FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories are derived according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenzi jinkisbu skont il-konvenzjonijiet li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: After the oral administration of single (167 mg) and multiple (83 mg twice a day during 8 days) doses of mexiletine, total clearance of mexiletine is significantly increased in smokers (1.3 to 1.7-fold) due to induction of CYP1A2, resulting in a correspondingly decreased elimination half-life and drug exposure.
Maltese: Wara l-għoti orali ta' doża/i waħda (167 mg) u multipli (83 mg darbtejn f'ġurnata għal 8 ijiem) ta' mexiletine, it-tneħħija totali ta' mexiletine tonqos b'mod sinifikanti f'dawk li jpejpu (1.3 sa 1.7 drabi) minħabba l-induzzjoni ta' CYP1A2, li jwassal għal nuqqas korrispondenti fil-half-life taleliminazzjoni u fl-esponiment għall-mediċina.
English: Maintenance treatment is between 167 mg - 500 mg daily (1 to 3 capsules per day), according to the intensity of symptoms and the clinical response, taken regularly throughout the day.
Maltese: It-trattament ta' manteniment huwa bejn 167 mg - 500 mg kuljum (1 sa 3 kapsuli kuljum), skont lintensità tas-sintomi u r-rispons kliniku, u jittieħed regolarment matul il-ġurnata.
English: Namuscla 167 mg capsules mexiletine
Maltese: Namuscla 167 mg kapsuli mexiletine
English: See section “Do not take Namuscla”.
Maltese: Ara s-sezzjoni “Tiħux Namuscla”.
English: The most commonly reported adverse reactions in patients treated with mexiletine are abdominal pain (12%), vertigo (8%) and insomnia (12%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni f'pazjenti ttrattati b'mexiletine huma wġigħ addominali (12%), mejt (8%) u nuqqas ta' rqad (12%).
English: Pharmacotherapeutic group: Cardiac therapy, antiarrhythmics, class Ib, ATC code: C01BB02.
Maltese: Terapija kardijaka, antiarritmiċi, klassi Ib, Kodiċi ATC:
English: In a clinical study, co-administration of mexiletine with phenytoin resulted in a significant decrease in exposure to mexiletine (p < 0.003) due to enhanced clearance as reflected in significantly decreased elimination half-life (17.2 to 8.4 hours, p < 0.02).
Maltese: Fi studju kliniku, l-għoti flimkien ta' mexiletine ma' phenytoin wassal għal nuqqas sinifikanti flesponiment għal mexiletine (p < 0.003) minħabba titjib fil-proċess tat-tneħħija kif indikat minn nuqqas sinifikanti fil-half-life tal-eliminazzjoni (17.2 għal 8.4 sigħat, p < 0.02).
English: • Co-administration with medicinal products inducing torsades de pointes (see section 4.5)
Maltese: • L-għoti flimkien ma' prodotti mediċinali li jinduċu torsades de pointes (ara sezzjoni 4.5)
English: Rare: hepatic function abnormal
Maltese: Rari: funzjoni tal-fwied anormali
English: In a single-dose interaction study, the clearance of mexiletine was decreased by 38% following the coadministration of fluvoxamine, an inhibitor of CYP1A2.
Maltese: Fi studju dwar interazzjoni b'doża waħda, it-tneħħija ta' mexiletine kienet imnaqqsa bi 38% wara lgħoti flimkien ma' fluvoxamine, inibitur ta' CYP1A2.
English: CYP2D6 polymorphism affects mexiletine pharmacokinetics.
Maltese: Il-polimorfiżmu f'CYP2D6 jaffettwa l-farmakokinetika ta' mexiletine.
English: The dose should not exceed 500 mg/day.
Maltese: Id-doża m'għandhiex taqbeż il-500 mg/jum.
English: Do not take Namuscla with certain medicines for treating heart rhythm disorders (quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant).
Maltese: Tiħux Namuscla ma' ċertu mediċini li qegħdin biex jittrattaw disturbi fir-ritmu tal-qalb (quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant).
English: A linear relationship between mexiletine dose and plasma concentration has been observed in the dose range of 83 to 500 mg.
Maltese: Ġiet osservata relazzjoni lineari bejn id-doża ta' mexiletine u l-konċentrazzjoni fil-plażma fil-medda tad-doża ta' 83 sa 500 mg.
English: CYP1A2 & CYP2D6 inducers
Maltese: Inibituri ta' CYP1A2 & CYP2D6
English: Mexiletine is weakly bound to plasma proteins (55%).
Maltese: Mexiletine jeħel b'mod dgħajjef mal-proteini tal-plażma (55%).
English: CYP2D6 polymorphism
Maltese: Polimorfiżmu f'CYP2D6
English: The organic cation transporter 2 (OCT2) provides an important pathway for the uptake of cationic compounds in the kidney.
Maltese: It-trasportatur katjoniku organiku 2 (OCT2, organic cation transporter 2) jipprovdi passaġġ importanti għall-assorbiment ta' komposti katjoniċi fil-kliewi.
English: Excretion of mexiletine essentially occurs through the kidney (90% of the dose, including 10% as unchanged mexiletine).
Maltese: It-tneħħija ta' mexiletine sseħħ essenzjalment mill-kliewi (90% tad-doża, inkluż 10% bħala mexiletine mhux mibdul).
English: The maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day.
Maltese: Id-doża ta' manteniment hija 1 sa 3 kapsuli kuljum li jittieħdu f'intervalli regolari matul il-ġurnata kollha.
English: Individuals who are CYP2D6 poor metabolisers (PM) exhibit higher mexiletine concentrations than CYP2D6 intermediate (IM), extensive (i.e. normal) or ultra-rapid (UM) metabolisers.
Maltese: Individwi li jkunu metabolizzaturi batuti ta' CYP2D6 (PM, poor metabolisers) juru konċentrazzjonijiet ta' mexiletine ogħla minn metabolizzaturi intermedji (IM, intermediate metabolisers), estensivi (jiġifieri, normali) jew rapidi ħafna (UM, ultra-rapid metabolisers).
English: Age There is no clinically relevant effect of age on the exposure of mexiletine in adults.
Maltese: Età M'hemm l-ebda effett klinikament rilevanti tal-età fuq l-esponiment ta' mexiletine fl-adulti.
English: The efficacy and safety of mexiletine in non-dystrophic myotonia was evaluated in MYOMEX, a multi-centre, double-blind, placebo-controlled, cross-over (2 treatment periods of 18 days) study with a 4-day wash-out period in 13 patients with myotonia congenita (MC) and 12 patients with paramyotonia congenita (PC).
Maltese: L-effikaċja u s-sigurtà ta' mexiletine f'mijotonija mhux distrofika kienet evalwata f'MYOMEX, studju multiċentriku, double-blind, ikkontrollat bil-plaċebo, cross-over (żewġ perjodi ta' trattament ta' 18il jum) b'perjodu ta' wash-out ta' 4 ijiem fi 13-il pazjent b'mijotonija konġenitali (MC, myotonia congenita) u 12-il pazjent b'paramijotonija konġenitali (PC, paramyotonia congenita).
English: Very rare: drug reaction with eosinophilia and systemic symptoms Not known: lupus-like syndrome, dermatitis exfoliative, Stevens-Johnson syndrome Psychiatric disorders
Maltese: Rari ħafna: reazzjoni tal-mediċina b'eosinofilija u sintomi sistemiċi Mhux magħruf: sindromu li jixbah lil dak tal-lupus, dermatite bil-qxur, sindrome ta' Stevens-Johnson Disturbi psikjatriċi
English: How to store Namuscla 6.
Maltese: Kif taħżen Namuscla 6.
English: CGI as judged efficient by the investigators CGI as judged efficient by the patients Effect of treatment (Mc Nemar test)
Maltese: CGI kif ġie ġġudikat effiċjenti mill-investigaturi CGI kif ġie ġġudikati effiċjenti mill-pazjenti L-effett tat-trattament (test ta' Mc Nemar)
English: Clinical Myotonia Scale - Disability Global Score Number of subjects
Maltese: Skala Klinika ta' Mijotonija - Punteġġ Globali tad-Diżabbiltà Numru ta' individwi
English: During Namuscla maintenance treatment, a detailed cardiac evaluation should be carried out every 24-48 hour.
Maltese: Matul it-trattament ta' manteniment ta' Namuscla, għandha ssir evalwazzjoni kardijaka dettaljata kull 24-48 siegħa.
English: Effect of treatment (binomial test)
Maltese: L-effett tat-trattament (test ta' binomju)
English: Cardiac arrhythmogenic effects
Maltese: Effetti kardijaċi arritmoġeniċi
English: Mexiletine is eliminated slowly in humans (with a mean elimination half-life of 10 hours, ranging from 5 to 15 hours).
Maltese: Mexiletine jitneħħa bil-mod fil-bnedmin (bil-medja tal-half-life tal-eliminazzjoni tkun 10 sigħat, li tvarja minn 5 sa 15-il siegħa).
English: The treatment is mainly symptomatic.
Maltese: It-trattament huwa prinċipalment sintomatiku.
English: Fatal outcomes have been reported for acute overdoses at 4.4 g of mexiletine hydrochloride ingestion but survival has also been reported following acute overdose of approximately 4 g of oral mexiletine hydrochloride.
Maltese: Riżultati fatali kienu rrappurtati għal dożi eċċessivi akuti ta' inġestjoni ta' 4.4 g ta' mexiletine hydrochloride, iżda s-sopravivenza kienet irrappurtata wkoll wara doża eċċessiva akuta ta' madwar 4 g ta' mexiletine hydrochloride orali.
English: CYP2D6 polymorphism may affect mexiletine pharmacokinetics (see section 5.2).
Maltese: Il-polimorfiżmu f'CYP2D6 jista' jaffettwa l-farmakokinetika ta' mexiletine (ara sezzjoni 5.2).
English: The patients were randomized according to a cross-over design to a sequence including the 2 following treatments: a) mexiletine, started at 167 mg/day and titrated by increments of 167 mg every 3 days to reach a maximum dose of 500 mg/day in 1 week or b) placebo.
Maltese: Il-pazjenti ntgħażlu b'mod każwali skont disinn cross-over għal sekwenza li tinkludi ż-żewġ trattamenti li ġejjin: a) mexiletine, li beda bi 167 mg/jum u kien ittitrat b'inkrementi ta' 167 mg kull 3 ijiem biex tintlaħaq doża massima ta' 500 mg/jum f'ġimgħa jew b) plaċebo.
English: Not known: circulatory collapse, hot flush Respiratory, thoracic and mediastinal disorders Not known: pulmonary fibrosis
Maltese: Mhux magħruf: kollass ċirkulatorju, fwawar jaħarqu Disturbi respiratorji, toraċiċi u medjastinali Mhux magħruf: fibrożi pulmonari
English: The influence of CYP2D6 phenotype on mexiletine metabolism has been extensively investigated.
Maltese: L-influwenza tal-fenotip ta' CYP2D6 fuq il-metaboliżmu ta' mexiletine ġiet investigata b'mod estensiv.
English: Common: flushing, hypotension
Maltese: Mhux komuni: puplesija, disturbi fid-diskors
English: Smoking affects mexiletine pharmacokinetics (see section 4.5).
Maltese: It-tipjip jaffettwa l-farmakokinetika ta' mexiletine (ara sezzjoni 4.5).
English: bundle branch block, bifascicular and trifascicular block),
Maltese: (≥ 120 ms), imblokk atrijoventrikulari tat-tieni grad, imblokk tal-bundle branch, imblokk bifaxxikulari u imblokk trifaxxikulari),
English: • Ventricular tachyarrhythmia
Maltese: FULJETT TA' TAGHRIF
English: Age of the overall study population ranged from 20 to 66 years old and about 2/3 of the patients were male.
Maltese: L-età talpopolazzjoni tal-istudju globali kienet tvarja bejn 20 u 66 sena u madwar 2/3 tal-pazjenti kienu rġiel.
English: • Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1
English: The safety and efficacy of mexiletine in children and adolescents aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' mexiletine fit-tfal u fl-adolexxenti minn età ta' 0 sa 18 -il sena għadhom ma ġewx determinati s'issa.
English: Co-administration of mexiletine and antiarrhythmics inducing torsades de pointes (class Ia: quinidine, procainamide, disopyramide, ajmaline; class Ic: encainide, flecainide, propafenone, moricizine; class III: amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant) increases the risk of potentially lethal torsades de pointes.
Maltese: Aġenti antiarritmiċi li jinduċu torsades de pointes (antiarritmiċi ta' klassi Ia, Ic, III): L-għoti flimkien ta' mexiletine u antiarritmiċi li jinduċu torsades de pointes (klassi Ia: quinidine, procainamide, disopyramide, ajmaline; klassi Ic: encainide, flecainide, propafenone, moricizine; klassi
English: The potential interactions between mexiletine and substrates of other common enzymes and transporters have not yet been assessed; it is currently contra-indicated to use mexiletine with any substrate having a narrow therapeutic window such as digoxin, lithium, phenytoin, theophylline or warfarin (see section 4.3).
Maltese: L-interazzjonijiet potenzjali bejn mexiletine u substrati ta' enzimi u trasportaturi komuni oħra għadhom ma ġewx evalwati s'issa; bħalissa l-użu ta' mexiletine ma' kwalunkwe substrat li jkollu parametru terapewtiku dejjaq, bħal digoxin, lithium, phenytoin, teofillina jew warfarin, huwa kontroindikat (ara sezzjoni 4.3).
English: See also sections 4.3 and 4.5 regarding association with other products with arrhythmogenic effects.
Maltese: Ara wkoll sezzjonijiet 4.3 u 4.5 dwar l-assoċjazzjoni ma' prodotti oħra b'effetti arritmoġeniċi.
English: Other antiarrhythmics (class Ib, II, IV antiarrhythmics):
Maltese: Ib, II, IV):
English: Common: vertigo
Maltese: Komuni: dardir
English: The most serious reported adverse reactions in patients treated with mexiletine are drug reaction with eosinophilia and systemic symptoms and arrhythmia (atrioventricular block, arrhythmia, ventricular fibrillation).
Maltese: Ir-reazzjonijiet avversi rrappurtati l-aktar serji f'pazjenti ttrattati b'mexiletine huma reazzjoni għallmediċina b'eosinofilija u sintomi sistemiċi u arritmija (imblokk atrijoventrikulari, arritmija, fibrillazzjoni ventrikulari).
English: Several of the resulting metabolites are submitted to further conjugation with glucuronic acid (phase II metabolism); among these are the major metabolites p-hydroxymexiletine, hydroxy-methylmexiletine and N-hydroxymexiletine.
Maltese: II); fost dawn hemm il-metaboliti maġġuri p-hydroxymexiletine, hydroxy-methylmexiletine u N-hydroxymexiletine.
English: Common side effects (may affect up to 1 in 10 people): - Somnolence (sleepiness) - Headache - Tingling in the arms and legs - Blurred vision - Vertigo (sensation of feeling off balance) - Rapid heart rate - Flushing - Low blood pressure (which can cause dizziness and feeling faint) - Nausea (feeling sick) - Acne - Pain in the arms and legs - Tiredness - Weakness - Chest discomfort - Malaise (a feeling of general discomfort and illness)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - Ngħas (ħedla) - Uġigħ ta' ras - Tnemnim fid-dirgħajn u fir-riġlejn - Vista mċajpra - Mejt (sensazzjoni li titlef il-bilanċ) - Rata mgħaġġla ta' taħbit tal-qalb - Fwawar - Pressjoni tad-demm baxxa (li tista' tikkawża sturdament jew li tħoss ħass ħażin) - Dardir (tħossok qisek se tirremetti) - Akne - Uġigħ fid-dirgħajn jew fir-riġlejn - Għeja - Dgħufija - Skonfort fis-sider - Telqa (sensazzjoni ta' skomfort ġenerali u mard)
English: Higher systemic exposure is expected in patients who are CYP2D6 poor metabolisers or who take medicinal products that inhibit CYP2D6 (see section 4.5).
Maltese: Hu mistenni esponiment sistemiku ogħla f'pazjenti li huma metabolizzaturi batuti ta' CYP2D6 jew li jieħdu prodotti mediċinali li jinibixxu CYP2D6 (ara sezzjoni 4.5).
English: Mexiletine pharmacokinetics are characterised by significantly lower total and renal clearance resulting in prolonged elimination half-life, higher exposure, and lower volume of distribution in poor metabolisers compared to extensive metabolisers.
Maltese: Il-farmakokinetika ta' mexiletine hija kkaratterizzata minn tneħħija totali u renali aktar baxxa b'mod sinifikanti li twassal għal half-life tal-eliminazzjoni mtawla, esponiment ogħla, u volum aktar baxx ta' distribuzzjoni f'metabolizzaturi batuti meta mqabbla ma' metabolizzaturi estensivi.
English: Namuscla capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder.
Maltese: Il-kapsuli ta' Namuscla huma kapsuli tal-ġelatina b'qoxra iebsa oranġjo Żvediż (20 mm) mimlija bi trab abjad.
English: Poor and extensive CYP2D6 metabolisers
Maltese: Metabolizzaturi batuti u estensivi ta' CYP2D6
English: • Information about the risk of cardiac arrhythmias in patients using Namuscla;
Maltese: • Informazzjoni dwar ir-riskju ta' arritmiji kardijaċi f'pazjenti li jużaw Namuscla;
English: Namuscla 167 mg hard capsules
Maltese: Namuscla 167 mg kapsuli ibsin
English: Experience with mexiletine in patients with myotonic disorders aged > 65 years is limited.
Maltese: L-esperjenza b'mexiletine f'pazjenti b'disturbi mijotoniċi li jkollhom > 65 sena hija limitata.
English: Co-administration of mexiletine with a hepatic enzyme inhibitor (CYP1A2 inhibitor: ciprofloxacin, fluvoxamine, propafenone; CYP2D6 inhibitor: propafenone, quinidine) significantly increases mexiletine exposure and thus the associated risk of adverse reactions to mexiletine.
Maltese: L-għoti flimkien ta' mexiletine ma' inibitur tal-enzimi tal-fwied (inibitur ta' CYP1A2: ciprofloxacin, fluvoxamine, propafenone; inibitur ta' CYP2D6: propafenone, quinidine) iżid b'mod sinifikanti lesponiment għal mexiletine, u b'hekk ir-riskju assoċjat ta' reazzjonijiet avversi għal mexiletine.
English: Each capsule contains mexiletine hydrochloride corresponding to 166.62 mg mexiletine .
Maltese: Kull kapsula iebsa fiha mexiletine hydrochloride li jikkorrispondi għal 166.
English: Mean (SD) value at Baseline Mean (SD) value at Day 18
Maltese: Il-medja (SD) tal-valur f'Jum 18
English: Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Germany
Maltese: Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt/Main il-Ġermanja
English: Other medicines and Namuscla
Maltese: It-tipjip u Namuscla
English: o certain antibiotics (ciprofloxacin, rifampicin), o certain antidepressants (fluvoxamine), o tizanidine (used to relax the muscles), o metformin (used against diabetes) o omeprazole (to treat stomach ulcer and gastric acid reflux).
Maltese: • ċertu mediċini oħra: o timolol għat-trattament ta' pressjoni għolja fl-għajn (glawkoma), o ċerti antibijotiċi (ciprofloxacin, rifampicin), o ċertu antidipressanti (fluvoxamine), o tizanidine (jintuża biex tirrilassa l-muskoli), o metformin (jintuża kontra d-dijabete) o omeprazole (għat-trattament ta' ulċera fl-istonku u rifluss tal-aċidu gastriku).
English: Co-administration of mexiletine with a hepatic enzyme inducer (CYP1A2 inducer: omeprazole; CYP2D6 inducer: phenytoin, rifampicin) may increase the clearance and elimination rate of mexiletine due to an increased hepatic metabolism, resulting in decreased plasmatic concentrations and half-life of mexiletine.
Maltese: L-għoti flimkien ta' mexiletine ma' induttur tal-enzimi tal-fwied (induttur ta' CYP1A2: omeprazole; induttur ta' CYP2D6: phenytoin, rifampicin) jista' jżid r-rata ta' tneħħija u eliminazzjoni ta' mexiletine minħabba żieda fil-metaboliżmu tal-fwied, li twassal għal konċentrazzjonijiet fil-plażma u half-life ta' mexiletine aktar baxxi.
English: There is an Alert Card distributed with Namuscla, to remind you and medical staff of the risk of cardiac arrythmias.
Maltese: Hemm Kard ta' Allert distribwita ma' Namuscla, biex tfakkrek u lill-istaff mediku bir-riskju ta' arritmiji kardijaċi.
English: Rare side effects (may affect up to 1 in 1,000 people): - Abnormal functioning of the liver (observed after blood analysis).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): - Funzjoni anormali tal-fwied (osservata wara l-analiżi tad-demm).
English: Hormosan Pharma GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main Germany
Maltese: Hormosan Pharma GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main IL-ĠERMANJA
English: No notable accumulation of mexiletine was observed after repeated administration.
Maltese: Ma kienet osservata ebda akkumulazzjoni notevoli ta' mexiletine wara għoti ripetut.
English: As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy.
Maltese: Bћala prekawzjoni hu preferribli li ma jintużax mexiletine waqt it-tqala.
English: The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day).
Maltese: Id-doża rakkomandata tal-bidu ta' mexiletine hija ta' 167 mg kuljum (kapsula (1) kuljum).
English: Mexiletine is mainly (90%) metabolized in the liver, the primary pathway being CYP2D6 metabolism, although it is also a substrate for CYP1A2.
Maltese: Mexiletine jiġi metabolizzat prinċipalment (90%) fil-fwied, il-passaġġ primarju jkun il-metaboliżmu ta' CYP2D6, għalkemm huwa wkoll substrat għal CYP1A2.
English: Very common: abdominal pain
Maltese: Komuni ħafna: uġigħ addominali
English: General disorders and administration site conditions Common: fatigue, asthenia, chest discomfort, malaise
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni: għeja, astenija, skonfort fis-sider, telqa
English: In a clinical study in 12 subjects (5 healthy subjects and 7 patients with cardiac arrhythmias), the clearance of caffeine was decreased by 50% following the administration of mexiletine.
Maltese: Fi studju kliniku fi 12-il individwu (5 individwi b'saħħithom u 7 pazjenti b'arritmija kardijaka), ittneħħija tal-kaffeina kienet imnaqqsa b'50% wara l-għoti ta' mexiletine.
English: Epileptic patients need to be monitored because mexiletine can increase the frequency of seizure episodes.
Maltese: Pazjenti epilettiċi jeħtieġu li jiġu mmonitorjati għax mexiletine jista' jżid il-frekwenza ta' episodji ta' aċċessjonijiet.
English: Very common side effects (may affect more than 1 in 10 people): - Abdominal (belly) pain - Insomnia (difficulty sleeping)
Maltese: Effetti sekondarji komuni hafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni): - Uġigħ addominali (fiż-żaqq) - Insomnija (diffikultà biex torqod)
English: Mexiletine is a potent inhibitor of CYP1A2; therefore, co-administration of mexiletine with medicinal products metabolised by CYP1A2 (such as theophylline, caffeine, lidocaine or tizanidine) may be associated with elevations in plasma concentrations of the concomitant medicine that could increase or prolong the therapeutic efficacy and/or the adverse reactions, especially if mexiletine is coadministered with CYP1A2 substrates with narrow therapeutic window, e.g. theophylline and tizanidine.
Maltese: Mexiletine huwa inibitur qawwi ta' CYP1A2; għalhekk, l-għoti flimkien ta' mexiletine ma' prodotti mediċinali oħrajn metabolizzati minn CYP1A2 (bħal teofillina, kaffeina, lidocaine jew tizanidine) jista' jiġi assoċjat ma' żidiet fil-konċentrazzjonijiet fil-plażma tal-mediċina konkomitanti li jistgħu jżidu jew itawlu l-effikaċja terapewtika u/jew ir-reazzjonijiet avversi, speċjalment jekk mexiletine jingħata flimkien ma' substrati ta' CYP1A2 b'parametru terapewtiku dejjaq, eż. theophylline u tizanidine.
English: During maintenance treatment, detailed cardiac evaluation, including ECG, 24-48 hour Holtermonitoring and echocardiography, is recommended at least annually, or more frequently if considered necessary as part of routine cardiac assessment.
Maltese: Matul it-trattament ta' manteniment, hija rakkomandata evalwazzjoni kardijaka dettaljata, inkluż ECG, 24-48 siegħa monitoraġġ tat-tip Holter u ekokardjografija, mill-inqas kull sena, jew aktar frekwenti jekk dan ikun ikkunsidrat neċessarju, bħala parti mill-evalwazzjoni kardijaka ta' rutina.
English: Mean (SD) absolute change from baseline Effect of treatment (linear mixed model)
Maltese: L-effett tat-trattament (Mudell Lineari ta' Effetti Mħallta)
English: Not known: diarrhoea, vomiting, oesophageal ulcers and perforation Hepatobiliary disorders
Maltese: Mhux magħruf: dijarea, rimettar, ulċeri esofagali u perforazzjoni Disturbi fil-fwied u fil-marrara
English: The potential of mexiletine as a drug-drug-interaction perpetrator is unknown.
Maltese: Il-potenzjal ta' mexiletine bħala l-awtur ta' interazzjoni bejn mediċina u oħra mhux magħruf.
English: The proportions of different ethnic populations across these various classes are tabulated below.
Maltese: Il-proporzjonijiet ta' popolazzjonijiet etniċi differenti fost dawn id-diversi klassijiet huma miġbura fit-tabella t'hawn taħt.
English: Chair test (s)
Maltese: Test(ijiet) tas-siġġu