natgillin/translations-raw huggingface dataset:
The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain).
Najpogosteje navedeni neželeni učinki so parestezije (kot so periferne in peribukalne parestezije) ter prebavne bolezni (kot so epigastralgija, driska, navzea in bolečine v trebuhu).
A diagnosis of Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or symptoms similar to a compressive neuropathy.
Na diagnozo švanoma je treba pomisliti pri bolnikih, pri katerih so izraženi simptomi, kot je masa, ki je ob dotiku boleča, ali simptomi, podobni kompresijski nevropatiji.
Bioavailability is approximately 93-100% based on recoveries of unmetabolised amifampridine and a major 3-N-acetylated amifampridine metabolite in urine.
Biološka uporabnost je približno 93 - 100%, na podlagi zaznanega nepresnovljenega zdravila in glavnega presnovka 3-N-acetiliranega amifampridina v urinu.
Tell any physician you consult that you are using FIRDAPSE.
Obvestite vse zdravnike, ki vas obravnavajo, da jemljete zdravilo FIRDAPSE.
* Eating a standardised high-fat meal
S hrano* (n=46) * Pri vnosu standardiziranega obroka z visoko vsebnostjo maščobe
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%).
Pri ljudeh se 93,2 % do 100 % amifampridina izloči z urinom v 24 urah po odmerjanju v obliki amifampridina (19 %) in presnovka 3-N-acetiliranega amifampridina.
• Chorea (movement disorder), myoclonia (muscle spasm or twitching)
• horea (motnja gibanja), mioklonija (mišični krči ali trzanje mišic)
The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of acetylcholine-containing vesicles, which in turn enhances neuromuscular transmission.
Posledično povečanje znotrajceličnih koncentracij kalcija pospešuje eksocitozo mešičkov z acetilholinom, ki nato pospešujejo živčno-mišični prenos.
If you experience any of these symptoms, you should contact your doctor or pharmacist immediately.
Če se pojavi kateri od teh simptomov, morate nemudoma obvestiti zdravnika ali farmacevta.
The 3-N-acetyl metabolite exposure by AUC0-∞ was up to 6.8-fold higher in slow acetylators and up to 4-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Izpostavljenost 3-N-acetiliranemu presnovku glede na AUC0-∞ je bila do 6,8-krat večja pri počasnih acetilatorjih in do 4-krat večja pri hitrih acetilatorjih pri hudi okvari ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
A 2-fold increase in the time to reach Cmax (Tmax) was observed in the presence of food.
V prisotnosti hrane so opazili 2-kratno podaljšanje časa do dosežene vrednosti Cmax (Tmax).
• Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine)
• zdravila za zdravljenje alergij - antihistaminiki (npr. terfenadin, astemizol, cimetidin),
• Asthma
• astme.
Exposure by Cmax was only marginally affected by renal impairment regardless of acetylation status.
Na izpostavljenost glede na Cmax je ledvična okvara vplivala le marginalno, ne glede na acetilacijski status.
If you take more FIRDAPSE than you should have, you may suffer from vomiting or a stomach ache.
Če ste vzeli večji odmerek zdravila FIRDAPSE, kot bi smeli Če ste vzeli večji odmerek zdravila FIRDAPSE, kot bi smeli, boste morda bruhali ali imeli bolečine v trebuhu.
Table 1 below lists the adverse reactions reported with amifampridine.
V preglednici 1 spodaj so navedeni poročani neželeni učinki z amifampridinom.
Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion.
Zato je potrebna posebna pozornost pri bolnikih, ki se sočasno zdravijo z zdravili, ki se izločajo s presnovo ali aktivnim izločanjem.
• Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)
• sočasna uporaba zdravil z ozkim terapevtskim oknom (glejte poglavje 4.5),
There are no data on the pharmacokinetics of amifampridine in patients with hepatic impairment (see sections 4.2 and 4.4).
Ni podatkov o farmakokinetiki amifampridina pri bolnikih z jetrno okvaro (glejte poglavji 4.2 in 4.4).
Amifampridine exposure by AUC0-∞ was up to 2-fold higher in slow acetylators and up to 3-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Izpostavljenost amifampridinu glede na AUC0-∞ je bila do 2-krat večja pri počasnih acetilatorjih in do 3-krat večja pri hitrih acetilatorjih pri hudi okvari ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
FIRDAPSE is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults.
Zdravilo FIRDAPSE se uporablja za zdravljenje simptomov bolezni živčevja in mišičja, ki ji pravimo Lambert-Eatonov miastenijski sindrom ali LEMS, pri odraslih bolnikih.
You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breastfeeding.
O tveganjih in koristih nadaljevanja zdravljenja z zdravilom FIRDAPSE med dojenjem se posvetujte z zdravnikom.
NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets
IME ZDRAVILA FIRDAPSE 10 mg tablete
Amifampridine had no adverse reaction on male or female fertility in rats at doses up to 75 mg/kg/day, and no effect on post-natal development or fertility was observed in the offspring of the treated animals.
Amifampridin v odmerkih do 75 mg/kg/dan ni imel neželenega učinka na plodnost pri podganjih samcih in samicah in ni imel vpliva na postnatalni razvoj ali plodnost mladičev živali, ki so prejemale zdravilo.
In contrast, the 3-N-acetyl metabolite exposure levels were affected to a greater extent by renal impairment than those for amifampridine.
V nasprotju s tem je na ravni izpostavljenosti 3-N-acetiliranemu presnovku okvara ledvic vplivala v večji meri kot na izpostavljenost amifampridinu.
These substances include most anti-depressants (tricyclic antidepressants, selective serotonin uptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, bupropion and tramadol (see sections 4.4 and 5.1).
Med te učinkovine spada večina antidepresivov (triciklični antidepresivi, selektivni zaviralci ponovnega privzema serotonina), nevroleptiki (fenotiazini in butirofenoni), meflokvin, bupropion in tramadol (glejte poglavji 4.4 in 5.1).
The tablets have a score-line to allow them to be broken in half.
Tablete imajo zarezo, da jih lahko razpolovite.
In this study, slow acetylators experienced more adverse reactions than the fast acetylators.
V tej študiji je pri počasnih acetilatorjih prišlo do več neželenih učinkov kot pri hitrih acetilatorjih.
• Medicines for malaria (e.g. halofantrine and mefloquine)
• zdravila za zdravljenje malarije (npr. halofantrin in meflokvin),
BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Ireland
BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Irska
t1/2 (hr)
Huda okvara t1/2 (hr)
Substances which are potent inducers of enzymes that metabolise medicinal products (see section 5.2) The results from in vitro studies suggest there is low potential for drug-drug interactions due to enzyme induction of CYP1A2, CYP2B6, and CYP3A4 enzymes by amifampridine.
Učinkovine, ki so močni induktorji encimov, ki presnavljajo zdravila (glejte poglavje 5.2) Rezultati iz študij in vitro kažejo, da je malo možnosti za medsebojno delovanje zdravil, ker amifampridin inducira encime CYP1A2, CYP2B6 in CYP3A4.
FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals.
Zdravilo FIRDAPSE deluje tako, da poveča sproščanje acetilholina in pripomore k prejemu živčnih signalov.
The pharmacokinetics of amifampridine has been assessed in a single dose Phase I study in patients with renal impairment (see section 5.2).
Farmakokinetiko amifampridina so ocenili v študiji I. faze z enkratnim odmerkom pri bolnikih z ledvično okvaro (glejte poglavje 5.2).
Table 1: Adverse Reactions Reported with FIRDAPSE
Preglednica 1: Poročani neželeni učinki z zdravilom FIRDAPSE
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.
V študiji z zdravimi prostovoljci sta na sistemsko izpostavljenost amifampridinu bistveno vplivala splošna presnovna acetilacijska aktivnost encimov n-acetil-transferaze (NAT) in genotip NAT2.
• Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion)
• antidepresive - triciklične antidepresive (npr. klomipramin, amoksapin), selektivne zaviralce ponovnega privzema serotonina (npr. citalopram, dapoksetin) in atipične antidepresive (npr. buproprion),
Overall, food slowed and decreased the absorption of amifampridine with a lowering of exposure by Cmax on average by ~44% and lowered exposure by AUC ~20%.
Hrana je na splošno upočasnila in zmanjšala absorpcijo amifampridina z zmanjšanjem izpostavljenosti glede na Cmax za povprečno
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Sočasna uporaba amifampridina in zdravil z atropinskimi učinki lahko zmanjša učinek obeh zdravilnih učinkovin, kar je treba upoštevati.
Animal studies evaluating the reproductive and developmental toxicity of amifampridine were conducted in rats and rabbits at doses up to 75 mg/kg/day.
Pri podganah in kuncih so bile izvedene študije reproduktivne in razvojne toksičnosti amifampridina v odmerkih do 75 mg/kg/dan.
Assessment of breast-feeding neo-natal animals showed no indication of adverse reactions when exposed to amifampridine through breast-milk.
Ocena dojenih novorojenih mladičev ni pokazala nobenih neželenih učinkov pri izpostavljenosti amifampridinu preko materinega mleka.
Dizziness1, hypoaesthesia1, paraesthesia1
Bolezni živčevja omotica1, hipestezija1, parestezija1
• Sedatives (e.g. barbiturates)
• uspavala (npr. barbiturati).
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.
V podobni študiji pri brejih podganjih samicah ni bilo opaženega vpliva na preživetje zarodka/ploda pred skotitvijo pri odmerkih do 57 mg/kg/dan.
• Together with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram), such as:  Sultropride (a medicine prescribed to treat certain behavioural disorders in adults),  Antiarrhythmic medicine (e.g., disopyramide)  Medicines to treat digestive problems (e.g., cisapride, domperidone)
• sočasno z zdravili, ki lahko spremenijo električno aktivnost srca (podaljšanje intervala QT, kar je razvidno na elektrokardiogramu), npr:  sultoprid (zdravilo, ki se predpiše za zdravljenje določenih vedenjskih bolezni pri odraslih),  antiaritmiki (npr. dizopiramid)  zdravila za zdravljenje prebavnih težav (npr. cisaprid, domperidon)
The concomitant use of amifampridine and medicinal products with cholinergic effects (e.g. direct or indirect cholinesterase inhibitors) may lead to an increased effect of both products and should be taken into consideration.
Sočasna uporaba amifampridina in zdravil s holinergičnimi učinki (npr. neposredni ali posredni zaviralci holinesteraze) lahko poveča učinek obeh zdravil, kar je treba upoštevati.
How to take FIRDAPSE
Kako jemati zdravilo FIRDAPSE
The European Medicines Agency (EMA) will review any new information which may become available every year and this SmPC will be updated as necessary.
Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
Hyperhidrosis1, cold sweat1
Bolezni kože in podkožja hiperhidroza1, hladen znoj1
Store in the original blister in order to protect from light and moisture.
Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred svetlobo in vlago.
 Medicines to treat infections - antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole)
 zdravila za zdravljenje okužb - antibiotiki (npr. rifampicin) in antimikotiki (npr. ketokonazol)
The decision to administer proconvulsant or epileptic-threshold lowering substances concomitantly should be carefully considered in the light of the severity of the associated risks.
O sočasni uporabi prokonvulzantnih učinkovin ali snovi, ki znižujejo prag za nastanek epileptičnega napada, je treba presoditi ob upoštevanju resnosti povezanih tveganj.
Cardiac disorders Cardiac rhythm disorders, palpitations
Srčne bolezni motnje srčnega ritma, palpitacije neznana
The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
Zdravilo FIRDAPSE je treba jemati v razdeljenih odmerkih, trikrat ali štirikrat na dan. Priporočeni začetni odmerek je 15 mg amifampridina na dan, ki pa se lahko povečuje po 5 mg vsakih 4 do 5 dni do največ 60 mg na dan.
• Tramadol (a painkiller)
• tramadol (zdravilo proti bolečinam),
QMG Scoresa
Ocene QMGa
Table 3: Mean PK Parameters of Amifampridine in Healthy Subjects after Single Oral Doses (5-30mg) in Slow and Fast Acetylator Phenotypes
Preglednica 3: Povprečni FK parametri za amifampridin pri zdravih prostovoljcih po enkratnem peroralnem odmerku (5-30mg) pri fenotipih počasnih in hitrih acetilatorjev
There was no effect of amifampridine phosphate on heart rate, atrioventricular conduction or cardiac depolarization as measured by the heart rate, PR and QRS interval durations.
Amifampridinfosfat glede na meritve srčnega utripa ter trajanja intervalov PR in QRS ni imel nobenega učinka na srčni utrip, atrioventrikularno prevajanje ali depolarizacijo srca.
Non-clinical safety data are available regarding the effects of amifampridine on reproductive function.
Na voljo so predklinični podatki o vplivu amifampridina na sposobnost razmnoževanja.
• Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine)
• zdravila za zdravljenje duševnih motenj (npr. haloperidol, karbamazapin, klorpromazin, klozapin),
Marketing Authorisation Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Imetnik dovoljenja za promet z zdravilom BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache
Psihiatrične motnje motnje spanja, tesnoba neznana konvulzije, horea, mioklonija, zaspanost, šibkost, utrujenost, glavobol neznana
• Fits (convulsions)
• napadov (konvulzij),
Table 4: Mean PK Parameters of Amifampridine in Normal and Renal Impaired Subjects after Single Oral Dose Administration (10mg) in Slow and Fast Acetylator Phenotypes
Preglednica 4: Povprečni FK parametri amifampridina pri osebah z normalnim in okvarjenim delovanjem ledvic po dajanju enkratnega peroralnega odmerka (10 mg) pri počasnih in hitrih fenotipih acetilatorja
NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets amifampridine
IME ZDRAVILA FIRDAPSE 10 mg tablete amifampridin
• Anxiety, sleep disorders, drowsiness
• tesnoba, motnje spanja, zaspanost
1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
1 Neželeni učinki, o katerih so poročali v klinični študiji za ocenitev učinkov amifampridina na repolarizacijo srca pri enkratnem odmerku 30 mg ali 60 mg pri zdravih prostovoljcih.
Do not stop treatment without consulting your doctor.
Zdravila FIRDAPSE ne smete prenehati uporabljati, ne da bi se prej posvetovali z zdravnikom.
Table 2: PK Parameters for Amifampridine in Fed and Fasted Subjects Following Administration of a Single Oral Dose of Amifampridine Phosphate
Preglednica 2: Farmakokinetični parametri za amifampridin na tešče in s hrano po dajanju enega preoralnega odmerka amifampridin fospfata
Medicinal products with cholinergic effects
Zdravila s holinergičnimi učinki
Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure.
Učinkovine, ki so močni zaviralci encimov, ki presnavljajo zdravila (glejte poglavje 5.2) Ni verjetno, da bi močni zaviralci encima citokrom P450 (CYP450), npr. cimetidin, ketokonazol, zavrli presnovo amifampridina s humanimi encimi N-acetil-transferaze (NAT) in povzročili povečano izpostavljenost amifampridinu.
The overall clearance of amifampridine is predominantly due to metabolism by N-acetylation and acetylator phenotype has a greater effect on an individual's metabolism and elimination of amifampridine than does elimination by renal function (See Table 4).
A je v prvi vrsti odgovorna presnova z N-acetilacijo; fenotip acetilatorja pa ima večji učinek na presnovo posameznika in izločanje amifampridina kot izločanje z delovanjem ledvic (glejte preglednico 4).
The dose of amifampridine should be titrated more slowly in patients with renal and hepatic impairment than those with normal renal and hepatic function.
Pri bolnikih z ledvično ali jetrno okvaro je treba odmerek amifampridina titrirati počasneje kot pri tistih z normalnim delovanjem ledvic ali jeter.
For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended.
Pri bolnikih z blago okvarjenim delovanjem ledvic ali jeter je priporočeni začetni odmerek 10 mg amifampridina (5 mg dvakrat na dan) na dan.
What FIRDAPSE contains
Kaj vsebuje navodilo
There was significantly higher exposure to amifampridine in slow acetylators compared to fast acetylators.
Pri počasnih acetilatorjih so v primerjavi s hitrimi acetilatorji opazili bistveno višjo izpostavljenost amifampridinu.
Amifampridine has shown no effect on embryo-foetal viability and development in rabbits; however, in rats, an increase in the number of mothers delivering still-born offspring was observed (see section 5.3).
Kliničnih podatkov o uporabi amifampridina pri nosečnicah ni. Amifampridin ni imel učinka na preživetje in razvoj zarodka/ploda pri kuncih, pri podganjih samicah pa je bila opažena višja stopnja mrtvorojenih mladičev (glejte poglavje 5.3).
Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Ena tableta vsebuje količino amifampridinijevega fosfata, ki ustreza 10 mg amifampridina.
Due to adverse reactions such as drowsiness, dizziness, seizures and blurred vision, amifampridine may have minor or moderate influence on the ability to drive or use machines (see section 4.8).
Amifampridin ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji zaradi neželenih učinkov kot so zaspanost, omotica, napadi in zamegljen vid (glejte poglavje 4.8).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 10 mg amifampridina v obliki amifampridinijevega fosfata.
Elevated liver enzyme levels (transaminases)
Bolezni jeter, žolčnika in žolčevodov zvišane ravni jetrnih encimo (transminaz)
Depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects (e.g. suxamethonium) may lead to a decreased effect of both products and should be taken into consideration.
Zdravila, ki delujejo kot depolarizirajoči mišični relaksanti Sočasna uporaba amifampridina in zdravil z depolarizirajočimi relaksacijskimi učinki na mišice (npr. suksametonij) lahko zmanjša učinek obeh zdravil, kar je treba upoštevati.
No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).
V predkliničnih študijah amifampridina ni bilo opaženega vpliva na plodnost (glejte poglavje 5.3).
MedDRA System organ class
MedDRA podatkovna baza glede na organske sisteme
For patients with mild liver or kidney problems a starting dose of 10 mg (5 mg twice a day) FIRDAPSE daily is recommended.
Pri bolnikih z blagimi težavami jeter ali ledvic je priporočeni začetni odmerek 10 mg (5 mg dvakrat na dan) zdravila FIRDAPSE.
Fed* (N=46)
Na tešče (n=45)
Medicinal products with atropinic effects include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic,
Zdravila z atropinskimi učinki so triciklični antidepresivi, večina atropinskih antihistaminikov H1, antiholinergiki, zdravila za zdravljenje Parkinsonove bolezni, atropinski antispazmodiki, dizopiramid, fenotiazinski nevroleptiki in klozapin.
Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Neželeni učinki, o katerih so poročali v klinični študiji za ocenitev učinkov amifampridina na repolarizacijo srca pri enkratnem odmerku 30 mg ali 60 mg pri zdravih prostovoljcih.
Non depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects (e.g. mivacurium, pipercurium) may lead to a decreased effect of both products and should be taken into consideration.
Zdravila, ki delujejo kot nedepolarizirajoči mišični relaksanti Sočasna uporaba amifampridina in zdravil z nedepolarizirajočimi relaksacijskimi učinki na mišice (npr. mivakurij in piperkurij) lahko zmanjša učinek obeh zdravil, kar morate upoštevati.
• Medicines that may change the electrical activity of your heart (QT-interval prolongation detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone,
• zdravila, ki lahko spremenijo električno aktivnost srca (podaljšanje intervala QT - ki ga zazna elektrokardiogram), npr. sultoprid, dizopiramid, cisaprid, domperidon, rifampicin in ketokonazol (glejte „Ne jemljite zdravila FIRDAPSE”)
Upward dose titration should be discontinued if any adverse reaction occurs (see section 4.2).
Če se pojavijo neželeni učinki, je treba titracijo s povečevanjem odmerka prekiniti (glejte poglavje 4.2).
For these patients the dose of FIRDAPSE should be increased more slowly than in those without liver or kidney problems with doses increased in 5 mg increments every 7 days.
Pri teh bolnikih je treba odmerek zdravila FIRDAPSE povečevati počasneje kot pri tistih brez težav z jetri ali ledvicami.
Patients with recent use of immunomodulatory therapies (e.g., azathioprine, mycophenolate, cyclosporine), rituximab, intravenous immunoglobulin G, and plasmapheresis were excluded from the study.
rituksimab, intravenski imunoglobulin G in plazmaferezo, so bile iz študije izvzeti.
Cold extremities1
Žilne bolezni hladne okončine1
• Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium)
• zdravila za relaksacijo mišic (npr. mivakurij, piperkurij, suksametonij),
No effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the QTc interval.
Po uporabi amifampridinfosfata niso pri nobenem preskušancu nastopile nove klinično pomembne morfološke spremembe EKG-ja. Amifampridinfosfat ni imel opaznega učinka na repolarizacijo srca, ocenjeno z uporabo intervala QTc.
Regardless, patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme or renal transporter inhibitor.
Ne glede na to je treba bolnike ob uvedbi zdravljenja z močnim zaviralcem encimov ali zaviralcem ledvičnih transporterjev natančno spremljati glede pojava neželenih učinkov.
Do not drive or operate machines if you experience these side effects.
Če se ti neželeni učinki pojavijo pri vas, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
Do not take FIRDAPSE
Ne jemljite zdravila FIRDAPSE: