natgillin/translations-raw huggingface dataset:
It is especially important to talk to your doctor if you are taking one of the following medicines or plan to start taking the following medicines:
Posebice je važno obavijestiti svog liječnika ako uzimate ili planirate početi uzimati jedan od sljedećih lijekova:
Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
Švanomi obično sporo rastu i mogu postojati mjesecima ili godinama bez pojave simptoma.
If you have LEMS but do not have cancer, your doctor will make a thorough assessment of the potential risk of cancer with FIRDAPSE before commencing treatment.
Ukoliko imate LEMS, ali nemate karcinom, Vaš liječnik će napraviti temeljitu procjenu mogućeg rizika od nastanka karcinoma s lijekom FIRDAPSE prije početka liječenja.
FIRDAPSE should be given in divided doses, three or four times a day.
FIRDAPSE se mora davati u podijeljenim dozama, tri ili četiri puta dnevno.
If you forget to take FIRDAPSE, do not take a double dose to make up for the dose you have forgotten but continue to take your treatment as prescribed by your doctor.
Ako ste zaboravili uzeti FIRDAPSE, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, ali nastavite s liječenjem kao što je propisao liječnik.
• Reduced sense of touch or sensation
• smanjen osjećaj dodira ili osjeta
No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Nisu postignute sigurnosne granice kod izloženosti ljudi u ispitivanjima na životinjama zbog osjetljivosti korištenih životinjskih modela.
Do not stop treatment without consulting your doctor.
Nemojte prekinuti liječenje bez dogovora s liječnikom.
The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time.
Korelacija između uporabe amifampridina i razvoja tumora kod ljudi u ovom trenutku nije poznata.
The dose of the concomitantly given medicinal product should be adjusted if necessary.
Dozu istodobno primijenjenog lijeka treba prilagoditi ako je potrebno.
If you discover that you are pregnant during the treatment, inform your doctor immediately.
Ako tijekom liječenja otkrijete da ste trudni, odmah obavijestite svog liječnika.
Do not take FIRDAPSE
Nemojte uzimati FIRDAPSE
What FIRDAPSE is and what it is used for What you need to know before you take FIRDAPSE How to take FIRDAPSE
Što je FIRDAPSE i za što se koristi Što morate znati prije nego počnete uzimati FIRDAPSE Kako uzimati FIRDAPSE
What FIRDAPSE contains
Što FIRDAPSE sadrži
FIRDAPSE should not be used if you are pregnant.
FIRDAPSE se ne smije uzimati ako ste trudni.
PHARMACEUTICAL FORM AND CONTENTS 100 tablets
OBLIK I SADRŽAJ 100 tableta
Your doctor will monitor carefully how FIRDAPSE works for you and may need to change the dose of the medicines you take.
Liječnik će pomno pratiti kako FIRDAPSE djeluje na Vas te će možda biti potrebno promijeniti dozu lijekova koje uzimate.
What you need to know before you take FIRDAPSE
Što morate znati prije nego počnete uzimati FIRDAPSE
• If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6)
• ako ste alergični na amifampridin ili neki drugi sastojak ovog lijeka (navedenog u dijelu 6.),
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju ove bolesti.
This dose suits you only.
Ova doza odgovara samo Vama.
Combinations requiring precautions for use
Kombinacije koje zahtijevaju mjere opreza pri uporabi
Other medicines and FIRDAPSE Tell your doctor if you are taking, have recently taken or might take any other medicines.
Drugi lijekovi i FIRDAPSE Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
e p-value based on the Wilcoxon Rank Sum Test for treatment differences.
e p-vrijednost na temelju Wilcoxonovog testa sume rangova za razlike u liječenju.
Total daily doses above 20 mg should be divided into two to four separate doses.
Ukupne dnevne doze iznad 20 mg treba podijeliti u dvije do četiri zasebne doze.
• If you have uncontrolled asthma
• ako imate nekontroliranu astmu,
Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter.
Kliničko i elektrokardiogramsko (EKG) praćenje indicirano je na početku liječenja te nakon toga jednom godišnje.
Most Schwannomas are benign and asymptomatic.
Većina švanoma je benigna i asimptomatska.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FIRDAPSE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom FIRDAPSE uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
U slučaju znakova i simptoma koji upućuju na srčane aritmije, EKG treba odmah provesti.
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05.
Farmakoterapijska skupina: drugi lijekovi za živčani sustav, ATK oznaka: N07XX05.
Total QMG score range 0 - 39, 13 items, 0-3 points on each test.
Raspon rezultata ukupnog QMG-a bio je 0 - 39, 13 stavki i 0 - 3 boda za svaki od testova.
Exposure to amifampridine is associated with an increased risk for epileptic seizures.
Izloženost amifampridinu povezana je s povećanim rizikom od epileptičkih napadaja.
Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male.
Medijan dobi bolesnika bio je 55,5 godina (raspon: od 31 do 75 godina), pri čemu je 62% bolesnika bilo ženskog spola a 38% bolesnika muškog spola.
• Raynaud's syndrome (circulation disorder affecting the fingers and toes)
• Raynaudov sindrom (poremećaj cirkulacije koji zahvaća prste ruku i nogu)
Raynaud's syndrome
Raynaudov sindrom
• The active substance is amifampridine.
• Djelatna tvar je amifampridin.
It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS).
Može se povezati s određenim tipovima tumora (paraneoplastični oblik LEMS-a) ili se može pojaviti u odsustvu ovih tumora (neparaneoplastični oblik LEMS-a).
The tablets should be swallowed with some water and are to be taken with food.
Tablete treba progutati s nešto vode te uzeti s hranom.
Very common side effects which may affect more than 1 in 10 people are:
Vrlo česte nuspojave koje se mogu javiti u više od 1 na 10 osoba su:
If you take more FIRDAPSE than you should
Ako uzmete više lijeka FIRDAPSE nego što ste trebali
If treatment is discontinued, patients may experience some of the symptoms of LEMS.
U slučaju prekida liječenja, bolesnici mogu iskusiti neke od simptoma LEMS-a.
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).
CGI-I je ljestvica od 1 do 7 temeljena na promjenama u simptomima, ponašanju i funkcionalnim sposobnostima (1 = izrazito poboljšano do 7 = vrlo pogoršano).
* Eating a standardised high-fat meal
* Standardni punomasni obrok
Supportive care should be given as clinically indicated, including close monitoring of vital signs.
Potrebno je osigurati suportivnu skrb prema kliničkim indikacijama uključujući pomni nadzor vitalnih znakova.
The manifestations of acute overdose include vomiting and abdominal pain.
Manifestacije akutnog predoziranja uključuju povraćanje i bol u abdomenu.
Warnings and precautions Talk to your doctor or pharmacist before taking FIRDAPSE.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete FIRDAPSE.
Amifampridine (n=13)
Amifampridin (n = 13)
Patients were allowed to use stable doses of peripherally acting cholinesterase inhibitors or corticosteroids.
Bolesnicima je bilo dopušteno koristiti stabilne doze periferno aktivnih inhibitora kolinesteraze ili kortikosteroida.
If the treatment is stopped, you may experience symptoms such as tiredness, slow reflexes and constipation.
Ako prekinete s liječenjem možete osjetiti simptome poput umora, usporenih refleksa i zatvora.
One box contains 100 tablets comprising 10 strips with 10 tablets each.
Jedna kutija sadrži 100 tableta u 10 stripova, svaki s 10 tableta.
No single dose should exceed 20 mg.
Nijedna pojedinačna doza ne smije premašiti 20 mg.
The tablets have a score-line to allow them to be broken in half.
Tablete imaju razdjelnu crtu koja omogućava da se prepolove.
A. LABELLING
A: OZNAČIVANJE
Some medicines may interact with FIRDAPSE when taken together.
Neki lijekovi mogu stupati u interakciju s lijekom FIRDAPSE ako se uzimaju zajedno.
If you take more FIRDAPSE than you should have, you may suffer from vomiting or a stomach ache.
Ako uzmete više lijeka FIRDAPSE nego što ste trebali može doći do povraćanja ili boli u trbuhu.
• If you are epileptic
• ako imate epilepsiju,
• Tingling and numbness around the mouth and extremities (such as feet and hands)
• trnci i obamrlost oko usta i udova (poput stopala i šaka),
The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day).
Maksimalna preporučena doza je 60 mg na dan (tj. ukupno šest tableta u razmacima tijekom dana).
Carcinogenicity risk
Rizik od kancerogenosti
MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/601/001
This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness.
Ova bolest je poremećaj koji zahvaća prijenos živčanih impulsa do mišića, što uzrokuje slabost mišića.
• If you were born with heart problems (congenital QT syndromes)
• ako imate urođene srčane poteškoće (kongenitalni QT sindromi).
For the full list of excipients, see section 6.1.
Za cjelovit popis pomoćnih tvari vidjeti dio 6.1.
• Increase in certain liver enzymes (transaminases) seen on blood tests
• porast razine određenih jetrenih enzima (transaminaza) što je vidljivo iz krvnih pretraga
Tell any physician you consult that you are using FIRDAPSE.
Recite svakom liječniku koji Vas liječi da uzimate FIRDAPSE.
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.
Lijekovi koji se eliminiraju metabolizmom ili aktivnom sekrecijom Nisu dostupni podaci o učincima amifampridina na metabolizam ili aktivnu sekreciju drugih lijekova.
Orally administered amifampridine is rapidly absorbed in humans, reaching peak plasma concentrations by 0.6 to 1.3 hours (mean values).
Peroralno primijenjeni amifampridin brzo se apsorbira u ljudi, a vršne koncentracije u plazmi postižu se za 0,6 do 1,3 sata (srednje vrijednosti).
Two further studies in a total of 57 patients with LEMS have reported data from higher doses of amifampridine.
U dva daljnja ispitivanja na ukupno 57 bolesnika s LEMS-om zabilježeni su podaci na višim dozama amifampridina.
Prolonging the action potential enhances the transport of calcium into the nerve ending.
Produljivanje akcijskog potencijala povećava transport kalcija u završetak živca.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 December 2009
Datum prvog odobrenja: 23. prosinca 2009.
Patients must be told to inform any physician they consult that they are taking this medicinal product, since close monitoring of a concomitant disease, particularly asthma, may be necessary.
Bolesnike se mora uputiti da obavijeste svakog liječnika koji ih liječi da uzimaju ovaj lijek s obzirom da može biti potrebno pomno praćenje istodobne bolesti, a posebice astme.
d CFB for QMG total score was modelled as the response, with fixed effects terms for treatment and QMG at Baseline.
d Rezultat CFB-a za ukupni QMG modeliran je kao odgovor, s uvjetima fiksnih učinaka za liječenje i početnoj vrijednosti QMG-a.
In the event of a seizure, treatment should be discontinued.
U slučaju napadaja liječenje treba prekinuti.
Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown.
Iako metabolit nije aktivan na kalijevim kanalima, mogući učinci zbog akumulacije, izuzev ciljnog učinka, nisu poznati.
No single dose should exceed 20 mg (two tablets).
Nijedna pojedinačna doza ne smije premašiti 20 mg (dvije tablete).
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.
U bolesnika koji boluju od ove bolesti, kemijska tvar zvana acetilkolin koja prenosi živčane impulse do mišića ne otpušta se na normalan način i mišić ne prima neke ili sve živčane signale.
Elevated liver enzyme levels (transaminases)
Povišene razine jetrenih enzima (transaminaze)
If you forget to take FIRDAPSE
Ako ste zaboravili uzeti FIRDAPSE
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.
U ispitivanjima toksičnosti ponovljene doze na štakorima i psima uočeni su učinci na središnji i autonomni živčani sustav, povećanje mase jetre i bubrega kao i učinci na srce (atrioventrikularni blok drugog stupnja).
You must use effective contraception throughout the treatment.
Tijekom liječenja morate koristiti učinkovitu kontracepciju.
Following oral administration of radiolabelled [14C] amifampridine, radioactive material is rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body.
Nakon peroralne primjene radioaktivno označenog amifampridina [14C], radioaktivni materijal se brzo apsorbira iz gastrointestinalnog trakta i široko raspodjeljuje u tijelu.
The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma.
Korist od nastavka liječenja s amifampridinom treba se razmotriti za svakog bolesnika koji razvije švanom.
NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET BioMarin International Limited
Patient should discontinue the treatment in the event of overdose.
Bolesnici trebaju prekinuti liječenje u slučaju predoziranja.
In humans, the rate and extent of absorption of amifampridine is influenced by food (see Table 2).
U ljudi su brzina i opseg apsorpcije amifampridina pod utjecajem hrane (vidjeti tablicu 2).
Hyperhidrosis1, cold sweat1
Hiperhidroza1, hladan znoj1
• Heart rhythm disorders, fast or irregular heartbeats (palpitations)
• poremećaji srčanog ritma, brzi ili nepravilni otkucaji (palpitacije)
The intensity and incidence of most side effects depends on the dose you are taking.
Težina i učestalost većine nuspojava ovise o dozi koju uzimate.
The plasma elimination half-life is approximately 2.5 hours for the amifampridine and 4 hours for the 3-N-acetylated amifampridine metabolite.
Poluvijek eliminacije iz plazme iznosi približno 2,5 sata za amifampridin i 4 sata za metabolit 3-N-acetilirani amifampridin.
Common side effects which may affect up to 1 in 10 people are:
Česte nuspojave koje se mogu javiti u do 1 na 10 osoba su:
• Concomitant use with medicinal products with a known potential to cause QTc prolongation
• Istodobna primjena s lijekovima za koje se zna da mogu prouzročiti produljenje QTc intervala.
SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30ºC.
If treatment with a potent inhibitor is discontinued, patients should be monitored for efficacy as an increase of amifampridine dose may be necessary.
U slučaju prekida liječenja potentnim inhibitorom, bolesnike treba nadzirati kako bi se pratila djelotvornost lijeka jer će možda biti potrebno povećanje doze amifampridina.
Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion.
Stoga treba biti posebno oprezan s bolesnicima koji se podvrgavaju istodobnom liječenju s lijekovima koji se eliminiraju metaboliziranjem ili aktivnom sekrecijom.
Sanders et al 1998 presented data on efficacy and safety of amifampridine treatment at doses up to 100 mg/day in 45 patients with LEMS who were treated for an average of 31 months.
Sanders et al 1998 prikazali su podatke o djelotvornosti i sigurnosti amifampridina pri dozama do 100 mg/dan na 45 bolesnika s LEMS-om koji su liječeni u prosjeku 31 mjesec.
• Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breastfeeding.
Vaš liječnik i Vi trebate razmotriti rizike i koristi nastavka liječenja lijekom FIRDAPSE za vrijeme dojenja.
MedDRA System organ class
MedDRA - klasifikacija organskih sustava
FIRDAPSE should not be used during pregnancy.
FIRDAPSE se ne smije primjenjivati tijekom trudnoće.
• In patients with congenital QT syndromes (see section 4.4)
• U bolesnika s kongenitalnim QT sindromima (vidjeti dio 4.4).
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).
Rizik od napadaja ovisi o dozi te je povećan u bolesnika s čimbenicima rizika koji snižavaju epileptički prag; uključujući uporabu u kombinaciji s drugim lijekovima koji su poznati da snižavaju epileptički prag (vidjeti dio 4.5).
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%).
Kod ljudi se 93,2% do 100% amifampridina izlučuje u mokraću unutar 24 sata nakon doziranja, kao amifampridin (19%) i njegov metabolit 3-N-acetilirani amifampridin (74,0% do 81,7%).
If you stop taking FIRDAPSE
Ako prestanete uzimati FIRDAPSE
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
U svakoj skupini učestalosti nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
Apparent plasma terminal elimination half-life differences were 3-4 fold between subjects in the food effect study.
Razlike prividnog terminalnog poluvijeka eliminacije iz plazme bile su 3-struke do 4-struke između ispitanika u ispitivanjima utjecaja hrane.
Non-clinical safety data are available regarding the effects of amifampridine on reproductive function.
Dostupni su neklinički podaci o sigurnosti utjecaja amifampridina na reproduktivnu funkciju.
It is recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7 days.
Preporučuje se titracija doze od 60 mg/dan do 80 mg/dan u povećanjima od 5 mg svakih 7 dana.
Women of childbearing potential must use effective contraception during FIRDAPSE treatment.
Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom FIRDAPSE.
No subjects developed new clinically relevant ECG morphological changes following administration of amifampridine phosphate.
Niti jedan ispitanik nije razvio nove klinički značajne morfološke promjene EKG-a nakon primjene amifampridin fosfata.
Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
Amifampridin se nije pokazao genotoksičan u standardnoj bateriji in vitro i in vivo testova.
What FIRDAPSE looks like and contents of the pack White, round tablet, flat-faced on one side and scored on the other side.
Kako FIRDAPSE izgleda i sadržaj pakiranja Bijela, okrugla tableta, plosnata na jednoj strani i s razdjelnom crtom na drugoj strani.
• Concomitant use with sultopride (see sections 4.5 and 5.1)
• Istodobna primjena sa sultopridom (vidjeti dijelove 4.5 i 5.1).
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.
Međutim, u sličnom ispitivanju na skotnim kunićima nije bilo učinka na embriofetalnu održivost procijenjenu neposredno prije okota pri dozama do 57 mg/kg/dan.
The patients were maintained on a stable dose and frequency of amifampridine phosphate for at least 7 days prior to randomization.
Kod bolesnika je održavana stabilna doza i učestalost primjene amifampridinfosfata kroz najmanje 7 dana prije randomizacije.
MedDRA Preferred term
MedDRA Preporučeni pojam
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.
U ispitivanju na zdravim dobrovoljcima, na sistemsku izloženost amifampridinu znatno je utjecala ukupna metabolička aktivnost acetilacije enzimima NAT i genotip NAT2.
Patients with liver/kidney problems:
Bolesnici s oštećenjem jetre/bubrega:
• Uncontrolled asthma
• Nekontrolirana astma.
Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal paraesthesias, nausea1
Oralna hipoestezija1, oralna parestezija1, periferne i peribukalne parestezije, mučnina1
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.
U ispitivanjima sigurnosne farmakologije na štakorima nisu uočeni učinci na dišni sustav u dozama do 10 mg/kg niti na središnji živčani sustav u dozama do 40 mg/kg.
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.
Došlo je do pada Cmax i AUC te produljenja vremena do postizanja maksimalne koncentracije u plazmi kad se amifampridin fosfat primjenjivao s hranom, a u usporedbi bez hrane.
This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines.
Ovaj lijek može izazvati omamljenost, omaglicu, napadaje (konvulzije) i zamagljen vid, što može utjecati na sposobnost upravljanja vozilom i rada sa strojevima.
FIRDAPSE 10 mg tablets amifampridine
FIRDAPSE 10 mg tablete amifampridin
Regardless, patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme or renal transporter inhibitor.
Bez obzira na to, bolesnike treba pomno nadzirati na nuspojave prilikom početka liječenja potentnim inhibitorom enzima ili bubrežnog transportera.
Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
Perforirani termoformirani blisteri s jediničnim dozama (termoformirani aluminij-PVC/PVDC laminirani listovi) s 10 tableta.
There was significantly higher exposure to amifampridine in slow acetylators compared to fast acetylators.
Postojala je znatno viša izloženost amifampridinu u sporih acetilatora u usporedbi s brzim acetilatorima.
The NAT genes are highly polymorphic and result in phenotypes with variable acetylation activity rates ranging from slow to fast.
Geni NAT visoko su polimorfni te izražavaju fenotipe s promjenjivom aktivnosti acetilacije u rasponima od sporih do brzih.
White, round tablet, flat-faced on one side and scored on the other side.
Bijela, okrugla tableta, plosnata na jednoj strani i s razdjelnom crtom na drugoj strani.
• Fits (convulsions)
• napadaji (konvulzije)
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Simptomatsko liječenje Lambert-Eatonovog mijasteničnog sindroma (LEMS) u odraslih.
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.
U dvogodišnjem ispitivanju kancerogenosti provedenom s djelatnom tvari u hrani, amifampridin je izazvao mali, ali statistički značajan porast povezan s dozom u incidenciji švanoma u oba spola te endometrijskih karcinoma u žena.