natgillin/translations-raw huggingface dataset:
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).
Potrebno je pozorno spremljanje za zagotovitev, da kromaturija ne prikrije sprememb barve zaradi drugih vzrokov (npr. ledvičnih ali krvnih bolezni).
This effect is harmless, not associated with haematuria, and does not require any adaptation of dose or discontinuation of treatment.
Ta učinek je neškodljiv, ni povezan s hematurijo in ne zahteva nobenega prilagajanja odmerka ali prekinitve zdravljenja.
Food increases the bioavailability of idebenone by approximately 5-7-fold and therefore, Raxone should always be administered with food.
Hrana poveča biološko uporabnost idebenona za približno 5-7-krat, zato je treba zdravilo Raxone vedno uporabljati skupaj s hrano.
No report of overdose has been received from the RHODOS study.
V študiji RHODOS niso prejeli nobenega poročila o prevelikem odmerjanju.
- Swallow the tablets whole with a glass of liquid.
- Tablete pogoltnite cele s kozarcem tekočine.
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.
To zdravilo se ne sme uporabljati pri otrocih, saj ni znano, ali je zdravilo Raxone varno oziroma učinkuje pri bolnikih, mlajših od 12 let.
- 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.
- 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.
What you need to know before you take Raxone 3.
Kaj morate vedeti, preden boste vzeli zdravilo Raxone 3.
QS6+QS6 represented 6.45% to 9.46%, whereas QS10+QS10-C and IDE+IDE-C were close to 1% or below.
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.
- He or she may do a urine check to make sure the change in colour is not hiding other problems.
- Opravil bo preiskavo urina in se prepričal, da sprememba barve ne prikriva drugih težav.
There are no data concerning the effect of exposure to idebenone on human fertility.
Podatkov o učinku izpostavljenosti idebenonu na plodnost pri človeku ni.
This medicinal product has been authorised under ‘exceptional circumstances'.
Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja.
Treatment with Raxone can restore the ability of cells to produce energy and so allow inactive eye cells to work again.
Zdravljenje z zdravilom Raxone lahko ponovno vzpostavi sposobnost celic za tvorbo energije, kar omogoča ponovno delovanje neaktivnih očesnih celic.
- Take the tablets with food - this helps to get more of the medicine from your stomach into your blood.
- Tablete vzemite skupaj s hrano, saj to izboljša prenos tega zdravila iz želodca v kri.
However, the change in colour could mean that you have problems with your kidneys or bladder.
Vendar lahko sprememba barve pomeni težave z ledvicami ali sečnim mehurjem.
The tablets should not be broken or chewed.
Tablete se ne smejo prelomiti ali žvečiti.
In addition, no induction of CYP1A2, CYP2B6 or CYP3A4 was observed.
Poleg tega niso opazili indukcije CYP1A2, CYP2B6 ali CYP3A4.
Doses up to 2250 mg/day have been administered in clinical studies showing a safety profile consistent with that reported in section 4.8.
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.
Idebenone is not a substrate for p-gp in vitro.
Idebenon ni substrat za p-gp in vitro.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake „Uporabno do“.
Some medicine may interact with Raxone.
Nekatera zdravila lahko medsebojno delujejo z zdravilom Raxone.
The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).
Priporočeni odmerek je 900 mg idebenona na dan (300 mg trikrat na dan).
Experimental data have shown that idebenone passes the blood-brain barrier and is distributed at significant concentrations in cerebral tissue.
Porazdelitev Eksperimentalni podatki so pokazali, da idebenon prehaja skozi krvno-možgansko pregrado in se s pomembnimi koncentracijami porazdeli v možganskem tkivu.
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.
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.
The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established.
Varnost in učinkovitost zdravila Raxone pri bolnikih, mlajših od 12 let, še nista bili dokazani.
Raxone should be administered with food because food increases the bioavailability of idebenone.
Zdravilo Raxone je treba jemati skupaj s hrano, saj ta poveča biološko uporabnost idebenona.
What Raxone is and what it is used for 2.
Kaj je zdravilo Raxone in za kaj ga uporabljamo 2.
Interim reports should be provided at the time of annual reassessments.
Vmesna poročila je treba predložiti v času letnih ponovnih ocen.
The main metabolites in plasma are IDE-C and QS4+QS4-C.
Glavna presnovka v plazmi sta IDE-C and QS4+QS4-C.
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).
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).
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.
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.
Neither idebenone nor its metabolites showed time-dependent pharmacokinetics.
Pri idebenonu in njegovih presnovkih niso ugotovili od časa odvisne farmakokinetike.
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.
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.
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 12 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 12 mesecih po pridobitvi dovoljenja za promet.
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.
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.
Table 1: RHODOS: Best recovery of VA and change in best VA from baseline to week 24
Preglednica 1: RHODOS: najboljša povrnitev VA in sprememba v najboljši VA od izhodišča do 24. tedna
According to this biochemical mode of action, idebenone may re-activate viable-but-inactive retinal ganglion cells (RGCs) in LHON patients.
Glede na ta biokemični način delovanja lahko idebenon ponovno aktivira viabilne, vendar neaktivne retinalne ganglijske celice (RGC) pri bolnikih z LHON.
In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg.
V farmakokinetičnih študijah faze I so sorazmerno povečanje koncentracij idebenona v plazmi opazili pri odmerkih od 150 do 1050 mg.
Reports to be provided at the time of annual re-assessment
Poročila je treba predložiti v času letnih ponovnih ocen.
If you forget a dose, skip the missed dose.
Če ste pozabili vzeti odmerek, preskočite izpuščeni odmerek.
Each bottle contains 180 tablets.
Ena plastenka vsebuje 180 tablet.
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.
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.
Due date of final report: 31 August 2021
31. avgust 2021
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.
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.
Table 2: Proportion of patients with clinically relevant recovery of VA after 6 months from baseline
Preglednica 2: delež bolnikov s klinično pomembno povrnitvijo VA od izhodišča do 6. meseca
Talk to your doctor or pharmacist before taking Raxone if: - you have any blood, liver or kidney problems.
Pred začetkom jemanja zdravila Raxone se posvetujte z zdravnikom ali farmacevtom: - če imate težave s krvjo, jetri ali ledvicami.
Raxone film-coated tablets should be swallowed whole with water.
Filmsko obložene tablete zdravila Raxone je treba pogoltniti cele in z vodo.
Other medicines and Raxone
Druga zdravila in zdravilo Raxone
One patient in the placebo group presented with ongoing spontaneous recovery of vision at baseline.
Pri enem bolniku v skupini s placebom so ob izhodišču ugotovili trajajočo spontano povrnitev vida.
- The active substance is idebenone.
- Zdravilna učinkovina je idebenon.
The following side effect may happen with this medicine:
Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki:
Excipients with known effect: Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow (E110).
Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 46 mg laktoze (v obliki monohidrata) in 0,23 mg sončno rumenega barvila (E110).
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).
Pri večkratnem odmerjanju se največje koncentracije idebenona v plazmi dosežejo v povprečno 1 uri (mediana 0,67 h, razpon:
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.
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.
After oral administration of Raxone, idebenone is rapidly absorbed.
Po peroralni uporabi zdravila Raxone se idebenon hitro absorbira.
Contents of the pack and other information What Raxone contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Raxone
Caution is advised in treatment of patients with hepatic or renal impairment (see section 4.4).
Pri zdravljenju bolnikov z jetrno ali ledvično okvaro je treba biti previden (glejte poglavje 4.4).
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.
Če vam je zdravnik povedal, da ne prenašate laktoze oziroma ne prenašate ali presnavljate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
Raxone has no or negligible influence on the ability to drive and use machines.
Zdravilo Raxone nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
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.
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.
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).
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
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)).
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)).
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.
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.
logMAR -0.135 ± 0.041 logMAR -0.071 ± 0.053 logMAR -0.064, 3 letters (-0.184; 0.055) p=0.291
logMAR -0,135 ± 0,041 logMAR -0,071 ± 0,053 logMAR -0,064, 3 črke (-0,184; 0,055) p = 0,291
logMAR -0.035 ± 0.046 logMAR 0.085 ± 0.060 logMAR -0.120, 6 letters (-0.255; 0.014) p=0.078
logMAR -0,035 ± 0,046 logMAR 0,085 ± 0,060 logMAR -0,120, 6 črke (-0,255; 0,014) p = 0,078
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.
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.
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.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Raxone.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Raxone was given as 3 daily doses of 300 mg each with meals.
Zdravilo Raxone se je dajalo v obliki 3 dnevnih odmerkov po 300 mg skupaj z obroki.
The metabolites of idebenone are coloured and may cause chromaturia, i.e. a reddish-brown discoloration of the urine.
Presnovki idebenona so obarvani, zato lahko povzročijo kromaturijo, tj. rdečerjavo obarvan urin.
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.
Podatki študije interakcij med zdravili pri 32 zdravih prostovoljcih kažejo, da se prvi dan peroralne uporabe 300 mg idebenona trikrat na dan presnova midazolama, substrata encima CYP3A4, pri sočasni uporabi obeh zdravil ni spremenila.
Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved with the Santhera logo on one side and ‘150' on the other side.
Oranžna, okrogla, bikonveksna filmsko obložena tableta s premerom 10 mm ter logotipom Santhera na eni strani in »150« na drugi.
CRS-untreated (N=94)
CRS-nezdravljeni (N = 94)
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Clinical particulars 4.1 Therapeutic indications
4.1 Terapevtske indikacije
- 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.
- Zdravnik vam bo zdravilo Raxone predpisal samo, če so koristi zdravljenja večje od tveganj za nerojenega otroka.
After repeated administration Cmax and AUC of midazolam were increased by 28% and 34%, respectively, when midazolam was administered in combination with 300 mg idebenone t.i.d.
Po ponavljajoči uporabi se je vrednost Cmax midazolama povečala za 28 %, AUC pa za 34 %, če so midazolam uporabljali v kombinaciji s 300 mg idebenona trikrat na dan.
Due to the high first-pass effect, the plasma concentrations of idebenone were generally only measurable up to 6 hours after oral administration of 750 mg Raxone, given either as a single oral dose or after repeated (14 days) t.i.d dosing.
Zaradi velikega učinka prvega prehoda je mogoče koncentracije idebenona v plazmi izmeriti samo do 6 ur po peroralni uporabi 750 mg zdravila Raxone v obliki enkratnega ali večkratnih (14 dni) odmerkov trikrat na dan.
What Raxone is and what it is used for
Kaj je zdravilo Raxone in za kaj ga uporabljamo
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.
V študiji RHODOS so izvedli analizo odzivnih bolnikov post hoc, s katero so ocenili delež bolnikov s klinično pomembno povrnitvijo VA od izhodišča v vsaj enem očesu, kar je bilo opredeljeno kot: (i) izboljšanje VA od nezmožnosti branja ene črke do zmožnosti branja vsaj 5 črk na lestvici ETDRS ali
Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber's Hereditary Optic Neuropathy (LHON).
Idebenon se uporablja za zdravljenje poslabšanja vida pri odraslih in mladostnikih z očesno boleznijo, imenovano Lebrova dedna optična nevropatija (LHON).
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.
Primarni opazovani dogodek »najboljša povrnitev vidne ostrine (VA- visual acuity)« je bil opredeljen kot rezultat na očesu z največjim izboljšanjem VA od izhodišča do 24. tedna, pri čemer so uporabili lestvice ETDRS.
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).
Zdravilo Raxone je indicirano za zdravljenje vidne okvare pri mladostnikih in odraslih z Leberjevo dedno optično nevropatijo (LHON- Leber's Hereditary Optic Neuropathy) (glejte poglavje 5.1).
No data regarding a continuous treatment with idebenone beyond 6 months is available from controlled clinical trials.
V nadzorovanih kliničnih preskušanjih ni nobenih podatkov o neprekinjenem zdravljenju z idebenonom, ki traja dlje kot 6 mesecev.
If you take more Raxone than you should, talk to your doctor straight away.
Če ste vzeli večji odmerek zdravila Raxone, kot bi smeli Če ste vzeli večji odmerek zdravila Raxone, kot bi smeli, se takoj posvetujte z zdravnikom.
- Do not crush or chew the tablets.
- Tablet ne smete zdrobiti ali žvečiti.
White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.
Bele plastenke iz polietilena velike gostote z belimi polipropilenskimi, za otroke varnimi navojnimi zaporkami z zaščito pred nedovoljenim odpiranjem, ki vsebujejo 180 filmsko obloženih tablet.
Pharmacotherapeutic group: Psychoanaleptics, Other psychostimulants and nootropics; ATC code: N06BX13
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Psihoanaleptiki, Drugi psihostimulansi in učinkovine za obnavljanje celic CŽS; oznaka ATC: N06BX13
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.
Povzetek varnostnega profila zdravila Najpogosteje poročani neželeni učinki idebenona so blaga do zmerna driska (ki navadno ne zahteva prekinitve zdravljenja), nazofaringitis, kašelj in bolečina v hrbtu.
The European Medicines Agency will review any new information which may become available every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
In vivo idebenone is a mild inhibitor of CYP3A4.
Idebenon je blag zaviralec CYP3A4 in vivo.
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.
58 bolnikih, ki se je izvedla povprečno 131 tednov po koncu zdravljenja, so ugotovili, da je učinek zdravila Raxone mogoče vzdrževati.
Raxone contains sunset yellow (E110) which may cause allergic reactions.
Sončno rumeno barvilo Zdravilo Raxone vsebuje sončno rumeno barvilo (E110), ki lahko povzroči alergijske reakcije.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
The main route of elimination is metabolism, with the majority of dose excreted via the kidneys as metabolites.
Glavna pot izločanja je presnova, pri čemer se večina odmerka izloči skozi ledvice v obliki presnovkov.
If you forget to take Raxone
Če ste pozabili vzeti zdravilo Raxone
Patients with hepatic or renal impairment have not been investigated.
Jetrna ali ledvična okvara Bolnikov z jetrno ali ledvično okvaro niso proučevali.
Metabolism occurs by means of oxidative shortening of the side chain and by reduction of the quinone ring and conjugation to glucuronides and sulphates.
Presnova poteka prek oksidativnega krajšanja stranske verige, manjšanja kinonskega obroča in konjugacije glukuronidov ter sulfatov.
What Raxone looks like and contents of the pack
Izgled zdravila Raxone in vsebina pakiranja
Following oral administration pharmacologically relevant concentrations of idebenone are detectable in the aqueous humor of the eye.
Po peroralni uporabi je mogoče farmakološko pomembne koncentracije idebenona zaznati v prekatni vodki očesa.