natgillin/translations-raw huggingface dataset:
The safety profile in this study is consistent with adverse reactions observed with patients on amifampridine.
Sigurnosni profil u tom ispitivanju u skladu je sa nuspojavama uočenim kod bolesnika koji su uzimali amifampridin.
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.
Preporučena početna doza je 15 mg amifampridina dnevno, koja se može povećavati za po 5 mg svakih 4 do 5 dana, do najviše 60 mg dnevno.
Then your doctor may continue to increase your total daily dose adding 5 mg (half a tablet) per day, every 4 or 5 days.
Potom liječnik može nastaviti povećavati Vašu ukupnu dnevnu dozu dodavanjem 5 mg (polovica tablete) na dan, svakih 4 ili 5 dana.
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).
Amifampridin nije pokazao utjecaj na embriofetalnu održivost i razvoj u kunića, ali je u štakora uočen povećan broj majki koje su rađale mrtvorođene potomke (vidjeti dio 5.3).
Stop the treatment and immediately consult your doctor in the event of:
Odmah prekinite liječenje i obratite se liječniku ako se jave:
The pharmacodynamic profile of amifampridine has been studied for a range of doses.
Farmakodinamički profil amifampridina proučavan je u rasponu doza.
In this four-day study, patients were randomized (1:1) to amifampridine phosphate (at patient's optimal dose) or placebo on Day 0.
U ovom četverodnevnom ispitivanju bolesnici su na dan 0 randomizirani (1:1) na amifampridinfosfat (pri optimalnoj dozi za svakog bolesnika) ili placebo.
It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with an overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77).
Poboljšava snagu mišića i amplitude sumacijskog mišićnog akcijskog potencijala (CMAP) u mirovanju s ukupnom ponderiranom srednjom vrijednosti razlike od 1,69 mV (95% CI 0,60 do 2,77).
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.
Srednja vrijednost omjera acetilatora kofeina za ovih 12 ispitanika koji su primili četiri rastuće doze bila je 0,408 za brze, odnosno 0,172 spore acetilatore.
Bronchial hypersecretion, asthma attack in asthmatic patients or patients with a history of asthma, cough
Hipersekrecija bronhija, astmatični napadaji u astmatičnih bolesnika ili u bolesnika s anamnezom astme, kašalj
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).
Ova je procjena provedena u dvostruko slijepom, randomiziranom, ukriženom ispitivanju faze 1 za definiranje EKG učinka amifampridin fosfata u tim dozama u usporedbi s placebom i moksifloksacinom (pozitivna kontrola) u zdravih muškaraca i žena koji su spori acetilatori (n=52).
Cardiac effects
Kardiološki učinci
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.
Odluku o istovremenoj primjeni prokonvulziva ili tvari koje snižavaju epileptički prag treba pažljivo razmotriti u svjetlu težine pridruženih rizika.
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.
McEvoy et al 1989 zabilježio je podatke iz kratkoročnog ispitivanja na 12 bolesnika s LEMS-om koji su pokazali da je primjena amifampridina pri dozama do 100 mg/dan tijekom razdoblja od 3 dana bila učinkovita u liječenju motoričkih i autonomnih simptoma LEMS-a.
To establish a Lambert Eaton Patient Registry as defined in the RMP and also incorporating measures of efficacy.
Osnovati registar bolesnika s Lambert Eatonovim sindromom kako je definirano u RMP-u te uspostaviti mjerenje djelotvornosti.
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 nije imao štetne učinke na plodnost mužjaka ili ženki štakora u dozama do 75 mg/kg/dan i nije uočen utjecaj na postnatalni razvoj ili plodnost potomaka liječenih životinja.
In vitro and in vivo studies in humans indicate that amifampridine is metabolised to a single major 3-N-acetylated amifampridine metabolite.
In vitro i in vivo ispitivanja na ljudima ukazuju da se amifampridin metabolizira u jedan glavni metabolit 3-N-acetilirani amifampridin.
• Weakness, tiredness, headache
• slabost, umor, glavobolja
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).
Osim toga, vrijednost CGI-I na dan 4 koju su odredili liječnici pokazala je značajno poboljšanje u bolesnika koji su nastavili primati amifampridinfosfat u usporedbi s bolesnicima koji su primali placebo (p = 0,0020).
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%.
Sveukupno, hrana je usporila i smanjila apsorpciju amifampridina sa snižavanjem izloženosti prema Cmax prosječno za ~44% i snižavanjem izloženosti prema AUC za ~20% temeljeno na omjerima geometrijskih srednjih vrijednosti (sitost prema natašte).
(hr) mean(S.D.), range t1/2
(hr) srednja vrijednost (S.D.), raspon t1/2
• Sedatives (e.g. barbiturates)
• sedative (primjerice barbiturate).
In this study, slow acetylators experienced more adverse reactions than the fast acetylators.
U tom ispitivanju spori acetilatori imali su više nuspojava od brzih acetilatora.
Your doctor may increase this dose slowly first to 5 mg (half a tablet) four times daily (i.e. 20 mg per day).
Vaš liječnik može povećati ovu dozu polako prvo na 5 mg (pola tablete) četiri puta dnevno (tj. 20 mg na dan).
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).
Zbog nuspojava kao što su omamljenost, omaglica, epileptički napadaji i zamagljen vid, amifampridin može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
Dizziness1, hypoaesthesia1, paraesthesia1
Omaglica1, hipoestezija1, parestezija1
If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).
Ako se javi bilo koja nuspojava, titriranje doze naviše treba prekinuti (vidjeti dijelove 4.4 i 5.2).
Subjects (N) NAT2 Phenotype
Ispitanici (N) 4 NAT2 fenotip Brzi
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.
Nakon četverodnevnog dvostruko slijepog razdoblja prekida liječenja, bolesnici koji su primali amifampridinfosfat održali su razinu mišićne snage u usporedbi s bolesnicima koji su primali placebo, a koji su pokazali pogoršanje mišićne snage.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Ovaj lijek se ne smije upotrebljavati nakon isteka roka valjanosti navedenog na pakiranju iza „Rok valjanosti“.
Medicinal products known to lower the epileptic threshold The concomitant use of amifampridine and substances known to lower the epileptic threshold may lead to an increased risk of seizures.
Lijekovi za koje se zna da snižavaju epileptički prag Istovremena uporaba amifampridina i tvari za koje se zna da snižavaju epileptički prag mogu uzrokovati povećani rizik od napadaja.
The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of acetylcholine-containing vesicles, which in turn enhances neuromuscular transmission.
Rezultirajući porast koncentracija unutarstaničnog kalcija olakšava egzocitozu vezikula koji sadrže acetilkolin što zauzvrat povećava neuromuslularnu transmisiju.
The effect of age on the pharmacokinetics of amifampridine has not been studied.
Učinak dobi na farmakokinetiku amifampridina nije proučavan.
Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache
Konvulzije, koreja, mioklonija, omamljenost, slabost, umor, glavobolja
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.
• Drugi sastojci su mikrokristalična celuloza, bezvodni koloidni silicijev dioksid i kalcijev stearat.
Concentrations in tissues are generally similar to or greater than concentrations in plasma, with the greatest concentration in organs of excretion (liver, kidney and the gastrointestinal tract) and some tissues of glandular function (lacrimal, salivary, mucous, pituitary and thyroid glands).
Koncentracije u tkivima općenito su slične ili veće od koncentracija u plazmi s najvišom koncentracijom u organima izlučivanja (jetra, bubrezi i gastrointestinalni trakt) te nekim tkivima sa žljezdanom funkcijom (suzne žlijezde, žlijezde slinovnice, sluznica, hipofiza i štitna žlijezda).
Distribution of amifampridine was studied in the rat.
Distribucija amifampridina proučavana je na štakorima.
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.
Nije bilo učinka amifampridin fosfata na srčanu frekvenciju, atriventrikularnu provodljivost ili srčanu depolarizaciju mjerene prema srčanoj frekvenciji i trajanju PR i QRS intervala.
A prospective, placebo-controlled, randomised study in 26 patients with Lambert-Eaton myasthenic syndrome (LEMS) reported clinical efficacy for amifampridine at the standard recommended maximum dose of 60 mg/day (Sanders et al 2000).
Prospektivno, placebom kontrolirano ispitivanje na 26 bolesnika s Lambert-Eatonovim mijasteničnim sindromom (LEMS) pokazalo je kliničku djelotvornost amifampridina u standardno preporučenoj maksimalnoj dozi od 60 mg/dan (Sanders et al 2000).
Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.
Amifampridin treba koristiti s oprezom u bolesnika s povećanim rizikom od švanoma, kao što su bolesnici s takvim tumorima, neurofibromatozom tipa 2 ili švanomatozom u anamnezi.
The intensity and incidence of most adverse reactions is dose-dependent.
Intenzitet i incidencija većine nuspojava ovise o dozi.
The starting dose is 5 mg amifampridine (half a tablet) three times daily (i.e. 15 mg per day).
Početna doza je 5 mg amifampridina (pola tablete) tri puta dnevno (tj. 15 mg na dan).
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).
U ispitivanju perinatalne/postnatalne reprodukcije na skotnim štakorima liječenima amifampridinom uočen je porast udjela majki s mrtvorođenim potomstvom (16,7% - 20%) povezan s dozom lijeka pri 22,5 mg/kg/dan i 75 mg/kg/dan (1,1 i 2,7 puta 80-miligramske dnevne doze u ljudi, temeljeno na Cmax).
How to take FIRDAPSE
Kako uzimati FIRDAPSE
FIRDAPSE is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults.
FIRDAPSE se koristi za liječenje simptoma bolesti živaca i mišića zvane Lambert-Eatonov mijastenički sindrom ili LEMS u odraslih bolesnika.
The effect of a single dose of 30 mg or 60 mg of amifampridine phosphate was used to evaluate the pharmacokinetic-QTc relationship of amifampridine concentration on cardiac repolarization exposure in healthy volunteers.
Učinak jednokratne doze od 30 mg ili 60 mg amifampridin fosfata korišten je za procjenu odnosa farmakokinetike i QTc intervala koncentracije amifampridina na izloženost srčane repolarizacije u zdravih dobrovoljaca.
No effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the QTc interval.
Nisu opaženi učinci amifampridin fosfata na srčanu repolarizaciju procijenjenu pomoću QTc intervala.
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).
Te tvari uključuju većinu antidepresiva (tricikličke antidepresive, selektivne inhibitore ponovne pohrane serotonina), neuroleptike (fenotiazine i butirofenone), meflokin, bupropion i tramadol (vidjeti dijelove 4.4 i 5.1).
• Cough, excessive or viscous mucus in the breathing passage, asthma attack in asthmatic patients or patients with a history of asthma
• kašalj, obilata ili gusta sluz u dišnim putevima, napad astme u bolesnika s astmom ili u bolesnika koji su imali astmu
• Epilepsy
• Epilepsija.
Animal studies evaluating the reproductive and developmental toxicity of amifampridine were conducted in rats and rabbits at doses up to 75 mg/kg/day.
Provedena su ispitivanja reproduktivne i razvojne toksičnosti amifampridina na životinjama; na štakorima i kunićima u dozama do 75 mg/kg/dan.
Exposure of amifampridine was generally higher in subjects with renal impairment than in subjects with normal renal function; however, NAT2 phenotype had a greater effect on an individual's exposure to amifampridine than renal function status (See Table 4).
Izloženost amifampridinu bila je općenito veća u ispitanika s oštećenjem funkcije bubrega nego u ispitanika s normalnom funkcijom bubrega; ipak, fenotip NAT2 imao je veći utjecaj na izloženost pojedinca amifampridinu nego status funkcije bubrega (vidjeti tablicu 4).
Assessment of breast-feeding neo-natal animals showed no indication of adverse reactions when exposed to amifampridine through breast-milk.
Procjena dojenih neonatusa životinja nije pokazala znakove nuspojava pri izlaganju amifampridinu putem majčinog mlijeka.
Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation.
Amifampridin blokira kalijeve kanale ovisne o naponu te tako produljuje depolarizaciju membrane presinaptičke stanice.
Based on the pharmacodynamic properties of amifampridine, the concomitant use with sultopride or other medicinal products known to cause QT prolongation (e.g., disopyramide, cisapride, domperidone, rifampicin and ketoconazole) is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes (see sections 4.3 and 5.1).
Na temelju farmakodinamičkih svojstava amifampridina, kontraindicirana je istodobna uporaba sa sultopridom ili ostalim lijekovima za koje je poznato da uzrokuju produljenje QT intervala (npr. dizopiramid, cisaprid, domperidon, rifampicin i ketokonazol) jer ta kombinacija može uzrokovati povećani rizik od ventrikularne tahikardije, a posebice torsade de pointes (vidjeti dijelove 4.3 i 5.1).
In the healthy volunteer study, fast acetylators were defined by having a caffeine metabolite ratio >0.3 and slow acetylators with a caffeine metabolite ratio <0.2 .
U ispitivanjima na zdravim dobrovoljcima brzi acetilatori definirani su kao oni s omjerom metabolita kofeina većim od 0,3, a spori acetilatori s omjerom metabolita kofeina manjim od 0,2.
Statistically significant differences in amifampridine PK parameters Cmax, AUC0-∞, t1/2 and apparent clearance was observed between fast and slow acetylators at all dose levels.
Statistički značajne razlike u farmakokinetičkim parametrima amifampridina poput Cmax, AUC0-∞, t1/2 i prividnog klirensa uočene su i kod sporih i kod brzih acetilatora pri svim dozama.
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.
Dijagnozu švanoma treba uzeti u obzir kod bolesnika sa simptomima kao što je masa koja je bolna prilikom palpitacije ili sa simptomima sličnim kompresivnoj neuropatiji.
MAO-B inhibitors (e.g. selegiline, deprenyl), COMT inhibitors (e.g. entacapone)
MAO-B inhibitore (npr. selegilin, deprenil), COMT inhibitore (primjerice, entakapon)
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.
Za te bolesnike dozu lijeka FIRDAPSE treba povećavati sporije nego u onih osoba bez oštećenja jetre ili bubrega s porastom doza za 5 mg svakih 7 dana.
The results from the in vitro CYP450 inhibition study indicate amifampridine is unlikely to play a role in metabolic-based clinical drug-drug interactions related to inhibition of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 metabolism of co-administered medicinal products.
Rezultati in vitro studije s inhibicijom CYP450 ukazuju da je malo vjerojatno da amifampridin ima ulogu u metaboličkim kliničkim interakcijama lijekova povezanim s inhibicijom CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4 metaboliziranja istodobno primijenjenih lijekova.
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).
Najčešće zabilježene nuspojave su parestezije (poput periferne i peribukalne parestezije) i poremećaji probavnog sustava (poput epigastralgije, proljeva, mučnine i boli u abdomenu).
• Medicines for malaria (e.g. halofantrine and mefloquine)
• lijekove za malariju (primjerice, halofantrin i meflokin)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Perforated unit dose thermoformed blisters
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Termoformirani perforirani blister s jediničnim dozama
• Chorea (movement disorder), myoclonia (muscle spasm or twitching)
• koreja (poremećaj pokreta), mioklonija (grčevi ili trzanje mišića)
Medicinal products with atropinic effects
Lijekovi s atropinskim učincima
Assessment
Ocjena
No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).
Nije uočeno smanjenje plodnosti u nekliničkim ispitivanjima amifampridina (vidjeti dio 5.3).
Available reproductive data in animals have shown presence of amifampridine in milk of breast-feeding mothers.
Dostupni podaci o reproduktivnosti u životinja pokazali su prisutnost amifampridina u mlijeku životinja koje doje.
Cardiac disorders Cardiac rhythm disorders, palpitations
Poremećaji srčanog ritma, palpitacije
FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals.
FIRDAPSE djeluje tako da povećava oslobađanje acetilkolina te pomaže da mišić primi živčane signale.
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.
Izloženost 3-N-acetil metabolitu prema AUC0-∞ bila je do 6,8 puta veća u sporih acetilatora i do 4 puta veća u brzih acetilatora s teškim oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
Bioavailability is approximately 93-100% based on recoveries of unmetabolised amifampridine and a major 3-N-acetylated amifampridine metabolite in urine.
Bioraspoloživost iznosi približno 93-100% na temelju izlučenog nemetaboliziranog amifampridina i glavnog metabolita 3-N-acetiliranog amifampridina u mokraći.
Store in the original blister in order to protect from light and moisture.
Čuvati u originalnom blisteru radi zaštite od svjetlosti i vlage.
In view of the risk of markedly increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully monitored.
Imajući u vidu rizik od značajne izloženosti lijeku, bolesnike s oštećenjem funkcije bubrega ili jetre mora se pomno pratiti.
• Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine)
• lijekove za liječenje alergija - antihistaminike (primjerice, terfenadin, astemizol, cimetidin)
A 2-fold increase in the time to reach Cmax (Tmax) was observed in the presence of food.
U prisutnosti hrane uočeno je dvostruko produljenje vremena do postizanja Cmax (Tmax).
• Anxiety, sleep disorders, drowsiness
• tjeskoba, poremećaji spavanja, omamljenost
If any side effects occur, please consult your doctor as you may need to stop increasing the dose.
U slučaju nuspojava obratite se svom liječniku jer će morati prekinuti povećavanje doze.
Fast
Brzi
In a 2-year dietary carcinogenicity study, benign and malignant Schwannomas have been observed in rats treated with amifampridine (see section 5.3).
U dvogodišnjem ispitivanju kancerogenosti provedenom s djelatnom tvari u hrani, benigni i maligni švanomi uočeni su u štakora liječenih amifampridinom (vidjeti dio 5.3).
Summary of Changes in Primary and Secondary Efficacy Endpoints from Baseline
Sažetak promjena u primarnim i sekundarnim mjerama ishoda djelotvornosti u odnosu na početnu vrijednost
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.
Zapažena srednja vrijednost razlike u rezultatu ukupnog QMG-a u odnosu na početnu vrijednost, u razdoblju između liječenja, iznosila je -6,54 (95% CI: -9,78, -3,29; p = 0,0004), dok je srednja vrijednost promjene SGI-a u odnosu na početnu vrijednost u razdoblju između liječenja iznosila 2,95 (95% CI: 1,53, 4,38; p = 0,0003).
It is unknown whether amifampridine is excreted in human breast milk.
Nije poznato izlučuje li se amifampridin u majčino mlijeko u ljudi.
Table 1: Adverse Reactions Reported with FIRDAPSE
Tablica 1: Nuspojave prijavljene za lijek FIRDAPSE
• Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion)
• antidepresive - tricikličke antidepresive (primjerice, klomipramin, amoksapin), selektivne inhibitore ponovne pohrane serotonina (primjerice, citalopram, dapoksetin) i atipične antidepresive (primjerice, bupropion)
• 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)
• zajedno s lijekovima koji mogu promijeniti električnu aktivnost Vašeg srca (produljenje QT intervala - vidljivo na EKG-u), poput:  sultoprida (lijeka koji se propisuje za liječenje nekih poremećaja ponašanja u odraslih osoba),  antiaritmika (npr. dizopiramid)  lijekova za liječenje probavnih smetnji (npr. cisaprid, domperidon)
Fed* (N=46)
poslije jela* (N=46)
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.
Tvari koje su potentni induktori enzima koji metaboliziraju lijekove (vidjeti dio 5.2) Rezultati iz in vitro ispitivanja ukazuju da je potencijal za interakcije lijekova nizak zbog indukcije enzima CYP1A2, CYP2B6 i CYP3A4 putem amifampridina.
• Tramadol (a painkiller)
• tramadol (lijek protiv bolova)