FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration of Raxone, idebenone is rapidly absorbed.
Croatian: Nakon peroralne primjene lijeka Raxone, idebenon se brzo apsorbira.
English: Depending on the time since symptom onset and the proportion of RGCs already affected, idebenone can promote recovery of vision in patients who experience vision loss.
Croatian: Ovisno o vremenu od nastupa simptoma i udjelu već zahvaćenih retinalnih ganglijskih stanica, idebenon može potaknuti oporavak vida u bolesnika koji su iskusili gubitak vida.
English: This will take into account the benefit of breast-feeding to the child and the benefit of the medicine for you.
Croatian: Pri donošenju odluke uzet će se u obzir korist dojenja za dijete i korist lijeka za vas.
English: logMAR -0.135 ± 0.041 logMAR -0.071 ± 0.053 logMAR -0.064, 3 letters (-0.184; 0.055) p=0.291
Croatian: logMAR -0,135 ± 0,041 logMAR -0,071 ± 0,053 logMAR -0,064, 3 slova (-0,184; 0,055) p=0,291
English: Main secondary endpoint: Change in best VA (mean ± SE; 95% CI)
Croatian: Glavna sekundarna mjera ishoda: Promjena u najboljoj oštrini vida (srednja vrijednost ± SE; 95%CI)
English: According to this biochemical mode of action, idebenone may re-activate viable-but-inactive retinal ganglion cells (RGCs) in LHON patients.
Croatian: Sukladno ovom biokemijskom načinu djelovanja, idebenon može ponovno aktivirati vijabilne, no neaktivne retinalne ganglijske stanice u bolesnika s LHON-om.
English: logMAR -0.035 ± 0.046 logMAR 0.085 ± 0.060 logMAR -0.120, 6 letters (-0.255; 0.014) p=0.078
Croatian: logMAR -0,035 ± 0,046 logMAR 0,085 ± 0,060 logMAR -0,120, 6 slova (-0,255; 0,014) p=0,078
English: Excipients with known effect: Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow (E110).
Croatian: Pomoćne tvari s poznatim učinkom: jedna filmom obložena tableta sadrži 46 mg laktoze (u obliku hidrata) i 0,23 mg boje sunset yellow (E110).
English: Gastrointestinal disorders Diarrhoea
Croatian: Gastrointestinalni poremećaji
English: Raxone has no or negligible influence on the ability to drive and use machines.
Croatian: Raxone ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Data from a drug-drug interaction study in 32 healthy volunteers indicate that on the first day of oral administration of 300 mg idebenone t.i.d., the metabolism of midazolam, a CYP3A4 substrate, was not modified when both drugs were administered together.
Croatian: Podaci iz ispitivanja interakcija lijekova u 32 zdrava dobrovoljca pokazuju da prvog dana peroralne primjene 300 mg idebenona tri puta na dan, metabolizam midazolama, supstrata CYP3A4, nije bio izmijenjen kada su oba lijeka bila primijenjena zajedno.
English: Table 2: Proportion of patients with clinically relevant recovery of VA after 6 months from baseline
Croatian: Tablica 2: Udio bolesnika s klinički relevantnim oporavkom oštrine vida nakon 6 mjeseci od početne vrijednosti
English: Metabolism occurs by means of oxidative shortening of the side chain and by reduction of the quinone ring and conjugation to glucuronides and sulphates.
Croatian: Metabolizam se odvija putem oksidativnog skraćivanja bočnog lanca te redukcijom kinonskog prstena i konjugacijom u glukuronide i sulfate.
English: White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.
Croatian: Bijele boce od polietilena visoke gustoće s bijelim polipropilenskim zatvaračem sigurnim za djecu s evidencijom otvaranja sadrže 180 filmom obloženih tableta.
English: If you take more Raxone than you should
Croatian: Ako uzmete više lijeka Raxone nego što biste trebali
English: Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Croatian: (≥ 1/100 do < 1/10), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Due date of final report: 31 August 2021
Croatian: 31. kolovoza 2021.
English: Raxone contains sunset yellow (E110) which may cause allergic reactions.
Croatian: Raxone sadrži boju sunset yellow (E110) koja može izazvati alergijske reakcije.
English: Clinical particulars 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvnog i limfnog sustava
English: Raxone was given as 3 daily doses of 300 mg each with meals.
Croatian: Raxone se primjenjivao kao doza od 300 mg 3 puta dnevno, a svaka se doza primjenjivala uz obrok.
English: Idebenone may inhibit P-glycoprotein (p-gp) with possible exposure increases of e.g. dabigatran etexilate, digoxin or aliskiren.
Croatian: Idebenon može inhibirati P-glikoprotein (p-gp) s mogućim povećanjima u izloženosti, primjerice dabigatraneteksilatu, digoksinu ili aliskirenu.
English: Non-interventional post-authorisation safety study (PASS): In order to further investigate the safety of Raxone in the treatment of LHON patients, the MAH should generate data based on an agreed protocol from a drug exposure registry of patients prescribed Raxone for the treatment of LHON in clinical practice.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS): Kako bi se dalje istražila sigurnost primjene lijeka Raxone u liječenju bolesnika s LHON-om, nositelj odobrenja treba generirati podatke na temelju dogovorenog protokola iz registra izloženosti lijeku bolesnika kojima je propisan lijek Raxone za liječenje LHON-a u kliničkoj praksi.
English: The main secondary endpoint “change in best VA” was measured as the difference between best VA in either the left or right eye at 24 weeks compared to baseline (Table 1).
Croatian: Glavna sekundarna mjera ishoda "promjena u najboljoj oštrini vida" izmjerena je kao razlika između najbolje oštrine vida bilo lijevog ili desnog oka u 24. tjednu u odnosu na početnu vrijednost (Tablica 1).
English: Azotaemia, chromaturia
Croatian: Azotemija, kromaturija
English: In a single-visit observational follow-up study of RHODOS VA assessments from 58 patients obtained on average 131 weeks after discontinuation of treatment indicates that the effect of Raxone may be maintained.
Croatian: U opservacijskom ispitivanju praćenja nakon RHODOS-a,temeljenom na jednom posjetu, određivanja oštrine vida u 58 bolesnika prikupljena u prosjeku 131 tjedan nakon prekida liječenja ukazuju da učinak lijeka Raxone može biti održan.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V..
English: Caution is advised in treatment of patients with hepatic or renal impairment (see section 4.4).
Croatian: Savjetuje se oprez u liječenju bolesnika s oštećenjem funkcije jetre ili bubrega (vidjeti dio 4.4).
English: The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain.
Croatian: Najčešće prijavljene nuspojave idebenona bile su blagi do umjereni proljev (najčešće nije zahtijevao prekid liječenja), nazofaringitis, kašalj i bol u leđima.
English: The European Medicines Agency will review any new information which may become available every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: - Raxone contains lactose (a type of sugar).
Croatian: - Raxone sadrži laktozu (vrsta šećera).
English: Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved with the Santhera logo on one side and ‘150' on the other side.
Croatian: Narančasta, okrugla, bikonveksna filmom obložena tableta promjera 10 mm, s utisnutim Santhera logom s jedne strane i oznakom "150" s druge strane.
English: Fax: +49 (0) 7621 1690 201
Croatian: Faks: +49 0 7621 1690 201
English: CRS-untreated (N=94)
Croatian: CRS-neliječeni (N=94)
English: Table 1: RHODOS: Best recovery of VA and change in best VA from baseline to week 24
Croatian: Tablica 1: RHODOS: Najbolji oporavak oštrine vida i promjena u najboljoj oštrini vida od početne vrijednosti do 24. tjedna
English: Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gammalutamyltransferase increased, blood bilirubin increased, hepatitis
Croatian: Povišena alanin aminotransferaza, povišena asparatat aminotransferaza, povišena alkalna fosfataza u krvi, povišena laktat dehidrogenaza u krvi, povišena gamaglutamiltransferaza, povišen bilirubin u krvi, hepatitis
English: The metabolites of idebenone are coloured and may cause chromaturia, i.e. a reddish-brown discoloration of the urine.
Croatian: Metaboliti idebenona su obojani i mogu uzrokovati kromaturiju, odnosno obojati urin u crvenkastosmeđu boju.
English: Raxone may make your urine become reddish brown.
Croatian: Raxone može promijeniti boju urina tako da urin postane crveno-smeđe boje.
English: In clinical trials in Friedreich's Ataxia, 32 patients between the ages of 8 and 11 years and 91 patients between the ages of 12 and 17 years received idebenone at ≥ 900 mg/day for up to 42 months.
Croatian: U kliničkim ispitivanjima Friedreichove ataksije, 32 bolesnika u dobi između 8 i 11 godina te 91 bolesnik u dobi između 12 i 17 godina primili su idebenon u dozi od ≥ 900 mg/dan tijekom razdoblja od najviše 42 mjeseca.
English: - Your doctor will prescribe Raxone to you only if the benefits of the treatment are greater than the risks to the unborn child. - Raxone may pass into the mother's milk.
Croatian: - Liječnik će Vam propisati Raxone samo ako su koristi liječenja veće od rizika za nerođeno dijete.
English: A post-hoc responder analysis was performed in RHODOS evaluating the proportion of patients who had a clinically relevant recovery of VA from baseline in at least one eye, defined as either: (i) improvement in VA from unable to read a single letter to able to read at least 5 letters on the ETDRS chart; or (ii) improvement in VA by at least 10 letters on the ETDRS chart.
Croatian: Post-hoc analiza bolesnika koji su odgovorili na liječenje provedena je u ispitivanju RHODOS pri čemu je procijenjen udio bolesnika koji su imali klinički relevantan oporavak oštrine vida u odnosu na početnu vrijednost u najmanje jednom oku, što je definirano kao: (i) poboljšanje oštrine vida od nemogućnosti čitanja nijednog slova do mogućnosti čitanja najmanje 5 slova s ETDRS ploče; ili (ii)
English: Tablet film-coating: macrogol, poly(vinyl alcohol), talc, titanium dioxide, sunset yellow (E110).
Croatian: Film ovojnica tablete: makrogol, poli(vinilni alkohol), talk, titanijev dioksid, boja sunset yellow (E110).
English: CARTONS/ HDPE BOTTLE LABEL
Croatian: KUTIJE/NALJEPNICE NA HDPE BOCI
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza kod primjene
English: feeling restless, lacking energy - nausea, vomiting, loss of appetite, stomach ache - high levels of some liver enzymes in the body which mean you have liver problems - shown in tests, high levels of “bilirubin” - this can make your skin and the whites of your eyes look yellow, hepatitis - rash, itching - pain in extremity - high levels of nitrogen in the blood - shown in tests change in urine colour - generally feeling unwell
Croatian: osjećaj nemira, manjak energije - mučnina, povraćanje, gubitak apetita, bol u želucu - visoke razine određenih jetrenih enzima u tijelu što znači da imate problema s jetrom - utvrđeno pretragama, visoke razine "bilirubina" - koji može uzrokovati žutilo kože i bjeloočnica, hepatitis - osip, svrbež - bol u udovima - visoke razine dušika u krvi - utvrđeno pretragama, promjena u boji urina
English: If you stop taking Raxone
Croatian: Ako prestanete uzimati Raxone
English: Talk to your doctor or pharmacist before taking Raxone if: - you have any blood, liver or kidney problems.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Raxone ako:
English: Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber's Hereditary Optic Neuropathy (LHON).
Croatian: Idebenon se koristi za liječenje oštećenja vida u odraslih osoba i adolescenata s bolešću oka koja se naziva Leberova nasljedna optička neuropatija (engl.
English: How to take Raxone
Croatian: Kako uzimati Raxone
English: The primary endpoint “best recovery of visual acuity (VA)” was defined as the result from the eye experiencing the most positive improvement in VA from baseline to week 24 using ETDRS charts.
Croatian: Primarna mjera ishoda "najbolji oporavak oštrine vida" definirana je kao rezultat oka koje je imalo najpozitivnije poboljšanje u oštrini vida od početne vrijednosti do 24. tjedna mjereno primjenom ETDRS ploče.
English: The following adverse reactions emerging from clinical trials in LHON patients or reported postmarketing in other indications are tabulated below.
Croatian: Sljedeće nuspojave prijavljene u kliničkim ispitivanjima provedenima u bolesnika s LHON-om ili uslijed primjene nakon davanja odobrenja za stavljanje lijeka u promet u drugim indikacijama navedene su u tabličnom prikazu.
English: Primary endpoint:
Croatian: Primarna mjera ishoda:
English: If you forget to take Raxone
Croatian: Ako ste zaboravili uzeti Raxone
English: Germany
Croatian: NJEMAČKA
English: - Raxone contains a colourant called “sunset yellow” (also called E110).
Croatian: - Raxone sadrži bojilo naziva "sunset yellow" (također poznato pod nazivom E110).
English: In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should conduct and submit the results of an external natural history controlled, open-label intervention study to assess the efficacy and safety of Raxone in the treatment of LHON patients, including long-term treatment.
Croatian: Kako bi se dalje istražile koristi lijeka Raxone u liječenju bolesnika s LHON-om, nositelj odobrenja treba provesti i dostaviti rezultate otvorenog intervencijskog ispitivanja, eksterno kontroliranog prirodnim tijekom, kako bi se ocijenile djelotvornost i sigurnost lijeka Raxone u liječenju bolesnika s LHON-om,
English: Unknown frequency (frequency cannot be estimated from the available data): - bronchitis - changes in blood test results: low level of white blood cells, or low level of red blood cells, or low level of platelets - increased cholesterol or fat in the blood -shown in tests - fits, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited,
Croatian: Nepoznata učestalost (učestalost se ne može procijeniti na temelju dostupnih podataka): - bronhitis - promjene u rezultatima nalaza krvi: niska razina bijelih krvnih stanica, ili niska razina crvenih krvnih stanica ili niska razina krvnih pločica - povišeni kolesterol ili masnoće u krvi - utvrđeno pretragama
English: Therefore, caution should be exercised when prescribing Raxone to patients with hepatic or renal impairment.
Croatian: Stoga, lijek Raxone treba oprezno propisivati bolesnicima s oštećenjem funkcije jetre ili bubrega.
English: Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
Croatian: Napadaj, delirij, halucinacije, agitacija, diskinezija, hiperkinezija, poriomanija, omaglica, glavobolja, nemir, stupor
English: A pre-specified analysis in RHODOS determined the proportion of patients with an eye with baseline VA of ≤0.5 logMAR in whom the VA deteriorated to ≥1.0 logMAR.
Croatian: Unaprijed određenom analizom u ispitivanju RHODOS utvrđen je udio bolesnika s okom čija se oštrina vida pogoršala od početne vrijednosti od ≤0,5 logMAR na ≥1,0 logMAR.
English: This medicine should not be used in children This is because it is not known if Raxone is safe or works in patients under 12 years of age.
Croatian: Razlog tomu je što nije poznato je li Raxone siguran za primjenu i djeluje li u bolesnika mlađih od 12 godina.
English: Contains lactose and sunset yellow (E110).
Croatian: Sadrži laktozu i boju sunset yellow (E110).
English: Package leaflet: Information for the user Raxone 150 mg film-coated tablets idebenone
Croatian: Uputa o lijeku: Informacije za korisnika Raxone 150 mg filmom obložene tablete idebenon
English: Treatment should be initiated and supervised by a physician with experience in LHON.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju LHON-a.
English: On repeat dosing, maximum plasma concentrations of idebenone are reached on average within 1 hour (median 0.67 h range: 0.33-2.00 h).
Croatian: U slučaju ponovljenog doziranja, maksimalne koncentracije idebenona u plazmi postižu se u prosjeku unutar 1 sata (medijan
English: Each film-coated tablet contains 150 mg idebenone.
Croatian: Svaka filmom obložena tableta sadrži 150 mg idebenona.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, magnesium stearate and colloidal silica.
Croatian: Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, povidon K25, magnezijev stearat i koloidni silicijev dioksid.
English: Similarly, in LHON idebenone can transfer electrons directly to complex III of the electron transport chain, thereby bypassing complex I which is affected by all three primary mtDNA mutations causing LHON, and restoring cellular ATP generation.
Croatian: III lanca prijenosa elektrona, te tako zaobilazi kompleks I na kojeg utječu sve tri primarne mutacije mtDNK koje uzrokuju LHON, i uspostaviti stvaranje staničnog ATP-a.
English: 6.6 Special precautions for disposal
Croatian: 6.6 Posebne mjere zbrinjavanja
English: Nausea, vomiting, anorexia, dyspepsia
Croatian: Često Mučnina, povraćanje, anoreksija, dispepsija Nepoznato
English: Results are shown in Table 2 including supporting data from 62 LHON patients using Raxone in an Expanded Access Programme (EAP) and from 94 untreated patients in a Case Record Survey (CRS).
Croatian: Rezultati su prikazani u Tablici 2. i uključuju potporne podatke prikupljene od 62 bolesnika s LHON-om koji su primjenjivali Raxone u programu proširenog pristupa (engl.
English: What you need to know before you take Raxone Do not take Raxone if you are allergic to idebenone or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na idebenon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia
Croatian: Agranulocitoza, anemija, leukocitopenija, trombocitopenija, neutropenija
English: Common (may affect up to 1 in 10 people): - diarrhoea (mild to moderate that usually does not require discontinuation of treatment) - back pain
Croatian: - proljev (blagi do umjereni koji najčešće ne zahtijeva prekid liječenja) - bol u leđima
English: Following oral administration pharmacologically relevant concentrations of idebenone are detectable in the aqueous humor of the eye.
Croatian: Nakon peroralne primjene, u očnoj vodici mogu se otkriti farmakološki relevantne koncentracije idebenona.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 12 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Raxone Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON) (see section 5.1).
Croatian: Raxone je indiciran za liječenje oštećenja vida u adolescenata i odraslih bolesnika s Leberovom nasljednom optičkom neuropatijom (engl.
English: Raxone 150 mg film-coated tablets idebenone
Croatian: Raxone 150 mg filmom obložene tablete idebenon
English: One patient in the placebo group presented with ongoing spontaneous recovery of vision at baseline.
Croatian: Analiza u skladu s mješovitim modelom ponovljenih mjerenja Jedan bolesnik iz skupine koja je primala placebo imao je u tijeku,spontani oporavak vida na početku ispitivanja.
English: Raxone 150 mg film-coated tablets
Croatian: Raxone 150 mg filmom obložene tablete
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, especially any of the following: - antihistamines to treat allergies (astemizole, terfenadine) - to treat heartburn (cisapride) - to treat muscle and speech tics associated with Tourette syndrome (pimozide) - to treat hearth rhythm disorders (quinidine) - to treat migraine (dihydroergotamine, ergotamine) - to put you to sleep called “anaesthetics” (alfentanil) - to treat inflamation in rheumatoid arthritis and psoriasis (cyclosporine) - to prevent the rejection of an organ transplant (sirolimus, tacrolimus) - to treat strong pain called “opioids” (fentanyl)
Croatian: - antihistaminici za liječenje alergija (astemizol, terfenadin) - za liječenje žgaravice (cisaprid) - za liječenje mišićnih i govornih tikova povezanih s Touretteovim sindromom (pimozid) - za liječenje poremećaja srčanog ritma (kinidin) - za liječenje migrene (dihidroergotamin, ergotamin)
English: Raxone contains lactose and sunset yellow (E110)
Croatian: Raxone sadrži laktotzu i boju sunset yellow (E110).
English: movements that you cannot control, a tendency to wonder away, feeling dizzy, headache,
Croatian: - napadaji, osjećaj smetenosti, vidjeti ili čuti stvari koje nisu stvarne (halucinacije), osjećaj uzbuđenosti, pokreti koji se ne mogu kontrolirati, sklonost lutanju, osjećaj omaglice, glavobolja,
English: Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus,
Croatian: Stoga je supstrate CYP3A4 za koje je poznato da imaju uzak terapijski indeks, kao što su alfentanil, astemizol,
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone K25
Croatian: Jezgra tablete laktoza hidrat mikrokristalična celuloza umrežena karmelozanatrij povidon K25 magnezijev stearat koloidni silicijev dioksid
English: - Raxone film-coated tablets are orange, round tablets of 10 mm diameter, engraved with the
Croatian: - Raxone filmom obložene tablete su narančaste, okrugle tablete promjera 10 mm, s utisnutim logotipom Santhera s jedne strane i "150" s druge strane.
English: You can also report side effects directly via the national reporting system in Appendix V. By reporting side effecs you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Talk to your doctor before you stop taking this medicine.
Croatian: Prije nego što prestanete uzimati ovaj lijek morate se obratiti svom liječniku.
English: Chromaturia
Croatian: Kromaturija
English: Patients with hepatic or renal impairment have not been investigated.
Croatian: Lijek nije ispitan u bolesnika s oštećenjem funkcije jetre ili bubrega.
English: Titanium dioxide Sunset yellow FCF (E110)
Croatian: Ovojnica makrogol 3350 poli(vinilni alkohol) talk titanijev dioksid sunset yellow FCF (E110)
English: In RHODOS and the EAP in LHON, a total of 3 patients between the ages of 9 and 11 years and 27 patients between the ages of 12 and 17 years received idebenone at 900 mg/day for up to 33 months.
Croatian: godina te 27 bolesnika u dobi između 12 i 17 godina primilo je idebenon u dozi od ≥ 900 mg/dan tijekom razdoblja od najviše 33 mjeseca.