FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the CMDh considered that a minor change was necessary to the wording proposed in Sections 4.2 and 4.6 of the Summary of Product Characteristics (SmPC) and Section 2 of the Package Leaflet (PL), in order to facilitate the practical implementation at the National level, taking into account the range of combination products included in the procedure.
Maltese: Madankollu, is-CMDh qies li kien hemm il-ħtieġa ta' tibdil żgħir fil-formolazzjoni tal-kliem propost fisSezzjonijiet 4.2 u 4.6 tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) u fis-Sezzjoni 2 tal-Fuljett ta' Tagħrif (PL), sabiex tiġi ffaċilitata l-implimentazzjoni prattika fil-livell Nazzjonali, b'kunsiderazzjoni talfirxa ta' prodotti ta' kombinazzjoni inklużi fil-proċedura.
English: All codeine containing medicinal products approved for the treatment of cough and/or cold in paediatric population, including single and combination products authorised in the European Union are included in this review.
Maltese: Il-prodotti mediċinali kollha li fihom il-kodeina, approvati għall-kura ta' sogħla u/jew ta' riħ fil-popolazzjoni pedjatrika, fosthom prodotti individwali u kkombinati awtorizzati flUnjoni Ewropea huma inklużi f'dan ir-rieżami.
English: Further to consideration of all data available at that time, the PRAC concluded that codeine remained an effective analgesic for the treatment of acute moderate pain in children above 12 years of age which is not considered to be relieved by other analgesics.
Maltese: Wara li qies id-data kollha disponibbli dak iż-żmien, il-PRAC ikkonkluda li l-kodeina baqgħet analġeżiku effettiv għall-kura ta' uġigħ moderat akut fit-tfal ta' aktar minn 12-il sena li mhuwiex meqjus li jittaffa b'analġeżiċi oħrajn.
English: Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Maltese: Konklużjonijiet xjentifiċi u spjegazzjoni dettaljata tar-raġunijiet xjentifiċi għad-differenzi mir-rakkomandazzjoni tal-PRAC
English: The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Maltese: L-MAH għandu jipprovdi dejta adegwata u sodisfaċenti li tikkonferma l-bijoekwivalenza tal-prodott tagħhom mal-prodott ta' referenza fi żmien sena mid-deċiżjoni tal-Kummissjoni Ewropea.
English: The National Competent Authorities of Member States shall ensure that the following conditions are fulfilled by the MAH:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu ssodisfati mill-MAH:
English: Conditions for lifting the suspension of the Marketing Authorisations
Maltese: Anness
English: Further information on Febuxostat Krka can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/febuxostat-krka.
Maltese: Aktar informazzjoni dwar Febuxostat Krka tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/febuxostat-krka.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20
English: Febuxostat Krka contains the active substance febuxostat and is a ‘generic medicine'.
Maltese: Krka fih is-sustanza attiva febuxostat u huwa ‘mediċina ġenerika'.
English: Febuxostat Krka is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Maltese: Krka jiġi bħala pilloli (80 u 120 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Febuxostat Krka is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Maltese: Krka jintuża f'pazjenti li jkollhom sinjali ta' akkumulazzjoni ta' kristalli, inkluż l-artrite gotta (uġigħ u infjammazzjoni fil-ġogi) jew tofi, (‘ġebla', depożiti akbar ta' kristalli tal-urat li jistgħu jikkawżaw ħsara fil-ġogi u fl-għadam).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Krka.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użijiet approvati bil-mediċina ta' referenza, Adenuric, u ma għandhomx għalfejn jiġu ripetuti għal Febuxostat Krka.
English: Febuxostat Krka is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Maltese: Krka jintuża wkoll għall-kura u għall-prevenzjoni ta' livelli għoljin ta' aċidu uriku fid-demm f'adulti b'kanċer fid-demm li jkunu qed jingħataw kimoterapija (mediċini għall-kura tal-kanċer) u li jkunu qegħdin f'riskju tas-sindromu tat-tumur ta' lisi (kumplikazzjoni kkawżata mit-tkissir ta' ċelloli talkanċer li jikkawża żieda f'salt tal-aċidu uriku fid-demm li tista' tikkawża ħsara lill-kliewi).
English: How does Febuxostat Krka work?
Maltese: Kif jintuża Febuxostat Krka?
English: This usually reduces blood uric acid levels within 2 weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after 2 to 4 weeks.
Maltese: Dan normalment inaqqas il-livelli ta' aċidu uriku fid-demm fi żmien ġimagħtejn, iżda d-doża tista' tiżdied għal 120 mg darba kuljum jekk il-livelli ta' aċidu uriku fid-demm jibqgħu għoljin (‘il fuq minn 6 mg kull deċilitru) wara perjodu ta' bejn ġimagħtejn u erba' ġimgħat.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Febuxostat Krka has been shown to have comparable quality and to be bioequivalent to Adenuric.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Febuxostat Krka wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Adenuric.
English: As for all medicines, data on the use of Febuxostat Krka are continuously monitored.
Maltese: Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: Why is Febuxostat Krka authorised in the EU?
Maltese: Għaliex Febuxostat Krka ġie awtorizzat fl-UE?
English: Because Febuxostat Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Febuxostat Krka huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
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.
Maltese: Billi jnaqqas il-produzzjoni tal-aċidu uriku, Febuxostat Krka jista' jbaxxi l-livelli ta' aċidu uriku fid-demm u jżommhom baxxi, u jwaqqaf il-kristalli milli jakkumulaw.
English: EAP and CRS
Maltese: EAP u CRS
English: Responders (N, %) 16 (30.2 %)
Maltese: Rispondituri (N, %) 16 (30.2 %)
English: Responders (N, %) 19 (30.6 %)
Maltese: Rispondituri (N, %) 19 (30.6 %)
English: - The active substance is idebenone.
Maltese: - Is-sustanza attiva hija idebenone.
English: The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).
Maltese: Id-doża rakkomandata hija ta' 900 mg/day idebenone (300 mg, 3 darbiet kuljum).
English: Due date of final report: 31 August 2021
Maltese: Data mistennija tarrapport finali: 31 ta' Awwissu 2021
English: logMAR -0.035 ± 0.046 logMAR 0.085 ± 0.060 logMAR -0.120, 6 letters (-0.255; 0.014) p=0.078
Maltese: 035 ± 0.046 logMAR 0.085 ± 0.060 logMAR -0.120, 6 ittri (-0.255; 0.014) p=0.078
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone K25
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone K25
English: Gastrointestinal disorders Diarrhoea
Maltese: Disturbi gastrointestinali Dijarea
English: Tablet film-coating: macrogol, poly(vinyl alcohol), talc, titanium dioxide, sunset yellow (E110).
Maltese: Kisi b'rita tal-pillola: macrogol, poly(vinyl alcohol), talc, dijossidu tat-titanju, sunset yellow (E110).
English: Endpoint (ITT)
Maltese: Punt ta' tmiem (ITT)
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, magnesium stearate and colloidal silica.
Maltese: Il-qalba tal-pillola: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, magnesium stearate u colloidal silica.
English: Best recovery of VA (mean ± SE; 95%CI)
Maltese: L-aqwa rkupru ta' VA (medja ± SE; 95%CI)
English: QS6+QS6 represented 6.45% to 9.46%, whereas QS10+QS10-C and IDE+IDE-C were close to 1% or below.
Maltese: QS6+QS6 irrappreżentaw 6.45% sa 9.46%, filwaqt li QS10+QS10-C
English: Main secondary endpoint: Change in best VA (mean ± SE; 95% CI)
Maltese: Punt ta' tmiem sekondarju ewlieni: Bidla fl-aqwa VA (medja ± SE; 95% CI)
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.
Maltese: Dożi sa 2250 mg/jum ġew amministrati fi studji kliniċi u wrew profil ta' sigurtà konsistenti ma' dak irrapportat fis-sezzjoni 4.8.
English: After oral administration of Raxone, idebenone is rapidly absorbed.
Maltese: Wara amministrazzjoni orali ta' Raxone, idebenone jiġi assorbit malajr.
English: In vivo idebenone is a mild inhibitor of CYP3A4.
Maltese: Idebenone in vivo huwa inibitur ħafif ta' CYP3A4.
English: The main metabolites in plasma are IDE-C and QS4+QS4-C.
Maltese: Il-metaboliti ewlenin fil-plażma huma IDE-C u QS4+QS4-C.
English: In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg.
Maltese: Fi studji farmakokinetiċi ta' fażi I, żiediet proporzjonali filkonċentrazzjonijiet ta' idebenone fil-plażma ġew osservati b'dożi minn 150 mg sa 1050 mg.
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.
Maltese: Data minn studji in vitro uriet li idebenone u l-metabolit tiegħu QS10 ma jagħmlux inibizzjoni sistemika tal-isoforom CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 u 3A4 taċ-ċitokrom P450 f'konċentrazzjonijiet ta' idebenone jew QS10 klinikament relevanti.
English: Placebo (N=29)
Maltese: Plaċebo (N = 29)
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.
Maltese: F'RHODOS u l-EAP f'LHON, total ta' 3 pazjenti bejn l-etajiet ta' 9 u 11-il sena u 27 pazjent bejn letajiet ta' 12 u 17-il sena rċevew idebenone f'900 mg/jum sa massimu ta' 33 xahar.
English: Pharmacotherapeutic group: Psychoanaleptics, Other psychostimulants and nootropics; ATC code: N06BX13
Maltese: Psikoanalettiċi, Psikostimulanti u nootropiċi oħra; kodiċi ATC:
English: RHODOS Placebo (N=29)
Maltese: RHODOS Plaċebo (N=29)
English: Clinical safety and efficacy of idebenone in LHON have been assessed in one double-blind, randomised, placebo-controlled study (RHODOS).
Maltese: Is-sigurtà u l-effikaċja klinika ta' idebenone f'LHON ġew evalwati fi studju wieħed double-blind, randomizzat, u kkontrollat bi plaċebo (RHODOS).
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.
Maltese: F'RHODOS, b'kollox ġew reklutati 85 pazjent b'LHON, tal-età ta' 14-66 sena, bi kwalunkwe waħda mit-3 mutazzjonijiet primarji tal-mtDNA (G11778A, G3460A jew T14484C) u tul tal-marda ta' mhux iktar minn 5 snin.
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.
Maltese: Fi provi kliniċi f'Atassja ta' Friedreich, 32 pazjent bejn l-età ta' 8 snin u 11-il sena u 91 pazjent bejn l età ta' 12-il sena u 17-il sena rċevew idebenone f'≥ 900 mg/jum sa massimu ta' 42 xahar.
English: CARTONS/ HDPE BOTTLE LABEL
Maltese: KARTUN/ TIKKETTA TAL-FLIXKUN HDPE
English: Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia
Maltese: Agranuloċitosi, anemija, lewkoċitopenija, tromboċitopenija, newtropenija
English: Nausea, vomiting, anorexia, dyspepsia
Maltese: Dardir, rimettar, anoressija, dispepsija
English: Clinical particulars 4.1 Therapeutic indications
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: 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.
Maltese: Wara għoti ripetut, is-Cmax u l-AUC ta' midazolam żdiedu bi 28% u bi 34%, rispettivament, meta midazolam ingħata flimkien ma' 300 mg ta'
English: In addition, no induction of CYP1A2, CYP2B6 or CYP3A4 was observed.
Maltese: Barra minn hekk, ma ġiet osservata ebda induzzjoni ta' CYP1A2, CYP2B6 jew CYP3A4.
English: Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gammalutamyltransferase increased, blood bilirubin increased, hepatitis
Maltese: Żieda fl-alanine aminotransferase, żieda flaspartate aminotransferase, żieda fl-alkaline phosphatase tad-demm, żieda fil-lactate dehydrogenase tad-demm, żieda fil-gamma lutamyltransferase, żied fil-bilirubin tad demm, epatite
English: Primary endpoint:
Maltese: Punt tat-tmiem primarju:
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).
Maltese: Ir-raggruppament tal-frekwenzi huma definiti fil-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux magħruf (ma tistax tiġi stmata mid-data disponibbli).
English: Azotaemia, chromaturia
Maltese: Ażotemija, kromaturja
English: - Raxone contains lactose (a type of sugar).
Maltese: - Raxone fih lattosju (tip ta' zokkor).
English: Other medicines and Raxone
Maltese: Mediċini oħra u Raxone
English: Date of first authorisation: 8 September 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta 'Settembru 2015
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.
Maltese: Wara doża orali waħda jew ripetuta ta' 750 mg ta' Raxone, QS4+QS4-C kienu l-iktar metaboliti derivati minn idebenone prominenti fl-awrina, u rrappreżentaw medja ta' bejn 49.3% u
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva.
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).
Maltese: F'dożaġġ ripetut, ilkonċentrazzjonijiet massimi ta' idebenone fil-plażma jintlaħqu bħala medja fi żmien siegħa (medda medjana ta' 0.67 siegħa: 0.33-2.00 h).
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)).
Maltese: Idebenone juri metaboliżmu tal-ewwel passaġġ għoli li jirriżulta f'konjugati ta' idebenone (glucuronides u sulfati (IDE-C)) u metaboliti tal-Fażi I QS10, QS6, u QS4 kif ukoll il-metaboliti ta' Fażi
English: CRS-untreated (N=94)
Maltese: CRS-mhux ikkurati (N=94)
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: Rash, pruritus
Maltese: irrekwitezza, mejt
English: Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus,
Maltese: Għalhekk, sottostrati ta' CYP3A4 magħrufa li għandhom indiċi terapewtiku dejjaq bħal alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus jew alkalojdi tal-ergotina (ergotamine, dihydroergotamine) għandhom jingħataw b'kawtela f'pazjenti li jkunu qegħdin jirċievu idebenone.
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.
Maltese: Pillola miksija-b'rita oranġjo, tonda, bikonvessa b'dijametru ta' 10 mm, imnaqqxa bil-logo ta' Santhera fuq naħa u b''150' fuq in-naħa l-oħra.
English: Raxone contains lactose.
Maltese: Raxone fih lattosju.
English: Raxone 150 mg film-coated tablets idebenone
Maltese: Raxone 150 mg pilloli miksijin b'rita idebenone
English: Each bottle contains 180 tablets.
Maltese: Kull flixkun fih 180 pillola.
English: logMAR -0.135 ± 0.041 logMAR -0.071 ± 0.053 logMAR -0.064, 3 letters (-0.184; 0.055) p=0.291
Maltese: 064, 3 ittri (-0.184; 0.055) p=0.291
English: Idebenone is not a substrate for p-gp in vitro.
Maltese: In vitro idebenone mhuwiex sottostrat għal p-gp.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Raxone.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, id-defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu Raxone.
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.
Maltese: Data minn studju ta' interazzjoni bejn il-mediċini fuq 32 voluntier b'saħħithom tindika li fl-ewwel jum ta' amministrazzjoni orali ta' 300 mg ta' idebenone tliet darbiet kuljum, il-metaboliżmu ta' midazolam, sottostrat ta' CYP3A4, ma kienx modifikat meta ż-żewġ mediċini ngħataw flimkien.
English: Raxone contains lactose and sunset yellow (E110)
Maltese: Raxone fih lattosju u sunset yellow (E110)
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.
Maltese: Fi studju ta' follow-up osservazzjonali b'vista waħda ta' RHODOS, l-evalwazzjonijiet tal-VA minn 58 pazjent miksubin fuq medja ta' 131 ġimgħa wara t-twaqqif tal-kura indikaw li l-effett ta' Raxone jista'
English: - Raxone is supplied in white plastic bottles.
Maltese: - Raxone jiġi fi fliexken tal-plastik bojod.
English: Chromaturia
Maltese: Kromaturja
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.
Maltese: Attwalment id-data disponibbli hija deskritta fit-taqsimiet 5.1 u 5.2 iżda ma tista'
English: Some medicine may interact with Raxone.
Maltese: Xi mediċini jistgħu jinteraġixxu ma' Raxone.
English: The recommended dose is 2 tablets three times a day - this is a total of 6 tablets per day.
Maltese: Kemm għandek tieħu Id-doża rrakkomandata hija ta' 2 pilloli tliet darbiet kuljum (dan huwa total ta' 6 pilloli kuljum).
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.
Maltese: Filwaqt li l-esperjenza mill-provi kliniċi f'pedjatriċi b'LHON hija limitata għal pazjenti ta' 14-il sena ‘l fuq, data farmakokinetika minn studji tal-farmakokinteika tal-popolazzjoni, li inkludiet pazjenti pedjatriċi b'Atassja ta' Friedreich ta' 8 snin ‘il fuq, ma żvelatx differenzi sinifikanti filfarmakokinetiċi ta' idebenone.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Neither idebenone nor its metabolites showed time-dependent pharmacokinetics.
Maltese: La idebenone u lanqas il-metaboliti tiegħu ma wrew farmakokinetiċi dipendenti fuq il-ħin.
English: Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
Maltese: Aċċessjoni, delirju, alluċinazzjonijiet, aġitazzjoni, diskinesja, iperkinesja, poriomania, sturdament, uġigħ ta' ras,
English: Idebenone may inhibit P-glycoprotein (p-gp) with possible exposure increases of e.g. dabigatran etexilate, digoxin or aliskiren.
Maltese: Idebenone jista' jinibixxi P-glikoproteina (p-gp) b'żieda fl-esponiment possibbli ta' eż. dabigatran etexilate, digoxin jew aliskiren.
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).
Maltese: Raxone huwa indikat għall-kura ta' vista batuta f'adolexxenti u f'pazjenti adulti b'Newropatija Ottika Ereditarja ta' Leber (LHON)
English: There is no specific antidote for idebenone.
Maltese: Ma jeżisti ebda antidotu speċifiku għal idebenone.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Table 2: Proportion of patients with clinically relevant recovery of VA after 6 months from baseline
Maltese: Tabella 2 Proporzjon ta' pazjenti b'irkupru ta' VA klinikament relevanti wara 6 xhur mil-linja bażi
English: Very common (may affect more than 1 in 10 people): - nasopharyngitis (cold) - cough
Maltese: Komuni ħafna (tista' taffettwa aktar minn persuna waħda minn kull 10 persuni): - nasofarinġite (riħ) - sogħla
English: Each film-coated tablet contains 150 mg idebenone.
Maltese: Kull pillola miksija b'rita fiha 150 mg idebenone.
English: Idebenone, a short-chain benzoquinone, is an anti-oxidant assumed to be capable of transferring electrons directly to complex III of the mitochondrial electron transport chain, thereby circumventing complex I and restoring cellular energy (ATP) generation under experimental conditions of complex I deficiency.
Maltese: Idebenone, benzoquinone b'katina qasira, huwa anti-ossidant li huwa preżunt li kapaċi jittrasferixxi elettroni direttament għall-kumpless III tal-katina ta' trasport tal-elettroni mitokondrijali, b'hekk jevita kumpless I u jirrestawra l-ġenerazzjoni ta' enerġija ċellulari (ATP) taħt kundizzjonijiet sperimentali ta'
English: Nasopharyngitis
Maltese: IL-ĠERMANJA