FrancophonIA/ELRC3.0 huggingface dataset:
English: Total QMG score range 0 - 39, 13 items, 0-3 points on each test.
Slovenian: Razpon ocen QMG 0-39, 13 elementov, pri vsakem testu 0-3 točke.
English: Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
Slovenian: Švanomi po navadi rastejo počasi, prisotni pa so lahko mesece ali leta, ne da bi prišlo do nastajanja simptomov.
English: 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
Slovenian: 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
English: What FIRDAPSE is and what is it used for
Slovenian: Kaj je zdravilo FIRDAPSE in za kaj ga uporabljamo
English: • If you were born with heart problems (congenital QT syndromes)
Slovenian: • če imate prirojene težave s srcem (kongenitalne sindrome QT)
English: 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).
Slovenian: CGI-I je 7-točkovna lestvica, ki temelji na spremembah simptomov, vedenja in funkcionalnih sposobnosti (1 = izredno izboljšanje o do 7 = izredno poslabšanje).
English: • If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na amifampridin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS).
Slovenian: Lahko je povezana z določenimi vrstami tumorjev (paraneoplastična oblika LEMS) ali je brez teh tumorjev (neparaneoplastična oblika LEMS).
English: Exposure to amifampridine is associated with an increased risk for epileptic seizures.
Slovenian: Izpostavljenost amifampridinu je povezana s povečanim tveganjem epileptičnih napadov.
English: In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed immediately.
Slovenian: V primeru znakov in simptomov srčnih aritmij je treba nemudoma opraviti EKG.
English: Most Schwannomas are benign and asymptomatic.
Slovenian: Večina švanomov je benignih in asimptomatičnih.
English: One box contains 100 tablets comprising 10 strips with 10 tablets each.
Slovenian: Ena škatla vsebuje 100 tablet v 10 dvojnih trakovih po 10 tablet.
English: Concomitant diseases
Slovenian: Sočasne bolezni
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX05.
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX05.
English: Unknown
Slovenian: neznana
English: To establish a Lambert Eaton Patient Registry as defined in the RMP and also incorporating measures of efficacy.
Slovenian: Vzpostavitev registra bolnikov z Lambert-Eatonovim sindromom, kakor je opredeljeno v RMP, z vključitvijo ukrepov učinkovitosti.
English: 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.
Slovenian: Če imate LEMS brez raka, bo zdravnik pred začetkom zdravljenja temeljito preučil možno tveganje raka v povezavi z zdravilom FIRDAPSE.
English: • If you have uncontrolled asthma
Slovenian: • če imate neobvladovano astmo,
English: • Tingling and numbness around the mouth and extremities (such as feet and hands)
Slovenian: • ščemenje ali odrevenelost okoli ust in po okončinah (kot so stopala in dlani),
English: • Increase in certain liver enzymes (transaminases) seen on blood tests
Slovenian: • zvišanje ravni določenih jetrnih encimov (transaminaz), razvidno iz analiz krvi
English: Supportive care should be given as clinically indicated, including close monitoring of vital signs.
Slovenian: Zagotavljati je treba podporno oskrbo glede na klinične indikacije, vključno z natančnim spremljanjem življenjskih znakov.
English: Summary of Changes in Primary and Secondary Efficacy Endpoints from Baseline
Slovenian: Povzetek sprememb pri primarnem in sekundarnem opazovanem dogodku učinkovitosti glede na izhodišče
English: • Concomitant use with medicinal products with a known potential to cause QTc prolongation
Slovenian: • sočasna uporaba zdravil, ki lahko podaljšajo QTc,
English: Total daily doses above 20 mg should be divided into two to four separate doses.
Slovenian: Skupne dnevne odmerke, večje od 20 mg, je treba razdeliti v dva do štiri ločene odmerke.
English: 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.
Slovenian: Zato so morda v izjemnih primerih ob ustreznem spremljanju varnosti koristni višji odmerki do največ 80 mg/dan.
English: 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.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek zdravila FIRDAPSE, ampak nadaljujte zdravljenje, kakor vam je predpisal zdravnik.
English: • Raynaud's syndrome (circulation disorder affecting the fingers and toes)
Slovenian: • Raynaudov sindrom (bolezen krvnega obtoka, ki vpliva na prste na rokah in nogah)
English: Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
Slovenian: Perforirani enoodmerni termoformirani pretisni omoti (termoformirane pole iz laminata aluminij-PVC/PVDC), ki vsebujejo 10 tablet.
English: What you need to know before you take FIRDAPSE
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo FIRDAPSE
English: 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.
Slovenian: 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.
English: Stop the treatment and immediately consult your doctor in the event of:
Slovenian: Prekinite zdravljenje in se nemudoma posvetujte s svojim zdravnikom v primeru:
English: Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown.
Slovenian: Čeprav je presnovek neaktiven za kalcijeve kanalčke, možni neciljni učinki zaradi kopičenja niso znani.
English: The NAT genes are highly polymorphic and result in phenotypes with variable acetylation activity rates ranging from slow to fast.
Slovenian: Geni NAT so močno polimorfni, kar povzroči fenotipe z različnimi stopnjami acetilacije, ki segajo od počasne do hitre.
English: NAME OF THE MARKETING AUTHORISATION HOLDER BioMarin International Limited
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM BioMarin International Limited
English: Two further studies in a total of 57 patients with LEMS have reported data from higher doses of amifampridine.
Slovenian: V dveh drugih študijah so pri 57 bolnikih z LEMS zbirali podatke o višjih odmerkih amifampridina.
English: Very common side effects which may affect more than 1 in 10 people are:
Slovenian: Pogosti stranski učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov, so:
English: Combinations requiring precautions for use
Slovenian: Kombinacije, ki zahtevajo previdnostne ukrepe
English: The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day).
Slovenian: Največji priporočeni odmerek je 60 mg na dan (tj. skupno šest tablet, ki se vzamejo v časovnih presledkih v enem dnevu).
English: Amifampridine (n=13)
Slovenian: Amifampridin (n = 13)
English: • Reduced sense of touch or sensation
Slovenian: • zmanjšana občutljivost za dotik ali zmanjšano čutenje
English: 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.
Slovenian: 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.
English: This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness.
Slovenian: Ta bolezen je motnja prenosa živčnih impulzov na mišice, ki povzroči mišično šibkost.
English: 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.
Slovenian: 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.
English: This dose suits you only.
Slovenian: Ta odmerek je prilagojen samo vam.
English: MedDRA Preferred term
Slovenian: MedDRA Priporočeni izraz
English: 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.
Slovenian: 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.
English: Amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests.
Slovenian: Amifampridin ni bil genotoksičen pri standardni skupini preskusov in vitro ter in vivo.
English: • In patients with congenital QT syndromes (see section 4.4)
Slovenian: • pri bolnikih s kongenitalnimi sindromi QT (glejte poglavje 4.4).
English: Patients were allowed to use stable doses of peripherally acting cholinesterase inhibitors or corticosteroids.
Slovenian: Bolniki so lahko prejemali stabilne odmerke periferno delujočih zaviralcev holinesteraze ali kortikosteroidov.
English: The manifestations of acute overdose include vomiting and abdominal pain.
Slovenian: Manifestacije akutnega prevelikega odmerjanja vključujejo bruhanje in bolečine v trebuhu.
English: This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines.
Slovenian: To zdravilo lahko povzroči zaspanost, vrtoglavico, epileptične napade (konvulzije) ter zamegljen vid, ki utegnejo vplivati na vašo sposobnost vožnje ali upravljanja s stroji.
English: Renal Status
Slovenian: Ledvični status
English: Some medicines may interact with FIRDAPSE when taken together.
Slovenian: Nekatera zdravila lahko medsebojno delujejo z zdravilom FIRDAPSE, če jih jemljete sočasno.
English: The plasma elimination half-life is approximately 2.5 hours for the amifampridine and 4 hours for the 3-N-acetylated amifampridine metabolite.
Slovenian: Razpolovna doba izločanja iz plazme je približno 2,5 uri za amifampridin in 4 ure za presnovek 3-N-acetilirani amifampridin.
English: The safety profile in this study is consistent with adverse reactions observed with patients on amifampridine.
Slovenian: Varnostni profil v tej študiji je skladen z neželenimi učinki, opaženimi pri bolnikih, ki so jemali amifampridin.
English: • If you are epileptic
Slovenian: • če imate epilepsijo,
English: 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).
Slovenian: 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).
English: Normal
Slovenian: Normalna
English: No single dose should exceed 20 mg (two tablets).
Slovenian: Posamezni odmerek ne sme preseči 20 mg (dve tableti).
English: 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.
Slovenian: 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.
English: It is recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7 days.
Slovenian: Priporočljivo je, da se titracija odmerka iz 60 mg/dan na 80 mg/dan opravi z zvišanji po 5 mg vsakih 7 dni.
English: • Concomitant use with sultopride (see sections 4.5 and 5.1)
Slovenian: • sočasna uporaba sultoprida (glejte poglavji 4.5 in 5.1),
English: 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).
Slovenian: 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).
English: If treatment with a potent inhibitor is discontinued, patients should be monitored for efficacy as an increase of amifampridine dose may be necessary.
Slovenian: Če se zdravljenje z močnim zaviralcem encimov prekine, je treba pri bolnikih spremljati učinkovitost zdravila, saj bo morda potrebno odmerek amifampridina povečati.
English: No single dose should exceed 20 mg.
Slovenian: Posamezni odmerek ne sme preseči 20 mg.
English: The benefit of continuing treatment with amifampridine should be reviewed for any patient who develops a Schwannoma.
Slovenian: Koristi nadaljnjega zdravljenja z amifampridinom je treba preučiti pri vseh bolnikih, pri katerih pride do razvoja švanoma.
English: In this four-day study, patients were randomized (1:1) to amifampridine phosphate (at patient's optimal dose) or placebo on Day 0.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Available reproductive data in animals have shown presence of amifampridine in milk of breast-feeding mothers.
Slovenian: Razpoložljivi podatki o razmnoževanju pri živalih kažejo prisotnost amifampridina v mleku doječih mater.
English: White, round tablet, flat-faced on one side and scored on the other side.
Slovenian: Bela, okrogla tableta, ki je ploska na eni strani in ima zarezo na drugi.
English: You must use effective contraception throughout the treatment.
Slovenian: Med zdravljenjem morate uporabljati učinkovite kontracepcijske metode.
English: If you forget to take FIRDAPSE
Slovenian: Če ste pozabili vzeti zdravilo FIRDAPSE
English: Distribution of amifampridine was studied in the rat.
Slovenian: Porazdelitev amifampridina so preučevali pri podganah.
English: Following oral administration of radiolabelled [14C] amifampridine, radioactive material is rapidly absorbed from the gastrointestinal tract and widely distributed throughout the body.
Slovenian: Po peroralnem dajanju radioaktivno označenega [14C] amifampridina se radioaktivna snov hitro absorbira iz prebavil in porazdeli po vsem telesu.
English: • Cough, excessive or viscous mucus in the breathing passage, asthma attack in asthmatic patients or patients with a history of asthma
Slovenian: • kašelj, čezmerna ali gosta sluz v dihalih, napad astme pri astmatičnih bolnikih ali bolnikih z astmo v preteklosti
English: The primary endpoints were change from baseline (CFB) in Patient Global Impression (SGI) and Quantitative Myasthenia Gravis (QMG) score at Day 4.
Slovenian: 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.
English: • Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: • Uncontrolled asthma
Slovenian: • neobvladovana astma,
English: This medicine has been authorised under “Exceptional Circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: Prolonging the action potential enhances the transport of calcium into the nerve ending.
Slovenian: Podaljšanje akcijskega potenciala pospeši prenos kalcija v živčne konice.
English: 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.
Slovenian: 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.
English: Patient should discontinue the treatment in the event of overdose.
Slovenian: Bolnik mora v primeru prevelikega odmerjanja prekiniti zdravljenje.
English: 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.
Slovenian: 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.
English: LS Mean Diff (95% CI) p-valued
Slovenian: Razlika v mediani LS (95-% IZ) p-vrednostd
English: The intensity and incidence of most side effects depends on the dose you are taking.
Slovenian: Jakost in pojavnost večine neželenih učinkov sta odvisna od odmerka, ki ga jemljete.
English: In humans, the rate and extent of absorption of amifampridine is influenced by food (see Table 2).
Slovenian: Pri ljudeh na hitrost in obseg absorpcije amifampridina vpliva vnos hrane (glejte preglednico 2).
English: 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.
Slovenian: Statistično značilne razlike v FK parametrih amifampridina, Cmax, AUC0-∞, t1/2 in navideznega očistka, so med hitrimi in počasnimi acetilatorji opazili na ravni odmerka.
English: Your doctor will monitor carefully how FIRDAPSE works for you and may need to change the dose of the medicines you take.
Slovenian: Zdravnik bo natančno spremljal delovanje zdravila FIRDAPSE in bo po potrebi spremenil odmerek zdravil, ki jih jemljete.
English: 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.
Slovenian: 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.
English: • Weakness, tiredness, headache
Slovenian: • šibkost, utrujenost, glavobol
English: EXCELLA GmbH & Co KG Nürnberger Strasse 12 90537 Feucht
Slovenian: KG Nürnberger Strasse 12 90537 Feucht
English: • Heart rhythm disorders, fast or irregular heartbeats (palpitations)
Slovenian: • motnje srčnega ritma, hitro in nepravilno utripanje srca (palpitacije)
English: 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).
Slovenian: 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).
English: If the treatment is stopped, you may experience symptoms such as tiredness, slow reflexes and constipation.
Slovenian: Po prekinitvi zdravljenja se lahko pojavijo utrujenost, upočasnjeni refleksi in zaprtost.
English: • The active substance is amifampridine.
Slovenian: • Zdravilna učinkovina je amifampridin.
English: FIRDAPSE 10 mg tablets amifampridine
Slovenian: FIRDAPSE 10 mg tablete amifampridin
English: The correlation between the use of amifampridine and the development of tumours in humans is unknown at this time.
Slovenian: V danem časovnem obdobju ni znana povezava med uporabo amifampridina in razvojem tumorjev pri ljudeh.
English: INFORMATION IN BRAILLE FIRDAPSE
Slovenian: PODATKI V BRAILLOVI PISAVI FIRDAPSE
English: 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.
Slovenian: 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.
English: What FIRDAPSE looks like and contents of the pack White, round tablet, flat-faced on one side and scored on the other side.
Slovenian: Izgled zdravila FIRDAPSE in vsebina pakiranja Bela, okrogla tableta, ki je ploska na eni strani in ima zarezo na drugi.
English: Mean (SD) p-valuee a
Slovenian: Mediana (SD) p-vrednoste a
English: FIRDAPSE should not be used if you are pregnant.
Slovenian: Zdravila FIRDAPSE ne smete uporabljati, če ste noseči.
English: d CFB for QMG total score was modelled as the response, with fixed effects terms for treatment and QMG at Baseline.
Slovenian: d Sprememba od izhodišča za celotno oceno QMG je bila oblikovana kot odziv, s fiksno določenimi učinki zdravljenja in QMG ob izhodišču.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).