natgillin/translations-raw huggingface dataset:
You MUST NOT take Riluzole Zentiva if you are or think you may be pregnant, or if you are breast-feeding.
NE SMIJETE uzimati Riluzole Zentiva ako ste trudni, mislite da ste trudni ili dojite.
These increases could be associated with jaundice.
Ovo povišenje vrijednosti moglo bi biti povezano sa žuticom.
Readministration of riluzole to patients in this situation cannot be recommended.
Ne može se preporučiti ponovna primjena riluzola bolesnicima u ovoj situaciji.
Riluzole did not show any carcinogenicity potential in either rats or mice.
Riluzol nije pokazao kancerogeni potencijal niti u štakora niti u miševa.
Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Riluzole Zentiva se nije pokazao djelotvornim u kasnim fazama ALS-a.
Glucuronides accounted for more than 85% of the metabolites in the urine.
Glukuronidi čine više od 85% metabolita u mokraći.
U kabelovny 130 102 37 Prague 10 Czech Republic
U kabelovny 130 102 37 Prague 10
The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours).
Doziranje Preporučena dnevna doza u odraslih ili starijih osoba iznosi 100 mg (50 mg svakih 12 sati).
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Možete voziti i rukovati alatima ili strojevima, osim ako osjećate omaglicu ili ošamućenost nakon uzimanja ovog lijeka.
Standard tests for genotoxicity performed with riluzole were negative.
Standardni testovi genotoksičnosti provedeni s riluzolom bili su negativni.
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Ako uzmete previše tableta, odmah se javite svom liječniku ili otiđite u hitnu službu najbliže bolnice.
Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this population.
Na temelju farmakokinetičkih podataka nema posebnih uputa za primjenu lijeka Riluzole Zentiva u ovoj populaciji.
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Farmakoterapijska skupina: ostali lijekovi koji djeluju na živčani sustav, ATK oznaka: N07XX02.
If you are less than 18 years of age, the use of Riluzole Zentiva is not recommended because there is no information available in this population.
Ako ste mlađi od 18 godina, ne preporučuje se primjena lijeka Riluzole Zentiva jer nema podataka za tu populaciju.
On the basis of these data, and taking into consideration the negative studies on the carcinogenesis of riluzole in the mouse and rat, the genotoxic effect of this metabolite is not considered to be of relevance in humans.
Na temelju tih podataka te uzimajući u obzir negativne rezultate ispitivanja kancerogenosti riluzola u miševa i štakora ne smatra se da je genotoksično djelovanje ovog metabolita važno za ljude.
Other medicines and Riluzole Zentiva
Drugi lijekovi i Riluzole Zentiva
Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Približno 97% riluzola veže se za proteine, uglavnom za serumski albumin i lipoproteine.
The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Brzina i stupanj apsorpcije smanjuju se kada se riluzol primjenjuje uz punomasne obroke (Cmax smanjen za 44%, AUC smanjen za 17%).
All these findings were noted at doses which were 2-10 times higher than the human dose of 100 mg/day.
Svi su ovi nalazi zabilježeni pri dozama koje su 2-10 puta veće od doze za ljude od 100 mg na dan.
Although the pathogenesis of ALS is not completely elucidated, it is suggested that glutamate (the primary excitatory neurotransmitter in the central nervous system) plays a role for cell death in the disease.
Iako patogeneza ALS-a nije u potpunosti rasvijetljena, smatra se da glutamat (primarni ekscitatorni neurotransmiter u središnjem živčanom sustavu) ima ulogu u odumiranju stanica u ovoj bolesti.
Patients should be warned to report any febrile illness to their physicians.
Bolesnike treba upozoriti da svaku bolest praćenu vrućicom prijave svojim liječnicima.
In case of overdose, treatment is symptomatic and supportive.
U slučaju predoziranja primjenjuje se simptomatsko i potporno liječenje.
In the majority of the reported cases, symptoms resolved after medicinal product discontinuation and symptomatic treatment.
U većini prijavljenih slučajeva simptomi su se povukli nakon prekida uzimanja lijeka i simptomatskog liječenja.
D-65926 Frankfurt am Main Germany
D-65926 Frankfurt na Majni
Intensive testing in seven other standard in vitro or in vivo assays did not show any genotoxic potential of the metabolite.
Intenzivna ispitivanja sa sedam drugih standardnih testova in vitro ili in vivo nisu pokazala genotoksični potencijal metabolita.
Riluzole is rapidly absorbed after oral administration with maximal plasma concentrations occurring within 60 to 90 minutes (Cmax=173 ± 72 (sd) ng/ml).
Riluzol se brzo apsorbira nakon oralne primjene, a maksimalne koncentracije u plazmi postižu se unutar 60 do 90 minuta (Cmax = 173 ± 72 (sd) ng/ml).
Tablets are packaged in opaque pvc/aluminium blister cards.
Tablete su pakirane u neprozirne PVC/aluminij blister kartice.
Date of first authorisation: 07 May 2012 Date of latest renewal: {DD month YYYY}
Datum prvog odobrenja: 7. svibnja 2012.
Patients should be warned about the potential for dizziness or vertigo, and advised not to drive or operate machinery if these symptoms occur.
Bolesnike treba upozoriti na moguću pojavu omaglice ili vrtoglavice te im savjetovati da ne voze i ne rukuju strojevima ako se pojave ti simptomi.
This metabolite is rapidly glucuronoconjugated to O- and N-glucuronides.
Taj se metabolit brzo konjugira u O-glukuronide i N-glukuronide.
Contents of the pack and other information What Riluzole Zentiva contains
Sadržaj pakiranja i druge informacije Što Riluzole Zentiva sadrži
In rats, riluzole decreased the pregnancy rate and the number of implantations at exposure levels at least twice the systemic exposure of humans given clinical therapy.
U štakora je riluzol smanjio stopu trudnoća i broj implantacija pri razinama izloženosti najmanje dva puta višima od sustavne izloženosti u ljudi tijekom kliničke primjene terapije.
if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).
ako kašljete ili otežano dišete jer to može biti znak bolesti pluća (zvane intersticijska bolest pluća).
Severe neutropenia (see section 4.4)
Teška neutropenija (vidjeti dio 4.4)
Study data indicate that Asian patients may be more susceptible to liver function test abnormalities3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
Podaci iz ispitivanja ukazuju na to da bolesnici azijskog podrijetla mogu biti skloniji poremećajima vrijednosti testova funkcije jetre - 3,2% (194/5995) bolesnika azijskog podrijetla i 1,8% (100/5641) bijelaca.
The metabolites identified in urine are three phenolic derivatives, one ureido-derivative and unchanged riluzole.
Metaboliti pronađeni u mokraći obuhvaćaju tri fenolna derivata, jedan ureidni derivat i nepromijenjeni riluzol.
IMPORTANT Tell your doctor immediately if you experience any fever (increase in temperature) because Riluzole Zentiva may cause a decrease in the number of white blood cells.
Odmah obavijestite svog liječnika ako dobijete vrućicu (povišenu temperaturu) jer Riluzole Zentiva može uzrokovati smanjenje broja bijelih krvnih stanica.
Each package contains 28, 56, 98, 112 or 168 tablets.
Jedno pakiranje sadrži 28, 56, 98, 112 ili 168 tableta.
What Riluzole Zentiva is and what it is used for What you need to know before you take Riluzole Zentiva How to take Riluzole Zentiva Possible side effects
Što je Riluzole Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Riluzole Zentiva Kako uzimati Riluzole Zentiva
Plasma levels increase linearly with the dose and the pharmacokinetic profile is dose-independent.
Razine u plazmi povećavaju se linearno s dozom, a farmakokinetički profil je neovisan o dozi.
56 film-coated tablets 28 film-coated tablets 98 film-coated tablets 112 film-coated tablets 168 film-coated tablets
56 filmom obloženih tableta 28 filmom obloženih tableta 98 filmom obloženih tableta 112 filmom obloženih tableta 168 filmom obloženih tableta
Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Ispitivanja plodnosti na štakorima otkrila su blagi poremećaj reproduktivne sposobnosti i plodnosti pri dozama od 15 mg/kg na dan (što je više od terapijske doze), vjerojatno zbog sedacije i letargije.
There have been no clinical studies to evaluate the interactions of riluzole with other medicinal products.
Nisu provedena klinička ispitivanja interakcija riluzola s drugim lijekovima.
Riluzole is eliminated mainly in the urine.
Riluzol se uglavnom eliminira mokraćom.
Riluzole is extensively distributed throughout the body and has been shown to cross the blood brain barrier.
Riluzol se široko raspodjeljuje po cijelom tijelu i prolazi kroz krvno-moždanu barijeru.
In dogs, haemolytic anaemia was observed.
U pasa je opažena hemolitička anemija.
ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
ALS je jedan oblik bolesti motoričkih neurona koji napada živčane stanice odgovorne za slanje signala mišićima, što dovodi do slabosti, propadanja mišića i paralize.
Meta-analysis including this study and those described above showed a less striking effect on survival for riluzole as compared to placebo although the differences remained statistically significant.
Meta-analiza u koju je uključeno ovo kao i ranije opisana ispitivanja nije pokazala toliko izrazit učinak riluzola na preživljenje u usporedbi s placebom, iako su razlike i dalje bile statistički značajne.
Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
Preživljenje je definirano kao razdoblje koje su bolesnici preživjeli bez intubacije za mehaničku ventilaciju i bez traheotomije.
Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Liječenje lijekom Riluzole Zentiva smije započeti samo liječnik specijalist s iskustvom u liječenju bolesti motoričkih neurona.
Summary of safety profile
Sažetak profila sigurnosti primjene
No malformations were seen in animal reproductive studies.
U ispitivanjima reprodukcije kod životinja nisu opažene malformacije.
Riluzole Zentiva stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Riluzole Zentiva blokira izlučivanje glutamata, što može pomoći u sprečavanju oštećenja živčanih stanica.
What you need to know before you take Riluzole Zentiva Do not take Riluzole Zentiva if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),
Što morate znati prije nego počnete uzimati Riluzole Zentiva Nemojte uzimati Riluzole Zentiva ako ste alergični na riluzol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), ako imate neku bolest jetre ili povišene razine nekih jetrenih enzima (transaminaza) u krvi,
Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Jedna tableta sadrži 50 mg riluzola i ima utisnutu oznaku "RPR 202" na jednoj strani.
Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Ne preporučuje se primjena lijeka Riluzole Zentiva u pedijatrijskoj populaciji jer nema podataka o sigurnosti primjene i djelotvornosti riluzola niti za jednu neurodegenerativnu bolest koja se javlja u djece i adolescenata.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet.
If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Razviju li se respiratorni simptomi poput suhog kašlja i/ili dispneje, treba učiniti radiogram prsnog koša te u slučaju nalaza koji upućuju na intersticijsku bolest pluća (npr. bilateralna difuzna zasjenjenja na plućima), odmah obustaviti primjenu riluzola.
EU/1/12/768/001 - 56 film-coated tablets EU/1/12/768/002 - 28 film-coated tablets EU/1/12/768/003 - 98 film-coated tablets EU/1/12/768/004 - 112 film-coated tablets EU/1/12/768/005 - 168 film-coated tablets
EU/1/12/768/001 - 56 filmom obloženih tableta EU/1/12/768/002 - 28 filmom obloženih tableta EU/1/12/768/003 - 98 filmom obloženih tableta EU/1/12/768/004 - 112 filmom obloženih tableta EU/1/12/768/005 - 168 filmom obloženih tableta
Survival, as defined in the second paragraph of section 4.1, was significantly extended for patients who received riluzole as compared to patients who received placebo.
Preživljenje, kako je definirano u drugom odlomku u dijelu 4.1, je bilo značajno dulje u bolesnika koji su primali riluzol u odnosu na bolesnike koji su primali placebo.
Only 2% of a riluzole dose was recovered unchanged in the urine.
Samo 2% doze riluzola pronađeno je u mokraći u nepromijenjenom obliku.
Abnormal liver function tests
Odstupanja od normalnih vrijednosti testova funkcije jetre
The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord.
Propadanje živčanih stanica u bolesti motoričkih neurona može biti posljedica prevelike količine glutamata (kemijskog prijenosnika) u mozgu i leđnoj moždini.
In a parallel group study designed to assess the efficacy and safety of riluzole in patients at a late stage of the disease, survival time and motor function under riluzole did not differ significantly from that of placebo.
U ispitivanju s paralelnim skupinama dizajniranom da procijeni djelotvornost i sigurnost primjene riluzola u bolesnika u kasnom stadiju bolesti, vrijeme preživljenja i motorička funkcija kod primjene riluzola nisu se značajno razlikovale u odnosu na placebo.
Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.
Povišenje vrijednosti alanin aminotransferaze obično se pojavilo unutar 3 mjeseca od početka terapije riluzolom; obično je bilo prolazno i vrijednosti su se uz nastavak liječenja vratile na manje od dva puta iznad GGN nakon 2 do 6 mjeseci.
If you take more Riluzole Zentiva than you should
Ako uzmete više Riluzole Zentiva tableta nego što ste trebali
Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
Zentiva ne smije koristiti u bolesnika s nekim drugim oblikom bolesti motoričkih neurona.
Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Nuspojave navedene u nastavku razvrstane su prema učestalosti pojavljivanja u sljedeće kategorije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
The effect of riluzole 50 mg/day was not statistically significant compared to placebo and the effect of 200 mg/day was essentially comparable to that of 100 mg/day.
Učinak riluzola u dozi od 50 mg na dan nije bio statistički značajan u odnosu na placebo, a učinak doze od 200 mg na dan bio je usporediv s onim kod doze od 100 mg na dan.
The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Medijan vremena preživljenja iznosio je 17,7 mjeseci za riluzol, a 14,9 mjeseci za placebo.
How to store Riluzole Zentiva Contents of the pack and other information
Kako čuvati Riluzole Zentiva Sadržaj pakiranja i druge informacije
Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Upitajte svog liječnika za više informacija o ALS-u i razlozima zašto
In this study, the efficacy was assessed on inability to walk alone, loss of upper limb function, tracheostomy, need for artificial ventilation, gastric tube feeding or death.
U ovom je ispitivanju ocijenjena djelotvornost lijeka prema nemogućnosti samostalnog hoda, gubitku funkcije gornjih ekstremiteta, traheotomiji, potrebi za umjetnom ventilacijom, hranjenju putem želučane sonde ili smrti.
Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Filmom obložena tableta Tablete su u obliku kapsula, bijele, s utisnutom oznakom "RPR 202" na jednoj strani.
Tests on the major active metabolite of riluzole gave positive results in two in vitro tests.
Od testova provedenih s glavnim aktivnim metabolitom riluzola, dva su testa in vitro dala pozitivne rezultate.
The AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency.
AUC riluzola nakon jednokratne oralne doze od 50 mg povećava se približno 1,7 puta u bolesnika s blagom kroničnom insuficijencijom jetre, a približno 3 puta u bolesnika s umjerenom kroničnom insuficijencijom jetre.
The overall urinary excretion accounts for about 90% of the dose.
Mokraćom se ukupno izluči oko 90% doze.
Riluzole is proposed to act by inhibiting glutamate processes.
Riluzol vjerojatno djeluje tako da inhibira procese povezane s glutamatom.
Clinical experience with riluzole in pregnant women is lacking.
Nema kliničkog iskustva s primjenom riluzola u trudnica.
Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
diklofenak, diazepam, nicergolin, klomipramin, imipramin, fluvoksamin, fenacetin, teofilin, amitriptilin i kinoloni) mogu potencijalno smanjiti brzinu eliminacije riluzola, dok induktori CYP1A2 (npr. dim cigareta, hrana pripremljena na žaru, rifampicin i omeprazol) mogu povećati brzinu eliminacije riluzola.
What Riluzole Zentiva looks like and content of the pack
Kako Riluzole Zentiva izgleda i sadržaj pakiranja
The tablets are film-coated, capsule-shaped and white.
Tablete su obložene filmom, bijele boje, u obliku kapsula.
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Primarni metabolički put za riluzol je početna oksidacija pomoću citokroma P450 1A2, pri kojoj nastaje N-hidroksiriluzol (RPR112512), najvažniji aktivni metabolit riluzola.
Riluzole should be discontinued if the ALT levels increase to 5 times the ULN.
Primjena riluzola mora se obustaviti ako se razine ALT-a povise 5 puta iznad GGN.
Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal.
Bolest jetre ili početna vrijednost transaminaza više od 3 puta iznad gornje granice normalnih vrijednosti.
The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.
Djelatna tvar u lijeku Riluzole Zentiva je riluzol koji djeluje na živčani sustav.
The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia (see section 4.8).
Prijava febrilne bolesti treba potaknuti liječnika da provjeri broj bijelih krvnih stanica i obustavi primjenu riluzola u slučaju neutropenije (vidjeti dio 4.8).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC/ALUMINIJSKI BLISTER
Safety and efficacy of Riluzole Zentiva has only been studied in ALS.
Sigurnost primjene i djelotvornost lijeka Riluzole Zentiva ispitana je samo u ALS-u.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza "Rok valjanosti".
Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Ne preporučuje se primjena lijeka Riluzole Zentiva u bolesnika s oštećenjem funkcije bubrega jer u ovoj populaciji nisu provedena ispitivanja s primjenom ponovljenih doza (vidjeti dio 4.4).
A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
N-hidroksiriluzola nakon oralne primjene ponovljenih doza dva puta na dan tijekom 8 dana u 16 zdravih odraslih Japanaca i 16 zdravih odraslih muškaraca bijelaca pokazalo je manju izloženost riluzolu u skupini s japanskim ispitanicima (Cmax 0,85 [90% CI 0,68-1,08] i AUCinf. 0,88 [90% CI
If you forget to take Riluzole Zentiva
Ako ste zaboravili uzeti Riluzole Zentiva
Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Riluzole Zentiva je kontraindiciran u trudnoći (vidjeti dijelove 4.3 i 5.3).
ALT levels should be measured more frequently in patients who develop elevated ALT levels.
ALT treba određivati češće u bolesnika u kojih se razine ALT-a povise.
Anaphylactoid reaction, angioedema
Anafilaktoidna reakcija, angioedem
In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
U bolesnika liječenih riluzolom u dozi od 100 mg na dan preživljenje je bilo značajno dulje nego u bolesnika koji su dobivali placebo.
Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1).
Klinička ispitivanja pokazala su da Riluzole Zentiva produljuje preživljenje u bolesnika s ALS-om (vidjeti dio 5.1).
Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Riluzole Zentiva je dostupan u pakiranju od 28, 56, 98, 112 ili 168 tableta koje se uzimaju kroz usta.
Headache, dizziness, oral paraesthesia, somnolence
Glavobolja, omaglica, parestezija usta, somnolencija
What Riluzole Zentiva is and what it is used for What Riluzole Zentiva is
Što je Riluzole Zentiva i za što se koristi Što je Riluzole Zentiva
This leaflet was last approved in {MM/YYYY}.
Uputa je zadnji puta revidiranau {MM/GGGG}.
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja o djelovanju lijeka na sposobnost upravljanja vozilima i rada sa strojevima.
The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid.
Farmakokinetika riluzola ispitana je u zdravih muških dobrovoljaca nakon oralne primjene jedne doze od 25 do 300 mg te nakon oralne primjene višekratnih doza od 25 do 100 mg dva puta na dan.
Each film-coated tablet contains 50 mg of riluzole.
Jedna filmom obložena tableta sadrži 50 mg riluzola.