FrancophonIA/ELRC3.0 huggingface dataset:
English: It should not be used if immunemediated thrombocytopenia from structurally related active substances including quinine and mefloquine is suspected, as cross-sensitivity can occur.
Maltese: Huwa m'għandux jintuża jekk ikun hemm suspett ta' tromboċitopenija medjata b'mod immuni minn sustanzi attivi strutturalment relatati fosthom quinine u mefloquine, billi tista' sseħħ sensitività trasversali.
English: In embryo-fetal and developmental toxicity studies (rats and rabbits) with dextromethorphan hydrobromide/quinidine sulfate, abnormalities were observed at mid and high dose with reduced ossification from the lowest dose in rats which is approximately 1 and 50 times the human dose of 30/18 mg/day on a mg/m basis, respectively.
Maltese: Fi studji dwar l-effett tossiku fuq l-embriju/fetu u l-iżvilupp (firien u fniek) b'dextromethorphan hydrobromide/quinidine -sulfate, kienu osservati abnormalitajiet bid-doża tan-nofs u għolja bi tnaqqis fl-ossifikazzjoni mill-inqas doża fil-firien li hija madwar 1 u 50 darba d-doża umana ta' 30/18 mg/jum fuq bażi ta' mg/m2, rispettivament.
English: In the event of inadequate clinical response, see recommended dose titration schedule.
Maltese: F'każ ta' rispons kliniku inadegwat, ara l-iskeda rakkomandata għat-titrazzjoni tad-doża.
English: NUEDEXTA with food, drink and alcohol
Maltese: NUEDEXTA ma' ikel, xorb u alkoħol
English: Reproductive system and breast disorders General disorders and administration site conditions
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Maltese: Kapsula tal-ġelatina ħamra lewn iċ-ċlamit, daqs 1, b'“DMQ / 20-10” stampati b'linka bajda fuq ilkapsula.
English: BOTTLE CARTON (60 hard capsules) - NUEDEXTA 23 mg/9 mg capsules
Maltese: KARTUNA TAL-FLIXKUN (60 kapsula iebsa) - NUEDEXTA kapsuli ta' 23 mg/9 mg
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and memantine 20 mg/day.
Maltese: Sar studju ta' interazzjoni bejn il-mediċini bejn doża kombinata aktar għolja ta' dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) u memantine 20 mg/jum.
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and desipramine 25 mg.
Maltese: Sar studju ta' interazzjoni bejn il-mediċini bejn doża kombinata aktar għolja ta' dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) u desipramine 25 mg.
English: Studies in animals (rats and rabbits) have shown developmental toxicity, including teratogenicity and embryolethality (see section 5.3).
Maltese: Studji f'annimali (firien u fniek) urew effett tossiku fuq l-iżvilupp, inklużi teratoġeniċità u mewt tal-embriju (ara sezzjoni 5.3).
English: Chest discomfort, Chest pain, Chills, Feeling hot, Gait disturbance, Influenza like illness, Pyrexia, Oxygen
Maltese: Ippurgar mhux normali, Dispepsja, Gastrite, Ipoestesija orali, Paresteżija orali, Proktalġja, Ilsien xott
English: No pharmacodynamic interactions were apparent.
Maltese: Ma dehret l-ebda interazzjoni farmakodinamika.
English: Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
Maltese: Sinjali u sintomi oħra ta' doża eċċessiva jistgħu jinkludu rimettar, dijarea, żarżir fil-widnejn, telf tassmigħ ta' frekwenzi għolja, vertigo, vista mċajpra, vista doppja, fotofobija, uġigħ ta' ras, konfużjoni, u delirju.
English: The adverse reactions considered at least possibly related to treatment with NUEDEXTA in the placebo-controlled and the open-label extension phase of the above mentioned clinical study are listed below by body system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi kkunsidrati bħala mill-anqas possibbilment relatati mal-kura b'NUEDEXTA flistudju kkontrollat bil-plaċebo u l-fażi ta' estensjoni ta' prova miftuħa tal-istudju kliniku hawn fuq imsemmi huma elenkati hawn isfel skont is-sistema tal-klassifika tal-organi u l-frekwenza.
English: • Co-administration of a strong CYP3A4 inhibitor
Maltese: • Koamministrazzjoni ta' inibitur CYP3A4 b'saħħtu
English: Renal clearance involves both glomerular filtration and active tubular secretion, moderated by (pH-dependent) tubular reabsorption.
Maltese: It-tneħħija millkliewi tinvolvi kemm filtrazzjoni glomerulari kif ukoll sekrezzjoni tubulari attivi, moderati minn riassorbiment tubulari (dipendenti fuq il-pH).
English: The combination dose of dextromethorphan/quinidine increased steady state desipramine levels approximately 8-fold.
Maltese: Id-doża kombinata ta' dextromethorphan/quinidine żiedet il-livelli fissi ta' desipramine b'madwar 8 darbiet.
English: Two additional phase III studies were conducted using a higher dose combination of dextromethorphan 23 mg/quinidine 26 mg.
Maltese: III li fihom intużaw kombinazzjonijiet ta' dożi ogħla ta' dextromethorphan 23 mg/quinidine 26 mg.
English: Tabulated summary of adverse reactions
Maltese: Sommarju f'tabella tar-reazzjonijiet avversi
English: • Epistaxis, Pharyngolaryngeal pain, Respiratory depression, Rhinorrhoea, Yawning
Maltese: Epistassi, Uġigħ fil-farinġi u l-larinġi, Depressjoni respiratorja, Imnieħer inixxi, Titwib
English: In both studies the primary outcome measure, CNS-LS, and the secondary outcome measure, “count of episodes of laughing and crying”, were statistically significantly decreased by the dextromethorphan/quinidine combination.
Maltese: Fiż-żewġ studji, il-kejl tal-eżitu primarju, isCNS-LS, u l-kejl tal-eżitu sekondarju, l-“għadd ta' episodji ta' daħk u biki”, naqsu statistikament b'mod sinifikanti bil-kombinazzjoni ta' dextromethorphan/quinidine.
English: In extensive metabolizers, mean Cmax and AUC0-12 values of dextromethorphan and dextrorphan increased as doses of dextromethorphan increased from 15 mg to 23 mg and mean Cmax and AUC0-12 values of quinidine were similar.
Maltese: F'metabolizzaturi estensivi, il-valuri medji tas-Cmax u l-AUC0-12 ta' dextromethorphan u dextrorphan żdiedu hekk kif id-dożi ta' dextromethorphan żdiedu minn 15 mg għal 23 mg u l-valuri Cmax u AUC0-12 ta' quinidine kienu simili.
English: • certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
Maltese: • ċerti mediċini użati għall-prevenzjoni tal-emboli tad-demm f'pazjenti b'kundizzjonijiet tal-qalb u f'riskju ta' puplesija, bħal ticagrelor u dabigatran-etexilate
English: • abnormally frequent daytime urination
Maltese: • għamil tal-awrina abnormalment frekwenti matul il-ġurnata
English: Both dextromethorphan and memantine are antagonists of the N-methyl-D-aspartate (NMDA) receptor which could theoretically result in an additive effect at NMDA receptors and potentially an increased incidence of adverse reactions.
Maltese: Kemm dextromethorphan kif ukoll memantine huma antagonisti tar-riċettur N-methyl-D-aspartate (NMDA) li teoretikament jistgħu jirriżultaw f'effett addittiv fir-riċetturi NMDA u potenzjalment żieda fl-inċidenza tar-reazzjonijiet avversi.
English: Uncommon
Maltese: Ansjetà komuni
English: Metabolism of dextromethorphan is inhibited by quinidine, such that adverse reactions of overdose due to NUEDEXTA might be more severe or more persistent compared to overdose of dextromethorphan alone.
Maltese: Il-metaboliżmu ta' dextromethorphan huwa inibit mill-quinidine, b'mod li r-reazzjonijiet avversi ta' doża eċċessiva minħabba NUEDEXTA jistgħu jkunu aktar severi u aktar persistenti meta mqabbla ma' doża eċċessiva ta' dextromethorphan waħdu.
English: While therapeutic doses of quinidine for treatment of cardiac arrhythmia or malaria are generally ≥10fold higher than the dose of quinidine in this medicinal product, potentially fatal cardiac arrhythmia, including torsades de pointes, can occur at quinidine exposures that are possible from NUEDEXTA overdose.
Maltese: Filwaqt li d-dożi terapewtiċi ta' quinidine għall-kura tal-arritmija tal-qalb jew il-malarja huma ġeneralment 10 darbiet ogħla mid-doża ta' quinidine f'dan il-prodott mediċinali, tista' sseħħ arritmija kardijaka fatali, inkluż torsades de pointes, b'esponimenti għal quinidine li huma possibbli minn doża eċċessiva ta' NUEDEXTA.
English: • muscle spasms
Maltese: • Is-sustanzi attivi huma:
English: When NUEDEXTA is used with other serotoninergic medicines, the risk of “serotonin syndrome” may be increased due to pharmacodynamic interaction.
Maltese: Meta NUEDEXTA jintuża ma' mediċini serotoninerġiċi oħra, ir-riskju tas-“sindromu tas-serotonin” jista' jiżdied minħabba l-interazzjoni farmakodinamika.
English: Quinidine at higher doses has also been associated with a lupus-like syndrome involving polyarthritis, sometimes with a positive antinuclear antibody test. Other associations include rash, bronchospasm, lymphadenopathy, haemolytic anaemia, vasculitis, uveitis, angioedema, agranulocytosis, the sicca syndrome, myalgia, elevation in serum levels of skeletal-muscle enzymes, and pneumonitis.
Maltese: Assoċjazzjonijiet oħra jinkludu raxx, bronkospażmu, limfadenopatija, anemija emolitika, vaskulite, uveite, anġjoedema, agranuloċitosi, is-sindromu ta' sicca, uġigħ fil-muskoli, żieda fil-livelli tal-enzimi muskoluskeletriċi fis-serum, u pulmonite.
English: The clinical relevance of this observation to drugs that are OCT1 substrates, such as metformin, is unknown.
Maltese: Ir-relevanza klinika ta' din losservazzjoni għall-mediċini li huma substrati ta' OCT1, bħal metformin, mhijiex magħrufa.
English: There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Maltese: M'hemmx użu rilevanti ta' NUEDEXTA fil-popolazzjoni pedjatrika għall-kura sintomatika tal-effett psewdobulbari.
English: Strong and moderate CYP3A4 inhibitors should be avoided during treatment with NUEDEXTA.
Maltese: Inibituri qawwija u moderati ta' CYP3A4 għandhom jiġu evitati matul il-kura b'NUEDEXTA.
English: Uncommon Decreased appetite
Maltese: Mhux komuni Rari
English: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy.
Maltese: Kien hemm rapporti ta' epatite, inkluża epatite granulomatuża, f'pazjenti li kienu qegħdin jirċievu quinidine, ġeneralment matul l-ewwel ftit ġimgħat tat-terapija.
English: BOTTLE CARTON (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Maltese: KARTUNA TAL-FLIXKUN (60 kapsula iebsa) - NUEDEXTA kapsuli ta' 15 mg/9 mg
English: • distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
Maltese: • tibdil fis-sens tat-togħma (disgewżja), ngħas (ipersomnja), spastiċità fil-muskoli, ħass ħażin
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild or moderate hepatic impairment (as indicated by the Child-Pugh method; 6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects with moderate hepatic impairment showed similar dextromethorphan AUC and Cmax and clearance compared to healthy subjects.
Maltese: Fi studju ta' doża kombinata ta' dextromethorphan 23 mg / quinidine 26 mg darbtejn kuljum fi 12-il pazjent b'indeboliment tal-fwied ħafif jew moderat (kif indikat bil-metodu Child-Pugh; 6 kull wieħed) imqabbla ma' 9 persuni b'saħħithom (li kienu jaqblu fis-sess, l-età u l-firxa tal-piż mal-persuni b'indeboliment), il-persuni b'indeboliment moderat tal-fwied urew AUC, Cmax u tneħħija simili ta' dextromethorphan meta mqabbla mal-persuni b'saħħithom.
English: • Studies with Higher Dose Combinations of dextromethorphan / quinidine
Maltese: • Studji b'Kombinazzjonijiet ta' Dożi Ogħla ta' dextromethorphan / quinidine
English: • musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
Maltese: • ebusija muskoluskeletrika, uġigħ fil-muskoli (majalġja), uġigħ fil-għonq, uġigħ fid-dirgħajn u r riġlejn
English: The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg, twice daily.
Maltese: Id-doża massima ta' kuljum minn ġimgħa 4 'il quddiem hija NUEDEXTA 23 mg/9 mg, darbtejn kuljum.
English: NUEDEXTA contains lactose.
Maltese: NUEDEXTA fih il-lattożju.
English: The quinidine component of NUEDEXTA serves to selectively inhibit CYP2D6-dependent oxidative metabolism of dextromethorphan, thus increasing dextromethorphan plasma concentrations.
Maltese: Il-komponent ta' quinidine f'NUEDEXTA jservi biex jinibixxi b'mod selettiv il-metaboliżmu ossidattiv ta' dextromethorphan dipendenti fuq CYP2D6, u b'hekk iżid il-konċentrazzjonijiet ta' dextromethorphan fil-plażma.
English: • you experience symptoms such as palpitations or fainting, which may be a sign of heart problems.
Maltese: • ikollok sintomi bħal palpitazzjonijiet jew ħass ħażin, li jistgħu jkunu sinjal ta' problemi f'qalbek.
English: Stopping treatment may cause your symptoms to return.
Maltese: It-twaqqif tal-kura jista' jwassal għat-tfaċċar mill-ġdid tas-sintomi.
English: Because of this effect on CYP2D6, accumulation of parent drug substances and/or failure of active metabolite formation may affect the safety and/or the efficacy of medicinal products used concomitantly with NUEDEXTA that are metabolised by CYP2D6 (see section 4.5).
Maltese: Minħabba dan l-effett fuq CYP2D6, l-akkumulazzjoni ta' sustanzi tal-mediċina prinċipali u/jew in-nuqqas ta' formazzjoni ta' metaboliti attivi jistgħu jaffettwaw is-sigurtà u/jew l-effikaċja tal-prodotti mediċinali użati b'mod konkomitanti ma' NUEDEXTA li jiġu metabolizzati minn CYP2D6 (ara sezzjoni 4.5).
English: The major metabolite is 3-hydroxyquinidine, which is considered to be at least half as pharmacologically active as quinidine with respect to cardiac effects such as QT prolongation.
Maltese: Ilmetabolit prinċipali huwa 3-hydroxyquinidine, li huwa kkunsidrat li huwa farmakoloġikament attiv mill-anqas in-nofs ta' quinidine fir-rigward ta' effetti kardijaċi bħat-titwil tal-QT.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Administration of activated charcoal in conventional dose of 1 g/kg, administered every 2 to 6 hours as a slurry with 8 mL/kg of tap water may enhance the systemic elimination of quinidine; this measures should be avoided if an ileus is present.
Maltese: L-għoti ta' faħam attivat fid-doża konvenzjonali ta' 1 g/kg, mogħti kull 2 sa 6 sigħat bħala sospensjoni magħquda bi 8 mL/kg ta' ilma tal-vit jista' jtejjeb it-tneħħija sistemika talquinidine; din il-miżura għandha tiġi evitata jekk ikun preżenti ileus.
English: This test dose is adequate to represent the steady state exposure in patients with CYP2D6 extensive metabolizer phenotype.
Maltese: Din id-doża tat-test hija adegwata sabiex tirrappreżenta l-esponiment ta' stat fiss f'pazjenti b'fenotip ta' metabolizzaturi estensivi ta' CYP2D6.
English: BOTTLE LABEL (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Maltese: TIKKETTA TAL-FLIXKUN (60 kapsula iebsa) - NUEDEXTA kapsuli ta' 15 mg/9 mg
English: • diarrhoea, nausea
Maltese: Astenja, Irritabilità
English: • Abnormal faeces, Dyspepsia, Gastritis, Hypoaesthesia oral, Paraesthesia oral, Proctalgia, Tongue dry Hepatobiliary disorders Uncommon Increased hepatic enzymes (GGT, AST, ALT) Cholelithiasis, blood bilirubin increased, Liver function test
Maltese: • dwejjaq fis-sider, uġigħ fis-sider, riħ, sensazzjoni ta' sħana, disturb fil-mixja (diffikultà biex timxi), mard jixbah lill-influwenza, tnaqqis fil-livelli tal-ossiġnu fid-demm
English: • tamoxifen, used to treat or prevent some cancers
Maltese: • tamoxifen, użat għall-kura jew il-prevenzjoni ta' ċerti tipi ta' kanċer
English: • NUEDEXTA 15 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Maltese: • NUEDEXTA 15 mg/9 mg huwa kapsula ħamra tal-ġelatina lewn iċ-ċlamit, daqs 1, b'“DMQ /
English: Concomitant use of NUEDEXTA and TCAs is not recommended (see section 4.4).
Maltese: L-użu konkomitanti ta' NUEDEXTA u TCAs mhuwiex rakkomandat (ara sezzjoni 4.4).
English: The first was a 4-week study in PBA subjects with underlying ALS, and the second was a 12-week study in subjects with underlying MS.
Maltese: L-ewwel studju kien studju ta' 4 ġimgħat f'pazjenti PBA b'ALS sottostanti, u t-tieni wieħed kien studju ta' 12-il ġimgħa f'individwi b'MS sottostanti.
English: During development of this medicinal product, dose combinations of dextromethorphan/quinidine containing up to 6-times higher dextromethorphan dose and 12-times higher quinidine dose were studied.
Maltese: Waqt l-iżvilupp ta' dan il-prodott mediċinali, kienu studjati kombinazzjonijiet ta' dożi ta' dextromethorphan/quinidine li kien fihom doża sa 6 darbiet ogħla ta' dextromethorphan u doża 12-il darba ogħla ta' quinidine.
English: telithromycin, erythromycin and rifampicin
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: When taking two capsules within 24 hours, you should leave about 12 hours between doses.
Maltese: M'għandhomx jittieħdu aktar minn 2 kapsuli fi kwalunkwe perjodu ta' 24 siegħa, bi 12-il siegħa bejn kull doża.
English: In all studies, the efficacy endpoints were “Count of episodes of laughing and crying” (PBA episodes) and subject scores on the Center for Neurologic Studies - Lability Scale (CNS-LS), a validated 7-item, self-administered questionnaire that provides a quantitative measure of the frequency and severity of PBA. CNS-LS scores range from a minimum of 7 (no symptoms) to a maximum of 35.
Maltese: Fl-istudji kollha, il-punti tat-tmiem tal-effikaċja kienu l-“Għadd ta' episodji ta' daħk u biki” (episodji ta' PBA) u l-punteġġi tal-individwu fuq il-Lability Scale taċ-Ċentru għall-Istudji Newroloġiċi (CNSLS), kwestjonarju validat ta' 7 elementi li l-individwu jamministra lilu nnifsu, li jipprovdi kejl kwantitattiv tal-frekwenza u s-severità tal-PBA.
English: The most commonly reported adverse reactions are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Maltese: L-aktar reazzjonijiet avversi rrappurtati huma disturbi gastrointestinali (bħal dijarea, dardir), disturbi fis-sistema nervuża (bħal sturdament, uġigħ ta' ras, ħedla ta' ngħas) u għeja.
English: Musculoskeletal stiffness, Myalgia, Neck pain, Pain in
Maltese: Ebusija muskoluskeletrika, Uġigħ fil-muskoli, Uġigħ filgħonq, Uġigħ fl-estremità
English: In patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (Creatinine Clearance < 30 mL/min/1.73m
Maltese: F'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) jew indeboliment sever tal-kliewi (Tneħħija tal-Krejatinina < 30 mL/min/1.73m2), irriskji potenzjali assoċjati mal-użu ta' din il-mediċina għandhom jiġu valutati mal-ħtieġa medika (ara sezzjoni 5.2).
English: Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Maltese: Reazzjonijiet avversi oħra jinkludu atassja, nystagmus, distonja, vista mċajpra, u bidliet fir-riflessi talmuskoli.
English: Patients receiving concomitant treatment with thioridazine, a medicinal product that both significantly prolongs QT interval and is primarily metabolized by CYP2D6.
Maltese: Pazjenti li jkunu qegħdin jirċievu kura konkomitanti b'thioridazine, prodott mediċinali li jtawwal b'mod sinifikanti l-interval QT u huwa metabolizzat prinċipalment minn CYP2D6.
English: • Patient alert cards
Maltese: • Kards ta' twissija għall-pazjent
English: • fatigue
Maltese: Sturdament
English: Brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Maltese: Kapsula tal-ġelatina ħamra lewn iċ-ċlamit, daqs 1, b'“DMQ / 30-10” stampati b'linka bajda fuq ilkapsula u tliet faxex bojod madwar iċ-ċirkonferenza.
English: Symptoms of quinidine overdose include irregular heartbeat and low blood pressure, and may also include vomiting, diarrhoea, ringing in the ears, high-frequency hearing loss, vertigo, blurred vision, double vision, increased sensitivity of the eyes to light, headache, confusion, and delirium (characterised by loss of attention, poor memory, disorientation, impaired speech).
Maltese: Is-sintomi ta' doża eċċessiva bi quinidine jinkludu taħbita tal-qalb irregolari u pressjoni baxxa taddemm, u jistgħu jinkludu wkoll rimettar, dijarea, żarżir fil-widnejn, telf tas-smigħ ta' frekwenzi għolja, vertigo, vista mċajpra, vista doppja, żieda fis-sensittività tal-għajnejn għad-dawl, uġigħ ta' ras, konfużjoni, u delirju (ikkaratterizzat minn telf tal-attenzjoni, memorja fqira, diżorjentament, indebolimet tad-diskors).
English: Eligible patients had a diagnosis of PBA defined by episodes of involuntary, uncontrollable emotional expressions of laughing and/or crying that are incongruous or disproportionate to their emotional state or mood.
Maltese: Il-pazjenti eliġibbli kellhom dijanjosi ta' PBA definita minn episodji ta' espressjonijiet emozzjonali involontarji u mhux kontrollabbli ta' daħk u/jew biki li jkunu inkonsistenti jew sproporzjonati mal-istat emozzjonali jew il-burdata tagħhom.
English: Metabolizer (PMs).
Maltese: Mhux applikabbli.
English: • if you have a history of low levels of blood cells caused by quinidine, quinine or mefloquine (this can cause a tendency to bleed or bruise more easily than normal)
Maltese: • jekk għandek storja ta' livelli baxxi ta' ċelloli tad-demm ikkawżati minn quinidine, quinine jew mefloquine (dan jista' jikkawża tendenza ta' fsada jew tbenġil aktar malajr min-normal)
English: Given the pharmacodynamic and pharmacokinetic interactions, concomitant use of NUEDEXTA and TCAs is not recommended due to the elevated risk of serotonin syndrome (see section 4.5).
Maltese: Minħabba l-interazzjonijiet farmakodinamiċi u farmakokinetiċi, l-użu konkomitanti ta' NUEDEXTA u TCAs mhuwiex rakkomandat minħabba żżieda fir-riskju tas-sindromu tas-serotonin (ara sezzjoni 4.5).
English: How to take NUEDEXTA
Maltese: X'fih NUEDEXTA
English: The most commonly reported side effects are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Maltese: L-aktar effetti sekondarji rrappurtati b'mod komuni huma disturbi gastrointestinali (bħal dijarea, dardir), disturbi fis-sistema nervuża (bħal sturdament, uġigħ ta' ras, ħedla ta' ngħas) u għeja.
English: Contains lactose.
Maltese: U LUŻU
English: The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily.
Maltese: Id-doża tal-bidu rakkomandata hija NUEDEXTA 15 mg/9 mg darba kuljum.
English: A 12 month open-label safety study, also using the higher dose combination of dextromethorphan 23 mg /quinidine 26 mg, included 553 subjects with PBA associated with thirty-four different neurological conditions.
Maltese: L-istudju ta' prova miftuħa ta' 12-il xahar dwar is-sigurtà, li wkoll uża l-kombinazzjoni ta' dożi aktar għolja ta' dextromethorphan 23 mg /quinidine 26 mg, kien jinkludi 553 individwu b'PBA assoċjata ma' erbgħa u tletin kundizzjoni newroloġika differenti.
English: Uncommon Motion sickness, Tinnitus
Maltese: imnieħer inixxi, titwib
English: • Dextromethorphan acts on the brain.
Maltese: dextromethorphan mill-fwied.
English: If concomitant treatment with strong or moderate CYP3A4 inhibitors is considered necessary, it is recommended that electrocardiographic (ECG) evaluation of the QT interval be carried out before NUEDEXTA is administered and at appropriate time point(s) subsequently.
Maltese: Jekk il-kura konkomitanti b'inibituri qawwija jew moderati ta' CYP3A4 tkun meqjusa bħala neċessarja, huwa rakkomandat li ssir evalwazzjoni elettrokardjografika (ECG) tal-intervall QT qabel ma jingħata NUEDEXTA u suċċessivament f'punti taż-żmien xierqa.
English: The most important effects of acute overdoses are ventricular arrhythmias and hypotension.
Maltese: L-aktar effetti importanti ta' dożi eċċessivi akuti huma l-arritmiji ventrikolari u l-pressjoni baxxa.