FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean changes in QTcF were 6.8 ms for NUEDEXTA 23 mg/ 9 mg and 9.1 ms for the reference positive control (moxifloxacin).
Maltese: Il-bidliet medji fil-QTcF kienu 6.8 ms għal NUEDEXTA 23 mg/ 9 mg u 9.1 ms għall-kontroll pożittiv ta' referenza (moxifloxacin).
English: 13 hard capsules
Maltese: 13-il kapsula iebsa
English: Patients taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the preceding 14 days due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome.
Maltese: Pazjenti li jkunu qegħdin jieħdu inibituri tal-monoamine oxidase (MAOIs) jew li jkunu ħadu MAOIs fl-14-il jum ta' qabel minħabba r-riskju ta' interazzjonijiet serji u possibbilment fatali bejn il-mediċini, inkluż is-sindromu tas-serotonin.
English: NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
Maltese: NUEDEXTA jintuża għall-kura tal-affett psewdobulbari (PBA) fl-adulti.
English: The potential for dextromethorphan and quinidine to inhibit or induce cytochrome P450 in vitro were evaluated in human microsomes.
Maltese: Il-potenzjal ta' dextromethorphan u ta' quinidine li jinibixxu jew jinduċu ċ-ċitokromu P450 in vitro ġie evalwat f'mikrosomi umani.
English: Each hard capsule contains 109.2 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha 109.2 mg ta' lattożju (bħala monoidrat).
English: • medicines used to treat schizophrenia and other psychotic disorders, such as haloperidol,
Maltese: • mediċini użati għall-kura tal-iskiżofrenija u disturbi psikotiċi oħra, bħal haloperidol,
English: Dextromethorphan is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence.
Maltese: Dextromethorphan huwa antagonist mhux kompetittiv ta' affinità baxxa għal NMDA u agonist tarriċettur sigma-1 li ma ġiex studjat b'mod sistematiku fl-annimali jew fil-bnedmin għall-potenzjal tiegħu ta' abbuż, tolleranza, jew dipendenza fiżika.
English: • you have had at any time a serious condition called “serotonin syndrome”, which can be caused by certain medicines e.g. antidepressants.
Maltese: • f'xi ħin kellek kundizzjoni serja msejħa “sindromu tas-serotonin”, li tista' tkun ikkawżata minn ċerti mediċini, eż. antidepressanti.
English: Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
Maltese: Pazjenti li jkunu qegħdin jirċievu kura konkomitanti bi quinidine, quinine, jew mefloquine (ara sezzjoni 4.5).
English: The quinidine in NUEDEXTA inhibits CYP2D6 in patients in whom CYP2D6 is not otherwise genetically absent or of low activity (“CYP2D6 Poor Metabolisers” see “Pharmacogenomics” in section 5.2).
Maltese: Il-quinidine f'NUEDEXTA jinibixxi CYP2D6 f'pazjenti li CYP2D6 fihom ma jkunx altrimenti ġenetikament assenti jew ta' attività baxxa (“Metabolizzaturi Ħżiena ta' CYP2D6” ara “Farmakoġenomika” f'sezzjoni 5.2).
English: This includes patients with a family history of QT abnormality, concomitant medicinal products that prolong the QT interval, and patients with left ventricular hypertrophy (LVH) and/or left ventricular dysfunction (LVD).
Maltese: Dan jinkludi pazjenti bi storja fil-familja ta' abnormalità fil-QT, prodotti mediċinali konkomitanti li jtawlu lintervall QT, u pazjenti b'ipertrofija tal-ventrikolu tax-xellug (LVH) u/jew disfunzjoni tal-ventrikolu tax-xellug (LVD).
English: NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Maltese: NUEDEXTA 23 mg/9 mg kapsuli ibsin dextromethorphan / quinidine
English: Do not take NUEDEXTA
Maltese: Tiħux NUEDEXTA
English: Approximately 7-8% of individuals of Caucasian descent, 3-6% of Black African descent, 2-3% of Arab descent and 1-2% of Asian descent generally lack the capacity to metabolize CYP2D6 substrates and are classified as Poor Metabolizer (PMs).
Maltese: Madwar 7-8% tal-individwi ta' nisel Kawkasu, 3-6% tal-individwi ta' nisel Iswed Afrikan, 2-3% tal-individwi ta' nisel Għarbi u 1-2% tal-individwi ta' nisel Asjatiku ġeneralment m'għandhomx il-kapaċità li jimmetabolizzaw is-substrati ta' CYP2D6 u huma kklassifikati bħala Metabolizzaturi Ħżiena (PMs).
English: Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
Maltese: Quinidine sulfate huwa inibitur speċifiku tal-metaboliżmu ossidattiv dipendenti fuq CYP2D6 li jintuża sabiex iżid il-bijodisponibbiltà sistemika ta' dextromethorphan.
English: NUEDEXTA 15 mg/9 mg hard capsules dextromethorphan / quinidine
Maltese: NUEDEXTA 15 mg/9 mg kapsuli ibsin dextromethorphan / quinidine
English: • Cardiac effects (QT prolongation) including pre-existing cardiovascular conditions and clinically significant electrolyte imbalances
Maltese: • Effetti kardijaċi (Titwil tal-QT) li jinkludu kundizzjonijiet kardjovaskulari pre-eżistenti u żbilanċi tal-elettroliti klinikament sinifikanti
English: • St John's wort, a herbal medicine used to treat depression
Maltese: • St John's wort, mediċina mill-ħxejjex użata għall-kura tad-depressjoni
English: Each hard capsule contains 119.1 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha 119.1 mg ta' lattożju (bħala monoidrat).
English: There are currently limited data on the magnitude of the effect of CYP3A4 inhibitors on the pharmacokinetic parameters of quinidine and its metabolites, including the potential for accumulation at steady state.
Maltese: Attwalment hemm dejta limitata dwar id-daqs tal-effett tal-inibituri ta' CYP3A4 fuq il-parametri farmakokinetiċi ta' quinidine u l-metaboliti tiegħu, inkluż il-potenzjal ta' akkumulazzjoni fi stat fiss.
English: INFORMATION IN BRAILLE NUEDEXTA 23 mg/9 mg
Maltese: NUEDEXTA 23 mg/9 mg
English: A population pharmacokinetic analysis of race with 109 subjects (21 Caucasian; 71 Hispanic; 18 Black) revealed no apparent racial differences in the pharmacokinetics of dextromethorphan/quinidine.
Maltese: Analiżi farmakokinetika tal-popolazzjoni fir-rigward tar-razza b'109 individwi (21 Kawkasi; 71 Spanjoli; 18 Suwed) ma żvelat l-ebda differenza apparenti bejn is-sessi fil-farmakokinetika ta' dextromethorphan/quinidine.
English: • medicines to reduce pain and/or cough, such as codeine and hydrocodone
Maltese: • mediċini għat-tnaqqis tal-uġigħ u/jew is-sogħla, bħal codeine u hydrocodone
English: The efficacy of dextromethorphan/quinidine for the treatment of PBA was demonstrated in three randomised, controlled, double-blind, multicentre clinical trials in PBA subjects with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).
Maltese: L-effikaċja ta' dextromethorphan/quinidine għall-kura tal-PBA ntweriet fi tliet provi kliniċi randomizzati, double-blind, multi-ċentri, ikkontrollati fuq individwi b'PBA bi sklerożi laterali amijotrofika (ALS) jew sklerożi multipla (MS) sottostanti.
English: Mild to moderate hepatic impairment had little effect on quinidine pharmacokinetics.
Maltese: Indeboliment ħafif sa moderat tal-fwied ftit kellu effett fuq il-farmakokinetika ta' quinidine.
English: Approximately 30% of study participants carried diagnoses other than ALS and MS, including stroke, traumatic brain injury, Parkinson's disease, Alzheimer's disease and other dementia, primary lateral sclerosis, progressive bulbar palsy, and progressive supranuclear palsy.
Maltese: Madwar 30% tal-parteċipanti fl-istudju kellhom dijanjosi differenti minn ALS u MS, fosthom puplesija, korriment trawmatiku fil-moħħ, ilmarda ta' Parkinson, il-marda ta' Alzheimer u tipi oħra ta' dimenzja, sklerożi laterali primarja, paraliżi bulbari progressiva, u paraliżi sopranukleari progressiva.
English: Paroxetine (CYP2D6 inhibitor and substrate)
Maltese: Paroxetine (inibitur u substrat ta' CYP2D6)
English: Subjects were 25 to 80 years of age with a mean age of approximately 51 years.
Maltese: Il-pazjenti kellhom bejn 25 u 80 sena, b'età medja ta' madwar 51 sena.
English: The frequency of PBA episodes as measured by “Count of Episodes” in both NUEDEXTA treatment groups decreased significantly throughout the course of the study by an incremental reduction of 47% and 49% relative to placebo, respectively (p <0.0001 for both comparisons).
Maltese: Il-frekwenza tal-episodji ta' PBA kif imkejla mill-“Għadd ta' Episodji” fiż-żewġ gruppi li ħadu NUEDEXTA naqset b'mod sinifikanti matul l-istudju bi tnaqqis inkrementali ta' 47% u 49% meta mqabbel mal-plaċebo, rispettivament (p <0.
English: Interaction with NUEDEXTA may result in an increased effect on QT interval (see sections 4.4 and 4.5).
Maltese: L-interazzjoni ma' NUEDEXTA tista' twassal għal effett akbar fuq l-intervall QT (ara sezzjonijiet 4.4 u 4.5).
English: Other effects include loss of coordinated movement (ataxia), involuntary eye movements (nystagmus), over contraction of the muscles (dystonia), blurred vision, and changes in muscle reflexes.
Maltese: Effetti oħra jinkludu t-telf tal-moviment ikkoordinat (atassja), movimenti involontarji tal-għajnejn (nystagmus), kontrazzjoni eċċessiva tal-muskoli (distonija), vista mċajpra, u bidliet fir-riflessi talmuskoli.
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild (CLCR 50-80 mL/min) or moderate (CLCR 30-50 mL/min) renal impairment (6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects showed little difference in quinidine or dextromethorphan pharmacokinetics compared to healthy subjects.
Maltese: Fi studju ta' doża kombinata ta' dextromethorphan 23 mg / quinidine 26 mg darbtejn kuljum fi 12-il persuna b'indeboliment tal-kliewi ħafif (CLCR 50-80 mL/min) jew moderat (CLCR 30-50 mL/min) (6 kull wieħed) imqabbla ma' 9 persuni b'saħħithom (li kienu jaqblu fis-sess, l-età u l-firxa tal-piż malpersuni b'indeboliment), l-individwi ftit urew differenza fil-farmakokinetika ta' quinidine jew ta' dextromethorphan meta mqabbla mal-persuni b'saħħithom.
English: Quinidine is an inhibitor of P-glycoprotein.
Maltese: Quinidine huwa inibitur tal-glikoproteina P.
English: Adverse reactions of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis.
Maltese: Ir-reazzjonijiet avversi ta' doża eċċessiva ta' dextromethorphan jinkludu dardir, rimettar, sturdament, koma, depressjoni respiratorja, aċċessjonijiet, takikardija, eċċitabilità eċċessiva, u psikosi tossika.
English: INFORMATION IN BRAILLE NUEDEXTA 15 mg/9 mg
Maltese: NUEDEXTA 15 mg/9 mg
English: In this placebo-controlled 12-week study, 326 PBA subjects with underlying ALS or MS were randomized to receive NUEDEXTA 15 mg / 9 mg, (n=107), NUEDEXTA 23 mg / 9 mg (n=110), or placebo (n=109) for 12 weeks.
Maltese: F'dan l-istudju ta' 12-il ġimgħa kkontrollat bil-plaċebo, 326 individwu PBA b'ALS jew MS sottostanti ġew randomizzati sabiex jirċievu NUEDEXTA 15 mg / 9 mg, (n=107), NUEDEXTA 23 mg / 9 mg (n=110), jew plaċebo (n=109) għal 12-il ġimgħa.
English: Approximately 74% were Caucasian, 4% were Black, 1% were Asian and 19% were of Hispanic origin.
Maltese: Madwar 74% kienu Kawkasi, 4% kienu Suwed, 1% kienu Asjatiċi u 19% kienu ta' nisel Spanjol. 60% tal-pazjenti kellhom ALS sottostanti u 40% tal-pazjenti kellhom MS sottostanti.
English: • very common (≥1/10)
Maltese: • komuni ħafna (≥1/10)
English: Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
Maltese: L-użu konkomitanti ta' flecainide, chlorpromazine jew haloperidol, li huma substrati ta' CYP2D6 li wkoll itawlu l-intervall QT, jeħtieġ kawtela (ara sezzjoni 4.4).
English: • Bruxism, Confusional state, Depressed mood, Depression, Disorientation, Early morning awakening, Flat affect, Hallucination, Impulsive behaviour, Indifference, Insomnia, Restlessness, Sleep disorder
Maltese: Tgħażżiż tas-snien, Stat konfużjonali, Burdata depressa, Depressjoni, Diżorjentament, Qawmien filgħodu kmieni, Nuqqas ta' rispons emottiv, Alluċinazzjoni, Imġiba impulsiva, Indifferenza, Nuqqas ta' rqad, Irrekwitezza, Disturb fl-irqad
English: Patients with complete atrioventricular (AV) block without implanted pacemakers, or in patients who are at high risk of complete AV block (see section 4.4).
Maltese: Pazjent b'imblokk atrijoventrikolari (AV) komplet mingħajr pacemakers impjantati, jew f'pazjenti li jkunu f'riskju għoli ta' imblokk AV komplet (ara sezzjoni 4.4).
English: Quinidine plasma concentrations are proportional to quinidine dose.
Maltese: Il-konċentrazzjonijiet ta' quinidine fil-plażma huma proporzjonali mad-doża ta' quinidine.
English: • balance disorder, abnormal coordination, speech difficulties (dysarthria), movement dysfunction, pins and needles / tingling or numbness (paraesthesia), loss of feeling or function in the lower limbs (paraparesis), sedation
Maltese: • disturb tal-bilanċ, koordinazzjoni abnormali, diffikultajiet fid-diskors (disartrija), disfunzjoni tal-moviment, tingiż u tnemnim (parasteżija), telf tas-sensazzjoni jew tal-funzjoni fir-riġlejn (paraparesi), sedazzjoni
English: Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Maltese: Is-sintomi tas-sindromu tas-serotonin jinkludu bidla fl-istatus mentali, pressjoni għolja, irrekwitezza, mijoklonus, ipertermija, iperrifleksija, dijaforesi, u tregħid.
English: Caution is required when administering NUEDEXTA in combination with flecainide, chlorpromazine and haloperidol.
Maltese: Hija meħtieġa kawtela meta NUEDEXTA jingħata flimkien ma' flecainide, chlorpromazine u haloperidol.
English: • if you have a heart problem called “complete heart block” or “long QT syndrome” or have had a problem with your heart called “torsades de pointes”.
Maltese: • jekk għandek problema fil-qalb imsejħa “imblokk komplet tal-qalb” jew “sindromu tal-QT twil” jew kellek problema f'qalbek imsejħa “torsades de pointes”.
English: • Off-label use
Maltese: • tnaqqis fl-aptit
English: Uncommon Dysgeusia, Hypersomnia, Muscle spasticity, Syncope, Fall
Maltese: Disgewżja, Ipersomnja, Spastiċità fil-muskoli, Sinkope,
English: The quinidine component is not expected to contribute to the effectiveness of NUEDEXTA in PMs, but adverse reactions of the quinidine component are still possible.
Maltese: Il-komponent quinidine mhuwiex mistenni li jikkontribwixxi għall-effikaċja ta' NUEDEXTA fil-PMs, iżda xorta huma possibbli reazzjonijiet avversi tal-komponent quinidine.
English: Each NUEDEXTA 23 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Maltese: Kull NUEDEXTA kapsula ta' 23 mg/9 mgfiha dextromethorphan hydrobromide monohydrate, ekwivalenti għal 23.11 mg dextromethorphan u quinidine sulfate dihydrate, ekwivalenti għal 8.69 mg quinidine.
English: Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
Maltese: Disturb fil-bilanċ, Koordinazzjoni mhux normali, Disartrija, Disfunzjoni tal-moviment, Parasteżija, Paraparesi, Sedazzjoni
English: OUTER CARTON - NUEDEXTA 15 mg/9 mg capsules: PACK OF 13 CAPSULES
Maltese: KARTUNA TA' BARRA - NUEDEXTA kapsuli ta' 15 mg/9 mg: PAKKETT TA' 13-IL KAPSULA
English: The effect of NUEDEXTA 23 mg / 9 mg (for 7 consecutive doses) on QTc prolongation was evaluated in a randomised, double-blind (except for moxifloxacin), placebo- and positive-controlled (400 mg moxifloxacin) crossover thorough QT study in 50 fasted normal healthy men and women with CYP2D6 extensive metabolizer (EM) genotype.
Maltese: L-effett ta' NUEDEXTA 23 mg / 9 mg (għal 7 dożi konsekuttivi) fuq it-titwil tal-QTc ġie evalwat fi studju crossover randomizzat, double-blind (ħlief għal moxifloxacin), ikkontrollat bil-plaċebo u b'mod pożittiv (400 mg moxifloxacin) dwar il-QT fuq 50 mara u raġel normali sajma b'saħħithom b'ġenotip ta' metabolizzaturi estensivi (EM) ta' CYP2D6.
English: After administration of NUEDEXTA 23 mg/9 mg to 14 extensive metabolizers, the elimination halflife of dextromethorphan was 18.8 hours and the elimination half-life of quinidine was 9.6 hours.
Maltese: Wara l-għoti ta' NUEDEXTA 23 mg / 9 mg lil 14-il metabolizzatur estensiv, il-half-life taleliminazzjoni ta' dextromethorphan kienet 18.8 sigħat u l-half-life tal-eliminazzjoni ta' quinidine kienet 9.6 sigħat.
English: Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6 (CYP2D6), which catalyses a major biotransformation pathway for dextromethorphan.
Maltese: Quinidine jżid il-livelli ta' dextromethorphan fil-plażma billi jinibixxi b'mod kompetittiv iċ-ċitokromu P450 2D6 (CYP2D6), li jikkatalizza mogħdija prinċipali ta' bijotrasformazzjoni għal dextromethorphan.
English: NUEDEXTA 23 mg/9 mg hard capsules
Maltese: NUEDEXTA 23 mg/9 mg kapsuli ibsin
English: • double vision, blurred vision
Maltese: • vista doppja, vista mċajpra
English: • to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
Maltese: • jagħtik doża ogħla u jordnalek NUEDEXTA 23 mg/9 mg kapsuli.
English: Patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes ventricular tachycardia (see section 4.4).
Maltese: Pazjenti b'intervall QT imtawwal, sindromu ta' QT twil konġenitali jew storja li tissuġġerixxi takikardija ventrikolari tat-torsades de pointes (ara sezzjoni 4.4).
English: • Studies to Assess Cardiac Effects
Maltese: • Studji sabiex jiġu Valutati l-Effetti Kardijaċi
English: CYP2D6 substrates
Maltese: Substrati ta' CYP2D6
English: • gall stones, increased bilirubin levels in the blood, abnormal liver function test
Maltese: Kolelitijasi, żieda ta' bilirubina fid-demm, Test abnormali
English: A population pharmacokinetic analysis based on data from 109 subjects (75 male; 34 female) showed no apparent gender differences in the pharmacokinetics of dextromethorphan/quinidine.
Maltese: Analiżi farmakokinetika tal-popolazzjoni bbażata fuq dejta minn 109 individwi (75 irġiel; 34 nisa) ma wriet l-ebda differenza apparenti bejn is-sessi fil-farmakokinetika ta' dextromethorphan/quinidine.
English: • sexual dysfunction
Maltese: • disfunzjoni sesswali
English: The least-squares mean CNS-LS scores were significantly reduced at the end of treatment in both treatment groups compared to placebo (8.2 point reduction for NUEDEXTA 23 mg /9 mg, 7.5 point reduction for NUEDEXTA 15 mg /9 mg, 5.7 point reduction for placebo).
Maltese: Il-punteġġi medji tal-inqas kwadri fuq is-CNS-LS naqsu b'mod sinifikanti fit-tmiem tal-kura fiż-żewġ gruppi ta' kura meta mqabbel mal-plaċebo (tnaqqis ta' 8.2 punti għal NUEDEXTA 23 mg /9 mg, tnaqqis ta' 7.5 punti għal NUEDEXTA 15 mg /9 mg, tnaqqis ta' 5.7 punti għall-plaċebo).
English: After administration of the combination product, protein binding remains essentially the same as that after administration of the individual components; dextromethorphan is approximately 60-70% protein bound, and quinidine is approximately 80-89% protein bound.
Maltese: Wara għoti tal-prodott kombinat, it-twaħħil mal-proteini tad-demm jibqa' essenzjalment l-istess bħal dak wara l-għoti tal-komponenti individwali; madwar 60-70% ta' dextromethorphan jeħel mal-proteini tad-demm, u madwar 80-89% ta' quinidine jeħel mal-proteini tad-demm.
English: Following repeated doses of NUEDEXTA 23 mg / 9 mg and NUEDEXTA 15 mg / 9 mg, maximal plasma concentrations (Cmax) of dextromethorphan are reached approximately 3 to 4 hours after dosing and maximal plasma concentrations of quinidine are reached approximately 2 hours after dosing.
Maltese: Wara dożi ripetuti ta' NUEDEXTA 23 mg / 9 mg u NUEDEXTA 15 mg / 9 mg, il-konċentrazzjonijiet massimi fil-plażma (Cmax) ta' dextromethorphan jintlaħqu bejn wieħed u ieħor 3 sa 4 sigħat wara lgħoti u l-konċentrazzjonijiet massimi fil-plażma ta' quinidine jintlaħqu bejn wieħed u ieħor sagħtejn wara l-għoti.
English: NUEDEXTA contains lactose
Maltese: NUEDEXTA fih il-lattożju
English: Through its binding to the NMDA, sigma-1, SERT and 5-HT1B/D receptors, dextromethorphan is thought to have a modulatory effect on neurotransmission involving glutamate, monoamines (including serotonin), as well as ion channel function.
Maltese: Permezz tat-twaħħil tiegħu mar-riċetturi ta' NMDA, sigma-1, SERT u 5-HT1B/D, dextromethorphan huwa maħsub li għandu effett modulatorju fuq in-newrotrasmissjoni li tinvolvi glutamate, monoamines (inkluż is-serotonin), kif ukoll fuq il-funzjoni tal-kanali tal-joni.
English: NUEDEXTA 15 mg/9 mg hard capsules
Maltese: NUEDEXTA 15 mg/9 mg kapsuli ibsin
English: NUEDEXTA must not be used with monoamine oxidase inhibitors (MAOIs), such as phenelzine and moklobemide, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serotonin syndrome (see section 4.3).
Maltese: NUEDEXTA m'għandux jintuża ma' inibituri tal-monoamine oxidase (MAOIs), bħal phenelzine u moklobemide, jew f'pazjenti li jkunu ħadu MAOIs fl-14-il jum ta' qabel minħabba r-riskju tassindromu tas-serotonin (ara sezzjoni 4.3).
English: BLISTER SLEEVE (13 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Maltese: SLEEVE TAL-FOLJA (13-il kapsula iebsa) - NUEDEXTA 15 mg/9 mg kapsuli
English: • medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant
Maltese: • mediċini użati għall-prevenzjoni tad-dardir u r-rimettar waqt kimoterapija u wara operazzjoni,
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Maltese: Kull kapsula fiha dextromethorphan hydrobromide monohydrate, ekwivalenti għal 23.11 mg dextromethorphan u quinidine sulfate dihydrate, ekwivalenti għal 8.69 mg quinidine.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Atrioventricular block first degree, Electrocardiogram QT prolonged
Maltese: Imblokk atrijoventrikolari tal-ewwel grad, Titwil tal-QT
English: NUEDEXTA 15 mg/9 mg hard capsules NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Maltese: NUEDEXTA 15 mg/9 mg kapsuli ibsin NUEDEXTA 23 mg/9 mg kapsuli ibsin dextromethorphan / quinidine
English: Dose adjustment is not required in patients with increased CYP2D6 activity, referred to as ultra-rapid metabolisers (UMs), see section 5.2.
Maltese: M'hemmx bżonn aġġustament tad-doża f'pazjenti b'żieda fl-attività ta' CYP2D6, imsejħa metabolizzaturi ultra-veloċi (UMs), ara sezzjoni 5.2.
English: Only for NUEDEXTA 15 mg/9 mg: Blister packs consist of a PVC based clear film with aluminium foil seal and contains 13 hard capsules.
Maltese: Għal NUEDEXTA 15 mg/9 mg biss: Pakkett ta' folji li jikkonsistu minn pellikola ċara bbażata fuq ilPVC b'siġill ta' folja tal-aluminju u li fih 13-il kapsula iebsa.
English: In the case of pro-drugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), efficacy may be substantially reduced by NUEDEXTA due to inhibition of CYP2D6 and hence impaired formation of the active metabolite.
Maltese: Fil-każ ta' pro-drugs li l-azzjonijiet tagħhom huma medjati mill-metaboliti prodotti minn CYP2D6 (pereżempju, codeine u hydrocodone, li l-effetti analġesiċi u kontra s-sogħla tagħhom jidhru li huma medjati mill-morfina u l-hydromorphone, rispettivament), l-effikaċja tista' titnaqqas b'mod sostanzjali minn NUEDEXTA minħabba l-inibizzjoni ta' CYP2D6 u b'hekk il-formazzjoni mdgħajfa talmetabolit attiv.