FrancophonIA/ELRC3.0 huggingface dataset:
English: Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure.
Maltese: .2) Inibituri qawwija tal-enzimi ċitokromju P450 (CYP450) eż. cimetidine, ketoconazole mhux probabbli li jistgħu jinibixxu l-metaboliżmu ta' amifampridine minn enzimi N-acetyl transferase (NATs) fil-bniedem iwassal għal żjieda fl-esponiment ta' amifampridine.
English: EXCELLA GmbH & Co KG Nürnberger Strasse 12 90537 Feucht
Maltese: KG Nürnberger Strasse 12
English: Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Maltese: Kull pillola fiha amifampridine phosphate ekwivalenti għal 10 mg ta' amifampridine.
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05.
Maltese: Kategorija farmakoterapewtika: mediċini oħra għas-sistema nervuża, Kodiċi ATC:
English: Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
Maltese: Folji perforati ta' dożi uniċi, iffurmati bis-sħana (Strixxi laminati ffurmati bis-sħana tal-aluminium-PVC/PVDC) li fihom 10 pilloli.
English: Medicinal products with cholinergic effects
Maltese: Prodotti mediċinali b'effetti kolinerġiċi
English: The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' FIRDAPSE fit-tfal minn età ta' 0 sa 17-il sena ma ġewx determinati s'issa.
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 wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: e p-value based on the Wilcoxon Rank Sum Test for treatment differences.
Maltese: Il-valur p kien ibbażat fuq it-Test ta' Wilcoxon Rank Sum għad-differenzi fit-trattament.
English: Cardiac disorders Cardiac rhythm disorders, palpitations
Maltese: Disturbi fil-qalb Disturbi fir-ritmu kardijaku, palpitazzjonijiet
English: NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets
Maltese: FIRDAPSE 10 mg pilloli
English: (ng/ml) mean (S.D.), range
Maltese: (ng/ml) medja (S.D.), firxa
English: Mean 3-N-acetyl Amifampridine PK Parameters
Maltese: Parametri PK Medji ta' 3-N-acetyl Amifampridine
English: • Dizziness
Maltese: • Dijarea
English: Patients with liver/kidney problems:
Maltese: Pazjenti bi problemi fil-fwied/kliewi:
English: The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day).
Maltese: Id-doża massima rrakkomandata hija 60 mg kull ġurnata (jiġifieri total ta' sitt pilloli li għandhom jittieħdu f'intervalli matul il-ġurnata).
English: It is recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7 days.
Maltese: Huwa rrakkomandat li t-titrazzjoni tad-doża minn 60 mg/ġurnata għal 80 mg/ġurnata ssir f'inkrementi ta' 5 mg kull 7 ijiem.
English: Amifampridine exposure by AUC0-∞ was up to 2-fold higher in slow acetylators and up to 3-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Maltese: Esponiment għal amifampridine skont l-AUC0-∞ kien sa 2 darbiet ogħla f'acetylators bil-mod u sa 3 darbiet ogħla f'acetylators mgħaġġla b'indeboliment renali sever meta mqabbel ma' individwi b'funzjoni renali normali.
English: If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).
Maltese: Jekk ikun hemm xi reazzjoni mhux mixtieqa, it-titrazzjoni 'l fuq tad-doża għandha titwaqqaf (ara sezzjonijiet 4.4 u 5.2).
English: • Concomitant use with sultopride (see sections 4.5 and 5.1)
Maltese: • Użu flimkien ma' sultopride (ara sezzjonijiet 4.5 u 5
English: This medicine has been authorised under “Exceptional Circumstances”.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: Statistically significant differences in amifampridine PK parameters Cmax, AUC0-∞, t1/2 and apparent clearance was observed between fast and slow acetylators at all dose levels.
Maltese: Differenzi statistikament sinifikanti fil-parametri PK Cmax, AUC0-∞, t1/2 u tneħħija apparenti ta' amifampridine kienu osservati bejn acetylators mgħaġġla u dawk bil-mod fil-livelli kollha tad-doża.
English: • Chorea (movement disorder), myoclonia (muscle spasm or twitching)
Maltese: • Korea (disturb tal-moviment), mijoklonja (spażmi jew kontrazzjonijiet tal-muskoli)
English: The starting dose is 5 mg amifampridine (half a tablet) three times daily (i.e. 15 mg per day).
Maltese: Id-doża tal-bidu hija 5 mg amifampridine (nofs pillola) tliet darbiet kuljum (jiġifieri 15-il mg fil-ġurnata).
English: The plasma elimination half-life is approximately 2.5 hours for the amifampridine and 4 hours for the 3-N-acetylated amifampridine metabolite.
Maltese: Il-half-life ta l-eliminazzjoni mill-plażma hija madwar 2.5 sigħat għal amifampridine u 4 sigħat għall-metabolita tiegħu 3-N-acetylated amifampridine.
English: Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.
Maltese: Jekk jogħġbok ara sezzjoni 5.2 għal aktar informazzjoni dwar il-bijodisponibilità ta' amifampridine fi stat mitmugħ u fi stat sajjem.
English: These substances include most anti-depressants (tricyclic antidepressants, selective serotonin uptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, bupropion and tramadol (see sections 4.4 and 5.1).
Maltese: Dawn is-sustanzi jinkludu l-biċċa l-kbira tal-antidepressanti (antidepressanti triċikliċi, inibituri selettivi tat-teħid ta' serotonin), newrolettiċi (phenothiazines u butyrophenones), mefloquine, bupropion u tramadol (ara sezzjonijiet 4.4 u 5.1).
English: There are no data on the pharmacokinetics of amifampridine in paediatric patients (see sections 4.2).
Maltese: M'hemmx informazzjoni dwar il-farmakokinetika ta' amifampridine f'pazjenti pedjatriċi (ara sezzjoni 4.2).
English: 1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Maltese: 1 Reazzjonijiet avversi rrappurtati fi studju kliniku sabiex jiġu evalwati l-effetti ta' amifampridine fuq ir-ripolarizzazzjoni kardiiaka wara doża waħda ta' 30 mg jew 60 mg f'voluntiera b'saħħithom.
English: Bioavailability is approximately 93-100% based on recoveries of unmetabolised amifampridine and a major 3-N-acetylated amifampridine metabolite in urine.
Maltese: Il-bijodisponibilità hija ta' madwar 93-100% bbażata fuq l-irkupru ta' amifampridine u mhux metabolizzata u tal-metabolit maġġuri 3-N-acetylated amifampridine fl-awrina.
English: • Tramadol (a painkiller)
Maltese: • Tramadol (mediċina biex tnaqqas l-uġigħ)
English: c CGI-I is a 7-point scale based on changes in symptoms, behaviour, and functional abilities (1=very much improved to 7=very much worse).
Maltese: CGI-I hija skala ta' 7 punti bbażata fuq bidliet fis-sintomi, l-imġiba, u l-abilitajiet funzjonali (1=titjib sinifikanti sa 7=aggravar sinifikanti).
English: Do not take FIRDAPSE
Maltese: Tiħux FIRDAPSE
English: (hr) mean (S.D.), range
Maltese: (hr) medja (S.D.), firxa
English: In a perinatal/postnatal reproduction study in pregnant rats treated with amifampridine, a dose-related increase in the percentage of mothers with stillborn offspring (16.7%-20%) was observed at 22.5 mg/kg/day and 75 mg/kg/day (1.1 and 2.7 times the 80 mg per day dose in humans based on Cmax).
Maltese: 7%-20%) b'doża ta' 22.5 mg/kg/jum u 75 mg/kg/jum (1.1 u 2.7 darbiet tad-doża ta' 80 mg kuljum fil-bnedmin ibbażata fuq is-Cmax).
English: Substances which are potent inducers of enzymes that metabolise medicinal products (see section 5.2) The results from in vitro studies suggest there is low potential for drug-drug interactions due to enzyme induction of CYP1A2, CYP2B6, and CYP3A4 enzymes by amifampridine.
Maltese: .2) Ir-riżultati minn studji in vitro jissuġġerixxu li hemm potenzjal baxx ta' interazzjoni bejn mediċina u oħra minħabba l-induzzjoni kkawżata minn enzima tal-enzimi CYP1A2, CYP2B6, u CYP3A4 minn amifampridine.
English: Hyperhidrosis1, cold sweat1
Maltese: Iperidrożi1, għaraq kiesaħ1
English: In the healthy volunteer study, fast acetylators were defined by having a caffeine metabolite ratio >0.3 and slow acetylators with a caffeine metabolite ratio <0.2 .
Maltese: Fi studju fuq voluntiera f'saħħithom, acetylators mgħaġġla kienu definiti bħala dawk li jkollhom proporzjon ta' metabolit tal-kaffeina ta' >0.3 u acetylators bil-mod bħala dawk li jkollhom proporzjon ta' metabolit tal-kaffeina ta' <0.2.
English: Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache
Maltese: Konvulżjonijiet, korea, ngħas, mijoklonija, dgħufija, għeja, uġigħ ta' ras
English: Most Schwannomas are benign and asymptomatic.
Maltese: Il-maġġoranza tax-Schwannomas huma beninji u asintomatiċi.
English: OTHER
Maltese: e
English: The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain).
Maltese: L-iżjed reazzjonijiet avversi huma l-parasteżiji (bħal parasteżiji periferali u peribukali) u d-disturbi gastro-intestinali (bħal epigastralġija, dijarea, dardir u wġigħ addominali).
English: Concentrations in tissues are generally similar to or greater than concentrations in plasma, with the greatest concentration in organs of excretion (liver, kidney and the gastrointestinal tract) and some tissues of glandular function (lacrimal, salivary, mucous, pituitary and thyroid glands).
Maltese: Konċentrazzjonijiet fit-tessuti ġeneralment huma simili għal jew ogħla mill-konċentrazzjonijiet fil-plażma, bl-akbar konċentrazzjoni fl-organi ta' tneħħija (fwied, kliewi u l-apparat gastro-intestinali) u f'xi tessuti ta' funzjoni glandolari (glandoli tad-dmugħ, tal-bżieq, tal-muku, pitwitarja u tat-tirojde).
English: Table 2: PK Parameters for Amifampridine in Fed and Fasted Subjects Following Administration of a Single Oral Dose of Amifampridine Phosphate
Maltese: Tabella 2: Parametri PK għal Amifampridine f'Individwi Mitmugħa u Sawma Wara Għoti ta' Doża Orali Waħda ta' Amifampridine Phosphate
English: d CFB for QMG total score was modelled as the response, with fixed effects terms for treatment and QMG at Baseline.
Maltese: d Is-CFB għall-punteġġ totali QMG kienet immudellata bħala r-rispons, b'termini għat-trattament b'effetti fissi u QMG fil-Linja bażi.
English: The safety profile in this study is consistent with adverse reactions observed with patients on amifampridine.
Maltese: Il-profil tas-sigurtà f'dan l-istudju huwa konsistenti ma' reazzjonijiet avversi osservati f'pazjenti fuq amifampridine.
English: Table 4: Mean PK Parameters of Amifampridine in Normal and Renal Impaired Subjects after Single Oral Dose Administration (10mg) in Slow and Fast Acetylator Phenotypes
Maltese: Tabella 4: Parametri PK Medji ta' Amifampridine f'Individwi b'Funzjoni Renali Normali u b'Indeboliment Renali wara
English: Table 1 below lists the adverse reactions reported with amifampridine.
Maltese: Tabella 1 hawn taħt telenka r-reazzjonijiet avversi b'amifampridine.
English: Amifampridi ne Dose (mg) Subjects (N) Acetylator Phenotype
Maltese: Individwi (N) Fenotip tal-Acetylator
English: • Together with medicines with a therapeutic dose close to the maximum safe dose
Maltese: • Flimkien ma' mediċini b'doża terapewtika qrib id-doża massima mingħajr periklu
English: There are no data on the pharmacokinetics of amifampridine in patients with hepatic impairment (see sections 4.2 and 4.4).
Maltese: Mhemmx dejta dwar il-farmakokinetika ta' amifampridine f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 4.4).
English: AUC 0-∞ (ng·h/ml)
Maltese: AUC 0-∞ (ng·siegħa/ml) 10.
English: Based on the pharmacodynamic properties of amifampridine, the concomitant use with sultopride or other medicinal products known to cause QT prolongation (e.g., disopyramide, cisapride, domperidone, rifampicin and ketoconazole) is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes (see sections 4.3 and 5.1).
Maltese: Ibbażat fuq il-kwalitajiet farmakodinamiku ta' amifampridine, l-użu flimkien ma' sultopride jew prodotti mediċinali oħra magħrufa li jikkawżaw titwil tal-QT (eż. disopyramide, cispride, domperidone, rifampicin u ketoconazole) huwa kontra-indikat billi din it-taħlita tista' twassal għal żjieda fir-riskju ta' takikardija ventrikolari, b'mod partikolari torsade de pointes (ara sezzjonijiet 4.3 u 5.1).
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: However, in a similar study in pregnant rabbits, there was no effect on embryo-foetal viability when evaluated just prior to birth at doses up to 57 mg/kg/day.
Maltese: Madankollu, fi studju simili f'firien tqal, ma kien hemm l-ebda effett fuq il-vijabilità embrijofetali meta ġew evalwati immedjatament qabel it-twelid f'dożi sa 57 mg/kg/jum.
English: To establish a Lambert Eaton Patient Registry as defined in the RMP and also incorporating measures of efficacy.
Maltese: Jitwaqqaf Reġistru ta' Pazjenti li għandhom Lambert Eaton kif definit fir-RMP u li jinkorpora wkoll miżuri ta' effikaċja.
English: • If you were born with heart problems (congenital QT syndromes)
Maltese: • Jekk twelidt bi problemi fil-qalb (sindromi konġenitali tal-QT)
English: • Medicines that may change the electrical activity of your heart (QT-interval prolongation detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone,
Maltese: • Mediċini li jistgħu jibdlu l-attività elettrika ta' qalbek (titwil fl-intervall tal-QT, li jidher fl-elettrokardjogramma) eż., sultopride, disopyramide, cisapride, domperidone, rifampicin, u ketoconazole (ara “Tiħux FIRDAPSE”)
English: Orally administered amifampridine is rapidly absorbed in humans, reaching peak plasma concentrations by 0.6 to 1.3 hours (mean values).
Maltese: Amifampridine mogħti mill-ħalq huwa assorbit malajr fil-bnedmin, u jilħaq konċentrazzjonijiet massimi fil-plażma fi żmien 0.6 sa 1.3 sigħat (valuri medja).
English: • Nausea
Maltese: • Sturdament
English: FIRDAPSE is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults.
Maltese: FIRDAPSE jintuża biex jiġu ttrattati s-sintomi ta' marda tan-nervituri u tal-muskoli msejħa s-sindrome mijasteniku ta' Lambert-Eaton jew LEMS f'persuni adulti.
English: Renal and hepatic impairment
Maltese: Indeboliment renali jew epatiku
English: In safety pharmacology studies in rats, no respiratory system related effects were seen up to 10 mg/kg or on the central nervous system up to 40 mg/kg.
Maltese: L-effett tal-età fuq il-farmakokinetika ta' amifampridine ma ġiex studjat. 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Fi studji ta' sigurtà farmakoloġika fuq il-firien, ma dehrux effetti relatati mas-sistema respiratorja sa 10 mg/kg jew fuq is-sistema nervuża ċentrali sa 40 mg/kg.
English: (ng/ml) Tmax (hr)
Maltese: Cmax (ng/ml) Tmax (siegħa) t1/2 (siegħa)
English: • Together with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram), such as:  Sultropride (a medicine prescribed to treat certain behavioural disorders in adults),  Antiarrhythmic medicine (e.g., disopyramide)  Medicines to treat digestive problems (e.g., cisapride, domperidone)
Maltese: • Flimkien ma' mediċini li jistgħu jibdlu l-attività fiżika ta' qalbek (titwil tal-intervall QTosservat fl-elettrokardjogramma), bħal:  Sultropride (mediċina preskritta għall-kura ta' ċerti disturbi fl-imġiba fl-adulti),  Mediċina antiarritmika (eż., disopyramide)
English: In vitro and in vivo studies in humans indicate that amifampridine is metabolised to a single major 3-N-acetylated amifampridine metabolite.
Maltese: Studji in vitro u in vivo fil-bniedem jindikaw li amifampridine huwa metabolizzat għal metabolita maġġuri wieħed, 3- N- aċetilatati amifampridine.
English: • Uncontrolled asthma
Maltese: • Ażma mhix ikkontrollata
English:  Medicines to treat infections - antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole)
Maltese:  Mediċini għall-kura ta' problemi diġestivi (eż., cisapride, domperidone)  Mediċini għall-kura ta' infezzjonijiet - antibijotiċi (eż., rifampicin) u antifungali (eż., ketoconazole)
English: Medicinal products with atropinic effects include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic,
Maltese: Prodotti mediċinali b'effetti atropiniċi jinkludu l-antidepressanti triċikliċi, ħafna mill-antiistamini atropiniċi
English: Medicinal products known to lower the epileptic threshold The concomitant use of amifampridine and substances known to lower the epileptic threshold may lead to an increased risk of seizures.
Maltese: Prodotti mediċinali magħrufa li jbaxxu l-limitu epilettiku L-użu ta' amifampridine flimkien ma' sustanzi li huma magħrufa li jbaxxu l-limitu epilettiku jista' jwassal għal żjieda fir-riskju ta' aċċessjonijiet.
English: A double-blind, placebo-controlled, randomized withdrawal Study to evaluate the efficacy and safety of amifampridine phosphate in Patients with LEMS was conduct in adult patients 18 years of age or older (n=26).
Maltese: Studju dwar it-twaqqif tal-mediċina double-blind, ikkontrollat bi plaċebo u randomizzat għall-evalwazzjoni tal-effikaċja u s-sigurtà ta' amifampridine phosphate f'Pazjenti b'LEMS twettaq f'pazjenti adulti li għandhom 18-il sena jew ikbar (n=26).
English: In addition, CGI-I scores at day 4 as determined by physicians showed significant improvement in patients remaining on amifampridine phosphate compared to placebo (p=0.0020).
Maltese: Barra dan, il-punteġġi CGI-I f'Jum 4 kif determinati mit-tobba wrew titjib sinifikanti f'pazjenti li baqgħu fuq amifampridine phosphate mqabbla ma' plaċebo (p=0.0020).
English: CGI-I Scoresc
Maltese: DATA TA' SKADENZA
English: In humans, the rate and extent of absorption of amifampridine is influenced by food (see Table 2).
Maltese: Fil-bnedmin, ir-rata u l-ammont ta' assorbiment ta' amifampridine huwa influwenzat mill-ikel (ara Tabella 2).
English: Exposure to amifampridine is associated with an increased risk for epileptic seizures.
Maltese: L-esponiment għal amifampridine huwa assoċjat ma' żjieda fir-riskju ta' aċċessjonijiet epilettiċi.
English: No effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the QTc interval.
Maltese: L-ebda effett ta' amifampridine phosphate ma ġie osservat fuq ir-ripolarizzazzjoni kardijaka kif evalwat bl-użu tal-intervall tal-QTc.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Following oral administration of radiolabelled [14C] amifampridine, radioactive material is rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body.
Maltese: Wara għoti orali ta' amifampridine radjutikkettat [14C], il-materjal radjuattiv huwa assorbit malajr mill-apparat gastro-intestinali u jiġi mifrux sew madwar il-ġisem.
English: The pharmacokinetics of amifampridine has been assessed in a single dose Phase I study in patients with renal impairment (see section 5.2).
Maltese: Il-farmakokinetika ta' amifampridine kienet evalwata fi studju ta' Fażi I b'doża waħda f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: The effect of a single dose of 30 mg or 60 mg of amifampridine phosphate was used to evaluate the pharmacokinetic-QTc relationship of amifampridine concentration on cardiac repolarization exposure in healthy volunteers.
Maltese: L-effett ta' doża waħda ta' 30 mg jew 60 mg ta' amifampridine phosphate intuża biex tiġi evalwata r-relazzjoni farmakokinetika-QTc tal-konċentrazzjoni tal-mediċina fuq l-esponiment tar-ripolarizzazzjoni kardijaka f'voluntiera b'saħħithom.
English: McEvoy et al 1989 reported data from a short-term study in 12 patients with LEMS, which demonstrated that administration of amifampridine at doses up to 100 mg/day for a period of 3 days was effective in treating the autonomic and motor symptoms of LEMS.
Maltese: Żewġ studji oħra fuq total ta' 57 pazjent b'LEMS irrapportaw dejta minn dożi akbar ta' amifampridinea McEvoy et al 1989, irrapportaw dejta minn studju fuq perijodu qasir fi 12-il pazjent b'LEMS, li wera li l-għoti ta' amifampridine a'dożi sa 100 mg / ġurnata għal perijodu ta' 3 ijiem kien effettiv fil-kura tas-sintomi awtonomiċi u motorili tal-LEMS.
English: • Raynaud's syndrome (circulation disorder affecting the fingers and toes)
Maltese: • Sindromu ta' Raynaud (disturb fiċ-ċirkolazzjoni li jaffettwa s-swaba' tal-idejn u tas-saqajn)
English: Substances which are potent inhibitors of enzymes that metabolise medicinal products (see section 5.2)
Maltese: Sustanzi li huma inibituri qawwija ta' enzimi li jimmetabolizzaw prodotti mediċinali (ara sezzjoni 5
English: Fast
Maltese: JIS
English: This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness.
Maltese: Din il-marda hija disturb li jaffettwa t-trasmissjoni tal-impulsi min-nervituri lejn il-muskoli, li jirriżulta fi dgħjufija tal-muskoli.
English: In patients suffering from this disease, a chemical substance called acetylcholine, which communicates nerve impulses to muscles is not released normally and the muscle doesn't receive some or all of the nerve's signals.
Maltese: Fil-pazjenti li jsofru minn din il-marda, sustanza kimika msejħa acetycholine, li tikkomunika l-impulsi tan-nervituri lejn il-muskoli ma tiġix rilaxxata b'mod normali u l-muskolu ma jirċevix xi wħud jew is-sinjali kollha tan-nervituri.
English: This evaluation was conducted in a Phase 1, double-blind, randomized, crossover study to define the ECG effects of amifampridine phosphate at these doses compared to placebo and moxifloxacin (a positive control) in healthy men and women who are slow acetylators (n=52).
Maltese: Din l-evalwazzjoni twettqet fi studju crossover ta' Fażi 1, double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, biex jiġu definiti l-effetti tal-ECG ta' amifampridine phosphate f'dawn id-dożi meta mqabbla mal-plaċebo u moxifloxacin (kontroll pożittiv) f'irġiel u nisa b'saħħithom u nisa li huma acetylators bil-mod (n=52).
English: Distribution of amifampridine was studied in the rat.
Maltese: Id-distribuzzjoni ta' amifampridine ġiet studjata fil-far.
English: Exposure by Cmax was only marginally affected by renal impairment regardless of acetylation status.
Maltese: Esponiment skont Cmax kien affettwat b'mod minimu biss permezz ta' indeboliment renali irrispettivament mill-istat ta' acetylation.
English: Animal studies evaluating the reproductive and developmental toxicity of amifampridine were conducted in rats and rabbits at doses up to 75 mg/kg/day.
Maltese: Studji fuq l-annimali li evalwaw l-effett ta'amifampridine fuq it-tossiċita riproduttiva u l-iżvilupp saru fuq firien u fniek f'dożi sa 75 mg/kg/jum.
English: MAO-B inhibitors (e.g. selegiline, deprenyl), COMT inhibitors (e.g. entacapone)
Maltese: • Mediċini għall-kura tal-marda ta' Parkinson - antikolinerġiċi (eż. trihexylphenidyl, mesylate), inibituri MAO-B (eż. selegiline, deprenyl), inibituri COMT (eż. entacapone)
English: • Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)
Maltese: • Użu flimkien ma' prodotti mediċinali b'tieqa terapewtika dejqa (ara sezzjoni 4.5).