FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of safinamide with levodopa/carbidopa resulted in additive effects in the embryo-foetal development studies with a higher incidence of foetal skeletal abnormalities than seen with either treatment alone.
Croatian: Kombinacija safinamida s levodopom/karbidopom rezultirala je aditivnim učincima u ispitivanjima embriofetalnog razvoja s višom incidencijom fetalnih koštanih abnormalnosti nego što je uočeno u samostalnom liječenju.
English: The tabulation below includes all adverse reactions in clinical trials where adverse reactions were considered related.
Croatian: Tablični prikaz u nastavku uključuje sve nuspojave u kliničkim ispitivanjima gdje su nuspojave smatrane povezanima.
English: The ‘N-dealkylated acid' (NW-1689) undergoes conjugation with glucuronic acid yielding its acyl glucuronide.
Croatian: „N-dealkilirana kiselina“ (NW-1689) podliježe konjugaciji s glukuronskom kiselinom dajući svoj acil glukuronid.
English: Dedicated drug-drug interaction studies performed with ketoconazole, L-dopa and CYP1A2 and CYP3A4 substrates (caffeine and midazolam), did not detect any clinically significant effects on the pharmacokinetics of safinamide, or L-dopa, caffeine and midazolam.
Croatian: Namjenska ispitivanja interakcija između lijekova provedena s ketokonazolom, L-dopom i supstratima CYP1A2 i CYP3A4 (kofein i midazolam), nisu otkrila nikakve klinički značajne učinke na farmakokinetiku safinamida ili L-dope, kofeina i midazolama.
English: Safinamide exposure in patients with mild hepatic disease increased marginally (30% in AUC), while in patients with moderate hepatic impairment exposure increased by approximately 80% (see section
Croatian: Izloženost safinamidu u bolesnika s blagom bolešću jetre neznatno se povećala (30% u AUC-u), dok je u bolesnika s umjerenim oštećenjem jetre izloženost povećana za oko 80% (vidjeti dio 4.2).
English: You must wait at least 7 days after stopping Xadago treatment before starting treatment with MAO inhibitors or pethidine.
Croatian: Morate čekati najmanje 7 dana između prestanka liječenja lijekom Xadago i početka liječenja MAO inhibitorima ili petidinom.
English: Potential for retinal degeneration in patients with prior history of retinal disease
Croatian: Moguća degeneracija mrežnice u bolesnika s prethodnom anamnezom bolesti mrežnice
English: Medicinal products that are inhibitors of OAT3 given concomitantly with safinamide may reduce clearance of NW-1153, i.e., and thus may increase its systemic exposure.
Croatian: Lijekovi koji su inhibitori OAT3 kada se daju istodobno sa safinamidom mogu smanjiti klirens NW1153, tj., i tako mogu povećati njegovu sistemsku izloženost.
English: The recommended starting dose of Xadago is one 50 mg tablet that may be increased to one 100 mg tablet, taken once daily preferably in the morning by mouth with water.
Croatian: Preporučena početna doza lijeka Xadago je jedna tableta od 50 mg koja se uzima jednom dnevno na usta s vodom, po mogućnosti ujutro.
English: In vitro metabolism studies have indicated that there is no meaningful induction or inhibition of cytochrome P450, CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A3/5 at concentrations which are relevant (Cmax of free safinamide 0.4 µM at 100 mg/day) in man.
Croatian: In vitro ispitavanja metabolizma pokazala su da ne postoji značajna indukcija ili inhibicija citokroma P450, CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A3/5 u koncentracijama koje su relevantne (Cmax slobodnog safinamida 0,4 µM kod 100 mg/dan) u ljudi.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
English: Arterial spasm, arteriosclerosis, hypertensive crisis
Croatian: Spazam arterija, arterioskleroza, hipertenzivna kriza
English: If you stop taking Xadago
Croatian: Ako prestanete uzimati Xadago
English: Preliminary in vitro studies have shown that safinamide is not a substrate for the transporters P-gp, BCRP, OAT1B1, OAT1B3, OATP1A2 or OAT2P1.
Croatian: Preliminarna in vitro ispitivanja pokazala su da safinamid nije supstrat za transportere P-gp, BCRP, OAT1B1, OAT1B3, OATP1A2 ili OAT2P1.
English: In humans, safinamide is almost exclusively eliminated via metabolism (urinary excretion of unchanged safinamide was <10%) mediated principally through high capacity amidases, that have not yet been characterized.
Croatian: U ljudi, safinamid se gotovo isključivo eliminira metabolizmom (ekskrecija nepromijenjenog safinamida urinom bila je <10%) posredovanim prvenstveno amidazama visokog kapaciteta, koje još uvijek nisu okarakterizirane.
English: This interaction has the potential to reduce the clearance of NW1153 and increase its exposure; however the systemic exposure of NW-1153 is low (1/10 of parent safinamide), and as it is metabolised to secondary and tertiary metabolites, it is unlikely to be of any clinical relevance.
Croatian: Ta interakcija ima potencijal smanjivanja klirensa NW-1153 i povećanja njegove izloženosti; međutim, sistemska izloženost NW-1153 je niska (1/10 ishodišnog safinamida), a kako se metabolizira u sekundarne i tercijarne metabolite, malo je vjerojatno da će biti od kliničke važnosti.
English: No retinal degeneration was noted in monkeys despite higher systemic exposure than in rodents or in patients at the maximum human dose.
Croatian: Degeneracija mrežnice nije uočena u majmuna usprkos većoj sistemskoj izloženosti nego u glodavaca ili u bolesnika na maksimalnoj ljudskoj dozi.
English: There are no or limited amount of data from the use of safinamide in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni safinamida u trudnica ograničeni.
English: In particular, the concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided, or if concomitant treatment is necessary these medicinal products should be used at low doses (see section 4.5).
Croatian: Osobito je potrebno izbjegavati istodobnu primjenu safinamida i fluoksetina ili fluvoksamina, a ako je istodobno liječenje neophodno ti se lijekovi moraju koristiti u niskim dozama (vidjeti dio 4.5).
English: Caution should be exercised when initiating treatment with safinamide in patients with moderate hepatic impairment.
Croatian: Potreban je oprez prilikom početka liječenja safinamidom u bolesnika s umjerenim oštećenjem jetre.
English: Safinamide used as an adjunct to levodopa may potentiate the side effects of levodopa, and preexisting dyskinesia may be exacerbated, requiring a decrease of levodopa.
Croatian: Safinamid primijenjen kao dodatna terapija uz levodopu može pojačati nuspojave levodope, a već postojeća diskinezija može se pogoršati, zahtijevajući smanjenje doze levodope.
English: Safinamide inhibits OCT1 in vitro at clinically relevant portal vein concentrations.
Croatian: Safinamid inhibira OCT1 in vitro pri klinički relevantnim koncentracijama u portalnoj veni.
English: Safinamide is almost exclusively eliminated via metabolism, largely by high capacity amidases that have not yet been characterized.
Croatian: Safinamid se gotovo isključivo eliminira putem metabolizma, najvećim dijelom amidazama visokog kapaciteta koje još nisu okarakterizirane.
English: Impulse control disorders; pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Croatian: Poremećaji kontrole impulsa; patološko kockanje, povećani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu se pojaviti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima.
English: Breast Feeding Xadago is likely to be excreted in breast milk.
Croatian: Dojenje Xadago se vjerojatno izlučuje u majčino mlijeko.
English: The results obtained from carcinogenicity studies in mice and rats showed no evidence of tumorigenic potential related to safinamide at systemic exposures up to 2.3 to 4.0 times respectively, the anticipated systemic exposure in patients given the maximal therapeutic dose.
Croatian: Rezultati dobiveni iz ispitivanja kancerogenosti u miševa i štakora nisu pokazali dokaze tumorogenog potencijala povezanog sa safinamidom pri sistemskim izloženostima od 2,3 do 4,0 puta većima od očekivane sistemske izloženosti u bolesnika koji su primili maksimalnu terapijsku dozu.
English: The efficacy of safinamide as add-on treatment in mid-to late-stage PD (LSPD) patients with motor fluctuations, currently receiving L-dopa alone or in combination with other PD medicinal products, was evaluated in two double-blind, placebo-controlled studies: Study SETTLE (Study 27919; 50-100 mg/day; 24 weeks), and Study 016/018 (50 and 100 mg/day; 2-year, double-blind, placebo-controlled study).
Croatian: Djelotvornost saflumida kao dodatka liječenju u srednjem do kasnom stadiju PB bolesnika s fluktuacijama motorike, koji trenutno primaju L-dopu samu ili u kombinaciji s drugim PB lijekovima, procijenjena je u dva dvostruko slijepa, placebom kontrolirana ispitivanja: Ispitivanje SETTLE (Ispitivanje 27919; 50 - 100 mg/dan; 24 tjedna) i Ispitivanje 016/018 (50 i 100 mg/dan; dvostruko slijepo, placebom kontrolirano ispitivanje u trajanju od 2 godine).
English: When safinamide is co-administered with products that are BCRP substrates, please refer to the SmPC for that particular medicinal product.
Croatian: Kada se safinamid primjenjuje istodobno s lijekovima koji su supstrati BCRP-a, pogledajte sažetak opisa svojstava lijeka za taj određeni lijek.
English: In vivo and in vitro pharmacokinetic drug interactions
Croatian: In vivo i in vitro farmakokinetičke interakcije lijekova
English: Population PK models developed from studies in patients with Parkinson's disease indicate that the pharmacokinetic and pharmacodynamics effects of safinamide were not dependent on age, gender, weight, renal function and exposure to levodopa, indicating that dose adjustments will not be required based on these variables.
Croatian: Modeli populacijske farmakokinetike, razvijeni iz ispitivanja u bolesnika s Parkinsonovom bolešću ukazuju da farmakokinetički i farmakodinamički učinci safinamida ne ovise o dobi, spolu, težini, funkciji bubrega i izloženosti levodopi, što ukazuje da neće biti potrebna prilagodba doze na temelju tih varijabli.
English: In vivo and in vitro pharmacodynamic drug interactions
Croatian: In vivo i in vitro farmakodinamičke interakcije lijekova
English: Metabolite NW-1153 is not a substrate for OCT2, or OAT1, but it is substrate for OAT3.
Croatian: Metabolit NW-1153 nije supstrat za OCT2 ili OAT1, ali je supstrat za OAT3.
English: Xadago is supplied in packs containing 14, 28, 30, 90 or 100 film coated tablets.
Croatian: Xadago tablete dostupne su u pakiranjima koja sadrže 14, 28, 30, 90 ili 100 filmom obloženih tableta.
English: Concomitant treatment with other monoamine oxidase (MAO) inhibitors (see sections 4.4 and 4.5).
Croatian: Istodobno liječenje s drugim inhibitorima monoaminooksidaze (MAO) (vidjeti dijelove 4.4 i 4.5).
English: Retinal degeneration was observed in rodents after repeated safinamide dosing resulting in systemic exposure below the anticipated systemic exposure in patients given the maximal therapeutic dose.
Croatian: Degeneracija mrežnice uočena je u glodavaca nakon ponovljenih doziranja safinamida što je rezultiralo sistemskom izloženošću ispod očekivane sistemske izloženosti u bolesnika koji su primili maksimalnu terapijsku dozu.
English: At least 7 days must elapse between discontinuation of safinamide and initiation of treatment with MAO inhibitors or pethidine (see section 4.3 and 4.5).
Croatian: Mora proći najmanje 7 dana između prestanka liječenja safinamidom i početka liječenja MAO inhibitorima ili petidinom (vidjeti dijelove 4.3 i 4.5).
English: Use in patients with albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy (see sections 4.4 and 5.3).
Croatian: Primjena u bolesnika s albinizmom, degeneracijom mrežnice, uveitisom, naslijeđenom retinopatijom ili teškom progresivnom dijabetičkom retinopatijom (vidjeti dijelove 4.4 i 5.3).
English: Safinamide transiently inhibits BCRP in the small intestine (see section 4.5).
Croatian: Safinamid prolazno inhibira BCRP u tankom crijevu (vidjeti dio 4.5).
English: Pooled analyses of adverse event data from placebo controlled studies in Parkinson's disease patients indicate that the concomitant administration of safinamide together with a broad category of commonly used medicinal products in this patient population (antihypertensive, beta-blockers cholesterol lowering, non-steroidal anti-inflammatory medicinal products, proton pump inhibitors, antidepressants, etc.) was not associated with an increased risk for adverse events.
Croatian: Objedinjene analize podataka o štetnim događajima iz placebom kontroliranih ispitivanja bolesnika s Parkinsonovom bolešću ukazuju na to da istodobna primjena safinamida zajedno sa širokom kategorijom uobičajeno primjenjivanih lijekova u populaciji tih bolesnika (antihipertenzivi, beta blokatori, lijekovi za snižavanje kolesterola, nesteroidni protuupalni lijekovi, inhibitori protonske pumpe, antidepresivi, itd.) nije povezana s povećanim rizikom za štetne događaje.
English: Total clearance was determined to be 4.6 L/h classifying safinamide as a low clearance substance.
Croatian: Ukupan klirens određen je u vrijednosti od 4,6 l/h što klasificira safinamid kao tvar niskog klirensa.
English: Xadago is a medicine that contains the active substance safinamide.
Croatian: Xadago je lijek koji sadrži djelatnu tvar safinamid.
English: Male rats showed minor abnormal morphology and reduced speed of sperm cells at exposures in excess of 1.4 times the anticipated human exposure.
Croatian: Mužjaci štakora pokazali su manju abnormalnu morfologiju i smanjenu brzinu stanica sperme, pri izloženostima 1,4 puta većima od očekivane izloženosti u ljudi.
English: Xadago is indicated for the treatment of adult patients with idiopathic Parkinson's disease (PD) as addon therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Croatian: Xadago je indiciran za liječenje odraslih bolesnika s idiopatskom Parkinsonovom bolešću (PB) kao dodatna terapija stabilnoj dozi levodope (L-dopa) same ili u kombinaciji s drugim lijekovima za Parkinsonovu bolest u bolesnika u srednjem do kasnom stadiju s fluktuacijama.
English: If you suffer from moderately reduced liver function, you should not take more than 50 mg a day; your doctor will advise if this applies to you.
Croatian: Ako bolujete od umjerenog oštećenja funkcije jetre, Vaša doza ne smije biti viša od 50 mg dnevno.
English: If you forget to take Xadago
Croatian: Ako ste zaboravili uzeti Xadago
English: In view of the MAO inhibitory activity of safinamide, the concomitant administration of safinamide and dextromethorphan is not recommended, or if concomitant treatment is necessary, it should be used with caution (see section 4.4).
Croatian: S obzirom na MAO inhibicijsku aktivnost safinamida, istodobna primjena safinamida i dekstrometorfana se ne preporučuje, a ako je istodobno liječenje neophodno, potrebno ga je primijenjivati s oprezom (vidjeti dio 4.4).
English: MAO inhibitors and pethidine
Croatian: MAO inhibitori i petidin
English: Xadago should not be used during breast-feeding.
Croatian: Xadago se ne smije koristiti tijekom dojenja.
English: Decreased appetite, hypertriglyceridaemia, increased appetite, hypercholesterolaemia, hyperglycaemia,
Croatian: Smanjen apetit, hipertrigliceridemija, povećan apetit, hiperkolesterolemija, hiperglikemija,
English: The metabolite NW-1153 is a substrate for OAT3 at clinically relevant concentrations.
Croatian: NW-1153 je supstrat za OAT3 u klinički relevantnim koncentracijama.
English: The following side effects have been reported in patients at a mid- to late-stage of Parkinson's disease (patients taking safinamide as add-on to levodopa alone or in combination with other medicines for Parkinson's disease):
Croatian: Sljedeće nuspojave prijavljene su u bolesnika u srednjem do kasnom stadiju Parkinsonove bolesti (bolesnici koji uzimaju safinamid kao dodatak lijeku levodopa, uzimanog samostalno ili u kombinaciji s drugim lijekovima za Parkinsonovu bolest):
English: - If you have been told that you have severe liver problems - If you have an eye condition which might put you at risk of potential damage to your retina (the light sensitive layers at the back of your eyes), e.g. albinism (lack of pigment in your skin and eyes), retinal degeneration (loss of cells from light sensitive layer at the back of the eye), or uveitis (inflammation inside of the eye), inherited retinopathy (inherited disorders of the vision), or severe progressive diabetic retinopathy (a progressive decrease of the vision due to diabetes).
Croatian: - Ako imate neko stanje oka koje bi Vas moglo izložiti riziku od mogućeg oštećenja mrežnice (sloja koji je osjetljiv na svjetlost u stražnjem dijelu oka), npr. albinizam (nedostatak pigmenta u Vašoj koži i očima), degeneraciju mrežnice (gubitak stanica u sloju osjetljivom na svjetlost u stražnjem dijelu oka) ili uveitis (upala unutrašnjosti oka), naslijeđenu retinopatiju (naslijeđeni poremećaji vida) ili tešku progresivnu dijabetičku retinopatiju (progresivno smanjenje vida zbog šećerne bolesti).
English: Safinamide should not be administered to patients with ophthalmological history that would put them at increased risk for potential retinal effects (e.g., family history of hereditary retinal disease, or history of uveitis) see sections 4.3 and 5.3.
Croatian: Safinamid se ne smije primjenjivati u bolesnika s anamnezom oftalmološke bolesti koja bi u njih povećala rizik od mogućeg učinka na mrežnicu (npr. obiteljska anamneza nasljedne bolesti mrežnice, ili anamneza uveitisa) vidjeti dijelove 4.3 i 5.3.
English: - The other ingredients are: - Tablet core: microcrystalline cellulose, crospovidone type A, magnesium stearate, silica colloidal anhydrous - Tablet coating: hypromellose, macrogol (6000), titanium dioxide (E171), iron oxide red (E172), mica (E555).
Croatian: Drugi sastojci su: Jezgra tablete: mikrokristalična celuloza, krospovidon vrste A, magnezijev stearat, koloidni bezvodni silicijev dioksid Filmska ovojnica: hipromeloza, makrogol 6000, titanijev dioksid (E171), željezov oksid, crveni (E172), mica (E555).
English: In view of the MAO inhibitory activity of safinamide, concomitant administration of safinamide and sympathomimetics, such as those present in nasal and oral decongestants or cold medicinal products containing ephedrine or pseudoephedrine, requires caution (see section 4.4).
Croatian: S obzirom na MAO inhibicijsku aktivnost safinamida, istodobna primjena safinamida i simpatomimetika, kao što su oni sadržani u nazalnim i oralnim dekongestivima ili lijekovima za prehladu koji sadrže efedrin ili pseudoefedrin, zahtijeva oprez (vidjeti dio 4.4).
English: In drug-drug-interaction studies in human, a weak interaction was observed with rosuvastatin (AUC increase between 1.25 and 2.00 fold) but no significant interaction was found with diclofenac.
Croatian: Safinamid može prolazno inhibirati BCRP in vitro.U ispitivanjima interakcije među lijekovima u ljudi, uočena je slaba interakcija s rosuvastatinom (AUC povećan između 1,25 i 2,00 puta), ali nije utvrđena značajna interakcija s diklofenakom.
English: These symptoms resolved on discontinuing the medicinal product, without sequelae.
Croatian: Ti simptomi su se prekidom lijeka povukli bez posljedica.
English: Safinamide acts through both dopaminergic and non-dopaminergic mechanisms of action.
Croatian: Safinamid djeluje i dopaminergičkim i nedopaminergičkim mehanizmima djelovanja.
English: (d) (a) Daily targeted dose, (b) Mean (SD), (c) analysis population (mITT); MMRM model for change from Baseline to Endpoint includes treatment, region, and visit as fixed effects, and baseline value as a covariate; (d) target dose of 100 mg/day; (e) analysis population (mITT); data are presented as the number (percentage) of patients in each group meeting the responder definition (f) chi-square test of the odds ratio of the treatment groups compared to placebo using a logistic regression model, with fixed effects for treatment and country.
Croatian: p-vrijednost CGI-C: bolesnici koji su se mnogo/vrlo mnogo poboljšali p-vrijednost(f) (a) Dnevna ciljana doza, (b) Srednja vrijednost (SD), (c) analiza populacije (mITT, engl. modified intention-to-treat); MMRM model (engl. mixed effects model repeated measures) za promjenu od početne vrijednosti do ishoda uključuje liječenje, regiju i posjetu kao fiksne učinke, a početnu vrijednost kao kovarijatu; (d) ciljana doza od 100 mg/dan; (e) analiza populacije (mITT); podaci su predstavljeni kao broj (postotak) bolesnika u svakoj skupini koji ispunjavaju definiciju ispitanika s odgovorom; (f) hikvadrat test omjera izgleda liječenih skupina u usporedbi s placebom primjenom modela logističke regresije s fiksnim učincima liječenja i zemljom.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP” The expiry date refers to the last day of that month.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“ i „EXP“.
English: The symptoms of an excessive MAO-B inhibition (increase in dopamine level) could include hypertension, postural hypotension, hallucinations, agitation, nausea, vomiting, and dyskinesia.
Croatian: Simptomi pretjerane MAO-B inhibicije (povećanje razine dopamina) mogu uključivati hipertenziju, posturalnu hipotenziju, halucinacije, agitaciju, mučninu, povraćanje i diskineziju.
English: With MAO-inhibitors there have been reports of drug interactions with concomitant use of sympathomimetic medicinal products.
Croatian: U vezi s MAO-inhibitorima bilo je izvještaja o interakciji između lijekova prilikom istodobne uporabe simpatomimetičkih lijekova.
English: It is recommended to monitor patients when safinamide is taken with medicinal products that are BCRP substrates (e.g., rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac or glyburide) and to refer to their SmPCs to determine if a dose adjustment is needed.
Croatian: Preporučuje se pratiti bolesnike kada se safinamid uzima s lijekovima koji su supstrati BCRP-a (npr., rosuvastatin, pitavastatin, pravastatin, ciprofloksacin, metotreksat, topotekan, diklofenak ili gliburid) te pogledati njihove sažetke opisa svojstava lijeka kako bi se utvrdilo je li potrebna prilagodba doze.
English: In a pre- and postnatal developmental rat study, pup mortality, absence of milk in the stomach and neonatal hepatotoxicity were observed at dose levels similar to the anticipated clinical exposure.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja štakora, mortalitet mladunaca, odsustvo mlijeka u trbuhu i neonatalna hepatotokičnost uočeni su pri dozama sličnim očekivanoj kliničkoj izloženosti.
English: In mid- to late-stage patients experiencing sudden switches between being “ON” and able to move and being “OFF” and having difficulties moving about, Xadago is added to a stable dose of the medicine called levodopa alone or in combination with other medicines for Parkinson's disease.
Croatian: U bolesnika u srednjem do kasnom stadiju koji doživljavaju iznenadne prelaske između razdoblja „ON“ s mogućnošću kretanja i razdoblja „OFF“ s poteškoćama u kretanju, Xadago je dodatak stabilnoj dozi lijeka koji se naziva levodopa, uzimanog samostalno ili u kombinaciji s drugim lijekovima za Parkinsonovu bolest.
English: Finally the ‘N-dealkylated acid' (NW-1689) is formed by oxidative cleavage of the amine bond of either safinamide (minor) or the primary safinamide acid metabolite (NW-1153) (major).
Croatian: Konačno „N-dealkilirana kiselina“ (NW-1689) stvara se oksidativnim cijepanjem aminske veze ili safinamida (manje) ili primarnog metabolita safinamidne kiseline (NW-1153) (znatno).