natgillin/translations-raw huggingface dataset:
Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component. 
Cepljene ptice je mogoče razlikovati od okuženih ptic z diagnostičnim testom za protitelesa proti sestavini N2.
Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more). 
Zdravilo Nobilis Influenza H5N2 je cepivo, ki vsebuje inaktivirani virus aviarne influence H5N2 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
Nobilis Influenza H5N2 has been authorised under “Exceptional Circumstances”. 
Zdravilo Nobilis Influenza H5N2 je bilo odobreno v »izjemnih okoliščinah«.
Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza. 
Zdravilo Nobilis Influenza H5N2 je cepivo, ki se uporablja pri piščancih za zaščito pred aviarno influenco.
• If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies. 
• Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
They also tested the safety of three standard production batches of Nobilis Influenza H5N2. 
Preizkušena je bila tudi varnost treh standardnih proizvodnih serij zdravila Nobilis Influenza H5N2.
Nobilis Influenza H5N2 is a vaccine. 
Zdravilo Nobilis Influenza H5N2 je cepivo.
Other information about Nobilis Influenza H5N2: 
Druge informacije o zdravilu Nobilis Influenza H5N2:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H5N2 
EMEA/V/C/118 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NOBILIS INFLUENZA H5N2 Povzetek EPAR za javnost
What benefit has Nobilis Influenza H5N2 shown during the studies? 
Kakšne koristi je zdravilo Nobilis Influenza H5N2 izkazalo med raziskavami?
What is the risk associated with Nobilis Influenza H5N2? 
Kakšna tveganja so povezana z zdravilom Nobilis Influenza H5N2?
Why has Nobilis Influenza H5N2 been approved? 
Zakaj je bilo zdravilo Nobilis Influenza H5N2 odobreno?
How has Nobilis Influenza H5N2 been studied? 
Kako je bilo zdravilo Nobilis Influenza H5N2 raziskano?
What is Nobilis Influenza H5N2? 
Kaj je zdravilo Nobilis Influenza H5N2?
What is Nobilis Influenza H5N2 used for? 
Za kaj se zdravilo Nobilis Influenza H5N2 uporablja?
How does Nobilis Influenza H5N2 work? 
Kako zdravilo Nobilis Influenza H5N2 deluje?
Annual reports: as part of the annual re-assessment dossier 
Letna poročila: kot del letnega poročila o ponovni oceni
The more points = worse symptoms. 
Več točk = slabši simptomi.
The clinical relevance of these results is unknown. 
Klinični pomen teh rezultatov ni znan.
• Cold hands and feet 
• hladne dlani in stopala
Your doctor will also monitor your heart at the start of your treatment and also every year thereafter. 
Zdravnik bo spremljal tudi vaše srce na začetku zdravljenja in nato vsako leto.
(1=terrible to 7=delighted). 
(1 = izjemno slabo do 7 = odlično).
The following side effects have also been reported (frequencies cannot be estimated from the available data): 
Ugotovili so tudi naslednje neželene učinke (njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
Baseline assessments were obtained on day 0. 
Izhodiščne ocene so bile pridobljene na dan 0.
Monitoring is advised when possible. 
Če je možno, je priporočljivo spremljanje.
They can present in many locations, therefore the clinical presentation can be varied. 
Nastanejo lahko na številnih mestih, zato so klinične slike lahko različne.
Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data). 
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
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: 
Zlasti je pomembno, da se pogovorite z zdravnikom, če jemljete katero izmed naslednjih zdravil ali nameravate začeti jemati katero izmed naslednjih zdravil:
• Increase sweating, cold sweat 
• povečano znojenje, hladen znoj
Tablets are to be taken with food. 
Tablete je treba vzeti s hrano.
The dose you should take is established by your doctor based on the intensity of your symptoms and certain genetic factors. 
Odmerek, ki ga boste jemali, določi zdravnik na podlagi jakosti vaših simptomov in nekaterih genskih dejavnikov.
Date of latest renewal: 1 December 2014 
Datum prve odobritve: 23. december 2009 Datum zadnjega podaljšanja: 1. december 2014
Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male. 
Mediana starost bolnikov je bila 55,5 let (razpon: 31 do 75 let), 62 % je bilo žensk in 38 % je bilo moških.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/601/001
The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established. 
Varnost in učinkovitost zdravila FIRDAPSE pri otrocih, starih od 0 do 17 let, še nista bili dokazani.
Combinations to be taken into consideration 
Kombinacije, ki jih je treba upoštevati
No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used. 
Varnostne meje za izpostavljenost pri človeku v študijah na živalih niso bile določene zaradi občutljivosti živalskih modelov.
The following medicines must not be combined with FIRDAPSE: 
Naslednjih zdravil ne smete kombinirati z zdravilom FIRDAPSE:
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve za predložitev občasno posodobljenih poročil o varnosti zdravila za to zdravilo so navedene na seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in morebitnih nadaljnjih posodobitev, objavljenih na evropskem spletnem portalu o zdravilih.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. 
Zdravljenje je treba začeti pod nadzorom zdravnika z izkušnjami pri zdravljenju te bolezni.
The tablets can be divided into equal halves. 
Tableta se lahko deli na enaki polovici.
PHARMACEUTICAL FORM AND CONTENTS 100 tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 100 tablet
Tell your doctor if you have 
Obvestite svojega zdravnika, če imate:
e p-value based on the Wilcoxon Rank Sum Test for treatment differences. 
e p-vrednost na podlagi Wilcoxonovega testa vsote rangov za razlike v zdravljenju.
• Together with medicines with a therapeutic dose close to the maximum safe dose 
• sočasno z zdravili, katerih terapevtski odmerek je blizu največjemu varnemu odmerku,
If you discover that you are pregnant during the treatment, inform your doctor immediately. 
Če med zdravljenjem ugotovite, da ste noseči, nemudoma obvestite svojega zdravnika.
Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter. 
Klinično in elektrokardiogramsko (EKG) spremljanje je indicirano ob uvedbi zdravljenja in nato vsako leto.
b SGI is a 7-point scale which rates the global impression of the effects of study treatment 
b SGI je 7-točkovna lestvica, ki ocenjuje globalno oceno učinkov študijskega zdravljenja
See section 4.8 for how to report adverse reactions. 
Glejte poglavje 4.8, kako poročati o neželenih učinkih.>
The dose of the concomitantly given medicinal product should be adjusted if necessary. 
Odmerek sočasno uporabljenega zdravila je treba po potrebi prilagoditi.
Total QMG score range 0 - 39, 13 items, 0-3 points on each test. 
Razpon ocen QMG 0-39, 13 elementov, pri vsakem testu 0-3 točke.
Schwannomas are generally slow-growing and can exist for months to years without producing symptoms. 
Švanomi po navadi rastejo počasi, prisotni pa so lahko mesece ali leta, ne da bi prišlo do nastajanja simptomov.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
PRILOGA II A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
What FIRDAPSE is and what is it used for 
Kaj je zdravilo FIRDAPSE in za kaj ga uporabljamo
• If you were born with heart problems (congenital QT syndromes) 
• če imate prirojene težave s srcem (kongenitalne sindrome QT)
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 7-točkovna lestvica, ki temelji na spremembah simptomov, vedenja in funkcionalnih sposobnosti (1 = izredno izboljšanje o do 7 = izredno poslabšanje).
• If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6) 
• če ste alergični na amifampridin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS). 
Lahko je povezana z določenimi vrstami tumorjev (paraneoplastična oblika LEMS) ali je brez teh tumorjev (neparaneoplastična oblika LEMS).
Exposure to amifampridine is associated with an increased risk for epileptic seizures. 
Izpostavljenost amifampridinu je povezana s povečanim tveganjem epileptičnih napadov.
In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately. 
V primeru znakov in simptomov srčnih aritmij je treba nemudoma opraviti EKG.
Most Schwannomas are benign and asymptomatic. 
Večina švanomov je benignih in asimptomatičnih.
One box contains 100 tablets comprising 10 strips with 10 tablets each. 
Ena škatla vsebuje 100 tablet v 10 dvojnih trakovih po 10 tablet.
Concomitant diseases 
Sočasne bolezni
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05. 
Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX05.
Unknown 
neznana
To establish a Lambert Eaton Patient Registry as defined in the RMP and also incorporating measures of efficacy. 
Vzpostavitev registra bolnikov z Lambert-Eatonovim sindromom, kakor je opredeljeno v RMP, z vključitvijo ukrepov učinkovitosti.
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. 
Če imate LEMS brez raka, bo zdravnik pred začetkom zdravljenja temeljito preučil možno tveganje raka v povezavi z zdravilom FIRDAPSE.
• If you have uncontrolled asthma 
• če imate neobvladovano astmo,
• Tingling and numbness around the mouth and extremities (such as feet and hands) 
• ščemenje ali odrevenelost okoli ust in po okončinah (kot so stopala in dlani),
• Increase in certain liver enzymes (transaminases) seen on blood tests 
• zvišanje ravni določenih jetrnih encimov (transaminaz), razvidno iz analiz krvi
Supportive care should be given as clinically indicated, including close monitoring of vital signs. 
Zagotavljati je treba podporno oskrbo glede na klinične indikacije, vključno z natančnim spremljanjem življenjskih znakov.
Summary of Changes in Primary and Secondary Efficacy Endpoints from Baseline 
Povzetek sprememb pri primarnem in sekundarnem opazovanem dogodku učinkovitosti glede na izhodišče
• Concomitant use with medicinal products with a known potential to cause QTc prolongation 
• sočasna uporaba zdravil, ki lahko podaljšajo QTc,
Total daily doses above 20 mg should be divided into two to four separate doses. 
Skupne dnevne odmerke, večje od 20 mg, je treba razdeliti v dva do štiri ločene odmerke.
Therefore, in exceptional circumstances higher doses up to a maximum of 80 mg/day may be of benefit when given with the appropriate safety monitoring. 
Zato so morda v izjemnih primerih ob ustreznem spremljanju varnosti koristni višji odmerki do največ 80 mg/dan.
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. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek zdravila FIRDAPSE, ampak nadaljujte zdravljenje, kakor vam je predpisal zdravnik.
• Raynaud's syndrome (circulation disorder affecting the fingers and toes) 
• Raynaudov sindrom (bolezen krvnega obtoka, ki vpliva na prste na rokah in nogah)
Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets. 
Perforirani enoodmerni termoformirani pretisni omoti (termoformirane pole iz laminata aluminij-PVC/PVDC), ki vsebujejo 10 tablet.
What you need to know before you take FIRDAPSE 
Kaj morate vedeti, preden boste vzeli zdravilo FIRDAPSE
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. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom FIRDAPSE, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Stop the treatment and immediately consult your doctor in the event of: 
Prekinite zdravljenje in se nemudoma posvetujte s svojim zdravnikom v primeru:
Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown. 
Čeprav je presnovek neaktiven za kalcijeve kanalčke, možni neciljni učinki zaradi kopičenja niso znani.
The NAT genes are highly polymorphic and result in phenotypes with variable acetylation activity rates ranging from slow to fast. 
Geni NAT so močno polimorfni, kar povzroči fenotipe z različnimi stopnjami acetilacije, ki segajo od počasne do hitre.
NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM BioMarin International Limited
Two further studies in a total of 57 patients with LEMS have reported data from higher doses of amifampridine. 
V dveh drugih študijah so pri 57 bolnikih z LEMS zbirali podatke o višjih odmerkih amifampridina.
Very common side effects which may affect more than 1 in 10 people are: 
Pogosti stranski učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov, so:
Combinations requiring precautions for use 
Kombinacije, ki zahtevajo previdnostne ukrepe
The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day). 
Največji priporočeni odmerek je 60 mg na dan (tj. skupno šest tablet, ki se vzamejo v časovnih presledkih v enem dnevu).
• Reduced sense of touch or sensation 
• zmanjšana občutljivost za dotik ali zmanjšano čutenje
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. 
Bolnikom morate povedati, da morajo vse zdravnike, ki jih obravnavajo, obvestiti, da jemljejo zdravilo FIRDAPSE, ker bo morda treba natančno spremljanje sočasnih bolezni, zlasti astme.
This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness. 
Ta bolezen je motnja prenosa živčnih impulzov na mišice, ki povzroči mišično šibkost.
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. 
V študijah farmakološke varnosti na podganah niso opazili učinkov, povezanih z dihalnim sistemom, do odmerka 10 mg/kg ali na osrednji živčni sistem do odmerka 40 mg/kg.
This dose suits you only. 
Ta odmerek je prilagojen samo vam.
MedDRA Preferred term 
MedDRA Priporočeni izraz
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. 
V prispevku Sanders et al 1998 so predstavili podatke o učinkovitosti in varnosti zdravljenja z odmerki amifampridina do 100 mg/dan pri 45 bolnikih z LEMS, ki so bili zdravljeni v povprečju 31 mesecev.
Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests. 
Amifampridin ni bil genotoksičen pri standardni skupini preskusov in vitro ter in vivo.
• In patients with congenital QT syndromes (see section 4.4) 
• pri bolnikih s kongenitalnimi sindromi QT (glejte poglavje 4.4).
Patients were allowed to use stable doses of peripherally acting cholinesterase inhibitors or corticosteroids. 
Bolniki so lahko prejemali stabilne odmerke periferno delujočih zaviralcev holinesteraze ali kortikosteroidov.
The manifestations of acute overdose include vomiting and abdominal pain. 
Manifestacije akutnega prevelikega odmerjanja vključujejo bruhanje in bolečine v trebuhu.
This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines. 
To zdravilo lahko povzroči zaspanost, vrtoglavico, epileptične napade (konvulzije) ter zamegljen vid, ki utegnejo vplivati na vašo sposobnost vožnje ali upravljanja s stroji.
Renal Status 
Ledvični status
Some medicines may interact with FIRDAPSE when taken together. 
Nekatera zdravila lahko medsebojno delujejo z zdravilom FIRDAPSE, če jih jemljete sočasno.
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.