FrancophonIA/ELRC3.0 huggingface dataset:
English: Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Maltese: L-iponatrimja tista' tiġi kkawżata minn sindromu ta' sekrezzjoni mhux f'loku ta' ormon anti-dijuretiku (SIADH).
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 ġurnata minn meta tkun intlaħqet xi ġrajja importanti (ta' farmakoviġilanza jew tnaqqis ta' riskju)
English: Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Maltese: Għandha tingħata attenzjoni meta duloxetine jingħata flimkien ma' sustanzi kontra l-koagulazzjoni tad-demm b'mod orali u ma' sustanzi kontra l-plejtlits minħabba riskju potenzjali akbar ta' fsada li tista' tiġi attribwita ma' interazzjoni farmakodinamika.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Maltese: Id-depressjoni hija assoċjata ma' riskju akbar ta' ħsibijiet suwiċidali, ħsara lill-persuna nnifisha, u suwiċidju (avvenimenti marbuta ma' suwiċidju).
English: Hypertension Hypertensive crisis
Maltese: Ipertensjoni Kriżi ipertensiva
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Maltese: Tagħrif minn studji kliniċi wera li hemm żieda fir-riskju ta' mġiba suwiċidali f'adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati b'antidipressivi.
English: Take special care with DULOXETINE BOEHRINGER INGELHEIM
Maltese: TAL-PRODOTT MEDIĊINALI DULOXETINE BOEHRINGER INGELHEIM
English: PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Maltese: DULOXETINE BOEHRINGER INGELHEIM 30 mg kapsuli gastro-reżistenti ibsin DULOXETINE BOEHRINGER INGELHEIM 60 mg kapsuli gastro-reżistenti ibsin
English: DULOXETINE BOEHRINGER INGELHEIM may cause a sensation of restlessness or an inability to sit or stand still.
Maltese: DULOXETINE BOEHRINGER INGELHEIM jista' jikkawża sensazzjoni ta' irrekwitezza jew linkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq.
English: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Maltese: Firien tas-sess femminil li rċevew duloxetine, qabel u waqt li kienu qed jgħamlu s-sess u fil-bidu tat-tqala, kellhom tnaqqis fil-konsum ta' l-ikel matern u fil-piż, diżordni fiċ-ċiklu oestrous, nuqqas fl-indiċi ta' twelid ta' frieħ hajjin u fis-sopravivenza tal-ferħ ta' lannimal, u dewmien biex jikbru l-frieħ f'livelli ta' espożizzjoni sistemika, stmata li hija mhux anqas mill-esponiment massimu kliniku (AUC).
English: Gastrointestinal Disorders Nausea (24.3%) Dry mouth
Maltese: Tqalligħ (24.3 %)
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
Maltese: Inibituri ta' CYP1A2: billi CYP1A2 huwa involut fil-metaboliżmu ta' duloxetine, bl-użu fl-istess ħin ta' duloxetine ma' inibituri qawwija ta' CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta' duloxetine. Fluvoxamine (100 mg darba kuljum), inibitur qawwi ta' CYP1A2, naqqas ittneħħija tal-plażma apparenti ta' duloxetine b'madwar 77% u żied b'6 darbiet l-AUCo-t .
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/011
Maltese: FIS-SUQ EU/1/08/471/011
English: What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for Before you take DULOXETINE BOEHRINGER INGELHEIM How to take DULOXETINE BOEHRINGER INGELHEIM Possible side effects
Maltese: Biex tiftakar tieħu DULOXETINE BOEHRINGER INGELHEIM, tista' ssibha aktar faċli li teħodha kuljum fl-istess ħinijiet.
English: Mania Hallucinations anger4
Maltese: Disturbi fl-għajnejn
English: Treatment of diabetic peripheral neuropathic pain in adults.
Maltese: Kura ta' uġigħ newropatiku periferiku tad-dijabete fl-adulti.
English: • blurred eyesight
Maltese: .8 Effetti mhux mixtieqa
English: Read the package leaflet before use.
Maltese: Aħżen fil-pakkett oriġinali.
English: INFORMATION IN BRAILLE DULOXETINE BOEHRINGER INGELHEIM 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE DULOXETINE BOEHRINGER INGELHEIM
English: However, the concomitant use of DULOXETINE BOEHRINGER INGELHEIM with selective, reversible MAOIs is not recommended (see section 4.4).
Maltese: Madankollu, mhux irrakkomandat l-użu fl-istess ħin ta' DULOXETINE BOEHRINGER INGELHEIM ma' MAOIs riversibbli u selettivi (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/003
Maltese: FIS-SUQ EU/1/08/471/003
English: What DULOXETINE BOEHRINGER INGELHEIM looks like and contents of the pack DULOXETINE BOEHRINGER INGELHEIM is a hard gastro-resistant capsule Each capsule of DULOXETINE BOEHRINGER INGELHEIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Maltese: Kull kapsula ta' DULOXETINE BOEHRINGER INGELHEIM fiha pritkuni ta' duloxetine hydrochloride b'kisja sabiex tipproteġihom mill-aċtu ta' l-istonku.
English: behaviour
Maltese: Iponatrimja
English: DULOXETINE BOEHRINGER INGELHEIM may be associated with sedation and dizziness.
Maltese: DULOXETINE BOEHRINGER INGELHEIM jista' jiġi assoċjat ma' sedazzjoni u sturdament.
English: Weight decrease Weight increase Creatine phosphokinase increased
Maltese: Żieda fil-piż Żieda filCreatine phosphokinase
English: PSURs
Maltese: Gastrite
English: Feeling hot Gait disturbance
Maltese: Tara sfokat Midrijażi Disturbi talvista
English: Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Maltese: Tηλ: +30 2 10 89 06 300
English: Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive episodes as well as stress urinary incontinence).
Maltese: Duloxetine huwa użat taħt trejdmarks differenti f'ħafna indikazzjonijiet (kura ta' uġigħ newropatiku tad-dijabete, episodji depressivi maġġuri kif ukoll inkontinenza ta' l-urina minħabba sforz).
English: 5Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4)
Maltese: 5Ġew irrapportati każijiet ta' formazzjoni ta' ideat suwiċidali u ta' mġiba suwiċidali waqt il-kura b'duloxetine jew ftit wara li twaqqfet il-kura (ara sezzjoni 4.4).
English: Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 69 50 50 83 09
Maltese: KG Tel: +49 (0) 69 50 50 83 09
English: Vertigo Ear pain Respiratory, thoracic and mediastinal disorders Yawning
Maltese: Duloxetine huwa metaboliżżat b'mod estensiv u l-eskrezzjoni tal-prodotti metaboliċi jsir l-aktar flurina.
English: This may be due to the noradrenergic effect of duloxetine.
Maltese: Is-sustanza attiva hi duloxetine.
English: In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Maltese: Fiż-żewġ studji, duloxetine 60mg darba kuljum u 60mg darbtejn kuljum naqqsu b'mod sinifikanti luġigħ meta mqabbla ma' plaċebo.
English: If while on DULOXETINE BOEHRINGER INGELHEIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Maltese: Jekk waqt il-kura b'DULOXETINE BOEHRINGER INGELHEIM, il-pazjent jiżviluppa sintomi ta' aġitazzjoni jew sintomi depressivi, għandu jittieħed parir mediku speċjalizzat, peress li d-depressjoni hija kundizzjoni medika serja.
English: • throat inflammation
Maltese: Palpitazzjo nijiet
English: Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Maltese: Sospensjoni tal-kura ta' duloxetine (speċjalment meta tkun f'daqqa) spiss twassal għal sintomi ta' rtirar.
English: Gastroenteritis Eructation Gastritis
Maltese: GASTRO-REŻISTENTI
English: Jaundice Hepatic failure
Maltese: Manija Alluċinazzjo nijiet
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Maltese: B'duloxetine ġew irrappurtati każi ta' ħsara fil-fwied, fosthom żidiet b'mod serju ta' enżimi tal-fwied (>10 darbiet il-limitu ta' fuq tan-normal), epatite u suffejra (ara sezzjoni 4.8).
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Maltese: Studji speċifiċi in vivo ta' interazzjoni bejn il-mediċini ma sarux.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Maltese: Jekk ifeġġu sintomi intollerabbli wara tnaqqis fid-doża jew wara sospensjoni tal-kura, jista' jiġi kkunsidrat li terġa' tinbeda id-doża preċedenti ordnata.
English: • (itchy) rash
Maltese: TWISSIJA/IET SPEĊJALI
English: It was to be available as tablets (125 mg and 250 mg).
Maltese: Kien disponibbli bħala pilloli (125 mg u 250 mg).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Mejju 2016 EMA/352428/2016 EMEA/H/C/004053
English: What is Xegafri?
Maltese: X'inhu Xegafri?
English: Xegafri is a medicine that contains the active substance rociletinib.
Maltese: Xegafri huwa mediċina li fiha s-sustanza attiva rociletinib.
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib) EMA/352428/2016
Maltese: (rociletinib) EMA/352428/2016
English: The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Xegafri, ir-rociletinib, hija inibitur tal-kinażi tat-tirożina.
English: On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.
Maltese: Fit-3 ta' Mejju 2016, Clovis Oncology UK Ltd għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għattqegħid fis-suq għal Xegafri, għall-kura ta' kanċer tal-pulmun ta' ċelloli mhux żgħar.
English: Xegafri was to be used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults who have the T790M mutation (a particular change in the gene for a protein called epidermal growth factor receptor or EGFR) and who had already been treated with EGFR-targeted therapy.
Maltese: Xegafri kellu jintuża biex jikkura tip ta' kanċer tal-pulmun imsejjaħ kanċer tal-pulmun ta' ċelloli mhux żgħar (NSCLC) fl-adulti li għandhom il-mutazzjoni T790M (bidla partikolari fil-ġene għal proteina msejħa riċettur tal-fattur tat-tkabbir epidermali jew EGFR (epidermal growth factor receptor) u li diġà ġew ikkurati b'terapija li timmira l-EGFR.
English: In addition, QT prolongation (a change in the heart's electrical activity) and cases of serious heart problems presented a safety concern.
Maltese: Barra minn hekk, il-prolongament QT (bidla fl-attività elettrika tal-qalb) u każijiet ta' problemi tal-qalb serji ppreżentaw tħassib għas-sigurtà.
English: What was Xegafri expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Xegafri?
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Xegafri (rociletinib)
English: Unlike most other tyrosine kinase inhibitors, rociletinib targets cancer cells with the T790M mutation in the EGFR gene.
Maltese: B'differenza mill-parti l-kbira tal-inibituri tal-kinażi tat-tirożina l-oħrajn, ir-rociletinib għandha fil-mira tiegħu ċelloli tal-kanċer bil-mutazzjoni T790M fil-ġene EGFR.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Xegafri could not have been approved for the treatment of NSCLC patients who have the T790M mutation.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Xegafri ma setax jiġi approvat għall-kura ta' pazjenti NSCLC li għandhom il-mutazzjoni T790M.
English: Xegafri is being investigated in two studies in 457 NSCLC patients who have the T790M mutation and had already been treated with EGFR-targeted therapy.
Maltese: Xegafri qiegħed jiġi investigat f'żewġ studji f457 pazjent b'NSCLC li għandhom il-mutazzjoni T790M u li diġà ġew ikkurati b'terapija li timmira l-EGFR. F'dawn l-istudji, Xegafri ma tqabbilx ma' xi kura oħra.
English: The data provided were too limited to enable evaluation of the effectiveness of Xegafri at this time.
Maltese: Id-dejta pprovduta kienet limitata wisq sabiex setgħet issir l-evalwazzjoni tal-effikaċja ta' Xegafri f'dan iż-żmien.
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack)
Maltese: 1 ml (100 mg/ml) 2 (2 x 1) siringi mimlijin għal-lest (pakkett multiplu)
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled pens (multipack)
Maltese: 1 ml (100 mg/ml) 2 (2 x 1) pinen mimlijin għal-lest (pakkett multiplu)
English: 2 pre-filled syringes + 2 safety needles
Maltese: 2 siringi diġa' mimlija + 2 safety needles
English: 1 pre-filled syringe + 1 safety needle
Maltese: Siringa diġa' mimlija + 1 safety needle
English: Invented name Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: Viale Certosa 130 Milano 20156 Italy
Maltese: Viale Certosa 130 Milano 20156
English: Einsteinova 25
Maltese: s r.o. Einsteinova 25
English: 2794-003 Carnaxide Portugal
Maltese: 2794-003 Carnaxide Portugal ls-Slovakkja
English: D-07745 Jena Germany
Maltese: D-07745
English: Bayer Austria GmbH Herbststrasse 6-10 1160 Wien Austria
Maltese: Bayer Austria GmbH Herbststrasse 6-10 1160
English: Jenapharm GmbH & Co. KG Otto-Schott-Str. 15
Maltese: KG Otto-Schott-Str. 15
English: Berlipharm BV.
Maltese: Berlipharm
English: s r.o.
Maltese: S.L.
English: Marketing authorisaton holder
Maltese: Id-Detentur talAwtorizzazzjoni għattqegħid fis-suq
English: List of the names, pharmaceutical form, strength of the medicinal product(s), route of administration, marketing authorisation holders in the member states
Maltese: Anness I Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodott(i) mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: 178, Berlin D-13342
Maltese: Bayer Pharma AG Müllerstr. 178, Berlin D-13342
English: Czech Republic
Maltese: Jena Germany
English: Annex I
Maltese: Il-Ġermanja
English: (EU) MA number Invented name
Maltese: Numru MA (UE) Isem ivvintat
English: Target species
Maltese: Speċijiet filmira
English: Route of administration
Maltese: Mod kif għandu jingħata
English: EMA/452944/2015 EMEA/H/C/003834
Maltese: EMEA/H/C/003834
English: Raxone is a ‘hybrid medicine'.
Maltese: Raxone huwa ‘mediċina ibrida'.
English: Raxone contains the active substance idebenone.
Maltese: Raxone fih is-sustanza attiva idebenone.
English: The reference medicine for Raxone is Mnesis (45 mg tablets).
Maltese: Il-mediċina ta' referenza għal Raxone hija Mnesis (pilloli ta' 45 mg).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Raxone jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Raxone.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Raxone.
English: The full EPAR and risk management plan summary for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Raxone is a medicine used to treat visual impairment in adults and adolescents aged 12 years and over with Leber's hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight.
Maltese: Raxone huwa mediċina li tintuża fil-kura ta' adulti u adoloxxenti li għandhom 12-il sena u aktar b'indeboliment viżwali b'newropatija ottika ereditarja ta' Leber (LHON), marda li tintiret, ikkaratterizzata minn telf progressiv tal-vista.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Raxone contains idebenone at a different strength.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda Raxone fih idebenone f'qawwa differenti.
English: Other information about Raxone
Maltese: Informazzjoni oħra dwar Raxone
English: Raxone has been investigated in one main study involving 85 patients with LHON, in which it was compared with placebo (a dummy treatment) over 24 weeks.
Maltese: Raxone ġie investigat fi studju ewlieni wieħed li involva 85 pazjent b'LHON, li fih ġie mqabbel ma' plaċebo (kura finta) fuq perjodu ta' 24 ġimgħa.
English: Why is Raxone approved?
Maltese: Għaliex ġie approvat Raxone?
English: What information is still awaited for Raxone?
Maltese: Liema informazzjoni għadha mistennija għal Raxone?
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Maltese: Pazjenti affettwati b'LHON għandhom mutazzjonijiet (difetti) fil-materjal ġenetiku tal-mitokondriji.
English: Raxone is available as 150 mg tablets, and the recommended dose is two tablets taken three times a day with food.
Maltese: Raxone huwa disponibbli bħala pilloli ta' 150 mg, u d-doża rakkomandata hija ta' żewġ pilloli meħudin tliet darbiet kuljum mal-ikel.
English: Furthermore, some patients who were classified as ‘off chart' (unable to read any letters on the chart) at the beginning of the study were able to read at least one line during the eye test after treatment, and this was also considered clinically important.
Maltese: Barra minn hekk, xi pazjenti li kienu kklassifikati bħala ‘off chart' (mhux kapaċi jaqraw ebda ittra mit-tabella) fil-bidu talistudju kienu kapaċi jaqraw tal-anqas linja waħda waqt it-test tal-għajnejn wara l-kura, u dan ġie kkunsidrat bħala klinikament importanti wkoll.
English: Additional supportive data on the benefits of Raxone came from an expanded access program through which Raxone was made available to individual patients not participating in a clinical study, and from a case record survey, which included data from patients with LHON who did not receive any treatment.
Maltese: Dejta ta' appoġġ addizzjonali dwar il-benefiċċji ta' Raxone ġiet minn programm ta' aċċess estiż li bih Raxone sar disponibbli għal pazjenti individwali li mhux qegħdin jipparteċipaw fi studju kliniku, u stħarriġ tar-rekords tal-każ, li inkluda dejta minn pazjenti b'LHON li ma rċevewx kura.
English: Because the number of patients with Leber's hereditary optic neuropathy is low, the disease is considered ‘rare', and Raxone was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 February 2007.
Maltese: Minħabba l-għadd ta' pazjenti li jbatu minn newropatija ottika ereditarja ta' Leber, il-marda hija kkunsidrata bħala ‘rari', u fil-15 ta' Frar 2007, Raxone ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari).
English: The most common side effects with Raxone (which may affect more than 1 in 10 people) are nasopharyngitis and cough; mild to moderate diarrhoea and back pain are also common (affecting up to 1 in 10 people).
Maltese: L-effetti sekondarji l-aktar komuni b'Raxone (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma nażofarinġite u sogħla; dijarea ħafifa sa moderata u uġigħ fid-dahar huma komuni wkoll (jaffettwaw sa 1 minn kull 10).
English: Additionally, 30% of patients treated with Raxone (16 out of 53) had a clinically relevant recovery of vision in at least one eye, compared with 10% of patients (3 out of 29) in the placebo group.
Maltese: Barra minn hekk, 30% tal-pazjenti kkurati b'Raxone (16 minn 53) kellhom irkupru klinikament rilevanti tal-viżjoni f'tal-anqas għajn waħda, meta mqabbel ma' 10% tal-pazjenti (3 minn 29) fil-grupp tal-plaċebo.
English: Raxone has been authorised under ‘exceptional circumstances'.
Maltese: Raxone ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: The active substance in Raxone, idebenone, is an anti-oxidant agent that acts on mitochondria (the structures inside cells that produce the energy necessary for cells to function).
Maltese: Is-sustanza attiva f'Raxone, l-idebenone, hija aġent anti-ossidant li jaġixxi fuq il-mitokondriji (listrutturi fiċ-ċelloli li jipproduċu l-enerġija neċessarja sabiex ikunu jistgħu jiffunzjonaw iċ-ċelloli).
English: What are the risks associated with Raxone?
Maltese: X'inhuma r-riskji assoċjati ma' Raxone?
English: A risk management plan has been developed to ensure that Raxone is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Raxone jintuża bl-aktar mod sigur possibbli.
English: For the full list of all side effects and restrictions with Raxone, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Raxone, ara l-fuljett ta' tagħrif.
English: Idebenone is thought to help improve production of energy by restoring mitochondrial function, thereby preventing the cellular damage and the loss of sight seen in LHON.
Maltese: Idebenone huwa maħsub li jgħin itejjeb il-produzzjoni ta' enerġija billi jirrestawra l-funzjoni mitokondrijali, b'hekk jipprevjeni ħsara ċellulari u t-telf ta' viżjoni li tidher f'LHON.
English: By the end of the study, patients treated with Raxone were able to read on average 3 to 6 letters more compared with patients receiving placebo.
Maltese: Sal-aħħar tal-istudju, il-pazjenti kkurati b'Raxone kienu kapaċi jaqraw medja ta' 3 sa 6 ittri iktar meta mqabbel ma' pazjenti li kienu qegħdin jirċievu plaċebo.
English: Since Raxone has been approved under exceptional circumstances, the company that markets Raxone will conduct additional studies on the long-term effects and safety of Raxone, and will establish and maintain a registry of LHON patients treated with Raxone.
Maltese: Billi Raxone ġie approvat f'ċirkostanzi eċċezzjonali, il-kumpanija li tqiegħed Raxone fis-suq ser twettaq studji addizzjonali fuq l-effetti fit-tul u s-sigurtà ta' Raxone, u ser tistabbilixxi u żżomm reġistru ta' pazjenti b'LHON ikkurati b'Raxone.
English: This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.
Maltese: Dan ifisser li l-mitokondriji ma jaħdmux sew biex jiġġeneraw l-enerġija, u jipproduċu forom tossiċi talossiġenu (radikali liberi), li jagħmlu ħsara liċ-ċelloli tan-nervituri fl-għajn li huma meħtieġa għallviżjoni.
English: What measures are being taken to ensure the safe and effective use of Raxone?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Raxone?
English: 10 (2 x 5) pre-filled pens
Maltese: 10 (2 x 5) pinen mimlijin għal-lest
English: 1 pre-filled pen
Maltese: Pakkett li jmiss mal-prodott
English: EU Procedure number Invented name Strength Pharmaceutical Form
Maltese: Isem inventat Qawwa Għamla farmaċewtika
English: - The active substance is perflutren.
Maltese: Is-sustanza attiva hi perflutren.