z deferoksaminom.
The mean serum ferritin levels were not significantly different in the two treatment groups, but mean hepatic iron concentration in deferiprone treated patients seems to increase more than in deferoxamine treated patients.
Srednji nivo serumskega feritina se v obeh skupinah ni bistveno razlikoval, vendar pa izgleda, da se je srednja koncentracija železa pri bolnikih, ki so se zdravili z deferipronom, povečala bolj kot pri bolnikih, zdravljenih z deferoksaminom.
PHARMACEUTICAL PARTICULARS
6. 1 Seznam pomožnih snovi
6.1 List of excipients
Prečiščena voda
Purified water Hydroxyethylcellulose Glycerol Hydrochloric acid, concentrated Artificial cherry flavour Peppermint oil Sunset Yellow (E110) Sucralose (E955)
14 Hidroksietilceluloza Glicerol Klorovodikova kislina, koncentrirana Umetna aroma češnje Olje poprove mete Oranžno barvilo (E110) Sukraloza (E955)
Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Rumenkastorjave polietilentereftalatne (PET) steklenice z zamaškom, ki otrokom onemogoča odpiranje (polipropilen), in merilno posodico (polipropilen).
Each pack contains one bottle of 250 ml or 500 ml oral solution.
V vsaki embalaži je ena steklenica po 250 ml ali 500 ml peroralne raztopine.
15 10.
15 DODATEK II
DATE OF REVISION OF THE TEXT
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
CONDITIONS OF THE MARKETING AUTHORISATION
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Bio Science Park Archimedesweg 2 2333 CN Leiden Netherlands
Bio Science Park Archimedesweg 2 2333 CN Leiden Nizozemska
Medicinal product subject to restricted medical prescription (See Annex I:
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I:
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA Navedba smiselno ni potrebna.
The MAH must ensure that the system of pharmacovigilance as described in version 01 (dated 4 May 2006) presented in Module 1.8.1 of the Marketing Authorisation Application is in place and functioning before and whilst the product is on the market.
• DRUGI POGOJI Sistem farmakovigilance MAH mora zagotoviti, da je sistem farmakovigilance, opisan v različici 01 (z dne 4. maja 2006), predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, uveden in v uporabi preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporaboi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan as agreed in version 2 (dated 19 September 2007) of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP
Načrt za obvladovanje tveganja MAH se obvezuje, da bo izvajal raziskave in dodatne farmakovigilančne aktivnosti, ki so podrobneje opisane v načrtu farmakovigilance, kot je bilo dogovorjeno v različici 2 (z dne 19. septembra 2007) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in kakršne koli nadaljnje posodobitve Načrta o obvladovanju tveganja, s katerim soglaša Odbor za zdravila za uporabo v humani medicini.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po Smernicah odbora za zdravila za uporabo v humani medicini za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 says of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Poleg tega je treba predložiti tudi posodobljen načrt za obvladovanje tveganja: • Ob prejemu novih informacij, ki utegnejo vplivati na trenutne varnostne specifikacije, načrt farmakovigilance ali dejavnosti za zmanjšanje tveganja. • V 60 dneh od doseženega pomembnega mejnika (pri farmakovigilanci ali zmanjševanju tveganja). • Na zahtevo Evropske agencije za zdravila EMEA.
PSURs: the MAH will continue to provide Periodic Safety Update Reports every 6 months.
PSURs – Periodično poročilo o varnosti zdravila: imetnik dovoljenja za promet z zdravilom bo zagotavljal redna periodična poročila o varnosti zdravila vsakih 6 mesecev.
LABELLING
19 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
One tablet contains 500 mg deferiprone
Ena tableta vsebuje 500 mg deferiprona.
Film-coated tablets 100 tablets
filmsko obložene tablete 100 tablet
21 11.
20 11.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
21 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
STEKLENICČKA PO 250 ML ALI 500 ML
Ferriprox 100 mg/ ml oral solution Deferiprone
Ferriprox 100 mg/ ml peroralna raztopina deferipron
Contains Sunset Yellow (E110); see leaflet for further information.
Vsebuje oranžno barvilo (E110); dodatne informacije najdete v priloženih navodilih.
PACKAGE LEAFLET
24 NAVODILO ZA UPORABO
Ferriprox 500 mg film-coated tablets Deferiprone
Ferriprox 500 mg filmsko obložene tablete Deferipron
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
Pred začetkom jemanja natančno preberite navodilo! − Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom. − Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
It may harm them, even if their symptoms are the same as yours. − If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. − Attached to this leaflet you will find a patient/ carer reminder card.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. − Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta. − Temu navodilu je priložena kartica, ki je namenjena bolniku/ skrbniku kot opomnik.
What Ferriprox is and what it is used for 2.
Kaj je zdravilo Ferriprox in za kaj ga uporabljamo 2.
Before you take Ferriprox 3.
Kaj morate vedeti, preden boste vzeli zdravilo Ferriprox 3.
How to take Ferriprox 4.
Kako jemati zdravilo Ferriprox 4.
How to store Ferriprox 6.
Možni neželeni učinki 5 Shranjevanje zdravila Ferriprox 6.
WHAT FERRIPROX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FERRIPROX IN ZA KAJ GA UPORABLJAMO
Deferiprone is the active substance in Ferriprox.
Zdravilna učinkovina Ferriproxa je deferipron.
Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Ferriprox se uporablja za zdravljenje prenasičenosti z železom pri bolnikih z veliko talasemijo za katere je zdravljenje z deferoksaminom kontraindicirano ali neustrezno.
BEFORE YOU TAKE FERRIPROX
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO FERRIPROX
Do not take Ferriprox − if you are allergic (hypersensitive) to deferiprone or any of the other ingredients of Ferriprox. − if you have a history of repeated episodes of neutropenia (low neutrophil count). − if you have a history of agranulocytosis (very low white blood cell count < 0.5x109/ l). − if you are currently taking medicines known to cause neutropenia. − if you are pregnant or breast-feeding.
Ne jemljite zdravila Ferriprox − če ste alergični na (preobčutljivi za) deferipron ali katerokoli sestavino zdravila Ferriproxa. − če ste imeli ponavljajoče epizode nevtropenije (nizkega števila nevtrofilcev). če ste imeli agranulocitozo (zelo nizko število levkocitov < 0, 5x109/ l). − − če trenutno jemljete zdravila, ki povzročajo nevtropenijo. − če ste noseči oziroma dojite.
Therapy with Ferriprox may be associated with the occurrence of a very low white blood cell count in some patients.
Zdravljenje s Ferriproxom je pri nekaterih bolnikih lahko povezano s pojavom zelo nizkega števila levkocitov.
This condition is known as severe neutropenia or agranulocytosis and may place you at risk of developing a serious infection.
To stanje imenujemo huda nevtropenija ali agranulocitoza in predstavlja tveganje za razvoj resne okužbe.
The way Ferriprox causes neutropenia is not known.
Ni znano, na kakšen način Ferriprox povzroča nevtropenijo.
Patients must not take any medicines known to be associated with neutropenia or those that can cause agranulocytosis.
Bolniki ne smejo jemati zdravil, povezanih z nevtropenijo, ali takšnih, ki lahko povzročijo agranulocitozo.
Take special care with Ferriprox − if you have a history of neutropenia, since one of the most serious side effects that may occur is a very low white blood cell (neutrophil) count.
Bodite posebno pozorni pri zdravilu Ferriprox − če ste že imeli nevtropenijo, saj je eden izmed najresnejših neželenih učinkov pojav zelo nizkega števila levkocitov (nevtrofilcev).
This condition, known as severe neutropenia or agranulocytosis, has occurred in about 1 out of 100 people who have taken Ferriprox in clinical studies.
To stanje, imenovano huda nevtropenija oziroma agranulocitoza, se je pojavilo pri približno 1 od 100 ljudi, ki so med kliničnimi študijami jemali Ferriprox.
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.
Ker levkociti pomagajo premagovati okužbe, se lahko zaradi nizkega števila nevtrofilcev razvije resna in mogoče življenjsko ogrožajoča okužba.