FrancophonIA/ELRC3.0 huggingface dataset:
English: By reducing the production of uric acid, Febuxostat Krka can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Slovenian: Z zmanjševanjem tvorbe sečne kisline lahko zdravilo Febuksostat Krka zniža njeno koncentracijo v krvi in jo vzdržuje na nizki ravni ter tako ustavi kopičenje kristalov.
English: Febuxostat Krka contains the active substance febuxostat and is a ‘generic medicine'.
Slovenian: Zdravilo Febuksostat Krka vsebuje učinkovino febuksostat in je „generično zdravilo“.
English: What is Febuxostat Krka and what is it used for?
Slovenian: Kaj je zdravilo Febuksostat Krka in za kaj se uporablja?
English: Febuxostat Krka is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Slovenian: Zdravilo Febuksostat Krka se uporablja za zdravljenje odraslih z dolgotrajno hiperurikemijo (visokimi koncentracijami sečne kisline ali urata v krvi).
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Therefore, the Agency's view was that, as for Adenuric, the benefit of Febuxostat Krka outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je agencija menila, da koristi zdravila Febuksostat Krka, enako kot pri zdravilu Adenuric, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
English: How is Febuxostat Krka used?
Slovenian: Kako se zdravilo Febuksostat Krka uporablja?
English: Febuxostat Krka treatment should not be stopped if an attack of gout occurs.
Slovenian: V primeru zagona protina se zdravljenje z zdravilom Febuksostat Krka ne sme prekiniti.
English: The active substance in Febuxostat Krka, febuxostat, reduces the formation of uric acid.
Slovenian: Učinkovina v zdravilu Febuksostat Krka, febuksostat, zmanjša tvorjenje sečne kisline.
English: Other information about Febuxostat Krka
Slovenian: Druge informacije o zdravilu Febuksostat Krka
English: How does Febuxostat Krka work?
Slovenian: Kako zdravilo Febuksostat Krka deluje?
English: For example in the morning at breakfast, with lunch at mid-day and with dinner in the evening.
Slovenian: Na primer, zjutraj ob zajtrku, opoldne pri kosilu in zvečer pri večerji.
English: This may cause allergic reactions.
Slovenian: To lahko povzroči alergijske reakcije.
English: The registry should also be used to generate data on long-term effectiveness.
Slovenian: Register je treba uporabiti tudi za ustvarjanje podatkov o dolgotrajni učinkovitosti.
English: Date of first authorisation: 8 September 2015
Slovenian: Datum pridobitve: 8. september 2015
English: Patients should be regularly monitored according to local clinical practice.
Slovenian: Bolnike je treba redno spremljati skladno z lokalno klinično prakso.
English: When needed, supportive symptomatic treatment should be given.
Slovenian: Po potrebi je treba nuditi podporno simptomatsko zdravljenje.
English: EAP and CRS
Slovenian: EAP in CRS
English: - Take the tablets at the same time of day each day.
Slovenian: - Tablete vsak dan vzemite ob istem času.
English: This can lead to some improvement in lost eyesight.
Slovenian: To lahko nekoliko izboljša izgubljen vid.
English: Take the next dose at the usual time.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: The safety of idebenone in pregnant women has not been established.
Slovenian: Varnosti idebenona pri nosečnicah niso dokazali.
English: Exclusion of this patient yielded similar results as in the ITT population; as could be expected, the difference between idebenone and placebo arm was slightly larger.
Slovenian: Izključitev tega bolnika je dala podobne rezultate kot v populaciji ITT; kot je bilo pričakovati, je bila razlika med skupinama z idebenonom in placebom rahlo večja.
English: Studies in rats have shown that idebenone is excreted into maternal milk.
Slovenian: Študije na podganah so pokazale, da se idebenon izloča v materino mleko.
English: - This eye problem is inherited - this means it runs in families.
Slovenian: - Ta težava z očmi je dedna, kar pomeni, da se prenaša v družini.
English: This change in colour is harmless - it does not mean your treatment needs to change.
Slovenian: Ta sprememba barve je neškodljiva, tj. zdravljenja ni treba spreminjati.
English: Change in urine colour
Slovenian: Sprememba barve urina
English: There is no specific antidote for idebenone.
Slovenian: Ni specifičnega antidota za idebenon.
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).
Slovenian: Pogostnost je opredeljena na naslednji način: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This will take into account the benefit of breast-feeding to the child and the benefit of the medicine for you.
Slovenian: Pri tem bo upošteval korist dojenja za otroka in korist zdravila za vas.
English: No data are available in these populations.
Slovenian: Pri teh skupinah bolnikov podatki niso na voljo.
English: Analysis according to Mixed Model of Repeated Measures
Slovenian: Analiza v skladu z mešanim modelom ponovljenih meritev.
English: The recommended dose is 2 tablets three times a day - this is a total of 6 tablets per day.
Slovenian: Priporočeni odmerek je 2 tableti trikrat na dan (skupno 6 tablet na dan).
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.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Caution should be exercised to ensure that the chromaturia does not mask changes of colour due to other reasons (e.g. renal or blood disorders).
Slovenian: Potrebno je pozorno spremljanje za zagotovitev, da kromaturija ne prikrije sprememb barve zaradi drugih vzrokov (npr. ledvičnih ali krvnih bolezni).
English: This effect is harmless, not associated with haematuria, and does not require any adaptation of dose or discontinuation of treatment.
Slovenian: Ta učinek je neškodljiv, ni povezan s hematurijo in ne zahteva nobenega prilagajanja odmerka ali prekinitve zdravljenja.
English: Food increases the bioavailability of idebenone by approximately 5-7-fold and therefore, Raxone should always be administered with food.
Slovenian: Hrana poveča biološko uporabnost idebenona za približno 5-7-krat, zato je treba zdravilo Raxone vedno uporabljati skupaj s hrano.
English: No report of overdose has been received from the RHODOS study.
Slovenian: V študiji RHODOS niso prejeli nobenega poročila o prevelikem odmerjanju.
English: - Swallow the tablets whole with a glass of liquid.
Slovenian: - Tablete pogoltnite cele s kozarcem tekočine.
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.
Slovenian: To zdravilo se ne sme uporabljati pri otrocih, saj ni znano, ali je zdravilo Raxone varno oziroma učinkuje pri bolnikih, mlajših od 12 let.
English: - It is caused by a problem with your genes (called a “genetic mutation”) that affects the ability of cells in the eye to produce the energy they need to work normally, so they become inactive.
Slovenian: - Povzroča jo težava z geni (imenovana »genska mutacija«), ki prizadene sposobnost celic v očesu za tvorbo energije, potrebne za njihovo normalno delovanje, zato te celice postanejo neaktivne.
English: What you need to know before you take Raxone 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Raxone 3.
English: QS6+QS6 represented 6.45% to 9.46%, whereas QS10+QS10-C and IDE+IDE-C were close to 1% or below.
Slovenian: QS6+QS6 je predstavljal od 6,45% do 9,46 %, medtem ko sta QS10+QS10-C in IDE+IDE-C predstavljala približno 1 % ali manj.
English: - He or she may do a urine check to make sure the change in colour is not hiding other problems.
Slovenian: - Opravil bo preiskavo urina in se prepričal, da sprememba barve ne prikriva drugih težav.
English: There are no data concerning the effect of exposure to idebenone on human fertility.
Slovenian: Podatkov o učinku izpostavljenosti idebenonu na plodnost pri človeku ni.
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja.
English: Treatment with Raxone can restore the ability of cells to produce energy and so allow inactive eye cells to work again.
Slovenian: Zdravljenje z zdravilom Raxone lahko ponovno vzpostavi sposobnost celic za tvorbo energije, kar omogoča ponovno delovanje neaktivnih očesnih celic.
English: - Take the tablets with food - this helps to get more of the medicine from your stomach into your blood.
Slovenian: - Tablete vzemite skupaj s hrano, saj to izboljša prenos tega zdravila iz želodca v kri.
English: However, the change in colour could mean that you have problems with your kidneys or bladder.
Slovenian: Vendar lahko sprememba barve pomeni težave z ledvicami ali sečnim mehurjem.
English: The tablets should not be broken or chewed.
Slovenian: Tablete se ne smejo prelomiti ali žvečiti.
English: In addition, no induction of CYP1A2, CYP2B6 or CYP3A4 was observed.
Slovenian: Poleg tega niso opazili indukcije CYP1A2, CYP2B6 ali CYP3A4.
English: Doses up to 2250 mg/day have been administered in clinical studies showing a safety profile consistent with that reported in section 4.8.
Slovenian: V kliničnih študijah so uporabili odmerke do 2250 mg/dan in pokazali, da je varnostni profil skladen z varnostnim profilom, opisanim v poglavju 4.8.
English: Idebenone is not a substrate for p-gp in vitro.
Slovenian: Idebenon ni substrat za p-gp in vitro.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake „Uporabno do“.
English: Some medicine may interact with Raxone.
Slovenian: Nekatera zdravila lahko medsebojno delujejo z zdravilom Raxone.
English: The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).
Slovenian: Priporočeni odmerek je 900 mg idebenona na dan (300 mg trikrat na dan).
English: Experimental data have shown that idebenone passes the blood-brain barrier and is distributed at significant concentrations in cerebral tissue.
Slovenian: Porazdelitev Eksperimentalni podatki so pokazali, da idebenon prehaja skozi krvno-možgansko pregrado in se s pomembnimi koncentracijami porazdeli v možganskem tkivu.
English: Idebenone should only be administered to pregnant women or women of child-bearing age likely to become pregnant if it is considered that the benefit of the therapeutic effect outweighs any potential risk.
Slovenian: Idebenon se sme pri nosečnicah ali ženskah v rodni dobi, za katere je verjetno, da bodo zanosile, uporabljati samo, če zdravnik presodi, da je korist terapevtskega učinka večja od katerega koli morebitnega tveganja.
English: The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Raxone pri bolnikih, mlajših od 12 let, še nista bili dokazani.
English: Raxone should be administered with food because food increases the bioavailability of idebenone.
Slovenian: Zdravilo Raxone je treba jemati skupaj s hrano, saj ta poveča biološko uporabnost idebenona.
English: What Raxone is and what it is used for 2.
Slovenian: Kaj je zdravilo Raxone in za kaj ga uporabljamo 2.
English: Interim reports should be provided at the time of annual reassessments.
Slovenian: Vmesna poročila je treba predložiti v času letnih ponovnih ocen.
English: The main metabolites in plasma are IDE-C and QS4+QS4-C.
Slovenian: Glavna presnovka v plazmi sta IDE-C and QS4+QS4-C.
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).
Slovenian: Rezultati so prikazani v preglednici 2, vključno s podpornimi podatki 62 bolnikov z LHON, ki so uporabljali zdravilo Raxone v programu z razširjenim dostopom (EAP), in 94 nezdravljenih bolnikov v analizi poročil o primerih (CRS).
English: In RHODOS a total of 85 LHON patients, 14-66 years of age, with any of the 3 primary mtDNA mutations (G11778A, G3460A or T14484C) and disease duration of not more than 5 years were enrolled.
Slovenian: V študijo RHODOS so vključili skupno 85 bolnikov z LHON, starih 14-66 let, s katero koli od 3 primarnih mutacij mtDNA (G11778A, G3460A or T14484C) in trajanjem bolezni, krajšim od 5 let.
English: Neither idebenone nor its metabolites showed time-dependent pharmacokinetics.
Slovenian: Pri idebenonu in njegovih presnovkih niso ugotovili od časa odvisne farmakokinetike.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 12 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 12 mesecih po pridobitvi dovoljenja za promet.
English: Whilst clinical trials experience in paediatrics with LHON is limited to patients of 14 years of age and above, pharmacokinetic data from population pharmacokinetic studies, which included paediatric Friedreich's Ataxia patients of age 8 years and above, did not reveal any significant differences in the pharmacokinetics of idebenone.
Slovenian: Medtem ko so izkušnje iz kliničnih preskušanj pri pediatričnih bolnikih z LHON omejene na bolnike, stare 14 let ali več, farmakokinetični podatki iz farmakokinetičnih študij populacij, ki so vključevale pediatrične bolnike s Friedrichovo ataksijo, stare 8 let in več, niso pokazali nobenih pomembnih razlik v farmakokinetiki idebenona.
English: Table 1: RHODOS: Best recovery of VA and change in best VA from baseline to week 24
Slovenian: Preglednica 1: RHODOS: najboljša povrnitev VA in sprememba v najboljši VA od izhodišča do 24. tedna
English: According to this biochemical mode of action, idebenone may re-activate viable-but-inactive retinal ganglion cells (RGCs) in LHON patients.
Slovenian: Glede na ta biokemični način delovanja lahko idebenon ponovno aktivira viabilne, vendar neaktivne retinalne ganglijske celice (RGC) pri bolnikih z LHON.
English: In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg.
Slovenian: V farmakokinetičnih študijah faze I so sorazmerno povečanje koncentracij idebenona v plazmi opazili pri odmerkih od 150 do 1050 mg.
English: Reports to be provided at the time of annual re-assessment
Slovenian: Poročila je treba predložiti v času letnih ponovnih ocen.
English: If you forget a dose, skip the missed dose.
Slovenian: Če ste pozabili vzeti odmerek, preskočite izpuščeni odmerek.
English: Each bottle contains 180 tablets.
Slovenian: Ena plastenka vsebuje 180 tablet.
English: Therefore, a decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Slovenian: Torej se je treba odločiti med prenehanjem dojenja in prenehanjem zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Due date of final report: 31 August 2021
Slovenian: 31. avgust 2021
English: In this small subgroup of patients (n=8), 0 of 6 patients in the idebenone group deteriorated to ≥1.0 logMAR whereas 2 of 2 patients in the placebo group showed such a deterioration.
Slovenian: V tej majhni podskupini bolnikov (n = 8) se je poslabšanje VA ≥ 1,0 logMAR pojavilo pri 0 od 6 bolnikov v skupini z idebenonom in 2 od 2 bolnikov v skupini s placebom.
English: Table 2: Proportion of patients with clinically relevant recovery of VA after 6 months from baseline
Slovenian: Preglednica 2: delež bolnikov s klinično pomembno povrnitvijo VA od izhodišča do 6. meseca
English: Talk to your doctor or pharmacist before taking Raxone if: - you have any blood, liver or kidney problems.
Slovenian: Pred začetkom jemanja zdravila Raxone se posvetujte z zdravnikom ali farmacevtom: - če imate težave s krvjo, jetri ali ledvicami.
English: Raxone film-coated tablets should be swallowed whole with water.
Slovenian: Filmsko obložene tablete zdravila Raxone je treba pogoltniti cele in z vodo.
English: Other medicines and Raxone
Slovenian: Druga zdravila in zdravilo Raxone
English: One patient in the placebo group presented with ongoing spontaneous recovery of vision at baseline.
Slovenian: Pri enem bolniku v skupini s placebom so ob izhodišču ugotovili trajajočo spontano povrnitev vida.
English: - The active substance is idebenone.
Slovenian: - Zdravilna učinkovina je idebenon.
English: The following side effect may happen with this medicine:
Slovenian: Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki:
English: Excipients with known effect: Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow (E110).
Slovenian: Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 46 mg laktoze (v obliki monohidrata) in 0,23 mg sončno rumenega barvila (E110).
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).
Slovenian: Pri večkratnem odmerjanju se največje koncentracije idebenona v plazmi dosežejo v povprečno 1 uri (mediana 0,67 h, razpon:
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.
Slovenian: Neintervencijska varnostna študija v obdobju trženja (PASS): za dodatno proučitev varnosti zdravila Raxone pri zdravljenju bolnikov z LHON mora imetnik dovoljenja za promet z zdravilom ustvariti podatke na podlagi dogovorjenega protokola iz registra o izpostavljenosti zdravila pri bolnikih, ki so jim v klinični praksi predpisali zdravilo Raxone za zdravljenje LHON.
English: After oral administration of Raxone, idebenone is rapidly absorbed.
Slovenian: Po peroralni uporabi zdravila Raxone se idebenon hitro absorbira.
English: Contents of the pack and other information What Raxone contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Raxone
English: Caution is advised in treatment of patients with hepatic or renal impairment (see section 4.4).
Slovenian: Pri zdravljenju bolnikov z jetrno ali ledvično okvaro je treba biti previden (glejte poglavje 4.4).
English: If you have been told by your doctor that you have lactose intolerance or that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate laktoze oziroma ne prenašate ali presnavljate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
English: Raxone has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Raxone nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Data from in vitro studies have demonstrated that idebenone and its metabolite QS10 do not exert systemic inhibition of cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4 at clinically relevant concentrations of idebenone or QS10.
Slovenian: Podatki iz študij in vitro so pokazali, da idebenon in njegov presnovek QS10 ne povzročata sistemske inhibicije izooblik CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 in 3A4 citokroma P450 pri klinično pomembnih koncentracijah idebenona ali QS10.
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).
Slovenian: Glavni sekundarni opazovani dogodek »sprememba najboljše VA« so merili kot razliko med najboljšo VA v levem ali desnem očesu po 24 tednih v primerjavi z izhodiščem
English: Idebenone shows a high first pass metabolism resulting in conjugates of idebenone (glucuronides and sulphates (IDE-C)) and the Phase I metabolites QS10, QS6, and QS4 as well as their corresponding Phase II metabolites (glucuronides and sulphates (QS10+QS10-C, QS6+QS6-C, QS4+QS4-C)).
Slovenian: Pri idebenonu so ugotovili veliko presnovo pri prvem prehodu, kar ustvari konjugate idebenona (glukuronide in sulfate (IDE-C)), presnovke faze I QS10, QS6 ter QS4 in njihove ustrezajoče presnovke faze II (glukuronide in sulfate (QS10+QS10-C, QS6+QS6-C, QS4+QS4-C)).
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.
Slovenian: Z vnaprej opredeljeno analizo v študiji RHODOS so določili delež bolnikov z očesom z izhodiščno VA ≤ 0,5 logMAR, pri katerih se je VA poslabšala na ≥ 1,0 logMAR.
English: logMAR -0.135 ± 0.041 logMAR -0.071 ± 0.053 logMAR -0.064, 3 letters (-0.184; 0.055) p=0.291
Slovenian: logMAR -0,135 ± 0,041 logMAR -0,071 ± 0,053 logMAR -0,064, 3 črke (-0,184; 0,055) p = 0,291
English: logMAR -0.035 ± 0.046 logMAR 0.085 ± 0.060 logMAR -0.120, 6 letters (-0.255; 0.014) p=0.078
Slovenian: logMAR -0,035 ± 0,046 logMAR 0,085 ± 0,060 logMAR -0,120, 6 črke (-0,255; 0,014) p = 0,078
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.
Slovenian: V kliničnih preskušanjih Friedrichove ataksije je 32 bolnikov, starih od 8 do 11 let, in 91 bolnikov, starih od 12 do 17 let, prejemalo idebenon v odmerku ≥ 900 mg/dan do 42 mesecev.
English: After a single or repeated oral dose of 750 mg Raxone, QS4+QS4-C were the most prominent idebenone-derived metabolites in urine, representing on average between 49.3% and 68.3% of the total administered dose.
Slovenian: Po enkratnem ali večkratnem odmerku 750 mg zdravila Raxone je bil prevladujoči presnovek idebenona v urinu QS4+QS4-C, ki je prdstavljal med 49,3 in 68,3 % skupnega uporabljenega odmerka.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Raxone.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Raxone was given as 3 daily doses of 300 mg each with meals.
Slovenian: Zdravilo Raxone se je dajalo v obliki 3 dnevnih odmerkov po 300 mg skupaj z obroki.
English: The metabolites of idebenone are coloured and may cause chromaturia, i.e. a reddish-brown discoloration of the urine.
Slovenian: Presnovki idebenona so obarvani, zato lahko povzročijo kromaturijo, tj. rdečerjavo obarvan urin.