natgillin/translations-raw huggingface dataset:
The plasma elimination half-life is approximately 2.5 hours for the amifampridine and 4 hours for the 3-N-acetylated amifampridine metabolite.
Razpolovna doba izločanja iz plazme je približno 2,5 uri za amifampridin in 4 ure za presnovek 3-N-acetilirani amifampridin.
The safety profile in this study is consistent with adverse reactions observed with patients on amifampridine.
Varnostni profil v tej študiji je skladen z neželenimi učinki, opaženimi pri bolnikih, ki so jemali amifampridin.
• If you are epileptic
• če imate epilepsijo,
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).
Poleg tega so ocene CGI-I na dan 4, kot so jih podali zdravniki, pokazale pomembno izboljšanje pri bolnikih, ki so še naprej prejemali amifampridinijev fosfat v primerjavi s placebom (p = 0,0020).
No single dose should exceed 20 mg (two tablets).
Posamezni odmerek ne sme preseči 20 mg (dve tableti).
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.
Pri bolnikih, ki imajo to bolezen, se kemična snov, imenovana acetilholin, ki prenaša živčne impulze na mišice, ne sprošča normalno, zato mišice ne prejmejo nekaterih ali nobenih živčnih signalov.
It is recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7 days.
Priporočljivo je, da se titracija odmerka iz 60 mg/dan na 80 mg/dan opravi z zvišanji po 5 mg vsakih 7 dni.
• Concomitant use with sultopride (see sections 4.5 and 5.1)
• sočasna uporaba sultoprida (glejte poglavji 4.5 in 5.1),
The risk of seizures is dose-dependent and is increased in patients with risk factors which lower the epileptic threshold; including use in combination with other medicinal products known to lower the epileptic threshold (see section 4.5).
Tveganje napadov je odvisno od odmerka in je večje je pri bolnikih z dejavniki tveganja, ki zmanjšajo prag za nastanek epileptičnega napada; vključno z uporabo zdravila skupaj z drugimi zdravili, za katere je znano, da znižajo prag za nastanek epileptičnega napada (glejte poglavje 4.5).
If treatment with a potent inhibitor is discontinued, patients should be monitored for efficacy as an increase of amifampridine dose may be necessary.
Če se zdravljenje z močnim zaviralcem encimov prekine, je treba pri bolnikih spremljati učinkovitost zdravila, saj bo morda potrebno odmerek amifampridina povečati.
No single dose should exceed 20 mg.
Posamezni odmerek ne sme preseči 20 mg.
The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma.
Koristi nadaljnjega zdravljenja z amifampridinom je treba preučiti pri vseh bolnikih, pri katerih pride do razvoja švanoma.
In this four-day study, patients were randomized (1:1) to amifampridine phosphate (at patient's optimal dose) or placebo on Day 0.
V tej štiridnevni študiji so bolnike randomizirali (1 : 1) v skupino z amifampridinijevim fosfatom (z optimalnim odmerkom za bolnika) ali skupino s placebom na dan 0.
There was a decrease in Cmax and AUC, and an increase in the time to reach maximum plasma concentrations when amifampridine phosphate was administered with food as compared to without food.
Prišlo je do zmanjšanja vrednosti Cmax in AUC in podaljšanja časa do doseženih največjih koncentracij v plazmi, ko se je amifampridinijev fosfat vnašal s hrano, v primerjavi z vnosom brez hrane.
Available reproductive data in animals have shown presence of amifampridine in milk of breast-feeding mothers.
Razpoložljivi podatki o razmnoževanju pri živalih kažejo prisotnost amifampridina v mleku doječih mater.
White, round tablet, flat-faced on one side and scored on the other side.
Bela, okrogla tableta, ki je ploska na eni strani in ima zarezo na drugi.
You must use effective contraception throughout the treatment.
Med zdravljenjem morate uporabljati učinkovite kontracepcijske metode.
If you forget to take FIRDAPSE
Če ste pozabili vzeti zdravilo FIRDAPSE
Distribution of amifampridine was studied in the rat.
Porazdelitev amifampridina so preučevali pri podganah.
Following oral administration of radiolabelled [14C] amifampridine, radioactive material is rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body.
Po peroralnem dajanju radioaktivno označenega [14C] amifampridina se radioaktivna snov hitro absorbira iz prebavil in porazdeli po vsem telesu.
• Cough, excessive or viscous mucus in the breathing passage, asthma attack in asthmatic patients or patients with a history of asthma
• kašelj, čezmerna ali gosta sluz v dihalih, napad astme pri astmatičnih bolnikih ali bolnikih z astmo v preteklosti
The primary endpoints were change from baseline (CFB) in Patient Global Impression (SGI) and Quantitative Myasthenia Gravis (QMG) score at Day 4.
Primarni opazovani dogodek je bila sprememba od izhodišča (CFB) pri bolnikovi globalni oceni (Patient Global Impression - SGI) in kvantitativni oceni miastenije gravis (QMG) na dan 4.
• Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
• preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
• Uncontrolled asthma
• neobvladovana astma,
This medicine has been authorised under “Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Prolonging the action potential enhances the transport of calcium into the nerve ending.
Podaljšanje akcijskega potenciala pospeši prenos kalcija v živčne konice.
Following the 4 day double-blind discontinuation period, patients treated with amifampridine phosphate maintained muscle strength compared to patients treated with placebo who showed worsening of muscle strength.
Po 4-dnevnem dvojno slepem obdobju odtegnitve zdravila so bolniki, ki so prejemali amifampridinijev fosfat, ohranili mišično moč v primerjavi z bolniki, ki so prejemali placebo in pri katerih se je mišična moč poslabšala.
Patient should discontinue the treatment in the event of overdose.
Bolnik mora v primeru prevelikega odmerjanja prekiniti zdravljenje.
In a repeat-dose toxicity studies in rats and dogs, effects on the central and autonomic nervous system, increased liver and kidney weights and cardiac effects (second degree atrioventricular block) were seen.
V študijah toksičnosti pri ponavljajočih se odmerkih na podganah in psih so ugotovili učinke na osrednji ali avtonomni živčni sistem, povečanje mase jeter in ledvic ter učinke na srce (atrioventrikularni blok II.
LS Mean Diff (95% CI) p-valued
Razlika v mediani LS (95-% IZ) p-vrednostd
The intensity and incidence of most side effects depends on the dose you are taking.
Jakost in pojavnost večine neželenih učinkov sta odvisna od odmerka, ki ga jemljete.
In humans, the rate and extent of absorption of amifampridine is influenced by food (see Table 2).
Pri ljudeh na hitrost in obseg absorpcije amifampridina vpliva vnos hrane (glejte preglednico 2).
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.
Statistično značilne razlike v FK parametrih amifampridina, Cmax, AUC0-∞, t1/2 in navideznega očistka, so med hitrimi in počasnimi acetilatorji opazili na ravni odmerka.
Your doctor will monitor carefully how FIRDAPSE works for you and may need to change the dose of the medicines you take.
Zdravnik bo natančno spremljal delovanje zdravila FIRDAPSE in bo po potrebi spremenil odmerek zdravil, ki jih jemljete.
The mean caffeine acetylator ratio for these 12 subjects receiving four escalating doses were 0.408 and 0.172 for fast and slow acetylators types respectively.
Povprečno razmerje acetilatorjev kofeina za teh 12 oseb, ki so prejele štiri stopnjevane odmerke, je bilo 0,408 za hitre tipe acetilatorjev in 0,172 za počasne tipe acetilatorjev.
• Weakness, tiredness, headache
• šibkost, utrujenost, glavobol
• Heart rhythm disorders, fast or irregular heartbeats (palpitations)
• motnje srčnega ritma, hitro in nepravilno utripanje srca (palpitacije)
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).
Ocenitev je bila izvedena v dvojno slepi, randomizirani, navzkrižni študiji 1. faze za določitev učinkov amifampridinfosfata v teh odmerkih na EKG v primerjavi s placebom in moksifloksacinom (pozitivna kontrola) pri zdravih moških in ženskah, ki so počasni acetilatorji (n = 52).
If the treatment is stopped, you may experience symptoms such as tiredness, slow reflexes and constipation.
Po prekinitvi zdravljenja se lahko pojavijo utrujenost, upočasnjeni refleksi in zaprtost.
• The active substance is amifampridine.
• Zdravilna učinkovina je amifampridin.
The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time.
V danem časovnem obdobju ni znana povezava med uporabo amifampridina in razvojem tumorjev pri ljudeh.
INFORMATION IN BRAILLE FIRDAPSE
PODATKI V BRAILLOVI PISAVI FIRDAPSE
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.
V prispevku McEvoy et al 1989 so objavljeni podatki kratkoročne študije pri 12 bolnikih z LEMS, ki dokazujejo, da je dajanje amifampridina v odmerkih do 100 mg/dan v trajanju 3 dni učinkovito pri zdravljenju avtonomnih in motoričnih simptomov LEMS.
What FIRDAPSE looks like and contents of the pack White, round tablet, flat-faced on one side and scored on the other side.
Izgled zdravila FIRDAPSE in vsebina pakiranja Bela, okrogla tableta, ki je ploska na eni strani in ima zarezo na drugi.
Mean (SD) p-valuee a
Mediana (SD) p-vrednoste a
FIRDAPSE should not be used if you are pregnant.
Zdravila FIRDAPSE ne smete uporabljati, če ste noseči.
d CFB for QMG total score was modelled as the response, with fixed effects terms for treatment and QMG at Baseline.
d Sprememba od izhodišča za celotno oceno QMG je bila oblikovana kot odziv, s fiksno določenimi učinki zdravljenja in QMG ob izhodišču.
Observed mean difference in QMG Total and SGI change from baseline score between treatments were -6.54 (95% CI: -9.78, -3.29; p=0.0004) and 2.95 (95% CI: 1.53, 4.38; p=0.0003) respectively, both statistically significant in favour of amifampridine phosphate.
Opažena povprečna razlika med zdravljenjema v celotni QMG in spremembi SGI od izhodišča je bila -6,54 (95-odstotni interval zaupanja: -9,78, -3,29; p = 0,0004) oziroma 2,95 (95-odstotni interval zaupanja: 1,53, 4,38; p = 0,0003); oboje je statistično pomembna razlika, ki je v korist amifampridinijevega fosfata.
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).
V perinatalni/postnatalni reproduktivni študiji pri brejih podganjih samicah, ki so prejemale amifampridin, je bilo opaženo od odmerka odvisno povečanje deleža samic z mrtvoskotenimi mladiči (16,7-20 %) pri odmerkih 22,5 mg/kg/dan in 75 mg/kg/dan (1,1 in 2,7-kratnik dnevnega odmerka 80 mg pri ljudeh na osnovi vrednosti Cmax).
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).
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).
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 .
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.
If any side effects occur, please consult your doctor as you may need to stop increasing the dose.
V primeru neželenih učinkov se posvetujte z zdravnikom, saj boste morda morali prenehati s povečevanjem odmerka.
Women of childbearing potential must use effective contraception during FIRDAPSE treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom FIRDAPSE.
Raynaud's syndrome
Raynaudov sindrom neznana
Similarly Cmax and AUC0-∞ were greater in the fasted state than in the fed state.
Podobno sta bili tudi vrednosti Cmax in AUC0-∞ večji v stanju na tešče kot s hrano.
Other medicines and FIRDAPSE Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The patients were maintained on a stable dose and frequency of amifampridine phosphate for at least 7 days prior to randomization.
Bolniki so prejemali amifampridinijev fosfat v stabilnih odmerkih in z enako pogostnostjo vsaj 7 dni pred randomizacijo.
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.
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).
Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation.
Amifampridin zavira napetostno odvisne kalijeve kanalčke in s tem podaljša predsinaptično depolarizacijo celične membrane.
In the event of a seizure, treatment should be discontinued.
V primeru epileptičnega napada je treba zdravljenje prekiniti.
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.
Zdravila, ki se izločajo s presnovo ali aktivnim izločanjem Ni podatkov o učinkih amifampridina na presnovo ali aktivno izločanje drugih zdravil.
The starting dose is 5 mg amifampridine (half a tablet) three times daily (i.e. 15 mg per day).
Začetni odmerek je 5 mg amifampridina (pol tablete) trikrat na dan (tj. 15 mg na dan).
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).
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).
The pharmacodynamic profile of amifampridine has been studied for a range of doses.
Farmakodinamični profil amifampridina so preučili v razponu odmerkov.
In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored.
Zaradi tveganja bistvenega povečanja izpostavljenosti zdravilu je treba bolnike z okvarjenim delovanjem ledvic ali jeter natančno spremljati.
Orally administered amifampridine is rapidly absorbed in humans, reaching peak plasma concentrations by 0.6 to 1.3 hours (mean values).
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).
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.
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.
No studies have been conducted in patients with hepatic impairment.
Študije pri bolnikih z okvarjenim delovanjem jeter niso bile opravljene.
Apparent plasma terminal elimination half-life differences were 3-4 fold between subjects in the food effect study.
Razlike v navidezni končni razpolovni dobi v plazmi v študiji vpliva hrane so bile med osebami 3-4-kratne.
Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3).
Sočasna uporaba zdravil z ozkim terapevtskim oknom je kontraindicirana (glejte poglavje 4.3).
A secondary efficacy endpoint was the change from baseline at Day 4 in CGI-I score, which was determined by treating physicians.
Drugi opazovani dogodek učinkovitosti je bila sprememba v rezultatu CGI-I od izhodišča na dan 4, ki jo je določil lečeči zdravnik.
Your doctor may increase this dose slowly first to 5 mg (half a tablet) four times daily (i.e. 20 mg per day).
Zdravnik bo morda ta odmerek počasi povečal najprej na 5 mg (pol tablete) štirikrat na dan (tj. 20 mg na dan).
If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).
Če se pojavijo neželeni učinki, je treba titracijo s povečevanjem odmerka prekiniti (glejte poglavji 4.4 in 5.2).
The tablets should be swallowed with some water and are to be taken with food.
Tablete pogoltnite z vodo in jih vzemite sočasno s hrano.
Subjects (N) NAT2 Phenotype
Osebe (n) Fenotip NAT2
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Simptomatsko zdravljenje Lambert-Eatonovega miastenijskega sindroma (LEMS) pri odraslih.
In vitro and in vivo studies in humans indicate that amifampridine is metabolised to a single major 3-N-acetylated amifampridine metabolite.
Študije in vitro in in vivo pri ljudeh kažejo, da se amifampridin presnavlja v en sam glavni presnovek 3-N-acetiliran amifampridin.
Medicinal products with atropinic effects
Zdravila z atropinskimi učinki
What FIRDAPSE is and what it is used for What you need to know before you take FIRDAPSE How to take FIRDAPSE
Kaj je zdravilo FIRDAPSE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo FIRDAPSE Kako jemati zdravilo FIRDAPSE Možni neželeni učinki
There is little experience with overdose.
Izkušenj s prevelikim odmerjanjem je malo.
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.
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.
The effect of age on the pharmacokinetics of amifampridine has not been studied.
Učinek starosti na farmakokinetiko amifampridina ni raziskan.
If you stop taking FIRDAPSE
Če ste prenehali jemati zdravilo FIRDAPSE
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).
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).
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).
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).
It is not known whether FIRDAPSE is excreted in human breast milk.
Ni znano, ali se zdravilo FIRDAPSE pri ljudeh izloča v materino mleko.
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.
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.
It is unknown whether amifampridine is excreted in human breast milk.
Ni znano, ali se amifampridin izloča v materino mleko.
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).
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).
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.
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.
The intensity and incidence of most adverse reactions is dose-dependent.
Jakost in pojavnost večine neželenih učinkih sta odvisna od odmerka.
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.
• Druge sestavine zdravila so mikrokristalna celuloza, brezvodni koloidni silicijev dioksid in kalcijev stearat.
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).
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).
Then your doctor may continue to increase your total daily dose adding 5 mg (half a tablet) per day, every 4 or 5 days.
Nato bo zdravnik morda nadaljeval s povečevanjem skupnega dnevnega odmerka po 5 mg (pol tablete) na dan vsake 4 ali 5 dni.
In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3).
V 2-letni študiji kancerogenosti so bili ugotovljeni benigni in maligni švanomi pri podganah, ki so v prehrani dobivale amifampridin (glejte poglavje 5.3).
Exposure by Cmax was marginally affected by renal impairment regardless of acetylation status.
Na izpostavljenost glede na Cmax je marginalno vplivala ledvična okvara, ne glede na acetilacijski status.
FIRDAPSE should not be used during pregnancy.
Zdravila FIRDAPSE ne smete uporabljati med nosečnostjo.