FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Koncentracije v tkivu so na splošno podobne koncentracijam v plazmi ali večje od njih, pri čemer je največja koncentracijah v organih izločanja (jetra, ledvice in prebavila) in v nekaterih tkivih z žlezno funkcijo (lakrimalna, salivarna, sluznična, hipofizna in ščitnična žleza).
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 .
Slovenian: V študiji z zdravimi prostovoljci so bili hitri acetilatorji opredeljeni kot tisti z razmerjem kofeinskega presnovka > 0,3 in počasni acetilatorji kot tisti z razmerjem kofeinskega presnovka < 0,2.
English: If any side effects occur, please consult your doctor as you may need to stop increasing the dose.
Slovenian: V primeru neželenih učinkov se posvetujte z zdravnikom, saj boste morda morali prenehati s povečevanjem odmerka.
English: Women of childbearing potential must use effective contraception during FIRDAPSE treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom FIRDAPSE.
English: Raynaud's syndrome
Slovenian: Raynaudov sindrom neznana
English: Similarly Cmax and AUC0-∞ were greater in the fasted state than in the fed state.
Slovenian: Podobno sta bili tudi vrednosti Cmax in AUC0-∞ večji v stanju na tešče kot s hrano.
English: Other medicines and FIRDAPSE Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The patients were maintained on a stable dose and frequency of amifampridine phosphate for at least 7 days prior to randomization.
Slovenian: Bolniki so prejemali amifampridinijev fosfat v stabilnih odmerkih in z enako pogostnostjo vsaj 7 dni pred randomizacijo.
English: Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.
Slovenian: Amifampridin je treba uporabljati previdno pri bolnikih s povečanim tveganjem za razvoj švanomov, npr. bolnikih, pri katerih je v preteklosti prišlo do razvoja takšnih tumorjev, ali bolnikih z anamnezo nevrofibromatoze tipa 2 ali schwannomatosis (obliko nevrofibromatoze).
English: Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation.
Slovenian: Amifampridin zavira napetostno odvisne kalijeve kanalčke in s tem podaljša predsinaptično depolarizacijo celične membrane.
English: In the event of a seizure, treatment should be discontinued.
Slovenian: V primeru epileptičnega napada je treba zdravljenje prekiniti.
English: Medicinal products eliminated through metabolism or active secretion There are no data on the effects of amifampridine on the metabolism or active secretion of other medicinal products.
Slovenian: Zdravila, ki se izločajo s presnovo ali aktivnim izločanjem Ni podatkov o učinkih amifampridina na presnovo ali aktivno izločanje drugih zdravil.
English: The starting dose is 5 mg amifampridine (half a tablet) three times daily (i.e. 15 mg per day).
Slovenian: Začetni odmerek je 5 mg amifampridina (pol tablete) trikrat na dan (tj. 15 mg na dan).
English: A prospective, placebo-controlled, randomised study in 26 patients with Lambert-Eaton myasthenic syndrome (LEMS) reported clinical efficacy for amifampridine at the standard recommended maximum dose of 60 mg/day (Sanders et al 2000).
Slovenian: V prospektivni, s placebom nadzorovani randomizirani študiji pri 26 bolnikih z Lambert-Eatonovim miastenijskim sindromom (LEMS) so poročali o klinični učinkovitosti amifampridina pri standardnem priporočenem največjem odmerku 60 mg/dan (Sanders et al 2000).
English: The pharmacodynamic profile of amifampridine has been studied for a range of doses.
Slovenian: Farmakodinamični profil amifampridina so preučili v razponu odmerkov.
English: In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored.
Slovenian: Zaradi tveganja bistvenega povečanja izpostavljenosti zdravilu je treba bolnike z okvarjenim delovanjem ledvic ali jeter natančno spremljati.
English: Orally administered amifampridine is rapidly absorbed in humans, reaching peak plasma concentrations by 0.6 to 1.3 hours (mean values).
Slovenian: Peroralno zaužit amifampridin se pri ljudeh hitro absorbira in doseže najvišje plazemske koncentracije (tmax) v 0,6 do 1,3 ure po zaužitju (povprečne vrednosti).
English: In a 2-year rat dietary carcinogenicity study, amifampridine caused small but statistically significant dose-related increases in the incidence of Schwannomas in both genders and of endometrial carcinomas in females.
Slovenian: V 2-letni študiji kancerogenosti pri podganah, ki so jim zdravilo dajali v prehrani, je amifampridin povzročil manjša, vendar statistično značilna povečanja, povezana z odmerki, pri incidenci švanomov pri obeh spolih in incidenci raka endometrija pri samicah.
English: No studies have been conducted in patients with hepatic impairment.
Slovenian: Študije pri bolnikih z okvarjenim delovanjem jeter niso bile opravljene.
English: Apparent plasma terminal elimination half-life differences were 3-4 fold between subjects in the food effect study.
Slovenian: Razlike v navidezni končni razpolovni dobi v plazmi v študiji vpliva hrane so bile med osebami 3-4-kratne.
English: Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravil z ozkim terapevtskim oknom je kontraindicirana (glejte poglavje 4.3).
English: A secondary efficacy endpoint was the change from baseline at Day 4 in CGI-I score, which was determined by treating physicians.
Slovenian: Drugi opazovani dogodek učinkovitosti je bila sprememba v rezultatu CGI-I od izhodišča na dan 4, ki jo je določil lečeči zdravnik.
English: Your doctor may increase this dose slowly first to 5 mg (half a tablet) four times daily (i.e. 20 mg per day).
Slovenian: Zdravnik bo morda ta odmerek počasi povečal najprej na 5 mg (pol tablete) štirikrat na dan (tj. 20 mg na dan).
English: If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).
Slovenian: Če se pojavijo neželeni učinki, je treba titracijo s povečevanjem odmerka prekiniti (glejte poglavji 4.4 in 5.2).
English: The tablets should be swallowed with some water and are to be taken with food.
Slovenian: Tablete pogoltnite z vodo in jih vzemite sočasno s hrano.
English: Subjects (N) NAT2 Phenotype
Slovenian: Osebe (n) Fenotip NAT2
English: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Slovenian: Simptomatsko zdravljenje Lambert-Eatonovega miastenijskega sindroma (LEMS) pri odraslih.
English: In vitro and in vivo studies in humans indicate that amifampridine is metabolised to a single major 3-N-acetylated amifampridine metabolite.
Slovenian: Študije in vitro in in vivo pri ljudeh kažejo, da se amifampridin presnavlja v en sam glavni presnovek 3-N-acetiliran amifampridin.
English: Medicinal products with atropinic effects
Slovenian: Zdravila z atropinskimi učinki
English: What FIRDAPSE is and what it is used for What you need to know before you take FIRDAPSE How to take FIRDAPSE
Slovenian: Kaj je zdravilo FIRDAPSE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo FIRDAPSE Kako jemati zdravilo FIRDAPSE Možni neželeni učinki
English: There is little experience with overdose.
Slovenian: Izkušenj s prevelikim odmerjanjem je malo.
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.
Slovenian: Učinek enega 30-miligramskega ali 60-miligramskega odmerka amifampridinfosfata so uporabili za oceno razmerja med farmakokinetiko in intervalom QTc koncentracije amifampridina na izpostavljenost repolarizaciji srca pri zdravih prostovoljcih.
English: The effect of age on the pharmacokinetics of amifampridine has not been studied.
Slovenian: Učinek starosti na farmakokinetiko amifampridina ni raziskan.
English: If you stop taking FIRDAPSE
Slovenian: Če ste prenehali jemati zdravilo FIRDAPSE
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).
Slovenian: Zaradi farmakodinamičnih lastnosti amifampridina je sočasna uporaba s sultopridom ali drugimi zdravili, ki dokazano podaljšujejo interval QT (npr. dizopiramid, cisaprid, domperidon, rifampicin in ketokonazol) kontraindicirana, saj lahko ta kombinacija poveča tveganje ventrikularne tahikardije, zlasti torsade de pointes (glejte poglavji 4.3 in 5.1).
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).
Slovenian: Dvojno slepa, s placebom nadzorovana, randomizirana študija odtegnitve zdravila je ocenjevala učinkovitost in varnost amifampridinijevega fosfata pri odraslih bolnikih z LEMS, ki so bili stari 18 let ali več (n = 26).
English: It is not known whether FIRDAPSE is excreted in human breast milk.
Slovenian: Ni znano, ali se zdravilo FIRDAPSE pri ljudeh izloča v materino mleko.
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.
Slovenian: Zdravila, ki znižujejo prag za nastanek epileptičnega napada Sočasna uporaba amifampridina in snovi, ki znižujejo prag za nastanek epileptičnega napada, lahko povzročijo povečano tveganje napadov.
English: It is unknown whether amifampridine is excreted in human breast milk.
Slovenian: Ni znano, ali se amifampridin izloča v materino mleko.
English: It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with an overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77).
Slovenian: Izboljša mišično moč in amplitude mirovnega sestavljenega mišičnega akcijskega potenciala (CMAP) s skupno razliko uteženih povprečnih vrednosti 1,69 mV (95-odstotni interval zaupanja od 0,60 do 2,77).
English: The results from the in vitro CYP450 inhibition study indicate amifampridine is unlikely to play a role in metabolic-based clinical drug-drug interactions related to inhibition of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 metabolism of co-administered medicinal products.
Slovenian: Rezultati iz študije zaviranja CYP450 in vitro kažejo, da ni verjetno, da bi imel amifampridin vlogo pri medsebojnem delovanju zdravil zaradi presnove, povezane z zaviranjem CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4 presnove sočasno dajanih zdravil.
English: The intensity and incidence of most adverse reactions is dose-dependent.
Slovenian: Jakost in pojavnost večine neželenih učinkih sta odvisna od odmerka.
English: • The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.
Slovenian: • Druge sestavine zdravila so mikrokristalna celuloza, brezvodni koloidni silicijev dioksid in kalcijev stearat.
English: Exposure of amifampridine was generally higher in subjects with renal impairment than in subjects with normal renal function; however, NAT2 phenotype had a greater effect on an individual's exposure to amifampridine than renal function status (See Table 4).
Slovenian: Izpostavljenost amifampridinu je bila na splošno večja pri osebah z ledvično okvaro kot pri osebah z normalnim delovanjem ledvic; vendar pa je imel fenotip NAT2 večji učinek na posameznikovo izpostavljenost amifampridinu kot status delovanja ledvic (glejte preglednico 4).
English: Then your doctor may continue to increase your total daily dose adding 5 mg (half a tablet) per day, every 4 or 5 days.
Slovenian: Nato bo zdravnik morda nadaljeval s povečevanjem skupnega dnevnega odmerka po 5 mg (pol tablete) na dan vsake 4 ali 5 dni.
English: In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3).
Slovenian: V 2-letni študiji kancerogenosti so bili ugotovljeni benigni in maligni švanomi pri podganah, ki so v prehrani dobivale amifampridin (glejte poglavje 5.3).
English: Exposure by Cmax was marginally affected by renal impairment regardless of acetylation status.
Slovenian: Na izpostavljenost glede na Cmax je marginalno vplivala ledvična okvara, ne glede na acetilacijski status.
English: FIRDAPSE should not be used during pregnancy.
Slovenian: Zdravila FIRDAPSE ne smete uporabljati med nosečnostjo.
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).
Slovenian: Najpogosteje navedeni neželeni učinki so parestezije (kot so periferne in peribukalne parestezije) ter prebavne bolezni (kot so epigastralgija, driska, navzea in bolečine v trebuhu).
English: A diagnosis of Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or symptoms similar to a compressive neuropathy.
Slovenian: Na diagnozo švanoma je treba pomisliti pri bolnikih, pri katerih so izraženi simptomi, kot je masa, ki je ob dotiku boleča, ali simptomi, podobni kompresijski nevropatiji.
English: Bioavailability is approximately 93-100% based on recoveries of unmetabolised amifampridine and a major 3-N-acetylated amifampridine metabolite in urine.
Slovenian: Biološka uporabnost je približno 93 - 100%, na podlagi zaznanega nepresnovljenega zdravila in glavnega presnovka 3-N-acetiliranega amifampridina v urinu.
English: Tell any physician you consult that you are using FIRDAPSE.
Slovenian: Obvestite vse zdravnike, ki vas obravnavajo, da jemljete zdravilo FIRDAPSE.
English: * Eating a standardised high-fat meal
Slovenian: S hrano* (n=46) * Pri vnosu standardiziranega obroka z visoko vsebnostjo maščobe
English: In humans, 93.2% to 100% of amifampridine is excreted into the urine within 24 hours after dosing as amifampridine (19%) and its 3-N-acetylated amifampridine metabolite (74.0% to 81.7%).
Slovenian: Pri ljudeh se 93,2 % do 100 % amifampridina izloči z urinom v 24 urah po odmerjanju v obliki amifampridina (19 %) in presnovka 3-N-acetiliranega amifampridina.
English: • Chorea (movement disorder), myoclonia (muscle spasm or twitching)
Slovenian: • horea (motnja gibanja), mioklonija (mišični krči ali trzanje mišic)
English: The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of acetylcholine-containing vesicles, which in turn enhances neuromuscular transmission.
Slovenian: Posledično povečanje znotrajceličnih koncentracij kalcija pospešuje eksocitozo mešičkov z acetilholinom, ki nato pospešujejo živčno-mišični prenos.
English: If you experience any of these symptoms, you should contact your doctor or pharmacist immediately.
Slovenian: Če se pojavi kateri od teh simptomov, morate nemudoma obvestiti zdravnika ali farmacevta.
English: The 3-N-acetyl metabolite exposure by AUC0-∞ was up to 6.8-fold higher in slow acetylators and up to 4-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Slovenian: Izpostavljenost 3-N-acetiliranemu presnovku glede na AUC0-∞ je bila do 6,8-krat večja pri počasnih acetilatorjih in do 4-krat večja pri hitrih acetilatorjih pri hudi okvari ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
English: A 2-fold increase in the time to reach Cmax (Tmax) was observed in the presence of food.
Slovenian: V prisotnosti hrane so opazili 2-kratno podaljšanje časa do dosežene vrednosti Cmax (Tmax).
English: • Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine)
Slovenian: • zdravila za zdravljenje alergij - antihistaminiki (npr. terfenadin, astemizol, cimetidin),
English: (ng/ml) Tmax (hr)
Slovenian: (ng/ml) Tmax (h)
English: • Asthma
Slovenian: • astme.
English: Exposure by Cmax was only marginally affected by renal impairment regardless of acetylation status.
Slovenian: Na izpostavljenost glede na Cmax je ledvična okvara vplivala le marginalno, ne glede na acetilacijski status.
English: If you take more FIRDAPSE than you should have, you may suffer from vomiting or a stomach ache.
Slovenian: Če ste vzeli večji odmerek zdravila FIRDAPSE, kot bi smeli Če ste vzeli večji odmerek zdravila FIRDAPSE, kot bi smeli, boste morda bruhali ali imeli bolečine v trebuhu.
English: Table 1 below lists the adverse reactions reported with amifampridine.
Slovenian: V preglednici 1 spodaj so navedeni poročani neželeni učinki z amifampridinom.
English: Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion.
Slovenian: Zato je potrebna posebna pozornost pri bolnikih, ki se sočasno zdravijo z zdravili, ki se izločajo s presnovo ali aktivnim izločanjem.
English: • Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)
Slovenian: • sočasna uporaba zdravil z ozkim terapevtskim oknom (glejte poglavje 4.5),
English: There are no data on the pharmacokinetics of amifampridine in patients with hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Ni podatkov o farmakokinetiki amifampridina pri bolnikih z jetrno okvaro (glejte poglavji 4.2 in 4.4).
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.
Slovenian: Izpostavljenost amifampridinu glede na AUC0-∞ je bila do 2-krat večja pri počasnih acetilatorjih in do 3-krat večja pri hitrih acetilatorjih pri hudi okvari ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
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.
Slovenian: Zdravilo FIRDAPSE se uporablja za zdravljenje simptomov bolezni živčevja in mišičja, ki ji pravimo Lambert-Eatonov miastenijski sindrom ali LEMS, pri odraslih bolnikih.
English: You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breastfeeding.
Slovenian: O tveganjih in koristih nadaljevanja zdravljenja z zdravilom FIRDAPSE med dojenjem se posvetujte z zdravnikom.
English: NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets
Slovenian: IME ZDRAVILA FIRDAPSE 10 mg tablete
English: Amifampridine had no adverse reaction on male or female fertility in rats at doses up to 75 mg/kg/day, and no effect on post-natal development or fertility was observed in the offspring of the treated animals.
Slovenian: Amifampridin v odmerkih do 75 mg/kg/dan ni imel neželenega učinka na plodnost pri podganjih samcih in samicah in ni imel vpliva na postnatalni razvoj ali plodnost mladičev živali, ki so prejemale zdravilo.
English: In contrast, the 3-N-acetyl metabolite exposure levels were affected to a greater extent by renal impairment than those for amifampridine.
Slovenian: V nasprotju s tem je na ravni izpostavljenosti 3-N-acetiliranemu presnovku okvara ledvic vplivala v večji meri kot na izpostavljenost amifampridinu.
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).
Slovenian: Med te učinkovine spada večina antidepresivov (triciklični antidepresivi, selektivni zaviralci ponovnega privzema serotonina), nevroleptiki (fenotiazini in butirofenoni), meflokvin, bupropion in tramadol (glejte poglavji 4.4 in 5.1).
English: The tablets have a score-line to allow them to be broken in half.
Slovenian: Tablete imajo zarezo, da jih lahko razpolovite.
English: In this study, slow acetylators experienced more adverse reactions than the fast acetylators.
Slovenian: V tej študiji je pri počasnih acetilatorjih prišlo do več neželenih učinkov kot pri hitrih acetilatorjih.
English: • Medicines for malaria (e.g. halofantrine and mefloquine)
Slovenian: • zdravila za zdravljenje malarije (npr. halofantrin in meflokvin),
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Ireland
Slovenian: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Irska
English: t1/2 (hr)
Slovenian: Huda okvara t1/2 (hr)
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.
Slovenian: Učinkovine, ki so močni induktorji encimov, ki presnavljajo zdravila (glejte poglavje 5.2) Rezultati iz študij in vitro kažejo, da je malo možnosti za medsebojno delovanje zdravil, ker amifampridin inducira encime CYP1A2, CYP2B6 in CYP3A4.
English: FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals.
Slovenian: Zdravilo FIRDAPSE deluje tako, da poveča sproščanje acetilholina in pripomore k prejemu živčnih signalov.
English: The pharmacokinetics of amifampridine has been assessed in a single dose Phase I study in patients with renal impairment (see section 5.2).
Slovenian: Farmakokinetiko amifampridina so ocenili v študiji I. faze z enkratnim odmerkom pri bolnikih z ledvično okvaro (glejte poglavje 5.2).
English: Table 1: Adverse Reactions Reported with FIRDAPSE
Slovenian: Preglednica 1: Poročani neželeni učinki z zdravilom FIRDAPSE
English: In a study of healthy volunteers, systemic exposure of amifampridine was notably influenced by the overall metabolic acetylation activity of NAT enzymes and NAT2 genotype.
Slovenian: V študiji z zdravimi prostovoljci sta na sistemsko izpostavljenost amifampridinu bistveno vplivala splošna presnovna acetilacijska aktivnost encimov n-acetil-transferaze (NAT) in genotip NAT2.
English: • Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion)
Slovenian: • antidepresive - triciklične antidepresive (npr. klomipramin, amoksapin), selektivne zaviralce ponovnega privzema serotonina (npr. citalopram, dapoksetin) in atipične antidepresive (npr. buproprion),
English: Overall, food slowed and decreased the absorption of amifampridine with a lowering of exposure by Cmax on average by ~44% and lowered exposure by AUC ~20%.
Slovenian: Hrana je na splošno upočasnila in zmanjšala absorpcijo amifampridina z zmanjšanjem izpostavljenosti glede na Cmax za povprečno
English: The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Slovenian: Sočasna uporaba amifampridina in zdravil z atropinskimi učinki lahko zmanjša učinek obeh zdravilnih učinkovin, kar je treba upoštevati.
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.
Slovenian: Pri podganah in kuncih so bile izvedene študije reproduktivne in razvojne toksičnosti amifampridina v odmerkih do 75 mg/kg/dan.