You searched for: amifampridin (Kroatiska - Engelska)

amifampridin 20 mg
amifampridine 20 mg

djelatna tvar je amifampridin.
the active substance is amifampridine.

firdapse 10 mg tablete amifampridin
firdapse 10 mg tablets amifampridine

firdapse je lijek koji sadrži djelatnu tvar amifampridin.
firdapse is a medicine that contains the active substance amifampridine.

nije poznato izlučuje li se amifampridin u majčino mlijeko u ljudi.
it is unknown whether amifampridine is excreted in human breast milk.

nisu opaženi učinci amifampridin fosfata na srčanu repolarizaciju procijenjenu pomoću qtc intervala.
no effect was observed of amifampridine phosphate on cardiac repolarization as assessed using the qtc interval.

amifampridin blokira kalijeve kanale ovisne o naponu te tako produljuje depolarizaciju membrane presinaptičke stanice.
amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation.

amifampridin nije u potpunosti testiran na modelima kancerogenosti te nije određen rizik od kancerogenosti povezan s liječenjem.
amifampridine has not been fully tested in carcinogenicity models, and the carcinogenicity risk associated with treatment has not been determined.

ako ste alergični na amifampridin ili neki drugi sastojak ovog lijeka (navedenog u dijelu 6),
if you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6)

niti jedan ispitanik nije razvio nove klinički značajne morfološke promjene ekg-a nakon primjene amifampridin fosfata.
no subjects developed new clinically relevant ecg morphological changes following administration of amifampridine phosphate.

tablica 2: pk parametri za amifampridin kod uzimanja poslije jela ili natašte nakon primjene jednokratne peroralne doze amifampridin fosfata
table 2: pk parameters for amifampridine in fed and fasted subjects following administration of a single oral dose of amifampridine phosphate

amifampridin se nije pokazao genotoksičan u standardnoj bateriji in vitro i in vivo testova, ali nisu dostupni rezultati potpunih ispitivanja kancerogenosti.
amifampridine was not genotoxic in a standard battery of in vitro and in vivo tests, but the results of full carcinogenicity studies are not available.

djelatna tvar lijeka firdapse, amifampridin, je blokator kanala natrija, što sprječava napunjene čestice natrija da napuste živčane stanice.
the active substance in firdapse, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells.

došlo je do pada cmax i auc te produljenja vremena do postizanja maksimalne koncentracije u plazmi kad se amifampridin fosfat primjenjivao s hranom, a u usporedbi bez hrane.
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.

nakon primjene amifampridin fosfata nisu opažene nikakve klinički značajne ekg morfološke promjene u ispitivanju na zdravim dobrovoljcima (vidjeti dio 5.1).
no clinically relevant ecg morphological changes following administration of amifampridine phosphate were observed in a study of healthy volunteers (see section 5.1).

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.
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 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).
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).

budući da se lijekovi koji sadrže amifampridin primjenjuju u europskoj uniji (eu) dulje od 20 godina, tvrtka je dostavila rezultate ispitivanja iz znanstvene literature o amifampridina, kako bi se potkrijepila primjena lijeka firdapse.
because amifampridine-containing medicines have been used in the european union (eu) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of firdapse.