FrancophonIA/ELRC3.0 huggingface dataset:
English: • Women exposed to siponimod during pregnancy are encouraged to join the pregnancy exposure programme (PRegnancy outcomes Intensive Monitoring, PRIM) that monitors outcomes of pregnancy.
Croatian: • Žene koje su izložene siponimodu za vrijeme trudnoće se potiče da se prijave u program za izložene trudnoće (PRegnancy outcomes Intensive Monitoring, PRIM) kojim se prate ishodi trudnoće.
English: In vitro investigations indicated that siponimod and its major systemic metabolites M3 and M17 do not show any clinically relevant drug-drug interaction potential at the therapeutic dose of 2 mg once daily for all investigated CYP enzymes and transporters, and do not necessitate clinical investigation.
Croatian: In vitro istraživanja ukazala su na to da siponimod i njegovi glavni sistemski metaboliti M3 i M17 ne pokazuju nikakav klinički relevantan potencijal za interakcije s lijekovima pri terapijskoj dozi od 2 mg jedanput na dan za sve ispitivane CYP enzime i prijenosnike te ne zahtijevaju kliničko istraživanje.
English: Although the majority of cases occurred within 3 to 4 months of commencing siponimod, cases were also reported in patients treated with siponimod for more than 6 months (see section 4.4).
Croatian: Iako se većina slučajeva pojavila u roku od 3 do 4 mjeseca od početka primjene siponimoda, bilo je prijavljenih slučajeva i u bolesnika liječenih siponimodom dulje od 6 mjeseci (vidjeti dio 4.4).
English: • Siponimod should be stopped at least 10 days before a pregnancy is planned.
Croatian: • Primjena siponimoda mora se prekinuti najmanje 10 dana prije nego je trudnoća planirana.
English: No interaction studies have been performed with oral contraceptives containing other progestagens, however an effect of siponimod on the efficacy of oral contraceptives is not expected.
Croatian: Nisu provedena ispitivanja interakcija s oralnim kontraceptivima koji sadrže druge progestagene, međutim, ne očekuje se učinak siponimoda na djelotvornost oralnih kontraceptiva.
English: If you forget to take Mayzent
Croatian: Ako ste zaboravili uzeti Mayzent
English: Siponimod did not exert any phototoxic or dependence potential and was not genotoxic in vitro and in vivo.
Croatian: Siponimod nije pokazao nikakav fototoksični potencijal ili potencijal za ovisnost te nije bio genotoksičan ni in vitro ni in vivo.
English: Your doctor will perform a blood or saliva test before you start treatment to determine which dose is best for you.
Croatian: Vaš liječnik će obaviti krvne pretrage ili pretrage sline prije nego započnete liječenje da bi odredio koja je doza najbolja za Vas.
English: The conduction abnormalities typically were transient, asymptomatic, resolved within 24 hours and did not require discontinuation of treatment.
Croatian: Poremećaji u provođenju obično su bili prolazni, asimptomatski, povukli su se unutar 24 sata i nisu zahtijevali prekid liječenja.
English: Your blood may also be tested before the start of treatment and periodically during treatment to check the white blood cell count.
Croatian: Vaša se krv također može testirati prije početka liječenja i povremeno tijekom liječenja radi provjere broja bijelih krvnih stanica.
English: In embryofoetal development studies conducted in rats and rabbits, siponimod induced embryotoxic effects in the absence of maternal toxicity.
Croatian: U ispitivanjima embriofetalnog razvoja provedenim u štakora i kunića, siponimod je inducirao embriotoksične učinke bez maternalne toksičnosti.
English: Starting other therapies during this interval will result in concomitant exposure to siponimod.
Croatian: Započinjanje drugih terapija tijekom tog intervala rezultirat će istodobnom izloženošću siponimodu.
English: • if you have ever had liver problems.
Croatian: • ako ste ikad imali problema s jetrom.
English: Before you start treatment, your doctor will explain the risk and ask you to do a pregnancy test to ensure that you are not pregnant.
Croatian: Prije nego započnete liječenje, liječnik će Vam objasniti rizik i zamoliti Vas da napravite test na trudnoću kako bi se provjerilo da niste trudni.
English: You must use effective contraception during treatment and up to 10 days after stopping treatment (see “Pregnancy, breast-feeding and fertility”).
Croatian: Morate upotrebljavati učinkovitu kontracepciju tijekom liječenja i još 10 dana nakon prestanka liječenja (vidjeti „Trudnoća, dojenje i plodnost“).
English: Active disease in SPMS is when there are still relapses or when MRI (magnetic resonance imaging) results show signs of inflammation.
Croatian: Aktivna bolest u SPMS-u je kad još uvijek postoje relapsi ili kad nalazi MR-a (magnetske rezonancije) pokazuju znakove upale.
English: This genotyping can be done using a Sanger sequencing method or PCR-based assay methods.
Croatian: Ova se genotipizacija može obaviti pomoću Sangerove metode sekvenciranja ili testova temeljenih na PCR-u.
English: Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy.
Croatian: Potrebno je primijeniti učinkovite dijagnostičke i terapijske pristupe u bolesnika sa simptomima infekcije dok su na terapiji.
English: Pain in extremity
Croatian: Bol u ekstremitetu
English: In clinical studies treatment was discontinued if the elevation exceeded a 3-fold increase and the patient showed symptoms related to hepatic function or if the elevation exceeded a 5-fold increase.
Croatian: U kliničkim ispitivanjima liječenje je bilo prekinuto ako su povišenja bila veća od trostrukog povećanja, a bolesnici su pokazivali simptome povezane s jetrenom funkcijom ili ako su povišenja bila veća od peterostrukog povećanja.
English: • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Extended observation (>6 hours after first dose): o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose, extend heart rate monitoring for at least 2 more hours and until the heart rate increases again.
Croatian: Produženo promatranje (>6 sati nakon prve doze): o Ako je nakon 6 sati srčana frekvencija na najnižoj vrijednosti nakon prve doze, produžiti praćenje srčane frekvencije za još najmanje 2 sata te dok se srčana frekvencija ne poveća.
English: • Have a negative pregnancy test before starting siponimod, which should be repeated at suitable intervals.
Croatian: • Imati negativan test na trudnoću prije početka uzimanja siponimoda, što je potrebno ponavljati u odgovarajućim intervalima.
English: If you do become pregnant while taking Mayzent, tell your doctor straight away.
Croatian: Ako ipak zatrudnite dok uzimate Mayzent, odmah obavijestite svog liječnika.
English: The majority of elevations occurred within 6 months of starting treatment.
Croatian: Do većine povišenja došlo je unutar 6 mjeseci od početka liječenja.
English: Siponimod has not been studied in patients aged 65 years and above.
Croatian: Siponimod se nije ispitivao u bolesnika u dobi od 65 godina i više.
English: • Irregular heartbeat (atrioventricular block)
Croatian: • Nepravilni otkucaji srca (atrioventrikularni blok)
English: Your doctor may want to perform blood tests to check your liver function before prescribing Mayzent.
Croatian: Vaš liječnik će možda zatražiti da obavite krvne pretrage da bi provjerio funkciju Vaše jetre prije nego Vam propiše Mayzent.
English: These may be symptoms of liver problems.
Croatian: To mogu biti simptomi problema s jetrom.
English: You must use effective contraception while taking Mayzent and for at least 10 days after you stop taking it to avoid becoming pregnant.
Croatian: Morate upotrebljavati učinkovitu kontracepciju dok uzimate Mayzent i još najmanje 10 dana nakon što ga prestanete uzimati da biste izbjegli trudnoću.
English: Siponimod has no or negligible influence on the ability to drive and use machines.
Croatian: Siponimod ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: You may not notice any symptoms in the early stages of macular oedema, and it can cause some of the same visual symptoms as an MS attack (optic neuritis).
Croatian: Možda nećete primijetiti nikakve simptome u ranim fazama makularnog edema, a može uzrokovati neke iste simptome s vidom kao i napadaj multiple skleroze (optički neuritis).
English: The time (Tmax) to reach maximum plasma concentrations (Cmax) after multiple oral administration of siponimod is about 4 hours (range: 2 to 12 hours).
Croatian: Vrijeme (Tmax) do postizanja maksimalnih koncentracija u plazmi (Cmax) nakon višekratne peroralne primjene siponimoda iznosi oko 4 sata (raspon: 2 do 12 sati).
English: Your doctor may want you to have an eye examination 3 or 4 months after starting treatment and possibly again later.
Croatian: Vaš liječnik će možda zatražiti da obavite pregled očiju 3 ili 4 mjeseca nakon početka liječenja te moguće i nakon toga.
English: The macular oedema generally improved or resolved spontaneously after discontinuation of treatment.
Croatian: Makularni edem općenito se popravio ili povukao spontano nakon prekida liječenja.
English: Physician's Checklist: The Physician's Checklist shall contain the following key messages:
Croatian: Kontrolni popis za liječnika: Kontrolni popis za liječnika mora sadržavati sljedeće ključne poruke:
English: • Monitor patients carefully for signs and symptoms of infections during and after treatment with siponimod:
Croatian: • Pažljivo pratite bolesnike radi uočavanja znakova i simptoma infekcija tijekom i nakon liječenja siponimodom:
English: • if you have ever had, or have, difficulties with your vision (in particular a condition called macular oedema) or an infection or inflammation of the eye (uveitis).
Croatian: • ako ste dosad imali ili imate poteškoće s vidom (pogotovo stanje koje se naziva makularni edem) ili infekciju ili upalu oka (uveitis).
English: Do not use this medicine after the expiry date which is stated on the carton/blister foil after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji/foliji blistera iza oznake „EXP“.
English: Primary efficacy endpoint:
Croatian: Primarni ishod djelotvornosti:
English: Patients with hypertension uncontrolled by medication were excluded from participation in clinical studies and special care is indicated if patients with uncontrolled hypertension are treated with siponimod.
Croatian: Bolesnici s hipertenzijom koja se ne kontrolira lijekovima bili su isključeni iz sudjelovanja u kliničkim ispitivanjima pa je indiciran poseban oprez ako se bolesnici s nekontroliranom hipertenzijom liječe siponimodom.
English: • Mayzent is contraindicated in:
Croatian: • Mayzent je kontraindiciran u:
English: During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food.
Croatian: Tijekom prvih 6 dana od početka liječenja preporučenu dnevnu dozu treba uzimati jedanput na dan ujutro s hranom ili bez nje.
English: The single-dose pharmacokinetic parameters were not different between Japanese and Caucasian healthy subjects, indicating absence of ethnic sensitivity on the pharmacokinetics of siponimod.
Croatian: Farmakokinetički parametri jednokratne doze nisu se razlikovali između zdravih Japanaca i bijelaca, što upućuje na odsutnost etničke osjetljivosti na farmakokinetiku siponimoda.
English: You should not breast-feed while you are taking Mayzent.
Croatian: Ne smijete dojiti dok uzimate Mayzent.
English: • medicines that slow down the heartbeat, such as diltiazem or verapamil (which belong to a group of medicines called calcium channel blockers), digoxin or ivabradine.
Croatian: • lijekove koji usporavaju otkucaje srca, kao što su diltiazem ili verapamil (koji pripadaju skupini lijekova zvanih blokatori kalcijevih kanala), digoksin ili ivabradin.
English: Bradyarrhythmic effects are more pronounced when siponimod is added to beta-blocker therapy.
Croatian: Bradiaritmijski učinci izraženiji su kad se siponimod dodaje terapiji beta blokatorom.
English: Average cumulative number of Gd-enhancing T1 weighted lesions (95% CI) Rate reduction
Croatian: Prosječan kumulativni broj Gd-pojačanih T1 lezija (95% CI)
English: Siponimod is eliminated from the systemic circulation mainly due to metabolism and subsequent biliary/faecal excretion.
Croatian: Siponimod se eliminira iz sistemske cirkulacije uglavnom zbog metabolizma i naknadnog izlučivanja putem žuči/stolice.
English: Most AV blocks and sinus pauses occurred above the therapeutic dose of 2 mg, with notably higher incidence under non-titrated conditions compared to dose titration conditions.
Croatian: Većina AV blokova i sinusnih pauza pojavila se iznad terapijske doze od 2 mg, sa zamjetno većom incidencijom u uvjetima bez titracije doze u usporedbi s titracijom.
English: • Convulsions, fits
Croatian: • Konvulzije, napadaji
English: One patient (with a history of depression) who took 84 mg siponimod experienced a slight elevation in liver transaminases.
Croatian: Jedan bolesnik (s depresijom u anamnezi) koji je uzeo 84 mg siponimoda imao je blago povećanje jetrenih transaminaza.
English: Due to its functional antagonism at S1P1 receptors, initial titration of siponimod successively desensitises GIRK channels until the maintenance dose is reached.
Croatian: Zbog svog funkcionalnog antagonizma na S1P1 receptorima, inicijalna titracija siponimoda uzastopno desenzibilizira GIRK kanale dok se ne postigne doza održavanja.
English: Class Ia and class III antiarrhythmic medicinal products have been associated with cases of torsades de pointes in patients with bradycardia.
Croatian: Antiaritmici klase Ia i klase III povezani su sa slučajevima torsades de pointes u bolesnika s bradikardijom.
English: The effect of siponimod on human fertility has not been evaluated.
Croatian: Učinak siponimoda na plodnost u ljudi nije bila ocjenjivana.
English: In these patients, it is recommended that an electrocardiogram (ECG) is obtained prior to dosing and at the end of the observation period.
Croatian: U tih se bolesnika preporučuje napraviti elektrokardiogram (EKG) prije doziranja te na kraju razdoblja promatranja.
English: Total and unbound AUCs were only slightly increased (by 23 to 33%) compared to healthy subjects.
Croatian: AUC-i za ukupni i nevezani siponimod bili su samo blago povišeni (za 23 do 33%) u usporedbi sa zdravim ispitanicima.
English: The differences in T2 lesion volume change and in percentage of brain volume change (average over months 12 and 24) compared to placebo were -1163 mm
Croatian: Razlike u promjeni volumena T2 lezija i u postotku promjene volumena mozga (prosijek tijekom 12 mjeseci i 24 mjeseca) u usporedbi s placebom bile su -1163 mm
English: Heart rates below 40 bpm were rarely observed.
Croatian: Srčane frekvencije ispod 40 otkucaja u minuti rijetko su bile opažene.
English: • Be using effective contraception during treatment and for at least 10 days after stopping treatment to avoid pregnancy due to the potential risk of harm to the unborn baby.
Croatian: • Koristiti učinkovitu kontracepciju tijekom liječenja i najmanje 10 dana nakon prekida liječenja radi izbjegavanja trudnoće, zbog mogućeg rizika od štetnog učinka na nerođeno dijete.
English: • Fever, sore throat and/or mouth ulcers due to infection (lymphopenia)
Croatian: • Vrućica, grlobolja i/ili čirevi u ustima zbog infekcije (limfopenija)
English: (Primary endpoint)
Croatian: (mjera primarnog ishoda)
English: If macular oedema is confirmed, your doctor may advise you to stop Mayzent treatment.
Croatian: Ako se potvrdi da je riječ o makularnom edemu, liječnik bi Vam mogao savjetovati da prekinete liječenje Mayzentom.
English: • Patients should call the doctor if a dose is missed during the first 6 days of treatment or for 4 or more consecutive days after initiating treatment with siponimod.
Croatian: • Bolesnici trebaju nazvati liječnika ako propuste dozu tijekom prvih 6 dana liječenja ili tijekom 4 ili više uzastopnih dana nakon početka liječenja siponimodom.
English: Anti-arrhythmic medicinal products, QT-prolonging medicinal products, medicinal products that may decrease heart rate
Croatian: Antiaritmici, lijekovi koji produljuju QT interval, lijekovi koji mogu smanjiti srčanu frekvenciju
English: Titration regimen
Croatian: Režim titracije
English: The immune system effects of siponimod may increase the risk of infections (see section 4.8).
Croatian: Učinci siponimoda na imunološki sustav mogu povećati rizik od infekcija (vidjeti dio 4.8).
English: • fluconazole and certain other medicines can increase the levels of Mayzent in the blood and are not recommended to be taken in combination with Mayzent.
Croatian: • flukonazol i neki drugi lijekovi mogu povećati razine Mayzenta u krvi i ne preporučuje se da se uzimaju u kombinaciji s Mayzentom.
English: The purpose of the titration phase is to reduce the risk of side effects on your heart at the start of treatment.
Croatian: Svrha faze titracije je smanjiti rizik od nuspojava povezanih sa srcem na početku liječenja.
English: Beta-blocker treatment can be initiated in patients receiving stable doses of siponimod.
Croatian: Liječenje beta blokatorom može se započeti u bolesnika koji primaju stabilne doze siponimoda.
English: Use of immunosuppressants within this period may lead to an additive effect on the immune system and therefore caution should be exercised for 3 to 4 weeks after the last dose.
Croatian: Primjena imunosupresiva tijekom ovog razdoblja može dovesti do aditivnog učinka na imunološki sustav pa je zato potreban oprez tijekom 3 do 4 tjedna nakon posljednje doze.
English: Worsening of MS after stopping Mayzent treatment Do not stop taking Mayzent or change your dose without talking to your doctor first.
Croatian: Pogoršanje MS-a nakon prestanka liječenja Mayzentom Nemojte prestati uzimati Mayzent ili promijeniti dozu a da niste prije razgovarali s liječnikom.
English: These toxicities developed at more than 30-fold higher systemic siponimod levels than the AUC-based human exposure at the maintenance dose of 2 mg/day.
Croatian: Te su se toksičnosti razvile pri više od 30-orostruko višim sistemskim razinama siponimda od izloženosti u ljudi na temelju AUC-a pri dozi održavanja od 2 mg/dan.
English: What Mayzent contains • The active substance is siponimod.
Croatian: Što Mayzent sadrži • Djelatna tvar je siponimod.
English: If you are a woman who could become pregnant, your doctor will inform you about this risk before you start treatment with Mayzent and will ask you to do a pregnancy test in order to ensure that you are not pregnant.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, liječnik će Vas obavijestiti o ovom riziku prije nego što započnete liječenje Mayzentom i zamoliti Vas da napravite test za trudnoću kako bi provjerio da niste trudni.
English: Test requires a DNA sample obtained via blood or saliva (buccal swab).
Croatian: Za test je potreban uzorak DNK dobiven iz krvi ili sline (bukalni bris).
English: Assessments of CBC are also recommended periodically during treatment.
Croatian: Također se preporučuju procjene KKS periodički tijekom liječenja.
English: - if you have severe liver problems.
Croatian: - ako imate teške probleme s jetrom.
English: Siponimod should be used with caution in the elderly due to insufficient data on safety and efficacy (see section 5.2).
Croatian: Siponimod se mora primjenjivati oprezno u starijih osoba zbog nedostatnih podataka o sigurnosti primjene i djelotvornosti (vidjeti dio 5.2).
English: If the overdose constitutes first exposure to siponimod or occurs during the dose titration phase of siponimod it is important to observe for signs and symptoms of bradycardia, which could include overnight monitoring.
Croatian: Ako prekomjerna doza predstavlja prvo izlaganje siponimodu ili se dogodi tijekom faze titracije doze siponimoda, važno je paziti na znakove i simptome bradikardije, što bi moglo uključivati praćenje preko noći.
English: These measures must be implemented before siponimod is prescribed to female patients and during treatment.
Croatian: Ove se mjere moraju provesti prije nego što siponimod bude propisan bolesnicama i tijekom liječenja.
English: Slow heart rate (bradycardia) and irregular heartbeat During the first days of treatment, Mayzent can cause the heart rate to slow down (bradycardia).
Croatian: Usporeni otkucaji srca (bradikardija) i nepravilni otkucaji srca Tijekom prvih nekoliko dana liječenja Mayzent može uzrokovati usporavanje otkucaja srca (bradikardija).
English: 64% of patients had no relapses in the 2 years prior to study entry and 76% had no gadolinium (Gd)-enhancing lesions on their baseline MRI scan.
Croatian: Ukupno 64% bolesnika nije imalo relapse u 2 godine prije uključivanja u ispitivanje, a 76% nije imalo gadolinijem (Gd) pojačane lezije na svojoj početnoj snimci MR-om.
English: Vaccinations may be less effective if administered during siponimod treatment.
Croatian: Cjepiva bi mogla biti manje učinkovita ako se primjenjuju tijekom liječenja siponimodom.
English: Poor metabolisers
Croatian: Brzi metabolizatori
English: • Caution should be exercised in elderly patients with multiple co-morbidities, or advanced disease/disability (due to possible increased risks of, for example, infections, bradyarrhythmic events during treatment initiation).
Croatian: • Potreban je oprez u starijih bolesnika s višestrukim komorbiditetima ili uznapredovalom bolešću/onesposobljenošću (zbog mogućeg povećanog rizika od, na primjer, infekcija, bradiaritmijskih događaja tijekom započinjanja liječenja).
English: Regular measurements of pulse rate and blood pressure are required and electrocardiograms should be performed (see sections 4.2 and 4.4).
Croatian: Potrebno je redovito mjeriti puls i krvni tlak te napraviti elektrokardiogram (vidjeti dijelove 4.2 i 4.4).
English: Prompt diagnostic evaluation should be performed in patients with symptoms and signs consistent with cryptococcal meningitis; appropriate treatment, if diagnosed, should be initiated.
Croatian: Potrebno je odmah provesti dijagnostičku procjenu u bolesnika sa simptomima i znakovima koji odgovaraju kriptokoknom meningitisu; ako se dijagnosticira, potrebno je započeti odgovarajuće liječenje.
English: Recent (i.e. within last 6 months) transaminase and bilirubin levels should be available before initiation of treatment with siponimod.
Croatian: Trebaju biti dostupni noviji (tj. unutar zadnjih 6 mjeseci) nalazi razina transaminaza i bilirubina prije početka liječenja siponimodom.
English: However, dizziness may occasionally occur when initiating therapy with siponimod.
Croatian: Međutim, povremeno može doći do omaglice kad se započinje terapija siponimodom.
English: • Macular oedema:
Croatian: • Makularni edem:
English: Number of patients at risk Siponimod
Croatian: Broj bolesnika pod rizikom Siponimod
English: Since siponimod reduces blood lymphocyte counts via re-distribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilised to evaluate the lymphocyte subset status of a patient treated with siponimod.
Croatian: Budući da siponimod smanjuje broj limfocita u krvi putem redistribucije u sekundarnim limfoidnim organima, broj limfocita u perifernoj krvi ne može se koristiti za evaluaciju statusa limfocitne podskupine u bolesnika liječenog siponimodom.
English: In the vast majority (90%) of SPMS patients, lymphocyte counts return to the normal range within 10 days of stopping therapy.
Croatian: U velikoj većini (90%) bolesnika oboljelih od SPMS-a, broj limfocita vraća se u normalan raspon u roku od 10 dana od obustave terapije.
English: Patients who are hypersensitive to peanut or soya should not take siponimod (see section 4.3).
Croatian: Bolesnici koji su preosjetljivi na kikiriki ili soju ne smiju uzimati siponimod (vidjeti dio 4.3).