natgillin/translations-raw huggingface dataset:
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster
Ker so predhemodializni in hemodializni bolniki še posebej izpostavljeni okužbi s HBV, in ker je pri njih tveganje za kronično okužbo večje, je potrebno razmisliti o previdnostnih ukrepih, npr. cepljenje z obnovitvenim odmerkom, da bi tako zagotovili takšen zaščitni titer protiteles kot je definiran z nacionalnimi priporočili in smernicami.
Ferriprox is a medicine containing the active substance deferiprone.
Ferriprox je zdravilo, ki vsebuje zdravilno učinkovino deferipron.
It is available as white, capsule- shaped tablets (500 mg) and as an oral solution (100 mg/ ml).
Zdravilo je na voljo v obliki belih tablet, ki imajo obliko kapsul (500 mg), in peroralne raztopine (100 mg/ ml).
Ferriprox is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major (an inherited disease where patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body).
Zdravilo Ferriprox se uporablja za zdravljenje prenasičenosti z železom (prevelike količine železa v krvi) pri bolnikih z veliko talasemijo (dedna bolezen, pri kateri bolniki ne ustvarjajo dovolj hemoglobina, proteina, ki se nahaja v rdečih krvničkah in po telesu prenaša kisik).
Ferriprox is used when deferoxamine (another medicine used to treat iron overload) cannot be used.
Zdravilo Ferriprox se uporablja, kadar zdravljenja z deferoksaminom (drugega zdravila za zdravljenje prenasičenosti z železom) ni mogoče uporabiti.
Ferriprox treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.
Zdravljenje z zdravilom Ferriprox mora uvesti in nadzirati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s talasemijo.
The total daily dose of Ferriprox is 75 -100 mg per kilogram body weight given in three separate doses per day.
Celotni dnevni odmerek zdravila Ferriprox je 75- 100 mg na kilogram telesne mase, ki ga bolniki prejmejo v treh ločenih odmerkih na dan.
If tablets are used, the number of tablets for each dose is adjusted to the nearest half tablet.
Če se jemljejo tablete, se število tablet pri vsakem odmerku prilagodi na najbližjo polovico tablete.
If the oral solution is used, the dose is adjusted to the nearest 2.5 ml.
Če se uporablja peroralna raztopina, se odmerek prilagodi na najbližja 2, 5 ml.
For example, a 70 kg patient will take three and a half tablets or 17.5 ml three times a day.
Tako bo na primer 70 kg težak bolnik jemal tri in pol tablete ali 17, 5 ml trikrat na dan.
Doses above 100 mg/ kg per day are not recommended because of an potentially increased risk of side effects.
Odmerki nad 100 mg/ kg na dan zaradi možnosti povečanega tveganja neželenih učinkov niso priporočeni.
Patients taking Ferriprox, or their carers, must be given a reminder card that reminds the patient how to take the medicine safely.
Bolniki, ki jemljejo zdravilo Ferriprox, ali njihovi skrbniki, morajo prejeti kartico s kratkimi navodili, ki jih bo opominjala, kako naj zdravilo jemljejo na varen način.
When patients receive repeated transfusions, the transfused red cells bring iron.
Če bolniki prejmejo večkratno transfuzijo, prenesene rdeče krvničke s seboj prinesejo tudi železo.
However, the body does not have a natural way of removing excess iron, so it builds up.
Vendar pa telo ne more po naravni poti odstraniti presežne količine železa, zato se to kopiči.
Over time, the excess iron can damage important organs such as the heart or liver.
Sčasoma lahko presežek železa poškoduje pomembne organe, kot sta srce ali jetra.
The active substance in Ferriprox, deferiprone, is an ‘ iron chelator’.
Zdravilna učinkovina zdravila Ferriprox je deferipron, ki je „ kelator železa “.
It binds to iron in the body to form a compound (a ‘ chelate’) that can be excreted by the body, mainly in the urine, and to a lesser extent in the faeces (stools).
Učinkovina veže železo v telesu in pri tem tvori spojino („ kelat “), ki jo telo lahko izloča, predvsem z urinom in v manjši meri z iztrebki.
This helps to correct the iron overload and prevent damage due to excess iron.
To pomaga odpraviti prenasičenost z železom in preprečevati poškodbe zaradi presežne količine železa.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged deferoxamine (the standard treatment to remove iron) in 71 patients over two years.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Ferriprox raziskano?
The study was an ‘ open label’ study, meaning that the doctor and patients knew which medicine they were using, because Ferriprox is given by mouth, whereas deferoxamine is given by subcutaneous infusion (a very slow injection under the skin) overnight.
Šlo je za „ odprto študijo “, kar pomeni, da so tako zdravniki kot bolniki vedeli, katera zdravila se uporabljajo, saj se zdravilo Ferriprox zaužije, deferoksamin pa se daje v obliki subkutane infuzije (zelo počasno vbrizganje v podkožno tkivo) preko noči.
A later study compared treatment alternating Ferriprox and deferoxamine (five days ’ Ferriprox plus two days ’ deferoxamine each week) with continuous treatment with deferoxamine on its own, in 60 patients over 12 months.
V kasnejši študiji so pri 60 bolnikih v času 12 mesecev zdravljenje z izmenjevanjem zdravila Ferrriprox in deferoksamina (vsak teden po pet dni zdravilo Ferriprox in dva dneva deferoksamin) primerjali z zdravljenjem samo z deferoksaminom.
In all studies, effectiveness was measured by looking at the levels of ferritin in the blood before and during treatment.
V vseh študijah so učinkovitost merili s primerjanjem ravni feritina v krvi pred in med zdravljenjem.
The serum ferritin level (the amount of ferritin in the blood) is indicative of the amount of iron stored in the body.
Raven serumskega feritina (količina feritina v krvi) kaže na količino železa, ki je v telesu.
In the initial comparative study, the mean serum ferritin levels were not significantly different in the two treatment groups, but average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
V začetni primerjalni študiji se povprečne ravni serumskega feritina v dveh zdravljenih skupinah niso znatno razlikovale, vendar pa se je za povprečno koncentracijo železa v jetrih bolnikov, zdravljenih z zdravilom Ferriprox, zdelo, da se je povečala bolj kot pri bolnikih, ki so se zdravili z deferoksaminom.
In the alternating treatment study, the treatment schedule combining Ferriprox for five days with deferoxamine for two days reduced ferritin levels to the same extent as deferoxamine taken on its own.
V študiji zdravljenja s spreminjanjem zdravil je urnik zdravljenja, po katerem so kombinirali pet dni zdravljenja z zdravilom Ferriprox in dva dni zdravljenja z deferoksaminom, znižal ravni feritina v enaki meri kot zdravljenje samo z deferoksaminom.
However, the number of patients in the study was not sufficient to prove that such a schedule is as effective as deferoxamine taken on its own.
Vendar pa število bolnikov v študiji ni bilo zadostno, da bi bilo mogoče dokazati, da je tak urnik res tako učinkovit kot jemanje samo deferoksamina.
The most common side effects with Ferriprox (seen in more than 1 patient in 10) are reddish/ brown urine (showing that iron is being excreted), nausea (feeling sick), abdominal (tummy) pain and vomiting.
Najpogostejši neželeni učinki pri jemanju zdravila Ferriprox (opaženi pri več kot 1 od 10 bolnikov) so rdečkastorjav urin (kaže na izločanje železa), navzeja (slabost), abdominalne (trebušne) bolečine in bruhanje.
An uncommon but serious side effect is agranulocytosis (very low levels of a type of white blood cell).
Občasen vendar resen neželeni učinek je agranulocitoza (zelo nizka raven vrste belih krvničk, imenovanih granulociti).
Ferriprox should not be used in people who may be hypersensitive (allergic) to deferiprone or any of the other ingredients.
Zdravila Ferriprox se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) deferipron ali katerokoli drugo sestavino zdravila.
Ferriprox should not be used in people who have had neutropenia (low levels of a type of white blood cell) repeatedly or agranulocytosis.
Zdravila Ferriprox ne smejo uporabljati osebe, ki so prebolele ponavljajoče epizode nevtropenije (nizko število vrste belih krvničk, imenovanih nevtrofilci) ali agranulocitozo.
Ferriprox should also not be used with medicines that might cause neutropenia or agranulocytosis.
Zdravila Ferriprox se poleg tega ne sme uporabljati skupaj z zdravili, ki bi lahko povzročila nevtropenijo ali agranulocitozo.
Ferriprox should not be used in women who are pregnant or breast-feeding.
Zdravila Ferriprox prav tako ne smejo prejemati ženske, ki so noseče ali dojijo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ferriprox’ s benefits are greater than its risks for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Ferriprox pri zdravljenju prenasičenosti z železom pri bolnikih z veliko talasemijo, pri katerih je zdravljenje z deferoksaminom kontraindicirano ali nezadostno, večje od z njim povezanih tveganj.
They recommended that Ferriprox be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Ferriprox.
Ferriprox was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, limited information was available at the time of approval.
Zdravilo Ferriprox je bilo prvotno odobreno „ v izjemnih okoliščinah “, saj so bile zaradi redkosti bolezni ob odobritvi dovoljenja na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 12 April 2002.
Ker je družba predložila dodatne zahtevane informacije, so „ izjemne okoliščine “ prenehale 12. aprila 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Ferriprox on 25 August 1999.
Evropska komisija je dovoljenje za promet z zdravilom Ferriprox, veljavno po vsej Evropski uniji, odobrila dne 25. avgusta 1999.
The marketing authorisation was renewed on 25 August 2004.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 25. avgusta 2004.
The marketing authorisation holder is Apotex Europe B. V.
Imetnik dovoljenja za promet je družba Apotex Europe B. V.
The full EPAR for Ferriprox is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ferriprox je na voljo tukaj.
EU Number EU/ 1/ 99/ 108/ 001 EU/ 1/ 99/ 108/ 002 EU/ 1/ 99/ 108/ 003
Številka EU EU/ 1/ 99/ 108/ 001 EU/ 1/ 99/ 108/ 002 EU/ 1/ 99/ 108/ 003
Invented name Ferriprox Ferriprox Ferriprox
Izmišljeno ime Ferriprox Ferriprox Ferriprox
Strength 500 mg 100 mg/ ml 100 mg/ ml
jakost 500 mg 100 mg/ ml 100 mg/ ml
Pharmaceutical Form Film-coated tablet Oral solution Oral solution
farmacevtska oblika filmsko obložena tableta Oralna raztopina Oralna raztopina
Route of Administration Oral use Oral use Oral use
pot uporabe za peroralno uporabo za peroralno uporabo za peroralno uporabo
Packaging bottle (HDPE) bottle (PET) bottle (PET)
ovojnina steklenička (HDPE) steklenička (PET) steklenička (PET)
Content 100 tablets 250 ml 500 ml
vsebina 100 tablet 250 ml 500 ml
Package size 1 bottle 1 bottle 1 bottle
velikost pakiranja 1 steklenička 1 steklenička 1 steklenička
Each tablet contains 500 mg deferiprone.
Vsaka tableta vsebuje 500 mg deferiprona kot zdravilno učinkovino.
White to off-white, capsule-shaped, film-coated tablets imprinted “ APO” bisect “ 500” on one side, plain on the other.
Bele do sivobele, filmsko obložene tablete v obliki kapsule; na eni strani je odtisnjeno "APO" razpoloviti “ 500 ”, druga stran je gladka.
The tablet is scored.
Tableta je zarezana.
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.
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 najpogosteje predpisuje v odmerku 25 mg/ kg telesne mase, peroralno, trikrat na dan, največji skupni dnevni odmerek je 75 mg/ kg telesne mase.
Dosage 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.
See table below for recommended doses for body weights at 10 kg increments.
Priporočljive odmerke za telesne mase na vsakih 10 kg najdete v spodnji tabeli.
Doses above 100 mg/ kg/ day are not recommended because of the potentially increased risk of adverse reactions; chronic administration of more than 2.5 times the maximum recommended dose has been associated with neurological disorders (see sections 4.4, 4.8, and 4.9).
Odmerki nad 100 mg/ kg/ dan niso priporočljivi zaradi možnosti povečanega tveganja neželenih učinkov; kronično dajanje več kot 2, 5 kratnega največjega priporočenega odmerka je povezano z nevrološkimi motnjami (glejte poglavja 4. 4, 4. 8 in 4. 9).
Due to the serious nature of agranulocytosis, that can occur with the use of deferiprone, special monitoring is required for all patients.
Zaradi resnosti agranulocitoze, ki se lahko pojavi pri uporabi deferiprona, se za vse bolnike zahteva poseben nadzor.
(see section 4.4).
Zelo previdno je treba ravnati pri bolnikih, pri katerih je absolutna vrednost nevtrofilcev nizka, in tudi pri zdravljenju bolnikov z ledvično insuficienco oziroma jetrno disfunkcijo (glejte poglavje 4. 4).
2 Dose table
Tabela odmerkov
To obtain a dose of about 75 mg/ kg/ day, use the number of tablets suggested in the following table for the body weight of the patient.
Za doseganje odmerka 75 mg/ kg/ dan glede na telesno maso bolnika uporabite število tablet po naslednji tabeli.
Sample body weights at 10 kg increments are listed.
Navedeni so primeri telesnih masa s koraki po 10 kg.
Body weight
2 Telesna masa
(mg, three times/ day) 500 750 1000 1250 1500 1750 2000 2250
(mg/ trikrat/ dan) 500 750 1000 1250 1500 1750 2000 2250
(three times/ day) 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5
(trikrat/ dan) 1, 0 1, 5 2, 0 2, 5 3, 0 3, 5 4, 0 4, 5
Contraindications
4. 3 Kontraindikacije
History of recurrent episodes of neutropenia.
Anamneza ponavljajočih se epizod nevtropenije.
History of agranulocytosis.
Anamneza agranulocitoze.
Pregnancy or breast-feeding (see section 4.6).
Nosečnost oziroma dojenje (glejte poglavje 4. 6).
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 nevtropenije, ki jo povzroči deferipron, bolniki ne smejo jemati zdravil, povezanih z nevtropenijo, ali takšnih, ki lahko povzročijo agranulocitozo (glejte poglavje 4. 5).
Neutropenia/ Agranulocytosis Deferiprone has been shown to cause neutropenia, including agranulocytosis.
Nevtropenija/ Agranulocitoza Dokazano je, da deferipron povzroča nevtropenijo, tudi agranulocitozo.
The patient ’ s neutrophil count should be monitored every week.
Vsak teden je treba pregledati število nevtrofilcev.
The risk of agranulocytosis and neutropenia is higher, if the baseline absolute neutrophil count (ANC) is less than 1.5x109/ l.
Nevarnost agranulocitoze in nevtropenije je višja, če je osnovno absolutno nevtrofilno število (ANC) manjše od 1, 5x109/ l.
Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily.
Te preiskave ponavljajte vsak dan.
It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to
Priporočljivo je, da se po okrevanju od nevtropenije opravljajo tedenske preiskave kompletne krvne slike, števila levkocitov, nevtrofilcev in trombocitov tri tedne zaporedoma.
3 be obtained for three consecutive weeks, to ensure that the patient recovers fully.
3 V primeru resne nevtropenije oziroma agranulocitoze:
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.
Upoštevajte zgornja navodila in dajajte ustrezno zdravljenje, kot so npr. kolonije granulocitov stimulirajoči faktorji.
In the event of severe neutropenia or agranulocytosis:
Zdravljenje pričnite na dan odkritja dogodka, nato pa ga dajajte dnevno, dokler se stanje ne popravi.
In the event of agranulocytosis, a rechallenge is contraindicated.
V primeru agranulocitoze je ponovna uporaba kontraindicirana.
Carcinogenicity/ mutagenicity/ effects on fertility In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Karcinogeni/ mutageni učinki na plodnost Glede na rezultate genotoksičnosti se ne izključuje možnosti karcinogenega delovanja deferiprona (glejte poglavje 5. 3).
No animal studies to evaluate the potential effects of deferiprone on fertility have been reported.
Študije o vplivu deferiprona na plodnost pri živalih niso bile izvedene.
Serum ferritin concentration/ plasma Zn2+ concentration 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.
Serumske koncentracije feritina/ plazemske koncentracije Zn2+ Priporočljivo je nadzorovanje serumskih koncentracij feritina oziroma drugih kazalcev telesne obremenitve z železom vsaj enkrat na dva do tri mesece, da se ugotovi dolgoročna učinkovitost keliranja za nadzorovanje količine železa v telesu.
Interruption of therapy with deferiprone should be considered if serum ferritin measurements fall below 500 μ g/ l.
Preučite možnost prekinitve zdravljenja z deferipronom, če serumske koncentracije feritina padejo pod 500 μg/ l.
Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Priporočljivo je spremljanje plazemske koncentracije Zn2+ in tudi dopolnjevanje v primeru deficience.
HIV positive or other immune compromised patients No data are available on the use of deferiprone in HIV positive or in other immune compromised patients.
Bolniki, ki so pozitivni za HIV oziroma imajo drugače prizadet imunski sistem Ni podatkov o uporabi deferiprona pri bolnikih, ki so HIV pozitivni oziroma imajo drugače prizadet imunski sistem.
Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immune compromised 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 tveganjem.
Renal or hepatic impairment and liver fibrosis There are no data available on the use of deferiprone in patients with renal or hepatic impairment.
Bolniki z motnjami v delovanju jeter oziroma ledvic in fibrozo jeter O uporabi deferiprona pri bolnikih z oslabljenimi ledvicami ali jetri podatki niso na voljo.
If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Če se vrednost serumske alanin - aminotransferaze (ALT) vztrajno povišuje, je treba preučiti možnost prekinitve zdravljenja z deferipronom.
In thalassaemia patients there is an association between liver fibrosis and iron overload and/ or hepatitis C.
Pri bolnikih s talasemijo je dokazana povezava med fibrozo jeter in prekomerno količino železa v telesu in/ ali hepatitisom C.
Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal.
Posebno pozorno je potrebno preveriti, da je keliranje železa pri bolnikih s hepatitisom C optimalno.
Discoloration of urine Patients should be informed that their urine may show a reddish/ brown discoloration due to the excretion of the iron-deferiprone complex.
Sprememba barve urina Bolnike je potrebno poučiti o možnosti, da lahko njihov urin postane rdečkastorjavo obarvan zaradi izločanja kompleksa železo- deferipron.
Chronic overdose and neurological disorders Neurological disorders have been observed in children treated with 2.5 to 3 times the recommended dose for several years.
Kronični prekomerni odmerek in nevrološke motnje Nevrološke motnje so opazili pri otrocih, ki so jih nekaj let zdravili z 2, 5 do 3 kratnim priporočenim odmerkom.
Prescribers are reminded that the use of doses above 100 mg/ kg/ day are not recommended (see sections 4.2, 4.8 and 4.9).
Predpisovalci zdravila se morajo zavedati, da uporaba odmerkov večjih od 100 mg/ kg/ dan ni priporočljiva (glejte poglavja 4. 2, 4. 8 in 4. 9).
Interactions between deferiprone and other medicinal products have not been reported.
Interakcije med deferipronom in drugimi zdravili niso znane.
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, kot so antacidi na osnovi aluminija.
Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Zato ni priporočljivo sočasno jemanje antacidov na osnovi aluminija in deferiprona.
The safety of concurrent use of deferiprone and vitamin C has not been formally studied.
4 Varnost sočasne uporabe deferiprona in vitamina C ni preučena.
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 4.3).
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).
Pregnancy There are no adequate data from the use of deferiprone in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi deferiprona pri nosečnicah.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost deferiprona (glejte poglavje 5. 3).
Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of the medicinal product.
Zaradi klastogenih in teratogenih lastnosti zdravila se ženskam v rodni dobi odsvetuje zanositev.
These women should be counselled to take contraceptive measures and must be advised to immediately stop taking deferiprone if they become pregnant or plan to become pregnant (see section 4.3).
Če ženska zanosi oziroma načrtuje nosečnost, ji je treba svetovati, naj nemudoma preneha jemati deferipron (glejte poglavje 4. 3).
Lactation It is not known whether deferiprone is excreted in human milk.
Dojenje Ni znano, ali se deferipron izloča v materinem mleku.
No prenatal and postnatal reproductive studies have been conducted in animals.
Reproduktivne študije prenatalnega in postnatalnega obdobja pri živalih niso bile izvedene.
Deferiprone must not be used by breast-feeding mothers.
Doječe matere ne smejo jemati deferiprona.