FrancophonIA/ELRC3.0 huggingface dataset:
English: Olazax is used to treat adults with schizophrenia.
Croatian: Olazax se koristi za liječenje shizofrenije u odraslih osoba.
English: Why has Olazax been approved?
Croatian: Zašto je lijek Olazax odobren?
English: Because Olazax is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zyprexa.
Croatian: Budući da je Olazax generički lijek, ispitivanja na bolesnicima bile su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Zyprexa.
English: For more information about treatment with Olazax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.This summary was last updated in 07-2014.
Croatian: Više informacija o terapiji lijekom Olazax pročitajte u uputi lijeka (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Zyprexa, the benefit outweighs the identified risk.
Croatian: Stoga je stav Odbora kako koristi nadmašuju utvrđene rizike, kao i kod Zyprexa.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Croatian: Smatra se da se korist olanzapina uglavnom temelji na inhibiranju receptora za neurotransmitere 5-hidroksitriptamin (također poznat pod nazivom serotonin) i dopamin. budući da su ovi neurotransmiteri uključeni u shizofreniju i bipolaran poremećaj, olanzapin pomaže pri normalizaciji moždane aktivnosti smanjujući simptome ovih bolesti.
English: What is Olazax used for?
Croatian: Za što se Olazax koristi?
English: How does Olazax work?
Croatian: Kako djeluje Olazax?
English: How has Olazax been studied?
Croatian: Kako je Olazax ispitivan?
English: How is Olazax used?
Croatian: Kako se Olazax koristi?
English: Social circumstances
Croatian: Socijalne okolnosti
English: Via della Chimica, 9 36100 Vicenza Italy
Croatian: Via della Chimica, 9 36100 Vicenza Italija
English: If necessary, the concomitant use of these medicinal products should be at the lowest effective dose.
Croatian: Ako je neophodna, istodobna primjena tih lijekova mora biti u najnižoj učinkovitoj dozi.
English: None of these metabolites are pharmacologically active.
Croatian: Niti jedan od tih metabolita nije farmakološki aktivan.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Contact your doctor immediately and take the Xadago pack with you.
Croatian: Odmah se obratite svom liječniku i ponesite pakiranje lijeka Xadago sa sobom.
English: No time-dependency was observed.
Croatian: Nije uočena vremenska ovisnost.
English: Safinamide should be taken with water.
Croatian: Safinamid je potrebno uzeti s vodom.
English: Do not stop taking Xadago without first talking to your doctor.
Croatian: Nemojte prestati uzimati Xadago bez prethodnog razgovora s Vašim liječnikom.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš liječnik.
English: The terminal elimination half-life of total radioactivity was approximately 80 hours.
Croatian: Terminalni poluvijek eliminacije ukupne radioaktivnosti bio je otprilike 80 sati.
English: What Xadago is and what it is used for
Croatian: Što je Xadago i za što se koristi
English: This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
Croatian: Ta se dnevna doza može povećati na 100 mg/dan na temelju individualne kliničke potrebe.
English: Steady-state is reached within one week.
Croatian: Stanje dinamičke ravnoteže postignuto je u roku od jednog tjedna.
English: (24 weeks)
Croatian: (24 tjedna)
English: (2 years)
Croatian: (2 godine)
English: If a dose is missed the next dose should be taken at the usual time the next day.
Croatian: Ako se doza propusti, sljedeću dozu potrebno je uzeti u uobičajeno vrijeme sljedećeg dana.
English: Experience of use of safinamide in patients over 75 years of age is limited.
Croatian: Iskustvo korištenja safinamida u bolesnika starijih od 75 godina je ograničeno.
English: Xadago is not recommended for use in children and adolescents, below 18 years old due to the lack of data on safety and efficacy in this population.
Croatian: Xadago se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina zbog nedostatka podataka o sigurnosti i djelotvornosti u toj populaciji.
English: The elimination half-life of safinamide is 20-30 hours.
Croatian: Poluvijek eliminacije safinamida je 20 - 30 sati.
English: Xadago is used for the treatment of Parkinson's disease in adults.
Croatian: Xadago se koristi za liječenje Parkinsonove bolesti u odraslih.
English: Date of first authorisation: 24 February 2015 Date of latest renewal:
Croatian: Datum prvog odobrenja: 24. veljače 2015.
English: A risk for the breast-fed child cannot be excluded.
Croatian: Rizik za dojeno dijete ne može se isključiti.
English: Safinamide is eliminated mainly in the urine.
Croatian: Safinamid se eliminira uglavnom urinom.
English: Ask your doctor for advice prior to driving or using machines.
Croatian: Obratite se svom liječniku za savjet prije upravljanja vozilima i rada sa strojevima.
English: Plasma protein binding of safinamide is 88-90%.
Croatian: Vezivanje safinamida na proteine plazme je 88 - 90 %.
English: PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.
Croatian: PVC/PVDC/aluminij blister pakiranja od 14, 28, 30, 90 i 100 tableta.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Do not take Xadago - If you are allergic to safinamide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Xadago: - Ako ste alergični na safinamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Treatment with safinamide should be started at 50 mg per day.
Croatian: Liječenje safinamidom potrebno je započeti s 50 mg dnevno.
English: It acts to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson's disease.
Croatian: Ona djeluje podizanjem razine tvari koji se naziva dopamin u mozgu, koja je uključena u kontrolu pokreta a prisutna je u smanjenim količinama u mozgu bolesnika s Parkinsonovom bolešću.
English: Substance-related radioactivity was largely excreted in urine (76%) and only to a low extent in faeces (1.5%) after 192 hours.
Croatian: Radioaktivnost povezana s tvari se velikim dijelom izlučuje urinom (76%), a samo u manjoj mjeri fecesom (1,5%) nakon 192 sata.
English: Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Nuspojave su rangirane prema učestalosti korištenjem sljedećih konvencija: vrlo često (≥1/10) često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The pharmacodynamic effects of safinamide have not been assessed in children and adolescents.
Croatian: Farmakodinamički učinci safinamida nisu procijenjeni u djece i adolescenata.
English: Foot fracture
Croatian: Fraktura stopala
English: In one patient suspected of consuming more than the daily prescribed dose of 100 mg for one month, symptoms of confusion, sleepiness, forgetfulness and dilated pupils were reported.
Croatian: U jednog bolesnika za kojeg se sumnja da je konzumirao više od propisane dnevne doze od 100 mg u trajanju od jednog mjeseca, prijavljeni su simptomi konfuzije, pospanosti, zaboravnosti i proširenih zjenica.
English: There is no known antidote to safinamide or any specific treatment for safinamide overdose.
Croatian: Nema poznatog antidota za safinamid ili specifičnog liječenja za predoziranje safinamidom.
English: To what extent the nondopaminergic effects contribute to the overall effect has not been established.
Croatian: U kojoj mjeri nedopaminergički učinci doprinose ukupnom učinku nije ustanovljeno.
English: Xadago may be taken with or without food.
Croatian: Xadago se može uzimati s hranom ili bez nje.
English: The pharmacokinetics of safinamide are linear after single and repeated doses.
Croatian: Farmakokinetika safinamida je linearna nakon jedne i ponovljenih doza.
English: Studies were not stratified for co-medication, and no randomized interaction studies were performed for these medicinal products.
Croatian: Ispitivanja nisu stratificirana za prateće lijekove i nisu provedena randomizirana ispitivanja interakcije za te lijekove.
English: The volume of distribution (Vss) is approximately 165 L which is 2.5-fold of body volume indicating extensive extravascular distribution of safinamide.
Croatian: Volumen distribucije (Vss) je oko 165 l, što je 2,5 puta volumen tijela i ukazuje na opsežnu ekstravaskularnu distribuciju safinamida.
English: 95% CI p-value
Croatian: 95 % CI p-vrijednost
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: If you take more Xadago than you should
Croatian: Ako uzmete više lijeka Xadago nego što ste trebali
English: Safinamide does not appear to significantly induce or inhibit enzymes at clinically relevant systemic concentrations.
Croatian: Izgleda da safinamid značajno ne inducira i ne inhibira enzime u klinički relevantnim sistemskim koncentracijama.
English: Amidase present in blood, plasma, serum, simulated gastric fluid and simulated intestinal fluid as well as human carboxylesterases hCE-1 and hCE-2 are not responsible for the biotransformation of safinamide to NW-1153.
Croatian: Amidaza prisutna u krvi, plazmi, serumu, simuliranoj želučanoj tekućini i simuliranoj crijevnoj tekućini, kao i ljudske karboksilesteraze hCE-1 i hCE-2 nisu odgovorne za biotransformaciju safinamida u NW-1153.
English: Safinamide undergoes almost complete metabolic transformation (<10% of the administered dose was found unchanged in urine).
Croatian: Safinamid prolazi gotovo potpunu metaboličku transformaciju (<10% primijenjene doze pronađeno je nepromijenjeno u urinu).
English: What you need to know before you take Xadago
Croatian: Što morate znati prije nego počnete uzimati Xadago
English: Dyskinesia occurred early in treatment, was rated “severe”, led to discontinuation in very few patients (approx. 1.5%), and did not require reduction of dose in any patient.
Croatian: Diskinezija se javila rano u liječenju, ocijenjena je kao „teška“, dovela je do prekida liječenja u vrlo malom broju bolesnika (oko 1,5 %) i nije zahtijevala smanjenje doze kod niti jednog bolesnika.
English: The primary efficacy parameter was the change from baseline to endpoint in ‘ON Time without troublesome dyskinesia'.
Croatian: Parametar primarne djelotvornosti bio je promjena od početne vrijednosti do ishoda u „ON razdoblju bez problematične diskinezije“.
English: The effect on ON Time was maintained at the end of the 24-month double-blind treatment period for both safinamide doses as compared to placebo.
Croatian: Učinak ON razdoblja održavan je na kraju razdoblja dvostruko slijepog liječenja u trajanju od 24 mjeseca za obje doze safinamida u usporedbi s placebom.
English: Long-term studies in animals have shown convulsions (1.6 to 12.8 times human clinical exposure, based on plasma AUC).
Croatian: Dugoročna ispitivanja na životinjama pokazala su konvulzije (pri kliničkoj izloženosti 1,6 do 12,8 puta većoj od one u ljudi, na temelju AUC-a u plazmi).
English: If an important overdose occurs, safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated.
Croatian: Ako se dogodi važno predoziranje, liječenje safinamidom mora se prekinuti i potrebno je primijeniti potporno liječenje kako je klinički indicirano.
English: The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost safinamida u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: The lower dose of 50 mg/day is recommended for patients with moderate hepatic impairment.
Croatian: Niža doza od 50 mg/dan se preporučuje za bolesnike s umjerenim oštećenjem jetre.
English: - Uncontrollable jerky movements may occur or worsen when Xadago is used together with levodopa.
Croatian: - Nevoljni trzajni pokreti mogu se pojaviti ili pogoršati kada se Xadago primjenjuje zajedno s levodopom.
English: Metabolite structure elucidation revealed three metabolic pathways of safinamide.
Croatian: Rasvjetljavanje strukture metabolita otkrilo je tri metabolička puta safinamida.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of safinamide in milk (for details see 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci za životinje pokazali su izlučivanje safinamida u mlijeko (za pojedinosti vidjeti dio 5.3).
English: Safinamide may be taken with or without food.
Croatian: Safinamid se može uzeti s hranom ili bez nje.
English: The relevant plasma concentrations of safinamide are substantially lower, therefore a clinically relevant interaction with co-administered substrates of these transporters is unlikely.
Croatian: Relevantne koncentracije safinamida u plazmi su znatno manje, stoga su klinički relevantne interakcije s istovremeno primjenjivanim supstratima tih transportera malo vjerojatne.
English: The amidase FAAH was able to catalyse the formation of NW-1153 at low rates only.
Croatian: Amidaza FAAH mogla je katalizirati stvaranje NW-1153 samo u niskim stopama.
English: Safinamide is a highly selective and reversible MAO-B inhibitor causing an increase in extracellular levels of dopamine in the striatum.
Croatian: Safinamid je visoko selektivni i reverzibilni MAO-B inhibitor koji uzrokuje porast u ekstracelularnim razinama dopamina u striatumu.
English: Description of selected adverse dreactions
Croatian: Opis odabranih nuspojava
English: The expected pattern of events or symptoms following intentional or accidental overdose with Safinamide would be those related to its pharmacodynamic profile: MAO-B inhibition with activity-dependent inhibition of Na channels.
Croatian: Očekivani slijed događaja ili simptoma nakon namjernog ili slučajnog predoziranja safinamidom bio bi povezan s njegovim farmakodinamičkim profilom: MAO-B inhibicija s inhibicijom ovisnom o aktivnosti Na+ kanala.
English: Therefore, other amidases are likely to be involved in the conversion to NW-1153.
Croatian: Stoga, druge amidaze su vjerojatno uključene u pretvorbu u NW-1153.
English: In human liver microsomes (HLM), the N-dealkylation step appears to be catalysed by CYP3A4, as safinamide clearance in HLM was inhibited by ketoconazole by 90%.
Croatian: U ljudskim mikrosomima jetre (engl. human liver microsomes, HLM), čini se da je korak N-dealkilacije kataliziran s CYP3A4, jer je klirens safinamida u HLM-u inhibiran ketokonazolom za 90 %.
English: Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD03.
Croatian: Farmakoterapijska skupina: Antiparkinsonici, inhibitori monoaminooksidaze B, ATK oznaka: N04BD03
English: Elderly No change in dose is required for elderly patients.
Croatian: Nije potrebna promjena doze u starijih bolesnika.
English: Safinamide did not present genotoxic potential in in vivo and in several in vitro systems using bacteria or mammalian cells.
Croatian: Safinamid nije pokazao genotoksični potencijal ni u in vivo ni u nekoliko in vitro sustava koji koriste bakterije ili stanice sisavaca.
English: Animal studies indicate that safinamide treatment is associated with adverse reactions on female rat reproductive performance and sperm quality.
Croatian: Ispitivanja na životinjama ukazuju da je liječenje safinamidom povezano s nuspojavama koje se odnose na reproduktivnu sposobnost ženki štakora i kvalitetu sperme.
English: Absolute bioavailability is high (95%), showing that safinamide is almost completely absorbed after oral administration and first pass metabolism is negligible.
Croatian: Apsolutna bioraspoloživost je visoka (95%), što pokazuje da se safinamid gotovo u potpunosti apsorbira nakon peroralne primjene i metabolizam prvog prolaza je zanemariv.
English: Change LSM (SE)
Croatian: Promjena LSM (SE) -0,8
English: Therefore, caution is necessary when safinamide is taken concomitantly with medicinal products that are OCT1 substrates and have a tmax similar to safinamide (2 hours) (e.g. metformin, aciclovir, ganciclovir) as exposure to these substrates might be increased as a consequence.
Croatian: Stoga je potreban oprez kada se safinamid uzima istodobno s lijekovima koji su supstrati OCT1 i imaju Tmax sličan safinamidu (2 sata) (npr. metformin, aciklovir, ganciklovir) budući da se posljedično može povećati izloženost tim supstratima.
English: Skip the missed dose and take the next dose at the time you normally take it.
Croatian: Preskočite propuštenu dozu i uzmite sljedeću dozu po redovitom rasporedu, u vrijeme kada ju uobičajeno uzimate.
English: Toxic effects on the liver and accompanying symptoms as yellow/orange skin and skull, in pups exposed to safinamide during lactation are mediated mainly via in utero exposure, whereas exposure via the mother's milk had only a minor influence.
Croatian: Toksični učinci na jetru i prateći simptomi kao žuta/narančasta koža i lubanja, u mladunaca izloženih safinamidu tijekom dojenja posredovani su uglavnom izloženošću in utero, dok je izloženost preko majčinog mlijeka imala samo manji utjecaj.
English: This potential increase is most likely of no clinical relevance as NW-1153, the first product in the metabolic pathway, is further transformed to secondary and tertiary metabolites.
Croatian: Taj mogući rast najvjerojatnije nije od kliničke važnosti, jer NW-1153, prvi produkt u metaboličkom putu, dalje se transformira u sekundarne i tercijarne metabolite.
English: At concentrations of 50µM, safinamide inhibited OATP1A2 and OATP2P1.
Croatian: Pri koncentracijama od 50μM, safinamid je inhibirao OATP1A2 i OATP2P1.
English: Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Croatian: Poremećaji kontrole impulsa mogu se pojaviti u bolesnika liječenih agonistima dopamina i/ili dopaminergičkim lijekovima.
English: In general, safinamide may be used with selective serotonin re-uptake inhibitors (SSRIs) at the lowest effective dose, with caution for serotoninergic symptoms.
Croatian: Općenito, safinamid se može primjenjivati sa selektivnim inhibitorima ponovne pohrane serotonina (engl. selective serotonin re-uptake inhibitors, SSRI) u najnižoj učinkovitoj dozi, uz oprez za serotoninergičke simptome.
English: Safinamide must not be administered along with other MAO inhibitors (including moclobemide) as there may be a risk of non-selective MAO inhibition that may lead to a hypertensive crisis (see section 4.3).
Croatian: Safinamid se ne smije primjenjivati zajedno s drugim MAO inhibitorima (uključujući moklobemid), jer može postojati rizik od neselektivne MAO inhibicije koja može dovesti do hipertenzivne krize (vidjeti dio 4.3).
English: Somnolence and dizziness may occur during safinamide treatment, therefore patients should be cautioned about using hazardous machines, including motor vehicles, until they are reasonably certain that safinamide does not affect them adversely.
Croatian: Tijekom liječenja safinamodom može doći do pojave somnolencije i omaglice, stoga je bolesnike potrebno upozoriti na oprez pri upravljanju opasnim strojevima uključujući motorna vozila, sve dok nisu razumno sigurni da safinamid ne utječe štetno na njih.
English: This effect was not seen when safinamide was used as an adjunct to dopamine agonists in early stage PD patients.
Croatian: Taj učinak nije uočen kada je safinamid primijenjen kao dodatna terapija uz agoniste dopamina u bolesnika u ranom stadiju PB-a.
English: Moderate or severe renal impairment did not alter the exposure to safinamide, compared to healthy subjects (see section 4.2).
Croatian: Umjereno ili teško oštećenje bubrega nije promijenilo izloženost safinamidu u usporedbi sa zdravim ispitanicima (vidjeti dio 4.2).
English: Other medicines and Xadago
Croatian: Drugi lijekovi i Xadago
English: Transporters
Croatian: Transporteri
English: Safinamide absorption is rapid after single and multiple oral dosing, reaching Tmax in the time range 1.82.8 h after dosing under fasting conditions.
Croatian: Apsorpcija safinamida je brza nakon jednog i više peroralnih doziranja, dostižući Tmax u rasponu vremena od 1,8 - 2,8 h nakon doziranja natašte.
English: In vitro experiments indicated that inhibition of amidases in human hepatocytes led to complete suppression of the NW-1153 formation.
Croatian: In vitro eksperimenti pokazuju da je inhibicija amidaza u humanih hepatocita dovela do potpunog potiskivanja stvaranja NW-1153.
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari (vidjeti dio 6.1).
English: The systemic exposure of NW-1153 is low (1/10 of parent safinamide).
Croatian: Sistemska izloženost NW-1153 je niska (1/10 ishodišnog safinamida).
English: In view of the selective and reversible MAO-B inhibitory activity of safinamide, antidepressants may be administered but used at the lowest doses necessary.
Croatian: S obzirom na selektivnu i reverzibilnu MAO-B inhibicijsku aktivnost safinamida, antidepresivi se mogu primijeniti, ali u najnižoj potrebnoj dozi.
English: NW-1153 is not an inhibitor of OCT2, MATE1, or MATE2-K up to concentrations of 5µM.
Croatian: NW-1153 nije inhibitor OCT2, MATE1 ili MATE2-K do koncentracije od 5 µM.
English: Liver hypertrophy and fatty changes were seen only in rodent livers at exposures similar to humans.
Croatian: Hipertrofija jetre i masne promjene uočene su samo u jetri glodavaca pri izloženosti sličnoj onoj u ljudi.
English: D- 73614 Schorndorf Germany
Croatian: D- 73614 Schorndorf, Njemačka
English: The high absorption classifies safinamide as a highly permeable substance.
Croatian: Visoka apsorpcija klasificira safinamid kao visoko propusnu tvar.
English: Both the SETTLE and 016/018 studies indicated significant superiority of safinamide, compared to placebo, at the target doses of 50 and 100 mg/day for the primary, and selected secondary, efficacy variables, as summarized in the table below.
Croatian: Oba ispitivanja, i SETTLE i 016/018, pokazala su značajnu superiornost safinamida u usporedbi s placebom, u ciljanim dozama od 50 i 100 mg/dan za primarnu i odabranu sekundarnu varijablu djelotvornosti, kako je sažeto u tablici u nastavku.
English: Safinamide's metabolism is not dependent on Cytochrome P450 (CYP) based enzymes.
Croatian: Metabolizam safinamida ne ovisi o enzimima citokroma P450 (CYP).
English: Phospholipidosis was seen mainly in the lungs in rodents (at exposures similar to humans) and monkeys (at exposures greater than 12 fold higher than human).
Croatian: Fosfolipidi su uglavnom uočeni u plućima glodavaca (pri izloženostima sličnima izloženosti u ljudi) i u majmuna (pri izloženostima 12 puta većima od one u ljudi).