FrancophonIA/ELRC3.0 huggingface dataset:
English: Mayzent can cause a swelling in the macula (the area of the eye that enables you to see shapes, colours and details) known as macular oedema.
Croatian: Mayzent može uzrokovati oticanje makule (područja oka koje Vam omogućuje da vidite oblike, boje i detalje), poznato kao makularni edem.
English: What Mayzent is and what it is used for What you need to know before you take Mayzent How to take Mayzent
Croatian: Što je Mayzent i za što se koristi Što morate znati prije nego počnete uzimati Mayzent Kako uzimati Mayzent
English: • if you are planning to have any vaccinations.
Croatian: • ako planirate primiti bilo koje cjepivo.
English: • Counsel the patient in case of inadvertent pregnancy.
Croatian: • Savjetujte bolesnicu u slučaju nenamjerne trudnoće.
English: Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body.
Croatian: Ni dijaliza ni izmjena plazme ne bi rezultirali znatnim uklanjanjem siponimoda iz tijela.
English: If Mayzent is used during pregnancy, there is a risk of harm to the unborn baby.
Croatian: Ako se Mayzent uzima tijekom trudnoće, postoji rizik da će naškoditi nerođenom djetetu.
English: • high blood pressure (hypertension), sometimes with symptoms such as headache and dizziness
Croatian: • visoki krvni tlak (hipertenzija), ponekad sa simptomima poput glavobolje i omaglice
English: In addition, the corresponding frequency category for each adverse drug reaction is based on 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).
Croatian: Uz to, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji: 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).
English: • Potential long-term safety implications in CYP2C9 poor metabolisers:
Croatian: • Moguće dugoročne sigurnosne implikacije kod sporih metabolizatora CYP2C9:
English: • involuntary shaking of the body (tremor)
Croatian: • nevoljno drhtanje tijela (tremor)
English: • Before starting treatment patients should provide a recent complete blood count.
Croatian: • Prije početka liječenja bolesnici trebaju donijeti nedavno učinjenu kompletnu krvnu sliku.
English: Siponimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
Croatian: Siponimod se općenito može započeti odmah nakon prestanka uzimanja beta interferona ili glatirameracetata.
English: Siponimod absorption is extensive (≥70%, based on the amount of radioactivity excreted in urine and the amount of metabolites in faeces extrapolated to infinity).
Croatian: Apsorpcija siponimoda je ekstenzivna (≥70%, na temelju količine radioaktivnosti izlučene u urinu i količine metabolita u stolici ekstrapolirane u beskonačnost).
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA42
Croatian: Farmakoterapijska skupina: Imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA42
English: • if you have an infection or if your immune system does not work properly (for example due to a disease or to medicines that suppress the immune system; see also “Other medicines and Mayzent”).
Croatian: • ako imate infekciju ili Vaš imunološki sustav ne funkcionira kako bi trebao (na primjer, zbog bolesti ili lijekova koji oslabljuju imunološki sustav; vidjeti također „Drugi lijekovi i Mayzent“).
English: Women of childbearing potential/Contraception in females
Croatian: Žene reproduktivne dobi / Kontracepcija u žena
English: At least overnight extended monitoring is recommended.
Croatian: Preporučuje se praćenje barem preko noći.
English: Potential of other medicinal products to affect siponimod pharmacokinetics
Croatian: Potencijal drugih lijekova da utječu na farmakokinetiku siponimoda
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Atrioventricular conduction
Croatian: Atrioventrikularno provođenje
English: A significant reduction of siponimod exposure (by up to 76% and 51%, respectively) is expected under these conditions according to evaluation of the drug interaction potential using PBPK modelling.
Croatian: Očekuje se značajno smanjenje izloženosti siponimodu (za do 76% odnosno 51%) pod ovim uvjetima prema evaluaciji potencijala za interakciju lijekova korištenjem PBPK modeliranja.
English: Concomitant use of these substances during treatment initiation may be associated with severe bradycardia and heart block.
Croatian: Istodobna primjena tih tvari tijekom započinjanja liječenja može biti povezana s teškom bradikardijom i srčanim blokom.
English: The absolute oral bioavailability of siponimod is approximately 84%.
Croatian: Apsolutna oralna bioraspoloživost siponimoda iznosi otprilike 84%.
English: • swollen hands, ankles, legs or feet (peripheral oedema)
Croatian: • oticanje šaka, gležnjeva, nogu ili stopala (periferni edem)
English: In rare cases, the test result may indicate that you should not take Mayzent.
Croatian: U rijetkim slučajevima nalazi pretraga mogu ukazivati na to da ne biste smjeli uzimati Mayzent.
English: The MAH shall ensure that in each Member State (MS) where Mayzent is marketed, all physicians who intend to prescribe Mayzent are provided with an updated Physician Education Pack, including:
Croatian: Nositelj odobrenja dužan je osigurati da u svakoj državi članici u kojoj je Mayzent na tržištu, svi liječnici koji namjeravaju propisivati Mayzent imaju ažuriran Edukacijski paket za liječnike, koji uključuje:
English: During and for up to 4 weeks after treatment with siponimod vaccinations may be less effective.
Croatian: Tijekom i do 4 tjedna nakon liječenja siponimodom cjepiva mogu biti manje učinkovita.
English: This reduces the recirculation of T cells into the central nervous system (CNS) to limit central inflammation.
Croatian: To smanjuje recirkulaciju T-stanica u središnji živčani sustav (SŽS) kako bi se ograničila središnja upala.
English: Annualised relapse rate (ARR) Rate reduction
Croatian: Anualizirana stopa relapsa (ARR) Smanjenje stope
English: Laboratory tests involving the use of circulating mononuclear cells require larger blood volumes due to reduction in the number of circulating lymphocytes.
Croatian: Laboratorijski testovi koji uključuju uporabu cirkulirajućih mononuklearnih stanica zahtijevaju veće volumene krvi zbog smanjenja broja cirkulirajućih limfocita.
English: On the first 6 days of treatment, it is recommended that you take the tablets in the morning with or without food.
Croatian: Prvih 6 dana liječenja preporučuje se da tablete uzimate ujutro s hranom ili bez nje.
English: Clinical studies included patients up to the age of 61 years.
Croatian: Klinička ispitivanja su uključivala bolesnike do dobi od 61 godine.
English: Discontinue treatment if significant liver injury is confirmed.
Croatian: Prekinite primjenu ako se potvrdi značajno oštećenje jetre.
English: A very rare brain infection called progressive multifocal leukoencephalopathy (PML) can cause symptoms similar to SPMS.
Croatian: Vrlo rijetka infekcija mozga zvana progresivna multifokalna leukoencefalopatija (PML) može izazvati simptome slične SPMS-u.
English: Siponimod is distributed to body tissues with a moderate mean volume of distribution of 124 litres.
Croatian: Siponimod se distribuira u tkiva s umjerenim srednjim volumenom distribucije od 124 litre.
English: Mayzent may pass into breast milk and there is a risk of serious side effects for the baby.
Croatian: Mayzent može prijeći u majčino mlijeko i postoji rizik od ozbiljnih nuspojava za dijete.
English: • After stopping treatment with Mayzent, patients should inform their doctor immediately if their disease symptoms are getting worse (e.g. weakness or visual changes) or if they notice any new symptoms.
Croatian: • Nakon prestanka liječenja Mayzentom, bolesnici trebaju odmah obavijestiti svog liječnika ako se njihovi simptomi bolesti pogoršavaju (npr. slabost ili promjene vida) ili ako uoče bilo kakav novi simptom.
English: Treatment dose The recommended dose is 2 mg once daily (one tablet of 2 mg Mayzent) with or without food.
Croatian: Doza liječenja Preporučena doza je 2 mg jedanput na dan (jedna tableta Mayzenta od 2 mg) s hranom ili bez nje.
English: • There is an increased risk of infections including serious infections, in patients treated with siponimod.
Croatian: • Postoji povećani rizik od infekcija uključujući ozbiljne infekcije, u bolesnika liječenih siponimodom.
English: If you have taken too many Mayzent tablets, or if you take your first tablet from the treatment dose pack instead of the titration pack by mistake, call your doctor straight away.
Croatian: Ako ste uzeli previše Mayzent tableta ili ako zabunom uzmete svoju prvu tabletu iz pakiranja s redovitom dozom liječenja umjesto iz pakiranja za titraciju, odmah obavijestite svog liječnika.
English: The effects of therapeutic (2 mg) and supratherapeutic (10 mg) doses of siponimod on cardiac repolarisation were investigated in a thorough QT study.
Croatian: Učinci terapijskih (2 mg) i supraterapijskih (10 mg) doza siponimoda na srčanu repolarizaciju bili su istraživani u temeljitom ispitivanju QT-a.
English: Low lymphocyte counts are maintained with daily dosing.
Croatian: Niski broj limfocita održava se uz svakodnevno doziranje.
English: Your doctor may need to stop or reduce your Mayzent dose if the white blood cell count is too low.
Croatian: Liječnik će možda morati prekinuti ili smanjiti Vašu dozu Mayzenta ako je broj bijelih krvnih stanica prenizak.
English: Advise women of potential serious risks to the foetus if siponimod is used during pregnancy or if the patient becomes pregnant while taking it.
Croatian: Savjetujte žene o potencijalnim ozbiljnim rizicima za fetus ako se siponimod uzima tijekom trudnoće ili ako bolesnica zatrudni dok ga uzima.
English: Your doctor may instruct you to take only 1 mg once daily (four 0.25 mg tablets) if the blood test performed before the start of treatment showed that your body breaks down Mayzent slowly (see “Tests before and during treatment”).
Croatian: Liječnik Vas može uputiti da uzimate samo 1 mg jedanput na dan (četiri tablete od 0,25 mg) ako su krvne pretrage koje su obavljene prije početka liječenja pokazale da Vaše tijelo sporo razgrađuje Mayzent (vidjeti „Pretrage prije i tijekom liječenja“).
English: Potential to prolong the QT interval
Croatian: Potencijal produljenja QT intervala
English: This reduces nerve damage caused by SPMS and as a result Mayzent helps to slow down the effects of the disease activity (such as worsening disability, brain lesions and relapses).
Croatian: To smanjuje oštećenje živaca uzrokovano SPMS-om i Mayzent tako pomaže usporiti učinke aktivnosti bolesti (poput pogoršanja onesposobljenosti, lezija u mozgu i ponovnih vraćanja bolesti).
English: It can occur in patients taking medicines like Mayzent and other medicines used for treating MS.
Croatian: Može se javiti u bolesnika koji uzimaju lijekove poput Mayzenta i druge lijekove koji se koriste za liječenje MS-a.
English: From Cox modelling for time to progression
Croatian: Iz Coxovog modeliranja za vrijeme do progresije Iz modela za rekurentne događaje
English: The pharmacological activity of the main metabolites M3 and M17 is not expected to contribute to the clinical effect and the safety of siponimod in humans.
Croatian: Ne očekuje se da će farmakološka aktivnost glavnih metabolita M3 i M17 doprinijeti kliničkom učinku i sigurnosti siponimoda u ljudi.
English: Results from population pharmacokinetics suggest that dose adjustment is not necessary in elderly patients (age 65 years and above).
Croatian: Rezultati populacijske farmakokinetike ukazuju na to da nije potrebna prilagodba doze u starijih bolesnika (u dobi od 65 i više godina).
English: Protein binding of siponimod is >99.9% in healthy subjects and in patients with hepatic or renal impairment.
Croatian: Vezanje siponimoda za proteine iznosi >99,9% u zdravih ispitanika i u bolesnika s oštećenjem jetre ili bubrega.
English: If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Croatian: Ako se propusti doza, propisanu dozu potrebno je uzeti kada je sljedeća doza i planirana; sljedeća doza ne smije se udvostručavati.
English: After siponimod therapy has been stopped, siponimod remains in the blood for up to 10 days.
Croatian: Nakon prekida terapije siponimodom, siponimod ostaje u krvi do 10 dana.
English: - if you are pregnant or could become pregnant and are not using effective contraception.
Croatian: - ako ste trudni ili biste mogli zatrudnjeti a ne upotrebljavate učinkovitu kontracepciju.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with siponimod in one or more subsets of the paediatric population in the treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka siponimod u jednoj ili više podskupina pedijatrijske populacije u liječenju multiple skleroze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Your doctor may decide not to prescribe Mayzent because it could intensify the effect on irregular heartbeat.
Croatian: Liječnik može odlučiti da Vam neće propisati Mayzent jer on može pojačati učinak na nepravilne otkucaje srca.
English: Your chance of developing macular oedema is higher if you have had it before or if you have ever had uveitis (an inflammation of the eye).
Croatian: Mogućnost da će se kod Vas razviti makularni edem veća je ako ste ga dosad imali ili ako ste ikad imali uveitis (upalu oka).
English: Patients should be instructed to report symptoms of infection to their physician promptly.
Croatian: Bolesnike je potrebno uputiti da odmah prijave simptome infekcije svom liječniku.
English: The need for observation (including an ECG monitoring) for 6 hours in a clinic after the first dose of siponimod on day 1, if the patient has heart problems.
Croatian: Potreba za promatranjem (uključujući praćenje EKG-a) tijekom 6 sati u klinici nakon prve doze siponomida 1. dana, ako bolesnik ima srčane tegobe.
English: • While on treatment, women must not become pregnant.
Croatian: • Za vrijeme liječenja žena ne smije zatrudnjeti.
English: Despite a delay in Tmax to 8 hours after a single dose, food intake had no effect on the systemic exposure of siponimod (Cmax and AUC), therefore siponimod may be taken without regard to meals (see section 4.2).
Croatian: Usprkos odgodi Tmax na 8 sati nakon jednokratne doze, unos hrane nije imao učinka na sistemsku izloženost siponimodu (Cmax i AUC) pa se siponimod može uzimati bez obzira na obroke (vidjeti dio 4.2).
English: Look out for the following while taking Mayzent If you get any of the following while taking Mayzent, tell your doctor immediately because it could be serious:
Croatian: Obratite pažnju na sljedeće dok uzimate Mayzent Ako primijetite bilo što od sljedećeg dok uzimate Mayzent, odmah obavijestite svog liječnika jer bi to moglo biti ozbiljno:
English: Missed dose(s) during treatment initiation
Croatian: Propuštena(e) doza(e) tijekom početka liječenja
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKOM OKOM
English: Siponimod had no effect on male reproductive organs in rats and monkeys or on fertility parameters in rats.
Croatian: Siponimod nije imao nikakav učinak na muške reproduktivne organe u štakora i majmuna ili na parametre plodnosti u štakora.
English: - if, in the last 6 months, you have had a heart attack, unstable angina, stroke or certain types of heart failure.
Croatian: - ako ste u zadnjih 6 mjeseci imali srčani udar, nestabilnu anginu, moždani udar ili neke vrste zatajenja srca.
English: Your doctor will decide to stop treatment (see “If you stop taking Mayzent” in section 3).
Croatian: Liječnik će odlučiti prekinuti liječenje (vidjeti „Ako prestanete uzimati Mayzent“ u dijelu 3).
English: • if you have changes in your vision, for example if the centre of your vision becomes blurred or has shadows, a blind spot develops in the centre of your vision, or you have problems seeing colours or fine detail.
Croatian: • ako imate promjene vida, na primjer, ako središte Vašeg vidnog polja postane mutno ili ima sjene, ako se razvije slijepa točka u središtu Vašega vidnog polja ili imate problema s razabiranjem boja ili sitnijih detalja.
English: There is no specific antidote to siponimod available.
Croatian: Nema specifičnog antidota za siponimod.
English: Table 1 Dose titration regimen to reach maintenance dosage
Croatian: Tablica 1 Režim titracije doze radi postizanja doze održavanja
English: The most common adverse drug reactions are headache (15%) and hypertension (12.6%).
Croatian: Sažetak sigurnosnog profila Najčešće nuspojave su glavobolja (15%) i hipertenzija (12,6%).
English: What you need to know before you take Mayzent
Croatian: Što morate znati prije nego počnete uzimati Mayzent
English: • if you could become pregnant, because siponimod can harm the unborn baby when used during pregnancy.
Croatian: • ako biste mogli zatrudnjeti, zato što siponimod može naškoditi nerođenom djetetu kad se uzima tijekom trudnoće.
English: Siponimod should not be used during breast-feeding.
Croatian: Siponimod se ne smije koristiti tijekom dojenja.
English: White blood cells fight infection, so you may get infections more easily while you are taking Mayzent (and up to 3 to 4 weeks after you stop taking it).
Croatian: Bijele krvne stanice bore se protiv infekcije pa biste lakše mogli dobiti infekcije dok uzimate Mayzent (i 3 do 4 tjedna nakon što ga prestanete uzimati).
English: Mayzent is used to treat adults with secondary progressive multiple sclerosis (SPMS) with active disease.
Croatian: Mayzent se koristi za liječenje odraslih osoba sa sekundarno progresivnom multiplom sklerozom (SPMS) s aktivnom bolešću.
English: If it is almost time for your next dose, skip the missed dose and continue as usual.
Croatian: Ako je uskoro vrijeme za Vašu sljedeću dozu, preskočite propuštenu dozu i nastavite prema uobičajenom rasporedu.
English: • What Mayzent is and how it works.
Croatian: • Što je Mayzent i kako djeluje.
English: Your doctor may monitor you closely at the start of treatment if you are at risk of your heartbeat becoming slower or irregular.
Croatian: Liječnik Vas može pažljivo pratiti na početku liječenja ako ste pod rizikom od usporavanja ili nepravilnih otkucaja srca.
English: If anything indicates that you may be at higher risk of suffering from these effects, your doctor may decide to monitor you more closely at the start of treatment, refer you first to a heart specialist (cardiologist), or choose not to give you Mayzent.
Croatian: Ako bilo što bude upućivalo na to da biste mogli biti pod većim rizikom od ovih nuspojava, Vaš će liječnik možda odlučiti pažljivije Vas pratiti na početku liječenja, uputiti Vas najprije specijalistu za srce (kardiologu) ili će možda odlučiti da Vam neće dati Mayzent.
English: A slight trend of reduced FEV1 was detected at non-therapeutic single doses (>10 mg).
Croatian: Blagi trend smanjenog FEV1 bio je primijećen pri neterapijskim jednokratnim dozama (>10 mg).
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: The effect persisted with continued treatment.
Croatian: Učinak se održao s nastavakom liječenja.
English: The atrioventricular conduction delays manifested in most of the cases as first-degree atrioventricular (AV) blocks (prolonged PR interval on electrocardiogram).
Croatian: Odgode u atrioventrikularnom provođenju očitovale su se u većini slučajeva kao atrioventrikularni (AV) blokovi prvog stupnja (produljeni PR interval na elektrokardiogramu).
English: These may be symptoms of a condition called posterior reversible encephalopathy syndrome (PRES).
Croatian: To mogu biti simptomi stanja koje se naziva sindrom posteriorne reverzibilne encefalopatije (PRES).
English: Cases of herpes viral infection (including one case of reactivation of varicella zoster virus [VZV] infection leading to varicella zoster meningitis) have been reported in the siponimod development programme.
Croatian: Prijavljeni su slučajevi herpes virusne infekcije (uključujući jedan slučaj reaktivacije infekcije varicella zoster virusom [VZV] koja je dovela do varicella zoster meningitisa) u programu razvoja siponimoda.
English: In monkeys, effects on muscle and skin were additionally observed.
Croatian: U majmuna je dodatno uočen učinak na mišiće i kožu.
English: • Pack containing 120 tablets
Croatian: • Pakiranje koje sadrži 120 tableta
English: During the first 6 days of treatment, if you have forgotten to take your dose on one day, call your doctor before you take the next dose.
Croatian: Tijekom prvih 6 dana liječenja, ako ste zaboravili jedan dan uzeti svoju dozu, obavijestite svog liječnika prije nego što uzmete sljedeću dozu.
English: Do not use Mayzent during pregnancy, if you are trying to become pregnant or if you are a woman who could become pregnant and you are not using effective contraception.
Croatian: Nemojte uzimati Mayzent tijekom trudnoće, ako pokušavate zatrudnjeti ili ako ste žena koja može zatrudnjeti a ne upotrebljavate učinkovitu kontracepciju.
English: Siponimod and its metabolites are excreted in the milk of rats.
Croatian: Siponimod i njegovi metaboliti izlučuju se u mlijeko štakora.
English: Do not take Mayzent - if you are allergic to siponimod, peanut, soya or any of the other ingredients of this medicine
Croatian: Nemojte uzimati Mayzent - ako ste alergični na siponimod, kikiriki, soju ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Gender Results from population pharmacokinetics suggest that gender-based dose adjustment is not necessary.
Croatian: Spol Rezultati populacijske farmakokinetike upućuju da nije potrebna prilagodba doze na osnovu spola.
English: The apparent elimination half-life of siponimod is approximately 30 hours.
Croatian: Prividni poluvijek eliminacije siponimoda iznosi otprilike 30 sati.
English: o Appropriate management should be initiated and observation continued until the symptoms/findings have resolved if the following events are observed: a.
Croatian: . o Potrebno je započeti odgovarajuće zbrinjavanje i nastaviti promatranje dok se simptomi/nalazi ne povuku ako se opaze sljedeći događaji: a.
English: These may be symptoms of a type of meningitis caused by a fungal infection (cryptococcal meningitis).
Croatian: To mogu biti simptomi jednog oblika meningitisa uzrokovanog gljivičnom infekcijom (kriptokokni meningitis).
English: Some patients presented with blurred vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmological examination.
Croatian: Neki su bolesnici imali zamagljeni vid ili smanjenu vidnu oštrinu, ali drugi su bili asimptomatski i dijagnoza im se postavila na rutinskom oftalmološkom pregledu.
English: If any of the above applies to you, tell your doctor before taking Mayzent.
Croatian: Ako bilo što od navedenoga vrijedi za Vas, obavijestite svog liječnika prije nego uzmete Mayzent.
English: • blood test results showing increased liver enzyme levels
Croatian: • nalazi krvnih pretraga koji pokazuju povišene razine jetrenih enzima
English: In addition, clinical experience with another sphingosine-1-phosphate receptor modulator indicated a 2-fold higher risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population.
Croatian: Uz to, kliničko iskustvo s drugim modulatorom sfingozin 1-fosfat receptora ukazalo je na dvostruko veći rizik od velikih kongenitalnih malformacija kad se primjenjuje tijekom trudnoće, u usporedbi sa stopom opaženom u općoj populaciji.