FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be informed that their urine may show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex.
Estonian: Patsiente tuleb informeerida, et seoses raud-deferiproon-komplekside eritumisega võib uriin omandada punakaspruuni värvuse.
English: Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Estonian: Õigustatud on kombinatsioonravi saavate patsientide tähelepanelik jälgimine, kui neil esineb südametöö häireid (vt jaotis 4.4).
English: Each pack contains one bottle of 250 ml or 500 ml oral solution.
Estonian: Igas pakis on üks 250 ml või 500 ml suukaudse lahuse pudel.
English: There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Estonian: Deferiprooni kasutamise kohta 6.10 aastastel lastel on andmed piiratud.
English: Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Estonian: Ferriproxi kasutakse raua ülekoormuse raviks, mille on põhjustanud sagedased vereülekanded raske talasseemiaga patsientidel, kui praegune kelaativ ravi on vastunäidustatud või ebapiisav.
English: If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay.
Estonian: Kui patsiendil tekib deferiprooni manustamise ajal infektsioon, tuleb ravi otsekohe katkestada ja viivitamatult määrata neutrofiilide absoluutarv.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. Do not store above 30ºC.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud sildil ja karbil pärast EXP.
English: - Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
Estonian: - Kuna deferiprooni kasutamisest põhjustatud neutropeenia mehhanism ei ole teada, ei tohi patsiendid kasutada neutropeeniaga seostatavaid ravimeid või ravimeid, mis võivad põhjustada agranulotsütoosi (vt lõik 4.5).
English: Provide protective isolation and if clinically indicated, admit patient to the hospital.
Estonian: Isoleerige patsient ja kliinilise näidustuse olemasolul hospitaliseerige.
English: The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Estonian: Kõige tõsisemaks Ferriproxi kõrvaltoimeks on vere valgeliblede (neutrofiilide) arvu kahanemine väga madalale tasemele.
English: After first opening use within 50 days.
Estonian: Pärast esmast avamist kasutada 50 päeva jooksul.
English: The amount of Ferriprox that you take will depend on your weight.
Estonian: Teile vajalik Ferriprox'i annus sõltub teie kehakaalust.
English: Sucralose (E955)
Estonian: Päikseloojangukollane värvaine (E110) Sukraloos (E955)
English: 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.
Estonian: Avatud, randomiseerimata, paralleelrühmadega kliiniline uuring viidi läbi, et hinnata neerufunktsiooni kahjustuse mõju Ferriproxi ühekordse 33 mg/kg suukaudse annuse ohutusele, taluvusele ja farmakokineetikale.
English: Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded pregnant rats and rabbits at doses at least as low as 25 mg/kg/day.
Estonian: Deferiproon osutus teratogeenseks ja embrüotoksiliseks raua ülekoormuseta tiinetel rottidel ja küülikutel juba annuses 25 mg/kg/ööpäevas.
English: Clear, reddish orange-coloured liquid.
Estonian: Läbipaistev punakas-oranži värvi vedelik.
English: 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.
Estonian: Kui koos neutropeeniaga esineb ka infektsiooninähte, tuleb võtta analüüsid tekitaja määramiseks, panna diagnoos ja määrata ravi.
English: In females, an effect on the oestrous cycle delayed time to confirmed mating at all doses tested.
Estonian: Emaste puhul oli toime innatsüklile, mistõttu pikenes aeg kinnitatud viljastumiseni kõikide testitud annuste puhul.
English: LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
Estonian: ABIAINED Sisaldab värvainet päikseloojangukollane (E110); täpsemalt vt ravimi infolehte.
English: After first opening use within 35 days.
Estonian: Pärast esmast avamist kasutada 35 päeva jooksul .
English: This may be extended to 2 hours in fed patients.
Estonian: Pärast sööki manustamisel võib see pikeneda kuni 2 tunnini.
English: A variable amount of elimination via the faeces has been reported.
Estonian: Väljaheitega erituv kogus on varieeruv.
English: Of patients with cardiac dysfunction at first assessment, none treated with deferiprone compared with four (33%) treated with deferoxamine had worsening of their cardiac status (p=0.245).
Estonian: Esimesel hindamisel tuvastatud südame väärtalitlusega patsientidel ei esinenud nelja deferoksamiiniga ravitud patsiendi kohta (33%) mitte ühelgi deferiprooniga ravitud patsiendil südame seisukorra halvenemist (p=0,245).
English: What Ferriprox contains The active substance is deferiprone.
Estonian: Mida Ferriprox sisaldab Toimeaine on deferiproon.
English: 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.
Estonian: Et saada annust ligikaudu 75 mg kehakaalu kilogrammi kohta ööpäevas, kasutage järgnevas tabelis vastavalt patsiendi kehakaalule soovitatud suukaudse lahuse kogust.
English: Ferriprox is packaged in bottles of 100 tablets.
Estonian: Ferriprox on pakendatud purkidesse, milles on 100 tabletti.
English: Each 1000 mg tablet contains 1000 mg deferiprone.
Estonian: Iga 1000 mg tablett sisaldab 1000 mg deferiprooni.
English: Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
Estonian: Selle uuringu tulemuste põhjal ei ole neerufunktsiooni kahjustusega patsientidel vaja Ferriproxi annustamisskeemi korrigeerida.
English: PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
Estonian: RAVIMVORM JA PAKENDI SUURUS 250 ml suukaudne lahus
English: 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).
Estonian: Raua ülekoormuseta isastel ja emastel rottidel, kellele manustati deferiprooni oraalsel teel annustena kuni 75 mg/kg kaks korda päevas 28 päeva jooksul (isased (või 2 nädala jooksul (emased) enne paaritumist ja kuni surmamiseni (isased) või varase tiinuse ajal (emased), ei täheldatud mingeid mõjusid fertiilsusele ega varasele lootearengule.
English: Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2).
Estonian: Kerge, mõõduka või raske neerukahjustusega patsientidel ei ole annuse kohandamine vajalik (vt lõik 5.2).
English: Rash Urticaria
Estonian: Lööve Urtikaaria
English: Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Estonian: Merevaiguvärvi polüetüleentereftalaadist (PET) pudelid, millel on (polüpropüleenist) lapsekindel sulgur ja (polüpropüleenist) gradeeritud mõõtelusikas.
English: In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
Estonian: Rauast põhjustatud südamepuudulikkuse korral tuleb deferoksamiiniga ravile lisada Ferriprox'i annuses 75...100 mg/kg/päevas.
English: Overall, fewer Ferriprox-treated patients than deferoxamine-treated patients showed a worsening of cardiac dysfunction from first assessment to last assessment (4% vs. 20%, p=0.007).
Estonian: Kokkuvõttes tuvastati südame väärtalitluse halvenemist esimese ja viimase hindamise vahelisel perioodil Ferriproxiga ravitud patsientidel vähem kui deferoksamiiniga ravitud patsientidel (4% võrrelduna 20%m p=0,007).
English: Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
Estonian: Eurofins PROXY Laboratories B.V.
English: A serious adverse event of acute liver and renal injury was seen in one subject with moderate hepatic impairment.
Estonian: Ägeda maksa- ja neerukahjustuse tõsist kõrvaltoimet täheldati mõõduka maksakahjustusega patsiendil.
English: No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Estonian: Deferiprooni süsteemse ekspositsiooni korral neerukahjustuse olulist toimet ei täheldatud.
English: ml of oral solution (three times/day)
Estonian: annus (ml) (3 korda ööpäevas)
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Estonian: RAVIMVORM JA PAKENDI SUURUS 100 õhukese polümeerikattega tabletti
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Estonian: Suure tihedusega polüetüleenist (HDPE) pudel, millel on lapsekindel polüpropüleenist kork ja desikant.
English: Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with mildly or moderately impaired hepatic function.
Estonian: Selle uuringu tulemuste põhjal ei ole kerge või mõõduka maksakahjustusega patsientidel Ferriproxi annustamisskeemi kohandamine vajalik.
English: INFORMATION IN BRAILLE Ferriprox 1000 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) Ferriprox 1000 mg
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).
Estonian: Üks milliliiter suukaudset lahust sisaldab 100 mg deferiprooni (25 g deferiprooni 250 ml-s ja 50 g deferiprooni 500 ml-s).
English: Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Estonian: Ferriprox monoteraapia on näidustatud raua ülekoormuse korral raske talasseemiaga patsientidel, kui praegune kelaativ ravi on vastunäidustatud või ebapiisav.
English: The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.
Estonian: Ferriproxi ohutus ja farmakokineetika lõppstaadiumis neeruhaigusega patsientidel ei ole teada.
English: Do not use Ferriprox if you are breast-feeding.
Estonian: Ärge kasutage Ferriprox'i rinnaga toitmise ajal.
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Estonian: Suure tihedusega polüetüleenist (HDPE) pudel, millel on lapsekindel polüpropüleenist kork.
English: Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section
Estonian: Kuna deferiprooni kasutamisest põhjustatud neutropeenia mehhanism ei ole teada, ei tohi patsiendid kasutada neutropeeniaga seostatavaid ravimeid või ravimeid, mis võivad põhjustada agranulotsütoosi (vt lõik 4.3).
English: What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Estonian: Ferriproxi suukaudne lahus on läbipaistev punakas-oranži värvi vedelik.
English: Coating: Hypromellose, Macrogol, Titanium dioxide.
Estonian: Tableti kate: Hüpromelloos, Makrogool, Titaandioksiid.
English: Coating: Hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide.
Estonian: Tableti kate: Hüpromelloos, Hüdroksüpropüültselluloos, Makrogool, Titaandioksiid.
English: Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Estonian: Enne C-vitamiini võtmist koos Ferriproxiga pidage nõu oma arsti või apteekriga.
English: A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Estonian: Müokardi rauakoormuse kvantifitseerimisel kasutati ka magnetresonants-piltdiagnostika (MRI) meetodit T2*.
English: Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Estonian: Teavitage kohe oma arsti, kui teil tekivad infektsioonile omased sümptomid, nagu palavik, kurguvalu või gripilaadsed sümptomid.
English: 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.
Estonian: Raua ülekoormuseta loomadel täheldati tüümuse, lümfoidkoe ja testiste atroofiat ning neerupealiste hüpertroofiat ravimannuse juures 100 mg/kg/ööpäevas või rohkem
English: INFORMATION IN BRAILLE Ferriprox 500 mg
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) Ferriprox 500 mg
English: EXP After first opening use within 35 days.
Estonian: EXP Pärast esmast avamist kasutada 35 päeva jooksul.
English: EXP After first opening use within 50 days.
Estonian: EXP Pärast esmast avamist kasutada 50 päeva jooksul.
English: Neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been observed in children with standard doses of deferiprone.
Estonian: Lastel, kellele mitme aasta jooksul vabatahtlikult määrati üle kahe korra soovitatavat maksimaalannust 100 mg/kg/päevas ületav annus, on täheldatud neuroloogilisi häireid (nagu näiteks treemorid, kõndimishäired, kahekordne nägemine, lihaste tahtmatu tõmblemine, liigutuskoordinatsiooni probleemid) ning ka lastel, kes said deferiprooni standardannuseid.
English: No carcinogenicity studies in animals have been conducted with deferiprone.
Estonian: Deferiprooniga ei ole kartsinogeensuse suhtes loomkatseid läbi viidud.
English: INFORMATION IN BRAILLE Ferriprox 100 mg/ml
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) Ferriprox 100 mg/ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 500 mg deferiprone.
Estonian: TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 500 mg deferiprooni.
English: − if you have a history of agranulocytosis (very low white blood cell (neutrophil) count).
Estonian: − kui teil on esinenud agranulotsütoosi (väga väike vere valgeliblede (neutrofiilide) arv);
English: The children recovered from these symptoms after Ferriprox discontinuation.
Estonian: Pärast Ferriprox'i katkestamist lastel need sümptomid kadusid.
English: How to take Ferriprox
Estonian: Kuidas Ferriprox'i võtta
English: Hydroxypropyl cellulose
Estonian: Mikrokristalne tselluloos
English: Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
Estonian: Nende patsientide puhul tuleb deferiprooniga ravi vältel jälgida neerude ja maksa funktsiooni.
English: − If you get any side effects, talk to your doctor or pharmacist.
Estonian: − Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Estonian: Üksikutel patsientidel on deferiproonraviga seostatud plasma tsingisisalduse langust.
English: Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Estonian: Annus kehakaalu kilogrammi kohta tuleb ümardada lähima 2,5 ml-ni. Soovitatavaid annuseid kehakaalu kohta (10 kg vahedega) vt alltoodud tabelist.
English: You must use effective contraception while you are taking Ferriprox.
Estonian: Ferriproxi kasutamise ajal peate kasutama tõhusaid rasestumisvastaseid vahendeid.
English: Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2).
Estonian: Kerge või mõõduka maksakahjustusega patsientidel ei ole annuse kohandamine vajalik (vt lõik 5.2).
English: − Attached to this leaflet you will find a patient/carer reminder card. You should detach,
Estonian: − Käesolevale infolehele on lisatud patsiendi/hooldaja jaoks meelespea-kaart.
English: Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml).
Estonian: Üks milliliiter suukaudset lahust sisaldab 100 mg deferiprooni (25 g deferiprooni 250 ml-s).
English: In thalassaemia patients there is an association between liver fibrosis and iron overload and/or hepatitis C. Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal.
Estonian: Seetõttu tuleb C-hepatiiti põdevate patsientide puhul eriti hoolikalt jälgida, et raua kelaatide moodustumine oleks optimaalne.
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other.
Estonian: Õhukese polümeerikattega tabletid on valged või peaaegu valged, kapslikujulised tabletid, mille ühel küljel on sissepressitud tähis “APO” 500”, teine külg on sile.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One tablet contains 1000 mg deferiprone.
Estonian: TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 1000 mg deferiprooni.
English: Neutropenia Agranulocytosis
Estonian: Neutropeenia Agranulotsütoos
English: Sample body weights at 10 kg increments are listed.
Estonian: Kehakaal on antud 10 kg vahedega.
English: Read the package leaflet before use.
Estonian: MANUSTAMISVIIS JA -TEE Suukaudseks kasutamiseks Enne ravimi kasutamist lugege pakendi infolehte.
English: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other.
Estonian: Õhukese polümeerikattega tabletid on valged või peaaegu valged, kapslikujulised tabletid, mille ühel küljel on sissepressitud tähis “APO” 1000”, teine külg on sile.
English: Pack size of 50 tablets.
Estonian: Pakendis 50 tabletti.
English: How to store Ferriprox
Estonian: Kuidas Ferriprox'i säilitada
English: Pack size of 100 tablets.
Estonian: Pakendis 100 tableti.
English: The use of combination therapy should be considered on a case-by-case basis.
Estonian: Samaaegne kasutamine teiste rauda kelaativate ainetega Kombinatsioonravi määramisel tuleb teha otsus ainult konkreetse patsiendi osas.
English: The safety and pharmacokinetics of Ferriprox in patients with severe hepatic impairment are unknown.
Estonian: Ferriproxi ohutus ja farmakokineetika raske maksakahjustusega patsientidel ei ole teada.
English: Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement, have been reported in children in the post-marketing setting with standard doses of deferiprone.
Estonian: Turuletulekujärgselt on deferiprooni standardannust saanud lastel teatatud hüpotoonia, ebastabiilsuse, kõndimisvõimetuse ja jäsemete piiratud liikuvusega hüpertoonia juhtudest.
English: Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
Estonian: Järgige eelnevalt kirjeldatud juhendit ning ordineerige vastav ravi, näiteks granulotsüütide produktsiooni stimuleeriva faktoriga.
English: Each ml of oral solution contains 100 mg deferiprone (50 g deferiprone in 500 ml).
Estonian: Üks milliliiter suukaudset lahust sisaldab 100 mg deferiprooni (50 g deferiprooni 500 ml-s).
English: FOR WOMEN OF CHILD BEARING AGE
Estonian: VILJASTUMISEALISTELE NAISTELE!
English: MARKETING AUTHORISATION NUMBER EU/1/99/108/002
Estonian: MÜÜGILOA NUMBRID EU/1/99/108/002
English: − nausea
Estonian: Neerukahjustus
English: The levels normalised with oral zinc supplementation.
Estonian: Tsingisisaldus normaliseerus suukaudse tsingi lisamisega raviskeemi.
English: See tables below for recommended doses for body weights at 10 kg increments.
Estonian: Soovitatavaid annuseid kehakaalu kohta (10 kg vahedega) vt alltoodud tabelid.
English: Treatment with deferiprone should not be initiated if the patient is neutropenic.
Estonian: Patsientidele, kellel on diagnoositud neutropeenia, ei tohiks määrata deferiproonravi.
English: Ferriprox 1000 mg film-coated tablets deferiprone
Estonian: Ferriprox 1000 mg õhukese polümeerikattega tablett deferiproon
English: Ferriprox 500 mg film-coated tablets deferiprone
Estonian: Ferriprox 500 mg õhukese polümeerikattega tablett deferiproon
English: PC:
Estonian: Tootja:
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution deferiprone
Estonian: RAVIMPREPARAADI NIMETUS Ferriprox 100 mg/ml suukaudne lahusdeferiproon deferiproon
English: Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Estonian: Deferiprooniga ravitud patsientidel on esinenud ka artropaatiaid, mis varieerusid kergekujulisest valust ühes või mitmes liigeses kuni raskekululise artriidini.
English: 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.
Estonian: Neutropeenia diagnoosimiseks on vajalik koheselt määrata vere rakkelementide arv (CBC), sealhulgas leukotsüütide arv (WBC), neutrofiilide ja trombotsüütide arv.
English: Tablet core: Methylcellulose, crospovidone, magnesium stearate.
Estonian: Teised koostisosad on: Tableti sisu: Metüültselluloos, Krospovidoon, Magneesiumstearaat.
English: − if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Ferriprox”).
Estonian: − kui te võtate ravimeid, mis teadaolevalt põhjustavad neutropeeniat või agranulotsütoosi (vt lõik
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets deferiprone
Estonian: RAVIMPREPARAADI NIMETUS Ferriprox 500 mg õhukese polümeerikattega tabletid deferiproon
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 100 mg/ml oral solution
Estonian: RAVIMPREPARAADI NIMETUS Ferriprox 100 mg/ml suukaudne lahus.
English: NAME OF THE MEDICINAL PRODUCT Ferriprox 1000 mg film-coated tablets deferiprone
Estonian: RAVIMPREPARAADI NIMETUS Ferriprox 1000 mg õhukese polümeerikattega tabletid deferiproon
English: The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Estonian: Ravimi ööpäevane koguannus on 75 mg/ kg kehakaalu kohta.
English: Peppermint oil
Estonian: Piparmündiõli
English: Each ml of oral solution contains 100 mg deferiprone.
Estonian: Üks milliliiter suukaudset lahust sisaldab 100 mg deferiprooni.
English: 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.
Estonian: Siiski on lastel, kellele mitme aasta jooksul vabatahtlikult määrati üle 2,5 korra soovitatavat maksimaalannust 100 mg/kg/päevas ületav annus, täheldatud neuroloogilisi häireid (nagu näiteks tserebellaarsed sümptomid, diploopia, lateraalne nüstagm, psühhomotoorne pidurdus, käeliigutused ja aksiaalne hüpotoonia).
English: Immediately interrupt deferiprone if the patient experience infection.
Estonian: Kui patsiendil tekib infektsioon, tuleb otsekohe katkestada ravi deferiprooniga.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/108/004
Estonian: MÜÜGILOA NUMBER(NUMBRID) EU/1/99/108/004
English: Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Estonian: Hüpromelloos Makrogool Titaandioksiid
English: In the event of agranulocytosis, rechallenge is contraindicated.
Estonian: Agranulotsütoosi tekkimisel on ravimi korduv kasutamine vastunäidustatud.
English: Ferriprox 500 mg film-coated tablets
Estonian: Ferriprox 500 mg õhukese polümeerikattega tabletid.