FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Slovenian: Imetnik(-i) dovoljenja (dovoljenj) za promet z zdravilom bo(-do) umaknil(-i) naslednji (naslednje) pogoj(-e) (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo je prečrtano)
English: Annex II Conditions to the Marketing Authorisation(s)>
Slovenian: Priloga II Pogoji dovoljenja (dovoljenj) za promet z zdravilom
English: The descriptive study final report submitted by the MAH complies with their obligation to conduct a prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated in routine clinical practice as imposed during the Article 107i procedure EMEA/H/A-107i/1373 for alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil containing products.
Slovenian: Opisno končno poročilo študije, ki ga je predložil imetnik dovoljenja za promet z zdravilom, je v skladu z obveznostjo izvajanja prospektivne neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom za nadaljnje ovrednotenje ravni magnezija, ki so jih opazili pri donošenih novorojenčkih in otrocih, starih do dve leti, zdravljenih v rutinski klinični praksi, kot je bilo naloženo v okviru postopka po členu 107i EMEA/H/A-107i/1373 za zdravila, ki vsebujejo alanin, arginin, asparaginsko kislino, cistein, glukozo, glutaminsko kislino, glicin, histidin, izolevcin, levcin, lizin monohidrat, metionin, ornitinijev klorid, fenilalanin, prolin, serin, tavrin, treonin, triptofan, tirozin, valin, kalcijev klorid, magnezijev acetat, kalijev acetat, natrijev klorid, natrijev glicerofosfat, rafinirano sojino olje, rafinirano olivno olje.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil and concerned by the PASS final report , the CMDh is of the opinion that the benefitrisk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za rezultate študije za zdravilo (zdravila), ki vsebuje(-jo) učinkovino alanin, arginin, asparaginsko kislino, cistein, glukozo, glutaminsko kislino, glicin, histidin, izolevcin, levcin, lizin monohidrat, metionin, ornitinijev klorid, fenilalanin, prolin, serin, tavrin, treonin, triptofan, tirozin, valin, kalcijev klorid, magnezijev acetat, kalijev acetat, natrijev klorid, natrijev glicerofosfat, rafinirano sojino olje, rafinirano olivno olje in je (so) zajeto (zajeta) v končno poročilo študije PASS, skupina CMDh meni, da je razmerje med koristjo in tveganjem zgoraj navedenega (navedenih) zdravil(-a) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil concerned by the non-interventional imposed PASS final report
Slovenian: Spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom (zdravili), ki vsebuje(-jo) učinkovino alanin, arginin, asparaginsko kislino, cistein, glukozo, glutaminsko kislino, glicin, histidin, izolevcin, levcin, lizin monohidrat, metionin, ornitinijev klorid, fenilalanin, prolin, serin, tavrin, treonin, triptofan, tirozin, valin, kalcijev klorid, magnezijev acetat, kalijev acetat, natrijev klorid, natrijev glicerofosfat, rafinirano sojino olje, rafinirano olivno olje in je (so) zajeto (zajeta) v končno poročilo naložene neintervencijske študije PASS.
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance Alanine, arginine, aspartic acid, cysteine, glucose, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride, magnesium acetate, potassium acetate, sodium chloride, sodium glycerophosphate, refined soybean oil, refined olive oil and concerned by the PASS final report , the scientific conclusions are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) za končno poročilo o zahtevani neintervencijski študiji o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS) za zdravilo (zdravila), ki vsebuje(-jo) učinkovino alanin, arginin, asparaginsko kislino, cistein, glukozo, glutaminsko kislino, glicin, histidin, izolevcin, levcin, lizin monohidrat, metionin, ornitinijev klorid, fenilalanin, prolin, serin, tavrin, treonin, triptofan, tirozin, valin, kalcijev klorid, magnezijev acetat, kalijev acetat, natrijev klorid, natrijev glicerofosfat, rafinirano sojino olje, rafinirano olivno olje in in je (so) zajeto (zajeta) v končno poročilo študije PASS, so bili sprejeti naslednji znanstveni zaključki:
English: Glass vial
Slovenian: Injekcijska viala (steklena)
English: Target species Route of administration
Slovenian: EU številka Izmišljeno ime Jakost Farmacevtska
English: Withdrawal period
Slovenian: Način uporabe zdravila
English: Ref.: EMA/751799/2009 EMA/H/C/572
Slovenian: : EMEA/751799/2009 EMEA/H/C/572
English: • major depression;
Slovenian: • veliko depresivno motnjo;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cymbalta to Eli Lilly Nederland BV on 17 December 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Cymbalta, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland BV dne 17. decembra 2004.
English: Cymbalta duloxetine EPAR summary for the public
Slovenian: Cymbalta duloksetin Povzetek EPAR za javnost
English: Cymbalta is used to treat adults with the following diseases:
Slovenian: Zdravilo Cymbalta se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The most common side effects with Cymbalta (seen in more than 1 patient in 10) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Slovenian: Najpogostejši neželeni učinki zdravila Cymbalta (opaženi pri več kot 1 bolniku od 10) so navzeja (slabost), glavobol, suha usta, somnolenca (zaspanost) in omotica.
English: Other information about Cymbalta:
Slovenian: Druge informacije o zdravilu Cymbalta:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Cymbalta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Cymbalta večje od z njim povezanih tveganj, in priporočil, da se za zdravilo odobri dovoljenje za promet.
English: Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks.
Slovenian: V štirih študijah so proučevali zdravljenje motnje tako, da so ocenjevali zmanjšanje simptomov po devetih do 10 tednih.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Slovenian: Pri generalizirani anksiozni motnji znaša priporočeni začetni odmerek 30 mg enkrat na dan, vendar se lahko odmerek poveča na 60, 90 ali 120 mg glede na odziv bolnika.
English: Any patients taking Cymbalta who have distressing thoughts or experiences at any time should tell their doctor immediately.
Slovenian: Vsak bolnik, ki jemlje zdravilo Cymbalta in opazi misli ali občutke, ki povzročajo stisko, mora o tem nemudoma obvestiti svojega zdravnika.
English: Cymbalta is a medicine that contains the active substance duloxetine.
Slovenian: Cymbalta je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
English: Cymbalta must also not be used in patients with certain types of liver disease or patients with severe kidney disease.
Slovenian: Zdravilo Cymbalta se prav tako ne sme uporabljati pri bolnikih z nekaterimi vrstami obolenj jeter ali bolnikih s hudimi obolenji ledvic.
English: What benefit has Cymbalta shown during the studies?
Slovenian: Kakšne koristi je zdravilo Cymbalta izkazalo med študijami?
English: As with other antidepressants, isolated cases of suicidal thoughts and behaviour have been seen in patients taking Cymbalta, particularly in the first few weeks of treatment for depression.
Slovenian: Kot pri drugih zdravilih proti depresiji so tudi pri zdravilu Cymbalta opazili posamezne primere samomorilnih misli in samomorilskega vedenja, še zlasti v prvih nekaj tednih zdravljenja depresije.
English: Cymbalta must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Slovenian: Zdravilo Cymbalta se ne sme uporabljati skupaj z zaviralci monoaminooksidaze (drugo skupino zdravila proti depresiji), fluvoksaminom (drugim zdravilom proti depresiji), ciprofloksacinom ali enoksacinom (vrsto antibiotika).
English: Cymbalta should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Slovenian: Zdravila Cymbalta ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) duloksetin ali katero koli drugo sestavino zdravila.
English: For major depression, the recommended dose of Cymbalta is 60 mg once a day.
Slovenian: Pri zdravljenju hude depresije je priporočeni odmerek zdravila Cymbalta 60 mg enkrat dnevno.
English: What is the risk associated with Cymbalta?
Slovenian: Kakšna tveganja so povezana z zdravilom Cymbalta?
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Cymbalta.
Slovenian: V peti študiji s 429 bolniki so proučevali, kako hitro se simptomi spet pojavijo pri bolnikih, ki so se sprva odzvali na zdravilo Cymbalta.
English: For generalised anxiety disorder, Cymbalta has been compared with placebo in five studies involving a total of 2,337 patients.
Slovenian: Pri generalizirani anksiozni motnji so zdravilo Cymbalta primerjali s placebom v petih študijah, v katere je bilo skupno vključenih 2 337 bolnikov.
English: In patients who respond to Cymbalta, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Slovenian: Za bolnike, ki se odzivajo na zdravilo Cymbalta, je zdravljenje priporočljivo nadaljevati še nekaj mesecev, da se prepreči ponovni pojav bolezni, za bolnike, ki so v preteklosti imeli ponavljajoča se obdobja depresije, pa še dlje.
English: In the two studies where the approved dose of Cymbalta was compared with placebo, Cymbalta was more effective.
Slovenian: V dveh študijah, v katerih so odobreni odmerek zdravila Cymbalta primerjali s placebom, se je zdravilo Cymbalta izkazalo za učinkovitejše.
English: For the full list of all side effects reported with Cymbalta, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cymbalta, glejte navodilo za uporabo.
English: The active substance in Cymbalta, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina zdravila Cymbalta, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina.
English: The full EPAR for Cymbalta can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cymbalta je na voljo tukaj.
English: For the treatment of diabetic neuropathic pain, Cymbalta was more effective at reducing pain than placebo.
Slovenian: Pri zdravljenju bolečine diabetične nevropatije je bilo zdravilo Cymbalta pri zmanjševanju bolečine učinkovitejše od placeba.
English: The dose of Cymbalta should be reduced gradually when stopping treatment.
Slovenian: Ob prenehanju zdravljenja je treba odmerek zdravila Cymbalta zmanjševati postopoma.
English: For generalised anxiety disorder, Cymbalta was also more effective than placebo at treating the disorder and preventing symptoms returning.
Slovenian: Pri generalizirani anksiozni motnji je bilo zdravilo Cymbalta prav tako učinkovitejše od placeba pri preprečevanju ponovnega pojava simptomov.
English: Although the results of the depression studies varied, Cymbalta was more effective than placebo in four of the studies.
Slovenian: Čeprav so se rezultati študij o depresiji med seboj razlikovali, je bilo zdravilo Cymbalta v štirih študijah učinkovitejše od placeba.
English: Why has Cymbalta been approved?
Slovenian: Zakaj je bilo zdravilo Cymbalta odobreno?
English: For neuropathic pain, Cymbalta has been compared with placebo in two 12-week studies in 809 diabetic adults.
Slovenian: Pri nevropatski bolečini so zdravilo Cymbalta v 12 tednov trajajoči študiji z 809 sladkornimi bolniki primerjali s placebom.
English: For major depression, Cymbalta has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Slovenian: Za zdravljenje večjih depresivnih motenj so zdravilo Cymbalta v osmih glavnih študijah, v katere je bilo vključenih 2 544 bolnikov, primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Cymbalta, including 288 patients with a history of repeated episodes of depression for up to five years.
Slovenian: V drugih dveh študijah, v katerih je sodelovalo 288 bolnikov z zgodovino ponavljajočih se epizod depresije v največ zadnjih petih letih, so proučevali, kako hitro se simptomi povrnejo pri bolnikih, ki so se sprva odzvali na zdravljenje z zdravilom Cymbalta.
English: What is Cymbalta used for?
Slovenian: Za kaj se zdravilo Cymbalta uporablja?
English: It also took longer for symptoms to return in patients taking Cymbalta than in those taking placebo.
Slovenian: Pri bolnikih, ki so jemali zdravilo Cymbalta, je trajalo dalj časa, da so se simptomi ponovno pojavili, kot pri bolnikih, ki so jemali placebo.
English: How does Cymbalta work?
Slovenian: Kako zdravilo Cymbalta deluje?
English: What is Cymbalta?
Slovenian: Kaj je zdravilo Cymbalta?
English: How has Cymbalta been studied?
Slovenian: Kako je bilo zdravilo Cymbalta raziskano?
English: How is Cymbalta used?
Slovenian: Kako se zdravilo Cymbalta uporablja?
English: Patients who also have major depression should start with 60 mg once a day.
Slovenian: Večina bolnikov bo morala jemati 60 mg na dan. Bolniki, ki imajo tudi hujše depresivne motnje, morajo začeti s 60 mg enkrat na dan. Za bolnike, ki se odzivajo na zdravilo Cymbalta, je zdravljenje priporočljivo nadaljevati še nekaj mesecev, da se prepreči ponovni pojav bolezni.
English: (unit dose)
Slovenian: (Izmišljeno) ime
English: Make sure you do the following:
Slovenian: Zagotovite, da boste:
English: The expiry date refers to the last day of that month.
Slovenian: Datum izteka roka uporabnosti je zadnji dan navedenega meseca.
English: For women of child bearing age
Slovenian: Za ženske v rodni dobi
English: In the event of neutropenia:
Slovenian: V primeru nevtropenije:
English: COMMON (≥1/100 to <1/10)
Slovenian: POGOSTI (≥ 1/100 DO < 1/10)
English: ((Inside 1))
Slovenian: ((Notranjost 1))
English: If you are HIV positive or if your liver function is severely impaired, your doctor may recommend additional tests.
Slovenian: Če ste HIV pozitivni ali je delovanje vaših jeter hudo okvarjeno, vam bo zdravnik morda priporočil dodatne preiskave.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1310/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/18/1310/001
English: In most cases, the pain disappeared while patients continued taking deferiprone.
Slovenian: V večini primerov so bolečine izginile, medtem ko so bolniki nadaljevali z jemanjem deferiprona.
English: Adverse reaction frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Slovenian: Pogostost neželenih učinkov: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: ((Inside 2))
Slovenian: ((Notranjost 2))
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Slovenian: Datum odobritve: 20. september 2018
English: The Patient/Carer reminder card shall contain the following key messages (full text is included in Annex IIIA of the marketing authorisation):
Slovenian: Opozorilna kartica za bolnike/skrbnike mora vsebovati naslednja ključna sporočila (celotno besedilo je v Prilogi IIIA dovoljenja za promet), ki bo:
English: Electronic mail: lipomed@lipomed.com
Slovenian: E-pošta: lipomed@lipomed.com
English: Not known (frequency cannot be estimated from the available data): - allergic reactions including skin rash or hives
Slovenian: Neznana pogostnost (pogostnosti ni mogoče določiti iz razpoložljivih podatkov): - alergijske reakcije, vključno s kožnim izpuščajem in koprivnico
English: • History of recurrent episodes of neutropenia.
Slovenian: • Anamneza ponavljajočih se epizod nevtropenije
English: In the event of agranulocytosis, re-challenge is contraindicated.
Slovenian: V primeru agranulocitoze je ponovna uporaba kontraindicirana.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli poleg oznake EXP.
English: Deferiprone was concluded to produce no significant prolongation of the QT interval.
Slovenian: Ugotovljeno je bilo, da deferipron ne podaljšuje bistveno intervala QT.
English: A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
Slovenian: Skupni dnevni odmerek nad 100 mg/kg telesne mase ni priporočen zaradi možnega povečanega tveganja za neželene učinke (glejte poglavja 4.4, 4.8 in 4.9).
English: Systemic exposure to the inactive 3-Oglucuronide increased with decreasing eGFR.
Slovenian: Sistemska izpostavljenost neaktivnemu 3-O-glukuronidu je naraščala z zmanjševanjem eGFR.
English: Plasma Zn2+ concentration Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Slovenian: Plazemske koncentracije Zn2+ Priporočljivo je spremljanje plazemske koncentracije Zn2+ in tudi dopolnjevanje v primeru pomanjkanja.
English: Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of deferiprone with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Slovenian: V študijah LA16-0102, LA-01 in LA08-9701 so primerjali učinkovitost zdravila deferipron in deferoksamina pri nadziranju serumskega feritina pri pacientih s talasemijo, ki so odvisni od transfuzije.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.
Slovenian: To stopnjo je potrebno upoštevati v kontekstu osnovno povečane pojavnosti nevtropenije pri bolnikih s talasemijo, predvsem pri tistih s hipersplenizmom.
English: • Pregnancy (see section 4.6).
Slovenian: • Nosečnost (glejte poglavje 4.6)
English: Have your blood monitored on a weekly basis.
Slovenian: 1. tedensko preverjali svojo kri,
English: • To warn women of childbearing age to not become pregnant because deferiprone may seriously harm the unborn baby
Slovenian: • posvarilo ženske v rodni dobi, naj ne zanosijo, saj lahko deferipron resno škoduje njihovemu nerojenemu otroku.
English: Dose (mg, three times/day)
Slovenian: Odmerek (mg/trikrat/dan)
English: This metabolite lacks ironbinding capability due to inactivation of the 3-hydroxy group of deferiprone.
Slovenian: Ta presnovek nima sposobnosti vezave železa zaradi inaktivacije 3-hidroksilne skupine deferiprona.
English: Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia.
Slovenian: Bolnika opozorite na takojšnje prenehanje jemanje deferiprona in vseh drugih zdravil, ki bi lahko povzročila nevtropenijo.
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 (ALT) neprekinjeno zvišuje, je treba razmisliti o prekinitvi zdravljenja z deferipronom.
English: Doses of deferiprone in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Slovenian: Odmerki zdravila deferipron v teh študijah so se gibali v razponu od 50 do 100 mg/kg/dan in odmerki deferoksamina od 40 do 60 mg/kg/dan.
English: The amount of Deferiprone Lipomed that you take will depend on your weight.
Slovenian: Količina zdravila Deferiprone Lipomed, ki ga boste jemali, je odvisna od vaše telesne mase.
English: Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Deferiprone Lipomed may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
Slovenian: Prilagoditve odmerka pri uporabi z drugimi kelatorji železa Pri bolnikih, pri katerih je monoterapija neprimerna, se zdravilo Deferiprone Lipomed lahko uporablja z deferoksaminom v standardnem odmerku (75 mg/kg/dan), vendar ne sme preseči 100 mg/kg/dan.
English: The MAH shall ensure that in each Member State where Deferiprone Lipomed is marketed, all patients/carers who are expected to use Deferiprone Lipomed are provided with the Patient/Carer reminder card as a part of the outer packaging.
Slovenian: Imetnik dovoljenja za promet zagotovi, da v vsaki državi, v kateri je Deferiprone Lipomed na trgu, vsi bolniki/skrbniki, za katere se pričakuje, da bodo uporabljali to zdravilo, prejmejo opozorilno kartico za bolnika/skrbnika, katere besedilo je del zunanje ovojnine.
English: 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.
Slovenian: Zdravilna učinkovina je deferipron (3-hidroksi-1,2-dimetilpiridin-4-on), bidentaten ligand, ki veže železo v molskem razmerju 3:1.
English: This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken deferiprone in clinical studies.
Slovenian: To stanje, znano kot huda nevtropenija ali agranulocitoza, se je pojavilo pri 1 do 2 od 100 ljudi, ki so jemali deferipron v kliničnih študijah.